Results from IAC’s 2001 and 2002 Birth Dose Surveys Presenter: Teresa A. Anderson, DDS, MPH Date: January 29, 2003 Place: National Hepatitis Coordinator’s Conference

History of the “birth dose” First universal recommendation: 11/22/91 Concern/controversy over thimerosal leading to AAP/PHS statement: 7/8/99 Thimerosal-free hepatitis B vaccine available: 9/10/99 Subsequent confusion and decreased use of hepatitis B vaccine at birth for HBsAg- and unscreened and HBsAg+ mothers

Big question of 2001 survey: What’s the status of the birth dose 2 years after thimerosal-free hepatitis B vaccine became available?

Birth Dose Survey Methodology Questionnaire sent to all state, metropolitan and territorial immunization programs, October 2001 Follow-up with e-mail and phone reminders

Response to 2001 Survey 50/50 states 9/11 metropolitan projects 1/8 territories

Question #1 Would it help your state if ACIP expressed a preference for the administration of hepatitis B vaccine to all infants prior to hospital discharge?

Responses to Question #1

Question #2 aware of any babies of HBsAg-positive During the past several years, are you aware of any babies of HBsAg-positive mothers who were not prophylaxed within 12 hours of birth with HBIG and vaccinated within 12 hours with hepatitis B vaccine? If so, please tell how many of these situations you know about and tell us how these situations happened.

Over 200 examples provided from 38 states and projects Response to Question #2 Over 200 examples provided from 38 states and projects

Reasons for infants not being appropriately prophylaxed when mother was HBsAg+ Hospital staff failed to notice or act upon HBsAg+ test result in mother’s or infant’s chart Mother delivered at a different hospital or with a different care provider Vaccine was erroneously withheld from preterm infants Lack of knowledge on part of provider

Question #3 Do you know of any babies born to mothers whose HBsAg status was unknown at the time of birth and who did not receive hepatitis B vaccine within 12 hours of birth? If so, please describe how these situations happened.

Reasons given for infants not being appropriately prophylaxed when mother was unscreened “Stat” lab turn-around time more than 12 hours Mother left hospital before results were available Physician assumptions

Question #4 Do you know of babies whose mother’s lab test for HBsAg was wrongly ordered, misinterpreted, or mistranscribed? If yes, please describe how these situations happened.

Reasons for infants not being appropriately prophylaxed due to errors in test ordering, recording, or interpreting Wrong screening test ordered-usually HBsAb (antibody to hepatitis B surface antigen) instead of HBsAg (hepatitis B surface antigen) test Test results misinterpreted Test results mistranscribed

2001 Survey Summary

Big question for 2002 survey: What’s the status of the birth dose after the January 2001 ACIP recommendation?

Response to 2002 Survey 50/50 states 6/6 local projects

Question #1 Has the new ACIP recommendation to give the birth dose had an impact in your state or project?

Response to Question #1

Question #2 During the past year (Oct. 2001-Oct. 2002), are you aware of any babies of HBsAg+ mothers who were not prophylaxed within 12 hours of birth with HBIG and vaccinated within 12 hours with hepatitis B vaccine? If YES, please estimate the number of cases describe why these situations happened.

166 examples provided from 24 states and projects Response to Question #2 166 examples provided from 24 states and projects

Question #3 During the past year (Oct. 2001-Oct. 2002), do you know of any babies born to mothers whose HBsAg status was unknown at the time of birth and who did not receive hepatitis B vaccine within 12 hours of birth? If so, please estimate how many cases you know about and describe how these situations happened.

Response to Question #3 An additional 33 cases were provided, in addition to the ones mentioned in response to Question #1.

Question #4 During the past year (Oct. 2001-Oct. 2002), are you aware of any babies whose mothers’ lab tests for HBsAg were wrongly ordered, misinterpreted, or mistranscribed? If yes, please estimate the number of cases.

Response to Question #4 Approximately 163 cases were provided, in addition to the ones mentioned in response to Question #1.

This is the tip of the iceberg… Health department staff primarily follow HBsAg+ women and their babies: there may be many more mistakes made than reported here.

Question #5 Are there health care providers in your state or area who do not routinely give the birth dose?

Response to Question #5

If YES, in your opinion, what is the main reason they don’t (please check all that apply)

They are confused about the hepatitis B vaccine recommendation for premature infants 10 (56 responders, 142 votes)

They don’t know about the ACIP and AAP statements recommending the birth dose for all infants 14 (56 responders, 142 votes)

They don’t understand the ACIP and AAP statements recommending the birth dose for all infants 14 (56 responders, 142 votes)

They use Comvax and don’t know how to correctly coordinate its use with single-antigen hepatitis B vaccine 18 (56 responders, 142 votes)

Other “Want to give first dose in office due to convenience and revenue” 20 (56 responders, 142 votes)

They use Comvax and don’t believe that it is necessary to begin the hepatitis B vaccine series before 2 months of age on infants born to HBsAg- women 32 (56 responders, 142 votes)

They don’t agree with the ACIP and AAP statements recommending the birth dose for all infants 34 (56 responders, 142 votes)

“Physicians tend to practice the way they want to, not necessarily the way that is recommended.”

2002 Survey Summary

Reasons for NOT giving the birth dose Administration in the office setting may cost less (and administration fee goes to provider) It is easier to keep track of doses if all administered in the office Combination vaccine can be given for first dose (Hib/Hepatitis B) Perceived continued risk from thimerosal

Reasons FOR giving the birth dose Prevents perinatal HBV transmission Provides a safety net for babies born to unscreened mothers Protects children from horizontal transmission in early infancy from caregivers and household contacts Increases timely completion of vaccines

Weigh the benefits...

Suggestions to improve administration of the birth dose

More education especially from peers “Physicians need to hear from other physicians, not from nurses begging them to participate in programs to vaccinate infants.”

Address cost and reimbursement issues “They want to charge for the first dose in their office.” “Hospitals are concerned about cost because the cost of hep B immunization is bundled into the prenatal care rate and there is no separate mechanism for billing.” Extra cost built in when giving an extra dose because of Comvax use.

Address Comvax issues “Find a way to sell the birth dose plus Comvax to providers.” “Although it may be safe to give an extra dose of hep B vaccine when using Comvax, this costs a great deal of money for the states, providers, and parents… the only one benefiting is the vaccine manufacturer.” “Comvax is an anti-birth dose product. It confuses everyone. VFC should stop providing it.”

Standardize laboratory terms “Ensure universal abbreviations for lab markers are used and educate providers in their meaning.” “The differences in lab forms and lack of standardization of lab tests increases the likelihood of errors.”

Make it a law “Make it a law with waivers allowed Make it a law “Make it a law with waivers allowed.” “Make it a mandatory action for babies to receive the birth dose.”

Make the recommendation stronger “The ACIP statement should say ‘Give the birth dose,’ period, not ‘soon after birth,’ or ‘at 2 months of age.’ Pediatricians don’t see that the new statement is any different than the old statement.”

Use scare tactics “Inform the providers of the liability they could face if a child develops hepatitis B as a result of missing the birth dose.” “Share cases where the hospital or physician did not follow ACIP recommendations and was sued.” “Give all doctors and clinics information on these types of errors.”

Visit IAC’s “Birth Dose” web page: www.immunize.org/birthdose (12,219 views in year since posted)

IAC’s “Birth Dose” web page: -2001 and 2002 survey results -journal articles -letter from Dr. Wexler -advice from state coordinators -article from State of Michigan -education pieces for providers