Drug shortages, especially for the supply of critical medicines, have emerged as an important global issue that impacts patients worldwide. Ensuring the uninterrupted supply of safe, efficacious products to patients requires the input of regulators, legislators, healthcare providers and industry together to develop and drive effective and implementable solutions.
To this end, PDA has developed Technical Report 68: Risk- Based Approach for Prevention and Management of Drug Shortages, which describes a risk-based triage of products (i.e., how to establish preventive controls for drug shortage risks in the end-to-end product value chain based on product criticality and patient impact) and the establishment of a Drug Shortage Risk Register and a Drug Shortage Prevention and Response Plan—a holistic framework and simple templates at a product level.