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1995 Angarola RT, Joranson DE, International efforts under way to provide adequate medication for pain control. APS Bulletin 5(6):9-10,23.

International Efforts Under Way to Provide Adequate Medication for Pain Control

Robert T. Angarola, Esq.; David E. Joranson, MSSW

The United Nations International Narcotics Control Board (INCB) has undertaken a special study during 1995 to determine the extent to which the actual medical need for opioids is being satisfied throughout the world. The INCB is an independent quasi-judicial body responsible for the implementation of UN drug conventions, in particular the Single Convention on Narcotic Drugs. The Single Convention recognizes that while opioids are a danger to the public health when abused, they are "indispensable" for the treatment of pain. The board has stated that governmental efforts to prevent and control abuse, diversion, and trafficking should not in any way deprive patients by creating a shortage of these drugs.

In 1989, INCB published a special study on the demand for and supply of opioids in the world. The study concluded that in many countries the legitimate need for opioids was far from being met. A number of factors accounted for this situation, including an absence of national policy, lack of healthcare resources, inadequate facilities for storage and distribution of drugs, insufficient training of health professionals, excessive fear of addiction, and overly restrictive laws and regulations governing the availability of opioids. INCB made a number of recommendations to national governments, the World Health Organization (WHO), and professional associations.

International Narcotics Control Board's 1989 Recommendations on the Availability and Use of Opioids

  • Governments should critically examine their methods of assessing domestic medical needs for opiates and of collecting and analyzing data, so as to make the changes required to ensure that future estimates will accurately reflect the actual need.
  • Governments should develop and apply a system for monitoring the extent to which medical need for opiates is being met, so that appropriate corrective action may be taken to cover any hitherto unmet needs.
  • Governments should examine the extent to which their healthcare systems and laws and regulations permit the use of opiates for medical purposes, identify possible impediments to such use, and develop plans of action to facilitate the supply and availability of opiates for all appropriate indications.
  • Governments should establish national policies and develop guidelines on the rational use of opiates and on the treatment of conditions for which opiates may be indicated.
  • Governments should ensure that health professionals receive sufficient education and up-to-date training in the use of opiates and have access to information on drug dependence.
  • WHO should develop guidelines and provide assistance to governments in establishing the most appropriate national system for assessing the domestic medical need for opiates.
  • Medical instructors and professional associations of physicians, pharmacists, nurses, and pharmaceutical manufacturers should be urged to promote rational use of opiates for medical purposes, bearing in mind their responsibility that opiates will not be abused.


Source: United Nations Report of the International Narcotics Control Board for 1989, "Demand for and supply of opiates for medical and scientific needs." Available from the INCB Secretariat, Vienna International Centre, PO Box 500, A-1400 Vienna, Austria.

In 1995, INCB reemphasized the urgency of the problem and asked national goverments, WHO, and a number of international professional associations, including the International Association for the Study of Pain (IASP), to provide detailed information on what actions have been taken to ensure that opioids are adequately available for medical needs. In 1996, INCB will issue new recommendations to governments to ensure that opioids are sufficiently available for medical needs throughout the world.

IASP, in turn, asked its national chapters, including the American Pain Society, for assistance in responding to INCB's request. The APS response was developed after consideration by the Public Affairs Committee and the Analgesic Regulatory Affairs Task Force. The APS position statement for INCB was approved by the APS Executive Board in August 1995.

APS statement

The following are excerpts from the APS position statement:

The American Pain Society is the major national multidisciplinary organization of U.S. scientists and clinicians who study and treat pain. In support of people with pain, the society provides programs to educate patients, their families, and healthcare professionals to monitor the quality of pain care and to advocate in the public policy arena for patients with pain. The aim of these programs is to ensure that pain control receives a high priority in the U.S. healthcare system.

In the United States, the U.S. Public Health Service Agency for Health Care Policy and Research (AHCPR) has issued federal guidelines for use of opioids in pain management. The guidelines also identify a number of barriers to acute and cancer pain management. These include problems related to healthcare professionals, such as inadequate knowledge of pain management, poor assessment of pain, unfounded fear of patient addiction, and concern about side effects of analgesics (AHCPR, 1992, 1994). Likewise, AHCPR has found that cancer patients are often reluctant to report pain or to take pain medications, again out of unwarranted fear of addiction or being thought of as an addict (AHCPR, 1992, 1994). Also, there are problems related to the healthcare system, including the low priority given to pain treatment generally, inadequate health insurance coverage, and uneven reimbursement policies. One of the major barriers to effective care is the fear healthcare professionals have about being investigated for prescribing controlled substances such as opioid analgesics, which AHCPR has determined are the "cornerstone" of effective pain care (AHCPR, 1992, 1994).

The United States is the largest consumer of opioids in the world. However, cancer pain, acute pain, and chronic pain remain seriously undertreated in this country (Cleeland et al., 1994; Melzack, 1988). As determined by AHCPR, the restrictive regulation of controlled substances has contributed significantly to the undertreatment of pain (AHCPR, 1992,1994). The federal Controlled Substances Act (CSA) implements the requirements of the United Nations Single Convention on Narcotic Drugs and requires the use of a written prescription for most opioid analgesics (21 U.S.C. 829). The CSA imposes two additional requirements beyond those needed to meet U.S. treaty obligations: (a) the prohibition of refilling schedule II controlled substance prescriptions, and (b) the prohibition of verbal prescriptions except in emergency situations. The potent and essential opioid analgesics such as morphine, oxycodone, and fentanyl are schedule II controlled substances. There have been recent calls for the Drug Enforcement Administration (DEA) and other federal agencies to consider adjusting regulatory policy to reduce restrictions and paperwork related to the prescribing of pain medications (Angarola, 1995).

By far the greatest regulatory and legislative restrictions on the availability of opioid analgesics rest with some state laws. Most state laws, unlike federal law, do not specifically recognize the use of opioids for intractable pain. Furthermore, some state laws are more strict than federal law. In particular, the requirement that physicians use government-issued prescription forms (triplicate prescriptions) has reduced the prescribing of the covered drugs by more than 50% in some states (DEA, 1990). The most widely used medications in these categories are opioid analgesics.

Other state restrictions include limits on the number of dosage units that may be dispensed, typically 120 dosage units per month. This is a serious barrier for many patients in need of large quantities of analgesics. Some states define patients who receive opioids for more than a certain period of time as "addicts" or "drug dependent persons," despite more recent clarification from WHO that physical dependence is insufficient evidence of addiction (Joranson & Gilson, 1994).

In addition to restrictive laws and regulations, the attitudes of medical, pharmacy, and nursing boards are often negative toward the use of opioids. Sometimes investigations are mounted solely on the basis of the quantity of an opioid analgesic a practitioner prescribes, dispenses, or administers. This has had a chilling effect on the use of these medications and a negative impact on pain treatment (Joranson, Cleeland, Weissman, & Gilson, 1992).

While these barriers to effective pain management do exist, great progress has been made over the past several years to increase the appropriate medical use of opioid analgesics. This increase has not resulted in an increase in the abuse or diversion of these substances. A significant contributor to this development is the existence of state cancer pain initiatives, which, according to the Wisconsin Cancer Pain Initiative, are currently operating in 42 states. Likewise, state legislatures and regulatory bodies are adopting intractable pain acts and guidelines on the use of opioid analgesics in order to give healthcare providers a measure of assurance that appropriate medical prescriptions will not result in regulatory scrutiny or the imposition of sanctions (Joranson, 1995a, 1995b). In addition, the AHCPR cancer and acute pain guidelines provide strong medical and scientific bases for appropriate use of opioid analgesics to manage increased pain.

APS predicts that the increased use of opioid analgesics will continue. It urges INCB to work to ensure that the raw materials for these drugs are available and are produced under appropriately tight controls in those countries that can meet all the requirements of the Single Convention.

References

Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services. (1992). Acute pain management: Operative or medical procedures and trauma-Clinical practice guideline (AHCPR Publication No. 92-0032). Rockville, MD: Author.

Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services. (1994). Management of cancer pain-Clinical practice guideline, number 9 (AHCPR Publication No. 94-0592). Rockville, MD: Author.

Angarola, R.T. (1995). Controlled substances regulatory reform act? Update, PDMA, 2(3), 1-2. (Pharmaceutical Distribution and Marketing Audits, Inc., Chantilly, VA)

Cleeland, C.S., Gonin, R., Hatfield, A.K., Edmonson, J.H., Blum, R.H., Stewart, J.A., & Pandya, K.J. (1994). Pain and its treatment in outpatients with metastatic cancer. The New England Journal of Medicine, 330, 592-596.

Drug Enforcement Administration. (1990). Multiple copy prescription programs resource guide. Washington, DC: U.S. Department of Justice, Office of Diversion Control.

International Narcotics Control Board. (1989). Demand for and supply of opiates for medical and scientific needs. United Nations report of the International Narcotics Control Board for 1989. Vienna: Author.

Joranson, D.E. (1995a). Intractable pain treatment laws and regulations. APS Bulletin, 5(2), 1-3,15-17.

Joranson, D.E. (1995b). State medical board guidelines for treatment of intractable pain. APS Bulletin, 5(3), 1-5.

Joranson, D.E., Cleeland, C.S., Weissman, D.E., & Gilson, A.M. (1992). Opioids for chronic cancer and non-cancer pain: A survey of state medical board members. Federation Bulletin, 79(4), 15-49.

Joranson, D.E., & Gilson, A.M. (1994). Controlled substances, medical practice, and the law. In H.I. Schwartz (Ed.), Psychiatric practice under fire: The influence of the media and special interests on somatic therapies. Washington, DC: American Psychiatric Press.

Melzack, R. (1988). The tragedy of needless pain: A call for social action. Scientific American, 262(2), 27-33.

David Joranson is associate director for policy studies with the Pain Research Group at the University of Wisconsin Medical School in Madison, WI. Robert Angarola is a director of the U.S. Cancer Pain Relief Committee and a partner in the law firm of Hyman, Phelps & McNamara, PC, in Washington, DC.