Pain Drug Use Policy
Many state medical boards have based their pain drug policies on—or adopted outright—the model policy developed by the Federation of State Medical Boards (FSMB) and last updated in May 2004. The purpose of updating the model policy was done to assure currency and adequate attention to the undertreatment of pain. The FSMB has been promoting adoption of this latest model policy by sponsoring workshops around the country (visit www.FSMB.com for further information). Given the evolving nature of pain management, it is recommended that each doctor be informed of the applicable state medical board policy and whether it has been updated to be compatible with the current FSMB model policy.
The latest model drug use policy describes guidelines under the following basic headings:1
- Evaluation of the Patient
- Treatment Plan
- Informed Consent and Agreement for Treatment
- Periodic Patient Evaluation
- Medical Records
- Compliance with Controlled Substances Laws and Regulations
While diligence in adhering to these guidelines will serve the doctor well in conforming to existing law, therapeutic blood serum drug levels (currently being compiled by Dr. Forest Tennant, MD, Dr.PH, Editor in Chief of this journal) are still a point of contention in the medical and enforcement community. Results of this ongoing study of chronic pain patients will be documented and disseminated by the end of this year to help establish reference blood ranges of therapeutic drugs for normal functioning. Until authoritative blood serum ranges are established, the typically high quantity of drugs prescribed for such patients continues to be a red flag for DEA investigation of possible drug diversion.
Model Policy for the Use of Controlled Substances for the Treatment of Pain
Reprinted with permission of Federation of State Medical Boards of the United States, Inc., www.fsmb.org. The recommendations contained herein were adopted as policy by the House of Delegates of the Federation of State Medical Boards of the United States, Inc., May 2004.
The Federation of State Medical Boards (the Federation) is committed to assisting state medical boards in protecting the public and improving the quality and integrity of health care in the United States. In 1997, the Federation undertook an initiative to develop model guidelines and to encourage state medical boards and other health care regulatory agencies to adopt policy encouraging adequate treatment, including use of opioids when appropriate for patients with pain. The Federation thanks the Robert Wood Johnson Foundation for awarding a grant in support of the original project, and the American Academy of Pain Medicine, the American Pain Society, the American Society of Law, Medicine, & Ethics, and the University of Wisconsin Pain & Policy Studies Group for their contributions.
Since adoption in April 1998, the Model Guidelines for the Use of Controlled Substances for the Treatment of Pain have been widely distributed to state medical boards, medical professional organizations, other health care regulatory boards, patient advocacy groups, pharmaceutical companies, state and federal regulatory agencies, and practicing physicians and other health care providers. The Model Guidelines have been endorsed by the American Academy of Pain Medicine, the Drug Enforcement Administration, the American Pain Society, and the National Association of State Controlled Substances Authorities. Many states have adopted pain policy using all or part of the Model Guidelines.1 Despite increasing concern in recent years regarding the abuse and diversion of controlled substances, pain policies have improved due to the efforts of medical, pharmacy, and nursing regulatory boards committed to improving the quality of and access to appropriate pain care.
Notwithstanding progress to date in establishing state pain policies recognizing the legitimate uses of opioid analgesics, there is a significant body of evidence suggesting that both acute and chronic pain continue to be undertreated. Many terminally ill patients unnecessarily experience moderate to severe pain in the last weeks of life.2 The undertreatment of pain is recognized as a serious public health problem that results in a decrease in patients’ functional status and quality of life and may be attributed to a myriad of social, economic, political, legal and educational factors, including inconsistencies and restrictions in state pain policies.3 Circumstances that contribute to the prevalence of undertreated pain include: (1) lack of knowledge of medical standards, current research, and clinical guidelines for appropriate pain treatment; (2) the perception that prescribing adequate amounts of controlled substances will result in unnecessary scrutiny by regulatory authorities; (3) misunderstanding of addiction and dependence; and (4) lack of understanding of regulatory policies and processes. Adding to this problem is the reality that the successful implementation of state medical board pain policy varies among jurisdictions.
In April 2003, the Federation membership called for an update to its Model Guidelines to assure currency and adequate attention to the undertreatment of pain. The goal of the revised model policy is to provide state medical boards with an updated template regarding the appropriate management of pain in compliance with applicable state and federal laws and regulations. The revised policy notes that the state medical board will consider inappropriate treatment, including the undertreatment of pain, a departure from an acceptable standard of practice. The title of the policy has been changed from Model Guidelines to Model Policy to better reflect the practical use of the document.
The Model Policy is designed to communicate certain messages to licensees: that the state medical board views pain management to be important and integral to the practice of medicine; that opioid analgesics may be necessary for the relief of pain; that the use of opioids for other than legitimate medical purposes poses a threat to the individual and society; that physicians have a responsibility to minimize the potential for the abuse and diversion of controlled substances; and that physicians will not be sanctioned solely for prescribing opioid analgesics for legitimate medical purposes. This policy is not meant to constrain or dictate medical decision-making.
Through this initiative, the Federation aims to achieve more consistent policy in promotion of adequate pain management and education of the medical community about treating pain within the bounds of professional practice and without fear of regulatory scrutiny. In promulgating this Model Policy, the Federation strives to encourage the legitimate medical uses of controlled substances for the treatment of pain while stressing the need to safeguard against abuse and diversion.