Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers

Author:

Christ PatrickORCID,Dubrall DianaORCID,Schmid MatthiasORCID,Sachs BernhardtORCID

Funder

Institute for Medical Biometry, Informatics and Epidemiology (IMBIE) at the University Hospital of Bonn

German Federal Institute for Drugs and Medical Devices

Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Reference49 articles.

1. Moore N, Berdaï D, Blin P, Droz C. Pharmacovigilance—the next chapter. Therapies. 2019. https://doi.org/10.1016/j.therap.2019.09.004.

2. Dubrall D, Schmid M, Alešik E, Paeschke N, Stingl J, Sachs B. Frequent adverse drug reactions, and medication groups under suspicion. Deutsches Ärzteblatt Int. 2018. https://doi.org/10.3238/arztebl.2018.0393.

3. Borg J-J, Aislaitner G, Pirozynski M, Mifsud S. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to?: A review of the new EU legislation on pharmacovigilance. Drug Saf. 2011. https://doi.org/10.2165/11586620-000000000-00000.

4. European Medicines Agency and Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP) Module VI: collection, management and submission of reports of suspected adverse reactions to medicinal products [EMA/873138/2011 Rev 2]. 2017. www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/08/WC500232767.pdf. Accessed 9 Dec 2022.

5. European Commission. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010. https://link.springer.com/content/pdf/10.1007/s40264-018-0647-1.pdf?pdf=button. Accessed 9 Dec 2022.

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