Function 2: Pharmacovigilance Activities including Surveillance of Adverse Events Following Immunization (AEFI). Thailand 23 - 27 Jul 2012. PMS function assessor team. Dr. Ananda Amarasinghe Consultant Epidemiologist EPI Unit MOH Colombo Sri-Lanka
Function 2: Pharmacovigilance Activities including Surveillance of Adverse Events Following Immunization (AEFI)
23 - 27 Jul 2012
Dr. Ananda Amarasinghe Consultant Epidemiologist EPI Unit MOH Colombo Sri-Lanka
Dr. Ajay Kera, Deputy Commissioner, Ministry of Health & Family Welfare New Delhi, India
Dr. Dina Pfeifer, Regional Advisor EPI, WHO regional Office for Europe
Mr. Stephane Guichard, Vaccine Supply and Quality, Immunization and Vaccine Development, WHO regional Office for South East Asia
Team 1: Visited Khon Kaen
Dr. Ajay Khera, Dr. Dina Pfeifer, Dr. Darin Areechokchai BOE/MOPH, Ms Papaiji Suangtho BOE/MOPH, Mr. Padejsak Chobdham Bureau general Communicable Department.
Team 2: Visited Angthong province
Dr. Ananda Amarasinghe, Mr. Stephane Guichard, Mrs Kanoktip Thiparat BOE/MOPH and Mrs Porpit Barinsathien MOPH.
The system has significantly improved since the last NRA assessment in 2008.
PMS system well established system
AEFI are notifiable under the national disease surveillance system
Expertise available at central, provincial and regional levels
The country has a good investigation capacity to address vaccine safety and performance.
Regular meetings at provincial and regional levels are conducted to review and analyze AEFI reports with good interactions with central level which review all cases.
Information feedback is provided through the MOPH internet and periodic reports are prepared by BOE/AEFI.
The system capture serious and non-serious AEFI throughout the National Immunization program
Regular training of staff at every levels.
QMS implemented in NRA but not fully extended to BOE to cover detection, reporting and detailed analysis including feed back.
Analysis methodology e.g.: analysis by rates, by dose of vaccines, by product,…
To address under-reporting there are needs to standardized selected non-serious AEFI by applying simplified Brighton case definition.
Further improvement of the system requires increased HR capacity at central level.
Need to be more actively engaged in international/regional PMS activities to foster capacity building and keep abreast of latest regulatory requirements. E.g participation in NRA assessment, facilitating training organized by WHO in other countries
Khob Kun Khab !