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California Medical Board
Text of "Guideline for Prescribing Controlled
Substances for Intractable Pain"
PREAMBLE
On May 6, 1994, the Medical Board of California formally adopted a policy statement entitled "Prescribing controlled substances for pain." (Action Report, July 1994) The statement outlines the Board's proactive approach to improving appropriate prescribing for effective pain management in California, while preventing drug diversion and abuse. The policy statement is the product of a year of research, hearings and discussions. California physicians are encouraged to consult the policy statement and these guidelines.
The Medical Board recognizes that inappropriate prescribing of controlled substances including the opioids can lead to drug abuse and diversion. Inappropriate prescribing can also lead to ineffective management of pain, unnecessary suffering of patients and increased health care costs. The Board recognizes that some physicians do not treat pain properly due to lack of knowledge or concern about pain. Fear of discipline by the Board may also be an impediment to medically appropriate prescribing for pain. This Guideline is intended to encourage effective pain management in California, and help physicians reach a level of comfort about appropriate prescribing by clarifying the principles of professional practice that are endorsed by the Board.
"A HIGH PRIORITY"
The Board strongly urges physicians to view effective pain management as a high priority in all patients, including children and the elderly. Pain should be assessed and treated promptly, effectively and for as long as pain persists. The medical management of pain should be based on up-to-date knowledge about pain, pain assessment and pain treatment. Pain treatment may involve the use of several drug and non-drug treatment modalities, often in combination. For some types of pain the use of drugs is emphasized and should be pursued vigorously; for other types, the use of drugs is better de-emphasized in favor of other therapeutic modalities. Physicians should have sufficient knowledge or consultation to make such judgments for their patients.
Drugs, in particular the opioid analgesics, are considered the cornerstone of treatment for pain associated with trauma, surgery, medical procedures, and cancer. Physicians are referred to the U.S. Agency for Health Care Policy and Research Clinical Practice Guidelines which have been endorsed by the Board as a sound yet flexible approach to the management of these types of pain.
The prescribing of opioid analgesics for other patients with intractable non-cancer pain may also be beneficial,
especially when efforts to remove the cause of pain or to treat it with other modalities have been unsuccessful.
Intractable pain is defined by law in California as: "a pain state in which the cause of the pain cannot be removed or otherwise treated and which in the generally accepted course of medical practice no relief or cure of the cause of the pain is possible or none has been found after reasonable efforts including, but not limited to, evaluation by the attending physician and surgeon and one or more physicians and surgeons specializing in the treatment of the area, system, or organ of the body perceived as the source of the pain." (Section 2241.5(b) California Business and Professions Code)
Physicians who prescribe opioids for intractable pain should not fear disciplinary action from any enforcement or regulatory agency in California if they follow California law (section 2241.5 (c)), which reads, "No physician and surgeon shall be subject to disciplinary action by the board for prescribing or administering controlled substances in the course of treatment of a person for intractable pain." Also, physicians should use sound clinical judgment, and care for their patients according to the following principles of responsible professional practice:
GUIDELINES
NEW, EASY GUIDELINES ON PRESCRIBING
Adopted unanimously by the Medical Board on July 29, 1994.
"No physician and surgeon shall be subject to disciplinary action by the board for prescribing or
administering controlled substances in the course of treatment of a person for intractable pain."
-Business and Professions Code §2241.5(c)
1. HISTORY/PHYSICAL EXAMINATION
A medical history and physical examination must be accomplished. This includes an assessment of the pain, physical and psychological function, substance abuse history, assessment of underlying or coexisting diseases or conditions, and should also include the presence of a recognized medical indication for the use of a controlled substance. Prescribing controlled substances for intractable pain in California, as noted in the definition in the text of the Report, also requires evaluation by one or more specialists.
2. TREATMENT PLAN, OBJECTIVES
The treatment plan should state objectives by which treatment success can be evaluated, such as pain relief and/or improved physical and psychosocial function, and indicate if any further diagnostic evaluations or other treatments are planned. The physician should tailor drug therapy to the individual medical needs of each patient. Several treatment modalities or a rehabilitation program may be necessary if the pain has differing etiologies or is associated with physical and psychosocial impairment.
3. INFORMED CONSENT
The physician should discuss the risks and benefits of the use of controlled substances with the patient or guardian.
4. PERIODIC REVIEW
The physician should periodically review the course of opioid treatment of the patient and any new information about the etiology of the pain. Continuation or modification of opioid therapy depends on the physician's evaluation of progress toward treatment objectives. If the patient has not improved, the physician should assess the appropriateness of continued opioid treatment or trial of other modalities.
5. CONSULTATION
The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. In addition, physicians should give special attention to those pain patients who are at risk for misusing their medications including those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse requires extra care, monitoring, documentation and consultation with addiction medicine specialists, and may entail the use of agreements between the provider and the patient that specify the rules for medication use and consequences for misuse.
6. RECORDS
The physician should keep accurate and complete records according to items 1-5 above, including the medical history and physical examination, other evaluations and consultations, treatment plan objectives, informed consent, treatments, medications, agreements with the patient, and periodic reviews.
7. COMPLIANCE WITH CONTROLLED SUBSTANCES LAWS AND REGULATIONS
To prescribe controlled substances, the physician must be appropriately licensed in California, have a valid controlled substances registration and comply with federal and state regulations for issuing controlled substances prescriptions. Physicians are referred to the Physicians Manual of the U.S. Drug Enforcement Administration and the Medical Board's Guidebook to Laws Governing the Practice of Medicine by Physicians and Surgeons for specific rules governing issuance of controlled substances prescriptions.
POSTSCRIPT
Under federal and state law, it is unlawful for a physician to prescribe controlled substances to a patient for other than a legitimate medical purpose (for example, prescribing solely for the maintenance of opioid addiction), or outside of professional practice (for example, prescribing without a medical examination of the patient).
It is lawful to prescribe opioid analgesics in the course of professional practice for the treatment of intractable pain according to federal regulations and California Business and Professions Code Section 2241.5, the California Intractable Pain Treatment Act (CIPTA). However, the CIPTA does not apply to those persons being treated by the physician and surgeon for chemical dependency because of their use of drugs or controlled substances (Section 2241.5(d)), and does not authorize a physician or surgeon to prescribe or administer controlled substances to a person the practitioner knows to be using drugs or substances for nontherapeutic purposes (Section 2241.5(e)).
THE MISSION OF THE MEDICAL BOARD OF CALIFORNIA
The mission of the Medical Board of California is to protect consumers through proper licensing of physicians and surgeons and certain allied health professions and through the vigorous, objective enforcement of the Medical Practice Act.