Since the turn of the 21st century, drug shortages, especially those related to anesthetics, have compounded. Despite the passing of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), which included the Strategic Plan for Preventing and Mitigating Drug Shortages, anesthesiologists across the country continue to be among the most affected by the shortages.
The underlying reasons behind the anesthesia drug shortage include difficulties in obtaining raw materials, changing drug company production schedules, increasing regulations, and the shutting down of many manufacturing plants by the government. In addition, the shortage is self-perpetuating and is caught in a vicious cycle that makes many facilities and their personnel feel like they have to hoard drugs in order to stay afloat and maintain a sound medical practice. Finally, the legal system and bureaucratic red tape also share some of the blame, as the amount of legislative and administrative work surrounding the manufacturing of anesthetic drugs can dissuade companies from increasing drug production.
Today, one of the most pressing issues in anesthesia includes the shortage of local anesthetics, which is forcing many anesthesiologists to adapt to a new school of thought for drug administration. In a May 2018 comment and response from JAMA Facial Plastic Surgery to the American Medical Association (AMA), physicians identified Hurricane Maria’s effect on Puerto Rico and the pharmaceutical manufacturing industry as a major issue. Centers across the country have recently started receiving various sizes of bottles for anesthetics in varying concentrations with non-standardized concentrations of epinephrine. The toxic effects of combining anesthetics are additive, meaning that 50% of the toxic dose of one drug (e.g. lidocaine) with 50% of the toxic dose of another drug (e.g. bupivacaine) is equivalent to 100% of the toxic dose for the patient. Therefore, anesthesiologists, now more than ever, need to consider how their current protocols for administration may be affected by varying doses and concentrations of received drugs. For some anesthesiologists, the most effective solution has been to develop new, malleable protocols that can be adjusted as medications become available.
The unfortunate reality remains that drug shortages necessitate the purchase, preparation, and administration of varying brands or concentrations of drugs, which ultimately jeopardizes patient safety. The anesthesia drug shortage is a fluid and increasingly complex issue that mandates adaptive medical practice as well as increased public and legislative action.
References
Orlovich, D. S., & Kelly, R. J. (2015, February). Drug Shortages in the U.S. A Balanced Perspective. Retrieved May 15, 2018, from https://www.apsf.org/article/drug-shortages-in-the-u-s-%C2%AD-a-balanced-perspective/
Vaidya, A. (2014, October 16). Anesthesia drug shortages are a reality: 5 options for ASCs. Retrieved May 15, 2018, from https://www.beckersasc.com/anesthesia/anesthesia-drug-shortages-are-a-reality-5-options-for-ascs.html
Carniol, E. T., Gantous, A., & Adamson, P. A. (2018). Local Anesthesia Shortages—Adapting to a New Way of Life. JAMA Facial Plastic Surgery.