States contact the prescriber and/or pharmacist if information is missing (such as
strength of substance prescribed, name of person for whom the controlled substance
was prescribed, or date the prescription was filled). California’s MCPP returns the
form to the pharmacy if crucial information is missing.

In most MCPP States, the same personnel that examine the incoming forms for
accuracy and completeness are responsible for identifying altered or fraudulent

prescriptions. In New York other staff specially trained to detect fraud are used for
this purpose.

STATES GENERATE REPORTS TO IDENTIFY PATTERNS AND POSSIBLE
PROBLEMS.

States produce standard reports based on MCPP data.

States generally produce monthly reports arranged by prescriber, patient, selected
substances, prescription series number, as well as other special reports. Some States
do not analyze drug usage by patient. These reports are analyzed for unusual or
suspicious prescribing, dispensing, or patient use activity.

California generates several monthly reports for diversion agents and the Medical
Board. These include exception Teports on particular substances (oxycodone,
Dilaudid, barbiturates, amphetamines, etc.), prescribers, patients, dosage prescribed,
and others. A monthly report is produced for departmental agents sorted by stolen,
lost, found, and never received serial numbers.

Michigan generates standard reports displaying summary statistics on all prescriptions
and on ail drugs prescribed. Other reports are produced as required, such as:
Pharmacy Summary Report listing information for a specific pharmacy for particular
time periods; Practitioner’s Summary Report, and various other summary reports.
Michigan’s system allows them to link all data fields in any combination desired.

New York produces daily update Teports to track processing and verify record counts
and filled prescriptions, a monthly report to monitor number of prescriptions,
prescribers, and doctor shoppers; a quarterly report for professional oversight and
enforcement by the county medical societies; and a report to review triplicate

riplicat

prescription activity by pharmacy, patients and doctors sorted by various fields.

Texas produces a monthly statistical report indicating how many prescriptions were
ordered, stolen, flagged as filled and stolen, as well as monthly intelligence reports of
the top prescribers and dispensers, and specialists prescribing substances outside of
their practice. Texas does not produce a summary analysis of the prescription data.
The program can respond to requests for specific information within a few days.


The extent to which rescheduling of these substances accounted for declines in
"mentions" of the drugs in emergency rooms is not known. Since Schedule II
substances require tighter controls and carry harsher penalties for diversion, it is

possible that ER mentions would have declined if the drugs had only been rescheduled
and not placed on a MCPP.

However, in New York State, Schedule IV benzodiazepines (tranquilizers) were
included under the MCPP in 1989 without rescheduling. In the first year

benzodiazepines were on MCPP, ER mentions declined 46 percent in New York while
declining 12 percent nationally. :

PROGRAM OFFICIALS CITE A NUMBER OF ADVANTAGES ASSOCIATED
WITH MCPPS, INCLUDING BETTER TARGETING OF INVESTIGATOR

RESOURCES AND MORE SUCCESSFUL PROSECUTIONS OF OFFENDERS
INVOLVED IN DRUG DIVERSION.

Better Targeting of Investigator Resources

In States without MCPPs, agents typically conduct audits of practitioners or
pharmacies to track down forgeries, doctor shoppers, or other diversionary drug
schemes. In an audit, inspectors usually select a random number of prescriptions to
examine for forgeries. Absent any prescriber, pharmacist, or patient-based data,
reviewers do not have an obvious starting point for research or inquiry. Reports that
are produced through the MCPP significantly narrow down the range of possible drug
diversion or abuse activity, and agents can more efficiently target cases or locations for
review and investigation. Cases are targeted efficiently by identifying the top
dispensers of controlled drugs, prescription writers, and abnormally high users.

Some situations in Texas illustrate this increased efficiency. In 1989, the Texas State
Board of Medical Examiners had 14 investigators (including management) and
approximately 26,000 licensees that were registered to handle controlled substances.
working and average of 20 days per month and allowing 2 days per investigation, it
would take 15 years to investigate all registered practitioners. Other licensees not

Tegistered would require additional time.

In 1980, the Texas State board of pharmacy had six investigators and two compliance

ad six investigators and two compliance

officers to inspect and investigate 11,717 pharmacies and 4,078 pharmacies spread
over 270,000 square miles.

During the three-year period prior to implementation of the MCPP in Texas, 20 to 25
investigators conducted 127 investigations and successfully prosecuted one medical
practitioner for diversion. Following implementation in 1982, 15 to 20 investigators
conducted 289 investigations from January 1982 through June 1984. This is a 173

percent increase in investigations using 25 percent fewer investigators than was
conducted over the prior three-year period.


TABLE OF MCPP CHARACTERISTICS

NO.YRS # SCRIPT
RESPONS. IN TRIPL PROCESS
STATE DRUGS OPER. OR PER
STATE AGENCY INCLUDED (1992) DUPL. YEAR *
CALIF. Bureau of Schedule II 52 tripl. 960,000
Narcotic
Enforcmt.
HAWAII Office of Schedule II 49 dupl. 90,000
Narcotics
Enforemt.
IDAHO Board of Schedule II 25 tripl. 50,400
Pharmacy
INDIANA Health Schedule II 3 tripl. 197,296
Professns
Bureau
ILLINOIS Dept. of designated 31 tripl. 200,000
Alcohoism Schedule IH
& Subst.
Abuse
MICH. Dept. of Schedule II, 3 tripl. 500,000
Commerce Selected
Steroids
NEW Dept. of Schedule HI, 15 tripl. 2.9 mill
YORK Heaith, Steroids,
Bureau of Benzos.
Prescripn
Analysis
RHODE Dept. of Schedule II, 13 dupl. 54,940
ISLAND Health, Syringes
Drug Con-
trol Divn
TEXAS Dept. of Schedule II 10 tripl. 639,331
Public
Safety

* Source: Michigan Multiple Copy Prescription Program Survey, 1991.

A-6


FINDINGS
»  MCPPs reduce vulnerability to theft and forgery.

>  MCPPs’ effect on overall prescribing of scheduled drugs is difficult to assess
from existing studies.

»  MCPPs appear to have shown some effect on abuse of scheduled drugs, as
measured by emergency room visits.

» Program officials associate MCPPs with better targeting of investigator

Tesources and more successful prosecutions of offenders involved in drug
diversion.

» Opponents of MCPPs express concerns about the program’s effect on medical
decisionmaking as well as confidentiality. MCPP States have attempted to
respond to practitioner and community concerns in several ways.


States use guidelines and threshold levels for initiating further analysis.

MCPP States use different measures, with varying degrees of sensitivity, to follow-up
On patterns they identify. For example, California flags prescribers who have written
in excess of 25 prescriptions during the Teporting period. Indiana flags its top 75
prescribers, patients receiving prescriptions from three or more doctors, and patients
visiting two or more pharmacies. Michigan flags its 100 most active pharmacies,

pharmacists, and prescribers. Rhode Island flags its top ten prescribers and top five
pharmacies.

Actions taken based on these reports and screens varies depending on State policies
and the extent to which drugs or individuals exceed expected patterns.

Based on this first level of analysis, States may invest further resources to develop an
understanding of the patterns they have identified.

While States differ in the credentials of personnel used to conduct their analysis of
practice patterns, the elements of analysis are quite similar from State to State.
Physician prescribing patterns, for example, are analyzed in light of specialty. An
oncologist, surgeon, or other specialist may prescribe greater amounts of certain
substances than a general practice practitioner. If analysis determines that a
practitioner has a specialty that is associated with prescribing relatively large amounts
of Scheduled substances, or has a unique situation, such as treatment of high numbers
of cancer patients, the prescriber is not scrutinized.

In Rhode Island, the Division of Diversion Control, the Rhode Island Medical Society,
and the Director of Health established a three-member physician advisory committee
to assist the Division in its analysis. The committee reviews cases to determine
whether the prescribing circumstances are in good faith and in the normal course of
professional practice. Cases requiring further study are carried out by pharmacists,
narcotics inspectors, or other health professionals with experience in the particular
area of health involved. In developing cases flagged by pharmacy/pharmacist data,
Rhode Island officials recognize that their set guidelines may be exceeded for
legitimate reasons, such as a pharmacy contract with one or more nursing homes to
supply prescription drugs.

STATES USE DATA FROM THEIR MCPP PROGRAMS TO BOTH EDUCATE
PROVIDERS AND TAKE REMEDIAL ACTION TO ADDRESS PROBLEMS
IDENTIFIED THROUGH THEIR ANALYSIS.

States use MCPP data to educate the provider community.
MCPP officials work with and assist health care professionals in various ways:
providing data for peer review; providing information to prescribers on potential

doctor-shoppers; offering educational in-service programs; and providing information
and answering questions about program policies, State law, ordering forms, etc. The

A-3


indiscriminately, agents might try to obtain a prescription undercover from the
prescriber without a medical reason. Agents also may conduct surveillance.
Investigative work may simply consist of talking to the practitioner and reviewing
medical records. If a prescription looks like it has been altered, MCPP officials follow
up with the prescriber or pharmacy to verify whether the prescription is valid.

MCPP information may also be used to support an ongoing investigation. Law
enforcement officials may request specific pharmacy, patient, or prescriber information
if street intelligence or a complaint indicate some sort of suspicious activity.

ALL NINE STATES ALLOW FOR EMERGENCY TELEPHONE
PRESCRIPTIONS.

As required by the Federal law’, all of the MCPP States allow an emergency
prescription to be given over the telephone. The verbal prescription must be followed
up within 72 hours with the written triplicate prescription.

' 21 Code of Federal Regulations 1306.11(d) (4).

A-5


with John Santana, Director of the National Association of Drug Diversion
Investigators.

13. In Hawaii, physicians may use any type of form for Schedule II prescriptions—even
the traditional plain white type. They simply must make a duplicate of the form so
that the pharmacist can keep one and send one to the State.

14. Prescriber Perceptions of Michigan’s Triplicate Prescription Program. Michigan
Department of Licensing and Regulation, July, 1991.

15. Department of Public Safety, Criminal Law Enforcement Division, Narcotics
Service, "Texas Triplicate Prescription Program," April 1989.

16. U.S. Department of Justice, Drug Enforcement Administration. Multiple Copy
Prescription Programs: Resource Guide. March 1990.

17. The Rhode Island Duplicate Prescription Program: The First Three Years,
Hachadorian, Charles; D’Arezzo, Edward M., Campbell, Norman, Paper presented for
the Association of Food and Drug Officials 86th Annual Conference. June 15, 1982, p.
8.

18. "The Impact of the Rhade Island Duplicate Prescription Law on Prescribing

Practices for Schedule I Drugs," Bridgit A. Anness, Albert Taubman, and Cynthia
Willey. Unpublished Masters Thesis, 1991.

19. Data sheets from the Illinois Department of Alcoholism and Substance Abuse,
June 1989.

20. New York data sheets for the Triplicate Prescription Program.

21, Consult the National Institute on Drug Abuse Statistical Series: Data from the
Drug Abuse Warning Network, Annual Data 1989, for a full discussion of data
gathering methodology.

22, Department of Public Safety, Criminal Law Enforcement Divisio: rcotics

Division, Narcotics

Service, "Texas Triplicate Prescription Program," April 1989.

23. Ironically, Texas MCPP officials point out that data from the program is utilized to

exonerate an accused professional about as often as it is used to convict guilty parties.
The data can be utilized to quickly and easily determine that nothing is amiss.

24. Department of Public Safety, Criminal Law Enforcement Division, Narcotics
Service, "Texas Triplicate Prescription Program," April 1989.

25. National Multiple Copy Prescription Survey, statistics complied by: Michigan:
Triplicate Prescription Program, April 1991.

12


MCPPs should be distinguished from electronic transmission programs such as the
Oklahoma Schedule Two Abuse Reduction (OSTAR) program. OSTAR has been in
effect since January 1991; it requires every pharmacy and dispensing physician to
submit data electronically on all Schedule II substances dispensed. As with MCPPs,
the State tracks the prescribing patterns using exception reports. Massachusetts will
be initiating a similar electronic system in April, 1992. These electronic transmission
programs do not require use of any special forms or multiple copies for prescribing.’

A more detailed description of MCPPs and how they operate, and a summary chart
with basic program characteristics is contained in appendix A.

METHODOLOGY

The information in this report was collected through interviews with national experts
and interest groups in pharmacology, medicine, pain control, and criminology;
interviews with officials in States and Canadian provinces with MCPPs, and an
extensive literature review including the National Multiple Copy Prescription Survey
conducted by the Michigan Triplicate Prescription Program.


INTRODUCTION

BACKGROUND

The diversion of prescription drugs from legitimate distribution channels for illicit use
is a serious national drug abuse and law enforcement problem. Estimates from the
Drug Abuse Warning Network (DAWN) for 1990 indicate that legal, controlled drugs
are involved in approximately 32 percent of all drug-related emergency room visits.!
According to the 1988 National Household Survey on Drug Abuse by the National
Institute on Drug Abuse (NIDA), 12 percent of the United States population over age
12 report using legitimate psychotherapeutic drugs for non-medical purposes.”

In 1970, the Controlled Substances Act (CSA) established a tight system of controls on
Scheduled prescription drug distribution from the manufacturer to distributor to the
pharmacy.? The Act also divides controlled substances into five Schedules and
requires distributors and dispensers of drugs in these Schedules to Tegister with the
Drug Enforcement Administration.* The five Schedules are arranged so that the
lower the Schedule number, the higher the abuse potential. Schedule I substances
have a high potential for abuse and have no accepted medical use in the United
States. Examples are heroin, LSD, and marihuana. Schedules IT through V have
currently accepted medical uses in the United States.

Schedule II is the most restrictive of these four schedules. Schedule II drugs are
Subject to production and import quotas; other Schedules are not. All Schedule II
drug transactions between suppliers and distributors must be reported routinely to the
government; only the narcotic drugs in other schedules must be reported. Special
physical security measures such as vault Storage and special order forms using a
unique Drug Enforcement Administration (DEA) registration number are required for
Schedule II drugs while less-intensive measures apply to the drugs in other schedules.
Prescriptions for Schedule IT drugs may not be refilled. Prescriptions for drugs in the
other schedules may be refilled up to five times within a certain time period. Finally,
the maximum criminal penalties for unauthorized trafficking in Schedule II narcotics
are greater than those for trafficking in other scheduled drugs.

The controls implemented by the CSA have greatly diminished the opportunity for
diversion of drugs from legitimate wholesale channels. However, once drugs leave the
wholesale distribution network, there are few controls or monitoring systems. The
weakest link in the distribution chain is at the retail level. The National Institute on
Drug Abuse estimates that 80 to 90 percent of licit (legal) drugs diverted for non-
medical use occurs at the retail (practitioner and pharmacy) level.° 7 Drug diversion
cases consume a considerable amount of pharmacy boards’ investigative resources.


TABLE OF CONTENTS

EXECUTIVE SUMMARY
INTRODUCTION .. 2.2... cece cece ee eveecceeee. 1
FINDINGS «2.0.22 c cee cece ee eeeecrececceece. 4
MCPPs reduce vuinerability to theft and forgery. 2.6... eee eee eee eee 5
MCPP3’ effect on overall Prescribing of scheduled drugs is difficult
$0 ASSESS. cece e cece ete ete s ee eeeeeences 5
MCPPs appear to have shown some effect on abuse of scheduled
drugs, as measured by emergency room visits. .................000 cece 7
Program officials cite a number of advantages associated with MCPPs,
including better targeting of investigator resources and more
successful prosecutions of offenders involved in drug diversion. ............. 8
Opponents of MCPPs express concerns about the program’s effect on
medical decisionmaking as well as confidentiality. MCPP States
have attempted to respond to practitioner and community concerns
in several ways... cece ccc c ccc cece cece. 9
ENDNOTES 2.0... e cece eee e cece ence cee eeeee cece. 11
APPENDIX A ooo. eee ec cce ccna e eee eeecceeeeeees A-l
CHARACTERISTICS OF MULTIPLE COPY
PRESCRIPTION PROGRAMS 0.0... 0.00 eee cece ceccecececeeeeee A-l


APPENDIX A

CHARACTERISTICS OF MULTIPLE COPY
PRESCRIPTION PROGRAMS

MCPPS ARE PAPER SYSTEMS WITH ESTABLISHED AUDIT TRAILS.

MCPPs generally require that prescribers write prescriptions on State-issued,
serialized, preprinted prescription forms for Schedule II substances. Schedule II drugs
have a high potential for abuse and have highly addictive properties. Examples of
Schedule II drugs are opium and codeine (narcotic analgesics), pentobarbital (a
depressant), and methamphetamine (a stimulant).

The State-issued forms are prenumbered, colored (similar to a payroll check), and
printed with the physician name and address. The forms have a minimum of two
Parts, one which is retained by the pharmacist and the other sent to the State by the
pharmacist. In States with triplicate forms, the third part of the form is retained by
the prescriber. MCPPs generaily Tequire that such records be maintained by
physicians and pharmacists for at least two years.

As computer technology advances, some States are considering new ways of
transmitting prescription data. Texas is considering permitting prescriptions to be
faxed from prescriber to pharmacy. Michigan is mandated by law to establish a
standardized database system to facilitate electronic or Storage media (tapes or
diskettes) transfer of multiple copy data from pharmacies to the State. New York is

also considering development of electronic transfer of data from pharmacist to State
as weil as from State to pharmacy.

Although electronic submission reduces administrative burdens and speeds collection

of data, the paper copy has certain advantages. In triplicate form States, a nurse or
receptionist can verify information for a pharmacist since a copy is retained by the
doctor’s office. Since the physician retains a written record of the prescription, the
physician will not have to rely on memory, or potentially incomplete patient records,
to answer questions regarding a patient’s prescription. Additionally, as discussed
above, the special qualities of the form deter drug diversion via fake or altered
prescriptions.

INCOMING DOCUMENTS ARE EXAMINED FOR ALTERATION, FRAUD,
INCOMPLETENESS AND INACCURACY.

MCPP States have staff that examine the incoming documents for accuracy,
completeness, and compliance with State information requirements. Action taken if
there is missing information on the forms varies among the States: most of the nine

A-1


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wesBog ayeoiding ||

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Department of Health and Human Services

OFFICE OF
INSPECTOR GENERAL

MULTIPLE COPY PRESCRIPTION
PROGRAMS: STATE EXPERIENCES

= sete
= Richard P. Kusserow
i C INSPECTOR GENERAL
cm

“read

JUNE 1992



percent.> After New York expanded its MCPP to include benzodiazepines

(Federal Schedule IV tranquilizers), the number of benzodiazepine prescriptions fell
approximately 65 percent from 1988 to 1989.!°

In Rhode Island, the total number of Schedule II prescriptions written declined by
36.3 percent during the first year of the program."’ To examine this phenomenon,
the University of Rhode Island surveyed prescribers to assess their perspectives on
changes in prescribing since institution of the MCPP. Interestingly, only 20 percent of
the group in practice in the State before 1979 perceived that their prescribing
Practices had changed. Of these, 44 percent agreed that the availability of better
therapeutic alternatives accounted for their decrease in prescribing. Forty four
percent indicated that there was a better risk-benefit ratio for the patient by using
Schedules III, IV, or V rather than II. Fourteen percent of the survey respondents
said that they were aware of a colleague who had his or her license limited,
suspended, revoked, or was placed in drug rehabilitation. Of this 14 percent, 23

percent (22 prescribers) felt that this awaréness caused them to limit the number of
Schedule II prescriptions that they write.!®

In other States, prescribing for certain drugs has actually increased. For example, in
Illinois, there have been increases in Schedule II prescriptions, especially in pain
management therapy: morphine sulfate (a narcotic analgesic) prescriptions increased
by 109 percent between FY 1985 and FY 1989, and oxycodone with acetaminophen
prescriptions increased 58 percent.'?

Since gross figures on increases or decreases in prescribing after implementation of
MCPPs are unadjusted for patient and prescriber populations, or for other variables, it
is difficult to interpret these numbers. Further evaluation of changes in prescribing of
scheduled substances after MCPP is necessary to accurately assess the program’s effect
on prescribing patterns. Experimental designs with control and comparison groups
could be used in non-MCPP States to provide such data. Interpretation of pre- and

post-data in MCPP States, especially in light of divergent outcomes in the States,
should be approached cautiously.

Two States show little or no substitution effect.

Two States, Michigan and New York, have attempted to assess if their MCPP has

resulted in other drugs being prescribed in place of drugs which had to be prescribed
on State issued triplicate forms.

According to analysis conducted by Blue Cross/Blue Shield of Michigan, a decline in
Schedule II prescriptions was not accompanied by an increase in other scheduled drug
prescriptions. Michigan BC analyzed prescribing of Schedules II through V week by
week from August 1988 through December, 1989 and found decreases in the average
weekly volume of prescriptions for each of Schedules III, IV, and V, along with the
declines in Schedule II prescribing. This analysis Suggests that the decline in Schedule


FINDINGS

MCPPs REDUCE VULNERABILITY TO THEFT AND FORGERY.

Drug traffickers or "doctor shoppers"! obtain and cash fraudulent prescriptions using
a variety of techniques: forgery and alteration of legitimate prescriptions, writing
prescriptions on standard plain white prescription pads that have been stolen, or
having fraudulent prescription pads printed at printing establishments.

The standard white single copy prescription form is relatively easy to print and/or
reproduce. Undercover agents have successfully ordered forms printed at print shops
with no identification, dressed in either casual or business attire.2 Drug enforcement
agents report that drug traffickers sell altered or clandestinely produced standard
prescription forms to addicts for about $20.00 each.

A distinctive element of multiple copy prescription programs is the use of special
State-issued forms for writing prescriptions for drugs covered under the MCPP. Of
the States with MCPPs, only Hawaii does not have a State-issued form.” All of the
forms have special features that make them difficult to clandestinely produce or
photocopy. Features that make the form extremely resistant to various types of fraud
include a color tint, design on the face of the form, water marks, invisible eradicator
sensitive ink, and hidden pantograph that shows "VOID" if the form is copied. These
characteristics are designed to have a sentinel effect to deter unscrupulous health care
providers or patients from illicit activity.

In addition, the States preprint the prescriber’s name and address on the form, and
some preprint the prescriber’; DEA number and/or controlled substances license
number and other prescriber information. All States require the patient name and
address to be entered on the form, and most Tequire the patient age or date of birth.

A Rhode Island survey found that 77 percent of practitioners in Rhode Island agree
that the MCPP makes forgery of Prescriptions for Schedule II drugs more difficult. A
Michigan survey of 2,000 prescribers found that 74 percent of respondents agreed that
the MCPP could deter abuse and diversion of scheduled drugs.'*

MCPPs’ EFFECT ON OVERALL PRESCRIBING OF SCHEDULED DRUGS IS
DIFFICULT TO ASSESS FROM EXISTING STUDIES.

Overall prescribing of prescription drugs generally declines following MCPP
implementation.

In several States, there is a precipitous decline in the amount of Schedule II drugs
prescribed after implementation of the MCPP. Texas experienced a 52 percent
decrease in the number of prescriptions for Schedule II controlled substances during
1982, the first year of the program. In 1983, Schedule IIs declined another 13


Controlled prescription drugs are diverted from the retail (practitioner or pharmacy)
level to illicit use by four main types of schemes or activities:

» theft, alteration, forgery, and counterfeiting of prescription forms;
» indiscriminate or careless prescribing and dispensing;

> purposeful misprescribing and dispensing by health care workers, frequently in
collusion with a purported "patient"; and

» theft of drugs from a hospital, pharmacy, or physician’s office.

Several initiatives have emerged to combat diversion and abuse of licit drugs at the
retail level, including third-party drug data review systems such as the Medicaid
Abusable Drug Audit System (MADAS) developed by the Office of Inspector
General.® Another initiative is State-based multiple copy prescription programs
(MCPPs). The OIG has previously recommended that States consider MCPP-type
programs as a measure to combat drug diversion.’ This report provides additional

information on MCPPs, particularly their impact on the first three sources of drug
diversion.

Nine States have some form of MCPP (see Figure 1): California, Hawaii, Idaho,
Illinois, Indiana, Michigan, New York, Rhode Island, and Texas.!° These nine States
contain approximately 38 percent (307, 148) of all practitioners registered with the
Drug Enforcement Administration (DEA). Most European countries and four
Canadian provinces have MCPPs in place.

MCPPs have three major elements: (1) multiple copies of the prescription are
produced to provide checks and balances, (2) prescription forms which are
prenumbered sequentially and tinted so that they are hard to reproduce, forge, or
erase, and (3) a retrospective data analysis component to identify suspicious
prescribing, dispensing, or patterns of use.

The forms have a minimum of two parts: one is retained by the pharmacist and the
other is sent to the State by the pharmacist. In States with triplicate forms, the third
part of the form is retained by the prescriber. MCPPs generally require that such

eran uire tnat sucn

records be maintained by physicians and pharmacists for at least two years.

MCPPs generally require that prescribers write prescriptions on these special forms for
Schedule II substances. Schedule II drugs have a high potential for abuse and have
highly addictive properties. Examples of Schedule IT drugs are opium and codeine

(narcotic analgesics), pentobarbital (a depressant), and methamphetamine (a
stimulant).


extent to which MCPPs have "outreach" or actively educate and work with medical
societies and other groups in the States varies considerably.

Many of the MCPPs are currently undertaking or plan cooperative ventures with
prescriber or pharmacist associations. New York, in addition to its current physician
peer review program, is planning educational efforts with State and local medical

societies and pharmaceutical manufacturers to try to increase understanding and flow
of information.

Illinois, Michigan, and New York assist their State medical societies and pharmacist
associations by providing educational Programs to inform them about prescribing
patterns and dispensing and administering of controlled substances. New York is also
considering sending prescribers and pharmacies, upon request, their own data to self
evaluate prescribing and dispensing. Illinois and Indiana are working with medical
schools to develop curricula to educate prospective practitioners on prescribing, pain
control, and other prescription drug issues.

In some States, MCPP officials might use the information generated from the program
to inform practitioners that their prescribing practices differ from that of their peers.
In California, if there is an apparent violation of law, the MCPP may send the
practitioner a letter stating what they are doing wrong, citing the law.

Based on analysis and investigation, States may refer practitioners to licensing boards or
refer practitioners and users for criminal prosecution.

As mentioned above, MCPP officials gather additional detailed information, such as
physician specialty, and analyze patient profiles and prescribing practices to see if
there is a logical explanation for any deviation. MCPP officials will try to determine if
a real problem exists prior to turning the investigation over to field agents. They do a
considerable amount of background work "from the desk," attempting to determine if
patterns of prescribing, dispensing, or use are due to legitimate medical reasons or the
nature of a physician’s or pharmacist’s practice.

When patterns are unexpiained by information review and medical practitioners are
unable to account for deviation, the case is referred to investigators or field agents.
Based on the results of investigations, cases may be referred to licensing boards, who
may institute a restriction on what type of drugs the prescriber may prescribe, revoke
or suspend a license, or require the practitioner to attend certain educational classes.
There may also be referral to enforcement authorities for prosecution under Federal
and State statutes involving penalties such as fines, restitution, or prison.

The activities in case development and investigation are decided on a case by case
basis depending on the nature of the suspected violation or illicit activity. During the
course of an investigation, agents might visit Pharmacies and check for any current
complaints or other ongoing investigations. There are times that an undercover
Operation may be initiated. If investigation shows that a prescriber may be prescribing

A-4


EXECUTIVE SUMMARY

PURPOSE

This report provides an overview of the operation and effectiveness of State Multipie
Copy Prescription Programs.

BACKGROUND

The diversion of prescription drugs from legitimate distribution channels for illicit use
is a serious national drug abuse and law enforcement problem. Estimates from the
Drug Abuse Warning Network (DAWN) for 1990 indicate that legal, controlled

substances are involved in approximately 32 percent of all drug-related emergency
room visits.

In 1970, the Controlled Substances Act (CSA) established a tight system of controls on
Scheduled prescription drug distribution from the manufacturer to distributor to the
pharmacy. The controls implemented by the CSA greatly diminished the opportunity
for diversion of drugs from legitimate wholesale channels.

However, once drugs leave the wholesale distribution network, there are few controls
or monitoring systems. The weakest link in the distribution chain is at the retail level.
The National Institute on Drug Abuse estimates that 80 to 90 percent of licit (legal)

drugs diverted for non-medical use occurs at the retail (practitioner and pharmacy)
level.

Several initiatives have emerged to combat diversion and abuse of licit drugs at the
retail level, including third-party drug data review systems such as the Medicaid
Abusable Drug Audit System (MADAS) developed by the Office of Inspector
General. Another initiative, which is the subject of this report, is State-based multiple
copy prescription programs (MCPPs). MCPPs have three major elements: (1)
multiple (usually three) copies of the prescription are produced which are maintained
by the physician, pharmacist, and State agency, (2) prescription forms are numbered
sequentially and tinted so that they are hard to reproduce, forge, or erase, and (3) a

retrospective data analysis is conducted to identify suspicious prescribing, dispensing,

or patterns of use. Nine States have MCPPs in place.

METHODOLOGY

The information in this report was collected through an extensive literature review;
interviews with national experts and interest groups in pharmacology, medicine, pain
control, criminology; and interviews with officials in the States with MCPPs.


Los Angeles agents use triplicate program information in about 80 percent of their
cases. The data provide concrete leads to sources of drug diversion by highlighting
irregularities in patient filling, pharmacy dispensing, or physician prescribing.. Agents
in Los Angeles report that without the program, they would be operating in a "hit or
miss" mode. °

More Successful Prosecutions and Regulatory Sanctions

Program officials in MCPP States report that program data allows them to make
better cases. According to Texas MCPP officials, information developed by the
Program leads to convictions as well as many out of court settlements due to the
strong evidence presented by the data. Over the three year period following MCPP
implementation, eighteen practitioners were indicted and/or convicted of diversion of
controlled drugs. Seventeen prescribers surrendered prescribing privileges for
Schedule II substances. Additionally, when Texas implemented its program, about 600

prescribers who had let controlled substance registrations lapse were immediately
identified.

In a specific Los Angeles 1989 case where program data were crucial, special agents
were unable to make a direct buy from a suspected prescriber. However, data from
the MCPP was responsible for the successful arrest of a doctor (and seizure of his

assets) who had diverted Dilaudid (a narcotic analgesic) for an estimated profit of $1.4
million.

In 1989, the Illinois MCPP provided nearly 2,000 investigative profile reports leading
to regulatory sanctions on the professional and controlled substances licenses of
practitioners, pharmacists, and others that have violated the State Controlled
Substances Act. Since 1985, the program has been involved in licensure sanctions of
71 medical practitioners, 28 pharmacists, and 23 pharmacies. Currently, the U.S.
District Attorney's office is reviewing triplicate prescription information on 12
suspected doctor shoppers.

In New York, in 1989, 135 civil and criminal diversion cases were successfully
prosecuted invoiving physicians, dentists, veterinarians, pharmacists, pharmacies,
nurses, and others. Information from the MCPP was used in 85 of these cases.

OPPONENTS OF MCPPS EXPRESS CONCERNS ABOUT THE PROGRAM'S
EFFECT ON MEDICAL DECISIONMAKING AS WELL AS CONFIDENTIALITY.
MCPP STATES HAVE ATTEMPTED TO RESPOND TO PRACTITIONER AND
COMMUNITY CONCERNS IN SEVERAL WAYS.

When initially implementing the programs, some States have encountered concerns
and/or opposition among associations or groups such as pharmaceutical manufacturing
companies, medical associations, and pharmaceutical associations. Some of the
concerns expressed have been that 1) the program interferes in health care decisions


ENDNOTES

1. Suicides are subtracted from licit and total drug mentions.

2. National Institute on Drug Abuse, Division of Epidemiology and Statistical Analysis.
1988. National Household Survey on Drug Abuse: Rockville, MD.

3. Comprehensive Drug Abuse Prevention and Control Act of 1970, Public Law 91-
513.

4. Title 21, CFR, Sections 1308.11 through 1308.15.

5. Controlled Substances Act, 84 Stat. 1242, P.L. 91-513 (1970), Title II.
6. Ibid. p.3

7. U. S. Department of Justice, Office of Justice Programs, Bureau of Justice
Assistance, "Program Brief: Pharmaceutical Diversion Program," May 1987.

8. The MADAS is a data analysis program designed to identify outlier prescription
drug patterns. It does not contain a data gathering component; it utilizes data
supplied by a data collection system separate from the MADAS.

9. U. S. Department of Health and Human Services, Office of Inspector General,
State Discipline of Pharmacists,
OAI-01-89-89020, July 1990.

10. Washington State has a Multiple Copy Prescription program that is used solely for
monitoring and disciplinary action against physicians for abuse of drugs themselves or
inappropriate prescribing. The program has been in Place since 1989. Currently 13
physicians and 2 dentists are on the Washington Triplicate Prescription Program.

11. A doctor shopper is a purported patient who goes to several different doctors to

obtain prescriptions. Each doctor is usually not aware that the "patient" is obtaining
the same drugs from other physicians. Doctor shoppers are sometimes referred to as

‘professional patients.”

12. Print shops are generally not required to obtain identification or verify information
Prior to filling orders for prescription pads. Agents conducting this type of undercover
Operation were simply attempting to determine how easy it would be to obtain the
prescription blanks from print shops. Law enforcement officials and medical
Practitioners do not contend that instituting requirements to verify information at the
print shop level is practical or desirable. The prescription forms would be very easy to
produce without a print shop. This information was obtained through an interview

11


Department of Health and Human Services

OFFICE OF
INSPECTOR GENERAL

MULTIPLE COPY PRESCRIPTION
PROGRAMS: STATE EXPERIENCES

oe,

= Richard P. Kusserow
Fl LC INSPECTOR GENERAL
“re

OEI-12-91-00490



OFFICE OF INSPECTOR GENERAL

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as
amended, is to protect the integrity of the Department of Health and Human Services’ (HHS)
programs as well as the health and welfare of beneficiaries served by those programs. This
statutory mission is carried out through a nationwide network of audits, investigations, and
inspections conducted by three OIG operating components: the Office of Audit Services, the
Office of Investigations, and the Office of Evaluation and Inspections. The OIG also informs

the Secretary of HHS of program, and management problems, and recommends courses to
correct them.

OFFICE OF AUDIT SERVICES

The OIG’s Office of Audit Services (OAS) provides all auditing services for HHS, either by
conducting audits with its own audit resources or by overseeing audit work done by others.
Audits examine the performance of HHS programs and/or its grantees and contractors in
carrying out their respective responsibilities and are intended to provide independent
assessments of HHS programs and operations in order to reduce waste, abuse, and
mismanagement and to promote economy and efficiency throughout the Department.

OFFICE OF INVESTIGATIONS

The OIG's Office of Investigations (OF) conducts criminal, civil, and administrative
investigations of allegations of wrongdoing in HHS programs or to HHS beneficiaries and of
unjust enrichment by providers. The investigative efforts of OI lead to criminal convictions,
administrative sanctions, or civil money penalties. The OI also oversees State Medicaid fraud
control units which investigate and prosecute fraud and patient abuse in the Medicaid program.

OFFICE OF EVALUATION AND INSPECTIONS

The OIG’s Office of Evaluation and Inspections (OEI) conducts short-term management and
program evaluations (called inspections) that focus on issues of concern to the Department,
the Congress, and the public. The findings and recommendations contained in these inspection
teports generate rapid, accurate, and up-to-date information on the efficiency, vulnerability,
and effectiveness of departmental programs.

This report was prepared by Vicki A. Greene, of the Health Care Branch, Office of Evaluation
and Inspections, Baltimore, Maryland, with the assistance of Mary Beth Clarke, R.Ph., Public
Health and Human Services Branch, Washington, DC.

To obtain a copy of this report, call the Health Care Branch at (410) 966-3148.


II prescribing following MCPP implementation in 1989 was not replaced by increased
Prescribing or "substitute prescribing" in other scheduled substances.

New York has performed a similar analysis for the Empire Plan and for Medicaid and
found approximately a 21 percent "substitution effect" of "benzodiazepine substitute"

drugs not on triplicate. Benzodiazepines were added to the New York MCPP in
1989.2 ,

It is not clear what conclusions should be drawn about the existence or lack of a
Substitution effect. Specific medical reviews need to be conducted to determine if

replacing a prescription requiring a MCPP form with one that does not is "good" or
"pad" for the particular patients involved.

MCPPS APPEAR TO HAVE SHOWN A DECREASE IN ABUSE OF
SCHEDULED DRUGS, AS MEASURED BY EMERGENCY ROOM VISITS.

The National Institute on Drug Abuse collects annual data to indicate the extent of
drug abuse problems in the United States through the Drug Abuse Warning Network
(DAWN). The DAWN is a drug abuse data collection system that targets 770 hospital
emergency rooms in 21 metropolitan areas, and 87 medical examiners in 27
metropolitan areas. The data in DAWN are collected from Teports submitted for each

drug abuse patient who visits a DAWN emergency room (ER) and each drug abuse
death encountered by an DAWN medical examiner (ME).”"

DAWN data is used by analysts to study trends in drug abuse. In several cases,
introduction of a MCPP has coincided with a decline in DAWN mentions. For
example, emergency room mentions in Chicago for pentazocine (a narcotic analgesic)
decreased from 477 in 1978 (when Illinois moved the drug up to Schedule II, thus
requiring a MCPP form) to 38 in 1987 (a 92 percent drop). Total pentazocine
DAWN mentions dropped 61 percent during the same time period.

In 1982, Illinois experienced diversion and abuse of glutethimide (a Federal Schedule
IV sedative/hypnotic). The drug was reclassified under Schedule II of the Illinois
Controlied Substances Act, thus Tequiring use of the multiple copy form. Chicago
DAWN ER drug mentions for glutethimide decreased from 34 in 1982 to 6 in 1987,
and ME drug mentions decreased from 16 to 0 duri 1g the same time period,

durin € same time period.

Meanwhile, ER glutethimide mentions for the total DAWN network increased from
353 in 1982 to 592 in 1987.

In New York short acting barbiturates (sedative drugs) were placed under MCPP
requirements in 1981 following Federal rescheduling to Schedule II. Just before that
time approximately 33 percent of total ER mentions for these drugs were in New
York (both Buffalo and New York City participate in DAWN). The New York
DAWN emergency room mentions for barbiturates declined by 94 percent between

1980 and 1987, at which time the State accounted for only 10 percent of total U.S.
DAWN ER mentions.


of practitioners, 2) confidentiality of patient information will be compromised, and 3)
patients will not receive adequate pain medication due to the law.

MCPP States have attempted to address concerns expressed by various groups, and
some States have continued to work closely with groups to obtain input. Many of the

groups that had expressed initial opposition currently support the programs in their
respective States.”

During implementation of their program in 1979, Rhode Island program officials
worked to inform prescribers and pharmacists through pamphlets and presentations
that the program would not interfere with legitimate medical practice and would
maintain confidentiality of data. In developing its program, Michigan has worked
closely with manufacturers and prescribers to develop uniform prescribing guidelines
and to reassure them that the focus of the program is improper practices that lead to
diversion and substance abuse. Additionally, the State has worked with the American
Civil Liberties Union to develop patient data protections, as well as with several other
groups to obtain input, answer questions, and alleviate misconceptions.

All MCPP States limit access to prescription information to program staff and
authorized law enforcement and regulatory agencies. Data are not released without
the authorization of the program director, pharmacy board, or other authorities.
Penalties for unauthorized access to or distribution of data range from a misdemeanor
(in Illinois) to a felony punishable by fine up to $30,000 and imprisonment up to 4
years (Michigan). The type of information that can be released to non-law
enforcement agencies varies by State. New York and Indiana release only information

that is deemed public knowledge, such as summary statistics not involving patient
identity.

The MCPP States have various types of systems and techniques to protect the
confidentiality of patient data. Examples include encrypting patient names, purging
patient data, omitting patient identification from Teports unless essential, and limiting
access to system data base and hard copy information. Michigan destroys patient
identifiers after one year, Rhode Island destroys all prescriptions not under

n after 2 years, and Texas destroys or renders irretrievable all patient
information after one year.

10