Pharmacovigilance guidance for countries participating in AMFm Phase 1
WHO-MMV joint technical consultation on active pharmacovigilance monitoring with a special focus on AMFm
Overview
This document provides countries participating in the first phase of the initiative Affordable Medicine Facility for malaria (AMFm) with minimal standard procedures for preparing project plans to submit for funding. It is the product of a consultation on pharmacovigilance among international experts and technical experts from several countries, which was convened by the Global Malaria Programme of the World Health Organization (WHO) and the Medicines for Malaria Venture (MMV) on 6–8 April 2009, in Geneva, Switzerland.
The report describes why countries should prepare a pharmacovigilance strategy that takes into consideration the existing health infrastructure and post-marketing experience with artemisinin-based combination therapies (ACT). Pharmacovigilance systems are needed to monitor and ensure the maximum possible safety of ACT used in the AMFm programme.