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. 2021 Mar;30(3):334-341.
doi: 10.1002/pds.5162. Epub 2020 Nov 8.

What are the patients' and health care professionals' understanding and behaviors towards adverse drug reaction reporting and additional monitoring?

Justina Januskiene  1 , Andrej Segec  1 , Jim Slattery  1 , Georgy Genov  1 , Kelly Plueschke  1 , Xavier Kurz  1 , Peter Arlett  1   2
Affiliations

What are the patients' and health care professionals' understanding and behaviors towards adverse drug reaction reporting and additional monitoring?

Justina Januskiene et al. Pharmacoepidemiol Drug Saf. 2021 Mar.

Abstract

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.

Keywords: additional monitoring; adverse drug reactions; black triangle; impact; pharmacoepidemiology; pharmacovigilance.

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Conflict of interest statement

The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties.

Figures

FIGURE 1
FIGURE 1
Mandatory scope of additional monitoring 3 , 4 [Colour figure can be viewed at wileyonlinelibrary.com]
FIGURE 2
FIGURE 2
Black triangle symbol and statement included in the summary of product characteristic (top) and package leaflet (bottom) of products under additional monitoring 3 , 4
FIGURE 3
FIGURE 3
Number of ADRs observed/experienced by various types of responders (n = 2918) [Colour figure can be viewed at wileyonlinelibrary.com]
FIGURE 4
FIGURE 4
Numbers of (%) responders who reported an ADR at least once, when the number of observed/experienced ADRs was 1 or more (n = 2230) [Colour figure can be viewed at wileyonlinelibrary.com]
FIGURE 5
FIGURE 5
Reasons for not reporting an ADR (n = 3532, multiple choice question) [Colour figure can be viewed at wileyonlinelibrary.com]
FIGURE 6
FIGURE 6
Attitudes towards reporting various types of ADRs, all respondents combined (top), HCPs (middle), and non‐HCPs (bottom) [Colour figure can be viewed at wileyonlinelibrary.com]
FIGURE 7
FIGURE 7
Understanding of black triangle and AM concept by different responders (n = 2918) [Colour figure can be viewed at wileyonlinelibrary.com]
See this image and copyright information in PMC

References

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