DEPARTMENT OF HEALTH Rheynn Slaynt. Immunoglobulin Policy

Transcription

1 DEPARTMENT OF HEALTH Rheynn Slaynt Immunoglobulin Policy February 2012

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3 Contents 1. Introduction Rabies Immunoglobulin (RIG) Indication for use Access to the immunoglobulin Prevention of rabies Varicella Zoster Immunoglobulin (VZIG) Indication for use Access to the immunoglobulin Hepatitis B Immunoglobulin (HBIG) Indication for use Access to the immunoglobulin Tetanus Immunoglobulin (TIG) Indication for use Access to the immunoglobulin Prevention of tetanus Human Normal Immunoglobulin (HNIG) Indications for use Access to immunoglobulin Prevention of measles Further information about immunoglobulins Table 1: Table 2: Table 3: Table 4 Table: 5 Table: 6 Guide to post-exposure prophylaxis following risk assessment for rabies Procedure for vaccinating healthcare workers VZIG algorithm for immunocompromised patients who have been exposed to varicella zoster VZIG algorithm for neonates VZIG algorithm for pregnant women Dosage of HBIG Immunoglobulin Policy - February

4 Table 7: Table 8: Table 9: Vaccination of term babies according to the hepatitis B status of the mother HBV prophylaxis for reported exposure incidents Tetanus - Immunisation recommendations for clean and tetanus-prone wounds Immunoglobulin Policy - February 2012

5 1. Introduction Historically the Isle of Man has received immunoglobulin on request from the Health Protection Agency (HPA). It has become apparent that the HPA is no longer going to provide this service to any of the independent jurisdictions. This prompted the Public Health Directorate to investigate alternative arrangements and issue a policy so that practitioners can access the immunoglobulins in a timely manner, as necessary. To aid your assessment of risk please refer to: Immunisations against Infectious Disease - aka The Green Book ndguidance/dh_ Whilst the HPA will not be supplying any immunoglobulin, they are still available for advice. oster/ Immunoglobulin Policy - February

6 2. Rabies Immunoglobulin (RIG) 2.1 Indication for use Rabies immunoglobulin (RIG) may be necessary for post-exposure management of a rabies exposure. Ideally this should be undertaken in the country where the exposure occurred but may occasionally be necessary on return home to the Isle of Man following a risk assessment. RIG gives rapid protection until the rabies vaccine becomes effective. The risk assessment is based on the circumstances of the exposure: epidemiology in the country where exposure occurred immune status of the patient site and severity of the wound circumstances of the bite (or other contact) species, behaviour and appearance of the animal epidemiology of rabies in that species vaccination status of the animal if known. Bat bites on the Isle of Man assessment of risk of rabies from local bat contact is more difficult. Contact the Government Veterinary Officers for advice. 2.2 Access to the immunoglobulin Any clinician who, after a thorough risk assessment, decides that postexposure prophylaxis is necessary for their patient should contact the on-call Consultant in Public Health. The Consultant will liaise with Noble s Pharmacy who will arrange for RIG and/or the appropriate doses of rabies vaccine to be released. It is the responsibility of the clinician to infiltrate the wound with RIG and to administer the appropriate doses of rabies vaccine. See Table 1 for dosage schedule. Because of the short shelf-life, expense of the RIG and infrequent requirements for its use, a working group decided that it was not cost-effective to stock RIG on the Island. The situation will be under constant review. 4 Immunoglobulin Policy - February 2012

7 2.3 Prevention of rabies Pre-exposure immunisation with the rabies vaccine is recommended to protect those who are at most risk of exposure to rabies. Adequate cover would negate the need for RIG as post-exposure prophylaxis two doses of vaccine on days 0 and 3 would be enough. General Practice should promote the vaccine for some travellers depending on countries to be visited, their activities and access to appropriate healthcare. The vaccine should also be offered to people who regularly handle bats because of the risk from European Bat Lyssavirus (EBLV) - criteria in the Green Book. The vaccinator must include advice of the practical steps to be taken if they are bitten by an animal or have some other types of exposure which puts them at risk of rabies. 3. Varicella Zoster Immunoglobulin (VZIG) 3.1 Indication for use The aim of post-exposure management is to protect individuals at high risk of suffering from severe chickenpox (for example, immunosuppressed patients, neonates and pregnant women) and those who may transmit infection to those at high risk (for example, healthcare workers). No antibodies to VZ virus is a vital factor in the decision to give VZIG. The definition of a significant exposure is contained in the Varicella chapter in the Green Book. The aim of VZIG prophylaxis in pregnant women is to: Reduce severity of maternal illness the risk of fatal varicella is five times higher for pregnant women than for non-pregnant women, particularly in the late second trimester / early third trimester. Reduce the risk of congenital varicella syndrome where exposure occurs in the first 20 weeks of pregnancy. VZIG is recommended for VZ antibody-negative pregnant contacts exposed at any stage of pregnancy, providing VZIG can be given within ten days of contact. However, when supplies of VZIG are low, administering to pregnant women may be restricted. Clinicians are advised to check availability of VZIG before offering it to pregnant women exposed more than 20 weeks after LMP but more than three weeks before EDD. Immunoglobulin Policy - February

8 VZIG is also recommended for: VZ antibody-negative infants exposed to chickenpox or herpes zoster (other than in the mother) in the first seven days of life. VZ antibody-negative infants of any age, exposed to chickenpox or herpes zoster while still requiring intensive or prolonged special care nursing. healthcare workers without VZ antibodies following a significant exposure should be offered varicella vaccine within 3 days of exposure, ideally, as there is evidence that this may be effective in preventing onset of disease (Varivax is licensed for post-exposure prophylaxis). Exclusion from work may be considered or the healthcare worker should report to Occupational Health services before having patient contact if they feel unwell or develop a fever or rash. Chapter 34 in the Green Book Varicella - contains comprehensive information about who is classed as immunosuppressed, etc. Tables 2, 3, 4 and 5 enclosed in this document refer to pages in the Green Book to enable a thorough risk assessment to be made. 3.2 Access to the immunoglobulin The Isle of Man Health Services will always have a stock of 4 vials of VZIG (250 mg) stored in Noble s Hospital Pharmacy. Following use or expiry, the stock will be replaced immediately. If a vulnerable patient - whether immunosuppressed, pregnant or a neonate in the first week of life - has a significant exposure to varicella, the algorithms should be consulted. General Practitioners should refer the case urgently to the Consultant in charge of the patient s care whilst organising a prompt antibody assessment. The Consultant will organise the administration of VZIG as necessary. 6 Immunoglobulin Policy - February 2012

9 4. Hepatitis B Immunoglobulin (HBIG) 4.1 Indication for use HBIG is used as post-exposure prophylaxis and is given concurrently with hepatitis B vaccine. It is recommended only in high-risk situations or for a known non-responder to vaccine. HBIG should be given as soon as possible, ideally within 48 hours, although it should still be considered up to a week after exposure. See table 6 for dosage required. Hepatitis B vaccine is highly effective at preventing infection if given shortly after exposure (see below). Ideally, immunisation should commence within 48 hours, although it should still be considered up to a week after exposure. The use of HBIG in addition to vaccine is recommended in the following circumstances: Pregnancy and birth Neonates born to mothers who are chronically infected with HBV see table 7. Mothers who have had acute hepatitis B during pregnancy. Babies with a birth weight of 1500g or less, born to mothers infected with hepatitis B regardless of the e-antigen status of the mother. For post-exposure prophylaxis in babies born to mothers infected with hepatitis B, the accelerated immunisation schedule is preferred. For these babies this will mean an initial dose of vaccine at birth, with further doses at 1 and 2 months of age and a fourth dose at 12 months of age. Testing for HBsAg at 12 months of age will identify any babies for whom this intervention has not been successful and who have become chronically infected with hepatitis B; this will allow them to be referred for assessment and any further management. This testing can be carried out when the fourth dose is given. Immunoglobulin Policy - February

10 Sexual contact Sexual partner of individuals suffering from acute hepatitis B, and who are seen within one week of last contact. Sexual contacts of an individual with newly-diagnosed chronic hepatitis B should be offered vaccine; HBIG may be added if unprotected sexual contact occurred in the previous week. Persons who are accidentally inoculated or contaminated Any individual potentially exposed to HBV-infected blood or body fluids, depending on their immune status and the status of the source of infection, should receive HBIG and/or HBV vaccine. This includes those who contaminate their eyes or mouth, or fresh cuts or abrasions of the skin, with blood from a known HBsAg-positive person. See table 8. For post-exposure prophylaxis, an accelerated vaccination schedule should be used, with vaccine given at 0, 1 and 2 months. For those who are at continued risk, a fourth dose is recommended at 12 months. The product licence for Engerix B has been granted to allow for a very rapid immunisation schedule of three doses, given at 0, 7 and 21 days (Bock et al, 1995). When this schedule is used, a fourth dose is recommended to be given 12 months after the first dose. This schedule is licensed for use in circumstances where adults over 18 years of age are at immediate risk and where a more rapid induction of protection is required. This includes persons travelling to areas of high endemicity, injecting drug users (IDUs) and prisoners. 4.2 Access to the immunoglobulin HBIG is available in 2ml ampoules containing approximately 200IU or 4ml, 500IU. One vial of 500IU is kept in stock at all times. Practitioners are to contact the Consultant in the Pathology Department to discuss the risk assessment and arrange receipt of the HBIG. 8 Immunoglobulin Policy - February 2012

11 5. Tetanus Immunoglobulin (TIG) 5.1 Indication for use Tetanus immunoglobulin (TIG) may be necessary for the prevention of tetanus disease where an individual has acquired a tetanus-prone wound. Tetanus-prone wounds include: Wounds or burns that require surgical intervention that is delayed for more than six hours. Wounds or burns that show a significant degree of devitalised tissue or a puncture-type injury, particularly where there has been contact with soil or manure. Wounds containing foreign bodies. Compound fractures. Wounds or burns in patients who have systemic sepsis. Tetanus vaccine given at the time of a tetanus-prone injury may not boost immunity early enough to give additional protection within the incubation period of tetanus. Therefore, if the wound, burn or injury fulfils the above criteria, and is considered to be high risk, tetanus immunoglobulin should be given for immediate protection, irrespective of the tetanus immunisation history of the patient. This is a precautionary recommendation since there is insufficient current evidence to support other alternatives. High risk is regarded as heavy contamination with material likely to contain tetanus spores and/or extensive devitalised tissue. In addition to the management of such a patient, thorough cleaning of wounds is essential. Whilst tetanus vaccine is not considered adequate for treating a tetanusprone wound, this provides an opportunity to ensure that the individual is protected against future exposure. To make a decision on the use of vaccine and/or TIG, please refer to Table 9. For prevention where a tetanus-prone wound is present: 250IU of TIG by intramuscular injection is recommended, or 500IU if more than 24 hours have elapsed since injury or there is a risk of heavy contamination, or following burns. Immunoglobulin Policy - February

12 For treatment of tetanus infection: Early recognition and treatment may be life saving but few clinicians in the UK have experience of managing tetanus. Recent experience has pointed to injecting drug users as being at significant risk of tetanus. Injecting drug users may be at risk from tetanus-contaminated illicit drugs, especially when they have sites of focal infection such as skin abscesses that may promote growth of anaerobic organisms. Every opportunity should be taken, by all healthcare professionals who have contact with IDUs, to facilitate appropriate immunisation. The dose of tetanus immunoglobulin for intravenous use is ,000IU by infusion. If intravenous administration is not possible, 150IU/kg of the intramuscular preparation may be given in multiple sites. 5.2 Access to the immunoglobulin Tetanus immunoglobulin is available in 1ml ampoules containing 250IU. A & E and Ramsey MIU usually keep some stock, (6 vials and 2 vials respectively). Noble s Pharmacy attempt to keep 20 vials especially for the TT and the Manx Grand Prix race events and will issue to the two emergency centres as necessary. 5.3 Prevention of tetanus The objective of the immunisation programme is to provide a minimum of five doses of tetanus-containing vaccine at appropriate intervals for all individuals. In most circumstances, a total of five doses of vaccine at the appropriate intervals are considered to give satisfactory long-term protection. Professionals in General Practice need to be vigilant in checking that all patients have received the required number of doses especially in individuals who are at increased risk such as IDUs. Some individuals may require additional doses depending on their circumstances see the Tetanus chapter of the Green Book for further information. A tetanus containing vaccine may be offered following a tetanus-prone wound see Table Immunoglobulin Policy - February 2012

13 6. Human Normal Immunoglobulin (HNIG) 6.1 Indications for use HNIG is used for the first line treatment of idiopathic thrombocytopenia (ITP). Children and adults with compromised immune systems, where vaccination with MMR has been contraindicated, should be considered for normal immunoglobulin as soon as possible after exposure to measles infection. Pregnant women who are exposed to measles may also be considered for intramuscular normal immunoglobulin. Measles infection in pregnancy can lead to intra-uterine death and pre-term delivery, but is not associated with congenital infection or damage. A very high proportion of pregnant women will be immune and therefore normal immunoglobulin is only offered to women who are likely to be susceptible based upon a combination of age, history and/or measles IgG antibody screening. Where the diagnosis in the index case is uncertain, this assessment should be done as part of the investigation of exposure to rash in pregnancy. Link to Guidance on Viral Rash in Pregnancy: Dosage of normal immunoglobulin - to prevent or attenuate an attack: Immunosuppressed patients: 0.15g/kg of intravenous normal immunoglobulin (IVIG) given by intravenous infusion or 0.6ml/kg of subcutaneous human normal immunoglobulin (HNIG) given by subcutaneous infusion. Immunocompetent infants and pregnant women: Infants under one year of age: 0.6 ml/kg of subcutaneous human normal immunoglobulin (HNIG) up to maximum of one vial (approximately 5ml) by intra-muscular injection. Pregnant women: 2250 mg of subcutaneous human normal immunoglobulin (HNIG) up to maximum of three vials (approximately 15ml) by intra-muscular injection. Immunoglobulin Policy - February

14 Please refer to the document - Post Exposure Prophylaxis for Measles: Revised Guidance May 2009, for further information about the timing of immunoglobulin administration: Access to immunoglobulin Normal immunoglobulin is prepared from pooled plasma derived from blood donations and contains antibody to measles and other viruses prevalent in the population. There are two types of preparations available, those for intramuscular or subcutaneous use and those for intravenous use. Access to HNIG * Normal immunoglobulin for measles prophylaxis is in short supply and from time to time alternative products and doses may need to be used. For latest advice please check with the Health Protection Agency ( or Health Protection Scotland ( Noble s Pharmacy hold the stock of HNIG. Clinicians should contact the On Call Consultant in Public Health, to discuss the case and agree an action plan. 6.3 Prevention of measles Pre-exposure The routine schedule for protection against measles infection consists of two doses of MMR vaccine. The first dose is given within the first month after the child s first birthday, with the second dose given at 3 years and four months of age or soon after. Post-exposure As vaccine-induced measles antibody develops more rapidly than that following natural infection, MMR vaccine should be used to protect susceptible contacts from suspected measles. To be effective against this exposure, vaccine must be administered very promptly, ideally within three days. Contact with suspected measles, mumps or rubella provides a good opportunity to offer MMR vaccine to previously unvaccinated individuals. If the individual is already incubating measles, mumps or rubella, MMR vaccination will not exacerbate the symptoms. In these circumstances, individuals should be advised that a measles-like illness occurring shortly after vaccination is likely to be due to natural infection. 12 Immunoglobulin Policy - February 2012

15 If there is doubt about an individual s vaccination status, MMR should still be given as there are no ill effects from vaccinating those who are already immune. Please refer to the document - Post Exposure Prophylaxis for Measles: Revised Guidance May 2009, for further information about when the vaccine should be administered: 7. Further information about immunoglobulins All post-exposure immunoglobulins, and rabies and hepatitis vaccines, are free of charge to the patient under the circumstances described in the respective chapters in the Green Book. Immunoglobulins should be stored between 2 o C to 8 o C. All are tolerant of ambient temperatures for up to one week. They can be distributed in sturdy packaging outside the cold chain if needed. See Chapter 3 of the Green Book. If immunoglobulin has been administered first, then an interval of three months should be observed before administering a live virus vaccine. If immunoglobulin has been given within three weeks of administering a live vaccine, then the vaccine should be repeated three months later. This does not apply to yellow fever vaccine since immunoglobins do not contain significant amounts of antibody to this virus. The following tables have been reproduced from the Green Book. Please check the web-based document for any updates which may have been added since the writing of this document. Immunoglobulin Policy - February

16 Table 1 Guide to post-exposure prophylaxis following risk assessment for rabies Post-exposure prophylaxis Rabies risk Unimmunised / incompletely immunised individual* Fully-immunised individual No risk None None Low risk Five doses (each 1ml) rabies vaccine on days 0, 3, 7, 14 and 30 Two doses (each 1ml) rabies vaccine on days 0 and 3 High risk Five doses (each 1ml) rabies vaccine on days 0, 3, 7, 14 and 30, plus HRIG on day 0 only Two doses (each 1ml) rabies vaccine on days 0 and 3 * Persons who have not received a full course of pre- or post-exposure tissue culture rabies vaccine. 14 Immunoglobulin Policy - February 2012

17 Procedure for vaccinating healthcare workers Table 2 Immunoglobulin Policy - February

18 Table 3 VZIG algorithm for immunocompromised patients who have been exposed to varicella zoster 16 Immunoglobulin Policy - February 2012

19 VZIG algorithm for neonates Table 4 Immunoglobulin Policy - February

20 VZIG algorithm for pregnant women Table 5 18 Immunoglobulin Policy - February 2012

21 Dosage of HBIG Table 6 Age group Dose Newborn and children aged 0 4 years 200IU Children aged 5 9 years 300IU Adults and children aged 10 years or over 500IU Table 7 Vaccination of term babies according to the hepatitis B status of the mother Hepatitis B status of mother Mother is HBsAg positive and HBeAg positive Mother is HBsAg positive, HBeAg negative and anti-hbe negative Mother is HBsAg positive where e-markers have not been determined Mother had acute hepatitis B during pregnancy Mother is HBsAg positive and anti-hbe positive A woman who is HBsAg seropositive and known to have an HBV DNA level equal or above 1x106IUs/ml in an antenatal sample* Baby should receive Hepatitis B vaccine Yes Yes Yes Yes Yes Yes Baby should receive HBIG Yes Yes Yes Yes No Yes * Where viral load testing has been performed to inform the management of the mother Immunoglobulin Policy - February

22 HBV prophylaxis for reported exposure incidents Table 8 Significant exposure Non-significant exposure HBV status of person exposed HBsAg positive source Unknown source HBsAg negative source Continued risk No further risk 1 dose HB vaccine pre-exposure Accelerated course of HB vaccine* HBIG x1 Accelerated course of HB vaccine* Initiate course of HB vaccine Initiate course of HB vaccine No HBV prophylaxis. Reassure 2 doses HB vaccine pre-exposure (anti-hbs not known) One dose of HB vaccine followed by second dose one month later One dose of HB vaccine Finish course of HB vaccine Finish course of HB vaccine No HBV prophylaxis. Reassure Known responder to HB vaccine(anti- HBs >10mIU/ml) Consider booster dose of HB vaccine Consider booster dose of HB vaccine Consider booster dose of HB vaccine Consider booster dose of HB vaccine No HBV prophylaxis. Reassure Known nonresponder to HB vaccine(anti- HBs < 10mIU/ml 2 4 months postimmunisation) HBIG x1 Consider booster dose of HB vaccine A second dose of HBIG should be given at one month HBIG x1 Consider booster dose of HB vaccine A second dose of HBIG should be given at one month No HBIG Consider booster dose of HB vaccine No HBIG Consider booster dose of HB vaccine No prophylaxis. Reassure * An accelerated course of vaccine consists of doses spaced at zero, one and two months. A booster dose may be given at 12 months to those at continuing risk of exposure to HBV. Source: PHLS Hepatitis Subcommittee (1992) 20 Immunoglobulin Policy - February 2012

23 Table 9 Tetanus - Immunisation recommendations for clean and tetanus-prone wounds Source: Green book Tetanus Section - page 381 Immunoglobulin Policy - February

24 DEPARTMENT OF HEALTH Rheynn Slaynt The information in this booklet can be provided in large print or in audio format on request Department of Health, Public Health Directorate, Cronk Coar, Noble s Hospital, Strang, Douglas, Isle of Man, IM4 4RJ. Tel: (01624) Fax: (01624) Website: