Assessment of Hepatitis B Birth Dose Program Participation in New York State Debra Blog, MD, MPH Director, Bureau of Immunization Kimberly Noyes, MD, MPH Director, Bureau of Communicable Disease Control New York State Department of Health National Immunization Conference March 30, 2009

Presentation Outline Historical overview of perinatal hepatitis B prevention strategies in New York State (excluding New York City) Hypothesized barriers and challenges to perinatal hepatitis B prevention Survey of all birthing hospitals in New York State (outside of NYC)

Basis for Perinatal Hepatitis B Prevention Strategy in New York State Perinatal disease leads to serious long-term health issues Chronic carrier status higher – 90% Liver cirrhosis Liver cancer HBV-infected women may be unaware of status or deny risk factors Post-exposure prophylaxis (vaccine + HBIG) is extremely effective Over 95% of cases can be prevented!! Hepatitis B virus infection affecting a pregnant woman may result in severe disease for the mother and chronic infection for the newborn. Neither pregnancy nor lactation should be considered a contraindication to vaccination.

Historical Overview of Perinatal Hepatitis B Prevention Efforts in New York State Public Health Law 2500-e enacted Lot Quality Assurance monitoring began Survey of hospitals shows cost barrier Hospital birth dose initiative began ACIP recommends universal birth dose Commissioner letter Birthing hospital survey 1990 1998 2002 2003 2004 2005 2006 2007 2008

Perinatal Hepatitis B Prevention in New York State 1990 Public Health Law (PHL) 2500-e mandates hepatitis B screening and reporting for all pregnant women Goals of PHL 2500-e: All pregnant women screened each pregnancy Treatment of all infants born to HBsAg-positive women Provide STAT testing for women with unknown status and treatment of their infants Require reporting

Lot Quality Assurance Monitoring Initiated around 1993 A systematic medical record review method to evaluate hospital compliance with state PHL 100% of the records reviewed must contain HBsAg status in both maternal and infant record Review performed by state Immunization staff with local health departments rather than hospital staff Opportunity for regional state immunization staff and local health department staff to interface with local hospital Valuable educational opportunity

Lot Quality Assurance Monitoring Provides opportunity to assess other variables Prenatal and post-partum immunization practices Tdap, influenza, varicella, MMR, etc. Immunization documentation Birth dose rates and practices

Hepatitis B Birth Dose Initiative Program Goal Eliminate transmission of hepatitis B Introduced in 10/2003 2002 survey of hospitals showed cost was a barrier Provides hepatitis B vaccine at no cost to hospitals Hospital enrolls in VFC program

Hepatitis B Birth Dose Initiative Hospital adopts a universal birth dose policy Hospital must have a hepatitis B birth dose standing order in place stating that all newborns, regardless of maternal HBsAg status, individual provider preference or infant’s insurance status, will be offered hepatitis B vaccine Parental consent is obtained as per NYS law

Official New York State Department of Health Letter to Facilities Defines Universal Birth Dose as the Standard of Care in NYS April 2006, Commissioner of Health “Standard of care that NYSDOH supports…all NYS birthing hospitals should immediately comply by implementing standing orders for vaccination of all newborns with hepatitis B vaccine within 12 hours of birth”

Enrollment in Birth Dose Initiative

National Immunization Survey Data New York State outside of New York City *National average in 2005 reflects birth to 2 days. National average in 2006 and 2007 reflects birth to 3 days

So, why such low numbers? Robust perinatal hepatitis B prevention program Strong public health law Routine hospital monitoring Vaccine provided to hospitals at no cost …..What are we missing?

Birth Dose – Hypothesized Challenges Lack of education (provider, parental, nursing, etc.) Misconception that hepatitis B infection is no longer a problem in NYS Misconception that hepatitis B infection is not a risk in certain locations, usually more rural parts of the state Complacency because NYS law requires screening of all pregnant women Physician concerns about administering 4 doses when combination vaccines are used for follow up doses Desire by some physicians to administer the 1st dose of hepatitis B vaccine in the office setting rather than at birth

Birth Dose – Hypothesized Challenges Physician desire to bill for vaccine in office Objection to government (CDC, NYSDOH, JCAHO) involvement in physician practices The birth dose initiative requires hospitals to have “standing orders” but many hospitals are not using true non patient specific standing orders Many physicians are still opting out of administering the birth dose Parental fear about vaccines

Birthing Hospital Survey, April 2008 To better understand the various factors that may be contributing to the overall low birth dose administration rate Quantify and describe Implementation of universal birth dose policies and standing orders Existence of barriers impeding full program participation Perceived effectiveness of potential remedies

Birthing Hospital Survey, April 2008 Methods Electronic Survey distributed to all birthing facilities via the Department’s Health Emergency Response Data System (HERDS) Medical Directors and Nurse Managers of Newborn Nursery Units were asked to individually complete the same 20-question survey Periodic telephone follow-up to all non-responders

Birthing Hospital Survey Self-administered, brief, voluntary Basic demographic and professional information Existence of a universal birth dose policy and standing orders at hospital Usefulness? Type of standing orders? Perceived barriers to administering birth dose Perceived effectiveness of potential strategies to address barriers

Results Overall survey response rate high—95% All hospitals represented Nurse response slightly higher than physician response Nurse response rate 99% Physician response rate 91.1%

Characteristics of Survey Respondents Proportion (%) Professional Degree (n=192) Physician 47.4 Nurse 51 Midlevel 1 Other 0.5 Profession/Specialty (n=192) Pediatrics 32.3 Obstetrics 28.1 Nursing 20.8 Administration 6.8 Neonatology 6.3 3.1 Family Medicine 2.6

Birth Dose Policy Proportion (%) Adopted birth dose policy? (n=192) No 2.1 Yes 97.9 Perceived usefulness? (n=184) Very 79.9 Somewhat 15.8 Not so much 4.3 Not at all

Standing Orders Use standing orders for hepatitis B vaccine? (n=192) Proportion (%) No 2.1 Yes 97.9 What type? (n=188) Patient specific (n=105) 55.9 Non patient specific (n=83) 44.1

Perceived barriers to use of non patient specific standing orders Proportion (%) Physicians not supportive 39.8 Physicians unaware of this option 21.4 Hospital unaware of this option 14.3 Hospital not supportive 11.2 Nurses not supportive 5.1 Other* 36.7 *Other=Perception of need for parental consent

Additional information Which provider completes newborn admission orders? (n=192) Proportion (%) Pediatric provider under whom newborn is admitted 92.7 Obstetrician/Delivering provider 7.3 Where is the hepatitis B dose given most of the time? (n=192) Delivery Room 25.5 Newborn Nursery/Postpartum Unit 74.5

Prenatal education classes Does your hospital provide prenatal/childbirth education classes? (n=192) Proportion (%) No 2.1 Yes 97.9 Does the curriculum include information on infant immunizations? (n=188) 77.1 9 Don’t Know 13.8

Perceived Barriers Frequently or Occasionally Seldom or Never When infants discharged home without receiving hepatitis B birth dose, how often do you feel this is related to: (n=192) Lack of awareness of recommendation by nursing 3.6 96.4 Lack of awareness of recommendation by obstetrician 6.3 93.8 Lack of awareness of recommendation by pediatrician 10.9 89.1 Lack of awareness of recommendation by parent(s) 22.9 77.1 Physician disagreement with recommendation 33.3 66.7 Nursing disagreement with recommendation VIS unavailable 1.6 98.4 Parent refusal 76.6 23.4 Parent preference to discuss with pediatrician 55.2 44.8 Lack of physician availability for vaccine counseling

Perceived Barriers: Provider-related factors Frequently or Occasionally Seldom or Never When physician disagreement and/or lack of physician awareness are the reasons for discharge without receipt of birth dose, how often do you feel this related to: (n=191) Physician plans to give vaccine in private office 56.5 13.5 Physician desires to bill for vaccine in private office 22 78 Physician not aware that vaccine is free for hospitals 5.2 94.8 Hospital pharmacy not aware that vaccine is free 2.1 97.9

Perceived Barriers: Parent-related factors Frequently or Occasionally Seldom or Never When parental refusal is the reason for discharge without receiving the birth dose, how often do you feel this is related to: (n=192) Plan for pediatrician to give vaccine in office 77.6 22.4 Parental fear of vaccination in newborn 65.6 34.4 Parental fear of vaccination in general 56.3 43.8 Parental cultural belief(s) 33.3 66.7 Community belief(s) 15.6 84.4

Prior Knowledge About Birth Dose Answer to the question: What percentage of pregnant women presenting to Labor & Delivery have prior knowledge of the recommendation for all infants to receive a hepatitis B dose? (provide estimate) Histogram: Proportion of women that were estimated to have prior knowledge

Perceived effectiveness of potential strategies to address barriers Very or Somewhat effective Not so/ not at all How effective would you find these potential remedies? (n=192) Parental education on hepatitis B birth dose prenatally 94.8 5.2 Obstetrician education 67.7 32.3 Pediatrician education 78.6 21.4 Nursing education 70.3 29.7 Adoption of non-patient specific standing orders 60.4 39.6 Offering providers financial incentives to vaccinate 45.3 54.7

Survey Limitations Subjective data Limited generalizeability Personal opinions about universal birth dose recommendation could have affected responses (in either direction) Some data reflects best estimates Limited generalizeability May not apply to all health care providers in the state Low representation of family physicians Responder bias Survey conducted by Immunization Program that provides vaccine at no cost to hospitals Could have skewed the results in positive direction

Interesting Discovery… New York State Immunization Information System (NYSIIS) became mandatory statewide in 2008 In December 2008, vital statistics loaded all birth records of infants born in NYS (outside of NYC) back to 2004 into NYSIIS Vital statistics has collected newborn hepatitis B immunization status since approximately 1997 Should reflect ACTUAL birth dose administration statewide

Vital Statistics Reporting of Hepatitis B Birth Dose by Hospital Size (annual birth cohort) % Receiving Birth Dose Represents NIS estimate for New York State

Percent of Births Receiving Hep B Birth Dose By Hospital NIS Estimates 2004 – 13.6 sd 5.4 2005 – 17.0 sd 5.9 2006 – 16.9 sd 5.3 2007 – 32.3 sd 7.7

Survey estimate vs. Vital statistics data vs. NIS estimate % Receiving Birth Dose

Next Steps Use vital statistics data and survey results to: Provide positive feedback to hospitals who are successfully implementing their universal birth dose policies Provide impetus to hospitals with low birth dose rates to adhere to the policy they have adopted Encourage use of non patient specific standing orders Education Parent (prenatal focus) Provider (Pediatrics and OB focus) Conduct QA review of hepatitis B immunization reporting to vital statistics (and ultimately, NYSIIS) Conduct QA review of doses ordered vs birth dose rates

Many thanks to… Survey evaluation Survey design and follow-up Michael Flynn Suzanne Solghan Survey design and follow-up John Kushner Geri Naumiec Barbara Wallace

New York State Department of Health Perinatal Hepatitis B Prevention Program Bureau of Immunization Corning Tower Room 649 Empire State Plaza Albany, NY 12237 (518) 473-4437 Perinatal Hepatitis B Coordinator Lynn Pollock, RN lxp01@health.state.ny.us