ENTITIES TO WHOM THIS POLICY APPLIES: Virginia Tech Sports Medicine Staff including Certified Athletic Trainers and Physicians.

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1 Virginia Tech Departmental Policy 35 Sports Medicine Key Function: Review: Yearly Title: Administration of Epi-Pen Auto Injector S-A Safety Director of Athletic Training Section: Physician Reviewed 2-07 POLICY STATEMENT: This policy insures and communicates complete and comprehensive procedures for Certified Athletic Trainers and Physicians who are administering epinephrine via Epi-Pen Auto Injector to an individual who is suffering from a severe allergic reaction (anaphylaxis). PURPOSE: To provide and communicate to sports medicine staff the proper procedures for the administration of epinephrine via Epi-Pen Auto Injector, the indications and contraindications of the drug, as well as possible side effects involved with the administration of epinephrine and the proper procedures to follow after injection of the drug. ENTITIES TO WHOM THIS POLICY APPLIES: Virginia Tech Sports Medicine Staff including Certified Athletic Trainers and Physicians. PROCEDURE: I. Epinephrine Auto-Injector Introduction Epinephrine is the drug of choice for the emergency treatment of severe allergic reactions to insect stings or bites, foods, drugs, other allergens and for basic life support treatment for severe asthma. Epinephrine mimics the responses of the sympathetic nervous system. It quickly constricts blood vessels to improve blood pressure, reduces the leakage from the blood vessels, relaxes smooth muscle in the bronchioles to improve breathing and alleviate the wheezing and dyspnea, stimulates the heartbeat, and works to reverse the swelling and hives. The drug takes effect within seconds, but the duration of its effectiveness is short (about minutes). The Virginia Tech sports medicine staff utilizes the Epi-Pen Auto-Injector, a disposable delivery system for self-administration. The Epi-Pen has a spring activated needle that is designed to deliver a precise dose (0.3 mg of 1:1000 solution to adults; 0.15 mg. For infants/children under 8 years old with Epi-Pen Jr.) of epinephrine when activated. A single dose is administered to the patient. It may be necessary in very severe reactions to administer a second dose after five minutes if initial response is inadequate. II. Emergency Care for Anaphylaxis and/or Severe Asthma with Epi-Pen The sports medicine staff should: maintain a patent airway Be prepared to suction any secretions (BANYAN kit) administer oxygen therapy at 15 liters/minute with non-rebreather device (located in BANYAN kits) be prepared to assist ventilation with positive pressure ventilation with bag-valve-mask (located in BANYAN kits) administer epinephrine by a prescribed auto-injector call for EMS (if not on-site or in-route) initiate early emergency transport III. Indications/Contraindications for Epinephrine Administration Epinephrine should be administered if the patient exhibits signs and symptoms of a severe allergic reaction (anaphylaxis), including respiratory distress and/or shock (hypoperfusion) or severe asthma. Patients who have progressed to severe asthma experience a combination of the following: shortness of breath (>30/min.), mental status changes (anxious, confused, combative, drowsy), inability to speak in sentences, sweaty and unable to lie down. There are no contraindications for the administration of epinephrine in a life-threatening allergic reaction or severe asthma; however, precautions should be taken with elderly patients or patients with heart disease or hypertension.

2 IV. Administration of Epinephrine Check the Epi-Pen to ensure the medication has not expired, has not become discolored, and does not contain particulates or sediments. Prep skin site with alcohol Remove the gray safety cap from the auto-injector Place the tip of the auto-injector against the lateral aspect of the patient s thigh midway between the waist and knee Push the injector firmly against the thigh until the spring-loaded needle is deployed and the medication is injected (at least 10 seconds) Dispose of the auto-injector in a biohazard container designed for sharp objects. Be careful not to prick yourself since the needle will now be protruding from the end of the injector Record that epinephrine was administered, the dose, and the time of administration V. Side Effects The patient may complain of side effects following the administration of epinephrine. Possible side effects include increased heart rate, pale skin (pallor), dizziness, chest pain, headache, nausea and vomiting, and excitability and anxiousness. VI. Reassessment Following the administration of epinephrine, it is necessary to reassess the patient. Reassessment should include continued evaluation of airway, breathing and circulatory status. Decreasing mental status, decreasing blood pressure and increasing difficulty in breathing indicate the allergic reaction or severe asthma is worsening. If the condition is worsening, consider the following interventions: consult with medical direction about injection of second dose of epinephrine if second auto-injector is available, provide emergency care for shock, be prepared to administer positive pressure ventilation with supplemental oxygen if breathing becomes inadequate, and be prepared to initiate CPR and apply AED if patient becomes pulseless. If the patient s condition improves following administration of epinephrine, continue to perform ongoing assessments. Be aware patient may complain of side effects from the epinephrine. Conscious patients may also be administered 50 mg. Diphenhydramine (Benedryl) orally or sublingually for antihistamine effects. Continue oxygen therapy with a non-rebreather device and treat for shock if necessary. Any patient requiring epinephrine administration should be transported to the closest available medical facility for follow-up evaluation and treatment as soon as possible. Remember that epinephrine is short-acting (10-20 minutes) and signs and symptoms may return as drug wears off. VII. Procedures for Training and Testing in Use of Epi-Pen Auto-Injector Personnel must complete a training session each year with review of signs and symptoms and emergency medical care for allergic reaction, anaphylaxis, anaphylactic shock, and severe asthma; instruction in the proper use and maintenance of the Epi-Pen, and practice with the Epi-Pen Trainer. Resource Cathy McDowel, RN

3 Instructions for Using Twinject Note: The following instructions appear on the WrapLabel permanently attached to each Twinject auto-injector. Step 1: Make Sure That the Medicine Is Ready When You Need It Look at the medicine in the Twinject regularly. It may not work if it looks cloudy (has particles in it), pinkish, or more than slightly yellow. If the expiration date has passed, Twinject may not help you. If the medicine is out of date or looks like it might not work and you have a life-threatening allergic reaction, call emergency help such as 911. In the event of a life-threatening allergic reaction, you should go ahead and use an out-of-date product, if that is all you have. Do not remove the GREEN cap or the RED cap until you are ready to use. Step 2: First Dose 1. Pull off the GREEN end cap labeled "1." You will now see a GRAY cap. Never put your thumb, finger, or hand over the GRAY cap. 2. Pull off the RED end cap labeled "2." 3. Put the GRAY cap against the middle of the outer side of your thigh (upper leg) as shown. It can go through clothes. 4. Press down firmly until the needle enters the middle of the outer side of your thigh through your skin. Hold it in place while slowly counting to Remove the Twinject from your skin. 6. Check the GRAY cap; if the needle is exposed, you received the dose. If not, repeat #3 and #4 under Step 2. Get ready for the second dose. Get emergency medical help right away. Step 3: Get Ready in Case You Need a Second Dose 1. Unscrew and remove the GRAY cap. Beware of the exposed needle. 2. Holding the BLUE hub at the needle base, pull the syringe from the barrel. 3. Slide the YELLOW or ORANGE collar off the plunger. Step 4: Decide if You Need a Second Dose 1. If your symptoms have not improved within about 5 minutes since the first injection, you need a second injection. Begin Step If a second dose is not needed, throw away the unused medication as directed. Go to Step 6 for disposal directions.

4 Step 5: Inject the Second Dose 1. Put the needle into your thigh (upper leg), through your skin, as shown. 2. Push the plunger down all the way. 3. Remove Twinject from your skin. Step 6: Proper Disposal 1. Bend the needle back against a hard surface and then put the syringe, needle first, into the carrying case. 2. Put on the other half of the case. 3. Get emergency medical help right away. 4. Give your used Twinject to a healthcare worker for proper disposal. Do not throw away in a regular trash can. Tips for Storing Twinject Keep at room temperature; do not refrigerate, and protect from freezing Keep out of direct sunlight, hot cars, and extreme cold Check the expiration date, and note it on a calendar Discard properly after use EPIPEN TRAINER Directions For Use PRACTICE INSTRUCTIONS -- Never put thumb, fingers, or hand over black tip. 1) Familiarize yourself with the blue TRAINER. 2) Grasp unit, with the black tip pointing downward. 3) Form fist around the unit (black tip down). 4) With your other hand, pull off the gray activation cap. 5) Hold black tip near outer thigh. 6) Swing and jab firmly into outer thigh (listen for click ) so that unit is perpendicular (at a 900 angle) to the thigh. 7) Hold firmly in thigh for several seconds. 8) Replace gray activation cap. Note: When practicing, the click tells you that the TRAINER worked properly. 9) Practice again: -- be sure gray activation cap is in place -- repeat steps #2-8 (until you are fast & accurate)

5 Each Practice Session -- Follow Practice Instructions above -- Repeat procedure many times, until you are fast & accurate -- Re-read: -- the TRAINER instructions for use -- Patient Insert sheet for EPIPEN /EPIPEN JR -- Inspect your EPIPEN /EPIPEN JR unit (yellow/white label) for solid particles or discoloration. Replace if either is present. -- Check the expiration date on your EPIPEN /EPIPEN JR (yellow/white label) -- Repeat this practice every few months Train Others -- Consider who might help in an emergency (e.g., parent, teacher, friend) -- Before an emergency occurs, have them: -- use the TRAINER to practice -- read these instructions & the Patient Insert (do NOT remove until ready to use) CAUTION There are important differences between the TRAINER and EPIPEN /EPIPEN JR: The Unit Itself Color of unit label...blue...yellow/white Contains drug product?...no...yes Contains needle?...no...yes Has expiration date?...no...yes Using the Unit Reusable?...Yes...No (use once only) OK to remove-&-replace gray cap?...yes...no (remove cap once- just before use) Hear click when used?...yes...no Pressure needed to activate unit?...moderate...strong

6 The following list of resources can help your patients learn more about anaphylaxis. Your patients can view these useful Web sites that discuss topics such as managing allergies at school, food allergies, finding a doctor, as well as general information relevant to all people with allergies. Allergies at School Managing allergies and asthma at school: tips for school teachers and staff University of Iowa Health Care Available at: Access the Virtual Children's Hospital section. This Web site is externally peer-reviewed by the National Institute of Allergy and Infectious Diseases. It was created in May 1995, and the last revision date was December Advocacy for proactive management of allergies and asthma in school settings National Association of School Nurses Available at: The position statements on students with special health needs and individual health plans are especially helpful to parents of children with severe allergies. These positions advocate empowering school nurses to respond appropriately to anaphylaxis, as well as to other health crises. Allergies and school The Food Allergy & Anaphylaxis Network (FAAN) Available at: FAAN is a nonprofit organization whose mission is to raise public awareness, to provide advocacy and education, and to advance research on behalf of all those affected by food allergies and anaphylaxis. Its frequently updated Web site includes information about common food allergens, anaphylaxis, advocacy efforts, resources for school, recipes, and Special Allergy Alerts." Resources for parents and teachers on keeping kids with allergies and asthma safe at school Allergy & Asthma Network Mothers of Asthmatics Available at: Visit Breatherville, USA, an online town where learning about asthma and allergies is a positive experience! Inside the School House, parents, teachers, and school administrators find helpful tips for managing allergies and asthma in the classroom, in the lunchroom, and on the playground. Food Allergies The Food Allergy and Anaphylaxis Network (FAAN) Available at: Supported by an educational grant from Kraft Foods, this Web site contains information about food allergy, food allergy research, FAAN activities, updates, daily tips, product alerts, and ordering information. The Web site's mission is " to increase public awareness about food allergies and anaphylaxis, to provide education, and to advance research on behalf of all those affected by food allergies." International Food Information Council Foundation (IFIC) Available at:

7 This site contains numerous documents regarding food safety and food allergy, all accessible through a searchable database. Center for Food Safety and Applied Nutrition Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) Available at: vm.cfsan.fda.gov/list.html An overview, recent news, program areas, and national food safety programs are available from the home page. There are alerts on mislabeling, and some practical advice on preventing children from being accidentally exposed to foods to which they are allergic. Peanut Allergy.com Owned and managed by people with peanut allergies, Chris and Patti Papkee. Available at: This Web site is a patient resource. It contains links to peanut-free businesses, chat rooms on issues of concern, products, school discussion boards, books, a newsletter, and information on how site visitors can help. The site includes a questionnaire for educational purposes, as well as a call for study volunteers. It also provides a link to EpiPen epinephrine auto-injector instructions for use. Tips for managing food allergies Allergy & Asthma Network Mothers of Asthmatics Available at: Visit Breatherville, USA, an online town where learning about asthma and allergies is a positive experience! At the Breatherville Farmer's Market, you'll learn what causes food allergies and how to manage them. Latex Allergy American Latex Allergy Association (A.L.E.R.T.) Available at: A.L.E.R.T. (which actually stands for Allergy to Latex Education and Resource Team) designed this Web site to help connect latex allergy patients with educational materials, support groups, publications, and product information. The mission of this national nonprofit organization is to assist in the understanding and management of natural rubber latex allergy. Finding a Doctor Physician Referral Directory American Academy of Allergy, Asthma and Immunology Available at: In addition to its online Physician Referral Directory, this site offers an array of links to various subjects and sites, including a Topic of the Month, the Allergy & Asthma Disease Management Center, information on best practices for pediatric asthma, recall information, training programs for professionals, and the Journal of Allergy & Clinical Immunology. How do I find an allergist? Allergy, Asthma & Immunology Online Available at: This Web site, maintained by the American College of Allergy, Asthma & Immunology (ACAAI), offers an Allergist Locator that lets you enter a street address and/or ZIP code to get a list of nearby allergists with their addresses and phone numbers, as well as driving distances and maps to their offices. How to find a good doctor Allergy & Asthma Network Mothers of Asthmatics Available at:

8 Visit Breatherville, USA, an online town where learning about asthma and allergies is a positive experience! Stop by the Medical Center for tips on how to find a good doctor, when to see a specialist, and how to work with your physician. And you can use the Physician Locator to find an AANMA member physician near you. General Allergy Information Allergy & Asthma Disease Management Center American Academy of Allergy, Asthma and Immunology (AAAAI) Available at: The AADMC Web site, according to its mission statement, "has been constructed to provide timely, practical and important information to physicians from a wide variety of backgrounds and clinical practice. The AADMC is designed to be interactive." American Academy of Pediatrics (AAP) American Academy of Pediatrics Available at: The You and Your Family section of the AAP Web site offers a Parent Resource Guide, immunization information, tips on safety and injury prevention, and more. The Research area provides links to authoritative documentation that can help parents advocating enhanced care for their children. Columbia College of Physicians and Surgeons (CMPC) Available at: cpmcnet.columbia.edu/texts Click on the Complete Home Medical Guide link (in the Resources section) for comprehensive information on a range of health topics, including allergies. It's not a bracelet, it's a lifeline. Wear it! MedicAlert Available at: The MedicAlert program can be a boon to patients at increased risk for anaphylaxis. MyAllergy Protocol Driven Health Care Available at: This Web site offers information based on guidelines issued by the American Academy of Allergy, Asthma and Immunology and the American College of Allergy, Asthma & Immunology. The Food Allergy and Anaphylaxis Network (FAAN) Available at: Supported by an educational grant from Kraft Foods, this Web site contains information about food allergy, food allergy research, FAAN activities, updates, daily tips, product alerts, and ordering information. The Web site's mission is " to increase public awareness about food allergies and anaphylaxis, to provide education, and to advance research on behalf of all those affected by food allergies." Learn about allergies and asthma in Breatherville, USA TM! Allergy & Asthma Network Mothers of Asthmatics Available at: Visit Breatherville, USA, an online town where learning about asthma and allergies is a positive experience! Take a free class at America's College of Allergy & Asthma, solve pet allergy woes at the Pet Shop, coordinate your little one's care at the Childcare Center, pick up allergy-proofing tips at Home Sweet Home, or learn about medications and devices at the Pharmacy. In all, Breatherville boasts 12 such destinations, as well as a Play Time area for kids.