Background Rationale for resource

Transcription

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 0

2 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 term shingles is used throughout this document. 0

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4 CMO letter for updates to programme September 2016 to August

5 As uptake is lower in the cohorts added in February 2016 (age 76 and 77 years) this group should be actively approached throughout the programme from September 2016 It is important that healthcare professionals encourage and offer vaccine to all eligible patients. 3

6 CMO letter for updates to programme September 2016 to August 2017 link to be added The Public Health England Green Book chapter for shingles and also Public Health England health care professional FAQs can be found at the following websites: chapter includes contraindications and precautions sections. 4

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8 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. 6

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10 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. 8

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14 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. 12

15 Data available from PTI data to 2011/12, ISD 13

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17 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. 15

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20 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 eye 3 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. 18

21 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. 19

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23 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. 21

24 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. 22

25 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. 23

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27 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. 25

28 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). Note-(Jan2016) Zostavax route of administration- by subcutaneous or intramuscular injection. Intramuscular injection is the preferred route of administration, as injection site adverse reactions were significantly less frequent in those who received the vaccine via this route of administration. The vaccine should be administered subcutaneously in patients with severe thrombocytopenia or any coagulation disorder 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. 26

29 Zostavax does not contain any thiomersal. Zostavax does not contain any latex. 27

30 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. 28

31 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 29

32 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. 30

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34 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. 32

35 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. 33

36 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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38 Administration of Zostavax with other vaccines Zostavax vaccine can be administered at the same time as other vaccines such as inactivated influenza vaccine and 23-valent pneumococcal polysaccharide vaccine (PPV) and other live vaccines except Yellow Fever vaccine. Zostavax can also be administered at any time before or after other live vaccine, except MMR. Where MMR and Zostavax cannot be administered at the same time, a four week interval period is recommended. Travel vaccines containing live attenuated virus e.g. yellow fever, may be given to the age group recommended for shingles vaccination. There is limited evidence on the timing of administration of Zostavax and Yellow Fever vaccine, with a single case report demonstrating good response to Yellow Fever vaccine 21 days after receiving Zostavax. Given the lack of data it would be appropriate to leave a four week interval between administration of Yellow Fever vaccine and Zostavax. Zostavax can be given at the same time as 23-valent pneumococcal polysaccharide vaccine for those who are eligible for both vaccines. Although a single manufacturer-conducted trial showed inferior VZV antibody responses in those receiving zoster vaccine and PPV-23 concomitantly compared with those receiving the vaccines 4 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 at the same time or 4 weeks apart from PPV Concurrent administration of Zostavax and anti-viral medications known to be effective against VZV has not been evaluated, but drugs such as aciclovir are likely to reduce replication of the vaccine virus and therefore attenuate response. Therefore, Zostavax should not be administered to patients currently receiving oral or intravenous antiviral agents such as aciclovir or who are within 48 hours after cessation of treatment as the therapy may reduce the response to the vaccine. 36

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40 Vegetarians should also note that pork gelatin is an ingredient in the vaccine. 38

41 It is crucial that practitioners refer to this the Public Health England Green Book Chapter for shingles when administering the shingles vaccine. The revised Public Health England Green Book chapter for shingles and also Public Health England health care professional FAQs can be found at the following websites:

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