Anaphylaxis Management: Problems with the Current Paradigm and the need for a Fail-Safe System for...

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Anaphylaxis Management

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

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ANAPHYLAXISCommon 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 inAnaphylaxis

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-recognizedUnderreportedUndertreatedPoorly 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 adults4. Can occur on first exposure5. 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. 

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EpiPen and TwinjectHow 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

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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

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EpiPen and TwinjectHow to Administer

EpiPenTwinject

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EpiPen and TwinjectHow to Administer

EpiPen & Twinject1.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-injector4.Place tip of auto-injector against patient’s thigh.

a. Lateral portion of the thighb. 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 currentAuto-Injector technology

No Feedback Loops

Patient-Doctor Relationship minimalNot amenable to EBMFaulty Mental ModelsDoes 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 reactions2. social circumstances3. 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, PushTTP