[Instruments of official communication by regulatory authorities on risks of drug use]. / Instrumente behördlicher Kommunikation zu Anwendungsrisiken von Arzneimitteln.

Active communication of authorities, such as the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI), including maintenance of contacts with health care professionals, as well as press and public relations work, are essential prerequisites for ensuring that information on the risks of using medicinal products reaches both affected patients and healthcare professionals quickly and in a targeted manner. The various instruments of targeted communication describe possible risks and also contain recommendations that help to reduce the risk of using a medicinal product. The supplementary public relations work aims to make the tasks and objectives of the authority known to the public and to experts with the goal of creating and expanding trust in the actions of the authorities. To this end, appropriate communication platforms must be established and accepted so that they are used by both experts and the general public and the authority is perceived and appreciated as a reliable source of risk information. The currently available instruments of targeted risk communication, such as Dear Health Care Professional Communication (DHPC), risk management plans, and educational materials are described in this paper as well as broader communication on official websites or towards the media. Finally, PEI's risk communication is highlighted with particular reference to COVID-19 vaccines.

[Educational material as part of risk minimisation]. / Schulungsmaterial zur Minimierung von Arzneimittelrisiken.

Educational material, for example in the form of information booklets, checklists, patient alert cards, therapeutic passports, emergency ID cards, or videos, is an important aid for the safe use of a medicinal product or drug and supplements the summary of product characteristics and package information. It is ordered, tested and approved by the competent national authorities, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI), and made available by the respective marketing authorization holder and published on the websites of BfArM and PEI. Educational material is part of the marketing authorization of a medicinal product. Since 1 December 2016, officially approved educational material can be recognized by the blue-hand logo in Germany. There is currently specific educational material for 202 active substances with further recommendations on how to avoid or reduce risks for patients. Although educational material is one of the most common additional risk minimisation measures, little is known about its effectiveness, including related process and outcome indicators. Key elements as well as an overview of educational material are described.

Frequent Adverse Drug Reactions, and Medication Groups under Suspicion.

BACKGROUND: The adverse drug reaction database of the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) contains reports of suspected adverse drug reactions (ADRs) that are spon- taneously submitted by physicians, pharmacists, or patients. The aim of the present study was a descriptive analysis of all of these spontaneous reports. METHODS: 345 662 spontaneously submitted reports were analyzed with respect to the number of reports per year, the sources of the reports, demographic variables, the most commonly reported ADRs, and the drug classes most commonly suspected. RESULTS: The number of reports submitted spontaneously each year has grown steadily since 1978. At the least detailed level of analysis, "drugs for the treatment of nervous system disorders" were the most common class of drugs under suspicion of causing the reported adverse drug reactions (23.1%). In a more detailed analysis by therapeutic subgroup, the three subgroups most commonly reported as suspected of causing side effects were antithrombotic agents, systemic antibiotics, and psycholeptics-causing thrombocytopenia, diarrhea, and drug dependency as the most frequently reported ADRs, respectively. The order of drug classes most commonly causing ADRs differed markedly between the physicians' reports (diazepines, fluoroquinolones, heparins) and the patients' reports (interferons, anti- thrombotic drugs, selective immunosuppressant drugs). Patients more commonly reported subjectively perceived ADRs, while physicians more commonly reported findings or diagnoses that require medical expertise. CONCLUSION: The increasing number of spontaneous reports is mainly due to reports forwarded from pharmaceutical companies to the BfArM. This, in turn, is probably a result of increasingly strict legal reporting requirements in Germany. The detected differences between physicians' and patients' ADR reports can be taken to indicate that patients should be more specifically informed and questioned about potential ADRs. By reporting adverse drug reactions, physicians may improve drug safety.

[Current cases of falsified medicinal products within the competence of the Federal Institute for Drugs and Medical Devices (BfArM) : Case studies and extent]. / Aktuelle Fälschungsfälle bei Arzneimitteln in der Zuständigkeit des Bundesinstituts für Arzneimittel und Medizinprodukte (BfArM) : Fallbeispiele und Ausmaß.

The nature of a falsification of a medicinal product can vary a lot. Therefore the means to detect them and the potential risk to patient safety can also be very different. The whole range of falsification will be described using observed cases from the Federal Institute for Drugs and Medical Devices (BfArM).Based on the relatively low number of detected cases of falsified medicines, the legal supply chain can still be regarded as safe. It has to be assumed that in the illegal supply chain, e. g. illegal internet trade, the majority of the offered medicinal products are not only falsifications due to illegal trade but because they are completely falsified. Therefore there is an especially high risk for the consumer to be harmed by medicinal products that do not fulfil the required specifications.The trend indicates that increased efforts will be necessary to keep the legal supply chain safe and to contain illegal trade with falsifications. The higher federal authorities BfArM, PEI and BVL are involved in this task by coordinating and ensuring the flow of information to the concerned authorities and stakeholders as well as informing the public. Increased efforts are also necessary due to the rising involvement of organised crime in the falsification of medicinal products. A package of measures was enacted with the Falsified Medicines Directive 2011/62/EU to protect the legal supply chain from falsified medicinal products.