Recognising Interactions of Different Medicines – Reporting Adverse Effects Is Important for the Safety of Medicines

The campaign is now taking place for the fourth time in succession. Altogether, 57 medicines authorities are involved. Countries of all continents are represented. The World Health Organisation (WHO) and the European Medicines Agency (EMA) are supporting this campaign.

Experience has shown that not all suspected cases of adverse effects are reported, since affected persons or their relatives ascribe the reactions observed after the administration of the medicines only to the underlying disease, and therefore refrain from reporting them. However, in such cases, too, the BfArM or the Paul-Ehrlich-Institut should be notified directly. In any case, the affected person should inform their doctor. Medical professionals should also keep in mind that pharmaceutical risks can only be identified rapidly if they report suspected cases of adverse effects to the authorities.

BfArM and PEI must rely on watertight data from the practice to identify possible signals of risk, e.g. for previously unknown adverse effects of a medicinal product. For this purpose, they have provided a modern reporting portal which is also accessible to disabled persons. It is available under this link: www.nebenwirkungen.pei.de. That way experts for the safety of medicines will have rapid, direct, and safe access. The reports will be transmitted to the “Central European Database of Suspected Cases of Drug Reactions”. This database has an extensive data pool which permits the supervision of drug risks throughout the EU. Only the joint online reporting portal of BfArM and PEI can ensure that suspected cases of adverse reactions in Germany will be included in the EU database. Data protection is assured on all reporting channels.

"To be able to identify possible risks of medicines in a timely manner, reporting plays an important part," explained Professor Dr Karl Broich, president of BfArM. "In evaluating these data, the use of artificial intelligence will also increasingly gain importance, for instance, to assess the quality of the reports automatically. All measures serve to gain insights in the application and use of medicines. Thus, each notification is also a contribution to patient protection."

"People are frequently not aware that medicines interact with each other or that combining them may cause adverse reactions. The more medicines take for various diseases, the more they should pay attention to new symptoms that may occur, and report these symptoms as suspected adverse events to the competent authority," explained Professor Klaus Cichutek, president of the Paul-Ehrlich-Institut. "Capturing large amounts of data is a prerequisite for assessing the risk/benefit profile more accurately and to identify possible signals. Big data will pave the way towards making medicines safer."

On Twitter, BfArM and Paul-Ehrlich-Institut will draw the attention to the importance of reporting adverse effects for medicines safety. For more information, please subscribe to these Twitter channels: twitter.com/bfarm_de and twitter.com/PEI_Germany.

If you suspect that an adverse effect has occurred and wish to report it, please note:

1. Reporting an adverse effect will not replace a visit to your doctor. Only the treating doctor may and is in a position to judge whether, for example, a reduction in the dose or even discontinuing the suspected medicine would be necessary and medically indicated.
2. The assessment of the case by a medical professional who knows the patient and the medical background well will represent an important source of information. Existing doctor’s letters or hospital reports should in principle be attached to the notification.

Background – Post-marketing authorisation obervation of the medicinal products

It is not possible that the knowledge on the safety of medicines is complete at the time of the first marketing authorisation. This can be explained by the fact that only a relatively small number of individuals usually participate in the clinical testing of a medicinal product. Rare and above all very rare adverse effects, interactions or other risks related to the use of the product cannot usually be identified in clinical trials. To identify a risk of 1:1,000, for example, at least 3,000 individuals would have to participate in the clinical trial. In addition, these individuals were selected for the clinical trial taking into account various aspects, which are not necessarily in keeping with the conditions of the broad use of the medicinal product.

The German Medicines Act therefore lays down that the post marketing authorisation experience in relation with the use of a medicinal product are continuously collected and evaluated systematically This is one of the tasks of BfArM and PEI. Reporting suspected cases of adverse effects is an important module for this.

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