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Medicine shortages guidance published
July 21, 2022
The European Medicines Agency (EMA) has published new guidance for patients and healthcare professionals’ organisations to help prevent and manage medicine shortages.
Labour disruptions, natural disasters, scarcity of raw materials, and production delays have caused severe medicine shortages in the EU and internationally, with the situation being exacerbated by the ongoing COVID-19 pandemic.
The key recommendations and examples of best practice laid out by the EMA seek to improve preparedness, planning, and rationed use for medicines that are in short supply, or that are expected to run out imminently.
The guidance draws on existing initiatives from individual EU member states and has been prepared based on consultations with member organisations of the EMA Patients’ and Consumers’ Working Party (PCWP) and Healthcare Professionals’ Working Party (HCPWP).
Patient organisations at EU and national levels are being encouraged to collaborate with national health authorities to draft and disseminate patient guidance on how to deal with supply tensions, avoid stockpiling, and report information on new or ongoing shortages.
The EMA has also emphasised that patient guidance should be informative without provoking unnecessary panic, which could lead to further stockpiling.
Key recommendations for good practice for healthcare professional organisations include specific advice on fair distribution measures, good prescribing practices, and risk assessments.
Medical professionals are being advised to perform risk assessments for medicines with high clinical impact, liaise with health authorities to issue guidance on dose-sparing measures, and implement measures to avoid stockpiling by flagging sudden unexpected increases in demand for medicines.
Healthcare professionals are also being encouraged to facilitate transparent communication within the supply chain and to enable pharmacists to source short-supply medicines from alternative authorised sources.
Other key recommendations apply both to healthcare professionals’ organisations and patients’ organisations. These include working with national authorities to develop registries of essential and critical medicines, establishing EU-wide awareness campaigns to discourage stockpiling, and developing observatories in collaboration with national authorities to collect and analyse information on early signs of shortages.
Drug shortages across the EU worsened in 2020, with medicines for the cardiovascular, respiratory, and nervous systems being worst affected.
Reduced availability of medicines has had a knock-on effect on healthcare, by delaying critical treatments, forcing patients to resort to less effective alternatives, and necessitating medicine rationing.
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