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

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

SUBMITTER: Januskiene J 

PROVIDER: S-EPMC7894330 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature