Klinische Arzneimittelprüfungen in der EU: Grundsätze für Standards der Guten Klinischen Praxis (GCP) bei der Durchführung von Studien mit Arzneimitteln am Menschen in der EU
In: Kompaktsammlung Klinische Prüfungen
In: Pharmind-Serie Dokumentation
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Open Access#62013
Proposal for Publishing and Parallel Reporting of Case Reports on Adverse Drug Reactions to Authorities by Physicians
For the safe use of medicinal products, it is important that physicians publish adverse experiences with a medicinal product—particularly regarding side effects—in the scientific literature. However, when searching applicable publications, we determined that adverse drug reactions (ADRs) are often published several months after their occurrence. In the context of patient safety, this is rather questionable as new and important information on ADRs is not available quickly enough to be considered in pharmacovigilance systems. This delay is also not acceptable on the background of the timelines—eg, European Union (EU) legislation requires that marketing authorization holders (MAH) report serious ADRs (SADRs) within 15 calendar days. The legal basis for ADR reporting by physicians and other healthcare professionals is specified in article 102 of the EU Directive 2001/83/ EC as amended (2010/84/EU).
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