A patient-centred web-based adverse drug reaction reporting system identifies not yet labelled potential safety issues.

ABSTRACT:

Purpose

Reporting of adverse drug reactions (ADRs) by patients is essential for a comprehensive risk-benefit evaluation of drugs after marketing, but only few data are available regarding patient-centred web-based ADR reporting systems. Hence, we aimed to analyze ADRs reported by patients with a particular emphasis on novel drugs and serious ADRs not yet labelled in the respective summary of product characteristics (SPC).

Methods

All ADR reports received by a web-based, patient-centred platform ( www.nebenwirkungen.de ) between April 1, 2019, and September 1, 2020, were descriptively analyzed. ADRs and drugs were coded automatically according to MedDRA and ATC classification system. SPC labelling of reported ADRs for novel drugs marketed since 2015 was checked manually.

R

SUBMITTER: Hasford J 

PROVIDER: S-EPMC8212270 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature