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OfflinemotamanM
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DEA Retraction of Pain FAQ Angers, Scares Doctors and Patients 12/3/04
    #3443932 - 12/03/04 11:44 PM (12 years, 6 days ago)

http://stopthedrugwar.org/chronicle/365/faq.shtml


DEA Retraction of Pain FAQ Angers, Scares Doctors and Patients 12/3/04




In August, after a long collaborative process with leading academic pain management specialists, the Drug Enforcement Administration (DEA) posted a document designed to provide guidelines for physicians involved in opioid pain management therapy. The document, "PRESCRIPTION PAIN MEDICATIONS: Frequently Asked Questions for Health Care Professionals and Law Enforcement Personnel," sought to balance the imperatives of drug law enforcement and those of medicine and, at least according to the pain professionals involved in the process, marked a fairly enlightened approach to navigating the turbulent intersection of law and medicine.

But in early October, the DEA pain FAQ mysteriously disappeared without warning to any of the pain professionals involved in creating it. The pain FAQ contained "misstatements" and was not an official document, the agency tersely explained (http://stopthedrugwar.org/chronicle/358/thefaq.shtml). On November 16, the DEA posted an "interim policy statement" on the Federal Register, detailing its objections to the earlier collaborative FAQ and hewing to a much harder line on the diversion of prescription medicines.

The move comes as one prominent pain physician, Northern Virginia's Dr. William Hurwitz, is on trial for alleged drug diversion. Hundreds of other physicians have been arrested or disciplined in recent years on similar charges. Combined with the federal government's recently announced campaign against prescription drug diversion, the new DEA statement is bound to have a chilling effect on the willingness of doctors to prescribe adequately for the estimated 50 million Americans suffering from chronic pain.

Where the pain FAQ said that the number of patients or the number of pills prescribed "should not be used as the sole basis for an investigation," the new statement said a high number of pain patients or a large quantity of prescribed pills "may indeed be indicative of diversion." As if that weren't enough, the agency asserted for good measure that the government "can investigate merely on suspicion that the law is being violated, or even just because it wants assurances it is not." In other words, the DEA can investigate a pain doctor whenever it feels like it.

While the pain FAQ said that physicians could write multiple prescriptions for a pain patient on a given day, the new statement expressly said they could not and qualified such behavior as indicative of possible diversion. And while the pain FAQ said that prescribing opioid pain medications to people with histories of drug abuse could be done if precautions were taken, the new statement said the FAQ "understated the degree of caution that a physician must exercise to minimize the risk of diversion when dispensing controlled substances to known or suspected addicts." In other words, if you have any history of substance use, count on having a very difficult time getting any doctor to subscribe pain medications for you.

The new DEA statement has been greeted with anger and dismay in the pain management community. In a November 24 letter to the DEA's Office of Diversion Control, Dr. David Joranson, director of the University of Wisconsin's Pain Policy Studies Group, who had worked closely with the DEA in crafting the original pain FAQ, complained that "DEA's abrupt withdrawal of support for the FAQ, without any consultation with coauthors about its concerns, raises questions about what communication the pain management community can expect to have with DEA." The DEA's changes, Joranson added, "are likely to interfere in medical practice and pain management."

Joranson also accused the DEA of failing to recognize "the well-established principle in federal law that enforcement of the Controlled Substances Act is not intended to interfere with ethical medical practice and patient care," a principle, he pointed out, the DEA has endorsed in the past. And he had particulars.

Regarding the new statement's criticism of the pain FAQ on whether a high number of pills prescribed in itself indicates a problem, Joranson pointed out that the FAQ was in line with Model Guidelines published by the Federation of State Medical Boards of the US, and that the DEA had earlier submitted written testimony supporting the federation guidelines.

As for the DEA's assertion of its ability to investigate any pain doctor for the merest suspicion of wrongdoing, Joranson warned that it is "this attitude that will exacerbate practitioner fears of investigation, even thought they could ultimately show, after a costly and demoralizing process, that the prescribing was medically appropriate."

Joranson also took issue with the DEA's stance on prescribing to people with histories of drug abuse. "The interim policy statement does not recognize that it is within the scope of federal law to prescribe opioids for the purpose of treating pain in patients with an addictive disease or a history of substance abuse, as did the FAQ." Even people who have substance abuse problems sometimes suffer severe pain from cancer or other diseases, Joranson noted. "Is DEA suggesting that it objects to the use of opioids in the treatment of pain in this population of medical patients?" he pointedly asked.

Further comments by Joranson in the letter (linked to below) challenge both the relevance and factuality of arguments presented by the DEA in its new statement.

Another academic pain specialist who had worked closely with the DEA on the pain FAQ, Dr. Russell Portenoy of Beth Israel Medical Center in New York City, told the Washington Post this week that the DEA has changed "the tone of the dialogue in a way that is very worrisome. We're seeing more of an emphasis on law enforcement and less on the legitimate use of prescription narcotics," he added.

Physicians, scholars, and pain advocates not involved in the collaborative process with DEA were less restrained in their reactions. "It's pretty obvious to me what they're up to," said University of North Florida Professor Ronald Libby, who is writing a book on the tangled intersection of law and medicine in pain management. "They basically don't want to be held to any standard for practicing pain medicine," he told DRCNet. "In the pain FAQ, the DEA basically said that there had to be criminal intent on the part of the doctor for it to bring charges, but they don't want to hold to that because then most of these cases they've been bringing against doctors will just collapse. What they are doing now is putting doctors on trial for the behavior of their patients."

"This is the sort of deceptive obfuscation we've come to expect from the DEA," said Siohban Reynolds, executive director of the patient advocacy group the Pain Relief Network (http://www.painreliefnetwork.org). "And it's replete with threats not only against doctors but against the very integrity of medicine. The DEA has been completely dishonest," she added. "I am very dismayed."

Although academic pain specialists like Dr. Portenoy and the University of Wisconsin pain group had spoken with DRCNet in the past, they did not respond to interview requests this time around. Reynolds thinks she knows why. "The academic pain specialists have had all their effort and good will trampled on," she said. "I feel very sad for them. On the other hand, the good news is that the pain management world will be extremely hard-pressed to continue to act as if the DEA and the Department of Justice are acting in good faith. We are watching a witch hunt going on and even these guys are beginning to understand that."

California physician Frank Fisher, himself a victim of overzealous prosecutors in a notorious Northern California case in which he was exonerated, isn't so sure. "The fact that law enforcement regulates medicine at all is a fundamental problem," he told DRCNet. "Doctors have been trying to work with the DEA on this for the past 15 years, but nothing gets better. Still, as a practical matter, most of the doctors are saying let's try again."

"What pain specialist with any responsibility is going to waste his time with this again?" disagreed Libby. "They are busy, busy people, and they were clearly used by the DEA. They put their time, energy, and professional reputations on the line, and the DEA burned them. How can anyone take the DEA at its word again?"

If the DEA's maneuvers around the pain FAQ and the new statement represent a retrenchment and a harder line toward pain doctors, the timing of the move also strongly suggests that the DEA had more sinister and nefarious reasons. Attorneys for Dr. Hurwitz had moved in late September to introduce the pain FAQ in his trial. The pain FAQ vanished from the DEA web site a few days later. Two weeks after that, US Attorney Paul McNulty, who is prosecuting Hurwitz, filed a motion seeking to have the pain FAQ excluded because it "did not have the force and effect of law." Presiding US District Court Judge Leonard Wexler ruled in favor of the government.

"This is all about winning," said Libby. "I'm sure these guys believe in what they're doing, but they have to justify their jobs and shut these 'drug dealer' doctors down. Now that prescription drugs are as much a part of the drug war as Schedule I substances, the doctors are legal game."

Visit http://www.medsch.wisc.edu/painpolicy/DEA/ to read the correspondence between the DEA and the University of Wisconsin Pain Policy Group.


-- END --


--------------------
http://heffter.org


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InvisibleEonTan
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Re: DEA Retraction of Pain FAQ Angers, Scares Doctors and Patients 12/3/04 [Re: motaman]
    #3444144 - 12/04/04 12:56 AM (12 years, 6 days ago)

That is very disturbing!!!

The supreme court looks like it is going to rule against Medical Marijuana on the grounds that possesion of marijuana is proof of participation in the enormous commercial market of recreational marijuana. They just can't imagine being able to differentiate between growing for personal use, by doctors orders, and growing for the commercial market. Possesing legally grown/purchased pot and illegaly grown/purchased pot.

They just can't view this in MEDICAL TERMS. They choose to focus entirely on the commercial illicit market, and the risk medical marijuana posses to their continued enforcement of illegal possesion/cultivation/sale.

The logic they are using is very similar to the DEA reasons for yanking the FAQ on pain relief. Nothing can stand in the way of the War on Drugs. Not even a bunch of terminally ill people trying to stay pain free until they die, or a bunch of chronically ill people just trying to improve their quality of life they have.

The people speak, the state acknowledges, the Federal governmnet intervenes. 5 say no, 2 don't care, 1 is dying, and 1 is waiting to see how the dying one votes. Looks like a 7-2 vote against, with potentially a 9-0 vote against. Even the liberal judges are against it!!! THE SUPREME COURT THINKS STOPPING ADULTS FROM POSSESING POT IS MORE IMPORTANT THEN KEEPING SICK PEOPLE ALIVE and COMFORTABLE. THE DEA WOULD RATHER LET PEOPLE DIE/LIVE IN CHRONIC PAIN THEN TO HAVE THE POSSIBILITY OF A FORMER HEROIN ATTACK GETTING ACCESS TO LEGAL JUNK ON HIS DEATH BED.

EVEN the Cheif Justice likes his Diluadid.


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OfflineEkstaza
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Re: DEA Retraction of Pain FAQ Angers, Scares Doctors and Patients 12/3/04 [Re: EonTan]
    #3447429 - 12/04/04 10:12 PM (12 years, 5 days ago)

This shit is just plain scary.


--------------------
YOUR EXPERIENCE WITH ANY GIVEN DRUG ISN'T THE DEFINITIVE MEASURE OF THE DRUGS EFFECTS.


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Invisibleboxtop703
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Re: DEA Retraction of Pain FAQ Angers, Scares Doctors and Patients 12/3/04 [Re: motaman]
    #3453490 - 12/06/04 06:55 AM (12 years, 4 days ago)

Quote:

The move comes as one prominent pain physician, Northern Virginia's Dr. William Hurwitz, is on trial for alleged drug diversion.




I would just like to point out that Doctor Hurwitz was my personal physician during the eighties. In fact, we rented him our driveway(crowded city street) in return for free medical care. He used our driveway for about 15 years.

He was DEFINITELY a quick prescriber but NOT necessarily for painkillers. I went to him for pneumonia once and said like 4 words, he listened to my chest for about 15 seconds and I was out the door 5 or 10 minutes later with a prescription.

I'll also add that his prescriptions ALWAYS cured me.

Really, that's all I want in a doctor.


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OnlineAsanteA
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Re: DEA Retraction of Pain FAQ Angers, Scares Doctors and Patients 12/3/04 [Re: boxtop703]
    #3455397 - 12/06/04 05:34 PM (12 years, 3 days ago)

retract my ass
----------------------------------------------------------

http://www.painmed.org/about/academy/pdfs/PainMedFAQ.pdf.



Page 1
1
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
1
Page 2
2
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., 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
Page 3
3
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.
3
Page 4
4
Contents
Section I:
Introduction
Section II:
Terms
1. What are the key addiction-related terms used in discussing pain
medications and risk management?
Section III: Pain and Its Treatment
2. Why is pain management important?
3. What are the goals of pain management?
4. How can a clinician assess a patient?s pain?
5. 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
6. How are opioids used to manage chronic pain?
7. What outcomes should be assessed when judging whether opioid therapy
is successful?
8. Where can clinicians find educational material on prescribing opioid
analgesics?
9. 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??
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5
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?
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6
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
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7
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:
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).
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 drug-seeking 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
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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.
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.
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9
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.)
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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.
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.
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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>
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.
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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 Resource:
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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.
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 short-acting 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.
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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.
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.
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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 life-threatening 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-
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term administration, should carefully consider whether there 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. Long-acting 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 short-acting opioid may be prescribed on a
?PRN? basis in combination with fixed scheduled administration of a long-acting 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
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? 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 9
th
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 10
th
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 Therapy17: 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.
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
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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 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).
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 drug-related behavior. This may be done through history-taking,
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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.
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.
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
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9. What are the common side effects associated with opioid therapy, and
how can they be managed?
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.
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.
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
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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.
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:
? 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:
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- 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 long-term 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
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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.
? 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.
- 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
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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 Pharmaceutical Association 41 (2): 213?220. (Available at
http://www.medsch.wisc.edu/painpolicy/publicat/01japhak/index.htm.)
Morrison, R. S., S. Wallenstein, D. K. Natale et al. (2000). ?We don?t carry that??
Failure of pharmacies in predominantly nonwhite neighborhoods to stock opioid
analgesics. New England Journal of Medicine 342 (14): 1023?1026.
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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 dose-
response 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.
25
Page 26
26
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/.)
14. What do the terms ?tapering? and ?drug holiday? mean?
Tapering (or ?weaning?) is when the physician discontinues a pain patient?s opioid
therapy by progressively reducing the dose to prevent withdrawal symptoms. If opioid
therapy must be stopped, the dose should be tapered rather than being discontinued
abruptly. The observation that opioid therapy can be discontinued without uncomfortable
abstinence by carefully tapering the dose supports the view that opioid therapy can be
initiated as a trial. If the pati


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