A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines 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 countries, according to EMA.
Shortages can lead to medicine rationing, delay in critical treatments and can mean patients may need to use less-effective alternatives and face an increased risk of medication errors.
The EMA Guidance for industry to prevent and mitigate medicine shortages outlines the roles and responsibilities of stakeholders the medicines supply chain in the prevention and management of medicine shortages.
Recommendations have been made for marketing authorisation holders, wholesalers, distributors and manufacturers to minimise medicine shortages and their impact
The recommendations include, inter alia:
- MAHs should notify the National Competent Authority of a potential or actual shortage as soon as possible in advance of any shortage
- Increase transparency relating to shortage information
- MAHs should increase the accuracy of notification detail provided
- MAHs should have a shortage management plan to respond to issues resulting in shortages
- Optimise pharmaceutical quality systems to strengthen the reliability and resilience of supply chains throughout the lifecycle of a medicine
- Increase resilience in the supply chain, considering known vulnerabilities
- Promote fair and equitable distribution to meet the needs of patients
- Take appropriate steps to minimise the risk of parallel trade or export exacerbating shortages
The recommendations are based on the analysis of causes of shortages and regulators’ first-hand experience in coordinating the management of shortages with industry associations input.
Additional informaiton to the following link: https://www.europeanpharmaceuticalreview.com/news/182655/ema-guidance-aims-to-prevent-medicine-shortages/