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

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.

Drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in vietnamese spontaneous adverse drug reaction database: A subgroup approach to disproportionality analysis

“…One notable point is that antituberculosis drugs were mentioned in many SJS/TEN reports, but no signals were generated in relation to these drugs. This could be attributed to the popularity of these drugs in other MLOSCAR reports because of the integration of the public health programme in the pharmacovigilance system …”

“…To be validated and recorded in the national ADR reporting database, every ADR report submitted to NDIADRMC had to be recorded on an official ADR form including the following essential information: patient's characteristic, suspected drugs, description of the ADR and the reporter's details . All ADR reports were then reviewed, and causality was assessed (using the World Health Organization‐Uppsala Monitoring Centre Causality Assessment) by trained NDIADRMC personnel and/or one or two members of the Technical Expert Committee, depending on the severity of the ADR . ADR terminology in every ADR report was classified according to World Health Organization Adverse Reaction Terminology (WHO‐ART), and the suspected drugs were categorized according to the ATC classification.…”

“…Since the establishment of the National Drug Information and Adverse Drug Reaction Monitoring Centre (NDIADRMC) in Vietnam in September 2009, the number of ADR reports received has increased significantly, year-on-year, reaching an annual rate of 118 reports/ million persons in 2016. 13,14 The use of cumulative ADR reporting in the database is necessary to summarize salient information and subsequently propose appropriate guidelines for rational drug use.…”

“…13 All ADR reports were then reviewed, and causality was assessed (using the World Health Organization-Uppsala Monitoring Centre Causality Assessment) by trained NDIADRMC personnel and/ or one or two members of the Technical Expert Committee, depending on the severity of the ADR. 14,19,20 ADR terminology in every ADR report was classified according to World Health Organization Adverse Reaction Terminology (WHO-ART), and the suspected drugs were categorized according to the ATC classification. Time to onset (TTO) is defined as the time interval from the start of administration of the suspected drug through to the onset of an ADR (ie specific symptoms for classification).…”

“…In addition, given the rare incidence rate of about 1‐6 cases/1 000 000 people per year, analysis using an ADR reporting source is always one of the most appropriate methods for identifying and managing the drug‐induced SJS/TEN risk at population level. Since the establishment of the National Drug Information and Adverse Drug Reaction Monitoring Centre (NDIADRMC) in Vietnam in September 2009, the number of ADR reports received has increased significantly, year‐on‐year, reaching an annual rate of 118 reports/million persons in 2016 . The use of cumulative ADR reporting in the database is necessary to summarize salient information and subsequently propose appropriate guidelines for rational drug use.…”