Ala. Admin. Code r. 540-X-19-.09 - Requirements For The Use Of Controlled Substances For The Treatment Of Pain

(1) Preamble.

(a) The Board recognizes that principles of quality medical practice dictate that the people of the State of Alabama 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 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 statutory requirements for prescribing controlled substances.

(b) Inadequate pain control may result from physicians' lack of knowledge about pain management or an inadequate understanding of tolerance, dependence or addiction. Fears of investigation or sanction by federal, state and local regulatory agencies may also result in inappropriate or inadequate treatment of chronic pain patients. Accordingly, these requirements 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.

(c) The Board recognizes 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. The medical management of pain should be based on current knowledge and research and should include the use of both pharmacologic and non-pharmacologic modalities. Physicians should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not synonymous with addiction.

(d) The Board is obligated under the laws of the State of Alabama 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 purposes.

(e) 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 MEDICAL KNOWLEDGE OF THE TREATMENT OF PAIN. ALL SUCH PRESCRIBING MUST BE BASED ON CLEAR DOCUMENTATION AND IN COMPLIANCE WITH APPLICABLE STATE OR FEDERAL LAW.

(f) The Board will judge the validity of prescribing based on the physician's treatment of the patient and on available documentation. The goal is to reduce pain and/or improve patients' function.

(g) Physicians are referred to the Federation of State Medical Boards' Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain, July 2013, as amended from time to time, and the Drug Enforcement Administration Office of Diversion Control manual, Narcotic Treatment Programs Best Practice Guidelines, as amended from time to time.

(2) Requirements. The Board requires the following when a physician evaluates the use of controlled substances for pain control:

(a) Evaluation of the Patient. A medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, 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.

(b) Treatment Plan. The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved 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 the patient. Alternative non-opioid treatment modalities or a rehabilitation program may be necessary and should be considered.

(c) Informed Consent and Agreement for Treatment. The physician shall discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient or with the patient's surrogate or guardian if the patient is incompetent. Written agreements between physician and patient outlining patient responsibilities should be utilized for all patients with chronic pain, and should include:

1. Drug screening with appropriate confirmation

2. A prescription refill policy; and

3. Reasons for which drug therapy may be discontinued (e.g., violation of agreement).

4. The patient should receive prescriptions from one physician and one pharmacy where possible.

(d) Periodic Review. At reasonable intervals based on the individual circumstances of the patient, the physician shall review the course of treatment and any new information about the etiology of the pain. The physician shall monitor patient compliance in medication usage and related treatment plans.

(e) 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.

(f) Medical Records. The physician shall 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.

These records shall remain current, be maintained in an accessible manner, and be readily available for review.

(g) Compliance With Controlled Substances Laws and Regulations. To prescribe, dispense or administer controlled substances, the physician must be licensed in the state and must comply with applicable federal and state regulations.

Notes

Ala. Admin. Code r. 540-X-19-.09

New Rule: Filed November 14, 2013; effective December 29, 2013.

Author: Alabama Board of Medical Examiners

Statutory Authority: Code of Ala. 1975, §§ 34-24-53; Act 2013-257.