Integrity of the Drug Supply Chain

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The drug supply chain has been under careful scrutiny given the costs of medications, but perhaps more critically, due to what some parties are resorting to in an effort to save costs and/or acquire medications during drug shortages.

Yadav et al wrote about a particular instance where some states have begun acquiring drugs or active ingredients for lethal injection from unapproved foreign manufactuers.1 Their paper highlights how sourcing practices for these drugs are undermining state and federal regulatory structures established to preserve the security and integrity of the medicines supply chain. These states have engaged foreign manufacturers or small compounding pharmacies to compound these ingredients. Many states have passed legislation barring the disclosure of information regarding the origin and chain of custody for prisons' stocks of compounded lethal injection drugs. This creates a regulatory vacuum and prevents the responsible authorities (e.g., FDA, Drug Enforcement Agency, state boards of pharmacy) from performing their crucial roles to ensure quality and supply chain transparency for medicines in circulation. The authors contend that by purchasing medicines from non–FDA-approved suppliers and enacting lethal injection sourcing secrecy laws, states are undermining supply chain transparency. The secrecy surrounding drug procurement risks creating illicit supply channels. Once an illicit supply channel is established with a supplier, it creates risks that other drug products move through it and that lawmakers have the obligation and authority to step in and close this regulatory gap to promote public health and safety.

The article here cites a very specific circumstance, that of prison executions. They also discuss ethics and the lack of clear policy on pharmacy’s involvement in such matters. However, they also make a broader point about the supply chain; specifically, that once the door is opened to circumvent well-reputed suppliers, this ushers in the possibility that those same channels will become used for additional medication supply. Pharmacy managers have obligations to ensure purchase of inventory from reputable sources, even insuring that those sources, too, have not begun any sort of circumvention or purchase of products outside what the FDA, DEA, state boards, and other regulatory bodies deem safe and appropriate. Pharmacies who compound, or even pharmacies who procure products from compounding pharmacies, must ensure that these pharmacies are in compliance with USP 797 and other applicable laws.

Additional information about Supply Chain Management in Pharmacy Management: Essentials for All Practice Settings, 5e. If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to Pharmacy Management: Essentials for All Practice Settings, 5e. If your institution does not provide access, ask your medical librarian about subscribing.

1Yadav P, Weintraub RL, Sterhachis A. When government agencies turn to unregulated drug sources: Implications for the drug supply chain and public health are grave. J Am Pharm Assoc. 2018;58:477-480. 

Shane Desselle

Professor of Social and Behavioral Pharmacy, Touro University California


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about 1 year ago

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