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## Complete Summary

#### GUIDELINE TITLE

Opioids in the management of chronic non-cancer pain: an update of
American Society of the Interventional Pain Physicians\' (ASIPP)
guidelines.

#### BIBLIOGRAPHIC SOURCE(S)

Trescot AM, Helm S, Hansen H, Benyamin R, Glaser SE, Adlaka R, Patel S,
Manchikanti L. Opioids in the management of chronic non-cancer pain: an
update of American Society of the Interventional Pain Physicians\'
(ASIPP) guidelines. Pain Physician 2008 Mar-Apr;11(2S):S5-62. \[350
references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Trescot AM, Boswell MV,
Atluri SL, Hansen NC, Deer TR, Abdi S, Jasper JF, Singh V, Jordan AE,
Johnson BW, Cicala RS, Dunbar EE, Helm S II, Varley KG, Suchdev PK,
Swicegood JR, Calodney AK, Ogoke BA, Minore WS, Manchikanti L. Opioid
guidelines in the management of chronic non-cancer pain. Pain Phys
2006;9(1):1-39.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Chronic non-cancer pain

#### GUIDELINE CATEGORY

Counseling\
Diagnosis\
Evaluation\
Management\
Risk Assessment\
Screening\
Treatment

#### CLINICAL SPECIALTY

Anesthesiology\
Internal Medicine\
Neurology\
Physical Medicine and Rehabilitation\
Psychiatry\
Psychology\
Rheumatology

#### INTENDED USERS

Health Care Providers\
Physicians\
Substance Use Disorders Treatment Providers

#### GUIDELINE OBJECTIVE(S)

-   To provide clear and concise guidelines to physicians, to improve
    patient access, and avoid diversion and abuse

-   To provide guidance for the use of opioids for the treatment of
    chronic non-cancer pain, to bring consistency in opioid philosophy
    among the many diverse groups involved, to improve the treatment of
    chronic non-cancer pain, and to reduce the incidence of abuse and
    drug diversion

#### TARGET POPULATION

All patients suffering with chronic moderate to severe pain of
non-cancer origin who may be eligible for appropriate, medically
necessary opioid analgesic management\*

**\*Note**: This management may include or be independent of
interventional techniques.

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Use of Opioid Therapy for Management of Chronic Pain**

1.  Effectiveness of long-term opioids: morphine, transdermal fentanyl,
    oxycodone, hydrocodone, methadone, tramadol, oxymorphone

2.  Adherence monitoring

    -   Screening for opioid use (misuse and abuse)

    -   Urine drug testing

        -   Immunoassay drug testing

        -   Gas chromatography/mass spectrometry, high performance
            liquid chromatography

    -   Periodic review and monitoring

        -   Medical and psychological diagnoses

        -   Informed consent and treatment agreement

        -   Appropriateness of therapy

        -   Evaluation of progress toward treatment goals

        -   Assessment of pain level and level of function

        -   Prescription drug monitoring

        -   Pill counts

        -   Education

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3.  Evaluation

    -   Pain, medical, and psychosocial history

4.  Management

    -   Physical, functional, and psychosocial assessment

    -   Diagnostic testing

    -   Diagnostic interventional techniques

    -   Treatment plan

    -   Therapeutic interventional techniques

    -   10-step process for chronic opioid therapy

    -   Consultation and referral

    -   Informed consent and controlled substance agreement

    -   Documentation and medical records

#### MAJOR OUTCOMES CONSIDERED

-   Effectiveness of opioids in the treatment of chronic pain

    -   Symptom control

    -   Quality of life

    -   Emotional well-being

    -   Functional status

-   Rate of unemployment

-   Adverse and comorbid effects of opioids in the treatment of chronic
    pain

-   Sensitivity of drug testing assays for opioids

-   Prevalence of controlled prescription drug abuse

-   Prevalence of drug diversion

-   Prevalence of drug interactions

-   Cost of opioid use

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Quality of Evidence**

  ---------- ---------------------------------------------------------------
  **I**      Evidence obtained from at least one properly randomized
             controlled trial.

  **II-1**   Evidence obtained from well-designed controlled trials without
             randomization.

  **II-2**   Evidence obtained from well-designed cohort or case-control
             analytic studies, preferably from more than one center or
             research group.

  **II-3**   Evidence obtained from multiple time series with or without the
             intervention. Dramatic results in uncontrolled experiments
             (such as the results of the introduction of penicillin
             treatment in the 1940s) could also be regarded as this type of
             evidence.

  **III**    Opinions of respected authorities, based on clinical experience
             descriptive studies and case reports or reports of expert
             committees.
  ---------- ---------------------------------------------------------------

Adapted from the Agency for Healthcare Research and Quality U.S.
Preventive Services Task Force (USPSTF)

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

A policy committee was convened and included a broad representation of
academic and clinical practitioners, representing a variety of practices
and geographic areas, all recognized as experts in opioid use and
management of patients with chronic non-cancer pain. This committee
formalized the essentials of the guidelines. The elements of the
guideline preparation process included literature searches, literature
syntheses, systematic review, consensus evaluations, open forum
presentations, formal endorsement by the American Society of
Interventional Pain Physicians (ASIPP) Board of Directors and peer
review.

Recommendations were provided based on methodological quality of
supporting evidence, benefit versus risks and burdens, and implications
(see \"Rating Scheme for the Strength of the Recommendations\" field
below).

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

  ----------------------------------------------------------------------------------
  **Grade of                     **Benefit vs  **Methodological   **Implications**
  Recommendation/Description**   Risk and      Quality of         
                                 Burdens**     Supporting         
                                               Evidence**         
  ------------------------------ ------------- ------------------ ------------------
  1A/strong recommendation,      Benefits      Randomized         Strong
  high-quality evidence          clearly       controlled trials  recommendation,
                                 outweigh risk (RCTs) without     can apply to most
                                 and burdens,  important          patients in most
                                 or vice versa limitations or     circumstances
                                               overwhelming       without
                                               evidence from      reservation
                                               observational      
                                               studies            

  1B/strong recommendation,      Benefits      RCTs with          Strong
  moderate quality evidence      clearly       important          recommendation,
                                 outweigh risk limitations        can apply to most
                                 and burdens,  (inconsistent      patients in most
                                 or vice versa results,           circumstances
                                               methodological     without
                                               flaws, indirect,   reservation
                                               or imprecise) or   
                                               exceptionally      
                                               strong evidence    
                                               from observational 
                                               studies            

  1C/strong recommendation,      Benefits      Observational      Strong
  low-quality or very            clearly       studies or case    recommendation but
  low-quality evidence           outweigh risk series             may change when
                                 and burdens,                     higher quality
                                 or vice versa                    evidence becomes
                                                                  available

  2A/weak recommendation,        Benefits      RCTs without       Weak
  high-quality evidence          closely       important          recommendation,
                                 balanced with limitations or     best action may
                                 risks and     overwhelming       differ depending
                                 burden        evidence from      on circumstances
                                               observational      or patients\' or
                                               studies            societal values

  2B/weak recommendation,        Benefits      RCTs with          Weak
  moderate-quality evidence      closely       important          recommendation,
                                 balanced with limitations        best action may
                                 risks and     (inconsistent      differ depending
                                 burden        results,           on circumstances
                                               methodological     or patients\' or
                                               flaws, indirect,   societal values
                                               or imprecise) or   
                                               exceptionally      
                                               strong evidence    
                                               from observational 
                                               studies            

  2C/weak recommendation,        Uncertainty   Observational      Very weak
  low-quality or very            in the        studies or case    recommendations;
  low-quality evidence           estimates of  series             other alternatives
                                 benefits,                        may be equally
                                 risks, and                       reasonable
                                 burden;                          
                                 benefits,                        
                                 risk, and                        
                                 burden may be                    
                                 closely                          
                                 balanced                         
  ----------------------------------------------------------------------------------

Adapted from Guyatt et al. Grading strength of recommendations and
quality of evidence in clinical guidelines. Report from an American
College of Chest Physicians task force. *Chest* 2006; 129:174-181.

#### COST ANALYSIS

**Health and Economic Impact**

Chronic non-cancer pain is associated with significant economic,
societal, and health impact. The cost of uncontrolled chronic pain is
enormous, both to individuals and to society as it leads to a decline in
the quality of life and disability. Estimates and patterns of direct
healthcare expenditures among individuals with back pain in the United
States reached \$90.7 billion for the year 1998. On average, individuals
with back pain generate healthcare expenditures about 60% higher than do
individuals without back pain (\$3,498 per year versus \$2,178). It has
been estimated that the cost of healthcare for patients with chronic
pain might exceed the combined cost of treating patients with coronary
artery disease, cancer, and AIDS. In the United States, it was estimated
that the cost of treatment in the first year after failed back surgery
for pain was approximately \$18,883 in 1997. Even further, annual
healthcare cost incurred by chronic pain patients, excluding cost for
surgical procedures, may range from \$500 to as high as \$35,400, with
averages ranging from \$12,900 to \$18,883 annually.

The economic costs for chronic pain in general have been estimated to be
over \$86 billion per year. A cross-sectional study, based on survey
data from 28,902 working adults in the USA was reported in 2003 with 13%
of the workforce experiencing a loss of productivity during a 2 week
period due to a common pain condition. In monetary terms, this loss of
productivity was calculated to cost \$61.3 billion, with \$14.4 billion
due to absenteeism and the rest due to the survey participants being at
work, but with impaired productivity due to the pain.

In a recent survey of expenditures and health status among adults with
back and neck problems, self-reported back and neck problems accounted
for a large proportion of health care expenditures and spine-related
expenditures have increased substantially from 1997 to 2005, without
evidence of corresponding improvement in self-assessed health status. In
this national estimate based on annual samples of survey respondents
with and without self-reported spine problems from 1997 through 2005, a
total of 23,045 respondents were sampled in 1997, including 3,139 who
reported spine problems. In 2005, the sample included 22,258
respondents, including 3,187 who reported spine problems. This survey
showed that in 1997, the adjusted medical cost for respondents with
spine problems was \$4,695 (95% CI, \$4,181 to \$5,209), compared with
\$2,731 (95% CI, \$2,557 to \$2,904) among those without spine problems
in terms in inflation-adjusted dollars. Conversely, in 2005, the
adjusted medical expenditures among respondents with spine problems was
\$6,096 (95% CI, \$5670 to \$6,522), compared with \$3,516 (95% CI,
\$3,266 to \$3,765) among those without spine problems. Consequently,
total estimated expenditures among respondents with spine problems
increased 65% after adjusting for inflation from 1997 to 2005, more
rapidly than overall health expenditures. This is in contrast to the
estimated proportion of persons with back or neck problems with
self-reported physical function and limitations increasing from 20.7%
(95% CI, 19.9% to 21.4%) to 24.7% (95% CI, 23.7% to 25.6%) from 1997 to
2005, which is an increase of 4%.

In one study evaluating the burden and determinants of neck pain in the
general population and in workers after evaluating numerous studies, the
12-month prevalence of pain typically ranged between 30 and 50%, while,
the 12-month prevalence of activity-limiting pain was 1.7% to 11.5% in
the general population, in workers, the annual prevalence of neck pain
varied from 27.1% to 47.8%, with between 11% and 14.1% of workers
limiting their activities due to neck pain.

**Economic Impact**

The cost of opioid abuse is enormous ranging as high as \$300 billion a
year as per the estimates of the White House Budge Office. The White
House Office of National Drug Control Policy, a component of the
Executive Office of the President, established by the Anti-Drug Abuse
Act of 1990, has been spending \$12 to \$13 billion each year.

A study by the Office of Management and Budget estimated drug abuse
costs to the United States at \$300 billion a year, including government
anti-drug programs and the costs of crime, healthcare, accidents, and
lost productivity. In the Aid to Family with Dependent Children (AFDC),
Medicaid and food stamp programs, the incidence of drug abuse varies
from 9.4% to 16.4%.

#### METHOD OF GUIDELINE VALIDATION

Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not stated

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Definitions for the quality of evidence (**I-III**) and recommendation
grades (**1A-2C**) are provided at the end of the \"Major
Recommendations\" field.

**[Clinical Effectiveness]{.underline}**

**Summary of Evidence**

Based on the review of multiple systematic reviews and the available
literature, the evidence for the effectiveness of long-term opioids in
reducing pain and improving the functional status for 6 months or longer
is variable. The evidence for transdermal fentanyl and sustained-release
morphine is Level II-2 based on the quality of evidence criteria
described by the U.S. Preventive Services Task Force as illustrated in
Table 1 in the original guideline document. For oxycodone, the level of
evidence is II-3, however, for hydrocodone and methadone, the level of
evidence is III.

**Recommendation**

Based on the review of multiple systematic reviews and the available
literature, the recommendation is 2A --- weak recommendation,
high-quality evidence with benefits closely balanced with risks and
burden; derived from randomized controlled trials (RCTs) without
important limitations or overwhelming evidence from observational
studies; with the implication that with a weak recommendation, best
action may differ depending on circumstances or patients\' or societal
values.

**[Adherence Monitoring]{.underline}**

**Introduction**

Important issues in opioid therapy in chronic pain revolve around
appropriate use of prescription opioids. Patients that describe symptoms
of pain, and lack of relief, are one of the most common patient
populations in the primary care community. Perceived interference of
activities of daily living creates the perception of a need of drugs,
and sometimes these patients are divulging signs and symptoms that may
threaten the patient-physician relationship that is built on trust. The
primary care physician is ill equipped to handle these patients, they
rapidly lose control, and then they often are referred to the pain
management physician as a \"risk shift.\" These patients expect
something to be done, and are often promised that the pain clinic will
maintain the same level of care. It is the pain physician\'s
responsibility to define their personal risk tolerance. Many times the
primary care physician will not engage in opioid agreements and not
fully explore non-narcotic medication alternatives. Adherence monitoring
is crucial to avoid abuse of the drugs and at the same time to encourage
appropriate use, and involves the initiation of drug screening, pill
counts, and patient care agreements, with the motto of \"trust but
verify.\"

A high-risk practice, such as a pain management practice, will readily
activate an adherence monitoring program, utilize advanced
documentation, have a strong office policy, a threshold policy, and will
define how many patients of this nature will be treated in the practice.
If available, a second opinion from an addictionologist or psychologist
may be advised, and a high-risk practice should understand that these
charts should be readily available for the Board of Medical Examiners to
review for legitimate need. Frequent functional assessments are
mandatory. The risk environment is increased with Medicaid and disabled
patients, patients with a previous history of substance abuse, and
psychiatric disorders, particularly bipolar personalities, borderline
personalities, history of alcohol abuse, and chaotic home environment.
Boundary violations, which unfortunately do occur in this patient
population, are never acceptable, and a difficult patient is best
chaperoned at each visit.

The high-risk patient may have an abnormal pill count or drug screen.
The patient that is discharged from a previous practice will have a
documented historical reason, and records from this previous practice
are recommended. High risk includes discharge from a previous practice,
chaotic lifestyle, recent arrival to the area, poor response to
multimodality approach to pain, sedentary lifestyle, cigarette smoker,
and possibly obesity. Also patients that are litigating, disabled, and
on Medicaid may also be at higher risk and may require more adherence
monitoring. Patients should be expected to take a proactive role in
their own healthcare. The risk/reward of the relationship is constantly
reassessed. The patient should understand that pills kill, pain does
not. The concept of legitimate medical need is reviewed with the
patient, and function, adherence, compliance, and co-managing physicians
are sometimes called upon.

Confusion surrounding a specific operational definition of opioid misuse
among chronic pain patients has complicated the process of effectively
assessing and predicting its occurrence. The typical elements of drug
diversion involve theft, forgery, counterfeit prescriptions, fraud
imposed against physician/pharmacy for other patients, and promoting
pill mills.

There is a need for better tamper-proof opioids. As long as long-acting
opioids can be easily converted into a rapidly absorbed form, there will
be an effort to divert these medications for illicit use.

**Screening for Opioid Abuse**

The decision to use opioids for chronic pain patients, like all medical
decisions, is based on a balance between risk and potential benefit.
Screening for opioid misuse and abuse is an exercise to strengthen the
patient-physician relationship. This should not be confrontational, and
the patient has to understand that this is like any other lab test. A
physician would respond to abnormal liver functions or anemia, just as a
pain physician responds to a screening questionnaire, urine drug screen,
or pill count.

Even though several investigators have described multiple screening
instruments in detecting opioid abuse or misuse in chronic pain
patients, there is no widely used screening instrument in the current
practice. Most look at problematic behaviors such as focusing on
opioids, escalation of opioid use, multiple phone calls and visits, lack
of improvement with increased medications, multiple prescription
problems (lost or stolen scripts), and opioids from multiple providers.

**Urine Drug Testing (UDT)**

Although drug testing may be performed by testing the urine, serum, or
hair, urine is considered as the best biologic specimen for detecting
the presence or absence of certain drugs due to specificity,
sensitivity, ease of administration, and the cost. However,
controversies exist regarding the clinical value of UDT, partly because
most current methods were designed for, or adapted from, forensic or
occupational deterrent- based testing for illicit drug use and are not
necessarily optimized for clinical applications in chronic pain
management. In chronic pain management, UDT should be used with an
appropriate level of understanding (which can improve a physician\'s
professional adherence, compliance, and co-managing physicians ability
to manage therapeutic prescription drugs with controlled substance), and
to diagnose substance abuse or appropriate intake of drugs, thereby
leading to proper treatment. They should be random, well organized, and
synchronized with a well-understood testing lab. The lab understands
you, and you understand what they are testing. False-positives,
negatives, and the scope of testing should also be understood.

It is also critical to understand the metabolism of opioids, to avoid
falsely accusing patients of abuse. For instance, codeine is metabolized
to morphine, and hydrocodone to hydromorphone. However, it has only been
recognized recently that morphine (in high doses) can be metabolized to
hydromorphone. The hydromorphone is usually about 2% of the morphine
dose (which can be determined by quantitative testing), and is usually
seen in patients taking at least 100 to 200 mg morphine per day. In a
retrospective case-control study, 66% of patients on morphine showed
evidence of hydromorphone in the UDT; this was seen more commonly in
females, despite the fact that the females were taking lower doses of
morphine.

In principle, UDTs can detect the parent drug and/or its metabolite(s)
and, therefore, demonstrate recent use of prescription medications and
illegal substances. For most clinical applications, initial testing is
done with class-specific immunoassay drug panels, which typically do not
identify individual drugs within a class. However, this may, and perhaps
should, be followed by a more specific technique such as a gas
chromatography/mass spectrometry (GC/MS) to identify or confirm the
presence or absence of a specific drug and/or its metabolite(s).
Numerous differences between various tests and even among the
laboratories and manufacturers of various rapid drug screen tests
include the number of drugs tested, cross-reactivity patterns, cut-off
concentrations, and drug interferences. Clinicians should remember that
the cut-off concentrations used for drugs in federally regulated
testing, particularly opioids, are too high to be of value in clinical
practice. Federally regulated testing includes 5 drugs or drug classes
that are tested for in federal employees and federally regulated
industries, including marijuana, cocaine, opiates, phencyclidine (PCP),
and amphetamines/methamphetamines, with pre-determined cut-off levels
with mandatory reconfirmation with the results by GC/MS, along with
split sample in chain of custody requirements. In contrast, nonregulated
testing is used for many purposes, including monitoring pain patients
clinically.

In clinical practice, UDT is used for accurate record keeping, to
identify use of undisclosed substances, to uncover diversion or
trafficking, and to determine appropriate intake of prescribed
substances. There are typically 2 types of UDT. These approaches used in
proper combination can reduce cost, ensure accuracy, and improve
efficiency. The 2 main types of UDT methods are:

1.  Immunoassay drug testing, either laboratory based or by rapid drug
    testing (\"site of service\").

2.  Laboratory-based specific drug identification with GC/MS,
    high-performance liquid chromatography (HPLC), etc.

Refer to the original guideline document for a discussion of
drug-testing methods.

Table 18 (in the original guideline document) illustrates cut-off levels
for various drugs detected by urine analysis. Ideally, a panel in
chronic pain management settings for rapid drug screening should include
not only opiates, but also oxycodone and methadone. In addition, the
panel should include cocaine, marijuana, amphetamines and
methamphetamines for illicit drugs, and benzodiazepines and barbiturates
for other controlled substances. If a custom panel is not available,
multiple tests may have to be performed as rapid drug screening.

Refer to the original guideline document for a list of common
cross-reacting substances.

Since false-negatives and false-positives are possible, when questions
arise, prior to taking any actions, a confirmatory test or no-threshold
test must be performed in the laboratory.

Physicians may establish zero or low tolerance, but this should be
discussed with the patient on the initial visit, and should be part of
the written clinic policy. This may include referral to an
addictionologist or psychologist, or may result in the refusal to
prescribe opioids. However, it usually does not warrant dismissal of the
patient. The practice limits for presence of cocaine and marijuana may
range from only one positive screen (zero tolerance) to 3 positive
screens and appropriate action later. Improper use of prescription drugs
and doctor shopping should be dealt in the same manner.

**Periodic Review and Monitoring**

*Periodic Review*

Periodic reviews should assess the medical diagnoses, psychological
diagnosis, informed consent, treatment agreement, appropriate opioid
therapy with or without adjuvant medications or with or without
interventional techniques, pre- and post-intervention assessment of pain
level and function, and reassessment of pain score and level of
function.

Regular assessment of the patient along with the periodic review of the
diagnosis is extremely important. Routine assessment of the \"4 As\"
(analgesia, activity, aberrant behavior, and adverse effects) will help
to direct therapy and support the pharmacologic actions taken.

Further assessment should be performed by periodic monitoring, pill
counts, and UDT (see below).

*Periodic Monitoring*

At reasonable intervals, depending on the specific circumstances of a
given patient, the physician should review the course of treatment and
any new information about the etiology of the pain. Continuation or
modification of therapy should depend on the physician\'s evaluation of
progress towards stated treatment goals, such as a reduction in a
patient\'s pain scores and improved physical and/or psychosocial
function (i.e., ability to work, utilization of healthcare resources,
activities of daily living, and quality of social life). If treatment
goals are not being achieved despite medication adjustments, the
physician should reevaluate the appropriateness of continued treatment
with the current medications. The physician should monitor patient
compliance in medication usage and related treatment plans.

*Prescription Drug Monitoring*

Prescription drug monitoring programs collect information to assist
state law enforcement and regulatory agents in identifying and
investigating illegal practices related to controlled substances.
However, some of the existing prescription programs and the recently
passed National All Schedules Prescription Electronic Reporting Act
(NASPER) should also assist physicians and pharmacists in identifying
controlled substance abuse. The purpose of NASPER is to ensure access to
care, delegate the appropriate use of opioids to those in the most need,
and identify potential abusers that misuse, divert, or doctor shop.

*Periodic Education*

Drug education for physicians, providers, and patients is crucial. While
it appears that certain medications have revolutionized the treatment of
chronic pain in the United States, physicians must balance the medical
need with the possibility of abuse and diversion, as well as the
necessity to comply with state and federal regulations. It is obvious
that healthcare practitioners are not only expected to prescribe
medications when there is medical need and document appropriately, but
they are also expected to prevent illegal diversion and identify drug
abuse. Consequently, education is a critical component of any program to
control the diversion of prescription drugs.

*Pill Counts*

Random pill counts, along with UDT and prescription monitoring, would
greatly reduce controlled substance abuse. Pill counts are essential in
patients with suspicion of abuse. However, these can also be performed
randomly on high risk patients.

A pill count is performed by notifying the patient a day before or on
the day of the appointment of the patient, requesting the patient to
bring with them their unused pills. The inability to provide pills or
providing a reduced number will indicate use beyond the prescription.
Pill counts above the expected ranges would indicate inappropriate low
intake (suggesting that the medications are being over-prescribed).
Recently, it has been reported that some unsuspected elderly patients
may be selling controlled substances to supplement their income.

**[Principles Of Opioid Use]{.underline}**

**Introduction**

In interventional pain management, patients may receive not only opioid
analgesics, but also other controlled or noncontrolled drugs. Further,
patients may be receiving controlled substances as an adjunct to
interventional techniques, as well as to manage comorbid psychiatric and
psychological disorders. Thus, the effectiveness studies published thus
far may not apply in the majority of interventional pain management
patients. Indeed, in an interventional pain practice, controlled
substances may be prescribed at lower doses, particularly opioid
analgesics, in conjunction with interventional techniques. It has also
been shown that interventional techniques reduce psychological distress
and improve functional status. More likely than not, the requirement for
opioids and adjuvant drugs may be reduced or at least become stable.
Hence, interventional pain physicians probably should not compare
patients in their settings undergoing interventional techniques with
others receiving drug therapy as mainstay. Monotherapy, particularly
with opioids, may be appropriate for only a small subgroup of those with
chronic pain.

The concept of \"universal precautions,\" first seen in medicine with
the explosion of human immunodeficiency virus (HIV) and hepatitis
tainted blood, was introduced to counter the misconception that a
provider would be able to predict \"by looking\" who might have a
communicable blood-borne disease. This led to the use of \"precautions\"
(gloves, etc.) for all patients, regardless of their age or
socieoeconomic class. A rational approach to the treatment of chronic
pain with opioids has been described using a pain and addiction
continuum and a substance use assessment in a pain patient leading to
the implementation of \"universal precautions\" in pain medicine.

**Recommendation**

Based on the grading recommendations, the recommendation is 2A --- weak
recommendation, high-quality evidence: with benefits closely balanced
with risks and burden; derived from RCTs without important limitations
or overwhelming evidence from observational studies, with the
implication that with a weak recommendation, best action may differ
depending on circumstances or patients\' or societal values.

**Basic Philosophy**

Principles for prescribing opioids must require a comprehensive
evaluation (mandatory physical and optional psychological), appropriate
documentation at regular intervals to assess the efficacy of therapy,
with specific evaluation of the impact on functional status, degree of
pain relief, identification and treatment of undesirable side effects,
and monitoring for abuse behaviors. In addition, there must be adherence
to a controlled substance agreement and with regulatory guidelines
promulgated by various agencies. Figure 6 in the original guideline
document shows an algorithmic approach to patient evaluation and
management. The table below shows an algorithmic approach for chronic
opioid therapy.

**Table. Ten Step Process: An Algorithmic Approach for Long-Term Opioid
Therapy in Chronic Pain**

+-------+--------------------------------------------------------------+
| *     | **Comprehensive initial evaluation**                         |
| *STEP |                                                              |
| I**   |                                                              |
+-------+--------------------------------------------------------------+
| *     | **Establish diagnosis**                                      |
| *STEP |                                                              |
| II**  | -   X-rays, magnetic resonance imaging (MRI), computed       |
|       |     tomography (CT), neuro-physiological studies             |
|       |                                                              |
|       | -   Psychological evaluation                                 |
|       |                                                              |
|       | -   Precision diagnostic interventions                       |
+-------+--------------------------------------------------------------+
| *     | **Establish medical necessity (lack of progress or as        |
| *STEP | supplemental therapy)**                                      |
| III** |                                                              |
|       | -   Physical diagnosis                                       |
|       |                                                              |
|       | -   Therapeutic interventional pain management               |
|       |                                                              |
|       | -   Physical modalities                                      |
|       |                                                              |
|       | -   Behavior therapy                                         |
+-------+--------------------------------------------------------------+
| *     | **Assess risk-benefit ratio**                                |
| *STEP |                                                              |
| IV**  | -   Treatment is beneficial                                  |
+-------+--------------------------------------------------------------+
| *     | **Establish treatment goals**                                |
| *STEP |                                                              |
| V**   |                                                              |
+-------+--------------------------------------------------------------+
| *     | **Obtain informed consent and agreement**                    |
| *STEP |                                                              |
| VI**  |                                                              |
+-------+--------------------------------------------------------------+
| *     | **Initial dose adjustment phase (up to 8 to 12 weeks)**      |
| *STEP |                                                              |
| VII** | -   Start low dose                                           |
|       |                                                              |
|       | -   Utilize opioids, nonsteroidal anti-inflammatory drugs    |
|       |     (NSAIDs) and adjuvants                                   |
|       |                                                              |
|       | -   Discontinue due to                                       |
|       |                                                              |
|       |     -   Lack of analgesia                                    |
|       |                                                              |
|       |     -   Side effects                                         |
|       |                                                              |
|       |     -   Lack of functional improvement                       |
+-------+--------------------------------------------------------------+
| *     | **Stable phase (stable - moderate doses)**                   |
| *STEP |                                                              |
| V     | -   Monthly refills                                          |
| III** |                                                              |
|       | -   Assess for four As                                       |
|       |                                                              |
|       |     -   Analgesia                                            |
|       |                                                              |
|       |     -   Activity                                             |
|       |                                                              |
|       |     -   Aberrant behavior                                    |
|       |                                                              |
|       |     -   Adverse effect                                       |
|       |                                                              |
|       | -   Manage side effects                                      |
+-------+--------------------------------------------------------------+
| *     | **Adherence monitoring**                                     |
| *STEP |                                                              |
| IX**  | -   Prescription monitoring programs                         |
|       |                                                              |
|       | -   Random drug screens                                      |
|       |                                                              |
|       | -   Pill counts                                              |
+-------+--------------------------------------------------------------+
| *     | **Outcomes**                                                 |
| *STEP |                                                              |
| X**   | -   Successful - continue                                    |
|       |                                                              |
|       |     -   Stable doses                                         |
|       |                                                              |
|       |     -   Analgesia, activity                                  |
|       |                                                              |
|       |     -   No abuse, side effects                               |
|       |                                                              |
|       | -   Failed - discontinue                                     |
|       |                                                              |
|       |     -   Dose escalation                                      |
|       |                                                              |
|       |     -   No analgesia                                         |
|       |                                                              |
|       |     -   No activity                                          |
|       |                                                              |
|       |     -   Abuse                                                |
|       |                                                              |
|       |     -   Side effects                                         |
|       |                                                              |
|       |     -   Non-compliance                                       |
+-------+--------------------------------------------------------------+

**Evaluation**

Appropriate history, physical examination, and medical decision-making
based on the initial evaluation of a patient\'s presenting symptoms are
essential. The guidelines of the Centers for Medicare and Medicaid
Services (CMS) provide various criteria for 5 levels of evaluation and
management services (E&M), with 3 crucial components: history, physical
examination, and medical decision-making. Other components include
counseling, coordination of care, nature of presenting problem, and time
required for face-to-face evaluation. While there are numerous
techniques to evaluate a chronic pain patient, which vary from physician
to physician, institution to institution, and textbook to textbook,
following the guidelines established by CMS will assist a physician in
performing a comprehensive and complete evaluation complying with
regulations.

Some of the aspects specific in controlled substance abuse and chronic
pain include evaluation of the effect of pain on physical and
psychological function, such as activities of daily living.

**Diagnostic and Therapeutic Injections**

Diagnostic interventional techniques will assist in making the proper
diagnosis by following an algorithmic approach. It has been shown that
in approximately 70% to 85% of the patients with spinal pain an accurate
diagnosis may not be provided in spite of the available history,
physical examination, electromyographic (EMG) nerve conduction studies,
and radiological evaluation. With precise diagnostic interventional
techniques, the chances of correct diagnosis may be improved
substantially, and proper treatment may be offered.

Therapeutic interventional techniques also may be used in a
monotherapeutic way rather than using opioids for pain management and
functional improvement. The effectiveness of various interventional
techniques has been evaluated in systematic reviews.

A written treatment plan should document objectives that will be used to
evaluate treatment success, including pain relief and improved physical
and psychosocial function, and should indicate if additional diagnostic
tests, consultations, or treatments are planned. After starting
treatment, the physician should adjust with care the drug therapy to the
individual medical needs of each patient. In the continuum of treatment,
other modalities, including interventional techniques, rehabilitation,
and psychological therapy may be necessary depending on the etiology of
the pain and the extent to which pain is associated with physical,
functional, and psychosocial impairment.

**Consultation**

Physicians should be willing to refer a patient as clinically indicated
for additional evaluation to achieve treatment objectives. Special
attention should be given to those patients who are at risk of misusing
their medications and those whose living arrangements create a risk for
medication misuse or diversion. The management of patients with a
history of substance abuse or with a coexisting psychiatric disorder may
require extra care, monitoring, documentation, and consultation with, or
referral to, an addictionologist. The lack of well-trained psychologists
and psychiatrists in many regions of the country may make this referral
difficult to obtain. Likewise in many locations there are no clinically
trained addiction specialists with whom to collaborate.

**Informed Consent and Controlled Substance Agreement**

At the initial visit, the physician should discuss the risks and
benefits of the use of controlled substances with the patient or
surrogate, including the risk of tolerance and drug dependence. It is
advisable to employ the use of a written agreement between physician and
patient outlining patient responsibilities. Agreements are helpful,
specifically if the patient is determined to be at high risk for
medication abuse or has a history of substance abuse. Possible items of
a controlled substance agreement between a physician and patient
include:

1.  One prescribing doctor and one designated pharmacy

2.  Urine/serum drug screening when requested

3.  No early refills and no medications can be called in.

4.  If medications are lost or stolen, then a police report could be
    required before considering additional prescriptions.

The reasons for which opioid drug therapy may be discontinued, such as
violation of a documented doctor/patient agreement, should be
delineated. Additional items to be included in an agreement are listed
in Table 20 of the original guideline document.

**[Documentation and Medical Records]{.underline}**

The physician should keep accurate and complete medical records, which
include all aspects of interventional pain management and medical care.
These comprise, but are not limited to:

-   The medical history and physical examination

-   Diagnostic, therapeutic, and laboratory results

-   Evaluations and consultations

-   Treatment objectives

-   Discussion of risks, benefits, and limitations of treatments

-   Details of different treatments, medications, including date, type,
    dosage, and quantity prescribed

-   Instructions to the patient

-   Periodic reviews of outcomes, including documentation of functional
    status, preferably using validated tools

Records should remain current and be maintained in an accessible manner
and readily accessible for review, not only for the physician and other
members of the practice, but also for authorities.

To be in compliance with controlled substance laws and regulations
required to prescribe, dispense, or administer controlled substances,
the physician must have an active license in the state and comply with
applicable federal and state regulations. Various boards have published
regulations and recommendations for prescribing controlled substances.
Physicians are advised to refer to these regulations for their
respective state. Physicians should not prescribe scheduled drugs for
themselves or immediate family except in emergency situations.

The following criteria should be considered carefully in providing
controlled substances:

1.  Complete initial evaluation, including history and physical
    examination

2.  Psychological evaluation

3.  Physiological and functional assessment, as necessary and feasible

4.  Definition of indications and medical necessity:

    -   Pain of moderate-to-severe degree

    -   Suspected organic problem

    -   Documentation of failure to respond to noncontrolled substances,
        adjuvant agents, physical therapy, and interventional techniques

    -   For patients with interventional techniques as primary modality,
        controlled substance drugs may be used as a second line
        treatment.

    -   For non-opioid controlled substances, appropriate documentation
        of psychological disorders should be maintained.

    -   Continued opioid prescription requires monitoring of \"the 4
        As\":

        -   Analgesia

        -   Activity

        -   Aberrant behavior

        -   Adverse effects

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5.  The use of the lowest possible dose to provide adequate analgesia
    with minimum side effects should be the goal of opioid therapy.

6.  In general, do not combine opioids with sedative-hypnotics,
    benzodiazepines, or barbiturates for chronic, non-cancer pain unless
    there is a specific medical indication for the combination.

7.  Adherence to the controlled substance agreement with patients
    understanding the risks and benefits of controlled substances and
    the policy and regulations of the practitioner, including controlled
    substances being prescribed by only one practitioner and being
    obtained from only one pharmacy.

8.  Monitoring for drug abuse or diversion should be routine and, if
    confirmed, referral to rehabilitation centers may be made, along
    with termination of prescriptions of controlled substances.

9.  Use caution when prescribing acetaminophen-containing opioids,
    especially given the ubiquitousness of acetaminophen in
    over-the-counter medications. Short-term use (\<10 days) should be
    less than 4,000 mg/day, while chronic use should probably be limited
    to 2,500 mg/day.

While there are no universally accepted tools to assess opioid
responsiveness, it is important to use a tool that monitors both
function and pain relief.

Although opioids may be useful for the treatment of chronic pain,
aberrant behavior and/or no improvement in function and pain after an
adequate trial of opioids should trigger a consideration to discontinue
the opioids, tapered over a several week period to avoid withdrawal
symptoms. Evidence of diversion or illegal use warrants an immediate
discontinuation of the medication. Clonidine orally (po) or transdermal
0.1 mg can be offered to counteract the majority of withdrawal symptoms.

**KEY POINTS**

1.  These opioid guidelines for the treatment of chronic non-cancer pain
    were developed to improve the quality and appropriateness of care,
    improve patient access, improve patient quality of life, improve
    efficiency and effectiveness, and achieve cost containment by
    improving the cost-benefit ratio.

2.  Opioids are extensively used in managing chronic pain.

3.  There is significant evidence of opioid abuse in conjunction with or
    without illicit drugs.

4.  Abuse terminology is variable. This document attempts to standardize
    and provide a common sense definition.

5.  Opioid pharmacology is variable and essential to understand for
    proper management of patients.

6.  Among the rules of opioid administration, comprehensive evaluation
    and diagnostic assessment is crucial, including diagnosis by
    interventional techniques.

7.  Establishing goals of treatment and using a controlled substance
    agreement are essential in the practice of pain management with
    opioids.

8.  Periodic review of the patient on opioids is essential, using
    appropriate adjustments, with routine assessment of analgesia,
    activity, aberrant behavior, and adverse effects.

9.  Documentation, keeping accurate and complete medical records with
    all the essential elements to provide proper patient care and also
    meet regulatory and legal requirements, is essential.

10. The rationalization and importance of these guidelines lies in the
    fact that most available evidence documents a wide degree of
    variance in the prescribing patterns of opioids for chronic pain.
    The strength of available evidence in the use of opioids for chronic
    non-cancer pain is weak.

**[Definitions]{.underline}**:

**Quality of Evidence\***

  ---------- ---------------------------------------------------------------
  **I**      Evidence obtained from at least one properly randomized
             controlled trial.

  **II-1**   Evidence obtained from well-designed controlled trials without
             randomization.

  **II-2**   Evidence obtained from well-designed cohort or case-control
             analytic studies, preferably from more than one center or
             research group.

  **II-3**   Evidence obtained from multiple time series with or without the
             intervention. Dramatic results in uncontrolled experiments
             (such as the results of the introduction of penicillin
             treatment in the 1940s) could also be regarded as this type of
             evidence.

  **III**    Opinions of respected authorities, based on clinical experience
             descriptive studies and case reports or reports of expert
             committees.
  ---------- ---------------------------------------------------------------

Adapted from the Agency for Healthcare Research and Quality U.S.
Preventive Services Task Force (USPSTF)

**Grade of Recommendations**

  ----------------------------------------------------------------------------------
  **Grade of                     **Benefit vs  **Methodological   **Implications**
  Recommendation/Description**   Risk and      Quality of         
                                 Burdens**     Supporting         
                                               Evidence**         
  ------------------------------ ------------- ------------------ ------------------
  1A/strong recommendation,      Benefits      Randomized         Strong
  high-quality evidence          clearly       controlled trials  recommendation,
                                 outweigh risk (RCTs) without     can apply to most
                                 and burdens,  important          patients in most
                                 or vice versa limitations or     circumstances
                                               overwhelming       without
                                               evidence from      reservation
                                               observational      
                                               studies            

  1B/strong recommendation,      Benefits      RCTs with          Strong
  moderate quality evidence      clearly       important          recommendation,
                                 outweigh risk limitations        can apply to most
                                 and burdens,  (inconsistent      patients in most
                                 or vice versa results,           circumstances
                                               methodological     without
                                               flaws, indirect,   reservation
                                               or imprecise) or   
                                               exceptionally      
                                               strong evidence    
                                               from observational 
                                               studies            

  1C/strong recommendation,      Benefits      Observational      Strong
  low-quality or very            clearly       studies or case    recommendation but
  low-quality evidence           outweigh risk series             may change when
                                 and burdens,                     higher quality
                                 or vice versa                    evidence becomes
                                                                  available

  2A/weak recommendation,        Benefits      RCTs without       Weak
  high-quality evidence          closely       important          recommendation,
                                 balanced with limitations or     best action may
                                 risks and     overwhelming       differ depending
                                 burden        evidence from      on circumstances
                                               observational      or patients\' or
                                               studies            societal values

  2B/weak recommendation,        Benefits      RCTs with          Weak
  moderate-quality evidence      closely       important          recommendation,
                                 balanced with limitations        best action may
                                 risks and     (inconsistent      differ depending
                                 burden        results,           on circumstances
                                               methodological     or patients\' or
                                               flaws, indirect,   societal values
                                               or imprecise) or   
                                               exceptionally      
                                               strong evidence    
                                               from observational 
                                               studies            

  2C/weak recommendation,        Uncertainty   Observational      Very weak
  low-quality or very            in the        studies or case    recommendations;
  low-quality evidence           estimates of  series             other alternatives
                                 benefits,                        may be equally
                                 risks, and                       reasonable
                                 burden;                          
                                 benefits,                        
                                 risk, and                        
                                 burden may be                    
                                 closely                          
                                 balanced                         
  ----------------------------------------------------------------------------------

Adapted from Guyatt et al. Grading strength of recommendations and
quality of evidence in clinical guidelines. Report from an American
College of Chest Physicians task force. *Chest* 2006; 129:174-181.

#### CLINICAL ALGORITHM(S)

A clinical algorithm is provided in the original guideline document for
evaluation and management of chronic pain.

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is identified and
graded for selected recommendations (see \"Major Recommendations\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

The perceived benefits of these guidelines include:

-   Increased physician awareness about the current issues involving
    opioids and non-cancer pain

-   Improved patient access

-   Reduced level of opioid abuse

-   Improved ability to manage patient expectations

-   Reduced diversion

-   Improved understanding by law enforcement about proper prescribing
    patterns

-   Improved cooperation among patients, providers, and regulatory
    agencies

-   Improved understanding by patients regarding their rights as well as
    their responsibilities when taking opioid medications

#### POTENTIAL HARMS

-   The most significant consequences of long-term opioid therapy
    include, but are not limited to, tolerance, physical and
    psychological dependence, abuse, and diversion. See sections 3.4 to
    3.8 in the original guideline document for discussions of nonmedical
    use of prescription drugs, substance abuse in chronic pain, and drug
    diversion.

-   Commonly known side effects of opioids include constipation,
    pruritus, respiratory depression, nausea, vomiting, delayed gastric
    emptying, sexual dysfunction, muscle rigidity and myoclonus, sleep
    disturbance (morphine has been shown to reduce REM sleep via
    inhibition of acetylcholine release in the reticular activating
    formation, pyrexia, diminished psychomotor performance (which
    appears to be more of a problem with acute rather than chronic use),
    cognitive impairment, dizziness and sedation, all reflecting the
    effects of opioids at multiple organ systems.

-   Implications and side effects of long-term opioid therapy include
    opioid-induced immunologic effects, hormonal changes, hyperalgesia,
    sedation, sleep disturbances, psychomotor disturbances,
    constipation, bladder dysfunction, and cardiac effects. Sections 4.2
    to 4.5 of the original guideline document discuss adverse effects
    and drug interactions of opioids in detail.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   These guidelines do not constitute inflexible treatment
    recommendations. These guidelines are not intended to address all
    possible clinical situations where opioids might be used for
    non-cancer pain in clinical practice. It is expected that a provider
    will establish a plan of care on a case-by-case basis, taking into
    account an individual patient\'s medical condition, personal needs,
    and preferences, as well as the physician\'s experience. Based on an
    individual patient\'s needs treatment different from that outlined
    here could be warranted. These guidelines do not represent a
    \"standard of care.\"

-   The focus of these guidelines is the effective management of chronic
    non-cancer pain, as well as the multiple issues involved in opioid
    administration. It is recognized that management of chronic
    non-cancer pain takes place in a wide context of healthcare
    involving multiple specialists and multiple techniques.
    Consequently, the decision to implement a particular management
    approach should be based on a comprehensive assessment of the
    patient\'s overall health status, disease state, patient preference,
    and physician training and skill.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Chart Documentation/Checklists/Forms\
Clinical Algorithm

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Living with Illness

#### IOM DOMAIN

Effectiveness\
Patient-centeredness\
Safety

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Trescot AM, Helm S, Hansen H, Benyamin R, Glaser SE, Adlaka R, Patel S,
Manchikanti L. Opioids in the management of chronic non-cancer pain: an
update of American Society of the Interventional Pain Physicians\'
(ASIPP) guidelines. Pain Physician 2008 Mar-Apr;11(2S):S5-62. \[350
references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2006 (revised 2008)

#### GUIDELINE DEVELOPER(S)

American Society of Interventional Pain Physicians - Medical Specialty
Society

#### SOURCE(S) OF FUNDING

American Society of Interventional Pain Physicians

#### GUIDELINE COMMITTEE

Not stated

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Authors*: Andrea M. Trescot, MD, Director, Pain Fellowship, University
of Florida, Director Malcolm Randall VA; Standiford Helm, MD, Pacific
Coast Pain Management Center; Hans Hansen, MD, Medical Director, The
Pain Relief Centers, PA; Ramsin Benyamin, MD, President and Medical
Director, Millennium Pain Center, Clinical Assistant Professor, College
of Medicine, University of Illinois; Scott E. Glaser, MD, Pain
Specialists of Greater Chicago; Rajive Adlaka, MD, Pain Control
Associates; Samir Patel, DO, Pain Fellow, University of Florida, Malcolm
Randall VA; Laxmaiah Manchikanti, MD, Chief Executive Officer, ASIPP,
Medical Director, Pain Management Center of Paducah, Associate Clinical
Professor, Anesthesiology and Perioperative Medicine, University of
Louisville, Kentucky; Sukdeb Datta, MD, Director, Vanderbilt University,
Interventional Pain Program, and Associate Professor, Dept. of
Anesthesiology, Vanderbilt University Medical Center; Nalini Sehgal, MD,
Associate Professor of Rehabilitation Medicine, Medical Director of
Interventional Pain Program, University of Wisconsin School of Medicine
and Public Health, Dept. of Orthopedics and Rehabilitation, James
Colson, MD, Assistant Professor of Anesthesiology, Department of
Anesthesiology, Pain Medicine Service, West Virginia University
Hospitals; Art Jordan, MD, Coastal Interventional Pain Associates;
Marion Lee, MD, Director of Pain Center at Affinity Health Group

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Internal funding provided by the American Society of Interventional Pain
Physicians was limited to travel and lodging expenses of the authors.

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Trescot AM, Boswell MV,
Atluri SL, Hansen NC, Deer TR, Abdi S, Jasper JF, Singh V, Jordan AE,
Johnson BW, Cicala RS, Dunbar EE, Helm S II, Varley KG, Suchdev PK,
Swicegood JR, Calodney AK, Ogoke BA, Minore WS, Manchikanti L. Opioid
guidelines in the management of chronic non-cancer pain. Pain Phys
2006;9(1):1-39.

#### GUIDELINE AVAILABILITY

Electronic copies: Not available at this time.

Print copies: Available from the American Society of Interventional Pain
Physicians, 2831 Lone Oak Road, Paducah, KY 42003; Phone: (270)
554-9412; Fax: (270) 554-8987; email: <asipp@asipp.org>.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

-   Sample controlled substance agreement. Table 20 of the guideline
    document, available from the [American Society of Interventional
    Pain Physicians Web site](http://www.asipp.org/Guidelines.htm).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on May 8, 2006. The information
was verified by the guideline developer on May 19, 2006. This summary
was updated by ECRI Institute on July 9, 2008. The updated information
was verified by the guideline developer on July 22, 2008.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions. This guideline is
available for download from the [American Society of Interventional Pain
Physicians (ASIPP) Web site](http://www.asipp.org/).

### DISCLAIMER

#### NGC DISCLAIMER

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All guidelines summarized by NGC and hosted on our site are produced
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Guidelines represented on the NGC Web site are submitted by guideline
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<http://www.guideline.gov/about/inclusion.aspx> .

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