Risk and Abuse Mitigation Strategies - latest amendments effective 8/8/2019

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ALABAMA STATE BOARD OF MEDICAL EXAMINERS RULES & REGULATIONS

540-X-4-.09 Risk and Abuse Mitigation Strategies (see also 540-X-12-.18, 540-X-18-15, and 540-X-20-.09, Risk and Abuse Mitigation Strategies for QACSC and LPSP holders)

(1)       The Board recognizes that all controlled substances, including but not limited to, opiates, benzodiazepines, stimulants, anticonvulsants, and sedative hypnotics, have a risk of addiction, misuse, and diversion. It is the opinion of the Board that the best practice when prescribing controlled substances shall include medically appropriate risk and abuse mitigation strategies, which will vary from patient to patient. Additional care should be used by practitioners when prescribing medication to a patient from multiple controlled substance drug classes.

(2)       Every practitioner shall provide his or her patient with risk education prior to initiating controlled substances therapy and prior to continuing the controlled substances therapy initiated by another practitioner.

(3)       Every practitioner shall utilize medically appropriate risk and abuse mitigation strategies when prescribing controlled substances. Examples of risk and abuse mitigation strategies include, but are not limited to:

(a)       Pill counts;
(b)       Urine drug screening;
(c)        PDMP checks;
(d)       Consideration of abuse-deterrent medications;
(e)       Monitoring the patient for aberrant behavior;
 (f)       Using validated risk-assessment tools, examples of which shall be maintained by the Board; and
(g)       Co-prescribing naloxone to patients receiving opioid prescriptions when determined to be appropriate in the clinical judgment of the treating practitioner.

(4)       The Board recognizes that the best available research demonstrates that the risk of adverse events occurring in patients who use controlled substances to treat pain increases as dosage increases. The Board adopts the "Morphine Milligram Equivalency" ("MME") daily standard as set out by the Centers for Disease Control and Prevention ("CDC") for calculating the morphine equivalence of opioid dosages. The Board further adopts the “Lorazepam Milligram Equivalency” (“LME”) daily standard for calculating sedative dosing when using the Alabama Prescription Drug Monitoring Program.

 (5)      For the purpose of preventing controlled substance diversion, abuse, misuse, addiction, and doctor-shopping, the Board sets forth the following requirements for the use of Alabama's Prescription Drug Monitoring Program (PDMP):

(a)       For controlled substance prescriptions totaling less than 30 MME or 3 LME per day, physicians are expected to use the PDMP in a manner consistent with good clinical practice.
(b)       When prescribing to a patient controlled substances of more than 30 MME or 3 LME per day, physicians shall review that patient's prescribing history through the PDMP at least two (2) times per year, and each physician is responsible for documenting the use of risk and abuse mitigation strategies in the patient’s medical record.
(c)        Physicians shall query the PDMP to review a patient's prescribing history every time a prescription for more than 90 MME or 5 LME per day is written, on the same day the prescription is written.

(6)       Exemptions: The Board's PDMP requirements do not apply to physicians writing controlled substance prescriptions for:

(a)       Nursing home patients;
(b)       Hospice patients, where the prescription indicates hospice on the physical prescription;
(c)        When treating a patient for active, malignant pain; or
(d)       Intra-operative patient care.

(7)       Due to the heightened risk of adverse events associated with the concurrent use of opioids and benzodiazepines, physicians should reconsider a patient's existing benzodiazepine prescriptions or decline to add one when prescribing an opioid and consider alternative forms of treatment. 

(8)       Effective January 1, 2018, each holder of an Alabama Controlled Substances Certificate (ACSC) shall acquire two (2) credits of AMA PRA Category 1™ continuing medical education (CME) in controlled substance prescribing every two (2) years as part of the licensee's yearly CME requirement. The controlled substance prescribing education shall include instruction on controlled substance prescribing practices, recognizing signs of the abuse or misuse of controlled substances, or controlled substance prescribing for chronic pain management.  

(9)      A violation of this rule is grounds for the assessment of a fine and for the suspension, restriction, or revocation of a physician's Alabama Controlled Substances Certificate or license to practice medicine.


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