AEFI surveillance systems and communication activities in Viet Nam

7/12/2012 in Chau Quang, Quy Hop, Nghe An have vaccination day with 65 injection. 8/12/2012 – 1 died, 10/12/2012 – 1 died, 12/12/2012 – 1 died. • 16/12 start the investigation. • 18/12 many newspaper report the cluster of dead due to vaccine • 18/12 committee meeting and conclude

AEFI surveillance systems and communication activities

in Viet Nam

CASE STUDY

Case #1: 3 children died after immunization

• 7/12/2012 in Chau Quang, Quy Hop, Nghe An have vaccination day with 65

died

• 16/12 start the investigation

• 18/12 many newspaper report the cluster of dead due to vaccine

• 18/12 committee meeting and conclude:

• All three children die were coincident,

• 21/12 newspaper still conclude that the vaccine is the cause of all dead Even

other 2 not related dead being included in the list that make 5 dead because of

vaccine

Case #2: child 45 days of age die after immunization

Afternoon 14-5, Tieu Can district police being informed …

• morning14-5, Mrs Trang bring Phuc to have BCG vaccination in commune

health center and then bring him home During that time, she feet her baby milk At 12 pm, the family found Phuc died so they bring him to the hospital and claim

that he died because of vaccine shock

team figure out that Phuc died because of milk stuck in respiratory path that cause obstruction lead to dead

Gross Domestic Product per capita (2015) 2,111 USD

Expenditure on health per capita (2014) 390 USD

Expenditure on health as % of GDP

NRA related to divisions/agencies

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Ministry of Health

NRA office

General Department of

Preventive Medicine

Drug Administration

of Vietnam (DAV);

Administration of Science Technology and

Training (ASTT);

National Institute for

Control of Vaccine and

Biologicals (NICVB); Professional

Advisory Council of assessing AEFIs after using vaccine

and biological products of MOH; National Expanded

Program on Immunization

(NEPI) (responsible for vaccine in EPI)

NRA (AEFI) related to divisions/agencies

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General Department of Preventive Medicine

National Institute of Hygiene and Epidemiology;

Health Department at provincial/city level

Provincial Professional Advisory committee

Preventive Medicine Center at provincial/city level

District health center, immunization unit

Pasteur Institute in Nha Trang

Health Department at provincial/city level

Provincial Professional Advisory committee

Preventive Medicine Center at provincial/city level

District health center, immunization unit

Tay Nguyen Institute of Hygiene and

Epidemiology

Health Department at provincial/city level

Provincial Professional Advisory committee

Preventive Medicine Center at provincial/city level

District health center, immunization unit

Pasteur Institute in Ho Chi Minh city

Health Department at provincial/city level

Provincial Professional Advisory committee

Preventive Medicine Center at provincial/city level

District health center, immunization unit

Provincial Professional Advisory committee : Professional Advisory committee of assessing AEFIs after using vaccine and biological at provincial level

Advisory Council at ministry level

- Decision No 4113/QD-BYT dated 15/10/2013 of the MOH: On completion and complement of the Professional Advisory Council of assessing AEFIs after using vaccine and biological products of MOH

a) Chairperson: Director of the GDPM;

b) Membership: leader of the Drug Administration, Administration of Science, Technology and Training, Department of Healthcare Management, Ministerial Inspectorates, Department of Legislation, International Cooperation Department, National Hospital of Tropical Diseases, National Hospital of Pediatrics, National Institute/Pasteur Institute, National Institute for Control of Vaccines and Biologics

- Responsibilities: Re-assess the assessments by the Advisory Council at provincial level on the causes of AEFI on the national scale at the proposals of the permanent body of the Advisory Council at ministry level

- Meet on the periodically basis of every 6 months by the middle and the end of the year

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Advisory Council at provincial level

- Set up by Directors of the Provincial Health Services with the following membership:

a) Chairperson: Representative of the leadership of the Provincial Health Services

b) Vice Chairperson: Director of the Preventive Medicine Center

c) Membership: a leader of Provincial Health Services, Preventive Medicine Center, Provincial Polyclinic, Center for forensic tests

- Responsibilities: Organize investigations into, assess the causes of adverse events following immunization in the respective location of authority at the proposals of the permanent body of the Council

- Meeting at the proposals of the permanent bodies of the Councils whereas the matters occur and require solutions

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Legal document and guidelines

- Decree No.104/2016/ND-CP dated 01/7/2016 of the Gov about the immunization activities

- Circular No 21/2011/TT-BYT dated 07/6/2011 of the MOH about the regulations for the establishment, organization and operation of Advisory Committee of complication assessment during the use of vaccine and biological

- Circular No 12/2014/TT-BYT dated 20/3/2014 of the MOH about the management guidelines vaccines used in immunization

- Decision No 1830/QD-BYT dated 26/5/2014 of the Ministry of Health about guidelines of supervising, investigating, analyzing and evaluate causes reactions after vaccination;

- Vaccine Quality Manual of the GDPM

- SOP of the GDPM about procedure on monitoring serious AEFI

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AEFI reporting & investigation, 2013 - 2015

BCG: 7 cases Quinvaxem: 10 cases

OPV: 8 cases Hepatitis B: 8 cases

BCG: 12 cases Quinvaxem: 14 cases

OPV: 12 cases Measles: 3 cases MR: 8 cases DPT: 2 cases

Hepatitis B: 3 cases

BCG: 8 cases

Quinvaxem: 34 cases OPV: 33 cases

Measles: 1 cases Hepatitis B: 7 cases

Number of AEFI cases investigated

Number of AEFI cases which were reviewed and evaluated by the AEFI committee

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AEFI Detection

Notification

Reporting

Investigation Analysis

Causality assessment

Feedback

The AEFI surveillance cycle

Surveillance: The ongoing systematic collection and analysis

of data and the provision of information which leads to action

AEFI surveillance system

Advisory Council at ministry level

Ministry of Health

Drug Administration of Vietnam (DAV)/ Department of Science,

Technology and Training

(ASTT)/National Institute for vaccines and biologicals (NICVB)

Provincial

Regional

National

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Immunization Unit

District Health Center, Center for

Preventive

Medicine and AEFI Advisory Council at provincial level

with the participation of regional institute

Carry out investigation with regional experts and independent experts

Collect reports on health, vaccines, transport, storage and reporting of tests (eg CSF, serum or other biological)

Evaluate the clear case, refer comments on difficult cases

AEFI surveillance system

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Regional Institute, Regional Expanded

Program on Immunization

Save data for analyzing& sharing

AEFI surveillance system

Department of Preventive

General Department of Preventive Medicine

Advisory Council at ministry level

Ministry of Health

Drug Administration of Vietnam/ Department of Science, Technology and

Training /National Institute for vaccines and

Instantly review and test the AEFI reports if there is any similarity in other areas

Support field investigation if necessary

Create a national database to be shared with the relevant units

Load data into the global data system

Inform manufacturers and related units

Line Listing AEFI

Feedback

AEFI surveillance system

AEFI Report form

AEFI CODE …………

1 General information Fullname: ……… DOB: -/ / -

SEX: male ฀ Female ฀ Ethnicity:………

Fullname of mother/father (when thhe vaccinated subjects are children ):…… ………

address: Villages:……….Ward:………

District:……… Province:………

Immunization unit:

EPI ฀ Private ฀Community Health Services ฀ At hospital / clinic ฀ outside the Community Health Services (EPI) ฀ others ฀Reporter:… … …

Unit:… … …

add:… … …

Tel & email: ………

2 Information about vaccination Type of vaccine Dose vaccination method injection area Health care officer (vaccinater) Vaccination time onset of AEFI 3 Information about the vaccines, injection solvent type of vaccine, solvent name of type of vaccine, solvent Manufacturer Providers LOT EXP 4 Reaction description Fever ≥39°C ฀ Encephalopathy within 7 days ฀ Swelling, high-temperature, redness at the injection site ฀ Seizures within 3 days ฀ Abscess at the injection site ฀ Shock within 72 hours ฀ Others ฀ detail………

Sequelae ฀ Dead ฀ Date of death -/ / -

Other (in detail) ฀……….

Reporter (sign with fullname) …… , date……month.… year 20…

Confirmation of the unit/department

(Sign and seal)

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AEFI Investigate form

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AEFI CODE …………

Date of receipt of the AEFI report: -/ / -Date of investigation: -/ / -

Place of the reported case:… … …

Investigation Group (fullname and unit/department) 1

………

………

b / Information from medical staff and from medical records at health facilities (description time to health facilities, original condition, changes in symptoms according to chronological order) ………

………

4.2 Results of clinical laboratory testing (blood / urine / CSF at the medical facility where children are treated) ………

b / forensic examination results (collect inspection results if any advailable) Inspection Agency:

Inspection Results:

1 Status at time of survey  Treatment  Recover How long after vaccination: … … … …

 Death How long after vaccination: … … … …

 sequelae (specify) H ow long after vaccination: … … … …

AEFI Investigate form

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5 Medical history

a / obstetric history

- History of the mother during pregnancy:

- The number of weeks of gestation at birth: Weight at birth: - The problem of child health at birth:

b / medical history of the child from birth to the time when vaccinations

c / vaccination history and the reactions after previous vaccination (vaccine,

injection time, stating reaction after vaccination if available)

istory of using medicine before this vaccination

d/ H

e/ Before, during and after this time,is there any abnormal when the child immunization eat, drink or breastfeed

f/ Family history (allergies or reactions to vaccines if any)

6 Investigation performed at the immunization service

a / vaccine, solventsstorage conditions (received vaccine from whom, when did the

vaccine receive, vaccine preservation in village, is there any tracking devices for vaccine storage temperature? Thermal Testing preservation of existing vaccines, temperature monitoring chart (if preserved vaccines in the refrigerator)

………

b/ the immunization sessions organize (the number of objects in half a day? Number

of staff involved in immunization? There examinations classification, counseling and follow-up after vaccination?)

………

c/ Practice immunization (are vaccination staff trained? Check knowledge and

practical examination specified contraindications, vaccine storage, vaccine preparation, diluent phase (technique, time of vaccine usage), use syringes, immunization techniques, destruction of vaccines, syringes after immunization sessions)

………

d/Noting and managing notebooks (Inspect the vaccine management, immunization

manager, window tracking abnormal reactions after vaccination)

………

e/ Status of immunization

 The number of objects in the same immunization time (half day) of each vaccine ………  The number of children immunized with vaccines: same vaccines lot:

… sameVaccivis (ifmultledosevis): AEFI seca

The number of cases of severe reactions after vaccination in immunization in 

recent times

 The situation of illness, death in the province in recent times nothing special

7 Investigation in community (combined medical staff and asked to visit households)

Vaccines origins Reception Time The number of received Means of transport

The number of vaccine issued to lower levels The number of units remaining in inventory Means preserved this vaccines

Storage temperature at investigation time Electronic Freezing Directive chip at test vaccine vial temperature at test (if applicable)

daily temperature monitoring tables Yes ฀ No ฀ Yes ฀ No ฀ The temperature is in the permissible limits, or

not?

Yes ฀ No ฀ Yes ฀ No ฀ is there a problem in cold chain storage of this

vaccines during stogate?

Yes ฀ No ฀ Yes ฀ No ฀ There is a vaccine notebook, needles, safe box Yes ฀ No ฀ Yes ฀ No ฀ Does vaccine notebook follow regulations? Yes ฀ No ฀ Yes ฀ No ฀ Vaccines are administered in the prescribed

books, or not?

Yes ฀ No ฀ Yes ฀ No ฀ Is there in-out bill for vaccine? Yes ฀ No ฀ Yes ฀ No ฀ Is in-out bill follow the guildline? Yes ฀ No ฀ Yes ฀ No ฀ Cán bộ quản lý kho vắc xin tại tuyến tỉnh đã

được tập huấn về bảo quản vắc xin không?

Personnel management in provincial vaccine warehouse has been trained, or not?

Yes ฀ No ฀ Yes ฀ No ฀

knowledge about vaccine preservation of warehouse managers can meet the requirements, or not?

Yes ฀ No ฀ Yes ฀ No ฀

1 Vaccine product-related

reaction

EXAMPLE

Extensive limb swelling after

DTP vaccine

Vaccine quality defect-related

reaction

EXAMPLE

Failure by the manufacturer to completely inactivate a

lot of inactivated polio vaccine leads to cases

of paralytic polio

Immunization error-related

reaction

EXAMPLE

Abscess formation due

to improper technique of

BCG vaccination

Immunization anxiety-related

reaction

EXAMPLE

Vasovagal syncope in an

adolescent following vaccination

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Coincidental event

EXAMPLE

A fever after vaccination

(temporal association) and malarial

parasite isolated from

blood

CIOMS/ WHO cause specific definition of AEFIs

1955- IPV-

120,000 injected 40,000 mild polio

200 paralysed 10 died

A Consistent causal association to immunization

A1 Vaccine product-related reaction (As per published

insufficient definitive evidence for vaccine causing

event (may be new linked event)

vaccine-C Inconsistent causal association to immunization

C Coincidental Underlying or emerging condition(s), or condition(s)

caused by exposure to something other than

vaccine

Unclassifiable

Specify the additional information required for classification

Adequate information

available

Adequate information not available

*B1 : Potential signal and maybe considered for investigation

B2 Qualifying factors result in conflicting trends of consistency and inconsistency

with causal association to immunization

AEFI causality assessment classification

AEFI Information sharing

1 Information sharing methodology when an serious AEFI occur:

AEFI Information sharing 2 Periodically information sharing (on a quarterly basis/an

annually basis):

- Detail of the information:

+ The utilization of vaccines usage + The situation of infectious diseases + AEFI

- Recipient of information: the Drug Administration,

Administration of Science, Technology and Training, National Institute for Control of Vaccines and Biologics

- Time of information sharing: information sharing is carried out at 1st of the second month of the next quarterly and annually sharing information at Feb 28th of the following year

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