A Survey on Pharmacovigilance Activities in ASEAN

Authors: Cheng Leng Chan Pei San Ang Shu Chuen Li

Publish Date: 2017/02/28

Volume: 40, Issue: 6, Pages: 517-530

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Abstract

Most Countries have pharmacovigilance PV systems in place to monitor the safe use of health products The process involves the detection and assessment of safety issues from various sources of information communicating the risk to stakeholders and taking other relevant risk minimization measuresThis study aimed to assess the PV status in Association of Southeast Asian Nation ASEAN countries sources for postmarket safety monitoring methods used for signal detection and the need for a quantitative signal detection algorithm QSDA Comparisons were conducted with centres outside ASEANData were collected from nine ASEAN countries and seven other countries PV activities were conducted in all these countries which were at different stages of development In terms of adverse drug reaction ADR reports the average number received per year ranged from 3 to 50000 reports for ASEAN countries and from 7000 to 1103200 for nonASEAN countries Thirtythree percent of ASEAN countries utilized statistical methods to help detect signals from ADR reports compared with 100 in the other nonASEAN countries Eighty percent agreed that the development of a QSDA would help in drug signal detection The main limitation identified was the lack of knowledge and/or lack of resourcesSpontaneous ADR reports from healthcare professionals remains the most frequently used source for safety monitoring The traditional method of casebycase review of ADR reports prevailed for signal detection in ASEAN countries As the reports continue to grow the development of a QSDA would be useful in helping detect safety signalsThe authors thank Prof Stephen Evans London School of Hygiene and Tropical Medicine and Mr Sten Olsson Uppsala Monitoring Centre the WHO Collaborating Centre for International Drug Monitoring Uppsala Sweden for providing comments and feedback to the questionnaire and Betty Chan for assisting in collation of the results We would like to acknowledge Dr Bronwen Harvey Australia Rosni Jair Brunei Darussalam Hean Kimseat Cambodia Jacob Porter Canada Suci Yunita Sari and Wilia Indarwanti Indonesia Dr Yusuke Matsunaga Japan Dr Sourisak Sounvoravong Lao PDR Rema Panickar Malaysia Mark Ryann A Lirasan Philippines Dr Dorothy Toh and Tan Siew Har Singapore Sujin Kim South Korea Dr Valeriu Toma Switzerland Sareeya Wechwithan Thailand Mick Foy UK Allen Brinker US and Ngo Thi Huong Minh Vietnam for providing valuable information

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