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A STATEMENT BY THE MEDICAL BOARD OF CALIFORNIA:

PRESCRIBING CONTROLLED SUBSTANCES FOR PAIN

On May 6 the Medical Board formally adopted the following statement on "Prescribing For Pain Management."

It is the first formal statement of its kind in the nation made by a licensing board.

This statement was adopted after a year of testimony at hearings held by the Board's Task Force on Appropriate Prescribing and a day-long "Summit," sponsored by Governor Wilson, involving scores of experts from around the country.

At the Board's July 28-29 meeting the members will consider formal adoption of a set of guidelines based on this policy statement. The guidelines. once adopted, will be published in the October Action Report and other publications read by physicians.

Introduction

The 1993 report of the Medical Board to the Governor signalled a new beginning in the history of medical regulation in California. An important part of this initiative is implementation of the recommendations made by the Board's Task Force on Appropriate Prescribing, chaired by Jacquelin Trestrail, M.D.

The Task Force was established to look into "malprescribing," one of the fastest growing categories of physician discipline. The Board continues to be concerned that controlled substances are subject to abuse by individuals who seek them for their mood altering and other psychological effects, rather than for legitimate medical purposes.

The Board is also concerned about effective pain management and the appropriate medical use of controlled substances. During the Task Force's public meetings, the members heard testimony that some physicians avoid prescribing controlled substances, including the "triplicate" drugs, for patients with intractable pain for fear of discipline by the Board. The Task Force recommended that the Board take a pro-active approach to emphasize to all California physicians that it supports prescribing of opioid analgesics (narcotics) and other controlled substances when medically indicated for the treatment of pain, including intractable pain. After careful review of this matter, the Board concurs with the following statement.

This statement is consistent with good medical practice, protection of public health and consumer interests, with international treaties, federal and California law, including the California Intractable Pain Treatment Act.

THE PAIN PROBLEM

The Board recognizes that pain, whether due to trauma, surgery, cancer and other diseases, is often undertreated. Minorities, women, children, the elderly and people with HIV/AIDS are at particular risk for under treatment of their pain. Unrelieved pain has a harsh and sometimes disastrous impact on the quality of life of people and their families.

While some progress is being made to improve pain and symptom management, the Board is concerned that a number of factors continue to interfere with effective pain management These include the low priority of pain management in our health care system, incomplete integration of current knowledge into medical education and clinical practice, lack of knowledge among consumers about pain management, exaggerated fears of opioid side effects and addiction, and fear of legal consequences when controlled substances are used.

PAIN MANAGEMENT SHOULD BE A HIGH PRIORITY IN CALIFORNIA

Principles of quality medical practice dictate that citizens of California who suffer from pain should be able to obtain the relief that is currently available. The Board believes that the appropriate application of current knowledge and treatments would greatly improve the quality of life for many California citizens, and could also reduce the morbidity and the costs that are associated with uncontrolled pain.

In addition to making this statement, the Board will take a number of steps to help make effective pain management a reality in California. The Board has provided information to all state physicians about new clinical practice guidelines for pain management that have been prepared by a panel of experts supported by the Agency for Health Care Policy and Research. The Board also co-sponsored and participated in the March 18, 1994 Pain Management and Appropriate Prescribing Summit in conjunction with the Department of Consumer Affairs on removing impediments to appropriate prescribing of controlled substances for effective pain management. Further, the Board will develop guidelines to help physicians avoid investigation if they appropriately prescribe controlled substances for pain management.

THE APPROPRIATE ROLE OF OPIOID ANALGESICS

There are numerous drug and non-drug treatments that are used for the management of pain and other symptoms. The proper treatment of any patient's pain depends upon a careful diagnosis of the etiology of the pain, selection of appropriate and cost effective treatments, and ongoing evaluation of the results of treatment. Opioid analgesics and other controlled substances arc useful for the treatment of pain, and are considered the cornerstone of treatment of acute pain due to trauma, surgery and chronic pain due to progressive diseases such as cancer. Large doses may be necessary to control pain if it is severe. Extended therapy may be necessary if the pain is chronic.

The Board recognizes that opioid analgesics can also be useful in the treatment of patients with intractable non-malignant pain especially where efforts to remove the cause of pain or to treat it with other modalities have failed. The pain of such patients may have a number of different etiologies and may require several treatment modalities. In addition, the extent to which pain is associated with physical and psychosocial impairment varies greatly. Therefore, the selection of a patient for a trial of opioid therapy should be based upon a careful assessment of the pain as well as the disability experienced by the patient Continuation of opioid therapy should be based on the physician's evaluation of the results of treatment, including the degree of pain relief, changes in physical and psychological functioning, and appropriate utilization of health care resources. Physicians should not hesitate to obtain consultation from legitimate practitioners who specialize in pain management.

The Board recommends that physicians pay particular attention to those patients who misuse their prescriptions, particularly when the patient or family have a history of substance abuse that could complicate pain management The management of pain in such patients requires extra care and monitoring, as well as consultation with medical specialists whose area of expertise is substance abuse or pain management

The Board believes that addiction should be placed into proper perspective. Physical dependence and tolerance are normal physiologic consequences of extended opioid therapy and are not the same as addiction. Addiction is a behavioral syndrome characterized by psychological dependence and aberrant drug related behaviors. Addicts compulsively use drugs for nonmedical purposes despite harmful effects-, a person who is addicted may also be physically dependent or tolerant. Patients with chronic pain should not be considered addicts or habitues merely because they are being treated with opioids.

PAIN MANAGEMENT, CONTROLLED SUBSTANCES AND THE LAW

The laws and regulations of the federal government and the State of California impose special requirements for the prescribing of controlled substances, including requirements as to the form of the prescription document, so as to prevent harm to the public health that is caused when prescription drugs are diverted to non-medical uses. For example, it is illegal to prescribe controlled substances solely to maintain narcotic addiction. However, federal and California law clearly recognize that it is a legitimate medical practice for physicians to prescribe controlled substances for the treatment of pain, including intractable pain.

The Medical Board will work with the Drug Enforcement Administration, the Bureau of Narcotic Enforcement, the Office of the Attorney General, the Board of Pharmacy and its own investigators in an attempt to develop policy and guidelines based on the physician's diagnosis and treatment program rather than amounts of drugs prescribed.

Concerns about regulatory scrutiny should not make physicians who follow appropriate guidelines reluctant to prescribe or administer controlled substances, including Schedule 11 drugs, for patients with a legitimate medical need for them. A physician is not subject to Board action when prescribing in the regular course of his or her profession to one under the physician's treatment for a pathology or condition and where the prescription is issued after a good faith examination and where there is medical indication for the drug. Good faith prescribing requires an equally good faith history, physical examination and documentation.

The Medical Board may identify a pattern of controlled substance use that merits further examination. A private, courteous and professional inquiry can usually determine whether the physician is in good faith appropriately prescribing for patients, or whether an investigation is necessary. The Board will judge the validity of prescribing based on the physician's diagnosis and treatment of the patient and whether the drugs prescribed by the physician are appropriate for that condition, and will not act on the basis of predetermined numerical limits on dosages or length of drug therapy.

The Board hopes to replace practitioners' perception of inappropriate regulatory scrutiny with recognition of the Board's commitment to enhance the quality of life of patients by improving pain management while, at the same time, preventing the diversion and abuse of controlled substances.


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