More drug shortages are expected and could impact ambulatory surgery centers (ASCs). Some of the most commonly used medications in ASCs, such as propofol and the local anesthetics, continue to show up on the most recent drug shortage lists. Does your facility have a plan in place to ensure an ongoing supply and minimize disruptions to patient care?
It’s not surprising to see propofol or local anesthetics like lidocaine and bupivacaine on the most recent shortages list. After all, these medications have been on and off the list intermittently over the last few years. The ongoing COVID-19 pandemic hasn’t helped the situation. Drug shortages are not new, and they likely will not go away anytime soon. What is most important is for facilities to be proactive instead of reactive. Beyond the plan to replace the medication, it’s also important to be proactive about protecting patients from the potential risks that come with using different products.
The issues caused by drug shortages go way beyond the simple problem of replacing that missing drug. Drug shortages have a way of impacting patient safety in dangerous ways when providers find workarounds for a particular drug they use commonly in their practice. It may be something as simple as ordering a multi-dose vial to replace the unavailable single-dose vials. This can lead to improper use, labeling and concerns with bloodborne pathogens. This is just one example. Do you have procedures and a system for properly handling single dose versus multi-dose vials? Remember, the multi-dose vial is not just a bigger version of the single-dose vial. Different rules apply and you need to make sure your staff and anesthesia team are aware and on the same page.
Due to the ongoing shortages, the U.S. Food and Drug Administration (FDA) has recently issued an Emergency Use Authorization (EUA) for propofol-lipuro 1% emulsion, which is not approved for use in the United States. If you’d like to learn more about EUAs, please see my previous post titled “What is an Emergency Use Authorization by the FDA?”. Propofol-lipuro 1% emulsion is only indicated to maintain sedation via continuous infusion for patients greater than 16 years of age who require mechanical ventilation in an intensive care unit. Although not approved for use in the ASC setting, the availability of an additional product, could help ease the ongoing shortages for ASCs.
What can you do at the facility level? There is no quick and easy solution here. Completely avoiding all drug shortages is nearly impossible. Navigating your way around them is very possible but requires expertise and pre-planning. If you’re not working with a consultant pharmacist who specializes in your area, consider doing so. Always make sure you are working with someone who is qualified…remember, anyone can call themselves a consultant. We have several tools at our disposal to help our clients make the right choices and then properly document and track them for compliance purposes.
One of my go-to lists of suggestions is something I wrote a while back, long before we worried about COVID. Here I discussed Ten Steps to Dealing with Drug Shortages, which should help you avoid the worst of the problem. Being ahead of the curve is critically important. I suggest starting with the list of FDA Drug Shortages. This will allow you to confirm shortages and perhaps stay ahead of the curve.
Secondly, the FDA’s Search List of Extended Use Dates to Assist with Drug Shortages will allow you to extend the expiration date on certain products, so you can continue using medications that would otherwise be considered expired. We recommend properly labeling any medications that have been extended by the FDA, or that may be unavailable, and track and document all attempts to obtain these medications. 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.
What about medications that have expired, but have not been extended for use by the FDA? Are expired medications still good? What happens after the expiration date? This is a topic that comes up all the time and I discussed in a recent post titled “Are Expired Medications Still Good?”.
One additional option that may save the day is the use of compounding pharmacies. Although they face many of the same restrictions in obtaining products, they often have options that may help you in a pinch. You will have to do some due diligence prior to exercising this option. Your consultant pharmacist should guide you on properly vetting a compounding pharmacy prior to working with them. This includes verifying state licensing, FDA 503B registration, and reviewing all FDA inspection findings to help you make an informed and safe decision. Don’t let the word “compounding” scare you. There are many great pharmacies providing safe and effective alternatives out there. The key is making sure you are working with a good one and your pharmacy consultant should be able to give you guidance on this topic.
If you have additional questions or find yourself struggling to navigate this difficult topic on your own, please reach out and we will answer your questions.
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.
