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      Comparison of the robustness and functionality of three adrenaline auto-injectors

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          Abstract

          Background

          Anaphylaxis is a medical emergency that requires the intramuscular injection of adrenaline using an adrenaline auto-injector (AAI). This study compared the robustness and performance characteristics of three AAIs available in Europe.

          Methods

          Three AAIs (Jext ®, EpiPen ®, and Anapen ®) were tested in terms of the force needed to activate the AAIs, exposed needle length, injection volume, and injection time. Three conditions were used to assess robustness: base conditions, after three successive free-fall drops from 1.5 m, and after a 40 kg static load challenge. The injection depth and estimated volume of solution delivered into ballistic gelatin were also assessed.

          Results

          Less force was required to remove the safety cap from Jext and EpiPen than from Anapen under base conditions. The required force was unaffected by free-fall drop tests, whereas the static load test significantly increased the force required to remove the safety cap from Jext (difference from base value 7.7 N; P < 0.001) and from EpiPen ( difference from base value 30.3 N; P < 0.001). Two Anapens could not be activated after the free-fall and static load tests. The mean exposed needle length was 15.36 mm (standard error [SE] 0.04) for Jext, 15.02 mm (SE 0.05) for EpiPen, and 7.49 mm (SE 0.15) for Anapen. The mean maximum injection depth in gelatin within 10 seconds was 28.87 mm (standard deviation [SD] 0.73) for Jext, 29.68 mm (SD 2.08) for EpiPen, and 18.74 mm (SD 1.25) for Anapen.

          Conclusion

          A comparison of the robustness and performance characteristics of the three AAIs showed that cartridge-based devices (Jext and EpiPen) appeared to be significantly more robust and capable of rapidly and consistently delivering the correct dose of adrenaline to the correct tissue compartment than the syringe-based Anapen. Overall, Jext performed better than EpiPen or Anapen following mechanical stress designed to mimic real-world use.

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          Most cited references29

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          The diagnosis and management of anaphylaxis practice parameter: 2010 update.

          These parameters were developed by the Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma and Immunology. The AAAAI and the ACAAI have jointly accepted responsibility for establishing "The Diagnosis and Management of Anaphylaxis Practice Parameter: 2010 Update." This is a complete and comprehensive document at the current time. The medical environment is a changing environment, and not all recommendations will be appropriate for all patients. Because this document incorporated the efforts of many participants, no single individual, including those who served on the Joint Task Force, is authorized to provide an official AAAAI or ACAAI interpretation of these practice parameters. Any request for information about or an interpretation of these practice parameters by the AAAAI or ACAAI should be directed to the Executive Offices of the AAAAI, the ACAAI, or the Joint Council of Allergy, Asthma and Immunology. These parameters are not designed for use by pharmaceutical companies in drug promotion. Copyright (c) 2010 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.
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            Epidemiology of anaphylaxis: findings of the American College of Allergy, Asthma and Immunology Epidemiology of Anaphylaxis Working Group.

            To improve understanding of the epidemiology of anaphylaxis. We performed a qualitative review by hand of the major epidemiology studies of anaphylaxis. This review was restricted to articles in the English language. Articles chosen were selected by the committee and dated back to 1968. There was no specific criterion used for selection except the determination of the members of the committee. Data on anaphylaxis incidence and prevalence are sparse and often imprecise. Findings are based on diverse study designs and are not entirely comparable. These factors have contributed to widely varying estimates of the frequency of this important condition. The roundtable discussion led to an improved estimation of the frequency of anaphylaxis: approximately 50 to 2,000 episodes per 100,000 persons or a lifetime prevalence of 0.05% to 2.0%. The largest number of incident cases is among children and adolescents. In addition to underdiagnosis, we noted undertreatment, especially for those at highest risk (ie, those without immediate access to treatment with epinephrine). Anaphylaxis is a relatively common problem, affecting up to 2% of the population. Further data on epinephrine dispensing could improve current estimates. Another way to improve current understanding would be through better population-based study designs in different geographic regions. A recurring theme was the importance of broader access to self-injectable epinephrine for high-risk populations. An improved epidemiologic understanding of this disorder would aid ongoing efforts to reduce morbidity and mortality from anaphylaxis and could provide important clues for primary prevention.
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              Time trends in allergic disorders in the UK.

              Allergic disorders are common in the UK. This study reviews recent UK time trends in the prevalence, morbidity and mortality for allergic disorders, excluding asthma. A trend analysis was performed over recent decades of national, representative or repeat surveys, primary care consultations, prescriptions, hospital admissions, and mortality. Serial surveys showed that the prevalence of diagnosed allergic rhinitis and eczema in children have both trebled over the last three decades. While these long term trends were paralleled by the prevalence of disease symptoms, more recent symptom prevalence data suggest a decline. Similarly, GP consultation rates rose by 260% for hay fever and by 150% for eczema overall during the period 1971-91, but rates have stabilised over the past decade. Hospital admissions for eczema have been stable since 1995, and hospital admissions for allergic rhinitis have fallen to about 40% of their 1990 levels. Since 1990, admissions for anaphylaxis have increased by 700%, for food allergy by 500%, for urticaria by 100%, and for angio-oedema by 40%. Prescriptions issued for all types of allergy have increased since 1991. The prevalence and healthcare usage for eczema and hay fever have increased substantially over recent decades, but may now be stabilising or even falling. In contrast, admissions for some systemic allergic diseases have risen sharply in the last decade which may indicate a rising incidence of these conditions. Although changes in treatment and other healthcare factors may have contributed to these trends, there may also be a change in the aetiology of allergic disease in the UK.
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                Author and article information

                Journal
                J Asthma Allergy
                J Asthma Allergy
                Journal of Asthma and Allergy
                Journal of Asthma and Allergy
                Dove Medical Press
                1178-6965
                2012
                20 August 2012
                : 5
                : 39-49
                Affiliations
                Pharma Consult GmbH, Vienna, Austria
                Author notes
                Correspondence: Andreas Schwirtz, Pharma Consult GmbH, Research and Development, Divischgasse 4, A-1210 Vienna, Austria, Tel +43 1 2910 7669, Fax +43 1 2910 76377, Email a.schwirtz@ 123456bmgrp.at
                Article
                jaa-5-039
                10.2147/JAA.S33688
                3430083
                22952410
                f4190909-157d-474b-9beb-205c04da53c9
                © 2012 Schwirtz and Seeger, publisher and licensee Dove Medical Press Ltd.

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

                History
                Categories
                Original Research

                Immunology
                anaphylaxis,adrenaline auto-injector,anapen,epipen,jext,injection depth,reliability
                Immunology
                anaphylaxis, adrenaline auto-injector, anapen, epipen, jext, injection depth, reliability

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