Implementation Science for Effective Risk Management of Medicines: A Call for Global Action.

Abstract

Pharmaceutical risk minimization, as an essential element of pharmacovigilance, aims to reduce medicinal product risks in order to improve a product's benefit-risk profile. However, to date the practical application of risk minimization has proved challenging. In particular, risk minimization standards developed by and for high-income countries have been shown to have limited suitability in low and middle income countries (LMICs) and high-income countries have struggled to deliver these programs with consistently high quality and demonstrable long-term impact. The World Health Organization's new 2025 framework for pharmacovigilance-'The Global Smart Pharmacovigilance Strategy'-calls for developing comprehensive and sustainable safety monitoring and risk management practices as integral components of healthcare and regulatory systems in all member countries globally. The field of implementation science offers a robust set of approaches to address current gaps and challenges in risk minimization, one that can help meet the needs of twenty-first century pharmacovigilance. We call for the convening of an internationally representative expert forum to develop a pragmatic framework and set of recommendations regarding the application of implementation science good practices to advance risk minimization for medicinal products globally. The framework and recommendations should be practical, sustainable and equally applicable for use in LMIC and high-income countries. In addition, the framework and recommendations should be accompanied by a blueprint for implementation science capacity building as well as a dissemination plan for promoting uptake of the framework and recommendations by industry and regulatory authorities worldwide.