Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis.

ABSTRACT:

Introduction

Involving patients in decision making adds value in the context of pharmacovigilance (PV). This added value goes beyond participation in spontaneous reporting systems for adverse drug reactions. However, there is a gap between allowing patients to report and actual patient involvement. Views regarding best practices from regulators, patient organizations and pharmaceutical companies could help increase and improve patient involvement in PV.

Objective

The aim of this study was to investigate the factors contributing to best practices for patient involvement in PV and to develop a definition of patient involvement based on a qualitative multistakeholder study across Europe.

Methods

A literature review was conducted to map the field of study and obtain insig

SUBMITTER: van Hoof M 

PROVIDER: S-EPMC9409619 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature