Fact Sheet: Promoting the Quality of Medicines
Program in Vietnam
July 2013
Photo: Mr. Trinh Ngoc Hai
BACKGROUND
HCMC IMPE staff collect antimalarial (AML)
samples in Binh Phuoc province, a hotspot of
antimalarial drug resistance
The Promoting the Quality of Medicines (PQM) program, funded by the
United States Agency for International Development (USAID) and
implemented by the United States Pharmacopeial Convention (USP), has
been active in providing technical assistance (TA) to Vietnam to: Improve
the quality of essential medicines. PQM helps build the capacity of the
National Institute of Malariology, Parasitology and Entomology (NIMPE),
Drug Administration of Vietnam (DAV), and National Institute of Drug
Quality Control (NIDQC) to improve the quality of medicines they
register, supply, and use in the priority health programs; support postmarking surveillance through the medicines quality monitoring (MQM)
program for antimalarial, anti-TB, antibiotic, and avian influenza medicines
and opportunistic infection (OI) products; strengthen quality control
laboratories through trainings and provision of essential lab equipment,
reference substances and materials, chemical reagents; and, support local
pharmaceutical manufacturers to operate with internationally accepted
good manufacturing practices to produce methadone.
Photo: Mr. Trinh Ngoc Hai
THE OBJECTIVES WITH THE APPROACH
HCMC IMPE staff visually inspect AML samples
collected in Binh Phuoc province
Provide TA for local production of methadone and
procurement of methadone finished products for the Vietnam
Administration of HIV/AIDS Control (VAAC), Ho Chi Minh
City Provincial AIDS Committee (HCMC PAC), and Hai Phong
Department of Health (HP DoH)
• Assess local pharmaceutical manufacturers for their compliance with
World Health Organization good manufacturing practices (GMP)
and help them build capacity to meet international standards.
• Help Vietnam MoH identify and select qualified local manufacturers.
• Provide TA and information to VAAC, HCMC PAC, and HP DoH to
select, procure, and import quality-assured methadone finished
products from reliable suppliers.
Provide TA on the pharmacovigilance (PV) system within the
Global Fund Round (GFR) 10 project of the National Drug
Information and Adverse Drug Reactions Center (NDI/ADR)
• Review all related documents, assessments, and reports to identify
gaps and propose areas where PQM could assist within the
framework of the GFR10 project.
• Help the NDI/ADR Center identify international experts for GFR10
who can help strengthen the PV system in Vietnam.
• Train the staff and develop an operational manual for national and
South Vietnam ADR and DI Centers.
CONTINUES >
Photo: Mr. Trinh Ngoc Hai
HCM IMPE staff collect AML samples in Ho
Chi Minh City
Photo: Dr. Vuong Tuan Anh
Souly Phanouvong, Pharm.D., Ph.D.
Manager, Asia Programs
Tel. +1-301-816-8582
sxp@usp.org
Vuong Tuan Anh, M.D., Ph.D.
Country Consultant for Vietnam
Tel. +84-943-901-375
vtanihe@yahoo.co.uk
Promoting the Quality of Medicines (PQM)
United States Pharmacopeial Convention (USP)
12601 Twinbrook Parkway
Rockville, MD 20852, USA
Continue technical support to NIDQC on WHO Prequalification
Strengthen national QA/QC systems to ensure access to high-quality
medicines in national HIV/AIDS, TB, and Malaria health programs.
ACCOMPLISHMENTS AND IMPACT
USP QMS expert conducts a mock audit and
provides TA to national QC lab towards WHO PQ
Contact:
Patrick Lukulay, Ph.D.
Director
Tel. +1-301-816-8166
phl@usp.org
Strengthen post-marketing surveillance of opportunistic
infection medicines in the public sector distribution chain
Establish baseline data of OI medicines in out-patient clinics in provinces
supported by the President’s Emergency Fund for AIDS Relief (PEPFAR).
Support DAV,VAAC, and NIDQC in implementing selected measures to
strengthen the quality assurance/quality control (QA/QA) system for OI
medicines in the distribution chain.
Since 2003 PQM has developed strong partnerships with the NIMPE,
NIDQC, DAV, and WHO-Vietnam, and has helped establish sentinel sites
for MQM in six provinces, leveraging three more from the Global Fund to
Fight AIDS, Tuberculosis and Malaria (GFATM) with the following outcomes:
• In 2012 PQM launched the Building Regional Expertise in Medicines
Regulation, Information Sharing, Joint Investigation, and Enforcement
(BREMERE) network to enhance regional cooperation and
collaboration among law enforcement agencies with access to experts
and information on counterfeit and substandard medicines for timely
investigation and enforcement. Vietnam was selected to co-chair the
first BREMERE term.
• Collaborating with the NIDQC and its partners, PQM provided a
training workshop on sampling and testing methods for selected OI
medicines and jointly conducted a baseline survey of OI medicines
quality from 46 randomly selected HIV/AIDS treatment centers in 25
PEPFAR-supported provinces. Quality testing of selected OI medicines
showed that no samples failed USP-34 or VNP-IV compendial analysis.
• A PQM specialist in quality management systems provided onsite TA
to help NIDQC correct non-conformities prior to a WHO reassessment. NIDQC greatly appreciated this support in preparing its
submission which resulted in renewal of its prequalification status.
• Recognition of the danger CSMs present and importance of medicines
quality has increased among health care professionals and the general
public due to public awareness-raising activities, including
contributions to filming MQM activities in the Greater Mekong Subregion.
• Developed technical specifications for methadone finished products
and dispensing pump and provided information on national, regional,
and global methadone producers/suppliers, enabling VAAC and
PAC to select, procure, and supply imported methadone finished
products from reliable sources at reasonable costs.
KEY PARTNERS
Vietnam Ministry of Health  Drug Administration of Vietnam  National
and HCMC Institutes of Drug Quality Control  National and HCMC
Institutes of Malariology, Parasitology and Entomology  National Adverse
Drug Reaction and Drug Information Center  Vietnam Administration of
HIV/AIDS Control and Prevention  Ho Chi Minh City Provincial AIDS
Committee  Hai Phong Department of Health  President’s Emergency
Fund for AIDS Relief  U.S. Centers of Disease Control and Prevention
(MOH-LifeGap Program)