Reporting side effects of medicines

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04/09/2017

Reporting side effects of medicines

EMA launches survey to assess whether patients and doctors are aware of the arrangements for reporting of side effects

The European Medicines Agency (EMA) has launched a survey to better understand patients’ and healthcare professionals’ awareness of reporting adverse drug reactions, including for medicines under ‘additional monitoring’.

Medicines under additional monitoring are monitored particularly closely by regulatory authorities. They are easily identified by a black inverted triangle displayed in their package leaflet and in the information for healthcare professionals, called the ‘summary of product characteristics’ (SmPC). Healthcare professionals and patients are encouraged to report any suspected adverse reactions.

Regulatory authorities continuously look at reports of side effects alongside all the information they already have to make sure that the benefits of medicines remain greater than their risks and to take any necessary action.

The survey’s main aim is to evaluate the awareness, attitudes and reporting behaviours of patients and healthcare professionals to report side effects. The questionnaire is translated into all official European Union languages and takes no more than 10 minutes to complete. It will be open for responses until 9 October 2017. The results of the survey will be analysed by EMA and the European Commission and the conclusions will be published in 2018.

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