News - january 2017
FOOD ALLERGY & ANAPHYLAXIS UPDATE
SEASONAL UPDATES FOR AAE HEALTHCARE PROFESSIONAL MEMBERS
By Anne F. Russell, BSN, RN, AE-C
AUVI-Q® EPINEPHRINE AUTO-INJECTORS EXPECTED TO RETURN TO MARKET
In October 2015, Sanofi U.S. voluntarily recalled all Auvi-Q® epinephrine auto-injectors due to concern over “potentially inaccurate dosage delivery, which may include failure to deliver drug.”1
On February 23, 2016, Sanofi U.S. then announced “the license and development agreement between Sanofi and kaléo, formerly Intelliject Inc., the developer of Auvi-Q® (epinephrine injection, USP), would terminate later that year followed by all U.S. and Canadian rights returning to kaléo."1
In mid-January 2017, kaléo announced plans for Auvi-Q® epinephrine auto-injectors to be back on the market and available for prescription nationwide on February 14, 2017.2
Additionally, kaléo announced its new Auvi-Q® AffordAbility
™ patient assistance program and direct delivery service.2
View full kaléo press release here
CVS OFFERS GENERIC FORM OF ADRENACLICK®EPINEPHRINE AUTO-INJECTORS
In mid-January 2017, CVS Pharmacy indicated “patients can now purchase the authorized generic for Adrenaclick® at a cash price of $109.99 for a two-pack – the lowest cash price in the market”.3
View full CVS Pharmacy information on this generic epinephrine auto-injector here
which includes a video demonstrating its use by Lineage Therapeutics, Inc.
, and Daily Med NIH prescribing information here
. View the generic epinephrine auto-injector savings card for patients by Lineage Therapeutics, Inc. here
MYLAN ANNOUNCES GENERIC VERSION OF EPIPEN® EPINEPHRINE AUTO-INJECTORS
In September of 2016, the CEO of Mylan Inc. provided testimony during Congressional hearings on the rationale behind the price increase of the EpiPen® over a seven-year period.4
See full coverage of the hearings via C-Span recording here
. Subsequently, in December of 2016, Mylan Inc. announced its first generic form of the EpiPen® which is planned to be made available at a “wholesale acquisition cost (WAC) of $300 per epinephrine injection USP two-pack, which is more than 50% lower than the WAC of EpiPen 2-Pak® Auto-Injectors”.5
View the full Mylan press release here
. More information on Mylan’s generic form of the EpiPen® is available here
including content on the MyGenericEAI Savings Card for patients.
NASEM REPORT ADDRESSES PUBLIC HEALTH CONCERNS OF FOOD ALLERGY
In late November 2016, the National Academies of Sciences, Engineering and Medicine (NASEM) announced the release of a new report entitled “Finding a Path to Safety in Food Allergy: Assessment of the Global Burden, Causes, Prevention, Management, and Public Policy”.6
The NASEM report aims to promote “greater public safety regarding food allergies” and recommends a variety of steps to achieve this objective including the “use of proper diagnostic methods and evidence-based health care; identification of evidence-based prevention approaches; improved education and training for health care providers, patients/caregivers, the food industry, and the general public; implementation of improved policies and practices to prevent the occurrence of severe reactions; and expanded research programs”.6,7
View the full NASEM press release here
. View the full NASEM food allergy report, including a free pdf and slide set of its highlights, here
NEW NIAID RECOMMENDATIONS TO PREVENT PEANUT ALLERGY
In early January 2017, the National Institute of Health announced release of the National Institute of Allergy and Infectious Diseases (NIAID) sponsored panel recommendations for clinical guidelines to prevent peanut allergy.8
The new clinical guidelines are an addendum to the 2010 NIAID Guidelines
for Diagnosis and Management of Food Allergy in the U.S.9
The new NIAID supplement includes three clinical guidelines for healthcare professionals regarding infants at different levels of risk for developing peanut allergy and includes “guideline one which focuses on infants deemed at high risk of developing peanut allergy because they already have severe eczema, egg allergy or both; guideline two which suggests that infants with mild or moderate eczema should have peanut-containing foods introduced into their diets around 6 months of age to reduce the risk of peanut allergy; and guideline three which suggests that infants without eczema or any food allergy have peanut-containing foods freely introduced into their diets”.8
Research informing the new NIAID guidelines includes the Learning Early About Peanut Allergy (LEAP) study
published in 2015.10
View the full NIH press release here
. View a NIAID two-page summary for clinicians of the addendum clinical guidelines here
. View the full text of the addendum clinical guidelines published in the Annals of Allergy, Asthma & Immunology here
CLINICAL TEAMS CAN HELP FOOD ALLERGIC STUDENTS CELEBRATE VALENTINE’S DAY SAFELY
Like many other special holiday festivities, Valentine’s Day celebrations at schools can pose challenges for students with IgE mediated food allergies with risk for anaphylaxis. Elementary school Valentine’s Day parties and gifts often include candy and other food which may contain allergens being strictly avoided by certain students. Such events may create additional stressors as school nurses, teachers, and school parents collaborate on strategies to safely include all the students while making efforts to reduce accidental allergen exposure on a student-specific basis. Clinical teams of physicians and registered nurses can assist patients and school nurses by sharing resources and pertinent updated information including medication forms, prescription refills, anaphylaxis emergency management plans, and any changes in the treatment of co-existing conditions, such as asthma, to assist in school monitoring and evaluation aimed at keeping the condition well-controlled.11
School registered nurses and/or clinical registered nurses may assist schools in preparing for Valentine’s Day events by providing educational updates to school staff on methods of anaphylaxis prevention and preparedness, including review of the proper use of an epinephrine auto-injector and food allergy/anaphylaxis school policy reminders. Selected Valentine’s Day resources to share with patients and school staff to help students with food allergies celebrate safely:
- Sanofi-aventis U.S. LLC. Sanofi US to return Auvi-Q® (epinephrine injection, USP) rights to kaléo. http://www.news.sanofi.us/2016-02-23-Sanofi-US-to-Return-Auvi-Q-epinephrine-injection-USP-Rights-to-kal-o. Accessed January 20, 2017.
- Kaleopharma. Kaléo announces U.S. availability and pricing to patients of Auvi-Q ® (Epinephrine Injection, USP) auto-injector, for life-threatening allergic reactions. http://www.multivu.com/players/English/7981051-auvi-q-epinephrine-auto-injector-access-and-availability-launch/. Accessed January 20, 2017.
- CVS Pharmacy Inc. A more affordable EpiPen® alternative. https://www.cvs.com/content/epipen-alternative. Accessed January 20, 2017.
- National Cable Satellite Corporation. C-Span - EpiPen price Increases. https://www.c-span.org/video/?415549-1/mylan-inc-ceo-heather-bresch-testifies-epipen-price-increases. Accessed January 20, 2017.
- Mylan N.V. Mylan launches the first generic for EpiPen® (epinephrine injection, USP) auto-injector as an authorized generic. http://newsroom.mylan.com/2016-12-16-Mylan-Launches-the-First-Generic-for-EpiPen-epinephrine-injection-USP-Auto-Injector-as-an-Authorized-Generic. Accessed January 20, 2017.
- National Academies of Sciences, Engineering, and Medicine. True prevalence of food allergies unknown due to misinterpretation of symptoms and lack of simple diagnostic tests; new report outlines steps to address public health concerns of food allergy safety. http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=23658. Accessed January 23, 2017.
- National Academy of Sciences. Report highlights: finding a path to safety in food allergy: assessment of the global burden, causes, prevention, management, and public policy. http://nationalacademies.org/hmd/~/media/Files/Report%20Files/2016/Food-Allergy-report-highlights.pdf. Accessed January 23, 2017.
- U.S. Department of Health and Human Services. NIH-sponsored expert panel issues clinical guidelines to prevent peanut allergy. https://www.nih.gov/news-events/news-releases/nih-sponsored-expert-panel-issues-clinical-guidelines-prevent-peanut-allergy. Accessed January 23, 2017.
- Boyce JA, Assa’ad A, Burks AW et al. Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel. Journal of Allergy and Clinical Immunology. 2010;126(6suppl):S1-S58.
- Du Toit G, Roberts G, Sayre PH, Bahnson HT, Radulovic S, Santos AF, Brough HA, Phippard D, Basting M, Feeney M and Turcanu V. Randomized trial of peanut consumption in infants at risk for peanut allergy. New England Journal of Medicine. 2015;372:803-813.
- Russell AF, Gosbee LL, Huber MM. Part 2: pertinent food allergy education in a pediatric ambulatory care setting with a focus on anaphylaxis. Journal of Asthma & Allergy Educators. 2012;3:162-171.
- Auvi-Q®: https://www.auvi-q.com/respond/#developed-by-patients-for-patients
- Generic epinephrine auto-injector by Lineage Therapeutics: http://lineagetherapeutics.com/lineage-therapeutics-products
- Mylan EpiPen®: https://www.my-generic-epinephrine-auto-injector.com/
- NASEM Food Allergy Report: http://nationalacademies.org/hmd/reports/2016/finding-a-path-to-safety-in-food-allergy.aspx
By Anne F. Russell, BSN, RN, AE-C
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