The recently-passed Michigan opioid and controlled substance legislation includes some new requirements and some confirmation of existing requirements for pharmacists/pharmacies who dispense controlled substances (“CS”). Here is a brief overview of those requirements which go into effect on March 27, 2018.
Limitations on Initial, Refill and Partial Fills of Controlled Substance Prescriptions
- Legislation confirms existing restriction that a schedule 2 CS prescription may not be filled more than 90 days after the prescription was issued.
- Existing statutory language permitting partial filling of schedule 2 CS prescriptions for terminally ill patients is eliminated in favor of language permitting partial filling of schedule 2 CS prescriptions “consistent with federal law and regulations on the partial filling of prescriptions.”
- Confirms existing requirement that a schedule 3-4 CS prescription may not be filled or refilled more than 6 months after the date of the prescription. Schedule 3-4 CS prescriptions may not be refilled more than 5 times unless renewed by the prescriber in accordance with the rules. Specific instructions are required for all schedule 3 and 4 CS prescription refills.
Reporting CS Dispensing in MAPS
- Continues the requirement that pharmacists/pharmacies, dispensing prescribers and veterinarians who dispense or administer CS to patient must report the dispensing/administration to MAPS. This requirement now specifically includes a prescriber who dispenses a drug containing buprenorphine or methadone to a patient in a substance use disorder program, unless federal law would prohibit such reporting.
- Reporting Exceptions: The following CS dispensing events are now exempted from the MAPS reporting requirement by statute, and the existing Board of Pharmacy rule specifying the exceptions is rescinded:
- Dispensing in a hospital licensed under Article 17 of the Code that administers the CS to a hospital inpatient;
- Dispensing in a facility or agency that is licensed under Article 17 of the Code if the CS is dispensed by a dispensing prescriber in a quantity adequate to treat the patient for not more than 48 hours; or
- Dispensing in a veterinary clinic or hospital when the CS is administered to an animal who is an inpatient.
Look here for a summary of all of the new Michigan opioid and controlled substance legislation.