Drug Shortage

The issue of drug shortages demands attention and collaboration from everyone involved; from regulators to developers, end users, and patients. PDA is working together with regulators and in collaboration with other industry associations. The complementary contribution by PDA focuses on risk based prevention at a product level. A risk triage approach for proactive management of drug shortage has been developed and will be trained.

PDA’s Contributions

Technical Report No. TR 68: Risk-Based Approach for Prevention and Management of Drug Shortages
PDA Technical Report No. TR 68: Risk-Based Approach for Prevention and Management of Drug Shortages, includes valuable tools to help organizations address the globally significant issue of drug shortages. To ensure these tools are available to all who will benefit from them, PDA is pleased to provide this singular technical report to the public for FREE. PDA Technical Reports are highly valued documents made available for free download to PDA Members or available for purchase at the PDA Bookstore.

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Risk Management Tools

• The Risk Triage Model from TR 68.
• Template: Drug Shortage Risk Register - Appendix A of TR 68.
• Template: Drug Shortage Prevention and Response Plan - Appendix B of TR 68.

Conferences and training opportunities are being scheduled. For details see:

• PDA's Global Event Calendar
• PDA Europe Event Calendar

Additional Resources Relating to the Subject and Project

• Preventing and Managing Drug Shortages, PDA Letter Article, April 2014 (free for PDA members)
• Drug Shortage Info Graphic, PDA Letter, November/December 2014
• PDA participates in an inter-association task force to deliver to the European Medicines Agency (EMA) a proposal and plan that addresses the prevention of drug shortages due to manufacturing quality issues and a complementary project on communications. For more details on the complementary contributions of the other associations please see the following:
  • Final report of the inter-association team: Prevention of Drug Shortages Based on Quality and Manufacturing Issues, December 2014
  • Industry communication principles to authorities by AESGP, EFPIA, EGA,ISPE and PPT.