What are the patients' and health care professionals' understanding and behaviors towards adverse drug reaction reporting and additional monitoring?
additional monitoring
adverse drug reactions
black triangle
impact
pharmacoepidemiology
pharmacovigilance
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
03 2021
03 2021
Historique:
received:
21
04
2020
revised:
09
09
2020
accepted:
21
10
2020
pubmed:
26
10
2020
medline:
25
11
2021
entrez:
25
10
2020
Statut:
ppublish
Résumé
The additional monitoring (AM)/black triangle concept is aimed to enhance ADR reporting for certain types of medicinal products for which the safety profile is less well established. The objective of this survey was to assess (a) attitudes towards ADR reporting and reasons for not reporting an ADR and (b) awareness of AM among HCPs, patients or their careers in EU countries. An online questionnaire which was available in all EU languages was completed by 2918 responders coming from all EEA countries. The main factors motivating to report an ADR were severity or novelty of the reaction or novelty of the medicine. The main factors for not reporting an ADR was the fact that the ADR is already known (35%), the ADR was not serious (18%) or reporter was not sure if the ADR was related to the medicine (15%). Half of the respondents indicated that they have seen AM statement before. Thirty percent of the responders had correct understanding of the AM concept while 20 % misunderstood the concept. Underreporting occurs but it seems this is because of reporter's prioritisation towards certain type of ADRs. AM aims to increase reporting for certain medicines, however, approximately half of responders have seen the AM symbol before and 20% of all responders (independent of their previous awareness) misunderstood the concept.
Sections du résumé
BACKGROUND
The additional monitoring (AM)/black triangle concept is aimed to enhance ADR reporting for certain types of medicinal products for which the safety profile is less well established.
PURPOSE
The objective of this survey was to assess (a) attitudes towards ADR reporting and reasons for not reporting an ADR and (b) awareness of AM among HCPs, patients or their careers in EU countries.
METHODS
An online questionnaire which was available in all EU languages was completed by 2918 responders coming from all EEA countries.
RESULTS
The main factors motivating to report an ADR were severity or novelty of the reaction or novelty of the medicine. The main factors for not reporting an ADR was the fact that the ADR is already known (35%), the ADR was not serious (18%) or reporter was not sure if the ADR was related to the medicine (15%). Half of the respondents indicated that they have seen AM statement before. Thirty percent of the responders had correct understanding of the AM concept while 20 % misunderstood the concept.
CONCLUSION
Underreporting occurs but it seems this is because of reporter's prioritisation towards certain type of ADRs. AM aims to increase reporting for certain medicines, however, approximately half of responders have seen the AM symbol before and 20% of all responders (independent of their previous awareness) misunderstood the concept.
Identifiants
pubmed: 33099846
doi: 10.1002/pds.5162
pmc: PMC7894330
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
334-341Informations de copyright
© 2020 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.
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