The Philippines is considered a high TB burden country by the World Health Organization’s Global Tuberculosis Report 2012. The situation is compounded by multi drug-resistant tuberculosis, which is generated primarily due to the large number of TB patients who are inadequately treated. There is a need to improve the quality assurance system for anti-TB medicines being purchased and used in the national TB control program, and to develop and implement strict regulatory control and put measures in place for the sale and supply of anti-TB medicines in the private sector.
Since 2007, USAID/Philippines and the United States Pharmacopeial Convention have been actively providing technical and professional assistance to the Philippines Food and Drug Administration (FDA) and the Department of Health National Tuberculosis Control Program to strengthen the Quality Assurance and Quality Control System for medicines in the Philippines.
The assistance focuses on establishing Post-Marketing Surveillance through the Medicines Quality Monitoring program to ensure the quality of tuberculosis medicines available in the Philippine market. The Medicines Quality Monitoring program also aims to enhance the FDA regulatory capacity in evaluation and registration of pharmaceutical products through the introduction and build-up of internationally accepted quality standards, guidance, processes and procedures.
ACTIVITIES
PQM’s main activities have been focused on (1) establishing a mechanism for detecting poor-quality TB medicines through Post-Marketing Surveillance; (2) strengthening the capacity of the FDA by providing essential equipment and training; and (3) disseminating objective and up-to-date information about medicines quality and raising awareness among the general public to mobilize policy makers, regulators and health professionals.
RESULTS
- Established eight sentinel sites in the Philippines for testing anti-TB medicines using the Global Pharma Health Fund (GPHF) Minilab Kit
- Assisted FDA central laboratory in getting ISO 17025 accreditation through PQM’s Good Laboratory Practice trainings and technical assistance
- Assisted FDA become a member of USP’s TAP (Technical Assistance Program) enabling purchase of USP Reference Standards at 75 percent discount
GOAL
To strengthen the capacity of the Philippines to improve and sustain quality assurance and quality control of medicines.
OBJECTIVES
- Improve capacity for pharmaceutical and laboratory supply management
- Improve capacity for transparent and evidence-based decision making
- Strengthen pharmaceutical services for improved outcomes in tuberculosis (TB) case management
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