Legal basis, predecessor rules, repeals
- The order rescinds Administrative Order No. 15-A, s. 1997 dated August 15, 1997.
- Any other administrative order inconsistent herewith is also rescinded.
Purpose and policy goals
- The order bases rabies control on the National Objectives for Health 1999–2004, treating rabies as a public health problem.
- The order emphasizes the prevention of human deaths due to rabies through post-exposure treatment.
- The order commits the Department of Health to elimination of rabies and to the goal of declaring the Philippines rabies-free in 2020.
- The order requires continued review and evaluation of the policy and implementation by technical experts.
- The order requires advocacy, training of health workers, system readiness, and secured funding before full implementation.
- The order requires support and collaboration among government, non-government, and private organizations.
Coverage and who must follow
- Government doctors at all levels must follow these guidelines.
- Private practitioners in the country must also follow these guidelines to ensure uniform management of animal bite patients.
Rabies exposure categories and management
- The order establishes three (3) categories of exposure to a rabid animal or an animal suspected to be rabid.
- Each exposure category corresponds to a specific management approach for potential rabies exposure.
- The detailed exposure-category management framework is provided in Annex A.
Immunization requirements and standards
- Active immunization is defined as vaccine administration that induces antibody and T-cell production to neutralize rabies virus.
- The order states active immune response occurs in 7–10 days after vaccination and may persist for one year or more.
- The order lists the anti-rabies vaccines available in the Philippines:
- Purified Free Cell Rabies Vaccine (PVRV) at 0.5 ml/vial.
- Purified Duck Embryo Vaccine (PDEV) at 1.0 ml/vial.
- Purified Chick Embryo Cell Vaccine (PCECV) at 1.0 ml/vial.
- The order requires that, for active immunization, any of the three vaccines may be administered intra-muscularly or intrader-mally.
Passive immunization and RIG controls
- Passive immunization is defined as providing immediate protection with Rabies Immunoglobulin (RIG) combined with anti-rabies vaccine for Category III exposure.
- The order states RIG has a half-life of approximately 21 days.
- The order requires only rabies vaccines and RIG evaluated and recognized by WHO and approved by BFAD be used.
- The order requires national health authorities to evaluate any new vaccine or RIG before use.
RIG types, dosing, and infiltration rules
- The order recognizes two RIG types:
- Human Rabies Immunoglobulin (HRIG) derived from plasma of human donors at 20 IU per kilogram body weight.
- Equine Rabies Immunoglobulin (ERIG) derived from horse serum at 40 IU per kilogram body weight.
- The order requires HRIG dosing and calculation based on IU concentration:
- HRIG at 20 IU/Kg with 150 IU/ML example computation.
- The order requires ERIG dosing and calculation based on IU concentration:
- ERIG at 40 IU/kg with 200 IU/ml example computation.
- The order requires RIG as a single dose for all Category III exposures.
- The order requires RIG infiltration around and into the wound as much as automatically feasible, even if the lesion has begun to heal.
- The order requires any remaining RIG to be administered intramuscularly at a site distant from the vaccine injection site.
- The order prohibits giving RIG beyond the calculated dose because it may reduce vaccine efficacy.
- The order permits dilution with sterile saline 2 or 3 fold for thorough infiltration when the calculated dose is sufficient to infiltrate bite wounds.
- The order requires RIG administration at the same time as the first vaccine dose.
- If RIG is unavailable when the first vaccine dose is injected, the order allows giving RIG up to 7 days after the first vaccine dose, assuming the patient received day 3 and day 7 doses.
- The order requires a skin test prior to ERIG administration and mandates readiness to treat hypersensitivity with adrenaline and antihistamines.
- The order states a positive interpretation is based on induration of 6 mm or more.
Post-exposure treatment: wound care
- The order requires immediate and vigorous wound washing and flushing with soap and water preferably for 10 minutes.
- The order requires application of alcohol, tincture of iodine, or any antiseptic.
- The order requires avoiding suturing of wounds when possible.
- If suturing is necessary, the order requires infiltrating anti-rabies immunoglobulin around and into the wound before suturing.
- The order prohibits applying any ointment, cream, or occlusive dressing to the bite site.
- The order requires or allows anti-tetanus immunization and anti-microbial if indicated.
- The order treats animal bites as tetanus prone wounds for purposes of tetanus management (referenced in Annex B).
Post-exposure treatment: vaccine regimens
- The order requires strict adherence to each treatment schedule to prevent treatment failure.
- The order recognizes the 2-site intradermal schedule, 2-1-1 intramuscular schedule, standard intramuscular schedule, and 8-site intradermal schedule, with details in Annex C1, Annex C2, Annex C3, and Annex C4.
2-site intradermal schedule (2-2-2-0-1-1)
- The order identifies the 2-site intradermal schedule as (2-2-2-0-1-1).
- The order defines intradermal dosing units:
- 0.1 ml per dose for PVRV.
- 0.2 ml per dose for PDEV/PCECV.
- The order requires one dose at two sites on Days 0, 3, and 7, and one site on Days 30 and 90.
- The order requires injections on the deltoid area of each upper arm in adults, or in infants at the anterolateral aspect of the thigh.
- The order requires use of a one (1) ml. insulin syringe with gauge 25 or 26 needle for intradermal injection.
- The order requires vaccine storage within 4°C and 8°C and after reconstitution use within 8 hours.
- The order sets rules for missed doses:
- If only day 0 was given and the time between day 0 and the day 3 dose is more than one week, repeat the first dose and do not repeat RIG.
- If at least day 0 and day 3 doses were given, adjust missed doses while giving remaining doses according to the original schedule.
- If the day 30 dose is missed, it may be given when the patient comes, and the day 90 dose may be given as originally scheduled or at least 1 month after the day 30 dose, whichever is longer.
- If day 90 is missed, it may be given when the patient comes.
2-1-1 intramuscular schedule
- The order identifies the 2-1-1 intramuscular schedule as 2-1-1.
- The order defines dosing equivalence:
- One dose equals 1 vial of 0.5 ml PVRV or 1 vial of 1.0 ml PDEV/PCECV.
- The order requires two (2) doses intramuscularly on Day 0, and one dose in the deltoid area of each upper arm in adults (or anterolateral thigh in infants) on Day 7 and Day 21.
- The order provides that treatment does not need restarting if a patient misses a scheduled succeeding date; the prescribed interval is followed.
- The order requires using the 2-1-1 regimen with RIG for Category III exposure.
- The order requires the patient be informed that 2-1-1 IM is not the optimum regimen for Category III exposures when RIG is not available.
- The order requires discontinuing the last dose if the dog is alive and healthy after a 14-day observation period.
Standard intramuscular schedule
- The order identifies the standard IM regimen with doses on days 0, 3, 7, 14 and 28.
- The order defines one dose as one vial of 0.5 ml PVRV or 1.0 ml PDEV/PCECV.
- The order requires administration into the deltoid muscle in adults and the anterolateral thigh in infants.
- The order provides that missed doses do not require restarting; prescribed intervals between injections are followed.
8-site intradermal schedule (8-site ID)
- The order identifies the 8-site intradermal regimen as involving intradermal dosing on day 0, day 7, and days 30 and 90.
- The order defines one dose as 0.1 ml of PCECV.
- The order requires eight (8) doses intradermal on day 0, four (4) doses on day 7, and one (1) dose on days 30 and 90.
- The order specifies injection sites:
- Day 0: two injections each on the deltoid muscles, anterolateral thigh, lower quadrant of the abdomen, and suprascapular region (back).
- Day 7: two injections each on the deltoid muscles and anterolateral thigh.
- Day 30: one injection on the deltoid.
- Day 90: one injection on the deltoid.
- The order requires using the 8-site ID regimen when RIG is not available and requires informing the patient that it is not the optimum regimen for Category III exposures.
Special conditions and special management rules
- Pregnancy and infancy do not contraindicate treatment with purified cell culture vaccines (PVRV, PDEV, PCEC).
- The order directs avoiding chloroquine, anti-epileptic drugs, systemic steroids, and heavy alcohol consumption during rabies immunization because these may interfere with the immune response.
- If avoiding these drugs is not possible, the order requires using the standard IM regimen.
- The order requires immuno-compromised individuals (including HIV infection, cancer/transplant patients on immunosuppressive therapy, and similar) be given vaccine using the standard IM regimen and RIG for both Category II and III exposures.
- The order requires that exposed persons presenting weeks or months after the bite be treated as if exposure occurred recently.
- The order permits no treatment if the biting animal remained healthy and alive until 14 days after the bite.
- The order provides that bites by rodents, rabbits, and domestic animals other than dogs and cats require no rabies post-exposure treatment unless the animal is proven rabid; anti-tetanus prophylaxis must be given.
- The order requires monkey bites and other wild animal bites to be managed similarly to dog and cat bites.
Previously immunized patients and pre-exposure prophylaxis
- The order requires local wound treatment for previously treated and previously immunized animal bite patients.
- The order provides vaccination rules for second exposure after previously receiving complete pre-exposure prophylaxis or post-exposure treatment with tissue culture vaccine:
- If second exposure occurs < than 1 month after completion: no booster dose.
- If second exposure occurs 1 to 3 years after completion: two booster doses on D0 and D3.
- If second exposure occurs > than 3 years after completion: another full course of active immunization.
- The order states booster doses may be given intradermally at 0.1 ml for PVRV or 0.2 ml for PDEV/PCECV or intramuscularly at 1 vial of PVRV, PDEV, or PCECV.
- The order states no rabies immunoglobulin is needed for these booster situations.
Pre-exposure prophylaxis (PrEP)
- The order recommends pre-exposure prophylaxis for individuals at high risk of rabies exposure, including personnel in rabies diagnostic laboratories, veterinarians, animal handlers, and others directly involved in rabies control.
- The order sets PrEP dosing:
- 0.1 ml for all vaccine types given intradermally (ID), or
- 1 vial of 0.5 ml for PVRV or 1 vial of PDEV/PCEC given intramuscularly (IM) at one site.
- The order sets initial PrEP schedules as one dose of either vaccine on Days 0, 7 and 21 or 28.
- The order requires a booster dose every two or three years depending on risk of work-related exposure.
Laboratory confirmation and handling
- The order requires animals for laboratory testing to be placed in a leak-proof double plastic bag, then placed in a bigger container with liberal amounts of ice.
- The order provides that if an animal can be brought to the laboratory within 12 hours of death, no ice is needed.
- The order prohibits adding chemical disinfectants or preservatives such as formalin or alcohol.
- The order requires bringing specimens to the nearest rabies diagnostic laboratories whose addresses are detailed in Annex E.
Biting animal management
- The order advises consulting a veterinarian on biting animal management when possible.
- The order provides specific observable signs supporting concern for rabies:
- Sudden change of behavior.
- Hoarse howl.
- Watchful, apprehensive expression; staring; blank gaze.
- Drooling of saliva.
- Paralysis or uncoordinated gait of forelimbs.
- Marked restlessness and pacing.
- Aimless running and biting anything in its way.
- Depraved appetite and self-mutilation.
- Quiescence with biting when provoked.
- Snapping at imaginary objects.
- Paralysis of lower jaw and tongue; inability to drink.
- Sudden death without associated signs and symptoms.
Dispensing and free treatment mechanisms
Referral and dispensing function
- The order requires referring patients needing post-exposure treatment to an Animal Bite Treatment Center where free human anti-rabies immunizing agents (vaccines and RIG) are administered.
- The order requires the assessment of animal bite patients and dispensing of vaccine and RIG through the following procedures:
- Thoroughly assess the victim and record in the Municipal/City/Hospital Rabies Surveillance Form (Facility-based form).
- Decide whether to initiate treatment using the Guide for Rabies Post-Exposure Treatment as reference.
- For immunization warranting Category II and Category III, provide the initial 2 doses of tissue culture vaccine for the 2-1-1 schedule; succeeding doses are the patients’ responsibility, except that when the intradermal regimen is used, the complete course of active immunization is given for free.
- Provide the required dose of rabies immunization (RIG) if indicated and available.
- Prefer the first RIG of choice as EIG.
- Explain decisions with emphasis on adherence to treatment schedules.
- Observe courtesy and tactfulness toward patients, particularly those who do not need immunization.
- Provide advice on Responsible Pet Ownership.
Government responsibility for free vaccine
- The order makes dispensing free anti-rabies immunizing agents the sole responsibility of government health agencies if available.
- The order requires providing vaccine for free to Category III patients who lack capacity to buy succeeding vaccine doses, if available.
- The order requires restricting free vaccine to properly assessed animal bite patients who are physically present.
- The order prohibits giving vaccine to non-patients.
Priority order for free vaccine assistance
- The order sets the program’s order of priority for free vaccine assistance:
- Patients bitten by animals found positive for "negri bodies", regardless of exposure category.
- Patients with Category III exposure.
- Individuals exposed to human rabies patients through bite/non-bite exposure (mouth-to-mouth resuscitation, licking of intact mucosa such as eyes, lips and vulva).
- Patients bitten by animals that are not available for observation (stray/slaughtered).
- Patients with Category II exposure.
Free PrEP for rabies personnel
- The order requires government veterinarians and laboratory technicians working for rabies diagnosis, prevention and control be provided free pre-exposure prophylaxis using the intradermal technique if available.
Vaccine allocation and distribution roles
- The order assigns vaccine procurement to the National Center for Disease Prevention and Control.
- The order requires the National Center for Disease Prevention and Control to ensure Regional Health Offices receive vaccine allocation every quarter, subject to availability.
- The order assigns distribution to the Centers for Health Development, acting through the Director and the Rabies Control Program Coordinator, for delivery to Provincial/City Health Offices.
- The order assigns local distribution to Provincial Rabies Control Coordinators to establish Animal Bite Treatment Center(s) for administering free human anti-rabies immunizing agents (vaccines and RIG).
Summary schedule annex references and integration
- The order integrates detailed exposure categorization in Annex A, tetanus-prone bite guidance in Annex B, and regimen schedules in Annex C1, Annex C2, Annex C3, and Annex C4.
- The order integrates delivery and dosing structure for pre-exposure prophylaxis in Annex D.
- The order integrates laboratory location details in Annex E.