Function 2:
Pharmacovigilance Activities
including Surveillance of Adverse
Events Following Immunization
(AEFI)
Thailand
23 - 27 Jul 2012
National Regulatory System,
1 | Status of vaccine indicators
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
National Regulatory System,
2 | Status of vaccine indicators
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.
National Regulatory System,
3 | Status of vaccine indicators
Function 2:
Pharmacovigilance Activities including Surveillance of Adverse Events Following
Immunization (AEFI)
Function status
NRA Function
Year
Function 2: Pharmacovigilance
Activities including Surveillance
of Adverse Events Following
Immunization (AEFI)
Before
2007
Function 2: Pharmacovigilance
Activities including Surveillance
of Adverse Events Following
Immunization (AEFI)
20072008
Function 2: Pharmacovigilance
Activities including Surveillance
of Adverse Events Following
Immunization (AEFI)
2012
National Regulatory System,
4 | Status of vaccine indicators
Indicator
Estimated
Indicator
implemented
%Subindicators
Function
Status
Not
implemented
7
7
94.23
Implemented
Pharmacovigilance Activities including Surveillance of
Adverse Events Following Immunization (AEFI)
Indicators results
Indicators
Indicators
achieved
Indicator
estimated
PV01: Institutional regulations and Guidelines for the monitoring and
management of adverse events following immunization (AEFI)
4
4
100
PV02: Quality Management System for pharmacovigilance activities
2.5
3
83
PV03: Human resource management
2
3
67
PV04: Routine and functional system for regular review of safety and
efficacy of the vaccine product for regulatory action
7
7
100
PV05: Capacity to detect and investigate significant vaccine safety issues
4
4
100
PV06: Regulatory action regarding vaccine performance
2
2
100
PV07: Communication system is in place to periodically inform stakeholders
about AEFI information.
3
3
100
National Regulatory System,
5 | Status of vaccine indicators
Indicators percent
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.
National Regulatory System,
6 | Status of vaccine indicators
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
National Regulatory System,
7 | Status of vaccine indicators
Khob Kun
Khab !
National Regulatory System,
8 | Status of vaccine indicators