Policy mandates and purposes
- AEFI surveillance and management are guided by Administrative Order No. 2007-0036 (PIDSR Framework, Implementing Guidelines) which includes AEFIs as an immediately notifiable disease/syndrome or event under the Philippine Integrated Disease Surveillance and Response (PIDSR) system.
- AEFI reporting and related support are further anchored on Administrative Order No. 2007-0028, which implements the national commitment on “Bakuna ang Una sa Sanggol at Ina” and provides mechanisms for reporting, treatment of AEFIs, and legal assistance for health workers.
- A patient-safety mandate is also followed through Administrative Order No. 0023 series of 2008, which calls for prevention of harm to patients through prevention, avoidance, and amelioration of risk, adverse outcomes, or injuries stemming from the health care process.
- The Order aims to guide stakeholders on the early detection and appropriate and quick response to adverse events following immunization.
Coverage, scope, and applicability
- The Order applies to health professionals from the public and private sectors providing vaccination nationwide.
- The Order applies to DOH concerned offices and attached agencies, epidemiology and surveillance units, private and government health facilities, local government units, and the community involved in AEFI surveillance and management.
- The Order covers all vaccines administered under the Expanded Program on Immunization (EPI) program.
- The Order also covers other vaccines given by DOH.
- The Order requires AEFI surveillance and response obligations across facilities and levels participating in vaccination and reporting.
Core definitions and classification
- An Adverse event following immunization (AEFI) is a medical incident after immunization that causes concern and is believed to be caused by immunization.
- An AEFI Table is a list of AEFIs/conditions and time frames after vaccine administration used as a tool for presumption of causation for all vaccines.
- Causation-in-fact is a standard of proof based on factual determination that a vaccine actually caused an injury or death.
- A Cluster is two or more cases of the same or similar event related in time, geography, and/or vaccine administered.
- A Coincidental adverse event is a medical event that would have occurred whether or not immunization was received before the event.
- A Disease Reporting Unit (DRU) is any health facility where cases of notifiable diseases are identified and reported (e.g., hospitals, clinics, municipal health offices, city health offices, barangay health stations, community, and quarantine stations).
- A Disease Surveillance Coordinator (DSC) is designated trained staff of government and non-government health facilities (e.g., hospitals, clinics, RHUs) designated as disease surveillance coordinator by the head of the facility.
- Immunization safety covers public health practices and policies on correct vaccination administration to minimize risk of disease transmission with injection and maximize vaccine effectiveness, spanning from proper manufacture to correct administration.
- Immunization safety surveillance is a system to ensure immunization safety through detecting, reporting, investigating, and responding to AEFIs.
- An Injection Reaction is an event from anxiety about vaccination or pain from the injection itself rather than the vaccine.
- Minor AEFIs are AEFIs not included or categorized as serious AEFIs.
- Pharmacovigilance is the science and activities relating to detection, assessment, understanding, and prevention of adverse events and other possible drug-related problems.
- A Program-related AEFI or program error is a medical incident caused by error in transportation, storage, handling, or administration of vaccine.
- Safe injection practice ensures injection carries minimum risk, regardless of the reason for the injection or product injected.
- Serious AEFIs are life-threatening AEFIs and those resulting in hospitalization (or prolonged hospitalization), disability (or potential to result in disability), or death.
- A Vaccine reaction is an event caused or precipitated by the active component or another vaccine component due to inherent vaccine properties.
AEFI surveillance: detection and reporting
- All serious AEFIs or unusual events believed caused by immunization must be reported to the Immunization Safety Board (ISB) through the National Epidemiology Center (NEC) as secretariat.
- Minor AEFIs must be documented and reported to the Rural Health Unit (RHU) using the AEFI form.
- Clustering of minor AEFI cases must be reported to the ISB.
- The Order assigns detection/reporting responsibility to:
- all health workers in government and private sectors providing immunization services and clinical treatment of AEFIs;
- individuals who received vaccination (and for minors, parents or guardians) to report to any health authority;
- researchers and research laboratories involved in clinical studies or field trials that result in AEFIs;
- vaccine manufacturers or distributors to report AEFIs.
- All serious AEFIs, deaths, and unusual events must be reported to the NEC within 24 hours.
- Initial serious AEFI reports must include basic information such as name, age, sex, address, onset of illness, vaccine administered, and outcome of patient.
- Reports must be transmitted through the fastest means using contact channels: 743-8301 loc. 1905-1906, fax: loc. 1903, and e-mail address: episo_doh@ yahoo.com.
AEFI investigation and causality assessment
- Investigations validate the existence of the event and establish causality of the reported event.
- Preliminary investigation must be made by DSCs in all public and private health facilities as soon as possible within 48 hours using a PIDSR AEFI case investigation form.
- All Serious AEFIs (AEFI list in Annex 1) or clusters must be thoroughly investigated by the AEFI team at the next higher level.
- The Regional AEFI Committee (RAEFIC) must conduct immediate preliminary causality assessment upon receipt of complete AEFI case investigation reports from the field.
- Final causality assessment of serious AEFIs must be conducted by the Immunization Safety Board (ISB).
- Assessment must be completed within 48 hours after each investigation.
Data management, feedback, and databases
- Data collection, consolidation, analysis, and interpretation must be done in all Epidemiology and Surveillance Units (ESUs) using PIDSR protocols.
- Data must be shared with the Food and Drug Administration (FDA).
- The PIDSR system must be used to maintain a database (paper-based or electronic) of AEFIs accessible to all reporting units.
- Investigating teams at all levels must provide feedback.
- The ISB must immediately provide feedback to the NIC and the Secretary of Health with final recommendations.
AEFI response and case management
Case management must follow classification-dependent response:
- If the AEFI is due to a vaccine reaction, the FDA must issue the necessary order within 24 hours after due process to temporarily withdraw the implicated vaccine lot/batch from the market pending final ISB recommendation; vaccination using other lots/batches must continue; only the Secretary of Health can stop vaccination activities.
- If the AEFI is co-incidental, the priority action must focus on developing and implementing a risk communication plan directed to the affected family and the general public.
- If the AEFI is program related, the local health office must immediately implement corrective actions based on investigation findings or recommendations of the RAEFIC or the ISB; CHD and PHO must provide appropriate technical and logistical assistance to LGUs.
- If the cause is unknown, the DSC must conduct a follow-up investigation and provide appropriate medical management; once additional information is available, the case must be subjected for ISB review for final classification.
- Individuals who had an injection reaction must receive appropriate medical management.
Assistance to AEFI cases and hospitalization
- The LGU must ensure immediate assistance for all serious AEFI cases, such as hospitalization and transport to a medical facility.
- For serious AEFI cases, the LGU must collaborate with CHD to discuss appropriate assistance to the patient.
- If a post mortem examination is required, the DOH must provide necessary assistance.
- Government health facilities, including DOH-retained and other government hospitals, must not charge any fee to patients with AEFI.
- If managed in private hospitals, assistance must be provided primarily by the LGU with support from DOH (National/CHD), based on factors such as distance/accessibility, capability of MDs, and availability of medical facilities.
- Private hospitals must provide assistance to AEFI cases who are their employees in accordance with the facility’s own rules and regulations.
Legal and protective assistance for health workers
- Concerned public health professionals must not be held liable for an AEFI as long as DOH standard operating procedures on immunization safety practices are complied with.
- The DOH must collaborate with PAO/OSG/IBP/Law Schools/volunteer lawyers to provide appropriate legal assistance to public health professionals if cases are filed against them for acts committed in the performance of duty and in good faith.
- The local police force must provide assistance to health workers for any received threat.
- If physical injury occurs, health workers must be given free medical assistance in DOH-retained and other government hospitals; if referral to a private hospital is required, expenses incurred must be reimbursed by the LGU/DOH.
- The concerned health workers must be given due process for any administrative, civil, or criminal sanctions filed against them, as mandated by E.O. 663 and Administrative Order No. 2007-0028.
- The DOH/Local Government Units must assist with expenses incurred in conducting the due process activity.
- The DSWD must assess the affected family’s concerns and gather information to facilitate provision of needs for assistance.
Risk communication and press releases
- Risk communication for AEFI is the responsibility of the health sector at all levels.
- Risk communication must cover these target audiences: family, community, general public, media, and health workers.
- Media coverage must be coursed through:
- OSEC–Media Relations Unit (MRU) at the national level; and
- HEPO–PIO at the regional level.
- Press releases are required when the AEFI incident has been publicized by local, national, or international media; other AEFI incidents that were investigated and resolved are handled based on determination by the Municipal Health Office (MHO) or Local Chief Executive (LCE).
- For LGUs, the LCE or duly designated official acts as spokesperson for AEFI inquiries, while the MHO/CHO provides technical inputs in consultation with the regional AEFI committee.
- At CHD level, the health promotion officer in coordination with program coordinators must formulate a health communication plan on AEFI and prepare key messages for advisories and press releases; the Regional Director convenes meetings with concerned LGUs for synchronous press releases.
- At the national level, the Secretary of Health or duly designated official serves as spokesperson.
- The DOH, through the National Center for Health Promotion (NCHP) in coordination with National Center for Disease Prevention and Control (NCDPC) and NEC, must prepare risk communication plans and key messages for advisories.
- The MRU prepares and disseminates press releases and facilitates press conferences.
- After Secretary of Health clearance, the NEC (as the International Health Regulation (IHR) focal point) must notify WHO and other concerned international organizations of serious AEFI incidents and the response taken.
Post-incident evaluation, documentation, repositories
- The Chair of the RAEFIC must facilitate post incident evaluation for all serious AEFI incidents.
- Post incident evaluation participation includes regional AEFI committee members, provincial EPI coordinators, city/municipal EPI coordinators, PHO, MHO/CHO, surveillance staff, and DOH representatives (including DOH representatives in attendance).
- Post incident evaluation must critically examine elements of AEFI surveillance and response and produce constructive recommendations to improve AEFI surveillance, response, and the immunization program.
- The ISB and the concerned LGU must be given feedback on post incident evaluation results.
- Documentation of AEFI surveillance and response must be done at all levels, covering compilation of records, meeting minutes, ISB reports, regional AEFI committee reports, and other relevant documents such as photographs, laboratory results, and clinical abstracts.
- Information from documentation must be accessible for research, program planning and evaluation, policy formulation, and development when required and authorized by ISB or RAEFIC.
- The NEC, RESU, and Local ESUs must serve as repositories for AEFI documentation records.
Roles and responsibilities by level
- The Immunization Safety Board (ISB) reviews and makes final causality assessment on all AEFIs referred by the Subcommittee on surveillance of the National Immunization Committee (NIC).
- The NIC Subcommittee on Surveillance must:
- review overall patterns of reports and investigations;
- refer all serious and doubtful AEFIs and validate other public AEFI concerns;
- establish crisis management guidelines in handling AEFI cases and controversies;
- provide recommendations on corrective actions related to reported AEFI cases, including withdrawal of implicated vaccines at regional level.
- The National Center for Disease Prevention and Control (NCDPC) must:
- modify policy and program based on ISB recommendations;
- coordinate with NEC for reported AEFI cases;
- provide guidance to NIC Subcommittee on formulation of recommendations for corrective actions.
- The NEC must:
- oversee design and implementation of AEFI surveillance;
- convene meetings of the NIC Subcommittee on Surveillance at least semi-annually and ISB as necessary;
- provide AEFI surveillance information for policy and program use;
- coordinate AEFI surveillance with FDA at national and regional levels;
- provide quality control of the AEFI reporting system.
- The NCHP must:
- develop and implement the national AEFI risk communication plan;
- capacitate sub-national levels to develop and implement their respective risk communication plans including Monitoring and Evaluation tools;
- monitor and evaluate implementation of risk communication plan at all levels and provide feedback to stakeholders.
- The FDA must:
- communicate international vaccine safety signals to NCDPC and other stakeholders;
- communicate suspected vaccine reactions reported through the pharmacovigilance unit to NCDPC, NEC, and other stakeholders;
- participate in investigation through National and Regional Food and Drug Regulation Officers;
- facilitate independent analysis of implicated vaccines with collaboration with RITM and other accredited reference laboratories;
- impose necessary regulatory actions in AEFI cases, including requiring hospitals and health facilities to submit pertinent clinical documents and medical records related to AEFI cases;
- actively participate in ISB meetings;
- provide feedback to stakeholders on safety, quality, and efficacy of implicated vaccines;
- issue timely advisory to the public regarding use of AEFI implicated vaccines.
- The CHD must:
- provide technical assistance (including training, policy advocacy), logistics, and laboratory analysis of samples to supplement local investigations and response;
- validate reported AEFIs from the field and conduct further and thorough investigations within 48 hours through the RESU, coordinated with program managers and FDRO;
- establish, operate, and maintain a Regional AEFI Committee (RAEFIC) chaired by the Regional Director or Assistant Regional Director and composed of a Legal Officer, Health Promotion Officer, HEMS coordinator, Regional FDA representative, and ad hoc experts on infectious disease, injection safety, and laboratory as necessary; with RESU as secretariat;
- enable the RAEFIC to conduct immediate preliminary causality assessment, issue immediate written reports to the Secretary of Health and concerned LGU copying NEC, NCDPC, and FDA, issue immediate recommendations on corrective actions, and ensure recommendations are carried out through monitoring/evaluation;
- prepare advisories/press releases when needed and provide copies to MRU-OSEC and local chief/health executives;
- maintain operational links with NEC, NCDPC, OSEC, HEMS, and other concerned national offices and private sectors;
- facilitate submission of AEFI surveillance reports through RESU;
- provide technical and logistical assistance in establishing provincial/city AEFI committees;
- track and monitor compliance of public and private hospitals in PIDSR, particularly AEFI surveillance, as part of license-to-operate renewal requirements through the Hospital Licensing Team, and issue a regional order to enforce compliance;
- develop, implement, and monitor the risk communication plan and provide technical assistance to LGUs through HEPO/PIO.
- LGUs must:
- provide timely feedback to the Local Chief Executives (governor/city mayor);
- provide assistance to health workers in technical, legal, social, financial, among others, assistance forms;
- assign the LCE or duly designated official as spokesperson for press releases on AEFI in consultation with the provincial AEFI committee;
- train/orient/disseminate AEFI policies and guidelines to all stakeholders including health facilities (government and private) and schools;
- report hospitals and related facilities that fail to comply with PIDSR reporting requirements to the CHDs.
- Provincial Health Office/City Health Offices of Highly Urbanize Cities (PHO/HUCs) must:
- establish provincial/city AEFI committees with specified composition (provincial/city health officer, provincial/city program coordinator, PESU/CESU, provincial/city HEPO, and provincial/city cold chain manager);
- validate and investigate reported AEFIs from cities, municipalities, and barangays from both public and private providers;
- prepare and submit initial reports to CHD;
- inform immediately the concerned municipality/health center for cases reported directly to the PHO;
- augment social and medical support to AEFI cases;
- follow up implementation by municipalities/cities of national/regional/provincial recommendations.
- Municipal Health Office/Health Offices of Component City must:
- detect, investigate, and report AEFI to the next higher level;
- provide initial management, social, and medical support to the AEFI case including hospitalization;
- implement national/regional/provincial recommendations;
- coordinate with other stakeholders regarding AEFI cases.
- Barangay must:
- detect and report AEFI to the next higher level;
- have the midwife institute initial case management and refer to next higher level (RHU/health centers or referral hospital);
- have the midwife organize community assembly and other health education activities;
- require the barangay council to provide assistance to the health worker including technical, legal, social, financial, among others, assistance;
- have the barangay council support AEFI cases including transportation, medicines, hospital referral, and communication to family and communities.
- Hospitals must:
- detect and report all AEFI cases to epidemiological and surveillance units;
- clinically manage AEFI cases;
- provide access to hospital/medical records of AEFI cases to AEFI investigation teams.
Repeal, revision, and inconsistency rule
- All provisions of previous Orders and other related issuances that are inconsistent or contrary to DOH Administrative Order No. 2010-0017 are revised, modified, repealed, or rescinded accordingly.
- All other provisions of existing issuances that are not affected by this Order remain valid and in effect.