Almost half of the top 100 medicines vulnerable to supply disruptions in the U.S. have at least one key starting material with a single source country, according to a new report from United States Pharmacopeia.
The United States Pharmacopeia has updated its list of products vulnerable to supply disruptions, adding drugs including Tamiflu and Trulicity after expanding its risk assessment to key starting materials.
Last year, the United States Pharmacopeia (USP) assessed medicines’ clinical importance, demand and supply chains to create a list of 100 vulnerable products. The nonprofit, which publishes a compendium of drug information each year, expanded the analysis this year to include key starting materials (KSMs). Because KSMs are used to make active ingredients, disruption to their supply can cause drug shortages.
The USP found 48 of the 100 vulnerable drugs use a KSM that is only sourced from one country. While the new analysis lacks information on where KSM supply is concentrated, the nonprofit said last year that 41% of KSMs in U.S.-approved active pharmaceutical ingredients (APIs) are only sourced from China. Another 16% of KSMs in U.S. APIs are only supplied by Indian companies. Most of the remaining 43% of KSMs are sourced from two or more countries.
The inclusion of KSM supply in the analysis affected which drugs the USP included on the latest list. The USP said the supply of more than one-quarter of the drugs on the latest list appears stable based on the finished product availability. However, the KSM analysis showed the products have “a single upstream potential point of failure,” leading the nonprofit to conclude they are vulnerable to supply disruption.
The USP named oseltamivir capsules, famotidine injection and metoprolol tartrate injection as drugs that it added to the list because of the KSM analysis. Oseltamivir, an antiviral that Roche sells as Tamiflu, and the two other drugs have “low measured shortage risk” and were not deemed vulnerable in last year’s analysis, the USP said. However, the three drugs rely on a single region for at least one of their KSMs.
None of the three products is on the FDA’s shortage list, but the presence of supply chain weaknesses led the USP to conclude they are vulnerable to supply disruption. Overall, 70 of the medicines on the list were readily available when the USP performed its analysis in February.
Those 70 products include dulaglutide, the GLP-1 receptor agonist that Eli Lilly sells as Trulicity. There is no explanation why the USP deemed dulaglutide, which was not on the previous list, to be vulnerable. The previous list included semaglutide, the GLP-1 drug that Novo Nordisk sells as Ozempic and Wegovy. The USP removed semaglutide from the latest list, reflecting the resolution of the drug’s shortage.
