Scottish Immunisation Programme Childhood Flu Programme 2014/15 Guidance on review of consent forms to support assessment of suitability of primary school children for Fluenz Tetra® as a result of severe asthma Purpose The purpose of this paper is to support an initial assessment of the suitability of children for vaccination with Fluenz Tetra® based on information provided on consent forms returned by the person with parental responsibility for the child. Background The live attenuated influenza vaccine (Fluenz Tetra®) is not recommended1 for children with severe asthma or active wheezing, defined as; A history of active wheezing at the time of vaccination (until at least 7 days after wheezing has stopped) or Those who are currently taking or have been prescribed oral steroids in the last 14 days or Those who are currently taking a high dose inhaled steroid – budesonide at a dose greater than 800 microgram per day or equivalent. In children aged 5-12 years, the definition of severe asthma corresponds to the British Thoracic Society (BTS) and Scottish Intercollegiate Guideline Network (SIGN) step 5. This step recommends the use of daily steroid tablet in lowest dose providing adequate control; maintaining the use of inhaled steroids up to 800microgram per day of budesonide/beclometasone dipropionate or equivalent; and refer to respiratory paediatrician2. See appendix for BTS/SIGN steps in 5-12 years. There are three inhaled steroids licensed for use for asthma in children aged 5-12 years. Beclometasone dipropionate (BDP) and budesonide are considered as approximately equivalent in clinical practice and a 1:1 dose ratio is assumed2. Fluticasone provides equal clinical activity to BDP and budesonide at half the dosage2. The three inhaled steroids licensed for children aged 5-12 years are available in a variety of presentations and strengths. The table below shows the dose equivalents for inhaled steroids in children aged 5-12 years above which would constitute a dose that would mean Fluenz Tetra® is not suitable. Inhaled steroid Beclometasone dipropionate Budesonide Fluticasone Dose above which Fluenz Tetra® unsuitable 800 microgram per day 800 microgram per day 400 microgram per day Therefore children aged 5-12 years taking daily steroid tablets for asthma or inhaled budesonide at a dose greater than 800 microgram per day or equivalent are not suitable for vaccination with Fluenz Tetra® but should be considered for inactivated vaccine. For example a child who is prescribed Seretide 125 inhaler 2 puffs twice daily is receiving a daily dose of 500 micrograms of fluticasone and is therefore on a dose which means Fluenz Tetra® should not be offered. Whereas a child who is prescribed Seretide100 accuhaler 2 puffs twice daily is taking a daily dose of 400 micrograms of fluticasone and is therefore suitable for Fluenz Tetra®. Checklist for staff reviewing consent forms Step 1 Check consent form to determine if the patient is taking oral steroids for asthma. If yes they are unsuitable for Fluenz Tetra® and after discussion with the person with parental responsibility consideration should be given to use an inactivated flu vaccine. If no then consider the dose of steroid inhaler (step 2) Step 2 Check consent form to determine which steroid inhaler and the number of puffs per day the patient is reportedly taking. Compare this to the number in the table above and check if the patient is taking more than the number of puffs per day included the table. If the number of puffs is greater than in the table then they are unsuitable for Fluenz Tetra® and after discussion with the person with parental responsibility consideration should be given to use an inactivated flu vaccine. If the number of puffs is at or lower than in the table the patient may be considered suitable for Fluenz Tetra® If there is uncertainty then the person with parental responsibility for the child should be contacted for more information to enable a decision on suitability for Fluenz Tetra® to be taken. The table below shows the number of puffs per day for each inhaler above which the patient has reached a dose equivalent to the BTS/SIGN step 5 inhaled steroid dose. Name of Inhaler Strength Manufacturer Number of Puffs per day 8 Flixotide Evohaler (Fluticasone Inhaler) Flixotide (Fluticasone) Accuhaler 50 microgram per dose Flixotide(Fluticasone) Accuhaler 100 microgram per dose Pulmicort (budesonide) turbohaler 100 microgram per dose Allen & Hanbury Ltd Allen & Hanbury Ltd Allen & Hanbury Ltd Astra Zeneca Pulmicort (budesonide) turbohaler 200 microgram per dose Astra Zeneca 4 Pulmicort (budesonide) turbohaler 400 microgram per dose Astra Zeneca 2 Budelin (budesonide) novoliser 100 microgram per dose 8 Budesonide easyhaler 100 microgram per dose Budesonide easyhaler 200 microgram per dose Budesonide easyhaler 400 microgram per dose Beclometasone easyhaler 100 microgram per dose Beclometasone easyhaler 200 microgram per dose Beclometasone easyhaler 400 microgram per dose Asmabec (Beclometasone)Clickhaler Asmabec (Beclometasone) Clickhaler Clenil Modulite (Beclometasone) 100 microgram per dose Meda Pharmaceuticals Orion Pharma UK Orion Pharma UK Orion Pharma UK Orion Pharma UK Orion Pharma UK Orion Pharma UK RPH 100 microgram per dose RPH 8 50 microgram per dose Chiesi 16 Clenil Modulite (Beclometasone 100 microgram per dose Chiesi 8 Pulvinal Beclometasone 100 microgram per dose Chiesi 8 Pulvinal Beclometasone 200 microgram per dose Chiesi 4 Pulvinal Beclometasone 400 microgram per dose Chiesi 2 Seretide Evohaler 50 microgram per dose 8 Seretide Accuhaler 50 microgram per dose Seretide Accuhaler 100 microgram per dose Symicort 100/6 turbohaler 100 microgram per dose Allen & Hanbury Ltd Allen & Hanbury Ltd Allen & Hanbury Ltd Astra Zeneca 50 microgram per dose 8 4 8 8 4 2 8 4 2 8 8 4 8 References 1 Chaper 19 (influenza) Immunisation against infectious disease. Available at https://www.gov.uk/government/publications/influenza-the-green-book-chapter-19 Accessed 04/08/14 2 BTS/SIGN Guideline on the management of asthma. Available at https://www.britthoracic.org.uk/guidelines-and-quality-standards/asthma-guideline/ Accessed 26/06/14 Appendix: BTS/SIGN steps for children aged 5-12 years
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