Detailed Mechanism Funding and Narrative

Years of mechanism: 2008 2009

Details for Mechanism ID: 7584
Country/Region: Rwanda
Year: 2009
Main Partner: Management Sciences for Health
Main Partner Program: NA
Organizational Type: NGO
Funding Agency: USAID
Total Funding: $760,000

Funding for Treatment: ARV Drugs (HTXD): $260,000


Pharmaceutical interventions are critical for the overall success of the PEPFAR program. However, along

with their life-saving and disease preventing properties, use and misuse of these medicines can also result

in adverse patient reactions or trigger resistance diminishing their therapeutic benefits. Many of the

antiretroviral and anti-infective drugs utilized by the PEPFAR program can have adverse effects that are not

well recognized in select certain clinical settings.

Primary activities for FY 2009 will include the establishment of an adverse drug reaction (ADR) notification

system and an accredited National Center for Pharmacovigilance (NCPV) located within the Pharmacy Task

Force (PTF) in compliance with World Health Organization (WHO) requirements. Additionally, it will be

important to develop standard operating procedures (SOP) to facilitate quality ADR reporting, and to

monitor and supervise the ADR system in selected sites. Furthermore, it will be necessary to develop

protocols for prevention and prompt identification of ADR, toxicities and drug interactions for chronic

patients. Finally, prophylaxis for OIs and TB treatment must also be administered appropriately.

PEPFAR funding will not only assist the PTF in establishing a pharmacovigilance system at the central

level, but also within the districts as well. This will be achieved through trainings for health providers,

implementation of data collection systems, and reporting on ADR notification. In addition to working with

the PTF, CIDC, and the National University of Rwanda, SPS works working with 12 district hospitals, 8

district pharmacies in the public sector, and 10 district pharmacies in the private sector.

To enhance capacity in this area, SPS will work with PTF pharmacists in order to help them finalize the

National Pharmacy Policy; update the Essential Medicines List and Standard Treatment Guidelines; and

establish a National Medicines Committee (NMC). Other capacity building measures will include a seminar

for members of the NMC and other partners to provide guidance on containing antimicrobial resistance and

the development of pharmaceutical management pre-service training modules for University of Rwanda

pharmacy students emphasizing rational drug use and pharmacovigilance. SPS will also identify three

national level staff to participate in PV courses organized by the National Drug Authority of Morocco (two

individuals were trained in this manner using FY 2007 funds).

In FY 2009, SPS will expand the ADR notification system to all district hospitals by training clinical and

pharmacy staff in pharmacovigilance (PV) while emphasizing the need to prepare for the challenges of

implementing the new ART treatment regimen. SPS will also assist with the implementation of recently

developed SOPs. Expansion of the PV program will also include the following quality assurance activities:

following-up with trained staff to ensure routine monitoring of the quality of the ADR system; conducting

targeted supervision for improvement and participation in evaluation of activities; monitoring drug cohorts

first in sentinel sites and eventually in all sites; and building PTF capacity in analyzing and validating PV


An important goal of this activity continues to be providing a small-scale passive and active surveillance

programs for adverse events experienced by Rwandan patients who receive PEPFAR distributed

pharmaceuticals. Preliminary work with the PTF has occurred and the need to conduct this activity through

regional collaboration based on experience in other African countries has been identified. The funds

necessary to further develop the surveillance program were reprogrammed to SPS (formerly RPM Plus) in

collaboration with the President's Malaria Initiative (PMI) and CIDC. To date, such funding has been used

to provide TA to establish a small-scale passive surveillance program for adverse events as part of a drug

safety program. SPS provided training to caregivers in select hospitals in the utilization of user-friendly

reporting forms as well. They also trained a GOR analyst in forms interpretation. In addition, SPS has

provided periodic QA and supervision to health care providers to ensure proper completion of reports,

quality of data, and reporting to the PTF. SPS will continue its involvement with all of these activities in FY


These activities will continue to complement PMI investments to ensure that pharmacovigilance system

strengthening is well-integrated into both HIV/AIDS and malaria medication distribution networks. This

approach is also in keeping with the goals of the Rwanda PEPFAR five-year strategy and the National

Prevention Plan by continuing to provide assurance and strengthening of quality treatment commodities and

ARV services.

New/Continuing Activity: Continuing Activity

Continuing Activity: 16880

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

16880 16880.08 U.S. Agency for Management 7584 7584.08 SPS $200,000

International Sciences for

Development Health

Emphasis Areas

Human Capacity Development

Estimated amount of funding that is planned for Human Capacity Development $70,000

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening



Table 3.3.15:

Funding for Health Systems Strengthening (OHSS): $500,000


In FY 2008, PEPFAR continues scaling up its technical and management support to the MOH and the

Pharmacy Task Force (PTF), a committee of stakeholders based within the MOH. Strengthening

Pharmaceutical Systems (SPS), receiving a five-year award with a mandate to build pharmaceutical

capacity in developing countries.

During FY 2009, SPS will be building institutional and individual capacity on RDU and pharmacovigilence as

well as policy level support to MOH. Institutional capacity building will be directed towards transferring

technical capacity to the institutions that impact the pharmaceutical system in planning, development and

implementing processes (Pharmacy Task Force, PTF, TRACPLUS-Center for Infectious Disease Control

(CICD), University of Rwanda, Rwandan Association of Pharmacies, ARPHA). ARPHA is in accord with

this mission. In FY 2008, SPS focused its technical assistance on pharmacovigilance and rational use of

medicines at both the national and peripheral levels. In the area of rational drug use, SPS in collaboration

with PTF, has undertaken activities to improve dispensing practices at public and private pharmacies. In

FY 2009, these activities will be continued and scaled-up to an additional ten districts. SPS will also support

ten private pharmacies in pharmacy care and counseling. Other SPS institutional capacity building RDU

activities will include: producing targeted materials and job aids for the dispensers in hospitals and health

centers; training and mentorship for one district pharmacist in each district; implementation of developed

tools in selected private pharmacies; messages to raise public awareness about RDU; establish Drug

Therapeutic Committees to an additional 12 hospitals, strengthen ability for management of HIV drugs

including rational use of first and second line therapies.

Individual capacity building will be directed towards those with chronic conditions, mainly HIV infected and

TB infected patients. The TA will focus on: managing appointments; identification of side effects/toxicity;

referral to clinical services as needed; counseling on taking medications properly; motivating patients to

adhere to treatment regimens; counseling patients going to the pharmacy without first having seen a

clinician; providing accurate dosages of drugs to children, including ART; identifying the most important

drug and food interactions, as well as contraindications for the 25 - 35 most commonly used medications

used for treatment of OIs. SPS will also promote hygienic practices with medications. Given the GOR's

priority and focus on decentralization and community involvement, SPS will provide training on good

dispensing practices and RDU for community health workers (CHWs) who will assist with case

management by visiting and encouraging patients to keep appointments, fill prescriptions, and take

medicines as prescribed.

Policy and procedure development support is directed towards the MOH. In FY 2008, SPS is creating a

process for national quality assurance (QA) in drug testing, inspection, and monitoring. SPS is also

providing support for developing policies and procedures for drug regulation. PEPFAR built 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 curriculum. Additionally, SPS is

developing a fee structure for commercial registration of drugs, including pricing policy and plans for

financial audits.

In FY 2009, SPS support will continue in the areas of drug registration, testing QA, inspection and

monitoring, and policy development for drug regulation. SPS will also continue to provide support in

developing pricing policies and procedures for health providers. While waiting for National Drug Authority

(NDA) approval and implementation, SPS will assist the PTF of the MOH to develop an implementation plan

that clearly defines roles and responsibilities, in addition to supporting a strategic plan to include a drug

registration system.

In FY 2008, SPS is providing district level support. More specifically, SPS is providing managerial and

technical assistance to the PTF and ensuring that PTF meets requirements to decentralize pharmaceutical

management at the district level, and providing TA to establish and make the national drug registration

system operational. SPS will continue these activities in FY 2009, and assist PTF in the development and

implementation of the National Pharmaceutical Pricing Policy. To ensure effective decentralization and

integration of pharmaceutical functions and activities, PEPFAR will continue to support the strengthening of

PTF systems and institutional capacity in FY 2009.

Under FY 2008, PEPFAR continues developing systems and building capacity at the PTF / ARPHA to

enhance implementation of the national pharmaceutical policy, in part through private sector RDU forums.

SPS is providing capacity development of RAMA in pharmaceutical management, rational drug use and

implementation of national pharmaceutical policy. Through working with the National University of Rwanda,

SPS will facilitate integration of pharmaceutical management modules in the academic curriculum and

assist NUR in operational RDU research. These activities will continue in FY09. In FY 2009, SPS will

provide full time TA to the PTF to assist with the implementation of National Medicines Committee activities

as well as with the establishment of DTCs as part of hospital structures. SPS will develop and implement a

plan to monitor the compliance of the Standard STD Treatment Guidelines.

These activities are in keeping with PEPFAR's five-year strategy and supports the GOR's national human

resources and organizational capacity building strategy.

New/Continuing Activity: Continuing Activity

Continuing Activity: 16883

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

16883 16883.08 U.S. Agency for Management 7584 7584.08 SPS $500,000

International Sciences for

Development Health

Emphasis Areas

Health-related Wraparound Programs

* TB

Human Capacity Development

Estimated amount of funding that is planned for Human Capacity Development $250,000

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening


Estimated amount of funding that is planned for Education $200,000


Table 3.3.18:

Cross Cutting Budget Categories and Known Amounts Total: $520,000
Human Resources for Health $70,000
Human Resources for Health $250,000
Education $200,000