Technical Report No. 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages

May 2024
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PDA Technical Report No. 68: Risk-Based Approach for Prevention and Management of Drug Shortages was originally developed in 2014. The approach to risk-based prevention of drug shortages presented in this revision remains unchanged. This revision focuses on updating references and progress related to the current regulatory environment, regional regulations and guidelines, and terminologies used for drug shortages that have since been published. Elements in the templates and forms included in this revision have been updated to reflect current regulatory expectations and terminology. Drug shortages have become more frequent, more severe, and longer-lasting globally since the early 2000s for a variety of reasons. Sustainable access to safe, efficacious, and high-quality products every time a patient needs them is just as important as the therapeutic advances that have transformed the lives and survival of patients worldwide. 


Table of Contents

1.0. Introduction

2.0. Glossary and Abbreviations

3.0. Recognizing Drug shortages as a global problem

4.0. Management Responsibilites

5.0. Risk-Based Approaches for Prevention of Drug Shortages

6.0. Risk Triage Model

7.0  Drug Shortage Prevention and Response Plan

8.0  Stakeholder Management and Communications Related to Drug Shortages

9.0  Conclusions

10.0 References

11.0 Appendix 1

12.0 Appendix 2

About the Authors