FDA, ASHP Actions to Prevent or Manage Chemotherapy Drug Shortages

Management strategies depend on the medication or product that is unavailable as well as the severity and duration of the shortage. If an appropriate alternate medication is available, patients may have their therapy changed until the original medication is available again. In cases where the product on shortage has an alternate formulation, use of the other formulation may also be considered. In some instances, the FDA may permit the import of product from new sources in order to ease a shortage or may encourage other manufacturers to increase production of that product.

In regard to long-term solutions, the FDA has developed multiple strategies to mitigate and prevent drug shortages.³ These include incentivizing manufacturers to improve quality practices to prevent shortages due to these issues, identifying early warning signals for manufacturing problems to prevent supply disruptions, and working with key stakeholders to identify new strategies.

References

1. Drug shortage roundtable: minimizing impact on patient care. Bethesda, MD: American Society of Health-System Pharmacists; November 6, 2017. https://www.ashp.org/-/media/assets/drug-shortages/docs/drug-shortages-nov-2017-shortage-meeting-report.ashx. Accessed March 7, 2018.

2. Drug shortages statistics. ASHP website. https://www.ashp.org/Drug-Shortages/Shortage-Resources/Drug-Shortages-Statistics. Accessed March 7, 2018.

3. Strategic Plan for Preventing and Mitigating Drug Shortages. Silver Spring, MD: Food and Drug Administration; 2013. https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM372566.pdf. Accessed March 7, 2018.