The European Medicines Agency (EMA) announced on 4 November 2013 the launch of its public catalogue on supply shortages of drugs.
In the European Union, most drug shortages are dealt with at national level by the national competent authorities. However, when these shortages affect more than one country in the European Union or are due to a safety concern EMA can be involved.
The catalogue launched by EMA includes information on drug shortages affecting more than one country in the European Union and that have been assessed by the agency. The aim of the catalogue is to provide up-to-date information on drug shortages that have been assessed by the agency.
Drug shortages can occur for many reasons, such as manufacturing difficulties, good manufacturing practice (GMP) compliance problems or problems affecting the quality of medicines that can impact on patient care. EMA catalogue provides:
- information on the reason of the shortage and the current status of the shortage (ongoing or resolved)
- information on the extent of the shortage
- specific information for patients and healthcare professionals
- links to relevant related documents.
The catalogue has been created as part of an implementation plan developed by EMA in 2012 to help the European medicines regulatory network deal with medicine supply shortages following manufacturing problems. The agency also held a workshop on the prevention of medicine shortages due to manufacturing and quality problems in October 2013. The workshop discussed how to improve existing risk-management strategies to prevent shortages due to manufacturing and quality issues, as well as how to mitigate the impact of shortages.
Drugs listed in the EMA catalogue include Gaucher disease treatment Cerezyme (imiglucerase), Fabry disease treatment Fabrazyme (agalsidase beta), Increlex (mecasermin), which is used to treat severe primary insulin-like growth factor-1 deficiency, and Vistide (cidofovir), which is used to treat cytomegalovirus retinitis in AIDs patients.
The EMA drug shortages catalogue can be found on the EMA website at http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000376.jsp&mid=WC0b01ac05807477a6.
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Source: www.gabionline.net
