Adverse reaction reporting - EMA launches survey
EMA launches survey for patients and healthcare professionals on knowledge of reporting adverse reactions - Federal Office for Safety in Health Care (BASG) recommends participation
The European Medicines Agency (EMA) has launched a ->Surveysurvey to better understand the awareness and willingness of both patients and healthcare professionals to report adverse drug reactions to the authorities. This is especially true for medicines that are marked with a "black triangle" and are therefore subject to additional monitoring.
The black triangle for medicinal products is used for particularly rapid identification of new findings on their safety. Health care professionals are required to report any suspected adverse drug reaction to the Austrian Federal Office for Safety in Health Care (BASG). Based on these adverse reaction reports, the European drug authorities continuously evaluate the safety of drugs to ensure that their benefits outweigh the risks.
"We recommend that all interested parties and healthcare professionals, physicians and pharmacists, participate actively in this important EU-wide survey, as the results will enable us to further improve the European reporting system in the future, and in particular that in Austria, where the reporting figures still have room for improvement," says Dr. Christoph Baumgärtel of the Federal Office for Safety in Health Care (BASG). "We also appeal at this point to all healthcare professionals to increasingly comply with the legal obligation to report adverse drug reactions in the future." At the summer academy of the Austrian Chamber of Pharmacists in Pörtschach at the end of June, the topic of drug safety was strongly emphasized and the health care professions were called upon to cooperate. Pharmacists were recently able to double the number of adverse reaction reports from 2016 already, starting from a low level.
"The aim of the survey is to query awareness, attitudes and reporting behavior of patients and healthcare professionals for adverse reaction reports, to systematically assess the data as a consequence and to derive new insights for even more drug safety." The questionnaire, which has been translated into all official languages of the European Union, is also available in German and participation takes no more than 10 minutes. The questionnaire is open for responses until October 9, 2017. The results of the survey will be analyzed by the EMA and the European Commission and the conclusions will be published subsequently.
Queries (technical):
Dr. Christoph Baumgärtel, Tel.: 050555/36004
E-mail: christoph.baumgaertel@ages.at
