Promoting the Quality of Medicines
Program in the Philippines
Photo: Maria Kathrina Olivarez
November 2012
Photo: Maria Kathrina Olivarez
FDA Davao Satellite Lab staff practices the
standardization of pH meter using buffers
4, 7 and 10.
Conducting Minilab® Basic Testing of ATBs
at the Sentinel Site in Zamboanga City.
Photo: Maria Kathrina Olivarez
Mystery shopper purchases ATBs medicines
from local pharmacy to test for quality.
USAID, through the Promoting Quality Medicines (PQM) Program
implemented by the United States Pharmacopeial Convention
(USP), is partnering with the Philippines to strengthen the capacity
of its national system to improve and sustain quality assurance and
quality control of medicines.
BACKGROUND
The Philippines is considered a high-burden tuberculosis (TB) country by
the World Health Organization (WHO), its position is among the top 15 for
many years. That situation is compounded by development of multidrugresistant tuberculosis (MDR-TB) which is generated primarily due to the
large numbers of TB patients who are inadequately treated. There is a
need to improve the quality assurance system for anti-TB (ATB) 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 ATB medicines in the private sector, which
challenges government efforts to control MDR-TB.
APPROACH
Since 2007, USP has been actively providing technical and professional
assistance, first through the USP Drug Quality and Information (DQI)
Program and currently, through the Promoting the Quality of Medicines
(PQM) program to Philippines Food and Drug Administration (FDA), the
Department of Health (DOH) and the National Tuberculosis Program (NTP)
in an effort to strengthen medicines Quality Assurance and Quality Control
System (QA/QC) with the financial support of USAID. The technical and
professional assistance has been emphasized in areas of establishing the
post-marketing surveillance through the medicines quality monitoring
(MQM) program to detect tuberculosis medicines available on the market in
Philippines; to enhance the FDA regulatory capacity in evaluation &
registration of pharmaceutical products through the introduction and
buildup of internationally accepted quality standards, guidance, processes
and procedures.
The main activities have been focused on (1) Establishing a mechanism for
detection of poor-quality tuberculosis medicines through post-marketing
surveillance; (2) Strengthening the capacity of the FDA by providing
essential equipment and training; (3) Disseminating objective and up-todate information about medicines quality and raising awareness among the
general public about medicine quality issues to mobilize policy makers,
regulators and health professionals.
CONTINUES >
Photo: Maria Kathrina Olivarez
HIGHLIGHTS OF PROGRESS
Photo: Maria Kathrina Olivarez
Participants in PQM TB Manufacturers
Workshop learn about WHO Prequalification
and PQM technical assistance.
Achievements in detection and investigation of substandard and
counterfeit TB medicines
• The Philippines FDA, DOH, NTP and PQM agreed to establish a
MQM program for TB medicines in order to obtain evidence-based
data on the quality of selected TB medicines. PQM and the FDA work
in close collaboration with CHDs and LGUs to monitor the quality of
TB medicines with the goal to ultimately reduce the poor quality TB
medicines circulating in the country. The MQM program established
at 6 sites in the Philippines to collect and test over 360 of TB samples
from 3 Local Government Unites (LGU) and 3 Centers for Health
development (CHD) since the beginnings of 2009 with 1.5% of
samples do not conform to quality specifications.
•
Achievements in strengthening the quality control and quality
assurance systems
•
FDA laboratories have become ISO 17025 accredited; PQM provided
a GLP training, technical assistance and feedback regarding the
documentation submitted to the Philippine Accreditation Office.
•
PQM conducted a Rapid Review of the Medicines Quality Assurance
and Quality Control Activities of the FDA to Determine Needs for
Capacity-building in order to identify strengths and weaknesses and
make suggestions for future PQM TA.
•
PQM brought two FDA scientists for a ten week training program at
USP headquarters in Rockville, Maryland. The program was tailored
to their needs and an implementation plan was designed for them to
apply at the FDA when they returned.
•
PQM has conducted a Training Workshop: Evaluation of Analytical
Validation and Stability Protocols and Reports to FDA staffs last
September 2011 for enhancing FDA abilities in drug review and
registration.
•
PQM delivered hands-on training on Compendial Analysis of Anti-TB
medicines and introduction to Good Lab Practices for FDA staff in
Davao, Cebu and Central lab in October 2012.
•
PQM delivered Training Workshop to FDA’s regulatory staff, scientist,
and officers on Pharmaceutical Process Validation in November
2012.
ATB MQM Training discussing Minilab® Kits
testing methods and procedures in the
GPHF Manual.
Contact at USAID: Dr. Yolanda Oliveros
Development Assistance Specialist, Office of Health
USAID/Philippines
8th Floor, PNB Financial Center Bldg. Macapagal Blvd.
Manila, Philippines
Email: yoliveros@usaid.gov
Contact at PQM: Dr. Elaine (Wei) Yuan
Program Manager, Southeast Asia
Promoting the Quality of Medicines Program
U. S. Pharmacopeial Convention
12601 Twinbrook Parkway, Rockville, MD 20852 USA
Email: exy@usp.org
Contact at PQM: Maria Kathrina D. Olivarez, RPh
USP PQM Country Consultant
Food and Drug Administration,
Alabang, Muntinlupa City, 1781, Philippines
Email: mariakathrinaolivarez@yahoo.com
During 2012, MQM program extended sentinel sites from 6 to 8
(Davao, Cebu, Iloilo, Malolos, Zamboanga, La Union, Bicol and
Calabarzon) with a focus to build closer surveillance at the areas with
a high TB incidence and increased resistance to TB medicines.
PARTNERS
Philippines Food and Drug Administration
National Tuberculosis Control Program
Center for Health Development (CHD)
Local government Unit (LGU)