The Role of European Patient Organizations in Pharmacovigilance

Overview

Journal Drug Saf

Specialties Pharmacology
Toxicology

Date 2018 Oct 26

PMID 30357648

Citations 6

Authors

Cristiano Matos

Gerda Weits

Florence van Hunsel

Affiliations

Soon will be listed here.

Abstract

Introduction: Patient organizations have a privileged position to be active agents for promoting pharmacovigilance and patient engagement, encouraging direct patient reporting and improving the awareness of pharmacovigilance.

Aim: The objective of this study was to understand the role of European patient organizations as stakeholders to optimize patient involvement in pharmacovigilance.

Methods: A descriptive correlational study was conducted to investigate the opinions and attitudes of patient organizations regarding general patient involvement in pharmacovigilance, and their initiatives to support drug safety through a web-based questionnaire during the months of March and April 2018.

Results: A total of 1898 patient organizations were invited to participate in the survey, including 89 pan-European organizations. In total, 337 questionnaires (17.76%) were collected from 31 countries, including 297 complete answers (88.31%). A large number of organizations stated that they would like to increase the awareness of patients regarding specific adverse drug reactions (ADRs) related to their medicines (43.19%, n = 130); however, 38.54% (n = 116) declared they do not have any pharmacovigilance goals. Barriers to supporting pharmacovigilance activities include low budget to promote pharmacovigilance among members (45.45%, n = 135), lack of resources to participate in pharmacovigilance activities (43.77%, n = 130), or lack of support from the National Competent Authorities (33.33%, n = 99). Organizations inform patients to report ADRs (40.40%; n = 120), information regarding new ADRs related to their medicines (40.07%; n = 119), or when a new drug is marketed (30.98%; n = 92); however, more than one-third indicated that they never had any involvement in pharmacovigilance (34.68%; n = 103).

Conclusion: Bringing pharmacovigilance stakeholders and patient organizations together could create a more optimal reporting culture. Patient organizations appear to have an important role in encouraging patients to talk with their doctors/pharmacists about ADRs experienced, or to help him/her report the ADRs to the pharmacovigilance systems. Lack of resources, budget, and support from NCAs are seen as the main barriers to being involved in pharmacovigilance awareness.

Citing Articles

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