In recent years, people around the world have experienced difficulty obtaining the medications they need to manage their acute and chronic health concerns. Adderall, amoxicillin, and Tamiflu have recently made news for being in short supply, but they’re just the latest in a long line of drugs whose availability has been disrupted. Many other drugs have suffered shortages over the years, as we in the anesthesiology community know all too well. Uncertainty over drug availability inevitably leads to questions. How big is the drug shortage problem? Is the problem getting worse or is recency bias simply making it feel that way? What is being done to combat it, and what can anesthesiologists and other physicians do locally and globally to alleviate supply challenges? In our role as clinical pharmacologists and patient safety advocates, anesthesiologists must understand the current problem and the answers to these questions.
The American Society of Health-System Pharmacists (ASHP) defines a drug shortage as “a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternate agent” (asamonitor.pub/3Edhq4k). Such shortages have existed for many years; the first recorded scarcity being that of insulin in the early 1920s (Front Pharmacol 2021;12:693426). Drug scarcity has been a global concern since then, with a Belgian pharmacy journal listing 21 countries affected by shortages during 2011 alone (Annales Pharmaceutiques Belges 2011;15:11-4). More recent statistics reported by the University of Utah’s Drug Information Service (UUDIS) show that 160 new drug shortages were identified and reported in 2022, with an average of 142 new shortages reported annually since 2001 and 152 annually in the last decade (asamonitor.pub/40TNKVa). The figures for active shortages are even more grim, with an average of 255 shortages ongoing at any point over the last five years. Among medical specialties, anesthesiology is particularly vulnerable to drug shortages. UUDIS statistics indicate that the three classes of medications experiencing the highest number of shortages at the end of 2022 were CNS-active agents, antimicrobials, and fluids and electrolytes, respectively. Moreover, injectable medications have accounted for 50% or more of reported new drug shortages in 16 of the past 22 years.
The Food and Drug Administration (FDA) reports that manufacturing quality issues are the primary reason behind drug shortages (asamonitor.pub/3KOR7XT). Sterile injectable drugs – even older ones – are made by a small number of manufacturers and have a complex manufacturing process and long production lead time, resulting in high production costs and limited production capacity. Individual companies may experience internal production delays or discontinue the production of a drug in favor of newer, more profitable agents – something the FDA has no power to prevent – and the aforementioned factors prevent other manufacturers from increasing their production quickly to fill unmet need in the market. Furthermore, pharmaceutical manufacturers rely on their own supply chains to provide the raw components for the drugs they make, and any disruption of that supply chain can cause downstream ripple effects that ultimately affect individual patients and providers.
While drug shortages have and will continue to exist, there are efforts being made at many levels to try to identify and mitigate their effects. The federal government has enacted legislation to help reduce drug shortages in the medical field. In 2012, the FDA enacted the Food and Drug Administration Safety and Innovation Act (FDASIA). This act requires manufacturers to notify the FDA of changes in the production of certain drugs with the intention of using this information to prevent and mitigate shortages. In conjunction with FDASIA, Executive Order 13588 allows early FDA notification and the ability to work with manufacturers to restore production of drugs. These actions by the FDA include determining alternative manufacturers, expediting inspections and reviews, investigating the root causes contributing to drug shortages, and developing risk mitigation strategies for a limited drug supply (asamonitor.pub/3moQmeD). The Coronavirus Aid, Relief, and Economic Security (CARES) Act, passed in 2020, expanded the requirements for manufacturers to notify the FDA of discontinuation or delays in certain drugs as well as reasons for each (asamonitor.pub/3GTA9Ft). It required that each person who registers with the FDA under section 510 of the Federal Food, Drug, and Cosmetic Act report annually the amount of drug manufactured. Additionally, in July 2021, the White House published the National Strategy for a Resilient Public Health Supply Chain, which outlined a strategy for supply manufacturing for future pandemics and biological threats (asamonitor.pub/41bB63u). This was a collaborative effort overseen by the Administration for Strategic Preparedness and Response, a division of the Public Health Service within the Department of Health and Human Services.
On a local level, when drug shortages occur, there are things that individuals and institutions can do to reduce the overall impacts. First and foremost, individuals should increase their awareness of drug shortages. By both being aware of and reporting known shortages, each of us can contribute to understanding the scope and magnitude of drug shortages. As consumers, being informed about shortages allows tailoring of our individual practice to reduce our impact on the drug shortage. ASA has an online form for reporting shortages (see graphic on the left) (asamonitor.pub/43lmCQf).
Additionally, both the FDA and the ASHP maintain databases of current shortages as well as the reasons for each shortage (asamonitor.pub/3Kq6Ue9; asamonitor.pub/3KMIOLZ). On an institutional level, the approach needs to be twofold. While communicating shortages is essential, there needs to be a robust plan for addressing the shortage. This includes actions such as determining patient populations that drugs will be allocated to, finding alternative drugs to substitute, and ensuring shared decision-making within clinical teams when drugs need to be apportioned. By collaborating and coordinating health system resources as well as modifying our individual practice to the extent possible, we can aid in solving the drug shortage crisis and maximize our collective ability to deliver outstanding perioperative care to our patients.