MPA COVID-19 Virtual Town Hall, FDA's New Guidance for 503A Pharmacies, Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19, and more!
April 23, 2020
MPA COVID-19 Virtual Town Hall
Monday, April 27 at 7:00 p.m.
MPA is providing an opportunity for you to participate in our COVID-19 Town Hall meeting this Monday, April 27, 2020 from 7 p.m.-8 p.m. The Town Hall will feature Jennifer Lixey Terrill Healthcare and Public Health Policy Specialist and Emergency Management Coordinator Bureau of EMS, Trauma, and Preparedness with the State of Michigan and Farah Jalloul, MPA State Pharmacy Emergency Preparedness Coordinator, with an update on current issues related to COVID-19 and the State of Michigan’s response to the epidemic. Individuals will also have the opportunity to identify issues that they believe MPA could assist them in solving.
After registering, you will receive a confirmation email containing information about joining the meeting.
CMS Revises Medicare Advantage Organizations and Part D Sponsors Guidance
CMS has released guidance to Medicare Advantage Organizations (MAOs) and Part D sponsors allowing a number of restrictions they may loosen in response to COVID-19. These include Medicare Advantage Cost-sharing, implementing telehealth, involuntary disenrollment due to temporary absence or loss of special needs status, and waiving prior authorizations. The entire guidance can beread here.
The FDA has issued guidance on pharmacy compounders who are not registered as outsourcing facilities. This guidance will allow hospitals to obtain compounded drug products that are not readily available due to COVID-19. The FDA does not intend to take action against a pharmacy for compounding a drug that is essentially a copy of a commercially available drug or for providing a drug to a hospital without obtaining a patient-specific prescription if all of the identified circumstances are present and the other conditions of section 503A of the FD&C Act are met.
The Governor signedExecutive Order 2020-56 extending the Executive Order (EO) 2020-25 (now rescinded) that MPA played a role in creating. The EO allows pharmacists to provide emergency refills, substitute therapeutically equivalent drugs, and provide COVID-19 related testing to patients. The new EO 2020-56 is in effect until May 19, 2020 at 11:59 p.m.
Extends the temporary enhancements to operational capacity and efficiency of health care facilities of Executive Order 2020-13 until May 12, 2020.
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency
FDA issued a guidance explaining a temporary policy regarding repackaging or combining propofol injectable emulsion, 10 milligram (mg) per milliliter (mL) (propofol) products for treating and managing hospitalized patients during the COVID-19 public health emergency.
FDA has received reports that hospitals are having difficulty obtaining adequate supplies of FDA-approved propofol products that are needed to care for critically ill COVID-19 patients. The guidance provides regulatory flexibility when state-licensed pharmacies (including hospital pharmacies), federal facilities and outsourcing facilities repackage or combine propofol for use in hospitals that are having difficulty obtaining adequate supplies of an FDA-approved propofol product.
Order Your Controlled Substance Inventory List Today!
Michigan law requires an annual inventory of controlled substances to be completed no more than 30 days prior to May 1 and no later than 60 days after May 1. You must keep a copy of the inventory on file, but it no longer has to be submitted to the state, but you must provide a copy if requested by the state. Because of COVID-19, LARA has indicated that the new deadline will be 60 days after Executive Order 2020-42 is rescinded.
Complete this important task by using the Controlled Substance Inventory List available from Pharmacy Services Inc. (PSI). Contact PSI at (517) 484-1466, email Products@PSI.solutions or click here to print the order form and fax back to (517) 484-4893.
Pharmacists, student pharmacists and pharmacy technicians are needed to volunteer to assist in the dispensing process at TCF center (previously known as COBO hall) in Detroit. If interested contact MPA Director of Emergency PreparednessFarah Jalloul or register here.