At the time medicinal products are first licensed, the information on their safety profile cannot be complete. Generally, rare and very rare adverse reactions, interactions with other medications, or other risks in relation to the use of a medicinal product cannot always be determined comprehensively in clinical trials. This is due to the fact that a limited number of persons is enrolled in the clinical trial of a medicinal product. For example: in order to recognise an adverse reaction with an incidence of 1:1000, at least 3000 persons would have to participate in the clinical trial. Also, these persons were chosen considering various aspects that do not necessarily reflect the conditions of a broader use of the medicinal product in the population.
Therefore, the German Medicinal Products Act (Arzneimittelgesetz, AMG) provides for the continuous and systematic collection and evaluation of experiences regarding the safety of a medicinal product after it has been granted marketing authorisation. This is one of the tasks of the National Competent Authorities Federal Institute for Drugs and Medical Devices (BfArM) and Paul-Ehrlich-Institut (PEI). The reporting of suspected adverse reactions is an important component in this process.
10 Questions and Facts around the Reporting of Adverse Reactions
What is an adverse reaction?
According to the definition in the German Medicinal Products Act, an adverse reaction is considered to be any noxious and unintended reaction to a medicinal product. In human medicine, the term 'adverse reaction' is not bound to the indications for use as specified in the package leaflet. Thus, reactions that are a result of overdose, medication errors, or so-called "off-label use" (i.e. use in other conditions than those approved by healthcare professionals exercising their therapeutic freedom), are likewise considered adverse reactions.
Reporting such adverse reactions to www.nebenwirkungen.bund.de helps BfArM and PEI to supervise medicinal products/vaccines and considerably contributes to the early recognition of signals of new risks and how to address them.
Why should I report an adverse reaction at all? Especially if it is already included in the package leaflet?
Frequently, certain risks will only be discovered after many people have taken a medicinal product. Sometimes, the risks associated with the use of a medicinal product might only be recognised years after its introduction to the market. Therefore, it is important to continue to collect information on a medicinal product on an ongoing basis and to take the necessary measures to protect patients where required. This also applies to adverse reactions already listed in the package leaflet. For example, a particular accumulation of reports could indicate the emergence of a new problem. Such reports can also contribute new aspects concerning the severity of a known adverse reaction as well as on the reversibility or more frequent occurrence in connection with pre-existing underlying diseases or concomitant medications.
Such an evaluation is not possible without the reporting of suspected cases. Every suspected case of an adverse reaction reported to the BfArM is therefore recorded in compliance with internationally applied standards and transmitted electronically to the joint European database "EudraVigilance", thus entering into the European risk assessment of medicinal products.
Anyone who reports suspected adverse drug reactions contributes to improving the safety of medicinal products, thus helping other patients. Ultimately, this forms the basis of the safety of medicines approved in Europe. This appeal is also directed at healthcare professionals: Risks of medicinal products can only be identified quickly if they too report suspected cases to the competent authorities.
Therefore, it is essential that suspected adverse reactions are reported to the competent authorities at www.nebenwirkungen.bund.de. In doing so, you will be supporting the scientific experts at BfArM and PEI in their supervision of medicinal products/vaccines, thus contributing significantly to their safe use.
Aren't adverse reactions reported by the physicians?
In accordance with their professional code of conduct, healthcare professionals are obligated to report adverse reactions to the Drug Commissions of the respective professional organisations (Drug Commission of the German Medical Association, Dental Drug Commission and/or the Drug Commission of German Pharmacists). These bodies then transmit the reports to the competent higher federal authority (BfArM or PEI).
The Drug Commission of the German Medical Association and the Drug Commission of German Pharmacists, for example, have published corresponding guidelines to support reporting. However, despite this, daily practice has shown that not every adverse reaction that occurs, is reported.
Patients and their relatives or representatives can also submit reports to www.nebenwirkungen.bund.de. From there, any report reaches the scientific experts working at BfArM and PEI quickly and directly.
Are all adverse reactions reported?
Unfortunately, still not all adverse reactions are reported. The reasons for such underreporting are varied: For example, the physician is not informed about every observation, or the possible connection between a reaction or its symptoms and the medicinal product is not recognised. Also, adverse reactions to medicinal products that have been on the market for a longer period of time are reported less frequently than those related to newer medicinal products.
Since 2015, BfArM and PEI have been participating in the campaign "MedSafetyWeek" to raise awareness of the issue in order to increase the number of reports. Aside from special pandemic-related factors, the BfArM has observed that over the years healthcare professionals are fortunately increasingly submitting such reports. The reporting figures from patients and their relatives or representatives has also been increasing continuously.
Adverse reactions can be reported to www.nebenwirkungen.bund.de. From there, any report reaches the scientific experts working at BfArM and PEI quickly and directly.
Is every report of an adverse reaction investigated?
Yes. Your report is important and we take reports of suspected adverse reactions very seriously. Every single report helps us to recognise signals of new risks at an early stage and, if necessary, to take effective measures for patient protection. Should your report not be complete, we will contact you for further inquiries. As is also the case with reports from healthcare professionals, the scientific experts from BfArM and/or PEI consider whether the submitted report represents a signal of a new risk - either alone in itself or in combination with further reports related to that medicinal product. This also applies to reports of already known adverse reactions. The reports are also forwarded to the central European Database for reported suspected adverse drug reactions. This database offers a comprehensive data pool which allows the EU-wide supervision of the risks of medicinal products.
Adverse reactions can be reported to www.nebenwirkungen.bund.de. From there, any report reaches the scientific experts working at BfArM and PEI quickly and directly.
How can I find out what happened with my report? Will I receive any information?
Yes. After having submitted your report to www.nebenwirkungen.bund.de, you will get an electronically generated confirmation of receipt summarising all your information. This will include a unique processing number which you should quote in case you have further inquiries regarding your report. For reasons of data protection, such inquiries must be made in writing.
What happens if evaluation of the adverse reaction suggests a new or modified risk of a medicinal product?
Identification of a possible risk of a medicinal product with a potential influence on the risk-benefit ratio of a medicinal product initiates a scientific discussion, at the end of which regulatory measures are recommended if necessary. Examples of such measures include updating the product information (summary of product characteristics and package leaflet), issuing of a Direct Healthcare Professional Communication, compilation of educational material, or publication of information on the websites of European Medicines Agency, BfArM, or PEI. Under certain conditions, however, the authorisation of a medicinal product can be revoked altogether.
In cases of an immediate risk to public health, the national competent authorities of the EU Member States (such as the BfArM or the PEI) can also introduce urgent action at any time - for example, they can issue a temporary order that the medicinal product may not be distributed or administered.
Therefore, it is essential that suspected adverse reactions are reported to the competent authorities at www.nebenwirkungen.bund.de. In doing so, you are contributing significantly to the safe use of medicinal products and vaccines.
Why is it important to use the portal www.nebenwirkungen.bund.de to report suspected adverse reactions?
Use of the portal provided by BfArM and PEI ensures that the reports will comply with globally recognised standards and that the information they contain is prepared in a scientifically sound manner for subsequent medical assessment. This also means that the content of the report is both treated confidentially in accordance with the valid data protection regulations as well as with the necessary scientific expertise. Every single report enters into the ongoing assessment of the safety of medicinal products on a European level under consideration of all relevant framework conditions.
In the BfArM's opinion, private providers who advertise the recording of adverse reactions, but are based on an entirely or partially commercial business approach and who are not subject to any regulatory control, are unable to provide this level of security.
Does it happen frequently that reports of adverse reactions lead to restrictions in the use of a medicinal product?
As a rule, no one single report on adverse reactions leads directly to restrictions in the administration of a medicinal product. However, if the multitude of reports received leads to changes in the risk profile of a medicinal product or active substance, the corresponding product information is generally updated in the course of other procedures (e.g. signal procedures, assessments of periodic safety update reports etc.), for instance in order to have a new adverse reaction included.
How many adverse reactions were reported to the BfArM in the course of the past year?
In the period from 1 January 2021 until 31 December 2021, the BfArM received a total of 16,780 direct reports of adverse reactions.
