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Calls for action on unlicensed medicines

Four European patient groups have called for more and improved measures against the use of unlicensed and off-label medicines, including the introduction of mandatory adverse event reporting

Four European patient groups have called for more and improved measures against the use of unlicensed and off-label medicines.

The European Alliance for Access to Safe Medicines (EAASM), the European Federation of Neurological Associations, the European Men's Health Forum and the European Depression Association all signed a statement demanding mandatory reporting by healthcare professionals of adverse events involving unlicensed and off-label use of medicines.

The groups want to establish the number of adverse events relating to unlicensed and off-label use of medicines and improve public awareness so that patients are aware when medicines are used in this way. Greater knowledge of the importance of reporting adverse events is also being encouraged.

The joint statement said there is an 'urgent need to address patient safety issues' regarding such use of medicines, with recent warnings from the US Food and Drug Administration (FDA) concerning a spate of serious eye infections in Florida related to the off-label use of an unlicensed medicine.

Jim Thomson, chair of the European Alliance for Access to Safe Medicines (EAASM) said the US authorities were only able to act on the issue due to obligatory adverse event reporting, and a similar process was needed in the EU.

He said: "In Europe it's a matter of chance as to whether the regulatory authorities are made aware of similar problems because there is no mandatory mechanism to report adverse events in medicines used this way."

All patient organisations involved in writing the statement are currently seeking meetings with European regulatory and professional bodies over the coming weeks to take their demands further.

20th September 2011

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