I

Republic of the Philippines

Department of Health
OFFICE OF TIIE SECRETARY

FEB 2 g 2016

ADMINISTRATIVE ORDER
No.2016 - 0OO(o

SLIBJECT: Revised Guidelines on Surveillance and Response to Adverse

Events Followins Immunization

BACKGROI.IND AND RATIONALE

In 2010, the Department of Health (DOH) issued Administrative Order (AO) No. 2OlO-
0017 otherwise known as the "Guidelines in Surveillance and Response to Adverse
Events Following Immunization" as part of its commitment to its AEFI
surveillance system and ensure delivery of safe and effective vaccine "nhance
and immunization
services at all levels. The guideline was made and disseminated to guide the concerned
stakeholders on the early detection, reporting, investigation and appiopriate response ro
adverse events following immunization (AEFI). Since then, the Ftritippinei had a
functional AEFI surveillance system. However, inadequate informatiorr and delayed
investigation was still observed in most of the regions reporting serious AEFI cases. This
significantly affected the quality of causality assessment during case review and
classification.

ln2Ol3, the World Health Organization Western Pacific Regional Office (WPRO) issued
-
a revised Immunization Safety Guidelines Manual which consists of additional information
abgut vaccine safety, common/unusual event for old and new vaccines including its rate per
million doses and a new algorithm for AEFI causality assessment. Hence, for furtler
strengthening of the current AEFI surveillance, it is beneficial to adopt it.

In the same year, a group of consultants from WHO were invited to provide technical
expertise and support improvement of the country's AEFI surveillance iystem and assist
thg gguntrf in aligning national guidelines with the WHO's revised immunization safety
guidelines. Together with representatives from Epidemiology Bureau and partner officei,
an Adverse Event Following Immunization (AEFI) Comprehensive National Assessment
was then conducted-

Anchored on the learning and insights from the said AEFI surveillance strengthening
activities in the country and the revised immunization safety surveillance manual, new
protocols have been adopted and concomitant changes to policies and guidelines are
imminent for scale-up and full-implementation. This revision of AO 2010-0017 is herebv
provided to guide implementers at all levels of health care delivery system.

Building l, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila oTrunk Line 651-78fi) Direct Line: 7ll-9501
Fax: 743- I 829o URL: httn://www.doh.gov.ph ; e-mail : [email protected]

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 U. OBJECTIVES

This AO is issued to provide guidelines for concerned stakeholders on the early

detection, reporting, investigation and appropriate response to adverse events following
immunization.
Further, this issuance aims to establish mechanisms for collaboration between and
among Epidemiology Bureau, Food and Drug Administration, Family Health Office and
other stakeholders involved in AEFI surveillance and response.

ilI. SCOPE AI\D COVERAGE

This issuance shall apply to health professionals who are providing all vaccines
administered under the Expanded Program on Immunization (EPI) and other vaccines given
by DOH nationwide. It shall also be applied in all DOH concerned offices and attached
agencies, epidemiology and surveillance units, private and government health facilities
treating AEFI cases, local govemment units and the community involved in the surveillance
and management of AEFIs.
Private sectors and./or medical institutions handling immunization services and
treating AEFI cases from non-DOH vaccines are mandated to report to the Food and Drug
Administration per existing rules and regulations.

IV. DEFINITION OF TERMS

a. Adverse Event Any untoward medical occurrence which follows

Following immunization and which does not necessarily have a causal
Immunization (AEFI) relationship with the usage of the vaccine. The adverse
event may be any unfavorable or unintended sign, abnormal
laboratory finding, symptom or disease.
b. CausalityAssessment A systematic review of data about an AEFI case to
determine the likelihood of a causal association between the
event and the vaccine(s) received.
c. Cluster Two or more cases of the same or similar event related in
time, geography, and/or vaccine administered.
d. Immunization Safety The public health practices and policies dealing with the
various aspects of the correct administration of vaccines,
focusing on minimizing the risk of transmission of disease
with vaccination and maximizing the effectiveness of the
vaccine. The term encompasses the spectrum of events
from proper manufacture to correct administration.
e. Minor AEFIs These are AEFIs that are not included or categorized as
serious AEFIs. These include local adverse events (such as
pain, swelling, redness) and systemic reaction (fever) that
are expected after immunization as part of the immune
response of the vaccine recipient to induce immunity.
f. Pharmacovigilance The science and activities relating to the detection,
assessment, understanding and prevention of adverse
effects or any other possible drug-related problems.

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 g. Philippine lrtegrated The Philippine Integrated Disease Surveillance and
Disease Surveillance Response (PIDSR) in an integrated disease surveillance
and Response system established in compliance to 2005 IHR for early
detection and response to epidemics.
h. Safe injection practice Those public health practices and policies which ensure that
the process of injection carries the minimum of risk,
regardless of the reason for the injection or the product
injected.
Serious AEFI An event that is causing a potential risk to the health/life of
recipient leading to death, life-threatening conditions,
congenital abnormalities/birth defects, disability/incapacity
or hospitalization.
j. Uppsala Monitoring A WHO collaborating center for intemational drug/vaccine
Center monitoring.

V. GENERAL GUIDELINES

1. AEFI Surveillance in the Epidemiology Bureau shall follow the basic principles for
surveillance as stipulated in the implementing guidelines of the Philippine Integrated
Surveillance and Response (PIDSR) system (AO 2007-0036). It shall be encouraged at
all levels for early detection and execution of appropriate measures.
2. AEFI investigation shall follow the standard epidemiological investigation principles.
3. Reported AEFIs in the Epidemiology Bureau shall be submitted to the Food and Drug
Administration for reporting to Uppsala Monitoring Center.
4. The National and Regional AEFI Committees shall be responsible in determining the
final causality assessment of an AEFI case of cluster of AEFIs and will be based on the
World Health Organization (WHO) Causality Assessment of an AEFI, User Manual for
the Revised WHO Classification (March 2013).
5. Response and follow-up activities shall be based on findings of investigations, causality
assessments and recommendations by the investigation team and expert committees.
Preliminary response shall be done at the LGU level and shall include medical treatment,
risk communication and immunization safety interventions.

VI. IMPLEMBNTING GUIDELINES

A. Surveillance
1. Detection and Reporting

Responsibility of Reporting
The following shall be responsible for the detection and/or reporting of
AEFIs:
i. All health professionals providing immunization services and clinical
treatment of AEFIs.
ii. Individuals who received the vaccination can report AEFIs to any
health professional. In cases of minors, parents or guardians can
report the same.
Researchers, sponsors, investigators and research laboratories
involved in clinical studies or field trials that result to AEFIs.

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 iv. Vaccine manufacturers or distributors.

b. Timing and Flow of Reporting

i. All AEFI cases including minor AEFIs such as local reactions, fever
and self-limiting systemic symptoms shall be reported to the next
higher epidemiology and surveillance unit (ESU) level on a weekly
basis using the AEFI Case Report Form (Annex A).
ii. In cases of serious/ cluster of AEFI cases, notification shall be made
to the epidemiology and surveillance unit of the next higher ESU
level and the Epidemiology Bureau within 24-48 hours of case
detection by the fastest means possible. Initial notification can be
verbal using the telephone, text message or via facsimile or email.
This is to notify the next higher level that an in-depth case
investigation is warranted (Annex B).

2. Investigation

a. Once report has been received by the epidemiology and surveillance unit,
an assessment shall be done to determine whether or not an investigation is
needed.
b. Reported AEFIs shall be investigated if it is:
i. A Serious event of known or unknown cause; all hospitalizations
ii. A Cluster of minor AEFIs
iii. Events associated with newly introduced vaccine
iv. Suspected to be caused by immunization error
v. Appears on the list of events defined for AEFI surveillance (Annex
c)
vi. Causing a significant parental or public concern
vii. All AEFIs suspected to be caused by the vaccine
c. AEFI investigations shall be conducted by a team composed of duly
authorized representatives from the following and observe respective roles
during investigation:
i. Epidemiology and Surveillance Unit (ESU) - conduct epidemiologic
investigation
ii. EPI Coordinator/ Cold Chain Manager - observe safe injection
practice, cold chain management
iii. FDA/ Food and Drug Regulation Officer (FDRO) - observe, inspect
and review compliance to cold chain management, review of vaccine
lot/batch number including diluent. A review of the product file
shall be conducted by the Center for Drug Regulation and Research
when deemed necessary.
iv. Health Promotion Officer shall lead in conducting risk
communication activities during and after investigation
d. AEFI investigations shall be led by the Local Government Unit
(City/Province). The regional office shall provide technical assistance as
needed bv the LGU.
e. Complete investigation and initial response activities shall be conducted
within 48 hours upon reporting of a serious AEFI. The AEFI Case
Investigation Form (Annex D) shall be used in the investigation of cases.
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 f. The investigators shall look directly at the suspected reaction as well as
gather information from the patient/parent, health workers and supervisors,
and community members. In addition, investigation of the vaccine(s),
immunization techniques and procedures, and service in action shall be
conducted.
g The investigating team shall also be allowed to access medical records of
the case and photocopy records as needed to support the investigation.
h. Laboratory testing of vaccines and./or human samples may be done only on
a clear suspicion and not as routine and never before the working
hypothesis.
In case of laboratory testing of suspected vaccines, the cost of the
laboratory test(s) shall be borne by the FDA-Marketing Authorizatron
Holder (MAH) or the DOH in case of WHO-assisted purchased vaccines
under the EPI and shall be paid directly to the laboratory.
J. The completed CIF together with all supporting documents shall be
submitted within 48 hours or immediately after completion of
investigation to the RESU for initial causality assessment by the Regional
AEFI Committee (RAEFIC).

3. Data Management

a. Epidemiology Bureau shall consolidate all AEFI reports submitted (serious

and minor) on a monthly basis and shall submit it to Food and Drug
Administration (FDA).
b. The PIDSR system shall be utilized to maintain a database (paper-based or
electronic) of AEFIs that is easily accessible to all reporting units.
c. Data analysis shall be carried out at different levels in the surveillance
system. Epidemiology and Surveillance Units of the different levels shall
lead the epidemiological analysis.
d. Corresponding EPI managers and FDA staff shall coordinate with the
ESUs and provide additional information (e.g. number of children
immunized, status of vaccine pre-qualification, international rates, etc.)
that will make the analysis more comprehensive.

4. Feedback

a. There shall be a regular (at least quarterly) and timely feedback within and
between all levels of the health delivery system (national, regional,
province, city) including data on investigation results, classification of
cases and data analysis among others.

B. Response

1. Case Management

a. Prompt treatment shall be the first response to an AEFI. Treatment may

vary depending on the signs and symptoms of the AEFI case.
b. If the AEFI is due to vaccine related-reaction occurring at a higher reaction
rate than expected from a specific vaccine or lot, the Secretary of Health

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 or FDA Director General can suspend corresponding immunization
activity and declare product recall and advisory.
c. If the AEFI is due to immunization errors, actions shall mainly focus in
correcting the case of the error and review at a later date that the
immunization errors have been corrected.
d. If the AEFI is coincidental, the priority action shall focus on developing
and implementing risk communication plan directed to the affected family
and the general public.

2. Program Support

a. The EPI program managers in their corresponding levels shall take the
lead to provide corrective actions and monitor outcomes of response
interventions.
b. LGUs shall immediately implement corrective actions based on the
preliminary investigation findings and causality assessment of the
Regional AEFI committees and implement all other measures
recommended by RAEFIC and./or NAEFIC.

C. Causality Assessment

1. A Regional AEFI Committee shall be established andsuggested to be composed

of the following:
a. 4ClinicalExperts(medicine/infectiousdisease/pediatrics)
b. Researchspecialist(academe),pharmaco-epidemiologist
c. Regional Director or Assistance Regional Director (observer)
d. Regional Food and Drug Authority (observers)
e. EPI Program Manager and cold chain manager (observer)
f. RESU head/staff (secretariat)
2. The Regional AEFI Committee shall conduct preliminary causality assessment as
soon as possible upon receipt of the AEFI case investigation reports. The
RAEFIC may require conduct of additional investigation.
3. The investigation team may offer a "first opinion" on the causality of a particular
AEFI or cluster of AEFIs. The first opinion can be derived from the result of the
investigation done by the team in collaboration with key stakeholders at the
regional and sub-regional levels.
4, AEFI investigations that have not reached conclusions and cases that are not
classified by the RAEFIC shall be presented to the National AEFI Committee
(NAEFIC) for final causality and provision of recommendations.
5. The minimum document requirement to facilitate an evidence-based causality
assessment are as follows:
a. Completed Case Investigation Form (Annex C)
b. A "valid diagnosis" for the unfavorable or unintended sign, abnormal
laboratory finding, symptom or disease in question
c. Hospital Records / Medical Charts lLaboratory Results
d. Preliminary Investigation Report / IMRAD
e. Death Certificate / Autopsy Report (for cases of deaths)
6. The expert committee may ask for additional supporting evidences as needed to
provide a final causality assessment.

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D. Assistance to AEFI cases

l. The LGU shall ensure that serious AEFI cases are provided with immediate
assistance which may include hospitalization and transport to medical facility.
2. The LGU shall collaborate with the Regional Offices to discuss appropriate
assistance to the patient. The LGU shall provide to the extent possible any
immediate assistance to serious AEFI cases.
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J. An autopsy shall be preferred and recommended following all deaths suspected to
cause by vaccine / immunization. The DOH shall provide the necessary
assistance to find or coordinate with an appropriate agencylfacility for autopsy
upon approval of consent.
4. Patients with serious AEFI shall be managed at a DOH retained and other
government hospitals for free. If medical services, diagnostics or laboratory
capacities needed by an AEFI case are not available in a public facility, the patient
shall be referred to a private health facility. Hospital expenses incurred shall be
shouldered by the LGU or the DOH. If the patient opts to be confined at a private
health facility, hospital expenses shall be shouldered by the patient themselves.

E. Assistance to health worker

I. Concerned public health professionals shall not be held liable for any AEFI as
long as DOH standard operating procedures on immunizatron safety practices are
complied and with proper assessment by National AEFI Committee.
2. DOH Legal Service shall collaborate with the Public Attorney's Office
(PAO)/Office of the Solicitor General (OSG)/Integrated Bar of the Philippines
(IBP) /Law Schools/volunteer lawyers in providing appropriate legal assistance
to public health professionals as necessary if any case is filed against them for
acts committed in the performance of their duty and in good faith.
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J. Local police force may provide assistance to any health worker/s for any threats
received.
4. In case of physical injury, the health worker shall be provided with free medical
assistance in DOH-retained and other government hospitals. In case of referral to
a private hospital is required, the expenses incurred shall be reimbursed by the
LGU or DOH.
5. As mandated by E.O. 663 and A.O. No 2007-0028, the concerned health
worker/s shall be given due process for any administrative, civil or criminal
sanctions filed against him/her. In addition, assistance shall be given to the
concerned health workers by LGU for any expenses incurred in the conduct of
this activity.

F. Risk Communication

L Risk communication for AEFI shall be the responsibility of the health sector at
all levels particularly the health promotion officers.
2. Risk communication shall be comprehensive to cover the following target
audiences: family, community, general public, media, and health workers.
3. A11 media coverage on AEFI shall be coursed through the OSEC-Media
Relations Unit (MRU) at the national level and HEPO-PIO (Health Education
Promotion Office - Public Information Offrce) at the regional level. The OSEC-
MRU and the Regional HEPO-PIO shall refer those concerns to the appropriate
offrces.
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 4. Press releases shall be done when the AEFI incident has been publicized (by
local, national or intemational media). Other AEFI incidents that had been
investigated and resolved may not necessarily require press releases as
determined by the MHO or Local Chief Executives (LCE).
5. At the city/provincial level, the LCE, or his duly designated official, shall be the
spokesperson for inquiries related to AEFI. The MHO/CHO, in consultation with
the regional AEFI committee, shall provide technical inputs to the LCE.
6. The health promotion officer, in coordination with the program coordinators shall
formulate a health communication plan pertaining to AEFI and prepare key
messages for advisories and press releases.
7. At the regional level, the Regional Director shall convene a meeting with the
concemed LGU for synchronous press releases.
8. At the national level, the Secretary of Health or his duly designated official shall
act as the spokesperson for national matters related to AEFI.
9. The DOH through the Health Promotion and Communications Service (HPCS) in
coordination with the Family Health Office (FHO), Epidemiology Bureau and
Food and Drug Administration (FDA) shall prepare risk communication plan and
key messages for advisories.
10. The MRU shall prepare and disseminate press releases and facilitate press
conferences.
11. Upon clearance by the Secretary of Health, the Epidemiology Bureau, being the
International Health Regulation (IHR) focal point, shall notify the WHO and
other concerned intemational organizations of the serious AEFI incidents and the
response taken. Likewise, FDA as the National Regulatory Authority (NRA)
shall notify international partners.

G. Post Incident Evaluation (PIE)

1. The Chair of the Regional AEFI Committee (RAEFIC) shall facilitate the
conduct of post incident evaluation for all serious AEFIs. This shall be attended
by the members of the regional AEFI committee, provincial, citylmunicipal EPI
coordinators, PHO, MHO/CHO, surveillance staff, and DOH representatives.
2. The focus of the PIE shall include critical examination on the elements of the
AEFI surveillance and response and come up with recommendations to improve
AEFI surveillance and response and the immunization program.
3. The National AEFI Committee and the LGU concemed shall be given feedback
of the PIE results.

H. Monitoring and Evaluation

1. The role of monitoring is delegated to all government health units at all levels. It
shall be done by person/s knowledgeable with AEFI surveillance and safe
immunization practices who can easily track discrepancies and give immediate
action to it. Hence, epidemiologist, DSO/DSCs, EPI coordinators and
FDA/FDRO shall be responsible of the monitoring system.
2. The surveillance system shall be monitored and evaluated regularly (at least
annually) based on the following criteria:
a. The data reported by the AEFI surveillance system (reporting rate, number
of adverse reactions reported)
b. Timeliness, completeness and accuracy of AEFI reporting
c. Timeliness, completeness of investigations
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 d. Audit of corrective action

VII. ROLES AI\D RESPONSIBILITIES

A. National Immunization Committee (NIC) shall:

1. Provide direction and technical support on policies and plans pertaining to the
immunization program as prescribed in Department Personnel Order No. 2007-
0323.

B. Regional Adverse Events Following Immunization Committee (RAEFIC) shall:

1. Deliberate preliminary causality assessment upon receipt of complete AEFI case

investigation reports from the provinciaVregional investigating team. The
committee should convene at least quarterly or as need arise.
2. Provide immediate written report regarding the deliberated preliminary
assessment to EB and concemed LGU, copy furnish FHO and FDA.
3. Provide information of the final causality assessment and recommendations to the
Regional Offices/PHO/CHO and concerned LGU.
4. Monitor implementation of the recommendations by the responsible
program/offices.

C. National Adverse Events Following Immunization Committee (NAEFIC) shalt:

1. Review all reported serious and cluster of AEFI cases presented for expert
opinion on a quarterly basis or as the need arise, and provide a final causality
assessment of the AEFI cases as well as the cases that were not classified by the
Regional AEFI Committee.
2. Ensure evidence-based causality assessment by recommending further
investigation and data collection as needed.
J. Make final decisions on causality assessment of inconclusive investigations.
4. Ensure standard protocols for AEFI surveillance and investigation are correctly
followed.
5. Engage with other national and international experts when requirements arise in
establishing causality and vaccine quality issues.
6. Provide recommendations to the EPI Program, Epidemiology Bureau and
National Cold Chain Manager on improving immunization service delivery,
compliance with injection safety and effective vaccine management, etc. based
on lessons from the AEFI cases.
7. Serve as technical advisory group to the Secretary of Health and the FDA on
vaccine and immunization safety-related issue of highest consideration such as
immediate recall of vaccine from NIP and"/or market or temporary/permanent
withdrawal of a vaccine from the immunization program.
8. Serve as resource person in other AEFI related meetings, conferences or capacity
building activities as requested.

D. Family Health Oflice shall:

1. Modify EPI program policies and programs based on NAEFIC

recommendations.
2. Coordinate with Epidemiology Bureau for any reported AEFI cases.
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J. Provide the Epidemiology Bureau of the data necessary for analysis (i.e. vaccine
doses administered/ doses used / doses distributed).
4. Provide technical assistance during AEFI investigation and immunization
program reviews at all levels.
5. Provide technical assistance for corrective actions and improving quality of
immunization service.
6. EPI program managers together with the FDA in their corresponding levels shall
take the lead to provide corrective actions and monitor outcomes of response
interventions.

E. Epidemiology Bureau (EB) shall:

1. Oversee the design and implementation of the National AEFI surveillance

system.
2. Lead in the conduct of case investigation and comprehensive data analysis.
3. Provide technical assistance or training to develop/enhance capacity of
regionaUlocal AEFI surveillance.
4. Convene meetings of and serves as secretariat for the NAEFIC (quarterly).
5. Provide AEFI surveillance information to all stakeholders for policy and
program use.
6. Coordinate AEFI surveillance activities with EPI and FDA both at the national
and regional levels.
7. Maintain database of all reported AEFIs and submits database to FDA within
the prescribed timeline.

F. Health Promotion and Communications Service GPCS) shall:

1. Develop and oversee the implementation of the national AEFI risk

communication plan.
2. Support sub-national levels in developing and implementing their respective risk
communication plans including monitoring and evaluation tools.
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J. Monitor and evaluate implementation of risk communication plan at all levels
and provide feedback to all stakeholders.

G. Media Relations Unit (MRU) shall:

1. Coordinate with FIPCS, Epidemiology Bureau, FDA and FHO in preparing and
developing key messages for advisories and press statement.
2. Facilitate in the dissemination of press releases.
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J. Facilitate in the preparation and conduct of press conference.

H. Food and Drug Administration (FDA) shall:

l. Communicate international vaccine safety signals and all serious AEFIs reported
through the Pharmacovigilance Unit to Epidemiology Bureau, FHO and other
stakeholders.
2. Provide the Epidemiology Bureau, Epidemiology and Surveillance Unit
counterparts and EPI Program of the data necessary for analysis (i.e. status of
vaccine pre-qualification, intemational rates, etc.).

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 3. Conduct collection of samples of implicated vaccine and facilitates laboratory
testing by a WHO-recognized National Control Laboratory.
4. Implement regulatory action/s and issues timely advisory to the public on
serious AEFI implicated vaccine.
5. Inspect warehouse and storage areas (cold chain facilities and equipments) of
vaccines under EPI at all levels.
6. The FDA being the National Regulation Authority shall submit reports to the
Uppsala Monitoring Centre.

I. Regional Offices shall:

1. Provide technical assistance (e.g. training, advocacy activities), logistics to local

AEFI investigations and response.
2. Establish a functional Regional AEFI Committee (RAEFIC).
3. RESU shall organize an AEFI investigation team (s) when needed and take the
lead in the investigation.
4. Regional EPI program managers in their corresponding levels together with the
FDRO shall be involved in the investigation and take the lead to provide
corrective actions and monitor outcomes of response interventions.
5. Regional EPI program managers and FDRO shall provide the RESU of the data
necessary for analysis (i.e. vaccine doses administered/ doses used / doses
distributed, status of vaccine pre-qualification).
6. Develop, implement and monitor regional risk communication plan through the
Regional HEPO/PIO, and provide technical assistance in the development of the
LGU risk communication plan.
7. The regional office shall track and monitor the compliance of public and private
hospitals in the implementation of PIDSR and AEFI surveillance as part of the
requirements for renewals of license to operate. The regional director shall issue
a regional order to enforce compliance. The team shall inform the Regional
Offices /PHOs/LGUs of activities taken against non-complying
ho spital/institutions.

J. ProvinciaV City/ Municipal Health Offices shall:

l. Provide timely feedback to the Local Chief Executives (governor/city mayor).

2. Provide assistance to the health worker in the form of technical, legal, social,
frnancial assistance among others.
3. Report hospitals and related facilities that fail to comply with the PIDSR
reporting requirements to the Regional Offices.
4. Conduct investigation of reported serious and clusters of minor AEFIs within 48
hours and submits report to next higher level.
5. Designate representatives to AEFI investigation team or during RAEFIC case
review.
6. Provide or coordinate with other agencies in the provision of assistance to
patients with serious AEFIs.
. 7 Submit and maintain database of all reported AEFI cases.
8. Analyze, interpret and communicate AEFI data.
9. Develop and implement local risk communication plan and strategies.

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 K. Barangay shall:

1. Shall detect and report AEFIs to next higher level.

2. The midwife/nurse assigned in the area shall institute initial case management
and refer to the MHO/CHO.
3. The barangay council shall provide support to the AEFI case including but not
limited to transportation, medicines, hospital referral, communication to family
and communities.

L. Hospitals shall:

1. Detect and report all AEFI cases to Epidemiology and Surveillance units.
2. Clinically manage AEFI cases.
3. Facilitate case investigation and specimen collection as needed.
4. Provide access of AEFI investisation teams to medical records of AEFI cases.

VI[. REPEALING CLAUSE

Provisions of AO 20I0-0Ul and other related issuances that are inconsistent or

contrary to the provisions of this Order are hereby rescinded or modified accordingly.

IX. EFFECTIVITY

This Order shall take effect immediately with a one year transition period.

JANETTE MD. MBA-H

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Annex A. AEFI Case Report Form

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 Annex B. ABFI Surveillance FIow

Philippine lntegrated Disease Surveillance and Response (EBf Pharmacwigilance IFDA]

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I All AEFI ca*s (serious and minor) are deteded by
Heahh heahh care providers, vacinators and personnel
Cases of A[Fls from private
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Facility clinicq hospitalq marketi ng
from the field.
s authorization holders,
r Casesare registered irto an AEFI Cese Rcpfrt
T distributors, clinical research
RHU Ffim (Farill ), encoded into the database and
t ert to the nott higher level on a weekly basis
organizationt patienty'
consumerc are reported to
E
Health . For serious AEFIs and clus{ers of minor AEFts,
the FDA usingthe presribed
v Center the nort higher level is immediately notified
form, network or system.
E within 2448 hours to inform that the case
t needs in-depth investi gation.

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r An inrtestigtion team is npbilized and conducts an
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in- FDROs inform the RESU for
c depth case investigation using the AEFI Crro lnucld- serious AEFIs and cluster of
o PESU grtlon Form (Forn 2l.

I
minor AEFIS that needs
N investigation using the AEFI
D AEF|database of sedqrs AEFIcases are ufrated with new
CESU Csr€ R€port Fqm, joins the
infurmation gathercd in the investigation.
t investigationteam and
E RESU foruards investigation
Resuhs of investigtion as well as supporting dootnents
v are compiled by the RESU for initbl causality aseess-
reports to the

E
Pharmacovogilance Unit.
ment bythe RegbnalAEF| Committee (MEFrcl.
t
\ -l
* {1"
T
H EB consolidates all AEFIs submitted {serious and mi-
I nor) monthly and coshares databae to FDA.
R FDA evaluates all reported
EB convenesthe National AEFI Commitee (NAEFIC) for AEFls, cond ucts appropriate
D
causality asessment of serious AEFI cases not regulatory actions, submits
t reports to the Uppsala
deliberated by the RAEFIC.
E
Monitoring centre and
v AEFI surveillance updates are disseminated among shares data with EB.

E stakeholders (i.e. EPI Program, FDA, Regions)

t

&\ to

f 'cv
Annex C. Adverse Events and Treatments

Adverse event Case definition Treatment* Vaccines

Acute flaccid Acute onset of flaccid No specific OPV

paralysis paralysis within 4 to 30 days treatment available;
(Vaccine of receipt of oral poliovirus supportive care.
associated vaccine (OPV), or within 4 to
paralytic 75 days after contact with a
poliomyelitis) vaccine recipient and
neurological deficits
remaining 60 days after onset,
or death.

Anaphylactoid Exaggerated acute allergic Self-limiting; anti- All

reaction (acute reaction, occurring within 2 histamines may be
hypersensitivity hours after immunization, helpful.
reaction) characterized by one or more
of the following:
. wheezing and shortness of
breath due to
bronchospasm
I one or more skin
manifestations, e. g. hives,
facial oedema, or
generalized oedema. Less
severe allergic reactions
do not need to be
reported.
. laryngospasm/laryngeal
oedema

Anaphylaxis Severe immediate (within 1 Epinephrine Ail

hour) allergic reaction leading
to circulatory failure with or
without bronchospasm and/or
laryngosp asm/laryngeal
oedem

Arthralgia Joint pain usually including Self-limiting; Rubella,

the small peripheral joints. analgesics MMR
Persistent if lasting longer
than 10 days, transient: if
lasting up to l0 days.

&v s/
vN
Brachial neuritis Dysfunction of nerves Symptomatic only; Tetanus
supplying the arm/shoulder analgesics.
without other involvement of
nervous system. A deep
steady, often severe aching
pain in the shoulder and
upper arm followed in days or
weakness by weakness and
wasting in armlshoulder
muscles. Sensory loss may be
present, but is less prominent.
May present on the same or
the opposite side to the
injection and sometimes
affects both arms.

Disseminated Widespread infection Should be treated BCG

BCG infections occurring within I to 12 with anti-
months after BCG tuberculous
vaccination and confirmed by regimens including
isolation of Mycobacterium isoniazid and
bovis BCG strain. Usually in rifampicin.
immunocompromised
individuals.

Encephalopathy Acute onset of major illness No specific Measles,

characterized by any two of treatment available; Pertussis
the following three supportive care.
conditions:
. seizures
! severe alteration in level of
consciousness lasting for
one day or more
. distinct change in behaviour
lasting one day or more.
Needs to occur within 48
hours of DTP vaccine or from
7 to 12 days after measles or
MMR vaccine. to be related
to immunization.

Fever The fever can be classified Symptomatic; All

(based on rectal temperature) Paracetamol.
as mild (38 to 38.9oC), high
(39 to 40.4"C) and extreme
(40.5'C or higher). Fever on
its own does not need to be
reported.

o''fut
 Hypotonic, Event of sudden onset The episode is Mainly
hyporesponsive occurring within 48 [usually transient and self- DTP, rarely
episode (HIIE or less than 121 hours of limiting, and does others
shock-collapse) vaccination and lasting from not require specific
one minute to several hours. treatment. It is not a
in children younger than 10 contraindication to
years of age. All of the further doses of the
following must be present: vaccine.
.limpness (hypotonic)
. reduced responsiveness
(hyporesponsive)
. pallor or cyanosis or
-
failure to observe/ recall

Injection site Fluctuant or draining fluid- Incise and drain; All

abscess filled lesion at the site of antibiotics if
injection. Bacterial if bacterial.
evidence of infection (e.g.
purulent, infl ammatory signs,
fever, culture), sterile abscess
if not.

Lymphadenitis Either at least one lymph Heals spontaneously BCG

(includes nodes enlarged to >1.5 cm in (over months) and
suppurative size (one adult finger width) best not to treat
lymphadenitis) or a draining sinus over a unless lesion is
lymph node. Almost sticking to skin. If
exclusively caused by BCG so, or already
and then occurring within 2 to draining, surgical
6 months after receipt of drainage and local
BCG vaccine, on the same instillation of anti-
side as inoculation (mostly tuberculous drug.
axillary). Systemic treatment
with anti-
tuberculous drugs is
ineffective
OsteitiV Inflammation of the bone Should be treated BCG
Osteomyelitis with isolation of with anti-
Mycobacterium bovis BCG tuberculous
strain. regimens including
isoniazid and
rifampicin.
Persistent Inconsolable continuous Settles within a day DTP,
inconsolable crying lasting 3 hours or or so; analgesics Pertussis
screaming longer accompanied by high- may help.
pitched screaming.

"*t
 Seizures Occurrence of generalized Self-limiting; All,
convulsions that are not supportive care; especially
accompanied by focal paracetamol and Pertussis,
neurological signs or cooling if febrile; Measles
symptoms. Febrile seizures: rarely
if temperature elevated anticonvulsants.
>38oC (rectal) Afebrile
seizures: if temperature
normal

Sepsis Acute onset of severe Critical to recognize All

generalized illness due to and treat early.
bacterial infection and Urgent transfer to
confirmed (if possible) by hospital for
positive blood culture. Needs parenteral
to be reported as possible antibiotics and
indicator of program effor. fluids.

Severe local Redness and./or swelling Settles All

reaction centred at the site of injection spontaneously
and one or more of the within a few days to
following: a week.
. swelling beyond the nearest Symptomatic
joint treatment with
. pain, redness, and swelling analgesics.
of more than 3 days Antibiotics are
duration inappropriate.
. requires hospitalization.
Local reactions of lesser
intensity occur commonly
and are trivial and do not
need to be reported.

Thrombo- Serum platelet count of less Usually mild and MMR

cytopenia than 50,000/ml leading to self-limiting;
bruising and/or bleeding occasionally may
need steroid or
platelets.
Toxic shock Abrupt onset of fever, Critical to recognize All
syndrome (TSS) vomiting and watery and treat early.
diarrhoea within a few hours Urgent transfer to
of immunization. Often hospital for
leading to death within 24 to parenteral
48 hours. Needs to be antibiotics and
reported as possible indicator fluids.
of program effor.

T,(,'
Annex D. AEFI Case Investigation Form

ffi trf '

tfiffiff.,ffilir.....
(onrv rorsedo,. orr?-T:*Llx':*ifl?lL:lJ':]f"usrerorMinorAEF,) FE}Ar,
V.rrl.n 2016
Surr.llhnca rnd Rarponr.
trRHU trCHO trGoVt Hospital trPri\€te Hospit€l trClinic
trGo/t Laboratory trPri to Laboratory trArporVSeaport

tr Yss O No E Unknown

Surpcct.d
Yrcclncfu
(PheirdtdteGcHt
andAre'dtl€ffi)

Vacci n6t on Centor/Facility

vaccinationSession: El Routnesession tr clinic E Masscampaign tr school-based tr otrers,

(acute hyporsensiti vity reaction)

o Febrile o Afebrile
tr Anaphylaxis tr Soosis
tr Brachial neuritis tr Se\€re local reaction
tr Diss€minated BCG inf€cton o Pain, redness and/or swelling of > 3 days
tr Encephalopathy
o Swelling beyond the nearestjoint
tr Hypotonic-Hyporesponsivs Episode (HHE)
O Injection site abscess
tr Thrombocytopenia

El Intussusceotion
tr Toxic Shock Syndrome
E Others (specify)
tr Lymphadsnitis
tr Osteitis/ Osteomyelitis
ft Persistent ( > 3hours) inconsolable crying

Case Dellnloon:
o Adverse eventfollowtrg lmrrnlzdon is defined as any untoivard medbal occunence wtrich follows irmunization and
wttich does not necessarily have a causal rclationship with the usage of the vaccine. The adwrse erant may be any unfir-
vourable or unintended sign, abnormal laboratory finding, symptomor disaase.
 Vcrslon 20'15
AEFI Gasc Inves{lgation Form
IV. E)(AMilATIOIFtrETAILs
Source of Inftrmation E Attending physicaan E Nurse EI Midwfe E ParenUGuardian tr Other
Mode of examinaton E Interview E lMedical records E Physical Examination E Verbal autopsy E Laboratory Result
E other
lf fi'om Verbal autopsy, please mention the source:

Name & Designation of person who first examinod the patient: Date & time:

Slgrc & Symptoms |n Cfrmobglcd Order:

"lnetructlonr -Attach copl.s ofALL avallablc docum.nG (lncludlng cas. sheet, dlscharge summary, cas. not63t lrb rnd autopsy repofts) and
th.n complrtr .ddltlond Informrtlon NOT AVAILAELE In .xlrdng docum.nts.
ff pat1€.nt hst mdicd care- (lncluding case sheet, discharge sunmary, l.bo'alp.ry rcpo,ts and port
'''ken &fuddocun ents betaiit.
If palient has nottak6n mor belw\i (use additional sheets if necessary)

Working/Final Diagnosis:

condltlon at Invcstlgatlon: E Alive : oRecovering o Fully racovered oWith Permanent Disability. Speciv. __
f Died. Date: I t
v. Relevilt patent Inioflmoon prltr to lmnrtrtlzatm YE8't|O Remrlre
History of allergy

Pre-existing illness / congenital disorder

History of hospitalization in last 30 days (indicate the cause)

Recent history of tsauma (indicats date, time and site)

For adult women
r Currendy pregnant? (lf YES, indicate AOG)
r Currendy breastfeeding?

For infants
r Natal History tr Full term tr Premalure tr Po$dated
r Delivery tr Normal tr Caesarian Seclion tr Assisted birth
tr Any compllcatlon, speclfy
Was the patient on any concurrent medication fur any illness?
(lf YES. indicate name of drug, indication, doses & date in the remarks)

Family History of similar event

Didthepatientreceiveanyprevrousvaccinationanderperiencedthesimilarevent?ENO trYES(lf YEs,completethetablebelow)

Date'of 'lims of Batch/ Namq of

Vrcclnt Vaccination Expiry Date Name of Vaccinator
Vaccination Lot No ManuJacirrgr

o'w/
 Version 2016
AEFI Gase Invcstigation Form
lv. lttl[vlut{lzATloil PRAcTlcEs
(Ftll up thls secilin by asflng aN obsedng tmnunhadon ygcilces 4 the N*e (s) vfierc corcemed vecc/re wes u.leo

S!,ringes and Needles Used YESNO/NAN Remarks

Are auto-disable syringes used for immunization?

ItNO,specitythetype: trGlass trDisposable trRecycleddisposable trPre-filledsyringes tr Other ________

Specific key findinqs/additional observations and comments:

Recotrtltutlon procedure (compleE only if applicable) * Not applicable

Same reconstihrtion syinge used br multiple vials of same vaccine?

Same reconstitution syinge used br reconstituting different vaccines?

Separate reconstitution syringe fur each vaccine vial?

Separats reconstitution syinge for each vaccination?

Are the vaccines and diluents used as recomnpnded by the manufacturer

Specifi c key fi ndings/additional observations and comments :

Injectlon technlque of vacclnator (s): (Observe anotlrer session in the same locality -same or difurent place)
Correct dose and route?
Time of reconstitution mentioned on the vial (in case of freeze dried vaccines)?
Non-touch technique followed?

Contraindication screened prior to vaccination?

How marry AEFI reporled from lhe cenler lhal distrlbuted the vacclne in the lasl 30 days?

Training received by the vaccinator: (Title) lf YES, spocifydeteof lesttraining

Specific key fi ndings/radditional observations and comments:

V. COf-O CHrUN Al{D TRANSPORT (Flll up thk seltton by es@ end &servtng pncfrn)
Last vaccine storage polnt: YES'NO Remarks
Type of vaccine storage: EFreezer tr Refrigerator tr Dry Store tr Other, specifu:
Temperature: Body of refrigerator ______ oC Freezer: ______ oC

Correct procedure of sbring vaccines, diluents and syringes fullovved?

Any other ltem (other than \raccines and diluenls) in the refrigeralor or freezer?

Partially used reconstituted vaccines in the refrigerator?

Unusable vaccinss in the refrigerator?
lf YES, check alllhat apply: tr expired tr no label tr VVM Stage 3/4 tr Frozen
Unusable diluents in the storage area?
lf YES, check allthat apply: tr explred E manulacturer not matched E cracked tr dlrly ampule

Specific kev findings/additional observations and comments:

Vacc ine transpodation:

Vaccine carrier used: O Polyurethane Foam Insulaton tr Insulated Plasbc Contarner tr Styrofoam tr Other, specify
Vaccine carrier sent to the site on the same day of vaceination?
Vaccindion carrier returned fiom the site on the same day of vaccination?
Condition of Ure vaccine carier: Was ice-pack used?
Specific key findings/additional observations and comments:

vv Lt /
 Yergion 2015
lEFl Gasc Investlgctlon Folm
Vl' VACCINE DETALS (lndicate rraccines provided at the site linked to AEF| on the coresponding day)
Number of reclplents im- Vaccinc
munized for €ach antigon Namc
at lhe sesslon slte. Altach
Total Docec
rocord (s) if available
Givcn

NOTE: Provlde explanatlon for eact YES answers on the following: YES/NO/#
a) When yyas the patient immunized? (ri* box betow)

trWithinthefirstvaccinationsolthesession trWithinthelastvaccinationsofthesession trUnknown

trWlthinthetirstfewdosesofthevlal admlnisteredtr Withinthelastdosesofthevial administered trUnknown
b) Was the rEcommendation br use of this vaccine not followed?

c) Based on tre investigation, does the vaccine (ingredbnts) administered could have been unsterile?

d) Based on the investigation, does the vaccine's physical condition (e.g. color, turbidity, foreign substances etc) was
abnormal at the time of administration?

e) Based on the investigation was there an error in vaccine reconstitution/preparation by the vaccinator (e.g., wrong
product, wrong diluent, improper mixing, improper syringe filling etc.)?

f) Based on the investigation, was there an error in vaccine handling? (e.g. Break in cold chain during transport,
storage and/or immunization session etc.)?

g) Based on the investigation, was the vaccine administered incorrectly (e.g. wrong dose, site or route of
adminisbation, vwong needle size, not folbwing good injection practice eb.)?

h) Number of OTHER recipients immunized from the conccrned vaccine vial/ampule

r) Number of OTHER rccipients immunized with the concemed vaccine in the same session:
Number of OTHER recipients immunized with the concerned vaccine having the same bdch number in other
locations: Speciff locations:
k) ls this case a pat of a clustef
lf yee, how many other cases have been detected in the cluster?

a. Did all the cases in the cluster receive vaccine from the same vial?

b. lf No, Number of vials used in the cluster (enter details separately)

vil. cottilutuNtw tNvEsncATtoN
Any known similar events reported recently in the locality/community? tr yES tr No n UNK
a. lf YES, Describe:

b. How many events/episodes?

Of those aftcbd, how marry are: Vaccinated _ Not vaccinated E Unknown

Other significant findings in the community

CAUSALITYASSESSYIEi]T tr NAEFIC tr RAEFIC Date Classified:

tr [41] Vacine prodmt-related reaction tr [44] mmunization anxiety- related reaction
|

tr [A2l Vaccine quality defect-related reaction tr [Bl] Consistent temporal relationship but insufficient
tr [A3] lmmunization error-related reaction evidence

E error in vaccine handling tr [82] Conflicting tsends of consisbncy and

inconsistency with causality
E error in'.raccine prescribing or no*aherence to tr [C'l] Co-incidental - Underlying emeqing condition (s)
recommendations for use or exposure to e)dernd factors/something
El error in administration other han uaccine
tr Other, speciff tr ID] Unclassifi able/l nadequate information

*t* /