1 |National Regulatory System, Status of vaccine indicators

Function 2: Pharmacovigilance Activities

including Surveillance of Adverse Events Following Immunization

(AEFI)

Function 2: Pharmacovigilance Activities

including Surveillance of Adverse Events Following Immunization

(AEFI)

Thailand

23 - 27 Jul 2012

2 |National Regulatory System, Status of vaccine indicators

PMS function assessor teamPMS 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

3 |National Regulatory System, Status of vaccine indicators

Place and institutions visitedPlace 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.

4 |National Regulatory System, Status of vaccine indicators

Function 2: Pharmacovigilance Activities including Surveillance of Adverse Events Following

Immunization (AEFI)Function status

Function 2: Pharmacovigilance Activities including Surveillance of Adverse Events Following

Immunization (AEFI)Function status

NRA FunctionYearIndicator Estimated

Indicator implemented

%Sub-indicators

Function Status

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

Before 2007

Not implemented

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

2007-2008

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

20127794.23Implemented

5 |National Regulatory System, Status of vaccine indicators

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

Indicators results

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

Indicators results

IndicatorsIndicators achieved

Indicator estimated

Indicators percent

PV01: Institutional regulations and Guidelines for the monitoring and management of adverse events following immunization (AEFI)

44100

PV02: Quality Management System for pharmacovigilance activities2.5383

PV03: Human resource management2367

PV04: Routine and functional system for regular review of safety and efficacy of the vaccine product for regulatory action

77100

PV05: Capacity to detect and investigate significant vaccine safety issues44100

PV06: Regulatory action regarding vaccine performance22100

PV07: Communication system is in place to periodically inform stakeholders about AEFI information.

33100

IndicatorsIndicators achieved

Indicator estimated

Indicators percent

PV01: Institutional regulations and Guidelines for the monitoring and management of adverse events following immunization (AEFI)

44100

PV02: Quality Management System for pharmacovigilance activities2.5383

PV03: Human resource management2367

PV04: Routine and functional system for regular review of safety and efficacy of the vaccine product for regulatory action

77100

PV05: Capacity to detect and investigate significant vaccine safety issues44100

PV06: Regulatory action regarding vaccine performance22100

PV07: Communication system is in place to periodically inform stakeholders about AEFI information.

33100

6 |National Regulatory System, Status of vaccine indicators

StrengthsStrengths

• 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.

7 |National Regulatory System, Status of vaccine indicators

Areas for improvementAreas 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

8 |National Regulatory System, Status of vaccine indicators

Khob Kun Khab!