Anesthesia Drug Shortage: An Ever-Changing Problem

By June 22, 2018Uncategorized

Drug shortages across disciplines of medicine are not uncommon and can occur for many reasons, including difficulties in obtaining raw materials, shifts in manufacturing companies, government regulations, and more. However, a few years into the 21st century, the United States began to suffer from a prolonged drug shortage, especially in anesthesia. In response, in 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA), which gave the FDA more authority to act on the issue. FDASIA mandated manufacturers to notify the FDA of almost any potential issues that may affect their production output. Shortly after, in 2013, the FDA released its Strategic Plan for Preventing and Mitigating Drug Shortages, which had two goals: 1) to mitigate drug shortages and 2) to develop strategies for long-term prevention.

Despite governmental action, anesthesiology remains one of the most affected areas of practice. A 2014 report released by the Government Accountability Office (GAO) found anesthetic and central nervous system drugs to be among the class of drugs that accounted for 17 percent of all shortages in the United States. The shortages resulted in anesthesiologists citing less than optimal anesthetic outcomes, an increase in minor complications, and prolonged surgical and recovery times.

Anesthesia Drug

When brands and concentrations of available drugs continuously change, the burden on anesthesiologists to develop and adhere to new protocols without jeopardizing patient safety significantly increases. As a result, some facilities and personnel hoard drugs that are susceptible to shortages. In turn, this causes many potential shortages to swiftly become actual, nation-wide shortages.2

Today, the 2017 nationwide shortage of lidocaine with epinephrine persists, as there continues to be an epinephrine shortage and only 2 pharmaceutical companies (Pfizer and Fresnius Kabi USA) still produce it. Additionally, over the past several months, several medication shortages in North America have been exacerbated by Hurricane Maria and its effect on Puerto Rican manufacturing plants. The shortages are now affecting health care facilities in new ways, as this is an issue whose landscape changes on a weekly basis. Care facilities are now receiving drugs in varying volumes and concentrations (including that of epinephrine), which further complicates standard anesthesia protocols.

Now more than ever, with no imminent solution in sight, increased public and governmental attention and action is critical to resolving the issue and ensuring patient safety. Furthermore, anesthesiologists and other care providers must collaborate to develop a new school of thought when it comes to developing adaptive drug administration protocols.

 

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

Bodie, B., Brodell, R. T., & Helms, S. E. (2018). Shortage of lidocaine with epinephrine: Causes and solutions. Journal of the American Academy of Dermatology.

Carniol, E. T., Gantous, A., & Adamson, P. A. (2018). Local Anesthesia Shortages—Adapting to a New Way of Life. JAMA Facial Plastic Surgery.

 

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