Further Improving Drug Safety and Reporting Adverse Effects

The campaign is now taking place for the fifth time. Altogether 75 medicines authorities are taking part. Countries of all continents are represented. International institutions from politics and health services are participating, including the World Health Organization (WHO), The European Commission, the International Coalition of Medicines Regulatory Authorities (ICMRA) and the European Medicines Agency (EMA).

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Anyone who reports suspected cases of adverse drug events will contribute to making medicines safer and that way, will help patients. Many suspected persons or their relatives often ascribe observed reactions after the administration of a medical product to the underlying disease. These suspected adverse events remain undetected. In these cases, too, the affected patients should inform the treating doctor. This also applies to medical professionals: drug risks can only be identified as soon as possible if they report suspected cases to the authorities.

The BfArM and the Paul-Ehrlich-Institut are dependent on data from the practice as comprehensive as possible. This enables them to identify possible risk signals, for example for previously unknown adverse effects related to a drug. For this purpose, the federal institutes provide a modern and barrier-free portal at: www.nebenwirkungen.bund.de. The suspected cases reported through this portal will reach the experts for drug safety quickly, directly and safely. The notifications are also entered into the central European database suspected cases of adverse effects of medicinal products. This database provides an extensive data pool which allows the monitoring of drug risks throughout the EU.

"Every single notification is important so that we identify risk signals from the wide use of a medicinal product and take effective measures for the protection of the patient if required," emphasises Professor Karl Broich, president of the BfArM. "Patients should report suspected adverse effects directly to the BfArM and the Paul-Ehrlich-Institut – the easiest way to do this is to use our online portal. This is the only way to ensure that these reports reach us without detours and are incorporated into the official risk monitoring as quickly as possible."

"To make medicines even safer for patients, every notification of a suspected adverse effect is crucial. People are different – and therefore react differently to medicines", explains Professor Klaus Cichutek, president of the Paul-Ehrlich-Institut. "Capturing major amounts of data is a prerequisite for assessing the benefit/risk profile more precisely and identifyingsignals. This is also particularly important for vaccines that are given to a large number people – as is expected to be the the case with vaccines against COVID-19 – and for biomedicines for the treatment of COVID-19."

The BfArM and the Paul-Ehrlich-Institut also use Twitter to raise the awareness for the importance of reporting adverse effects for drug safety. To do so, please subscribe to the Twitter channels twitter.com/bfarm_de and twitter.com/PEI_Germany.

If you ish to report a suspected adverse effect, please note:

1. Reporting adverse effects does not replace a visit to a doctor. Only the treating doctor can judge whether a reduction in the dose or even discontinuing the administration of the medicine is necessary and medically indicated.
2. The medical assessment of the case by a doctor who knows the medical background well represents an important source of information. The available doctor’s letters or hospital reports should always be attached to the notification.

Background - Post-Marketing Authorisation Observation of Medicines

The knowledge on the safety of medicines cannot be complete at the time of their first marketing authorisation. This derives from the fact that only a limited number of subjects participate in the clinical trial. Rareand, above all, very rare adverse effects, cross-reactions with other medicines, or other risks in connection with the use of the drug can usually not be identified in clinical trials. For example, in order to detect a risk of 1:1,000, at least 3,000 subjects must participate in a clinical trial. Besides, these subjects were selected for a clinical trial taking into account various aspects that do not necessarily correspond to the conditions of a broad use of the drug.

The German Medicines Act (Deutsches Arzneimittelgesetz, AMG) thus requires post-marketing data on the experience from a medicinal product to be collected and evaluated continuously and systematically. This is one of the official duties of the BfArM and the Paul-Ehrlich-Institut. The reporting of suspected cases of adverse effects is an important module in this reporting system.

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