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David E. Joranson
In this issue of the journal, Dr. C. Stratton Hill discusses the negative influences of regulatory boards and state laws on the use of opioids to manage pain. Concern about regulatory barriers to appropriate prescribing has recently been discussed by others as well. 1-5 There is considerable evidence to support Dr. Hill's assertions:
- Individual cases of discipline for legitimate prescribing of opioid analgesics for chronic cancer and non-cancer pain have been reported,6-8 but systematic reporting and study of such cases is lacking.
- A review of controlled substances laws and regulations confirms that federal law specifically recognizes the use of opioids in intractable pain. But state laws, while implicitly allowing the practice, do not give it explicit recognition. Unfortunately, some states' legal definitions confuse addiction with physical dependence and restrict the number of dosage units that may be prescribed. Some states require special government-issue prescription forms.6,9
- A survey of state medical licensing and disciplinary board members showed that only three-fourths were confident that prescribing opioids for an extended period for cancer pain was both legal and acceptable medical practice. If opioids were prescribed for more than several months to a person with chronic non-malignant pain, only 12% thought the practice was both legal and acceptable, half would discourage it and approximately one- third would have it investigated as a probable violation of law. If a history of drug abuse was also present, the perception that the practice was illegal was even greater. Most board members recognized the extent to which people with cancer are likely to suffer pain, but underestimated the degree to which cancer patients are under medicated, and overestimated the incidence of addiction. Overall, board members were interested in pain management issues.10
- A recent survey of Wisconsin physicians found that although concerns about regulatory scrutiny ranked low compared to concerns about addiction, more than half of the respondents indicated that due to concerns about regulatory scrutiny, they either reduce drug dose or prescription quantity, reduce the number of refills, or choose a less potent drug in a lower schedule because of concerns about regulatory scrutiny.11
- Surveys in Texas showed that the new triplicate prescription regulation discouraged the prescribing of Schedule II opioids and encouraged the substitution of non-Schedule II opioids,12 and that physicians reported that triplicate prescriptions hampered appropriate prescribing for terminally ill patients with chronic pain.13
- A nationwide study of physicians in oncology practice showed that "reluctance to prescribe" opioids and concern about "excessive regulations" was perceived as a barrier to cancer pain management, and that these concems were greater among physicians in states with triplicate prescription programs.14
Once identified, regulatory-related impediments should be corrected so as to ultimately achieve a situation where there is no undue interference in the medical and pharmacy practices necessary to manage pain. Dr. Hill has offered a number of important recommendations toward this end. However, no good purpose will be served if impediments are identified and then only become a source of contention between practitioners and regulators. In this regard, there are hopeful signs of progress. Dr. Hill points out that Wisconsin has clarified its amphetamine regulations to allow their use in treating opioid- induced sedation. Wisconsin has also repealed the rule that limited controlled substances dispensing to 120 dosage units. Several state medical boards are taking positive steps to study and clarify the appropriate prescribing of opioids for pain, including Minnesota and Massachusetts.15,16 The efforts by Dr. Hill and others resulted in Texas' adoption of the Intractable Pain Treatment Act, the law that served as the model for California's statute. Furthermore, pain management authorities have begun to participate in the programs of regulatory groups, and vice versa, in order to improve communication and mutual understanding. The Position Paper of the Utah Division of Occupational and Professional Licensing also published in this issue of the journal 17 is a particularly noteworthy example of sensitivity to medical practice issues on the part of a state regulatory agency.
It must also be recognized that diversion of prescription controlled substances can indeed be a problem, which if left unchecked can harm efforts to manage pain by precipitating stricter drug regulations. In the current atmosphere of intense negative feelings about drugs, it may be difficult but it is all the more important to critically examine the nature and magnitude of diversion problems before proceeding with new legislative or regulatory interventions. Depending upon the type of problems found, e.g., "script doctors," forgers, pharmacy theft or "doctor shoppers," interventions should be designed to address the individual sources, or vectors, that are responsible for diversion. Interagency cooperation is essential in order to make use of available information about diversion and to pool investigative resources. Great care should be taken to avoid interventions that interfere with legitimate medical practice. At least one state has acknowledged the possibility that diversion control efforts may have hampered medical practice with controlled substances and has taken steps to correct the situation.18 The Virginia Department of Health Professions recently conducted a study of diversion and reported that the problem was not growing and did not place the public at substantial risk. The Department cautioned against interventions that produce an undesirable chilling effect on the appropriate prescription of beneficial drugs and recommended continuation, expansion and better coordination of the state's existing interagency diversion program.19
The current federal interest in limiting abuse and improving use of prescription controlled substances must also be noted. Congressman Fortney H. (Pete) Stark (D-CA) is pursuing anti-diversion legislation that would urge states with triplicate programs to switch to electronic monitoring and to cover controlled substances prescriptions in Schedules II-IV, in return for financial assistance, albeit of uncertain duration (Prescription Accountability and Patient Care Improvement Act of 1992 20. Not just an electronic data transfer (EDT) program, the proposal would require a new state bureaucracy to oversee the confidential prescription information data base, to produce exception reports based on "practice parameters" or limits that would be established by a state agency, and to refer these "exceptions" to any of a variety of state or federal agencies for investigation. The possibility of replacing triplicate with a less intrusive monitoring system is appealing. However, the use of "practice parameters" to determine illegal prescribing is inappropriate. How could such a system avoid mistaking "addiction" for the use of opioids to treat chronic cancer pain? Great effort has been directed at diversion in the last 10 years. Whether there is a need for a new national anti-diversion program should be based upon an evaluation of the nature and magnitude of the problem and careful study of the electronic systems that have recently been implemented in Oklahoma and Massachusetts.21
In March, 1992, the federal Agency for Health Care Policy and Research (AHCPR, an agency of the United States Public Health Service) released a clinical practice guideline for acute pain which clearly outlines the appropriate use of opioid analgesics.22 Principles and guidelines for opioid management of cancer pain have been available for a number of years.23-25 Release of a cancer pain guideline by the AHCPR is anticipated in early 1993. There is a vital need to finally bring this knowledge into the mainstream of professional education, practice and practice regulation. The guidelines produced by the Agency's panel of experts will provide visible, authoritative and timely guidance on the appropriate role and use of opioids in pain management to practitioners and regulators alike.
Commentaries
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