Shortages of frequently used drugs are a problem within the United States and abroad, with multiple implications on patient care.1 Drug shortages can occur for many different types of medication, ranging from chemotherapy to ADHD drugs to agents used in anesthesia.
The medication distribution system employed in the United States is a just-in-time system, meaning supplies are not re-ordered until they are low, thereby decreasing a hospital’s financial risk of purchasing unused medication. Accordingly, there are rarely, if ever, excess medications within the supply chain.2
To combat the clinical and economic ramifications of drug shortages, the United States Food and Drug Administration (FDA) proposed the Drug Shortage Prevention Act of 2023, which would require drug manufacturers to notify the FDA of increased demand, export restriction, or other circumstances which pose risk of inability of drug production to meet its demand.3 Currently, most drug shortages in the US are listed on the FDA “Drug Shortages” website.4
Anesthesia is one of the fields most affected by drug shortages. An American Society of Anesthesiology survey found that over 98% of respondents noted regular drug shortages at their institutions, with greater than 95% of respondents identifying these shortages as impactful on patient care.5 Currently, commonly used paralytics (e.g., rocuronium bromide injection and vecuronium bromide injection) as well as commonly used anesthetics and sedatives (e.g., dexmedetomidine hydrochloride injection and ketamine hydrochloride injection) are among the drugs noted to be in shortage on the FDA’s website.4
Drug shortages in anesthesia pose clinical and ethical concerns regarding the use of acceptable alternatives. Some anesthesiologists have expressed concerns about the uncertainty with using less familiar alternatives to the medications in short or no supply. Additionally, concern has been raised in using alternatives when they are known to cause more harm than the first-line medication. For example, one retrospective study found a higher incidence of post-operative nausea and vomiting when propofol was in shortage and anesthesiologists were forced to use alternatives than when propofol was not in shortage (incidence 5% vs 11%, respectively).6 With extremes in shortages, some anesthesiologists have noted concern regarding the safety and feasibility of starting or continuing a case, noting a feeling of personal responsibility for any adverse outcomes resulting from the use of the alternative medications.7
Hospitals and clinicians are acclimating to the frequent and prolonged shortages of key medications. Proposed methods to attenuate the deleterious effects of medication shortages include early warnings of drug shortages, education on alternatives, and frequent communication with pharmaceutical companies and wholesalers.8 A case series from one hospital demonstrated innovative uses of 0.75% plain bupivacaine due to shortages in the usual 0.75% hyperbaric bupivacaine employed during single-injection spinal anesthesia. A contingency plan was developed for spinal anesthesia during emergency cesarean delivery and was shown to be without delays and without an increase in the rate of general anesthesia.9
Drug shortages are a dilemma that many anesthesia professionals face in daily practice. Innovative use of acceptable alternatives is often employed during clinical care while legislative changes are occurring to address the systemic factors contributing to these shortages. The use of alternatives comes with tradeoffs including unavoidable side effects, potential for lack of comfortability with use, and possibility for cancellation of cases.

References

1. Ventola CL. The drug shortage crisis in the United States: causes, impact, and management strategies. P T Peer-Rev J Formul Manag. 2011;36(11):740-757.
2. Fox ER, Birt A, James KB, Kokko H, Salverson S, Soflin DL. ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. Am J Health Syst Pharm. 2009;66(15):1399-1406. doi:10.2146/ajhp090026
3. Klobuchar A. Drug Shortage Prevention Act of 2023.; 2023. https://www.congress.gov/bill/118th-congress/senate-bill/2362.
4. United States Food and Drug Administration. Drug Shortages. Published online 2024. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages
5. American Society of Anesthesiologists. Anesthesia Drug Shortages Negatively Affecting Patient Care, American Society of Anesthesiologists (ASA) Survey Finds. Published online April 24, 2018. https://www.asahq.org/about-asa/newsroom/news-releases/2018/04/anesthesia-drug-shortages-negatively-affecting-patient-care
6. Neff MP, Wagner D, Phillips BJ, et al. Propofol Drug Shortage Associated With Worse Postoperative Nausea and Vomiting Outcomes Despite a Mitigation Strategy. AANA J. 2018;86(2):147-154.
7. Sinow C, Burgart A, Char DS. How Anesthesiologists Experience and Negotiate Ethical Challenges from Drug Shortages. AJOB Empir Bioeth. 2021;12(2):84-91. doi:10.1080/23294515.2020.1839596
8. Moffett BS, Mossad EB. Drug shortages: implications on pediatric anesthesia practice and management resources. J Clin Anesth. 2012;24(8):677-679. doi:10.1016/j.jclinane.2012.04.015
9. Thenuwara KN, Dexter F, Ituk US, Weetman D. Case Series of Adaptive Changes in Clinical Practice and Trainee Education for Cesarean Delivery due to Drug Shortages of 0.75% Hyperbaric Bupivacaine in 2018. AA Pract. 2020;14(7):e01214. doi:10.1213/XAA.0000000000001214