Detailed Mechanism Funding and Narrative

Years of mechanism: 2013 2014

Details for Mechanism ID: 16669
Country/Region: Burundi
Year: 2013
Main Partner: U.S. Pharmacopeial Convention
Main Partner Program: NA
Organizational Type: Private Contractor
Funding Agency: USAID
Total Funding: $250,000

The pharmaceutical system in Burundi is negatively affected by various challenging issues. The quality assurance for medicines as well as for other medical supplies is one of them. Although the National Institute of Public Health in Bujumbura has been recently accredited as a quality assurance center, it still needs capacity building and the PQM activity will bring its expertise in that process. The PQM activity will:

Strengthen the capacity of the national quality assurance center recently accredited and other national institutions involved in pharmaceutical management;

Bring its technical assistance in the development of key regulatory documents in the area of the pharmaceutical management;

Assure the consistent quality control/quality assurance of HIV-related products including medicines and reagents in the PEPFAR supported areas as well for the products from the Global Fund;

PQM will develop an annual work plan and will provide measurable indicators to track progress in this area.

Funding for Health Systems Strengthening (OHSS): $250,000

The purchase of medicines, laboratory reagents, HIV test kits, and other HIV related commodities for the PEPFAR program in Burundi are bought by SCMS. SCMS makes sure that these products respond to the quality assurance requirements until there are shipped to Burundi. PQM will be responsible of assuring quality control and quality assurance of the products once in Burundi. It will work with the various institutions involved in the pharmaceutical management to build their capacity while contributing to the improvement of the regulatory package of the pharmaceutical sector. More specifically, PQM will bring its expertise in maintaining the efficacy, quality, and safety of medicines at all levels of the distribution chains and throughout their shelf life in promoting: (1) Good Storage and Distribution Practices WHO standards; (2) storage of medicines according to manufacturers specified conditions; (3) storage of medicines in appropriate facilities; and (4) quality systems. PQM will establish a quality monitoring program which will: cover all the products procured by PEPFAR funding and the Global Fund; perform random sampling from all levels of distribution, testing based on international standards in qualified QC laboratories. The sampling and testing processes will be based on good knowledge of compendial sciences and sampling approaches. For that, it will procure the required minilabs with all needed supplies and will train the relevant staff on sampling of medicines.

Key Issues Identified in Mechanism
Safe Motherhood