With the recent addition of famotidine to the U.S. Food and Drug Administration’s (FDA) list of drug shortages, the number of unavailable drugs is now well over 100. As a consultant pharmacist, I know that drug shortages have been on the radar for many years and will likely continue to be…so, why is it any different this time around?
As we are all far too aware by now, the ongoing COVID-19 pandemic has led to many disruptions in our daily lives — from minor inconveniences to major disruptions. In addition to altering many routines, this public health emergency has led to many shortages. Almost as soon as we learned about the lack of personal protective equipment (PPE), we started to hear about severe shortages of some critical medications. As usual, some of the most common frequent flyers on this list are anesthesia medications, antibiotics, controlled substances such as fentanyl and midazolam and, at times, even intravenous fluids.
Let’s explore three key reasons as to why, this time, the situation is a bit different:
- Shortages are more severe: Unfortunately, the shortages being experienced are, in some cases, more severe than usual. The reason for this is the global nature of both the economy and the current public health emergency. Many of the shortages we have experienced in the past have been related to a single crisis or incident in one country or location. Additionally, many disruptions are usually related to one reason such as lack of raw materials or interruptions at a particular plant. The COVID-19 outbreak, however, has impacted just about every country on the globe and the various phases of the drug supply chain. As a result, the disruptions are more common and more severe.
- Shortages will last longer: Some of the shortages will last longer than past shortages. Uncertain situations often cause people to act in irrational ways. You have probably noticed that toilet paper has been difficult to find at the supermarket — similar dynamics are also at play when it comes to managing medical supplies. Not only do people stock up on items they will likely need, they also stock up on items they probably will never use, but they do it “just in case”. Although it always pays to be well prepared, it rarely pays to hoard items. This often leads to unavailability for those who truly need supplies and, for those who didn’t need them, it will also cost time and money to later dispose of medications that go unused. Due to the unknown nature of this crisis, the additional strain upon current supplies will likely continue for some time. Following Centers for Disease Control and Prevention (CDC) updates will be a good way to determine predictions on the likelihood of a second phase or even the possibility of a seasonal impact of COVID-19.
- Compounding pharmacies have more guidance from the FDA: The FDA, like the rest of us, has had to make adjustments based on the day-to-day changes the pandemic has caused. Among those changes have been emergency use authorizations for some medications and medical supplies. If you’re wondering what an EUA is, read our post “What is an Emergency Use Authorization by the FDA?” Additionally, the FDA has provided more guidance and eased some restrictions for compounding pharmacies. This could allow these pharmacies to make available medications that would otherwise be on the shortage list and unavailable.Facilities should consider using compounding pharmacies — not just to mitigate some of these shortages, but also as another resource for other products that may be available in different dosage forms and may provide convenience and even for cost savings. Before you engage a compounding pharmacy, however, be sure to perform due diligence. Not all compounding pharmacies are alike: determining if one is a good fit for your operation requires a bit of legwork (it’s an area where your consultant pharmacist should excel). If you haven’t, engage the services of an expert consultant pharmacist to ensure a proper vetting process is followed. Doing so will not only enhance patient safety, but will likely save you a lot of money too by reducing your risk and liability.
In a previous post I discussed Ten Steps to Dealing with Drug Shortages: item number two on that list is checking the list of FDA Drug Shortages. One additional FDA resource that may be useful in dealing with shortages is the Search List of Extended Use Dates to Assist with Drug Shortages. This list provides expiration extensions by the FDA to allow facilities to continue to use medications that would otherwise be considered expired. We recommend properly labeling any medication that has been extended by the FDA, or that may be unavailable and additionally track and document all attempts at obtaining it. We provide a tracking tool for all our customers. Please reach out to us if you are currently not following this process or need help with a proper tracking document.
If you have questions or need help navigating drug shortages to avoid interruptions in care and maintain patient safety, please contact us and we will walk you through a plan that is specific to your facility.
The Consultant Pharmacists at OctariusRx provide guidance on safe medication management, survey readiness and cost savings to ambulatory healthcare facilities/surgery centers, senior care facilities and pharmacies We also help individual patients optimize their medications to improve their quality of life and save money. Contact us for assistance.