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

6

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;

NRA (AEFI) related to divisions/agencies

7

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

8

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

9

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

10

AEFI reporting & investigation,

Cases = 37 Doses= 54.243.800

Cases = 48 Doses=48.200.000

Number of serious

cases reported with

each antigen (add

appropriately)

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

11

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

EPI Project (for vaccine in EPI Project),General

Department of Preventive Medicine

General Department of Preventive Medicine

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

14

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

15

Regional Institute, Regional Expanded Program on Immunization

Save data for analyzing& sharing

AEFI surveillance system

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

biologicals

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

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 ………

………

5 History of disease ( including a history of similar reactions or allergies) ………

………

………

………

………

………

6 Current status Recover ฀

Sequelae ฀ Dead ฀ Date of death -/ / -

Other (in detail) ฀ ……….

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

Confirmation of the unit/department

(Sign and seal)

17

AEFI Investigate form

18

AEFI CODE …………

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

Place of the reported case:… … …

Investigation Group (fullname and unit/department) 1

2

3

4

5

1 General information Name of the childrent:

Sex:

Ethnicity

DOB : /… / ( month of age, day of age -infants) The order of AEFI child in his/her family ………

Full name of mother (father): Tel:

address: V i l l a g e s :… … … Ward:… … …

District:… … … Province:… … …

EPI฀Private฀ Immunization campaign฀ Community Health Services ฀ At hospital / clinic ฀ outside the Community Health Services (EPI) ฀others฀ 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 Evolution process of the AEFI 4.1 Symptoms and clinical signs a / Information directly from the caregiver and the history traceback from parent (description appears time, the first symptoms of the reaction, changes in symptoms after vaccination) ………

………

………

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) ………

………

4.3 Medical treatment facility final diagnosis ………

………

4.4 Mortality: a/ description condition when discovered mortality (posture, position, secretions, ………

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

19

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/ N oting and managing notebooks (Inspect the vaccine management, immunization

manager, window tracking abnormal reactions after vaccination)

s ( if

mu lt le

 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)

• T o ta l n um b e r o f p e o p l e surve ye d :

• T h e n um b e r o f o b j e c ts th a t re a c t to th e va c c i n e :

• O th e r i ssue s: .

8 Situation of receipt, storage, distribution and use of vaccines in AEFI vaccine(s)

at provincial and district levels

8.1.The receipt, storage and distribution of vaccines at provincial and district levels

Investigation Information At the

provincial level

At the district level

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

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 ฀

EXAMPLE

Failure by the manufacturer

to completely inactivate a lot of inactivated polio vaccine leads to cases

of paralytic polio

3 Immunization error-related reaction

EXAMPLE

Abscess formation due

to improper technique of BCG vaccination

4 Immunization anxiety-related reaction

EXAMPLE

Vasovagal syncope in an adolescent following vaccination

5

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