Health Law Attorney BlogMI Gov. Whitmer Signs Order Allowing Pharmacists to Dispense Emergency Refills of Prescriptions
On March 25, 2020, Michigan Governor Whitmer signed an order allowing pharmacists to dispense emergency refills of prescriptions. This order was in response to the urgent demands created by the COVID-19 pandemic. Executive Order 2020-25 will help increase access to therapeutic pharmaceuticals for Michiganders while providing temporary and limited relief from certain regulatory restrictions for pharmacies.
Effective immediately and continuing through April 22, 2020 at 11:59pm:
1. Pharmacists located in any county in this state may dispense emergency refills of up to a sixty (60) day supply of any non-controlled maintenance medication for residents of any county in this state if, in the pharmacist’s professional judgment, failure to refill the prescription might interrupt the patient’s ongoing care and have a significant adverse effect on the patient’s well-being.
2. The following shall apply to all emergency refills dispensed under section 1 of this order:
- The pharmacist must inform the patient that the prescription was refilled under section 1 of this order.
- The pharmacist must inform the prescriber in writing within a reasonable period of time of any refills the pharmacist dispensed under section 1 of this order.
- Prior to refilling a prescription under section 1 of this order, the pharmacist, clinic, or mobile pharmacy must make every reasonable effort to communicate with the prescriber regarding the refilling of the prescription. The pharmacist must make an appropriate record of that effort, including the basis for proceeding under section 1 of this order.
- A prescriber must not incur any criminal or civil liability or licensing disciplinary action as the result of a pharmacist refilling a prescription under section 1 of this order.
3. Pharmacists may temporarily operate a pharmacy in an area not designated on the pharmacy license, but they may not prepare sterile drug products beyond low-risk preparations, as defined by USP standards, for immediate inpatient administration in such temporary facilities.
4. Pharmacists may dispense and/or administer drugs as needed to treat COVID-19 pursuant to protocols established by the Centers for Disease Control and Prevention or the National Institute of Health, or as determined appropriate by the chief medical executive of the Department of Health and Human Services or her designee.
5. Pharmacists may substitute a therapeutically equivalent medication for a medication subject to critical shortages without the authorization of a prescriber. The pharmacist must inform the patient of any such substitution. The pharmacist must inform the prescriber within a reasonable period of time of any prescriptions or refills dispensed under this section. A prescriber must not incur any criminal or civil liability or licensing disciplinary action as the result of a pharmacist filling or refilling a prescription under this section.
6. To increase the number of pharmacists who can serve patients during this time of need, preceptors may supervise student pharmacists remotely to fulfill eligibility for licensure and avoid delaying graduation.
7. Insurers and health maintenance organizations issuing health insurance or disability insurance policies that provide prescription drug benefits must cover any emergency refills of covered prescription drugs dispensed by a pharmacist under section 1 of this order. Insurers and health maintenance organizations must also allow for early refills of all 30-day or 60-day covered prescription maintenance medications to allow for up to a 90-day supply to be dispensed by a pharmacy, without regard to whether the pharmacy is mail-order or in-person. Insurers and health maintenance organizations may still apply policy or contract provisions governing out-of-network benefits and cost-sharing.
8. Pharmacists may supervise pharmacy technicians and other pharmacy staff remotely. Supervision must be conducted through a real-time, continuous audiovisual camera system, capable of allowing the pharmacist to visually identify the markings on tablets and capsules. The pharmacist must have access to all relevant patient information to accomplish the remote supervision and must be available at all times during the supervision to provide real-time patient consultation. A pharmacy technician may not perform sterile or nonsterile compounding without a pharmacist on the premises.
9. Pharmacies holding a license, certificate, or other permit in good standing issued by another state must be deemed licensed to do business in this state. These out-of-state licensed pharmacies must not deliver controlled substances into this state; must abide by all Michigan regulations applicable to the practice of pharmacy, but need not have a pharmacist-in-charge with a license to practice in Michigan; and must hold a current accreditation from a national organization approved by the Michigan Board of Pharmacy before providing sterile compounding services to patients in this state.
10. Wholesale distributors holding a license, certificate, or other permit in good standing issued by another state must be deemed licensed to do business in this state. These out-of-state wholesale distributors must not deliver controlled substances into this state and must abide by all Michigan regulations applicable to a Michigan-licensed wholesale distributor.
To the extent any statutes, rules, or regulations may be inconsistent with this order, strict compliance with them is temporarily suspended.
Consistent with MCL 10.33 and MCL 30.405(3), a willful violation of this order is a misdemeanor.
Should you have any questions or concerns regarding this executive order or any Michigan pharmacy related matter, please do not hesitate to contact Robert S. Iwrey, Esq. at riwrey@thehlp.com as a significant portion of his practice involves Michigan pharmacy-related matters.