By Brian Sapita, government affairs manager, Michigan Pharmacists Association
The administrative rules process can be a lengthy process. In short, state agencies draft rules in consultation with the respective Board. The draft rules are then presented to the public during a public hearing, allowing the public to comment on the proposed rules. Workgroups are held that take all the public comments under consideration and stakeholder groups are able to give additional input. Finally, the draft rules are presented to the Joint Committee on Administrative Rules (JCAR) for approval. The Committee (JCAR) is made up of 10 legislators, responsible for the legislative oversight of administrative rules proposed by state agencies.
The Committee has the authority to approve or deny any set of rules presented and historically, the committee has always approved the rules, believing that the department and its boards had done their due diligence and was sending the rules in good faith. Unfortunately, sometimes that is not always the case. In early September, a rule change in the Controlled Substance Rules (R 338.3162b) was proposed to JCAR by the Department without the support of the public or the Board of Pharmacy.
The proposed rule (R 338.3162b) made changes to the reporting requirements of pharmacists and dispensing prescribers to the Michigan Automated Prescription System (MAPS), including submitting information about persons unrelated to the prescriber-patient relationship to MAPS when picking up a prescription for a patient. Note that the information collected and reported will include the name of the person picking up a prescription, his or her ID number and the relationship to the patient.
Those proposed changes would have required pharmacies throughout the State of Michigan to make necessary, costly, programmatic changes to comply with the rule, thus placing unnecessary economic burden on Michigan small businesses. MPA strongly opposed the proposed rule since there is not data that supports a decrease in diversion with the proposed increase in reporting requirements.
MPA and other individuals wrote letters to JCAR and spoke with legislators on the committee to implore them to deny the rules. On the day of the committee hearing LARA rescinded their rules and took them off the agenda. They have not announced what they plan to do with the rules or if they will continue to work on them, but MPA will continue to monitor the situation on all administrative rules that affect the profession.