Hepatitis B protocol (CG487)

Hepatitis B protocol (CG487) Approval and Authorisation Approved by Maternity Clinical Guidelines Committee Job Title or Chair of Committee Chair, Maternity Clinical Governance Committee Date 6 th April 2018 Change History Version Date Author Reason 1.0 April 2010 J Harris Trust requirement 2.0 Feb 2012 J Harris Reviewed 3.0 March 2014 J Harris Reviewed 4.0 Oct 2016 J Harris (AN screening coord) & S Wong (ST7 Obs & Gynae) 5.0 Mar 2018 J Young, AN Screening coordinator Reviewed changes to pg 3-5 & 7-8 and pg 11 references updated Reviewed changes in process throughout due to Path lab move This Protocol should be read in conjunction with the following: Antenatal Screening Protocol CG 474 Hep B in neonates guideline GL368 This document is valid only on the date last printed Page 1 of 14

Contents 1.0 Purpose... 3 2.0 Protocol Function... 3 3.0 Protocol Content... 3 3.1 Introduction... 3 3.2 Aim of Screening and Immunisation... 3 3.3 Other At-Risk groups... 3 3.4 Family Screening and Follow up... 3 3.5 Families where English is a second language... 4 3.6 Universal antenatal testing for Hepatitis B... 4 3.7 Declining Screening and re-offering of screening... 4 3.8 Re-offering Screening... 4 3.9 Confirmation and Result Distribution... 5 3.10 Ordering Vaccine and Immunoglobulin... 5 3.11 Counselling Referral and Follow Up for Women... 6 3.12 Responsibility of the Screening Coordinator... 6 3.13 Responsibility of the Virology Laboratory... 7 3.14 Responsibility of the Child Health Record Department... 7 3.15 Immunisation of the Newborn... 7 3.16 Delivery of a Complete Course of Immunisation... 9 3.17 Mothers who present Late in Pregnancy or in Labour:... 10 3.18 During Labour... 10 4.0 Consultation... 12 5.0 Dissemination/Circulation... 12 6.0 Monitoring of Effectiveness and Compliance... 12 7.0 Suspected Screening Incidents... 12 8.0 References... 12 Appendix 1 Infectious diseases screening pathway... 13 Appendix 2 IDS positive proforma... 14 This document is valid only on the date last printed Page 2 of 14

1.0 Purpose The Purpose of Screening and Immunisation for Hepatitis B is; To identify women at risk of transmitting Hepatitis B to their babies To immunise infants at risk of acquiring Hepatitis B To prevent at risk infants becoming chronic carriers of Hepatitis 2.0 Protocol Function The function of this Protocol is to clearly define the processes involved in screening and immunisation for Hepatitis B within the acute Trust, and to identify individual responsibilities within the programme. 3.0 Protocol Content 3.1 Introduction Infants born to mothers who are infected with Hepatitis B (HBsAg positive) have a high risk of acquiring Hepatitis B infection. Infants who acquire Hepatitis B at birth commonly develop chronic infection and run the risk of serious liver damage and even liver cancer. Neonatal immunisation with Hepatitis B vaccine is over 90% effective in reducing the risk of infection. To be fully effective, however, the infant must be immunised shortly after birth and complete a full course of immunisation. Some infants (see below) should also receive Hepatitis B Immunoglobulin in addition to the vaccine. This is determined by the testing of hepatitis B e markers and will be detailed on the mothers pathology report by the Virology Laboratory. 3.2 Aim of Screening and Immunisation To identify women at risk of transmitting Hepatitis B to their babies To immunise infants at risk of acquiring Hepatitis B To prevent at risk infants becoming chronic carriers of Hepatitis B 3.3 Other At-Risk groups Immunisation is also recommended for: Infants of substance-abusing mothers Infants of mothers who are Hepatitis C Positive Infants of fathers who are Hepatitis B positive 3.4 Family Screening and Follow up The sexual partner and other children should be offered screening for Hepatitis B. The sexual partner of the woman should be walked to the Florey This document is valid only on the date last printed Page 3 of 14

unit when the SCO meets with the couple.. Immunisation should be offered to contacts found to be susceptible. 3.5 Families where English is a second language Arrangements will be made for interpreters as necessary. Written information is available 13 different languages from:- https://www.gov.uk/government/publications/hepatitis-b-explaining-thescreening-result 3.6 Universal antenatal testing for Hepatitis B In the Royal Berkshire Foundation Trust, all pregnant women are offered hepatitis B screening as part of routine booking blood tests. This screening is offered during each pregnancy. If a woman is known Hepatitis B positive the Community Midwife will contact the SCO directly on the generic screening email rbft.screening@nhs.net, and document the status known positive on the Antenatal Pathology Request Form The purpose and potential benefits of this screening will be explained to the pregnant woman by her midwife. The woman will have been given Screening Tests For You And Your Baby available in 13 different languages from https://www.gov.uk/government/publications/screeningtests-for-you-and-your-baby-description-in-brief Those providing antenatal care will be sufficiently informed about Hepatitis B to be able to discuss the test and its implications with the pregnant women. Appropriate training for the community midwives and the antenatal clinic staff will be organised. After staff will have completed their initial training, updates will be listed with other training opportunities. All relevant staff should be up-to date with appropriate training. 3.7 Declining Screening and re-offering of screening Women should be informed that if they decline screening for Hepatitis B she will be contacted by the SCO and re-offered screening. The Community Midwife will inform the SCO directly on the generic screening email rbft.screening@nhs.net. The Community Midwife will also document that Hepatitis B has been declined on the Antenatal Pathology Request Form. The SCO will make contact by 20 weeks of pregnancy, with the intention of facilitating informed choice and not to coerce the woman into accepting the screen. If the initial offer is declined the Community Midwife should documented this in the hand-held record 3.8 Re-offering Screening If the woman declines screening on re-offer the SCO will inform Consultant in charge of the woman s care and the Consultant Neonatologist responsible for Infectious Diseases This document is valid only on the date last printed Page 4 of 14

3.9 Confirmation and Result Distribution All positive results are notified to the generic screening email rbft.screening@nhs.net. It is the responsibility of the SCO to check this email regularly and ideally daily. The SCO commences an IDPS audit form see appendix 1The SCO maintains a record of all Hepatitis B positive reports in the Hepatitis B register held by the screening team. The Screening Midwife will invite the woman and her partner for a face to face appointment within 10 working days of receipt of the result. The purpose of this appointment is to ensure that essential health education messages are explained to the couple. The importance of completion of the vaccination programme is completely understood and partner testing organised by accompanying the couple to the Florey unit to ensure opportunity for partner testing. Finally the SCO will take a blood test for the woman for:- 1. Core TotalE AntigenAB 2. Hepatitis B surface antigen 3. Liver Function Tests 4. Hepatitis B viral load DNA The SCO will document the result in the woman s hand held notes at this appointment The SCO will inform Child Health Information Services, to ensure follow up of the neonate for the vaccine programme The SCO will inform the woman s GP, to ensure follow up of the neonate for the vaccine programme All results for routine antenatal booking bloods are checked for availability by the midwife responsible for the woman s care 10 days after sampling. Routine negative Hepatitis B results are reported to the woman at 16 weeks and all results recorded in the woman s hand held notes at this time. The Virology Laboratory also informs the o Consultant in Communicable Diseases for West Berkshire. 3.10 Ordering Vaccine and Immunoglobulin Hepatitis B vaccine is stored in the labour ward fridge as a stock item. The SCO will provide information leaflet Hepatitis B: what does my positive result mean available in13 different languages from:- https://www.gov.uk/government/publications/hepatitis-b-explaining-thescreening-result The immunoglobulin if required will be ordered by the SCO form Public Heath England using a request form available https://www.gov.uk/government/publications/hepatitis-b-requesting-issue- This document is valid only on the date last printed Page 5 of 14

of-immunoglobulin-for-infants and then sending a copy to phe.hepatitisbbabies@nhs.net will be available from the Royal Berkshire Hospital Pharmacy as a named patient pack, this named patient pack should not be used for any other baby. In the event of needing immunoglobulin in an emergency situation, PHE can be contacted 24 hours a day on 020 832 76439. PHE will dispatch the immunoglobulin immediately to the hospital. All immunoglobulin is tracked and audited by PHE, and administration to the incorrect baby will require explanation and DATIX. Pharmacy also hold an emergency stock of 500iu of immunoglobulin, this can be discussed with pharmacy for release, to ensure the correct dose of 200iu is given. 3.11 Counselling Referral and Follow Up for Women All women will be referred to the Viral Hepatitis Clinic under gastroenterology. The SCO will email the team following the information on the IDPS audit form (Appendix 1). New diagnosis and highly infectious women s referral to specialist assessment within 6 weeks data is collected for Key Performance Indicators KPI ID2 quarterly All woman seen by the Gastroenterology Team will receive a letter, a copy of this letter is also distributed to the SCO, who will ensure filing in the woman s maternity notes Women may be started on Tenofovir Disoproxil by the hepatologist if HBV DNA greater than 107 IU/ml in the third trimester to reduce the risk of transmission of HBV to the baby HBV DNA level will be monitored 2 months after starting Tenofovir Disoproxil and ALT monthly after the birth to detect postnatal HBV flares Stop Tenofovir Disoproxil 4 to 12 weeks after the birth unless the mother meets criteria for long-term treatment 3.12 Responsibility of the Screening Coordinator A Hepatitis B pack is made up by the Screening Coordinator and filed in the Hospital notes. The alert page at the front of the maternity notes is marked with the words Hepatitis B positive. The Hepatitis B pack contains: contents page the carbonised information sheet, detailing the vaccine to be given and the immunisation schedule immunisation plan for the baby parent information leaflet This document is valid only on the date last printed Page 6 of 14

5 pre-addressed envelopes to the Consultant in Communicable Disease Control, the Child Health record Department, the GP,SCO and the Health Visitor. Insert for the Personal Child Health record (Red Book) These are available in the SCO office. An example Hepatitis B folder is available in the SCO s office to enable those deputising for the screening coordinator to follow the same procedure. A register of Hepatitis B positive women is maintained and updated by the SCO The SCO also informs the Child Health Information Services of all Hepatitis B positive women as soon as the team is informed by the Virology Laboratory. The SCO is responsible for timely referral to the Gastroenterology team for Specialist Assessment The SCO is responsible for initial contact of all Hepatitis B positive women within 10 working days as a standard 3.13 Responsibility of the Virology Laboratory To inform the SCO by generic screening email rbft.screening@nhs.net of all hepatitis B positive women. The Virology department also provide a weekly failsafe list of all women referred to the SCO in the preceding week. The laboratory will notify the SCO of any samples which are unsuitable for testing by a weekly failsafe sent to the generic screening email rbft.screening@nhs.net. Also the Community Midwife who is responsible for the woman s care must look up booking blood results within 10 days of sampling. On discovery of an unsuitable sample, the responsible Community Midwife must organise a repeat as soon as possible and not wait until the 16 week appointment. The SCO will be monitoring the completion of repeat sample. 3.14 Responsibility of the Child Health Record Department The Child Health record Department will send out reminders to the registered GP of each baby when the subsequent vaccinations are due at one month, 2 months and 12 months of age. 3.15 Immunisation of the Newborn The baby should be immunised within 24 hours of birth and receive immunoglobulin if indicated. The paediatric SHO will give these initial immunisations. This needs to be given regardless of gestation and birth weight. The attending Paediatrician should check the pathology report for the Hepatitis B serology result. A baby may be high risk because of the mother s acute hepatitis. See Hep B in neonates guideline GL368 This document is valid only on the date last printed Page 7 of 14

Instructions for the Paediatrician regarding vaccination of the newborn will be in the Hepatitis B pack Infants who are discharged shortly after birth require immunisation before discharge. If the 24 hour time period is exceeded and vaccine and immunoglobulin are indicated, these should be given as soon as practical The Paediatrician should re-explain the treatment. Verbal consent should be obtained (and documented in the neonatal notes and the Child Health record) for the Hepatitis B vaccine (HBV) and Hepatitis B specific immunoglobulin (HBIG), if indicated, to be administered to the newborn baby. The appropriate regimes for the use of HBV and HBIG are; Baby should receive Hepatitis B Status of Mother Hep B Vaccine HBIG HBsAg pos and HBeAg pos + + HBsAg pos and HBeAG neg/anti-hbeab neg + + HBAg positive, e markers undetermined + + Acute Hepatitis B during pregnancy + + HbsAg pos, anti-hbeab pos HBsAG pos and known HBV DNA level equal to or above 1x106 IUs/ml in an antenatal sample (even if anti-hbe pos)* *where viral load testing has been performed to inform the management of mother. HBsAg pos and infant born < or = 1500gm, regardless of e antigen status + - + + + + Note all babies regardless of gestation should receive the vaccine or immunoglobulin if they fit the criteria. This document is valid only on the date last printed Page 8 of 14

Dose of Hepatitis B vaccine (Engerix B) is 10 micrograms (0.5mls) or HBvaxPRO 5mcg in 0.5ml given intramuscularly in the anterolateral aspect of the thigh within 24 hours of birth. (Can be given up to 7 days after birth) The dose of Hepatitis B immunoglobulin for the newborn is 200 international units, (2ml) administered intramuscularly within 24 hours. The immunoglobulin will be ordered by the SCO in the antenatal period ) and will be available from the Royal Berkshire Hospital Pharmacy as a named patient pack. If necessary contact the On-Call Pharmacist if outside normal working hours. Do not delay administration.. Send an In-patient prescription to Pharmacy for the pack. If immunoglobulin is not available see 3.10 The buttock should not be used as the vaccine effectiveness is reduced if given in this site. The paediatrician will document the date, time and site of immunisation. Document the batch number in the neonatal record and the hepatitis B insert for the Child Health Record, and carbonated notification forms for Consultant in Communicable Disease Control, the Child Health record Department, the GP, SCO and the Health Visitor. 3.16 Delivery of a Complete Course of Immunisation The accelerated schedule is recommended for all infants who require Hepatitis B immunisation. First one: At birth, ideally within 24 hours Second one: 4 weeks after birth Third one: 8 weeks after birth the infant joins the routine vaccination programme for Hepatitis B (routinely offered since August 2017) Fourth one: 12 weeks of age Routine Hepatitis B vaccination programme Fifth one: 16 weeks of age-routine Hepatitis B vaccination programme Sixth one: At twelve months after birth Mothers with Hepatitis B will be given information on the number of doses the newborn requires to complete a full course of immunisations both antenatally and by. The Paediatrician will do this at the time of the immnuisation or before the mother and baby are discharged from the postnatal ward. The mother will be given the parent information leaflet in the Hepatitis B pack The Paediatric SHO will provide written information about the timing of future Hepatitis B vaccines for the infant, which will be forwarded to the GP with the obstetric discharge summary. This information, using the carbonised information sheet, will be sent by the post-natal ward to: GP Health Visitor Child Health record Department - using addressed envelopes in the Hepatitis B pack CCDC - using addressed envelopes in the Hepatitis B pack This document is valid only on the date last printed Page 9 of 14

Screening Co-ordinator The Paediatric SHO will complete the carbonated copies for the PHCR and insert into the red book Administration of the vaccine at one month, two months and at 12 months will usually be within primary care. A course started with one vaccine brand can be completed with another. To ensure that all the dosages of vaccination are administered at the right time, it is advisable that the Health Visitor ensures appointments are made and checks that the child has attended. There is no contra-indication to administering the Hepatitis B vaccine at the same time as the DTP, HIB, polio and meningococcal vaccines of the primary immunisation or the 4 th dose being given with the 1 st MMR. The Berkshire Health Protection Team will seek confirmation from the GP practice that the second, third and fourth doses have been given. The Health Protection Nurse will inform the Child Health Information Services of the dates when the immunisations have been given. 3.17 Mothers who present Late in Pregnancy or in Labour: Where screening has not been performed in early pregnancy, it should be offered to all women later in pregnancy or even at the time of delivery. Results of an urgent HBsAg screen will be available within 24 hours, Mon Fri, and an on-call service for this screening is also available on Saturday mornings. Contact the on-call microbiologist and request an urgent serology on the request form. In case the Hepatitis B immunoglobulin neo-natal preparation (2ml ampoule containing 200 iu international units) is NOT available and a delay for obtaining this is predicted to be significant, then the adult preparation, containing 500 international units in 5ml ampoules could be used. Provided that the correct dosage is used (200 iu). 3.18 During Labour It is recommended to avoid both fetal blood sampling and the use of fetal scalp electrodes. Hepatitis B information packs are available on the neonatal ward. Breast Feeding: There is no contra-indication to breast feeding when a baby born to a Hepatitis B positive mother has been immunised at birth and proceeds with a complete course of immunisation. Birth of a Premature Baby: The usual recommendation for the newborn applies to all neonates regardless of gestational age or birth weight. If the This document is valid only on the date last printed Page 10 of 14

baby is under 1500gms then immunoglobulin may be considered. See Hep B in neonates guideline GL368. This includes giving further doses if the baby remains in hospital for a month or more. Home Delivery of a Hepatitis B Positive Mother: Vaccines are kept as stock in the delivery suite fridge. The immunoglobulin will be ordered by the SCO in the antenatal period and will be available from the Royal Berkshire Hospital Pharmacy as a named patient pack. If necessary contact the On- Call Pharmacist if outside normal working hours. Do not delay administration. Send an In-patient prescription to Pharmacy for the pack. If immunoglobulin is not available see 3.10 The delivering midwife should refer the infant as soon as possible after birth to the paediatric team for administration of Hepatitis vaccination +/- immunoglobulin. The recommended vaccine and immunoglobulin should be administered within 24 hours of birth. The Paediatrician will ensure that the Hepatitis B pack is completed and the information sent to the relevant personnel. Miscarriage Women who miscarry and have a positive Hepatitis screening result will be informed by the SCO and advised to contact their GP for follow on care. The SCO will contact the GP to ensure the GP is aware of the result and can provide appropriate follow up care. Home Delivery of an Un-booked Pregnancy: The midwife attending the delivery will collect a blood sample for serology and mark it as urgent and send it to the virology laboratory at the Royal Berkshire Hospital the next working day. In the case of a positive result, the midwife shall refer the baby to the Neonatal Registrar at the hospital as soon as possible. Babies of Intravenous Drug users, Methadone Dependent and Hepatitis C Positive Mothers: These babies will be immunised according to this procedure regardless of the mother s Hepatitis B status. Movements of Patients in and out of the Area: Hepatitis B positive women who move into West Berkshire and are pregnant will have the routine booking blood tests performed. Cases found to be Hepatitis B positive will be referred to the SCO by generic screening email rbft.screening@nhs.net. It is the responsibility of the SCO to check this email regularly and ideally daily. The SCO commences an IDPS audit form see appendix 1The SCO maintains a record of all Hepatitis B positive reports in the Hepatitis B register held by the screening team, the Consultant Obstetrician will also be informed. Those moving out of the district will carry with them their obstetric patient held records, which will hold the result of the Hepatitis B screening test recorded in them. This document is valid only on the date last printed Page 11 of 14

4.0 Consultation This Protocol was written following consultation with personnel from these departments: Antenatal Services manager, Paediatrics, Pathology, Pharmacy, and Health Protection Agency. 5.0 Dissemination/Circulation This Protocol will be disseminated by the Maternity Clinical Governance Committee. 6.0 Monitoring of Effectiveness and Compliance Compliance with this Protocol will be monitored, reviewed, and action plans made. 7.0 Suspected Screening Incidents Screening Incidents will be reported by the Trusts reporting process DATIX Suspected safety or serious incidents within the screening programme will be notified by the Screening Midwives to the QA team and the screening and immunization team at PHE via the Screening incident assessment Form (SIAF).She will then act as guided by the QA Team. Managing Safety incidents in NHS Screening Programmes Guidance and the Screening Incident Assessment form (SIAF) can be obtained at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/6 72737/Managing_safety_incidents_in_National_screening_programmes.pdf 8.0 References 1. Infectious diseases in pregnancy screening: programme handbook 2016-2017. July 2016. Available at www.gov.uk/publications 2. https://www.gov.uk/government/publications/nhs-population-screening- reporting-data-definitions/antenatal-and-newborn-screening-kpis-for-2018-to- 2019-definitions#id3-antenatal-infectious-disease-screening--hepatitis-bcoverage 3. NH Infectious Diseases in Pregnancy Screening 2016-2017 4. Immunisation against Infectious Disease, Department of Health, 2006. The Green Book Available at www.gov.uk/government/publications/hepatitis- b- the-green-book-chapter-18 li Updated February 2016 5. https://www.gov.uk/government/publications/infants-born-to-hepatitis-binfected-mothers-immunisation-policy 6. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file /635584/Hexavalent_combination_vaccine_guidance_selective.pdf 7. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file /660357/Hexavalent_combination_vaccine_guidance_routine.pdf This document is valid only on the date last printed Page 12 of 14

Appendix 1 Infectious diseases screening pathway This document is valid only on the date last printed Page 13 of 14

Appendix 2 IDS positive proforma This document is valid only on the date last printed Page 14 of 14