EMA Guidance Looks to Prevent Drug Shortages
The agency has published guidance on good practices for securing the supply of medicines.
On May 17, 2023, the European Medicines Agency announced it has published a guidance document that recommends good practices for securing the supply of medicines and preventing shortages. The document discusses the stakeholders involved in the supply chain and their responsibilities in preventing drug shortages. There are 10 recommendations for minimizing drug shortages. These are:
- Informing national competent authorities of potential and actual shortages
- Establishing prevention and shortage management plans
- Optimizing quality systems
- Communicating with supply chain stakeholders
- Promoting fair and equitable distribution of medicines.
“Medicine shortages are a global health problem and are increasingly affecting European countries. Shortages can lead to medicine rationing and delay in critical treatments, with a significant impact on patient care. In addition, patients may need to use less effective alternatives and face an increased risk of medication errors. Ensuring the availability of authorized medicines in the European Union (EU) is a key priority for EMA and the European medicines regulatory network,” the agency stated in a press release.
Source: EMA
