**National All Schedules Prescription Electronic Reporting Act of 2005:
A Review of Implementation of Existing State Controlled Substance
Monitoring Programs**

**Center for Substance Abuse Treatment**

**Substance Abuse and Mental Health Services Administration**

**U.S. Department of Health and Human Services**

**[Acknowledgements]{.smallcaps}**

Numerous people contributed to the development of this report (see
Appendix J). This report was produced by DB Consulting Group, Inc. (DB)
and JBS International, Inc. (JBS) under the Center for Substance Abuse
Treatment (CSAT) contract number 270-05-0109 (Substance Abuse and Mental
Health Services Administration, U.S. Department of Health and Human
Services).

Anton C. Bizzell, M.D., served as the CSAT Government Project Officer,
Fred Carlini, Sharon Dow, M.S., and Douglas Rugh, Ph.D., served as DB
Project Directors, Bonnie Wilford, M.S., served as JBS Project Director.
Other DB personnel who contributed to this report included Richard
Offner, Ph.D. Other JBS personnel included Ellen Dreyer, R.N., Mary A.
Kelly, M.S.L.S., Erika Olsen, M.A., and Manu Singh, Ph.D.

The authors acknowledge with gratitude the input and advice provided by
outside reviewers. However, the appearance of their names does not
necessarily indicate that they have endorsed the findings and
conclusions appearing in this report, for which the authors assume sole
responsibility. A list of outside reviewers is listed in Appendix J.

**[Originating Office]{.smallcaps}**

Division of Pharmacologic Therapies

Center for Substance Abuse Treatment

Substance Abuse and Mental Health Services Administration

1 Choke Cherry Road

Rockville, MD 20857

**TABLE OF CONTENTS**

**Executive Summary 1**

**Introduction 4**

**Overview and Context 6**

**Assessment 17**

Assessment
Findings..................................................................................
17

Access to Pain Treatment 18

Addiction Treatment 25

Pediatric Care 25

Research and Clinical Trials 25

Summary of
Findings....................................................................................
25

Conclusions 29

Lessons Learned from the Assessment 29

Key Informant Suggestions 31

**References 33**

**Appendices 44**

**[Executive Summary]{.smallcaps}**

**[Introduction]{.smallcaps}**

The report presents the findings of an assessment of existing State
Controlled Substance Monitoring Programs (CSMPs) and other information
related to the National All Schedules Prescription Electronic Reporting
Act of 2005 (NASPER; Public Law 109-60), which provides for the
establishment of a CSMP in each State.

The non-medical use of prescription psychotherapeutic drugs in the
United States has become a matter of increasing concern in recent years.
According to the Substance Abuse and Mental Health Services
Administration's (SAMHSA) 2005 National Survey on Drug Use and Health
(NSDUH), an estimated 15.2 million persons aged 12 or older (6.2 percent
of all persons in that age group) used prescription-type
psychotherapeutic drugs non-medically in the past 12 months. In 2005,
there were 6.4 million (2.6 percent) persons aged 12 or older who used
prescription-type psychotherapeutic drugs non-medically in the past
month. Of these, 4.7 million used pain relievers, 1.8 million used
tranquilizers, 1.1 million used stimulants (including 512,000
methamphetamine users), and 272,000 used sedatives.

Furthermore, the 2005 NSDUH found that 4.9 million young adults aged 18
to 25 (12.4 percent) used prescription pain relievers (analgesics) such
as OxyContin® non-medically; in addition, 1.7 percent of the young
adults met the criteria for dependence or abuse of prescription pain
relievers in the past year. In 2005, the most common source from which
recently used drugs were obtained among non-medical users of
prescription-type drugs was "from a friend or relative for free."

States began to address the issue of prescription misuse and abuse more
than 60 years ago by creating programs to monitor the dispensing of
prescription drugs. By the 1980s, 10 States had adopted CSMPs, but they
were quite diverse in features. These early programs required physicians
to use special multiple-copy, two- or three-part prescription order
forms.

Beginning in fiscal year 2002, Congress appropriated funding to the U.S.
Department of Justice to support the Harold Rogers Prescription Drug
Monitoring Program (U.S. Department of Justice Appropriations Act;
Public Law 107-77). The purpose of the program is to enhance the
capacity of regulatory and law enforcement agencies to collect and
analyze controlled substance prescription data. The program focuses on
providing help for States that want to establish new or enhance existing
programs.

As part of a continuing effort to improve CSMPs, President Bush signed
The NASPER Act on August 11, 2005. The Act authorizes the U.S.
Department of Health and Human Services (HHS) to award grants to States
to construct prescription drug monitoring programs and enhance existing
ones. As of the time of this report's preparation, funding has not been
provided for this activity.

NASPER provides a national plan and standardizes the program features in
order to:

1.  Foster the establishment of State-administered controlled substance
    monitoring systems to ensure that health care providers have access
    to accurate, timely prescription history information that can be
    used for the early identification of patients at risk for addiction.
    Early identification allows for early intervention of appropriate
    treatment to avert the tragic personal, family and community
    consequences of untreated addiction.

2.  Establish, based on the experiences of existing State prescription
    monitoring programs, a set of best practices that can be used to
    guide the establishment of new State programs and the improvement of
    existing programs.

As a requirement of NASPER, SAMHSA presents findings of an assessment of
existing State CSMPs and other relevant information in order to
determine whether such programs have had a substantial negative impact
on: 1) patient access to treatment, including therapy for pain or
controlled substance abuse; 2) pediatric patient access to treatment;
and 3) patient enrollment in research or clinical trials.

**[Sources of Information]{.smallcaps}**

Four sources of information were used to complete the report. The
sources included: 1) a literature review; 2) data analysis; 3) key
informant questionnaires; and 4) publicly available information.

**[Findings of Assessment]{.smallcaps}**

The first major change in the design of CSMPs occurred in the 1990s when
some States adopted electronic CSMPs that employed technology to capture
prescribing information in ways similar to that pioneered by health
insurers and other third-party payers. Such "electronic CSMPs" captured
information more quickly, rendered it into usable form, allowed
monitoring of a larger number of drug classes, and rendered results to
State officials on a basis much close to real time (Alliance of States
with Prescription Monitoring Programs and National Association of State
Controlled Substance Authorities, 2002). As a result, some States
switched from multiple-copy programs to electronic CSMPs, while other
States that had not been able to afford a multiple-copy program
established a CSMP for the first time.

We can provide "lessons learned" and strategies that States may find
useful as they refine existing CSMPs and design and implement new
programs. The findings of the analysis include:

-   *[Access to Pain Treatment]{.smallcaps}*. Evidence of a negative
    impact on patients' access to pain treatment was consistent across
    the literature reviewed, the data analyzed, and the information
    gathered from key informants. A negative effect was evidenced in
    jurisdictions where a CSMP required the use of a special
    prescription form, and/or where the CSMP covered Schedule II but not
    Schedule III analgesics.

-   *[Addiction Treatment]{.smallcaps}*. The evidence as to whether or
    not CSMPs have had a significant negative effect on patients' access
    to opioid agonist therapies for addiction (e.g., treatment with
    methadone or buprenorphine) was not consistent across the literature
    review, the data analysis, and the key informants' responses.

-   *[Pediatric Care.]{.smallcaps}* There are concerns about a potential
    effect of CSMPs on pain management in pediatric patients. Given that
    cancer is the second leading cause of death in children under age
    12, this is a significant concern.

-   *[Research and Clinical Trials.]{.smallcaps}* There is little
    published literature and no data that address the effect of CSMPs on
    enrollment in clinical trials.

**[Conclusions]{.smallcaps}**

The results of the assessment are inconclusive and underscore the fact
that further study is needed to determine the true impact of CSMPs on
physicians' willingness to prescribe and patients' ability to access
pharmacologic treatments.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

^\*^ For the purpose of this report, Controlled Substance Monitoring
Program (CSMP), Prescription Monitoring Program (PMP), and Prescription
Drug Monitoring Program (PDMP) are used interchangeably.

**[Introduction]{.smallcaps}**

The report presents the findings of an assessment of existing State
Controlled Substance Monitoring Programs (CSMPs) and other information
related to the National All Schedules Prescription Electronic Reporting
Act of 2005 (NASPER; Public Law 109-60), which provides for the
establishment of a CSMP in each State.

The non-medical use of prescription psychotherapeutic drugs in the
United States has become a matter of increasing concern in recent years.
According to the Substance Abuse and Mental Health Services
Administration's (SAMHSA) 2005 National Survey on Drug Use and Health
(NSDUH), an estimated 15.2 million persons aged 12 or older (6.2 percent
of all persons in that age group) used prescription-type
psychotherapeutic drugs non-medically in the past 12 months. In 2005,
there were 6.4 million (2.6 percent) persons aged 12 or older who used
prescription-type psychotherapeutic drugs non-medically in the past
month. Of these, 4.7 million used pain relievers, 1.8 million used
tranquilizers, 1.1 million used stimulants (including 512,000 using
methamphetamine), and 272,000 used sedatives.

Furthermore, the 2005 NSDUH found that 4.9 million young adults aged 18
to 25 (12.4 percent) used prescription pain relievers (analgesics) such
as OxyContin® non-medically; in addition, 1.7 percent of the young
adults met the criteria for dependence or abuse of prescription pain
relievers in the past year. In 2005, the most common source from which
recently used drugs were obtained among non-medical users of
prescription-type drugs was "from a friend or relative for free."

States began to address the misuse and abuse of prescription medications
more than 60 years ago by creating programs to monitor the dispensing of
prescription drugs. By the 1980s, 10 States had adopted CSMPs, but they
were quite diverse in features. These early programs required physicians
to use special multiple-copy, two- or three-part prescription order
forms.

Beginning in fiscal year 2002, Congress appropriated funding to the U.S.
Department of Justice (DOJ) to support the Harold Rogers Prescription
Drug Monitoring Program (U.S. Department of Justice Appropriations Act;
Public Law 107-77). The purpose of the program is to enhance the
capacity of regulatory and law enforcement agencies to collect and
analyze controlled substance prescription data. The program focuses on
providing help for States that want to establish new or enhance existing
programs.

As part of a continuing effort to improve CSMPs, President Bush signed
the NASPER Act on August 11, 2005. The Act authorizes the U.S.
Department of Health and Human Services (HHS) to award grants to States
to construct prescription drug monitoring programs and enhance existing
ones. As of the time of this report's preparation, funding has not been
provided for this activity.

NASPER provides a national plan and standardizes the program features in
order to:

1.  Foster the establishment of State-administered controlled substance
    monitoring systems to ensure that health care providers have access
    to accurate, timely prescription history information that can be
    used for the early identification of patients at risk for addiction.
    Early identification will allow for early intervention of
    appropriate treatment and avert the tragic personal, family and
    community consequences of untreated addiction.

2.  Establish, based on the experiences of existing State prescription
    monitoring programs, a set of best practices that can be used to
    guide the establishment of new State programs and the improvement of
    existing programs.

As a requirement of NASPER, SAMHSA's Center for Substance Abuse
Treatment (CSAT) presents findings of an assessment of existing State
CSMPs and other information in order to determine whether such programs
have had a substantial negative impact on (1) patient access to
treatment, including therapy for pain or controlled substance abuse; (2)
pediatric patient access to treatment; and (3) patient enrollment in
research or clinical trials.

**[Overview and Context]{.smallcaps}**

**[Overview: The Principle of Balance]{.smallcaps}**

The abuse of controlled substances is one facet of America's drug
problem that is particularly complex because access to these substances
must be maintained for legitimate medical purposes. In fact, millions of
persons are successfully treated each year with medications that have
abuse potential, and the majority do not develop problems with misuse,
abuse or addiction. Yet the use of such drugs is not without risk. The
diversion of controlled substances to non-medical use is a public health
and safety concern of considerable magnitude, which contributes to
serious health consequences, including drug addiction and death.

The methods employed in drug diversion are deceptive and sometimes
violent. They involve theft, forgery, and counterfeiting of prescription
forms and the drugs themselves; illegal importation; frauds perpetrated
against physicians, pharmacies, and patients; and deliberate
misprescribing or illegal dispensing by a small percentage of
physicians, pharmacists and other health care professionals (AMA, 1987;
DEA, 2000).

To address the dichotomy between the medical usefulness of certain drugs
and their potential for diversion and abuse, drug control programs
traditionally are based on the principle of balance (a term introduced
by Joranson and Dahl in 1989 and subsequently widely adopted). In
essence, the principle of balance holds that the promotion of effective
medical care and the reduction of drug misuse and abuse are equally
important regulatory objectives, and that neither should be sacrificed
in pursuit of the other (DEA, 2002).

In practice, the principle of balance means that physicians and
pharmacists are required by Federal law to prevent the diversion of
controlled substances and that they share with regulatory and
enforcement authorities a responsibility to assure that controlled
substance prescriptions are issued only for a legitimate medical purpose
and within the usual course of professional practice (21 Code of Federal
Regulations (C.F.R.) §1306.04, 2001).

The principle of balance has been endorsed in the official policies of a
wide array of international and national agencies and organizations,
ranging from the World Health Organization to the U.S. Drug Enforcement
Administration (DEA); from the American Medical Association (1990) to
the Federation of State Medical Boards (1998). In fact, in October 2001,
the DEA released a joint statement with 21 health care organizations
that called for a "balanced approach" to regulation of opioid
analgesics. The statement affirmed that "\[b\]oth healthcare
professionals and law enforcement and regulatory personnel share a
responsibility for ensuring that prescription pain medications are
available to the patients who need them and for preventing these drugs
from becoming a source of harm or abuse" (DEA, 2001).

**[Historical Context]{.smallcaps}**

The current debate over how best to address the misuse and abuse of
prescription medications has its origins more than a century ago, at a
time when the most commonly abused drugs were freely available to any
willing buyer (Musto, 1999). As DuPont (2005) describes the situation,
"heroin was sold over the counter as a soothing syrup for colicky babies
and cocaine was the reason a then-new beverage invented in an Atlanta
pharmacy was called 'Coke.'"

In the first two decades of the 20^th^ Century, Congress adopted two
seminal pieces of legislation to address this open market in dangerous
drugs: the Pure Food and Drug Act of 1906 and the Harrison Narcotics Act
of 1914. Enactment of these laws marked the adoption of a new social
contract, which recognized that many of the most widely abused drugs
also had important medical uses (DuPont, 2005).

The third bedrock of contemporary drug regulation -- the Federal
Controlled Substances Act (CSA) -- was not adopted until 1970. In
essence, the CSA established a "closed" distribution system -- that is,
one in which every step in drug manufacture and distribution was subject
to reporting to and monitoring by Federal authorities. It also created a
series of five schedules into which all drugs with a recognized
potential for abuse could be classified. The schedules range from
Schedule I (for drugs with high abuse potential and no accepted medical
use) to Schedule V (for drugs such as paregoric, which have a
demonstrated medical use and such minor abuse potential that they can be
sold over the counter).

In the 1990s, prescription medications assumed a dramatically larger
place in the treatment of many medical disorders, sometimes replacing
surgery and frequently offering hope for the relief of conditions that
previously had been untreatable. In the mental health arena, there was a
new emphasis on use of pharmacologic treatments for psychotic disorders,
mood and anxiety disorders (e.g., depression and panic disorder), and
attention deficit/hyperactive disorder (ADHD). Even advances such as the
development of effective treatments for cancer meant that patients, who
in an earlier era would have rapidly succumbed to the disease, now could
add months and years to their lives, although often increasing the need
for ongoing pain management.

[Existing Control Mechanisms]{.smallcaps}

Parallel with these developments, Federal and State governments adopted
a series of regulatory and enforcement mechanisms. Such approaches
generally focus on one of two potential points of intervention. Demand
reduction approaches seek to address the underlying causes of
prescription diversion and abuse by treating the addicted population or
educating the practitioners who prescribe or dispense the drugs. The
majority of these approaches are sponsored by government agencies but
executed by private-sector organizations. Supply reduction approaches
involve efforts to monitor and control access to the drugs themselves,
as well as to delimit the actions of those who are legally empowered to
prescribe and dispense them. For the most part, these approaches rely on
statutory authority and are employed by Federal and State governments.

**Federal Responsibilities.** Most Federal programs to address
prescription drug abuse fall under the rubric of supply reduction. For
example, to reach the market in the U.S., all prescription drugs --
including controlled drugs -- must be approved by the U.S. Food and Drug
Administration (FDA) as safe and effective for human use under medical
supervision. The FDA derives its authority from the Federal Food, Drug
and Cosmetic Act of 1962. (It is important to note here that the FDA
regulates approval and marketing of drugs for medical use, but not the
medical practitioners who prescribe, administer and dispense them.
Physicians generally are allowed to prescribe according to their best
judgment \[Federal Register, 1975, 1983\].)

In addition to review and approval by the FDA, certain drugs and
precursor chemicals are subject to additional requirements of the
Federal Controlled Substances Act of 1970 (C.F.R., Title 21, Chapter 2),
which consolidated more than 50 separate laws into a unified system of
drug control. The CSA is intended to achieve both drug control and drug
availability. The DEA is the lead Federal agency responsible for
regulating controlled substances and enforcing the CSA.

Licensed physicians and other licensed health care professionals who
wish to prescribe, dispense or administer controlled drugs must first
register with the DEA (and usually also with the State) and be
periodically renewed (DEA, 1990).

A prescription for a controlled drug is legal only if it is written for
a legitimate medical purpose by a practitioner who holds a current
license and DEA registration and who is acting within the usual course
of professional practice. Most States have requirements that mirror (and
occasionally exceed) the Federal rules.

**State Responsibilities.** In contrast to regulation of the drugs
themselves, the regulation of the professionals who prescribe and
dispense prescription medications falls primarily to the States.
Physicians, pharmacists and other health professionals who prescribe or
dispense controlled drugs must be licensed by the State in which they
practice, have a current registration with the DEA, and maintain records
of drugs prescribed, dispensed or administered in a manner that complies
with State and Federal laws.

State legislatures have granted statutory authority to professional
licensing boards (such as boards of medicine, pharmacy, or nursing) to
license and discipline members of their respective professions. The
boards also have the authority to review, suspend, or revoke licenses
for cause.

In addition to statutes governing professional practice, all States have
adopted some version of the Federal Controlled Substances Act. It is
under this authority that States have established CSMPs to facilitate
the collection, analysis, and reporting of information on the
prescribing, dispensing, and use of controlled substances (GAO, 2002).

[Impetus for Additional Controls]{.smallcaps}

For almost a century, the social contract governing the use of
prescription drugs with abuse potential (as codified in the Harrison
Narcotics Act) worked reasonably well to permit access to medically
necessary drugs while protecting the public from their misuse. However,
problems became evident in the 1990s and early 2000s, which saw the
introduction of new medications and formulations to treat a variety of
disorders, including ADHD, sleep disorders and pain (Curtis, Stoddard,
et al., 2006a; DuPont, 2005). Technological developments loosened the
existing controls over drug distribution by making it possible to
purchase even controlled drugs over the Internet, often without a
legitimate prescription (Wilford, Smith, et al., 2005). The resulting
increase in distribution and use of medications was accompanied by
increased problems with drug diversion and abuse (Exhibit 1), and
experts concluded that expanded availability of psychotherapeutic
medications was a significant factor in the increased rates of abuse
(Dasgupta, Kramer, et al., 2006; Paulozzi, Budnitz, et al., 2006; Novak,
Nemeth, et al., 2004; Jaffe and O'Keeffe, 2003).

**Exhibit 1. U.S. Trends in Distribution and Problematic Use of Commonly
Prescribed Pain Medications**

**Table 1. U.S. Trends in Distribution of Selected Opioid Analgesics, as
Reported in Automation of Reports and Consolidated Orders Systems
(ARCOS)**

![](media/image1.wmf){width="6.49375in" height="4.235416666666667in"}

Source: Drug Enforcement Administration, ARCOS-2, 2006.

\*Data were not available for codeine and methadone for 2000.

**Table 2. Estimated Mentions of Selected Opioid Analgesics: 1997 --
2002 , as Reported in DAWN**

  ------ ---------------- -------------- ------------------- --------------- ----------------- ------------- -----------
  Year   Meperidine^\*^   Morphine^\*^   Hydromorphone^\*^   Oxycodone^\*^   Hydrocodone^\*^   Codeine^\*^   Methadone

  1997   864              1,300          604                 5,012           11,570            7,869         3,832

  1998   730              1,955          937                 5,211           13,611            6,620         4,810

  1999   882              2,217          1,313               6,429           15,252            4,974         5,426

  2000   1,085            2,483          1,983               10,825          20,098            5,295         7,819

  2001   665              3,403          2,003               18,409          21,567            3,720         10,725

  2002   722              2,775          2,667               22,397          25,197            4,961         11,709

                                                                                                             
  ------ ---------------- -------------- ------------------- --------------- ----------------- ------------- -----------

Table 2 includes "drug abuse."

Values are expressed in number of estimated mentions.

ED visits includes dependence, drugs taken for psychic effects or
suicide attempts.

\*Combination products are included.

Source: Office of Applied Studies, SAMHSA, DAWN, 2003.

**Table 3. Drug Abuse Warning Network: 2005**

**Nonmedical Use of Specified Opioid Analgesics Emergency Department
Visits: 2004 and 2005**

  ---------------------------------- ----------- --------- ---------- ------ -----------
  Drug category and selected         Estimated             Rates^3^          Percent
  drugs^1^                           ED                                      Change^4^
                                     visits^2^                               

                                     2004        2005      2004       2005   2004, 2005

  **CNS Agents**                                                              

  *Opiates/opioid analgesics*        158,284     196,225   53.9       66.2   24%

  Codeine/combinations               5,836       5,550     2.0        1.9     

  Hydrocodone/combinations           42,491      51,225    14.5       17.3    

  Hydromorphone/combinations         2,779       5,344     0.9        1.8    92%

  Meperidine/combinations            1,310       763       0.4        0.3     

  Methadone                          31,874      41,216    10.9       13.9   29%

  Morphine/combinations              12,558      15,183    4.3        5.1     

  Oxycodone/combinations             36,559      42,810    12.4       14.4    
  ---------------------------------- ----------- --------- ---------- ------ -----------

Notes:

^1^ The classification of drugs in DAWN is derived from the Multum
Lexicon 2005, Multum Information Services, Inc. The classification was
modified to meet DAWN\'s unique requirements (2006). The Multum
Licensing Agreement governing use of the Lexicon is provided in Appendix
A of DAWN, 2005: National Estimates of Drug-Related Emergency Department
Visits and can be found on the internet at
[http://www.multum.com.]{.underline}

^2^ These are estimates of ED visits based on a representative sample of
non-Federal, short-stay hospitals with 24-hour EDs in the United States.

^3^ ED visits per 100,000 population.

^4^ This column denotes statistically significant (p\<0.05) increases or
decreases between estimates for the period shown.

Source: Office of Applied Studies, SAMHSA, DAWN, 2005 (2006 update).

Non-medical use of prescription-type psychotherapeutic drugs has become
a matter of increasing concern in recent years (OAS, 2006), with the
problem of prescription drug abuse characterized by Compton and Volkow
(2006) as "staggering." One indication of the problem is found in a
steady rise in the number of Americans aged 12 and older who have
initiated use of a prescription medication nonmedically.

According to SAMHSA's 2005 NSDUH, 32.7 million persons (13.4 percent of
the U.S. population) aged 12 or older had used prescription pain
relievers non-medically at least once in their lifetime. This is up from
29.6 million persons (12.6 percent) in 2002, indicating an increase in
the number of Americans using prescription medication other than under a
physician's supervision.

Combined data from the 2002, 2003, and 2004 NSDUH indicate that an
annual average of 14.8 million persons aged 12 or older (6.2 percent of
all persons in that age group) had used prescription-type
psychotherapeutic drugs non-medically in the past 12 months (OAS,
2006c). In 2005, 6.4 million or 2.6 percent of the U.S. population aged
12 or older were current nonmedical users of psychotherapeutic drugs. Of
these, 4.7 million used pain relievers, 1.8 million used tranquilizers,
1.1 million used stimulants, and 272,000 used sedatives (OAS, 2006a).

Furthermore, the 2005 NSDUH found that 4.9 million young adults aged 18
to 25 (12.4 percent) used prescription pain relievers (analgesics) such
as OxyContin® non-medically within the past year; in addition, 1.7
percent of the young adults met the criteria for dependence or abuse of
prescription pain relievers in the past year (OAS, 2006a). Combined data
for 2002 through 2004 revealed that young adults ages 18 to 25 had a
higher prevalence of dependence or abuse for pain relievers,
tranquilizers, and stimulants compared with the rates of dependence or
abuse for these medications for persons in other age groups (OAS,
2006c).

In 2005, SAMHSA reports in the NSDUH that the most prevalent source from
which recently used drugs were obtained among non-medical users of
prescription-type drugs was "from a friend or relative for free." Among
persons aged 12 or older who used pain relievers non-medically in the
past 12 months, 59.8 percent reported that the source of the drug the
most recent time they used was from a friend or relative for free.
Another 16.8 percent reported they got the drug from one doctor. Only
4.3 percent got the pain relievers from a drug dealer or other stranger,
and only 0.8 percent reported buying the drug on the Internet. Over
half, or 57.6 percent, of past year non-medical users of stimulants aged
12 or older reported getting the drug from a friend or relative for
free. Also, 6.5 percent bought the drug from a drug dealer or other
stranger, and 7.2 percent bought it on the Internet (OAS, 2006a).

The NSDUH defines non-medical use as the use of prescription-type
psychotherapeutic drugs not prescribed for the respondent by a physician
or used for the experience or the feeling they cause (OAS, 2006a). The
term encompasses all uses of prescription pain relievers, tranquilizers,
stimulants, and sedatives other than those that are directed by a
physician and used by a patient in a manner consistent with the
prescribed regimen of treatment.

Nonmedical use of prescription drugs is associated with a variety of
deleterious health consequences. The Drug Abuse Warning Network (DAWN)
shows that nearly 1.3 million emergency department (ED) visits in 2004
were associated with drug misuse/abuse (OAS, 2006b). Nonmedical use of
pharmaceuticals was involved in nearly 500,000 of the ED visits; over
half of these ED visits involved multiple drugs.   Opioid analgesics and
benzodiazepines were each involved in more than 100,000 visits.
According to DAWN, the most frequent diagnoses for the ED visits
involving the nonmedical use of pharmaceuticals were overdose (in 38
percent of visits) and depression or another psychiatric condition (23
percent).  Toxic effects were reported in 10 percent of visits (OAS,
2006b).

Of the half million ED visits involving non-medical use of
pharmaceuticals in 2004, 31.9 percent involved opiates/opioids, 29.1
percent involved benzodiazepines, and 5.1 percent involved muscle
relaxants (Exhibit 2).

DAWN's definition of non-medical use includes ED visits involving the
misuse/abuse of pharmaceuticals, as well as visits where the patient
took too much of his or her own medication or was given the drug by
another person who intended to cause harm.  DAWN's definition of
nonmedical use does not include drug-related suicide attempts, adverse
reactions, patients seeking drug rehabilitation, or accidental poisoning
(OAS, 2006).

Reports on admissions to addiction treatment programs show that, in the
decade between 1992 and 2002, admissions for problems with opioid
analgesics more than doubled. (While such treatment admissions increased
for all age groups, the increase was especially notable among persons
aged 20 to 30 \[OAS, 2005\]).

**Exhibit 2. Emergency Department (ED) Visits Involving Nonmedical Use
of Selected Pharmaceuticals, 2004**

+------------------------+----------------------+----------------------+
| Drug                   | Estimated Visits     |                      |
+------------------------+----------------------+----------------------+
|                        | Number               | Percentage           |
+------------------------+----------------------+----------------------+
| Opiates/opioids        | 158,281              | 31.9                 |
+------------------------+----------------------+----------------------+
| > Hy                   | 42,491               |                      |
| drocodone/combinations |                      |                      |
+------------------------+----------------------+----------------------+
| >                      | 36,559               |                      |
| Oxycodone/combinations |                      |                      |
+------------------------+----------------------+----------------------+
| > Methadone            | 31,874               |                      |
+------------------------+----------------------+----------------------+
| Benzodiazepines        | 144,385              | 29.1                 |
+------------------------+----------------------+----------------------+
| > Alprazolam           | 49,842               |                      |
+------------------------+----------------------+----------------------+
| > Clonazepam           | 26,238               |                      |
+------------------------+----------------------+----------------------+
| Muscle relaxants       | 28,338               | 5.1                  |
+------------------------+----------------------+----------------------+
| > Carisoprodol         | 17,366               |                      |
+------------------------+----------------------+----------------------+
| > Cyclobenzaprine      | 5,932                |                      |
+------------------------+----------------------+----------------------+
| All ED visits          | 495,732              | 100                  |
| involving nonmedical   |                      |                      |
| use of pharmaceuticals |                      |                      |
+------------------------+----------------------+----------------------+

Source: Office of Applied Studies, SAMHSA, DAWN, 2004 (September 2005
update).

**[Controlled Substance Monitoring Programs (CSMPs)]{.smallcaps}**

CSMPs are among the most important components of State efforts to
prevent and reduce prescription drug diversion and abuse. Such programs
are used to monitor the prescribing of certain prescription drugs in an
effort to detect patterns that suggest inappropriate actions on the part
of physicians or patients. The primary goal of CSMPs is the detection
and prevention of prescription drug diversion, although many programs
also use the data for physician education and early intervention
(Council of State Governments, 2004).

The first such program was adopted by California in 1939, followed by
Hawaii in 1943 and Illinois in 1961. By the 1980s, seven more States had
adopted CSMPs. These early programs required physicians to use special
multiple-copy, two- or three-part prescription order forms. All were
limited to drugs in Federal Schedule II (see Appendix B). Physicians
generally were required to obtain the special multiple-copy prescription
forms from a State agency, and some States charged a fee for the forms,
thereby generating revenues to underwrite program costs. Pharmacists who
dispensed the drugs were required to send one copy of the multiple-part
order form to the State, where information from the forms was tallied
and analyzed by State personnel (Brushwood, 2003).

The earliest CSMPs covered all drugs in CSA Schedule II. Some covered
drugs in other schedules as well (the CSMP in New York State, for
example, covered all drugs in Schedule II plus benzodiazepines, which
are classified in Schedule IV). Typically, the States use various
criteria (involving the total number of prescriptions written or volume
of drugs prescribed, or prescribing medications in certain combinations,
or the fact that a given patient is obtaining prescriptions for the same
or similar medications from multiple physicians) to "flag" physicians or
patients for further investigation. The information collected also could
be used to monitor a particular physician's prescribing patterns. For
example, the CSMP in Washington State is used solely to monitor the
activities of certain physicians adjudged to be engaged in problematic
prescribing.

The potential of the multiple-copy programs was limited by the fact that
the prescribing information was recorded on a paper form, and thus had
to be manually entered into a database before it could be compiled and
analyzed. This entailed considerable expense and meant that
investigative staff could not obtain the resulting information in
anything like "real time."

In the 1990s, some States adopted electronic CSMPs that employed
technology to capture prescribing information electronically. Such
"electronic CSMPs" captured information more quickly, rendered it into
usable form with less intervening work, allowed monitoring of a larger
number of drug classes, and rendered results to State officials in real
time (Alliance of States with Prescription Monitoring Programs and
National Association of State Controlled Substance Authorities, 2002).
As a result, some States switched from multiple-copy programs to
electronic CSMPs, while other States that had not been able to afford a
multiple-copy program established a CSMP for the first time. A few
States combined the features of the two approaches by continuing to
require use of a special (usually State-issued and serialized)
prescription form for certain classes of drugs, but also required that
pharmacists input the data and transmit it to the State.

The change from paper-based to electronic monitoring marks "a
significant paradigm shift in CSMPs' operations that began in the
mid-1990s and is currently escalating. The core of this is the
developing partnership between CSMPs and treating physicians and
pharmacists; a partnership in which CSMPs provide ever-increasing
volumes of information in response to direct requests from the
practitioners and pharmacists to aid them in clinical care" (John Eadie,
Personal communication, November 27, 2006).

John Eadie, past President of the Alliance of States with Prescription
Monitoring Programs (ASPMP) and of the National Association of State
Controlled Substance Authorities (NASCSA) and former Director of the
Division of Public Health Protection in the New York State Department of
Health, adds that "Recent developments identify additional ways CSMPs
are responding to the paradigm shift" (personal communication, November
27, 2006):

-   In response to physicians' requests for rapid access to CSMP data,
    States are establishing web-based portals through which data users
    can request the data. This process began a few years ago with only
    one or two States, but it is now established in a majority of CSMPs.

-   Physicians are now seeking real time access to the CSMP data.
    Kentucky, Maine, and Utah have established methods for practitioners
    and pharmacists to be authenticated; once authenticated, they are
    able to retrieve data regarding their patients (they must certify
    that the data sought is for their patients only).

As of December 1, 2006, 33 States have signed laws authorizing the
creation of a CSMP, 25 States have active CSMPs, and 8 States have begun
implementation of legislatively authorized programs. Other States are
currently preparing legislation that would establish CSMPs.

CSMPs are administered by diverse government agencies, including
professional licensing boards, health departments, human services
agencies, or consumer protection agencies in 12 States; and by justice
departments, public safety agencies, or State police in five more.
States also vary markedly in terms of who has access to the information
collected. In some States, for example, physicians and pharmacists can
acquire a medication profile for a given patient from the administering
agency (Peine, 2000). In other States, only regulatory or law
enforcement personnel have access to the information (Alliance of States
with Prescription Monitoring Programs and National Association of State
Controlled Substance Authorities, 2001).

In practice, CSMPs take different forms because each State government
determines the goals, structure, and organization of its program. The
manner in which a program is implemented depends on its stated goals and
the mission of the responsible agency (Peine, 2000). However, most State
CSMPs articulate the following goals (Alliance for Model State Drug Laws
and National Association of State Controlled Substance Authorities,
1999):

-   To educate and inform practitioners and the public,

-   To develop and advance public health initiatives,

-   To facilitate early identification and intervention in cases of drug
    misuse or abuse,

-   To aid investigation and law enforcement, and

-   To safeguard the integrity and access to the programs' database.

A recent report sponsored by the U.S. Department of Justice (DOJ),
Office of Justice Programs examined the interrelationship between the
presence of a CSMP and the supply and abuse of prescription drugs
(Simeone, 2006).  The evaluation compares trends in abuse of
prescription pain relievers and stimulants between States that have a
CSMP and those that do not. The evaluation uses a series of models for
estimating patterns of availability and abuse, applying a state-based
ecological approach to evaluate the effects of the programs. 

The principal findings of the evaluation suggest that: 1) the presence
of a CSMP may reduce the per capita supply of prescription pain
medications and stimulants and thereby reduce the probability of abuse
of these drugs, and 2) States that are proactive in their approach may
be more effective in reducing the per capita supply of prescription pain
relievers and stimulants than States that are reactive in their approach
to regulation. 

The report attempts to quantify prescription drug abuse in the context
of CSMPs, using the Treatment Episode Data Set (TEDS) treatment
admissions data; examining drugs that are not in the top most misused or
abused drugs; and restricting attention to Schedule II drugs.  However,
defining abuse based upon treatment admissions has several limitations.
 For example, many people who abuse drugs never seek treatment. 
Furthermore, restricting attention to Schedule II drugs leaves out some
of the major drugs of abuse (Darvocet, Darvon, Tylenol with Codeine,
Vicodin, Lortab and Lorcet).  In addition, drugs in other schedules have
a higher availability and are often abused more extensively that those
in Schedule II.

The DOJ-sponsored study, along with the NASPER report, demonstrates the
need for further evaluations of CSMPs for improved public health
programming (Simeone, 2006).

######### [The NASPER Act of 2005]{.smallcaps}

The NASPER Act was signed by President George W. Bush on August 11,
2005, as Public Law 109-60. NASPER authorizes the U.S. Department of
Health and Human Services to issue a system of grants to the States for
the purpose of establishing a new CSMP or improving an existing program.
As of the time of this report's preparation, funding has not been
provided for this activity. Furthermore, it creates a formula for
determining the amount of such grants, which involves: 1) a minimum
amount allocated to each approved State equal to 1.0 percent of the
amount appropriated to carry out NASPER, and 2) an additional amount
based on a ratio of the number of pharmacies in a State to the number of
pharmacies in all States. It also requires that States establishing such
programs be given preference in future competitive grant awards related
to drug abuse.

The NASPER Act directs HHS to review whether the implementation of CSMPs
had had a "substantial negative impact" on patient access to treatment
or enrollment in research or clinical trials. This report summarizes the
findings of this review.

The NASPER Act identifies several populations and areas of medical
practices as topics of special concern. These include the care of
patients in need of treatment for pain or addiction, the care of
pediatric patients, and enrollment of patients in research and clinical
trials.

**Pain Treatment**. Approximately 75 million persons in the United
States suffer from severe pain. An estimated 50 million experience
chronic pain, while 25 million suffer acute pain related to surgery, a
medical disorder, or a traumatic injury. In fact, pain is the most
common presenting complaint of patients who seek medical care (American
Chronic Pain Association, 2002). It has been estimated that 40 to 90
percent of patients treated in specialized pain treatment facilities
receive opioid analgesics for their pain (Manchikanti, Pampati et al.,
2001; Turk and Okifuki, 1997; Flor, Fydrich, et al., 1992). The number
of patients who receive similar medications from primary care providers
is unknown. Joranson and Berger posit that only about one in four pain
patients receives adequate pain relief (Joranson and Berger, 2000).

**Addiction Treatment**. Opioid agonist therapy (OAT), in which a
prescribed drug is given to occupy the receptor sites that otherwise
would respond to an illicit agent such as heroin, is a widely accepted
medical treatment for opioid addiction whose efficacy has been
documented in hundreds of studies (Center for Substance Abuse Treatment,
2004, 2005). The best-known and most widely used form of OAT involves
methadone maintenance treatment. A second and newer form of OAT employs
buprenorphine. Buprenorphine is able to block the effects of morphine
and other opioids, while offering opioid-like effects that appear likely
to encourage better patient adherence with the treatment regimen than
would a non-opioid or antagonist drug (Vocci, Acri, et al., 2005).

Methadone is classified in Schedule II of the Federal Controlled
Substances Act. The formulations of buprenorphine that are approved for
the treatment of addiction (Subutex® and Suboxone®) are classified in
CSA Schedule III.

**Pediatric Care**. Among the relatively few published reports on
prescribing for pediatric patients, a large number address the treatment
of cancer pain in children because cancer is the leading cause of
non-accidental death in childhood (Joranson, Gilson, et al., 2003;
Institute of Medicine, 2002; Gaughan, Hughes, et al., 2002). Although
high-quality palliative care is now the standard during active treatment
and at the end of life (American Medical Association, 2005; American
Pain Society, 2004; Institute of Medicine, 2002), few studies have
examined whether the care of children with cancer meets this standard
(Goldman, 1998; Frager, 1996; Bossert, Van Cleve, et al., 1996; Collins,
Grier, et al., 1995).

In an effort to address the issue of pediatric pain relief, Wolfe and
colleagues (2000) interviewed the parents of children who had died of
cancer and abstracted data from the children's charts to determine the
patterns of care, the symptoms they experienced in the last month of
life, the effectiveness of the pain and other palliative treatment
offered, and any factors related to suffering from pain at the end of
life. The majority of parents reported that their children experienced
substantial suffering from at least one symptom in the last month of
life. Among the most commonly reported symptoms was pain, which was
actively treated in 76 percent of the children. However, based on the
parents' reports, such treatment was successful in providing pain relief
in only one child in three (Wolfe, Grier, et al., 2000).

Similar questions have been raised about the adequacy of pediatric care
for attention-deficit/hyperactivity disorder (ADHD), which is estimated
to affect about six percent of children and youth (Dey and Bloom, 2005;
Secnik, Swenson, et al., 2004; Swensen, Birnbaum, et al., 2003).

Although the treatment of ADHD sometimes is categorized as either
pharmacologic or non-pharmacologic, this is a somewhat artificial
distinction because the two approaches are not mutually exclusive and
often are used concurrently (Brown, Amler, et al., 2005; Remschmidt,
2005). Following an extensive review of the literature on ADHD, the
Committee on Quality Improvement of the American Academy of Pediatrics
(AAP) concluded that "the evidence strongly supports the use of
stimulant medications for treating the core symptoms of children with
ADHD and, to a lesser degree, for improving functioning" (Brown, Amler,
et al., 2005).

**Enrollment in Research and Clinical Trials**. The conduct of research
and clinical trials requires a distinct shift in attitudes and
procedures from ordinary clinical practice, insofar as such trials
require a proactive approach to the identification and recruitment of
trial participants (Anderson, Kragstrup, et al., 2006; Greenhill,
Vitiello, et al., 2003; Trauth, Musa, et al., 2000; Kiev, 1997; Howard
and Beckwith, 1996). Any factor -- such as a CSMP -- that discourages
physicians from referring patients to research or clinical trials, or
that discourages patients from following through on such a referral,
conceivably could exert a negative effect on the quality of the ensuing
research.

[assessment]{.smallcaps}

[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.smallcaps}

**[Purpose of the Assessment]{.smallcaps}**

In conformance with the language of the National All Schedules
Prescription Electronic Reporting Act of 2005 (NASPER; Public Law
109-60), the primary purpose of this assessment is to determine whether
or not State CSMPs have had a "substantial negative impact" on patients'
access to treatment.

The language of the NASPER requires that the assessment address the
following questions:

-   Have CSMPs negatively affected access to treatment for pain?

-   Have CSMPs negatively affected access to treatment for addictive
    disorders?

-   Have CSMPs negatively affected access to treatment for children and
    adolescents?

-   Have CSMPs negatively affected enrollment in research and clinical
    trials?

According to the general directions contained in NASPER, this report
focuses solely on the impact of CSMPs on access to care. Thus,
information as to whether or not CSMPs in general, or a particular
State's program, have been successful in reducing drug diversion and
abuse was excluded from the assessment.

**[Methodology and Sources of Information]{.smallcaps}**

The assessment employed four approaches to information-gathering:
literature review, data analysis, key informants, and publicly available
information. The methods specific to each of the components of the
assessment are described in the report (Appendix A).

**[Assessment Findings]{.smallcaps}**

Because of the brief period of time afforded by NASPER and the relative
recency of significant changes in CSMPs (i.e., conversion of CSMPs to
electronic monitoring, the initiation of data-sharing with physicians
and other practitioners, the establishment of web-based portals for
practitioner access, and the elimination in all but one State of
separate serialized prescriptions for certain controlled substances), it
was not possible to gather sufficient data to support a robust
conclusion as to whether or not current CSMPs have a substantial
negative effect on access to treatment. However, the assessment did
compile information that may be useful.

The information gathered for the assessment suggests that some CSMPs
(largely the older multiple-copy programs), through their design or
operation or both, have had a negative impact on some patients' access
to accepted pharmacologic treatments. This effect is seen most clearly
with patients' access to opioids for the treatment of pain, but may
exist in subtler forms.

**Access to Pain Treatment**. Evidence that some CSMPs may exert a
negative impact on patients' access to pain treatment was consistent
across the literature review, the data analysis, and the information
gathered from key informants. The negative effect was particularly
pronounced in jurisdictions where a CSMP required the use of a special
prescription form, and/or where the CSMP covered Schedule II but not
Schedule III analgesics.

*[**Opioid Analgesics**:]{.smallcaps}* All of the opioid analgesics used
to control moderate to severe pain are classified as Schedule II drugs
under the Federal Controlled Substances Act and thus are subject to the
requirements of every State's CSMP. Results of the assessment suggest
that some CSMPs may have an adverse effect on patients' access to
analgesics used for pain relief. In addition, the literature makes clear
that a large number of practitioners, policy analysts, and patient
advocates have come to believe that CSMPs are an impediment to
appropriate care.

For the assessment, nine States were identified that had enacted a CSMP
between 1997 and 2004 (the period in which ARCOS data for drugs of
interest were available online). The dosage units in grams per 100,000
population for oxycodone, hydromorphone, hydrocodone, and morphine then
were graphed by year for the period preceding and following enactment of
the CSMP. Similar data were graphed for control States (that is, States
without a CSMP) for the same period of time.

To examine the possibility that the presence of a CSMP in one State
might have an effect on prescribing and drug use activity in an adjacent
State, ARCOS data for two of the most heavily distributed Schedule II
drugs (hydrocodone and oxycodone) were arrayed in dosage units per
100,000, by quintiles, and multiple points of comparison were examined.
The comparison showed no differences in the distribution of the study
drugs between the CSMP and non-CSMP States during the period 1997-2004.

To determine whether the presence of a CSMP in one State had any effect
on activity in an adjacent State, ARCOS data for hydrocodone and
oxycodone were arrayed in dosage units per 100,000, by quintiles, and
multiple points of comparison were examined. In all cases, the ARCOS
data did not show any effect of a CSMP in one State on drug distribution
to adjoining States.

In summary, the ARCOS data for CSMP and non-CSMP States showed virtually
no differences in the prescribing of the study drugs, either in
comparison to the control States or to national averages (Exhibit 3).
Also using the ARCOS data, analysis showed little difference between
CSMP and non-CSMP States in State rankings by per capita consumption of
opioid analgesics (Exhibit 4).

However, these data need to be approached with caution for two reasons.
First, as discussed by Brushwood (2003), the true measure of impact is
in the difference between the amount of drug actually used and the
amount that would have been used if a CSMP had not been in place.
Unfortunately, we do not have a dataset that can provide that
information, although some of the published comparisons of contiguous
States are proxies for such a measure.

Second, ARCOS is an excellent indicator of drug distribution, but cannot
track drug use. The differences are important, because hospitals,
pharmacies and others order supplies of drugs (and DEA sets the quotas
for their manufacture and distribution) based on past utilization.

**Exhibit 3. Per Capita Distribution of Selected Opioid Analgesics to
CSMP and Non-CSMP States, 2004\***

**Exhibit 4. Relative Ranking of CSMP and Non-CSMP States by Per Capita
Distribution of Selected Opioid Analgesics, 2004\***

Occasionally, an event (such as the negative media reports about
OxyContin, or implementation of a CSMP) changes prescribing behaviors in
ways that are not immediately detectable. Also, pharmacies routinely
resell unused drug supplies to "reverse distributors" and, for a variety
of technical reasons, these transactions are not always reflected in the
ARCOS data.

For these and other reasons, the Medical Expenditure Panel Survey (MEPS)
is a better system than ARCOS for monitoring actual drug use because it
tracks prescriptions as they are dispensed to consumers. MEPS is an
ongoing survey by the Center for Financing Access and Cost Trends of the
Agency for Healthcare Research and Quality (AHRQ) that collects
nationally representative data on health care utilization, expenditures,
sources of payment, insurance coverage, and health status for the U.S.
civilian, non-institutionalized population.

In fact, data from MEPS did show an effect of CSMPs on prescriptions for
opioid analgesics. For example, Exhibit 5 presents unadjusted mean
purchases by persons living in States with and without a CSMP.

In the MEPS data, 2.90 percent of persons in non-CSMP States purchased
at least one Schedule II opioid analgesic during each year of the study
period. This was approximately twice the rate (1.16 percent) found in
States that did have a CSMP. Differences between CSMP and non-CSMP
States in purchases of Schedule III analgesics were not statistically
significant.

Exhibit 6 presents coefficient estimates for Ordinary Least Squares
(OLS) models. These coefficient estimates are similar to the estimates
of means in Exhibit 5, but differ in two ways: first, the coefficients
are estimates of differences over time in the means (rather than the
actual means); second, the coefficients are adjusted for differences in
individuals' demographic characteristics and health status, which may
vary across States.

In most cases, the coefficients shown in Exhibit 6 present a very
similar picture to the unadjusted means shown in Exhibit 5. However, an
important difference between Exhibits 5 and 6 is seen in the data on
non-Schedule II opioid analgesics. There, the study found a
statistically significant difference between CSMP and non-CSMP States.
Specifically, investigators found that persons living in a State with a
CSMP are 0.95 percentage points more likely to use at least one
non-Schedule II opioid analgesic during the year, and to have about 3.6
more purchases per 100 persons, than are persons living in States
without a CSMP.

This suggests the type of "substitution effect" (that is, switching from
a higher-scheduled drug covered by a CSMP to a lower-scheduled drug that
is not covered) posited by Twillman (2006), based on an examination of
retail drug distribution patterns in CSMP and non-CSMP States. Using
ARCOS data for Schedule II and III drugs, Twillman found that
distribution of Schedule II opioid analgesics was lower in CSMP States
than in non-CSMP States (morphine and oxycodone appeared to be the most
strongly affected), but that CSMP States reported significantly higher
distribution of Schedule III analgesics, particularly combination
products containing hydrocodone (Exhibit 7). Specifically, in States in
which the CSMP monitored only Schedule II drugs, Twillman found
significantly less prescribing of morphine and oxycodone than in States
where the CSMP covered both Schedule II and III drugs. In fact, in the
latter States, prescribing of Schedule II and Schedule III analgesics
did not differ significantly from States without a CSMP in the
distribution of any opioid analgesic *except* for Schedule II
hydrocodone combination products, which were prescribed at a much higher
rate in the CSMP than the non-CSMP States.

The study by Curtis, Stoddard and colleagues (2006a, b) used the largest
database and showed the clearest association -- independent of all other
variables -- between the presence of a CSMP and reduced rates of opioid
distribution. These investigators used the outpatient drug claims
database of a national pharmacy benefit manager (Advance PCS, since
acquired by Caremark Rx, Inc.) to examine geographic variations in
outpatient prescriptions for opioid analgesics. They focused on
geographic variation as a measure of the impact of State policies on use
of opioid analgesics. Their work built on a 1996 study by Wastila and
Bishop, which used data from the National Ambulatory Medical Care Survey
to show that physicians in States in which the CSMPs required special
prescription forms were less likely to prescribe opioids during an
office visit than physicians in a non-CSMP State.

  ----------------------- --------------- --------------- ------ ------ ------- ---- ------ ------- ------ ------ ------ ---- ---- ------ ------ ------ ------- ------- ---- --
  **Exhibit 5. Average                                                                                                                                                       
  Number of Purchases Per                                                                                                                                                    
  Person of Schedule II                                                                                                                                                      
  Drugs in CSMP and                                                                                                                                                          
  Non-CSMP States,                                                                                                                                                           
  1996-2003**                                                                                                                                                                

                          Percent of                                                                                                                                         
                          Population with                                                                                                                                    
                          Any                                                                                                                                                
                          Prescriptions                                                                                                                                      

                          All Years                                                  1996                                          2003                         ** **        
                          1996-2003                                                                                                                                          

  State CSMP Category     With CSMP^1^                           No                  With           No                             With          No                          
                                                                 CSMP                CSMP           CSMP                           CSMP          CSMP                        

  Type of Drug                                                                                                                                                               

  All Schedule II Drugs   1.97                                   3.94           \*   1.42           3.14                 \*        2.66          4.63           \*           

  Schedule II:                                                                                                                                                               

  Opioid Analgesic        1.16                                   2.90           \*   0.81           2.24                 \*        1.64          3.52           \*           

  Stimulant               0.82                                   1.08           \*   0.62           0.93                           1.02          1.17                        

  Non-schedule II:                                                                                                                                                           

  Opioid Analgesic        7.56                                   7.46                8.05           8.07                           7.93          8.12                        

                          Number of                                                                                                                                          
                          Prescriptions                                                                                                                                      
                          Per 100                                                                                                                                            
                          Persons^2^                                                                                                                                         

                          All Years                                                  1996                                          2003                         ** **        
                          1996-2003                                                                                                                                          

  State CSMP Category     With CSMP                              No                  With           No                             With          No                          
                                                                 CSMP                CSMP           CSMP                           CSMP          CSMP                        

  Type of Drug                                                                                                                                                               

  All Schedule II Drugs   9.4                                    16.2           \*   6.2            10.1                 \*        13.5          20.3           \*           

  Schedule II:                                                                                                                                                               

  Opioid Analgesic        4.7                                    9.0            \*   2.2            4.5                  \*        6.9           11.9           \*           

  Stimulant               4.7                                    7.2            \*   3.9            5.6                            6.6           8.4                         

  Non-schedule II:                                                                                                                                                           

  Opioid Analgesic        18.6                                   18.1                20.9           19.0                           20.4          20.1                        

  ^1^ \"With CSMP\"                                                                                                                                                          
  indicates that States                                                                                                                                                      
  implemented a program                                                                                                                                                      
  to monitor Schedule II                                                                                                                                                     
  drugs prior to 1996.                                                                                                                                                       
  \"No CSMP\" indicates                                                                                                                                                      
  that States had not                                                                                                                                                        
  implemented a program                                                                                                                                                      
  to monitor schedule II                                                                                                                                                     
  drugs by 2003.                                                                                                                                                             

  ^2^ Use is estimated                                                                                                                                                       
  across all persons in                                                                                                                                                      
  the                                                                                                                                                                        
  non-institutionalized                                                                                                                                                      
  U.S. population,                                                                                                                                                           
  regardless of whether                                                                                                                                                      
  they had any drug                                                                                                                                                          
  purchases during the                                                                                                                                                       
  year.                                                                                                                                                                      

  \*The difference                                                                                                                                                           
  between the \"With                                                                                                                                                         
  CSMP\" and \"No CSMP\"                                                                                                                                                     
  estimate is significant                                                                                                                                                    
  at p \< .05, or better.                                                                                                                                                    

  *Source:* Preliminary                                                                                                                                                      
  estimates are based on                                                                                                                                                     
  the 1996-2003 MEPS:                                                                                                                                                        
  Center for Financing,                                                                                                                                                      
  Access and Cost Trends,                                                                                                                                                    
  Agency for Healthcare                                                                                                                                                      
  Research and Quality.                                                                                                                                                      

  **Exhibit 6.                                                                                                                                                               
  Association of State                                                                                                                                                       
  CSMP Category with the                                                                                                                                                     
  Probability of Any                                                                                                                                                         
  Schedule II Drug Use                                                                                                                                                       
  and With the Number of                                                                                                                                                     
  Purchases of Schedule                                                                                                                                                      
  II Drugs, 1996-2003**                                                                                                                                                      

                                          Percent of                                                                                                                         
                                          Population with                                                                                                                    
                                          Any                                                                                                                                
                                          Prescriptions                                                                                                                      

                                          All Years                                         1996                                          2003                               
                                          1996-2003                                                                                                                          

  State CSMP Category                     With CSMP^1^                  No CSMP             With           No                             With          No CSMP              
                                                                                            CSMP           CSMP                           CSMP                               

  Type of Drug                                                                                                                                                               

  All Schedule II Drugs                   1.97                          3.94    \*          1.42           3.14               \*          2.66          4.63            \*   

  Schedule II:                                                                                                                                                               

  Opioid Analgesic                        1.16                          2.90    \*          0.81           2.24               \*          1.64          3.52            \*   

  Stimulant                               0.82                          1.08    \*          0.62           0.93                           1.02          1.17                 

  Non-schedule II:                                                                                                                                                           

  Opioid Analgesic                        7.56                          7.46                8.05           8.07                           7.93          8.12                 

                                          Number of                                                                                                                          
                                          Prescriptions                                                                                                                      
                                          Per 100                                                                                                                            
                                          Persons^2^                                                                                                                         

                                          All Years                                         1996                                          2003                               
                                          1996-2003                                                                                                                          

  State CSMP Category                     With CSMP       No                                With                  No                      With          No CSMP              
                                                          CSMP                              CSMP                  CSMP                    CSMP                               

  Type of Drug                                                                                                                                                               

  All Schedule II Drugs                   9.4             16.2                  \*          6.2                   10.1        \*          13.5          20.3            \*   

  Schedule II:                                                                                                                                                               

  Opioid Analgesic                        4.7             9.0                   \*          2.2                   4.5         \*          6.9           11.9            \*   

  Stimulant                               4.7             7.2                   \*          3.9                   5.6                     6.6           8.4                  

  Non-schedule II:                                                                                                                                                           

  Opioid Analgesic                        18.6            18.1                              20.9                  19.0                    20.4          20.1                 

  ^1^ \"With CSMP\"                                                                                                                                                          
  indicates that States                                                                                                                                                      
  implemented a program                                                                                                                                                      
  to monitor Schedule II                                                                                                                                                     
  drugs prior to 1996.                                                                                                                                                       
  \"No CSMP\" indicates                                                                                                                                                      
  that States had not                                                                                                                                                        
  implemented a program                                                                                                                                                      
  to monitor schedule II                                                                                                                                                     
  drugs by 2003.                                                                                                                                                             

  ^2^ Use is estimated                                                                                                                                                       
  across all persons in                                                                                                                                                      
  the                                                                                                                                                                        
  non-institutionalized                                                                                                                                                      
  U.S. population,                                                                                                                                                           
  regardless of whether                                                                                                                                                      
  they had any drug                                                                                                                                                          
  purchases during the                                                                                                                                                       
  year.                                                                                                                                                                      

  \*The difference                                                                                                                                                           
  between the \"With                                                                                                                                                         
  CSMP\" and \"No CSMP\"                                                                                                                                                     
  estimate is significant                                                                                                                                                    
  at p \< .05, or better.                                                                                                                                                    

  Source: Preliminary                                                                                                                                                        
  estimates are based on                                                                                                                                                     
  the 1996-2003 MEPS:                                                                                                                                                        
  Center for Financing,                                                                                                                                                      
  Access and Cost Trends,                                                                                                                                                    
  Agency for Healthcare                                                                                                                                                      
  Research and Quality.                                                                                                                                                      
  ----------------------- --------------- --------------- ------ ------ ------- ---- ------ ------- ------ ------ ------ ---- ---- ------ ------ ------ ------- ------- ---- --

**Exhibit 7. Patterns of Retail Distribution of Opioid Analgesics in
CSMP and Non-CSMP States Compared, 2003\***

In their study, Curtis, Stoddard et al. examined State-level prevalence
of and variations in the prescribing of Schedule II opioid analgesics.
They also examined the influence of a variety of factors -- including
CSMPs -- on county-level rates of drug claims for all opioid analgesics
and for controlled-release oxycodone (such as OxyContin®).

The data set used in the study included all prescription drug claims for
more than 7 million persons who were enrolled continuously during
calendar year 2000 and who filed at least one prescription drug claim
for any drug in that year. A total of 1,171 health insurers -- covering
all 50 States, the District of Columbia, and the Virgin Islands -- were
represented in the data.

Based on 567,778 claims for oral opioid analgesics, the investigators
calculated a national average of 74.2 opioid claims per 1,000 total
claims; however, they found distinct geographic variations, with ratios
ranging from less than 20 to more than 100 opioid claims per 1,000 total
claims. The lowest rates were found in States with long-standing CSMPs
(Exhibit 8).

The authors cautioned that the data do not allow an interpretation as to
whether the association between CSMPs and lower rates of opioid claims
should be attributed to a reduction in either appropriate or
inappropriate prescribing. Instead, they recommended additional studies
using individual-level data to make this important distinction (Curtis,
Stoddard, et al., 2006a).

*[Non-Opioid Medications]{.smallcaps}*. In the peer-reviewed literature,
the effect of CSMPs on medications other than opioids has not been
examined closely; however, a pair of studies focusing on the addition of
benzodiazepines to the New York triplicate prescription program yields
interesting results. In 1989, New York State added benzodiazepines to
its existing CSMP, which previously had been limited to Schedule II
drugs. The result of the change was that, for the first time, New York
physicians were required to write prescription orders for
benzodiazepines on triplicate prescription forms, with one copy of each
form forwarded by the dispensing pharmacy to a State surveillance unit.

To assess the impact of this policy change, Ross-Degnan et al. (2004)
employed interrupted time series analyses of benzodiazepine
prescriptions in the New York (intervention) and New Jersey (control)
Medicaid programs for 12 months before and 24 months after New York
added benzodiazepines to its CSMP.

In the year preceding the policy change, 20.2 percent of the New York
cohort and 19.3 percent of the New Jersey cohort received at least one
prescription for a benzodiazepine. In the 24 months after the effective
date of the new requirement, there was a 54.8 percent reduction in
benzodiazepine prescriptions in New York, but no change in
benzodiazepine prescribing in New Jersey.

*[Persistence of the Effect:]{.smallcaps}* In a second study of the
addition of benzodiazepines to New York's triplicate prescription
program, which was designed to address the effects of the program change
over time, the same group of investigators examined benzodiazepine
prescribing in New York State at two and seven years after the program
change. Again using interrupted time series and logistic regression
analyses, they examined data from 124,867 non-institutionalized persons
aged 18 years or older who had been enrolled continuously in New York's
Medicaid program during the 12 months preceding, and at two and seven
years following the addition of benzodiazepines to the State's CSMP
(Pearson, Soumerai, et al., 2005).

The Medicaid data showed a sustained reduction in the number of
benzodiazepine prescriptions even seven years after the program change.
Moreover, even after adjusting for gender, Medicaid eligibility status,
neighborhood poverty, and baseline use of the drug, the investigators
found that black study subjects were more likely than white subjects to
have had their use of benzodiazepines discontinued. Even though Medicaid
enrollees in predominantly black neighborhoods had the lowest rates of
benzodiazepine use at baseline, they also experienced the highest rates
of discontinuation of therapy after introduction of the CSMP. This
difference persisted over time.

The investigators concluded that, while the CSMP appeared to have
reduced inappropriate prescribing of benzodiazepines, it also resulted
in an unintended decrease in therapeutic use that disproportionately
affected black populations (Pearson, Soumerai, et al., 2006).

Comparable results have been reported in other studies by the same group
of investigators (Khandker and Simoni-Wastila, 1998), as well as in
studies by Edwards, Fillingim and Keefe (2001), Bonham (2001), Cleeland,
Gonin, et al. (1997), Fillenbaum, Horner, et al. (1996); and Fillenbaum,
Hanlon, et al. (1993) and Green, Anderson, et al. (2003).

**Addiction Treatment**. The evidence as to whether CSMPs have had an
adverse effect on patients' access to opioid agonist therapies for
addiction (e.g., treatment with methadone or buprenorphine) was not
consistent across the literature review, the data analysis, and the key
informants' responses.

While the ARCOS data provide some evidence that the presence of a CSMP
may have an adverse effect on the use of methadone to treat addiction,
the number of confounding variables (including other Federal and State
requirements, the gap between treatment need and availability, and
practitioner and public attitudes toward methadone and addictive
disorders) is too large to draw a definitive conclusion.

**Pediatric Care.** The evidence that CSMPs have an adverse effect on
the prescribing of opioids for pain is sufficiently strong, and the
history of undermedicating pain in children is so clear, as to raise
concerns about a potential effect of CSMPs on pain management in
pediatric patients. Given that cancer is (after traumatic injury) the
second leading cause of death in children under age 12, this is a
significant concern. Similarly, reports showing that children who are
appropriately treated for ADHD are actually less likely to engage in
later substance abuse than untreated or inadequately treated children
argue for a closer look at the effect of CSMPs on access to such
pharmacotherapies.

However, in the current study, the data analysis yielded little direct
evidence as to whether CSMPs have had an adverse effect on pediatric
patients' access to care. The difficulty of segmenting the pediatric
population and the drugs prescribed for them are a particular impediment
in this regard. As a result, no clear conclusion can be drawn, pending
the results of additional studies. Of particular interest would be
studies involving community-based practitioners and institutions, as
well as institutions and practitioners who specialize in pediatric
oncology and ADHD.

Research and Clinical Trials. The assessment found little published
literature and no data sets that address the effect of CSMPs on
enrollment in clinical trials.

**Summary of Findings**. There continues to be disagreement as to
whether CSMPs exert a negative effect on prescribing for pain and other
medical disorders.

With one exception, the assessment did not have access to an evaluation
of this problem by the CSMP States themselves. Of the 11 reports
obtained from CSMP States (Appendix D), only the report from Virginia
addresses the question of a potential "chilling effect" on prescribing
for pain. Virginia adopted an electronic CSMP in 2002 as a pilot program
in the southwestern region of the State (Health Planning Region III).
The CSMP became operational in September 2003. The report incorporates
data on 2002, 2003, and 2004, and so captures the period immediately
preceding and following implementation of the CSMP (Department of Health
Professions and Virginia State Police, 2004). The executive summary of
the report states "review of data collected thus far appears to show
that implementation of the program has not had a 'chilling' effect on
the legitimate prescribing of Schedule II controlled substances. The
amount of oxycodone and hydrocodone being distributed in wholesale
distribution channels continued to increase throughout Virginia at a
rate of 9 percent and 8 percent respectively in 2002 and 2003.
Information maintained by the Department of Medical Assistance Services
(DMAS) shows that after a substantial drop in claims for oxycodone
containing prescriptions in the first and second quarters of 2002, the
number of claims submitted in the first quarter of 2004 for these
products are 21 percent higher than they were in the first quarter of
2001" (Department of Health Professions and Virginia State Police, 2004,
pages iv-v).

*[Concern About Drug Diversion and Abuse:]{.smallcaps}* Some experts
have suggested that a significant barrier to the use of opioids to treat
pain is that physicians, pharmacists, and other clinicians have
difficulty discerning the difference between a patient who legitimately
suffers pain and one who is pretending to be in pain for the sake of
obtaining drugs (Brushwood, 2003; FSMB, 2001). This is based on the fact
that chronic pain is a disorder that cannot be ruled out by an
evaluation of laboratory values, radiological imaging, or a physical
examination. Physicians must rely largely on patient interviews and
histories to evaluate the presence and intensity of pain, and thus to
determine a patient's need for pain medications (Patel and Ogle, 2000).
This is a complex process that involves a large element of experience
and judgment (NIDA, 2001).

Such factors were examined in a survey of Virginia physicians conducted
in mid-2004 and compiled by the Survey and Evaluation Research
Laboratory of Virginia Commonwealth University. In the survey,
physicians were asked if in the preceding three years, they had
prescribed fewer Schedule II medications. A little more than a third of
the respondents said that, in fact, they had reduced their prescribing
of Schedule II drugs. Of this group, 48 percent cited intense media
coverage of drug diversion as the reason, while and 41 percent cited
increased law enforcement activity. Almost a third (31 percent)
acknowledged that prescribing fewer Schedule II drugs had a negative
effect on helping patients manage their pain (Department of Health
Professions and Virginia State Police, 2004, pages iv-v).

Access to care also may be impeded by policies that create confusion
about the distinctions between addiction, tolerance and physical
dependence (FSMB, 1998). For example, a physician who receives
information from a CSMP showing that a patient has received pain
medications from multiple physicians may incorrectly conclude that the
patient is a "doctor-shopper" for whom pain medications should not be
provided, rather than an individual whose pain has been inadequately
treated (Brushwood, 2003; Passik and Kirsh, 2004).

*[Lack of Understanding of the CSMP:]{.smallcaps}* Physicians' lack of
understanding of the goals and operations of CSMPs was cited by Barrett
and Watson (2005) as a result of their 2003 survey of 672 physicians in
southwest Virginia. Conducted during implementation of a pilot
electronic CSMP in that part of the State, the mailed survey was
designed to elicit physicians' knowledge of and attitudes toward the
CSMP, as well as to assess its likely impact on their opioid prescribing
behaviors. A total of 275 surveys were returned (a response rate of 41
percent). Less than half the responding physicians said they were aware
of the CSMP before receiving the survey.

A total of 68 percent of the respondents said they expected the CSMP to
be helpful in monitoring patients\' prescription histories and reducing
"doctor shopping," although only 11 percent had actually requested
information from the prescription monitoring program database (Barrett
and Watson, 2005).

*Uncertainty about Standards of Care:* Physicians' inadequate knowledge
of pain control standards and protocols is a theme that runs through
many current studies (Brushwood, 2003). In 1997, The American Academy of
Pain Medicine and the American Pain Society identified the following
issues as sources of confusion to prescribing physicians and thus as
potential impediments to adequate management of pain.

-   *Addiction:* Misunderstanding of addiction and mislabeling of
    patients as addicts result in unnecessary withholding of opioid
    medications. Addiction is a compulsive disorder in which an
    individual becomes preoccupied with obtaining and using a substance,
    the continued use of which results in a decreased quality of life.
    Studies indicate that the *de novo* development of addiction when
    opioids are used for the relief of pain is a relatively infrequent
    event. Moreover, experience shows that even addicted individuals can
    benefit from the carefully supervised, judicious use of opioids for
    the treatment of pain resulting from cancer, surgery, traumatic
    injury, or illnesses such as sickle cell disease.

-   *Respiratory Depression and Other Side Effects*: Fear of inducing
    respiratory depression is cited by physicians as a factor that
    limits the use of opioids in pain management. However, respiratory
    depression induced by opioids tends to be a short-lived phenomenon,
    generally occurs only in the opioid-naive patient, and is
    antagonized by pain. Therefore, withholding appropriate opioid
    analgesics from a patient who is experiencing pain because of
    respiratory concerns is unwarranted.

-   *Tolerance*: Many physicians incorrectly believe that the
    development of tolerance to opioid analgesics limits the efficacy of
    such drugs for the long-term management of pain. Tolerance -- which
    results in reduced pain relief with the same dose over time -- has
    not proved to be a prevalent limitation to long-term opioid use.
    Experience with treating cancer pain has shown that what initially
    appears to be tolerance often is caused by progression of the
    disease.

-   *Diversion:* Attention to patterns of prescription requests, as well
    as prescribing opioid analgesics as part of an ongoing relationship
    between a patient and a health care provider can reduce the risk of
    diversion without impeding patient care (AAPM and APS, 1997).

*[Avoidance of Regulatory Oversight:]{.smallcaps}* In 1990, experts at
the World Health Organization hypothesized that, in the presence of
CSMPs, health care professionals may be reluctant to prescribe, stock or
dispense opioids if they perceive a possibility that their professional
licenses would be suspended, even though the medical need for such
actions could be demonstrated (WHO, 1990). Similar concerns are found in
the results of a survey by Barrett and Watson (2005), in which nearly 60
percent of the respondents said that Virginia's implementation of a CSMP
would result in their prescribing behaviors being more closely
monitored.

Concern about regulatory oversight also is evident in a survey of
physicians by Weinstein and colleagues (2000), in which 23.8 percent of
respondents agreed with the statement, "I give my patients a limited
supply of pain medication to avoid being investigated." In the same
survey, 26.4 percent of physicians said they were concerned about an
investigation by regulators if they prescribed controlled substances for
a chronic pain patient (Barrett and Watson, 2005).

Similar results have been found in surveys of family physicians in West
Virginia (n = 186; Ponte and Johnson-Tribino, 2005), primary care
physicians in California (n = 161; Potter, Schafer, et al., 2001), and
even abroad. For example, in a telephone survey of Canadian physicians
(Morley-Forster, Speechley et al., 2003, n = 100), 35 percent of general
practitioners and 10 percent of palliative care specialists cited fear
of regulatory sanctions as a barrier to opioid prescribing.

The impact of these attitudes was explored in a survey conducted in
mid-2004 and compiled by the Survey and Evaluation Research Laboratory
of Virginia Commonwealth University. In the survey, physicians were
asked if in the preceding three years, they had prescribed fewer
Schedule II medications. Almost a third (31 percent) acknowledged that
prescribing fewer Schedule II drugs had a negative effect on helping
patients manage their pain (Department of Health Professions and
Virginia State Police, 2004, pages iv-v).

*[Avoidance of Special Prescription Order Forms:]{.smallcaps}* The
administrative burden associated with obtaining, storing, and using
multiple-copy or other special prescription forms may tend to suppress
prescribing. However, only one State now requires use of a State-issued
serialized form for a limited number of drugs and the future impact of
the forms likely will lessen.

*[Anxiety Triggered by High-Profile Cases:]{.smallcaps}* High-profile
arrests and prosecutions focus physicians' attention on the risks
entailed in prescribing controlled substances in general, and have the
specific effect of increasing physicians' and pharmacists' reluctance to
prescribe, stock or dispense opioid analgesics (Brushwood, 2003;
Fishman, 2006a).

*[Negative Stereotypes Associated with Patients' Demographic or Economic
Status]{.smallcaps}*: A number of studies published over more than a
decade report that CSMPs have had a disproportionately negative effect
on access to care among certain patient populations (Payne, Medina, et
al., 2003; Freeman and Payne, 2000; Morrison, Wallenstein, et al., 2000;
Todd, Deaton, et al., 2000; Ng, Dimsdale, et al., 1996; Schneider,
Zaslavsky, et al., 2002). The effect appears to be correlated most
strongly with race and ethnicity, but some studies also have found
correlations with age and gender, economic status, and certain
stigmatized clinical diagnoses such as HIV.

Poverty also appears to be a factor. Medicaid eligibility is a widely
accepted proxy for economic status, and one that has been used by a
number of investigators to assess the effect of CSMPs on economically
disadvantaged populations (Gornick, Eggers, et al., 1996; Khandker and
Simoni-Wastila, 1998; Swartz, Landerman, et al., 1991). McNutt, Coles,
et al. (1994), also examined the effect of income and found that
low-income elderly in New York State received prescriptions for
benzodiazepines at a rate less than that for the population as a whole.

What the data alone cannot do is explain the reasons for the
differences. Morrison, Wallenstein, et al. (2000) examined this
question, based on their observation that many black and Hispanic
patients who were receiving palliative care at a major urban teaching
hospital were unable to obtain prescribed opioids from their
neighborhood pharmacies.

For their study, investigators calculated that 176 pharmacies (51
percent) did not carry sufficient supplies of opioids to treat patients
with severe pain. In predominantly non-white neighborhoods, only 25
percent of pharmacies had opioid supplies sufficient to treat patients
with severe pain. In predominantly white areas, by contrast, 72 percent
of pharmacies had sufficient supplies.

Morrison and colleagues concluded that stereotypes about race and
ethnicity contribute to pharmacists' or pharmacy owners' decisions as to
what supplies of opioid analgesics to carry in stock. Patients' reports
that local pharmacies do not carry certain medications in stock may be a
factor physicians will take into account when deciding which drug to
prescribe.

**[Conclusions]{.smallcaps}**

There is widespread agreement that diversion and abuse of prescription
medications are large and growing problems. For example, in 2005, an
estimated 33 million persons had used pain relievers nonmedically in
their lifetime, 19 million had engaged in nonmedical use of stimulants,
and 21 million used tranquilizers nonmedically in their lifetime (OAS,
2006a). Data from DAWN show that the most frequent diagnoses for ED
visits involving the nonmedical use of pharmaceuticals were overdose (in
38 percent of the visits) and depression or another psychiatric
condition (23 percent of visits). Toxic effects were reported in 10
percent of visits (OAS, 2006b). Reports on admissions to addiction
treatment programs show that, in the decade between 1992 and 2002,
admissions for problems with opioid analgesics more than doubled. (While
such treatment admissions increased for all age groups, the increase was
especially notable among persons aged 20 to 30 \[OAS, 2004\].)

CSMPs have been developed and refined over a period of 60 years to
address this persistent problem. Yet some CSMPs appear to have some
negative effects: information analyzed for the assessment suggests that
some CSMPs -- through their design or operation, or both -- have exerted
a negative impact on some patients' access to accepted pharmacologic
therapies. This effect is seen most clearly with the older multiple-copy
prescription programs, and the effect is most dramatic on patients'
access to opioids for the treatment of pain, but there may be more
subtle effects involving other medications and populations as well.

What the available information sources do not reveal are the reasons a
CSMP would exert such an effect. Nor do the data clearly demonstrate
what other factors might be at work. Only further research will provide
these answers.

**[Lessons Learned from the Assessment]{.smallcaps}**

Suggestions have been offered by a variety of individuals and
organizations to strengthen prescription monitoring programs. For
example, the Council of State Governments (2004) has advised that, in
order to alleviate any concern about the effect of CSMPs on sound
medical practice, certain objectives should be met. These include:

-   Providing the medical community with detailed information as to the
    purpose of the CSMP;

-   Devising clear policies with regard to the management of pain and
    other debilitating conditions (such as the model policies endorsed
    by the Federation of State Medical Boards, which have been adopted
    by more than 20 States); and

-   Evaluating resulting prescribing trends and program effectiveness.

In a June 2002, "Statement on State Prescription Monitoring Programs,"
the American Alliance of Cancer Pain Initiatives (AACPI) offered similar
suggestions that appear to be consistent with the intent of Congress in
its passage of NASPER. AACPI, a national network of State, regional and
Native American cancer pain initiatives, health care professionals,
researchers, educators and patient advocates, recommended that CSMPs:

-   Be administered by the State agency responsible for regulating
    healthcare;

-   Adopt a number of design and organizational features to avoid the
    potential for CSMPs to suppress appropriate use of medications for
    patient care (e.g., avoiding the use of special prescription forms
    for certain drugs; monitoring of all medications in Schedules II,
    III, and IV; and incorporating safeguards to protect patient
    confidentiality);

-   Establish an interagency diversion prevention and control program;

-   Allow health care professionals access to CSMP data concerning their
    patients for use in evaluating the patients' use of controlled
    drugs;

-   Allow law enforcement agencies to have access to the data when
    probable cause justifies such access in the course of investigating
    possible abuse or diversion;

-   Establish a multidisciplinary medical review group (e.g., Nevada) to
    oversee the CSMP; and

-   Provide educational programs to inform physicians and other health
    care professionals about the purpose of the CSMP (an approach that
    has been effectively employed in Michigan and Pennsylvania).

In another example, the American Academy of Pain Medicine (AAPM) and the
American Pain Society (APS) jointly released a statement in 1997 that
articulated a number of reasons for physicians' failure to adequately
treat pain. These included concerns about addiction, respiratory
depression and other side effects of opioid analgesics, the development
of tolerance, worries about diversion, and fear of regulatory actions.
To address these concerns, AAPM and APS recommend that practice
guidelines be developed to help physicians appropriately manage acute
and chronic pain as "an extension of the basic principles of good
professional practice" (AAPM and APS, 1997). The societies endorsed the
following content areas for such guidelines:

*[Patient Evaluation:]{.smallcaps}* Evaluation should initially include
a pain history and assessment of the impact of pain on the patient, a
directed physical examination, a review of previous diagnostic studies,
a review of previous interventions, a drug history, and an assessment of
coexisting diseases or conditions.

*[Treatment Planning:]{.smallcaps}* Treatment planning should be
tailored to both the individual and the presenting problem.
Consideration should be given to different treatment modalities, such as
a formal pain rehabilitation program, the use of behavioral strategies,
the use of noninvasive techniques, or the use of medications, depending
upon the physical and psychosocial impairment related to the pain. If a
trial of opioids is selected, the physician should ensure that the
patient or the patient's guardian is informed of the risks and benefits
of opioid use and the conditions under which opioids will be prescribed.
Some practitioners find a written agreement specifying these conditions
to be useful. An opioid trial should not be done in the absence of a
complete assessment of the pain complaint.

*[Consultation as Needed:]{.smallcaps}* Consultation with a specialist
in pain medicine or with a psychologist may be warranted, depending on
the expertise of the practitioner and the complexity of the presenting
problem. The management of pain in patients with a history of addiction
or a comorbid psychiatric disorder requires special consideration, but
does not necessarily contraindicate the use of opioids.

*[Periodic Review of Treatment Efficacy:]{.smallcaps}* Review of
treatment efficacy should occur periodically to assess the functional
status of the patient, continued analgesia, opioid side effects, quality
of life, and indications of medication misuse. Periodic reexamination is
warranted to assess the nature of the pain complaint and to ensure that
opioid therapy is still indicated. Attention should be given to the
possibility of a decrease in global function or quality of life as a
result of opioid use.

*[Documentation:]{.smallcaps}* Documentation is essential for supporting
the evaluation, the reason for opioid prescribing, the overall pain
management treatment plan, any consultations received, and periodic
review of the status of the patient.

The societies also suggested that regulators would find practice
guidelines helpful in targeting their investigative, educational, and
disciplinary resources so as to address prescription drug diversion and
abuse while avoiding interference with legitimate medical care (AAPM and
APS, 1997).

**[Key Informant Suggestions]{.smallcaps}**

Key informants also offered suggestions to enhance the effectiveness of
CSMPs and to minimize any adverse impact on patients' access to
treatment. Their comments follow:

*[Program Administration]{.smallcaps}*:

"Programs should be administered by a State agency responsible for
health matters and not by a law enforcement agency."

"Medical review groups should be created to assist in analysis of the
data obtained and therefore to assure protection of legitimate
prescribing and dispensing of controlled substances."

*[Program Design:]{.smallcaps}*

"Programs should adequately address the differences between adults and
children. 'One size fits all' doesn't apply here and we continue to
advocate for a separate list and discussions for the pediatric
population."

"Using a security prescription form for all schedules of medications
should avoid the chilling effect that has characterized CSMPs
historically."

"Eliminate inconsistencies -- have the same rules and access across
State lines."

*[Access to Program Data:]{.smallcaps}*

"Prescribers should have timely access to data about their individual
patients so they can use it in making critical clinical decisions."

"Data from CSMPs must be made available to clinicians at the point of
care."

"Law enforcement agencies should only have access to the data when
justified by probable cause; for example, when investigating possible
diversion and abuse."

"The confidentiality of patients should be vigorously guarded."

*[Provider Education and Communication:]{.smallcaps}*

"Educational programs should be developed to address health care
professionals' perceptions about the risks of regulatory scrutiny and to
assure that there is understanding of the laws and regulations that
govern the prescribing and dispensing of controlled substances."

"Providing adequate pain management and preventing diversion and abuse
of prescription controlled substances are both important public health
goals. Achieving both goals requires exchange of information and
perspectives, identification of issues, and concerted action. Increased
communication and cooperation between regulatory and pain groups can
contribute to a good balance between drug control and drug
availability."

*[Outcomes Evaluation:]{.smallcaps}*

"\[There has been\] little if any outcomes evaluation for efficacy and
safety. If efficacy is evaluated, the outcome should be a reduction in
diversion, but is usually the extent that prescriptions are reduced,
which can have a detrimental impact on medication availability."

"There should be regular (ideally annual) assessment of health care
professionals to determine the impact of CSMPs on their use of
controlled substances for the treatment of pain, anxiety, insomnia,
ADHD. How are CSMPs impacting the quality of patient care? Medical
decisions should be based on appropriate assessment of patient needs,
not on fears of regulators."

**[References]{.smallcaps}**

Alliance for Model State Drug Laws (2006). *State Prescription
Monitoring Statutes and Regulations Citation List*. Alexandria, VA: The
Alliance.

Alliance of States with Prescription Monitoring Programs and National
Association of State Controlled Substances Authorities (2002).
*Background Information on the Prescription Monitoring Program Model
Act*. Troy, NY: The Alliance and the Association, October.

Alliance of States with Prescription Monitoring Programs and National
Association of State Controlled Substances Authorities (1999). *The
Goals of Prescription Monitoring*. Troy, NY: The Alliance and the
Association.

Alliance of States with Prescription Monitoring Programs (2006).
*Alliance of States with Prescription Monitoring Programs Web site.*
\[On-line\]. Retrieved October 16, 2006 from the World Wide Web:
[http://www.nascsa.org]{.underline}.

Amato, Davoli, 2004.Amato L, Davoli M, Perucci CA et al. (2005). An
overview of systematic reviews of the effectiveness of opiate
maintenance therapies: Available evidence to inform clinical practice
and research. *Journal of Substance Abuse Treatment,* 28: 321-329.

American Academy of Pain Medicine and American Pain Society (1997). *The
Use of Opioids for the Treatment of Chronic Pain*. Glenview, IL.American
Pain Society.

American Pain Society.American Academy of Pain Medicine, American Pain
Society, and the American Society of Addiction Medicine (2001).
*Definitions Related to the Use of Opioids in the Treatment of Chronic
Pain.* Glenview, IL: American Pain Society.

American Academy of Pain Medicine, American Pain Society, and the
American Society of Addiction Medicine (2001). *Definitions Related to
the Use of Opioids in the Treatment of Chronic Pain.* Glenview, IL:
American Pain Society.

American Academy of Pain Medicine, American Pain Society, and the
American Society of Addiction Medicine (2001). *Definitions Related to
the Use of Opioids in the Treatment of Chronic Pain.* Glenview, IL:
American Pain Society.

American Alliance of Cancer Pain Initiatives (2002). *AACPI Statement on
State Prescription Monitoring Programs*. Madison, WI: The Alliance,
June.

American Bar Association (ABA) Commission on Legal Problems of the
Elderly (2000). *Report to the House of Delegates --- Proposed ABA
Policy on Legal Obstacles to Effective Pain Management.* Chicago, IL:
The Association, April (accessed at:
[www.abanet.org/ftp/pub/elderly/painmanagement.pdf](http://www.abanet.org/ftp/%0Bpub/elderly/painmanagement.pdf)).

American Chronic Pain Association (2005). *Medications and Chronic Pain:
Supplement 2005*. Rocklin, CA: The Association.

> American Geriatrics Society (AGS) Panel on Persistent Pain in Older
> Persons (2002). The management of persistent pain in older persons.
> *Journal of the American Geriatrics Society,* 50(6S):S205-S224
> (accessed at:
> [http://www.americangeriatrics.org/education/manage_pers_pain.shtml]{.underline}).

American Medical Association (1999). Use of Opioids in Chronic Noncancer
Pain (Report 11 of the Council on Scientific Affairs). *Proceedings of
the House of Delegates of the American Medical Association.* Chicago,
IL: The Association (accessed at:
[www.amaassn.org/ama/pub/category/11541.html](http://www.amaassn.org/ama/pub/category/11541.html)).

American Medical Association (2005). Pain Management Using Opioid
Analgesics. *Proceedings of the House of Delegates of the American
Medical Association.* Chicago, IL: The Association (accessed at:
[www.ama-assn.org/ama/pub/category/11541.html](http://www.ama-assn.org/ama/pub/category/11541.html)).

American Methadone Treatment Association (1998). *Survey of Methadone
Treatment Programs*. New York, NY: The Association.

American Pain Society (1999). *Guideline for the Management of Acute and
Chronic Pain in Sickle Cell Disease (Clinical Practice Guideline Number
1).* Glenview, IL: The Society.

American Pain Society (1999). *Guideline for the Management of Cancer
Pain in Adults and Children (Clinical Practice Guideline Number 2).*
Glenview, IL: The Society.

American Pain Society (2004). *Guideline for the Management of Acute and
Chronic Pain in Sickle Cell Disease (Clinical Practice Guideline Number
1).* Glenview, IL: The Society.

American Pain Society (APS) (1999). *Principles of Analgesic Use in the
Treatment of Acute Pain and Cancer Pain, 4th Edition*. Glenview, IL: The
Society.

American Psychiatric Association (1994). *Diagnostic and Statistical
Manual of Mental Disorders, 4^th^ Edition*. Washington, DC: American
Psychiatric Press.

Anderson KO, Mendoza TR, Valero V, et al. (2000). Minority cancer
patients and their providers: Pain management attitudes and practice.
*Cancer,* 88(8): 1929-1938.

Anderson M, Kragstrup J and Sandergaard J (2006). How conducting a
clinical trial affects physicians' guideline adherence and drug
preferences. *Journal of the American Medical Association,* 295(23):
2759-2764.

Barrett K and Watson A (2005). Physician perspectives on a pilot
prescription monitoring program. *Journal of Pain and Palliative Care
Pharmacotherapies,* 19(3): 5-13.

Bearn J, de Wet C and Reed L (2005). Trends in prescribing buprenorphine
(letter). *Addiction,* 100(9): 1374-1375.

Bernabei R, Gambassi G, Lapane K, et al. (1998). Management of pain in
elderly patients with cancer. *Journal of the American Medical
Association,* 279(23): 1877-1882.

Bjornstad G and Montgomery P (2005). Family therapy for
attention-deficit disorder or attention-deficit/hyperactivity disorder
in children and adolescents. *Cochrane Database System Review,* 18(2):
CD005042.

Bonham V. (2001). Race, ethnicity and pain treatment: Striving to
understand the causes and solutions to the disparities in pain
treatment. *Journal Law Medical Ethics,* 29(1): 52-69.

Bossert EA, Van Cleve L and Savedra MC (1996). Children with cancer: The
pain experience away from the health care setting. *Journal of Pediatric
Oncologic Nursing,* 13(3): 109-120.

Breitbart W and Dibiase L (2002a). Current perspectives on pain in AIDS:
Part 1. *Oncology,* 16(6): 818-835.

Breitbart W, Passik S, McDonald MV, et al. (1998). Patient-related
barriers to pain management in ambulatory AIDS patients. *Pain,* 76,
9-16.

Brown RT, Amler RW, Freeman WS, et al., for the American Academy of
Pediatrics Committee on Quality Improvement; Subcommittee on
Attention-Deficit/Hyperactivity Disorder (2005). Treatment of
attention-deficit/hyperactivity disorder: Overview of the evidence.
*Pediatrics,* 115(6): 749-757.

Brushwood DB (2003). Maximizing the value of electronic prescription
monitoring programs. *Journal of Law, Medicine and Ethics,* 31: 41-54.

CASA (2005). The National Center on Addiction and Substance Abuse at
Columbia University. *Under the counter: The diversion and abuse of
controlled prescription drugs in the U.S.*

Center for Substance Abuse Treatment (1999). *Treatment for Stimulant
Use Disorders.* Treatment Improvement Protocol (TIP) Series 33. DHHS
Publication No. (SMA) 99-3296, Rockville, MD: Substance Abuse and Mental
Health Services Administration.

Center for Substance Abuse Treatment (2004). *Clinical Guidelines for
the Use of Buprenorphine in the Treatment of Opioid Addiction*.
Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No.
(SMA) 04 -3939. Rockville, MD: Substance Abuse and Mental Health
Services Administration.

Center for Substance Abuse Treatment (2005). *Medication-Assisted
Treatment for Opioid Addiction in Opioid Treatment Programs*. Treatment
Improvement Protocol (TIP) Series 43. DHHS Publication No. (SMA)
05-4048. Rockville, MD: Substance Abuse and Mental Health Services
Administration.

Clark HW and Bizzell AC (2005). Federal perspective on the abuse of
prescription stimulants. *Psychiatric Annals,* 35: 261-263.

Cleeland CS, Gonin R, Baez L et al. (1997). Pain and treatment of pain
in minority patients with cancer. *Annals of Internal Medicine,* 127:
813-816.

Collins JJ, Grier HE, Kinney HC, et al. (1995). Control of severe pain
in children with terminal malignancy. *Journal of Pediatrics,* 126(4):
653-657.

Compton WM and Volkow ND (2006). Abuse of prescription drugs and the
risk of addiction. *Drug and Alcohol Dependence* (online; accessed May
26, 2006).

Cooper JR, Czechowicz DJ, Molinari SP, et al., eds. (1993*). Impact of
Prescription Drug Diversion Control Systems on Medical Practice and
Patient Care (NIDA Research Monograph 131).* Rockville, MD: National
Institute on Drug Abuse, National Institutes of Health.

Council of State Governments (2004). Drug abuse in America --
Prescription drug diversion. *Trends Alert*. Lexington, KY: The Council,
April.

[Curtis
LH](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term="Curtis+LH"%5BAuthor%5D),
[Stoddard
J](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term="Stoddard+J"%5BAuthor%5D),
[Radeva
JI](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term="Radeva+JI"%5BAuthor%5D),
et al. (2006a). Geographic variation in the prescription of schedule II
opioid analgesics among outpatients in the United States. *Health
Services Research*, 41: 837-855.

[Curtis
LH](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term="Curtis+LH"%5BAuthor%5D),
[Stoddard
J](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term="Stoddard+J"%5BAuthor%5D),
[Radeva
JI](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itool=pubmed_Abstract&term="Radeva+JI"%5BAuthor%5D),
et al. (2006b). Correction to "Geographic variation in the prescription
of schedule II opioid analgesics among outpatients in the United
States." *Health Services Research*, 41: 856-859.

Dasgupta N, Kramer ED, Zalman MA, et al. (2006). Association between
non-medical and prescriptive usage of opioids. *Drug and Alcohol
Dependence,* 82(2): 135-142.

Department of Health Professions and Virginia State Police (2004).
*Prescription Monitoring Program.* Richmond, VA: Department of Health
Professions and Virginia State Police.

Dey AN and Bloom B (2005). Summary: Health statistics for U.S. children:
National Health Interview Survey, 2003. *Vital Health Statistics*, 223:
1-78.

Doyle AE, Willcutt EG, Seidman LJ et al. (2005).
Attention-deficit/hyperactivity disorder endophenotypes. *Biological
Psychiatry,* 57(11): 1324-1335.

Drayer RA, Henderson J, Reidenberg M (1999). Barriers to better pain
control in hospitalized patients. *Journal of Pain and Symptom
Management*, 17(6), 434-440.

Drug Enforcement Administration (DEA), Office of Diversion Control
(2001). *21 Health Groups Call for Balanced Policy on Prescription Pain
Medication Like OxyContin,* October 23 (accessed at:
<http://www.deadiversion.usdoj.gov/pubs/pressrel/newsrel_102301.pdf>.

Drug Enforcement Administration (DEA), Office of Diversion Control
(1990). *Physician\'s Manual: An Informational Outline of the Controlled
Substances Act of 1970*. Washington, DC: U.S. Department of Justice,
Drug Enforcement Administration.

Drug Enforcement Administration (DEA), Office of Diversion Control
(2002). *Working to Prevent the Diversion and Abuse of OxyContin*®
(accessed at:
[www.deadiversion.usdoj.gov/pubs/brochures/alert_oxycontin/alert_oxy.htm]{.underline}).

DuPont RL, chair (2005). *Non-Medical Use of Methylphenidate: Defining
the Problem, Creating Solutions -- Report of an Advisory Committee to
the Institute for Behavior and Health.* Bethesda, MD: Institute for
Behavior and Health.

Eadie J, personal communication, November 27, 2006.

Edwards CL, Fillingim RB and Keefe F (2001). Topical review: Race,
ethnicity and pain. *Pain,* 94: 133--137.

Faraone SV, Perlis RH, Doyle AE, et al. (2005). Molecular genetics of
attention-deficit/ hyperactivity disorder. *Biological Psychiatry,*
57(11): 1313-1323.

Federation of State Medical Boards of the United States, Inc. (1998).
*Model Guidelines for the Use of Controlled Substances for the Treatment
of Pain* (adopted May 2). Dallas, TX: The Board (accessed at:
<http://www.medsch.wisc.edu/painpolicy/domestic/model.htm>).

Fiellin DA, Kleber H, Trumble-Hejduk JG et al. (2004). Consensus
statement on office-based treatment of opioid dependence using
buprenorphine. *Journal of Substance Abuse Treatment,* 27: 153-159.

Fillenbaum GG, Hanlon JT, et al. (1993). Prescription and
nonprescription drug use among black and white community-residing
elderly. *American Journal of Public Health,* 83(11): 1577-82.

Fillenbaum GG, Horner RD, Hanlon JT, et al. (1996). Factors predicting
change in prescription and nonprescription drug use in a
community-residing black and white elderly population. *Journal of
Clinical Epidemiology,* 49: 587-593.

Fishman SM (2005). From balanced pain care to drug trafficking: The case
of Dr. William Hurwitz and the DEA. *Pain Medicine,* 6(2): 162-164.

Fishman SM (2006a). Pain and politics: DEA, Congress and the courts
(editorial). *Pain Medicine,* 7(1): 87-88.

Fishman SM (2006b). The DEA and pain medicine (editorial). *Pain
Medicine* 7(1).

Flor H, Fydrich T and Turk DC (1992). Efficacy of multidisciplinary pain
treatment centers: A meta-analytic review. *Pain,* 49: 221-230.

Frager G (1996). Pediatric palliative care: Building the model, bridging
the gaps. *Journal of Palliative Care,* 12: 9-12.

Freeman HP and Payne R (2000). Racial injustice in health care. *New
England Journal of Medicine,* 342: 1045-1047.

Fudala PJ and Woody GW (2004). Recent advances in the treatment of
opiate addiction. *Current Psychiatry Reports,* 6: 339-346.

Gallagher R, Hawley P and Yeomans W (2004). A survey of cancer pain
management knowledge and attitudes of British Columbian physicians.
*Pain Research and Management* Winter; 9(4): 188-194.

Gaughan DM, Hughes MD, Seage GR, et al. (2002). The prevalence of pain
in pediatric human immunodeficiency virus/acquired immunodeficiency
syndrome as reported by participants in the Pediatric Late Outcomes
Study. *Pediatrics,* 109(6): 1144-1152.

General Accounting Office (2002). *Prescription Drugs: State Monitoring
Programs Provide Useful Tool To Reduce Diversion.* Washington, DC: GAO
(GAO-02-634), May 17.

[Gilson AM and Joranson DE (2002). U.S. policies relevant to the
prescribing of opioid analgesics for the treatment of pain in patients
with addictive disease. *Clinical Journal of Pain,* 18(4 Suppl):
S91-S98.](http://www.medsch.wisc.edu/painpolicy/publicat/02cjpn/index.htm)

[Gilson AM, Joranson DE, Maurer MA, et al. (2005). Progress to achieve
balanced state policy relevant to pain management and palliative care:
2000-2003. *J Pain Palliat Care* *Pharmacotherapy*, 19(1):
7-20.](http://www.medsch.wisc.edu/painpolicy/publicat/05jppcp/05jppcp.pdf)

Gilson AM, Maurer MA, and Joranson DE (2005). State policy affecting
pain management: Recent improvements and the positive impact of
regulatory health policies. *Health Policy*, 74(2), 192-204.
(<http://www.painpolicy.wisc.edu/publicat/05hlthpol/05hlthpol.pdf>).

Goldman A (1998). ABC of palliative care: Special problems of children.
*British Medical Journal,* 316: 49-52.

Gornick ME, Eggers PW, Reilly TW, et al. (1996). Effects of race and
income on mortality and use of services among Medicare beneficiaries.
*New England Journal of Medicine,* 335: 791-799.

Green CR, Anderson KO, Baker TA, et al. (2003). The unequal burden of
pain: Confronting racial and ethnic disparities in pain. *Pain
Medicine,* 4(3): 277-294.

Green CR, Baker TA, Smith EM, et al. (2003). The effect of race in older
adults presenting for chronic pain management: A comparative study of
black and white Americans. *Journal of Pain,* 4(2): 82-90.

Greenhill LL, Vitiello B, Abikoff H et al. (2003). Developing
methodologies for monitoring long-term safety of psychotropic
medications in children: Report on the NIMH conference, September 25,
2000. *Journal of the American Academy of Child and Adolescent
Psychiatry,* 42(6): 651-655.

Heit HA (2006). The DEA and pain medicine: Trying to get back in
balance. *Pain Medicine,* 7(1): 72-74.

Hollen CJ, Hollen CW, and Stolte K (2000). Hospice and hospital oncology
unit nurses: A comparative survey of knowledge and attitudes about
cancer pain. *Oncology Nursing Forum*, 27(10), 1593-1599.

Howard J and Beckwith L. (1996). Issues in subject recruitment and
retention with pregnant and parenting substance abusing women. *NIDA
Research Monograph, 166: 68-86.*

Huang, N., Cunningham, F., Laurito, C., and Chen, C. (2001). Can we do
better with postoperative pain management? *American Journal of
Surgery*, 182(5), 440-448.

Institute of Medicine (2002). *When Children Die: Improving Palliative
Care and End-of-Life Care for Children and Their Families.* Washington,
DC: National Academy Press (accessed at:
<http://www.nap.edu/books/0309084377/html/index.html>).

Institute of Medicine (1996). *Pathways of Addiction: Opportunities in
Drug Abuse Research.* Washington, DC: National Academy Press.

Jaffe HJ & O'Keeffe C (2003). From morphine clinics to buprenorphine:
Regulating opioid agonist treatment of addiction in the United States.
*Drug and Alcohol Dependence* 70:S3-S1Jaffe HJ & O'Keeffe C (2003). From
morphine clinics to buprenorphine: Regulating opioid agonist treatment
of addiction in the United States. *Drug and Alcohol Dependence* 70:
S3-S11.

Jaffe JH and O'Keeffe C (2003). From morphine clinics to buprenorphine:
Regulating opioid agonist treatment of addiction in the United States.
*Drug and Alcohol Dependence* 70:S3-S11.From morphine clinics to
buprenorphine: Regulating opioid agonist treatment of addiction in the
United States. *Drug and Alcohol Dependence* 70:S3-S11.

Joranson DE and Dahl JS (1989). Achieving balance in drug policy: The
Wisconsin Model. In CS Hill, Jr. and WS Fields (eds.) *Advances in Pain
Research and Therapy, Vol. 11.* New York, NY: Raven Press.

Joranson DE and Gilson AM (2002). Pain management and prescription
monitoring. *Journal of Pain and Symptom Management,* 23: 231--238.

Joranson DE and Gilson AM (2003). Legal and regulatory issues in the
management of pain. In AW Graham, TK Schultz, MF Mayo-Smith, RK Ries and
BB Wilford (eds.) *Principles of Addiction Medicine, Third Edition*.
Chevy Chase, MD: American Society of Addiction Medicine, Inc.,
1465-1474.

Joranson DE and Payne R (2003). Will my pain be managed? In WAD
Edmondson (ed.) *Improving End-of-Life Care: The Role of Attorneys
General*. Washington, DC: National Association of Attorneys General,
27-34.

Joranson DE, Carrow GM, Ryan KM, et al. (2002). Pain management and
prescription monitoring. *Journal of* *Pain and Symptom Management,*
23(3): 231-238.

Joranson DE, Gilson AM, Ryan KM, et al. (2003). Availability of opioid
analgesics for cancer pain relief in children. In: McGrath PJ, Finley GA
(eds.) *Pediatric Pain: Biological and Social Contex*t. Seattle, WA:
IASP Press; 201-216.

Kalivas PW, Volkow ND (2005). The neural basis of addiction: A pathology
of motivation and choice. *American Journal of Psychiatry,* 162:
1403-1413.

Khandker RK and Simoni-Wastila LJ (1998). Differences in prescription
drug utilization and expenditures between Blacks and Whites in the
Georgia Medicaid population. *Inquiry,* 35: 78-87.

Kiev A (1997). Management of clinical trials with new medications for
cocaine dependence and abuse. *NIDA Research Monograph 175*. Rockville,
MD: National Institute on Drug Abuse, 96-117.

[Kreek MJ, Bart G, Lilly C, LaForge KS, Nielsen
DA.](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15734726&query_hl=27)
(2005). Pharmacogenetics and human molecular genetics of opiate and
cocaine addictions and their treatments (Review). *Pharmacol Reviews*
Mar, 57(1): 1-26.

Larue F, Colleau SM, Fontaine A, et al. (1995). Oncologists and primary
care physicians' attitudes toward pain control and morphine prescribing
in France. *Cancer,* 76(11): 2375-2382.

Legal Action Center (2004). *Of Substance* (newsletter). March/April.

Manchikanti L (2006). Prescription drug abuse: What is being done to
address this new drug epidemic? Testimony before the Subcommittee on
Criminal Justice, Drug Policy and Human Resources. *Pain Physician,*
9(4): 287-321 (epub in advance of print).

Manchikanti, L., Whitfield, E., and Pallone F. (2005). Evolution of the
national all schedules prescription electronic reporting act (NASPER): A
public law for balancing treatment of pain and drug abuse and diversion.
*Pain Physician*, 8, 335-347.

Marsch LA, Bickel WK, Badger GJ, et al. (2005). Comparison of
pharmacological treatments for opioid-dependent adolescents. *Archives
of General Psychiatry,* 62: 1157-1164.

McNutt LA, Coles FB, McAuliffe T, et al. (1994). Impact of regulation on
benzodiazepine prescribing to a low income elderly population, New York
State. *Journal of Clinical Epidemiology,* 47: 613-625.

Miaskowski C, Cleary J, Burney R, et al. (2005). Guideline for the
Management of Cancer Pain in Adults and Children. *APS Clinical Practice
Guidelines Series, No. 3*. Glenview, IL: American Pain Society.

Morley-Forster PK, Clark AJ, Speechley M, et al. (2003). Attitudes
toward opioid use for chronic pain: A Canadian physician survey. *Pain
Research and Management* Winter; 8(4): 189-194.

Morrison RS, Wallenstein S, Natale DK, Senzel RS, and Huang L. (2000).
\"We don\'t carry that\"\--Failure of pharmacies in predominantly
nonwhite neighborhoods to stock opioid analgesics. *New England Journal
of Medicine*, 342(14), 1023-1026.

Musto D (1999). *The American Disease*, 3rd Edition. New York, NY:
Oxford University Press.

National Association of State Controlled Substance Authorities (1996).
*Model Prescription Accountability Act.* Richmond, VA: The Association.

National Conference of Commissioners on Uniform State Law (1994).
*Uniform Controlled Substances Act*. Chicago, IL: NCCUSL; July 29-August
5, p. 13.

National Institute on Alcohol Abuse and Alcoholism (2005). *Helping
Patients Who Drink Too Much: A Clinician's Guide, 2005 Edition.*
Bethesda, MD: National Institutes of Health.

National Institute on Drug Abuse (2001). *Prescription Drugs: Abuse and
Addiction (*NIH Pub. No. 01-4881). Bethesda, MD: National Institutes of
Health.

Ng B, Dimsdale JE, Rollnik JD, et al. (1996). The effect of ethnicity on
prescriptions for patient-controlled analgesia for post-operative pain.
*Pain* 66:9-12.

Noah L (2003). Challenges in the Federal regulation of pain management
technologies. *Journal of Law, Medicine and Ethics,* 31(1): 55--74.

Novak S, Nemeth WC and Lawson KA (2004). Trends in medical use and abuse
of sustained-release opioid analgesics: A revisit. *Pain Medicine* Mar,
5(1): 59-65.

Oberlander TF, Symons F, van Dongen K, et al. (2003). Pain in
individuals with developmental disabilities: Challenges for the future.
In JO Dostrovsky, DB Carr and M Koltzenburg (eds.) *Proceedings of the
10th World Congress on Pain*. Seattle, WA: IASP Press, pages 705-723.

Office of Applied Studies (2003a). *NHSDA Report: Non-Medical Use of
Prescription-Type Drugs Among Youths and Young Adults*. Rockville, MD:
Substance Abuse and Mental Health Services Administration, January 16,
page 2.

Office of Applied Studies (2003b). *Emergency Department Trends From the
Drug Abuse Warning Network, Final Estimates 1995-2002*. Rockville, MD:
Substance Abuse and Mental Health Services Administration.

Office of Applied Studies (2005a). *National Survey of Substance Abuse
Treatment Services (N-SSATS), 2000, 2002-2005*. Rockville, MD: Substance
Abuse and Mental Health Services Administration.

Office of Applied Studies (2005b). *Treatment Episode Data Set (TEDS)
Report: Admission to Treatment Programs, 2004.* Rockville, MD: Substance
Abuse and Mental Health Services Administration.

Office of Applied Studies (2006a). *Results from the 2005 National
Survey on Drug Use and Health: National Findings.* Rockville, MD:
Substance Abuse and Mental Health Services Administration.

Office of Applied Studies (2006b). *Drug Abuse Warning Network, 2004:
National Estimates of Drug-Related Emergency Department Visits*. DAWN
Series D-28, DHHS Publication No. (SMA) 06-4143, Rockville, MD.

Office of Applied Studies (2006c). *Misuse of Prescription Drugs: Data
From the 2002, 2003 and 2004 National Surveys on Drug Use and Health*.
Rockville, MD: Substance Abuse and Mental Health Services
Administration.

Office of Applied Studies (2007). *Drug Abuse Warning Network,
2005(4/2006 update).* Rockville, MD: Substance Abuse and Mental Health
Services Administration.

Pain and Policy Studies Group (2003). *Achieving Balance in Federal and
State Pain Policy: A Guide to Evaluation*. (Madison, WI: University of
Wisconsin Comprehensive Cancer Center).

Passik SD and Kirsh KL (2004). Opioid therapy in patients with a history
of substance abuse. *CNS Drugs,* 18(1): 13-25.

Paulozzi LJ, Budnitz DS and Yongli X (2006). Increasing deaths from
opioid analgesics in the United States. *Pharmacoepidemiology and Drug
Safety* (epub ahead of print).

Payne R, Medina E and Hampton JW (2003). Quality of life concerns in
patients with breast cancer: Evidence for disparity of outcomes and
experiences in pain management and palliative care among
African-American women. *Cancer,* 97(1S): 311-317.

Pearson SA, Soumerai S, Mah C et al. (2006). Racial disparities in
access after regulatory surveillance of benzodiazepines. *Archives of
Internal Medicine,* 166, 572-579.

Peine SI, ed. (2000). *A Closer Look at State Prescription Monitoring
Programs*. Washington, DC: Drug Enforcement Administration (accessed at:
[http://www.deadiversion.usdoj.\
gov/pubs/program/rx_monitor/index.html]{.underline}).

Pliszka SR (2005). The neuropsychopharmacology of
attention-deficit/hyperactivity disorder. *Biological Psychiatry*
57(11):1385-1390.

Ponte CD and Johnson-Tribino J (2005). Attitudes and knowledge about
pain: An assessment of West Virginia family physicians. *Family
Medicine* Jul-Aug; 37(7):477-480.

Portenoy R, Dole V, Joseph H, et al. (1997). Pain management and
chemical dependency: Evolving perspectives. *Journal of the American
Medical Association 2*78:592-593.

Potter M, Schafer S, et al., (2001). Opioids for chronic nonmalignant
pain: Attitudes and practices of primary care physicians in the
UCSF/Stanford Collaborative Research Network. *Journal of Family
Practice,* 50(2):145-51.

Remschmidt H (2005). Global consensus on ADHD/HKD. *European Child and
Adolescent Psychiatry* 14(3):127-137.

Ross-Degnan, D., Simoni-Wastila, L., Brown, J. S., Gao, X., Mah, C.,
Cosler, L. E., et al. (2004). A controlled study of the effects of state
surveillance on indicators of problematic and non-problematic
benzodiazepine use in a Medicaid population. *International Journal of
Psychiatry in Medicine, 34*(2), 103-123.

Schneider EC, Zaslavsky AM and Epstein AM (2002). Racial disparities in
the quality of care for enrollees in Medicare managed care. *Journal of
the American Medical Association,* 287, 1288-1294.

Scimeca MM, Savage SR, Portenoy R, et al. (2000). Treatment of pain in
methadone-maintained patients. *Mount Sinai Journal of Medicine,*
67(5-6), 412-422.

Secnik K, Swensen A and Lage MJ (2004). Comorbidities and costs of adult
patients diagnosed with attention deficit hyperactivity disorder.
*Pharmacoeconomics,* 23(1), 93-102.

Sees KL (1999). Pain management in a patient with an addiction history.
*Journal of the American Osteopathic Association,* 99(6: Suppl), 11-15.

Simeone R and Holland L (2006). An Evaluation of Prescription Monitoring
Programs. U.S. Department of Justice, Office of Justice Programs, Bureau
of Justice Assistance.

Simoni-Wastila L and Tompkins C (2001). Balancing diversion control and
medical necessity: The case of prescription drugs with abuse potential.
*Substance Use and* *Misuse, 36(9-10), 1275-1296.*

Simoni-Wastila L (2000). The use of abusable prescription drugs: The
role of gender. Journal of Women's Health and Gender-Based Medicine,
9(3), 289-297.

Simoni-Wastila, L., Ross-Degnan, D., Mah, C., Gao, X., Brown, J.,
Cosler, L. E., et al. (2004). A retrospective data analysis of the
impact of the New York triplicate prescription program on benzodiazepine
use in Medicaid patients with chronic psychiatric and neurologic
disorders. *Clinical Therapeutics, 26*(2), 322-336.

Smith MY and Woody G (2005). Non-medical use and abuse of scheduled
medications prescribed for pain, pain-related symptoms, and psychiatric
disorders: patterns, user characteristics, and management options.
*Current Psychiatry Reports*, 337-343.

Swartz M, Landerman R, George LK, et al. (1991). Benzodiazepine
anti-anxiety agents: Prevalence and correlates of use in a southern
community. *American Journal of Public Health*, 81, 592-596.

Swenson AR, Birnbaum HG, Secnik K, et al. (2003).
Attention-deficit/hyperactivity disorder: Increased costs for patients
and their families. *Journal of the American Academy of Child and
Adolescent Psychiatry,* 42, 1415-1423.

Teno JM, Weitzen S, Wetle T, et al. (2001). Persistent pain in nursing
home residents (research letter). *Journal of the American Medical
Association,* 285(16), 2081.

Todd KH, Deaton C, D'Adamo AP, et al. (2000). Ethnicity and analgesic
practice. *Annals of Emergency Medicine,* 35(1), 11-16.

Todd KH, Samaroo N and Hoffman JR (1993). Ethnicity as a risk factor for
inadequate emergency department analgesia. *Journal of the American
Medical Association,* 269(12), 1537-1539.

Trauth JM, Musa D, Siminoff L (2000). Public attitudes regarding
willingness to participate in medical research studies. *Journal of
Health and Social Policy,* 12(2), 23-43.

Turk DC and Okifuji A (1997). What factors affect physicians' decisions
to prescribe opioids for chronic noncancer pain patients. *Clinical
Journal of Pain,* 13, 330-336.

Twillman R (2006). Impact of prescription monitoring programs on
prescription patterns and indicators of opioid abuse. *The Journal of
Pain,* 7(4S), 7.

U.S. General Accounting Office. (2002). *Prescription drugs: State
monitoring programs provide useful tool to reduce diversion* (GAO Pub.
No. 02-634). Washington, DC: U.S. General Accounting Office.

Vocci F, Acri J and Elkashef A (2005). Medications development for
addictive disorders: The state of the science. *American Journal of
Psychiatry,* 162, 1432-1440.

Volkow ND, Wang GJ, Fowler JS, et al. (2005). Imaging the effects of
methylphenidate on brain dopamine: New model on its therapeutic actions
for attention-deficit/hyperactivity disorder. *Biological Psychiatry,*
57(11), 1410-1415.

Wagner AK, Soumerai SB, Zhang F, et al. (2003). Effects of state
surveillance on new post-hospitalization benzodiazepine use.
*International Journal for Quality in Health Care,* 15(5), 423-431.

Wastila LJ and Bishop C (1996). The influence of multiple copy
prescription programs on analgesic utilization. *Journal of
Pharmaceutical Care in Pain and Symptom Management,* 4(3), 3-19.

Weinstein SM, et al. (2000). Physicians' attitudes toward pain and the
use of opioid analgesics: Results of a survey from the Texas Cancer Pain
Initiative. *Southern Medical Journal,* 93, 479--487.

Wilford BB and Deatsch JH (2003). Prescribing Controlled Drugs: Helping
Your Patients, Protecting Your Practice (course syllabus). Tampa, FL:
University of South Florida College of Medicine.

Wilford BB, Smith DE and Bucher RD (2005). Internet pharmacy: A new
source of abused drugs. *Psychiatric Annals*, 35(3), 241-252.

Wolfe J, Grier HE, Klar N, et al. (2000). Symptoms and suffering at the
end of life in children with cancer. *New England Journal of Medicine,*
342, 326-333.

World Health Organization (1996). *Cancer Pain Relief, With a Guide to
Opioid Availability*. Geneva, Switzerland: WHO.

Zacny J, Bigelow G, Compton P, Foley K, Iguchi M and Sannerud C (2003).
College on Problems of Drug Dependence taskforce on prescription opioid
non-medical use and abuse: Position statement. Drug and Alcohol
Dependence, 69, 215-232.

**[Appendix A: Methodology]{.smallcaps}**

[Timeline]{.smallcaps}

The work plan for the assessment was approved by CSAT on April 26, 2006.
The assessment research was conducted between April 30 and June 30,
2006. The results were compiled and the report drafted between July 1
and July 30, 2006. The report was submitted to CSAT and to a group of
outside experts for review, beginning August 1, 2006. Comments and
suggestions received from CSAT officials and the outside reviewers as of
December 7, 2006, are reflected in this document.

[**Organization**]{.smallcaps}

The assessment was conducted under the direction of senior staff of DB
Consulting Group, Inc. and JBS International, Inc. The work was
conducted by the staffs of those organizations, based on a study design
and work plan approved by CSAT.

**[Sources of Information]{.smallcaps}**

The assessment employed four approaches to information-gathering (i.e.,
literature review, data analysis, key informant questionnaires and
publicly available information). The methods specific to each component
of the assessment are described in the report.

**[The Literature Review]{.smallcaps}**

**Sources**. The medical literature published since 1980 -- that is,
within the past 25 years -- was the subject of a search through the
National Library of Medicine's PubMed system. To ensure that no relevant
literature was overlooked, a separate search was conducted through the
library at England's Cambridge University.

In addition, a Library Information Specialist contacted the manager of
each state CSMP to ask if the State had published a report, study or
evaluation of the CSMP. If so, a copy of the document was requested.

**Methods**. The Library Information Specialist first searched for any
reports or evaluations produced by or for the States that operate CSMPs.
In each of those States, the manager of the CSMP was contacted by phone
and asked if the State had published a report, study or evaluation of
the controlled substance monitoring program. If so, a copy of the
document was requested.

For the literature search, the principal search terms employed were:

-   National All Schedules Prescription Electronic Reporting Act/NASPER

-   Prescription monitoring program/PMP

-   Triplicate prescription program/TPP/3Rx

-   Multiple-copy prescription program/MCPP

-   Prescription monitoring/prescription control

-   Prescription drug diversion/prescription drug abuse

-   Controlled substances/controlled drugs

-   Barriers to medication use/hassle factor/chilling effect

Only articles published in peer-reviewed journals or reports sponsored
by established organizations (e.g., government entities, health
professions associations or academic institutions) were selected for
review.

**Limitations.** The principal limitation encountered in conducting the
literature review, which affects all research of this type, is related
to the lag time between the occurrence of an event, completion of an
article describing it, submission to and peer review/acceptance by a
journal, and actual publication of the article. With the leading
peer-reviewed journals, this process frequently requires 12 to 18
months. Thus, it is difficult to find published articles on very recent
events.

**Results.** The literature search yielded more than 400 articles
published in peer-reviewed journals, of which approximately 275 were
found to be relevant to the assessment. In addition, reports were
obtained from the CSMPs in 11 States: California, Hawaii, Illinois,
Indiana, Kentucky, Maine, Massachusetts, Michigan, Oklahoma, Virginia,
and Washington State (see Appendix D).

**[The Data Analysis]{.smallcaps}**

**Sources**. The data analysis employed information from publicly
accessible datasets, such as the Automation of Reports and Consolidated
Orders System (ARCOS) data from the Drug Enforcement Administration. One
of the indicators of the impact of a CSMP on access to pharmacotherapies
is the volume of drugs distributed before and after enactment of laws
establishing a CSMP, as well as comparative data on drug distribution
within CSMP and non-CSMP States. ARCOS allows measurement of such
distribution through its comprehensive drug reporting system that
monitors the flow of DEA controlled substances from their point of
manufacture through commercial distribution channels to point of sale or
distribution at the retail level through hospitals, retail pharmacies,
practitioners, and teaching institutions.

The study was enhanced by access to preliminary findings of research
under way by the Center for Financing Access and Cost Trends of the
Agency for Healthcare Research and Quality (AHRQ), using data from the
Medical Expenditure Panel Survey (MEPS) to examine the association
between State CSMPs and purchases of Schedule II drugs. MEPS is an
ongoing survey that collects nationally representative data on health
care utilization, expenditures, sources of payment, insurance coverage,
and health status for the U.S. civilian, non-institutionalized
population.

**Methods**. With the ARCOS data, DEA's reports of total drug
distribution at the national and State levels were employed, as were the
DEA rankings of States by per capita consumption.

Within MEPS, the Prescribed Medicines (PMED) files capture date on
households' reported use of outpatient prescription drugs (drugs used in
inpatient hospital, nursing home, or other institutional setting are not
included). Household respondents are asked for permission to contact
pharmacies and for every reported use of a prescribed medicine during
the survey year, pharmacies are asked to provide computerized printouts
containing information on the medication name, national drug code (NDC),
strength, quantity, total charge, and payments by source.

Data were drawn from the MEPS household component for the years 1996
through 2003. Investigators assigned each drug mentioned in MEPS to a
therapeutic class, subclass, active ingredient, brand name and CSA
Schedule, using the National Drug Code to link the PMED files to the
Multum Lexicon database (a proprietary product of Cerner Multum, Inc.).
Information on implementation of State CSMPs was taken from a table
prepared by the national Alliance for Model State Drug Laws. They then
compared drug use in States that had a CSMP with States that never had a
CSMP for every year from 1996-2003 (States that first implemented a CSMP
during the study period were excluded from the analysis).

**Published Studies.** To compensate for some of the limitations of the
available datasets (such as the lack of statistical information on the
benzodiazepines), the researchers also sought out epidemiologic and
other data-based studies published in peer-reviewed journals. The data
in such studies were incorporated into the report wherever they were
found to shed additional light on the issues addressed in the
assessment.

**Limitations.** Because of changes in Federal data collection methods,
only ARCOS data for the years 1997 through 2004, plus the first six
months of 2005, were suitable for the assessment. This limitation should
be borne in mind when reviewing the findings presented here.

**Results.** With the ARCOS data, DEA's reports of total drug
distribution at the national and State levels were employed, as were the
DEA rankings of States by per capita consumption.

With the MEPS data, two different indicators of Schedule II drug use
were used: 1) the percentage of persons who made any purchase of a
Schedule II drug during the year; and 2) the average number of purchases
per person. Both measures were examined for four classes of drugs: all
Schedule II drugs, Schedule II and Schedule III combination analgesic
products, Schedule II stimulants.

**[Key Informants]{.smallcaps}**

**Sources**. Key informants were selected to represent the populations
identified in the NASPER statute, as well as to be representative of
States that have adopted CSMPs. A list of 24 national organizations, six
types of State organizations, and 12 potential study States were
identified as appropriate sources of information (Appendix C). From
these lists, a narrower group of nine national organizations, four types
of State organizations, and nine study States were selected. Once the
organizations were identified, each was contacted to identify a specific
key informant.

**Methods**. Information was collected through use of a series of
structured questionnaires (Appendix C), which consisted of 14 questions,
some with branching sub-questions. Questions invited multiple types of
responses, including "Yes/No," Likert scale, and open-ended responses.
Some questions asked about the policies or activities of an organization
(e.g., "Does your organization have a formal position on NASPER?"),
while other questions asked about opinions and/or experiences reported
by the organizations' members (e.g., "If your organization has received
reports that prescription monitoring programs are having a negative
impact on access to pharmacotherapies, how would you characterize the
intensity of that effect?)

**Limitations*. ***This component of the assessment encountered a number
of process and content limitations specific to this assignment, as well
as limitations routinely encountered in studies of this type. The
principal process limitations were:

-   Some national organizations had yet to develop formal position
    statements on the Federal NASPER statute or State CSMPs.

-   The executives of some organizations, at both the national and State
    levels, were unwilling to participate without first consulting with
    or obtaining the approval of their Boards of Directors -- a process
    that could not be completed within the timeframe of the study.

-   Because of the short study period, there was not sufficient time for
    a large survey and the burden imposed by the questionnaires had to
    be kept within carefully defined limits.

-   Many State organizations operated in jurisdictions that had enacted
    but not yet fully implemented their CSMPs (a process that typically
    requires about two years), so their actual experience with the
    programs was somewhat limited.

The principal content limitations are related to the small number of
participants and the limited time available to administer the
questionnaires. For example:

-   Given the limit on the number of potential participants, the sample
    could not be fully representative of the geographically and
    demographically diverse populations of patients and providers
    identified in the NASPER Act.

-   Also because of the small number of participants, a robust response
    from one community or type of organization had the potential to
    exert a larger effect on the overall results than would have been
    the case with a larger pool of responders.

-   In States that had adopted but not yet fully implemented CSMPs, the
    only effect that could be measured was that of discussion and debate
    around adoption of the CSMP, rather than its actual operation. Some
    reports in the literature describe such "expectation effects" as
    potentially more intense than the effects arising from actual
    experience with a program.

Finally, several limitations are common to studies of this type and
should be considered when interpreting the results:

-   The self-report nature of the questionnaires means that results are
    limited by the potential inaccuracy of human recall.

-   Despite the application of rigorous methods, some limitations to the
    study design could not be avoided. For example, the small sample
    size limits the generalizability of the findings.

-   In an effort to maximize the opportunity to obtain useful
    information, the participants selected were those most likely to be
    knowledgeable about CSMPs. While this group was unusually productive
    in terms of collecting information, it was not representative of the
    universe of health care professionals or patient advocacy
    organizations.

**Results.** Of the nine national organizations invited to participate,
five or 55.6 percent had key informants complete and return
questionnaires. Of the 36 State-level organizations invited to
participate, 18 or 50 percent had key informants complete and return
questionnaires. In total, completed questionnaires were received from
key informants representing 23 of the 45 organizations invited to
participate, for a response rate of 51 percent. The distribution of key
informants is depicted in Appendix C.

Several national and State organizations declined the invitation to
participate or did not return a completed questionnaire. Reasons cited
for non-participation included insufficient time to prepare a response,
as well as concern about the political ramifications of expressing an
opinion on this politically sensitive topic (despite assurances of
confidentiality). A number of organizations accepted the invitation to
submit related documents (position papers, testimony, etc.), which were
analyzed for this report.

**[Limitations]{.smallcaps}**

Because of the relative recency with which most of the electronic
monitoring systems have been implemented, it was not possible to gather
enough data on the performance of electronic CSMPs to support a
conclusion as to whether they have a substantial negative impact on
access to treatment.

For example, a large-scale survey of stakeholder groups or physician and
patient populations, while desirable, would have required approval of
the Office of Management and Budget and thus could not be undertaken.
Similarly, time and resource limitations precluded the use of data from
private vendors such as health insurers, pharmaceutical benefit
managers, or firms such as the IMS National Prescription Audit Plus.
(Such datasets are ideally suited to studies of this type because they
capture information on drugs actually dispensed by brand name,
formulation and strength; and track the distribution to very small
geographic areas.)

Therefore, the assessment compiled available information on *all*
prescription monitoring systems -- paper-based or electronic -- and
analyzed it for relevance to the current assignment. The results are
presented in this report.

**[Appendix B: Federal Schedules of Controlled Drugs]{.smallcaps}**

Certain drugs, called "controlled substances," are subject to additional
requirements of the Controlled Substances Act (CSA). The CSA is designed
to ensure both the availability and control of regulated substances. Its
requirements parallel the provisions of international treaties to which
the United States is signatory. Under the CSA, availability of regulated
drugs is accomplished through a system that establishes quotas for drug
production and a distribution system that closely monitor the
importation, manufacture, distribution, prescribing, dispensing,
administering, and possession of controlled drugs. To effectively
regulate the availability of and commerce in controlled substances, and
to comply with international treaty obligations, the CSA established an
elaborate system of administrative reporting requirements to track
regulated drugs and chemicals from their point of origin to the end-user
at the retail pharmacy or health care facility. Civil and criminal
sanctions for serious violations of the statute are part of the
government\'s control apparatus. The Drug Enforcement Administration
(DEA) implements the CSA through guidelines set out in Title 21, Chapter
II, of the Code of Federal Regulations.

The CSA provides that responsibility for scheduling controlled
substances is shared between the FDA and the DEA. In granting regulatory
authority to these agencies, the Congress noted that both public health
and public safety needs are important and that neither takes primacy
over the other, but that both are necessary to ensure the public
welfare. To accomplish this, the Congress provided guidance in the form
of factors that must be considered by the FDA and DEA when assessing
public health and safety issues related to a new drug or one that is
being considered for rescheduling or removal from control. The factors
that must be considered in deciding whether a drug ought to be
controlled and, if so, in what schedule include:

• The drug\'s actual or relative potential for abuse.

• Scientific evidence of the drug\'s pharmacologic effects, if known.

• The state of current scientific knowledge regarding the drug.

• The drug\'s history and current pattern of abuse.

• The scope, duration and significance of abuse.

• The degree of risk (if any) the drug poses to the public health.

• The drug\'s \"psychic or physiological dependence liability.\"

• Whether the drug is an immediate precursor of a substance already
controlled.

The CSA designates the Attorney General, after consultation with the
Secretary of Health and Human Services, as the official who determines
the appropriate schedule for any drug or other substance proposed to be
controlled in, or removed from, the Schedules. (The Attorney General and
the Secretary of Health and Human Services have delegated the authority
for making these determinations to the DEA and FDA, respectively.) The
factors cited earlier must be used in establishing findings that justify
the level of scheduling, according to the following standards and
definitions:

*Schedule I* drugs and other substances have a high potential for abuse
and no currently accepted medical use, and there is a lack of accepted
safety for use of the drug or other substance under medical supervision.
Thus, these drugs are not available for medical practice. Schedule I
includes certain opium derivatives (heroin), some synthetic opioids
(alpha-methylfentanyl), and the hallucinogens (LSD).

*Schedule II* drugs and other substances have a high potential for abuse
and a currently accepted medical use in treatment in the U.S. with
severe restrictions; abuse of the drug or other substance may lead to
severe psychological or physical dependence. Opioid analgesics,
stimulants such as the amphetamines and methylpheni­date, and the
short-acting barbitu­rates are in this schedule.

*Schedule III* drugs and other substances have less potential for abuse
than drugs in Schedules I and II and a currently accepted medical use in
treatment in the U.S.; abuse of the drug or other substance may lead to
moderate or low physical dependence or high psychological dependence.
Some stimulant and depressant drugs (such as barbiturates not included
in other schedules), as well as preparations containing limited
quantities of codeine, are in this schedule.

*Schedule IV* drugs and other substances have a low potential for abuse
relative to the drugs or other substances in Schedule III and a
currently accepted medical use in treatment in the U.S., as well as a
limited potential to produce physical or psychological dependence
relative to the drugs in Schedule III. Drugs included in this schedule
include certain sedative-hypnotics and anti-anxiety agents not in
another schedule (e.g., phenobarbital and the benzodiazepines),
analgesics such as pentazocine and propoxyphene, and the stimulant drug
phenter­mine.

*Schedule V* drugs and other substances (including a few
over-the-counter preparations) have a low potential for abuse relative
to the drugs or other substances in Schedule IV and a currently accepted
medical use in treatment in the U.S.; they have limited potential to
produce physical or psychological dependence relative to the drugs in
Schedule IV. Antitussive, antidiarrheal, and other mixtures containing
limited quantities of opioids with nonopioid drugs are included in this
schedule (CSA, 1970).

Note that some drugs are classified in more than one schedule. For
example, codeine alone is classified in Schedule II, but combination
products containing codeine (such as Tylenol #3, Tussionex, and Vicodin)
are classified in Schedule III.

**NOTE: The following table is based on Federal law. State law may
result in different classifi­cations.**

+------------+-----------+----------+----------+----------+-----------+
|            | *         | **       | **       | **       | *         |
|            | *Schedule | Schedule | Schedule | Schedule | *Schedule |
|            | I**       | II**     | III**    | IV**     | V**       |
+------------+-----------+----------+----------+----------+-----------+
| **OPIOID   | Benzy     | Codeine  | Bupre    | Prop     | Opium     |
| AGONISTS** | lmorphine |          | norphine | oxyphene |           |
|            |           | various  |          |          | pre       |
|            | Dihydrom  |          | B        | Darvon®  | para­tions |
|            | orphinone | Fentanyl | uprenex® |          |           |
|            |           |          |          | D        | Donnagel  |
|            | Heroin    | Su       | Subutex® | arvocet® | PG®       |
|            |           | blimaze® |          |          |           |
|            | Ket       |          | Codeine  |          | Kao       |
|            | obemidone | Hyd      |          |          | pectalin® |
|            |           | rocodone | c        |          |           |
|            | Lev       |          | om­pounds |          |           |
|            | omoramide | Hydro    |          |          |           |
|            |           | mor­phone | Tylenol  |          |           |
|            | Morphine- |          | #3®      |          |           |
|            |           | D        |          |          |           |
|            | methyl    | ilaudid® | Hyd      |          |           |
|            | sulfanote |          | rocodone |          |           |
|            |           | Me       |          |          |           |
|            | Ni        | peridine | c        |          |           |
|            | cocodeine |          | ompounds |          |           |
|            |           | Demer­ol® |          |          |           |
|            | Nic       |          | Lorcet®  |          |           |
|            | omorphine | M        |          |          |           |
|            |           | ethadone | Lortabs® |          |           |
|            | Rac       |          |          |          |           |
|            | emo­ramide | Morphine | Tu       |          |           |
|            |           |          | ssionex® |          |           |
|            |           | O        |          |          |           |
|            |           | xycodone | Vicodin® |          |           |
|            |           |          |          |          |           |
|            |           | Endocet® |          |          |           |
|            |           |          |          |          |           |
|            |           | Ox       |          |          |           |
|            |           | yContin® |          |          |           |
|            |           |          |          |          |           |
|            |           | P        |          |          |           |
|            |           | ercocet® |          |          |           |
|            |           |          |          |          |           |
|            |           | Oxy      |          |          |           |
|            |           | morphone |          |          |           |
|            |           |          |          |          |           |
|            |           | Nu       |          |          |           |
|            |           | morphan® |          |          |           |
+------------+-----------+----------+----------+----------+-----------+
| **MIXED    |           |          | Bupreno  | Pen      |           |
| AGONIST-** |           |          | rphine + | ­tazo­cine |           |
|            |           |          | naloxone | +        |           |
| **ANT      |           |          |          |          |           |
| AGO­NI­STS** |           |          | S        | naloxone |           |
|            |           |          | uboxone® |          |           |
|            |           |          |          | Ta       |           |
|            |           |          |          | lwin-Nx® |           |
+------------+-----------+----------+----------+----------+-----------+
| **ST       | N-methyl- | Amp      | Benzp    | Diethy   | 1-deoxy-  |
| IMULANTS** |           | hetamine | hetamine | lpropion |           |
|            | am        |          |          |          | ­ephe­drine |
|            | phetam­ine | A        | Didrex®  | Tenuate® |           |
|            |           | dderall® |          |          | Vicks     |
|            | 3,4-methy |          | Pem­oline | Fenf     | Inhal­er®  |
|            | lenedioxy­ | Cocaine  |          | luramine |           |
|            | am        |          | Cylert®  |          |           |
|            | phetamine | Dextro-  |          | Phe      |           |
|            |           |          | Phendi-  | ntermine |           |
|            | MDMA,     | amp      |          |          |           |
|            | Ecstasy   | het­a­mine | m        | Fastin®  |           |
|            |           |          | etra­zine |          |           |
|            |           | De       |          |          |           |
|            |           | xedrine® | Plegine® |          |           |
|            |           |          |          |          |           |
|            |           | Methamp  |          |          |           |
|            |           | het­amine |          |          |           |
|            |           |          |          |          |           |
|            |           | Desoxyn® |          |          |           |
|            |           |          |          |          |           |
|            |           | Methylp  |          |          |           |
|            |           | henidate |          |          |           |
|            |           |          |          |          |           |
|            |           | C        |          |          |           |
|            |           | oncerta® |          |          |           |
|            |           |          |          |          |           |
|            |           | M        |          |          |           |
|            |           | etadate® |          |          |           |
|            |           |          |          |          |           |
|            |           | Ritalin® |          |          |           |
|            |           |          |          |          |           |
|            |           | Phenm    |          |          |           |
|            |           | etra­zine |          |          |           |
|            |           |          |          |          |           |
|            |           | Fastin®  |          |          |           |
|            |           |          |          |          |           |
|            |           | P        |          |          |           |
|            |           | reludin® |          |          |           |
+------------+-----------+----------+----------+----------+-----------+
| **HALLU-** | Lysergic  |          | Dr       |          |           |
|            | acid      |          | onabinol |          |           |
| **C        |           |          |          |          |           |
| INO­GE­NS,** | dia­mine   |          | Marinol® |          |           |
|            |           |          |          |          |           |
| **OTHER**  | LSD       |          |          |          |           |
|            |           |          |          |          |           |
|            | Marijuana |          |          |          |           |
|            |           |          |          |          |           |
|            | Mescaline |          |          |          |           |
|            |           |          |          |          |           |
|            | Peyote    |          |          |          |           |
|            |           |          |          |          |           |
|            | Phen      |          |          |          |           |
|            | cyclidine |          |          |          |           |
|            |           |          |          |          |           |
|            | PCP       |          |          |          |           |
|            |           |          |          |          |           |
|            | P         |          |          |          |           |
|            | silocybin |          |          |          |           |
|            |           |          |          |          |           |
|            | Te        |          |          |          |           |
|            | trahydro- |          |          |          |           |
|            |           |          |          |          |           |
|            | c­a        |          |          |          |           |
|            | n­nabinols |          |          |          |           |
+------------+-----------+----------+----------+----------+-----------+
| **S        | Met       | Amo      | Buta     | Al       | Diph      |
| EDATIVE-** | haqualone | barbital | barbital | prazolam | enoxylate |
|            |           |          |          |          |           |
| **H        | Quaalude® | Amytal®  | Butisol® | Xanax®   | pre       |
| YPNOTICS** |           |          |          |          | parations |
|            | Gamm      | Glut     | Bu       | Chl      |           |
|            | a-hydroxy | ethi­mide | tal­bital | ordiaze- | Lomotil®  |
|            |           |          |          |          |           |
|            | butyrate  | Doriden® | F        | pox­ide   |           |
|            |           |          | iorecet® |          |           |
|            | GHB       | Pento    |          | Librium® |           |
|            |           | barbital | F        |          |           |
|            |           |          | iorinal® | Chloral  |           |
|            |           | N        |          | betaine  |           |
|            |           | embutal® | Met      |          |           |
|            |           |          | hyprylon | Chloral  |           |
|            |           | Seco     |          | hydrate  |           |
|            |           | barb­ital | Noludar® |          |           |
|            |           |          |          | Noctec®  |           |
|            |           | Seconal® |          |          |           |
|            |           |          |          | Cl       |           |
|            |           |          |          | ona­zepam |           |
|            |           |          |          |          |           |
|            |           |          |          | K        |           |
|            |           |          |          | lonopin® |           |
|            |           |          |          |          |           |
|            |           |          |          | Clo      |           |
|            |           |          |          | r­azepate |           |
|            |           |          |          |          |           |
|            |           |          |          | T        |           |
|            |           |          |          | ranxene® |           |
|            |           |          |          |          |           |
|            |           |          |          | Diazepam |           |
|            |           |          |          |          |           |
|            |           |          |          | Valium®  |           |
|            |           |          |          |          |           |
|            |           |          |          | E        |           |
|            |           |          |          | stazolam |           |
|            |           |          |          |          |           |
|            |           |          |          | Prosom®  |           |
|            |           |          |          |          |           |
|            |           |          |          | Ethch    |           |
|            |           |          |          | lorvynol |           |
|            |           |          |          |          |           |
|            |           |          |          | P        |           |
|            |           |          |          | lacidyl® |           |
|            |           |          |          |          |           |
|            |           |          |          | Et       |           |
|            |           |          |          | hinamate |           |
|            |           |          |          |          |           |
|            |           |          |          | Fl       |           |
|            |           |          |          | urazepam |           |
|            |           |          |          |          |           |
|            |           |          |          | Dalmane® |           |
|            |           |          |          |          |           |
|            |           |          |          | H        |           |
|            |           |          |          | alazepam |           |
|            |           |          |          |          |           |
|            |           |          |          | Paxipam® |           |
|            |           |          |          |          |           |
|            |           |          |          | L        |           |
|            |           |          |          | orazepam |           |
|            |           |          |          |          |           |
|            |           |          |          | Ativan®  |           |
|            |           |          |          |          |           |
|            |           |          |          | M        |           |
|            |           |          |          | azindol® |           |
|            |           |          |          |          |           |
|            |           |          |          | Sanorex® |           |
|            |           |          |          |          |           |
|            |           |          |          | Mepho    |           |
|            |           |          |          | barbital |           |
|            |           |          |          |          |           |
|            |           |          |          | Mebaral® |           |
|            |           |          |          |          |           |
|            |           |          |          | Mep      |           |
|            |           |          |          | robamate |           |
|            |           |          |          |          |           |
|            |           |          |          | Equanil® |           |
|            |           |          |          |          |           |
|            |           |          |          | Meth     |           |
|            |           |          |          | ohexital |           |
|            |           |          |          |          |           |
|            |           |          |          | Brevital |           |
|            |           |          |          |          |           |
|            |           |          |          | Sodi­um®  |           |
|            |           |          |          |          |           |
|            |           |          |          | Methyl-  |           |
|            |           |          |          |          |           |
|            |           |          |          | pheno    |           |
|            |           |          |          | bar­bital |           |
|            |           |          |          |          |           |
|            |           |          |          | M        |           |
|            |           |          |          | idazolam |           |
|            |           |          |          |          |           |
|            |           |          |          | Versed®  |           |
|            |           |          |          |          |           |
|            |           |          |          | Oxazepam |           |
|            |           |          |          |          |           |
|            |           |          |          | Serax®   |           |
|            |           |          |          |          |           |
|            |           |          |          | Par      |           |
|            |           |          |          | aldehyde |           |
|            |           |          |          |          |           |
|            |           |          |          | Paral®   |           |
|            |           |          |          |          |           |
|            |           |          |          | Pheno    |           |
|            |           |          |          | barbital |           |
|            |           |          |          |          |           |
|            |           |          |          | Luminal® |           |
|            |           |          |          |          |           |
|            |           |          |          | Prazepam |           |
|            |           |          |          |          |           |
|            |           |          |          | Centrax® |           |
|            |           |          |          |          |           |
|            |           |          |          | T        |           |
|            |           |          |          | emazepam |           |
|            |           |          |          |          |           |
|            |           |          |          | R        |           |
|            |           |          |          | estoril® |           |
|            |           |          |          |          |           |
|            |           |          |          | T        |           |
|            |           |          |          | riazolam |           |
|            |           |          |          |          |           |
|            |           |          |          | Halcion® |           |
|            |           |          |          |          |           |
|            |           |          |          | Zaleplon |           |
|            |           |          |          |          |           |
|            |           |          |          | Sonata®  |           |
|            |           |          |          |          |           |
|            |           |          |          | Zolpidem |           |
|            |           |          |          |          |           |
|            |           |          |          | Ambien®  |           |
+------------+-----------+----------+----------+----------+-----------+
| **OPIOID   | Benzy     | Codeine  | Bupre    | Prop     | Opium     |
| AGONISTS** | lmorphine |          | norphine | oxyphene |           |
|            |           | various  |          |          | pre       |
|            | Dihydrom  |          | B        | Darvon®  | para­tions |
|            | orphinone | Fentanyl | uprenex® |          |           |
|            |           |          |          | D        | Donnagel  |
|            | Heroin    | Su       | Subutex® | arvocet® | PG®       |
|            |           | blimaze® |          |          |           |
|            | Ket       |          | Codeine  |          | Kao       |
|            | obemidone | Hyd      |          |          | pectalin® |
|            |           | rocodone | c        |          |           |
|            | Lev       |          | om­pounds |          |           |
|            | omoramide | Hydro    |          |          |           |
|            |           | mor­phone | Tylenol  |          |           |
|            | Morphine- |          | #3®      |          |           |
|            |           | D        |          |          |           |
|            | methyl    | ilaudid® | Hyd      |          |           |
|            | sulfanote |          | rocodone |          |           |
|            |           | Me       |          |          |           |
|            | Ni        | peridine | c        |          |           |
|            | cocodeine |          | ompounds |          |           |
|            |           | Demer­ol® |          |          |           |
|            | Nic       |          | Lorcet®  |          |           |
|            | omorphine | M        |          |          |           |
|            |           | ethadone | Lortabs® |          |           |
|            | Rac       |          |          |          |           |
|            | emo­ramide | Morphine | Tu       |          |           |
|            |           |          | ssionex® |          |           |
|            |           | O        |          |          |           |
|            |           | xycodone | Vicodin® |          |           |
|            |           |          |          |          |           |
|            |           | Endocet® |          |          |           |
|            |           |          |          |          |           |
|            |           | Ox       |          |          |           |
|            |           | yContin® |          |          |           |
|            |           |          |          |          |           |
|            |           | P        |          |          |           |
|            |           | ercocet® |          |          |           |
|            |           |          |          |          |           |
|            |           | Oxy      |          |          |           |
|            |           | morphone |          |          |           |
|            |           |          |          |          |           |
|            |           | Nu       |          |          |           |
|            |           | morphan® |          |          |           |
+------------+-----------+----------+----------+----------+-----------+
| **MIXED    |           |          | Bupreno  | Pen      |           |
| AGONIST-** |           |          | rphine + | ­tazo­cine |           |
|            |           |          | naloxone | +        |           |
| **ANT      |           |          |          |          |           |
| AGO­NI­STS** |           |          | S        | naloxone |           |
|            |           |          | uboxone® |          |           |
|            |           |          |          | Ta       |           |
|            |           |          |          | lwin-Nx® |           |
+------------+-----------+----------+----------+----------+-----------+
| **ST       | N-methyl- | Amp      | Benzp    | Diethy   | 1-deoxy-  |
| IMULANTS** |           | hetamine | hetamine | lpropion |           |
|            | am        |          |          |          | ­ephe­drine |
|            | phetam­ine | A        | Didrex®  | Tenuate® |           |
|            |           | dderall® |          |          | Vicks     |
|            | 3,4-methy |          | Pem­oline | Fenf     | Inhal­er®  |
|            | lenedioxy­ | Cocaine  |          | luramine |           |
|            | am        |          | Cylert®  |          |           |
|            | phetamine | Dextro-  |          | Phe      |           |
|            |           |          | Phendi-  | ntermine |           |
|            | MDMA,     | amp      |          |          |           |
|            | Ecstasy   | het­a­mine | m        | Fastin®  |           |
|            |           |          | etra­zine |          |           |
|            |           | De       |          |          |           |
|            |           | xedrine® | Plegine® |          |           |
|            |           |          |          |          |           |
|            |           | Methamp  |          |          |           |
|            |           | het­amine |          |          |           |
|            |           |          |          |          |           |
|            |           | Desoxyn® |          |          |           |
|            |           |          |          |          |           |
|            |           | Methylp  |          |          |           |
|            |           | henidate |          |          |           |
|            |           |          |          |          |           |
|            |           | C        |          |          |           |
|            |           | oncerta® |          |          |           |
|            |           |          |          |          |           |
|            |           | M        |          |          |           |
|            |           | etadate® |          |          |           |
|            |           |          |          |          |           |
|            |           | Ritalin® |          |          |           |
|            |           |          |          |          |           |
|            |           | Phenm    |          |          |           |
|            |           | etra­zine |          |          |           |
|            |           |          |          |          |           |
|            |           | Fastin®  |          |          |           |
|            |           |          |          |          |           |
|            |           | P        |          |          |           |
|            |           | reludin® |          |          |           |
+------------+-----------+----------+----------+----------+-----------+
| **HALLU-** | Lysergic  |          | Dr       |          |           |
|            | acid      |          | onabinol |          |           |
| **C        |           |          |          |          |           |
| INO­GE­NS,** | dia­mine   |          | Marinol® |          |           |
|            |           |          |          |          |           |
| **OTHER**  | LSD       |          |          |          |           |
|            |           |          |          |          |           |
|            | Marijuana |          |          |          |           |
|            |           |          |          |          |           |
|            | Mescaline |          |          |          |           |
|            |           |          |          |          |           |
|            | Peyote    |          |          |          |           |
|            |           |          |          |          |           |
|            | Phen      |          |          |          |           |
|            | cyclidine |          |          |          |           |
|            |           |          |          |          |           |
|            | PCP       |          |          |          |           |
|            |           |          |          |          |           |
|            | P         |          |          |          |           |
|            | silocybin |          |          |          |           |
|            |           |          |          |          |           |
|            | Te        |          |          |          |           |
|            | trahydro- |          |          |          |           |
|            |           |          |          |          |           |
|            | c­a        |          |          |          |           |
|            | n­nabinols |          |          |          |           |
+------------+-----------+----------+----------+----------+-----------+
| **S        | Met       | Amo      | Buta     | Al       | Diph      |
| EDATIVE-** | haqualone | barbital | barbital | prazolam | enoxylate |
|            |           |          |          |          |           |
| **H        | Quaalude® | Amytal®  | Butisol® | Xanax®   | pre       |
| YPNOTICS** |           |          |          |          | parations |
|            | Gamm      | Glut     | Bu       | Chl      |           |
|            | a-hydroxy | ethi­mide | tal­bital | ordiaze- | Lomotil®  |
|            |           |          |          |          |           |
|            | butyrate  | Doriden® | F        | pox­ide   |           |
|            |           |          | iorecet® |          |           |
|            | GHB       | Pento    |          | Librium® |           |
|            |           | barbital | F        |          |           |
|            |           |          | iorinal® | Chloral  |           |
|            |           | N        |          | betaine  |           |
|            |           | embutal® | Met      |          |           |
|            |           |          | hyprylon | Chloral  |           |
|            |           | Seco     |          | hydrate  |           |
|            |           | barb­ital | Noludar® |          |           |
|            |           |          |          | Noctec®  |           |
|            |           | Seconal® |          |          |           |
|            |           |          |          | Cl       |           |
|            |           |          |          | ona­zepam |           |
|            |           |          |          |          |           |
|            |           |          |          | K        |           |
|            |           |          |          | lonopin® |           |
|            |           |          |          |          |           |
|            |           |          |          | Clo      |           |
|            |           |          |          | r­azepate |           |
|            |           |          |          |          |           |
|            |           |          |          | T        |           |
|            |           |          |          | ranxene® |           |
|            |           |          |          |          |           |
|            |           |          |          | Diazepam |           |
|            |           |          |          |          |           |
|            |           |          |          | Valium®  |           |
|            |           |          |          |          |           |
|            |           |          |          | E        |           |
|            |           |          |          | stazolam |           |
|            |           |          |          |          |           |
|            |           |          |          | Prosom®  |           |
|            |           |          |          |          |           |
|            |           |          |          | Ethch    |           |
|            |           |          |          | lorvynol |           |
|            |           |          |          |          |           |
|            |           |          |          | P        |           |
|            |           |          |          | lacidyl® |           |
|            |           |          |          |          |           |
|            |           |          |          | Et       |           |
|            |           |          |          | hinamate |           |
|            |           |          |          |          |           |
|            |           |          |          | Fl       |           |
|            |           |          |          | urazepam |           |
|            |           |          |          |          |           |
|            |           |          |          | Dalmane® |           |
|            |           |          |          |          |           |
|            |           |          |          | H        |           |
|            |           |          |          | alazepam |           |
|            |           |          |          |          |           |
|            |           |          |          | Paxipam® |           |
|            |           |          |          |          |           |
|            |           |          |          | L        |           |
|            |           |          |          | orazepam |           |
|            |           |          |          |          |           |
|            |           |          |          | Ativan®  |           |
|            |           |          |          |          |           |
|            |           |          |          | M        |           |
|            |           |          |          | azindol® |           |
|            |           |          |          |          |           |
|            |           |          |          | Sanorex® |           |
|            |           |          |          |          |           |
|            |           |          |          | Mepho    |           |
|            |           |          |          | barbital |           |
|            |           |          |          |          |           |
|            |           |          |          | Mebaral® |           |
|            |           |          |          |          |           |
|            |           |          |          | Mep      |           |
|            |           |          |          | robamate |           |
|            |           |          |          |          |           |
|            |           |          |          | Equanil® |           |
|            |           |          |          |          |           |
|            |           |          |          | Meth     |           |
|            |           |          |          | ohexital |           |
|            |           |          |          |          |           |
|            |           |          |          | Brevital |           |
|            |           |          |          |          |           |
|            |           |          |          | Sodi­um®  |           |
|            |           |          |          |          |           |
|            |           |          |          | Methyl-  |           |
|            |           |          |          |          |           |
|            |           |          |          | pheno    |           |
|            |           |          |          | bar­bital |           |
|            |           |          |          |          |           |
|            |           |          |          | M        |           |
|            |           |          |          | idazolam |           |
|            |           |          |          |          |           |
|            |           |          |          | Versed®  |           |
|            |           |          |          |          |           |
|            |           |          |          | Oxazepam |           |
|            |           |          |          |          |           |
|            |           |          |          | Serax®   |           |
|            |           |          |          |          |           |
|            |           |          |          | Par      |           |
|            |           |          |          | aldehyde |           |
|            |           |          |          |          |           |
|            |           |          |          | Paral®   |           |
|            |           |          |          |          |           |
|            |           |          |          | Pheno    |           |
|            |           |          |          | barbital |           |
|            |           |          |          |          |           |
|            |           |          |          | Luminal® |           |
|            |           |          |          |          |           |
|            |           |          |          | Prazepam |           |
|            |           |          |          |          |           |
|            |           |          |          | Centrax® |           |
|            |           |          |          |          |           |
|            |           |          |          | T        |           |
|            |           |          |          | emazepam |           |
|            |           |          |          |          |           |
|            |           |          |          | R        |           |
|            |           |          |          | estoril® |           |
|            |           |          |          |          |           |
|            |           |          |          | T        |           |
|            |           |          |          | riazolam |           |
|            |           |          |          |          |           |
|            |           |          |          | Halcion® |           |
|            |           |          |          |          |           |
|            |           |          |          | Zaleplon |           |
|            |           |          |          |          |           |
|            |           |          |          | Sonata®  |           |
|            |           |          |          |          |           |
|            |           |          |          | Zolpidem |           |
|            |           |          |          |          |           |
|            |           |          |          | Ambien®  |           |
+------------+-----------+----------+----------+----------+-----------+

**APPENDIX C: KEY INFORMANTS AND QUESTIONS**

**National Organizations**

American Academy of Pain Medicine

American Academy of Pediatrics

American Alliance of Cancer Pain Initiatives

American Association for the Treatment of Opioid Dependence

American Medical Association

American Osteopathic Academy of Addiction Medicine

American Society of Anesthesiologists

CHADD (Children and Adults with Attention Deficit Disorder)

Clinical Trials Network

**State Medical Associations**

Alabama

California

Hawaii

Kentucky

Maine

Michigan

New York

Tennessee

Texas

**State Pain Initiatives**

Alabama

California

Hawaii

Maine

Massachusetts

Michigan

New York

Tennessee

Wisconsin

**State Addiction Treatment Organizations**

Alabama

California

Hawaii

Maine

Maryland

Michigan

New York

Tennessee

Texas

**State Chapters of the American Academy of Pediatrics**

Alabama

California

Hawaii

Indiana

Maine

Michigan

New York

Tennessee

Texas

# [questions asked of the key informants]{.smallcaps}

# [Your Society's Policies and Activities]{.smallcaps}

1.  **Does your State Medical Society have a formal position on
    prescription monitoring programs?**

>  Yes  No **(If no, Skip to Question 2)**
>
> 1a. If it is in a written form, may we have a copy?  Yes (please mail
> to address below)  No

2.  **Did your State Medical Society testify at the time your State's
    prescription monitoring program was being considered?**

 Yes  No **(If no, Skip to Question 3)**

2a. In what form/capacity did they testify? (Please check all that
apply)

At Hearings

> In Writing

Other (Please specify)

2b. What was the nature of the testimony?

2c. If it is in written form, may we have a copy?

 Yes (please mail to address below)  No

3.  **Did your State Medical Society have any input into the design of
    your State's prescription monitoring program?**

>  Yes  No **(If no, Skip to Question 4)**
>
> 3a. If so, what was your organization's role?

4.  **Is anyone in your State Medical Society assigned to follow the
    implementation of your State's prescription monitoring program?**

>  Yes  No **(If no, Skip to Question 5)**
>
> 4a. Who is that person?

4b. What is his/her title?

# [[Feedback From Members of Your State Medical Society]{.underline}]{.smallcaps}

5.  **Has your State Medical Society created a process to receive
    physicians' feedback about your State's prescription monitoring
    program?**

 Yes  No **(If no, Skip to Question 6)**

5a. Has your State Medical Society compiled any reports based on
members' feedback as to the effects of your State's prescription
monitoring program?

>  Yes  No
>
> 5b. What kinds of information are collected? (Please check all that
> apply)
>
> Statistical information
>
> Anecdotal reports
>
> Other (Please specify)

5c. If the information is in written form, may we have a copy?

>  Yes (please mail to address below)  No

6.  **How would you characterize the feedback you have received
    regarding the impact of your State's prescription monitoring
    programs on patients' access to care?**

>  1  2  3  4  5
>
> Negative Impact No impact Positive impact

7.  **If your State Medical Society has received feedback that your
    State's prescription monitoring program is having a negative impact
    on access to care, how would you characterize the intensity of that
    effect?**

>  1  2  3  4  5

Minimal Moderate Significant

8.  **If your State Medical Society has received feedback that your
    State's prescription monitoring program is having a negative impact
    on enrollment in clinical trials, how would you characterize the
    intensity of that effect?**

>  1  2  3  4  5
>
> Minimal Moderate Significant

9.  **If your State Medical Society has received feedback that your
    State's prescription monitoring program is having a negative impact
    on physicians' willingness to treat and/or refer patients with pain
    or substance use disorders, how would you characterize the intensity
    of that effect?**

>  1  2  3  4  5

Minimal Moderate Significant

10. **Based on the feedback you have received, do you believe that your
    State's prescription monitoring program is having an effect on
    physicians' willingness to:**

10a. Prescribe opioids for pain in children?

>  1  2  3  4  5
>
> No effect Moderate effect Significant effect
>
> 10b. Prescribe opioids for pain in adults?
>
>  1  2  3  4  5
>
> No effect Moderate effect Significant effect
>
> 10c. Prescribe sedative-hypnotic drugs for anxiety or sleep disorders?
>
>  1  2  3  4  5

No effect Moderate effect Significant effect

> 10d. Prescribe stimulant drugs for ADHD in children or adults?
>
>  1  2  3  4  5
>
> No effect Moderate effect Significant effect
>
> 10e. Other (please specify)
>
>  1  2  3  4  5
>
> No effect Moderate effect Significant effect

11. **Based on the feedback you have received, which classes of drugs do
    you think are most likely to be affected by prescription monitoring
    programs?** \[check all that apply\]

> 11a. \_\_\_ Opioids/pain relievers (e.g., OxyContin, Duragesic,
> Dilaudid, Percodan, morphine)
>
> 11b. \_\_\_ Sedative-hypnotics (e.g., Valium, Xanax, other
> tranquilizers or sleep aids)
>
> 11c. \_\_\_ Stimulants/ADHD drugs (e.g., Ritalin, Adderall,
> methylphenidate)
>
> 11d. \_\_\_ Psychiatric medications
>
> 11e. \_\_\_ Other (please specify)
>
> 11f. \_\_\_ Unknown

12. **Based on the feedback you have received, if physicians are less
    willing to prescribe certain drugs because of your State's
    prescription monitoring program, why do you think that is the
    case?** \[check all that apply\]

> 12a. \_\_\_ Protect patient privacy/concerns about confidentiality
>
> 12b. \_\_\_ Avoid intrusion into the doctor-patient relationship
>
> 12c. \_\_\_ Fear of regulatory oversight
>
> 12d. \_\_\_ Negative publicity about prescription monitoring programs
>
> 12e. \_\_\_ Lack of information about your State's prescription
> monitoring program
>
> 12f. \_\_\_ The "hassle factor" involved in the requirement to use a
> special prescription form
>
> 12g. \_\_\_ Press reports of sanctions against physicians
>
> 12h. \_\_\_ Other (please specify)
>
> 12i. \_\_\_ Unknown

13. **Are you aware of any other indicators of or reports on the impact
    of your State's prescription monitoring program on patients' access
    to care?**

>  Yes  No
>
> 13a. If yes, please describe those indicators or reports:

14. **Based on the feedback you have received, does your State Medical
    Society have any**

**suggestions or comments regarding ways in which prescription
monitoring programs**

**could be improved in their design or implementation?**

**Appendix D: Reports Obtained from CSMP States**

# Copies of the following reports were obtained and analyzed for the assessment:

# [California]{.underline}

California Bureau of Narcotic Enforcement (2002). CURES (Controlled
Substance Utilization Review and Evaluation System) Report to the
Legislature. Sacramento, CA: California Department of Justice.

# [Illinois]{.underline}

State of Illinois (n.d.). Comparison of Illinois' Triplicate
Prescription Program/Electronic Monitoring Program. Springfield, IL:
Illinois Department of Law Enforcement.

# [Indiana]{.underline}

Anonymous (n.d.). Indiana Scheduled Prescription Electronic Collection
and Tracking

(INSPECT Program). Indianapolis, IN: Controlled Substances Advisory
Committee.

# [Kentucky]{.underline}

Kentucky Cabinet for Health and Family Services (2004). 2004 KASPER
Satisfaction Survey Executive Summary Reducing the Diversion of
Scheduled Prescription Medications in the Commonwealth of Kentucky.
Frankfurt, KY: Office of the Inspector General.

# [Maine]{.underline}

Lambert, D (2006). Evaluation of the Implementation of Maine's
Prescription Drug Monitoring Program. Portland, ME: Muskie School of
Public Service, University of Southern Maine.

# [Massachusetts]{.underline}

Carrow G (2006). Informational Briefing on Amendments to 105 CMR
700.000; Implementation of M.G.L. c.94C. Boston, MA: January 24^th^.

# [Michigan]{.underline}

Anonymous (2003). Overview of the Michigan Automated Prescription System
(MAPS) -- First Year of Operation 2003. Ann Arbor, MI: Bureau of
Narcotics and Dangerous Drugs.

# [Oklahom]{.underline}a

Oklahoma State Bureau of Narcotics and Dangerous Drugs Control (1994).
OSTAR Update. Oklahoma City, OK: The Bureau.

# [Virginia]{.underline}

Department of Health Professions and Virginia State Police (2004).
Prescription Monitoring Program. Richmond, VA: Department of Health
Professions and Virginia State Police.

# [Washington]{.underline}

Williams DH (1993). Triplicate Prescriptions in Washington State
(Research Monograph 131:194-199). Rockville, MD: National Institute on
Drug Abuse (NIH Pub. No. 93-3507).

**[Appendix E: Status of State CSMPS]{.smallcaps}**

As of December 1, 2006, 33 States have signed laws authorizing the
creation of a CSMP, 25 States have active CSMPs, and 8 States have begun
implementation of legislatively authorized programs.

**[Operational CSMPs (25)]{.underline}**

Alabama New York

California Ohio

Hawaii Oklahoma

Idaho Pennsylvania

Illinois Rhode Island

Indiana Tennessee

Kentucky Texas

Maine Utah

Massachusetts Virginia

Michigan Washington

Mississippi West Virginia

Nevada Wyoming

New Mexico

**[Non-Operational CSMPs with Enacted Laws (8)]{.underline}**

Colorado North Carolina

Connecticut North Dakota

Iowa South Carolina

Louisiana Vermont

Other States are in the process of proposing, preparing, or considering
legislation.

This section provides a lists the program name, year of implementation,
links to the authorizing legislation, manager of the program, the
controlled drugs monitored by each State's program, average number of
prescriptions collected per year, advisory/oversight, operating budget,
the frequency of data collection, funding source, the group requesting
summary reports, average requests received per month, the number of DEA
registered pharmacies.

The majority States (20) monitor schedules II-IV. Of the 21 States for
which we obtained information on pertaining to the average number of
prescriptions collected annually, California reported the highest number
with approximately 21 million and the lowest was Virginia with 400,000.
Twenty-one States used public health departments or professional boards.
New York had the largest with \$17,000,000 and Utah the smallest with
\$47,000. More States (14) collected data monthly than on any other
schedule. California and Michigan had the highest average number of
information requests per month (5,000) and Illinois the lowest (2).

The cost of implementing and operating a monitoring program differs from
State to State. The average cost to start a program is approximately
\$350,000, and annual operating costs for CSMPs range from \$47,000 to
\$17 million. Cost variations occur due to the frequency of data
collection (bi-weekly vs. monthly, for example), the use of a third
party vendor, the number of prescriptions written/filled in a State, the
number of schedules (II-V) collected, and the use of official forms.

Pharmacies are registered by the Drug Enforcement Agency, and each
registered pharmacy is required to submit information to the States'
CSMP. California had the greatest number of pharmacies (5,982) and
Wyoming had the least (121).

**[State Controlled Substance Monitoring Reports]{.underline}**

**[Alabama's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  ----------------------------- ---------------------------------------------------------------------------------
  **Program Name**              Controlled Substance Prescription Database

  **Year of Implementation**    2006

  **Authorizing Legislation**   [www.pdmp.alabama.gov/pdm_laws.html](http://www.pdmp.alabama.gov/pdm_laws.html)

  **Contact**                   Charles Thomas

  **Controlled Drugs            Schedules: II-V
  Monitored**                   

  **Average Number of           9-10 Million
  Prescriptions Collected per   
  year**                        

  **Advisory and Oversight**    Department of Justice, Bureau of Narcotic Enforcement

  **Operating Budget**          Start-Up \$1,150,000

  **Frequency of Data           4 x month
  Collection**                  

  **Funding Source**            Grants, Portion of controlled substance registration Fee

  **Group Requesting Summary    Licensing Boards (100 %)
  Reports**                     

  **Average Requests Received   80
  Per Month**                   

  **Number of DEA Registered    1,315
  Pharmacies *(September        
  2006)***                      
  ----------------------------- ---------------------------------------------------------------------------------

**[California's Prescription Drug Monitoring Program
(CSMP)]{.underline}**

  ----------------------------- ---------------------------------------------------------------------------------
  **Program Name**              Controlled Substance Utilization Review and Evaluation Systems (CURES)

  **Year of Implementation**    1939

  **Authorizing Legislation**   [www.caag.state.ca.us/bne/trips.htm](http://www.caag.state.ca.us/bne/trips.htm)

  **Contact**                   Katherine Ellis

  **Controlled Drugs            Schedules: II
  Monitored**                   

  **Average Number of           21 Million
  Prescriptions Collected per   
  year**                        

  **Advisory and Oversight**    Pharmacy and Law Enforcement

  **Operating Budget**          \$296,000 (Personnel Costs not included; start-up: \$1,000,000)

  **Frequency of Data           1 x month
  Collection**                  

  **Funding Source**            State General Fund/Regulatory board reimbursement

  **Group Requesting Summary    Physicians (70 %), Law Enforcement and Licensing Boards (15 %) Pharmacies (15 %)
  Reports**                     

  **Average Requests Received   5,000
  Per Month**                   

  **Number of DEA Registered    5,982
  Pharmacies *(September        
  2006)***                      
  ----------------------------- ---------------------------------------------------------------------------------

**[Colorado's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  ----------------------------- -----------------------------------------
  **Program Name**              Not Yet Operational

  **Year of Implementation**    Not Yet Operational

  **Authorizing Legislation**   Laws are drafted but not ratified.

  **Contact**                   Jody Gingery

  **Controlled Drugs            Schedules: II-V
  Monitored**                   

  **Average Number of           Not Yet Operational
  Prescriptions Collected per   
  year**                        

  **Advisory and Oversight**    Department of Regulatory Agencies

  **Operating Budget**          \$400,000

  **Frequency of Data           Not Yet Operational
  Collection**                  

  **Funding Source**            Grants

  **Group Requesting Summary    Not Yet Operational
  Reports**                     

  **Average Requests Received   Not Yet Operational
  Per Month**                   

  **Number of DEA Registered    806
  Pharmacies *(September        
  2006)***                      
  ----------------------------- -----------------------------------------

**[Connecticut's Prescription Drug Monitoring Program
(CSMP)]{.underline}**

  ----------------------------- ------------------------------------------------------------
  **Program Name**              Not Yet Operational

  **Year of Implementation**    Enacted Not Operational

  **Authorizing Legislation**   [www.search.cga.state.ct.us/dtSearch_lpa.html]{.underline}

  **Contact**                   John Gadea

  **Controlled Drugs            Schedules: II-V
  Monitored**                   

  **Average Number of           Not Yet Operational
  Prescriptions Collected per   
  year**                        

  **Advisory and Oversight**    Commissioner of Consumer Protection

  **Operating Budget**          \$400,000

  **Frequency of Data           Not Yet Operational
  Collection**                  

  **Funding Source**            Grants

  **Group Requesting Summary    Not Yet Operational
  Reports**                     

  **Average Requests Received   Not Yet Operational
  Per Month**                   

  **Number of DEA Registered    664
  Pharmacies *(September        
  2006)***                      
  ----------------------------- ------------------------------------------------------------

**[Hawaii's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  ----------------------------- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------
  **Program Name**              Electronic Prescription Accountability System

  **Year of Implementation**    1943

  **Authorizing Legislation**   [www.capitol.hawaii.gov/hrscurrent/Vol06_Ch0321-0344/HRS0329/HRS_0329-0014.htm](http://www.capitol.hawaii.gov/hrscurrent/Vol06_Ch0321-0344/HRS0329/HRS_0329-0014.htm)

  **Contact**                   Glen Kimura

  **Controlled Drugs            Schedules: II-IV
  Monitored**                   

  **Average Number of           1.4 Million
  Prescriptions Collected per   
  year**                        

  **Advisory and Oversight**    Law Enforcement

  **Operating Budget**          \$250,220

  **Frequency of Data           1 x Month
  Collection**                  

  **Funding Source**            Grants

  **Group Requesting Summary    Law Enforcement (70 %) Pharmacies (15 %) Physicians (15 %)
  Reports**                     

  **Average Requests Received   270
  Per Month**                   

  **Number of DEA Registered    194
  Pharmacies *(September        
  2006)***                      
  ----------------------------- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------

**[Idaho's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  ----------------------------- -----------------------------------------------------------
  **Program Name**              Prescription Tracking Program

  **Year of Implementation**    1967

  **Authorizing Legislation**   [www.state.id.us/idstat/TOC/3702702KTOC.html]{.underline}

  **Contact**                   Richard Markuson

  **Controlled Drugs            Schedules: II-IV
  Monitored**                   

  **Average Number of           1.5 Million
  Prescriptions Collected per   
  year**                        

  **Advisory and Oversight**    Pharmacy Board

  **Operating Budget**          \$143,000

  **Frequency of Data           1 x Month
  Collection**                  

  **Funding Source**            Licensing Fees and Grants

  **Group Requesting Summary    Physicians (90 %), Pharmacies (5 %), Law Enforcement (3 %),
  Reports**                     Licensing Boards (2 %)

  **Average Requests Received   1,100
  Per Month**                   

  **Number of DEA Registered    311
  Pharmacies *(September        
  2006)***                      
  ----------------------------- -----------------------------------------------------------

**[Illinois's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  ----------------------------- -----------------------------------------------------------------------------------------
  **Program Name**              Illinois Prescription Drug Monitoring Program

  **Year of Implementation**    1961

  **Authorizing Legislation**   [www.natlalliance.org/pdfs/illinois.pdf](http://www.natlalliance.org/pdfs/illinois.pdf)

  **Contact**                   Stanley Tylman

  **Controlled Drugs            Schedules: II
  Monitored**                   

  **Average Number of           1.6 Million
  Prescriptions Collected per   
  year**                        

  **Advisory and Oversight**    Public Health

  **Operating Budget**          \$169,000 (Start-up \$200,000)

  **Frequency of Data           2 x Month
  Collection**                  

  **Funding Source**            Annual Appropriations

  **Group Requesting Summary    Law Enforcement (50 %) Licensing Board (50 %)
  Reports**                     

  **Average Requests Received   2
  Per Month**                   

  **Number of DEA Registered    2,383
  Pharmacies *(September        
  2006)***                      
  ----------------------------- -----------------------------------------------------------------------------------------

**[Indiana's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  ----------------------------- -------------------------------------------------------------------------------------------------------
  **Program Name**              Indiana\'s Scheduled Prescription Electronic Collection and Tracking (INSPECT)

  **Year of Implementation**    1997

  **Authorizing Legislation**   [www.in.gov/pla/bandc/isbp/inspectmanual-2.pdf](http://www.in.gov/pla/bandc/isbp/inspectmanual-2.pdf)

  **Contact**                   Marty Allain

  **Controlled Drugs            Schedules: II-V
  Monitored**                   

  **Average Number of           5 Million
  Prescriptions Collected per   
  year**                        

  **Advisory and Oversight**    Professional Licensing Agency

  **Operating Budget**          \$250,000

  **Frequency of Data           2 x Month
  Collection**                  

  **Funding Source**            Percentage of Licensing Fee

  **Group Requesting Summary    Law Enforcement (100 %)
  Reports**                     

  **Average Requests Received   80
  Per Month**                   

  **Number of DEA Registered    1,208
  Pharmacies *(September        
  2006)***                      
  ----------------------------- -------------------------------------------------------------------------------------------------------

**[Iowa's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  --------------------------- --------------------------------------------------------------------------------
  **Program Name**            Not Yet Operational

  **Year of Implementation**  Enacted Not Operational

  **Authorizing Legislation** [www.natlalliance.org/pdfs/PMP %20Bill %20Status %20August
                              %202006.pdf](http://www.natlalliance.org/pdfs/PMP Bill Status August 2006.pdf)

  **Contact**                 Terry Witowski

  **Controlled Drugs          Schedules: II-IV
  Monitored**                 

  **Average Number of         Not Yet Operational
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  State Board of Pharmacy Examiners

  **Operating Budget**        Not Yet Operational

  **Frequency of Data         Not Yet Operational
  Collection**                

  **Funding Source**          Not Yet Operational

  **Group Requesting Summary  Not Yet Operational
  Reports**                   

  **Average Requests Received Not Yet Operational
  Per Month**                 

  **Number of DEA Registered  801
  Pharmacies *(September      
  2006)***                    
  --------------------------- --------------------------------------------------------------------------------

**[Kentucky's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  --------------------------- ---------------------------------------------------------------------------------
  **Program Name**            Kentucky All Schedule Prescription Electronic Reporting (KASPER)

  **Year of Implementation**  1999

  **Authorizing Legislation** [www.lrc.ky.gov/kar/902/055/110.htm](http://www.lrc.ky.gov/kar/902/055/110.htm)

  **Contact**                 Zach Ramsey

  **Controlled Drugs          Schedules: II-V
  Monitored**                 

  **Average Number of         8.2 Million
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Public Health

  **Operating Budget**        \$350,000 (start-up \$1,400,000)

  **Frequency of Data         4 x Month
  Collection**                

  **Funding Source**          General State Funds/State Legislature

  **Group Requesting Summary  Prescribers (92 %), Pharmacies (3 %), Law Enforcement (3 %), Licensing Boards (1
  Reports**                   %), Other (1 %)

  **Average Requests Received 2,200
  Per Month**                 

  **Number of DEA Registered  1,115
  Pharmacies *(September      
  2006)***                    
  --------------------------- ---------------------------------------------------------------------------------

**[Louisiana's Prescription Drug Monitoring Program
(CSMP)]{.underline}**

  --------------------------- --------------------------------------------------------------------------------
  **Program Name**            Not Yet Operational

  **Year of Implementation**  Enacted (6/29/06) Not Operational

  **Authorizing Legislation** [www.natlalliance.org/pdfs/PMP %20Bill %20Status %20August
                              %202006.pdf](http://www.natlalliance.org/pdfs/PMP Bill Status August 2006.pdf)

  **Contact**                 Malcolm Broussard

  **Controlled Drugs          Not Yet Operational
  Monitored**                 

  **Average Number of         Not Yet Operational
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Board of Pharmacy

  **Operating Budget**        \$400,000

  **Frequency of Data         Not Yet Operational
  Collection**                

  **Funding Source**          Grants

  **Group Requesting Summary  Not Yet Operational
  Reports**                   

  **Average Requests Received Not Yet Operational
  Per Month**                 

  **Number of DEA Registered  1,234
  Pharmacies *(September      
  2006)***                    
  --------------------------- --------------------------------------------------------------------------------

**[Maine's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  --------------------------- -----------------------------------------------------------------------------------
  **Program Name**            Maine\'s Prescription Monitoring Program

  **Year of Implementation**  2004

  **Authorizing Legislation** [www.natlalliance.org/pdfs/maine.pdf](http://www.natlalliance.org/pdfs/maine.pdf)

  **Contact**                 Chris Baumgartner

  **Controlled Drugs          Schedules: II-IV
  Monitored**                 

  **Average Number of         1.8 Million
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  HHS, Office of Substance Abuse

  **Operating Budget**        \$300,000, (Start-up: \$190,000)

  **Frequency of Data         2 x month
  Collection**                

  **Funding Source**          Grants

  **Group Requesting Summary  Physicians (83 %) Pharmacies (17 %)
  Reports**                   

  **Average Requests Received 1,100
  Per Month**                 

  **Number of DEA Registered  297
  Pharmacies *(September      
  2006)***                    
  --------------------------- -----------------------------------------------------------------------------------

**[Massachusetts' Prescription Drug Monitoring Program
(CSMP)]{.underline}**

  --------------------------- ---------------------------------------------------------------------------------------------------
  **Program Name**            Massachusetts Prescription Monitoring Program

  **Year of Implementation**  1992

  **Authorizing Legislation** [www.natlalliance.org/pdfs/massachusetts.pdf](http://www.natlalliance.org/pdfs/massachusetts.pdf)

  **Contact**                 Grant Carrow

  **Controlled Drugs          Schedules: II
  Monitored**                 

  **Average Number of         2.6 Million
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Public Health

  **Operating Budget**        Not calculated independently part of retained revenue account

  **Frequency of Data         1 x month
  Collection**                

  **Funding Source**          Returned Revenue Account/Licensing Fees

  **Group Requesting Summary  Law Enforcement (61 %) Licensing Boards (30 %) other (9 %)
  Reports**                   

  **Average Requests Received 10
  Per Month**                 

  **Number of DEA Registered  1,150
  Pharmacies *(September      
  2006)***                    
  --------------------------- ---------------------------------------------------------------------------------------------------

**[Michigan's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  --------------------------- -----------------------------------------------------------------------------------------
  **Program Name**            Michigan Automated Prescription System (MAPS)

  **Year of Implementation**  1988

  **Authorizing Legislation** [www.natlalliance.org/pdfs/michigan.pdf](http://www.natlalliance.org/pdfs/michigan.pdf)

  **Contact**                 Michael Wissel

  **Controlled Drugs          Schedules: II-V
  Monitored**                 

  **Average Number of         15 Million
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Board of Health Professions

  **Operating Budget**        \$60,000, (Start-up: \$400,000)

  **Frequency of Data         1 x month
  Collection**                

  **Funding Source**          Licensing Fees

  **Group Requesting Summary  Physicians (80 %), Pharmacies (15 %), Law Enforcement (5 %)
  Reports**                   

  **Average Requests Received 5,000
  Per Month**                 

  **Number of DEA Registered  2,335
  Pharmacies *(September      
  2006)***                    
  --------------------------- -----------------------------------------------------------------------------------------

**[Mississippi's Prescription Drug Monitoring Program
(CSMP)]{.underline}**

  --------------------------- -------------------------------------------
  **Program Name**            Mississippi Prescription Monitoring Program

  **Year of Implementation**  2005

  **Authorizing Legislation** [www.pmp.ms.gov/](http://www.pmp.ms.gov/)

  **Contact**                 Mac McDivitt

  **Controlled Drugs          Schedules: II-V
  Monitored**                 

  **Average Number of         6 Million
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Board of Pharmacy, MS Controlled Substance
                              Authority (MCSA)

  **Operating Budget**        \$150,000, (Start-up: \$50,000)

  **Frequency of Data         1 x month
  Collection**                

  **Funding Source**          State Pharmacy Board/Grants

  **Group Requesting Summary  Licensing Board (50 %), Law Enforcement (50
  Reports**                   %)

  **Average Requests Received 100
  Per Month**                 

  **Number of DEA Registered  818
  Pharmacies *(September      
  2006)***                    
  --------------------------- -------------------------------------------

**[Nevada's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  --------------------------- -------------------------------------------------------------------------------------
  **Program Name**            Prescription Controlled Substance Abuse Prevention Program

  **Year of Implementation**  1995

  **Authorizing Legislation** [www.natlalliance.org/pdfs/nevada.pdf](http://www.natlalliance.org/pdfs/nevada.pdf)

  **Contact**                 Joanee Quirk

  **Controlled Drugs          Schedules: II-IV
  Monitored**                 

  **Average Number of         3 Million
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Pharmacy Board, Law Enforcement

  **Operating Budget**        \$300,000, (Start-up: \$131,000)

  **Frequency of Data         2 x month
  Collection**                

  **Funding Source**          Board of Pharmacy/Grants

  **Group Requesting Summary  Physicians (85 %), Pharmacies (5 %), Licensing Boards (5 %), Law Enforcement (5 %)
  Reports**                   

  **Average Requests Received 1,100
  Per Month**                 

  **Number of DEA Registered  483
  Pharmacies *(September      
  2006)***                    
  --------------------------- -------------------------------------------------------------------------------------

**[New Mexico's Prescription Drug Monitoring Program
(CSMP)]{.underline}**

  --------------------------- -----------------------------------------------------------------------------------------
  **Program Name**            New Mexico Prescription Monitoring Program

  **Year of Implementation**  2005

  **Authorizing Legislation** [www.state.nm.us/pharmacy/statutes.html](http://www.state.nm.us/pharmacy/statutes.html)

  **Contact**                 Bill Harvey

  **Controlled Drugs          Schedules: II-IV
  Monitored**                 

  **Average Number of         N/A
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Board of Pharmacy

  **Operating Budget**        N/A

  **Frequency of Data         1 x month
  Collection**                

  **Funding Source**          N/A

  **Group Requesting Summary  N/A
  Reports**                   

  **Average Requests Received N/A
  Per Month**                 

  **Number of DEA Registered  294
  Pharmacies *(September      
  2006)***                    
  --------------------------- -----------------------------------------------------------------------------------------

**[New York's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  --------------------------- -------------------------------------------------------------------------------------------------------------------------------------
  **Program Name**            Prescription Monitoring Program

  **Year of Implementation**  1972

  **Authorizing Legislation** [www.public.leginfo.state.ny.us/menugetf.cgi?COMMONQUERY=LAWS](http://www.public.leginfo.state.ny.us/menugetf.cgi?COMMONQUERY=LAWS)

  **Contact**                 James Giglio

  **Controlled Drugs          Schedules: II-V
  Monitored**                 

  **Average Number of         12 Million
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Public Health

  **Operating Budget**        \$17,000,000

  **Frequency of Data         1 x month
  Collection**                

  **Funding Source**          Sub allocation from the state insurance fund

  **Group Requesting Summary  N/A
  Reports**                   

  **Average Requests Received N/A
  Per Month**                 

  **Number of DEA Registered  4,521
  Pharmacies *(September      
  2006)***                    
  --------------------------- -------------------------------------------------------------------------------------------------------------------------------------

**[North Carolina's Prescription Drug Monitoring Program
(CSMP)]{.underline}**

  --------------------------- -------------------------------------------
  **Program Name**            Not Yet Operational

  **Year of Implementation**  Enacted Not Operational

  **Authorizing Legislation** Laws are drafted but not ratified

  **Contact**                 John Womble

  **Controlled Drugs          Schedules: II-V
  Monitored**                 

  **Average Number of         \$400,000
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Department of Health and Human Services

  **Operating Budget**        Not Yet Operational

  **Frequency of Data         Not Yet Operational
  Collection**                

  **Funding Source**          Not Yet Operational

  **Group Requesting Summary  Not Yet Operational
  Reports**                   

  **Average Requests Received Not Yet Operational
  Per Month**                 

  **Number of DEA Registered  1,927
  Pharmacies *(September      
  2006)***                    
  --------------------------- -------------------------------------------

**[North Dakota's Prescription Drug Monitoring Program
(CSMP)]{.underline}**

  --------------------------- -------------------------------------------
  **Program Name**            Not Yet Operational

  **Year of Implementation**  Enacted Not Operational

  **Authorizing Legislation** Laws are drafted but not ratified

  **Contact**                 Not Yet Operational

  **Controlled Drugs          Not Yet Operational
  Monitored**                 

  **Average Number of         Not Yet Operational
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Department of Health and Human Services

  **Operating Budget**        Not Yet Operational

  **Frequency of Data         Not Yet Operational
  Collection**                

  **Funding Source**          Grants

  **Group Requesting Summary  Not Yet Operational
  Reports**                   

  **Average Requests Received Not Yet Operational
  Per Month**                 

  **Number of DEA Registered  178
  Pharmacies *(September      
  2006)***                    
  --------------------------- -------------------------------------------

**[Ohio's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  --------------------------- -------------------------------------------------------------------------------------------------------------------------------------------------------------
  **Program Name**            Prescription Monitoring Program

  **Year of Implementation**  2006

  **Authorizing Legislation** [www.ohioshp.org/index.php?option=com_contentandtask=viewandid=80andItemid=2](http://www.ohioshp.org/index.php?option=com_content&task=view&id=80&Itemid=2)

  **Contact**                 Tim Benedict

  **Controlled Drugs          Schedules: II-V
  Monitored**                 

  **Average Number of         N/A
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Bureau of Pharmacy

  **Operating Budget**        \$400,000 (Start-up: \$350,000)

  **Frequency of Data         2 x month
  Collection**                

  **Funding Source**          N/A

  **Group Requesting Summary  N/A
  Reports**                   

  **Average Requests Received N/A
  Per Month**                 

  **Number of DEA Registered  2,442
  Pharmacies *(September      
  2006)***                    
  --------------------------- -------------------------------------------------------------------------------------------------------------------------------------------------------------

**[Oklahoma's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  --------------------------- ----------------------------------------------
  **Program Name**            Oklahoma Prescription Monitoring Program

  **Year of Implementation**  1990

  **Authorizing Legislation** [www.obn.state.ok.us/index.html]{.underline}

  **Contact**                 John Duncan

  **Controlled Drugs          Schedules: II-V
  Monitored**                 

  **Average Number of         \$600,000
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Law Enforcement

  **Operating Budget**        \$350,000, (Start-up: \$350,000)

  **Frequency of Data         1 x month
  Collection**                

  **Funding Source**          N/A

  **Group Requesting Summary  Law Enforcement (60 %) Licensing Boards (40 %)
  Reports**                   

  **Average Requests Received 200
  Per Month**                 

  **Number of DEA Registered  886
  Pharmacies *(September      
  2006)***                    
  --------------------------- ----------------------------------------------

**[Pennsylvania's Prescription Drug Monitoring Program
(CSMP)]{.underline}**

  --------------------------- -------------------------------------------------------------------------------------------------
  **Program Name**            Prescription Monitoring Program

  **Year of Implementation**  2002

  **Authorizing Legislation** [www.natlalliance.org/pdfs/pennsylvania.pdf](http://www.natlalliance.org/pdfs/pennsylvania.pdf)

  **Contact**                 Lawrence Cherba

  **Controlled Drugs          Schedules: II
  Monitored**                 

  **Average Number of         4.1 Million
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Office of the Attorney General

  **Operating Budget**        \$257,216, (Start-up: \$260,000)

  **Frequency of Data         1 x month
  Collection**                

  **Funding Source**          Office of the Attorney General

  **Group Requesting Summary  Law Enforcement (100 %)
  Reports**                   

  **Average Requests Received 80
  Per Month**                 

  **Number of DEA Registered  3,014
  Pharmacies *(September      
  2006)***                    
  --------------------------- -------------------------------------------------------------------------------------------------

**[Rhode Island Prescription Drug Monitoring Program
(CSMP)]{.underline}**

  --------------------------- -------------------------------------------------------------------------------------------------------------------
  **Program Name**            Prescription Monitoring Program

  **Year of Implementation**  1978

  **Authorizing Legislation** [www.health.ri.gov/hsr/professions/csr_reporting.php](http://www.health.ri.gov/hsr/professions/csr_reporting.php)

  **Contact**                 Catherine Cordy

  **Controlled Drugs          Schedules: II-III
  Monitored**                 

  **Average Number of         N/A
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Public Health

  **Operating Budget**        N/A

  **Frequency of Data         1 x month
  Collection**                

  **Funding Source**          N/A

  **Group Requesting Summary  N/A
  Reports**                   

  **Average Requests Received N/A
  Per Month**                 

  **Number of DEA Registered  191
  Pharmacies *(September      
  2006)***                    
  --------------------------- -------------------------------------------------------------------------------------------------------------------

**[South Carolina's Prescription Drug Monitoring Program
(CSMP)]{.underline}**

  --------------------------- -------------------------------------------
  **Program Name**            Not Yet Operational

  **Year of Implementation**  Enacted Not Operational

  **Authorizing Legislation** Laws are drafted but not ratified

  **Contact**                 Wilbur Harling

  **Controlled Drugs          Not Yet Operational
  Monitored**                 

  **Average Number of         Not Yet Operational
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Department of Health and Environmental
                              Control

  **Operating Budget**        \$350,000

  **Frequency of Data         Not Yet Operational
  Collection**                

  **Funding Source**          Grants

  **Group Requesting Summary  Not Yet Operational
  Reports**                   

  **Average Requests Received Not Yet Operational
  Per Month**                 

  **Number of DEA Registered  1,031
  Pharmacies *(September      
  2006)***                    
  --------------------------- -------------------------------------------

**[Tennessee's Prescription Drug Monitoring Program
(CSMP)]{.underline}**

  -------------------------- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  **Program Name**           Tennessee Controlled Substance Database

  **Year of Implementation** 2006

  **Authorizing              [www.state.tn.us/commerce/boards/pharmacy/controlled_substance/pdf/TNRxReportingManual.pdf](http://www.state.tn.us/commerce/boards/pharmacy/controlled_substance/pdf/TNRxReportingManual.pdf)
  Legislation**              

  **Contact**                Terry W. Grinder

  **Controlled Drugs         Schedules: II-V
  Monitored**                

  **Average Number of        N/A
  Prescriptions Collected    
  per year**                 

  **Advisory and Oversight** The Tennessee Board of Pharmacy

  **Operating Budget**       N/A

  **Frequency of Data        2 x Month
  Collection**               

  **Funding Source**         N/A

  **Group Requesting Summary N/A
  Reports**                  

  **Average Requests         N/A
  Received Per Month**       

  **Number of DEA Registered 1,584
  Pharmacies *(September     
  2006)***                   
  -------------------------- -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

**[Texas's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  --------------------------- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  **Program Name**            Texas Prescription Program

  **Year of Implementation**  1981

  **Authorizing Legislation** [www.txdps.state.tx.us/criminal_law_enforcement/narcotics/pages/prescription.htm](http://www.txdps.state.tx.us/criminal_law_enforcement/narcotics/pages/prescription.htm)

  **Contact**                 Kelli Cox

  **Controlled Drugs          Schedules: II
  Monitored**                 

  **Average Number of         3.3 Million
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Department of Public Safety

  **Operating Budget**        \$1,400,000

  **Frequency of Data         1 x Month
  Collection**                

  **Funding Source**          N/A

  **Group Requesting Summary  Physicians (40 %), Licensing Board (40 %), Law Enforcement (20 %)
  Reports**                   

  **Average Requests Received 100
  Per Month**                 

  **Number of DEA Registered  4,384
  Pharmacies *(September      
  2006)***                    
  --------------------------- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------

**[Utah's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  --------------------------- ---------------------------------------------------------------------------------
  **Program Name**            Utah Controlled Substance Database Program

  **Year of Implementation**  1995

  **Authorizing Legislation** [www.natlalliance.org/pdfs/utah.pdf](http://www.natlalliance.org/pdfs/utah.pdf)

  **Contact**                 Marvin Sims

  **Controlled Drugs          Schedules: II-V
  Monitored**                 

  **Average Number of         3.9 Million
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Commerce\'s Licensing Division

  **Operating Budget**        \$47,000, (Start-up: \$50,000)

  **Frequency of Data         1 x Month
  Collection**                

  **Funding Source**          Portion of Controlled Licensing Fee

  **Group Requesting Summary  Physicians (40 %), Licensing Board (40 %), Law Enforcement (20 %)
  Reports**                   

  **Average Requests Received 4,200
  Per Month**                 

  **Number of DEA Registered  476
  Pharmacies *(September      
  2006)***                    
  --------------------------- ---------------------------------------------------------------------------------

**[Vermont's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  --------------------------- -------------------------------------------
  **Program Name**            Vermont Prescription Monitoring System
                              (VPMS)

  **Year of Implementation**  Enacted (5/31/06) not operational

  **Authorizing Legislation** Laws are drafted but not ratified.

  **Contact**                 Mark Ames

  **Controlled Drugs          Schedules: II-IV
  Monitored**                 

  **Average Number of         N/A
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Department of Health

  **Operating Budget**        \$350,000

  **Frequency of Data         Not Yet Operated
  Collection**                

  **Funding Source**          Grants

  **Group Requesting Summary  N/A
  Reports**                   

  **Average Requests Received N/A
  Per Month**                 

  **Number of DEA Registered  140
  Pharmacies *(September      
  2006)***                    
  --------------------------- -------------------------------------------

**[Virginia's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  --------------------------- ---------------------------------------------------------------------------------------------------------------
  **Program Name**            Virginia Prescription Monitoring Program

  **Year of Implementation**  2003 (pilot) 2006 (statewide)

  **Authorizing Legislation** [www.dhp.state.va.us/dhp_programs/pmp/pmp_laws.asp](http://www.dhp.state.va.us/dhp_programs/pmp/pmp_laws.asp)

  **Contact**                 Ralph Orr

  **Controlled Drugs          Schedules: II-IV
  Monitored**                 

  **Average Number of         400,000 PILOT
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Department of Health Professions

  **Operating Budget**        \$230,553 (FY 2006) (Start-up: \$128,000)

  **Frequency of Data         2 x month
  Collection**                

  **Funding Source**          Grants

  **Group Requesting Summary  Physicians (78 %), Law Enforcement (19 %), Licensing Board (3 %)
  Reports**                   

  **Average Requests Received 600
  Per Month**                 

  **Number of DEA Registered  1,468
  Pharmacies *(September      
  2006)***                    
  --------------------------- ---------------------------------------------------------------------------------------------------------------

**[Washington's Prescription Drug Monitoring Program
(CSMP)]{.underline}**

  --------------------------- ---------------------------------------------------------------------------------------------
  **Program Name**            Prescription Monitoring Program

  **Year of Implementation**  1984

  **Authorizing Legislation** [www.natlalliance.org/pdfs/washington.pdf](http://www.natlalliance.org/pdfs/washington.pdf)

  **Contact**                 Steven Saxe

  **Controlled Drugs          N/A
  Monitored**                 

  **Average Number of         N/A
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Department of Health

  **Operating Budget**        N/A

  **Frequency of Data         N/A
  Collection**                

  **Funding Source**          N/A

  **Group Requesting Summary  N/A
  Reports**                   

  **Average Requests Received N/A
  Per Month**                 

  **Number of DEA Registered  1,261
  Pharmacies *(September      
  2006)***                    
  --------------------------- ---------------------------------------------------------------------------------------------

**[West Virginia's Prescription Drug Monitoring Program
(CSMP)]{.underline}**

  --------------------------- ---------------------------------------------------------
  **Program Name**            Prescription Monitoring Program

  **Year of Implementation**  1995

  **Authorizing Legislation** [www.wvbop.com/main.htm](http://www.wvbop.com/main.htm)

  **Contact**                 William Douglass

  **Controlled Drugs          Schedules: II-IV
  Monitored**                 

  **Average Number of         3.3 Million
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Board of Pharmacy

  **Operating Budget**        \$152,173

  **Frequency of Data         4 x month
  Collection**                

  **Funding Source**          N/A

  **Group Requesting Summary  Physicians (65 %), Pharmacies (25 %), Law Enforcement (8
  Reports**                   %), Licensing Board (2 %)

  **Average Requests Received 1,000
  Per Month**                 

  **Number of DEA Registered  516
  Pharmacies *(September      
  2006)***                    
  --------------------------- ---------------------------------------------------------

**[Wyoming's Prescription Drug Monitoring Program (CSMP)]{.underline}**

  --------------------------- ---------------------------------------------------------------------------------------
  **Program Name**            Prescription Drug Monitoring Program

  **Year of Implementation**  2004

  **Authorizing Legislation** [www.natlalliance.org/pdfs/wyoming.pdf](http://www.natlalliance.org/pdfs/wyoming.pdf)

  **Contact**                 James Carder

  **Controlled Drugs          Schedules: II-IV
  Monitored**                 

  **Average Number of         540,000
  Prescriptions Collected per 
  year**                      

  **Advisory and Oversight**  Wyoming Board of Pharmacy

  **Operating Budget**        \$85,000, (Start-up: \$215,000)

  **Frequency of Data         1 x month
  Collection**                

  **Funding Source**          Controlled Substance Licensing Fee

  **Group Requesting Summary  Physicians (85 %), Pharmacies (10 %), Licensing Board (3 %), Law Enforcement (2 %)
  Reports**                   

  **Average Requests Received 200
  Per Month**                 

  **Number of DEA Registered  121
  Pharmacies *(September      
  2006)***                    
  --------------------------- ---------------------------------------------------------------------------------------

**Appendix F: [KEY FEATURES OF A NASPER CSMP]{.smallcaps}**

Consistent with NASPER, all States that wish to establish a statewide
program must adhere to the provisions discussed in the statute. NASPER
has an array of provisions that must accompany a functioning CSMP.

  ------------------------ -----------------------------------------------------
  **Limitations**          The effective establishment of a CSMP must not
                           adversely affect a person's access to treatment if
                           he/she is prescribed controlled substances.

  **Controlled             All CSMPs are required to monitor drugs in Schedules
  Substances**             II, III, and IV.

  **Database Creation**    There must be the creation of an electronic database
                           that will be used for storing all the information
                           necessary to running an effective CSMP.

  **Disclosure of          Only a select group of professionals, under
  Information**            restricted circumstances, may obtain access to
                           database information (i.e., Physician, Dentist,
                           Veterinarian, Scientific Investigator, Pharmacy,
                           Hospital, or person licensed or certified by the
                           State). Local, State and Federal law enforcement
                           authorities have only limited access to summary
                           statistics of CSMP information, unless otherwise
                           authorized by law.

  **Interoperability\***   CSMPs electronically share database information with
                           other CSMP States.

  **Notification**         A mechanism must be designed that alerts
                           practitioners and pharmacies of information that
                           might assist them in identifying possible
                           prescription drug abuse and notifying the appropriate
                           law enforcement officials like the DEA when
                           necessary.

  **Advisory and           A State's CSMP may have an advisory council which
  Oversight**              oversees the activities of the program. The advisory
                           council can consist of either State pharmacy
                           councils, law enforcement agencies, or both.

  **Funding**              Much of the CSMP funding comes from Federal grants
                           monies. After money is allocated from the Federal
                           Government, States begin to fund their own programs
                           either through the State legislature, States fees or
                           grants.

  **Confidentiality**      Confidentiality of individually identifiable patient
                           information must be maintained.

  **Review Process**       After a designated period of no later than 3 years,
                           the review process must start. The process must
                           examine the effectiveness of State CSMPs. All
                           information is then submitted to the United States
                           Congress for further consideration and review.
  ------------------------ -----------------------------------------------------

**[\*Interoperability or Sharing Information Across State
Borders]{.smallcaps}**

To share health data, agencies need to adopt the same clinical
vocabularies and the same ways of transmitting that information." The
Consolidated Health Informatics (CHI) establishes a portfolio of
existing clinical vocabularies and a "grammar" of messaging standards
that enable Federal agencies to build interoperable Federal health data
systems. These systems "speak the same language," allowing agencies to
share information without the high cost of translation or data re-entry.
Interoperability is "the ability of the program to electronically share
reported information, including each of the required report components
described in subsection (d) with another State if the information
concerns either the dispensing of a controlled substance to an ultimate
user who resides in such other State, or the dispensing of a controlled
substance prescribed by a practitioner whose principal place of business
is located in such other State." CHI initiative standards are compatible
with the Health Insurance Portability and Accountability Act of 1996
(HIPAA) transactions and code sets, security and privacy standards.
About 20 department/agencies including HHS, Veterans Affairs (VA),
Department of Defense (DOD), Social Security Administration (SSA),
General Services Administration (GSA), and National Institute of
Standards and Technology (NIST) are active in the CHI governance
process. Since November, 2003, the Department of Justice has been a CHI
Federal partner.

On March 21, 2003, HHS, DOD and VA announced the National Council on
Prescription Drug Programs (NCPDP) standards for ordering drugs from
retail pharmacies to standardize information between health care
providers and the pharmacies. The NCPDP SCRIPT standard, v. 5.0, has
been adopted under the Medicare Modernization Act for entities
prescribing covered part D drugs for part D eligible individuals.

Beginning in fiscal year 2002, Congress has appropriated funds to the
U.S. Department of Justice (DOJ) for support of CSMPs. The problem DOJ
addressed was the ineffective communication between CSMPs.

The Alliance of State with Prescription Monitoring Programs participates
with the Integrated Justice Information Systems Institute (IJIS)
committee for setting standards for transfer of prescription data
between State programs. The project provides a systematic way for States
to communicate prescription data across State lines, and has created a
model standard for the exchange of information between States.

Types of reports that can be shared between States using the system
include patient activity reports, a history of patients' prescriptions;
a history of prescriptions issued by practitioners; an activity report;
a history of prescriptions dispensed by pharmacies; bulk data reports; a
method for transmitting to an adjoining State all prescriptions filled
in the transmitting State for residents of the adjoining State or for
practitioners who issued the prescription in the adjoining State; and
alert notifications.

The IJIS CSMP committee is currently working on a pilot project to share
CSMP data between the States of California and Nevada. The next phase
will include a data sharing project involving Kentucky, Indiana, Ohio,
West Virginia and Michigan. The IJIS committee effort is focused on
developing a technical architecture for CSMP data exchange and
establishing technical guidelines, formats, processes and agreements for
sharing the data that will be consistent with the laws and regulations
for each State.

**APPENDIX G: GLOSSARY**

Accurate use of terminology is essential to understanding and
formulating a balanced approach that fosters appropriate use while
discouraging the non-medical use of prescription medications. Yet
scientists, clinicians, regulators, and the lay public use disparate
definitions of terms related to addiction.

Many of the terms used in this report have definitions that differ
somewhat from one group to another. Where possible, the authors employ
standardized terminology from established organizations and experts. The
following list contains the definitions used herein.

**Abuse.** The definition of "abuse" varies widely, depending on the
context in which it is used and who is supplying the definition. For
example, the Drug Enforcement Administration defines drug abuse as
involving the use of prescription medications outside "the scope of
sound medical practice" (DEA, 2002). In contrast, the American
Psychiatric Association in its *Diagnostic and Statistical Manual of
Mental Disorders* (1994) defines drug abuse as "a maladaptive pattern of
substance use, leading to clinically significant impairment or distress,
as manifested by one or more behaviors." More recently, the American
Society of Addiction Medicine (ASAM) described abuse of a medication as
use in a manner that "deviates from approved medical, legal, and social
standards, generally to achieve a euphoric state ('high') or sustain an
established dependence." This report employs the ASAM definition, which
reflects a consensus among addiction experts.

**Abuse Potential.** The *abuse potential* of a drug -- licit or illicit
-- has been described as "the relative ease with which a prescribed
medication can be extracted or modified to yield the desired psychic
effect" (Ling, Wesson et al., 2003). Pharmacologically, the abuse
potential of a drug usually is assessed according to (1) the drug\'s
reward-reinforcing effects, as measured by various indicators of liking
or "high" in humans and their propensity to vigorous self-administration
in non-human animals, and (2) the characteristic induction of
sensitization when given to laboratory animals on a daily basis (DuPont
and DuPont, 2003; DuPont and Gold, 1995). Abuse potential also is
related to drug formulation, in that formulations that impede ingestion
by the intranasal and intravenous routes of administration -- through
which the active agents circulate more rapidly to the brain -- are less
likely to be abused (Compton and Volkow, 2006; CPDD, 2006; Woody,
Cottler et al., 1993).

**Addiction.** Addiction to a prescription medication, like every other
form of addiction, in­volves a complex interplay of biological and
environ­mental factors (Vaillant, 2003). Alan Leshner, Ph.D., former
director of the National Institute on Drug Abuse, has described
addiction as a "disease of the brain," explaining that in vulnerable
individuals, repeated self-administration of a drug produces a
qualitative change in the way the brain functions. As a result, "the
affected individual has an intense need for, and focus on, repeating the
drug experience. But there comes a point**...** at which the drug user
becomes an addict. At that point, it appears that a figurative 'switch'
has been thrown and the individual suffers a signifi­cant loss of his or
her ability to make free choices about continued use of the drug"
(Leshn­er, 2001). Reflecting this understanding of addiction, the
American Academy of Pain Medicine, the American Pain Society, and the
American Society of Addiction Medicine have agreed on the following
definition: "Addiction is a primary, chronic, neurobiological disease,
with genetic, psychosocial, and environmental factors influencing its
development and manifestations. It is characterized by behaviors that
include one or more of the following: impaired control over drug use,
compulsive use, continued use despite harm, and craving" (AAPM, APS, and
ASAM, 2001).

**Analgesic.** Most potent analgesic agents are derived from opium or
are synthetic adaptations of opium. They depress the central nervous
system and relieve pain. They also can be used by persons who are
addicted to opioids to avoid or suppress withdrawal (Brushwood, 2003).

**Appropriate Use** (also termed "therapeutic use"): Appropriate use
involves avoidance of undermedication (underprescribing), overmedication
(overprescribing), and drug misuse or abuse.

**ARCOS Data.** Data from the *Automation of Reports and Consolidated
Orders System* (ARCOS) measure the amounts of controlled substances
distributed to the retail level from manufacturers and importers. The
data are collected by the U.S. Drug Enforcement Administration (DEA) and
reported in total grams and in grams per 100,000 population. Changes
made in the data collection methodology in 1997 resulted in
significantly increased quantities reported to ARCOS. Consequently, it
is not valid to compare ARCOS data for periods after 1997 with those
before that date. The DEA Office of Diversion Control has recently made
ARCOS reports available on its Web site; they can be accessed at
[www.deadiversion.usdoj.gov/arcos/index.html](http://www.deadiversion.usdoj.gov/arcos/index.html).

**Chilling Effect.** Used to describe a (hypothesized) action in which
prescription monitoring systems discourage the prescribing of covered
drugs, particularly opioid analgesics. Multiple mechanisms (such as the
inconvenience associated with a requirement to use a special
prescription form, fear of regulatory oversight, and concern for patient
privacy), have been offered to explain the presence of such an effect.

**Controlled Substance.** A *controlled substance* or *controlled drug*
is one that has been classified by the Drug Enforcement Administration
under one of the schedules of the Federal Controlled Substances Act of
1970 (Code of Federal Regulations, Title 21, Chapter 2). The CSA
designates the Attorney General, in consultation with the Secretary of
Health and Human Services, as the official who determines the
appropriate schedule for any drug or other substance proposed for
control under the CSA. The Attorney General and the Secretary of Health
and Human Services have delegated the authority to make such
determinations to the DEA and FDA, respectively. See Appendix B for
examples of federally controlled drugs.

**Dependence.** In various editions of the American Psychiatric
Association's *Diagnostic and Statistical Manual of Mental Disorders*,
the term "addiction" has been replaced with the term "dependence," which
has caused confusion among caregivers and policymakers alike. Such
confusion loses the important distinction between physical dependence
arising from abuse of a drug, and the *physical depen­dence without
addiction* that can and does occur within the context of good medical
care (as when a patient prescribed an opioid analgesic for pain becomes
physically dependent on the medication) (DuPont and DuPont, 2003).
According to the World Health Organization, "The development of
tolerance and physical dependence denote normal physiologic adaptations
of the body to the presence of an opioid" (WHO, 1996, p. 41). The
American Academy of Pain Medicine, the American Pain Society, and the
American Society of Addiction Medicine have agreed on the following
definition: "Physical dependence is a state of adaptation that is
manifested by a drug class specific withdrawal syndrome that can be
produced by abrupt cessation, rapid dose reduction, decreasing blood
level of the drug, and/or administration of an antagonist" (AAPM, APS,
and ASAM, 2001). This distinction is reflected in the two primary
diagnostic classification systems used by health care professionals: the
*International Classification of Mental and Behavioural Disorders, 10th
Edition* (*ICD-10*; WHO, 1996) of the World Health Organization (WHO),
and the *Diagnostic and Statistical Manual* of the American Psychiatric
Association (*DSM;* APA, 1994). The distinction is observed in this
report.

**Diversion.** The Federal Controlled Substances Act (21 U.S.C. §§ 801
et seq.) establishes a closed system of distribution for drugs
classified as controlled substances. Records must be kept from the time
a drug is manufactured to the time it is dispensed. Health care
professionals who are authorized to prescribe, dispense, and otherwise
control access to these drugs are required to register with the Drug
Enforcement Administration (DEA). Drugs that make their way outside this
closed system are said to have been "diverted" from the system, and
those individuals who are responsible for the diversion are in violation
of the law.

Although not identical, *abuse* and *diversion* are closely related, in
that the degree to which a prescribed medication is abused depends in
large part on how easily it is redirected (diverted) from the legitimate
distribution system (Ling, Wesson and Smith, 2003).

**Doctor-Shopping**. Used to describe a practice in which an individual
visits multiple physicians in roughly the same period of time to seek
prescriptions for the same or similar drugs. A defining characteristic
is the failure to disclose to any physician the fact that the "patient"
is obtaining prescriptions for similar drugs from other practitioners.
It generally is assumed that such drugs are sought for non-medical
purposes, although some experts suggest that certain "doctor shoppers"
actually are individuals who seek help for undertreated or untreated
medical disorders such as pain.

**Hassle Factor**. Like "doctor-shopping," the term "hassle factor" has
found wide use in medical circles to describe conditions created by what
physicians perceive to be excessive paperwork. With regard to CSMPs, it
is a term of art used to describe physicians' reactions to requirements
that they use a special type of form (e.g., State-issued, multiple-part,
et al.) to order certain drugs. It is used in the report to convey that
specific set of physician attitudes.

**Inappropriate Prescribing.** This term is used to describe the
behavior of a *physician* who prescribes a medication for the wrong
indication, to a patient who will not benefit, at too high a dose, or
for too long.

**Misuse.** The term *misuse* often is used to describe incorrect use of
a medication by a patient who uses a drug for other than the prescribed
purpose, takes too little or too much, takes it too often, or takes it
for too long.

**Narcotic*.*** The terms "opioid" and "narcotic" are virtually
synonymous, but the former term is used consistently in the health care
community, while the latter term is used consistently in the regulatory
and law enforcement communities. Both terms refer to drugs that are
derived from opium or are synthetic adaptations of opium (Brushwood,
2003).

**Non-Medical Use**. "Non-medical use" of a prescription medication is
defined in the NSDUH as use of a psychotherapeutic agent "even once,
that was not prescribed for you, or that you took only for the
experience or feeling it caused" (OAS, 2003a). The term encompasses all
uses of prescription medications other than those that are directed by a
physician and used by a patient within the law and the requirements of
good medical practice.

**Opioid.** The term *opioid* refers to natural and semi-synthetic
derivatives of the opium poppy, as well as to similar synthetic
compounds that have analgesic (or pain-relieving) properties because of
their effects on the central nervous system. These agents include
codeine, morphine, hydromorphone, hydrococone, oxycodone and fentanyl.
Opioids sometimes are inappropriately referred to as *narcotics*, a
legal term that is no longer used in medicine because it incorrectly
suggests that opioids relieve pain by inducing sedation (Joranson,
Gilson et al., 2003).

**Overmedication.** Overmedication involves the medically unjustified
use of a drug. The prescription of a drug is deemed unjustified when a
drug is used for an indication that is no longer accepted medical
practice (obsolete) as determined by drug utilization criteria and
standards; when there is no proper indication or sound scientific basis
for its use; when administration continues despite proven
ineffectiveness in curing the disease, disorder, or condition or
ameliorating its symptoms; when more effective or less hazardous drugs
are available; when the dose is excessive; when a mixture is used but
only one of its components is indicated; or when more drugs are
prescribed than are required (polypharmacy).

**Prescription Monitoring Program.** Prescription monitoring programs
(PMPs) facilitate the collection, analysis, and reporting of information
on the prescribing, dispensing, and use of controlled substances (GAO,
2003). Most such programs employ electronic data transfer systems, under
which prescription information is transmitted from the dispensing
pharmacy to a State agency, which collates and analyzes the information.
The older, paper-based monitoring programs (so-called "triplicate
prescription programs" or "multiple-copy prescription programs") are
being phased out (Alliance for Model State Drug Laws, 2002).

**Problematic Use.** Although more frequently associated with alcohol
use (NIAAA, 2005), the concept of "problematic use" has relevance for
prescription drug use as well. It is used to describe a range of
behaviors -- which may fall short of the criteria for abuse or addiction
-- that serve to elevate the risk for drug-related problems or
complicate the management of other health problems. Thus, it encompasses
*risk* for adverse results, as well as the actual *presence* of such
consequences.

**Pseudo-addiction.** Addiction and pseudo-addiction are easily
confused, but they are very different. Addiction is a neurobehavioral
syndrome that results in psychological dependence and "is characterized
by compulsive use despite harm." Pseudoaddiction is a "pattern of
drug-seeking behavior of pain patients who are receiving inadequate pain
management that can be mistaken for addiction" (FSMB, 1998).

**Undermedication.** Undermedication occurs when the patient fails to
receive adequate drug therapy. For example, the negative impact of
excessive concern about psychological and/or physical dependence is
revealed by reports that acute and chronic pain often is inadequately
treated. Relief of suffering is a legitimate goal of medical practice.
Failure to provide such relief may result from timidity
(\"pharmacophobia\"), incorrect or assessment of severity, or lack of
knowledge or faith in the value of a controversial drug, even when its
administration is indicated. Finally, patients may fail to comply or to
convey the severity of their symptoms to the physician. Thus, the
factors contributing to undermedication are diverse and disparate and
span the fields of medicine, psychology, economics, and sociology.

**Appendix H: Model Prescription Monitoring Act**

*Alliance of States with Prescription Monitoring Programs*

*and*

*National Association of State Controlled Substances Authorities*

### [PRESCRIPTION MONITORING PROGRAM MODEL ACT]{.underline}

###  October 2002

*Section 1. Short Title*

This Act shall be known and may be cited as the "Prescription Monitoring
Program Model Act."

*Section 2. Legislative Findings*

\[insert State findings\]

*Section 3. Purpose*

This act is intended to improve the State's ability to identify and stop
diversion of prescription drugs in an efficient and cost effective
manner that will not impede the appropriate medical utilization of licit
controlled substances or other licit drugs of abuse.

*Section 4. Definitions*

1.  \(a\) "Controlled substance" has the meaning given such term in
    \[section of the State controlled substances act\].

    \(b\) \[Designated State agency\] means the State agency responsible
    for the functions listed in Section 5.

    \(c\) "Patient" means the person or animal who is the ultimate user
    of a drug for whom a prescription is issued and/or for whom a drug
    is dispensed.

    \(d\) "Dispenser" means a person who delivers a Schedule II--V
    controlled substance as defined in subsection (e) to the ultimate
    user, but does not include:

    0.  \(I\) a licensed hospital pharmacy that distributes such
        substances for the purpose of inpatient hospital care \[or the
        dispensing of prescriptions for controlled substances at the
        time of discharge from such a facility\];

        \(II\) a practitioner, or other authorized person who
        administers such a substance; or

    ```{=html}
    <!-- -->
    ```
    0.  \(III\) a wholesale distributor of a Schedule II--V controlled
        substance.

```{=html}
<!-- -->
```
1.  \(e\) "Schedule II, III, IV and/or V controlled substances" mean
    controlled substances that are listed in Schedules II, III, IV, and
    V of the Schedules provided under \[insert section of the State
    controlled substances act\] or the Federal Controlled Substances Act
    (21 U.S.C. 812).

*Section 5. Requirements for Prescription Monitoring Program*

1.  \(a\) The \[designated State agency\] shall establish and maintain a
    program for the monitoring of prescribing and dispensing of all
    Schedule II, III and IV controlled substances \[and, if selected by
    the State, Schedule V controlled substances and/or additional drugs
    identified by the designated State agency as demonstrating a
    potential for abuse\] by all professionals licensed to prescribe or
    dispense such substances in this State.

    \(b\) Each dispenser shall submit to the \[designated State agency\]
    by electronic means information regarding each prescription
    dispensed for a drug included under paragraph (a) of this section.
    The information submitted for each prescription shall include, but
    not be limited to:

    0.  \(I\) Dispenser identification number.

        \(II\) Date prescription filled.

        \(III\) Prescription number.

        \(IV\) Prescription is new or is a refill.

        \(V\) NDC code for drug dispensed.

        \(VI\) Quantity dispensed.

        \(VII\) Number of days supply of the drug

        \(VIII\) Patient identification number.

        \(IX\) Patient name.

        \(X\) Patient address.

        \(XI\) Patient date of birth.

        \(XII\) Prescriber identification number.

        \(XIII\) Date prescription issued by prescriber.

        \(XIV\) Person who receives the prescription from the dispenser,
        if other than the patient.

        \(XV\) Source of payment for prescription.

        \(XVI\) State issued serial number \[if State chooses to
        establish a serialized prescription system\].

    \(c\) Each dispenser shall submit the information in accordance with
    transmission methods and frequency established by the \[designated
    State agency\]; but shall report at least every thirty days, between
    the 1st and the 15th of the month following the month the
    prescription was dispensed.

> \(d\) The \[designated State agency\] may issue a waiver to a
> dispenser that is unable to submit prescription information by
> electronic means. Such waiver may permit the dispenser to submit
> prescription information by paper form or other means, provided all
> information required in paragraph (b) of this section is submitted in
> this alternative format.

Note: the following paragraphs, (e) - (h), are intended for those States
that choose to establish a serialized prescription system as part of the
prescription monitoring program.

1.  \(e\) A serialized \[single copy or multiple copy\] prescription
    form, shall be issued by the \[designated State agency\] to
    individual \[insert "and institutional" if practitioners in health
    care institutions issue prescriptions that can be filled in
    pharmacies outside the institutions\] prescribers and shall be used
    for all prescriptions for drugs in \[Schedule II, III, IV and/or V\]
    controlled substances. Each series of prescriptions shall be issued
    to a specific prescriber and shall only be used by that prescriber.

    \(f\) Each prescriber shall only prescribe drugs in \[Schedule II,
    III, IV and/or V\] controlled substances on official serialized
    prescription forms issued by the \[designated State agency\].

    \(g\) Each dispenser shall only dispense drugs in \[Schedule II,
    III, IV and/or V\] controlled substances on such official serialized
    prescription forms.

    \(h\) The \[designated State agency\] shall charge each prescriber
    an amount sufficient to cover the costs of processing requests for
    forms, printing the prescription forms, and operating the
    prescription monitoring program.

> Note: States may chose to use alternative method than paragraph (h) to
> pay the cost of their serialized prescription forms and monitoring
> system, for example, through controlled substances registration fees.
> In such instances, paragraph (h) can be deleted.

*Section 6. Access to Prescription Information*

1.  \(a\) Prescription information submitted to the \[designated State
    agency\] shall be confidential and not subject to public or open
    records laws, except as provided in paragraphs (c), (d), and (e) of
    this section.

> Note: States may choose to also amend their open record statutes to
> specifically exclude from disclosure prescription information
> collected by their prescription monitoring program.

2.  \(b\) The \[designated State agency\] shall maintain procedures to
    ensure that the privacy and confidentiality of patients and patient
    information collected, recorded, transmitted, and maintained is not
    disclosed to persons except as in paragraphs (c), (d), and (e) of
    this section.

```{=html}
<!-- -->
```
1.  \(c\) The \[designated State agency or entity\] shall review the
    prescription information. If there is reasonable cause to believe a
    violation of law or breach of professional standards may have
    occurred, the \[designated State agency\] shall notify the
    appropriate law enforcement or professional licensing, certification
    or regulatory agency or entity, and provide prescription information
    required for an investigation.

    \(d\) The \[designated State agency\] shall be authorized to provide
    data in the prescription monitoring program to the following
    persons.

    0.  \(I\) Persons authorized to prescribe or dispense controlled
        substances, for the purpose of providing medical or
        pharmaceutical care for their patients.

        \(II\) An individual who requests the individual's own
        prescription monitoring information in accordance with
        procedures established under \[insert State statute granting
        individuals access to State held data concerning themselves\].

        \(III\) \[insert name or type of State boards and regulatory
        agencies that supervise or regulate a profession that is
        authorized for controlled substances activity\].

        \(IV\) Local, State and Federal law enforcement or prosecutorial
        officials engaged in the administration, investigation or
        enforcement of the laws governing licit drugs.

        \(V\) \[insert State Medicaid agency\] regarding Medicaid
        program recipients.

        \(VI\) \[insert judicial authorities\] under grand jury subpoena
        or court order \[or equivalent judicial process in each State\].

        \(VII\) Personnel of the \[designated State agency\] for
        purposes of administration and enforcement of this Act, or
        \[insert State controlled substances act\], \[if any other State
        statute is applicable, insert "or" and reference the other
        statutes\].

> \(e\) The \[designated State agency\] may provide data to public or
> private entities for
>
> statistical, research, or educational purposes after removing
> information that could
>
> be used to identity individual patients and/or persons who received
> prescriptions
>
> from dispensers.

## Section 7. Authority to Contract 

The \[designated State agency\] is authorized to contract with another
agency of this State or with a private vendor, as necessary, to ensure
the effective operation of the prescription monitoring program. Any
contractor shall be bound to comply with the provisions regarding
confidentiality of prescription information in Section 6 of this Act and
shall be subject to the penalties specified in Section 8 of this Act for
unlawful acts.

*Section 8. Rules and Regulations*

The \[designated State agency\] shall promulgate rules and regulations
setting forth the procedures and methods for implementing this Act.

*Section 9. Unlawful Acts and Penalties*

1.  \(a\) A dispenser who knowingly fails to submit prescription
    monitoring information to the \[designated State agency or entity\]
    as required by this Act or knowingly submits incorrect prescription
    information shall be subject to \[insert appropriate administrative,
    civil or criminal penalty\].

    \(b\) A person authorized to have prescription monitoring
    information pursuant to this Act who knowingly discloses such
    information in violation of this Act shall be subject to \[insert
    appropriate administrative, civil or criminal penalty.\]

    \(c\) A person authorized to have prescription monitoring
    information pursuant to this Act who uses such information in a
    manner or for a purpose in violation of this Act shall be subject to
    \[insert appropriate administrative, civil or criminal penalty.\]

*Section 10. Severability*

If any provision of this Act or application thereof to any person or
circumstance is held invalid, the invalidity does not affect other
provisions or applications of the Act which can be given effect without
the invalid provisions or applications, and to this end the provisions
of this Act are severable.

*Section 11. Effective Date*

This Act shall be effective on \[insert specific date or reference to
normal State method of determination of the effective date\].

> **Adopted by *Alliance of States with Prescription Monitoring
> Programs*, October 22, 2002 and *National Association of State
> Controlled Substances Authorities*, October 25, 2002**

**[Appendix I: case Studies]{.smallcaps}**

**[Sources of Information]{.smallcaps}**

Information was collected from government organizations such as the
United States' Government Accountability Office, Texas Department of
Public Safety ([www.txdps.\
state.tx.us/criminal_law_enforcement/narcotics/pages/goals.htm]{.underline}),
and nonprofit organizations such as the National Alliance for Model
State Drug Laws
([www.natlalliance.org/prescriptiondrug.asp]{.underline}). Kentucky's
CSMP Web site was useful
([www.techlines.ky.gov/2004/dec/drugmonitor.htm]{.underline}). Basic
information on CSMPs was retrieved from the University of Wisconsin's
Pain and Policy Studies Group
([www.medsch.wisc.edu/painpolicy/domestic/diversion.htm]{.underline}).
James Giglio, President of the Alliance of States with Prescription
Monitoring Programs, provided information about interoperability between
programs.

**Alabama.** In April 2006, the State Department of Public Health
instituted a monitoring program that requires reporting of all
prescriptions for Schedule II --V drugs. The program includes an
educational and outreach effort to inform practitioners and the general
public about the nature and extent of prescription misuse or abuse. The
program is capturing data at a rate that would average 8-10 million
prescriptions per year.

**California.** In 1996, the State implemented a program through the
State Department of Justice to monitor prescriptions for Schedule II
drugs. In 2005 the program was expanded to include Schedule III drugs.
Data on approximately 21 million prescriptions per year is available to
licensing and professional boards, law enforcement agencies, and
individual practitioners and pharmacies. Physicians make most (70
percent) requests for information; law enforcement and pharmacies each
make 15 percent of all requests, which average 5,000 per month.

**Kentucky.** The Kentucky All Schedule Prescription Electronic
Reporting (KASPER) program began in 1999. It captures data on more than
8 million prescriptions (Schedule II-V drugs) annually and responds to
an average 2,200 requests per month (92 percent from practitioners, 3
percent from pharmacies, 3 percent from law enforcement, and 1 percent
each from licensing boards and "other"). In a 2004 survey, users
(practitioners, pharmacies, law enforcement) reported a generally high
level of satisfaction with the system as a tool to assist treatment. A
web-based version of the system was implemented in 2005.

**Maine.** The Maine program began operation in 2004 under the
jurisdiction of the Office of Substance Abuse (OSA). It captures data
for all prescriptions issued to State residents for Schedule II, III,
and IV drugs. The program mandates disclosure by pharmacies and requires
that law enforcement agencies obtain a specific court order to gain
access to any information in the program. The State reports that 83
percent of information requests come from physicians, 17 percent from
pharmacies. An OSA survey found that stakeholders feel the program
respects confidentiality, is properly focused on public health rather
than law enforcement considerations, has not had a negative impact on
patient care, and includes an extensive education and outreach
component. The most commonly expressed criticism was slow response to
information requests.

**Nevada.** In 1995, the State implemented a monitoring program
consistent with the intent of the NASPER Act. The program collects data
twice a month from pharmacies and dispensing practitioners regarding
controlled substance prescriptions (schedules II through IV). The State
established a task force to oversee the implementation of the monitoring
program. Nevada's program produces three reports: patient drug
utilization report, threshold report, and a monthly pharmacy report. In
2005, 431 out of approximately 483 (89 percent) pharmacies in the State
reported to the CSMP. The number of reports requested has increased
considerably since the year 2000. In 2005, 26,264 reports were
requested, while in the year 2000, 4,530 reports were requested. The
majority of the reports (85 percent) were requested by physicians. In
addition to the in-State reporting, CSMP has taken initial steps in
developing interoperability between States.

**New York**. The State implemented a monitoring program in 1972 for
prescriptions written for Schedule II drugs. In 1989, the program was
expanded to include Schedule III and IV drugs in an effort to monitor
benzodiazepine use and possible abuse. The program was amended in 1998
to require electronic transmission of prescription information and
eliminate triplicate prescription forms. Evaluations of the program
suggest that it has reduced illicit prescription drug activity without
having a negative influence on patient care.

**Virginia.** A pilot program, limited to the southwest region of
Virginia, was implemented in September 2003. The program gathered
information twice each month on prescriptions (averaging 400,000 per
year) for Schedule II-IV drugs. The program received an average of 600
requests for information each month---78 percent from physicians, 19
percent from law enforcement, 3 percent from licensing boards. An
evaluation of the pilot program indicated that illicit prescription drug
activity shifted away from the region, with no effect on legitimate
prescription activity. A statewide program took effect in May 2006.

**[Case Studies: Program Evaluation Results]{.smallcaps}**

The program evaluation (Maine and Kentucky) results reviewed in this
section show evidence of effective program components. The program
descriptions (Virginia, New York, Alabama, and California) in this
section demonstrate organizational structures across different States.

**Maine's Controlled Substance Monitoring Program**. State statute
creating the program was enacted in 2003 and regulations put in place in
June, 2004. Under Maine's CSMP, all transactions from pharmacies
dispensing prescriptions to Maine residents for Schedules II, III, and
IV drugs are submitted electronically to a database maintained by the
Maine Office of Substance Abuse (OSA).

An alarming increase in the abuse of prescription drugs in Maine
prompted State policymakers to develop Maine's CSMP. Treatment
admissions for prescription drug abuse had increased from 83 in 1995 to
1,148 in 2003. The number of overdose deaths increased steadily -- as
did the proportion of these deaths caused by prescription drug abuse. In
2001, there were 90 drug deaths in the State; 70 (78 percent) were
caused by a pharmaceutical. One year later, in 2002, the number of
overdose deaths had nearly doubled to 166; 148 of these deaths (89
percent) were caused by a pharmaceutical. Arrests for prescription drug
diversion increased steadily, accounting for 16 percent of arrests made
by Maine Drug Enforcement Agency in 2003. In 2002, more than 20 percent
of Maine high school seniors reported that they have used prescription
drugs to get high.

A consensus emerged that a monitoring program should be used as a public
health and clinical intervention tool to reduce the illicit use of
prescription drugs. Under the leadership of Maine's Office of Substance
Abuse and with the participation and support of Maine's medical
community, pharmacies, attorney general's office, department of
licensure and regulation, and other stakeholders a working consensus was
formed for how Maine's monitoring program should work to support this
goal. This group evolved into the CSMP Advisory Committee. The passage
of the Bill in 2003 gave the Office of Substance Abuse the authority to
develop the program, but did not authorize a State expenditure. The
program secured funding in October 2003**.**

The Muskie School of Public Service, University of Southern Maine,
conducted a process evaluation of Maine's CSMP in late summer and fall
2005. The purpose was to assess the implementation of the program from
the perspective of stakeholders participating in the development of the
CSMP and the experience of participating practitioners and pharmacies.
The evaluation consisted of three components:

1.  Key stakeholder interviews with OSA staff, members of the CSMP
    Advisory Committee, and the contractor (GHS Data Management).

2.  Survey of pharmacies who submit data to the program.

3.  Survey of practitioners who have registered in the CSMP system.

*Stakeholder Interviews*. Interviews were conducted with OSA staff,
members of the CSMP Advisory Committee, and the data contractor.
Although questions varied somewhat for each stakeholder group,
stakeholders were asked about their participation in the CSMP program,
what the major goals of the CSMP were, whether the program would be
likely to meet these goals in the long-run, how the program was working
so far (including the generation and use of data reports), whether they
had any issues or concerns, and how program outcomes should be
evaluated. Respondents were also asked what two things they would
recommend to OSA. Findings from these interviews are synthesized below.

Stakeholders agreed that the major goal of the Maine CSMP was to reduce
the illicit use of prescription drugs in Maine by giving practitioners a
tool for improved patient care and giving both practitioners and
pharmacies information that helps identify patients who might be abusing
prescription drugs. Nearly all stakeholders were clear to draw the
distinction between the public health focus of these goals and the law
enforcement goals found in other States. A number of stakeholders noted
that early and timely clinical intervention was important, before a
patient's prescription abuse became more severe or had greater
consequences. Several stakeholders indicated that there was also a more
global and long term public health goal for the program, in which the
CSMP database could be used to show the extent and distribution of
prescription drug abuse geographically and by age group across Maine.

The major concern in developing the program was patient confidentiality.
At a political and policy level, this issue was resolved relatively
early. Confidentiality is an ongoing consideration that needs to be
addressed while balancing access to and speed of data retrieval with the
accuracy and confidentiality of the data.

Stakeholders uniformly praised the CSMP Advisory Committee, saying it
provided an important and productive forum for identifying and resolving
potential problems. Stakeholders reported that the OSA Director listened
and responded to stakeholder concerns, trying to find a satisfactory
solution to problems and issues (often around confidentiality). Advisory
Committee members interviewed were appreciative of the clear and useful
information presented at the meetings.

Stakeholders reported that the CSMP had been successfully implemented.
Early use of Threshold Reports and Patient History Reports appear to
have gone well. Both State medical associations reported that their
members participating in the CSMP seem pleased with the program. Early
concerns over patient confidentiality or the potential use of CSMP data
by law enforcement---a potential barrier to care---have not
materialized. Reporting of data from pharmacies to the data contractor
has improved steadily over time, both with respect to the timeliness and
the accuracy of the data. Similarly, the generation of threshold reports
has improved with respect to how low or high to set the threshold and
for regularity and timeliness of the reports. Participants look forward
to implementation of an on-line portal.

There were relatively few and minor concerns expressed about the
program. Concerns included calibrating the level on threshold reports;
more timely access to the database; more timely and consistent
submission of data to the data contractor, particularly by smaller and
non-computerized pharmacies. Several stakeholders noted the need to
secure and maintain external funding and that any effort to shift some
of the costs of the program onto participants could jeopardize the
program.

The trade-off between accuracy and confidentiality of information and
the speed and usefulness of this information remains. There is
enthusiasm about the CSMP web portal which will offer enhanced access to
practitioners and pharmacies. Yet creating this access (almost
universally desired by practitioners and pharmacies) increases the
potential for security violations. Under the present system there is an
opportunity for someone to review manually requests for reports. This
will not be true under the new web portal. However, consensus exists
that the benefits of quick access for providers, particularly emergency
room doctors, outweigh the reduced oversight.

*Practitioner Survey.* A survey was mailed to the 350 practitioners who
had registered under the Program. One-hundred and thirty-six
practitioners completed the survey for a response rate of 38.9 percent.

Nearly three out of four practitioners (71.3 percent) reported receiving
a threshold report on one or more of their patients. The majority of
these respondents found the threshold report easy to understand (94.5
percent) and helpful (80.4 percent). Two--thirds of the respondents
indicating that they had received a threshold report gave an answer to
the question "What happened as a result of the report?" Their responses
(which allow for multiple answers) indicate that the threshold report
was being used much as the program hoped it would be---as a potential
flag for possible abuse and to result in follow-up action.

Just under half of the respondents had requested a patient history
report; 75 percent of those requesting the patient history file found it
useful. Over half (61 percent) of those who had not requested a patient
history report expected to request one over the next six months.
Sixty-three percent indicated that they had requested a patient history
report gave an answer to the question "What happened as a result of the
report?" Their responses (which allow for multiple answers) indicate
that the patient history report was being used much as the program hoped
it would be---to serve as a potential flag for possible abuse and to
result in follow-up action. Five respondents reported that they had
requested a report and never received one.

Twenty-one percent of the respondents had a concern about the program.
The major concern was that there was too long of a delay between
requesting and receiving information. Practitioners wanted real-time,
internet-based access that would help them when their patients were in
their office or emergency room.

The most common recommendation for improving the CSMP is to reduce the
time lag between requesting and receiving data; other common
recommendations were to improve the process for registering and using
the program and to provide better information about the program.

*Pharmacy Survey.* A survey was mailed to 66 registered pharmacies; 21
returned completed surveys (31.8 percent response rate). The most common
questions pharmacies had about the program were about software and
implementation issues and general data reporting requirements. The
majority of pharmacies thought the reporting requirements under the
monitoring program were easy or very easy. Twenty-five percent of
respondents thought that the reporting requirements were somewhat
difficult or very difficult.

Respondents were evenly divided about whether or not the monitoring
program was useful (somewhat or very) or not useful (not very/not at
all) to their pharmacy. Less than half of the pharmacies had requested a
patient history report and only six of those eight found the report
helpful. One third of those not requesting a patient history reported
that they expected to request a report over the next six months.
Pharmacies requesting a patient history report were asked what happened
as a result of that report. The most common result was that it was
confirmed that the patient was misusing medications.

Half the respondents reported concerns about the CSMP. The most common
concern was that it was too long of a lag between requesting and
receiving information; a related concern was that there should be
proactive reporting to pharmacies. Not surprisingly the most common
recommendation for improving the program was to reduce the time lag
between requesting and receiving information.

*Discussion and Recommendations*. The CSMP has been implemented
successfully and is meeting its current goals. By all accounts, the
Office of Substance Abuse has done an excellent job in developing and
implementing the program. Stakeholders commended the Office of Substance
Abuse for (1) establishing and maintaining a prevention and treatment
goal for the CSMP (and not a law enforcement goal); (2) listening to the
medical and other stakeholders in establishing and implementing the
program, and (3) its extensive outreach and educational efforts. Chris
Baumgartner, the data manager and currently the acting Director was
praised for his technical expertise, clarity, and availability to answer
any questions or concerns.

Practitioner registration for the program is increasing and, in general,
practitioners have requested and used Patient History Reports as
intended.

To meet its longer term goals, the CSMP must continue to increase the
number of registered prescribers actively using the program and its
database. This requires that the number of prescribers registered and
actively using the program continue to increase. There is every reason
to believe this will happen. Prescribers currently using the program
find it very useful and an important source of information (and
encouragement) for other prescribers registering and using the program.
Nevertheless prescribers are very busy and face increasing
administrative and clinical demands from many sources in their
day-to-day clinical practice.

Generally, pharmacies have participated in and realized the benefits of
the CSMP as it was designed. Compared to the practitioners, there may be
a bit more "wait and see" attitude among pharmacies as to the utility of
the Program, relative to their reporting requirements. Continued
technical refinements in the database system (primarily involving
reducing the time between requesting and receiving information) should
continue to bolster the support and use of the program by pharmacies.

A central consideration in establishing the monitoring program was the
assurance of data security and confidentiality. This concern represents
an on-going challenge for the CSMP to balance the needs of data users to
have "real-time" access to the data with the need to maintain data
security and confidentiality.

The CSMP has established credibility and support within Maine's medical
community. For the most part, practitioners who are engaged in this
program are using it and realizing the benefits intended by the
developers of the program. The CSMP should continue to expand this
support and extend the number of actively participating practitioners
by:

-   Providing ongoing outreach and information sessions.

-   Providing accessible technical assistance to remind practitioners
    how to register and use the system (including finding the password
    they may have forgotten).

-   Reducing the time between requesting and receiving information.

Given its successful implementation, the program should begin to
consider longer-term issues of sustainability and how the program may be
used to booster the public health substance abuse prevention goals of
the State. Under a separate, but potentially related
initiative---SAMHSA's Strategic Prevention Framework, State Incentive
Grant (SPF-SIG)---Maine is currently undertaking a major transformation
of its public health and substance abuse prevention infrastructure and
has identified reducing abuse of prescription medication as a major
objective for local communities to address. Areas of strategic
convergence between the CSMP and SPF-SIG programs should be identified
and explored.

**Kentucky's Controlled Substance Monitoring Program**. The Kentucky All
Schedule Prescription Electronic Reporting (KASPER) system was
implemented in 1999. It was designed to be both a source of health care
information for practitioners and pharmacies and as an investigative
tool for law enforcement. Requests for reports have continued to grow
from 3,105 requests processed in the first six months of operation to
166,452 requests in 2006 (see Exhibit 9). In October 2004, a survey was
launched to gather the opinions of the user community to assess user
satisfaction, and to evaluate the effectiveness of the program as a tool
for practitioners, pharmacies, and law enforcement.

> **Exhibit 9: Kentucky Controlled Substance Monitoring Program Report
> Requests per Year: 2000-2006**

![](media/image2.wmf){width="4.781944444444444in"
height="3.2736111111111112in"}

In 2004, Kentucky surveyed manager, program staff, law enforcement
personnel, and members of the licensure boards. The satisfaction survey
was designed to address objectives identified for the FY 2004
Prescription Drug Monitoring Program grant.

The survey indicated a high level of CSMP use by respondents. The
results suggest that once a health care practitioner becomes aware of
the capabilities of Kentucky's CSMP, they realize the usefulness of the
system and begin to request reports for their patients when appropriate.
The results further indicate that users tend to believe the system is an
effective tool to assist in treatment, however there appear to be
concerns about the quality (and possibly the timeliness) of the data.
Initial analyses indicate that the system and reports are relatively
easy to use and require minimal training. In March 2005, Kentucky
implemented a web-based version of the system called Enhanced KASPER
(eKASPER), intended to increase the number of practitioners using the
web-based system and improve the overall efficiency of the system.

A 2006 KASPER Satisfaction Survey is planned for users of the eKASPER
system. The 2006 Satisfaction Survey will apply to the eKASPER system
and allow a comparison of satisfaction with the original system versus
the web-based system.

**[Case Studies: Program Descriptions]{.smallcaps}**

**Nevada's Controlled Substance Monitoring Program (CSMP)**. In 1995,
the Nevada State Legislature passed into law Nevada Revised Statute
(NRS) 453.1545 mandating that the Nevada State Board of Pharmacy, the
Nevada Division of Investigation and the State Bureau of Alcohol and
Drug Abuse develop a computerized program to track controlled substance
prescriptions. The statute also directed the establishment of a group,
named the Controlled Substance Abuse Prevention Task Force, to oversee
the implementation of the CSMP. The Task Force consists of 22
representatives from three State agencies, health care boards,
practitioner associations, pain management specialists, and the district
attorney's association.

Nevada's CSMP was developed to help prevent the inappropriate
distribution and use of prescription controlled substances. Day-to-day
operation and administration of the CSMP are carried out by one staff
person with management and analytical skills, a full-time database
analyst, and the data collection contractor. The first year costs for
the program have been offset by grants from the Nevada State Board of
Medical Examiners and two private corporations. A portion of the
biannual controlled substance registration fee of \$50 (paid for by
practitioners) covers subsequent year costs.

The CSMP collects data twice a month from pharmacies and dispensing
practitioners regarding controlled substance prescriptions (schedules II
through IV). This data collection allows for the identification of
consumers who use multiple pharmacies and practitioners and are
suspected of drug seeking behavior. With the funding from a 2004
enhancement grant, the CSMP hired a case manager. Once the case manager
becomes involved, the doctors' care is coordinated, and the patient is
referred to specialists as needed.

The CSMP produces three reports: patient drug utilization report,
threshold report, and a monthly pharmacy report.

*Patient Drug Utilization Report*. The patient drug utilization report
is produced when a patient is identified as potentially abusing
controlled substance prescription medication. The report contains
information regarding the patient, the practitioners who prescribed the
controlled substances, the pharmacies that dispensed the prescriptions,
and the prescriptions filled for the patient. The report is sent to each
practitioner and pharmacy that has prescribed or dispensed controlled
substances to the patient. This report provides information regarding
the total prescriptions obtained by their patient so they can better
treat the patient and, when appropriate in their professional judgment,
modify prescribing.

*Threshold Report*. The Threshold Report is an internal report listing
patients who have exceeded exception thresholds. It contains 12-month\'s
summary information on each patient who exceeds the thresholds,
including patient name, the number of controlled substances
prescriptions filled and dosage units received, number of practitioners
who issued prescriptions to patient, and number of pharmacies that
dispensed prescriptions to patient. It can be sorted by number of

practitioners who issued controlled substances prescriptions to the
patient so the program can readily identify the patients going to the
highest volume of practitioners. It helps the CSMP categorize patients'
access to controlled substances.

*Monthly Pharmacy Report*. The Monthly Pharmacy Report is used to verify
that all pharmacies are transmitting data. It contains 12 months of
information regarding each pharmacy, with the total number of controlled
substances dispensed during each month.

A summary of Nevada's CSMP reporting follows. In 2005, 431 out of
approximately 483 (89 percent) pharmacies in the State reported to the
CSMP. The number of reports requested has increased considerably since
the year 2000. In 2005, 26,264 reports were requested, while in the year
2000, 4,530 reports were requested. The majority of the reports (85
percent) were requested by physicians. In addition to the in-State
reporting, the CSMP has taken initial steps in developing
interoperability between States. Nevada and California have volunteered
to participate in a pilot project to demonstrate the feasibility of an
automated information exchange between the State programs.

**Virginia's Controlled Substance Monitoring Program.** The 2002 Acts of
Assembly amended the *Code of Virginia* to create a CSMP as a pilot
program limited to State Health Planning Region III in Southwest
Virginia. The Department of Health Professions was awarded a Federal
grant through the Prescription Drug Monitoring Program to implement and
support initial operations of the program in April 2003. An additional
grant was awarded in 2004 to sponsor a conference on prescription drug
abuse and prescription monitoring programs and to conduct a survey of
practitioners regarding the prescribing of controlled substances and
their impressions of the program.

Although not required by the statute, the Director of Health Professions
formed an advisory committee in June 2003. The committee includes
representatives of organizations with an interest in the monitoring
program. The organizations include the American Cancer Society, the
Hospice organization, the State Police, Boards of Pharmacy and Medicine,
and the Medicaid Fraud unit of the Attorney General\'s Office. The
committee advises the Department on the extent to which the statute had
been successfully implemented, any changes that should be made in
policies and practices of the program, what aspects of the program
should be evaluated and any other issues related to the illegal
diversion of controlled substances or access to appropriate drug
therapy. The committee has met quarterly beginning in September, 2003
and has been instrumental in developing an evaluation work plan for the
program, determining policy issues and making recommendations resulting
from the review of these issues.

The program began operation in September 2003. Approximately 300
pharmacies and other pharmacies submitted twice-monthly reports of
prescriptions dispensed for Schedule II controlled substances.
Instituting the pilot program in only the Southwest portion of the
Commonwealth appears to have caused some illegal prescription drug
diversion to move outside the program area. State Police Drug Diversion
Unit data comparing 2003 to 2004 show complaints received by the unit
increased 26 percent statewide while decreasing in the program area by
47 percent. Arrests increased by 35 percent statewide versus 31 percent
in the program area. It also appears that using the program may save
substantial man-hours in performing investigations. Data from the
program showed a 53 percent decrease in man-hours spent doing pharmacy
profiles between 2003 and 2004.

It appears that implementation of the CSMP has not significantly reduced
the use of Schedule II medications; the amount of oxycodone and
hydrocodone distributed in wholesale channels increased throughout
Virginia at rates of 9 percent and 8 percent respectively from 2002 to
2003. Moreover, data compiled by the Department of Medical Assistance
Services show that claims related to prescriptions for these drugs were
21 percent higher in the first quarter of 2004 than in the first quarter
of 2001.

Accidental deaths due to prescription drug abuse or misuse continue to
be a significant public health concern in Virginia, especially the
southwest region of the Commonwealth. Since 2000, there has been a 100
percent increase in drug deaths in the Western District of the Office of
the Chief Medical Examiner.

Data from SAMHSA shows substance abuse treatment admissions in Virginia
for non-heroin opiates have increased significantly from 2000 to 2004. A
staff member from the Department of Mental Health, Mental Retardation
and Substance Abuse Services explained this does not reflect an increase
in treatment capacity but rather a dramatic shift to persons seeking
admission and treatment for abuse of opiates.

Under its original structure, the Virginia CSMP severely restricted
access to data. For example, a pharmacy (pharmacist) could not query the
system at all. The Advisory Committee evaluated the Virginia CSMP and
recommended these changes:

1.  Continue the program indefinitely;

2.  Expand the program to include Schedule II through IV controlled
    substances;

3.  Expand the program to the entire Commonwealth;

4.  Allow pharmacies to access the program;

5.  Allow a prescriber licensed in another State to request information
    from the CSMP;

6.  Allow access to the CSMP for Department of Health Professions
    investigative personnel and designated Health Practitioners\'
    Intervention Program personnel on a specific licensee, registrant,
    or certificate holder where there is an open investigation;

7.  Allow Medical Examiners access to the CSMP for the purpose of
    performing their duties in accordance with the appropriate statues
    of the Code of Virginia*;*

8.  Allow access to the Department of Medical Assistance Services for
    the purpose of investigating fraud when there is an open
    investigation on a recipient;

9.  Allow access to the Drug Enforcement Agency when there is an open
    investigation on a practitioner or pharmacy;

10. Allow access to the program for research purposes to public and
    private entities where all personal identifying information is
    removed;

11. Allow access to the program for health/education purposes, providing
    information to practitioners and pharmacies on their patients who
    may be abusing, misusing, or fraudulently obtaining controlled
    substances; and

12. Require non-resident pharmacies to report to the program.

The revised program began May 1, 2006, for those pharmacies already
reporting under the Southwest Virginia pilot program and incorporated
all data already collected during the pilot program. The new program
covers the entire State and requires all pharmacies to report, at least
twice a month, prescriptions dispensed in Schedules II, III, and IV. The
program also requires non-resident pharmacies to report dispensing of
covered substances to Virginia residents.

All transactions must be submitted electronically at least twice
monthly. Pharmacies who so choose may report more frequently than twice
a month. Pharmacies with multiple facilities can submit one data
transmission on behalf of all their facilities.

At present, there are 2,384 pharmacies licensed or permitted to dispense
by the Board of Pharmacy. A pharmacy my request a waiver or exemption
from reporting if they do not dispense any Schedule II, III, or IV
controlled substances or meet the requirements for an exemption; 442
pharmacies now hold a waiver or exemption. Federal entities such as
Veteran\'s Administration or Department of Defense pharmacies do not
report to the CSMP.

To request information from the database, a practitioner must have a
patient's specific written consent. A pharmacy must either post a sign
notifying patients that the program may be used to verify the validity
of a prescription, provide written notice, or obtain the patient's
explicit consent.

There are two ways by which an authorized user may request information
from the program. The first is to use a secure Web site through which,
after registering as a user; the user may request information, and the
report will be sent back on the Web site. The second method is to print
out a request form from the program main web page and fax the request.
The report will be faxed back to the requestor. Telephone or e-mail
requests are not accepted. In most cases, requests will be processed
within 30 minutes of being received during normal business hours. Online
access will make most program information available 24/7 access to
program information in most cases.

More than 4 million prescription records have been added to the data
base since June 1, 2006. Requests for information from the program have
increased from roughly 200 requests in May 2006 to more than 700 in
September 2006. More requests were processed from June to September 2006
(2,198) than in all of 2005 (1,791). Practitioners made 70 percent of
the requests, pharmacies made 15 percent, and other authorized users
made 15 percent of requests. The program has also seen a substantial
increase in the number of registered users.

New York's Controlled Substance Monitoring Program. New York's CSMP was
established by the 1972 enactment of Article 33 of the Public Health
Law, known as the New York State Controlled Substances Act (CSA). The
purpose of the program is to curtail the diversion of prescription
controlled substances prone to addiction and abuse by requiring them to
be prescribed only on an official New York State prescription form. The
program originally applied to Schedule II controlled drugs. In 1989, in
response to increasing abuse of benzodiazepines, a class of drugs used
to treat anxiety, monitoring was extended to the schedule IV controlled
substances.

New York's Department of Health distributes official prescription forms
to practitioners and healthcare facilities. After dispensing prescribed
medications, pharmacies submit official prescription information to the
Department where it is stored in a secure database. The data is accessed
for analysis by the Bureau of Narcotic Enforcement. Official
prescription information is confidential and may be provided to other
agencies only as specified by law.

The official prescriptions contain security features to deter
alterations, counterfeiting, and forgeries. The prescriptions are
serialized and can be tracked from vendor to practitioner to pharmacy.
Lost or stolen serial numbers are posted on the Department's Web site
for access by pharmacies prior to dispensing.

From 1972 to 2001, the official New York State prescription form
consisted of three copies, often referred to as a "triplicate." A
prescribing practitioner retained one copy for record keeping and gave
the remaining two copies to the patient to take to a pharmacy. After
dispensing the prescription, the pharmacy retained the second copy for
its records and mailed the third copy to the Department of Health, where
information from the prescription was manually entered into a secure
database. In 2001, the "triplicate" prescription was converted to a
single-part form to facilitate electronic transmission.

At the outset of the Official Prescription Program, the Department
issued approximately 750,000 prescriptions annually, of which
approximately 500,000 were reported dispensed. When benzodiazepines were
added to the program, the Department's issuance increased to 3.8 million
per year. By 2004, the Department was issuing some 8 million
prescriptions annually, 4 million of which were reported as being
dispensed.

The Department's experience with monitoring benzodiazepines demonstrates
the effectiveness of the Official Prescription Program in curtailing
drug abuse and diversion. A 1989 Office of Public Health study reported
a decrease of, respectively, 55 percent, 27 percent, and 41 percent in
the number of benzodiazepine prescriptions for Medicaid, the Empire
Plan, and the EPIC program after monitoring began. This decrease was not
offset by an increase in prescribing of substitute drugs indicates that
the reduction in prescribing curtailed only illegal activities with
benzodiazepines and not their legitimate use.

The effectiveness of the program is further demonstrated by Federal Drug
Enforcement Administration (DEA) reports on the State-by-State
consumption of OxyContin. For the years 1999 through 2002, New York
ranked either 49^th^ or 50^th^ countrywide in consumption of the drug,
leading DEA and New York's Bureau of Narcotics Enforcement to jointly
conclude that monitoring by the Official Prescription Program curtails
the diversion of OxyContin in New York.

In 1998, at the request of the Commissioner of Health, the New York
State Public Health Council established the Ad Hoc Committee on Pain
Management to identify barriers to effective pain management in the CSA
and recommend ways to overcome those impediments. All of the Committee's
recommendations were incorporated into Public Health Law that ensured
and enhanced access to controlled substances for legitimate use in
healthcare, including palliative care, while combating their illegal use
and trade.

The centerpiece of the amendments to the CSA was the conversion of the
"triplicate" prescription to a single-part form and pharmacy submission
of official prescription information to the Department by electronic
transmission for more efficient monitoring. The statute also allowed
prescribing of an increased quantity of a controlled substance to treat
approved chronic medical conditions and the partial filling of
prescriptions by pharmacists to better provide for a patient's changing
needs.

In 2004, a new Public Health Law expanded the Official Prescription
Program to require that all prescriptions written in New York be issued
on an official prescription form. By extending the program's monitoring
success to all drugs, the new law will curtail prescription fraud. In
January 2005, the Department began providing newly designed official
prescriptions to practitioners and healthcare facilities free of charge.
The Department anticipates that the number of prescriptions issued will
increase to an estimated 220 million annually.

The 2004 law encourages electronic prescribing, an efficient method
whereby a practitioner transmits a prescription to a pharmacy by
electronic means. The Department plans to use \$1 million in Federal
grant funds to promote electronic prescribing, which minimizes
medication errors due to misinterpretation of handwriting. Because
electronic prescribing also does not require a paper prescription, the
prescription can not be fraudulently altered to obtain drugs. The law
also permits the Department to notify practitioners when an analysis of
prescription data reveals individuals to be obtaining drugs from
multiple sources.

**Alabama's Controlled Substance Monitoring Program.** A law inacted in
2004 placed responsibility for Alabama's CSMP within the Alabama
Department of Public Health. The objectives of the program are:

-   Promote appropriate use of controlled prescription drugs;

-   Reduce the number of illegal prescriptions for Schedule II, III, IV,
    and V drugs,;

-   Reduce the time and effort required by law enforcement and
    regulatory investigators to explore leads and assess the merits of
    possible drug diversion cases; and

-   Educate practitioners, pharmacies, policy makers and the public
    about the existence and extent of diversion, and the drugs most
    likely to be diverted by individuals.

Mandatory reporting of controlled substance prescriptions to the
database began April 1, 2006. In the first six months, more than 5
million controlled substance prescriptions were reported. Educational
outreach is in the planning phase and has not yet been implemented.
Plans include educating practitioners, pharmacies, policy makers and the
public about the existence of the drug diversion problem in Alabama with
brochures and Public Service Announcements. These

announcements will include facts about the extent of the problem in
Alabama and will provide information to help recognize when a friend or
loved one is suffering from abuse or addiction.

**California's Controlled Substance Monitoring Program.** In 1996, the
Legislature passed Assembly Bill (AB) 3042 requiring that the California
Department of Justice (DOJ) establish the Controlled Substance
Utilization Review and Evaluation System (CURES), which automates the
collection and analysis of all Schedule II controlled substance
prescriptions issued in California.

On January 1, 2005, the program began collecting all prescribed Schedule
III substances. In addition, prescriptions for Schedule II-V Controlled
Substances are now written on new, tamper-resistant prescription forms.
The data is available to the Medical, Pharmacy, Dental, Osteopathic,
Veterinary and Registered Nursing Boards via the internet. DOJ provides
the maintenance and technical support of the system, with annual
financial assistance from the boards. Information is available to
authorized employees as well as law enforcement and outside agencies who
conduct investigations with or through California's Department of
Justice.

California's program has developed a system of working with medical
practitioners and pharmacy to assist them when they suspect a patient
may be misusing prescription medication. The medical practitioner or
pharmacy may request a prescribing history for a patient. DOJ can obtain
copies of the data, which is considered medical information subject to
the provisions of confidentiality. It is also the policy of DOJ to
provide program information to law enforcement agencies and regulatory
boards as a tool for investigations. The information maintained in
California's CSMP includes:

-   Prescription series numbers used until December 31, 2004;

```{=html}
<!-- -->
```
-   Prescription date;

-   Patient's name and address;

```{=html}
<!-- -->
```
-   Practitioner's Drug Enforcement Administration registration number,
    address, and degree of license;

-   Name, form, strength and quantity of the drug prescribed;

```{=html}
<!-- -->
```
-   Date filled; and

```{=html}
<!-- -->
```
-   Pharmacist's State number.

**Appendix J: Field Reviewers**

Nancy D. Berkman, Ph.D.

Project Director, Co-Occurring Disorders Study

Research Triangle Institute

Research Triangle Park, North Carolina

Daniel S. Connolly

Vice Chair, Rx Action Alliance, and

Managing Partner, Giuliani Partners LLC, and

Former Counsel to the Criminal Justice Coordinator, City of New York

New York, New York

June L. Dahl, Ph.D.

President, American Alliance of Cancer Pain Initiatives, and Professor
of Medicine

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin

Robert L. DuPont, M.D.

Chair, Advisory Committee on Non-Medical Use of Stimulant Drugs, and

President, Institute for Behavior and Health, Inc., and

Former Director, National Institute on Drug Abuse, and Former Director,
White House Drug Policy Office

Rockville, Maryland

John L. Eadie

Eadie Consulting

Former Director, Division of Public Health Protection, New York State
Department of Health

Former President, National Association of State Controlled Substances
Authorities

Rensselaer, New York

Scott Fishman, M.D.

Professor of Anesthesiology and Pain Medicine

and Chief, Division of Pain Medicine

University of California at Davis, and

Past President, American Academy of Pain Medicine, and Member of the
Board, American Pain Foundation

Davis, California

Mark S. Gold, M.D.

Distinguished Professor, Department of Psychiatry, and Chief, Division
of Addiction Medicine

University of Florida Brain Institute

Gainesville, Florida

Larry L. Greenhill, M.D.

Professor of Clinical Psychiatry, and Director, Research Unit on
Pediatric Psychopharmacology

New York State Psychiatric Institute

New York, New York

Howard A. Heit, M.D., FACP, FASAM

Assistant Clinical Professor

Georgetown University School of Medicine, and

Private Practice of Pain and Addiction Medicine

Fairfax, Virginia

J. Harry Isaacson, M.D.

Associate Professor of Medicine, and

Director of Clinical Education

Department of General Internal Medicine

Cleveland Clinic Foundation

Cleveland, Ohio

Jennifer Kasten, M.S.W.

Senior Analyst

NSDUH, N-SSATS, TEDS, and DASIS Information Systems

Research Triangle Institute

Research Triangle Park, North Carolina

Jane C. Maxwell, Ph.D.

Director, Center for Excellence in Epidemiology,

Gulf Coast Addiction Technology Transfer Center, and Research Professor,
School of Social Work

University of Texas

Austin, Texas

Francis B. Palumbo, Ph.D., Esq.

Professor of Pharmacy and Executive Director Center on Drugs and Public
Policy

University of Maryland College of Pharmacy

Baltimore, Maryland

Martha J. Wunsch, M.D., FAAP, FASAM

Associate Professor and Chair of Addiction Medicine

Edward Via Virginia College of Osteopathic Medicine, and Board Member,
American Society of Addiction Medicine

Blacksburg, Virginia

Richard A. Yoast, Ph.D.

Director, Office of Alcohol, Tobacco and Other Drug Abuse Prevention

Robert Wood Johnson Foundation Coordinating Center

American Medical Association

Chicago, Illinois