Survey Findings Reveal Incidence of First-Time Reactions in School Setting
Pittsburgh — Mylan Specialty, the fully integrated specialty pharmaceutical business of Mylan Inc. (NASDAQ: MYL), today announced new EpiPen4Schools® program offerings as part of the company’s commitment to support the growing need for education among school staff about anaphylaxis, a life-threatening allergic reaction. The EpiPen4Schools program, launched in 2012, provides four free EpiPen® (epinephrine) or EpiPen Jr® (epinephrine) Auto-Injectors to qualifying* schools.
Results from a recent survey conducted by Mylan Specialty among more than 6,000 program participants during the 2013-2014 school year found that of 919 reported cases of anaphylaxis in the schools, more than one in five occurred in individuals without an established or known allergic trigger. In addition, of the reported incidents of anaphylaxis that were treated with epinephrine, the first-line treatment for anaphylaxis, nearly half (48.7%) used an EpiPen Auto-Injector received through the EpiPen4Schools program.
“This is the first nationwide, comprehensive survey evaluating anaphylaxis and use of epinephrine auto-injectors in U.S. schools,” Dr. Martha White, a survey investigator, stated. “As the program continues, research like this will be important in understanding how schools are responding when anaphylaxis occurs and what resources may be needed to support efforts to manage potentially life-threatening allergies within the school setting.”
New EpiPen4Schools program resources, including a training video for school staff and administrators that features an anaphylaxis overview and step-by-step demonstration of how to administer EpiPen Auto-Injector, are available at EpiPen4Schools.com.
“Nearly three years ago, a series of in-school tragedies highlighted the need for immediate access to epinephrine. We recognized that Mylan Specialty was in a unique position to address the evolving needs of the school community, and we introduced the EpiPen4Schools program to improve epinephrine access in this important setting,” Mylan CEO Heather Bresch said. “To date, more than 42,000 schools have participated in the program and 45 states have enacted laws or policies allowing or requiring schools to stock epinephrine auto-injectors. We commend the collective efforts of the community that have made this impressive progress possible in such a relatively short amount of time, but we must continue to strive to ensure access for schools in every state and preparedness in schools nationwide.”
The free EpiPen4Schools program resources now include:
- Four EpiPen or EpiPen Jr Auto-Injectors: Schools can apply online to receive two EpiPen 2-Pak® cartons, two EpiPen Jr 2-Pak® cartons or one 2-Pak of each kind. Qualifications for this offer include having a valid prescription.
- Anaphylaxis: Know It. See It. Treat It. Training Video: Available on DVD or for download at EpiPen4Schools.com, the video features an anaphylaxis overview from Dr. Ruchi Gupta, Associate Professor of Pediatrics at Northwestern University and Lurie Children’s Hospital; and a step-by-step demonstration of how to administer EpiPen Auto-Injector.
- EpiPen® Trainer Units: Designed to practice administration, EpiPen Trainer units contain no drug product or needle.
- EpiLocker™: A brightly colored unit, to store the free EpiPen and/or EpiPen Jr Auto-Injectors received through the program, so they are easily identifiable in the event of an emergency.
- Replenishment Offer: Qualifying schools that use the free supply of EpiPen or EpiPen Jr Auto-Injectors to respond to anaphylaxis may order a replenishment supply at no additional cost.
- Online Order Process: Schools may now submit and track their orders online.
“As a pediatrician and mother of a child with life-threatening allergies, I know all too well that life happens and the school community needs to be prepared should anaphylaxis occur,” Dr. Gupta said. “With kids spending so much time in school, there is increased emphasis placed on programs to educate staff about anaphylaxis risk and management, making resources like the Anaphylaxis: Know It. See It. Treat It. training video so important. We hope that schools will continue to enroll in the EpiPen4Schools program and that resources like the training video are helpful in their anaphylaxis preparedness efforts.”
Anaphylaxis can happen quickly and without warning, and children are among the most at risk - approximately one in 13 U.S. children has a potentially life-threatening (severe) food allergy.
For more information, visit EpiPen4Schools.com.
Dr. Martha White is a paid medical consultant of Mylan Specialty.
Dr. Ruchi Gupta is a paid spokesperson of Mylan Specialty.
*A school will only receive EpiPen Auto-Injectors in accordance with all applicable laws. The school must submit a valid prescription in order to qualify for this program. There is no requirement for a school to purchase additional EpiPen or EpiPen Jr Auto-Injectors or any other Mylan Specialty products.
Anaphylaxis is a life-threatening allergic reaction that has many possible triggers, occurs quickly, without warning, and must be treated immediately with epinephrine. Symptoms may include hives or redness of the skin, tightness in the throat, nausea, dizziness, breathing problems, a decrease in blood pressure and/or fainting. Anaphylaxis can be caused by triggers, such as food, stinging and biting insects, medicines, latex or even exercise. While symptoms of an allergic reaction vary from person to person, reactions can quickly progress to become life-threatening.
An epinephrine auto-injector, such as EpiPen Auto-Injector, should be given at the first sign of anaphylaxis, followed by seeking immediate emergency medical care. Antihistamines do not prevent or relieve the life-threatening symptoms of anaphylaxis. Delays in epinephrine administration have been associated with negative health consequences, even possibly death.
EpiPen® (epinephrine) 0.3 mg and EpiPen Jr® (epinephrine) 0.15 mg Auto-Injectors are for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for people who are at increased risk for these reactions. EpiPen and EpiPen Jr are intended for immediate self-administration as emergency supportive therapy only. Seek immediate emergency medical treatment after use.
Important Safety Information
EpiPen Auto-Injectors contain a single dose of epinephrine, which you inject into your outer thigh. DO NOT INJECT INTO YOUR VEIN, BUTTOCK, FINGERS, TOES, HANDS OR FEET. In case of accidental injection, please seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.
Tell your doctor if you have certain medical conditions such as asthma, depression, thyroid disease, Parkinson’s disease, diabetes, high blood pressure and heart disease, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Be sure to also tell your doctor all the medicines you take, especially medicines for asthma. If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you take the EpiPen or EpiPen Jr Auto-Injector.
The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness or anxiety. These side effects usually go away quickly, especially if you rest.
Talk to your healthcare professional to see if EpiPen or EpiPen Jr Auto-Injector is right for you.
Please see the full Prescribing Information and Patient Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.