EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact .
Medicine shortages are a global health problem and are increasingly affecting European patients. 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.
The guidance describes the various stakeholders involved in the medicine supply chain and their role in the prevention and management of medicine shortages. It provides ten recommendations for marketing authorisation holders, wholesalers, distributors and manufacturers to minimise the occurrence of medicine shortages and their impact.
The recommendations include:
- informing national competent authorities of potential or actual shortages as early as possible and providing detailed information to better predict the possible impact and implement preventive measures;
- establishing robust shortage prevention and shortage management plans;
- optimising pharmaceutical quality systems and increasing resilience of complex, multinational supply chains;
- timely communication between the various stakeholders in the medicine supply chain;
- general principles to promote fair and equitable distribution of medicines to meet the needs of patients.
It complements the guidance for patients’ and healthcare professionals’ organisations published last year to help prevent and manage shortages of human medicines.