Current through Register Vol. 42, No. 11, August 30, 2024
(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.
Author: Alabama Board of Medical
Examiners
Statutory Authority:
Code of Ala.
1975, §§
34-24-53.
