A Guide to State Opioid Prescribing Policies

Pain Policy and Regulation: Maine

Summary

Maine's Board of Licensure in Medicine has adopted a position statement on the Use of Controlled Substances for Treatment of Pain. The rules follow many of those in the country patterned off of the Federation of State Medical Boards' old Model Policy Statement.

Maine's health-related 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.

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.

Definitions

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.

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: Physicians should tailor treatment to both the individual and the presenting problem, and consider 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 the physician selects a trial of controlled substances, the physician should inform the patient or the patient's legally authorized representative of the risks and benefits of controlled substance use and the conditions under which the physician will prescribe controlled substances. Some practitioners find a written agreement specifying these conditions to be useful. Do not embark on a trial of controlled substances in the absence of a complete assessment of the pain complaint.

If the physician cannot complete the evaluation at the initial visit, the physician should prescribe only limited quantities of controlled substances until completion of the evaluation, and do so using the physician's best judgment on the basis of the information available.

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. The Maine Board provides suggested elements of an agreement. The agreement is likely to be very old and outdated, so check with the Board.

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. The physician should pay attention to the possibility of a decrease in global function or quality of life because 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.

The physician must clearly document every prescription 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. The physician should contract this type of information with situations where 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. Physicians should appropriately deal with reports from other providers, such as pharmacists and ER physicians, suggesting inappropriate or drug-seeking behavior by current patients.

Maine's 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 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.

Controlled Substances Contract

(Do not call it a contract, or at least check with your lawyer before you do.) Maine suggests the following elements for the controlled substances agreement:

1. specifies that the physician is the single source of controlled substances;
2. may specify the pharmacy;
3. written, informed consent to release contract to local emergency departments and pharmacies;
4. if written consent is given for release to local emergency departments and/or pharmacies, consent is also being given to the other providers to report violations of the contract back to the physician;
5. specifies that if the physician becomes concerned that there has been illegal activity, the physician may notify the proper authorities;
6. if the physician has obtained a written release, ER personnel and other providers shall report violations of the contract back to the doctor who prescribed the controlled substance(s);
7. specifies that a violation of the contract will result in a tapering and discontinuation of the narcotics prescription;
8. specifies that a risk of chronic narcotics treatment is physical dependence (as defined);
9. specifies that a risk of chronic narcotics treatment is addiction (as defined);
10. specifies that it is the responsibility of the patient to be discreet about possessing narcotics and keeping medications in an inaccessible place so that they may not be stolen;
11. if the patient violates the terms of the contract, the violation should be documented. The physician response to the violation should be documented, as well as the rationale of and changes in the treatment plan;
12. Physician may consider "fill only at ___ pharmacy" on the prescription form. [This document was prepared in 1999.]