pharmacovigilance

This commentary highlights the challenges for pharmacovigilance (PV) posed by the COVID-19 pandemic and how PV practitioners in Africa can use this opportunity to strengthen patient safety. The commentary discusses remedies that lack clinical evidence and are potentially dangerous and the hidden effects of irrational use of medicines and medical products. It also examines the increase in poor reporting of adverse effects as well as the weakening of PV systems. It concludes that drug safety practitioners need to be vigilant about these risks and strengthen reporting systems to document, characterize, communicate, and minimize the risks of such remedies.

Abstract Introduction: Active surveillance pharmacovigilance is a systematic approach to medicine safety assessment and health systems strengthening, but has not been widely implemented in low- and middle-income countries.

Abstract Purpose: Active surveillance pharmacovigilance systems better estimate the burden of adverse events (AEs) and can generate useful information on risk factors of AEs for more effective medicine use, especially in conjunction with introduction of new medicines and/or changes in treatment guidelines.

With increasing numbers of people worldwide on antiretroviral drugs, the need for improved and sustained global drug safety monitoring or pharmacovigilance is critical. Pharmacovigilance includes monitoring for substandard products, diversion, inappropriate use, and toxicity and is an essential component of safe and effective drug usage. The Forum for Collaborative HIV Research was asked to use its neutral setting for key stakeholders from the UN and government agencies, donors, industry, academia, multilateral organizations, and implementers to discuss the creation of a sustainable global pharmacovigilance system for antiretrovirals (ARVs). Important but contrasting priorities and values among stakeholders—all of whom are dedicated to establishing global pharmacovigilance—were identified as barriers to progress. Recognition, understanding, and respect for these contrasts is a pathway for increased collaboration and cooperation that will then lead to a sustainable system involving all stakeholders including industry and experienced regulatory agencies.

Purpose of review: This review focuses on current status, progress, challenges and opportunities in global pharmacovigilance for HIV/AIDS treatment.

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