Database: massive side effects from medication
As we have reported many times before, medications can have serious side effects: whether liver damage from painkillers, an increased risk of miscarriage due to anti-inflammatory drugs or a pulmonary embolism from taking the birth control pill - the list is long and whenever a new “drug scandal” becomes public , the question arises again whether this could not have been prevented and why drugs with such high risks may even be brought onto the market.
Federal Institute for Drugs and Medical Devices puts database online
But now there is a new way for patients to get valuable information about drugs and possible side effects, because the Federal Institute for Drugs and Medical Devices (BfArM) is now making its database for adverse drug reactions (UAW) public on the Internet.
According to the BfArM, all "reported suspected cases of adverse drug reactions (ADR) from Germany in connection with the use of drugs (synonymous:" suspected cases of side effects ") have been listed here since 1995" - but this does not mean that this causal connection with the Medicines actually exist. For this reason, the next step is for doctors to check the approximately 50,000 negative effects caused by medications for actual side effects - if the Federal Institute for Drugs and Medical Devices finds the negative effects to be "genuine" after a thorough examination of the data, the assessment or recall will follow of the corresponding preparation.
However, free access to raw data could also cause confusion
The database is freely accessible for an unlimited period, but it remains to be seen whether the current form does not provide confusion rather than support. Because the data are not easy to understand, especially for non-medical professionals, what it means for yourself, for example, if, for example, five patients experienced dizziness within one year after taking medication X remains questionable at first. If, on the other hand, there is additional information that 20 cases of dizziness occurred in women between the ages of 20 and 40 in the period of 10 years, then the patient can get a better picture of the risks of the preparation.
BfArM tries to avoid misinterpretations by providing information
So there is a certain risk that the data may be misinterpreted and may cause panic rather than reassurance. The BfArM is obviously aware of this danger, because if you want to use the database, you will first be confronted with a lot of information, information and warnings about the research, which must first be accepted before the page can go any further. Nevertheless, it is reasonable to assume that free access to the data will lead to much discussion and criticism in the near future, precisely because, for example, pharmaceutical opponents could now easily use the data in their favor.
Discovery of rare side effects through patient reports
But despite the risk of misinterpretation, the free accessibility of data, in addition to clarification, also offers great potential for the discovery of massive side effects, which may be so rare that they are not even mentioned on the usual package insert. It is all the more important that negative medication effects are not only researched, but can also be reported by patients - this is why a corresponding internet portal is to be opened in autumn, on which those affected can quickly and easily report drug interactions and side effects.
Registration system for patients in the test phase since 2012
The reporting system for patients and consumers has been in the test phase since October 2012. As Heilpraxisnet.de reported, the Federal Institute for Drugs and Medical Devices, together with the Paul Ehrlich Institute (PEI) for vaccines, launched the www.consumer-uaw.pei.de portal, which has since been used to report side effects to the federal authorities can be done by forwarding the notification of the corresponding medication - depending on the responsibility - to the BfArM or the Paul Ehrlich Institute. (No)
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