Drug Shortages and Solutions

Catalyst Corner |The National Association of Boards of Pharmacy has sounded an alarm about counterfeit product entering the supply chain because of the drug shortage.

by Marsha Millonig

The new U.S. Pharmacopeia (USP) report exposes a decade of drug shortages impacting patient care. Average shortage now lasts over three years.

My first column of the year focused on the enforcement delay of the Drug Supply Chain Security Act (DSCSA) and its provisions to help reduce the risk of counterfeit drugs entering the U.S. market. I provided trend data on drug counterfeiting and diversion incidents from the Pharmaceutical Security Institute. I also noted that a leading factor contributing to counterfeit drug products is when a drug is in high demand but in short supply. A current example is the nonstop demand for the glucagon-like peptide 1 agonists (GLP-1s) dulaglutide (Trulicity), exenatide (Bydureon), liraglutide (Saxenda, Victoza), semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound). Shortages vary among each of these products, but the demand for them continues. During each of my pharmacy shifts, I usually field several calls from patients inquiring if the pharmacy has this medication in stock. The answer is usually no, and we have limited information on when it will be available.

This shortage has led to bad actors getting involved in the GLP-1 game. Many are selling counterfeit product. FDA (U.S Food and Drug Administration) reports have found insulin instead of the active ingredient in the counterfeit Ozempic pens, leading patients to experience severe hypoglycemia requiring hospitalization, and at least one death. Compounded Ozempic has been found to contain the wrong salt form of semaglutide, active ingredients from unregulated facilities, or to be the wrong concentration. Between 2019 and 2023, U.S. poison control centers experienced a 1500% increase in calls about semaglutide.