Health authority calls for increased reporting of side effects

Patients called for reporting drug side effects

If patients suspect that symptoms such as headache, nausea, dizziness, or even severe symptoms are caused by taking a drug, they should report the suspicion. Such reports can be an important contribution to drug safety.

Patients should report side effects

Actually, medicines are meant to cure people or alleviate their suffering. But in drug therapy it also often comes to change and side effects, in some cases only years later. Quite often, such unwanted side effects occur during antibiotic use. But even with over-the-counter medicines this problem exists. In a joint campaign, all European drug regulatory authorities are now calling on patients to increasingly report suspected side effects to them.

The European Medicines Authorities call on patients to report more suspected side effects to them. Such reports can be an important contribution to drug safety. (Image: Andrzej Tokarski / fotolia.com)

Important contribution to drug safety

As the Federal Institute for Drugs and Medical Devices (BfArM) reports, the focus is mainly on reports of side effects that have occurred after taking over-the-counter medicines.

After all, even with these so-called OTC products, side effects may occur whose reporting is an important contribution to drug safety. OTC is the abbreviation of the English term "Over The Counter" and literally means "over the counter".

The term refers to all non-prescription products and self-medication.

Detect risk signals as early as possible

Pharmaceutical companies as well as physicians and pharmacists or their drug commissions are obliged by their respective professional regulations to report adverse drug reactions, the so-called side effects.

These messages are important in order to identify drug risks as quickly as possible, because the authorities rely on reliable data and risk signals from the practice.

From the abundance of reported symptoms, they filter out those that may be the first signal of a previously unknown adverse event.

"Whether after taking prescription or over-the-counter medicines: It is important in both cases that as many suspected cases of side effects are reported," says Prof. Dr. med. Karl Broich, President of the BfArM.

"This helps drug regulatory agencies identify risk signals as early as possible and then take effective action to protect patients when needed."

Message does not replace the doctor's visit

Experience has shown that not all suspected cases are reported. The reasons for this are diverse.

Thus, patients do not inform their doctor about every observation, or the connection between a reaction or a symptom and the drug is not established because, for example, the symptoms are attributed to an underlying disease.

Adverse reactions to medicines that have been on the market for longer are known to be reported less frequently than those of new medicines.

Patients have the option of reporting side effects on the BfArM website at www.bfarm.de/uawmelden.

There is a specially designed for consumers online reporting form and a registration form with which suspected cases can be reported by letter or fax.

The BfArM points out that reporting the side effect does not replace the doctor's visit. Only the attending physician can and may judge whether, for example, a dose reduction or even a discontinuation of the suspected drug is necessary and medically useful. (Ad)