The impact of COVID-19 on Pharmacy Personal Protective Equipment (PPE)

COVID-19 has taught us many things, among them that our healthcare supply chain is poorly designed and flimsy. Just a few weeks into the pandemic and our supply chain for Personal Protective Equipment (PPE) has been completely disrupted. PPE is now in short supply, and I suspect that we will run out of PPE in just a few weeks if things continue on their current trajectory.

Are we using more PPE because of COVID-19? Of course! But we are unable to spin up production because a vast majority of the products we need are not made in the United States and the world is in lock down. An industry that is literally designed to provide care to others and save lives has no supply chain redundancy, no failover strategy for shortages, and no geographical diversity for equipment and supplies.

Any pharmacy that compounds sterile medications – intravenous antibiotics, for example – is required to wear a lot of PPE. Guidelines have lead to staff being required to wear a clean, low-lint gown, bouffant (head cover), mask, shoe covers, and sterile gloves when entering the buffer area of a pharmacy cleanroom; I also have to wear a beard cover, but most do not.

When leaving the area, a vast majority of the aforementioned PPE gets tossed, i.e. wasted. Up until about a week ago, much of the PPE worn by pharmacy personnel could not be reused. Now, because of the pandemic, regulatory agencies are lifting these restrictions. It’s an interesting shift in thinking.

In general – in theory? – the use of PPE during sterile compounding is designed to decrease risk of introducing bioburden into process. I suppose that makes sense. Unfortunately, the risk has never been quantified to any appreciable manner. There are no before and after statistics to determine whether or not strict adherence to PPE guidelines has done anything to improve sterile compounding safety, or lesson the risk of contamination. One thing is does, however, is generate a ton of waste and increase the cost of sterile compounding significantly .(1)

Current garbing practices are basically at the whim of groups like the United States Pharmacopeia (USP). The process by which USP creates these guidelines is not at all transparent. We have no idea what thought and/or research goes into their recommendations. Unfortunately, USP guidelines are frequently – almost universally – adopted in whole or part by other regulatory agencies like Boards of Pharmacy, Departments of Public Health, The Joint Commission (TJC), and so on. Few ever question the decisions because everyone is too busy trying to follow the rules and take care of patients to fight it.(2)

Over the past couple of weeks, organizations and regulatory agencies have been pulling back on the requirements for sterile compounding PPE, due in no small part to the disruption in the supply chain caused by COVID-19. It’s an evolving situation.

As we move through this crisis, I recommend the following:

  • Review your current PPE practices. Some folks are doing way more than is required. While noble on the surface, doing so is adding to the shortage and not necessarily benefiting anyone.  A prime example is pharmacies that use full PPE in anterooms.
  • Re-use PPE when allowed. See most recent USP recommendations here.
  • Do not place re-used PPE in plastic bags for safekeeping. I saw this recommendation somewhere and it makes no sense to me. People perspire in PPE, and zipping it up in a bag is akin to a makeshift incubator.
  • Sign up for USP, TJC, and local Board of Pharmacy email communications. Things are changing rapidly, at least they have been here in California. We’ve had to make several adjustments over the past 7-10 days, and I expect we’ll have to make even more in the coming weeks. It’s going to get weird.
  • Use common sense. Folks, pharmacists are highly trained, specialized professionals. Now is not the time to be averse to making judgement calls. It’s why we spent all those years in school and get paid the big bucks. Use your head. Be smart but be flexible.

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  1. It is not uncommon for large hospital pharmacies with busy cleanrooms to spend more than $10K per month on disposable PPE. Think about that the next time a hospital administrator complains about spending $3K on a “non-formulary” course of therapy
  2. Recently, a group successfully blocked the publication of new USP <797> guidelines. One of the reasons the group went after USP was due to lack of transparency in their process and failure to provide information when comments and requests were ignored.

Pharmacy Integration is Starting to Make Sense

I’ve been writing about the need for pharmacy integration for years. Most of it negative, and deservedly so because it’s been lousy.

With that said, things appear to have changed in recent years. Integration, it seems, has slowly become a thing. Maybe because I’ve been out of general pharmacy practice for so long that it seems decent, or maybe it’s getting better. Hard to tell, honestly.

Pharmacy systems aren’t really talking to each other better than before, per se, but the number of disparate systems seem to have decreased over the years. Once there were many, now there are seeming few. Once, everything was “best-of-breed”, now things are moving to one system to rule them. Case in point, electronic health records. (EHRs).

I always thought pharmacy integration would take place from the inside out, i.e. pharmacy systems would integrate with other systems and drive information sharing across the hospital. Not even close. Instead, pharmacy systems have become more integrated by being consolidated and sucked into the EHR.

The advent of EHRs has done more for system integration in healthcare than just about anything else. I have plenty of negative things to say about EHRs, but it’s clear that they’ve changed the way we practice, forever.

The way I see things – at least now – most healthcare systems have fallen into two large buckets: 1) documentation – clinical and other; and 2) operational logistics.

Clinical Documentation: Clinical documentation used to take place in “the chart”, among many other places. The chart was nothing more than a binder filled with dividers, separating one bit of information from another. Think of a Trapper Keeper, minus the cool picture on the cover. Paper was everywhere. If you wanted to read something about a patient, like a progress note or radiology report, you had to go to the chart, which wasn’t always easy. They had a way of walking away with physicians and not making their way back to the nursing station.

This all changed when EHRs hit the scene. Everything from demographic data to notes, lab values, medication information, and so on is at your fingertips. If you need information, all you do is log into the EHR and go hunting. Admittedly, it’s not as easy to navigate as a paper chart, but it’s a heck of a lot more data rich and never walks away.

Most of the information coming out of hospital pharmacies these days can be found in EHRs. That includes medication distribution information, pharmacist notes, barcode archives, and so on.

Operational Logistics: Think Amazon warehouse. That’s the easiest way I can explain pharmacy logistics. You buy something from a third party, store it in the pharmacy for a period of time, and send it to a patient when it’s ordered. Simple, really. We’re still not very good at it, but that’s the gist.

For the most part, pharmacy logistics has maintained its distance from the influence of EHRs. Instead, inventory management has been driven largely by a other, non-EHR companies: CareFusion, Omnicell, and to a lesser extent, Swisslog. These companies have grown and expanded over the years, increasing their portfolios to cover more and more areas of the pharmacy.

I’ve mentioned the “four areas of pharmacy” many times: standard storage, refrigerated storage, controlled substance storage, and the iv room. The first three areas are still dominated by these companies. Carousels, inventory software, refrigerators, various cabinets controlled by remote locks, and automated packagers can be found in most large pharmacies. All of which are offered by the aforementioned companies. There was a time when it was common for any number of these products to be supplied by different vendors. Not so much anymore.

These days, it’s all about integrated systems from a single vendor. When given a choice, pharmacies are deciding to purchase from a vendor that can “do it all”. For example, CareFusion offers Pyxis ES ADUs for medication distribution at the point of care; Pyxis Logistics software and hardware for medication distribution from the pharmacy; Pyxis CII safe to manage controlled substances; BD Cato for the IV room; and so on.

With that said, the IV room is in a state of flux. The nature of this area lends itself to both operational logistics and documentation, the latter of which seems to be more important now more than before. It may be the only area of the four where inventory management means less than documentation. I expect this trend to continue.  

Surprisingly, I really have seen better integration amongst pharmacy systems these days. I fully expect it to improve even more as EHRs expand and eventually creep into operational logistics. At least one EHR vendor has already made a significant impact in the IV room. Eventually, pharmacy will be just another department within the EHR’s web of control. I see both good and bad in such a future, but that’s a blog post for another time.