PDA Publishes Drug Shortage Technical Report

The Parenteral Drug Association (PDA) has published Technical Report No. 68 (TR 68), Risk-Based Approach for Prevention and Management of Drug Shortages, which was developed from PDA's participation in a collaborative inter-association drug shortage team to develop solutions to address prevention and communication of drug shortages caused by manufacturing and quality related disruptions.

The report is the first practical approach to identifying and mitigating drug-shortage risks in a structured way, and once implemented, it could lead to fewer drug shortages, said PDA in a press release. The report was developed with input and support from the European Medicines Agency (EMA), several European Union National Competent Authorities (NCAs), and FDA. EMA and European inspectors will be promoting TR 68 in the European Union as best practice for proactively identifying and managing risks to supply caused by manufacturing and quality issues.  

Although causes of drug shortages are many, a high percentage are related to sterile injectable products, and a majority of these shortages in the US are caused by manufacturing and quality issues, notes PDA in the introduction to the report. The report addresses a risk-based framework for prevention and management of drug shortages caused by manufacturing and quality issues and explains a risk triage model to assess risks and implement appropriate controls. The report also includes templates for developing a Drug Shortage Risk Register and a Drug Shortage Prevention and Response Plan at a product level. The risk triage model and templates will also be made available from the EMA website. PDA will soon be launching training on this technical report including practical application and use of the risk triage model and templates.