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PRESCRIPTION PAIN MEDICATIONS:
Frequently Asked Questions and Answers
for Health Care Professionals and
Law Enforcement Personnel
Supported by
Drug Enforcement Administration
Last Acts Partnership
Pain & Policy Studies Group,
University of Wisconsin
3
Important Disclaimer
Although the FAQs reflect a consensus view of an expert panel, lack of strict adherence to these suggestions does not imply that a
particular practice is outside the scope of legitimate medical practice. The FAQ is not intended to be used as medical practice
guidelines or standards or as legal advice with regard to specific practices or cases for which clarification should be obtained by
consulting relevant practice guidelines, laws, and regulations; the agencies that administer them; and experts in law and in pain and
addiction medicine. Practitioners, law enforcement, and regulators should always keep abreast of changes in federal and state
statutes, in regulations, and in other policies relevant to pain management.
Preface
The Drug Enforcement Administration, Last Acts Partnership, and the Pain & Policy Studies Group at the University of Wisconsin
joined forces in 2001 to develop a consensus statement, "Promoting Pain Relief and Preventing Abuse of Pain Medications: A
Critical Balancing Act" (the statement can be found on www.lastacts.org). This consensus statement, which was joined by
numerous other health care organizations, called for a balanced policy addressing both the necessity of medical access to
prescription pain medications and active approaches to stem abuse, addiction and diversion. After the statement was released,
the group met to discuss the need for education of both the health care community, and the law enforcement and regulatory
community. Although educational programs that promoted the philosophy, science and practical issues surrounding the policy of
balance had begun to appear, there was a compelling need for a clear and concise educational product, which would be targeted
to both health care professionals and professionals in the law enforcement and regulatory communities. The group met several
times during the last year to review existing educational material and ultimately decided to produce a highly readable "Frequently
Asked Questions" that would cover the clinical and regulatory issues surrounding the prescribing of controlled drugs.
These Frequently Asked Questions (FAQs) were produced by a Principal Working Group, which included the experts who
developed the consensus statement, and a Review Committee, which included experts from the fields of nursing, neurology,
psychiatry, pharmacology, pharmacy and addiction medicine. The material represents a consensus, supported by the available
literature and by the laws and regulations that govern the use of controlled prescription drugs.
Principal Working Group
Patricia M. Good, Chief, Liaison and Policy Section,Office of Diversion Control,Drug Enforcement Administration
David E. Joranson, MSSW, Senior Scientist, Director, Pain & Policy Studies Group, University of Wisconsin–Madison Medical
School
Karen Orloff Kaplan, MPH, ScD., Former President and Chief Executive Officer, Last Acts Partnership
Steven D. Passik, Ph.D., Director, Symptom Management and Palliative Care Program Markey Cancer Center,University of
Kentucky
Russell Portenoy, M.D., Chairman, Department of Pain Medicine and Palliative Care, Beth Israel Medical Center
Robert C. Williamson, Deputy Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration
Review Committee
Ian Buttfield, M.D., Senior Specialist Physician, Drug and Alcohol Services Council of South Australia
Michael P. Cinque, R.Ph, Pharm D.(c), FAPhA, President, Academy of Pharmacy Management and Practice, American
Pharmaceutical Association
Margaret (Peggy) Compton, RN, Ph.D., Associate Professor, School of Nursing, University of California, Los Angeles
June L. Dahl, Ph.D., Professor, Pharmacology, University of Wisconsin Medical School
Dennis Doherty, DO, Southeastern Pain Specialists, Atlanta
Kathleen M. Foley, M.D., Chief of the Pain Service at Memorial Sloan-Kettering Cancer Center, and Professor of Neurology,
Neuroscience and Clinical Pharmacology at Cornell University Medical College
Douglas Gourlay, M.D., MSc, FRCPC, Medical Consultant, Pain and Chemical Dependency, Center for Addiction and Mental
Health, Toronto, Ontario
Howard Heit, M.D, Assistant Clinical Professor, Georgetown University
Nathaniel Katz, M.D., MS, Assistant Professor of Anesthesia, Harvard Medical School
Walter Ling, M.D., Professor of Psychiatry and Director of the Integrated Substance Abuse Programs, University of California, Los
Angeles
Arthur G. Lipman, PharmD, Professor of Pharmacotherapy, College of Pharmacy; Adjunct Professor of Anesthesiology, School of
Medicine; Director of Clinical Pharmacology, Pain Management Center, University of Utah
Will Rowe, MA, Executive Director, American Pain Foundation
Burness Communications (www.burnesscommunications.com) assisted the Principal Working Group in developing, editing and
disseminating the document.
2
Relevant Resources:
Drug Enforcement Administration, Last Acts, Pain & Policy Studies Group, et al. (2000). Promoting Pain Relief and Preventing Abuse of Pain
Medications: A Critical Balancing Act. Washington, DC: Last Acts. (Available at http://www.medsch.wisc.edu/painpolicy/dea01.htm)
Research America. (2003). Chronic Pain Pervasive in All Age Groups, New Study Shows. Alexandria, VA, September 4.
(Available at http://www.researchamerica.org/opinions/pain.html)
4 5
SECTION I
INTRODUCTION
The purpose of this document is to provide information to
health care professionals and professionals in the law
enforcement and regulatory communities about the medical
treatment of pain. The goal is to achieve a better balance in
addressing the treatment of pain while preventing abuse and
diversion of pain medications. The authors of this document
stand committed to the core principle of balance that was
expressed in the 2001 joint consensus statement by the U.S.
Drug Enforcement Administration and numerous health care
organizations:
Controlled substances that are prescription drugs, such as
opioids, are essential for the care of patients but carry a risk
that goes beyond the usual clinical concern about toxicity.
These drugs can become the object of abuse and addiction or
be a target for diversion to an illicit market. This potential for
abuse, addiction, and diversion raises concern among all
clinicians, including physicians and pharmacists, and those in
law enforcement, drug regulation, and policy makers.
When potentially abusable drugs are also necessary medicines,
assessment and management of drug-related problems can be
complex. The parameters of acceptable medical practice
include patterns of drug prescription—such as long-term
administration of an opioid drug at escalating doses and
administration of more than one controlled prescription drug—
that may raise a "red flag" for both clinicians and regulators.
Problematic drug-related behavior takes many forms and has
many causes in the clinical setting. Even relatively severe drugseeking
behaviors in the context of a legitimate medical need,
such as uncontrolled pain, cannot immediately be ascribed to
addiction. The desperate search for pain relief, and the
complex psychosocial disturbances accompanying chronic
pain, may influence the phenomenology of drug use and greatly
complicates the assessment of drug-related problems.
At the same time, however, even patients with severe pain can
develop patterns of abuse or addiction, or engage in criminal
activity. Physicians who encounter such patients must control
the behaviors, diagnose the comorbidities, and react in a way
that is both medically appropriate and consistent with the laws
and regulations that apply to the medical use of controlled
drugs. Although physicians have expressed concern about
criminal prosecution when treating such patients, the arrest and
indictment of a physician cannot occur unless he or she can be
shown to have knowingly and intentionally distributed or
prescribed controlled substances to a person outside the scope
of legitimate practice.
Drug abuse exacts a huge social cost, and some have been
tempted to address prescription drug abuse by greatly limiting
access. When drugs are needed for legitimate medical
purposes, such as pain management, this action may have
unintended consequences that could be just as harmful to the
public. Surveys have found that chronic pain is highly prevalent
and exacts a huge toll in terms of lost productivity, health care
costs, and human suffering. As the U.S. population ages,
people will live longer with chronic, often painful, diseases.
Even if opioids are appropriate for only a small proportion of
these patients, nothing should be done to limit access to the
drugs when they are needed, or to increase the reluctance of
prescribers to recommend them.
Society has a compelling interest in ensuring both the ready
access to controlled prescription drugs when medically needed
and ongoing efforts to minimize their abuse and diversion.
These two goals are not in conflict; they coexist and must be
balanced. Those who are licensed to prescribe, dispense and
administer these drugs, and those in the law enforcement or
regulatory communities need continual education to improve
their ability to balance these goals. There should be an ongoing
dialogue between practitioners and those in law enforcement
and regulation.
The FAQs in this document support the need for dialogue and
reflect an effort to answer basic questions about the appropriate
use of opioids given their unquestioned medical value, as well
as their potential for abuse, addiction, and diversion. The goal
is to provide medically and legally sound and balanced
education to practitioners, law enforcement, and regulators.
Clinical items have been drafted by experts in pain
management, and the items addressing regulatory issues have
been drafted by members of law enforcement and experts in
the regulation of controlled substances. All responses derive
from the fundamental view that practitioners must try to relieve
pain, but also must obey laws and regulations, and avoid
contributing to diversion, while law enforcement personnel and
regulators must address the sources of diversion, but do so in a
manner that never interferes in clinical pain management.
Both healthcare professionals, and law enforcement and
regulatory personnel, share a responsibility for ensuring that
prescription pain medications are available to the patients
who need them and for preventing these drugs from
becoming a source of harm or abuse. We all must ensure
that accurate information about both the legitimate use and
the abuse of prescription pain medications is made available.
The roles of both health professionals and law enforcement
personnel in maintaining this essential balance between
patient care and diversion prevention are critical (DEA et al.,
2001).
Contents
Section I: Introduction
Section II: Terms
01. What are the key addiction-related terms used in discussing pain medications and risk management?
Section III: Pain and Its Treatment
02. Why is pain management important?
03. What are the goals of pain management?
04. How can a clinician assess a patient’s pain?
05. When should a primary care physician turn to a pain medicine specialist to manage a patient’s pain?
Section IV: Medical Use of Opioid Analgesics
06. How are opioids used to manage chronic pain?
07. What outcomes should be assessed when judging whether opioid therapy is successful?
08. Where can clinicians find educational material on prescribing opioid analgesics?
09. What are the common side effects associated with opioid therapy, and how can they be managed?
10. What information do patients need about using opioids for chronic pain?
11. What kinds of problems might patients encounter when obtaining opioid prescriptions, in having them filled, or in taking the
medications properly?
12. Can more than one opioid at a time be prescribed to a patient?
13. What is "opioid rotation," and when is it appropriate?
14. What are "tapering" and "drug holidays"?
15. Is a written agreement between the clinician and the patient required before instituting treatment with an opioid?
16. What should be documented when prescribing opioids?
Section V: Risks in the Medical Use of Opioid Analgesics
17. What is the extent of prescription opioid abuse?
18. What are the common ways opioids are diverted to illicit uses?
19. How can clinicians assess for risks of abuse, addiction, and diversion and manage their patients accordingly?
20. What behaviors are potential indicators of problems for patients on long-term opioid therapy?
21. If a patient receiving opioid therapy engages in an episode of drug abuse, is the physician required by law to discontinue therapy or
report the patient to law enforcement authorities?
22. Is it legal and acceptable medical practice to prescribe long-term opioid therapy for pain to a patient with a history of drug abuse or
addiction, including heroin addiction?
23. What strategies can be used to treat pain successfully in patients who are currently abusing drugs?
Section VI: Other Legal and Regulatory Considerations
24. What requirements must physicians and pharmacists meet to comply with federal and state laws regulating opioids?
25. What regulations do physicians need to know and observe when prescribing opioid analgesics for pain?
26. Can methadone be used for pain control and, if so, is a clinician required to have a special license to prescribe it?
27. Under what circumstances will the federal Drug Enforcement Administration (DEA) investigate and prosecute a doctor or pharmacist or
refer cases to other agencies?
28. Should efforts to address diversion avoid interfering with medical practice and patient care?
29. When should a law enforcement officer turn to a pain medicine specialist for advice?
30. Does the number of patients in a practice who receive opioids, the number of tablets prescribed for each patient, or the duration of
therapy with these drugs by themselves indicate abuse or diversion?
Appendix A: Key Addiction-Related Terms
6 7
SECTION III
PAIN AND ITS TREATMENT
2. Why is pain management important?
Uncontrolled pain is an enormous public health problem in the United States. Already accounting for many tens of billions of dollars
of needed health care and lost productivity, it is expected that the costs will grow dramatically as the population ages and people live
longer with chronic diseases. Equally important, unrelieved pain has a devastating impact on the physical, emotional, social, and
economic well-being of patients and their families. Diagnosing and treating pain is, therefore, fundamental to the public health.
Many medical and regulatory organizations have recognized the imperative to relieve pain in official statements and guidelines.
Relevant Resources:
American Geriatrics Society Panel on Persistent Pain in Older Persons. (2002). The management of persistent pain in older persons. Journal of
the American Geriatric Society 50 (6 suppl): S205-S224. (Available at http://www.americangeriatrics.org/education/manage_pers_pain.shtml)
American Pain Society. (1999). Guideline for the Management of Acute and Chronic Pain in Sickle Cell Disease. Clinical Practice Guideline
Number 1. Glenview, IL: American Pain Society.
American Pain Society. (2002). Guideline for the Management of Pain in Osteoarthritis, Rheumatoid Arthritis, and Juvenile Chronic Arthritis.
Clinical Practice Guideline Number 2. Glenview, IL: American Pain Society.
Arnold R, Berger A, Billings JA, et al. (2004) Clinical Practice Guidelines for Quality Palliative Care. Brooklyn, NY: National Consensus Project for
Quality Palliative Care. (Available at http://www.nationalconsensusproject.org/guideline.pdf)
Cancer Pain Management Policy Review Group.(2001). American Cancer Society Policy Statement on Cancer Pain Management. National
Government Relations Department, American Cancer Society.
Federation of State Medical Boards of the United States Inc. (2004). Model Policy for the Use of Controlled Substances for the Treatment of
Pain. Dallas, TX: Federation of State Medical Boards of the United States Inc. (Available at http://www.fsmb.org)
Foley, K. M., and H. Gelband (eds). (2001). Improving Palliative Care for Cancer. Washington, DC: National Academy Press.
(Available at http://www.nap.edu/catalog/10149.html)
Institute of Medicine Committee on Care at the End of Life. (1997). Approaching Death: Improving Care at the End of Life. Washington, DC:
National Academy Press. (Available at http://books.nap.edu/catalog/5801.html)
National Institutes of Health Consensus Development Program. (2002). Symptom Management in Cancer: Pain, Depression and Fatigue.
Statement prepared following a National Institutes of Health State-of-the-Science Conference on Symptom Management in Cancer;
Bethesda, MD, July 15–17. (Available at http://consensus.nih.gov/ta/022/022_intro.htm)
Research America. (2003). Chronic Pain Pervasive in All Age Groups, New Study Shows. Alexandria, VA, September 4.
(Available at http://www.researchamerica.org/opinions/pain.html)
Rich, B. A. (2001). Physicians’ legal duty to relieve suffering. Western Journal of Medicine 175:151–152.
Tucker, K. L. (2001). A new risk emerges: Provider accountability for inadequate treatment of pain. Annals of Long-Term Care 9 (4): 52–56.
Tucker, K. L. (2002). Anatomy of a claim for failure to treat pain adequately: $1.5M jury verdict in first case to be tried.
Progress in Palliative Care 10 (1): 14-15.
SECTION II
TERMS
1. What are the key addiction-related terms used in discussing pain medications and risk management?
It is imperative to use clear terminology when discussing medical matters. Terms such as abuse, addiction, physical dependence,
pseudoaddiction, and tolerance are often used incorrectly by researchers, clinicians, regulators, the media, and patients. This
contributes to misunderstandings about the risk of addiction when opioids are used to manage pain. Definitions of these and other
terms are provided in Appendix A to:
• encourage accurate and consistent use of addiction-related terms,
• promote communication and better care of patients with pain and other conditions when the use of controlled prescription
drugs is appropriate, and
• encourage controlled substances regulatory policies and enforcement strategies that do not confuse the necessary
treatment of pain with abuse or addiction.
8 9
5. When should a primary care physician turn to a pain
medicine specialist to manage a patient’s pain?
Treatment of pain is an expected part of good medical practice,
and all physicians should address the problem to the best of
their abilities. Physicians have an obligation to 1) know about
the range of therapies used to manage acute and chronic pain;
2) recognize their own level of expertise in pain assessment,
treatment selection, and management; 3) understand the nature
of the consultative resources in the community; and 4) refer
appropriately. Consultation may be needed to obtain a more
comprehensive evaluation, to clarify the optimal therapeutic
strategy, to implement a therapy that is outside of the referring
physician’s expertise, or to respond to the patient’s desire for
another opinion.
If the use of a controlled prescription drug, such as an opioid, is
considered to be a potentially useful element in the therapeutic
strategy, the physician may consider consultation for any of a
variety of specific reasons. Consultation is considered part of
good medical practice and is encouraged by the Federation of
State Medical Boards’ "Model Policy for the Use of Controlled
Substances for the Treatment of Pain" (available at
http://www.fsmb.org). Specialist input may be helpful to clarify
the appropriateness of therapy; define the optimal regimen or
monitoring approach; assist in the evaluation of problematic
behavior, or evaluate specific recommendations, such as a
switch from "PRN" to fixed scheduled dosing, or from a shortacting
to a long-acting drug.
In all cases, the decision to request a consultation should be
based on both a critical self-evaluation on the part of the
physician and an assessment of the clinical challenges posed
by the patient. The physician’s self-evaluation should define
which types of patients or therapies can be implemented
without additional help, which can be implemented with
guidance through consultation, and which are better left to a
specialist. Where these lines are drawn depends on existing
knowledge and skills, and the availability of support systems for
monitoring. Ideally, most patients who undergo evaluation by
the specialist will then return to the primary physician for
ongoing treatment.
In some situations, consultation prior to, or during, opioid
therapy may be requested solely to address the concern that
specialist review would be reassuring to a regulator should the
therapy ever be questioned. Although this is not a medical
justification per se, it may be appropriate given the evolving
nature of opioid therapy in medical care. Consultation is not
required under federal law, but some states do require
consultation when treating patients with pain (see
http://www.medsch.wisc.edu/painpolicy/2003_balance for
examples). Some states have done away with this requirement.
If the patient is referred to a specialist or pain treatment center
to receive treatment, the referring physician should understand
whether the expertise needed is in fact available. Not all pain
specialists are knowledgeable or experienced in opioid therapy,
for example, and not all provide access to psychological or
rehabilitative treatments. The referring physician should
understand the nature of the consultative services in the
community before sending a patient for evaluation or care. A
searchable list of credentialed pain specialists can be found at
the American Academy of Pain Medicine’s website:
http://www.painmed.org/membership; a searchable list of pain
clinics can be found at http://www.pain.com/frameindex.cfm.
3. What are the goals of pain management?
The goals of pain treatment are to reduce pain and suffering,
enhance quality of life, and increase the ability to function—all
while minimizing the risk of adverse effects. These goals are the
same for all pain patients regardless of addiction history. To
accomplish these goals, pain management may involve any of a
broad array of interventions, one of which is drug therapy.
There are numerous options for analgesic drug therapy,
including opioids. When drug therapy is one of the strategies
used to address pain, the primary goal is to reduce pain without
causing distressing side effects or other drug-related problems.
Functional restoration may be another important goal and
clinical decisions about the ongoing use of analgesic drugs
typically require a careful assessment of all outcomes.
4. How can a clinician assess a patient’s pain?
Pain assessment is a critically important component of pain
treatment because it can yield a pain diagnosis (usually
described in terms of etiology, pathophysiology and/or
syndrome) that may clarify the need for further evaluation, guide
the selection of treatments, suggest prognosis, and indicate the
status of coexisting diseases. A documented pain assessment
provides a clinical basis for prescribing controlled substances
and a recorded baseline against which to measure progress
during treatment. The measurement of pain intensity is an
important aspect of the pain assessment. Self-report is the
"gold standard" for pain measurement. This should be done
with a tool appropriate for the patient’s cognitive development,
language, culture, and preferences; the same tool should be
used in subsequent assessments to allow for reliable evaluation
of change. Pain measurement tools include numeric scales,
visual analog scales, and verbal rating scales. In addition to
pain measurement, the assessment should describe the pain in
terms of location, temporal characteristics (onset, duration,
course, and fluctuation), quality, and factors that increase and
decrease pain. The assessment also should evaluate the
impact of the pain on physical and psychosocial functioning.
Other tools, such as body maps, daily diary records, and
multidimensional pain scales, may be used to capture some of
this additional information.
A comprehensive pain assessment also includes a physical
examination, which can help define the etiology and
pathophysiology of the pain. The need for a physical
examination is most compelling when a patient with pain is
initially evaluated. The extent of this examination is considered
to be a matter of clinical judgment and is determined by the
nature of the clinical problem; the physician’s discipline; and the
availability of previously documented examinations, imaging,
and laboratory findings relevant to the pain problem. At the end
of an examination, the physician should have sufficient
information about the physical status of the patient to support a
reasonable diagnostic formulation and decide on next steps.
Whether further physical examination is required on subsequent
visits also is a matter of clinical judgment, based on the need to
confirm or monitor specific findings, track specific treatment
effects, or assess comorbidities.
Relevant Resources:
Miaskowski C, Cleary J, Burney R, Coyne,P.; Finley,R.; Foster,R.;
Grossman,S.; Janjan,N.; Ray,J.; Syrjala,K.; Weissman,S.;
Zahrbock,C. (2004) Guideline for the Management of Cancer
Pain in Adults and Children. Glenview, IL: American Pain Society.
Simon, L.S., AG Liman, and A Jacox et al. (2002). Guideline for the
Management of Pain in Osteoarthritis, Rheumatoid Arthritis, and
Juvenile Chronic Arthritis. Clinical Practice Guideline Number 2.
Glenview, IL: American Pain Society.
10 11
are other treatment options that are likely to work as well
in the specific case, at the level of risk associated with
opioid therapy.
• Is the patient particularly vulnerable to opioid side effects?
The analysis of risk-to-benefits shifts in those who are
predisposed to severe opioid side effects.
• Is the patient likely to take medications responsibly or, if
problems seem likely, could a plan for structuring the
therapy and monitoring it be successful? Risk
assessment and management should be considered a
fundamental aspect to long-term opioid therapy. An
assessment that reveals characteristics, such as a history
of substance abuse in the recent past, that suggests a
relatively high risk of problematic drug-related behaviors
may influence the decision to initiate treatment or lead to
more intensive monitoring if opioid therapy is still
indicated.
Based on the answers to these questions, the clinician should
be able to make an informed judgment about the potential value
of an opioid trial in a particular patient.
Opioid treatment options include short-acting opioids, such as
codeine, hydrocodone, hydromorphone, morphine, or
oxycodone. Some of these drugs are available in combination
with aspirin, acetaminophen or ibuprofen; in this case, caution is
needed to avoid toxicity from the nonopioid component. Longacting
opioids, such as one of the modified-release opioids
(e.g., fentanyl, morphine, or oxycodone) or the long half-life drug
methadone (see Question 26) are preferred for chronic pain
because they are more convenient and may provide more
consistent pain relief. Less frequent dosing with long-acting or
controlled-release opioids also can improve adherence to the
therapy (fewer missed doses). In appropriate patients, a shortacting
opioid may be prescribed on a "PRN" basis in
combination with fixed scheduled administration of a longacting
drug to assist in the management of "breakthrough" pain.
For more information on the use of opioids in the management
of pain, see:
• American Academy of Pain Management
http://www.aapainmanage.org/education/Education.php
• American Academy of Pain Medicine
http://www.painmed.org/cme
• American Academy of Physician Assistants
http://www.mecgeducation.com/jaapa/
pain_management/default.asp
• American Board of Pain Medicine
http://www.abpm.org/index.htm
• American Headache Society
http://www.ahsnet.org
• American Medical Association
http://www.ama-assn.org/ama/pub/category/10171.html
• American Pain Society
http://www.ampainsoc.org
• Beth Israel Department of Pain Medicine and Palliative Care
http://www.stoppain.org
• California Academy of Family Physicians
http://www.familydocs.org
• National Pain Education Council
http://www.npecweb.org
Relevant Resources:
American Society of Addiction Medicine. (1997). Rights and Responsibilities of Physicians in the Use of Opioids for the Treatment of Pain.
Chevy Chase, MD: American Society of Addiction Medicine. (Available at http://www.asam.org/ppol/opioids.htm)
Gourlay, G. K. (2002). Clinical pharmacology of opioids in the treatment of pain. In M. A. Giamberadino (ed.), Pain 2002—An Updated Review:
Refresher Course Syllabus. Seattle: IASP Press, pp. 381–394.
Graven, S., H. C. W. deVet, M. van Kleef, and W. E. J. Weber (2000). Opioids in chronic nonmalignant pain: a criteria-based review of the
literature. In M. Devor, M. C. Rowbotham, and Z. Wiesenfeld-Hallin (eds.), Proceedings of the 9th World Congress in Pain Research and
Management 16, Seattle: IASP Press.
Kalso, E. (2000). Opioids for chronic noncancer pain. In J. O. Dostrovsky, D. B. Carr, and M. Koltzenburg (eds.), Proceedings of the 10th World
Congress on Pain, Seattle: IASP Press, pp. 751–765.
Passik, S. D., and H. J. Weinreb Managing chronic nonmalignant pain; Overcoming obstacles to the use of opioids.
Advances in Therapy 17: 70–80.
Savage, S. R. (2003). Opioid medications in the management of pain. In A. W. Graham, T. K. Schultz, M. F. Mayo-Smith et al. (eds.). Principles
of Addiction Medicine (3rd ed.). Chevy Chase, MD: American Society of Addiction Medicine, Inc., pp.1451–1463.
Zacny, J., G. Bigelow, P. Compton et al. (2003). College on Problems of Drug Dependence taskforce on prescription opioid non-medical use
and abuse: Position statement. Drug and Alcohol Dependence 69: 215–232.
SECTION IV
MEDICAL USE OF OPIOID
ANALGESICS
6. How are opioids used to manage chronic pain?
There are many approaches to treating chronic pain that should
be considered based on a comprehensive assessment of the
pain syndrome and its impact, the level of disability, and the
existence of medical and psychiatric comorbidities. In some
cases, specific treatment targeting the cause of the pain is
available and appropriate. For example, good glycemic control
is central to the treatment of painful diabetic neuropathy and
joint replacement can eliminate pain due to severe
osteoarthropathy. When pain becomes chronic, there are
numerous specific therapies that may be appropriate to lessen
discomfort or address the need for functional restoration. On
the basis of the assessment, pain treatment may emphasize or
de-emphasize pharmacotherapy and incorporate any of a
variety of non-drug treatments. These may include physical
therapy or other rehabilitative approaches; cognitive and
behavioral strategies; interventional treatments such as
injections or implantation of spinal cord stimulators and pumps;
or numerous complementary approaches such as acupuncture
and massage.
Drug treatments include nonopioid medications, such as
acetaminophen, aspirin and the nonsteroidal anti-inflammatory
drugs (NSAIDs); numerous drugs known collectively as the
adjuvant medications (including antidepressants, antiseizure
medications, and others); and opioid analgesics. Like the
decision to use any other treatment, the decision to try an
opioid, or to continue opioid therapy on a long-term basis,
should be based on a careful evaluation of the issues specific to
this approach.
Opioid therapy is accepted around the world as the most
important approach to managing severe, acute pain (such as
pain after surgery), moderate to severe chronic cancer pain, and
moderate to severe chronic pain caused by other lifethreatening
diseases (such as AIDS). The use of opioid therapy
to treat chronic nonmalignant pain has been more controversial
and is still being actively discussed by medical experts. The
consensus now is that some patients with chronic pain should
be considered as candidates for long-term opioid therapy, and
some will gain great benefit from this approach.
The controversy over the use of opioid drugs to treat chronic
pain is multifaceted. To some extent, it is related to limited
scientific literature that does not yet clearly define the most
appropriate patient subpopulations, best treatments, and range
of outcomes. More research is seriously needed to address
these questions.
The controversy also stems from a lack of education about
these drugs on the part of clinicians, regulators, law
enforcement, policy makers, patients and the public at large.
The scientific literature that does exist is often poorly
recognized. This literature is generally viewed by pain
specialists as having established the effectiveness of opioid
therapy in selected patients. It also has helped define the risks
and range of benefits that are associated with the approach.
There also is substantial confusion about the meaning of, and
the true risks associated with, drug-related phenomena such as
physical dependence, tolerance, and addiction (see Appendix A
for definitions). This confusion can lead to the withholding of
opioid medication because of a mistaken belief a patient is
addicted when he or she is merely physically dependent. It can
lead to inappropriate targeting of practitioners and patients for
investigation and prosecution, and to excessive and unfounded
fear of opioid use among patients and the public. This
confusion must be resolved to settle the important medical
questions relating to patient selection, treatment goals, dosing,
and monitoring. The answers to these questions should be
informed by research.
Ideally, the clinician’s decision about how to treat a patient’s
pain is based on a full understanding of the likelihood of both
benefit and harm from reasonable treatment alternatives.
However, there are few data on risks and benefits for many
treatments, including the long-term use of opioids.
Nevertheless, it is widely agreed that opioids are an option for
long-term pain treatment and that a trial may be a reasonable
step for patients who have moderate to severe chronic pain. To
make this decision, the assessment should attempt to answer
the following questions:
• What is conventional medical practice in the treatment of
this type of pain? If there is widespread acceptance of an
approach, such as trials of nonsteroidal anti-inflammatory
drugs in painful osteoarthropathy, then the decision to
use an opioid may require documentation that the
accepted approach has been tried and failed, or carries
an unacceptably high risk in the specific patient.
• Are there other treatments that may be effective and
feasible, and have a risk-to-benefit profile as good as, or
better than, the opioids? This question is difficult to
resolve, given the lack of comparative data from clinical
trials. Nonetheless, the clinician who is considering the
administration of an opioid, particularly long-term
administration, should carefully consider whether there
12 13
8. Where can clinicians find educational material on
prescribing opioid analgesics?
• American Academy of Pain Management
http://www.aapainmanage.org/education/Education.php
• American Academy of Pain Medicine
http://www.painmed.org/cme
• American Academy of Physician Assistants
http://www.mecgeducation.com/jaapa/
pain_management/default.asp
• American Geriatrics Society
http://www.americangeriatrics.org/education/
manage_pers_pain.shtml
• American Medical Association
http://www.ama-assn.org/ama/pub/category/10171.html
• Beth Israel Department of Pain Medicine and Palliative Care
http://www.stoppain.org
• California Academy of Family Physicians
http://www.familydocs.org
• National Pain Education Council
http://www.npecweb.org
9. What are the common side effects associated with
opioid therapy, and how can they be managed?
Physicians should periodically inquire about side effects. If side
effects are present and are not tolerated well, treatment should
be adjusted. The drug or how it is administered can be
changed, or a specific treatment can be given for the side
effect. Typically, successful therapy depends on achieving and
maintaining a favorable balance between analgesic effects and
side effects.
Constipation is very common during opioid therapy, particularly
among those patients who are predisposed (the elderly, patients
taking other constipating drugs, patients with diseases that
affect the gastrointestinal track). Tolerance may not develop to
opioid-induced constipation, and laxative therapy may be
needed throughout the course of treatment.
Somnolence and mental clouding are common when therapy is
initiated or the dose is increased. Although these effects
typically decline over time, some patients experience persistent
impairment. The risk presumably is higher among those who
are concurrently using other CNS depressants and those with
diseases associated with encephalopathy. Selected patients
with analgesia compromised by somnolence or mental clouding
may be candidates for specific therapy with a psychostimulant
drug.
Nausea and vomiting may be treated with antiemetics such as
phenothiazines, butyrophenones, or metoclopramide. When
nausea is due to motion-related vestibular effects, a trial of an
antihistamine, such as meclizine or scopolamine, should be
considered. If opioid-induced gastroparesis is suspected
(postprandial nausea, bloating, reflux symptoms),
metoclopramide is a preferred drug because of its positive
effects on gastrointestinal motility. To help manage nausea, it
may be worthwhile to consider switching to a nonoral route of
administration, at least for a time.
It is very important that physicians anticipate, recognize, and
treat side effects when patients are receiving opioids for pain.
Common side effects at the start of therapy or after dose
escalation include somnolence or mental clouding, nausea,
and constipation. Uncommon side effects include fatigue;
itching; adverse mood change; dry mouth, loss of appetite,
bloating, or heartburn; urinary hesitancy; sweating; sexual
dysfunction; and headache. Although any side effect can
persist, the most common long-term side effect is
constipation. With overdose, opioids can cause serious
respiratory depression, the risk of which is again highest in
the setting of limited or no ongoing opioid therapy.
7. What outcomes should be assessed when judging
whether opioid therapy is successful?
Opioid analgesics have the ability to relieve pain. Improved
comfort may be associated with better physical and
psychosocial functioning, and enhanced quality of life. Opioids
also have the potential for side effects and adverse effects
(including abuse or addiction). Given the variation in the
responses associated with this therapy, the management of
opioid therapy should include ongoing evaluation of a range of
outcomes. The relevant categories include:
Pain intensity, or the extent of pain relief, should be measured
over time and documented in the medical record. This may
involve questions using a simple verbal rating scale (none, mild,
moderate, severe), a numeric scale ("0 to 10"), or some other
type of measure. Documentation in the medical record that
pain is being followed over time is important evidence of the
appropriateness of therapy.
Although opioids can provide pain relief, complete pain relief is
uncommon during the treatment of chronic pain. Pain
measurements during the treatment of chronic pain are seldom
"zero," and in some cases, can fluctuate at relatively high levels.
In the clinical setting, the overall benefit, or success, of opioid
therapy often cannot be determined by pain scores alone.
Although clinical studies have suggested that meaningful pain
relief is associated with defined reductions in pain scores (e.g.,
two points on a 0 to 10 scale or 30% on a visual analogue
scale), these values are helpful in research but do not capture
the complexity of the clinical situation. For some patients, pain
relief may be "meaningful" when specific tasks can be
performed, mood improves, sleep is better, or relationships with
others can occur. The monitoring of pain intensity is important
but the clinician should be prepared to assess all these
outcomes in an effort to understand the overall effects of
therapy.
Side effects are common during opioid therapy. The potential
for side effects should be explained to the patient and
anticipated, assessed, and managed. With the exception of
constipation, side effects are usually of short duration and can
be expected to lessen with time as the body adapts to the
opioid (see Question 9 for more information on side effects.)
Although a large clinical experience suggests that most patients
use opioid drugs responsibly—following instructions,
communicating with the clinician, and avoiding actions that
would be worrisome to the prescriber—some patients engage
in problematic drug-related behaviors. These problematic
behaviors are very diverse and may reflect any of a wide array
of clinical disorders (including addiction); they could potentially
reflect diversion as well. Practitioners who prescribe controlled
prescription drugs, such as the opioids, should monitor drugrelated
behavior. This may be done through history-taking, or if
indicated, through more structured plan that includes behavioral
assessments. Such a structured approach is most clearly
indicated if the patient has a known history of addiction or
significant substance abuse (see Question 23).
In summary, pain treatment with opioids should be evaluated
over time by assessing improvement in pain and the extent to
which this outcome is associated with side effects, gains in
function and quality of life, and the occurrence of any
problematic behaviors. These outcomes are important to
assess in all cases, regardless of their history.
• pain relief;
• side effects;
• functioning, both physical and psychosocial (and overall
quality of life); and
• problematic drug-related behaviors (which may suggest
misuse, abuse, addiction, or even diversion).
Relevant Resources:
Gourlay, G. K. (2002).Clinical pharmacology of opioids in the
treatment of pain. In M. Giamberadino (ed.), Pain 2002—An
Updated Review: Refresher Course Syllabus.Seattle: IASP Press,
pp. 381–394.
McQuay, H. J. (1999). How should we measure the outcome?
Opioid Sensitivity of Chronic Noncancer Pain. In E. Kalso, H. J.
McQuay, and Z. Weisenfeld-Hallin (eds.), Progress in Pain
Research and Management 14. Seattle: IASP Press, pp.
371–383.
Rowbotham, M. C. (2001). Editorial: What is a "clinically meaningful"
reduction in pain? Pain 94: 131–132.
14 15
10. What information do patients need about using
opioids for chronic pain?
Informing patients about issues surrounding pain management
and the use of opioid analgesics is good medical practice.
Sometimes, this is accomplished as part of informed consent,
which is recommended and, in fact, required in some states (to
see if your state requires informed consent, refer to
http://www.medsch.wisc.edu/painpolicy/matrix.htm).
Physicians can provide information through discussions with the
patient or by distributing a handout, booklet, or medication
agreement. Patients and their caregivers also can gain access
to valuable information by using the Internet to reach a number
of organizations (see links provided below).
Although not a complete list, patients should understand this
information:
• Some "Dos" and One "Don’t" for Patients
- Do talk to the doctor and other health care professionals
involved in your pain care about the pain; keep notes and
write down questions to ask about the pain.
- Do talk to the doctor if the medication is not working.
- Do talk to the doctor if there are problems with side effects.
• Patients’ rights
- Patients have the right to have their pain assessed and
treated.
- Accredited medical facilities should recognize this right.
• Diagnosis and treatment plan
Patients should:
- know the diagnosis and as much as possible about
reasons for the pain.
- know the goals of treatment and how the physician will
measure progress to achieve the goals.
- know why opioid analgesics are part of the treatment
plan and how and when to take them.
- know the realistic expectations for sustained pain relief
and improved functioning, and that it may not be
possible to relieve all their pain.
- realize that opioids are only one part of a treatment plan
that may include other treatments such as physical
therapy or psychological techniques.
- recognize that decisions about starting, changing, or
stopping opioid treatment should be made with patient
input.
- know that they can ask for changes in treatment or a
consultation with a specialist if pain relief is not
adequate.
• Side effects
Patients should:
- know what side effects to expect and how to manage
them.
- understand that most side effects are transitory, but any
effect can persist and potentially compromise the longterm
value of the treatment.
- recognize that concurrent therapies for side effects may
be recommended.
- know that the occurrence of intolerable and untreatable
side effects means that the treatment is not appropriate
and must be changed.
- know that opioids may impair thinking and alertness at
first and, if this occurs, the patient should avoid driving
or other similar activities until these effects dissipate.
• Abuse, addiction, physical dependence, and tolerance
Patients should:
- know the definitions of physical dependence, tolerance,
and addiction.
- understand that the use of an opioid in a manner
different from what is instructed is a form of drug abuse,
and that the clinician must continually assess whether
this is occurring and take steps to prevent it or, should
it be identified, stop it.
- know that the use of alcohol and any other prescribed
drugs during opioid therapy must be assessed by the
clinician, and should the use of these substances be
perceived to be problematic, the clinician must assess
the situation and take appropriate actions.
- recognize that the use of illicit drugs can be a significant
problem, and that the clinician must monitor the patient
for this occurrence and act appropriately if it is
discovered.
- know that addiction is a serious illness, and that the
clinician must monitor drug-related behaviors in part to
make sure that this problem is not developing; if there is
a possibility that problematic behaviors surrounding
medicines are due to an addiction, the physician must
treat this.
- know that true addiction is believed to be a rare
occurrence in patients who receive opioids for a
medical reason and have no history of drug abuse or
addiction; clinicians must monitor drug-related
behaviors in all patients, however, have accurate and
balanced information about addiction and how it is
assessed.
- know that physical dependence, which is the capacity
for withdrawal, is normal during opioid therapy, does
not prevent discontinuation of the therapy if the pain
stops, and, most important, is not addiction.
- know that analgesic tolerance occurs when a stable
dose of pain medication has a decreasing effect over
time and does not indicate addiction.
Itching, which results at least in part from the release of
histamines triggered by opioids, usually resolves within a few
days. If itching persists, it may be treated with an antihistamine.
Among the commonly used opioids, and fentanyl and
oxymorphone have a relatively low propensity to release
histamine.
Respiratory depression is a rare adverse effect during chronic
opioid treatment. Respiratory depression is possible if dose
escalation occurs very quickly, beyond the ability of
compensatory mechanisms to adjust; if some intercurrent
cardiopulmonary event occurs (for example, pulmonary
embolism or pneumonia), or if something happens to eliminate
the source of the pain (for example, a nerve block). Except in
rare circumstances, respiratory depression is preceded by
somnolence and slowed breathing. Respiratory depression that
occurs from some intercurrent cardiopulmonary event may be
partially reversed by naloxone. Accordingly, a response to
naloxone does not mean that the opioid was the primary
problem. When patients develop respiratory depression in the
setting of stable dosing, a prompt search for another cause
usually is indicated, even if the patient improves with naloxone.
Because the administration of naloxone carries substantial risks
in the physically dependent patient (severe withdrawal), it should
not be used unless clinically significant respiratory depression is
feared. Naloxone should not be given for somnolence in the
absence of existing or impending respiratory effects. If the time
of peak effect of the drug has passed, and the patient has
adequate respirations, it is safer to observe for a period of hours
than to treat with naloxone. If naloxone must be given, it is
safer to give small doses repeatedly and monitor effects.
Relevant Resources:
American Pain Society. (2003). Principles of Analgesic Use in the
Treatment of Acute Pain and Cancer Pain (5th ed.). Glenview, IL:
American Pain Society.
Fohr, S. A. (1998). The double effect of pain medication:
Separating myth from reality. Journal of Palliative Medicine 1 (4):
315–328.
16 17
12. Can more than one opioid at a time be prescribed
to a patient?
The physician may determine that it is beneficial for the patient
to use more than one opioid at a time. In the treatment of
cancer pain, the typical approach involves the prescription of a
long-acting opioid to relieve baseline pain plus a short-acting
opioid (known as the "rescue" dose) to be taken as needed for
episodes of breakthrough pain. Many pain specialists now
apply this approach to the management of chronic noncancer
pain. The use of this rescue medication should be considered
on a case-by-case basis. Some patients appear to be good
candidates because their pain fluctuates, opioids help, and
there is a reasonable expectation of responsible drug use;
others may benefit more from administration of a single drug
according to a fixed schedule. Other nonopioid controlled
substances also may be coadministered during opioid therapy
(see Question 9). A separate prescription form should be used
for each opioid or other controlled substance prescribed.
13. What is "opioid rotation," and when is it
appropriate?
Opioid rotation refers to a switch from one opioid to another. It
is a common strategy to address the occurrence of intolerable
side effects during opioid therapy. When a switch is made, the
starting dose of the new drug is selected based on the
information in an "equianalgesic dose table." Versions of this
table are widely available, and the values it contains should be
considered a broad guide to selecting the dose. In most cases,
the dose of the new opioid is reduced from the calculated
equianalgesic dose because cross-tolerance between opioids is
incomplete and there is substantial variation in the doseresponse
across individuals. This reduction reduces the risk of
side effects from a calculated dose that may be, in effect, too
high for the patient. The extent of the dose reduction varies
with the specific drug and the clinical situation of the patient.
The usual 30-50% reduction in the calculated equinalgesic dose
is increased (usually to 75-90%) when the switch is to
methadone, and is decreased (sometimes to no reduction at all)
when the switch is to transdermal fentanyl; the reduction is
increased if the patient has significant opioid side effects or is
medically frail, and it is decreased if the patient has a high level
of pain. After treatment with the new drug is initiated, the dose
usually must be adjusted, often repeatedly, to optimize the
balance between pain relief and side effects.
Relevant Resources:
Anderson, R., et al. (2001). Accuracy in equianalgesic dosing.
Conversion dilemmas. Journal of Pain and Symptom
Management 21 (5): 672–687.
Arnold, R., and D. E. Weissman (2003). Calculating opioid dose
conversions #36. Journal of Palliative Medicine 6 (4): 619–620.
Pereira, J., et al. (2001). Equianalgesic dose ratios for opioids. A
critical review and proposals for long-term dosing. Journal of
Pain and Symptom Management 22 (2): 672–687.
Southern California Cancer Pain Initiative. Pocket Card.
(Available at http://sccpi.coh.org)
- Do talk to the pharmacist openly about this therapy if he or
she could potentially help with information about the pain or
the management of side effects.
- Do keep the medications in a safe place and out of
children’s reach.
- Do look for another physician, or request referral to a
specialist, if the pain is not taken seriously.
- Do use the medication only as it is prescribed and handle
the therapy with a high level of responsibility.
- Do notify the physician if you are planning to become
pregnant or are already pregnant.
- Don’t allow others to use the prescription medication; the
patient is the only person who is legally permitted to have
the prescribed opioids.
For more information about pain, patients’ rights,
communicating with the physician, and support:
American Alliance of Cancer Pain Initiatives
http://www.aacpi.org
American Cancer Society
http://www.cancer.org/docroot/home/index.asp
American Chronic Pain Association
http://www.theacpa.org
American Pain Foundation (homepage)
http://www.painfoundation.org
American Pain Foundation (brochure "Finding Help for your Pain")
http://www.painfoundation.org/downloads/FindingCare.pdf
Cancer Information Service
http://cis.nci.nih.gov
National Chronic Pain Outreach Association
http://www.chronicpain.org
National Pain Foundation
http://www.painconnection.org
11. What kinds of problems might patients encounter
when obtaining opioid prescriptions, in having
them filled, or in taking the medications properly?
• Some physicians may be reluctant to prescribe pain
medications due to uncertainty about the medical
appropriateness, inadequate or inaccurate knowledge about
pain management, limited information about opioid
pharmacology, concern about the development of
problematic drug-related behavior or addiction, and fear of
scrutiny by regulatory and law enforcement agencies and the
insurance industry. Physician communication with regulatory
agencies, as well as information disseminated by
organizations such as medical boards, can help to overcome
these problems.
• Pharmacists sometimes react with suspicion to patients who
are prescribed opioid drugs because of concern about drug
abuse or lack of information about the proper role of opioid
therapy in pain management. Some pharmacists even refuse
to dispense controlled substances, and some do not
understand what the law allows. Communication between
the physician and pharmacist, as well as consultation with
and information disseminated by pharmacy boards, can
reduce these problems.
• Some pharmacies do not stock pain medications due to high
cost, poor reimbursement, low prescription demand, and
concerns about theft or robbery; clinicians may recommend
certain pharmacies or may call ahead to be sure that the
prescribed medication is in stock.
• Pharmacies sometimes provide drug information, including
computer printouts, that provide an inaccurate perspective of
the benefits and risks of opioid drugs, reinforcing patient
concerns about the medicine.
• Family and friends, or health care providers who are not
directly involved in the therapy, may express concerns about
the use of opioids. These concerns may result from a poor
understanding of the role of this therapy in pain management
or from an unfounded fear of addiction; they may be
exacerbated by widespread, sometimes inaccurate, media
coverage about abuse of opioid pain medications.
Relevant Resources:
Joranson, D. E., and A. M. Gilson (2001). Pharmacists’ knowledge
of and attitudes toward opioid pain medications in relation to
federal and state policies. Journal of the American

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