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Colorado State Board of Medical Examiners
GUIDELINES FOR PRESCRIBING CONTROLLED
SUBSTANCES FOR INTRACTABLE PAIN
ADOPTED 05/16/96
COLORADO BOARD OF MEDICAL EXAMINERS
INTRODUCTION
The Colorado Board of Medical Examiners (CBME) strongly urges physicians to view effective pain management as a high priority in all patients. Minorities, women, children, the elderly, and people with HIV/AIDS are at particular risk for under treatment of their pain.
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 judgements for their patients.
The Board recognizes that inappropriate prescribing of controlled substances, including opiates, 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. Concerns about regulatory scrutiny should not make physicians who follow appropriate guidelines reluctant to prescribe or administer substances for patients with a legitimate medical need for them.
Drugs, particularly the opioid analgesics, are considered the cornerstone of treatment for pain associated with trauma, surgery, medical procedures, and cancer. Large doses may be necessary to control pain if it is severe, and extended therapy may be necessary if the pain is chronic. The CBME firmly believes that physicians have a duty to provide maximal comfort levels and alleviate suffering in their dying patients in a skillful and compassionate manner. The Board is concerned that fear on the part of physicians may result in ineffective pain control and unnecessary suffering in terminal patients. Physicians are referred to the U.S. Agency for Health Care Policy and Research Clinical Practice Guidelines, which reflect a sound yet flexible approach to the management of these types of pain.
The prescribing of opioid analgesics for patients with intractable non-cancer pain may also be beneficial. Intractable pain is defined as pain in which the cause cannot be removed or otherwise treated and no relief or cure has been found after reasonable efforts, including evaluation by one or more physicians specializing in the treatment of the area of the body perceived as the source of the pain. Physicians who prescribe opiates for intractable pain should not fear disciplinary action from any enforcement or regulatory agency in Colorado if they use sound clinical judgment and care for their patients according to the following principles of responsible professional practice.
GUIDELINES FOR PRESCRIBING CONTROLLED SUBSTANCES FOR CHRONIC NON-MALIGNANT PAIN
Guidelines do not have the legal status of laws and regulations, but guidelines can explain what activities the Medical Board considers to be within the boundaries of professional practice. Guidelines alert licensees to unprofessional practices of concern to the Board and give physicians practical information about how to avoid these problems.
1. HISTORY/PHYSICAL EXAMINATION/ASSESSMENT
A medical history and physical examination documenting the presence of a recognized medical indication for the use of a controlled substance must be performed. This includes an assessment of the pain, physical and psychological function, substance abuse history, and assessment of underlying or coexisting diseases or conditions. A statement of alternative strategies used for managing the pain and why these modalities are inappropriate or ineffective, as well as a summary of the evaluations performed by one or more specialists, should be included.
2. TREATMENT PLAN/OBJECTIVES
The treatment plan should state objectives by which treatment success can be evaluated. This may include: and ongoing assessment of the patient's functional status, including the ability to engage in work or other gainful activities; patient consumption of health care resources; positive answers to specific questions about the pain intensity and its interference with activities of daily living; quality of family life and social activities; and physical activity of the patient as observed by the physician. The plan should 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. A written consent is strongly advised when using drugs with a high dependence/tolerance potential.
4. PERIODIC REVIEW
The physician should periodically review the course of treatment of the patient and any new information about the etiology of progress toward treatment objectives. If the patient has not stabilized, the physician should assess the appropriateness of continued treatment with controlled substances.
The physician is responsible for monitoring the dosage of controlled substances to ensure that it does not escalate over time without maintenance of the patient's function. Monitoring also includes ongoing assessment of patient compliance with the controlled prescribing practice of the physician. Utilization of a single prescribing physician and a single pharmacy is advised.
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 ongoing consultation with an addiction medicine specialist.
6. RECORDS
The physician should keep accurate and complete records according to items 1-5 above. The physician should keep detailed records of each drug dosage, amount, and number of refills. Again, the use of a single prescribing physician and a single pharmacy is advised.
A written contract is recommended, which includes: contingencies for management of pain exacerbations; substance abuse; loss of prescriptions; misuse of medications; and noncompliance with treatment.
7. COMPLIANCE WITH CONTROLLED SUBSTANCES LAWS AND REGULATIONS
To prescribe controlled substances, the physician must be appropriately licensed in Colorado, have a valid controlled substances registration, and comply with federal and state regulations for issuing controlled substances prescription.
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 (i.e., prescribing opiates for the treatment of opioid addiction without a specialized license), or outside of professional practice (i.e., prescribing without a medical examination of the patient). The law does not allow the physician to prescribe or administer controlled substances to a person the physician knows to be using drugs or substances for non-therapeutic purposes.
It is lawful to prescribe opioid analgesics in the course of professional practice for the treatment of intractable pain.
8. ADDICTION VERSUS PHYSICAL DEPENDENCE
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 non-medical 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 merely because they are being treated with opiates.
CONCLUSION
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.
The Colorado Board of Medical Examiners wishes to acknowledge the work of the State Boards of California, Ohio, Oregon, Texas and Washington, upon which these guidelines are based.