"Together, we are encouraging patients and healthcare professionals to report all suspected side effects - because every report can help to protect people," says Health Minister Korinna Schumann, emphasising the benefits of the campaign, which is now in its tenth year. "Each and every individual can make a contribution. The safety of medicines starts with all of us," says Health Minister Schumann.
The Ministry of Health, the Chamber of Pharmacists, the Medical Association, the Medical University of Vienna, the Federal Office for Safety in Health Care (BASG) and AGES are working together to promote the safe use of medicines. "At AGES, we test, monitor and evaluate medicinal products on a daily basis in order to increase safety and strengthen trust - before and after authorisation. Every piece of feedback from patients, doctors and pharmacies helps to further improve the safety of medicines," says AGES Managing Director Johannes Pleiner-Duxneuner. "Safety is not achieved through control alone, but through cooperation and trust. Every report strengthens the system that protects us."
In Austria, the Austrian Medicines Agency BASG uses adverse drug reaction reports to monitor the safety of medicines nationally and respond to potential risks. Unfortunately, studies show that only 5 to 10 per cent of all suspected side effects are reported. "This means that we are only seeing the tip of the iceberg and that it can sometimes take longer to identify important safety issues. By raising awareness as part of #MedSafetyWeek, we want to make as many people as possible aware that their reporting is important," says Günter Waxenecker, Head of AGES Medical Market Surveillance and Head of Procedures at the BASG.
Underreporting of side effects is a problem worldwide
In Austria, all reports are thoroughly evaluated and reviewed by the BASG in order to take the necessary and correct steps to protect users of medicinal products. Since 2018, over 290,000 adverse drug reaction reports have been submitted. It is sufficient if a connection between the medicinal product and the adverse reaction is considered possible, for example due to temporal proximity or because no other cause is recognisable. After being recorded in the BASG adverse reaction database, all suspected reports are transferred to the Eudravigilance database of the European Medicines Agency (EMA) and are available to the European medicines authorities for ongoing monitoring of the safety of all medicines authorised in the EU.
In 2024, a total of 17,027 pharmacovigilance reports (initial and follow-up reports) on side effects, interactions and medication errors were reported to the BASG. Of these, 12,899 reports came from marketing authorisation holders, 2,364 reports from patients and 1,996 reports from healthcare professionals. Underreporting of adverse drug reactions is a problem worldwide. Reasons for underreporting across all healthcare professions could be a lack of time and a perceived high administrative burden, as well as the view that reporting adverse drug reactions does not appear to be effective - see studies: "Factors associated with underreporting of adverse drug reactions by patients: a systematic review" and "Association with underreporting of adverse drug reactions by healthcare professionals: an updated systematic review".
Austria supports global #MedSatefyWeek campaign
Adverse reaction reports enable drug authorities worldwide to take action, for example to change the package leaflet or implement risk-minimising measures. Reporting adverse drug reactions takes very little time and can also be easily done electronically in a reporting portal provided by the BASG . All reports are treated in strict confidence and are subject to data protection. The "Be a drug superhero too!" poster with QR code , specially designed for the current campaign, provides direct and easy access to the adverse drug reaction reporting portal and is available for free use.
The #MedSafetyWeek is an international campaign led by the Uppsala Monitoring Centre (UMC), the World Health Organization's (WHO) collaborating centre for international pharmacovigilance, and is supported by the members of the International Coalition of Medicines Regulatory Authorities (ICMRA) and a number of national and international organisations. The campaign was first launched in 2016 to raise awareness of why, how and where to report adverse drug reactions. Celebrating its tenth anniversary in 2025, #MedSafetyWeek is the largest campaign of its kind to date: 131 organisations in 117 countries have committed to spreading the campaign's message in more than 62 languages. Austria is represented by the BASG as the responsible partner organisation. From 3 to 9 November 2025, everyone can spread the message of #MedSafetyWeek. Free materials can be found on the #MedsafetyWeek campaign website.
APA-OTS: #MedSafetyWeek celebrates its 10th anniversary - Together for safe medicines