Regulatory Issues and Effective Pain Management Thank you David for inviting the Federation to participate in today’s panel. For those of you not familiar with the Federation, we are an association of the 70 state medical licensing and disciplinary boards of United States and territories of Guam, Puerto Rico, US Virgin Islands, and the Commonwealth of the Northern Mariana Islands. Primary mission is the continual improvement in the quality, safety and integrity of health care through the development and promotion of high standards for physician licensure and practice. Variety of products and services on behalf of state medical boards – USMLE, FCVS, Physician Data Center, as well as services including policy analysis and development, research, education, and legislative monitoring and assistance. As a part of its policy development function, the Federation regularly addresses issues at the forefront affecting public health and safety. The Federation recognizes the unique challenges state medical boards encounter in fulfilling their statutory mandate to protect the public and time ensure patients have access to quality medical care. James N. Thompson, MD President and CEO

Challenge to State Medical Boards To protect the medical uses of controlled substances and simultaneously prevent drug diversion and abuse Assure public access to effective pain control Protect the public health and safety Pain management has been an area that has challenged state medical boards. Complexities of the issue – in the past decade there have been significant changes in accepted clinical practice standards surrounding the appropriate use of controlled substances in treating pain. A gap remains between what is known about the medical management of pain and the actual practices of health care providers and institututions. increasing recognition of problems of prescription drug abuse and diversion Protecting the legitimate uses of controlled substances in treating pain while preventing drug diversion and abuse. Medical boards are responsible to the public not only to protect them from unqualified, unethical, or incompetent practitioners but also for improving the overall quality of care, - - - including access to up-to-date, effective, and adequate pain treatments.

Controlled Substance Violations (Prescribing Violations) Data gathered from the Federation’s Physician Data Center (board action data bank) demonstrates the number of controlled substance prescribing violations for the period 1993 through 2002 as compared to total disciplinary actions taken against physician licenses for that same time period. It appears the total number of actions taken for controlled substance prescribing violations as compared to total disciplinary declined. In 1993, 11% of the total disciplinary actions were taken against physicians for inappropriately prescribing. Since 2000, the percentage has remained at about 7% of the total actions.

Actions by Percentage of Totals On this slide, you will see a breakdown of controlled substance prescribing violations by type of action by percentage of the total, specifically: License revocation License suspension Probation, and Miscellaneous – which may range from reprimands, fines, stipulations, and letters of concern (could include orders for remediation) There has been an overall decline in license revocations for inappropriately prescribing over the past decade.

Risk of Disciplinary Action DEA actions against doctors in FY 2003: .06% of DEA registered doctors Informal review of FSMB actions Multiple violations in addition to overprescribing Reciprocal actions Prescribing for themselves, fictitious or non-patients Failure to obtain history and physical Prescribing to known addicts w/out documentation of therapeutic reason for prescribing Sexual misconduct In a recent news release (October 30, 2003), the DEA released statistics showing that the vast number of practitioners registered with DEA comply with the requirements of the Controlled Substances Act and prescribe controlled substances in a responsible manner in treating their patients’ medical needs. This data supports the position that physician fear of regulatory scrutiny is perception and not based in fact for physicians operating within the bounds of accepted medical practice. An informal review of board actions banked by the Federation supports this position. A single physician may have multiple actions so the number of physicians disciplined for inappropriate prescribing is less than the number of actions. The total number of actions shown on the previous slides include other actions such as (1) reciprocal actions taken based on an action in another jurisdiction (2) for self-prescribing or prescribing for fictitious or individuals that are not patients (3) failing to obtain an adequate history and physical before initiating treatment or treating known addicts without a therapeutic reason for prescribing and (4) sexual misconduct, trading prescriptions for sexual favors.

Prescribing Practices Warranting Regulatory Scrutiny Failing to keep accurate records Failing to evaluate/monitor patients Prescribing to drug-dependent persons without adequate consultation/evaluation and monitoring The AMA National Steering Committee on Prescription Drug Abuse describes physicians who inappropriately prescribe in the following categories: The dishonest physician – willfully and knowingly prescribes controlled drugs for abuse and profit The disabled physician – professional competence diminished due to substance abuse or physical/mental impairments The duped physician – victim of unscrupulous patients/individuals who misuse or sell the prescriptions The dated physician – has not kept up with current pharmacology developments and drug therapies. Data supports that fear of regulatory scrutiny is virtually unwarranted; however, there are practices likely to get the attention of regulators, particularly when a pattern exists. In the vast majority of cases, discipline for prescribing violations is based upon a pattern of behaviors such as failing to keep accurate medical records, failing to properly evaluate and monitor patients, and prescribing to drug-dependent persons without adequate consultation, evaluation or monitoring.

Prescribing Practices Warranting Regulatory Scrutiny (continued) Being a “source” of drug diversion Prescribing despite warnings from pharmacists that patient receives similar prescriptions from other physicians Prescribing to self or immediate family Being a source of drug diversion – this is often evidenced by criminal indictment and/or conviction; Prescribing to patients when the physician knew or should have known the patient was receiving prescriptions from multiple sources; Self-prescribing or prescribing to fictitious or non-patients – this is also likely to result in criminal charges.

Medical Boards Respond Education Board members and staff Licensees Policy Development Guidelines Rules Joint board policies/statements In the past decade – how have medical boards responded? The Federation and individual state medical boards have provided education to licensees. Educational programs usually focus on – The nature, extent, impact and reasons for undertreatment of pain Recent advances in pain physiology Appropriate uses of controlled substances in the treatment of acute conditions in individuals with a history of substance abuse Differences between physical dependence, tolerance, addiction and pseudo addiction Pain policies and state law governing use of controlled substances.

Status of State Pain Policies/Laws This slide shows the number of states that have adopted a pain policy in the form of a guideline or statement, a law or regulation, or a combination of such, as well as those states that have no policy in place. We now see states revising policies. California has just revised their pain guidelines to expand guidelines from intractable pain to all patients with pain, better articulate the board’s expectation regarding good pain treatment and better address undertreatment. New Mexico has revised its medical practice act to specify the undertreatment of pain may be considered grounds for unprofessional conduct. Oregon has created an ombudsman position to represent the interests of dying patients; and Oregon, Colorado, and Nevada have policy affirmatively stating that failure to apply proven methods of pain control to dying patients will be considered unprofessional conduct. We are also seeing states beginning to consider the undertreatment of pain in a similar manner as over prescribing. Cases in Oregon, California, and Kansas indicate this to be the case.

Pain Management and State Regulatory Policy A project funded by the Robert Wood Johnson Foundation Purpose Develop model guidelines for use by state medical boards and other healthcare regulatory agencies to promote the appropriate prescribing of controlled substances (opioids) in the management of chronic malignant and non-malignant pain Model guidelines adopted by the Federation have been the basis for policy adopted by at least 22 states. The model guidelines were the result of a project funded by the Robert Wood Johnson Foundation in 1997.

Project Objectives Establish consistent standards for managing chronic pain based on current research data Promote a non-legislative approach to address the use of controlled substances in the management of chronic pain The project had 2 stated objectives: Establish consistent standards for a managing pain based on current research data Promote a non-legislative approach to these issues. It is the position of the Federation that a non-legislative approach is in the best interest of patients as it leaves the medical board more discretion in evaluating cases and physicians are not restricted in using their clinical and judgment skills in individualizing treatment modalities.

FSMB House of Delegates May 1998 Model Guidelines for the Use of Controlled Substances for the Treatment of Pain To date, more than half a million copies of the Federation’s model guidelines have been distributed. The policy is divided into 3 sections: Preamble, guidelines, and glossary of pertinent terms. FSMB House of Delegates May 1998

Model Guidelines Recognizes adequate pain control as a part of quality of medical practice Recognizes use of opioids may be essential in the treatment of pain States that the validity of prescribing will be judged on the physician’s treatment of the patient, rather than on the quantity and chronicity of prescribing The preamble affirmatively states the medical board’s position that patients are entitled to effective pain relief and that controlled substances (opioid analgesics) may be essential in such treatment. The preamble emphasizes that the validity of prescribing will be judged on the physician’s management of the patient, rather than on the quantity or chronicity of medications prescribed.

Model Guidelines Complete patient evaluation Written treatment plan Informed patient consent and agreement for treatment Periodic review of the course of treatment Willingness to refer Maintenance of complete and current medical record The second section contains guidelines the board will use in evaluating cases involving the prescribing of controlled substances for pain. These guidelines reflect sound medical practice, regardless of the diagnosis or treatment modality.

DEA Position “The DEA has strongly supported the Federation of State Medical Boards’ Model Guidelines for the Use of Controlled Substances in Pain Management. The DEA recognizes that these guidelines reflect currently accepted standards that may be used by both medical professionals and regulators in determining the appropriateness of opioid prescribing.” Donnie R. Marshall, Administrator Drug Enforcement Administration The Federation’s model guidelines have been endorsed by a number of organizations and agencies, including the American Pain Society, the National Association of State Controlled Substances Authorities, and the Drug Enforcement Administration.

Pain Management: A Balanced Approach Education on appropriate prescribing and dispensing, balancing the needs of patients with abuse and diversion potential of opioids Need for continued collaboration to maintain positive trend in pain management policy while curbing drug diversion State and Federal Agencies Medical and pharmaceutical communities Patient advocacy groups Achieving balance in state pain policy continues to be a challenge. A report released by the Pain and Policy Studies Group of the University of Wisconsin in September of this year, recognizes the progress made in the last decade and identifies areas for improvement. There continues to be a need for states to evaluate policy to assure there are no provisions that impede medical use of opioids. (I.e. opioids are considered tx of last resort; confusing physical dependence with addiction; restricting medical decision-making of physicians, such as mandated consultations) The report finds 14 states made positive changes between 2000 and 2003 due to their adoption of policies encouraging pain management or palliative care. 3 states adopted joint policies with the boards of medicine, nursing and pharmacy. Balancing access while curbing drug diversion necessitates collaboration among federal and state agencies, the medical and pharmaceutical communities, and patient advocacy organizations. The abuse of opioid analgesics relative to total drug abuse declined for the period 1990-1996 while their medical uses significantly increased. However, it is particularly concerning that this trend has not continued. Recent data from the Drug Abuse Warning Network (DAWN), a nationally representative sample of hospital emergency department admissions resulting from drug abuse, indicates a recent rise in abuse of opioid analgesics, with abuse of opioids accounting for about 10% of the national drug abuse problem.

FSMB Initiatives in Pain Management Education Facing Fears: Pain, Medication and End of Life Care, a presentation of the FSMB, produced by Fred Friendly Seminars Comprehensive educational program for state medical and pharmacy Revision of FSMB Model Guidelines The Federation continues its efforts to improve the quality of care being received by individuals who are suffering from chronic and acute pain. Good pain management can be inhibited by incomplete or inaccurate knowledge about pain and the use of opioid medications. Accordingly, a focus on education for providers, regulators, and the public is necessary to change attitudes and provide up-to-date clinical information. As a result of a program hosted by the Federation in April 2003, we have produced a video, Facing Fears: Pain, Medication and End of Life Care. The video will be shown during the luncheon today. It will be available, together with an accompanying study guide, through the Federation in the next few weeks. With funding expected from Purdue Pharma, the Federation will conduct a comprehensive educational program during 2004 for members and staff of health regulatory boards. As a result of a resolution adopted by the Federation’s House of Delegates last April, the Federation is in the process of revising the model guidelines to better address the undertreatment of pain.

Revisions to Model Guidelines Clarification of purpose Addressing the undertreatment of pain Emphasizing the principle of balance Updating definitions Revisions will focus on four areas: Clarification of purpose to state the guidelines are designed to assist state medical boards in addressing the inadequate management of pain and barriers that are relevant to medicine and the regulation of medical practice. The guidelines are not a new standard of care but rather are already part of law and appropriate medical practice. The revised guidelines will affirmatively state that the standard of care allows neither the overtreatment or undertreatment and that boards will consider undertreatment of pain to be a violation equal to overtreatment. We have added emphasis on the principle of balance, which is the dual obligation of governments to establish a system of controls to prevent abuse, trafficking, and diversion of controlled substances while, at the same, time ensuring their availability for legitimate medical purposes. And finally, the definitions of addiction and physical dependence have been revised to reflect current consensus and expertise of the medical community, including the American Academy of Pain Medicine, American Pain Society, and the American Society of Addiction Medicine. A draft of the revised guidelines will soon be distributed to a wide audience for comment. We expect a final draft to be considered by the Federation’s House of Delegates in April 2004.

James N. Thompson, MD President and Chief Operating Officer PO Box 619850 Dallas, TX 75261-9850 Tel: 817.868.4060  Fax: 817.868.4097 Email: jthompson@fsmb.org