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

Khac-Dung Nguyen, Phuong-Thuy Nguyen, Hoang-Anh Nguyen, Anne Roussin, Jean-Louis Montastruc, Haleh Bagheri () and Sten Olsson
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Khac-Dung Nguyen: Hanoi University of Pharmacy
Phuong-Thuy Nguyen: Hanoi University of Pharmacy
Hoang-Anh Nguyen: Hanoi University of Pharmacy
Anne Roussin: Faculté de Médecine de l’Université Paul-Sabatier et Centre Hospitalier Universitaire de Toulouse
Jean-Louis Montastruc: Faculté de Médecine de l’Université Paul-Sabatier et Centre Hospitalier Universitaire de Toulouse
Haleh Bagheri: Faculté de Médecine de l’Université Paul-Sabatier et Centre Hospitalier Universitaire de Toulouse
Sten Olsson: Pharmacovigilance Consulting

Drug Safety, 2018, vol. 41, issue 2, No 2, 159 pages

Abstract: Abstract 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.

Date: 2018
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DOI: 10.1007/s40264-017-0598-y

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