Mandy East Professional’s Conference November 10th 2016 Campaign to introduce Spare Adrenaline Auto Injectors (AAIs) into educational establishments in the UK Mandy East Professional’s Conference November 10th 2016

NICE Definition Anaphylaxis is a severe, life-threatening, generalised or systemic hypersensitivity reaction. Characterised by rapidly developing, life-threatening problems involving: the airway (pharyngeal or laryngeal oedema) and/or breathing (bronchospasm with tachypnoea) and/or circulation (hypotension and/or tachycardia).

Is there a problem? Up to 6% of school-aged children have IgE-mediated food allergy 1 anaphylaxis episode per 10,000 children p.a. 82% of food anaphylaxis occurs in school-age children 61% of schools have at least 1 child with prior anaphylaxis / AAI prescription Bohlke et al. JACI 2004;113:536–542 Nwaru et al. Allergy 2014;69:62-75.

Anaphylaxis Anaphylaxis cannot be predicted Most fatalities occur in people with previous mild reactions Many children with prior anaphylaxis have mild reactions in the future Fatal anaphylaxis is rare but unpredictable 17% of fatal reactions occur in schools / preschool settings Adrenaline auto-injectors commonly prescribed as rescue medication to treat anaphylaxis

Adrenaline auto-injector devices Data: NHS Prescription Cost Analysis for England, 2000-2012

AAI devices Most children respond to one AAI but some may require a further dose device may misfire due to user error or malfunction Most children with AAI therefore prescribed 2 devices, consistent with MHRA and EMA guidance Children and Families Act (2014) requires schools to make arrangements for supporting children with medical conditions individual care plan

UK National Survey April to June 2015

Methodology Bespoke online survey Parents, HCPs and teachers were invited to complete the survey using patient group databases and social media Surveys open for completion for 8 weeks from April 27th 2015

Results Responses were received from: 1609 parents 519 healthcare professionals 821 teachers

Research questions How common are AAIs in schools? Are there situations where the AAI may not be correctly administered to children? e.g. Lack of availability, misfiring or device out of date? Is there support for the introduction of spare AAIs into educational establishments from parents, HCPs and teachers?

% of parents and teachers reporting AAIs in schools 93% 83%

How many devices are children prescribed?

Conclusions AAIs are very common in educational establishments Misfiring, forgetting to carry and out of date devices are commons This can place allergic children at risk Spare AAIs would increase availability and help ensure an in-date device is available

Overall summary There is a clear rationale for the introduction of spare AAIs The majority of UK schools have at least one food allergic child The introduction of spare AAIs addresses all current barriers which may prevent the correct use of AAIs in an emergency …and facilitate improved awareness and training Finally, there is overwhelming support from parents, healthcare professional and teachers

The campaign so far Initial meeting with DH Dec 2014 First half of 2015 evidence gathering Evidence presented to DH July 2015 DH present to MHRA July/August 2015 Response and follow up questions and clarifications October 2015 Further follow up questions throughout early 2016 Update meeting with DH March 2016

The campaign so far Further discussions DH and MHRA All Party Group prepare to lobby MHRA agree to table for discussion at future meeting DH ask us to prepare a draft guidance for teachers MHRA meeting September 2016 Decision to begin process to change legislation made public October 2016 Awaiting date for public consultation

Observations Be patient! DH prefer to work with coalitions via one central contact Lobbying needs to be carefully considered Decisions are made only at certain times of the year Clinical input essential As is patient support Good, well planned and evidence based campaigning gets the result

Any questions? mandy@anaphylaxis.org.uk www.anaphylaxis.org.uk @AllergyCampaign