The EP relies heavily upon pharmaceutical interventions for the success of the overall program. However,

these drugs often have secondary adverse effects that diminish their primary therapeutic benefits. While

the antiretroviral and anti-infective drugs employed by the EP are well characterized, many could have

adverse effects that remain unrecognized in certain clinical circumstances.

In FY 2007, the overall goal of this activity was to provide a simple, small-scale program of passive

surveillance for adverse events among Rwandan patients who receive EP-distributed pharmaceuticals. This

activity was programmed to receive support from the FDA. However, because of the preliminary work done

by RPM+ with the Rwandan national drug task force and the need to conduct this activity through regional

collaboration based on experiences in other African countries, the funds were reprogrammed to RPM+.

RPM+ in collaboration with PMI, TRAC and APHAR provided TA to establish a small-scale program of

passive surveillance for adverse events. This is the first categorical drug safety program instituted in

Rwanda. RPM+ trained caregivers in select hospitals in the use of simplified reporting forms, and trained a

GOR-based analyst in their appropriate interpretation. In addition, RPM+ has provided periodic QA and

supervision to those health care providers to ensure appropriate completion of the reports, quality of data,

and reporting to the NDA and PTF.

In FY 2008, EP will build on this innovative activity by assisting the Pharmaceutical Task Force to establish

a pharmacovigilance system at the central and district levels. In FY 2008, SPS (the new follow-on

mechanism to RPM+), will conduct training for health providers, implement data collection, reporting,

assessing, communicating and monitoring on drug cohort in sentinel sites, scale up data collection and drug

cohort monitoring to all facilities, build capacity of the NDA and PTF to analyze and validate

pharmacovigilance data and evaluate the pharmacovigilance system.

This activity will complement PMI investments to ensure that pharmacovigilance systems strengthening is

integrated across HIV/AIDS and Malaria drugs. This activity reflects the ideas presented in the Rwanda EP

five-year strategy and the National Prevention Plan by providing quality assurance of treatment

commodities, and strengthening the quality of ARV services.

In FY 2007, the EP scaled up its technical and management support to the NDA. RPM-Plus helped develop

an implementation plan that defined the roles and responsibilities of a pharmaceutical regulatory authority.

RPM-Plus also supported a strategic plan that established a drug registration system; created national QA

in drug testing, inspection, and monitoring; and supported policies and procedures for drug regulation. The

EP built the capacity of pharmacists by providing materials, training pharmacists, and supporting the

University of Butare's School of Pharmacy to integrate HIV/AIDS pharmaceutical management into its pre-

service curriculum. Additionally, RPM-Plus developed a fee structure for commercial registration of drugs,

including pricing policy and plans for financial audits. Strengthening Pharmaceutical Systems (SPS) is the

RPM-Plus follow-on in FY 2008. SPS will continue to support the NDA in FY 2008 primarily in drug

registration, testing QA, inspection and monitoring, and policies for drug regulation. SPS will also provide

support in developing pricing policies and procedures for health providers.

In addition to the NDA support in FY 2007, RPM-Plus also provided managerial and technical assistance to

the Pharmaceutical Task Force (PTF). RPM-Plus ensured that the PTF met the requirements to

decentralize pharmaceutical management to districts and provided TA to establish and make the national

drug registration system operational. SPS will continue these activities in FY 2008, as well as assist PTF in

the development and implementation of the National Pharmaceutical Pricing Policy. Furthermore, the EP

will support the strengthening of systems and institutional capacity of the PTF to ensure effective

decentralization and integration of pharmaceutical functions and activities.

In FY 2007, RPM-Plus began to promote rational drug use in the public and private sector. In collaboration

with the Rwanda Medical Board and PTF, RPM-Plus consolidated Drugs and Therapeutics Committees

(DTC) activities in eight hospitals and expanded to 10 others. In FY 2008, SPS will expand DTC activities to

22 new hospitals. In FY 2008, the EP will also continue to build and strengthen systems and institutional

capacity of the PTF and ARPHA to reinforce the implementation of the national pharmaceutical policy and

organize forums on rational drug use in the private sector. SPS will also build the capacity of RAMA in

pharmaceutical management, rational drug use and implementation of national pharmaceutical policy. In

collaboration with the National University of Rwanda (NUR), SPS will facilitate the integration of the

pharmaceutical management in the academic curriculum and assist NUR in operational research on rational

drug use.

This activity reflects the Rwanda EP five-year strategy and supports the GOR's national strategy of human

resources and organizational capacity building.