The privilege of prescribing controlled substances in Alabama comes with the immense responsibility to protect the patient's safety as well as that of the public by preventing misuse and diversion.
Physicians, PAs, CRNPs, and CNMs who have been granted this privilege must be cognizant of and comply with all state and federal laws, rules, and regulations relating to controlled substances.
Board rules contain requirements for prescribing and dispensing controlled substances as well as requirements specific to using controlled substances for the treatment of pain and for weight loss.
- Prescription Guidelines
- Guidelines for the Use of Controlled Substances
- Dispensing Controlled Substances
- Maintenance of Records and Inventories
- Contact with Patients Before Prescribing
- Prescribing Controlled Substances for Weight Loss
- Risk and Abuse Mitigation Strategies
Board Rule 540-X-4-.06 states the requirements for all prescriptions for controlled substances, including:
- Dated as of, and signed on, the day when issued.
- Full name and address of the patient.
- Drug name, strength, dosage form, and quantity.
- When oral orders are not permitted (Schedule II), written with ink or printed and manually signed (non-electronic, handwritten signature) or transmitted via an approved e-prescribing platform.
- Employee may communicate prescription to pharmacy.
- Two signature lines with “dispense as written” and “product selection permitted” below.
- No person may sign in the place of or on behalf of the physician.
- It is improper under any circumstance to pre-sign blank prescriptions and make them available to employees or support personnel.
- It is improper to utilize blank prescriptions upon which the signature has been mechanically or photostatically reproduced.
The Board may assess administrative fines up to $10,000 for each violation or failure to comply with these guidelines.
Guidelines for the Use of Controlled Substances for the Treatment of Pain
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 Board encourages physicians to view effective acute and chronic pain management as a part of quality medical practice, especially for patients with pain from a terminal illness.
Board Rule 540-X-4-.09 states the requirements for the use of controlled substances for treating acute and chronic pain, including:
- Evaluation of the Patient
- Treatment Plan
- Informed Consent and Agreement for Treatment
- Periodic Review
- Requirements for Medical Records
Dispensing Controlled Substances
Who Is a Dispensing Physician?
- Orders for and delivers a controlled substance to a patient.
- Patient consumes the medication off the premises.
- Does not matter whether patient pays for medication or not.
- Medications labeled as samples and are not for resale are excluded.
Who is Not a Dispensing Physician?
- Distributes pre-packaged samples and starter packs.
- Administers oral or injectable controlled substances in the office.
- Dispenses non-controlled substances.
- Dispenses controlled substances purchased with hospital's or clinic's DEA registration.
Registration as a Dispensing Physician
- Pursuant to Board of Medical Examiners Rule 540-X-4-.05, dispensing physicians are required to register with the Board.
- Registration is accomplished by completing and returning the dispensing physician registration form.
- Complete the form and return via email to the Dispensing Physician Coordinator
- OR mail to: Attn: Dispensing Physician Registration, PO Box 946, Montgomery AL 36101-0946.
- Every location where medications are dispensed must be registered and the separate DEA numbers listed.
- Physicians are responsible for updating address changes, additional sites, additional DEA numbers, and removal of sites.
- Do not submit a dispensing registration form if you do not purchase controlled substances (other than pre-packaged samples and starter packs) to be dispensed to your patients. Doing so may result in false information being provided to the Alabama Department of Public Health's Prescription Monitoring Data Bank and may result in an unnecessary investigation into your practice.
Prescription Drug Monitoring Database
- Physicians who dispense controlled substances must report all controlled substances dispensed to the Alabama Department of Public Health Prescription Drug Monitoring Program database.
- The Board of Medical Examiners regularly sends to the Health Department a list of licensees who have registered as dispensing physicians.
Fines for Not Registering or Reporting as Required
- Board Rule 540-X-4-.05 requires dispensing physicians to report to the prescription monitoring database and authorizes the Board to assess administrative fines against physicians who act as dispensing physicians but are not registered with the Board and physicians who fail to report to the database as required by the Health Department and Board rules.
Maintenance of Records and Inventories
Board Rule 540-X-4-.04 sets recordkeeping and inventory requirements for physicians who purchase, maintain, and dispense controlled substances in the office, including:
- Inventory requirement
- Dispensing record (sample dispensing log)
- Labeling requirement
- Special requirement for CII amphetamines
- Board may assess fines up to $10,000 for each violation
Contact with Patients Before Prescribing
Board Rule 540-X-9-.11 states the policy of the Board concerning performing a physical examination before prescribing medications to a patient:
- When possible, prescriber should personally examine the patient.
- Prescriber should make informed medical judgment based on appropriate history, the circumstances, and the prescriber’s training and experience.
- Prescribing without personal exam may be suitable under certain circumstances: telemedicine, admission orders for new patient, prescribing for another physician while on call, continuing medication on a short-term basis before a new patient’s first appointment.
Prescribing Controlled Substances for Weight Loss
Board Rules, Chapter 540-X-17, provides guidelines and standards for the use of controlled substances for weight reduction.
- Prescribing or dispensing a controlled substances for weight reduction or the treatment of obesity should be based on accepted scientific knowledge and sound clinical grounds.
- It is illegal to prescribe a CII stimulant for the purpose of weight control, weight loss, weight reduction, or the treatment of obesity.
- Certified Registered Nurse Practitioners, Certified Nurse Midwives, and Physician Assistants are not authorized to prescribe or dispense any controlled substance for the purpose of weight control.
- A prescription or order must be signed on the date the medication is dispensed or the prescription given to the patient. These prescriptions may not be called in to a pharmacy. The prescribing/ordering physician must be present at the facility at the time of the prescription.
- Initial Requirements:
- Initial evaluation with appropriate physical and complete history, appropriate tests and referrals.
- BMI of 30 or above, or BME greater than 25 with at least one comorbidity; OR 25% body fat for males and 30% for females; or an abdominal girth of at least 40 inches for males or 35 inches for females.
- Assess and document patient’s freedom from signs of drug or alcohol abuse and the presence or absence of contraindications and adverse side effects.
- Continued use of a Controlled Substance for Weight Reduction:
- No more than 35-day supply.
- Within first 35 days after initiating, see the patient for monitoring the effects of therapy.
- Continue the controlled substance only if there is continued progress towards medically established goals and patient has no significant adverse effects from medication.
- Reevaluate patient at least once every 35 days.
- Once goals have been met, reduce dosing and suggest drug holidays for patients in maintenance.
Risk and Abuse Mitigation Strategies
Board Rule 540-X-4-.09 states the guidelines and standards for mitigating the risks of addiction, misuse, and diversion inherent in prescribing controlled substances.
These guidelines apply to the prescribing of all controlled substances for all reasons, with specific requirements with regard to opioids and benzodiazepines.
- Provide patient with risk education.
- As appropriate to the patient, use pill counts, drug screening, PDMP checks, abuse-deterrent medications, risk-assessment tools, and co-prescribing naloxone.
- Morphine Milligram Equivalency (MME) and Lorazepam Milligram Equivalency (LME) standard is adopted.
- FDA-approved daily dosage thresholds are higher for Tapentadol and other atypical opioids. The Board has not placed limits on dosage amounts but does require RMS and PDMP checks for dosages over certain MMEs.
- Query the PDMP:
- Less than 30 MME/3 LMC per day, review PDMP consistent with good clinical practice.
- More than 30 MME/3 LMC per day, review PDMP at least twice a year and document use of risk and abuse mitigation strategies in the medical record.
- More than 90 MME/5 LMC per day, review PDMP every time and on the same day the prescription is written.
- Nursing home patients
- Hospice patients (prescription must indicate hospice)
- Treatment of active, malignant pain
- Intra-operative care
- There is a heightened risk of adverse events associated with the concurrent use of opioids and benzodiazepines. Physicians should reconsider an existing benzodiazepine prescription or decline to add one when prescribing an opioid and consider alternative forms of treatment.