Today, I attended a joint event on shortages of medicines, organised here in Amsterdam by the Standing Committee of European Doctors (CPME) and the Pharmaceutical Group of the European Union (PGEU). It was an excellent opportunity to highlight that managing shortages has become a key priority for EMA, even though we only received a mandate to coordinate shortages two years ago. What are some key actions we have taken since then? 🔍 Continuous monitoring of critical shortages These are shortages that cannot be resolved by national measures only and require that we all work together at EU level. We continuously monitor shortages across the EU so that we can take swift action across the medicines network as soon as we become aware of a signal of a potential critical shortage. 🕰️ Swift response and dialogue As soon as we receive a signal of a potential critical shortage, we immediately contact companies to understand the root cause of the problem and to identify contingency plans and mitigation measures. If we are unable to resolve the problem, we invite the companies concerned to an in-depth discussion. We also collaborate with other regulators and international partners to gain a holistic view of the situation. 🤝 Cooperation with patients and healthcare professionals Healthcare professionals have an important role to play. When there was a global shortage of antibiotics, doctors, pharmacists and nurses played a key role in promoting prudent and appropriate use, for example restricted to the treatment of bacterial infections. Hospital and community pharmacists can help us avoid local stockpiling which can exacerbate shortages. We also invite healthcare professionals to share early signals of supply disruptions with EMA. 💊 The Union list of critical medicines The list sets out those medicines that have to be available in EU healthcare systems at all times. Some medicines on the list will be prioritised for EU-wide actions to strengthen their supply chains and minimise the risk of supply disruptions. Let’s continue working together to address shortages and make sure patients have access to the medicines they need! 🌐💙 #MedicineShortages #Healthcare #PatientSafety #PublicHealth
Emer Cooke - Thank you and EMA for the important work that you are doing to help patients. Mutual recognition by EMA of FDA approved US Source Plasma Centers is long overdue and will free up EMA member state resources and help solve the shortage of plasma in Europe until member states achieve self-sufficiency. Your leadership and support in this matter would tremendously help the patients, regulators and industry.
Cordula Landgraf
2mo
It's great to see how much the EMA is doing on this topic - congratulations! Shortages of medicines are complex with many stakeholders involved. They do not stop in front of borders. Therefore, international cooperation across borders is key to understand and address the root causes. Looking forward to hearing more about all the initiatives.
Pat PH
2mo
The only way to avoid drugs shortage is an industrial and financial politics of private pharmaceutical companies worldwide. The shortage is mainly due to raw materials supply with only one supplier in Asia. The only way is backups in East Europe. That could be acceptable by the financial part of those industries. We did it for products in Hungaria at the beginning of the 90's. It's never to late. Dr Pat
Great that the importance of #dialogue is also embraced at this level! However, you cannot learn dialogue skills quickly; developing them requires openness, putting your own judgments on hold, listening carefully, and a willingness to examine your own beliefs. It is great that there is this willingness to deal with this major issue of #drugshortages
David Murray
2mo
Excellent initiative! It's great to hear about this. These kinds of collaborative efforts to tackle shortages and make sure patients have access to the medicines they need is commendable. Well done to all involved!
O uso e o destino dos medicamentos já são computados pelas políticas públicas. Se o paradigma no atendimento está defasado então repensamos seriamente em aplicar uma gestão de mudanças (MEG).
Aris Prins
2mo
Emer Cooke thank for attending our event and thank you for your key note speech and the panel discussion
Jan Broeren
2mo
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Senior Vice President and General Manager
2moGreat to learn about these measures, Emer. However, we need to look beyond "managing shortages" to resolving shortages. This responsibility lies with the pharma manufacturers, some of which have staff working 14 hours per day, 7 days a week.