Cui bono?
(Who benefits?) is not just for crime investigation! It's the #1 question to ask when the rules change for your healthcare or your license/workplace.
The Bureau of Professional Licensing (BPL) within the Department of Licensing and Regulatory Affairs (LARA) would like to inform you that the new Pharmacy Administrative Rules were effective as of February 29, 2024. A list of the notable changes is below. This is not intended to provide a comprehensive listing of all changes or current requirements. Licensees should review the rules and statute for a complete understanding of all applicable requirements.
The summary of changes is below:
For Pharmacy Services in Medical Institutions: Updates were made indicate that the limited number of medications may be stocked in patient care areas if pharmacist review and interpretation of the order before the administration of the first dose would adversely affect the patient’s medical condition.
For Pharmacist Licenses:
An individual participating in an unconventional internship is required to annually submit an affidavit from the internship supervisor including the type of activities performed and the number of hours completed.
A graduate from a program outside the United States may petition the board for approval of a maximum of 1,400 internship hours if the hours are not obtained through an approved educational program or under the personal charge of a Michigan-licensed pharmacist.
An internship preceptor is required to submit an affidavit including the number of internship hours completed by the intern in the practice of pharmacy, unless the hours are completed in an educational program.
The Multistate Pharmacy Jurisprudence Examination requirement is eliminated and replaced with an attestation that the applicant has sufficient knowledge of the Public Health Code and the Board of Pharmacy’s rules to competently practice pharmacy in Michigan.
For Pharmacy Licenses:If a pharmacist in charge (PIC) is unable to fulfil their duties for 120 consecutive days, the pharmacy shall appoint a new PIC and notify the department.
The 2023 revisions of USP Chapters 795 and 797 are adopted, with the exception of flavoring; inspection requirements are modified, including a 2-step inspection process for an in-state pharmacy that will compound sterile products and requiring out-of-state pharmacies that will not ship compounded sterile products into Michigan to submit inspections from their resident state boards of pharmacy or the National Association of Boards of Pharmacy (NABP) Verified Pharmacy Program.
Requirements for a pharmacy’s access to pharmacy laws and rules and reference texts are clarified.
A pharmacy that dispenses drugs is required to maintain a sink with running water, a refrigerator for the exclusive use of prescription drugs, and a telephone.
For Manufacturer Licenses:If a PIC or facility manager is unable to fulfil their duties for 120 consecutive days, the pharmacy shall appoint a new PIC or facility manager and notify the department.
Inspection and accreditation requirements were modified to provide the option of submitting an inspection from the United States Food and Drug Administration, the manufacturer’s resident state board of pharmacy, or NABP drug distributor accreditation.
For Wholesale Distributor and Wholesale Distributor-Broker Licenses:If a PIC or facility manager is unable to fulfil their duties for 120 consecutive days, the pharmacy shall appoint a new PIC or facility manager and notify the department.
For the Practice of Pharmacy:If a pharmacy intern completes final product verification under the supervision of a pharmacist, initials of both the pharmacy intern and the delegating pharmacist are required; modifies the locations where a pharmacy may operate an automated device; requires pharmacist review of orders and authorization of further dispensing within 48 hours when an automatic device is used as an after-hours cabinet, emergency kit, or when the system is accessed to treat the emergent needs of a patient;
The requirements for automated devices used in non-inpatient settings and in medical institutions were clarified.
A pharmacist may remotely access a pharmacy database as well as any other necessary databases that are routinely accessed to perform their functions and requires the pharmacist to provide adequate security.
The requirements for a pharmacist to dispense an emergency supply of insulin.
Please click HERE to view the revised Pharmacy rules.Our office is diligently working on updating relative information on our website to reflect the revisions of the revised rules. For more information, please visit our website at www.michigan.gov/bpl.
Please send questions about the revised rules to BPLHELP@michigan.gov.
More on the elimination of the Multistate Pharmacy Jurisprudence Examination requirement for pharmacist licenses:
Legal exam removed from pharmacist certification in Michigan
By Dustin Walsh - March 11, 2024It’s now easier to become a licensed pharmacist in the state of Michigan.
State regulators recently eliminated a widely used certification requirement by removing the Multistate Pharmacy Jurisprudence Exam, becoming only the second state in the U.S. to do so.
The jurisprudence exam is a 2.5-hour, 120-question multiple choice examination of federal and state laws formerly required in the state to become a certified pharmacist. Pharmacists are the only discipline in health care required to pass a law exam to receive licensure.
Experts are torn on whether removing the exam will jeopardize industry safety at a time when pharmacists are seeking more autonomy in the health care industry.
Keep up with all things West Michigan business. Sign up for our free newsletters today.
The elimination of the exam was quickly pushed through the Michigan Board of Pharmacy last summer in a controversial move and the new set of regulator rules was submitted to the Joint Committee on Administrative Rules in the legislature in July.
The committee finalized axing the exam on Feb. 29 and filed the rule change with the Secretary of State, making it official.
The elimination of the exam was supported by many in the industry, including national pharmacy chains and pharmacy benefits manager organizations.
During public comment last June, several individuals spoke in favor of getting rid of the exam. While none of the commenters disclosed their affiliations, at least one appeared to be a representative of a major insurer.
Jessica Morris, who according to her LinkedIn profile is a clinical consultant of strategic partnerships for Optum Inc., the pharmacy benefits subsidiary of UnitedHealth Group — the largest health insurer in the U.S. — called the exam “pointless” due to stopgap technology that ensures pharmacists follow all laws, state and federal.
But many pharmacists in the state disagreed with its removal, including the Michigan Pharmacists Association, who submitted complaints against the removal to the Joint Committee on Administrative Rules but were ultimately unsuccessful.
Eric Roath, director of government affairs for the industry group, questioned the wholesale removal of the exam from licensure in an interview with Crain’s last year.
“Pharmacists are far more likely to be brought before the pharmacy board for potential legal violations than any other provider,” Roath said. “Physician cases are usually due to a clinical error. Pharmacy is the highest-regulated field in health care. To say there are no better solutions to ensuring practice competency than to just remove the exam is wrong. The competency assessment is actually effective in verifying.”
Detractors say it’s likely chain pharmacies and multi-state health care providers favor eliminating the jurisprudence exams across the country in a bid to control their own costs and consolidate operations. Removing the exam could make it it easier for a consolidated pharmacy center in another state to fill scripts in Michigan, a move that could save millions of dollars.
Pharmacists are also one of the more prosecuted health care professions for violating laws.
A simple Google search of health insurance fraud by pharmacists in the region reveals more than a dozen indictments in the past five years that include distributing opioids to patients without a prescription to defrauding Medicare or Medicaid for reimbursement on drugs they didn’t prescribe or sold without a prescription.
In April last year, regulators in Idaho published a white paper in the American Journal of Pharmaceutical Education that stated there has been no evidence of public safety being jeopardized by its removal of the jurisprudence exam requirement. That article was co-written by Deeb Eid, who was listed as voluntary faculty at Ferris State University’s College of Pharmacy. His full-time job, though, is as a senior advisor of regulatory affairs for CVS.
It’ll likely take years to determine whether the removal of the MJPE impacts pharmacy operations or patient safety.
Great reporting!
Quite possibly the only deregulatory measure Michigan has taken, following Idaho or not.
Sure hope it doesn't offer the "bigs" an advantage over small start-ups. Finding out should be interesting.
Sign Up for MHF Insights to keep up on the latest in Michigan Health Policy
