Pennsylvania State Board of Medicine
Source: State Board of Medicine bulletin, Winter 1998/99, pp. 4-5
Effective date: October 20, 1998

Section I: Preamble

The Pennsylvania State Board of Medicine recognizes that principles of quality medical practice dictate that the citizens of the Commonwealth have access to appropriate and effective pain relief. The appropriate application of up-to-date knowledge and treatment modalities can serve to improve the quality of life for those patients who suffer from pain as well as to reduce the morbidity and costs associated with untreated or inappropriately treated pain. The board encourages physicians to view effective pain management as a part of quality medical practice for all patients with pain, acute or chronic, and it is especially important for patients who experience pain as a result of terminal illness. All physicians should become knowledgeable about effective methods of pain treatment as well as legal requirements for prescribing controlled substances.

Inadequate pain control may result from physicians’ lack of knowledge about pain management or an inadequate understanding of addiction. Fears of investigation or sanction by federal, state and local regulatory agencies may also result in an inappropriate or inadequate treatment of chronic pain patients. Accordingly, these guidelines have been developed to clarify the board’s position on pain control, specifically as related to the use of controlled substances, to alleviate physician uncertainty and to encourage better pain management. The board has found that these guidelines are consistent with the board’s regulations pertaining to prescribing, administering and dispensing controlled substances located at 49 Pa. Code §16.92.

The board recognizes that controlled substances, including opioid analgesics, are essential in the treatment of acute pain due to trauma, surgery and chronic pain due to cancer and other progressive diseases. Physicians are referred to the U.S. Agency for Health Care Policy and Research Clinical Practice Guidelines for a sound approach to the management of acute and cancer-related pain.

The medical management of pain should be based upon current knowledge and research and includes the use of both pharmaceutical and non-pharmaceutical modalities. Pain should be assessed and treated promptly and the quantity and frequency of doses should be adjusted according to the intensity and duration of the pain. Physicians should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not synonymous with addiction.

The State Board of Medicine is obligated under the law to protect the public health and safety. The board recognizes that inappropriate prescribing of controlled substances, including opioid analgesics, may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use. Physicians should be diligent in preventing the diversion of drugs for illegitimate and non-medical uses.

Physicians should not fear disciplinary action from the board or other state regulatory or enforcement agency for prescribing, dispensing or administering controlled substances, including opioid analgesics, for a legitimate medical purpose and in the usual course of professional practice. The board will consider prescribing, ordering, administering or dispensing controlled substances for pain to be for a legitimate medical purpose if based on accepted scientific knowledge of the treatment of pain and in compliance of applicable state or federal law.

The board will judge the validity of prescribing based on the physician’s treatment of the patient and on available documentation, rather than on the quantity and chronicity of prescribing. The goal is to treat the patient’s pain for its duration while effectively addressing other aspects of the patient’s functioning, including physical, physiological, social and work-related factors. The following guidelines are not intended to define complete or best practice, but rather to communicate what the board considers to be within the boundaries of professional practice.

Section II: Guidelines

The board has found that the following guidelines indicate acceptable standards of practice when evaluating the use of controlled substances for pain control:

1. Evaluation of the Patient

A complete medical history and physical examination must be conducted and documented in the medical report. The medical record should document the nature and intensity of the pain, evaluate underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record should also document the presence of one or more recognized medical indications for the use of a controlled substance.

2. Treatment Plan

The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

3. Informed Consent and Agreement for Treatment

The physician should discuss the risks and benefits of the use of controlled substances with the patient, significant other(s) or guardian. The patient should receive prescriptions from one physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician may employ the use of a written agreement between physician and patient outlining patient responsibilities including (1) urine/serum medication levels screening when requested (2) number and frequency of all prescription refills and (3) reasons for which drug therapy may be discontinued (i.e., violation of agremeent).

4. Periodic Review

At reasonable intervals based upon the individual circumstance of the patient, the physician should review the course of opioid treatment and any new information about the etiology of the pain. Continuation or modification of opioid therapy should depend on the physician’s evaluation of progress toward stated treatment objectives such as improvement in patient’s pain intensity and improved physical and/or psychosocial function, such as ability to work, need of health care resources, activities of daily living and quality of social life. If reasonable treatment goals are not being achieved despite medication adjustments, the physician should monitor patient compliance in medication usage and related treatment plans.

5. Consultation

The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those pain patients who are at risk for misusing their medications and those whose living arrangement poses a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder require extra care, monitoring, documentation and consultation with a referral to an expert in the management of such patients.

6. Medical Records

The physician should keep accurate and complete records to include (1) the medical history and physical examination; (2) diagnostic, therapeutic and laboratory results; (3) evaluations and consultations; (4) treatment objectives; (5) discussion of risks and benefits; (6) treatments; (7) medications (including date, type, dosage and quantity prescribed); (8) instructions and agreements; and (9) periodic reviews. Records should remain current and be maintained in an accessible manner and readily available for review.

7. Compliance with Controlled Substances Laws and Regulations

To prescribe controlled substances, the physician must be licensed in the state, 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 regulations of the board for specific rules governing issuance of controlled substances prescriptions as well as applicable state regulations.