title: Pharmacovigilance activities in ASEAN countries.
abstract: This study aimed to explore the current landscape and identify challenges of pharmacovigilance (PV) among Association of Southeast Asian Nations (ASEAN) countries.
  
  
  
  This cross-sectional survey collected data from May 2014 to December 2015. Questionnaires seeking to collect information on resources, processes, roles and responsibility, and functions of PV systems were sent to relevant persons in the ASEAN countries. Functions of PV centers were measured using the minimum World Health Organization requirements for a functional national PV system. Performances of PV centers were measured by the following: (1) the indicators related to the average number of individual case safety reports (ICSR); (2) presence of signal detection activities and subsequent action; and (3) contribution to the global vigilance database.
  
  
  
  Cambodia, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam completed the survey. PV systems in four surveyed countries (Indonesia, Malaysia, Singapore, and Thailand) achieved all aspects of the World Health Organization minimum requirement for a functional national PV system; the remaining countries were deemed to have unclear communication strategies and/or no official advisory committee. Average numbers of recent ICSR national returns ranged from 7 to 3817 reports/year/million population; three countries (Malaysia, Singapore, and Thailand) demonstrated good performance in reporting system and reported signal detection activities and subsequent actions. All participating countries had submitted ICSRs to the Uppsala Monitoring Center during the survey period (2013-2015).
  
  
  
  Four participating countries had functional PV systems. PV capacity, functionality, and legislative framework varied depending on local healthcare ecosystem networks. Implementing effective communication strategies and/or technical assistance from the advisory committee are needed to strengthen PV in ASEAN. Copyright © 2016 John Wiley & Sons, Ltd.
authors.affiliation: Health Product Vigilance Center, Thai Food and Drug Administration, Nonthaburi, Thailand.
authors.forename: Wimon
authors.initials: W
authors.lastname: Suwankesawong
authors.affiliation: Pharmaceutical Care Research Unit, Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.
authors.forename: Teerapon
authors.initials: T
authors.lastname: Dhippayom
authors.affiliation: Vigilance, Compliance and Enforcement Division, Health Products Regulation Group, Health Sciences Authority, Singapore.|Saw Swee Hock School of Public Health, National University of Singapore.
authors.forename: Wei-Chuen
authors.initials: WC
authors.lastname: Tan-Koi
authors.affiliation: Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.
authors.forename: Chuenjid
authors.identifier: 0000-0002-4588-9777
authors.initials: C
authors.lastname: Kongkaew
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D001210:Asia, Southeastern / Q000453:epidemiology; D003430:Cross-Sectional Studies; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D006801:Humans; D060735:Pharmacovigilance; D011795:Surveys and Questionnaires; D014944:World Health Organization
keywords: ASEAN; Uppsala Monitoring Center; adverse drug reaction; pharmacoepidemiology; pharmacovigilance