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American Pain Society
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Glenview, IL 60025
Corey D. Fox, PhD, Department Editor
APS Analgesic Regulatory Affairs Committee, with an introduction by Aaron Gilson, PhD
As the Decade of Pain Control and Research enters its fourth year, we have had ample opportunity to recognize both the multifaceted nature of pain management and the factors that impede patients’ access to effective pain relief. Inadequate pain treatment results from the beliefs and attitudes of patients, family members, and healthcare professionals and the healthcare system itself. Drug regulatory policy is another barrier to adequate pain treatment.
Although there are many pharmacologic and nonpharmacologic approaches to pain treatment, opioid analgesics are considered essential drugs by the World Health Organization (WHO) and are indispensable for the relief of pain. Because opioids pose abuse potential, their prescribing and dispensing is governed by federal and state statutes and regulations. As a result, there is a public policy link between drug abuse prevention and diversion efforts and efforts to improve pain relief.
International and national authorities have called attention to the inadequate treatment of pain. They conclude that laws and regulations impeding the availability and medical use of opioids are at least partially to blame. In fact, the United Nations, the WHO, the Institute of Medicine, and the American Cancer Society have acknowledged policy language as an impediment to appropriate use of opioids for pain relief.
To enhance awareness of the issue, the APS Analgesic Regulatory Affairs Committee has created a resource list for APS members entitled, “Policy-Related Resources for Pain Management.” The list includes publications and Web sites that address policy and regulatory issues affecting pain management and end-of-life care. The compilation of these documents signifies increased cooperation among regulators, health professionals, professional licensing boards (including medical, nursing, and pharmacy boards), and healthcare practitioners from various disciplines. Professional collaboration is also being recognized in healthcare regulatory board policies, which are beginning to encourage a multidisciplinary approach to pain management and end-of-life care.
The resource list features references to recent policy statements developed by national healthcare, regulatory, and law enforcement organizations including APS, the American Academy of Pain Medicine, the American Society of Addiction Medicine, Last Acts, the Federation of State Medical Boards, and the U.S. Drug Enforcement Administration. These policies were created to encourage effective pain management by addressing healthcare professionals’ concerns about opioid analgesics. Each policy was developed by an interdisciplinary group of experts who could provide accurate information about current issues and clinical practices.
A number of resources detail the status of pain-related policy, legal and regulatory issues, and end-of-life care initiatives. These references will be of particular interest to APS members, as they include information about current state legislative and regulatory activity and the establishment of legislative end-of-life care commissions and task forces.
The reference list also includes documents from the University of Wisconsin-Madison’s Pain & Policy Studies Group (PPSG); the documents include the results of a systematic evaluation of federal and state policies that regulate medical and pharmacy practice and the prescribing and dispensing of controlled substances. These policies have the potential to influence pain management. The policy analyses were guided by evaluation criteria derived from the international principle of Balance, which is found in drug control policy. This principle asserts that governments have an obligation to address drug abuse while ensuring the availability of opioid analgesics for medical purposes.
Ultimately, efforts to prevent drug abuse and diversion must not interfere with adequate availability of opioid analgesics for pain relief. Each PPSG reference presents a conceptual framework for understanding existing policies’ potential to either enhance or impede pain management. The purpose of these documents is to promote more balanced and consistent pain policy in the United States by increasing knowledge about existing federal and state policy and, ultimately, to align government policy with medical and scientific standards.
The American Society of Law, Medicine & Ethics Web site (titled Pain & the Law) focuses on pain management and palliative care legal and regulatory issues. Federal- and state-controlled substances and prescribing policies are featured, as well as selected state policies and the model Pain Relief Act. The Web site also offers explanations about malpractice liability, civil claims, and criminal prosecutions involving the use of controlled substances for pain management and palliative care (see www.painandthelaw.org).
The PPSG Web site provides access to pain relief and public policy information, including material published by the PPSG and other authoritative sources. Domestic and international policy issues are featured. The Web site also offers a table from which to download the full text of all state pain and end-of-life policies and model pain policies developed by national organizations (see www.medsch.wisc.edu/painpolicy/matrix.htm).
Although the Decade of Pain Control & Research was legislated to promote the development of a pain research agenda through 2010, pain management and end-of-life care must remain prominent in the healthcare forum after the congressional mandate has expired. Fundamental to this effort is enhanced awareness of clinical and regulatory developments related to pain management practices; increased communication among regulators, practitioners, and the general public; and continued communication with practitioners and patients regarding their state’s pain policy and positive policy change.
Ongoing attention to these issues will continue to effectively identify and remove barriers posed by state government policies. In an environment of increased media attention surrounding the misuse of pain medications, policy designed to minimize drug abuse and diversion must not interfere with the availability of these drugs for pain management. We must achieve and preserve balanced pain policies in our efforts to improve care for patients with pain.
2001 Annual Review of State Pain Policies: A Question of Balance
Joranson, D.E., Maurer, M.A., Gilson, A.M., Ryan, K.M. Pain & Policy Studies Group, University of Wisconsin Comprehensive Cancer Center. Madison, Wisconsin (February 2002)
Available at
www.medsch.wisc.edu/
painpolicy/publicat/01annrev
Achieving Balance in Federal and State Pain Policy: A Guide to Evaluation
Joranson, D.E., Gilson, A.M., Ryan, K.M., Maurer, M.A., Nischik, J.A., Nelson, J.M. The Pain & Policy Studies Group, University of Wisconsin Comprehensive Care Center. Madison, Wisconsin (July 2000)
Available at
www.medsch.wisc.edu/
painpolicy/eguide2000/index.html
Annual Review of State Pain Policies, 2000
Joranson, D.E., Maurer, M.A., Gilson, A.M., Ryan, K.M., Nischik, J.A. Pain & Policy Studies Group, University of Wisconsin Comprehensive Cancer Center. Madison, Wisconsin (February 2001)
Available at
www.medsch.wisc.edu/
painpolicy/publicat/01ppsgar/contents.htm
Definitions Related to the Use of Opioids for the Treatment of Pain
A consensus statement from the American Academy of Pain Medicine, the American Pain Society, and the American Society of Addiction Medicine (2001)
Available at
www.asam.org/Frames.htm
Issue Brief: End-of Life Issues
Health Policy Tracking Service, National Conference of State Legislatures (1999)
Available at
www.hpts.org
Model Guidelines for the Use of Controlled Substances for the Treatment of Pain (May 1998)
Federation of State Medical Boards of the United States, Inc.
Available at
www.medsch.wisc.edu/
painpolicy/domestic/model.htm
or www.fsmb.org
Physician’s Manual: An Informational Outline of the Controlled Substances Act of 1970
Drug Enforcement Administration. Washington D.C., U.S. Department of Justice (March 1990)
Note: The Physician’s Manual is currently under revision. The Pharmacist’s Manual is now available at
www.deadiversion.usdoj.gov/
pubs/manuals/pharm2/index.htm
Position of the Federation of State Medical Boards in Support of Adoption of Pain Management Guidelines (February 2000)
Federation of State Medical Boards of the United States, Inc.
Available at
www.medsch.wisc.edu/
painpolicy/domestic/FSMBwp.htm
Promoting Pain Relief and Preventing Abuse of Pain Medications: A Critical Balancing Act
Last Acts, Drug Enforcement Administration, Pain & Policy Studies Group, et al. A joint statement from 21 health organizations and the Drug Enforcement Administration (October 2001)
Available at
www.deadiversion.usdoj.gov/
pubs/pressrel/consensus.pdf
or www.medsch.wisc.edu/
painpolicy/dea01.htm
Protection for Physicians Who Prescribe Pain Medication
Available from the American Medical Association House of Delegates (1997)
Resource Guide: Information About Regulatory Issues in Pain Management
Pain & Policy Studies Group, University of Wisconsin Comprehensive Cancer Center. Madison, Wisconsin (1998)
Available at
www.medsch.wisc.edu/
painpolicy/domestic/resource.htm
State Initiatives in End-of-Life Care
Community-State Partnerships to Improve End-of-Life Care. Advances in state pain policy and medical practice (1999, 4:1-8)
State Initiatives in End-of-Life Care
Community-State Partnerships to Improve End-of-Life Care. How end-of-life care can be a positive issue for policy leaders (2001, 9:1-6)
The Use of Opioids for the Treatment of Chronic Pain: A Consensus Statement
American Academy of Pain Medicine, American Pain Society (1997)
Available at
www.painmed.org/
productlibrary/statements/opioidstmt.html
American Society of Law, Medicine, & Ethics, Center for Health Law Studies, St. Louis University
www.painandthelaw.org
Pain & Policy Studies Group, Comprehensive Cancer Center, University of Wisconsin-Madison
www.medsch.wisc.edu/painpolicy
Aaron Gilson is assistant director of the Pain and Policy Studies Group/WHO Collaborating Center at the University of Wisconsin in Madison.
