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Anaphylaxis Management:  Problems with the Current Paradigm and the need for a Fail-Safe System for IM Epinephrine Delivery.  Epi-Port Auto-Injector is Designed for Compliance, Simplicity, and Accuracy and use is Intuitive  TTP (Twist, Turn, Push).
 

Anaphylaxis Management: Problems with the Current Paradigm and the need for a Fail-Safe System for IM Epinephrine Delivery. Epi-Port Auto-Injector is Designed for Compliance, Simplicity, and Accuracy and use is Intuitive TTP (Twist, Turn, Push).

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Michael Langan, MD ...

Michael Langan, MD
Geriatrician, MGH Senior Health
September 10, 2012

Epi-Port (cartridge housing, portable, fashionable, easy to use)
Epi-Pod (cartridge, removable, replaceable)

A new drug delivery system for treatment of anaphylactic shock

Twist, Turn, Push (TTP)

From concept to patent to market


1:30P.M.-2:30P.M.
Fox Hill Village Auditorium


Sponsored by the MGH Wellness Center


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  • As you approach the patient some of these generalized findings will be obvious.
  • Gallagher M, Worth A, Cunningham-Burley S, Sheikh A. Epinephrine auto-injector use in adolescents at risk of anaphylaxis: a qualitative study in Scotland, UK. ClinExp Allergy. Jun 2011;41(6):869-877.
  • The study population included persons with a high degree of severity of food-induced allergic disease, with numerous food allergies, and frequent and severe reactions. Even in this high risk group compliance compliance was poor. Sampson MA, Munoz-Furlong A, Sicherer SH. Risk-taking and coping strategies of adolescents and young adults with food allergy. J Allergy ClinImmunol 2006;117:1440-5.

Anaphylaxis Management:  Problems with the Current Paradigm and the need for a Fail-Safe System for IM Epinephrine Delivery.  Epi-Port Auto-Injector is Designed for Compliance, Simplicity, and Accuracy and use is Intuitive  TTP (Twist, Turn, Push). Anaphylaxis Management: Problems with the Current Paradigm and the need for a Fail-Safe System for IM Epinephrine Delivery. Epi-Port Auto-Injector is Designed for Compliance, Simplicity, and Accuracy and use is Intuitive TTP (Twist, Turn, Push). Presentation Transcript

  • { Anaphylaxis Management: Problems with the Current System The EpiPort® Epinephrine Auto-Injector Michael Langan, M.D.
  •  1st recorded 2640BC in hieroglyphics  bee sting of a pharoah  First described Portier and Richet 1902  “Without protection”  “ana” - against  “prophylaxis” - protection  Profound shock & subsequent death in dogs after 2nd challenge with a foreign antige  Characterized by explosive release of mediators by mast cells mediated by IgE Anaphylaxis
  • Anaphylaxis An acute systemic allergic reaction The result of a re-exposure to an antigen that elicits an IgE mediated ic response Usually caused by a common environmental protein that is not intrinsically harmful Often caused by medications, foods, and insect stings It is a Type I hypersensitivity
  •  Allergic Reaction  An exaggerated response by the immune system to a foreign substance  Anaphylaxis  An unusual or exaggerated allergic reaction  A life-threatening emergency Allergies and Anaphylaxis
  • { ANAPHYLAXIS Common Causes •Foods, such as Peanut •Tree nuts, i.e. almonds, walnuts, hazel, brazil, and cashew nuts. •Shellfish, i.e. shrimp and lobster •Dairy Products •Eggs •Insect stings, i.e. wasps, bees, ants •Latex •Medications •Exercise
  • Frequency of symptoms in Anaphylaxis Urticaria/angioedema 88% Upper airway edema 56% Dyspnea or wheeze 47% Flush 46% Dizziness, hypotension, syncope 33% Gastrointestinal sx 30% Rhinitis 16%
  • Anaphylaxis- is an acute life-threatening reaction caused by an IgE-mediated reaction and results from the sudden systemic release of mast cells and basophil mediators .
  • Clinical Manifestations of Anaphylaxis  Skin: Flushing, pruritus, urticaria, angioedema  Upper respiratory: Congestion, rhinorrhea  Lower respiratory: Bronchospasm, throat or chest tightness, hoarseness, wheezing, shortness of breath, cough
  • Symptoms that can occur during an Allergic or Anaphylactic Reaction  Skin: Hives, swelling, itchy red rash  Gut:Cramps, nausea, vomiting, diarrhea, gas  Neuro: Weakness, impending doom feeling  Respiratory: Itchy, watery eyes; runny nose; stuffy nose; sneezing; cough; itching or swelling of lips, tongue or throat; changes in voice; difficulty swallowing; tightness in chest; wheezing; shortness of breath; repetitive throat clearing.  Cardiovascular: reduced blood pressure, increased heart rate, shock, pale and sweaty. Common sites for allergic reactions Mouth (swelling of the lips, tongue, itching lips) Airways (wheezing or breathing problems Digestive tract (stomach cramps, vomiting, diarrhea) Skin (hives, rashes, or eczema)
  • -Sudden, rapid, and unexpected -historically occurred in health care setting -76% of food related deaths due to foods outside the home -foods, medications, insect stings  150-200 fatalities  Death caused by respiratory compromise or cardiovascular collapse Under-recognized Underreported Undertreated Poorly Understood
  • Its typical explosive onset and unforeseen nature of severity is frightening
  • Anaphylaxis Fatalities  Estimated 500–1000 deaths annually  1% risk  Risk factors:  Failure to administer epinephrine immediately  Peanut, Soy & tree nut allergy (foods in general)  Beta blocker, ACEI therapy  Asthma  Cardiac disease  Rapid IV allergen  Atopic dermatitis (eczema)
  • The first documented case of a food fatal reaction was described in 1926 by a pediatrician. A 1 -year- old boy with atopic eczema experienced three episodes of generalized allergic reactions at home after intake of a few spoons of mashed peas. In the hospital setting an oral challenge with carrots/mashed peas was performed under the supervision of a chief nurse. Immediately after the intake of the test meal the child developed angioedema, cyanosis and collapsed. He died despite emergency treatment.
  •  Most knew they were allergic to causative food  Peanuts and tree nuts most common foods (90%)  Individual did not ask about ingredients, were misinformed or incorrect labeling of product  Most patients had a diagnosis of asthma even if well controlled  Injectable epinephrine was not carried or administered in a timely fashion  Skin reactions (hives, swelling) mainly absent in these severe reactions Fatal anaphylaxis
  • Epinephrine = The only medication that can stop the progression of anaphylaxis and reverse the symptoms. Effect immediate .
  • The events leading up to fatal anaphylaxis are unseen and unpredictable. 1. Occurs in the absence of medical professionals (school, restaurant) 2. Interval between exposure to allergen and death 10-15 minutes for insect stings and 25-30 minutes for food induced. 3. Most fatalities in teenagers and young adults 4. Can occur on first exposure 5. IM epinephrine drug of choice. No alternative.
  •  Epinephrine (adrenaline) is the drug of choice in the treatment of anaphylaxis.  There is no other medication with a similar effect on the many body systems that are potentially involved in anaphylaxis.  Epinephrine narrows blood vessels and opens airways in the lungs. These effects can reverse severe low blood pressure, wheezing, severe skin itching, hives, and other symptoms of an allergic reaction.  The first step in the management of anaphylaxis is the subcutaneous or intramuscular injection of 0.01 ml/kg of aqueous epinephrine 1:1000 (maximal dose 0.3 to 0.5 ml or 0.3-05 mg).
  • Epinephrine is the medication of choice for treating an anaphylactic episode . The recommended dose of epinephrine is 0.01 mg/kg I.M to as much as 0.3 mg-in children, and it may be repeated within 5 minutes if symptoms worsen or severe symptoms persist. (1:1,000 aqueous solution (1 mg/mL) ). The lateral aspect of the thigh appears to be the optimal location of administration. There are 2 doses of self –injectable epinephrine : Epipen jr 0.15mg , Epipen 0.3mg. Use of I.V should be reserved for the most extreme conditions ( more adverse reaction). The more advanced the anaphylactic reaction- development of hypotension- the less likely epinephrine is to reverse the reaction.
  •  Treats all symptoms of anaphylaxis and prevents progression  Intramuscular injection in lateral thigh produces most rapid rise in blood level  0.01 mg/kg in children, 0.3-0.5 mg in adults  Patients who receive epinephrine and have symptoms other than hives should be lying down with feet elevated (empty heart syndrome)  Up to 20% of time, more than one dose needed  New recommendations: have 2 or more devices Epinephrine
  • Epipen The epinephrine auto-injector was introduced in 1980. Epinephrine auto-injectors such as EpiPen and EpiPen Jr. contain 0.3 and 0.15 mg of epinephrine respectively and are designed for single dose intramuscular injection for emergency treatment of anaphylaxis.
  • { EpiPen and Twinject How to Administer EpiPenTwinject
  • Epinephrine Allows time to safely transport the patient to a medical facility. The risk to benefit ratio is overwhelmingly favorable. In the year 2000 there were only 7 states that allowed first responders to carry and administer epinephrine.
  • VASTUS LATERALIS
  • Vastus Lateralius
  • { Intramuscular injection of epinephrine is preferable to subcutaneous administration I because of the faster and higher rate of absorption in the muscle.
  • Fear of needles may also play a role
  • { EpiPen and Twinject How to Administer EpiPenTwinject
  • { EpiPen and Twinject How to Administer EpiPen & Twinject 1.Obtain patient’s prescribed auto-injector Esure: a. Prescription is written for the patient who is experiencing the severe allergic reaction or your protocols permit carrying the auto-injector on the ambulance. b. Medication is not discolored (if visible) 2.Obtain order from medical direction, either on-line or offline. 3.Remove safety cap(s) from auto-injector 4.Place tip of auto-injector against patient’s thigh. a. Lateral portion of the thigh b. Midway between waist and knee 5.Push the injector firmly against the thigh until the injector activates. 6.Hold the injector in place until the medication is injected (at least 10 seconds). 7.Record activity and time. 8.Dispose of a single-dose injector, such as the EpiPen, in a biohazard container. Save a two-dose injector, such as Twinject, and transport it with the patient in case the second dose is later required.
  •  Can deliver only a single dose –One chance  Accidental misfires common (digital auto-injection)  Poor compliance (not carried, fear of using)  Counterintuitive design  Complex instructions  Needle length inadequate in up to 1/3 of patients  May require second dose (probable secondary to needle length)  Inconvenient portability, unappealing, not designed for active lifestyle Problems with current Auto-Injector technology
  • No Feedback Loops
  • Patient-Doctor Relationship minimal Not amenable to EBM Faulty Mental Models Does not conform to acute or chronic disease History, treatment, and outcome are binary options.
  • No evidence based studies (logistical and ethical reasons) Lack of feedback
  • Something you buy but hope you never have to use (airbag, smoke detector) No positive or negative feedback
  • Digital Auto-injection Counter-intuitive Design
  • In teenagers, failure to carry epinephrine varied 1.perceived risk of reactions 2. social circumstances 3. convenience of carrying. Many teenagers expressed desire for a less bulky design in a 2011 study looking at adolescents attitudes towards and experience with epinephrine auto-injectors.
  •  Risk-taking behaviors varied by social circumstances, convenience, and perceived risks. Compliance with carrying an epinephrine auto- injector was poor.  61% reported that they “always” carry frequencies varied with activity  : traveling (94%)  restaurants (81%)  friends’ homes 67%),  school dance (61%),  wearing tight clothes (53%), and  sports (43%).45 Survey: Adolescents and young adults at high risk for fatal anaphylaxis due to food allergens
  • Myth: Epinephrine is Dangerous REALITY:  Risks of anaphylaxis far outweigh risks of epinephrine administration  Minimal cardiovascular effects in children (Simons et al, 1998)  Caution when administering epinephrine in elderly patients or those with known cardiac disease
  • Twist, Turn, Push TTP