Health: Authority calls for increased reporting of side effects

Health: Authority calls for increased reporting of side effects

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Patients called to report drug side effects

If patients suspect that symptoms such as headache, nausea, dizziness, or even severe symptoms result from taking a medication, they should report the suspicion. Such reports can make an important contribution to drug safety.

Patients should report side effects

Medicines are actually used to heal people or alleviate their suffering. But drug therapy often comes with side effects and side effects, in some cases only years later. Quite often, such undesirable side effects occur when using antibiotics. But this problem also exists with over-the-counter medications. In a joint campaign, all European pharmaceutical authorities are now asking patients to report suspected side effects more often.

Important contribution to drug safety

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

Because even with these so-called OTC products, side effects can occur, the reporting of which represent 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 medicines for self-treatment.

Detect risk signals as early as possible

Pharmaceutical companies as well as doctors and pharmacists or their drug commissions are obliged to report undesirable drug effects, the so-called side effects, via their respective professional regulations.

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

From the plethora of reported symptoms, they filter out those that may be a first signal for a previously unknown side effect.

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

"This helps the pharmaceutical authorities to recognize risk signals as early as possible and then take effective measures to protect patients if necessary."

Notification does not replace a visit to the doctor

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

For example, 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 assigned to an underlying disease.

It is known that side effects of drugs that have been on the market for a longer time are reported less frequently than those of new drugs.

Patients can report side effects themselves on the BfArM website at “”.

There is an online registration form specially designed for consumers as well as a registration form with which suspected cases can also be reported by letter or fax.

The BfArM points out that the notification of the side effect does not replace the doctor's visit. Only the attending doctor can and may assess whether, for example, a dose reduction or even discontinuation of the suspected medication is necessary and medically sensible. (ad)

Author and source information

Video: 2019 Novel Coronavirus COVID-19: A Primer for Health Care Providers (July 2022).


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