Identifying and addressing vulnerabilities in the upstream medicines supply chain to build resilience and reduce drug shortages
Identifying and addressing vulnerabilities in the upstream pharmaceutical supply chain are essential to mitigating and preventing drug shortages and to ensuring patients have access to the critical and routine medical care they need.
Supply chain vulnerabilities manifest as shortages when supply is unable to meet demand due to demand spikes, supply disruptions, or both. Currently, there is little insight available into the upstream supply chain for medicines, which refers to the drug manufacturing process where raw chemicals, key starting materials (KSMs), active pharmaceutical ingredients (APIs), and finished dosage forms (FDFs) are produced, refined, packaged, tested, and labeled. Addressing upstream supply chain vulnerabilities will build resilience that is essential for mitigating drug shortages, along with additional measures that are necessary for strengthening downstream supply chain reliability.
A wide range of governmental and nongovernmental efforts aim to bolster supply chain resilience and mitigate or prevent drug shortages, however neither a single government agency nor any industry entity has a comprehensive view of the medicines supply chain. Companies and the U.S. Government need a better understanding and mapping of their full supply chains to identify potential vulnerabilities. Additional clarity is needed to identify the root causes of many drug shortages and to effectively deploy resources to improve medicines supply chain resiliency and reduce drug shortages in the United States.