A new drug shortage for ambulatory surgery centers (ASCs) is something we hear about all too frequently. Today we discuss the shortage of fat emulsion, a necessary reversal agent and the impact it can have both on patient safety and regulatory compliance.
Are you familiar with Local Anesthetic Systemic Toxicity (LAST)? It’s rare, but a potential life-threatening complication of using local anesthetics for regional anesthesia and one that anesthesiologists and certified nurse anesthetists (CRNAs) have known about and dealt with since local anesthetics were introduced. So, what are the clinical and regulatory requirements to consider? How does this shortage affect patient care and what can you do about it?
Licensing and accrediting organizations such as the Centers for Medicare and Medicaid Services (CMS), Accreditation Association for Ambulatory Health Care (AAAHC), The American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) and The Joint Commission (TJC), recommend that facilities have reversal agents available when one exists. AAAHC specifically requires that whenever a “high-alert medication is present for which there is an antidote, rescue, or reversal agent, the agent is stocked in the same area as the medication along with appropriate directions for use.”
From a regulatory standpoint, we are required to have the medication. From a clinical standpoint, it is a best practice and part of the American Society of Regional Anesthesia and Pain Medicine Local Anesthetic Systemic Toxicity checklist. Specifically, the list recommends practitioners consider administering lipid emulsion early. Having fat emulsion is one step, the other step is having the required dosing posted. To meet this requirement, we provide a poster to each of our clients which clearly breaks down the dosing and administration of lipid emulsion. If you have questions or are not meeting this requirement, let us know and we can help.
Why is lipid emulsion in short supply and how does this impact patient care?
There are various preparations of fat emulsion and the reasons for the different shortages are varied, but usually involve disruptions of the global supply chain. On August 3rd, Baxter announce that it was placing two products (Intralipid and Clinolipid) on allocation and expect the products to be on allocation until sometime in the fourth quarter of 2021. The potential impact to patient care ranges from disruptions in parenteral nutrition, where lipid emulsion is most used, to unavailability for emergent situations such as LAST.
Even though it is unlikely to be used, we have established the clinical and regulatory requirements to make lipid emulsion available. Most lipid emulsion is being used for the purposes of enteral nutrition and although ASCs need to have it, the quantities are much smaller, and this helps to mitigate the impact. The American Society of Parenteral and Enteral Nutrition ASPEN) has developed a list of ways to deal with shortages of lipid emulsion. Among the recommendations is to consider using an alternative fat emulsion product such as a four-oil (soybean oil, medium chain triglycerides, olive oil and fish oil) during a soybean oil-based shortage. Additionally, consider ordering only what you need to avoid worsening the shortage and to allow for fair allocation for patients who need it nationally. For additional tips on dealing with drug shortages, read my previous post titled “Ten Steps to Dealing with Drug Shortages”.
Drug shortages are never fun to deal with and their impact on our practices are always different. This particular shortage impacts a product that in rarely used, but when needed, it can be lifesaving.
Navigating shortages takes effort and expertise. If you have questions about this post or need help with this or other shortages, please reach out.
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.
