Predicting and preventing drug shortages

Currently, neither a single government agency nor any industry entity has a comprehensive view of the medicine supply chain. Increased visibility and insights are needed so that industry and governments can better identify potential vulnerabilities, understand the root causes of drug shortages and effectively deploy resources to improve the resiliency and reliability of the supply chain. 

The USP Medicine Supply Map, which uses machine learning and predictive analytics to provide end-to-end visibility into the upstream supply chain, has identified four main drivers that make a drug more vulnerable to shortage: low prices, geographic concentration, quality concerns and manufacturing complexity. Understanding these drivers can help ensure that effective solutions are deployed so that people can have access to the critical and routine medicines they need.  ​

Utilizing standards to foster quality

Issues with quality not only threaten medicines supply chain resilience, but supply chain disruptions can lead to quality issues, increasing the risk of substandard and falsified medicines that put patients at risk. Adherence to USP public quality standards helps ensure medicines are safe, work as intended, and are available when needed.

From the sourcing of raw materials to packaging, labeling, distribution, and point-of-care administration, standards help ensure quality across the pharmaceutical product lifecycle.

Optimizing manufacturing capacity

A strong, diverse manufacturing base is essential to a resilient medicine supply chain. USP is working with industry and governments to support efforts to optimize the global pharmaceutical manufacturing base to reduce the risk of disruptions and shortages.

These efforts include promoting geographic diversification of manufacturing for key drugs and their active ingredients and components, establishing manufacturing capabilities in low- and middle-income countries, and reducing the technical barriers to aid in wider adoption of advanced manufacturing technologies (AMT).

Strengthening regulatory frameworks

A strong medicine supply chain requires strong and effective regulatory frameworks. By sharing scientific expertise and providing technical support and leadership, USP is working alongside governments and health experts around the world to create resilient and sustainable local health systems.