Patients can report side effects as of today

Patients can inform authorities about side effects of medicines

02/10/2012

There are some portals on the Internet where patients can report drug side effects. However, these websites are operated commercially and usually serve only for the exchange of experience of patients. From now on, however, affected persons can report directly to the responsible monitoring authorities the reciprocal and side effects of medicinal products. To this end, the Federal Institute for Drugs and Medical Devices (Bfarm) and the Paul Ehrlich Institute (Pei) for vaccines in co-operation has launched its own portal.

As of today (Tuesday), patients may report side effects from oral medicines or vaccines. The beta phase for the new Internet portal has already been set up according to the authorities, so that information can be recorded faster, more effectively and more easily in the future. The Federal Institute for Drugs and Medical Devices hopes that this will make previously unknown side effects clearer and, if necessary, initiate risk minimization measures, as the PEI in Langen explained. „The transmission of side effects to the higher federal authorities can be made via www.verbraucher-uaw.pei.de by activating the input form via the displayed link. The notification is forwarded to the authority responsible for the respective drug (BfArM or PEI).“, so the PEI.

Thus, the new portal gives patients and consumers quick access to the simplified reporting system. If a patient is suspected to have symptoms such as headache, nausea, dizziness or even severe symptoms from taking a medicine, the suspicion can be reported without the doctor's approval. The PEI explicitly emphasizes that „the data is subject to confidentiality“. The in the „Suspicion of adverse reactions or personal data given in the submitted documents will not be included in the central adverse reaction database of the PEI / BfArM“. However, people should „with possible side effects for further diagnosis and therapy immediately contact the attending physician“, even if a message has already been sent via the form.

Often side effects despite clinical studies unknown
If a new drug is approved, the knowledge of side effects is limited to results from clinical trials, which in principle can only be performed with a limited number of persons and a selected group of people. Even if the number of cases in clinical trials before admission is large, widespread use usually yields new insights and side effects that were previously unknown.

The European Union is currently planning far-reaching legislative changes to strengthen patient rights. The reports from patients should be significantly strengthened. In some countries, patient reporting is already in progress. Experience so far has shown that direct reports from patients of potential drug side effects help detect risks more early. In addition, pharmaceutical companies, doctors and pharmacists are obliged to report cases of suspected adverse drug reactions in a timely manner.

Positive experience in other countries
The experiences in other countries were rather good. Research in England, the US, and Canada has shown that patients are more likely to describe generalized complaints such as nausea, general malaise, dizziness, palpitations, difficulty falling asleep, or inner anxiety. The symptoms differed from those of the doctors, who also use the system. Healthcare professionals were more likely to be limited to "specifics," but patients were much more symptomatic than nurses or physicians.

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