Health System Shortages; What’s Going On.

Solomon (Sol) Aronson, MD, MBA, FASA, FACC, FACCP, FAHA, FASE
October 30, 2024

For anesthesia providers everywhere, a nationwide IV shortage is now front and center of our concerns and has invoked priority to modify routine care protocols. This problem of course we all know occurred after Hurricane Helene damaged a Baxter manufacturing plant in North Carolina.
But what we may or may not know (or have forgotten) is that shortages of essential products have been ongoing for years.

Saline solutions have been in shortage since 2018, sterile water has been in shortage since 2021, and dextrose solution has been in shortage since early 2022.

A propofol shortage in the early 2010s was caused by a verdict against Teva Pharmaceuticals, a major supplier, and Hospira closing its North Carolina manufacturing plant. A Pfizer plant that produced the most prefilled opioid syringes ceased production in 2017 after experiencing technical problems. Sufentanil production had experienced shortages due to manufacturing delays and Akorn ceasing operations in February 2023.

Atropine, calcium chloride, Dantrolene, Dopamine, Dobutamine, Epinephrine, Etomidate, Ketamine and Neostigmine have been in short supply. Lidocaine and Bupivacaine have been and continue to be in short supply. This shortage has lasted for over 10 years. In addition, Albumin, Albuterol, hydromorphone, fentanyl, morphine, Ropivacaine, Rocuronium, labetalol and glycopyrrolate have been in short supply over the recent years to name a few.

Drug shortages occur for many reasons, including increased demand, manufacturing delays, quality problems, discontinuations of product by the manufacturer, ongoing geopolitical volatility, increased energy costs, and supply chains issues. Although raw materials shortages are not often cited as one of the primary reasons for drug shortages, it has been a significant problem in the past exemplified by the heparin raw ingredient contamination several years ago.

Often, the underlying reason for the tight supply of IV solutions as well as many drugs is their low profitability. IV solutions, for example, have high barriers to market entry, large time and cost commitments to meet regulatory requirements, high demands for space and weight and external pressures to keep prices low.

Similarly, a drug supply shortage may occur because of a profit-loss decision to change a manufacturer formulation thereby delaying availability during the transition. Business decisions may also drive a shift in production efforts to another product, discontinue manufacturing of a product because of poor returns or delay production because of a need for a large investment to correct a manufacturing issue.

A hospital’s financial risk is mitigated by using a medication distribution system known as a “just-in-time” system, meaning supplies are not re-ordered until they are low, thereby decreasing the expense of purchasing unused medication.

To combat the clinical and economic ramifications of drug and now IV solution shortages, the United States Food and Drug Administration (FDA) proposed the Drug Shortage Prevention Act of 2023, which requires 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.

Currently, HHS has invoked the Defense Production Act to help Baxter obtain materials needed to clean and rebuild its North Carolina IV solution production facility.

Today the IV fluid market is sustained by only four manufacturers: Baxter International (60%), B. Braun Medical (23%), ICU Medical and Fresenius Kabi. The Baxter plant alone produced about 1.5 million bags per day.

In summary, the number of drug shortages in the U.S. has steadily risen. Although no drug class has eluded the drug shortage list, the practices of oncology and anesthesiology have had the most significant drug supply disruptions over the past years.

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