#MedSafetyWeek 2020 - Every report counts. An appeal to patients and health professionals to report suspected adverse reactions from 2-8 November 2020

messages in brief | 30/10/2020

"Every report counts" - an appeal to patients and health professionals in #MedSafetyWeek: 2-8 November 2020 to report suspected adverse reactions.

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

The motto of the campaign is "Every report counts" and is intended to help further increase the safety of medicines. Patients are encouraged - as well as health professionals as part of their legal obligation - 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 adverse drug reaction on their behalf, but that they do so reliably themselves if they suspect or become aware of such a reaction.

Medicines are strictly tested, effective and safe, but side effects can occur in principle nevertheless, in different kind, severity and frequency with each medicine. It is difficult to predict with whom, if and when an adverse reaction will occur, but it is important that such potential risks are monitored, reported and recorded. Only through appropriate reporting can these observations and the associated potential risks be evaluated, understood and subsequently transparently communicated to all patients, users and prescribers through safety information and/or updated Summary of Product Characteristics (SmPC) and Package leaflet (PL).

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

The Head of the Austrian Medicines Agency, DI Dr. Christa Wirthumer-Hoche says
"Patient safety is always our top priority. Together with the other national European authorities and the European Medicines Agency (EMA), we have already identified numerous potential risks and safety problems in recent years that were previously unknown. Through appropriate adverse drug reaction reports, the appropriate measures could be taken to minimize these risks. We hope that this important campaign will therefore encourage everyone, patients, physicians and pharmacists to report suspected adverse drug reactions 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 74 national drug authorities from countries around the world are participating in this international campaign, which is led by the Uppsala Monitoring Center (UMC), the Collaborating Center for International Drug Monitoring of the World Health Organization (WHO). Together with the European Medicines Agency (EMA) and its partner authorities in the EU countries, the Federal Office for Safety in Health Care (BASG) 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.

Notification possibility:
In accordance with the legal provisions, patients can voluntarily report any harmful or unintended reactions to a drug to the BASG, while it is even mandatory for health professionals (e.g. doctors, pharmacists...). It is irrelevant whether the person reporting the adverse drug reaction can prove a causal relationship between the adverse drug reaction and the drug. It is sufficient if such a connection is considered possible, e.g. because of the temporal relationship or because another cause (co-medication, underlying disease, etc.) is not apparent.
An adverse drug reaction report can be made quickly and easily electronically by using the electronic reporting portal VigiWeb, in writing by form or by e-mail. Further information can be found on the website of the BASG at: https://www.basg.gv.at/en/market-surveillance/reporting/adverse-reactions

Questions (technical):
Dr. Christoph Baumgärtel, Phone: +43 505 55-36004
e-mail: christoph.baumgaertel@ages.at

Further inquiries (for media):
Communication Management, Tel.: +43 505 55-25000
e-mail: presse-basg@basg.gv.at

Video 01 https://youtu.be/6MM6HiL6s7A

Video 02 https://youtu.be/Hv13pGMN9FY