Extension of the seasonal flu vaccination programme to children: Phase /15

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1 Extension of the seasonal flu vaccination programme to children: Phase /15 Administration of the intranasal flu vaccine by Healthcare Support Workers (Level 3 and 4 on NHS Career Framework) to children in a school setting* August 2014 *School Setting may be interpreted as schoolchildren within a school setting or similar setting designated by the NHS board. Quality Quality Education Education for for a Healthier a Healthier Scotland Scotland 1 1

2 Aims of resource The aim of this Education and Training Resource is to equip Healthcare Support Workers at Level 3 and 4 on the NHS Career Framework with the knowledge and skills to support safe and effective administration of the intranasal flu vaccine to children in school settings. Quality Education for a Healthier Scotland 2

3 Resource learning outcomes On completion of this education and training resource Healthcare Support Workers at Level 3 and 4 on the NHS Career Framework will be able to: Use knowledge and understanding of the effects of flu to explain the benefits of the intranasal flu vaccine Understand their role and limitations in the administration of intranasal flu vaccine and when to consult / defer to a Registered Healthcare Practitioner Practice in line with the Code of Conduct for Healthcare Support Workers (Scottish Government 2009) Quality Education for a Healthier Scotland 3

4 Structure of this resource This resource is presented in two parts: Part 1- considers the knowledge base around flu and the intranasal flu vaccine Part 2- considers aspects related to the administration of the intranasal flu vaccine to children in school settings This resource is accompanied by a booklet to support competence in the administration of the intranasal flu vaccine which can be used by NHS boards to record progress towards, and the achievement of competence in this skill. All flu educational resources can be found on the NHS Education for Scotland, Health Protection website: public-health/health-protection.aspx. Quality Education for a Healthier Scotland 4

5 Contents Part 1 Overview of the phasing of extension to flu immunisation programme What is flu? Vaccination of children against flu Part 2 Legislation governing the administration of vaccines Storage and administration of the intranasal flu vaccine Anaphylaxis, basic life support and adverse reactions Documentation, record keeping and reporting Quality Education for a Healthier Scotland 5 Quality Education for a Healthier Scotland 5

6 Part 1 Influenza virus, flu and the intranasal flu vaccine Quality Education for a Healthier Scotland 6 Quality Education for a Healthier Scotland 6

7 Learning outcomes On completion of Part 1 HCSW will: Know what type of infection flu is Describe the main features of flu Outline the complications of flu Describe the current flu vaccination programme for children Outline how the intranasal vaccine works Know how to administer the intranasal vaccine Outline main issues related to the intranasal vaccine Quality Education for a Healthier Scotland 7

8 Extension to flu vaccination programme in Scotland Phase /14 All pre-school children aged 2 and 3 years Pilots in primary schools Phase /15 All pre-school children aged 2-5 years All primary school aged children Quality Education for a Healthier Scotland 8

9 What is flu? Quality Education for a Healthier Scotland 9 Quality Education for a Healthier Scotland 9

10 What is flu? Flu is a highly infectious viral illness Quality Education for a Healthier Scotland 10

11 Influenza viruses There are 3 types of influenza viruses: A Causes epidemics and pandemics Animal reservoir wildfowl and pigs, also carried by other mammals B May cause epidemics Predominantly found in humans C Minor respiratory illness only Quality Education for a Healthier Scotland 11

12 Influenza A virus The virus contains genetic material at its centre There are 2 proteins on the surface of the virus called H and N There are different types of H and N referred to by numbers The role of the H protein is to help the virus attach to the cells in the body The role of the N protein is to help release the virus into the body Quality Education for a Healthier Scotland 12

13 Influenza A virus genetic change Influenza viruses change in two different ways: Drift when tiny changes take place in the H and N proteins- this happens constantly Shift this is a much more major change Genetic change happens when one individual is infected with two different strains of the influenza A virus at the same time The genetic material from each mixes up and then re-combines resulting in a completely new strain Few people have immunity so this may lead to widespread epidemics or even a pandemic Quality Education for a Healthier Scotland 13

14 Features of flu Acute viral infection of the respiratory tract Transmitted by droplets, sneezing and by hand to mouth / eye contamination from an infected surface Incubation period of 1-5 days (average 2-3 days) though may be longer especially in children or those with lowered immunity e.g. undergoing treatment for cancer Common symptoms include: -- Sudden onset of fever, chills, headache, muscle pains and severe tiredness -- Dry cough, sore throat and stuffy nose - - In young children, gastrointestinal symptoms such as vomiting and diarrhoea may be frequently seen Quality Education for a Healthier Scotland 14

15 Possible complications of flu Common: Bronchitis Ear infections Sinusitis Less common: Pneumonia Meningitis More serious illness in neonates, pregnant women, older people and those with underlying disease Quality Education for a Healthier Scotland 15

16 Why vaccinate children? Extension of the seasonal flu vaccination programme to all children aims to appreciably lower the public health impact of flu by: -- Providing direct protection to children thus averting a large number of cases of influenza disease in this group -- Lowering influenza transmission from: -- Child to child -- Child to adult -- Child to those in the clinical risk groups of any age The expected effect of the vaccination of children will then be a reduction in the impact of flu. Quality Education for a Healthier Scotland 16

17 Impact of flu In an average flu season it is estimated that up to 1 in 10 children below 14 years present to their GP with flu Children are more vulnerable to infection than adults and when exposed, flu can be very severe in children The younger the child, the higher the risk that they may require hospitalisation if they have an flu infection Children with flu contribute to the impact of flu in all age groups because they are more likely to pass on the infection than adults Quality Education for a Healthier Scotland 17

18 Is there an effective flu vaccine? An intranasal vaccine Fluenz was used from October 2013 during the first phase of the extension to the flu programme in children In 2014/5 season Fluenz Tetra will be used for the majority of children. This is also an intranasal vaccine It is a live attenuated vaccine which means that during the manufacturing process the virus has been weakened and cannot cause flu, but protects against flu in the future Most flu vaccine protect against two strains of influenza A and one strain of influenza B Fluenz Tetra protects against two strains of influenza A and two strains of influenza B Quality Education for a Healthier Scotland 18

19 The immune response to vaccine When a vaccine is administered, the body responds by producing antibodies These antibodies will protect a person in the future who is exposed to that particular infection Fluenz Tetra is administered via the intranasal route and stimulates the immune system in the same way as exposure to natural flu infection This means antibodies are produced in the lining of the nose as well as in the bloodstream thus protecting the individual Quality Education for a Healthier Scotland 19

20 Use of Fluenz Tetra Quality Education for a Healthier Scotland 20 Quality Education for a Healthier Scotland 20

21 Use of the intranasal flu vaccine Fluenz Tetra Generic name: influenza vaccine (live attenuated, nasal) Brand name: Fluenz Tetra Marketed by Astra Zeneca Licensed for use from 24 months of age to less than 18 years of age Nasal Spray (suspension) in a prefilled nasal applicator Supplied as a pack containing 10 individual prefilled applicators Contains some substances necessary for the manufacturing process including porcine gelatin, egg proteins and traces of the antibiotic gentamicin Quality Education for a Healthier Scotland 21

22 Use of Fluenz Tetra Fluenz Tetra presentation Prefilled nasal applicator Nasal spray (suspension) Each applicator contains 0.2ml Quality Education for a Healthier Scotland 22

23 Use of Fluenz Tetra (cont.) Fluenz Tetra dosage and schedule The dose of Fluenz Tetra is 0.2ml, administered as a divided dose (0.1ml) in both nostrils After administering half of the dose in one nostril, administer the remaining half in the other nostril immediately or shortly thereafter Most children will require only one dose Children in a risk group under nine years who have never had flu vaccine before will need two doses with the second dose given four weeks after the first Quality Education for a Healthier Scotland 23

24 Administration of Fluenz Tetra Fluenz Tetra has been manufactured for nasal use and must not be injected Fluenz Tetra can be administered at the same time as other vaccines including live vaccines Child should breathe normally - no need to actively inhale or sniff No need to repeat either half of dose if patient sneezes, blows their nose or their nose drips following administration Quality Education for a Healthier Scotland 24

25 When not to give Fluenz Tetra There are clinical reasons not to give Fluenz Tetra The Registered Healthcare Practitioner will have carried out screening to identify any children who cannot have Fluenz Tetra Important reasons not to give Fluenz Tetra include: Below 2 years of age and over 18 years of age Confirmed anaphylactic reaction to a previous dose of flu vaccine Confirmed anaphylactic reaction to any component of the vaccine including an antibiotic called gentamicin and a substance called gelatin Quality Education for a Healthier Scotland 25

26 Important reasons not to give Fluenz Tetra include: Severe asthma Conditions which cause immunosuppression Allergy to eggs Pregnancy On the day of vaccination you must refer to a Registered Healthcare Practitioner if the child looks or states that he/ she feels unwell e.g. fever, heavily blocked or runny nose, active wheezing. Quality Education for a Healthier Scotland 26

27 Administration of Fluenz Tetra and pork gelatin Fluenz Tetra contains pork (porcine) gelatin, an essential ingredient in many medicines, including some vaccines Many faith groups have approved the use of gelatin-containing vaccines It is, however, an individual choice whether or not to receive this vaccine and we recognise there will be diversity of thought within different communities Quality Education for a Healthier Scotland 27

28 Part 2 Administration of the intranasal flu vaccine by Healthcare Support Workers (Level 3 and 4 on NHS Career Framework) to children in a school setting Quality Education for a Healthier Scotland 28 Quality Education for a Healthier Scotland 28

29 Learning outcomes Part 2 Describe the strategies to promote the uptake of the intranasal flu vaccine Know the correct procedures for storage and handling of the intranasal flu vaccine Demonstrate safe and effective practice in the administration of the intranasal flu vaccine Quality Education for a Healthier Scotland 29

30 Learning Outcomes Part 2 (cont.) Recognise the signs and symptoms of anaphylaxis and immediately alert the Registered Healthcare Practitioner Correctly complete all the relevant documentation Be aware of the law and NHS board policy as it relates to vaccine administration Know how to access the Green Book and relevant vaccine policy and guidance documents Quality Education for a Healthier Scotland 30

31 Legislation governing the administration of vaccines All vaccines are Prescription only Medicines (POMs) and therefore 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 (PGD); or Against a Patient Specific Direction (PSD) Quality Education for a Healthier Scotland 31

32 Patient Group Direction (PGD) Allows specified Registered Healthcare Practitioners to administer / supply a medicine without an individual prescription Cannot be used by Healthcare Support Workers Responsibility cannot be delegated (so the vaccine cannot be given on behalf of the Registered Healthcare Practitioner) Quality Education for a Healthier Scotland 32

33 Patient Specific Direction (PSD) A Patient Specific Direction (PSD) is a written instruction signed by a doctor, dentist or other independent prescriber for a medicine to be supplied or administered to a named patient or several named patients The patient must have been considered as an individual, as the prescriber is accepting clinical responsibility for the appropriateness of the vaccine being administered Quality Education for a Healthier Scotland 33

34 Patient Specific Direction (PSD) (cont.) As a minimum a PSD should specify: Name of the patient and other patient identifiers (date of birth as a minimum and preferably the CHI number) The name of the medicine to be administered The route of administration The dose Date and the signature of the prescriber In a school vaccination session, the list of named children to receive a medicine be will be signed and dated by the prescriber Quality Education for a Healthier Scotland 34

35 Patient Specific Direction (PSD) (cont d) If these conditions are met and a PSD is in place, the vaccine may be administered by a Healthcare Support Worker if the employing organisation is satisfied that he or she is competent to do so Quality Education for a Healthier Scotland 35

36 Storage and handling of vaccines: The Cold Chain The cold chain is the system of transporting and storing vaccines within the safe temperature range of 2-8 o C at all times Vaccines are biological products and become less potent with time if not stored correctly effectiveness may be lost Quality Education for a Healthier Scotland 36

37 Storage of the intranasal vaccine Fluenz Tetra Fluenz Tetra must be stored in accordance with manufacturer s instructions Store between 2-8 o C Store in original packaging Protect from light Before use, Fluenz Tetra intranasal vaccine may be taken out of the refrigerator, without being replaced, for a maximum period of 12 hours at a temperature not above 25 o C If the vaccine has not been used after this 12 hour period, it should be disposed of in accordance with local procedures for disposal of clinical waste Check expiry dates regularly Quality Education for a Healthier Scotland 37

38 Informed consent for vaccination Informed consent will already have been given when the child presents on the day of vaccination however it is important that Healthcare Support Workers are confident that consent has been given before administration of the vaccine For consent to be informed, the following information must be given: Information about the vaccine The benefits and risks of immunisation versus the risks of flu Possible side effects and their treatments All of the points above are included in the leaflet given to parents / carers prior to intranasal flu vaccine administration Quality Education for a Healthier Scotland 38

39 Administration of Fluenz Tetra video Video clip showing administration Click on the following link to access the video clip showing how to administer Fluenz Tetra vaccine: health-protection/seasonal-flu.aspx Quality Education for a Healthier Scotland 39

40 Fluenz Tetra applicator Barrel Dose divider Rubber tip protector Plunger Quality Education for a Healthier Scotland 40

41 Administration of Fluenz Tetra Step 1: Before administering Fluenz Tetra, remember to check the expiration date. If it has expired, dispose of the device in your medical waste container. Step 2: When you are ready to administer Fluenz Tetra, simply remove the rubber tip protector. But do not remove the dose-divider clip at the other end of the sprayer. Quality Education for a Healthier Scotland 41

42 Administration of Fluenz Tetra (cont.) Step 3: Deliver 0.1ml dose of Fluenz Tetra just inside the patients nostril. Step 4: With a single motion, push the plunger as rapidly as possible until the dose-divider clip presents you from going any further. Quality Education for a Healthier Scotland 42

43 Administration of Fluenz Tetra (cont.) Step 5: Remove the device from the patient s nostril. Now, pinch and remove to nose-divder clip from the plunger. Step 6: Depress plunger as rapidly as possible to deliver the remaining 0.1 ml of vaccine in the patient s other nostil. Quality Education for a Healthier Scotland 43

44 Common side effects following Fluenz Tetra administration The most common side-effects following administration of Fluenz Tetra are: Blocked / runny nose Reduced appetite Weakness Headache Quality Education for a Healthier Scotland 44

45 Infection control issues There are no specific infection control precautions required when administering Routine hand hygiene procedures should be performed before and after each child contact As a precaution those who have severely reduced immunity should not administer the vaccine Other healthcare workers who have reduced immunity to infection or who are pregnant should follow routine clinical practice to avoid inhaling the vaccine and ensure that they are appropriately vaccinated Quality Education for a Healthier Scotland 45

46 Infection control issues (cont.) Disposal of clinical waste: Empty vaccine applicators should be disposed of in accordance with local procedures for disposal of clinical waste Quality Education for a Healthier Scotland 46

47 Anaphylaxis, basic life support and adverse reactions Anaphylaxis severe, life-threatening generalised or systemic hypersensitivity reaction All Healthcare Support Workers must be trained to perform Basic Life Support (Adult and Paediatric) which should include anaphylaxis training in accordance with local policy The Healthcare Support Workers responsibility is to recognise signs and symptoms of anaphylaxis and to immediately alert the Registered Healthcare Practitioner The following tables are adapted from the Green Book, Chapter 8 and are helpful in helping to differentiate between fainting and anaphylaxis Quality Education for a Healthier Scotland 47

48 Differentiation between Fainting and Anaphylaxis** Onset Fainting Anaphylaxis Before, during or within minutes of vaccine administration. Usually within five minutes, but can occur within hours of vaccine administration. Symptoms/signs Skin Generally pale, cold clammy skin. Skin itchiness, pallor or flushing of skin, red or pale weals or angioedema*. Respiratory Normal respiration may be shallow, but not laboured. *Angioedema is the swelling of the deeper layers of the skin, caused by a build-up of fluid. **Adapted from the Green Book, Chapter 8. Cough, wheeze, high pitched noisy breathing or signs of respiratory distress (rapid breathing rate, blue lips). Quality Education for a Healthier Scotland 48

49 Differentiation between Fainting and Anaphylaxis** (Cont.) Onset Fainting Anaphylaxis Cardiovascular Slow pulse, low blood pressurenormally corrects when individual lies down. Fast pulse, low blood pressure which does not correct when lying flat. Central Nervous System **Adapted from the Green Book, Chapter 8. Complains of light headedness, loss of consciousness, improves when lying flat or head down, transient jerking of limbs and eye rolling which may be confused with seizure, may be incontinent. Sense of severe anxiety and distress, loss of consciousness no improvement once lying flat or head down position. Quality Education for a Healthier Scotland 49

50 Documentation, record keeping and reporting After administration, document details of vaccine correctly Signature (first entry should include printed name and job title the vaccination consent form will have a space for signature, printed name and designation) Complete all section of the for official use only part of the consent form Quality Education for a Healthier Scotland 50

51 Documentation, record keeping and reporting (cont.) Complete other appropriate documentation (refer to national and local policies as appropriate) i.e. tear off slip for parent confirmation of administration, post immunisation advice sheet and local letter Child Health register information completed as per national and local policies Remember that good record keeping is a legal requirement and a fundamental part of good health care Quality Education for a Healthier Scotland 51

52 Organisation of flu vaccination sessions In order to assist the Registered Healthcare Practitioner, it is important that they are familiar with local processes for the organisation of sessions to maximise safety and uptake of intranasal flu vaccine An understanding of the need for partnership working between education and health at the individual school level is essential to the smooth running of the vaccination session Quality Education for a Healthier Scotland 52

53 Confidentiality Confidentiality is essential to protect the interests of patients and members of the public. It is a main feature of any code of conduct and of most terms of conditions of service for healthcare workers, including Healthcare Support Workers Do not give out personal information Be careful with patient records Ensure discussion about patients cannot be overheard Do not access patient records that are not relevant to the care that you are giving If you do not protect a patients confidentiality you may be breaking data protection laws Quality Education for a Healthier Scotland 53

54 Resources You should be familiar with any other local or national resources produced to support the administration of intranasal flu vaccine. Green Book influenza-the-green-book-chapter-19 CMO letter CMO(2014)13.pdf Immunisation Scotland vaccines-and-diseases/seasonalflu/index.aspx Patient Group Directions Policy for the Storage and Handling of Vaccines guidelinedetail.aspx?id=45674 NES website health-protection/seasonal-flu.aspx Quality Education for a Healthier Scotland 54

55 Administration of Childhood Flu Immunisation (birth to pre-school age groups) Birth to under six months Six months to under two years Pre-school aged two - five years Vaccination not required In Clinical Risk Group? (See table 19.5 Green Book flu chapter for further details) In Clinical Risk Group? (See table 19.5 Green Book flu chapter for further details) NO YES NO YES Vaccination not required One dose of trivalent inactivated vaccine Suitable for Fluenz Tetra? Suitable for Fluenz Tetra? YES NO NO YES Be careful with Tetras Fluenz Tetra (Live vaccine given by nasal administration) If never had flu vaccine before give a second dose at least four weeks later One dose of Fluenz Tetra One dose of trivalent inactivated vaccine Aged three years or above? NO YES One dose of quadrivalent inactivated vaccine (Fluarix Tetra) One dose of Fluenz Tetra If never had flu vaccine before give a second dose at least four weeks later Fluarix Tetra (Inactivated vaccine given by intramuscular injection) If never had flu vaccine before give a second dose at least four weeks later If never had flu vaccine before give a second dose at least four weeks later Quality Education for a Healthier Scotland 55

56 Administration of Childhood Flu Immunisation (primary school age group) Primary school children In Clinical Risk Group? (See table 19.5 Green Book flu chapter for further details) NO YES Suitable for Fluenz Tetra? Suitable for Fluenz Tetra? YES NO NO YES One dose of Fluenz Tetra Aged nine years or above? Aged nine years or above? NO YES NO YES Be careful with Tetras Fluenz Tetra (Live vaccine given by nasal administration) Fluarix Tetra (Inactivated vaccine given by intramuscular injection) One dose of quadrivalent inactivated vaccine (Fluarix Tetra) If never had flu vaccine before give a second dose at least four weeks later One dose of quadrivalent inactivated vaccine (Fluarix Tetra) One dose of Fluenz Tetra If never had flu vaccine before give a second dose at least four weeks later One dose of Fluenz Tetra Quality Education for a Healthier Scotland 56

57 Administration of Childhood Flu Immunisation (secondary school to over 65 years age groups, pregnant women and other special groups) Secondary school children (up to 18 years) Aged 18 years to under 65 years All pregnant women (at any stage of pregnancy) All people 65 years and over Others* In Clinical Risk Group? (See table 19.5 Green Book flu chapter for further details) In Clinical Risk Group? (See table 19.5 Green Book flu chapter for further details) One dose of trivalent inactivated vaccine One dose of trivalent inactivated vaccine One dose of trivalent inactivated vaccine NO Vaccination not required YES Suitable for Fluenz Tetra? NO One dose of quadrivalent inactivated vaccine (Fluarix Tetra) YES One dose of Fluenz Tetra NO Vaccination not required YES One dose of trivalent inactivated vaccine * Health and social care workers People in long stay residential care homes or other long stay facilities Carers Household contacts of immunocompromised patients Quality Education for a Healthier Scotland 57

58 Acknowledgments Fluenz Tetra vaccine pack images and Fluenz Tetra administration step-by-step images courtesy of AstraZeneca UK. Quality Education for a Healthier Scotland 58 Quality Education for a Healthier Scotland 58

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