“Patients and health care professionals, do you report side effects?” – participate in the survey and help European authorities to better assess the awareness of patients/consumers and healthcare professionals on reporting medicines side effect.
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.
AGE is actively involved in the activities of the European Medicines Agency notably to promote adequate and safe medicines in older age. An enhanced and improved reporting on adverse drug reactions is key to ensure a safer use of medicines.