1. Susan Reeser RN, BSN Nurse Consultant Public Health and Health Care Providers Working Together

2.  Perinatal Hepatitis B Prevention ◦ Hepatitis B ◦ Key Points of Perinatal Hep B Prevention ◦ Roles and Responsibilities ◦ Resources  VAERS 101 ◦ Vaccine Adverse Event Reporting System

3.  Hepatitis B is a liver disease caused by the hepatitis B virus (HBV).  HBV is found in the blood and other body fluids of infected people (e.g., serum, semen, saliva, and vaginal secretions).  An infant can acquire HBV from: -An infected mother (transmitted at birth) -A chronically infected member of the household 3

4. HBV can cause acute or chronic infection. Chronic HBV infection can lead to liver failure and liver cancer. 4 Acute HBV infection (may be symptomatic or asymptomatic) Chronic HBV infection Resolved and immune (over years) Liver cirrhosis and cancer Resolved and immune

5. A. Yes B. No

6. 6 90% 30% <5%

8.  Clinical case definition: ◦ Perinatal hepatitis B in the newborn may range from asymptomatic to fulminant hepatitis.  Laboratory criteria for diagnosis: ◦ Hepatitis B Surface Antigen (HBsAg) positive  Case classification ◦ HBsAg positivity in any infant aged >1-24 months who was born in the United States or in U.S. territories to an HBsAg positive mother

9.  The rate of new HBV infections declined by 82% since 1991  The decline has been greatest among children born since 1991, when routine vaccination of children was first recommended.

10. HBsAg screening of pregnant women recommended Wasley A, et al. MMWR Surveill Summ. 2008;57(2):1-24. Wasley A, et al. MMWR Surveill Summ. 2007;56(3):1-24. OSHA. Available at: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=1005 1. HBV Incidence by Year: United States (1966-2005) 14 12 10 8 6 4 2 0 Cases per 100,000 Population Yr 1967197119751979198319871991199519992003 Decline among MSM & HCWs Decline among IDUs Vaccine licensed Infant immunization recommended OSHA rule enacted Adolescent immunization recommended

12. HBsAg Prevalence [2] ≥ 8% (high) 2% to 7% (intermediate) < 2% (low) Immigration Numbers by Continent: 2000-2009 [1] ~ 3.6 million Asians ~ 875,000 South Americans ~ 804,000 Africans ~ 1.3 million Europeans

13.  Rationale ◦ Studies have shown that while Asian Americans and Pacific Islanders (AAPI) represent 5% of the total U.S. population, they make up 50% of hepatitis B cases. ◦ Nearly 2 in 3 people living with chronic hepatitis B do not know they are infected ◦ Testing for chronic hepatitis B plays an important role in the detection, classification, management and medical care for patients with hepatitis B

14.  Patients born in: ◦ Any Asian country ◦ Any Pacific island ◦ Other countries with moderate to high rates of hepatitis B (see map)  Patients * with at least one parent born in: ◦ Any East or Southeast Asian countries, except Japan ◦ Any Pacific island ◦ Other countries with high rates of hepatitis B (see map) * Born in the US but not vaccinated at birth

16. 1. Maternal HBsAg Testing 2. Reporting and Tracking HBsAg(+) Pregnant Women 3. Vaccination of Infants at Birth 4. Infant Follow-up

17. A. True B. False

19.  All pregnant women must be tested for HBsAg during each pregnancy MCA 50-19-103  Montana Administrative Rule 37.114.540 mandates follow-up of positive HBsAg results, and prophylactic treatment of all infants born to HBsAg positive women.  All women who are in a high-risk category should be re-tested for HBsAg at the time of admission to the birthing hospital.

21.  Persons with multiple sex partners  Persons with a sexually transmitted disease  Injection drug users  Household contacts of infected persons  Healthcare and public safety workers exposed to blood on the job  Hemodialysis patients  Residents and staff of facilities for developmentally disabled persons  Travelers to regions with intermediate or high rates of Hepatitis B (HBsAg prevalence of ≥2%)

22.  All HBsAg positive pregnant women must be reported to the local health department (LHD). ◦ The LHD will notify the Montana Perinatal Hepatitis B Prevention Program at DPHHS. (ARM 37.114.201)  Infants born to HBsAg positive mothers and all household, sexual, and needle sharing contacts ◦ must be identified and case-managed by the local health department.

24.  Make sure your baby gets vaccinated ◦ At birth: HBIG and Hepatitis B vaccine ◦ 1-2 months: 2 nd dose of hepatitis B vaccine ◦ 6 months: 3 rd dose of hepatitis B vaccine  (4 th dose if using Pediarix)  C-Sections don’t prevent HBV transmission  Breastfeeding is safe

25.  Probably have no symptoms  Need to follow-up for medical screenings ◦ ALT- liver damage ◦ AFP-liver cancer ◦ Ultrasound-liver cancer  Review all medications with provider  Avoid drinking alcohol  Get vaccinated for hepatitis A  Protect loved ones ◦ Family members and household contacts tested and vaccinated

26. a)Mother HBsAg + b)Mother HBsAg Status Unknown c)Mother HBsAg –

27. a) Mother HBsAg + ◦ HBIG & hepatitis B vaccine within 12 hours of birth  Preterm infants weighting <2000 grams (initial dose not counted)

28. b) Mother Status Unknown ◦ Vaccine within 12 hours of birth ◦ Mother tested stat for HBsAg and if + infant to receive HBIG as soon as possible, but no later than 7 days after birth  Preterm infants <2000 grams, should get HBIG and vaccine within 12 hours of birth if mom’s status cannot be determined

29. c) Mother HBsAg – ◦ Birthing hospitals implement standing orders for universal birth dose for all stable infants  Preterm infants <2000 grams should get vaccine at one month of age or at hospital discharge

30. A. It prevents mother to infant transmission B. It prevents household transmission to infant C. It protects infant when medical errors occur D. None of the above E. All of the above

32.  All infants should complete the vaccine series ◦ With either single-antigen vaccine or combination vaccine, according to the recommended vaccine schedule.  Infants born to HBsAg positive mothers should be tested for both ◦ HBsAg and ◦ Hepatitis B surface antibody (anti-HBs) titer  after completion of vaccine series, between age 9–12 months, but no sooner than age 9 months

33. So, how do we accomplish this

36. State Health Department Local Health Department  Administers the Program  Oversees case management statewide  Provides consultation  Maintains statewide database (MIDIS)  Supplies birth dose & HBIG  MTPHL provides testing  Provides direct case management to ensure:  Notification of birthing hospital for admin. HBIG and birth dose  Completion (timely) of vaccines series and post- vaccination serology of infant and reports to State  Follow-up of maternal contacts

37. Healthcare Workers  Laboratory Staff ◦ Reports + test results  Prenatal Care Providers ◦ Tests all pregnant women ◦ Informs women of their status  Counsels, assesses, and vaccinates as needed ◦ Sends HBsAg results to birth hospital  Hospital Labor and Delivery Unit and/or Nursery Staff ◦ Notes HBsAg test results ◦ If no results, STAT test is ordered ◦ Administers birth dose  HBIG if mom is + and reports to LHD  Infant Provider ◦ Vaccine doses ◦ PVST

38. Approximately 18 months later… Thanks Health Care Team From the prenatal lab testing to infant fully vaccinated and PVST complete at age 9-12 months

39. Resources Websites Montana Immunization Program http://www.dphhs.mt.gov/publichealth/immunization/ A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States Recommendations of the Advisory Committee on Immunization Practices (ACIP) Part 1: Immunization of Infants, Children, and Adolescents http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5416a1.htm?s_cid=rr5416a1_e Centers for Disease Control and Prevention, Hepatitis B Information for Health Professionals http://www.cdc.gov/hepatitis/HBV/PerinatalXmtn.htm Recommendations for Identification and Public Health Management of Persons with Chronic Hepatitis B Virus Infection http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5708a1.htm Immunization Action Coalition, Handout for Health Care Professionals: Give the Birth dose http://www.immunize.org/catg.d/p2125.pdf Asian Liver Center, Stanford School of Medicine, Brochure: Hepatitis B and Moms-to-be http://liver.stanford.edu/Media/publications/Pregnancy/English.pdf

41. Vaccine Adverse Event Reporting System

42.  A national vaccine safety surveillance program co-sponsored by the CDC and the FDA  Collects and analyzes information from reports of adverse events following the administration of US-licensed vaccines  Purpose to detect possible signals of adverse events associated with vaccines

43. A. True B. False

44.  A report of an adverse event to VAERS does not indicate that a vaccine caused the event. ◦ It only indicates the event occurred some time after vaccine was administered.  Reports are signals that alert scientists of possible cause-and-effect relationships that need to be investigated.

45.  VAERS is a spontaneous reporting system, meaning it is voluntary  Data is often incomplete and/or incorrect  Underreporting or failure to report  Serious medical events are more likely to be reported than minor ones

46.  Anyone can submit a VAERS report ◦ Most reports are submitted by  vaccine manufacturers  health care providers (required by law to report certain problems) ◦ Others may submit reports  i.e. vaccine recipients, parents/guardians

47.  Pink Book Appendix D  Search VAERS on the web

51. VAERS encourages reporting of:  Any clinically significant adverse event that occurs after the administration of any vaccine licensed in the US

52. Requires health care providers to report:  Any health event listed by the vaccine manufacturer as a contraindication to subsequent doses of the vaccine.  Any event listed in the Reportable Events Table that occurs within the specified time period after the vaccine.

54. A. True B. False

55. Medication Errors  Healthcare professionals can use clinical judgment whether or not to report a medical error  The error may not have an associated adverse health event but it may pose a safety risk i.e. ◦ Administering a live vaccine to an immunocompromised patient

56.  Administration of only one component of a vaccine (using the wrong diluent with a lyophilized)  Notes from the Field: Administration Error Involving Meningococcal Conjugate Vaccine - United States, March 1, 2010 - September 22,2015  Administration by injection (wrong route)  Notes from the Field: Rotavirus Vaccine Administration Errors – United States, 2006 - 2013

57.  Susan Reeser RN, BSN  Nurse Consultant  Montana Immunization Program  (406)444-1805  sreeser@mt.gov sreeser@mt.gov