"Who can report?" - a call to patients and healthcare professionals to report suspected adverse reactions during #MedSafetyWeek: November 6-12, 2023.

The Federal Office for Safety in Health Care (BASG) is taking part in the global social media campaign called #MedSafetyWeek to raise public awareness of the importance of adverse drug reaction reporting.

The motto of the campaign is "Who can report?" and aims to help further increase the safety of medicines. Patients are encouraged - and healthcare professionals are called upon as part of their legal duty - to report suspected adverse drug reactions to the Austrian Medicines Agency. It is important that no one waits for someone else to report a possible side effect for them, but that they reliably do so themselves if they suspect or become aware of one.

Medicines are rigorously tested, effective and safe, but side effects can still occur with any medicine in varying types, severity and frequency. It is difficult to predict in whom, if and when an adverse reaction will occur, but it is important that such potential risks are observed, reported and recorded. Only through appropriate reporting can these observations and any associated risks be evaluated, understood and subsequently communicated transparently to all patients, users and prescribers as part of safety information and/or updated information for healthcare professionals and for use.

Each individual's adverse reaction report thus helps to reliably identify new adverse reactions or unexpected and serious safety problems and to obtain more and more robust information about possible avoidable risks. By reporting, each individual can therefore make a significant contribution to ensuring that medicines are safer for everyone and that the BASG (Federal Office for Safety in Health Care) can protect public health even better through effective measures.

Dr. Günter Waxenecker, member of the Austrian Medicines Agency in charge of the procedure, says: "Patient safety is always our top priority. Together with the other national authorities in Europe and the European Medicines Agency (EMA), we have already identified numerous potential risks and safety problems in recent years that were previously unknown. By reporting side effects, we have been able to take appropriate measures to minimize these risks. We hope that this important campaign will therefore encourage everyone - patients, doctors and pharmacists - to report suspected side effects of medicines even more diligently in the future. Every report counts and contributes to improving drug safety for all patients."

Background information on the campaign:
A total of 100 national medicines agencies and non-governmental organizations (NGOs) from 88 countries around the world are participating in this international campaign, which is led by the Uppsala Monitoring Center (UMC), the World Health Organization's (WHO) Collaborating Centre for International Drug Monitoring.  The UMC, together with the European Medicines Agency (EMA) and its partner authorities in EU countries, is responsible for ensuring that the health of millions of people is protected and improved every day through the responsible regulation of effective and safe medicines.

Reporting option:
In accordance with the legal provisions, patients can report all adverse or unintended reactions to a medicinal product to the BASG on a voluntary basis, while it is even mandatory for healthcare professionals (e.g. doctors, pharmacists...). It does not matter whether the reporter can prove a causal relationship between the adverse reaction and the medicinal product. It is sufficient if such a connection is considered possible, e.g. due to the temporal relationship or because another cause (co-medication, underlying diseases, etc.) is not recognizable.
An adverse reaction report can be made quickly and easily electronically using the electronic reporting portal, in writing by form or by e-mail - see information on reporting by e-mail or electronic reporting form.

Enquiries (professional):
Dr. Christoph Baumgärtel, Phone: +43 505 55-36004
E-Mail: christoph.baumgaertel@ages.at

Enquiries (for media):
Communications Management, Tel.: +43 505 55-25000
E-mail: presse-basg@basg.gv.at