National Manual for Surveillance of Adverse Events Following Immunization in Saudi Arabia

65 Pages·2016·3.47 MB·English

by  Hussain A. Bafagih

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Adopted from: Framework for Developing National Manual for Surveillance of
Adverse Events Following Immunization

Version 1.0

Date of adoption
22/11/2016
Date of implementation
22/11/2016

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National Manual for Surveillance
of Adverse Events Following
Immunization in Saudi Arabia

Drug Sector
Saudi Food & Drug Authority

Please visit SFDA’s website at http://www.sfda.gov.sa/En/Drug
for the latest update

For Inquiries [email protected]

For Comments or Suggestions [email protected]

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Drug Sector
Vision and Mission

Vision
To be the leading regional Drug Regulatory Authority for pharmaceuticals and cosmetic
products, with professional excellence and services that contribute to the protection and
advancement of public health in the Kingdom of Saudi Arabia.
ةيؤرلا
ةيماح في مهست ةيزتمم ةينهبم هتامدخ مدقيو ،ليمجتلا تاضرحت سمو ةيودل ا لىع ةباقرلا في اًييملقا ًادئار ءاولدا عاطق نوكي نأ
.ةيدوعسلا ةيبرعلا ةكلملما في ةحصلا زيزعتو

Mission
Protecting public health by ensuring safety, quality, efficacy and accessibility of human,
veterinary drugs and biological products, and safety of cosmetics, through administration of a
national regulatory system which is consistent with international best practice. Through our
mission, we also provide accurate and scientific-based information to the public and healthcare
professionals.
لةاسرلا
داوم ةملاسو ةيويلحا تاجتنلماو ةيرطيبلاو ةيشربلا ةيودل ا رفوتو ةيلاعفو ةدوجو نامأ نماض للاخ نم ةماعلا ةحصلا ةيماح
ةيملع سسأ لىع ةينبلما ةيئاولدا تامولعلما يمدقتو ةيلولدا تاسرمالما لضفأ عم قفاوتم ةباقرلل نيطو ماظن قيبطت برع ليمجتلا
.ينيحصلا ينينهلماو ةماعلل

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Document Control

Version Author Implementation Date Comments
Vigilance and Benefit- Risk
Final
1.0 Assessment Executive 22/11/2016
Directorate

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Contents
Foreword .................................................................................................................................... 8
Acknowledgements ................................................................................................................... 10
Glossary .................................................................................................................................... 11
1. Abbreviations .................................................................................................................... 15
1. Introduction ........................................................................................................................... 16
2. Basic concepts of vaccines and adverse events following immunization ................................. 17
2.1 Vaccines .......................................................................................................................... 17
2.1.1 Primary components of vaccines ............................................................................... 17
2.1.2 Other components of vaccines ................................................................................... 18
2.1.3 Classification of vaccines .......................................................................................... 18
2.1.4 Contraindications and precautions to vaccination ...................................................... 19
2.2 Adverse Events Following Immunization (AEFI) ............................................................. 19
2.2.1 Vaccine reactions .......................................................................................................... 20
A. Cause-specific vaccine reactions ................................................................................ 20
B. Vaccine reactions by seriousness and frequency ......................................................... 21
Immunization error-related reactions ................................................................................. 24
Immunization anxiety-related reactions .............................................................................. 25
Coincidental events ........................................................................................................... 25
2.2.2 Key AEFI terminology .............................................................................................. 27
3. Prevention and management of AEFI .................................................................................... 27
3.1 General principles of prevention and management of AEFI .............................................. 27
3.2 Prevention and management immunization error-related reactions ................................... 28
3.3 Prevention and management of immunization anxiety-related reactions ........................... 29
3.4 Management of suspected anaphylaxis or collapse after vaccination................................. 30
4: AEFI surveillance in Saudi Arabia ..................................................................................... 31
4.1 Stakeholders in AEFI reporting and investigation; their roles and responsibilities ............. 35
4.2 Field investigation of AEFI .............................................................................................. 35
4.2 1 Role of the Subnational stakeholders ......................................................................... 36
Investigation of AEFI with fatal outcome .............................................................................. 41
4.2.2 Investigating AEFI clusters ........................................................................................... 41
Interpretation of results from AEFI clusters ....................................................................... 42
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5: Laboratory testing of specimens ............................................................................................ 43
Human specimens ................................................................................................................. 43
Vaccines and logistics ........................................................................................................... 43
5.1 Human Specimens ........................................................................................................... 44
5.1.1 Guide to human specimen sample collection ............................................................. 44
5.2 Vaccines and logistics...................................................................................................... 45
6: Data and performance analysis .............................................................................................. 46
6.1 Sources of AEFI data ....................................................................................................... 46
6.2 Analysis of AEFI reports ................................................................................................. 47
6.3 Data analysis at different levels ........................................................................................ 47
6.4 Process of data analysis ................................................................................................... 48
6.5 Interpretation of data ....................................................................................................... 49
6.6 Monitoring and Evaluating the performance of the AEFI surveillance system .................. 49
7. Brief overview of AEFI causality assessment ........................................................................ 50
7.1 Case selection for causality assessment ............................................................................ 51
7.2 Preparation for causality assessment ................................................................................ 51
7.3 Causality assessment team ............................................................................................... 52
8. Action and response to AEFI ................................................................................................. 53
9: Communication and media management................................................................................ 54
9.1 Risk communication ........................................................................................................ 54
Need for improved communication .................................................................................... 54
Challenges to effective communication .............................................................................. 54
9.2 Communication with clients, parents or guardian and community .................................... 54
9.3 Role of health care worker in community communication on AEFI .................................. 55
9.4 Communication with other health care staff ..................................................................... 56
9.5 Communicating with stakeholders ................................................................................... 56
9.6 Communicating with media ............................................................................................. 56
Advance preparedness ....................................................................................................... 56
A database of journalists .................................................................................................... 56
Information packages: ....................................................................................................... 57
Draft media release: ........................................................................................................... 57
A spokesperson system: ..................................................................................................... 57
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Orientation workshops and field visits for media:............................................................... 57
Media Management during an AEFI crisis ......................................................................... 57
Monitoring of media: ......................................................................................................... 57
Prepare a media release: .................................................................................................... 58
Call a media conference:.................................................................................................... 58
9.7 Media Management post AEFI ........................................................................................ 59
Keeping promises to the media: ......................................................................................... 59
Providing answers to unanswered questions: ...................................................................... 59
Keeping media informed about subsequent developments: ................................................. 59
9.8 Dealing with rumours and misinformation ....................................................................... 59
Annex 1 Standard AEFI Reporting Form ................................................................................... 61
Annex 2 AEFI Linelist .............................................................................................................. 62
Annex 3 AEFI Investigation Form ............................................................................................. 63

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Foreword

Vaccines are largely used to protect individuals particularly children from acquiring deadly
infectious diseases which are preventable. Such products are relatively safe and can rarely
cause adverse events following immunization (AEFI). A proportion of these may occur
during immunization campaigns when vaccinating large populations in a short period or
when new vaccines are introduced. Because serious adverse events are very rare and occur
primarily in children who were apparently healthy, monitoring vaccine safety is of
paramount importance in a healthcare system of any country.
AEFI surveillance system focuses on vaccine safety and it utilizes tools, guidelines and
procedures geared to assure public health protection through the use of vaccines with
proven safety profile.
In Saudi Arabia, the Expanded Programme on Immunization (EPI) which was established
in 1974, has been involved in increasing immunization coverage to all age groups in the
country. Saudi Arabia envisions a vaccine safety system with national dedicated vaccine
pharmacovigilance capacity, with designated staff, with clear mandates and well-defined
structures and roles.
The current system for monitoring drug safety (pharmacovigilance) is being coordinated
by the National Regulatory Authorities (NRAs) through the Saudi Food and Drugs
Authority (SFDA). The SFDA has been able to improve patient care and safety in relation
to the use of medicines and other medical interventions.
Monitoring vaccine safety has been challenging as the national immunization program
(NIP), which has actively been engaged in enhancing immunization coverage is also
primarily collecting vaccine safety data from the districts. AEFI reports which reach NIP
may not find their way to SFDA for further regulatory actions. Furthermore, since the
establishment of the pharmacovigilance system, the SFDA has not been able to share AEFI
reports with the Global community through the WHO Programme for International Drug
Monitoring). Currently NIP and SFDA are in the process of establishing coordinating
mechanisms for sharing vaccine safety data.
By bringing these important stakeholders together, as well as engaging healthcare
providers at all levels, the AEFI surveillance system will be well coordinated and vaccines
will be effectively monitored for safety. This will contribute to assessing risks, benefits and
effectiveness of vaccines thus minimizing harm and risks while maximizing known
benefits.
An effective and well-functioning AEFI surveillance system will eventually boost trust,
public confidence and will also help improve the quality of the immunization programme
in the long run. It is therefore essential that all stakeholders like NIP, SFDA, vaccine
manufacturers, laboratories and healthcare providers make concerted efforts to provide
documented evidence through an effective AEFI surveillance system. This will ensure that
the best immunization services are being provided to the community including effective
monitoring and response to AEFIs.
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This manual was developed in line with the strategic objective 4 of the Global Vaccine
Action Plan (GVAP) 2011 - 2020 (Strong immunization systems that are an integral part
of a well-functioning health system) to ensure capacity for vaccine safety activities,
including capacity to collect and interpret safety data, with enhanced capacity in countries
that introduce newly developed vaccines.
It is envisaged that this document will guide stakeholders at all levels to be involved in and
take part in the strengthening of the AEFI surveillance system in Saudi Arabia.
Readers are also requested to provide inputs and suggestions that will be used when
revising and adapting the manual in the future.

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Acknowledgements

Saudi Food & Drug Authority wishes to acknowledge the World Health Organization for
the technical support and guidance offered for developing this work.

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