Collection of Data on Adverse Events Related to Medicinal Products: A Survey Among Registries in the ENCePP Resources Database

Kelly Plueschke (), Carla Jonker, Valerie Strassmann and Xavier Kurz
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Kelly Plueschke: European Medicines Agency
Carla Jonker: European Medicines Agency
Valerie Strassmann: European Medicines Agency
Xavier Kurz: European Medicines Agency

Drug Safety, 2022, vol. 45, issue 7, No 5, 747-754

Abstract: Abstract Introduction As patient registries are not subject to regulatory requirements on the collection of adverse events (AEs) related to medicinal products, they may not have foreseen the collection of such information on a routine basis or as part of specific data collection schemes. Objective The European Medicines Agency conducted a survey among registries to better understand their approach towards the collection, management and reporting of AEs related to medicines. Method An online survey composed of 15 questions was distributed in May 2020 to registries listed in the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) resources database for completion by August 2020. Aggregated results are presented in this paper. Results One third of the registries completed the survey (31/85; 36.5%). Most of the respondents routinely collect information on medicines (29/31; 93.5%), out of which 65.5% (19/29) also collect data on AEs and adverse drug reactions (ADRs). Frequencies and timelines for collecting and reporting AEs/ADRs vary widely across registries, as does their level of experience in providing data to third parties for regulatory purposes. Conclusions The low response rate may indicate little interest in this topic or that registries were not originally developed for routine data collection on AEs/ADRs and, ultimately, monitoring of the safety of medicines. Results indicate that clear guidance on the collection and use of real-world data in regulatory frameworks and strengthened collaboration between registry holders, academia, regulators and medicines developers are needed to achieve comprehensive and high levels of quality of safety data captured by registries to support regulatory decision making. These will hopefully be enabled by the European Medicines Regulatory Network strategy to 2025.

Date: 2022
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DOI: 10.1007/s40264-022-01188-x

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