Adverse reactions

Definition and objectives

An adverse reaction is a reaction to a medicinal product that is harmful and unintended. It shall be considered a serious adverse reaction if the reaction is fatal or life-threatening, requires hospitalisation or prolongation of hospitalisation, results in permanent or serious disability or invalidity, or is a congenital anomaly or birth defect.

Healthcare professionals, physicians, dentists, veterinarians, midwives, pharmacists, druggists and traders who are authorised to manufacture or wholesale medicinal products in accordance with the Trade, Commerce and Industry Regulation Act (Gewerbeordnung) from 1994 are obliged to report any adverse reactions occurring in Austria to the Austrian Federal Office for Safety in Healthcare in accordance with the Austrian Medicines Act and the Regulation on Pharmacovigilance.

Patients and their relatives also have the opportunity to report suspected adverse drug reactions directly to the Federal Office for Safety in Health Care.

Human adverse reaction notification

Reporting possibilities human medicinal products

online:

electronic form

additional forms:

paper form

by e-mail

nebenwirkungbasg.gvat

by post

BASG, 1200 Wien, Traisengasse 5

by fax

+ 43 (0) 50 555 36207

telephone support:

+ 43 (0) 50 555 36600

24-hour emergency telephone number for pharmacovigilance officers or safety officers:

Tel.: +43 (0) 664 831 28 43

Please note: The emergency number is only to be used for emergencies within the meaning of § 10 Regulation on Pharmacovigilance or § 70 Austrian Medical Devices Act.

An emergency only exists if there is an immediate danger to life or a serious and considerable danger to health.

Any further questions or information should be submitted via the contacts of the Austrian Federal Office for Safety in Health Care.

Your reports will be treated confidentially. There are no negative consequences for the notifier.

By reporting adverse reactions, you can help provide more information about the safety of this medicine.

Once the Federal Office for Safety in Health Care has identified medically unacceptable risks, it can support the safe handling of medicinal products by imposing restrictions on use - possibly until the withdrawal of a marketing authorisation already granted by the authorities. The Federal Office for Safety in Health Care cooperates with the relevant authorities in other European Member States and with the European Medicines Agency.

The reporting of suspicious cases is therefore indispensable in terms of consumer protection.

We would also like to draw your attention to the European database, where you will find information on adverse reactions of medical products and active substances (at EU level).

Report templates human (in German only)

Information for marketing authorisation

Marketing authorisation holder should send all suspected serious and non-serious post-marketing case reports, which occurred within Austria, directly electronically to EVPM (EudraVigilance post-authorization module). This also includes case reports from the worldwide literature and non-interventional data collection schemes which occurred in Austria.

Medical literature monitoring – MLM Service EMA

Since September 2015 the European Medicines Agency (EMA) is responsible for monitoring a number of substances and selected medical literature to identify suspected adverse reactions with medicines authorised in the European Union, and for entering the relevant information into the EudraVigilance database.

The MLM service currently includes 300 active substances and 100 herbals.

The results of this research is available for MAHs and member states as Individual Case Safety Reports (ICRS) in the Eudravigilance database. However, this does not release pharmaceutical companies from their obligation to monitor the literature (local literature search) with regard to their marketing authorisations.

Reporting of suspected adverse reactions

In the interests of effective pharmacovigilance, it is essential that reports of suspected adverse reactions are received by the competent authority.

Accordingly, § 75g Austrian Medicines Act stipulates that healthcare professionals must report suspected adverse reactions to the Federal Office for Safety in Health Care without delay.

According to § 75h Austrian Medicines Act, patients can and should also report suspected adverse reactions to the Federal Office for Safety in Health Care.

Another way of reporting suspected adverse reactions is to report them to the marketing authorisation holder. According to § 75j Austrian Medicines Act, a marketing authorisation holder may not refuse the acceptance and examination of reports from healthcare professionals and patients. Marketing authorisation holders are obliged to submit information on all suspected adverse reactions electronically to the Eudravigilance database. This ensures that the competent authorities also become aware of reports of suspected adverse reactions received by the marketing authorisation holder. Furthermore, the marketing authorisation holder is obliged to inform himself regularly about the reports in accordance with §§ 75g and 75h Austrian Medicines Act by means of the Eudravigilance database.

The Austrian Medicines Act does not provide for other types of reporting of a suspected adverse reaction.

The reporting channels for suspected adverse reactions described above ensure that these reports of suspected adverse reactions are assessed for causality, that the benefit-risk ratio of all approved drugs is continuously monitored in close cooperation with the European network of authorities, and that a continuous evaluation takes place, which is reflected in the current version of the technical information.

Medication errors

Medication errors are unintentional errors in the prescribing, dispensing, administration or monitoring of a medicine while under the control of a healthcare professional, patient or consumer. They are the most common single preventable cause of adverse events in medication practice: An estimated 19 - 56% of all adverse drug events among hospital patients result from medication errors that would be preventable1.

According to a WHO statistics, 18% of all European citizens claim to have experienced a serious medical error in a hospital and 11% to have been prescribed wrong medication.

Since July 2012, the new European pharmacovigilance legislation has required all adverse drug reactions resulting from medication errors at the European level to be reported to EudraVigilance, the European database of adverse drug reactions.

The legal requirements detailed in Title IX of Directive 2001/83/EC and chapter 3 of Regulation (EC) No 726/2004, which are applicable to competent authorities in Member States, marketing authorisation holders and the European Medicines Agency as regards the collection, data management and reporting of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorised in the European Union are addressed in Module VI of the "Guideline on Good Pharmacovigilance Practices“ (GVP): Module VI – Collection,management and submission of reports of suspected adverse reactions to medicinal products(Rev 2) ".

Medication errors are an important topic on the agenda of the European Medicines Agency. In February 2013 the European Medicines Agency organised a regulatory workshop on medication errors.

The Committee for Medicinal Products for Human Use published a position paper on potential medication errors in the context of risk-benefit balance and risk minimisation measures (EMA/274183/2012).

1 'Creation of a better medication safety culture in Europe: Building up safe medication practices', Council of Europe Expert Group on Safe Medication Practices (2006).

Is any testing for marketing authorisation holders with Federal Office for Safety in Health Care required?

No. Testing should be performed only with the European Medicines Agency. For further information see http://www.ema.europa.eu.

How do MAHs transmit literature cases?

Literature cases have to be submitted electronically to the European Medicines Agency. The copy of the original literature article should be sent to evlit @ema.europa.eu

How to report "Emerging Safety Issues“?

Events may occur, which do not fall within the definition of reportable valid Individual Case Study Reports (ICSR), and thus are not subject to the reporting requirements, even though they may lead to changes in the known risk-benefit balance of a medicinal product and/or impact on public health. Examples include:

• major safety findings from a newly completed non-clinical study;

• major safety concerns identified in the course of a non-interventional post-authorisation study or of a clinical trial;

• signal of a possible teratogenic effect or of significant hazard to public health;

• safety issues published in the scientific and medical literature;

• safety issues arising from the signal detection activity (see Module IX) or emerging from a new ICSR and which impact on the risk-benefit balance of the medicinal product and/or have implications for public health;

• safety issues related to the use outside the terms of the marketing authorisation;

• safety issues due to misinformation in the product information;

• marketing authorisation withdrawal, non-renewal, revocation or suspension outside the European Union for safety-related reasons;

• urgent safety restrictions outside the European Union;

• safety issues in relation to the supply of raw material;

• lack of supply of medicines.

These events/observations, which may affect the risk-benefit balance of a medicinal product, are not to be submitted as ICSRs. They should be notified as emerging safety issues in writing to the competent authorities in Member States where the medicinal product is authorized via email and to European Medicines Agency via email; this should be done immediately within 3 working days when becoming aware of them. The document should indicate the points of concern and the actions proposed in relation to the marketing application/authorisation for the concerned medicinal product. Those safety issues should also be analysed in the relevant sections of the periodic safety update report of the authorised medicinal product.

Veterinary adverse reaction notification

Reporting possibilities for veterinary medicinal products

per form:reporting forms
by e-mail:basg-v-phvbasg.gvat
By mail:BASG, 1200 Vienna, Traisengasse 5

Reporting forms veterinary

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