SUMMARY OF INTRODUCED BILL
The bill would amend the Public Health Code to do the following:
-- Prohibit the Department of Licensing and Regulatory Affairs (LARA) from exempting the administration or dispensing of a controlled substance from reporting requirements under circumstances in which an exemption is currently required.
-- Require LARA to exempt from the reporting requirements the dispensing of a controlled substance in specific types of facilities, including an emergency room, a hospice, and the oncology department of a licensed hospital.
-- Rescind an administrative rule that makes an exemption from the reporting requirements for certain circumstances.
The Code requires the Department to establish, by rule, an electronic system for monitoring Schedule 2, 3, 4, and 5 controlled substances dispensed in Michigan by veterinarians, and by pharmacists and dispensing prescribers (physicians and dentists who dispense prescription drugs to their own patients); or dispensed to a Michigan address by a pharmacy licensed in the State. The rules must provide an electronic format for the reporting of data, including patient identifiers, the name of the controlled substance dispensed, the date of dispensing, the quantity dispensed, the prescriber, and the dispenser.
The rules must exempt the following circumstances from the reporting requirements:
-- The administration of a controlled substance directly to a patient.
-- The dispensing from a health facility or agency licensed under the Code of a controlled substance by a dispensing prescriber in a quantity adequate to treat a patient for not more than 48 hours.
The bill, instead, provides that LARA's authority to promulgate rules would not include the authority to promulgate or enforce a rule that would exempt any of the following circumstances from the reporting requirements:
-- The administration of a controlled substance directly to a patient, except as provided below.
-- The dispensing from a licensed health facility or agency of a controlled substance by a dispensing prescriber in a quantity adequate to treat a patient for not more than 48 hours.
-- The dispensing or administration of buprenorphine or a drug containing buprenorphine or methadone.
The rules would be required to exempt from the reporting requirements the dispensing of a controlled substance in all of the following:
-- An emergency department, emergency room, or trauma center of a hospital that is licensed under the Code.
-- A hospice.
-- An oncology department of a licensed hospital.
-- A licensed hospital that administers the controlled substance to an inpatient.
The bill also would rescind Rule 338.3162e of the Michigan Administrative Code. (Rule 3162d provides that a pharmacist, pharmacy, dispensing prescriber, or veterinarian must report all Schedule 2 to 5 controlled substances dispensed to the Department of Community Health (now part of the Department of Health and Human Services) or its contractor. Rule 3162e provides that a pharmacist, dispensing prescriber, or veterinarian is exempt from the reporting requirements under the following circumstances:
-- When a controlled substance in Schedules 2 to 5 is administered directly to a patient.
-- When a controlled substance in Schedules 2 to 5 is dispensed from a licensed health facility agency by a dispensing prescriber in a quantity adequate to treat a patient for not more than 48 hours.)
The bill would take effect 90 days after its enactment.
The bill would have no fiscal impact on State or local government.
This analysis was prepared by nonpartisan Senate staff for use by the Senate in its deliberations and does not constitute an official statement of legislative intent.