Overview of Pharmacovigilance System in Vietnam: Lessons Learned in a Resource-Restricted Country

Drug safety issues in developing countries are complex and sensitive, and health authorities cannot always simply implement decisions from developed countries because the health system, disease patterns, and lists of marketed drugs all differ. A system for proactive and effective surveillance of dru...

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Bibliographic Details
Published in:Drug safety 2018-02, Vol.41 (2), p.151-159
Main Authors: Nguyen, Khac-Dung, Nguyen, Phuong-Thuy, Nguyen, Hoang-Anh, Roussin, Anne, Montastruc, Jean-Louis, Bagheri, Haleh, Olsson, Sten
Format: Article
Language:English
Subjects:
Acquired immune deficiency syndrome
AIDS
Colleges & universities
Communications systems
Developed countries
Developing countries
Drug Safety and Pharmacovigilance
Drugs
Functional morphology
Generic products
Health care policy
Health insurance
Health surveillance
Hospitals
Industrialized nations
LDCs
Leading Article
Medicine
Medicine & Public Health
Pharmaceutical industry
Pharmacology
Pharmacology/Toxicology
Pharmacovigilance
Pharmacy
Product safety
Public health
Quality assessment
Quality control
Risk assessment
Risk communication
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Summary:Drug safety issues in developing countries are complex and sensitive, and health authorities cannot always simply implement decisions from developed countries because the health system, disease patterns, and lists of marketed drugs all differ. A system for proactive and effective surveillance of drugs in each nation is needed to identify and manage the exact drug-related problems faced by patients in these countries. Vietnam launched its university-based National Drug Information and Adverse Drug Reaction Monitoring Centre (NDIADRMC) in 2009, a significant step towards catching up with international trends. Although the center is still in its infancy and has limited resources, it has attained some achievements and largely met the minimum World Health Organization requirements for a functional pharmacovigilance center. The number of reports has increased rapidly, with some important signals generated from the national database leading to regulatory actions at a national level. In addition, this system can help detect drug-quality problems that are less common in developed countries. The success of the quantity and quality of reporting, risk assessment, and communication is still limited compared with more developed systems. A number of opportunities remain to enhance the system, particularly in risk communication and evaluation of the impact of pharmacovigilance, and to apply reporting outcomes to reduce drug-related risks throughout the country. More internal and external support is needed to develop a stronger and more comprehensive pharmacovigilance system.
ISSN:0114-5916
1179-1942
DOI:10.1007/s40264-017-0598-y