As of today, patients can report side effects



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Patients can inform authorities about side effects of drugs

There are some portals on the Internet where patients can report side effects of medicines. However, these websites are operated commercially and mostly only serve to exchange experiences among patients. From now on, however, those affected can directly report drug changes and side effects to the responsible monitoring authorities. To this end, the Federal Institute for Drugs and Medical Devices (Bfarm) and the Paul Ehrlich Institute (Pei) for vaccines have launched their own portal in cooperation.

As of today (Tuesday), patients can report side effects from oral drugs or vaccinations. According to the authorities, the beta phase for the new Internet portal has already been set up so that information can be recorded faster, more effectively and more easily in the future. The Federal Institute for Drugs and Medical Devices is hoping to publish previously unknown side effects more quickly and, if necessary, to initiate measures to minimize risks, as the PEI in Langen explained. "The transmission of side effects to the higher federal authorities can take place via www.consumer-uaw.pei.de by activating the input form via the displayed link. The notification will be forwarded to the authority responsible for the respective medicinal product (BfArM or PEI), ”says the PEI.

This means that the new portal gives patients and consumers quick access to the simplified reporting system. If a patient suspects that symptoms such as headache, nausea, dizziness, or even severe symptoms were caused by taking a medicine, the suspicion can be reported without the doctor's confirmation. The PEI expressly emphasizes that "the data are subject to confidentiality". The personal data given in the “Suspect report of the side effect or in the transmitted documents will not be transferred to the central side effects database of the PEI / BfArM”. However, people "with possible side effects for further diagnosis and therapy should contact the treating doctor immediately", even if a report has already been made via the form.

Side effects are often unknown despite clinical studies
If a new drug is approved, knowledge of side effects is limited to results from clinical trials, which can generally only be carried out with a limited number of people and a selected group of people. Even if the number of cases in clinical trials before approval is large, widespread use usually results in new insights and side effects that were previously unknown.

The European Union is currently planning far-reaching changes to the law to strengthen patient rights. The reports from patients should be strengthened significantly. The procedure for patient reporting is already in operation in some countries. Experience to date has shown that direct reports from patients about possible drug side effects help to identify risks at an early stage. In addition, pharmaceutical companies, doctors and pharmacists remain obliged to promptly report suspected cases of negative drug effects.

Positive experience in other countries
The experience in other countries was rather good. Studies in England, the USA and Canada showed that patients described general symptoms such as nausea, general malaise, dizziness, rapid heartbeat, problems falling asleep or inner restlessness. The symptoms differed from those of the doctors who also used the system. The medical professionals were limited to "specific information", but patients entered a lot more symptoms than nurses or medical professionals.

A Norwegian study also showed that 70 percent of the side effects entered were not life-threatening or serious. In Denmark, however, the rate was only 55 percent of the self-contributors. About 35 percent of the reported side effects in Danish patients were those that had not yet appeared on the package insert. (sb)

Image: Image of the portal

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