18 / 2018
Since 26 September 2018, a modernized and barrier-free version of the website for the reporting of suspected adverse drug reactions is online. At nebenwirkungen.pei.de, citizens can now report side effects more easily to the competent medicines authorities, the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and the Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines. The online reporting system is an important tool for statutory drug monitoring and part of the early detection system in the area of drug safety.
The reporting of side effects helps to gather extensive information about possible drug risks after the marketing authorisation. Affected patients or their relatives can report suspected cases of adverse effects voluntarily, easily and comfortably using the new website. The message does not replace the visit to the doctor. Physicians can use this reporting portal to inform the higher federal authorities (Bundesoberbehörden, BOB), too.
The clearly structured, barrier-free form will guide the reporting person through the process in a generally understandable way. A report may cover both multiple adverse reactions to one drug as well as several drugs that cause a single adverse reaction. Optimized for desktop, tablet or smartphone - the form remains clear and easy to use and provides additional information in the various steps. The reporting person does not need to know whether the BfArM or the PEI is responsible for the medicinal product in question. The amount of time required for the message is small. At the request of the reporting person, every message will remain anonymous, even if it receives a processing number.
The fact that reports about suspected cases of adverse drug reactions via the former reporting portal have sharply risen also shows that they are coming increasingly into the public's attention. Regular awareness campaigns by the drug regulatory agencies BfArM and PEI and the joint Bulletin on Drug Safety (Bulletin für Arzneimittelsicherheit) have contributed to this.
The reports of suspicious cases will be forwarded to the "European database for suspected adverse drug reaction reports" according to legal requirements. In addition, notifications can be made in any other EU language through this database. It shows suspected cases of drug side effects reported across Europe.
The reporting of suspected cases will be of particular importance for the safety of medicines, especially if the reported information contains sufficiently differentiated and reliable clinical data on the symptoms or illnesses observed. With the use of the joint reporting portal of PEI and BfArM, all reports of suspected cases flow directly into the regulatory drug monitoring system, so that the drug safety experts can take them into account in the risk monitoring.
"The cooperation between BfArM and PEI has enabled us to improve our digital offer in the area of drug safety in favour of the citizens,"
says Professor Klaus Cichutek, President of the PEI. Professor Karl Broich, President of the BfArM emphasizes: "With the new reporting portal we want to make it even easier for patients to report side effects. Because the sooner and more detailed we receive reports, the sooner we can detect risk signals and, if necessary, take effective measures for patient protection."
The new website is directly accessible via nebenwirkungen.pei.de and the websites of BfArM and PEI.
Nebenwirkungen von Arzneimitteln melden: Europaweite Kampagne soll Patientinnen und Patienten sensibilisieren
Definition of side effect:
Adverse reactions are harmful and unintended reactions to a drug intended for human use.
Paul-Ehrlich-Institut
The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main is a senior federal authority reporting to the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). It is responsible for the research, assessment, and marketing authorisation of biomedicines for human use and immunological veterinary medicinal products. Its remit also includes the authorisation of clinical trials and pharmacovigilance, i.e. recording and evaluation of potential adverse effects.
Other duties of the institute include official batch control, scientific advice and inspections. In-house experimental research in the field of biomedicines and life science form an indispensable basis for the manifold tasks performed at the institute.
The Paul-Ehrlich-Institut, with its roughly 800 members of staff, also has advisory functions nationally (federal government, federal states (Länder)), and internationally (World Health Organization, European Medicines Agency, European Commission, Council of Europe etc.).
BfArM
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health. The BfArM is located in Bonn.
At the BfArM, roughly 1100 employees are involved in the tasks of licensing, improving the safety of medicinal products, detecting and evaluating the risks of medical devices, and monitoring the legal traffic in narcotic drugs and precursors. The most important aim of these activities is to increase the safety of medicinal products and thus that of the patients. Consequently, the BfArM makes a major contribution towards the prevention of risks to public health.
Contact:
Paul-Ehrlich-Institut
Press Office
Telefon: +49 6103 77 1030
Email: presse@pei.de
Updated: 27.09.2018
