Republic of the Philippines Department of Health OFFICE OF THE SECRETARY APR 1G 2018 ADMINISTRATIVE ORDER No. 2018-0013 SUBJECT: Revised Guidelines on the Management of Rabies Exposures I. BACKGROUND AND RATIONALE Rabies is a fatal disease in developing countries where animal immunization and control of dogs are inadequate. In view of the 100% case fatality of human rabies, the prevention. i of rabies infection after exposure is of utmost importance. ‘The Department of Health (DOH), having committed itself to the Prevention of human deaths due to rabies, provides vaccines to high-risk exposed patients for Post-Exposure Prophylaxis (PEP) through the Animal Bite Treatment Centers (ABTCs). In 1997, the National Rabies Prevention and Control Program introduced the intradermal (ID) ‘administration of rabies cell culture and embryonated egg-based vaccines (CCEEV), an economical regimen that reduces the cost of PEP by as much as 60- 80%, The DOH ‘maintains the use of the intradermal regimen for PEP at the ABTCs, The DOH procures human anti-rabies vaccines which are registered by the Philippine Food and Drug Administration (FDA), listed in the Philippine National Drug Formulary and pre- qualified by the World Health Organization (WHO). Over the past two years, the number of animal bite victims secking PEP has increased to over I Million cases per year. While the demand for human rabies vaccine is increasing in the country, there is an anticipated global shortage of the said vaccine due to issues in the production of one WHO prequalified vaccine, Of recent, WHO provided recommendations on shorter and more feasible protocols for PEP and Pre-Exposure Prophylaxis (PrEP). This AO is to update the guidelines on PEP and PrEP and to provide guidance on the selection and use of human rabies vaccine to help address the global shortage of WHO pre-qualified human rabies vaccines All government health workers at all levels shall adopt these treatment guidelines to ensure standard and rational management of rabies exposures, Private practitioners in the country are strongly encouraged to adopt these treatment guidelines f ] |CERTIFIED TRUE COPY! APR 16 2019 { Building 1, San Lazato Compound, Rizal Avene, Sta. Cruz, 1003 Manila’ ® Trak Line 651-7800 local 1108, 111%, 1112, 1113 Diret Line: 711-8502; 711-9503 Fax: 743-1829 © URL: hor doh gov ph: email Adve dah gov phi Iv. OBJECTIVE To update policy guidelines and procedures on provision of PEP and PrEP to address the global shortage of human rabies vaccine and immunoglobulins, COVERAGE All government health workers at all levels shall adopt these treatment guidelines to ensure standard and rational management of rabies exposures. Private practitioners in the country are strongly encouraged to adopt these treatment guidelines. DEFINITION OF TERMS A. Active Immunization — refers to the administration of a vaccine to induce protective immune response. B. Cell Culture & Embryonated Egg based Vaccine (CCEEV) - vaccines that use ‘mammalian cell lines (cell-culture) as well as embryonated eggs in the isolation, titration of animal viruses and cultivation to produce vaccines. CCEEV include Purified Vero Cell Rabies Vaccine (PVRV), Human Diploid Celi Vaccine (HDCV) and Purified Chick Embryo Vaccine (PCEC). CCEEV will replace everything that refers to Tissue Culture Vaccine (TCV). C. Immunocompromised host ~ refers to patients receiving immunosuppressive drugs such as systemic steroids (not topical or inhaled) and chemotherapeutic drugs for cancer, AIDS and HIV infected patients and patients with immune deficiency. These Patients are expected to have lower immune response to immunization. D. Incubation Period ~ refers to the period from the time of exposure up to the appearance of first clinical symptoms of rabies. It is extremely variable ranging from 4 days to 7 years; but generally 20 to 90 days, E. Observation Period ~ refers to animal observation for 14 days from the time of bite until the appearance of expected symptoms of rabies, F. Passive Immunization — refers to the administration of pre-formed antibodies (immune globulins or passive immunization products) to provide immediate protection. These antibodies come from either human or animal source. G. Post-Exposure Prophylaxis (PEP) ~ formerly post exposure treatment (PET); refers ‘to anti-rabies treatment administered after an exposure (such as bite, scratch, lick, ete.) to potentially rabid animals. Tt includes local wound care, administration of rabies vaccine with or without Rabies Immune Globulin (RIG) depending on category of exposure, H. Pre-exposure prophylaxis (PrEP) ~ refers to rabies vaccination administered before an exposure to potentially rabid animals. This is usually given to those who are at high risk of getting rabies such as veterinarians, animal handlers, staff in the rabies laboratory, hospitals handling rabies patients and school children from high risk areas, etc. IED TRUE COF1. Prodromal Period — refers to the period lasting for 10 days with non-specific manifestations, which include fever, sore throat, anorexia, nausea, vomiting, generalized body malaise, headache and abdominal pain. Paresthesia or pain at the site of the bite is due to viral multiplication at the spinal ganglion just before it enters the brain, J. Rabid Animal ~ refers to biting animal confirmed laboratory findings. K. Suspected Rabid Animal ~ refers to biting animal with a potential to have rabies infection based on unusual behavior, living condition like stray dogs, endemicity of rabies in the area and no history of immunization, L. Rabies Immunoglobulin (RIG) - is an injectable preparation of rabies antibody administered to unvaccinated persons to provide immediate but temporary protection until the body can actively produce antibodies of its own induced by the human rabies vaccine. Vaccine Potency ~ refers to the amount of acceptable active ingredients in a rabies vaccine which is expected to provide at least minimum protection, clinical manifestation of rabies and/or GENERAL GUIDELINES ‘A. Management of animal bite cases, including provision of human rabies vaccine, is a Joint responsibility of the Department of Health and the Local Government Units B. Rabies Control Program shall be integrated to the regular health services provided by local health facilities of bite victims, as a measure. C. PEP and PrEP shall be carried out by Local Government Units through the Animal Bite Treatment Centers with the technical and logistical assistance from the Department of Health. 1D. Funding requirements needed for management of rabies exposures and pre-exposure prophylaxis and for operational systems shall be planned, secured and allotted for by the implementing agencies, particularly, the Department of Health and the Local Government Units. E, Advocacy through information dissemination and training of health workers shall be conducted at all levels. F, Collaboration and coordination among government agencies, non-government and private organizations to ensure successful implementation shall be strengthened, SPECIFIC GUIDELINES AND PROCEDURE. A. Management of Potential Rabies Exposure 1. Initiation of post-exposure prophylaxis (PEP) shall not be delayed for any reason regardless of interval between exposure and consultation as it increases the tisk of rabies and it is associated with treatment failure. 2. Immediate washing of the bite wound/ exposed area with soap and water and application of an antiseptic solution reduces the risk of rabies transmission, 3. There are no absolute contraindications to rabies PEP. Patients allergic to a specific vaccine/RIG or its components shall be given the alternative vaccine/RIG, [CERTIFIED Th APR 16 2013