(Vienna, 03-11-2025) Reporting side effects makes medicines safer. That is the message of the World Health Organisation (WHO) #MedSafetyWeek, which runs from 3 to 9 November 2025. "Together, we encourage patients, healthcare professionals and health workers to report all suspected side effects – because every report can help protect people," says Health Minister Korinna Schumann, emphasising the benefits of the campaign, which is now in its tenth year. "Every single one of us 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 jointly support the safe use of medicines. "At AGES, we test, monitor and evaluate medicines on a daily basis to increase safety and strengthen confidence – before and after approval. Any feedback from patients, doctors and pharmacies helps to further improve drug safety," said AGES Managing Director Johannes Pleiner-Duxneuner. "Safety does not come from control alone, but from cooperation and trust. Every report strengthens the system that protects us."
In Austria, the Medicines Agency BASG uses adverse 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 adverse reactions are reported. "This means that we only see the tip of the iceberg, and that it can sometimes take longer to identify important safety issues. By raising awareness during #MedSafetyWeek, we want to make as many people as possible aware that their reports are important," says Günter Waxenecker, Head of AGES Medical Market Surveillance and Procedural Manager at BASG.
Reporting side effects makes medicines safer
"Medicines save lives and improve the health of millions of people worldwide. However, they can sometimes cause unintended effects," emphasises Markus Zeitlinger from the "Medicine Outpatient Clinic" at the Medical University and Vienna General Hospital. His team of pharmacologists and pharmacists deals, among other things, with interactions between different medicines. These are a major issue "because of the often parallel treatment of chronic and acute diseases," says Zeitlinger. For him, it is clear that "every report of a suspected side effect strengthens the scientific evidence and serves the well-being of all patients."
Drug safety is not a given, but requires constant vigilance and consistent action. The quality and quantity of reports received are therefore critical success factors for an effective spontaneous reporting system for the early identification of new risks. Doctors and pharmacies play an essential role in reporting possible side effects. "The spontaneous reporting system is essential for medicines. That's why professional advice in pharmacies also includes a trusting conversation after use," says Ulrike Mursch-Edlmayr, President of the Austrian Chamber of Pharmacists. "Pharmacies are often the first point of contact for health questions about adverse drug reactions."
"The quality of side effect reports by doctors is particularly crucial for a valid assessment of the causality between the suspected drug and the observed reaction," adds Johannes Steinhart, President of the Medical Association. In fact, over 80 per cent of the safety-related signals discussed in the EU Committee for Medicinal Products for Human Use originate from spontaneous reporting. "They prove to be particularly useful and underline their importance as an early warning system," says Steinhart, who emphasises: "medical consultants are happy to advise on any side effects observed and discuss the optimal treatment with their patients."
Underreporting of side effects is a global problem
In Austria, all reports are thoroughly evaluated and reviewed by the BASG in order to take the necessary and appropriate steps to protect drug users. Since 2018, there have been over 290,000 reports of side effects. It is sufficient if a connection between the drug and the side effect is considered possible, for example because of the proximity in time or because no other cause can be identified. After being recorded in the BASG side effect database, all suspected cases are forwarded to the Eudravigilance database of the European Medicines Agency (EMA) and are available to European medicines authorities for the 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 submitted to the BASG. Of these, 12,899 reports came from marketing authorisation holders, 2,364 from patients and 1,996 from healthcare professionals. Inadequate reporting of drug side effects is a global problem. Reasons for underreporting across all healthcare professions could include a lack of time, the perceived high administrative burden, and the view that reporting side effects is not 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 #MedSafetyWeek campaign
The BMASGPK, ÖÄK, ÖAK, MedUni Vienna, AGES and BASG therefore jointly appeal to the public to report suspected side effects in order to make medicines safer for everyone. Reports of side effects enable medicines authorities worldwide to take measures such as changing the package leaflet or implementing risk-minimising measures. Reporting a side effect takes very little time and can be done easily online via a reporting portal provided by the BASG. All reports are treated as strictly confidential and are subject to data protection. The "Be a medicine superhero too!" poster with QR code (see download link), designed especially for the current campaign, provides direct and easy access to the reporting portal for side effects and is available free of charge for anyone to use!
#MedSafetyWeek is an international campaign led by the Uppsala Monitoring Centre (UMC), the World Health Organisation (WHO) Collaborating Centre for International Drug Monitoring, and is supported by 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. Marking its tenth anniversary in 2025, #MedSafetyWeek is the largest campaign of its kind to date, with 131 organisations in 117 countries committed to spreading the campaign message in more than 62 languages. Austria is represented by the BASG as the responsible partner organisation.