Assessment on Phamacovigilance Activities and Surveillance of Adverse Events Following Immunization (AEFI) using Standards of World Health Organization in Thailand, 23 – 27 July 2012
Keywords:
standards, World Health Organization, Adverse Events Following Immunization, surveillance and investigationAbstract
Phamacovigilance activities, including surveillance of adverse events following immunization (PMS & AEFI), of Thailand was assessed by World Health Organization during 23-27 July 2012 in order to ensure standards and quality of operational system for vaccine safety in terms of surveillance, investigation and response to problems dealing with vaccines safety. The result showed achievement of Thailand by percentage score of 94.23. WHO standards for PMS &A EFI are concerned with 3 principal elements, including related organizations, operational system and human resources, which have effective functions of cooperation and coordination in PMS & AEFI network under quality management system. The standards can be illustrated in covering areas of satisfactory sensitive reporting system, investigation, timeliness and zero reporting, AEFI country database analysis and regular report, process to review/assess AEFI by experts, feedback AEFI report to health facilities/public/community/patients/parents, operational system at national level to respond to serious events, legal provision for action to manufacturer, quality management system and human resource management.
References
World Health Organization. A WHO manual for assessment of the national regulatory system for vaccines, Part 3: Guiding principles for using the NRA assessment tools. 2011 [cited 16 February 2012]. Available from URL: https://workspace.who.int/sites/att/default.aspx
World Health Organization. Presentation slide of Assessment on Phamacovigilance Activities Including Surveillance of Adverse Events Following Immunization (AEFI), 23-27 July 2012. Available from URL: http://www.boe.moph.go.th/files/meeting/AEFI_Asse ssment_WHO.ppt
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