Background Rationale for resource Note: Shingles is also known as herpes zoster. For the purpose of this resource the

Transcription

1 Slide 1 Background The Joint Committee on Vaccination and Immunisation 1 reviewed all the available medical, epidemiological and economic evidence as well as vaccine safety and efficacy relevant to offering a universal vaccination programme for shingles. As part of the review, age-specific incidence of shingles and associated disease burden were taken into account. Disease burden was measured in terms of those that developed secondary complications as a result of shingles infection, those that required hospitalisation and those that eventually resulted in or contributed to an individual s death. The JCVI concluded that the incidence of shingles is closely associated with older age groups, with the severity and disease burden increasing as the individual gets older. As a result, in Scotland, the vaccine was introduced and offered routinely to adults aged 70 years from 1 September In conjunction with the routine vaccination of adults aged 70 years, a catch-up programme was commenced from September Rationale for resource This resource is designed to support registered healthcare practitioners involved in discussing the issue of vaccination against shingles and providing them with evidence based information. This resource does not cover the actual administration techniques involved in vaccinating against shingles. If administration technique training is required staff should access this through their line manager. The resource does not cover the clinical management of acute shingles or post-herpetic neuralgia (PHN). Note: Shingles is also known as herpes zoster. For the purpose of this resource the 1

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3 Slide 3 Season 2015/16 change Prior to vaccine introduction an estimated 7000 cases of shingles occur in people aged 70 years and above each year in Scotland with approximately five cases resulting in death. 3

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5 Slide 5 Key roles of registered health care practitioners in relation to vaccination against shingles in older people: To advise eligible individuals and their carers that it is strongly recommended that older people are vaccinated against shingles. To explain the risks and complications of shingles in older people and in particular explain that disease severity is associated with increased age. To explain how a single dose of vaccine given from the age of 70 can provide protection against shingles and associated post-herpetic neuralgia (PHN). To explain what vaccine will be used, the contraindications and possible side effects of vaccination and the evidence for this new vaccination programme. To safely administer this new vaccine in accordance with the vaccine schedule. To ensure any adverse effects are managed and reported appropriately. To advise older people eligible for shingles vaccination how they can arrange for vaccination and, where appropriate, the registered healthcare practitioner should facilitate the arrangements for the appointment to be vaccinated. 5

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9 Slide 9 Changed to reflect season 2015/16 Notes In 2010, the Joint Committee on Vaccination and immunisation (JCVI) reviewed all the available epidemiological and economic evidence as well as vaccine safety and efficacy relevant to a shingles programme for adults aged 60 years and above. This age group was specifically reviewed in light of the disease burden that they are likely to experience as they get older. Offering the vaccination from the age of 70 years may result in boosting immunity against the disease; thus providing protection to the individual in later years. The aim is to prevent the development of the disease in the first instance and secondly to reduce the severity of the complications such as postherpetic neuralgia (PHN). Based on the available evidence, the JCVI recommended a universal shingles vaccination programme or adults aged 70 with a catch-up programme for those up to 79 years of age (up to the 80th birthday) to help prevent the development of shingles and shingles related PHN. The JCVI decision to offer this vaccine to individuals aged 70 to 79 years, was based on the economic analysis that suggested the vaccine would be most cost effective in this age group. The decision was based on the incidence of shingles, the severity and risk of complications, the efficacy of the vaccine and estimated duration of protection provided by the vaccine. Since 2013, the shingles vaccine has been offered routinely to all those aged 70 years on 1 September of any given year. Since 2013 there has also been a catch-up programme. Each year has involved different cohorts: : 79 years ; 78 years and 79 years : 78 years. 9

10 Slide 10 Changed to reflect season 2015/16 Notes -Continued All those who were eligible in years one and two of the programme but remain less than age 80 years currently remain eligible. Cohort details are given on the slide. Individuals who are now aged 80 years or older are no longer eligible because of the decreased efficacy of the vaccine in persons in this age group. The economic analysis suggested the vaccine would not be cost effective in individuals over the age of 80 years. 10

11 Slide 11 Infection with varicella zoster (chickenpox) is a pre-requisite for the development of shingles. You do not develop shingles from being in contact with chickenpox. Increasing incidence of shingles infection amongst older age groups is thought to be associated with a decline in cell mediated immunity to varicella zoster virus. 3 Shingles can not be transmitted from one person to another, although it can cause chickenpox in individuals who have not previously had the disease and who have direct contact with the fluid from the shingles vesicles. Although rare, it is possible to have shingles more than once. Shingles is not caused by the same virus that causes genital herpes. 11

12 Slide 12 New addition to first line prior to vaccine introduction--- Data available from PTI data to 2011/12, ISD. 12

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14 Slide 14 Shingles can affect any part of the body, although most commonly affected areas include face (including eyes) chest and abdomen. Individuals may also experience pain in the arms and legs and may feel exhausted. A dermatome can be defined as an area of skin that is supplied by a single nerve. Shingles can affect one or more isolated dermatomes. 14

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17 Slide 17 Shingles can cause a number of secondary complications and the severity of these can be dependent on how weak the individual s immune system is. Most commonly reported complications in the older age groups include secondary bacterial infections at the site of the rash (that may require antibiotic therapy) and PHN. Other less common complications can include ophthalmic shingles and peripheral motor neuropathy. Ophthalmic shingles affects the facial nerve (trigeminal) and can cause ulceration and scarring of the eye3 and uveitis (inflammation of the inner eye). Ophthalmic shingles can also cause loss of vision if untreated and is often associated with long term pain. Estimates show between 10-20% of shingles cases result in ophthalmic zoster 4 with approximately 4% of these cases resulting in long term sequelae. 5 Peripheral motor neuropathy is more common in the elderly population and results in temporary nerve damage (peripheral motor nerve) that controls movement of limbs such as the arm or leg, causing paralysis in the associated limb. 3 This affect is temporary and individuals can make a good recovery. 17

18 Slide 18 PHN is defined as an intense pain that persists for, or develops after 90 days following the onset of the shingles rash and can persist between 3 and 6 months in 50% of those affected. 6 This pain can last longer and is dependent on the individuals immune system. As the pain can be intense and is not generally relieved by common pain killers, PHN can have a negative impact on the individuals quality of life. PHN can contribute to fatigue, insomnia, depression, anxiety and can impair the basic activities of daily living for the individual. 7 18

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20 Slide Existing slide 19 -Updated Notes The above graph shows the estimated number of patients consulting their GP per 1000 registered, prior to vaccine introduction. The graph shows a continued increase in age related shingles, outlining that the incidence of shingles is largely associated with older age who are more at risk of developing the disease. These are estimates (based on available Practice Team Information data sources from ISD) as shingles is only clinically diagnosed, thus no lab confirmation of this is available - so actual figures may be much higher. 20

21 Slide 21 The data show that the burden of disease is disproportionately higher in those aged 70 or older. It is important to recognise that rate of hospitalisation per does not refer to individual patients since many patients will have several episodes of shingles, which may require frequent stays in hospital. Data were derived from SMR01 data, derived from ISD. 21

22 Slide 22 Vaccination for individuals over the age of 80 years is not recommended due to the decreased efficacy of the vaccine in this age group and the economic analysis suggested that the vaccine would not be cost-effective in individuals over the age of 80 years. 22

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24 Slide 24 Zostavax is recommended for the prevention of shingles infection and shingles related PHN. Zostavax should not be used for the treatment of PHN. Zostavax contains a significantly higher antigen level of varicella zoster virus than the routine varicella (chickenpox) vaccine and is not recommended for the prevention of chickenpox infection. 24

25 Slide 25 The aim of the national shingles immunisation programme is to lower the incidence and severity of shingles in older people.2 Administration after 80 years is less cost-effective due to the limited effectiveness of the vaccine beyond this age. Zostavax is a live attenuated vaccine (a weakened form of virus which cannot cause disease but which protects against shingles). Zostavax should be given by subcutaneous injection. It should not be given by intramuscular injection. The packaging is similar in size to many currently used childhood vaccines. The vaccine was procured following a tendering exercise undertaken by the Department of Health on behalf of UK nations and ensured the vaccine was available at a cost-effective price. 25

26 Slide 26 Zostavax does not contain any thiomersal. Zostavax does not contain any latex. 26

27 Slide 27 Zostavax must be stored in accordance with the manufacturer s instructions. As with most vaccines Zostavax should be stored between +2 C and +8 C. The vaccine should be stored in the original packaging. This makes it easy to identify in the vaccine fridge, provides some protection against fluctuation of temperature and will protect from light. Vaccines are expensive and it is important to minimise wastage through inappropriate storage. 27

28 Slide 28 Zostavax is supplied as a vial and a pre-filled syringe of diluent, with two separate needles in the secondary packaging. Zostavax is only available in single packs. 28

29 Slide 29 A 21G green needle should be used to reconstitute vaccine (21G needles are not included with the vaccine). It is recommended that the vaccine be administered immediately after reconstitution. Discard reconstituted vaccine if it is not used within 30 minutes.8 29

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31 Slide 31 The vaccine is expected to provide protection against shingles for at least seven years 9 and at this time, a one dose schedule of the vaccine is recommended with no requirement for a second/booster vaccine. 31

32 Slide 32 The efficacy of the vaccine in this age group is estimated to be as low as 38% 7 and may not fully prevent the development of shingles infection. However, vaccinating adults aged 70 years and over can help to significantly reduce the severity of the illness by 55% and associated PHN by 66.8%. The vaccine is expected to provide protection against shingles for a minimum period of 7 years 9 and at this time, a one dose schedule of the vaccine is recommended with no requirement for a second/booster vaccine. 32

33 Slide 33 Zostavax must be administered by subcutaneous injection preferably in the deltoid region of the upper arm. It should not be given by intramuscular injection as there are few data on the effectiveness of the vaccine given by this route. The vaccine must not be given intravascularly. Further information on vaccinations given by subcutaneous injection can be found in chapter 4 of the Green Book

34 Slide 34 The JCVI (2010) recommendations to offer the vaccine to individuals aged 70 to 79 years were based on all the available evidence. After carefully considering the epidemiological evidence, it was clear that people in this age group are more at risk of severe complications of the disease, resulting in an increased disease burden compared to individuals aged 50 years. Currently, the vaccine manufacturers do not know whether a second dose is required or what the timing of a second dose. Current recommendations are based on a one dose schedule of the vaccine with no plans for a second/booster dose. Registered healthcare practitioners are reminded that in some circumstances the recommendations regarding vaccines given in the Green Book chapters may differ from those in the Summary of Product Characteristics (SPC) for a particular vaccine. When this occurs, the recommendations in the Green Book are based on current expert advice received from the JCVI and this advice should be followed. The Green Book recommendations and/or further advice from the Department of Health should be reflected in PGDs. 34

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36 Slide 36 Updated notes Zostavax vaccine can be given at same time as other vaccines such as inactivated influenza vaccine and 23- valent pneumococcal polysaccharide vaccine (PPV) Given that individuals eligible for seasonal influenza vaccination may be immunosuppressed, it is important to check that there are no contraindications to administering a live vaccine to these at risk groups. Zostavax can be given at the same time as 23-valent pneumococcal polysaccharide vaccine for those who are eligible for both vaccines. Although a manufacturer conducted trial showed inferior VZV antibody responses in those receiving zoster vaccine and PPV-23 concomitantly than those receiving the vaccines four weeks apart, there is no established correlation between antibody titres to VZV and protection from herpes zoster. Furthermore a more recent observational study showed that herpes zoster vaccine was equally effective at preventing herpes zoster whether it was administered simultaneously or four weeks apart. 11 Registered healthcare practitioners are reminded that in some circumstances the recommendations regarding vaccines given in the Green Book chapters may differ from those in the Summary of Product Characteristics (SPC) for a particular vaccine.when this occurs, the recommendations in the Green Book are based on current expert advice received from the JCVI and this advice should be followed. The Green Book recommendations and/or further advice from the Department of Health should be reflected in PGDs. The vaccines should be given at a separate site, preferably in a different limb. If more than one vaccine is given in the same limb, they should be given at least 2.5cm apart. The sites at which each vaccine was given should be noted in the individual s health records. Zostavax can be given at the same time as some live vaccines Updated notes from this point- Public Health England have updated advice on intervals between live vaccines. The recommendation is now that while a four-week interval should still be observed between zoster and MMR vaccines, if not given on the same day, this does not apply to zoster and other live vaccines. mendations_for_administering_more_than_one_live_vaccine_april_2015final_.pdf. 36

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38 Slide 38 Changed to reflect 2015/16 Health Scotland Public Facing Information Vegetarians should also note that pork gelatin is an ingredient in the vaccine. 38

39 Slide 39 * See next slide 39

40 Slide 40 Notes for 2015 Strengthened recommendations for communication between specialist clinicians and primary care 40

41 On basis of limited Phase II trial data (Benson et al., 2012) and extrapolation from other live vaccines (Koenig et al., 2013), a CD4 count of 200 cells/μl may be a suitable cut off value below which vaccination should not be given. Immunosuppressed patients who require protection against shingles should seek advice from a specialist. Zostavax should not be given to individuals who have had a bone marrow transplant, until at least 12 months after finishing all immunosuppressive treatment, or longer where the patient has developed graft-versus-host disease. The decision to vaccinate should depend upon the type of transplant and the immune status of the patient. Immunosuppressed patients who require protection against shingles should seek advice from a specialist. 41

42 Slide 41 Please refer to the Green Book shingles chapter for more detailed information on contraindications and precautions. Unless stated differently here, the information on contraindications and special considerations for vaccination found in Chapter 6 of the Green Book apply to Zostavax. Department of Health (2013) Immunisation against infectious diseases: Contraindications and special considerations chapter. TSO publishing, Crown Copyright. contraindications-and-special-considerations-thegreen-book-chapter-6. People receiving 40mg Prednisolone per day for more than one week should not receive the vaccine until at least 3 months after cessation of therapy. A longer delay, up to 6 months, may be appropriate for the age cohorts included in the national vaccination programme. The vaccine is not contraindicated for use in individuals who are receiving topical / inhaled corticosteroids and in people who are receiving corticosteroids as replacement therapy (e.g. for adrenal insufficiency). Therapy with a single, low-dose, non-biological oral immune modulating drug, either alone or with low dose steroids, for treatment of rheumatoid arthritis, psoriasis, polymyositis, sarcoidosis, inflammatory bowel disease, and other conditions, are not necessarily sufficiently immunosuppressive to contraindicate administration of zoster vaccine. Examples of such therapies include methotrexate (<0.4mg/kg/week), Azathioprine (<3.0mg/kg/day), or 6-mercaptopurine (<1.5mg/kg/day). In these individuals, the degree of immunosuppression should be assessed on a case by case basis. Specialists with responsibility for patients in the vaccine eligible age cohorts should include a statement of their opinion on the patient s suitability for Zostavax in their correspondence with primary care. Primary care professionals with concerns about the nature of therapies (including biologics) or degree of immunosuppression) should contact the relevant specialist for advice. 42

43 Slide 42 NB Strengthened recommendations for specialists with responsibility for patients in the vaccine eligible age cohorts should include a statement of their opinion on the patient s suitability for Zostavax in their correspondence with primary care. Primary care professionals administering the vaccine may wish to discuss the patient s eligibility to receive the vaccine with the specialist prior to administration. 2. Patients who remain under follow up for lymphoproliferative disorders including haematological malignancies such as indolent lymphoma, leukaemia or plasma cell myeloma should not receive Zostavax. Although not exhaustive, examples of these malignancies may include acute and chronic lymphocytic leukaemia, follicular lymphoma or multiple myelomas. Specialists with responsibility for patients in the vaccine eligible age cohorts should include a statement of their opinion on the patient s suitability for Zostavax in their correspondence with primary care. Primary care professionals managing patients who have a previous history of lymphoproliferative disorder but who are no longer under follow up may wish to discuss the patient s eligibility with a secondary care specialist or immunologist prior to administration. 43

44 Slide 43 Updated notes Please refer to the Green Book shingles chapter for more detailed information on contraindications and precautions. Unless stated differently here, the information on contraindications and special considerations for vaccination found in Chapter 6 of the Green Book apply to Zostavax. Department of Health (2013) Immunisation against infectious diseases: Contraindications and special considerations chapter.tso publishing, Crown Copyright. contraindications-and-special-considerations-thegreen-book-chapter-6. The use of topical aciclovir is not a contraindication to vaccination. Asplenia/splenectomy is not of itself a contraindication, though the underlying cause may be (such as leukaemia or lymphoma infiltration). Humoral deficiencies affecting IgG or IgA antibodies are not of themselves a contraindication unless associated with T cell deficiencies. If there is any doubt (e.g. common variable immune deficiency), immunological advice should be sought. New addition to notes for 2015/16 For the 2015 programme, a screening tool for contraindications to shingles vaccine has been developed by Health Protection Scotland. This tool can be used to aid identification of patients who are contra-indicated for shingles vaccine, which is a live vaccine. Healthcare practitioners should ensure knowledge is current via Green Book, the relevant Patient Group Direction (PGD) and NHS Education Scotland Shingles vaccine Training Slides for Registered Healthcare Practitioners, Notes for Registered Healthcare Practitioners and FAQs for Registered Healthcare Practitioners. A link to the screening tool will be available on the NES website. 44

45 Slide 44 Immunisation of individuals who are acutely unwell should be postponed until they have recovered fully. This is to avoid confusing the diagnosis of any acute illness by wrongly attributing any sign or symptoms to the adverse effects of the vaccine. Zostavax is not recommended for the treatment of shingles or PHN. The natural boosting that occurs following an episode of shingles makes the benefit of offering the zoster vaccine immediately following recover limited. Individuals with PHN should wait until symptoms have ceased before being considered for shingles vaccination. In immunocomplent individuals who develop shingles, vaccination should be delayed for one year. The safety and efficacy of Zostavax have not been established in adults who are known to be infected with HIV with or without evidence of immunosuppression (see contraindications). Immunosuppressed patients who require protection against shingles should seek advice from a specialist. Post-marketing experience with varicella vaccines suggests that transmission of vaccine virus may occur rarely between those vaccinated who develop a varicella-like rash and susceptible contacts. As a precautionary measure, any person who develops a vesicular rash after receiving Zostavax should avoid direct contact with a susceptible (chickenpox naïve) person until the rash is dry and crusted. 45

46 Slide 45 Based on limited data from two clinical trials including VZV-seronegative or low seropositive adults aged 30 years and older, the rates of local and systemic reactions were similar to those reported by other subjects who received the vaccine as part of a clinical trial. No serious vaccine related reactions were reported. Although Zostavax is similar to the varicella vaccine, it has a significantly higher antigen content. Early trials of varicella vaccine in susceptible children used doses of virus approaching the range used in Zostavax (Weibel et al., 1984). The high dose formulation was well tolerated and efficacious. Inadvertent vaccination with Zostavax in varicella naïve children is unlikely to result in serious adverse reactions and should count as a valid dose of varicella vaccine. 46

47 Slide 46 For those women who are found to be VZV IgG negative on testing samples may be requested to be sent for storage. Please contact your local NHS Health Protection Team for further advice and consideration of the use of VZIG within 10 days of inadvertent vaccination. Ideally, VZIG should be administered within 7 days where practically possible but can be offered up to 10 days following vaccination. All incidents of inadvertent administration of Zostavax during pregnancy should be reported to your local NHS Health Protection Team for collation on a national basis via Health Protection Scotland using the vaccine administered in pregnancy reporting form. 47

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49 Slide 48 In the event of a person developing a varicella (widespread) or shingles-like (dermatomal) rash post-zostavax, a vesicle fluid sample should be sent for analysis to confirm the diagnosis and determine whether the rash is vaccine associated. Contact tracing is not required if an immunocompetent person develops a localised vesicular rash following vaccination. Your local NHS Health Protection Team should be contacted for advice. The full list of adverse reactions associated with Zostavax is available in manufacturers authorisation holder s summary of product characteristics (SPC). Anaphylaxis is a very rare adverse effect of most vaccines and facilities for its recognition and management must be available. 49

50 Slide 49 Updated new notes for 2015/16 As with all vaccines and other medicines registered healthcare practitioners and patients are encouraged to report suspected adverse reactions using the yellow card reporting scheme. Updated Registered Health Care Practitioners should report any administration errors via their local governance system(s) so that appropriate action can be taken, lessons can be learnt and the risk of future errors minimised. 50

51 Slide 50 Please note: The screening tool is designed to help identify patients who may be contra-indicated for shingles vaccine and does not replace the clinical judgement of registered healthcare practitioners. Full details are provided in Green Book Chapter on shingles (herpes zoster) 51

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54 Slide 53 To be replaced by Graphics on slide Chief Medical Officer for Scotland (2015)Details of the Shingles(herpes zoster)vaccination programme CMO (2015)

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