Medicines authorities world-wide call for consistent reporting of adverse effects

The 'actors' from the campaign videos (mother, children, pregnant women)

"The more reports of suspected cases we receive, the earlier we can identify risk signals and take effective measures to protect the patients if required", Professor Dr Klaus Chichutek, president of the PEI emphasised. As he explained "The campaign is so far unique in the world in its present form and provides the opportunity to report adverse effects directly using the online reporting portal of the PEI and the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, Federal Institute for Drugs and Medical Devices) under the link nebenwirkungen.pei.de. That way, the medicines experts can take into account any possible signals in risk monitoring".

The online reporting system provided by the authorities is an important instrument of statutory pharmacovigilance and part of the early warning system in the field of medicines safety – at a national and a European level. For this reason, patients in Germany should exclusively use the joint portal of PEI and BfArM.

To identify risks of medicines as fast as possible, it is particularly important to report suspected cases of medicines to the national competent authorities. PEI and BfArM depend on data from the every-day practice and the patients’ sphere of experience. From the great number of symptoms and/or reactions reported, the experts – after evaluating the reports – filter out those which indicate a previously unknown adverse effect of a product.

However, experience has shown that the authorities will not receive reports on all suspected cases. This is due to a number of reasons. Maybe patients do not inform their treating doctor on all their observations, or a possible relationship between the reaction and the use of the product is not identified. In addition, the reporting rate decreases the longer a medicinal product has been on the market.

The reporting portal is available on all mobile devices and is accessible for disabled persons, too. The reports are transmitted to the "European database of suspected adverse drug reaction reports". It is guaranteed that the data transmission complies with the data protection regulations and other regulations subject to law.

Additional information

If you wish to report an adverse effect, please note:

1. The report on an adverse effect does not replace a visit to your doctor. Only the treating doctor is in a position and entitled to judge the action to be taken, for instance, whether it is necessary or indicated from the medical point of view that you should reduce or even stop taking the medicinal product suspected to cause the adverse effect.
2. The medical judgement of the observation by a doctor who is familiar with the patient’s medical background is an important source of information. For this reason, please attach any doctor’s letters or hospital reports (if available) to the actual report.

Background: Post-marketing authorisation observation of medicinal products

It is impossible for any knowledge on the safety of medicines to be complete at the time of their first marketing authorisation. This above all derives from the fact that only a limited number of persons can participate in the clinical trial for a product. Even if this involves several thousand persons as in the case of major clinical trials for vaccines, rare and very rare adverse effects can hardly be identified. This also applies to cross-reactions, counter-indications, and other risks in connection with the use of the medicine. Furthermore, in selecting the participants in a clinical trial, not all conditions can be captured which may occur later during the large-scale use of the product.

The German Medicines Act (Arzneimittelgesetz, AMG) thus stipulates that, after a marketing authorisation of a medicinal product, the experience with this product should be recorded and evaluated systematically at an on-going basis. This is one of the duties of PEI and BfArM. As the president of the PEI, Professor Cichutek reminds us: "If you communicate any suspected cases of adverse effects yourself using our reporting portal, you are making an active contribution to medicines safety."

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