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. Their objectives are: to monitor the risk for adverse drug reactions associated with ACT made available through the AMFm programme and supplied by the public sector, the for-profit private sector or the not-for-profit private sector (e.g. nongovernmental and faith-based organizations); to build a strategy for communication and feedback with health professionals and the public about the safe use of ACT, based on information generated through the pharmacovigilance system; to monitor and assess the quality of the components of the pharmacovigilance system; and to monitor the safety of ACT in pregnancy by setting up or strengthening a pregnancy register at selected sites (where feasible). The relevant pharmacovigilance approaches include: spontaneous reporting; strategies to stimulate spontaneous reporting, particularly by private accredited retailers who are likely to dispense ACT in the context of the AMFm, such as a patient register, a patient-held card for those prescribed antimalarials, a patient referral form for private accredited retailers and community health workers to refer severely ill patients and patients who have failed to respond to therapy, a simplified adverse drug reaction reporting form and active follow-up of patients to assess the value and validity of data obtained through the reporting systems; active monitoring of a cohort of patients exposed to ACT (cohort event monitoring); and pregnancy registers. Communication and feedback should be seen to be as important as data collection and analysis. Approaches to optimizing the benefits of the Pharmacovigilance programme through communication, feedback and collaboration with other agencies are briefly described.

The report describes factors for the success of a pharmacovigilance plan, including strengthening existing national infrastructure, obtaining the support of policy-makers, health professionals and the public through advocacy and training, adoption of a phased, pragmatic approach to the plan and monitoring and evaluation of the plan to ensure its effectiveness in meeting the objectives. Finally, the document provides guidance to countries for completion of the application form, including a budget guideline.