Drug Shortages: Implications for Anesthesiology

February 5, 2020

Drug shortages can occur for various reasons, including manufacturing and quality problems, delays and discontinuations.1 Problems in the medical supply chain can lead to “stock outs,” which can affect patient care on a global scale.2 In some cases, medication shortages represent deeper public health issues that cause patients’ medical needs to surpass production rates.2 In particular, shortages of anesthetic medications can have a particularly harmful effect on patients given their uses in pain management and anesthesia.3 Anesthesia providers should be familiar with the causes and ramifications of drug shortages and the implications for anesthesiology.

According to the United States Food and Drug Administration (FDA), drug shortages in the U.S. are caused by lack of incentives for manufacturers to produce less profitable drugs, failure to reward manufacturers that focus on supply chain improvement and logistical and regulatory challenges that make it difficult for the market to recover from disruption.4 Additionally, manufacturing quality problems account for almost half of all U.S. drug shortages.5 Delays in shipping and quality or quantity issues with an active pharmaceutical ingredient can lead to further shortages.5 Unanticipated increases in global demand can make it difficult to distribute enough medicine for all patients.6 In order to manage drug shortages, health systems and institutions should have a plan that includes assessment, preparation and contingency; implement structured communications between distributors and health centers; avoid buying from unofficial supply channels, even in dire cases; and optimize inventory stocks.7 A lack of structures and plans may lead to increased workload on staff, greater institutional costs and risks to patient care.8 Recent studies have proposed changes to mitigate medicine shortages that range from establishing an international definition of drug shortage2 to creating facility-based drug shortage task forces.8 Because drug research, policy and distribution are so complex, health professionals and policymakers must evaluate each step in the process to properly prevent shortages.

The practice of anesthesiology can be particularly affected by drug shortages. De Oliveira et al. found shortages of anesthetic drugs due to manufacturer issues, recalls and delays, as well as increased demand.9 These drugs included those critical to anesthesia care, such as hypnotics, benzodiazepines, opioids, muscle relaxants, opioid antagonists for overdose emergencies, non-opioid analgesics, diuretics, antihypertensive drugs, vasopressors, antiarrhythmic drugs and others.9 Twelve of the drugs—including diazepam, morphine, thiopental and propofol—showed shortages for than a year.9 In a survey of the Canadian Anesthesiologists’ Society, 65.7 percent of respondents described a shortage of one or more anesthesia or critical care drugs.3 Drug shortages in anesthesiology can be dangerous, as many drugs do not have viable substitutes, drug rationing may occur, medication errors are more likely, patient side effects will differ and replacements may be more expensive.10 A study by Neff et al. found that a propofol shortage was associated with worse postoperative nausea and vomiting outcomes despite a mitigation effort with prophylactic antiemetics and inhalational anesthetics.11 Carniol et al.’s showed that Hurricane Maria’s effect on Puerto Rico led to shortages in lidocaine and bupivacaine in North America.12 These shortages led to various sized bottles of anesthetics with various concentrations, thus complicating the typical anesthesia protocol and posing potential dangers to patients.12 Because patients can be directly affected by these shortages, it is crucial to alert patients and their caregivers when a shortage occurs.9 According to Hsia et al.’s study, the majority of surveyed patients in a Canadian hospital wanted to be informed of any drug shortages that might affect their care.13 Additionally, Orlovich et al. stress that patients should be part of the decision-making process regarding their postoperative pain management during a drug shortage.14 The effects of drug shortages on anesthesia providers’ practices are significant, and clinicians and patients alike should be informed of the potential effects.

Drug shortages are caused by problems with materials, manufacturing and distribution, and they can have harmful effects on institutions, clinicians and patient care. Anesthesia providers should be prepared to deal with drug shortages and should actively communicate with patients if a shortage occurs. Future studies should aim to quantify the extent to which anesthetic drug shortages affect patient care and institutional health care costs.

1.         U.S. Food and Drug Administration. Drug Shortages. Drug Safety and Availability January 15, 2020; https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages.

2.         Acosta A, Vanegas EP, Rovira J, Godman B, Bochenek T. Medicine Shortages: Gaps Between Countries and Global Perspectives. Frontiers in Pharmacology. 2019;10(763).

3.         Hall R, Bryson GL, Flowerdew G, Neilipovitz D, Grabowski-Comeau A, Turgeon AF. Drug shortages in Canadian anesthesia: A national survey. Canadian Journal of Anesthesia/Journal canadien d’anesthésie. 2013;60(6):539–551.

4.         Drug Shortage Task Force. Drug Shortages: Root Causes and Potential Solutions. White Oak, MD: U.S. Food and Drug Administration; October 29, 2019.

5.         U.S. Food and Drug Administration. A Review of FDA’s Approach to Medical Product Shortages. Washington, D.C.: U.S. Department of Health and Human Services; October 31, 2011.

6.         Gray A, Manasse HR. Shortages of medicines: A complex global challenge. Bulletin of the World Health Organization. 2012;90(3):158–158A.

7.         Cooley H, Leventis C. Best Practices for Hospitals and Health Systems in an Era of Drug Shortages. Preparing for Drug Shortages 2015; https://www.mckesson.com/Blog/Preparing-for-Drug-Shortages/.

8.         Shaban H, Maurer C, Willborn RJ. Impact of Drug Shortages on Patient Safety and Pharmacy Operation Costs. Federal Practitioner. 2018;35(1):24–31.

9.         De Oliveira GS, Theilken LS, McCarthy RJ. Shortage of Perioperative Drugs: Implications for Anesthesia Practice and Patient Safety. Anesthesia & Analgesia. 2011;113(6):1429–1435.

10.       Fields R. 7 Serious Effects of Anesthesia Drug Shortages on Surgery Centers. Becker’s ASC Review. Web: Becker’s; February 9, 2012.

11.       Neff MP, Wagner D, Phillips BJ, et al. Propofol Drug Shortage Associated With Worse Postoperative Nausea and Vomiting Outcomes Despite a Mitigation Strategy. AANA Journal. 2018;86(2):147–154.

12.       Carniol ET, Gantous A, Adamson PA. Local Anesthesia Shortages—Adapting to a New Way of Life. JAMA Facial Plastic Surgery. 2018;20(5):430.

13.       Hsia IK, Dexter F, Logvinov I, Tankosic N, Ramakrishna H, Brull SJ. Survey of the National Drug Shortage Effect on Anesthesia and Patient Safety: A Patient Perspective. Anesthesia & Analgesia. 2015;121(2):502–506.

14.       Orlovich DS, Mincer SL, Domino KB. Analgesic Medication Shortages: Inform Our Patients via a Shared Decision-Making Process. Anesthesia & Analgesia. 2020;130(1):265–270.