Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug related problem”
Project objectives

• To implement a system for monitoring the safety of antimalarial treatment in Uganda at both health facility and community levels
• To coordinate with the National Drug Authority, Ministry of Health, and other stakeholders
• To support the NDA in monitoring the safety of antimalarial treatment in Uganda

 

UMSP set out to develop strategies for establishing a sustainable system in two phase.
Phase 1 objectives:

• To investigate perceptions and experiences with antimalarial drugs of community members
• To assess the current reporting systems in public and private sectors
• To develop strategies for establishing a sustainable system for reporting adverse events at the community and health facility levels

 

FGD’s and interviews were conducted with community members, health care workers, drug shop owners, and key stakeholders. Phase I was completed at the end of 2006
Phase II objectives

• To develop a pilot system for pharmacovigilance of antimalarial treatment in Uganda based at the health facility and community levels
• To evaluate the performance of the pilot surveillance system.
• To communicate study results to the NDA and other organizations focusing on pharmacovigilance to develop a plan to scale-up the pilot system in a sustainable manner

 

A number of activities were conducted that included training HCW’s and key community members, distribution and collection of AE report forms, analysis of data and generation reports, monitoring and evaluation of the system.

Passive surveillance activities were expanded from Jinja to Tororo. The pilot system in Jinja was expanded to include active surveillance. A census was conducted in two parishes followed by active follow-up of cohorts of patients in two parishes. Data was collected on ACT exposure, and the incidence of adverse events was estimated.

A pregnancy register was developed as part of active surveillance to monitor for ACT exposure in the first trimester and to monitor maternal and fetal outcomes