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Gross Domestic Product per capita (2015) <b>2,111 USD </b>
Expenditure on health per capita (2014) <b>390 USD </b>
Expenditure on health as % of GDP
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<small>Ministry of Health </small>
<small>NRA office </small>
<small>General Department of </small>
<small>Preventive Medicine </small>
<small>Drug Administration </small>
<small>of Vietnam (DAV); </small>
<small>Administration of Science Technology and </small>
<small>Training (ASTT); </small>
<small>National Institute for </small>
<small>Control of Vaccine and </small>
<small>Biologicals (NICVB); Professional </small>
<small>Advisory Council of assessing AEFIs after using vaccine </small>
<small>and biological products of MOH; National Expanded </small>
<small>Program on Immunization </small>
<small>(NEPI) (responsible for vaccine in EPI). </small>
</div><span class="text_page_counter">Trang 7</span><div class="page_container" data-page="7"><small>7 </small>
<b><small>General Department of Preventive Medicine </small></b>
<small>National Institute of Hygiene and Epidemiology; </small>
<small>Health Department at provincial/city level </small>
<small>Provincial Professional Advisory committee </small>
<small>Preventive Medicine Center at provincial/city level </small>
<small>District health center, immunization unit. </small>
<small>Pasteur Institute in Nha Trang </small>
<small>Health Department at provincial/city level </small>
<small>Provincial Professional Advisory committee </small>
<small>Preventive Medicine Center at provincial/city level </small>
<small>District health center, immunization unit. </small>
<small>Tay Nguyen Institute of Hygiene and </small>
<small>Epidemiology </small>
<small>Health Department at provincial/city level </small>
<small>Provincial Professional Advisory committee </small>
<small>Preventive Medicine Center at provincial/city level </small>
<small>District health center, immunization unit. </small>
<small>Pasteur Institute in Ho Chi Minh city. </small>
<small>Health Department at provincial/city level </small>
<small>Provincial Professional Advisory committee </small>
<small>Preventive Medicine Center at provincial/city level </small>
<small>District health center, immunization unit. </small>
<small> Provincial Professional Advisory committee : Professional Advisory committee of assessing AEFIs after using vaccine and biological at provincial level </small>
</div><span class="text_page_counter">Trang 8</span><div class="page_container" data-page="8">- 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
<small>8 </small>
</div><span class="text_page_counter">Trang 9</span><div class="page_container" data-page="9">- 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.
<small>9 </small>
</div><span class="text_page_counter">Trang 10</span><div class="page_container" data-page="10">- 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
<small>10 </small>
</div><span class="text_page_counter">Trang 11</span><div class="page_container" data-page="11"><small>BCG: 7 cases Quinvaxem: 10 cases </small>
<small>OPV: 8 cases Hepatitis B: 8 cases </small>
<small>BCG: 12 cases Quinvaxem: 14 cases </small>
<small>OPV: 12 cases Measles: 3 cases MR: 8 cases DPT: 2 cases </small>
<small>Hepatitis B: 3 cases </small>
<small>BCG: 8 cases </small>
<small>Quinvaxem: 34 cases OPV: 33 cases </small>
<small>Measles: 1 cases Hepatitis B: 7 cases </small>
<small>Number of AEFI cases investigated </small>
<small>Number of AEFI cases which were reviewed and evaluated by the AEFI committee </small>
<small>11 </small>
</div><span class="text_page_counter">Trang 12</span><div class="page_container" data-page="12"><b><small>AEFI Detection </small></b>
<b><small>Notification </small></b>
<b><small>Reporting </small></b>
<b><small>Investigation Analysis </small></b>
<b><small>Causality assessment </small></b>
<b><small>Feedback </small></b>
<b><small>Surveillance: The ongoing systematic collection and analysis </small></b>
<b><small>of data and the provision of information which leads to action </small></b>
</div><span class="text_page_counter">Trang 13</span><div class="page_container" data-page="13"><b><small>Advisory Council at ministry level</small></b>
<b><small>Ministry of Health</small></b>
<b><small>Drug Administration of Vietnam (DAV)/ Department of Science, </small></b>
<b><small>Technology and Training </small></b>
<b><small>(ASTT)/National Institute for vaccines and biologicals (NICVB)</small></b>
<b><small>Provincial </small></b>
<b><small>Regional </small></b>
<b><small>National </small></b>
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<b>Immunization Unit</b>
<b>District Health Center, Center for </b>
<b>Preventive </b>
<b>Medicine and AEFI Advisory Council at provincial level </b>
<b>with the participation of regional institute</b>
<b><small>Carry out investigation with regional experts and independent experts </small></b>
<b><small>Collect reports on health, vaccines, transport, storage and reporting of tests (eg CSF, serum or other biological) </small></b>
<b><small>Evaluate the clear case, refer comments on difficult cases. </small></b>
<small>15 </small>
<b>Regional Institute, Regional Expanded </b>
<b>Program on Immunization </b>
<small>Save data for analyzing& sharing </small>
<b><small>Department of Preventive </small></b>
<b><small>General Department of Preventive Medicine</small></b>
<b><small>Advisory Council at ministry level</small></b>
<b>Ministry of Health</b>
<b><small>Drug Administration of Vietnam/ Department of Science, Technology and </small></b>
<b><small>Training /National Institute for vaccines and </small></b>
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
<small>Line Listing AEFI </small>
<small>Feedback </small>
<small> AEFI CODE ………… </small>
<i><b><small>1. General information </small></b></i><small>Fullname: ………...DOB:---/----/--- </small>
<small>SEX: male Female Ethnicity:………...</small>
<small>Fullname of mother/father (when thhe vaccinated subjects are children ):……..……… </small>
<small>address: Villages:……….Ward:………...</small>
<small> District:………...Province:………. </small>
<small>Immunization unit:... </small>
<small>EPI Private Community Health Services At hospital / clinic outside the Community Health Services (EPI) others Reporter:… … … ..</small>
<small>Unit:… … … ... </small>
<small>add:… … … .. </small>
<small>Tel & email: ……….. </small>
<i><b><small>2. Information about vaccination </small></b></i><b><small>Type of vaccine </small><sup>Dose </sup><small>vaccination method injection area Health care officer (vaccinater) Vaccination time onset of AEFI </small></b><i><b><small>3. Information about the vaccines, injection solvent </small></b></i><b><small>type of vaccine, solvent name of type of vaccine, solvent Manufacturer Providers LOT EXP </small></b><i><b><small>4. Reaction description </small></b></i><small>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……… </small>
<small>Sequelae Dead Date of death ---/----/--- </small>
<small>Other (in detail) ……….</small>
<b><small>Reporter </small></b><small>(sign with fullname) …….., date……month.… ..year 20… .. </small>
<b><small>Confirmation of the unit/department </small></b>
<small>(Sign and seal) </small>
<small>17 </small>
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<small>AEFI CODE ………… </small>
<small>Date of receipt of the AEFI report: ---/----/---Date of investigation: ---/----/--- </small>
<small>Place of the reported case:… … … .</small>
<small>Investigation Group (fullname and unit/department) 1.... </small>
<small>……… </small>
<small>……… </small>
<b><small>b / Information from medical staff and from medical records at health facilities </small></b><small>(description time to health facilities, original condition, changes in symptoms </small><i><small>according to chronological order) </small></i><small>……… </small>
<small>……… </small>
<b><small>4.2 Results of clinical laboratory testing (blood / urine / CSF ... at the medical </small></b><small>facility where children are treated) ……… </small>
<b><small>b / forensic examination results (collect inspection results if any advailable) </small></b><small>Inspection Agency: ... </small>
<small>Inspection Results: ... </small>
<i><b><small>1. Status at time of survey </small></b></i><small> Treatment Recover How long after vaccination: … … … … .</small>
<small> Death How long after vaccination: … … … … .</small>
<small> sequelae (specify) ...H ow long after vaccination: … … … … .</small>
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<i><b><small>5. Medical history </small></b></i>
<b><small>a / obstetric history </small></b>
<small>- History of the mother during pregnancy: ... </small>
<small>- The number of weeks of gestation at birth: ... Weight at birth: ... - The problem of child health at birth: ... ... </small>
<b><small>b / medical history of the child from birth to the time when vaccinations </small></b>
<b><small>c / vaccination history and the reactions after previous vaccination (vaccine, </small></b>
<small>injection time, stating reaction after vaccination if available). </small>
<b><small>istory of using medicine before this vaccination </small></b>
<i><b><small>d/ H</small></b></i>
<b><small>e/ Before, during and after this time,is there any abnormal when the child immunization eat, drink or breastfeed </small></b>
<b><small>f/ Family history (allergies or reactions to vaccines ... if any) </small></b>
<i><b><small>6. Investigation performed at the immunization service </small></b></i>
<b><small>a / vaccine, solventsstorage conditions (received vaccine from whom, when did the </small></b>
<small>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) </small>
<small>……… </small>
<b><small>b/ the immunization sessions organize (the number of objects in half a day? Number </small></b>
<small>of staff involved in immunization? There examinations classification, counseling and follow-up after vaccination?) </small>
<small>……… </small>
<b><small>c/ Practice immunization (are vaccination staff trained? Check knowledge and </small></b>
<small>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) </small>
<small>……… </small>
<b><small>d/Noting and managing notebooks (Inspect the vaccine management, immunization </small></b>
<small>manager, window tracking abnormal reactions after vaccination) </small>
<small>……… </small>
<b><small>e/ Status of immunization </small></b>
<small> The number of objects in the same immunization time (half day) of each vaccine ……… The number of children immunized with vaccines: ... same vaccines lot: </small>
<small>…..sameVaccivis ...(ifmultledosevis):....AEFI .seca</small>
<small> The number of cases of severe reactions after vaccination in immunization in </small>
<i><small>recent times ... </small></i>
<small> The situation of illness, death in the province in recent times nothing special </small>
<i><b><small>7. Investigation in community (combined medical staff and asked to visit households) </small></b></i>
<small>Vaccines origins Reception Time The number of received Means of transport </small>
<small>The number of vaccine issued to lower levels The number of units remaining in inventory Means preserved this vaccines </small>
<small>Storage temperature at investigation time Electronic Freezing Directive chip at test vaccine vial temperature at test (if applicable) </small>
<small>daily temperature monitoring tables Yes No Yes No The temperature is in the permissible limits, or </small>
<small>not? </small>
<small>Yes No Yes No is there a problem in cold chain storage of this </small>
<small>vaccines during stogate? </small>
<small>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 </small>
<small>books, or not? </small>
<small>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 </small>
<small>được tập huấn về bảo quản vắc xin không?</small>
<small>Personnel management in provincial vaccine warehouse has been trained, or not? </small>
<small>Yes No Yes No </small>
<small>knowledge about vaccine preservation of warehouse managers can meet the requirements, or not? </small>
<small>Yes No Yes No </small>
</div><span class="text_page_counter">Trang 20</span><div class="page_container" data-page="20"><small>1 Vaccine product-related </small>
<small>reaction </small>
<b><small>EXAMPLE </small></b>
<small>Extensive limb swelling after </small>
<small>DTP vaccine </small>
<small>Vaccine quality defect-related </small>
<small>reaction </small>
<b><small>EXAMPLE </small></b>
<small>Failure by the manufacturer to completely inactivate a </small>
<small>lot of inactivated polio vaccine leads to cases </small>
<small>of paralytic polio. </small>
<small>Immunization error-related </small>
<small>reaction </small>
<b><small>EXAMPLE </small></b>
<small>Abscess formation due </small>
<small>to improper technique of </small>
<small>BCG vaccination. </small>
<small>Immunization anxiety-related </small>
<small>reaction </small>
<b><small>EXAMPLE </small></b>
<small>Vasovagal syncope in an </small>
<small>adolescent following vaccination. </small>
<small>5 </small>
<small>Coincidental event </small>
<b><small>EXAMPLE </small></b>
<small>A fever after vaccination </small>
<small>(temporal association) and malarial </small>
<small>parasite isolated from </small>
<small>blood. </small>
<small>1955- IPV- </small>
<small>120,000 injected 40,000 mild polio </small>
<small>200 paralysed 10 died </small>
</div><span class="text_page_counter">Trang 21</span><div class="page_container" data-page="21"><small>A. Consistent causal association to immunization </small>
<small>A1. Vaccine product-related reaction (As per published </small>
<small>insufficient definitive evidence for vaccine causing </small>
<small>event (may be new linked event) </small>
<small>vaccine-C. Inconsistent causal association to immunization </small>
<small>C. Coincidental Underlying or emerging condition(s), or condition(s) </small>
<small>caused by exposure to something other than </small>
<small>vaccine </small>
<small>Unclassifiable </small>
<small>Specify the additional information required for classification </small>
<b><small>Adequate information </small></b>
<b><small>available </small></b>
<b><small>Adequate information not available </small></b>
<small>*B1 : Potential signal and maybe considered for investigation </small>
<small>B2. Qualifying factors result in conflicting trends of consistency and inconsistency </small>
<small>with causal association to immunization </small>
<small>23 </small>
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