PMID- 35729468
OWN - NLM
STAT- MEDLINE
DCOM- 20220721
LR  - 20221020
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Print)
IS  - 0114-5916 (Linking)
VI  - 45
IP  - 7
DP  - 2022 Jul
TI  - Collection of Data on Adverse Events Related to Medicinal Products: A Survey 
      Among Registries in the ENCePP Resources Database.
PG  - 747-754
LID - 10.1007/s40264-022-01188-x [doi]
AB  - 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.
CI  - (c) 2022. The Author(s).
FAU - Plueschke, Kelly
AU  - Plueschke K
AUID- ORCID: 0000-0002-1824-4148
AD  - Data Analytics and Methods Task Force, European Medicines Agency, Domenico 
      Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands. 
      Kelly.plueschke@ema.europa.eu.
FAU - Jonker, Carla
AU  - Jonker C
AD  - Data Analytics and Methods Task Force, European Medicines Agency, Domenico 
      Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.
AD  - Medicines Evaluation Board, Utrecht, The Netherlands.
FAU - Strassmann, Valerie
AU  - Strassmann V
AD  - Data Analytics and Methods Task Force, European Medicines Agency, Domenico 
      Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.
FAU - Kurz, Xavier
AU  - Kurz X
AD  - Data Analytics and Methods Task Force, European Medicines Agency, Domenico 
      Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.
LA  - eng
PT  - Journal Article
DEP - 20220621
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - Databases, Factual
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Humans
MH  - Pharmacoepidemiology
MH  - *Pharmacovigilance
MH  - Registries
MH  - Surveys and Questionnaires
PMC - PMC9296377
COIS- The authors Kelly Plueschke, Carla Jonker, Valerie Strassmann and Xavier Kurz 
      declared no competing interests for this work. The views expressed in this 
      article are the personal views of the authors and may not be understood or quoted 
      as being made on behalf of or reflecting the position of the European Medicines 
      Agency or one of its committees or working parties.
EDAT- 2022/06/22 06:00
MHDA- 2022/07/22 06:00
PMCR- 2022/06/21
CRDT- 2022/06/21 23:34
PHST- 2022/05/10 00:00 [accepted]
PHST- 2022/06/22 06:00 [pubmed]
PHST- 2022/07/22 06:00 [medline]
PHST- 2022/06/21 23:34 [entrez]
PHST- 2022/06/21 00:00 [pmc-release]
AID - 10.1007/s40264-022-01188-x [pii]
AID - 1188 [pii]
AID - 10.1007/s40264-022-01188-x [doi]
PST - ppublish
SO  - Drug Saf. 2022 Jul;45(7):747-754. doi: 10.1007/s40264-022-01188-x. Epub 2022 Jun 
      21.