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PA Sterile Compounding PPE Waiver

Monday, March 23, 2020   (0 Comments)
Posted by: Gabrielle Webster
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Sterile Compounding PPE Waiver

The Department of State, Bureau of Professional and Occupational Affairs (BPOA), has issued specific regulatory/statutory provisions related to the State Board of Pharmacy be suspended for the duration of the COVID-19 emergency. The press release announcing these actions is available online herePlease check the State Board of Pharmacy website for full details on the specific regulation, waivers and guidance. It should be posted soon. 

PSHP has been engaged with the Board of Pharmacy on sterile compounding in the setting of PPE shortages, please read below. The press release issued by the Department of State does not mention allowing modifications of policies on use of protective attire used for sterile compounding. 

Guidance Regarding the Use of Personal Protective Equipment (PPE) and Compounding During the COVID-19 Emergency

“With regard to the requirements of 49 Pa. Code § 27.601 (“Compounding of Preparations”),[1] as they relate to the use or re-use of personal protective equipment (PPE) such as masks and the like, the State Board of Pharmacy advises applicable licensees to follow the recommendations and guidelines distributed by the United States Pharmacopeia (USP) itself, which may be found here.  A copy of that guidance (as of 3/18/20) is provided herewith at Appendix A.

During the COVID-19 emergency, the State Board of Pharmacy will likewise follow USP’s guidance for state regulators, which is to “use risk-based enforcement discretion related to the implementation of USP compounding standards.”

USP Response to Shortages of Garb and Personal Protective Equipment (PPE) for Sterile Compounding During COVID-19 Pandemic:

The most important statement in the USP document is “Garb for direct patient care personnel should take priority”.  The USP committee “offers strategies for consideration”.  The document provides recommendations but does not intend to take away any options.

We are aware to meet this need, hospitals in Pennsylvania have already instituted practices to reuse masks, by adapting recommendations from sources such as the Critical Point and the CDC. These steps would be reasonable with appropriate policies, procedures and facility specific rationale of resource availability at that time. 

Policy and procedures in support of any adjusted PPE practices are mandatory if a facility must take these steps.  Facility specific policies around use of alternative products must be dynamic as availability changes.  Policy changes must be accompanied by staff training in these modified procedures.  Facility specific policies around use of alternative products must be dynamic as availability changes.  Policy changes must be accompanied by staff training in these modified procedures.

One PSHP Board member spoke of their institution tiering their sterile compounding PPE policy based on availability, so that there is a phased in process based on their current stockpile availability.  They used a Green-Yellow-Red approach!  

Other PSHP Board members are making staff their own disposable masks with lint free material and rubber bands and have a commissioned local business to sew washable cloth masks made from non-cotton material for use in the cleanroom per USP guidance.

In addition to advocacy through frequent communication with the Board of Pharmacy, PSHP is trying to help through idea sharing is detailed at the bottom of the email.

If you have figured out good procedures to comply with the USP please share them with your colleagues by email.

Other Important Guidance / Waiver’s include (this is abbreviated for the purpose of an alert and the original board document MUST be references to understand full scope):

  • Temporary waivers around direct supervision of Pharmacy Technicians, such that during the COVID-19 emergency the Board will interpret the phrase “direct, immediate and personal supervision” to include: “A pharmacist may provide direct or personal supervision of pharmacy interns and pharmacy technicians conducting remote processing via technological means.”
  • Temporary waivers to allow for out-of-state practitioners to practice in Pennsylvania during the COVID-19 emergency, to assist in the event that there is a shortage of available Pennsylvania-licensed practitioners.
  • Temporary guidance Regarding Notification to State Board of Pharmacy in the Event of Pharmacy Closures
  • Temporary Waivers around non-resident pharmacies with business relationships with Pennsylvania pharmacies and access to common patient files, to help  ensure that Pennsylvania citizens receive their medications with little to no interruption.
  • Waivers to support Pharmacists with Active Authorizations to Administer Injectables in the face of cancelations of CPR classes.

What PSHP is doing to help?

Our national organization, ASHP, is supporting us with a variety of valuable information.  Within Pennsylvania we are trying to help share creative efforts to support patient care and sterile compounding.  Please contribute and we will share these daily in a blast and post them on PSHP’s website.  Also, please email with concerns that you may have so we can ask others to share.

Concerns expressed from our Pharmacy Technician Board member including communication to pharmacy technicians delivering medications to patient care units and personal protective equipment. 

The State is considering if actions related to increased chloroquine and hydroxychloroquine outside of FDA approved use in outpatients is warranted.  Some health systems with outpatient facilities have decided not to fill new prescriptions for chloroquine or hydroxychloroquine, to patients that have not previously been on this therapy. What is your experience and suggestions to pass on to the Board of Pharmacy?

During this crisis, PSHP will be posting a Daily 7:00 am, E-Mail BLAST to all Directors’ of Pharmacy throughout Pennsylvania, and hope to make this information useful and applicable to PA Pharmacists.

To make this information meaningful, please provide us feedback on what you would like to see in this BLAST and all are invited to please contribute information to post by submitting your information to either: Larry Jones or Christine Roussel

Disclaimer:  The information provided in our message is intended to be shared across all Directors of Pharmacy in Pennsylvania and our PSHP members for individual determination, to assist facilities with product and/or service alternatives (suggestions only) as appropriate for Peer Review.  It is not intended to be interpreted as a mandate or as a PSHP-supported modification nor as an acceptable regulation alternative.  For this the PA State Board of Pharmacy has the final authority.

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