US shortages of agents used to treat poisonings over the last 10 years (2012-2021)

ABSTRACT

Background: Drug shortages represent a longstanding challenge for healthcare providers, including toxicologists, who continue to confront scarcities of antidotes and other agents used to treat poisonings. Prior research examining availability of drugs with toxicologic applications from 2001 to 2013 demonstrated broad shortages including anticholinergic, cholinergic, and cyanide antidotes, anti-hypoglycemics, chelators, antivenom, naloxone, sedative- hypnotics, and decontamination products, many of which were unresolved and involved xenobiotics without therapeutic alternative. Reports of vital agents being scarce or unobtainable have continued since 2013, and new pressures on global and US (United States) supply chains have emerged, most notably the COVID-19 pandemic. Given this, up-to-date analysis of shortages of agents used to treat poisonings is needed. Method(s) US drug shortage data from January 2012 to December 2021 were obtained from the University of Utah Drug Information Service. Shortage data for agents used to treat poisonings were analyzed. Information on drug type, formulation, shortage reason, shortage duration, number of manufacturing sources, substitute availability, and substitute agent shortage during the study period were investigated. Result(s) 1570 drug shortages were reported during the study period;230 (14.6%) involved agents used to treat poisonings. Of the 230 shortages, 21.3% were unresolved as of December 2021. Mean shortage duration was 13.6 months. The longest shortage involved intravenous calcium gluconate and lasted 78 months. Intravenous dextrose products were the agent most frequently affected by shortage, with 20 shortages in total. 58 agents had multiple shortages. Total shortages peaked in 2017 with 33 shortages reported. 20 shortages were reported in 2020 and 24 in 2021 during the COVID-19 pandemic. 10.9% of shortages involved single-source products;however, this number is limited by incomplete reporting. 80.9% of shortages involved parenteral products. Agent classes with the most shortages reported were Sedative-hypnotics (12.2% of shortages), anti-hypoglycemics (9.6%), anticoagulant reversal (7.8%), vitamins/electrolytes (7.4%), blood pressure support (7%), antihypertensives (6.5%), antimuscarinic delirium (4.8%), and chelators (4.3%). Three naloxone shortages were reported, one of which is ongoing due to increased demand. Buprenorphine and methadone shortages were reported but are resolved as of December 2021. New shortages of multiple pressors and flumazenil were reported. The most common reason for shortage was a manufacturing issue, occurring in 36.1% of shortages. Shortage reason was not reported 37.8% of the time. For 77% of shortages an alternative therapeutic agent was available, however 97% of alternatives were also affected by shortage at some point during the study period. Conclusion(s) Shortages of agents used to treat poisonings remain problematic. For the time period 2011-2021 previously reported shortages of many products persist and new shortages have emerged. The ongoing naloxone shortage is particularly concerning given the continued rise in drug overdose deaths in the US in 2021, as are shortages of buprenorphine and methadone used to treat opioid use disorder. Despite supply chain stressors, total shortages did not peak during the COVID-19 pandemic.