OB Provider Guide to Alaska s Perinatal Hepatitis B Prevention Program

OB Provider Guide to Alaska s Perinatal Hepatitis B Prevention Program

Dear Colleague, This letter is to introduce myself and explain the role I play with the Alaska Perinatal Hepatitis B Program. Alaska has recently implemented a perinatal hepatitis B case management program designed to identify, track, educate, and continue to further prevent this vaccine-preventable disease. I am responsible for ensuring all HBsAg-positive pregnant women are reported to the State and are receiving appropriate care for themselves, their sexual partner, household contacts and their infant(s). As a provider of obstetrical care in our state, you are a pivotal partner in the identification of HBsAgpositive pregnant women. As I am sure you are aware, according to Alaska Statute 18.15.370 hepatitis B is a mandatory reportable condition in Alaska. The reporting process is easy; the information needed includes: client demographics, a copy of HBsAgpositive lab work, estimated delivery date and the name of the delivery hospital (Appendix A). Once the infant is born, our program will work with the pediatrician to ensure timely vaccination and postvaccination serology testing. Notifying us when the mother has selected a pediatrician will contribute towards our ability to follow-up with the provider in a timely manner. Sincerely, Perinatal Hepatitis B Prevention Program Alaska Immunization Program 3601 C Street, Suite 540 Anchorage, AK 99503 (907) 269-8000 We Can Prevent This!!! 2

Background Hepatitis B virus (HBV) infection is a major cause of acute and chronic hepatitis, cirrhosis of the liver, and primary hepatocellular carcinoma. It is the most prevalent chronic infectious disease in the world, a common cause of morbidity and mortality worldwide, and a major health problem in the United States. One mode of transmission of HBV is perinatal transmission (from mother to infant during birth). An estimated 24,000 infants are born each year to women in the United States who are infected with HBV; between 30% and 40% of all chronic HBV infections result from perinatal transmission. Infants and young children are at particular risk for developing chronic hepatitis B infection after exposure to the virus. 90% of infants infected as a neonate and 25% to 50% of children between the ages of one and five years who are acutely infected with HBV will progress to develop chronic infection < 5% of symptomatic and only 5% to 10% of asymptomatic infected adults and teenagers will develop chronic hepatitis B Proper prophylaxis and completion of the hepatitis B vaccine series can reduce neonatal infection and the potential sequelae by 95% Alaska s Background The 2011 National Immunization Survey (NIS) published in Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly report (MMWR) September 2012 estimated the hepatitis B birth dose coverage among Alaskan children 19 to 35 months of age to be 63.9% (CI± 71.2); a seven percent drop in coverage from 2010. Historically, the Alaskan Native population has had a higher prevalence of hepatitis B than the general population. As a result in the 1980 s, the Alaska Native Health Services instituted a comprehensive perinatal hepatitis B 3

program; which includes screening for completeness of immunizations and testing for seroconversion of exposed infants. However, due to changing demographics, the epidemiological picture of hepatitis B in Alaska is changing. Alaska has experienced increased immigration of people from Asia and the Pacific Island (including the Philippines and Samoan) regions. Asians and Pacific Islanders (A/PI) have an elevated HBV prevalence rate of eight percent. Due to the high prevalence rate in the A/PI region, women (especially those who are foreign born) are at increased risk for being HBsAgpositive. CDC s National Immunization Survey (NIS) conducted in 2007 revealed that out of the 11,052 expected births in Alaska 67 would be to HBsAg-positive women. Although the NIS estimate of expected births to HBsAg-positive women in Alaska is relatively low in absolute numbers, proportional to the number of total births, Alaska ranks # 10 nationally. According to the Alaska Health Care Data Book, Selected Measures 2007, Asian and Pacific Islanders (A/PI s) are the third largest minority population in Alaska representing ~ 35,000 people with an estimated 2,000 women of reproductive age (15-49 years of age). According to the 2007 NIS, A/PI s (both foreign and U.S. born) account for 7.44% of total estimated births for Alaska. In the United States, Alaska ranks # 6 for number of births by A/PI women. 4

Alaska State Public Health Law Infectious disease reporting in Alaska has resulted in the identification of many outbreaks. Rapid investigation and institution of control measures prevents additional morbidity and mortality. The following section contains selected Alaska State Statutes and Regulations relevant to disease reporting and control. These statutes and regulations were in effect as of June 6, 2007. A complete set of statutes and regulations may be found at http://www.law.state.ak.us. Reporting Perinatal Hepatitis B in Alaska The State of Alaska has provided legislative directives to require reporting cases of hepatitis B; this allows the protection of all residents. Alaska Statute 18.15.370 reportable disease list states: The department shall maintain a list of reportable disease or other conditions of public health importance that must be reported to the department. The list may include birth defects, cancers, injuries, and disease or other conditions caused by exposure to microorganisms; pathogens; or environmental, toxic, or other hazardous substances. The department may also establish registries for disease and conditions that must be reported to the department. The regulations dictate that BOTH providers and laboratories must report the lab results with evidence of human infection caused by selected agents including hepatitis B virus. Alaska Statutes 7 AAC 27.005 reporting by health care providers and 7 AAC 27.007 reporting by laboratories is summarized as follows: 5

A health care provider who diagnoses or suspects a diagnosis of one or more of the following diseases or other conditions of public health importance must report the information to the Division of Public Health. A public, private, military, hospital or other laboratory performing serologic, immunologic, microscopic, biochemical, or cultural examinations or tests in Alaska or on samples obtained within Alaska must report evidence of human infection caused by the following agents at the time of identification or suspected identification to the Division of Public Health. Reporting and Health Insurance Portability and Accountability Act (HIPAA) The HIPAA Privacy Rule has been in effect since April 14, 2003. The intent of HIPAA is to establish national standards for consumer privacy protection and insurance market reform. The Privacy Rule strikes a balance between protecting patient information and allowing traditional public health activities to continue. Disclosure of patient health information without the authorization of the individual is permitted for purposes including, but not limited to: 1. Disclosures required by law (45 CFR 164.512 (a)) or 2. For public health activities and purposes. This includes disclosure to a public health authority that is authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including but not limited to, the reporting of disease, injury, vital events, and the conduct of public health surveillance, investigations, and interventions. (45 CFR 164.512 (b) (i)). 6

Recommendations for Prenatal Care Providers Prenatal care providers should test every woman for HBsAg during an early prenatal visit (e.g., in the first trimester), even if a woman has been previously vaccinated or tested. In addition, prenatal care settings should incorporate each of the following actions into their policies and protocols: For a pregnant woman with a positive HBsAg test result Report the positive test result to the health DHHS/DPH, Section of Epidemiology (Appendix A) Provide a copy of the original laboratory report indicating the pregnant woman s HBsAg status to the hospital where the delivery is planned and to the health-care provider who will care for the newborn Attach an alert notice or sticker to the woman's medical record to remind the delivery hospital/nursery that the infant will need hepatitis B vaccine and HBIG at birth Educate the mother about the need for immunoprophylaxis of her infant at birth, and obtain consent for immunoprophylaxis before delivery. Consider printing additional reminder notices for mothers about the importance of immunoprophylaxis for infants and attaching the notices to the inside front or back cover of the medical record Advise the mother that all household, sexual, and needle-sharing contacts should be tested for HBV infection and vaccinated if susceptible Provide information to the mother about hepatitis B, including modes of transmission, prenatal concerns (e.g., infants born to HBsAg-positive mothers may be breastfed), medical evaluation and possible treatment of chronic hepatitis B, and substance abuse treatment (if appropriate) 7

Refer the mother to a medical specialist for evaluation of chronic hepatitis B For a pregnant woman with a negative HBsAg test result Provide a copy of the original laboratory report indicating the pregnant woman s HBsAg status to the hospital where the delivery is planned and to the health-care provider who will care for the newborn Include information in prenatal care education about the rationale for and importance of newborn hepatitis B vaccination for all infants Administer the hepatitis B vaccine series if the patient has a risk factor for HBV infection during pregnancy (e.g., injection-drug use, more than one sex partner in the previous 6 months or an HBsAg-positive sex partner, evaluation or treatment for a sexuallytransmitted disease. Repeat HBsAg testing upon admission to labor and delivery for HBsAg-negative women who are at risk for HBV infection during pregnancy or who have had clinical hepatitis since previous testing. 8

Frequently Asked Questions Where can I obtain a copy of the most recent recommendation of the Advisory Committee on Immunization Practices (ACIP) for the prevention of perinatal transmission of HBV infection? You can access the official document and appendices at: www.cdc.gov/mmwr/pdf/rr/rr5416.pdf. What blood test should be used to screen a pregnant woman to prevent perinatal hepatitis B virus (HBV) infection? Screening should be done with the hepatitis B surface antigen (HBsAg) test only. This blood test will tell whether a woman has current HBV infection that can be transmitted to her infant. Ordering other blood tests such as total antibody to hepatitis B core antigen (total anti-hbc) and/or antibody to HBsAg (anti-hbs) are not useful when screening to prevent perinatal HBV infections and should not be included in screening pregnant women for perinatal HBV infection. Total anti-hbc will be positive in all HBsAg-positive persons and anti-hbs are rarely positive in an HBsAg-positive person. Women who are found to be HBsAg positive should then be referred for counseling and medical evaluation that will include further testing. If there is reason to suspect recently acquired HBV infection in a pregnant woman, IgM class anti-hbc (IgM anti- HBc) could be done to differentiate recently acquired HBV infection from chronic HBV infection. IgM anti-hbc is the blood test that is positive in recently acquired HBV infection. Our laboratory screens pregnant women with a hepatitis B panel. Is this correct? No. A routine hepatitis B panel for screening pregnant women is not advised, nor is it necessary to determine current infection in a pregnant woman. This practice has led to a number of women being incorrectly labeled as HBsAg positive due to misinterpretation of the results on the lab report. In reporting results, some labs use the nomenclature "HBsAb" rather than the more commonly used term "anti-hbs" to designate antibody to HBsAg. Because the term "HBsAb" is only one character different from "HBsAg," the lab report is subject to misinterpretation and a number of "immune" women are incorrectly labeled as "HBsAg positive". Their infants are 9

given unnecessary postexposure treatment with hepatitis B immune globulin (HBIG) and the women experience unnecessary stress. Do women who have been vaccinated previously against HBV infection still need to be screened during pregnancy? Yes. Women who have received hepatitis B vaccine should still be screened for HBsAg early with each pregnancy. Just because a woman has been vaccinated does not mean she is HBsAg negative. Since postvaccination testing is not performed for most vaccinated persons, she could have been vaccinated even though she was already HBsAg positive. Is it safe to give hepatitis B vaccine to a pregnant woman? Yes. Limited data indicate no apparent risk for adverse events to developing fetuses. Current vaccines contain noninfectious HBsAg and should cause no risk to the fetus. If the mother is being vaccinated because she is at risk for HBV infection (e.g., a healthcare worker [HCW], a person with an STD, an IDU, multiple sex partners), vaccination should be initiated as soon as her risk factor is identified during the pregnancy. In contrast, HBV infection affecting a pregnant woman might result in severe disease for the mother and chronic infection for the newborn. I've identified a patient in my OB practice who is HBsAg positive. Should she be evaluated for liver disease during her pregnancy, or should the evaluation wait until the postpartum period? What should I recommend for her husband and her children? How urgent is the time frame? The earlier the evaluation is done, the better. Consultation with or referral to a liver disease specialist (i.e., hepatologist, gastroenterologist, infectious disease specialist) should be done. The consulting/referral physician should be completely aware of the patient's obstetrical status. In addition, the patient's sex partner and children or other household contacts should be tested for HBV infection (total antihbc and HBsAg) as soon as possible. If any are susceptible to HBV infection (anti-hbc and HBsAg negative), they should be vaccinated; if any are HBsAg positive, they should be referred to or have consultation with a liver disease specialist. 10

If a mother's HBsAg test result is not available at the time of birth, how should the infant be managed? Women admitted for delivery without documentation of HBsAg test results should have blood drawn and tested as soon as possible after admission. While test results are pending, all infants born to women without documentation of HBsAg test results should receive the first dose of single-antigen hepatitis B vaccine (without HBIG) by 12 hours of birth. If the mother is determined to be HBsAg positive, her infant should receive HBIG as soon as possible but no later than age 7 days, and the vaccine series should be completed according to a recommended schedule for infants born to HBsAg-positive mothers. If the mother is determined to be HBsAg negative, the vaccine series should be completed according to a recommended schedule for infants born to HBsAg-negative mothers. If the mother has never been tested to determine her HBsAg status and testing is not available (e.g., in remote locations), the vaccine series should be completed according to a recommended schedule for infants born to HBsAg-positive mothers. Administration of HBIG is not necessary for these infants. Is it safe for an HBsAg-positive mother to breastfeed her infant? Yes! An HBsAg-positive mother who wishes to breastfeed should be encouraged to do so, including immediately following delivery. However, the infant should receive HBIG and hepatitis B vaccine within 12 hours of birth. Although HBsAg can be detected in breast milk, studies done before hepatitis B vaccine was available showed that breastfed infants born to HBsAg-positive mothers did not demonstrate an increased rate of perinatal or early childhood HBV infection. More recent studies have shown that, among infants receiving postexposure prophylaxis to prevent perinatal HBV infection, there is no increased risk of infection among breastfed infants. What is the possibility of maternal HBV transmission when breastfeeding an infant if the mother is HBsAg positive and has cracked or bleeding nipples? 11

As stated before, although HBsAg can be detected in breast milk, there is no evidence that HBV is transmitted by breastfeeding. Babies born to HBsAg-positive mothers should be immunized with hepatitis B vaccine and HBIG, which will substantially reduce the risk of perinatal transmission and protect the infant from modes of postnatal HBV transmission, including the theoretical exposure to HBV from cracked or bleeding nipples during breastfeeding. To prevent cracked and bleeding nipples, all mothers that breastfeed should be instructed on proper nipple care. What if my baby does not get these shots? Up to 9 out of 10 babies born to infected mothers will end up being carriers for the rest of their lives, if they do not get the shots. Babies who end up as carriers have a 1 out of 4 chance of dying from liver problems. 19 out of 20 babies who get the shots will be protected for life! 12

References 1. American Academy of Family Physicians. U.S. Preventive Services Task Force, Screening for Hepatitis B Virus Infection in Pregnancy: Reaffirmation Recommendation Statement. American Family Physician. 2010 Feb 15; 81(4):502-504. Available at: http://www.aafp.org/afp/2010/0215/p502.html 2. Center for Disease Control and Prevention. A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States, 2005. MMWR December 23, 2005/54(RR16); 1-23. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5416a1.htm 3. Immunization Action Coalition. Ask the Experts, Hepatitis B. Vaccination Information for Healthcare Professionals. Available at: http://www.immunize.org/askexperts/experts_hepb.asp 4. Center for Disease Control and Prevention. Managing a Hepatitis B Prevention Program: A Guide to Life as a Program Coordinator. April 2007. Available at: http://www.cdc.gov/hepatitis/partners/perihepbcoord.htm# Websites: Centers for Disease Control and Prevention: www.cdc.gov/hepatitis National Immunization Program: www.cdc.gov/nip Immunization Action Coalition: www.immunize.org Healthy People 2020: www.healthypeople.gov Parents of Kids with Infectious Diseases: www.pkids.org HIPAA: www.cdc.gov/nip/policies/hipaa 13

Appendix A 14