PEDIATRIC EMERGENCY DEPARTMENT CLINICAL GUIDELINE: NON- OCCUPATIONAL EXPOSURE TO BLOOD-BORNE PATHOGENS (HIV, Hepatitis B, AND Hepatitis C)

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1 General Definition: Blood-borne pathogens are infectious agents that can be transmitted through contact with blood or certain other body fluids. The primary pathogens are HIV, Hepatitis B, and C. Before Proceeding: In cases of pediatric sexual abuse/assault, please refer to the separate Comer ER Sexual Abuse/ Assault Guidelines BEFORE proceeding. If the patient is an EMPLOYEE or VOLUNTEER of the UNIVERSITY OF CHICAGO and sustained the exposure while providing patient care do NOT use this guideline: o Page the NEEDLE STICK HOTLINE at pager #9990 and follow their instructions 1. Document the Exposure Record date & time of exposure and mechanism of injury / exposure Any witnesses or others present? Were others exposed? Any details / knowledge of exposure source? 2. Evaluate the Exposure and Risk Fluids capable of transmitting a blood-borne pathogen include: blood, semen, vaginal secretions, amniotic fluid, peritoneal fluid, CSF, synovial fluid, and pleural fluid Fluids NOT capable of transmitting a blood-borne pathogen include: urine, saliva, stool, emesis, nasal secretions, tears, and sweat Document vaccination history, especially Hepatitis B Risk from different exposures for HIV, Hep B, and Hep C HIV Hep B* Hep C** Percutaneous needle stick % 22 62% 0 7% Blood splashed in mouth or eye 0.09% 0.3 9% Low Risk Receptive anal intercourse 0.5 3% > 3% Low Risk Receptive vaginal intercourse % > 1% Very Low Risk Insertive anal intercourse 0.065% > 1% Very Low Risk Insertive vaginal intercourse 0.05% > 0.5% Very Low Risk Oral sex w/ejaculation Very low risk Low risk Very Low Risk Human bite with blood Very low risk Moderate risk Low Risk * The risk of acquiring Hep B is highly dependent on the source s viral antigen status. Transmission of Hep B during sex has been well documented but transmission risk has not been determined and are estimated based on Hep B being times more infectious than HIV **Transmission of Hep C through mucous membranes/sexual contact has been reported but rare 3. Blood borne Pathogen Testing Hepatitis B & C Acute Hepatitis Panel AND Hepatitis B Surface Antibody (to assess vaccine status) HIV HIV1/HIV2 Antibody Antigen Screen General Labs: CMP and CBC with Differential Perform additional STI TESTING as per Comer ER Sexual Abuse/Assault Guidelines

2 4. Administer Post-exposure Prophylaxis (PEP) Hepatitis B Review the patient s vaccine status in the Immunization History tab and with the family. If exposure is LESS than 14 days ago AND the source is of unknown Hep B status AND the patient has completed the primary Hep B vaccine series, no treatment is indicated. If exposure is LESS than 14 days ago AND the source is of unknown Hep B status AND the patient is unvaccinated, give Hep B vaccine 0.5 ml IM. If exposure is GREATER than 14 days ago OR the source is known to be Hep B positive, please discuss with Peds ID Fellow (#4784). Hepatitis C currently no prophylaxis available HIV If exposure occurred GREATER than 72 hours ago: Test only and do NOT offer HIV PEP o Proceed to step 5 of pathway If exposure occurred LESS than 72 hours ago: Test and offer HIV PEP o If patient REFUSES HIV PEP, document the refusal and proceed to step 5 o If patient ACCEPTS HIV PEP, page Peds ID Fellow (#4784) to discuss case, follow guidelines below, and complete HIV PEP form (Page 5) and Addendum E (Page 6). HIV PEP is taken for 28 days o First doses given in Comer ED Order through EPIC, order set #928. (See tables below) o 5-day supply of medications given to patient from UCMC pharmacy Order through paper form, Addendum E (Page 6). It is difficult to get these medications at outpatient pharmacies so we give them a 5-day supply in the ED to start. o Outpatient prescriptions Prescribe the remaining 23 days of medications (See tables below). Encourage the patient to submit the prescription to their pharmacy TODAY, as insurance processing can take several days. Perform additional STI TREATMENT as per Comer ER Sexual Abuse or Assault Guidelines 5. Follow-up (Linkage to Outpatient Care): If patient does not qualify for or does not accept HIV PEP, no further follow-up with Infectious Diseases team is necessary. Please ensure patient follows up with PMD within 2 weeks. If patient accepts HIV PEP o Make sure Peds ID Fellow (#4784) has been paged o COMPLETE HIV PEP Form (Page 5) and Addendum E (Page 6) FAX form to Pediatric Infectious Disease Office: GIVE a copy of the form to patient/family PLACE original form in the patient s medical record o Patient should go home with: 5-day supply of medication from UCMC pharmacy 23-day prescription for remaining doses Copy of HIV PEP Form (Page 5) o Educate patient/family that they need to submit the 23-day prescription today o The follow-up appointment with Peds ID will be next Wednesday evening at Friend Family Health Center. A Peds ID team member will contact the family to schedule

3 Table 1. HIV PEP MEDICATIONS OVERVIEW Patient First doses given in Comer ED Weight 35 kg AND Truvada (200mgcan swallow pills 300mg) PO AND Raltegravir 400mg PO Weight < 35 kg AND 2 years old or cannot swallow pills* Age < 2 years old or weight <11kg** Zidovudine AND Lamivudine AND Raltegravir Zidovudine Lamivudine Kaletra 5-day supply from UCMC pharmacy Order through paper form, Addendum E (Page 6; Code R/SISA Rx request form). Order through paper form, Addendum E (Page 6; Code R/SISA Rx request form). Zidovudine Lamivudine Kaletra Outpatient prescriptions Truvada 1 pill PO Q 24 hours X 23 days AND Raltegravir (film-coated tablets) 400 mg PO Q 12 hours X 23 days Zidovudine AND Lamivudine AND Raltegravir (chewable tablets) Zidovudine Lamivudine Kaletra *See Table 2 below for weight-based dosing **Discuss specific dosing with Pediatric Infectious Disease Fellow and arrange directly with UCMC pharmacy to provide 5-day supply Table 2. WEIGHT-BASED DOSING OF HIV PEP MEDICATIONS* Medication Dose Zidovudine 10mg/mL syrup (Max 300mg/dose) Lamivudine 10mg/mL syrup (Max 150mg/dose) Raltegravir 100mg chewable tablets (Max 300mg/dose) 11kg - <33kg: 9mg/kg/dose PO Q12H >33kg: 300mg PO Q12H 11kg - <33kg: 4mg/kg/dose PO Q12H >33kg: 150mg PO Q12H >11kg - <14kg: 75mg PO Q12H 14kg - <20kg: 100mg PO Q12H 20kg - <28kg: 150mg PO Q12H 28kg - <40kg: 200mg PO Q12H >40kg: 300mg PO Q12H *For children <35kg AND 2 years old, or for children who cannot swallow pills DISCLAIMER: This clinical guideline has been developed for the purpose of unifying the general emergency care of patients with suspected exposure to bloodborne pathogens. It is intended to aid, rather than substitute for, professional judgment. It is not intended to serve as a rigid protocol or a written proxy for the standard of care. Failure to comply with this guideline does not represent a breach of the standard of care.

4 The following two forms (pages 5 & 6) should be completed only for a patient who accepts HIV Post-Exposure Prophylaxis. If HIV prophylaxis is not indicated (exposure greater than 72 hours) or the patient does not accept HIV prophylaxis, STOP here. Ensure that Steps 1-5 (pages 1-3) are completed.

5 Patient Label HIV POST-EXPOSURE PROPHYLAXIS (PEP) FORM INSTRUCTIONS FOR PROVIDER FAX THE COMPLETED FORM TO: Pediatric Infectious Disease Office ( ) GIVE A COPY OF THE COMPLETED FORM TO: Patient/Family QUESTIONS? Call , and page Pediatric Infectious Disease Fellow On-Call (#4784) CLINICAL CARE SUMMARY ER VISIT DATE: TIME: EXPOSURE DATE: TIME: ER ATTENDING: ER RESIDENT: PEDIATRIC INFECTIOUS DISEASE FELLOW: CONTACT INFORMATION PLEASE obtain directly from patient/family AND get as many numbers as possible PHONE NUMBER NAME/RELATIONSHIP TO PATIENT HIV PEP MEDICATIONS TAKE these medications for 28 DAYS to prevent HIV infection Medications must be taken on an exact schedule AND taken with food. Option 1: If 35kg and can swallow pills: Truvada (Every 24 hours) Next dose AM/PM Raltegravir (Every 12 hours) Next dose AM/PM Option 2: If < 35 kg and 2 years old OR cannot swallow pills and 2 years old Zidovudine (Every 12 hours) Next dose AM/PM Lamivudine (Every 12 hours) Next dose AM/PM Raltegravir (Every 12 hours) Next dose AM/PM INSTRUCTIONS FOR PATIENT/FAMILY Bring your prescriptions to your pharmacy TODAY. Insurance processing can take several days. Your follow-up appointment is next Wednesday evening at Friend Family Health Center (800 E. 55 th Street). The Pediatric Infectious Disease team will contact you with a time. If you do not receive a call within 2 business days, please call and page Pediatric Infectious Disease (#4784). IF YOU HAVE QUESTIONS, OR CANNOT FILL YOUR PRESCRIPTIONS, please call and page Pediatric Infectious Disease (#4784)

6 CODE R / SISA PEDIATRIC SEXUAL ASSAULT/ABUSE ADDENDUM E Code R / SISA Prescription Request Patient Label INSTRUCTIONS FOR PRESCRIBERS/PHARMACISTS: This form is used to order the first 5-day supply of HIV PEP ONLY. This does NOT include the initial doses of HIV PEP given in the ED or the 23-day supply that must be written as a discharge prescription. During business hours (M-F, 8AM-5:30PM), DCAM Outpatient Pharmacy will dispense these medications. o TUBE completed form to station #511. o CALL (or ) to confirm receipt of form. After hours these medications will be dispensed by Comer Inpatient Pharmacy o TUBE completed form to station #820. o CALL to confirm receipt of form. Medications will be tubed from pharmacy to Comer ED (station#813). If there are questions or concerns regarding this form, please contact the Comer ED Attending at HIV Post-Exposure Prophylaxis Prescription CHECK THE BOX with the appropriate weight-based regimen. COMPLETE DOSING INFORMATION for patients weighing <33kg. SIGN your name at the bottom. If 35 kg AND can swallow pills: Truvada 1 Tab (200MG-300MG) PO Q24H x 5 days Raltegravir (film-coated tablets) 1 Tab (400MG) PO Q12H x 5 days If <35 kg and 2 years old OR cannot swallow pills and 2 years old: Weight Medications <11kg Discuss with Peds ID Fellow (#4784) 11kg - <14kg Lamivudine (10mg/ml syrup); 4mg/kg/dose ( MG) PO Q12H x 5 days Raltegravir (100mg chewable tablets); 75mg (0.75 x 100mg tablet) PO Q12H x 5 days 14kg - <20kg 20kg - <28kg 28kg - <33kg 33kg - <40kg 40kg Lamivudine (10mg/ml syrup); 4mg/kg/dose ( MG) PO Q12H x 5 days Raltegravir (100mg chewable tablets); 100mg (1 x 100mg tablet) PO Q12H x 5 days Lamivudine (10mg/ml syrup); 4mg/kg/dose ( MG) PO Q12H x 5 days Raltegravir (100mg chewable tablets); 150mg (1.5 x 100mg tablet) PO Q12H x 5 days Lamivudine (10mg/ml syrup); 4mg/kg/dose ( MG) PO Q12H x 5 days Raltegravir (100mg chewable tablets); 200mg (2 x 100mg tablet) PO Q12H x 5 days Zidovudine (10mg/ml syrup); 300mg (30ml) PO Q12H x 5 days Lamivudine (10mg/ml syrup); 150mg (15ml) PO Q12H x 5 days Raltegravir (100mg chewable tablets); 200mg (2 x 100mg tablet) PO Q12H x 5 days Zidovudine (10mg/ml syrup); 300mg (30ml) PO Q12H x 5 days Lamivudine (10mg/ml syrup); 150mg (15ml) PO Q12H x 5 days Raltegravir (100mg chewable tablets); 300mg (3 x 100mg tablet) PO Q12H x 5 days PHYSICIAN NAME: PHYSICIAN SIGNATURE: