Ala. Admin. Code r. 540-X-21-.02 - Preamble

Current through Register Vol. 40, No. 6, March 31, 2022

(1) The Alabama Board of Medical Examiners (Board) Requirements.
(a) The Board is obligated under the laws of the state of Alabama to protect the public health and safety. The Board recognizes that the principles of high-quality medical practice dictate that the people of Alabama have access to appropriate, safe and effective medical care, including the treatment of addiction. The application of up-to-date knowledge and evidence-based treatment modalities can help to restore function and thus improve the quality of life of patients who suffer from addiction.
(b) In this context, the Board recognizes the body of evidence for the effectiveness of buprenorphine in the office-based treatment of opioid addiction, when such treatment is delivered in accordance with current standards of care and the requirements of DATA 2000 and the Board.
(c) The Board will determine the appropriateness of a particular physician's prescribing practices on the basis of the physician's overall treatment of patients and the available documentation of treatment plans and outcomes. The goal is to provide appropriate treatment of the patient's opioid addiction (either directly or through referral), while adequately addressing other aspects of the patient's functioning, including co-occurring medical and psychiatric conditions and pressing psychosocial issues.
(2) Federal Requirements to Prescribe Buprenorphine for Addiction.
(a) Physicians who wish to treat opioid addiction with buprenorphine in their medical offices must demonstrate that they have met the requirements of the DATA 2000 legislation and obtained a waiver from SAMHSA2. To qualify for such a waiver, physicians must hold a current controlled substance registration with the U. S. Drug Enforcement Administration (DEA) and a current license in the state in which they practice. They also must meet one or more of the following qualifications:
1. Subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties;
2. Subspecialty board certification in addiction medicine from the American Osteopathic Association;
3. Addiction certification from the American Board of Addiction Medicine;
4. Completion of not less than eight hours of training related to the treatment and management of opioid addiction provided by the American Academy of Addiction Psychiatry, the American Society of Addiction Medicine, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or other approved organizations; or
5. Participation as an investigator in one or more clinical trials leading to the approval of an opioid drug in Schedule III, IV, or V or a combination of such drugs for treatment of opioid-addicted patients.
(b) To obtain a waiver, a physician must notify SAMHSA in writing of his or her intent to prescribe an approved opioid medication to treat addiction, certifying the physician's qualifications and listing his/her DEA registration number. SAMHSA will then notify DEA whether a waiver has been granted. If SAMHSA grants a waiver, DEA will issue an identification number no later than 45 days after receipt of the physician's written notification. (If SAMHSA does not act on the physician's request for a waiver within the 45-day period, DEA will automatically assign the physician an identification number.) This process is explained, and can be accessed at the following website: http://buprenorphine.samhsa.gov/howto.html.
(c) If a physician wishes to prescribe or dispense an appropriately available and approved opioid medication for maintenance treatment or detoxification (so as to fulfill the requirements of DATA 2000) on an emergency basis before the 45-day waiting period has elapsed, the physician must notify SAMHSA and the DEA of his or her intent to provide such emergency treatment.
(d) In addition to a waiver, a physician who wishes to prescribe buprenorphine or another approved opioid for the treatment of addiction in an office setting must have a valid DEA registration number and a DEA identification number that specifically authorizes him or her to engage in office-based opioid treatment.
(3) Prescription Requirements. Prescriptions for buprenorphine and buprenorphine/naloxone must include full identifying information for the patient, including his or her name and address; the drug name, strength, dosage form, and quantity; and directions for use. Prescriptions for buprenorphine and/or buprenorphine/naloxone must be dated as of, and signed on, the day they are issued ( 21 CFR 1306.05 [a]). Both the physician's regular DEA registration number and the physician's DATA 2000 identification number (which begins with the prefix X) must be included on the prescription ( 21 CFR 1301.28 [d][3]).
(4) For detailed guidance, physicians are referred to the Buprenorphine Clinical Practice Guidelines published by CSAT/SAMHSA, which can be accessed at http://buprenorphine.samhsa.gov/Bup_Guidelines.pdf.

2The "waiver" allows an exception to the Harrison Narcotics Act of 1914, which made it illegal for a physician to prescribe an opioid to any patient with opioid addiction for the purpose of managing that addiction or acute withdrawal. Prior to DATA 2000, the only exception to the Harrison Act was federal legislation that allowed the establishment of methadone maintenance treatment (MMT) clinics, now referred to as Opioid Treatment Programs (OTPs). That exception only allowed the use of methadone to treat addiction or withdrawal within specially licensed and regulated facilities, but not in office-based medical practice.

Notes

Ala. Admin. Code r. 540-X-21-.02
Adopted by Alabama Administrative Monthly Volume XXXIII, Issue No. 06, March 31, 2015, eff. 4/23/2015.

Author: Alabama Board of Medical Examiners

Statutory Authority: Code of Ala. 1975, §§ 34-24-53.

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