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07/05/2014
1
Paul Turner
MRC Clinician Scientist & Honorary Consultant in Paediatric Allergy & Immunology,
Imperial Colleg...
07/05/2014
2
Unnecessary avoidance?
•  Sensitisation is a poor marker of clinical reactivity:
•  Should peanut-allergic pa...
07/05/2014
3
Ø  PALs helpful if they provide reliable information,
but use is widespread1
Ø  Phrasing is confusing
1FSA ...
07/05/2014
4
The reality:
•  Wide inconsistencies in labelling
•  Significant increase in awareness of the
hazards posed b...
07/05/2014
5
We need:
1.  Recognition
2.  Appropriate management in community
3.  Appropriate management by healthcare
pro...
07/05/2014
6
Do we need to shift our focus? Current management… NOW & THEN
•  Dietary Avoidance
•  Rescue treatment
•  Imm...
07/05/2014
7
•  49/85 (58%) desensitised to 1400mg protein (~6 PN)
•  75 (88%) partially desensitised to 800mg protein
•  ...
07/05/2014
8
THE FUTURE: Rescue treatment
•  Recognition of symptoms
•  More intuitive AAI
•  Apps to aid AAI use/emergenc...
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Mx of fa in 2024 handout

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Mx of fa in 2024 handout

  1. 1. 07/05/2014 1 Paul Turner MRC Clinician Scientist & Honorary Consultant in Paediatric Allergy & Immunology, Imperial College London; Honorary Clinical Lecturer, University of Sydney How we will manage food allergy in 2024 Adrenaline auto-injector devices 0 50 100 150 200 250 300 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 150mcg 300+mcg TOTAL Thousandsofprescriptions Data: NHS Prescription Cost Analysis for England, 2000-2012 Risk of anaphylaxis Umasunthar et al, Clin Exp Allergy. 2013;43:1333-41. Current management… NOW & THEN •  Dietary Avoidance •  Rescue treatment •  Immunotherapy Allergen Labelling Ø  Allergen disclosure required under law: • key allergens in ingredients of prepacked foods Ø  Mandatory disclosure applies only to allergens in ingredients Ø  Until now, no statutory requirement for: • Label format • Potential allergens from cross-contamination
  2. 2. 07/05/2014 2 Unnecessary avoidance? •  Sensitisation is a poor marker of clinical reactivity: •  Should peanut-allergic patients avoid all nuts? • 31% of 94 peanut-allergic children were ‘sensitised’ to a tree nut • Only 7 (of 29) were allergic at formal OFC Osborne et al. JACI 2011; 127:668–676. Ball et al. PAI 2011; 22:808-12. Improved diagnostics? New in vitro diagnostics: •  Component resolved diagnostics (CRD) •  Basophil activation test Examples of precautionary allergy labelling: BMJ | 22 OCTOBER 2011 | VOLUME 343 831 ANALYSIS listing cows’ milk as an ingredient) containing cows’ milk protein on analysis.11 One UK pro- ducer began to list milk powder in the ingredi- ents of its dark chocolate despite this not being used as a raw ingredient,16 although it has now stopped this, suggesting a change in policy. There are also anecdotal reports of some producers intentionally adding small amounts of allergen to foods where cross-contamination may be a risk, so that they can list the allergen as an ingredi- ent and thus avoid the need to address the issue altogether (Food Standards Agency, personal communication). Alternatives to the status quo Attempts to standardise the content of advisory labels using voluntary guidance have not been successful. Almost two thirds of enforcement officers and food manufacturers think that the current voluntary UK guidance should become compulsory.1 Thelistingofallpotentialallergensasaningre- dient when cross-contamination is likely might reduce ambiguity but would further restrict consumer choice. The best solution would be to quantify the hazard—that is, whether the degree of contamination is sufficient to trigger an aller- gic reaction—and communicate this clearly to the consumer. However, obtaining robust data on allergen thresholds has proved difficult. The minimum eliciting dose varies widely between individuals, and there will always be a few highly sensitised individuals who react to minute amounts of allergen. Furthermore, the threshold can vary by several orders of magnitude within the same person, depending on various factors. These include: Processing and denaturation of the allergen— Many people who are allergic to egg or milk tolerate the allergen in products that have been baked at high temperature for long periods such as cakes or biscuits.17 The processing probably changes the structure of the allergen, making it less allergenic. Derived ingredients—Immunoglobulin E medi- atedfoodallergyreactionsarecausedbyproteins, and thus products such as wheat derived glucose syrup (a carbohydrate) do not require allergen disclosure under current legislation. However, legislation regarding disclosure of derived ingre- dients is inconsistent. Soy derived lecithin (a lipid)andrefinedsoyoilgenerallycontainsimilar (low) amounts of soy protein, and most people with soy allergy can tolerate these ingredients.18 Regulatory authorities require products made with soy lecithin to be labelled as containing soy, but not those containing refined soy oil.1 Food matrix—Chemical and physical interactions between allergenic proteins and other proteins, fats, and carbohydrates within the molecular structure of the food (known as the food matrix) altertheabilityofanallergentoinduceanallergic response. The mechanism for such interactions is complex and poorly understood.17 Individualfactors—Thelevelsofallergenrequired totriggeranallergicresponseinapersoncanvary significantly from day to day. This variation is probablytheresultofviralillnessesandthestatus of the lower airways in patients with asthma.19 Thus,atruesafethresholdforanyonefoodand person is impossible to determine. However, the aim of quantitative risk assessment is to reduce the risk of harm from cross-contamination to a level considered tolerable, rather than to eliminatetheriskaltogether.13 Researchers have therefore developed the concept of the lowest observed adverse effect level (LOAEL), a threshold below which most people will not react. Only a few studies have been published assessing LOAELs for the more common food allergens by double blind, placebo controlled food challenges.19 One concern is that highly allergic people may have been excluded from these studies. The Food Examples of advisory warnings found on food labels2 DUETOTHE METHODSUSEDIN THEMANUFACTURE OFTHISPRODUCT,IT MAYOCCASIONALLY CONTAIN........ PACKED IN AN ENVIRONMENT WHERE........ MAY BE PRESENT NOT SUITABLE FOR........ALLERGY SUFFERERS MAY CONTAIN TRACES OF ........ MADE IN A PRODUCTION AREA THAT ALSO USES ........ MAY CONTAIN ........ PRODUCED ON SHARED EQUIPMENT WHICH ALSO PROCESSES ........ PRODUCED IN A FACTORY WHICH HANDLES ........ MADE IN A FACTORY THAT ALSO PRODUCES ........ Standards Agency stated in 2007 that “there is a lack of scientific and clinical evidence on which to base firm conclusions regarding the mini- mum amounts of some allergens needed to trig- ger adverse reactions in sensitive individuals.”1 Nonetheless, for many common food allergens, there is a high degree of agreement between pub- lished LOAELs. Further data are expected from high quality double-blind placebo-controlled studies, particularly the Euro-PREVALL collabo- ration, in the next 12 months.13  19 Vital information Australia and New Zealand have already started to use LOAEL data to improve labelling. In 2007, the food manufacturing industry, with the input of consumer groups and regulatory authori- ties, developed a standardised risk assessment tool called voluntary incidental trace allergen labelling (VITAL).20 This allows manufacturers to assess potential cross-contamination quan- titatively and determine the need for advisory warnings. Threshold levels were based on pub- lished LOAEL data with a 10-fold safety factor (this derives from toxicology, where a 10-fold uncertainty factor is typically applied to account for intraspecies variation within a population, although this has not been validated for allergic responses). When the amount of allergen present is above the threshold level (but not at sufficient amounts to be listed as an ingredient), manu- facturers use an advisory statement with the format “may be present.” No advisory warning is recommended if levels are lower than this cut-off. Although some very sensitive people might react to levels of allergen below the cut-off, these peo- ple are in general more likely to avoid potentially problematic foods. The scheme means that advi- sory warnings are used only when warranted and that the warnings are standardised, so providing clear and simple information to consumers. A true safe threshold for any one food and person is impossible to determine BMJ | 22 OCTOBER 2011 | VOLUME 343 831 ANALYSIS listing cows’ milk as an ingredient) containing cows’ milk protein on analysis.11 One UK pro- ducer began to list milk powder in the ingredi- ents of its dark chocolate despite this not being used as a raw ingredient,16 although it has now stoppedthis,suggestingachangeinpolicy.There are also anecdotal reports of some producers intentionallyaddingsmallamountsofallergento foods where cross-contamination may be a risk, so that they can list the allergen as an ingredi- ent and thus avoid the need to address the issue altogether (Food Standards Agency, personal communication). Alternatives to the status quo Attempts to standardise the content of advisory labels using voluntary guidance have not been successful. Almost two thirds of enforcement officers and food manufacturers think that the current voluntary UK guidance should become compulsory.1 Thelistingofallpotentialallergensasaningre- dient when cross-contamination is likely might reduce ambiguity but would further restrict consumer choice. The best solution would be to quantify the hazard—that is, whether the degree of contamination is sufficient to trigger an aller- gic reaction—and communicate this clearly to the consumer. However, obtaining robust data on allergen thresholds has proved difficult. The minimum eliciting dose varies widely between individuals, and there will always be a few highly sensitised individuals who react to minute amounts of allergen. Furthermore, the threshold can vary by several orders of magnitude within the same person, depending on various factors. These include: Processing and denaturation of the allergen— Many people who are allergic to egg or milk tolerate the allergen in products that have been baked at high temperature for long periods such as cakes or biscuits.17 The processing probably changes the structure of the allergen, making it less allergenic. Derived ingredients—Immunoglobulin E medi- atedfoodallergyreactionsarecausedbyproteins, and thus products such as wheat derived glucose syrup (a carbohydrate) do not require allergen disclosure under current legislation. However, legislation regarding disclosure of derived ingre- dients is inconsistent. Soy derived lecithin (a lipid)andrefinedsoyoilgenerallycontainsimilar (low) amounts of soy protein, and most people with soy allergy can tolerate these ingredients.18 Regulatory authorities require products made with soy lecithin to be labelled as containing soy, but not those containing refined soy oil.1 Foodmatrix—Chemicalandphysicalinteractions between allergenic proteins and other proteins, fats, and carbohydrates within the molecular structure of the food (known as the food matrix) altertheabilityofanallergentoinduceanallergic response.Themechanismforsuchinteractionsis complex and poorly understood.17 Individualfactors—Thelevelsofallergenrequired totriggeranallergicresponseinapersoncanvary significantly from day to day. This variation is probablytheresultofviralillnessesandthestatus of the lower airways in patients with asthma.19 Thus,atruesafethresholdforanyonefoodand person is impossible to determine. However, the aim of quantitative risk assessment is to reduce the risk of harm from cross-contamination to a level considered tolerable, rather than to eliminatetheriskaltogether.13 Researchers have therefore developed the concept of the lowest observed adverse effect level (LOAEL), a threshold below which most people will not react. Only a few studies have been published assessing LOAELs for themorecommonfoodallergensbydouble blind, placebo controlled food challenges.19 One concern is that highly allergic people may have been excluded from these studies. The Food Examples of advisory warnings found on food labels2 DUETOTHE METHODSUSEDIN THEMANUFACTURE OFTHISPRODUCT,IT MAYOCCASIONALLY CONTAIN........ PACKED IN AN ENVIRONMENT WHERE........ MAY BE PRESENT NOT SUITABLE FOR........ALLERGY SUFFERERS MAY CONTAIN TRACES OF ........ MADE IN A PRODUCTION AREA THAT ALSO USES ........ MAY CONTAIN ........ PRODUCED ON SHARED EQUIPMENT WHICH ALSO PROCESSES ........ PRODUCED IN A FACTORY WHICH HANDLES ........ MADE IN A FACTORY THAT ALSO PRODUCES ........ Standards Agency stated in 2007 that “there is a lack of scientific and clinical evidence on which to base firm conclusions regarding the mini- mum amounts of some allergens needed to trig- ger adverse reactions in sensitive individuals.”1 Nonetheless, for many common food allergens, there is a high degree of agreement between pub- lished LOAELs. Further data are expected from high quality double-blind placebo-controlled studies, particularly the Euro-PREVALL collabo- ration, in the next 12 months.13  19 Vital information Australia and New Zealand have already started to use LOAEL data to improve labelling. In 2007, the food manufacturing industry, with the input of consumer groups and regulatory authori- ties, developed a standardised risk assessment tool called voluntary incidental trace allergen labelling (VITAL).20 This allows manufacturers to assess potential cross-contamination quan- titatively and determine the need for advisory warnings. Threshold levels were based on pub- lished LOAEL data with a 10-fold safety factor (this derives from toxicology, where a 10-fold uncertainty factor is typically applied to account for intraspecies variation within a population, although this has not been validated for allergic responses). When the amount of allergen present is above the threshold level (but not at sufficient amounts to be listed as an ingredient), manu- facturers use an advisory statement with the format “may be present.” No advisory warning is recommended if levelsarelower thanthis cut-off. Although some very sensitive people might react to levels of allergen below the cut-off, these peo- ple are in general more likely to avoid potentially problematic foods. The scheme means that advi- sorywarningsareusedonlywhenwarrantedand that the warnings are standardised, so providing clear and simple information to consumers. A true safe threshold for any one food and person is impossible to determine Turner  et  al,  2011   BMJ | 22 OCTOBER 2011 | VOLUME 343 A listing cows’ milk as an ingredient) containing cows’ milk protein on analysis.11 One UK pro- ducer began to list milk powder in the ingredi- ents of its dark chocolate despite this not being used as a raw ingredient,16 although it has now stopped this, suggesting a change in policy. There are also anecdotal reports of some producers intentionally adding small amounts of allergen to foods where cross-contamination may be a risk, so that they can list the allergen as an ingredi- ent and thus avoid the need to address the issue altogether (Food Standards Agency, personal communication). Alternatives to the status quo Attempts to standardise the content of advisory labels using voluntary guidance have not been successful. Almost two thirds of enforcement officers and food manufacturers think that the current voluntary UK guidance should become compulsory.1 Thelistingofallpotentialallergensasaningre- dient when cross-contamination is likely might reduce ambiguity but would further restrict consumer choice. The best solution would be to quantify the hazard—that is, whether the degree of contamination is sufficient to trigger an aller- gic reaction—and communicate this clearly to the consumer. However, obtaining robust data on allergen thresholds has proved difficult. The minimum eliciting dose varies widely between individuals, and there will always be a few highly sensitised individuals who react to minute amounts of allergen. Furthermore, the threshold can vary by several orders of magnitude within the same person, depending on various factors. These include: Processing and denaturation of the allergen— Many people who are allergic to egg or milk tolerate the allergen in products that have been baked at high temperature for long periods such as cakes or biscuits.17 The processing probably changes the structure of the allergen, making it less allergenic. Derived ingredients—Immunoglobulin E medi- atedfoodallergyreactionsarecausedbyproteins, and thus products such as wheat derived glucose syrup (a carbohydrate) do not require allergen disclosure under current legislation. However, legislation regarding disclosure of derived ingre- dients is inconsistent. Soy derived lecithin (a lipid)andrefinedsoyoilgenerallycontainsimilar (low) amounts of soy protein, and most people with soy allergy can tolerate these ingredients.18 Regulatory authorities require products made with soy lecithin to be labelled as containing soy, but not those containing refined soy oil.1 Food matrix—Chemical and physical interactions between allergenic proteins and other proteins, fats, and carbohydrates within the molecular structure of the food (known as the food matrix) altertheabilityofanallergentoinduceanallergic response. The mechanism for such interactions is complex and poorly understood.17 Individualfactors—Thelevelsofallergenrequired totriggeranallergicresponseinapersoncanvary significantly from day to day. This variation is probablytheresultofviralillnessesandthestatus of the lower airways in patients with asthma.19 Thus,atruesafethresholdforanyonefoodand person is impossible to determine. However, the aim of quantitative risk assessment is to reduce the risk of harm from cross-contamination to a level considered tolerable, rather than to eliminatetheriskaltogether.13 Researchers have therefore developed the concept of the lowest observed adverse effect level (LOAEL), a threshold below which most people will not react. Only a few studies have been published assessing LOAELs for the more common food allergens by double blind, placebo controlled food challenges.19 One concern is that highly allergic people may have been excluded from these studies. The Food Examples of advisory warnings found on food labels2 DUETOTHE METHODSUSEDIN THEMANUFACTURE OFTHISPRODUCT,IT MAYOCCASIONALLY CONTAIN........ PACKED IN AN ENVIRONMENT WHERE........ MAY BE PRESENT NOT SUITABLE FOR........ALLERGY SUFFERERS MAY CONTAIN TRACES OF ........ MADE IN A PRODUCTION AREA THAT ALSO USES ........ MAY CONTAIN ........ PRODUCED ON SHARED EQUIPMENT WHICH ALSO PROCESSES ........ PRODUCED IN A FACTORY WHICH HANDLES ........ MADE IN A FACTORY THAT ALSO PRODUCES ........ Standards Agency stated in 2007 t lack of scientific and clinical evide to base firm conclusions regard mum amounts of some allergens n ger adverse reactions in sensitive Nonetheless, for many common fo there is a high degree of agreement lished LOAELs. Further data are e high quality double-blind placeb studies, particularly the Euro-PRE ration, in the next 12 months.13  19 Vital information Australia and New Zealand have a to use LOAEL data to improve label the food manufacturing industry, w of consumer groups and regula ties, developed a standardised ris tool called voluntary incidental t labelling (VITAL).20 This allows m to assess potential cross-contami titatively and determine the need warnings. Threshold levels were b lished LOAEL data with a 10-fold (this derives from toxicology, wh uncertainty factor is typically appl for intraspecies variation within although this has not been validat responses). When the amount of al is above the threshold level (but no amounts to be listed as an ingred facturers use an advisory statem format “may be present.” No advis recommended if levels are lower th Although some very sensitive peop to levels of allergen below the cut-o ple are in general more likely to avo problematic foods. The scheme me sory warnings are used only when w that the warnings are standardised clear and simple information to co A true safe threshold for any one food and person is impossible to determine BMJ | 22 OCTOBER 2011 | VOLUME 343 listing cows’ milk as an ingredient) containing cows’ milk protein on analysis.11 One UK pro- ducer began to list milk powder in the ingredi- ents of its dark chocolate despite this not being used as a raw ingredient,16 although it has now stoppedthis,suggestingachangeinpolicy.There are also anecdotal reports of some producers intentionallyaddingsmallamountsofallergento foods where cross-contamination may be a risk, so that they can list the allergen as an ingredi- ent and thus avoid the need to address the issue altogether (Food Standards Agency, personal communication). Alternatives to the status quo Attempts to standardise the content of advisory labels using voluntary guidance have not been successful. Almost two thirds of enforcement officers and food manufacturers think that the current voluntary UK guidance should become compulsory.1 Thelistingofallpotentialallergensasaningre- dient when cross-contamination is likely might reduce ambiguity but would further restrict consumer choice. The best solution would be to quantify the hazard—that is, whether the degree of contamination is sufficient to trigger an aller- gic reaction—and communicate this clearly to the consumer. However, obtaining robust data on allergen thresholds has proved difficult. The minimum eliciting dose varies widely between individuals, and there will always be a few highly sensitised individuals who react to minute amounts of allergen. Furthermore, the threshold can vary by several orders of magnitude within the same person, depending on various factors. These include: Processing and denaturation of the allergen— Many people who are allergic to egg or milk tolerate the allergen in products that have been baked at high temperature for long periods such as cakes or biscuits.17 The processing probably changes the structure of the allergen, making it less allergenic. Derived ingredients—Immunoglobulin E medi- atedfoodallergyreactionsarecausedbyproteins, and thus products such as wheat derived glucose syrup (a carbohydrate) do not require allergen disclosure under current legislation. However, legislation regarding disclosure of derived ingre- dients is inconsistent. Soy derived lecithin (a lipid)andrefinedsoyoilgenerallycontainsimilar (low) amounts of soy protein, and most people with soy allergy can tolerate these ingredients.18 Regulatory authorities require products made with soy lecithin to be labelled as containing soy, but not those containing refined soy oil.1 Foodmatrix—Chemicalandphysicalinteractions between allergenic proteins and other proteins, fats, and carbohydrates within the molecular structure of the food (known as the food matrix) altertheabilityofanallergentoinduceanallergic response.Themechanismforsuchinteractionsis complex and poorly understood.17 Individualfactors—Thelevelsofallergenrequired totriggeranallergicresponseinapersoncanvary significantly from day to day. This variation is probablytheresultofviralillnessesandthestatus of the lower airways in patients with asthma.19 Thus,atruesafethresholdforanyonefoodand person is impossible to determine. However, the aim of quantitative risk assessment is to reduce the risk of harm from cross-contamination to a level considered tolerable, rather than to eliminatetheriskaltogether.13 Researchers have therefore developed the concept of the lowest observed adverse effect level (LOAEL), a threshold below which most people will not react. Only a few studies have been published assessing LOAELs for themorecommonfoodallergensbydouble blind, placebo controlled food challenges.19 One concern is that highly allergic people may have been excluded from these studies. The Food Examples of advisory warnings found on food labels2 DUETOTHE METHODSUSEDIN THEMANUFACTURE OFTHISPRODUCT,IT MAYOCCASIONALLY CONTAIN........ PACKED IN AN ENVIRONMENT WHERE........ MAY BE PRESENT NOT SUITABLE FOR........ALLERGY SUFFERERS MAY CONTAIN TRACES OF ........ MADE IN A PRODUCTION AREA THAT ALSO USES ........ MAY CONTAIN ........ PRODUCED ON SHARED EQUIPMENT WHICH ALSO PROCESSES ........ PRODUCED IN A FACTORY WHICH HANDLES ........ MADE IN A FACTORY THAT ALSO PRODUCES ........ Standards Agency stated in lack of scientific and clinica to base firm conclusions mum amounts of some alle ger adverse reactions in sen Nonetheless, for many com there is a high degree of agre lished LOAELs. Further da high quality double-blind studies, particularly the Eu ration, in the next 12 month Vital information Australia and New Zealand to use LOAEL data to impro the food manufacturing ind of consumer groups and ties, developed a standard tool called voluntary incid labelling (VITAL).20 This al to assess potential cross-c titatively and determine th warnings. Threshold levels lished LOAEL data with a (this derives from toxicolo uncertainty factor is typical for intraspecies variation w although this has not been responses). When the amou is above the threshold level amounts to be listed as an facturers use an advisory format “may be present.” N recommended if levelsarelo Although some very sensitiv to levels of allergen below t ple are in general more likel problematic foods. The sche sorywarningsareusedonly that the warnings are stand clear and simple informatio A true safe threshold for any one food and person is impossible to determine Turner  et  al,  2011   VOLUNTARY NOT LEGISLATED FOR Ø  69% of cereals and 56% of confectionery labelled ‘may contain’ despite not listing nut as an ingredient1 Ø  Shopping for a nut-allergic person took: •  40% longer •  cost an average of 11% more Ø  Adversely impacts on quality of life 1FSA report 2007, available at www.food.gov.uk/multimedia/pdfs/maycontainguide.pdf Impact on the consumer Do PALs contribute to anxiety? •  Paediatric food allergy causes more anxiety than other chronic diseases such as DM 1 •  Labelling is a particular concern: 2,3 “…considerable confusion over the extent to which parents should exclude allergens… including whether foods labelled ‘‘may contain traces’’ should be avoided…” 4 1 Avery et al, PAI 2003;14:378-82 2 Cummings et al. PAI 2010;21:586-94; 3 Sheth et al, Ann Allergy Asthma Immunol 2010;104:60-5 4 Hu et al, Arch Dis Child 2007;92:771-5
  3. 3. 07/05/2014 3 Ø  PALs helpful if they provide reliable information, but use is widespread1 Ø  Phrasing is confusing 1FSA report 2007, available at www.food.gov.uk/multimedia/pdfs/ maycontainguide.pdf 2Imamura et al. PAI 2008;19:270-4 So why bother? Do allergic individuals heed PAL? UK (n=184) Australia (n=246) “May contain nuts” 80% avoid 75% avoid “May contain traces of nuts” 60% avoid 45% avoid “Does not contain nuts but made in a factory that uses nuts” 40% avoid 35% avoid Noimark et al. PAI 2009 Zurzolo et al. MJA 2013 But wording used bears no relation to risk of contamination1,2 1Pele et al. Food Add Contam 2007; 24:1334-44. 2Hefle et al. JACI 2007; 120:171-6. Ø  Consumers less likely to heed more ambiguous warnings2 • Can labelling lead to increased risk taking? 1FSA report 2007, available at www.food.gov.uk/multimedia/pdfs/ maycontainguide.pdf 2Imamura et al. PAI 2008;19:270-4 So why bother? Ø  From Dec 2014, allergen labelling will be a legal requirement for non-prepacked foods too e.g. delicatessens, restaurants, take-aways Ø  Potential cross-contamination will still not be legislated for New legislation: Do foods with / without PAL contain allergen? So… Ø  Most foods with PAL don’t contain the allergen •  … but some do, and enough to trigger reactions •  Snack/confectionery items at particular risk (nut contamination) Ø  Some foods without PAL do contain the allergen
  4. 4. 07/05/2014 4 The reality: •  Wide inconsistencies in labelling •  Significant increase in awareness of the hazards posed by food allergens …but understanding is still far from complete •  Foods can become contaminated with residues of allergenic foods at multiple points: •  Harvesting on farms •  Storage & transportation •  Manufacture: shared equipment •  Measures to reduce cross-contamination not uniform across manufacturers The future… Hypoallergenic foods Not a novel concept: e.g. hydrolysed cow’s milk-based formula Current management… NOW & THEN •  Dietary Avoidance •  Rescue treatment •  Immunotherapy Accidental/inadvertent reactions are common: •  1 in 8 peanut-allergic children experienced at least one accidental reaction every year1 •  Over 50% of 512 infants had at least one reaction over 3 years follow-up2 Avoidance is, therefore, inadequate on its own All food-allergic children need: •  Personalised Allergy Management Plan •  Rescue treatment (which may include AAI) 1Nguyen-Luu et al, PAI 2012; 23:133–139. 2Fleischer et al. Pediatrics 2012; 130:e25–32. Management of accidental reactions… Allergy Action Plan Name: DOB: Parent / Carer details: 1) 2) THIS CHILD HAS THE FOLLOWING ALLERGIES: AIRWAY: Persistent cough, hoarse voice, difficulty swallowing, swollen tongue BREATHING: Difficult or noisy breathing, wheeze or persistent cough CONSCIOUSNESS: Persistent dizziness / Pale or floppy Suddenly sleepy, collapse, unconscious If ANY ONE of these signs are present: 1. Lie child flat. If breathing is difficult, allow to sit 2. Give EpiPen® or EpiPen® Junior 3. Dial 999 for an ambulance* and say ANAPHYLAXIS (“ANA-FIL-AX-IS”) If in doubt, give EpiPen® After giving Epipen: 1. Stay with child, contact parent/carer 2. Commence CPR if there are no signs of life 3. If no improvement after 5 minutes, give a further EpiPen® or alternative adrenaline autoinjector device, if available Photo Keep your EpiPen device(s) at room temperature, do not refrigerate. For more information and to register for a free reminder alert service, go to www.epipen.co.uk Patient support groups: http://www.allergyuk.org or www.anaphylaxis.org.uk The British Society for Allergy & Clinical Immunology www.bsaci.org *You can dial 999 from any phone, even if there is no credit left on a mobile. Medical observation in hospital is recommended after anaphylaxis. Watch for signs of ANAPHYLAXIS (life-threatening allergic reaction): Child’s Weight: Kg Mild-moderate allergic reaction: Swollen lips, face or eyes Itchy / tingling mouth Hives or itchy skin rash ACTION: Stay with the child, call for help if necessary Give antihistamine: Contact parent/carer Abdominal pain or vomiting Sudden change in behaviour (if vomited, can repeat dose) This is a medical document that can only be completed by the patient's treating health professional and cannot be altered without their permission. This plan has been prepared by: Hospital/Clinic: Date: British Society for Allergy and Clinical Immunology Additional instructions: Clinic details
  5. 5. 07/05/2014 5 We need: 1.  Recognition 2.  Appropriate management in community 3.  Appropriate management by healthcare professionals 1) Recognition •  Symptoms of anaphylaxis (DIB, LOC, pharyngeal swelling) are poorly recognized by adolescents1 •  One in 7 report difficulty in knowing when to use their AAI in a US survey (n=1885)3 1Sampson et al. JACI 2006: 117: 1440–5. 2Simons et al JACI 2009: 124: 301–6. 2) Appropriate Management •  83% of (204) teenagers with anaphylaxis don’t use their AAI1 1Noimark et al. CEA 2012: 42:284–92 Allergy Action Plan Name: DOB: Parent / Carer details: 1) 2) THIS CHILD HAS THE FOLLOWING ALLERGIES: AIRWAY: Persistent cough, hoarse voice, difficulty swallowing, swollen tongue BREATHING: Difficult or noisy breathing, wheeze or persistent cough CONSCIOUSNESS: Persistent dizziness / Pale or floppy Suddenly sleepy, collapse, unconscious If ANY ONE of these signs are present: 1. Lie child flat. If breathing is difficult, allow to sit 2. Dial 999 for an ambulance* and say ANAPHYLAXIS (“ANA-FIL-AX-IS”) 3. Stay with child, contact parent/carer 4. Commence CPR if there are no signs of life Photo This BSACI Action Plan for Allergic Reactions is for children with mild to moderate allergies, who need to avoid certain allergens. For people with severe allergies (and at risk of anaphylaxis) there are BSACI Action Plans which include adrenaline autoinjector instructions. These are available at our website, www.bsaci.org For further information consult NICE Clinical Guidance CG116 Food allergy in children and young people at http://guidance.nice.org.uk/CG116 Patient support groups: http://www.allergyuk.org or www.anaphylaxis.org.uk The British Society for Allergy & Clinical Immunology www.bsaci.org *You can dial 999 from any phone, even if there is no credit left on a mobile. Medical observation in hospital is recommended after anaphylaxis. Watch for signs of ANAPHYLAXIS (life-threatening allergic reaction): Mild-moderate allergic reaction: Swollen lips, face or eyes Itchy / tingling mouth Hives or itchy skin rash Abdominal pain or vomiting Sudden change in behaviour ACTION: Stay with the child, call for help if necessary Give antihistamine: Contact parent/carer (if vomited, can repeat dose) Child’s Weight: Kg This is a medical document that can only be completed by the patient's treating health professional and cannot be altered without their permission. This plan has been prepared by: Hospital/Clinic: Date: British Society for Allergy and Clinical Immunology Additional instructions: Clinic details NOT JUST PATIENTS…. NOT JUST PATIENTS…. Anaphylaxis Knowledge and Practice Preferences of Pediatric Emergency Medicine Physicians: A National Survey Sandra L. Grossman, MD1,2 , Brigitte M. Baumann, MD, MSCE2 , Barbara M. Garcia Pe~na, MD, MPH1 , Marc Y.-R. Linares, MD1 , Barry Greenberg, PhD3,4 , and Vivian P. Hernandez-Trujillo, MD5 Objectives To assess the knowledge and practice preferences of anaphylaxis in pediatric emergency medicine (PEM) physicians by practice setting, and to identify factors associated with intramuscular (IM) epinephrine admin- istration and admission of patients with anaphylaxis. Study design The cohort was a cross-sectional convenience sample; potential participants were recruited using contact information obtained from the American Board of Pediatrics and American Board of Medical Specialties membership databases and were asked to complete a 12 item survey. Board-certified PEM physicians were categorized by practice setting: university hospital, non-university hospital with a residency training program, or community hospital with no residency training program. Management practices based on practice setting are presented as proportions. Multivariate logistic regression identified factors associated with IM epinephrine administration and admission of patients with anaphylaxis for observation. Results Of the 1114 PEM physicians solicited, 620 (56%) completed the survey. The majority (93.5%) correctly identified epinephrine as the treatment of choice for anaphylaxis, yet only 66.9% used the IM route of administra- tion, and only 37.4% admitted affected patients for observation. Factors associated with the use of IM epinephrine included the presence of a residency program at the site of care (OR, 2.28, 95% CI, 1.3-4.04) and higher volume of anaphylaxis cases (OR, 1.21; 95% CI, 1.06-1.38). Increasing anaphylaxis case volume was associated with decreased likelihood of admission of patients with anaphylaxis (OR, 0.81; 95% CI, 0.72-0.92). Conclusion Even though the majority of PEM physicians correctly report using epinephrine in pediatric anaphy- laxis, not all use the preferred administration route, and many discharge patients home after an abbreviated period. (J Pediatr 2013;-:---). A naphylaxis, a life-threatening medical emergency requiring prompt recognition and treatment, has been described var- ious ways since it was first reported in the early 1900s. In an attempt to provide a simpler yet comprehensive definition, allergy and immunology experts convened in 2005 and published an update in 2010, both times defining anaphylaxis as 1 of 3 clinical scenarios: (1) the acute onset of a reaction involving the skin, mucosal tissue, or both and at least 1 of the fol- lowing: respiratory compromise, reduced blood pressure, or symptoms of end-organ dysfunction; (2) 2 or more of the follow- ing occurring soon after exposure to a likely allergen for that patient: involvement of the skin/mucosal tissue, respiratory compromise, reduced blood pressure or associated symptoms, and/or persistent gastrointestinal symptoms; or (3) reduced blood pressure after exposure to a known allergen.1,2 This broad definition may account for the wide range of reported inci- dence of anaphylaxis. In the general US population, this reported incidence ranges from 100 000 to as high as 500 000 annually, of which two-thirds are new cases and almost 1% are fatal.3,4 It is estimated that anaphylaxis occurs in 1 of every 170 children, compared with a rate of 30 per 100 000 person-years in adults.5,6 Considering the increasing incidence of food allergies, a rise in the prevalence of allergic reactions and anaphylaxis is anticipated.7 Fatal outcomes have been associated with a delay in administering or failure to administer epinephrine.8-11 Yet despite the prevalence and severity of anaphylaxis, this condition remains underrecognized and underreported.3,12 A case-based survey revealed that a large percentage of pediatricians (46%) had difficulty recognizing and treat- ing food-induced anaphylaxis, and nearly one-third underestimated its sever- ity.13 Another study documented pediatricians’ concerns regarding their ability to appropriately care for children with food allergies and devise effective man- agement plans.14 The aim of this investigation was to assess anaphylaxis knowledge and practice preferences of pediatric emergency medicine (PEM) physicians by practice From the 1 Department of Emergency Medicine, Miami Children’s Hospital, Miami, FL; 2 Department of Emergency Medicine, Cooper Medical School of Rowan University, Camden, NJ; 3 Department of Educational Research, 4 Division of Research & Information Herbert Wertheim College of Medicine, Florida International University; and 5 Department of Allergy and Immunology, Miami Children’s Hospital, Miami, FL V.H.-T. is on the speaker’s bureaus of Baxter Healthcare and CSL-Behring, and serves as a spokesperson for the Claritin Council and Schering-Plough/Merck. The other authors declare no conflicts of interest. Portions of this study were presented as an oral abstract at the annual meeting of the American College of Allergy, Asthma, and Immunology, Phoenix, Arizona, November 14, 2010. 0022-3476/$ - see front matter. Copyright ª 2013 Mosby Inc. All rights reserved. http://dx.doi.org/10.1016/j.jpeds.2013.02.050 ED Emergency department IM Intramuscular PEM Pediatric emergency medicine 1 •  Only two doctors (2%) demonstrated use correctly. •  Most frequent errors: § 57% - not holding pen in place for >5 seconds § 21% - failure to apply pressure to activate § 16% - self-injection into thumb •  60% failed to use device correctly even after reading instructions •  In 37% NO adrenaline would have been administered
  6. 6. 07/05/2014 6 Do we need to shift our focus? Current management… NOW & THEN •  Dietary Avoidance •  Rescue treatment •  Immunotherapy Immunotherapy to food Nowak-Wegrzyn & Sampson. JACI 2011; 127(3):558-73 Nowak-Wegrzyn & Fiocchi, Curr Opin Allergy Clin Immunol. 2010; 10:214-9. Studies completed or underway… Egg Milk Peanut Other Subcutaneous ✓ Baked, oral ✓ ✓ Native, oral ✓ ✓ ✓ ✓ SLIT ✓ ✓ ✓ Epicutaneous ✓ ✓ Tolerising peptides ✓ Studies completed or underway… Safety •  Desensitisation typically achieved in >80% •  High rate of adverse events during SOTI: •  70-80% experience adverse events •  Rates of ‘anaphylaxis’ vary •  Severity of anaphylaxis vary •  Up to 10% of patients withdraw
  7. 7. 07/05/2014 7 •  49/85 (58%) desensitised to 1400mg protein (~6 PN) •  75 (88%) partially desensitised to 800mg protein •  Cumulative safety data not reported •  At least 81% of children experienced an adverse event •  Most of these mild, but at least 1 in 5 children developed wheeze •  One child ‘required’ IM adrenaline twice (child subsequently withdrawn) NB: Most OIT protocols for peanut utilise higher dosing regime, up to 5000mg protein (~20 peanuts) Desensitisation vs long term tolerance… Nowak-Wegrzyn & Sampson. JACI 2011; 127(3):558-73 Desensitisation vs long term tolerance… Peanut 12 (50%) of 24 children who completed SOTI were tolerant after 2 months1 Egg 11 (37%) of 30 children who completed SOTI were tolerant after 2 months2 Cow’s Milk 10 (31%) of 32 children were able to tolerate at least one portion of CM daily 1-5 years after completing SOTI3 1Vickery et al. JACI 2014 Feb;133(2):468-475.e6. 2Burks et al. N Engl J Med 2012; 367:233–243. 3Keet et al. JACI 2013; 132:737–739; e6. Some clinical concerns… •  How to select those suitable for SOTI •  Risk of increasing sensitisation? •  Risk of inducing a false sense of security in those only temporarily desensitised •  Effect on QoL of patient •  Potential for causing other problems e.g. EoE THE FUTURE: Dietary avoidance •  Accurate diagnosis and therefore appropriate avoidance •  Clearer food labelling •  Apps to help avoid potential allergens •  Better understanding when eating out •  Hypoallergenic foods
  8. 8. 07/05/2014 8 THE FUTURE: Rescue treatment •  Recognition of symptoms •  More intuitive AAI •  Apps to aid AAI use/emergency services •  More training for HCPs THE FUTURE: Treatment options •  Use of baked CM / egg •  More research into SOTI: • Safer protocols • Better understanding of long-term tolerance induction • SOTI as primary prevention THE FUTURE… is already here? •  Accurate diagnosis and therefore appropriate avoidance •  Clearer food labelling •  Apps to help avoid potential allergens •  Better understanding when eating out •  Hypoallergenic foods •  Recognition of symptoms •  More intuitive AAI •  Apps to aid AAI use/emergency services •  More training for HCPs •  Baked CM / Egg •  More research into SOTI: •  Safer protocols •  Better understanding of long-term tolerance induction •  SOTI as primary prevention

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