Author
Marion Wilkens, 1st Chairwoman Alpha1 Germany e. V.
Report side effects – but when is it a side effect and where do I report it? And why is it actually important?
Reporting side effects makes medicines safer.
The pandemic has had one positive effect: it has led to more discussion about side effects, and many people have reported their adverse reactions, especially after vaccinations. However, we shouldn't only do this during pandemics, because:
We patients, and our families, are indispensable when it comes to reporting potential side effects of medications. We are the ones experiencing the side effects, and only we can report them and warn others. Only by reporting everything can information about medications remain up-to-date and necessary measures be taken when needed. Because everyone is different, everyone reacts differently, and you may experience an adverse reaction that did not occur among the participants in the approval studies. To prevent others from having to go through the same experiences you did, please be sure to report your reactions.
Especially in the first few years after a new drug is approved, reports are particularly important. This includes all reports, even those that seem insignificant, such as a lack of effect. If interactions with other medications are reported frequently, information about them may be added to the package insert.
What exactly is a side effect, and where can I check if it's already known?
Medications can have effects, side effects, and interactions. Interactions can occur not only with other medications but also, for example, through the simultaneous intake of food. If you are instructed to take a medication "before meals," this ideally means two hours beforehand so that it can be absorbed in an empty stomach. Similarly, "after meals" usually means two hours after your last meal. Known side effects and interactions of medications are listed in the Summary of Product Characteristics (SmPC) and the package leaflet, which are compiled for every medication approved in Europe. The SmPC and the package leaflet also provide information on how the medication should be used, as only correct use can ensure optimal effectiveness.
The package insert should be written in easily understandable language, but is often printed in very small type. Unfortunately, many patients don't want to know what side effects the product might have and prefer to hope for its effectiveness in addressing their actual problem. Therefore, the package insert is often not read. Ultimately, only an informed patient is on the safer side and can better assess their symptoms.
To report side effects, we also need information on how and where we can do that.
Side effects can be reported to your doctor or pharmacist. The websites www.nebenwirkungen.bund.de and www.nebenwirkungen.de also offer a direct way to inform the national regulatory authorities, the Federal Institute for Drugs and Medical Devices (BfArM), and the Paul Ehrlich Institute (PEI). Side effects can also be reported directly to the manufacturer of a medication.
So-called "Dear Doctor Letters" provide important new information about medications to physicians. In Germany, a Dear Doctor Letter is a common form of informational letter used by pharmaceutical companies to inform healthcare professionals about newly identified drug risks, recall defective drug batches, or communicate other important information. (Source: de.wikipedia.org/wiki/Rote-Hand-Brief)
It is best to discuss this with your doctors, who are legally obligated to report side effects. Ultimately, all reports are entered into a large European database of adverse drug reactions, which can be accessed by anyone interested.
