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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

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Thailand 23 - 27 Jul 2012

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Thailand 23 27 jul 2012

Function 2: Pharmacovigilance Activities including Surveillance of Adverse Events Following Immunization (AEFI)

Thailand

23 - 27 Jul 2012


Pms function assessor team

PMS function assessor team

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


Place and institutions visited

Place and institutions visited

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.


Thailand 23 27 jul 2012

Function 2: Pharmacovigilance Activities including Surveillance of Adverse Events Following Immunization (AEFI)Function status


Thailand 23 27 jul 2012

Pharmacovigilance Activities including Surveillance of Adverse Events Following Immunization (AEFI) Indicators results


Strengths

Strengths

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.


Areas for improvement

Areas for improvement

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


Thailand 23 27 jul 2012

Khob Kun Khab !


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