- Keywords > adverse drug reactions (ADRs)
- Keywords > antimalarials – standards
- Keywords > Artemisinin based Combination Therapies (ACT)
- Keywords > monitoring
- Keywords > pharmacovigilance
- Keywords > post marketing surveillance
- Keywords > reporting
- Keywords > reporting system
- Keywords > safety
- Keywords > surveillance
(2006; 24 pages)
In February 2006, the U.S. Agency for International Development (USAID) Mission in Tanzania, under the mandate of the President’s Malaria Initiative (PMI), requested assistance from the Rational Pharmaceutical Management (RPM) Plus Program of Management Sciences for Health (MSH) to assist the Tanzanian Food and Drugs Authority (TFDA) to improve their pharmacovigilance (PV) system. Specific attention is needed for the monitoring of adverse drug reaction (ADR) of artemisinin-based combinations (ACTs) in pregnant women in Tanzania.
The need to strengthen ADR reporting for this class of antimalarials is urgent for two reasons:
- its safety profile in pregnant women has not been well established and
- a policy change to use ACTs as first-line antimalarials to be implemented in Tanzania from July 2006 to May 2008.
As the first step, RPM Plus/MSH organized a two-day consultative meeting to assist TFDA in gathering ideas on how best to strengthen the ADR reporting of ACTs. The meeting focused on Tanzania’s ADR reporting structure, specifically, its design and management. The meeting brought together participants from a diverse range of experience and expertise, including: TFDA; U.S. Centers of Disease Control and Prevention (CDC); Ifakara Health and Development Research Center (IHDRC); and PV experts from the national programs of Ghana, Mozambique, and Zanzibar, countries with relevant experience in ADR monitoring of antimalarials.
The key objectives of the meeting were to:
- Share experience and key lessons learned from ADR monitoring of antimalarials in pregnant women and related issues in Tanzania, Ghana, and Mozambique;
- Identify gaps in ADR monitoring system in Tanzania;
- Based on meeting discussion, assist TFDA in identifying key components for the design of a cost-effective PV system to monitor ADR of ACTs in pregnant women (and other medicines in the future).
The meeting consisted of presentations from key partners, followed by three small group discussions. RPM Plus/MSH facilitated these discussions between TFDA and relevant partners to identify key ADR system components required to effectively monitor the use of ACTs in pregnant women in Tanzania. The meeting discussion drew from TFDA’s PV activities and other partners’ experience in ADR monitoring of antimalarials: CDC and IHRDC in Tanzania and PV programs of Ghana, Mozambique, and Zanzibar.