April 17, 2020
Guidance Allowing Pharmacists to Order and Administer
COVID-19 Tests
COVID-19 Nasal swab laboratory test in hospital lab
Last week the Department of Health and Human Services (DHHS) Secretary Alex Azar released guidance which would allow for pharmacists to order and administer COVID-19 tests that have been approved by the FDA. The secretary issued the following statement:

“Giving pharmacists the authorization to order and administer COVID-19 tests to their patients means easier access to testing for Americans who need it. Pharmacists play a vital role in delivering convenient access to important public health services and information. The Trump Administration is pleased to give pharmacists the chance to play a bigger role in the COVID-19 response, alongside all of America’s heroic healthcare workers.”

MPA is in conversations with the State on how Michigan pharmacists can safely be part of a solution that would include testing at pharmacies across the state. More information will follow as it becomes available.
CDC Updated Guidance to Pharmacies and Personnel
During COVID-19
Pharmacies are essential to the health of Michigan residents. Timely and accurate medication delivery is the foundation to treatment of disease. It is essential that we maintain the health of pharmacy staff so that pharmacies can maintain operations.

Based on an update from CDC MPA has revised the Best Practices document distributed on April 3. The revised items are in blue font with an "update" icon at the end of the item.
An Update from LARA:
Annual Inventory of All Schedule 2 to 5 Controlled Substances Deadline Extended
MCL 333.7321 requires an annual inventory of all schedule 2 to 5 controlled substances to be conducted no more than 30 days before May 1, and no later than 60 days after May 1.

At this time, the Governor has not explicitly waived this requirement. However, Executive Order 2020-42 states that businesses and operations that employ critical infrastructure workers (healthcare and public health workers) may continue in person operations, but “in-person activities that are not necessary to sustain or protect life must be suspended until normal operations resume.” The Department considers the annual inventory an activity not necessary to sustain or protect life. Therefore, pharmacies would be exempt from completing the annual inventory as long as Executive Order 2020-42 remains in effect.

Once Executive Order 2020-42 is rescinded, licensees would have sixty days to complete their annual inventories.
DEA Provides TWO Allowances for Non-registered Hospital Satellite/Clinics CS Management
The DEA has made new allowances as it pertains to the need to obtain separate DEA licenses for satellite hospitals or clinics as a result of COVID-19. These allowances will be in effect until the public health emergency ends, or until DEA specifies.

  1. The DEA will allow a DEA-registered hospital/clinic, under its existing DEA registration, to handle controlled substances at a satellite hospital/clinic location under their current registrations. (Seven requirements stipulated in DEA memo)
  2. DEA is providing flexibility to allow distributors to ship controlled substances directly to these satellite hospitals/clinics. (Five requirements stipulated in DEA memo)

The DEA also recognizes there will be cases where hospitals will be in situations where hospital patients are being cared for in a satellite hospital/clinic that is not a corporate affiliate of, or owned by, the entity that holds the DEA registration of hospital/clinic. The DEA provides instruction on a possible solution of entering into a written agreement that creates an agency relationship with the satellite hospital/clinic.
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.
A hand with a marker writing  Requirements .
FDA Announces Flexibilities for Compounding by
Outsourcing Facilities
The Food and Drug Administration (FDA) has announced new flexibilities for 503B outsourcing facilities that are compounding these medications for hospital use.
 
For the duration of the public health emergency, FDA will not take enforcement action against a 503B for compounding a drug for hospital use that is:
  • Essentially a copy of an approved drug;
  • Using bulk drug substances that are not on FDA's 503B bulks list; or
  • Not meeting good manufacturing practice (GMP) requirements regarding product stability testing and expiration dating. 
FDA's enforcement discretion only applies if a number of conditions are met, including:
  • The drug must appear on the FDA's list of drugs hospitals use to treat COVID-19 patients (the list is an appendix in the guidance).
  • The hospital purchasing the drug must inform the 503B that the drug will be used to treat COVID-19 patients and that the hospital made "reasonable attempts to obtain an FDA-approved drug product containing the same active ingredient for the same route of administration and has been unable to do so."
The guidance also includes details regarding the criteria for extended expiration dating and stability testing that does not meet GMP requirements. 
DEA Increases CII Quotas
The Drug Enforcement Administration (DEA) announced immediate actions it is taking to increase the availability of controlled substances for the manufacturing of drugs needed to treat COVID-19 patients. DEA's actions include:
  • Increasing annual production quota for controlled substances used for the treatment of mechanically ventilated COVID-19 patients, including fentanyl, morphine and hydromorphone
  • Increasing the amount of controlled substances, including, among others, ketamine and diazepam, that can be imported into the United States 
USP Operational Considerations for Sterile Compounding
during COVID-19 Pandemic
Many of you are aware that several drugs required to care for ventilator patients have been in critically short supply. Pharmacies in areas with widespread COVID-19 infections are sometimes faced with difficult decisions to discard these medications or use them past the current maximum <797> beyond-use dates. In response, USP has posted a document with considerations from the Compounding Expert Committee with considerations for sterile compounding during the COVID-19 pandemic.

The document includes a statement from USP supporting risk-based enforcement discretion related to compounding standards. It addresses the assignment of beyond-use dates, considerations for certification and re certification of engineering controls, and recommendations for cleaning and disinfecting a facility when someone is sick.

Note that the document includes support for some beyond used dates (BUDs) in the 2019 revision of Chapter <797>, including a four-day BUD for low- and medium-risk CSPs stored at room temperature. While the 2019 revision was remanded due to appeals, USP explains that these BUDs were based on stakeholder input during two previous rounds of chapter revisions and were thoroughly evaluated by the Expert Committee during that process.

Also note that USP establishes standards but does not enforce them. We will continue engaging regulatory agencies to request discretionary enforcement during this unprecedented shortage of critical pharmacy resources.
How to Defeat COVID-19 While Social Distancing:
A Pharmacist’s Guide to Folding@home
Oftentimes, small tasks can achieve large outcomes. Folding@home.org , a Stanford University computer network, is one of the largest and most powerful in the world. The organization’s roughly 2.4 million volunteers are currently donating unused processing powers derived from idle time spent on computers. Cluster computing excels when it is used to take on large tasks that can be broken down into smaller work units (WUs) and distributed across multiple computers for independent processing. Now it’s our turn to be part of this network battle to understand the current diseases that face mankind. Here’s what YOU can do to join Folding@home’s latest initiative to help out during the COVID-19 pandemic:

  • Become a member of the Michigan Pharmacists Association, team number 252410.
  • You will need a computer with a discrete graphic card
  • Download and install the Folding@home program by clicking here
  • Set up Folding@Home
  • Here’s a video on setup basics
  • Reboot your device after installing and setup
  • Note that our team number is 252410. Do NOT use your email address as your username; this is an open system.

It would be great if we could get enough Michigan pharmacists to help our team achieve a raking in the top 100. Keep up the good fight, and go team!
Michigan Seeking Qualified Volunteers
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 Preparedness Farah Jalloul or register here .
Re-credentialing Changes Related to COVID-19
In order to alleviate administrative burdens on network pharmacies, Express Scripts is immediately enacting changes to their policies regarding re-credentialing. You can read more here .