H1 N1 Immunisation Programme


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H1 N1 Immunisation Programme

  1. 1. H1N1 Immunisation Programme Influenza A (H1N1) Immunisation programme A resource pack to support the training of immunisers 0 01 y2 3 Jul d1 ate Upd Front cover Add notes: 1
  2. 2. H1N1 Immunisation Programme Contents 1. Background to Influenza A(H1N1) & 2009/10 pandemic 2. H1N1 Vaccines 3. Immunisation by nurses & other healthcare professionals 4. Administration 5. Resources 2 Contents Add notes: 2
  3. 3. H1N1 Immunisation Programme Background to Influenza A(H1N1) & 2009/10 pandemic • Influenza viruses • Genetic change/antigenic shift • 20th Century pandemics • 2009/10 A(H1N1) virus • Disease • Current epidemiology 1. Background to Influenza A(H1N1) & 2009/10 pandemic Add notes: 3
  4. 4. H1N1 Immunisation Programme Influenza viruses Three types: •A - Causes epidemics and pandemics - Animal reservoir – wildfowl; also carried by other mammals •B - May cause epidemics - Predominantly found in humans •C - Do not cause epidemics - Minor respiratory illness only - Type C occurs only in humans and pigs Background to Influenza A(H1N1) & 2009/10 pandemic 4 Influenza viruses – three types It’s important to start with an appreciation that there are three types of influenza virus, and to note that the seasonal flu vaccine protects against the two main circulating types of A virus, and one B virus. A wide range of animals are known to carry type A. Type B may infect other mammals e.g. seals and pigs. The seasonal flu vaccine in any year is designed to protect against the main flu viruses known to be circulating. It generally offers protection against the two main circulating type A viruses, and one type B virus. 4
  5. 5. H1N1 Immunisation Programme Influenza A virus • Genetic material (RNA) in the centre • Two surface antigens: - Haemagglutinin (H) - Neuraminidase (N) • Different types of each Background to Influenza A(H1N1) & 2009/10 pandemic 5 Influenza A virus Schematic model of an influenza A virus. There are two antigens on the surface, as illustrated. The role of the H antigen is to bind to the cells of the host and there are 16 different types of H. The role of the N antigen is to release the virus from the cell surface, and there are 9 different types. There are different types of H and N, identified by numbers. 5
  6. 6. H1N1 Immunisation Programme Genetic change What this means: Antigenic drift small constant mutations of H and N occurs in all types of flu virus Antigenic shift only occurs in type A Background to Influenza A(H1N1) & 2009/10 pandemic 6 Genetic change – what this means It’s important to understand that flu viruses are constantly changing, and to appreciate how this happens. Flu viruses lack proof-reading enzymes that maintain the fidelity of RNA replication, and are therefore subject to high rates of mutation. Antigenic drift: Small mutations affecting the H and N antigens occur constantly. When changes enable the virus to multiply in an individual immune to previous strains, the new subtype can reinfect the community. This is because mutants emerge that express surface antigens (Hs and Ns) sufficiently different as to be unable to combine with existing antibody. This is why new flu vaccines have to be developed each year, and why individuals at risk require to be immunised annually. 6
  7. 7. H1N1 Immunisation Programme Antigenic shift • A major change in one or both surface antigens, characteristic of type A influenza viruses. • It is due to genetic recombination when virus particles of more than one strain infect a cell simultaneously. • It can result in a worldwide pandemic. • The previous major antigenic shift occurred in 1968 when H3N2 (Hong Kong) influenza appeared and replaced the type A strain (H2N2, or Asian influenza). Background to Influenza A(H1N1) & 2009/10 pandemic 7 Antigenic shift Only occurs in type A. A sudden major change occurs as a result of recombination of different virus cells when they infect the same cell. The new strain can then spread through a population immune to previous strains, and lead to a pandemic. 7
  8. 8. H1N1 Immunisation Programme 20th Century pandemics Pandemics are caused by antigenic shift which usually appear in China and then spread westward through Asia, Europe and America. There have been three major influenza pandemics in the past 100 years when epidemic activity reached global proportions. Year Pandemic Virus subtype Severity 1918 Spanish H1N1 Severe 1957 Asian H2N2 Severe 1968 Hong Kong H3N2 Moderate Background to Influenza A(H1N1) & 2009/10 pandemic 8 20th Century pandemics What are pandemics? Pandemics are when a new influenza A emerges to which most or many of the population have no immunity. They result usually from an animal influenza combining some of its genes with a human influenza. To be a pandemic strain an influenza A virus needs to have three or four characteristics: It needs to be able to infect humans to cause disease in humans, and to spread from human to human quite easily. An additional criteria that is often applied is that many or most of the population should be non-immune to the new virus. Pandemic is a term used by epidemiologists to describe infections that are spreading in the population of a number of different countries. A pandemic does not have to be a serious illness. Flu that spreads rapidly causing widespread epidemics around the world is described as a pandemic. Pandemic flu occurs when a new, highly infectious, strain of the influenza virus appears. In contrast to the ‘ordinary’ or ‘seasonal’, flu outbreaks which we see every winter in the UK, flu pandemics occur infrequently - usually every few decades. NB Spanish flu: A first mild wave in the Spring of 1918 was replaced by a second wave in September to November of 1918 that resulted in mortality rates of over 2.5%. 8
  9. 9. H1N1 Immunisation Programme 2009/10 A(H1N1) virus • Mid February 2009 - outbreak of respiratory disease in La Gloria, Mexico • Mid April – new virus identified in two specimens in California – reported to WHO • April 27th: First Scottish/UK case, 1st wave commences • Contains genes from avian, swine and human viruses – new unique combination of swine origin • June 2009 – WHO moved to pandemic phase 6 Background to Influenza A(H1N1) & 2009/10 pandemic 9 2009/10 A(H1N1) virus The virus isolated in California was found to contain genes from triple-assortment swine influenza viruses that were know to circulate among swine herds in North America, plus some genes related to those circulating in swine populations of Eurasia Phase 6 – what does it mean? The World Health Organisation describes 6 phases of pandemic flu preparedness. Phase 6 is when a new flu virus causes infection in humans, and there is evidence of community transmission causing community level outbreaks in more than one WHO Region. It is NOT an indicator of the severity of the illness that is caused by the new virus. See: http://www.who.int/csr/disease/swineflu/frequently_asked_questions/levels_pandemic_alert/en/ index.html for a link to definitions of all the different phases. 9
  10. 10. H1N1 Immunisation Programme Disease • Mild self-limiting illness in most cases (Fever, cough, sore throat, rhinorrhea, limb/joint pain, headache. Some cases have vomiting & diarrhoea) • Severe outcomes - Viral pneumonia - Secondary bacterial pneumonia - Exacerbations of underlying chronic conditions Background to Influenza A(H1N1) & 2009/10 pandemic 10 Disease H1N1 may result in a whole spectrum of illness from mild to severe, and in some cases, death. 10
  11. 11. H1N1 Immunisation Programme Epidemiology – international situation as at end May 2010 • Laboratory confirmed cases reported by 214 countries • Total number of deaths now over 18114 • Most cases and deaths are in people aged < 50 years • 10% of cases in EU are hospitalised • CFR – up to 0.1% • H1N1 is the dominant influenza strain in most parts of the world • 290 oseltamivir resistant H1N1 cases (as of 26th May) • No signs that the virus is mutating • Most active parts regarding pandemic flu activity is currently parts of the Caribbean and SE Asia. Background to Influenza A(H1N1) & 2009/10 pandemic 11 Epidemiology – international situation as at 23 December 2009 Overall disease activity has recently peaked in much of the Northern hemisphere. There continues to be increases in influenza activity in later affected areas of central and eastern Europe, and in parts of west, central, and south Asia. In Europe, geographically widespread and active transmission of pandemic influenza virus continued to be observed throughout the continent, however, overall pandemic influenza activity appears to have recently peaked across a majority of countries. At least ten countries reported that 30% or more of their sentinel respiratory specimens had tested positive for influenza. Greater than 98% of subtyped influenza A viruses detected in Europe were pandemic H1N1 2009, however, seasonal influenza viruses (H1N1, H3N2, and type B) continue to be detected at low levels. Up to 8 December 2009, 109 oseltamivir-resistant H1N1 viruses have been detected worldwide, characterized and reported to WHO. Around one third of the cases of oseltamivir-resistant H1N1 viruses have occurred in patients whose immune systems were severely immunocompromised. Although all incidents of oseltamivir resistance merit investigation, and are fully investigated, no evidence suggests that events to date constitute a public health threat. (Source: Update 80, www.who.int ) 11
  12. 12. H1N1 Immunisation Programme Epidemiology – Scotland • Flu activity remains low across Scotland (GP consultation rate is currently around 50-60 per 100,000 – end May 2010) • Consultation rates are highest in the 0 – 4 year age group • No further laboratory confirmed cases since early March • No further deaths since early March (total 69 to date) • 9 cases of resistance to antivirals Background to Influenza A(H1N1) & 2009/10 pandemic 12 Epidemiology – Scotland Updates on flu epidemiology in Scotland is available at: www.hps.scot.nhs.uk/resp/influenzaseason.aspx#report 12
  13. 13. H1N1 Immunisation Programme H1N1 vaccines • Why immunise? • Thiomersal • Governance structure • Schedule • Vaccine supply • Interchangeability • Licensing •Co-administration • Priority groups • Contraindications/precautions • Who will immunise? • Pregnancy • Presentation & composition • Immunocompromised • Adjuvants • Safety data & Side effects 2. H1N1 vaccines Add notes. 13
  14. 14. H1N1 Immunisation Programme Why immunise? • Around 5-10% of people will get flu each year (H1N1 is highly likely to be one of the flu strains circulating this season) • Significant morbidity associated with flu particularly in at-risk individuals (e.g. young children, pregnant women and those with chronic underlying illness) • It is estimated that 3,000-4,000 excess deaths occur annually in the UK, which are attributable to seasonal flu • Immunisation reduces the risk of complications and hospitalisations related to flu H1N1 vaccines 14 Why immunise? This slide and the next one explain the rationale for immunising. It is important that immunisers are able to answer patients’ questions adequately, and to convey confidence in the programme. Concept of “excess” deaths – increases in the number of deaths during an influenza epidemic beyond the expected number of deaths if there were no epidemic are attributed to influenza. 14
  15. 15. H1N1 Immunisation Programme Public Health aims of the immunisation programme • Protect those who are at most risk of serious illness or death should they develop influenza • Reduce the transmission of the H1N1 virus within health and social care premises • Indirectly protect those who may have a suboptimal response or are too young to be immunised • Avoid disruption to essential care services H1N1 vaccines 15 Public Health aims of the immunisation programme 15
  16. 16. H1N1 Immunisation Programme Vaccine supply • Government has contracts with GlaxoSmithKline and Baxter Healthcare Ltd. • Vaccines delivered to NHS Board vaccine holding centres • Needles and syringes have also been procured on a UK basis H1N1 vaccines 16 Vaccine supply Vaccine and consumables procured on UK wide basis by Department of Health on behalf of Scotland and other devolved nations. Vaccines can be ordered from the vaccine holding centre in a hospital pharmacy department in each NHS Board. 16
  17. 17. H1N1 Immunisation Programme Licensing process Pandemrix® manufactured by GSK licensed for use by European Commission on 1st October 2009 Celvapan® manufactured by Baxter licensed for use by European Commission on 9th October 2009 H1N1 vaccines 17 Licensing process Pandemrix® and Celvapan® were licensed using process for approval of Pandemic Strain vaccines as agreed by European Medicines Agency. This approach allowed development and authorisation of these vaccines in advance of a pandemic, based on information generated with a different strain that could have caused a pandemic(H5N1). Once the H1N1(v) virus strain causing the pandemic was identified by the WHO, the manufacturers were able to include in the final vaccine. Decades of experience with seasonal influenza vaccines indicate that insertion of a new strain in a vaccine should not substantially affect the safety or the level of protection offered. 17
  18. 18. H1N1 Immunisation Programme Priority Groups – Phase 1 • Individuals aged over six months and up to 65 years in the current seasonal flu vaccine clinical at risk-groups • Pregnant women, subject to licensing considerations • Household contacts of immunocompromised individuals • People aged 65 and over in the current seasonal flu vaccine clinical at-risk groups. Priority Groups – Phase 2 • All individuals aged from 6 months and up to 5 years - completed 31st March 2010 H1N1 vaccines 18 Priority Groups – Phase 1 These are the priority groups for H1N1 vaccine announced by the Scottish Government on 13 August 2009. The expert advice recommends the vaccination of these groups as a priority as they have been identified as at highest risk from the virus. A second phase to offer immunisation to all individuals from age 6 months and up to 5 years was commenced in December 2009 and was completed by 31st March 2010 Those individuals in the phase 1 priority groups should continue to be offered vaccination when the opportunity arises www.sehd.scot.nhs.uk/cmo/CMO(2010)06.pdf 18
  19. 19. H1N1 Immunisation Programme Priority staff groups • Healthcare workers with direct patient contact • Social care staff who are employed to provide personal care to children and adults, both in care homes and in the community. H1N1 vaccines 19 Priority staff groups Staff involved in direct patient care This includes staff who have regular clinical contact with patients and who are directly involved in patient care. This includes doctors, dentists, midwives and nurses, paramedics and ambulance drivers, occupational therapists, physiotherapists and radiographers. Students and trainees in these disciplines and volunteers who are working with patients must also be included. In addition to these groups it is recognised that community pharmacists providing face to face consultations have a key role to play during the pandemic and as such should be considered for H1N1 vaccination if they have regular clinical contact with patients and are directly involved in patient care. NHS 24 staff will also be offered the vaccine given their role in underpinning out of hours services and maintaining the delivery of existing health services to patients in Scotland. Definition of frontline social care worker The Government has agreed the following definition that “personal care” means: • physical assistance given to a person in connection with: - eating or drinking (including the administration of parenteral nutrition) - toileting (including in relation to the process of menstruation) - washing or bathing - dressing - oral care, or - the care of skin, hair and nails (with the exception of nail care provided by chiropodist or podiatrist) or • the prompting, together with supervision, of a person, in relation to the performance of any of the activities listed in paragraph (a) where that person is unable to make a decision for themselves in relation to performing such an activity without such prompting and supervision (Source: Influenza A (H1N1) Vaccination Programme: Definition of Priority Staff and Occupational Groups. H1N1 Vaccination Team, Public Health Division, Scottish Government. 4 September 2009.) 19
  20. 20. H1N1 Immunisation Programme Who will immunise? • Those < 65 years in clinical at-risk groups – General practice • Health and social care staff – Occupational Health led service, plus local solutions • Pregnant women – General practice or maternity services • Household contacts of immunocompromised individuals – General practice • Those aged 65 and over in clinical at-risk groups – General practice H1N1 vaccines 20 Who will immunise? - variable according to priority group The Primary Care Division of the Scottish Government announced on 15 September that agreement with the BMA’s General Practitioners’ Committee (GPC) had been reached, and that subject to the vaccine being licensed, GPs will immunise individuals in the priority groups listed in slide 22. 20
  21. 21. H1N1 Immunisation Programme H1N1 (Swine flu) vaccine clinical priority groups - uptake figures week ending 4 April 120.0 % practices responding to valid data 100.0 65+ (% dose 1) <65 (% dose1) 80.0 All data is provisional 60.0 40.0 20.0 0 15/11/09 22/11/09 29/11/09 06/12/09 13/12/09 20/12/09 27/12/09 03/01/10 10/01/10 17/01/10 24/01/10 31/01/10 07/02/10 14/02/10 21/02/10 28/02/10 07/03/10 14/03/10 21/03/10 28/03/10 04/04/10 Week ending date H1N1 vaccines 21 H1N1 (Swine flu) vaccine clinical priority groups - uptake figures week ending 4 April All data is provisional 21
  22. 22. H1N1 Immunisation Programme Two H1N1 specific vaccines GSK - Pandemrix Baxter - Celvapan Slit virion inactivated vaccine Whole virion inactivated vaccine Egg based production Vero cell based production Split cell virus Whole virus vaccine AS03 adjuvant No adjuvant 3.75μg target dose 7.5μg target dose H1N1 vaccines 22 Two H1N1 specific vaccines Both vaccines were originally for protection against H5N1 when the trials took place. Because there has been concern for some years regarding the possibility of a pandemic occurring as a result of the H5N1 avian influenza virus, manufacturers had already begun production of H5N1 vaccines which had undergone trials, What has now happened is that the manufacturers have substituted the H1N1 virus for the previous H5N1 virus in production, but in all other respects the vaccines are similar. The approved indication is prophylaxis of influenza caused by A (H1N1) 2009 virus’ 22
  23. 23. H1N1 Immunisation Programme Pandemrix (GSK) vaccine - presentation • Will be presented in a pack of multidose vials • Each pack will contain: - 1 box (50 vials) each containing 2.5ml antigen suspension - 2 boxes (25 vials each) each containing 2.5ml of adjuvant • Antigen & adjuvant must be mixed together before administration • Each 5ml vial for administration should provide 10 doses • Each pack should provide 500 doses • Pack size: 260mm x 113mm x 97mm H1N1 vaccines 23 Pandemrix (GSK) vaccine - presentation The volume of adjuvant may be larger than 2.5ml, but the whole volume must be drawn up and mixed with the antigen. Some immunisers may find that a vial will provide 11 doses. 23
  24. 24. H1N1 Immunisation Programme Pandemrix (GSK) Each 0.5ml dose contains Excipients Polysorbate 80 Active Ingredient Octoxynol 10 3.75 μg Haemagglutinin Thiomersal (A/California/7/2009) Sodium chloride Disodium Hydrogen phosphate Adjuvant (AS03) Potassium dihydrogen phosphate Squalene Potassium chloride Alpha-tocopherol Magnesium chloride Polysorbate 80 Water for injections H1N1 vaccines 24 Pandemrix (GSK) Pandemrix (GSK) Summary of Product Characteristics is available at: www.ema.europa.eu/influenza/vaccines/pandemrix/pandemrix_pi.html 24
  25. 25. H1N1 Immunisation Programme Celvapan (Baxter) - presentation • Will be presented in a pack of multidose vials of 5ml suspension per vial • Each vial will contain 5ml suspension for injection • Each 5ml vial should provide 10 doses • Each pack will contain 20 multidose vials • Each pack should provide 200 doses • Pack size – 206mm x 166mm x 55mm H1N1 vaccines 25 Celvapan (Baxter) - presentation Box size: 8 x 6.5 x 2 inches. This is just slightly bigger than a box of tissues. Note that one advantage of the multidose vials is that the fridge space required is considerably less than with individual doses. Celvapan is being reserved for administration only to those individuals in whom Pandemrix is contraindicated, i.e. they have a history of an anaphylactic reaction to egg. 25
  26. 26. H1N1 Immunisation Programme Celvapan (Baxter) Each 0.5ml dose contains Active Ingredient 7.5 μg Haemagglutinin (A/California/07/2009 (H1N1)v) Excipients: • Trometamol • Sodium chloride • Water for injections • Polysorbate 80 H1N1 vaccines 26 Celvapan (Baxter) Summary of Product Characteristics is available at: www.ema.europa.eu/influenza/vaccines/celvapan/celvapan.html 26
  27. 27. H1N1 Immunisation Programme Adjuvants • The functions of adjuvants are: - To improve immunogenicity - To minimise the amount of antigen required • Pandemrix (GSK) uses AS03, an oil in water emulsion • >40,000 adults/children have received AS03 adjuvanted vaccine during development of seasonal & pandemic vaccines H1N1 vaccines 27 Adjuvants An adjuvant is a substance added to a vaccine to increase the immune response, or its immunogenicity. The name comes from the Latin verb adjuvare meaning to help, so think of it as a helper! Most adjuvants used in vaccines in the UK are aluminium salts. They have been in use for over 70 years and adverse effects (such as a subcutaneous nodule formation) are extremely rare. There is still much to be understood about their mode of action, but they appear to act in the following ways: Having a depot effect, resulting in the slow release of antigen at the injection site Attracting antigen-presenting cells by causing inflammation at the injection site Helping to convert the antigen into a form that is more easily taken up by antigen-presenting cells Stimulating the production of other factors, such as cytokines, that increase the immune response. Research into new adjuvants is ongoing. 27
  28. 28. H1N1 Immunisation Programme Thiomersal • Preservative in multidose vial • Has no impact on effectiveness of vaccine • Has been used widely in vaccine production for over 60 years. • 5 microgram per 0.5ml dose • MHRA and CHM statement of safety - No evidence of neurodevelopmental adverse effects caused by levels of thiomersal in vaccines - Only evidence of harm is small risk of local reactions - Balance of risk and benefit of thiomersal containing vaccines overwhelmingly positive H1N1 vaccines 28 Thiomersal Thiomersal is a mercury based preservative added to multidose vials, where repeated doses are drawn from the vial, to prevent contamination by bacteria and fungi. Thiomersal does not interfere with the immunogenicity of the vaccine. It has been used widely in vaccines for more than 60 years and has prevented many deaths or illnesses from contamination. Only a very small amount of thiomersal is used = 5microgram per dose which is equivalent to 2.5 microgram of mercury content. Thiomersal is quickly broken down by the body to form ethylmercury which is then converted rapidly to inorganic mercury and excreted in faeces and bile. The MHRA and Commission on Human Medicines (formerly Committee of Safety of Medicines) has considered the available evidence for the safety of thiomersal in vaccines and issued a statement of safety www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Vaccinesafety/ Thiomersal(ethylmercury)containingvaccines/CON026254 Link to MHRA information on thiomersal in vaccines Department of Health have a factsheet to address any concerns by summarising the scientific evidence for the safety of thiomersal in vaccines and aims to answer questions from parents around immunisation of their children with thiomersal containing vaccines. This is being updated www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4070148 28
  29. 29. H1N1 Immunisation Programme Schedule – Pandemrix • Children from 6 months to 10 years of age - Immunocompetent: a single dose of 0.25ml - Immunocompromised: 2 doses of 0.25ml given at least 3 weeks apart • Children aged 10 years and over and adults - Immunocompetent: a single does of 0.5ml - Immunocompromised: 2 doses of 0.5ml given at least 3 weeks apart NB When two doses are required, the second should be given at least three weeks after the first. In such cases if the course is interrupted it should be resumed but not repeated. The course must be completed using Pandemrix H1N1 vaccines 29 Schedule – Pandemrix It is likely that not everyone will attend for their second dose exactly three weeks after the first. Although the three week interval should not be reduced, in some circumstances it will inevitably be longer. In most documents this is put in terms “at least three weeks apart” Or “with a minimum . interval of three weeks between doses” What hasn’t been determined yet is what the maximum . interval is. The Green Book (page 79) states: “If any course of immunisation is interrupted, it should be resumed and completed as soon as possible. There is no need to start any course of immunisation again.” 29
  30. 30. H1N1 Immunisation Programme Schedule – Celvapan • The course for all ages consists of two x 0.5ml doses, with an interval of at least three weeks between the first and second. • If the course is interrupted it should be resumed but not repeated • The course must be completed with Celvapan H1N1 vaccines 30 Schedule – Celvapan Add notes. 30
  31. 31. H1N1 Immunisation Programme Co-administration Current advice is that H1N1 vaccines can be co-administered with other vaccines, including routine childhood vaccines, HPV, MMR and seasonal flu vaccine If it is necessary to co-administer, ensure that a separate site is used for the H1N1 vaccine, and accurately recorded H1N1 vaccines 31 Co-administration 31
  32. 32. H1N1 Immunisation Programme Contraindications & precautions Pandemrix • Confirmed anaphylactic reaction to a previous dose of Influenza A H1N1(v) vaccine (Pandemrix®) • Confirmed anaphylactic reaction to any component of Influenza A H1N1(v) vaccine (Pandemrix®) • Confirmed anaphylactic reaction to eggs/egg product Celvapan • Confirmed anaphylactic reaction to a previous dose of Influenza A H1N1(v) vaccine (Celvapan®) • Confirmed anaphylactic reaction to any component of Influenza A H1N1(v) vaccine (Celvapan®) H1N1 vaccines 32 Contraindications & precautions Individuals who have had laboratory confirmed H1N1v infection can be safely vaccinated, however it is unnecessary. In the absence of a laboratory confirmed H1N1v infection, individuals should be vaccinated. As with all immunisations, if the patient presents with acute severe illness, consider postponing immunisation until they are fully recovered. The Department of Health has confirmed that both vaccines have been manufactured and packaged without latex and therefore are suitable for people with latex allergy. 32
  33. 33. H1N1 Immunisation Programme Pregnancy • Evidence indicates that pregnant women are at increased risk • WHO strategic advisory group of experts has recommended that H1N1 vaccine should be given to pregnant women • Risk increases later in pregnancy • All pregnant women should be offered immunisation • No evidence of harm; evidence of benefit H1N1 vaccines 33 Pregnancy Neither of the H1N1 vaccines are live, and therefore they are safe to give during pregnancy. However, the vaccine of choice for pregnant women is Pandemrix, since this is a one dose schedule which appears to give adequate levels of antibodies and thereby confers more rapid protection than would be afforded by the two dose Celvapan schedule. Influenza-related excess deaths among pregnant women were reported during the pandemics of 1918--1919 and 1957--1958. Case reports and several epidemiologic studies also indicate that pregnancy increases the risk for influenza complications for the mother. See: www.cdc.gov/mmwr/preview/mmwrhtml/rr58e0724a1.htm for further information. Seasonal flu vaccine has been recommended in the US for a number of years. In developing countries pregnant women are offered immunisation against tetanus because of the increased risk of neonatal tetany. Pregnancy is a risk factor for severe illness related to Influenza A H1N1. It can cause maternal and neonatal morbidity and mortality. 1 1 The ANZIC Influenza Investigators and Australasian Maternity Outcomes Surveillance System. Critical illness due to 2009 A/H1N1 influenza in pregnant and postpartum women: a population based cohort study. BMJ 2010;340:c1279 33
  34. 34. H1N1 Immunisation Programme Immunocompromised • Individuals with immunosuppression and HIV infection (regardless of CD4 count) should be given influenza A H1N1(v) vaccine in accordance with national recommendations • These individuals may not make a full antibody response. • Household contacts of these individuals should also be vaccinated following an assessment made by their GP H1N1 vaccines 34 Immunocompromised Add notes. 34
  35. 35. H1N1 Immunisation Programme Safety data & side effects • Local reactions such as pain, swelling, redness, induration and bruising • Systemic reactions many include headache, tiredness, fever, aching muscles, joint pain, dizziness, vertigo • As with all vaccines there is a very small possibility of anaphylaxis For full details of all possible side effects, please refer to the Summary of Product Characteristics of each product H1N1 vaccines 35 Safety data & side effects In MHRA final public summary of UK suspected adverse reaction analysis: Celvapan and Pandemrix on 26th March no unexpected new safety issues have been identified from reports received to date. This is based on 3,310 UK reports of suspected adverse reaction to H1N1 vaccines. The latest figures indicate that more than 5 million people have now been vaccinated. 35
  36. 36. H1N1 Immunisation Programme Immunisation by nurses & other healthcare professionals • Patient Group Directions • Patient Specific Directions 3. Immunisation by nurses & other healthcare professionals 36
  37. 37. H1N1 Immunisation Programme Immunisation by nurses & other healthcare professionals The vaccine may only be administered: • Against a prescription written manually or electronically by a registered medical practitioner or other authorised prescriber, or • Against a Patient Group Direction, or • Against a Patient Specific Direction Prescribing 37 Immunisation by nurses & other healthcare professionals 37
  38. 38. H1N1 Immunisation Programme Use of Patient Group Direction (PGD) (1) • PGDs are defined as written instructions for the supply or administration of medicines to groups of patients who may not be individually identified before presentation for treatment • PGDs are not a form of prescribing but provide a legal framework for a range of qualified healthcare professionals, laid out in legislation to supply or administer medicines • Qualified healthcare professionals must be trained in the appropriate use of the PGD and be familiar with all of the content • They must be authorised as being competent by their employing organisation to use the PGD • Managers should retain a record all those authorised to use the PGD Prescribing 38 Use of Patient Group Direction (PGD) (1) For further information concerning PGDs please refer to www.nes.scot.nhs.uk/pgds 38
  39. 39. H1N1 Immunisation Programme Use of PGD (2) • When using a PGD, administration cannot under legislation be delegated • A PGD cannot be authorised for use by non-NHS nursing staff employed in Care Homes Prescribing 39 Use of PGD (2) The person authorised to use the PGD cannot delegate administration to anyone, neither to a student nurse, nor to a health care assistant. This also means that the same registrant should both draw up and administer the vaccine. Although a PGD cannot be utilised in a Care Home, residents may be immunised by either NHS employed staff, or their own Registered Nurses, when authorised by a Patient Specific Direction. The Registered Nurse should of course be competent in the administration of vaccines, and the management of any adverse effects. 39
  40. 40. H1N1 Immunisation Programme Use of Patient Specific Directions • A Patient Specific Direction (PSD) is a written instruction from a doctor or dentist or other independent prescriber for a medicine to be supplied or administered to a named patient. • In primary care, this might be a simple instruction in the patient’s notes. • In a flu vaccine clinic/Care Home, a list of named patients to be administered the vaccine can be signed by the doctor/independent prescriber. Prescribing 40 Use of Patient Specific Directions 40
  41. 41. H1N1 Immunisation Programme Administration • Communication • Site & route • Consent • Method • Infection control • Documentation • Equipment • Storage & handling • Preparation • Adverse events & management • Reconstitution 4. Administration 41
  42. 42. H1N1 Immunisation Programme Communication • Staff immunising should be prepared to discuss the benefits and risks • Knowledge required of: - Type of vaccine - i.e. non-live - How it works - How long to take effect - Expected side effects and how to manage them - Risks of not being immunised Administration 42 Communication Type of vaccine – communicate that it is non-live. It cannot cause infection. How it works – explain that the active ingredient haemagglutinin stimulates the body’s immune system to produce antibodies, just as would happen in natural infection. 42
  43. 43. H1N1 Immunisation Programme Consent Valid consent is: • Given by a legally competent person • Given voluntarily • Informed Nationally produced consent forms will be used for health and social care workers. Administration 43 Consent Consent forms will be produced for use in occupational health settings. The main purpose of this is to obtain consent from individuals for the transfer of data to GPs. This is to ensure that they will not then be called for immunisation by the practice when adults in the general population are offered immunisation. It is recognised that in other settings written consent is not legally required. Practitioners should also be aware that the giving and obtaining of consent is viewed as a process, and not a one-off event, and should therefore be sought for each dose of the vaccine. See chapter 3 of the Green Book for further information. 43
  44. 44. H1N1 Immunisation Programme Who can give consent? • Any person *16 year unless they are deemed to lack capacity • A young person under the age of 16 can give consent themselves if a health professional deems they are capable of understanding what is being proposed - see www.hris.org.uk – leaflet for under 16s • Young children – parent/guardian with parental responsibility • The Adults with Incapacity (Scotland) Act 2000 Administration 44 Who can give consent? The Age of Legal Capacity (Scotland) Act 1991 provides that: A person of or over the age of 16 years is presumed to be competent to give legal valid consent to medical treatment A person under the age of 16 years has the legal capacity to consent to treatment if capable of understanding the benefits and risks as deemed by the person giving the immunisation. The Children (Scotland) Act 1995 covers the situation of a child under 16 years who does not have competence to give legally valid consent. In such cases, various categories of individual (such as the mother, natural father if married to the mother, natural father even if divorced, unmarried father with parental responsibilities and parental rights agreement, legal guardian, adult with care of control of child, person with residence order, or person with delegated parental responsibilities) may consent on behalf of the child. The Adults with Incapacity (Scotland) Act 2000 defines incapacity as an adult over the age of 16 incapable (by reason of mental disorder or inability to communicate because of physical disability) of one or more of the following: Acting Making decisions Communicating decisions Understanding decisions Retaining the memory of decisions If an adult over the age of 16 is deemed incapable of making decisions regarding their health, treatment may only be administered if the Welfare Attorney/Guardian gives consent, or there is a Certificate of Incapacity. See Adults with Incapacity (Scotland) Act 2000.The medical practitioner with primary responsibility for the medical treatment of such a person must determine whether a certificate of incapacity should be issued. 44
  45. 45. H1N1 Immunisation Programme Consent – other considerations • If young people are considered competent and consent for themselves, it is still good practice to involve parents in the decision making process • Only young people * 12 years of age may be deemed competent • However, their right to confidentiality must be respected Administration 45 Consent – other considerations Re young people < 16 years of age: The law states that competence must be judged by a “qualified medical practitioner” . If a nurse has been trained and professionally authorised to undertake a clinical procedure which is normally that of a medical practitioner, then that nurse can be considered to have the necessary power to assess the capacity of a child under the Age of Legal Capacity (Scotland) Act 1991. Although there is no lower age limit detailed in legislation, certainly for the purposes of this programme, only young people aged 12 years or older may be deemed competent to give their own consent. In most Boards, the above “authorisation” will be given via the instructions in a Patient Group Direction. If a young person wishes to take up the immunisation, contrary to the wishes of their parent(s), then the assessment for immunisation can take proceed without reference to the parents. In practice, it may be advisable in certain circumstances, if the young person wishes to take up immunisation contrary to the wishes of the parent(s), for the qualified health professional dealing with the case, with the consent of the young person in question, to discuss the matter with their parent(s) so that immunisation can be made acceptable to the family as a whole. Where the parent(s) has not signed or no consent form is available and the young person indicates that she wishes to take up immunisation, immunisation should proceed. 45
  46. 46. H1N1 Immunisation Programme Infection control • Handwashing – hands should be decontaminated with alcohol gel between patients, and washed with liquid soap & water when sticky or when visibly soiled • Wear plastic disposable apron for each session • Gloves are not required unless immuniser has open skin lesions • Place used syringes & needles directly into sharps box Administration 46 Infection control 46
  47. 47. H1N1 Immunisation Programme Bung management – use of alcohol wipes To ensure the procedure is aseptic: • Before first use, decontaminate the bung with an alcohol wipe. • During a continuous session, the bung may be re-pierced without subsequent wiping with alcohol. • If there has been a break in the vaccination session (e.g. vaccine taken to patient’s home or stored overnight), decontaminate the bung with an alcohol wipe. • To prevent contamination of the vaccine with alcohol allow the alcohol to dry before piercing the bung (approx 30 seconds) Administration 47 Bung management – use of alcohol wipes Trainers should draw attention to the fact that this advice differs from that in slide 21 of the Department of Health slide set, The national swine flu vaccination programme on vaccine preparation and administration. The above guidance has been produced by Health Protection Scotland, and can be accessed at: www.healthscotland.com/H1N1vaccination 47
  48. 48. H1N1 Immunisation Programme Equipment • Needles and syringes for mixing and administration have been procured on UK wide basis • For mixing Pandemrix – 3ml mixing syringe – Green needle 21G x 38mm • For drawing up and administration Pandemrix and Celvapan – integrated needle/syringe combination called Flu+ – syringe with fixed 25mm (1 inch) orange needle (25G) – 0.5ml and 1ml dose markings – Has been shown to provide most accurate dose and minimum waste – Same needle used for drawing up and administration • Bins for disposal of sharps also procured on UK basis Administration 48 Equipment UK stockpile of needles and syringes – Scotland’s share will be stored and distributed by National Procurement. These will be delivered into a single point in each NHS Board –most likely to be the NHS board stores or supplies department from where they will be distributed to GP practices and other sites where immunisation will take place. Flu+ is an integrated system which is designed to withstand the manoeuvre of drawing up a dose from the vial and its subsequent administration without the need to change needles as is customary in UK. It has a plunger tip which is designed to fit into the cone shape of the barrel and as such this considerably reduces the dead (waste) space in the syringe and it has been shown to be the best syringe to ensure the maximum number of doses is drawn from each vial – thereby minimising wastage. 48
  49. 49. H1N1 Immunisation Programme Preparation • Has the cold chain been maintained? • Check name of vaccine, expiry date • Check that the appearance of the vaccine is as described • If giving the second dose, check that it is the same vaccine as used for first dose, and that there has been a minimum gap of 3 weeks Administration 49 Preparation Pandemrix vaccine remains stable for 24 hours after mixing Celvapan is stable for use three hours after opening Once opened the vaccines can be stored at room temperature for these periods but where possible they should be stored in a fridge. This is to minimise the risk of bacterial contamination rather than temperature stability of the vaccine. 49
  50. 50. H1N1 Immunisation Programme Site & route • Route – intramuscular • Site: - deltoid for children >1 year and adults - anterolateral aspect of thigh for infants < 1 year old Site & route can affect both the immunogenicity and reactogenicity of the vaccine Administration 50 Site & route Immunogenicity = how effectively the vaccine causes the immune system to respond Studies have demonstrated that vaccines are not as immunogenic when injected into subcutaneous fat as they are when injected into muscle, (Zuckerman, 2000). In particular, lower antibody responses to hepatitis B vaccine have been demonstrated when the vaccine is given into the buttock rather than the deltoid muscle, ( Shaw et al 1989). There is evidence that many injections intended to reach the gluteus maximus muscle are actually delivered into fat. Fat is poorly supplied with phagocytes and antigen-presenting cells; there is therefore delay in processing the antigens and in presentation to the T and B cells. It is also believed that some antigens may be denatured by enzymes if they remain in fat for too long. In contrast, when the vaccine is administered IM, it is circulated far more quickly because of the abundant blood supply to muscles. The blood supply to the deltoid muscle is 17% more than to the gluteal muscle, (Campbell 1995). This is therefore the ideal site for vaccination in children over the age of 12 months. In younger infants, the deltoid is not sufficiently developed, and the vastus lateralis (anterolateral aspect of the thigh) should be used. Reactogenicity The aluminium content of vaccines is thought to be responsible for many of the local reactions that follow immunisation. This is less likely to occur when injected into muscle. Diggle and Deeks (2000)observed a significant decrease in local reactions such as redness and swelling when vaccines were administered to four-month old babies using a 25mm needle, as compared with those given via a 16mm needle. Diggle et al (2006) have more recently conducted further research regarding needle length and the incidence of reactogenicity in babies aged two, three and four months of age ( Diggle et al., 2006). The most plausible reason for this is that vaccines given using the shorter needle may fail to reach the muscle mass. There is also likely to be less discomfort, as there are fewer pain receptors in skeletal muscle than in subcutaneous tissue, ( Greenblatt and Koch-Weser J, 1976). It is essential to use the correct length and gauge of needle, and an appropriate technique to ensure that the vaccine is correctly delivered to muscle. 50
  51. 51. H1N1 Immunisation Programme Sites Acromion Injection site Level of armpit Elbow IM or deep SC injection site Preferred site for intramuscular and Preferred site for intramuscular and deep subcutaneous injections in deep subcutaneous injections in older children and adults infants under one year of age Administration 51 Sites When injecting into the deltoid, ensure that the whole of the muscle is exposed The needle should be inserted approx 2.5cm below the acromial process. You won’t be able to correctly identify this if a sleeve is rolled up! If it is given too low there is a danger of nerve damage, and an increase in local reactions. 51
  52. 52. H1N1 Immunisation Programme Method To give a vaccine by IM injection: • Gently stretch the skin flat between your thumb and forefinger • Insert the needle at a 90º angle • Quickly push the needle straight down into the muscle (it is not necessary to aspirate first) • Inject slowly to reduce pain Administration 52 Method Techniques for individuals with bleeding disorders For individuals with a bleeding disorder, vaccines should be given by deep subcutaneous injection (instead of IM) to reduce the risk of bleeding. Firm pressure should be applied to the site for two minutes after administration, and advice should be given concerning the risk of haematoma. If the individual receives antihaemophilia or similar therapy, immunisations can be planned for shortly after administration of therapy. 52
  53. 53. H1N1 Immunisation Programme Document the following: • Name and product name of vaccine. • Batch number – this is necessary in case problems associated with a particular batch are identified at a later date. • Expiry date – recording this provides evidence that it was checked prior to administration. • The date given. • The site of injection. • Name and signature of vaccinator. Administration 53 Document the following: 53
  54. 54. H1N1 Immunisation Programme Documentation systems Occupational Health • All occupational health departments use different record systems. • NHS Boards have been asked to notify general practices promptly of all patients immunised, e.g. by sending a copy of the consent form General Practice • New Read codes will be available to record immunisation Pregnant women • NHS Boards have developed models of service delivery for H1N1 immunisation of pregnant women that best fit local needs • The exact data recording and data flow will depend on the model of service delivery locally (i.e. whether via General Practice, Maternity Services or a mixed model) Administration 54 Documentation systems For details in general practices please see: H1N1 Vaccination programme – data entry and extraction SGHD/CMO (2009)11 54
  55. 55. H1N1 Immunisation Programme Vaccine storage & handling • Both H1N1 vaccines must be stored at a temperature of 2 to 8 degrees Celsius • Use of vaccine/pharmaceutical fridge (i.e., not domestic) • Daily min/max recordings Administration 55 Vaccine storage & handling ALL vaccines in common use in the UK must be stored at a temperature of 2 to 8 degrees Celcius. It is essential that a pharmaceutical fridge is used, as opposed to one designed for domestic use. Domestic fridges must not be used because: They have wide fluctuations in temperature They have shelves in the door where the temperature may be higher There may be a freezer compartment and any vaccines in contact with this may become frozen Many have solid glass/plastic shelves which do not allow air circulation Although modern pharmaceutical fridges have external temperature indicators, their accuracy is not guaranteed. A maximum/minimum thermometer should be kept in the fridge at all times to ensure that the temperature never exceeds 8 degrees Celcius, or falls below 2 degrees Celcius. The minimum and maximum temperature reached during each 24 hour period should be recorded daily. Records should be retained indefinitely. It is recommended that a named individual be specifically designated to undertake local monitoring. Maintenance of the correct temperature is dependent upon correct use of the fridge. It should never be filled to more than 50% capacity to allow for air circulation. Vaccine stock should be kept to a minimum by ordering only what will be required before the next delivery. You should calculate the fridge space required by estimating vaccine usage over the period, allowing extra space for ‘flu and pneumococcal vaccine storage in the autumn. Many vaccines are now produced in pre-filled syringes, so your current fridge may be too small. The location of the fridge is also important; it should be away from all heat sources (including direct sunlight), and have adequate space for air circulation at the back. Food and drink should not be stored in a vaccine fridge. This would cause the door to be opened frequently for access, resulting in a raised temperature. Unless the fridge has an auto defrost facility, it should be defrosted regularly (at least monthly). Vaccines should be moved to a second fridge when defrosting or cleaning, which must also be monitored to ensure that the correct temperature (2 to 8 degrees Celcius) is maintained. Alternatively, a chilled insulated coolbox may be used, but the temperature within this needs to be monitored. Records of when the fridge is defrosted should be retained. Any vaccine that has not been stored at a temperature of 2 to 8 degrees Centigrade, as per its licensing conditions, is no longer a licensed product. If the cold chain has been broken, consult your local NHS pharmacist. 55
  56. 56. H1N1 Immunisation Programme Adverse Events Following Immunisation (AEFI) • Vaccine reaction • Programme error – e.g. in handling or administration • Coincidental event – i.e. chance association • Injection reaction • Unknown Administration 56 Adverse Events Following Immunisation (AEFI) The World Health Organization categorises AEFI as above (WHO, 2005 - AEFI): 56
  57. 57. H1N1 Immunisation Programme Reporting of adverse events • Use MHRA yellow card system • http://yellowcard.mhra.gov.uk/ • Open to members of the public Administration 57 Reporting of adverse events Adverse events can be reported by all healthcare professionals, and members of the public. the previous specific reporting portal for adverse reactions to H1N1 vaccines has been closed and all suspected reaction should be reported using the standard MHRA yellow card system 57
  58. 58. H1N1 Immunisation Programme Vaccine reactions • Local: e.g. pain, redness, swelling • Systemic: e.g. fever, headache, myalgia • Hypersensitivity: anaphylaxis NB Many local & systemic reactions are evidence that the immune system is making a healthy response to the vaccine! Administration 58 Vaccine reactions Local reactions The most common type of AEFI is local reactions – pain, redness and swelling at the injection site. Local reactions are especially common when non-live vaccines containing adjuvants are given. They are usually mild and self-limiting and can be minimised by administration using a needle of appropriate gauge and length. On a few occasions, the reaction may be severe. Such reactions are called Arthus reactions, and are thought to be due to high levels of pre-existing antibody resulting in the formation of antigen-antibody complexes. They are most commonly seen following administration of tetanus and diphtheria toxoids. Systemic reactions Systemic reactions are also common, and may include fever, malaise, headache, loss of appetite and myalgia. They are more common following administration of live vaccines, and symptoms may be similar to a mild form of the actual disease, but which is not communicable. N.B: Many local and systemic reactions are in fact a demonstration that the immune system is making an appropriate and healthy response to something recognised as non-self! 58
  59. 59. H1N1 Immunisation Programme What is anaphylaxis? • A severe, life-threatening, generalised or systemic hypersensitivity reaction • Characterised by: - Rapidly developing, life-threatening, Airway and /or Breathing and or Circulation problems - Usually with skin and/or mucosal changes • ABCDE approach Administration 59 What is anaphylaxis? (This slide and the following six are taken from the Resuscitation Council (UK)’s website at www.resus.org.uk The full slide set is available from: http://www.resus.org.uk/pages/anaslset.htm ) All staff who are immunising must have undertaken an update in Basic Life Support within the last 12 months and be knowledgeable in the management of anaphylaxis. What is anaphylaxis? Anaphylaxis is one of four types of hypersensitivity reactions, all of which may be described as inappropriate immune responses: Type l anaphylactic hypersensitivity Type ll cytotoxic, such as Rhesus incompatibility Type lll immune complex Type lV cell-mediated or delayed The immune system will mount a response when first exposed to any antigen. The usual immune response results initially in the production of IgM, and then production switches to other types of immunoglobulin, most commonly IgG or IgA. At the same time, extremely small amounts of IgE are usually produced, becoming associated with mast cells and basophils (both types of leucocytes). Mast cells are plentiful in the skin and are also found around blood vessels and in the gut; basophils are found in the blood. Their function is to increase the blood supply to sites of trauma and infection by releasing the content of their granules, which include histamine, leukotrienes and other molecules that increase vascular permeability ( Playfair and Bancroft, 2004). In an allergic individual, excessively large amounts of IgE are synthesised against certain antigens. When the individual next encounters the antigen to which they are allergic, the abnormally large amount of IgE causes release of mediators from granules found within mast cells. The principal mediator released is histamine, which induces smooth muscle contraction, vasodilation and vascular permeability ( Weir and Stewart, 1997). This is the mechanism responsible for allergic rhinitis and asthma. In these cases, symptoms are localised because the allergen comes in contact with respiratory mucus membrane. If the offending antigen is injected parenterally, as is the case with a vaccine or bee sting, mediators are released into the circulation and will consequently have systemic effects. It will be obvious from the above that true anaphylaxis does not occur on first exposure to the offending antigen, but requires prior sensitisation. However, there is also a clinically indistinguishable syndrome known as ‘anaphylactoid reaction.’ This also results from mast cell activation, but is neither IgE mediated nor dependent upon previous exposure. In practice, it is common to use the term ‘anaphylaxis’ to describe both of these clinical syndromes. From an immunological perspective, the word anaphylaxis denotes the pathological response described above, which may vary in severity. It is more useful, however, to reserve the word to denote an event of life-threatening severity which features a sudden onset, rapid progression and multi-system involvement. 59
  60. 60. H1N1 Immunisation Programme Airway problems • Airway swelling e.g. throat and tongue swelling • Difficulty in breathing and swallowing • Sensation that throat is “closing up” • Hoarse voice • Stridor Administration 60 Airway problems 60
  61. 61. H1N1 Immunisation Programme Breathing problems • Shortness of breath • Increased respiratory rate • Wheeze • Patient becoming tired • Confusion caused by hypoxia • Cyanosis (appears blue) – a late sign • Respiratory arrest Administration 61 Breathing problems 61
  62. 62. H1N1 Immunisation Programme Circulation problems • Signs of shock – pale, clammy • Increased pulse rate (tachycardia) • Low blood pressure (hypotension) • Decreased consciousness level • Myocardial ischaemia/angina • Cardiac arrest Do not stand patient up Administration 62 Circulation problems 62
  63. 63. H1N1 Immunisation Programme Disability • Sense of “impending doom” • Anxiety, panic • Decreased consciousness level caused by airway, breathing or circulation problem Administration 63 Disability 63
  64. 64. H1N1 Immunisation Programme Exposure – look for skin changes • Skin changes often the first feature • Present in over 80% of anaphylactic reactions • Skin, mucosal, or both skin and mucosal changes Administration 64 Exposure – look for skin changes 64
  65. 65. H1N1 Immunisation Programme Exposure – look for skin changes (2) • Erythema – a patchy, or generalised red rash • Urticaria (also called hives, nettle rash, weals or welts) anywhere on the body • Angioedema – similar to urticaria but involves swelling of deeper tissues e.g., eyelids and lips, sometimes in the mouth or throat Administration 65 Exposure – look for skin changes (2) 65
  66. 66. H1N1 Immunisation Programme Anaphylaxis or syncope (fainting)? Syncope Anaphylaxis Full carotid pulse persists, but may be Usually sinus tachycardia. bradycardic. Possible apnoea, especially in children. Respiration continues. Upper airway oedema; sneezing may No upper airway oedema. occur. No bronchospasm. Bronchospasm, possible retrosternal tightness, dyspnoea; may be audible No itching. expiratory wheeze. Pallor. Urticarial lesions. Patient regains consciousness when Erythema. lying down. Patient does not revive when lying down. Administration 66 Anaphylaxis or syncope (fainting)? 66
  67. 67. H1N1 Immunisation Programme Recognition of anaphylaxis Mild Itching, rash & swelling around injection site Painless swelling in part of body, e.g., face or mouth. Flushed, itching skin, nasal congestion, sneezing, tears. Painless swelling in part of body, e.g., face or mouth. Flushed, itching skin, nasal congestion, sneezing, tears, abdominal pain. Life threatening Wheezing, noisy, difficult breathing, swelling in the throat, symptoms collapse, low BP, irregular weak pulse. Administration 67 Recognition of anaphylaxis You will note that the symptoms are principally due to the action of histamine, which can be summarised as follows. Capillary permeability. Histamine increases capillary permeability, allowing fluid to escape from the capillaries into the tissues. This contributes to a decrease in blood pressure in anaphylaxis, and it may present as swelling/urticaria around the injection site in localised allergic reactions. Vasodilation. This intensifies the loss of intravascular fluid, further contributing to a drop in blood pressure and resulting in tachycardia, reduced urinary output and peripheral shutdown. Bronchoconstriction. Bronchoconstriction and restricted airflow through the lungs will result in wheezy breathing. Increased permeability may cause laryngeal oedema, resulting in noisy breathing (stridor). Adrenaline is therefore effective as the mainstay of treatment. It suppresses the effects of histamine resulting in: Contraction of dilated vessels, causing:- blood pressure rise and restoration of vital blood supply to the brain - reversal of peripheral vasodilation, reducing oedema Reversal of bronchial smooth muscle contraction, opening up the airways and allowing the patient to breathe again Increase in the force of myocardial contraction. 67
  68. 68. H1N1 Immunisation Programme The following must be available: Adrenaline 1:1000 (3 ampoules) 3 x 1ml syringes 3 x 23 gauge needles, 3 x 21 gauge needles Pocket mask In a clinic setting, oxygen should be available - i.e. GP surgery or hospital A second adult must be present, though this does not have to be a healthcare professional Immediate access to a telephone to contact emergency services; if a mobile phone is to be used, the battery must be fully charged and a signal available Administration 68 The following must be available: Please access the resources available on the website of the Resuscitation Council: http://www.resus.org.uk Read Emergency treatment of anaphylactic reactions. Guidelines for healthcare providers (2008) You will also find it useful to look at the Frequently Asked Questions Print out the posters of Treatment algorithms 68
  69. 69. H1N1 Immunisation Programme Management (1) • Make a quick assessment to exclude syncope (fainting) • Call ambulance • Lie patient flat and raise legs (if breathing not impaired) • Administer adrenaline • If available, administer oxygen at high flow rates (10-15 L per minute) • Check airway, breathing, circulation (ABC) Administration 69 Management (1) 69
  70. 70. H1N1 Immunisation Programme Management (2) • Remember that anaphylaxis can progress very rapidly, so do not wait for cardio- pulmonary collapse before giving adrenaline. • In case of any dyspnoea – give adrenaline 1:1000 intramuscularly • If there is a sense of impending doom – give adrenaline 1:1000 intramuscularly • Adrenaline may be repeated after five minutes if no improvement • If patient not breathing, start CPR Administration 70 Management (2) ALL immunisers should access the algorithm Anaphylactic reactions – Initial treatment available at: www.resus.org.uk and have it on the wall of the clinic! 70