WELSH HEALTH CIRCULAR

Transcription

1 WELSH HEALTH CIRCULAR WHC (2015) 029 Issue Date: 11 June 2015 STATUS: ACTION CATEGORY: HEALTH PROFESSIONAL LETTER Title: The National Influenza Immunisation Programme (Revised) This includes the Service Specification for the Childhood Vaccination Programme referred to under enclosures and omitted from WHC(2015) 028 issued on 8 June. No other changes apply. Date of Expiry / Review N/A For Action by: General Practitioners Community Pharmacists Immunisation Leads, Health Boards Chief Executives, Health Boards/Trusts Medical Directors, Health Boards/Trusts Nurse Executive Directors, Health Boards/Trusts Chief Pharmacists, Health Boards/Trusts Directors of Public Health, Health Boards Directors of Maternity Services, Health Boards Directors of Workforce and Organisational Development, Health Boards/Trusts Directors of Primary, Community and Mental Health, Health Boards Chief Executive, Public Health Wales Executive Director of Public Health, Public Health Wales Nurse Director, Public Health Wales Head Vaccine Preventable Disease Programme, Public Health Wales Chief Executive, Welsh Local Government Association For information to: Welsh NHS Partnership Forum British Medical Association GPC(Wales) Royal College of GPs Royal College of Nursing Royal College of Midwives British Dental Association Royal Pharmaceutical Society Community Pharmacy Wales 1

2 Sender: Chief Medical Officer for Wales DHSS Welsh Government Contact(s) : David Vardy, Health Resilience Branch, Department for Health and Social Services, Welsh Government, Cathays Park, Cardiff. CF10 3NQ Tel: Enclosure(s): Childhood Influenza Vaccination Programme Service Specification 2

3 The Influenza Immunisation Programme I would like to take this opportunity to thank all those working in the NHS, social care agencies and the private sector for their continued hard work on the flu immunisation programme. Eligibility I am now writing with key information for the programme. 2. In the following groups are eligible for flu vaccination: those aged 65 years and over those aged six months to under 65 years in clinical risk groups pregnant women those in long-stay residential care homes carers all two and three year olds (age on 31 August 2015) All children in reception classes and year 1 and 2 in primary school 3. In addition, all health and social care workers who are in direct contact with patients or service users should be offered flu vaccine by their employer. 4. A full list of groups recommended to receive influenza (flu) vaccine is provided at Annex A. The list is not exhaustive; medical practitioners, including nurse and pharmacy prescribers, should apply clinical judgment to take into account an individual s risk from flu. Changes to the Programme 5. The main change to the programme this year is to the children s programme: The school year 7 programme (age years) has been withdrawn to concentrate funding and effort on expanding the programme to younger children. We anticipate returning to this cohort once all primary school years are included in the routine programme. Children in school years 1 and 2 (ages 5-6 and 6-7 years) are to be offered the vaccine in school via the school nursing service. Children aged 4 to 5 years who are in school reception year will be offered vaccination via the school nursing service in conjunction with years 1 and 2. Four year olds who do not attend school (as attendance is not mandatory until the age of five) will continue to be vaccinated through primary care but this is expected to apply to very few children. 3

4 Children aged two and three years will continue to be vaccinated through primary care. Further details of the children s programme are provided in Annex B. Vaccine Effectiveness 6. Selection of strains for inclusion in the flu vaccine is made by the World Health Organization (WHO) each year in February (for the northern hemisphere). These strains are those predicted to circulate in the coming season. 7. Early estimates of vaccine effectiveness published from several countries during the influenza season indicated that levels of protection against flu infection provided by this seasons vaccine were very low, This was because the flu strain which dominated the season was a drifted strain of flu A (H3N2) which emerged too late to be included in the Northern Hemisphere flu vaccine. 8. It is crucial that this does not discourage people in any of the eligible groups from having flu vaccination this coming flu season. Flu vaccination remains the best way to protect people from flu and throughout the last decade there has been a good match between the strains of flu virus in the vaccine and those that subsequently circulated. 9. The estimates of vaccine effectiveness relate to the overall programme which mainly uses inactivated vaccine in adults. One of the reasons for the Joint Committee on Vaccination and Immunisation (JCVI) recommending the use of the live attenuated influenza vaccine (LAIV) in children was the potential to provide coverage against circulating strains that have drifted from those contained in the vaccine. Vaccine effectiveness data on LAIV in children is not yet available. Programme Delivery 10. The seasonal flu vaccination programme is one of the targets contained within the Delivery and Outcome Framework for the NHS and is one of the key accountability requirements for each health board. 11. In line with the aim of the Minister for Health and Social Services to improve accountability, delivery of the flu programme will be the responsibility of health boards, assisted by Public Health Wales. Health board chief executives are responsible to the Chief Executive, NHS Wales for the service provided in their area. Chief Executives have responsibility for ensuring that local programmes are adequately resourced and targeted. The Welsh Government will monitor delivery of the programme. 4

5 12. All eligible individuals should be offered flu vaccine in a timely manner and every effort should be made to ensure as high an uptake rate as possible. Vaccine uptake for those in clinical risk groups needs to improve, particularly for those who are at the highest risk of severe disease and mortality from flu but have low rates of vaccine uptake, including those with chronic liver and neurological diseases. 13. The targets for seasonal flu vaccination remain unchanged and are as follows: 75% uptake for: Those aged 65 years and older. Those aged six months to under 65 years in clinical risk groups. Pregnant women. 50% uptake for: Health care workers providing direct patient care. 14. As routine flu vaccination of children is still comparatively new and public awareness is still growing, specific targets will not be set until the programme is more established. Local services should offer the vaccine to 100% of eligible children through personal invitations by letter; phone call or electronic communication and uptake should be as high as possible Vaccine Uptake 15. Provisional end of season flu vaccine uptake figures for the season as collected and reported by Public Health Wales (as at 23 March 2015) are: 68.1% for those aged 65 years or older. 49.5% for those aged under 65 years in clinical risk groups. 72.4% for pregnant women (from a point of delivery survey). 44.3% for healthcare staff with direct patient contact. 36.8% for children aged 2, 3 and 4 years. 74.3% for children in School Year There is significant variability in uptake between health boards. Welsh Government expects low uptake to be tackled through targeted improvements during Seasonal Flu Plans 17. The Welsh Government will be publishing an updated version of its Flu Plan shortly. The Plan describes the processes and the actions required to deliver seasonal flu vaccination in Wales as effectively and efficiently as possible within current constraints. It will continue to be updated annually to reflect changing circumstances and lessons 5

6 learned. It is not intended to provide prescriptive guidance, but will assist health professionals and others to plan for the flu season. Local needs and changing circumstances will still require flexible and innovative responses. Health board flu plans should be reviewed and updated to ensure measures are in place to address local needs. Health and Social Care Workers 18. I expect all health and social care providers in Wales to ensure that 100% of their frontline staff are offered and encouraged to take up flu vaccination, and to be exploring the full range of measures necessary to address low uptake. 19. There is always pressure on the NHS and social care services during the winter. Vaccinating staff against flu is an important infection control measure as part of the annual winter planning process to ensure the NHS and social care services are resilient as possible. 20. During we saw many cases of flu in Welsh hospitals and a number of wards closed due to flu. There were also 31 outbreaks of flu in residential care settings in the community. In hospitals and residential care settings (as well as in the community), respiratory infections, including influenza, are easily spread, putting both staff and their patients at risk. As well as ensuring that they protect themselves through vaccination, health and social care workers have a duty of care to protect their patients from infection. 21. I welcome the significant progress that has been made over recent years to improve uptake. In uptake by NHS staff with direct patient contact was just 18%. Last season, three health boards/ trusts exceeded the 50% target, with an overall uptake across Wales in staff with direct patient contact of 44.3%. I would like to see this progress continued next season with all health boards improving uptake and reaching the target. 22. Further information about vaccination for health and social care workers in contained in Annex C. Pregnant Women 23. Pregnant women are particularly vulnerable to severe complications of flu and there is also evidence that flu during pregnancy may be associated with premature birth and smaller birth size and weight. All pregnant women are recommended to receive the flu vaccine irrespective of their stage of pregnancy to reduce the risk of avoidable harm to mother and baby. Health boards should take all reasonable steps to support this. Whenever possible, pregnant women should receive their flu vaccine in an antenatal clinic rather than having to arrange a separate appointment with their practice nurse. 24. Further information can be found in Annex D. 6

7 Carers 25. Flu vaccination is recommended for those who are a carer of an elderly or disabled person whose welfare may be at risk if the carer falls ill. This group consists primarliy of family members and close friends but volunteer carers who work, unpaid, for third sector organisations are also eligible for NHS vaccination. Carers are not always easily identified and uptake may be underestimated; working with the third sector may help encourage uptake. 26. Every effort to identify eligible carers and offer flu vaccination is encouraged. Practices should remind at risk patients that if they have someone who cares for them, this person is also eligible for the flu vaccine. 27. It is the employer s responsibilty to provide flu vaccine to staff who are paid to provide care. Community Pharmacies 28. During the season, health boards were expected to enter into arrangements with at least 25% of their community pharmacies to provide vaccination from the start of the season. Health boards are expected to make arrangements with at least those pharmacies that provided the service in in the forthcoming season. 29. GPs will continue to be the main provider of flu vaccinations, with community pharmacies supporting those individuals who are less than 65 years of age in at risk groups and those who do not routinely get vaccinated. Health boards should identify and build on examples of good practice, where GP practices and their community pharmacy partners have worked collaboratively, to develop a coordinated approach that strengthens local arrangements and improves coverage. 30. Community pharmacies will again have discretion to immunise individuals aged 65 years or over if they consider they are unlikely to visit their GP for vaccination. 31. Further information regarding pharmacy involvement in this year s programme will be made available later in 2015 at: Vaccine Supply and Ordering 32. Welsh Health Circular 2015 (010) provided early guidance on ordering flu vaccine for the forthcoming season. A copy can be found at: Further information can be found in Annex B for the children s programme, and also in Annex F. 7

8 Flu Vaccine Contingency Reserve 34. The Welsh Government will again be holding a small reserve stock of injectable flu vaccine to mitigate against potential shortgages. Access to the reserve stock will be co-ordinated through Health Board Immunisation Co-ordinators. Antivirals 35. Antiviral treatment of influenza is indicated when Influenza A or B are circulating and there is a substantial likelihood that people presenting with an influenza-like illness are infected with influenza virus. This may be based on disease surveillance data or laboratory confirmation of circulating virus available from Public Health Wales at: The Welsh Government will notify prescribers when surveillance indicates the start and end of virus circulation in the community. Patient Group Directions 37. The usual method for the supply and administration of vaccines is via a Patient Specific Direction (PSD). The authorisation for this is usually the responsibility of the GP or an independent nurse prescriber. Where a PSD exists, there is no need for a Patient Group Direction (PGD). 38. In school situations or where a PSD is not available, a PGD may be used. A PGD is a written instruction that allows for the supply and/or administration of medicines to groups of patients who present for treatment where it offers an advantage to patient care without compromising safety. Template PGDs are available for amendment by health boards to authorise appropriate health professionals to administer the vaccine where a PSD is not available. More information is available from the Public Health Wales Vaccine Preventable Disease Programme NHS Wales intranet site at: Publicity and Information Materials 39. Leaflets, posters and other publicity materials will be made available on the NHS Direct (Wales) web site via the link below. There will be a separate leaflet for the children s vaccination programme. %09 - Leaflets 40. Further information for healthcare professionals, including examples of good practice and ways to positively influence vaccine uptake are 8

9 available from the Public Health Wales Vaccine Preventable Disease Programme, NHS Wales intranet site at: The beat flu internet page also contains useful information for the public at: Surveillance and Reporting 41. Public Health Wales provides year round weekly updates of influenza activity in Wales along with a UK and world summary. From October to April, the weekly report also contains an update of progress in the influenza immunisation campaigns for the public and NHS staff. The report is available at: From October, for the duration of the flu season, Public Health Wales will again be providing individual weekly immunisation uptake reports for all general practices in Wales which use Audit+. These reports are available through the Public Health Wales Influenza Vaccination Online Reporting (IVOR) scheme at: and can help to inform activity to increase uptake at practice and primary care cluster level. The Green Book 43. The Green Book, Immunisation Against infectious Diseases provides guidance to healthcare practitioners on the flu vaccine. This is regularly updated, sometimes during the season, and can be found at: Further detailed information is set out in the attached annexes as follows: Annex A Annex B Annex C Annex D Annex E Annex F Annex G Groups recommended to receive flu vaccine. Children s flu programme. Health and social care workers. Pregnant women. Vaccine strains and available vaccines. Direct Enhanced Services. Data collection. 45. Flu is a key factor in NHS winter pressures. It impacts on those who become ill, the NHS services that provide direct care as a result, and on the wider health and social care system that supports people in at risk groups. The annual immunisation programme helps to reduce unplanned hospital admissions and pressures on A&E; this is a critical 9

10 element of the system-wide approach for delivering robust and resilient health and care services during winter. 46. Flu is unpredictable. It is not possible for the WHO to predict fully the strains that will circulate in any given season. There is always a risk of a drift and subsequent mismatch occurring as was seen in the last flu season. However, it is important to note that this occurs rarely. In nine out of the last ten seasons, the vaccine has provided good to moderate protection against the circulating strains. Flu vaccine is still the best protection we have against an unpredictable virus that can cause severe illness and deaths each year. 47.I am grateful for your continuing co-operation in helping protect vulnerable people against the annual challenges of seasonal flu and I am confident that together we can deliver an effective vaccination programme. Yours sincerely Dr Ruth Hussey DR RUTH HUSSEY OBE Chief Medical Officer / Medical Director NHS Wales 10

11 Groups included in the national flu immunisation programme In , flu vaccinations should be offered to the following groups: Annex A Eligible groups Further details Children Children aged two and three years to be offered vaccination through primary care (i.e. date of birth on or after 1 September 2011 and on or before 31 August 2013). Children aged four years (i.e. date of birth on or after 1 September 2010 and on or before 31 August 2011) who attend school in Reception class to be offered vaccination by the school nursing service. Those of this age range who do not attend school to be offered vaccination through primary care. Children in school years 1 and 2 to be offered vaccination through the school nursing service. For practical reasons, all children in the eligible school years should be offered vaccination irrespective of their actual date of birth. Children not in the age groups mentioned should be offered vaccination in line with eligibility outlined below. All patients aged 65 years and over Sixty five and over is defined as those 65 and over on 31 March 2016 (i.e. born on or before 31 March 1951). Chronic respiratory disease aged six months or older Asthma that requires continuous or repeated use of inhaled or systemic steroids or with previous exacerbations requiring hospital admission. Chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema; bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary dysplasia (BPD). Children who have previously been admitted to hospital for lower respiratory tract disease. A-1

12 Chronic heart disease aged six months or older Congenital heart disease, hypertension with cardiac complications, chronic heart failure, individuals requiring regular medication and/or follow-up for ischaemic heart disease. Chronic kidney disease aged six months or older Chronic kidney disease at stage 3, 4 or 5, chronic kidney failure, nephrotic syndrome, kidney transplantation. Chronic liver disease aged six months or older Cirrhosis, biliary atresia, chronic hepatitis. Chronic neurological disease aged six months or older Stroke, transient ischaemic attack (TIA). Conditions in which respiratory function may be compromised due to neurological disease (e.g. polio syndrome sufferers). Clinicians should offer immunisation, based on individual assessment, to clinically vulnerable individuals including those with cerebral palsy, learning difficulties, multiple sclerosis and related or similar conditions; or hereditary and degenerative disease of the nervous system or muscles; or severe neurological disability. Diabetes aged six months or older Type 1 diabetes, type 2 diabetes requiring insulin or oral hypoglycaemic drugs and diet controlled diabetes. A-2

13 Immunosuppression aged six months or older Immunosuppression due to disease or treatment, including patients undergoing chemotherapy leading to immunosuppression, bone marrow transplant, HIV infection at all stages, multiple myeloma or genetic disorders affecting the immune system (e.g. IRAK-4, NEMO, compliment disorder). Individuals treated with or likely to be treated with systemic steroids for more than a month at a dose equivalent to prednisolone at 20mg or more per day (any age) or for children under 20kg a dose of 1mg or more per kg per day. It is difficult to define at what level of immunosuppression a patient could be considered to be at a greater risk of the serious consequences of flu and should be offered flu vaccination. This decision is best made on an individual basis and by the patient s clinician. Some immunocompromised patients may have a suboptimal immunological response to the vaccine. Consideration should also be given to the vaccination of household contacts of immunocompromised individuals, i.e. individuals who expect to share living accommodation on most days over the winter and therefore for whom continuing close contact is unavoidable. This may include carers (see below). Asplenia or dysfunction of the spleen This also includes conditions such as homozygous sickle cell disease and coeliac syndrome that may lead to splenic dysfunction. Pregnant women All pregnant women at any stage of pregnancy (first, second or third trimesters). People living in long-stay residential care homes or other long-stay care facilities. Vaccination is recommended for people living in long-stay residential care homes or other longstay care facilities where rapid spread is likely to follow introduction of infection and cause high morbidity and mortality. This does not include, for instance, prisons, young offender institutions, or university halls of residence. A-3

14 Carers Third sector carers Those who are in receipt of a carer s allowance, or those who are a carer of an elderly or disabled person whose welfare may be at risk if the carer falls ill. Individuals who work on a voluntary basis (are not paid for their time and effort) providing care on a frequent basis to one or more elderly, disabled or otherwise vulnerable people whose welfare would be at risk if the individual became ill. These should be identified by a letter from their parent organisation naming the person and confirming their membership of, and role in, the organisation. (Please note this category refers to carers entitled to a free flu vaccine on the NHS, not professional health and social care workers who should be vaccinated by their employer as part of an occupational health programme). Members of voluntary organisations providing planned emergency first aid. Individuals who work on a voluntary basis (are not paid for their time and effort) in organisations which provide planned emergency first aid at organised public events. (This does not include individuals who are qualified to provide first aid in other circumstances). These should be identified by a letter from their parent organisation naming the person and confirming their membership of, and role in, the organisation. Community First Responders Those who are active members of a Welsh Ambulance Service Trust (WAST) community first responder scheme providing first aid directly to the public. These should be identified by a letter from their parent organisation naming the person and confirming their membership of, and role in, the organisation. A-4

15 Health and social care staff Health and social care workers who are in direct contact with patients or /clients should be vaccinated by their employer as part of an occupational health programme. Locum GPs Locum GPs may be vaccinated at the practice where they are registered. 1. The Joint Committee on Vaccination and Immunisation (JCVI) has also advised that morbidly obese people (defined as BMI 40+) could also benefit from a flu vaccination. Many in this patient group will already be eligible due to complications of obesity that place them in another risk category. Practices will need to use clinical judgement to decide whether to vaccinate this group of patients, but vaccinations for morbidly obese patients with no other recognised risk factor will not attract a payment in The inclusion of this patient group into the flu programme from is currently under consideration. 2. The table above is not exhaustive, and medical practitioners should apply clinical judgement to take into account the risk of flu exacerbating any underlying disease that a patient may have, as well as the risk of serious illness from flu itself. Inactivated flu vaccine should be offered in such cases even if the individual is not in the clinical risk groups specified above. 3. Individuals recommended to receive flu vaccine who are long term inpatients during the flu season should be vaccinated in hospital. Health boards are expected to make suitable arrangements to identify and vaccinate these individuals, and notify their GP 4. Clinicians are encouraged to consider the needs of patients waiting for transplants. The current recommendations for flu vaccine cover a wide range of chronic diseases and therefore most transplant-list patients should be eligible for immunisation. Medical practitioners should apply clinical judgement to take into account the risk of flu exacerbating any underlying condition a patient may have. 5. Guidance on the list of eligible groups and on administering the flu vaccine can be found in the influenza chapter of the Green Book: Immunisation against Infectious Disease. This is regularly updated, sometimes during the season, and can be found at: A-5

16 Annex B The Children s Flu Immunisation Programme 1. The Joint Committee on Vaccination and Immunisation (JCVI) has recommended that the routine annual flu immunisation programme be extended to all children aged two to school year 11 ages. As well as offering protection to the vaccinated child, the extended programme is expected to appreciably lower the public health impact of flu by directly averting a large number of cases of disease in children. Also, through lowering flu transmission in the community, this will indirectly prevent flu in unvaccinated younger children, people in clinical risk groups and older adults. This is expected to substantially reduce flu-related illnesses, GP consultations, hospital admissions and deaths. JCVI found that extending the flu immunisation programme in this way is likely to be highly cost effective. 2. It is anticipated that extending the flu immunisation programme to all children will also raise awareness of the benefits of flu immunisation amongst parents and children. We anticipate that as flu immunisation for children becomes accepted as routine, this will have a positive impact on uptake rates for others, who are eligible for flu immunisation, particularly those in clinical groups for whom the risk of serious complications is highest, and for whom coverage is presently poor. Eligible Groups for During the forthcoming season the programme in Wales will be extended as follows: All children aged two and three years (including those in at risk groups). GPs should offer immunisation to all registered patients aged two and three years on 31 August 2015 (i.e. dates of birth from 1 September 2011 to 31 August 2013 inclusive). The vaccine should be offered on a pro-active call basis; children considered at risk should be offered on a pro-active call and recall basis. This should be, for example, through direct invitation by letter, , phone call, text or otherwise (although such strategies are for GP practices to determine) inviting them to a flu vaccination clinic or to make an appointment. Where recall is required, the GP practice will follow-up patients who do not respond or fail to attend for vaccination. All children aged four years (including those in at risk groups). Immunisation should be offered to all children aged four years on 31 August 2015 (i.e. dates of birth from 1 September 2010 to 31 August 2011 inclusive). B-1

17 It is expected that the majority of children in this age group will be attending school in reception classes and therefore school nursing teams should offer vaccination in school as part of their planned programme. For practical reasons, all children in this school year should be offered vaccination irrespective of their date of birth. Where consent for the vaccination has been received but the child is unable to attend the arranged school vaccination session, a letter will be provided by the school nursing service advising that a flu vaccination appointment may be made with their GP. Where no consent has been received, the option to have the vaccine at the GP will not be offered. For children who do not attend a school covered by a health board seasonal flu immunisation programme, GPs should offer the vaccine at parental request, or opportunistically to children who attend for other purposes. All children in school years 1 and 2 School nursing teams should offer vaccination to all children in school years 1 and 2 in school. For practical reasons, all children in this school year should be offered vaccination irrespective of their date of birth. Where consent for the vaccination has been received but the child is unable to attend the arranged school vaccination session, a letter will be provided by the school nurse service advising that a flu vaccination appointment may be made with their GP. Where no consent has been received, the option to have the vaccine at the GP will not be offered. For children who do not attend a school covered by a health board seasonal flu immunisation programme, GPs should offer the vaccine at parental request, or opportunistically to children who attend for other purposes. 4. Health boards should make appropriate arrangements to offer the vaccine to eligible children who are not in mainstream schools Programme 5. During the flu season, it is planned that the programme will be extended to include one additional cohort year in primary school i.e. children in school year 3 (ages 7 to 8 years). Health boards should begin to prepare plans on this basis. B-2

18 Uptake 6. As routine flu vaccination of children is still new, specific targets will not be set until the programme is more established. Local services should offer the vaccine to 100% of eligible children. Use of Fluenz Tetra vaccine for children 7. JCVI has advised that a live attenuated influenza vaccine (LAIV) be used as the vaccine of choice for children. There is currently only one LAIV on the market, Fluenz Tetra. 8. JCVI recommended Fluenz Tetra as it: Has higher efficacy in children, particularly after only a single dose. Has the potential to provide coverage against circulating strains that have drifted from those contained in the vaccine. Is more acceptable to children, their parents and carers due to intranasal administration. May offer important longer term immunological advantages to children by replicating natural exposure/infection to induce potentially better immune memory to influenza that may not arise from the annual use of inactivated flu vaccines. 9. Fluenz Tetra is authorised for children aged from two to under 18 years. 10. The Patient Information Leaflet (PIL) provided with Fluenz Tetra suggests children should be given two doses of this vaccine if they have not had flu vaccine before. However, JCVI considers that a second dose of the vaccine provides only modest additional protection. 11. On this basis, JCVI has advised that most children should be offered a single dose of Fluenz Tetra. However, children in clinical risk groups aged two to less than nine years and who have not received flu vaccine before, are recommended to have two doses of Fluenz Tetra given at least four weeks apart. Contraindications and Precautions 12. Fluenz Tetra should not be given to children less than two years of age. 13. Fluenz Tetra should not be given to children or adolescents who are clinically severely immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; HIV infection not on highly active antiretroviral therapy (HAART); cellular immune deficiencies; and high dose corticosteroids. It is not contraindicated for use in children or adolescents with HIV infection receiving stable antiretroviral therapy; or who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or B-3

19 those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency. 14. It is contraindicated in children and adolescents receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection. 15. Advice for children with egg allergy is published in the Green Book. 16. In February 2015, JCVI (February 2015), has advised that except for those with severe anaphylaxis to egg which has previously required intensive care, children with an egg allergy can be safely vaccinated with Fluenz Tetra in any setting (including primary care and schools). 17. Fluenz Tetra is not recommended for children currently taking oral steroids or those who have been prescribed high dose inhaled steroids in the previous 14 days. Vaccination with Fluenz Tetra should be deferred for children with a history of active wheezing in the past 72 hours or those who have had to increase their use of bronchodilators in the previous 72 hours. If their condition has not improved after a further 72 hours, then to avoid delaying protection a suitable inactivated vaccine should be offered. See Green Book for details. 18. There is a potential for transmission of live attenuated influenza virus in Fluenz Tetra to very severely immunocompromised contacts (e.g. bone marrow transplant patients requiring isolation) for one to two weeks following vaccination. Where close contact with very severely immunocompromised patients (for example household members) is likely or unavoidable, appropriate alternative inactivated influenza vaccines should be considered. 19. The advice on contraindications and precautions sections in the Green Book influenza chapter should be referred to: For the small proportion of children for whom Fluenz Tetra is contraindicated a suitable inactivated injectable flu vaccine should be offered. If these children are aged six months to less than nine years and have not received flu vaccine before, two doses of the injected inactivated vaccine should be offered (given at least four weeks apart). Porcine Gelatine 21. Fluenz Tetra contains a wide range of ingredients, including porcine gelatine (as do many other pharmaceutical products). There is currently no alternative vaccine of equivalent efficacy that does not contain porcine gelatine. 22. For children in the cohorts who receive Fluenz Tetra routinely, only those who are in clinical risk groups or have clinical contraindications B-4

20 should receive an inactivated injectable vaccine as an alternative to Fluenz Tetra. Use of Nasal Flu Vaccine 23. Fluenz Tetra is supplied in a divided dose applicator that allows intranasal vaccination to be administered to each nostril. Neither divided dose needs to be repeated if the patient sneezes or blows their nose following administration. Live attenuated influenza vaccine can be given at the same time as other vaccines including live vaccines. 24. The vaccine may be taken out of the refrigerator, without being replaced, for a maximum period of 12 hours at a temperature not above 25 C. If the vaccine has not been used after this 12-hour period, it should be disposed of. 25. Fluenz Tetra has a shorter shelf life (18 weeks) than other influenza vaccines and some of this will have passed by the time the vaccine has been supplied to you. The expiry date should be checked before use. Vaccine has been ordered in batches with varying expiry dates to cover the period over which, historically, the flu vaccine has been used, extending from September to mid-december. It is expected that all the Fluenz Tetra will expire in early 2016, though this will depend on actual vaccine production dates. In the light of this, it will be important to ensure that efforts are made to vaccinate children before the Christmas holidays. Vaccine Ordering 26. Fluenz Tetra has been procured centrally to cover anticipated demand and coverage of the specified cohorts, including children in at risk groups. It will be available to order via Immform in the same way as other vaccines for the current national childhood vaccine programmes. 27. The dates vaccines will become available, and the quantities, will not be known with certainty until near the date. Supplies are highly likely to be restricted initially, with more being available later in the season. This must be taken in to account in planning vaccination sessions. 28. Practices will be asked to place orders up to a maximum figure depending on the size of the practice; it is also hoped to allow for previous uptake rates so that high performing practices are not unduly penalised. This figure will increase as the season progresses. It is essential that practices adhere to the recommended limits in order to ensure equitable distribution of vaccines. 29. It is important that practices do not order above their indicative quota, as this will reduce the amount of vaccine available to other Practices. B-5

21 Data Collection 30. Public Health Wales will collect fortnightly in-season figures for flu immunisations given in school settings through an online data collection form. Final end of season figures will be calculated using data provided by the National Community Child Health Database, which is comprised of records from each Health Board Local Child Health administration database in Wales. 31. Vaccine uptake data for children immunised in general practice will be collected by Public Health Wales, working with the NHS Wales Informatics Service, through the Audit+ software. 32. Immunisers should endeavour to ensure that health board Child Health Offices are notified of all immunisations given to children. Health boards should also ensure that sufficient information on children immunised in school settings, and adults immunised in community pharmacies, is provided to general practice to allow accurate updating of general practice records, using appropriate Read codes. 33. Advice on which Read codes to use for data entry in general practice and guidance on the on-line data collection for children immunised in school settings will be available from: Funding and service arrangements 34. Agreement has been reached with the General Practitioners Committee (Wales) to provide this programme for 2 and 3 year old children, and 4 year old children not in school; also for those children in reception class and school years 1 and 2 who miss a school vaccination appointment or do not attend a school covered by a health board flu vaccination programme. 35. The programme will be delivered via a National Enhanced Service and a Service Specification. Copies of the National Enhanced Service agreements are attached below. GMS contractors can claim an item of service fee of 7.71 for administering each vaccine. This fee is subject to ongoing negotiations with GPC(Wales). 36. Health boards will be reimbursed at the same rate for vaccinations delivered through the schools programme. A top-up funding allocation for the programme will be made to health board allocations. B-6

22 Annex C Health and Social Care Workers Background 1. Frontline health and social care workers have a duty of care to protect their patients and service users from infection. Therefore, as in previous years, flu immunisation should be offered by NHS organisations to all employees directly involved in delivering care. This is not an NHS service, but an occupational health responsibility being provided to NHS staff by employers. Social care providers and independent primary care providers such as GP, dental and optometry practices and community pharmacists, should offer vaccination to staff. 2. NHS staff can access a 10 minute online e-learning module on influenza and flu vaccination at: 3. Doctors are reminded of the General Medical Council s (GMC) guidance on Good Medical Practice (2013), which advises immunisation against common serious communicable diseases (unless otherwise contraindicated) in order to protect both patients and colleague; see paragraph 29 at: 4. Nurses are reminded that the Royal College of Nursing states that: Vaccination of health and social care workers with direct patient / client contact is essential to help protect patients and it is an important way to help reduce the risk of patient infections and advises those involved in front line health care should have the seasonal flu vaccination annually. See: 5. Chapter 12 of the Green Book provides information on which groups of staff can be considered to have direct patient contact, but examples might include: Clinicians, midwives, nurses, and ambulance crew. Occupational therapists, physiotherapists and radiographers. Primary care providers such as GPs, practice nurses, district nurses, school nurses and health visitors. Social care staff working in care settings. Pharmacists, both those working in the community and in clinical settings, and staff working in direct support of clinical staff, often with direct patient care. Students and trainees in these disciplines and volunteers who are working with patients/clients should also be included. C-1

23 This is not an exhaustive list and decisions to provide immunisation should be based on local assessment of likely risk and exposure. Rationale for Vaccination 6. Employers are responsible for ensuring that arrangements are in place for the vaccination of their staff with direct patient contact. Flu outbreaks can, and do, arise in health and social care settings with both staff and their patients/clients being affected. In January and February 2015 a total of 24 flu outbreaks were reported in residential care homes in Wales. It is important that staff protect themselves by having the flu vaccine, and, in doing so, they also reduce the risk of spreading flu to their colleagues and family members. 7. Vaccination of health and social care workers against flu significantly lowers rates of flu-like illness, hospitalisation and mortality in the elderly in healthcare settings. Vaccination of staff in social care settings may provide similar benefits. Flu immunisation of front line health and social care staff may reduce the transmission of infection to vulnerable patients, some of whom may have impaired immunity that may not respond well to immunisation. 8. Healthcare workers are at increased occupational risk of influenza infection and vaccination reduces that risk. In healthy adults, the average efficacy of vaccination in reducing the risk of confirmed influenza infection is 60% (range 53%-66%). Vaccination prevents one case of influenza like illness in recipients for every 40 vaccinations given and reduces the proportion developing symptoms of influenza from 15.6% in unvaccinated persons to 9.9% in vaccinated individuals Vaccination of front line workers also helps reduce the level of sickness absences, which will contribute to keeping the NHS and care services running. This is particularly important when responding to winter pressures. 10. NHS and social care bodies are responsible for ensuring, so far as is reasonably practicable, that health and social care workers are free of and are protected from, exposure to infections that can be caught at work and that all staff are suitably educated in the prevention and control of infections. This includes ensuring that occupational health policies and procedures in relation to the prevention and management of communicable diseases in healthcare workers, including immunisation, are in place. Communications 1 Data from latest Cochrane review at C-2

24 11. Health care employers, including primary care contractors, must actively promote the positive benefits of vaccination to front line workers by giving staff balanced and factually correct information in a timely way. Health boards need to demonstrate strong clinical leadership in helping staff understand that if they refuse to be vaccinated, they put themselves, their families and the people they care for at unnecessary risk. 12. Social care employers should take similar action for their staff with direct client contact. 13. Local Authorities should contact those care homes with which they have contractual arrangements before the start of the season to remind them of the need to ensure that staff are vaccinated in order to protect vulnerable residents. 14. Misconceptions about flu vaccine are common, including amongst health and social care workers. The following messages should be promoted to frontline staff in acute, primary, community and social care services: As professionals, it is part of our duty of care to patients or residents to do everything in our power to protect them against infection, including being immunised against flu. Getting vaccinated against flu can help protect us, our patients and family. We are all susceptible to flu, even if we are in good health and eat well. Frontline health and social care staff are, however, in frequent contact with people who are particularly vulnerable to complications of flu, which can be severe. You can be infected with the virus and have no symptoms of flu but can still pass the virus to others including patients or residents. Good infection control measures are also essential. They reduce the spread of flu and other acute respiratory infections in healthcare settings, but are not sufficient alone to prevent them. The impact of flu on frail and vulnerable patients can be fatal and outbreaks of the virus can cause severe disruption in communities, care homes and hospitals. The flu vaccine has a good safety record and will help protect you. It cannot give you flu. Having the vaccination can help encourage your colleagues to do likewise. C-3

25 Throughout the last ten years there has generally been a good to moderate match between the strains of flu virus in the vaccine and those that subsequently circulated. It means that staff act as positive role models for patients aged 65 and over, those with long-term health conditions and pregnant women, to take up the offer too. 15. The Flu Fighter Cymru campaign provides useful resources to support flu vaccination among healthcare workers. Information on its campaign and the clinical evidence behind the key messages outlined above can be found at: Vaccination for Non-NHS Staff 16. For non-nhs organisations, responsibility for provision of occupational flu immunisation also rests with employers. Immunisation should be provided through occupational health services or other arrangements with private healthcare providers. 17. Staff should not be asked to go to their GP for their immunisation unless they fall within one of the recommended at-risk groups, or GPs have been contracted specifically to provide this service. Vaccination Uptake Data Collection of Healthcare Workers 18. All health board Occupational Health departments should report flu vaccination uptake levels using agreed methods to Public Health Wales on a monthly basis. 19. General Practices are also expected to provide data on vaccine uptake among practice staff to their health board Immunisation Coordinator and Public Health Wales on request. C-4

26 Annex D Pregnant Women 1. All pregnant women are recommended to receive the flu vaccine irrespective of their stage of pregnancy. Health boards should take steps to accommodate this. Rationale and Target Groups 2. There is good evidence that pregnant women are at increased risk from complications if they contract flu. In addition, there is evidence that flu during pregnancy may be associated with premature birth, smaller birth size and weight and that flu vaccination may reduce the likelihood of prematurity and smaller infant size at birth associated with influenza infection during pregnancy. Furthermore, a number of studies show that flu vaccination during pregnancy provides passive immunity against flu infection to infants in the first few months of life. 3. A review of studies on the safety of flu vaccine in pregnancy concluded that inactivated flu vaccine can be safely and effectively administered during any trimester of pregnancy and that no study to date has demonstrated an increased risk of either maternal complications or adverse foetal outcomes associated with inactivated influenza vaccine. When to Offer the Vaccine to Pregnant Women 4. The ideal time for flu vaccination is before flu starts circulating, however, vaccination may be offered throughout the flu season. Clinicians should apply clinical judgement to assess the needs of an individual patient, taking into account the level of flu in their community and the fact that the immune response following flu vaccination takes about two weeks to develop fully. Up to date information on the levels of flu circulating are provided by Public Health Wales on a weekly basis. See: Data Review and Data Recording 5. Every woman who is identified as pregnant during the immunisation season should be offered flu vaccination. GPs will need to work in their locality groups to agree procedures with their local midwives for identifying women who are not pregnant at the start of the immunisation programme but become pregnant during the winter. 6. Health boards should encourage midwives to raise awareness of the benefits of seasonal flu vaccine among pregnant women. The linking of midwifery services with GP practices will further support uptake. There is evidence to show that when midwives administer the flu vaccine to pregnant women, there is a positive effect on uptake rates. If arrangements are put in place where midwives administer the D-1