Department of Professional & Financial Regulation

Board of Licensure in Medicine, a joint chapter with the Board of Osteopathic Medicine 

Chapter 11: Use of Controlled Substances for Treatment of Pain 

Preamble: The Boards recognize that principles of quality medical practice dictate that the people of the State of Maine have access to appropriate and effective pain relief. 

The Boards acknowledge that controlled substances, including opioid analgesics, may be essential in the treatment of acute pain due to trauma or surgery, and chronic pain, whether due to cancer or non-cancer origins. Fears of investigation by federal, state and local regulatory agencies should not preclude appropriate and adequate treatment of chronic pain patients. However, the Boards recognize 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. 

The Boards encourage physicians to view effective pain management as a part of quality medical practice for all patients with pain, acute or chronic, and as especially important for patients who experience pain as a result of a terminal illness. All physicians should become knowledgeable about effective methods of pain treatment as well as statutory requirements for prescribing controlled substances. 

Accordingly, the Boards adopt these rules to clarify their positions on pain control and prescribing, specifically related to the use of controlled substances, to alleviate physician uncertainty and to encourage better pain management. 

§ 1. Definitions: As used by the Boards when evaluating practice and prescribing issues.

A.           “Acute Pain” is the normal, predicted physiological response to an adverse chemical, thermal, or mechanical stimulus and is associated with surgery, trauma and acute illness. It is generally time limited and is responsive to controlled substances therapy, among other therapies. 

B.           “Addiction” is a neurobehavioral syndrome with genetic and environmental influences that results in psychological dependence on the use of substances for their psychic effects and is characterized by compulsive use despite harm. Addiction may also be referred to by terms such as “drug dependence” and “psychological dependence.” Physical dependence and tolerance are normal physiological consequences of extended opioid therapy for pain and should not be considered addiction.

 C.            “Analgesic Tolerance” is the need to increase the dose of controlled substances to achieve the same level of analgesia. Analgesic tolerance may or may not be evident during opioid treatment and does not equate with addiction.

 D.            “Chronic Pain” is a pain state which is persistent and in which the cause of the pain cannot be removed or otherwise treated. Chronic pain may be associated with a long-term incurable or intractable medical condition or disease.

 E.            “Pain” is an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.

 F.            “Physical Dependence” on a controlled substance is a physiologic state of neuroadaptation which is characterized by the emergence of a withdrawal syndrome if drug use is stopped or decreased abruptly, or an antagonist is administered. Physical dependence is an expected result of opioid use. Physical dependence, by itself, does not equate with addiction.

 G.            “Pseudoaddiction” is a pattern of drug-seeking behavior of pain patients who are receiving inadequate pain management that can be mistaken for addiction.

 H.            “Substance Abuse” is the use of any controlled substance(s) for non-therapeutic purposes; or use of medication for purposes other than those for which it is prescribed.

 I.            “Tolerance” is a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce the same effect or a reduced effect is observed with a constant dose.

§ 2.            Principles of Proper Patient Management: Each of these principles is essential in the treatment of patients with pain.

 A.            Evaluation of the Patient: Evaluation should initially include a pain history and assessment of the impact of pain on the patient, a directed physical examination, a review of previous diagnostic studies, a review of previous interventions, a drug history, and an assessment of coexisting diseases or conditions.

 B.            Treatment Plan: Treatment planning should be tailored to both the individual and the presenting problem. Consideration should be given to different treatment modalities, such as a formal pain rehabilitation program, the use of behavioral strategies, the use of non-invasive techniques, or the use of medications, depending upon the physical and psychosocial impairment related to the pain. If a trial of controlled substances is selected, the physician should ensure that the patient or the patient’s legally authorized representative is informed of the risks and benefits of controlled substance use and the conditions under which controlled substances will be prescribed. Some practitioners find a written agreement specifying these conditions to be useful. A controlled substances trial should not be done in the absence of a complete assessment of the pain complaint.

 If the evaluation cannot be completed at the initial visit, controlled substances should only be prescribed in limited quantities, until completion of the evaluation, using the best judgment of the prescribing practitioner based on the information available.

 In the instance of chronic end of life pain, please see Section 3.

 C.            Informed Consent and Agreement for Treatment: The physician should discuss treatment with the patient, persons designated by the patient, or with the patient’s legally authorized representative if the patient is incompetent. 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 has a history of substance abuse, the physician may employ the use of a written agreement between physician and patient outlining patient responsibilities. Suggested elements of such an agreement are provided in Appendix 1.

 D.            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 arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a co-morbid psychiatric disorder may require extra care, monitoring, documentation, and consultation with or referral to an expert in the management of such patients.

 E.            Periodic review of treatment efficacy: Review of treatment efficacy should occur periodically to assess the functional status of the patient, continued analgesia, controlled substances side effects, quality of life and indications of medications abuse. Periodic re-examination is warranted to assess the nature of the pain complaint and to ensure that controlled substances therapy is still indicated. Attention should be given to the possibility of a decrease in global function or quality of life as a result of controlled substance abuse.

F.            Documentation: Documentation is essential for supporting the evaluation, the reason for controlled substance prescribing, the overall pain management treatment plan, any consultations received, and periodic review of the status of the patient. The physician should document drug treatment outcomes and rationale for changes. Every prescription must be clearly documented in the patient record. All written prescriptions must include name, address, drug name, amount prescribed, as well as instructions.

 G.            Reportable Acts: Information gained as part of the doctor/patient relationship, even if it gives knowledge of possible criminal acts, remains part of the confidential doctor/patient relationship. This needs to be contrasted with persons who use the physician to perpetrate illegal acts such as illegal acquisition or selling of drugs, etc. The physician has an obligation to deal with this behavior up to and including reporting to law enforcement. Reports from other providers, such as pharmacists and ER physicians, suggesting inappropriate or drug-seeking behavior, should be dealt with appropriately.

 § 3. The Principles of End of Life Pain Therapy:

In the instance of chronic end of life pain, a treatment plan which addresses the goals of comfort and personal dignity, developed at the time of original diagnosis is sufficient. Certain suggestions and considerations as noted in Section 2.2,3,4, &5 may well not apply to this category of patient. Evaluation and documentation to ensure patient comfort and dignity as well as to manage other aspects of the underlying illness are expected to continue.

 STATUTORY AUTHORITY:           Title 32 M.R.S.A § §2562 and 3269(3) and (7)

 EFFECTIVE DATE:

March 22, 1999