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A Survey on Pharmacovigilance Activities in ASEAN and Selected Non-ASEAN Countries, and the Use of Quantitative Signal Detection Algorithms

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Abstract

Introduction

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 measures.

Objectives

This 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 ASEAN.

Methods

A questionnaire was sent to all PV centres in ASEAN countries, as well as seven other countries, from November 2015 to June 2016. The questionnaire was designed to collect information on the status of PV, with a focus on the use of a QSDA.

Results

Data 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 50,000 reports for ASEAN countries and from 7000 to 1,103,200 for non-ASEAN countries. Thirty-three percent of ASEAN countries utilized statistical methods to help detect signals from ADR reports compared with 100% in the other non-ASEAN 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 resources.

Conclusion

Spontaneous ADR reports from healthcare professionals remains the most frequently used source for safety monitoring. The traditional method of case-by-case 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 signals.

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Acknowledgements

The 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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Authors and Affiliations

  1. Health Products Regulation Group, Health Sciences Authority, 11 Biopolis Way #11-01 Helios, Singapore, 138667, Singapore

    Cheng Leng Chan & Pei San Ang

  2. School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, NSW, Australia

    Cheng Leng Chan & Shu Chuen Li

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  1. Cheng Leng Chan
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  2. Pei San Ang
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Correspondence to Cheng Leng Chan.

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No sources of funding were used to assist in the preparation of this study.

Conflict of interest

Cheng Leng Chan, Pei San Ang and Shu Chuen Li have no conflicts of interest to declare that are directly relevant to the content of this study.

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Chan, C.L., Ang, P.S. & Li, S.C. A Survey on Pharmacovigilance Activities in ASEAN and Selected Non-ASEAN Countries, and the Use of Quantitative Signal Detection Algorithms. Drug Saf 40, 517–530 (2017). https://doi.org/10.1007/s40264-017-0510-9

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