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11/12/2012 1 1 Anaphylaxis Screening and Protection Program Development and Support This webinar was developed by the American Pharmacists Association and supported by an independent educational grant from Mylan Specialty L. P. Speakers and Disclosures Philip Johnston, PharmD Professor and Dean Belmont University College of Pharmacy Elisa Greene, PharmD Assistant Professor, Pharmacy Practice Belmont University College of Pharmacy The speakers and APhA’s education staff declares no conflicts of interest or financial interests in any product or service mentioned in this activity, including grants, employment, gifts, stockholdings, and honoraria. For complete staff disclosures, please see the Education and Accreditation Information section at www.pharmacist.com.

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Page 1: Anaphylaxis Screening and Protection Programelearning.pharmacist.com/Portal/Files/LearningProducts/...because presentation and treatment are identical Most commonly peanuts, milk,

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1

1

AnaphylaxisScreening

and Protection Program

Development and Support

This webinar was developed by the American

Pharmacists Association and supported by an independent educational grant from

Mylan Specialty L. P.

Speakers and Disclosures

Philip Johnston, PharmDProfessor and Dean

Belmont University College of Pharmacy

Elisa Greene, PharmDAssistant Professor, Pharmacy PracticeBelmont University College of Pharmacy

The speakers and APhA’s education staff declares no conflicts of interest or financial interests in any product or service mentioned in this activity, including grants, employment, gifts, stockholdings, and honoraria. For complete staff disclosures, please see the Education and Accreditation Information section at www.pharmacist.com.

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Accreditation Information

The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education (CPE). This activity, Anaphylaxis Screening and Protection is approved for 1.5 hours of CPE credit (0.15 CEUs). The ACPE Universal Activity Number assigned by the accredited provider is 0202-0000-12-255-L04-P for pharmacist and 0202-0000-12-255-L04-T for technicians.

To obtain CPE credit for this activity, participants will be requires to actively participate in the entire webinar and complete an online evaluation and assessment located at www.pharmacist/com/live-activities by November 27, 2012. Instructions and an attendance code will be provided at the completion of the webinar.

Target audience: Pharmacist and Technicians

ACPE Activity Type: Knowledge-based

Learning Level: 2

Initial Release Date: November 13, 2012

Recall the pathophysiology, clinical presentation, and treatment of anaphylaxis.

Identify factors that increase a person’s risk of experiencing anaphylaxis as well as factors that increase the severity of anaphylaxis.

Outline a comprehensive strategy for preventing and treating episodes of anaphylaxis in the community setting.

Explain the appropriate use of epinephrine auto-injectors and identify errors commonly made by patients.

Prepare an emergency action plan for an individual patient at risk of anaphylaxis and counsel the patient on implementing the plan.

Learning Objectives for Pharmacists

Define the term “anaphylaxis,” list common symptoms, and identify key elements of anaphylaxis treatment.

Name factors that increase a person’s risk of experiencing anaphylaxis as well as factors that increase the severity of anaphylaxis.

Describe the elements of a comprehensive strategy for preventing and treating episodes of anaphylaxis in the community setting.

Explain the appropriate use of epinephrine auto-injectors and identify errors commonly made by patients.

Summarize the usual components of an emergency action plan for an individual patient at risk of anaphylaxis.

Learning Objectives for Technicians

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Only 1 does of epinephrine should be used to reverse a severe allergic reaction or anaphylaxis event?

True

False

When should an epinephrine autoinjector be replaced?

a.If it was obtained more than 6 months ago.

b.If it will expire before the patient can return to the pharmacy for a replacement.

c.After it has expired.

d.It does not need to be replaced unless it has been used.

Side effects of epinephrine include:

a.Palpitations and difficulty breathing

b.Dizziness and lightheadedness

c.Leg weakness

d.Nausea

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Roy Petrey is a 32-year-old male with a history of allergic reactions

Through trial and error, he has eliminated multiple possible causes, such as dust, grass, and animal dander

The most recent incident included complete body rash, facial swelling, and bronchospasm

Introduction to Patient Case

Definition◦ “A severe and sometimes fatal allergic reaction that is

characterized by hives, itching, respiratory difficulty, and shock; this condition requires immediate medical attention”◦ “A severe, life-threatening, generalized or systemic

hypersensitivity reaction that is characterized by rapidly developing life-threatening airway and/or breathing and/or circulation problems usually associated with skin and mucosal changes”

Anaphylaxis Overview

Highly likely when any one of the following 3 criteria are fulfilled:

◦ 1. Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, or both (e.g., generalized hives, pruritus or flushing, swollen lips-tongue-uvula) AND AT LEAST ONE OF THE FOLLOWING A. Respiratory compromise

B. Reduced Blood Pressure or symptoms of end-organ dysfunction

Clinical Criteria for Diagnosis of Anaphylaxis

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◦2. Two or more of the following that occur rapidly after exposure to a likely allergen for that patient (minutes to several hours): A. Involvement of the skin-mucosal tissue

B. Respiratory compromise

C. Reduced BP or associated symptoms

D. Persistent gastrointestinal symptoms

Clinical Criteria for Diagnosis of Anaphylaxis

◦3. Reduced blood pressure after exposure to known allergen for that patient (minutes to several hours): A. Infants and children: low systolic blood pressure (age specific)

or >30% decrease in systolic blood pressure

B. Adults: systolic blood pressure of <90 mm Hg or >30% decrease from that person’s baseline

Clinical Criteria for Diagnosis of Anaphylaxis

Overall incidence◦ Estimates range widely◦ Up to 49.8 per 100,000 person years◦ Up to 10.5-70 per 100,000 person years in those <19

years

Compare to colorectal cancer◦ 52.7 per 100,000 person years (males)◦ 39.7 per 100,000 person years (females)

Anaphylaxis Incidence

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Admissions rate for anaphylactic shock◦ 3.8 cases per 100,000 hospital admissions

Emergency room visits◦ 71% of patients present to ED or urgent care ◦ Of these, only 11% required hospitalization

Inpatients◦ 1 in 3,000 inpatients in US has an anaphylactic reaction

Anaphylaxis Statistics

Ages ◦ Peak occurrence: 15-55 years◦ Mean age 29 years, highest rates in <20 years

Gender◦ 56% female

Epinephrine prescriptions ◦ More in men if <15 years◦ More in women if >15 years

Anaphylaxis Statistics

Season◦ Peak: July-Sept (stings)

Geographic region◦ More in North/East vs South/West

Deaths ◦ 1,443-1,503 deaths per year (0.002%)

Anaphylaxis Statistics

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Anaphylaxis: IgE mediated ◦ First exposure: sensitization◦ Subsequent exposure: release of inflammatory mediators

(e.g., histamine, cytokines)

Anaphylactoid: Non-IgE mediated ◦ May occur after first exposure

Pathophysiology

Note: Distinction not recommended because presentation and treatment are identical

Most commonly peanuts, milk, eggs, tree nuts, shellfish, soy, fish, wheat, sesame seed

Usually immediate although may be delayed or return

Common Triggers: Food

Antibiotics◦ Penicillin most common medication cause

NSAIDs or ASA◦ 2nd most common◦ May be med specific

Other medications◦ Radio contrast media◦ IV anesthetics◦ Opioid analgesics◦ Omalizumab All patients should have epinephrine Rx

Common Triggers: Medications

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Insect venom◦ Most commonly Hymenoptera order – honeybees,

bumblebees, sweat bees, yellow jackets, hornets, wasps, ants

Latex

Exercise

Idiopathic

Autoimmune

Other Common Triggers

Food 33.2%

Insect sting 18.5%

Medication 13.7%

Contrast 0.5%

Other known 9 %

Unknown 25.1%

Incidence

Typical ◦ Exposure to trigger May not be identified

◦ Rapid onset of symptoms◦ Resolves within minutes to hours Spontaneous or with medical attention

Less likely◦ Delayed onset◦ Prolonged duration◦ Biphasic reaction

Clinical Presentation

May vary between people

and between episodes!

May vary between people

and between episodes!

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Most frequently encountered signs/symptoms◦ Mucocutaneous 94%◦ Respiratory 88%◦ Gastrointestinal 22%◦ Cardiovascular 21%

Early signs/symptoms◦ Flushing◦ Urticaria

Clinical Presentation

Recurrence after remission of initial symptoms ◦ Maximum incidence 20%◦ Variable severity◦ Difficult to predict◦ May require second dose

Increased likelihood with:◦ Delay in epinephrine ◦ Inadequate epinephrine◦ Need for large amounts of epinephrine

Biphasic Reactions

Mucocutaneous Respiratory Cardiovascular Gastrointestinal Other

Pruritis Congestion Hypotension Nausea Weakness

Flushing Sneezing Vascular collapse Vomiting Dizziness

Angioedema Bronchospasm Shock Abdominal cramps

Urticaria Upper respiratory obstruction•Dyspnea•Stridor•Wheezing•Throat tightness•Aphonia

Arrest Diarrhea

Arrhythmias

Syncope or pre-syncope

Chest pain

Increased vascular permeability

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◦ Diffuse urticaria 51.2%◦ Local angioedema 48.8%◦ Dyspnea 48.8%◦ Pruritis 48.3%◦ Throat tightness/fullness 39.8%◦ Flushing 38.4%◦ Tachycardia 35.6%◦ Wheezing/bronchospasm 26.5%◦ Emesis 18.0%◦ Local urticaria 17.1%

Most Common Symptoms

Dyspnea/difficulty breathing 48.8%

Intra-oral angioedema 15.6%

Hypotension 12.3%

Oro/hypo-pharyngeal edema 10.9%

Arrhythmia 6.6%

Syncope 6.6%

Diffuse angioedema 6.2%

Cyanosis 5.2%

Laryngeal edema 4.3%

Shock 1.0%

Severe Symptoms

RP has determined that his most recent allergic reaction was actually anaphylaxis◦ Skin testing has revealed an allergy to beef protein

RP has been educating himself about trigger avoidance but is worried and fearful about future episodes of anaphylaxis

RP calls and asks if you can talk him through what might happen if he needs to be treated again

The Case of Mr. Petrey

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First line therapy◦ Epinephrine first and always!

Management of Acute Anaphylaxis

http://www.epipen.com/about-epipen [Accessed 08/31/2012]http://www.auvi-q.com/ [Accessed 09/13/12]

Second-line therapy◦ Antihistamines Symptomatic for urticaria, angioedema and pruritis May use H1 + H2

◦ Systemic corticosteroids May prevent protracted or biphasic reaction

Management of Acute Anaphylaxis

Sample Regimen:

Diphenhydramine 25-50 mg

Ranitidine 300 mg

Methylprednisolone 1-2 mg/kg

*or equivalents

Third-line therapy◦ Bronchodilators◦ Supportive measures Oxygen Fluid resuscitation Vasopressors Glucagon

Positioning ◦ Remain recumbent (unless vomiting/SOB prevents)◦ Legs elevated

It is not recommended to induce vomiting

Management of Acute Anaphylaxis

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Observe patient after initial event ◦ Recommended: 8 hours ◦ Longer if more severe◦ Caution in patients with reactive airway disease More fatalities

At discharge◦ Prescription: epinephrine auto-injector ◦ Education: avoidance if trigger known◦ Follow-up: notify PCP/refer to allergist

Management of Acute Anaphylaxis

That was awful—am I ever going to have to do it again?

You really want me to give myself a shot?

The Case of Mr. Petrey

Access◦ Epinephrine auto-injector is not available◦ Not prescribed◦ Not on their person◦ Not able to use epinephrine auto-injector◦ Regulatory restrictions (schools, day care. etc.)

Fear◦ Needle◦ Adverse effects

Denial◦ Recognition of reaction◦ Severity of reaction

Behavioral Barriers

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“I had plenty of auto-injectors available, but that time the symptoms were different…it wasn’t until we got into the car (that) I suddenly thought, ‘no, this is the same thing.’”

“I thought I was having an asthma attack; I thought if I had anaphylactic shock I would be throwing up, because that’s what I did when I was little.”

“I didn’t realize that I could use it if I was just going into the reaction. You don’t know if you should take it now or wait until it develops and see how it goes. Are you bad enough to use it, that’s the big issue…”

Behavioral Barriers

Self-education◦ Food labels “May contain”

◦ Eating out◦ Travel

Vigilance

Parental role◦ Educating child on trigger avoidance◦ Reinforcement ◦ Gradual hand over of responsibility/management to

adolescent

Overcoming Barriers

Psychosocial Impact

“I think if you have experienced an anaphylactic shock and you know what it’s like. Very, very frightening…the second time he had an anaphylactic reaction he hardly ate for 6 months.”

—Parent of child with anaphylaxis

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“Quite a lot of my friends go and kiss boys and things and it’s kind of awkward for me because I’ll have to kind of ask have you eaten nuts. And you can’t really do that in a club…”

Psychosocial Impact

After discussing treatment of acute anaphylaxis, RP feels reassured and is confident he can overcome any of the barriers he is facing

He asks if he is at high risk for experiencing a future episode—if so, is there anything he can do to prevent it?

The Case of Mr. Petrey

Previous episode: greatest predictor of future event ◦ Within 10 years:◦ Median 395 days◦ Range 7 days to 13 years later

Atopic history: present in 54%-60% of patients◦ i.e. Asthma, allergic rhinitis, atopic dermatitis, hives ◦ More likely if food-induced or idiopathic

Identifying Patients at Risk

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Patient age

Concomitant disease states◦ Asthma◦ Allergies to anaphylaxis-causing substances◦ Heart Disease

Medications◦ Beta blockers, alpha blockers (block epinephrine activity)◦ ACE inhibitors, ARBs (may interfere with endogenous

compensatory responses)

Identifying Patients with Increased Severity

Identify and avoid patient-specific triggers

Manage relevant comorbidities

Assess benefits, risks of concurrent meds

Assess need for prophylactic therapy◦ Trigger not identified or not avoidable◦ Consider: H1 and/or H2 antagonist Leukotriene modifier Corticosteroids

Consider immunomodulation ◦ Venom-induced anaphylaxis

Preventing Anaphylaxis

ACE inhibitors

ARBs

Beta blockers

Alpha blockers

Cocaine

Amphetamines

Tricyclic antidepressants

Monoamine oxidase inhibitors

Epinephrine Drug Interactions

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Has RP eliminated all possible allergens to protect himself from future episodes of anaphylaxis?

What education does RP require to be prepared for the future?◦ Hint: He has never used an epinephrine auto-injector

What are the elements of a complete emergency plan?

The Case of Mr. Petrey

Also known as adrenaline

Mechanism of action◦ Alpha and beta adrenergic agonist

Therapeutic effects ◦ Vasoconstriction◦ Bronchodilation◦ Decreased mucosal edema◦ Decreased release of mast calls, basophils, tryptase,

histamine◦ Increased myocardial output and contractility

Autoinjectable Epinephrine

Adverse effects◦ Anxiety◦ Tremor◦ Headache◦ Difficulty breathing◦ Palpitations (could be drug or disease)

Contraindications◦ None!

Autoinjectable Epinephrine

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Delivery systems◦ EpiPen◦ Auvi-Q◦ No longer marketed: Twinject, Adrenaclick

Available in 0.15 mg or 0.3 mg doses◦ Weight-based dosing: If 10-25 kg: give 0.15 mg If >25 kg: give 0.3 mg

Route of administration: intramuscular

Autoinjectable Epinephrine

Site of administration: anterior lateral thigh◦ Inject through clothing

May repeat every 5-15 minutes

If in doubt, administer!

13% required >2 doses

Autoinjectable Epinephrine

Both doses are available as auto-injections◦ EpiPen – Yes Auvi-Q – Yes

Needle left exposed after auto-injection◦ EpiPen – Yes Auvi-Q – No

Second dose can be saved and used later◦ EpiPen – Yes Auvi-Q - Yes

Trainer device is included◦ EpiPen – Yes Auvi-Q - Yes

Autoinjectable Epinephrine Comparison

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[NOTE

Autoinjector Administration Technique

1

2

3

4

Common adverse effects◦ Anxiety◦ Tremors◦ Pallor◦ Tachycardia

10 seconds may feel like eternity

Should feel improvement within 5-10 minutes

What to Expect After Administration

You receive a call from an EMT en route to the emergency room with RP, who appears to be having an acute cyanotic episode◦ The EMT has found the pharmacy telephone number on a

prescription for a metered dose inhaler in RP’s hand

The EMT asks you what other medications RP is getting and if you have a history that would help them manage RP

On questioning you find that they do not know of RP’s history of anaphylaxis!

The Case of Mr. Petrey

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The EMT determines that RP has already self administered an epinephrine auto-injector

Based on patient reaction and vital signs, the EMT administers an additional dose (0.3mg) of epinephrine en route to the nearest ED

RP is given supportive treatment and kept for observation, but makes a full recovery

The Case of Mr. Petrey

RP arrives in your pharmacy and asks for you by name

He shakes your hand and thanks you for “saving his life” during his recent ambulance ride

You assure him that you are happy to assist and that keeping all of his records in one pharmacy helped his chances of having a complete medication history available for the EMT

RP states that he will always keep his emergency action plan on his person, and needs to acquire an emergency ID bracelet

The Case of Mr. Petrey

Emergency action plan ◦ Information necessary for urgent care◦ Instructions for family, others

Emergency preparedness◦ Medical alert bracelet◦ Vigilance and education

Emergency Action Plan

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Practice Improvements◦ Keep all brands of epinephrine necessary for your

clientele◦ Keep emergency plan forms for patient education◦ Offer patients a method of purchasing a medical

emergency identification◦ Consider collaborative drug therapy management

agreement with allergist of primary care physician◦ Administer epinephrine and call 911 in patient presenting

with anaphylaxis

Tips for Pharmacists

Educate!◦ patients, parents, teachers, and others 46% of people contacted friend or family member first when

they had severe reactions Counsel on secondary treatments and preventive measures,

as necessary Teach proper use, storage and administration of epinephrine Review product insert/instructions with patients Avoid excessive heat or cold Remind about intramuscular injection Replace if submersed in water Inspect regularly for changes in color or clarity

Tips for Pharmacists

Alleviate patient fears◦ Provide necessary, patient specific information◦ Assure them this is a manageable situation◦ Address psychosocial barriers

Help resolve access barriers◦ Physician collaboration for initial prescription◦ Second prescription for keeping at school or work◦ Prescription renewal/expiration reminders

Tips for Pharmacists

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Provide support◦ Offer to help complete the patient emergency plan Suggest who should be informed and trained

◦ Give the patient your contact information for follow up information with a copy for his/her primary care provider◦ Call the patient if an incident has occurred recently◦ Keep specialist contact information available

Tips for Pharmacists

◦ Educate close contacts◦ Check expiration date on epinephrine◦ Know and avoid triggers◦ Recognize symptoms◦ Carry self-injectable epinephrine at all times◦ Use epinephrine early and correctly◦ Seek medical care after epinephrine use

Patient Steps for Successful Management

Only 1 does of epinephrine should be used to reverse a severe allergic reaction or anaphylaxis event?

True

False

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When should an epinephrine autoinjector be replaced?

a.If it was obtained more than 6 months ago.

b.If it will expire before the patient can return to the pharmacy for a replacement.

c.After it has expired.

d.It does not need to be replaced unless it has been used.

Side effects of epinephrine include:

a.Palpitations and difficulty breathing

b.Dizziness and lightheadedness

c.Leg weakness

d.Nausea

For more information: ◦ EpiPen: www.myepipen.com

◦ The American College of Allergy, Asthma, and Immunology: http://www.acaai.org/allergist/allergies/Anaphylaxis/Pages/anaphylaxis-patient-tip-sheet.aspx

◦ The Food Allergy and Anaphylaxis Network: http://www.foodallergy.org/section/education◦ http://www.foodallergy.org/section/support-groups

Additional Resources

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Camargo CA, Clark S, Kaplan MS, Lieberman P, Wood RA. Regional differences in EpiPen prescriptions in the United States: The potential role of Vitamin D. J Allergy Clin Immunol 2007;120:131-6.

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Johannes CB, Ziyadeh N, Seeger, Tucker E, Reiter, and Faich G. Incidence of Allergic Reactions Associated with Antibacterial Usei in a Large, Managed Care Organisation. Drug Safety. 2007; 30 (8): 705-13.

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Lieberman P. Biphasic anaphylactic reactions. Ann Allergy Asthma Immunol. 2005; 95:217-26.

Lieberman P, Decker W, Camargo CA, O’Connor R, Oppenheimer J, Simons FE. SAFE: a multidisciplinary approach to anaphylaxis education in the emergency department. Ann Allergy Asthma Immunol. 2007;98:519-23.

Lieberman P, Nicklas RA, Oppenheimer J, Kemp SF, Lang D. The diagnosis and management of anaphylaxis practice parameter: 2010 update. J Allergy Clin Immunol 2010; 126:477-80.

Manivannan V, Campbell RL, Bellolio MR, Stead LG, Li JTC, Decker WW. Factors associated with repeated use of epinephrine for the treatment of anaphylaxis. Ann Allergy Asthma Immunol. 2009;103:395-400.

Muelleman RL, Tran TP. Chapter 113: Allergy, hypersensitivity, and anaphylaxis. In: Rosen’s emergency medicine: concepts and clinical practice. 5th ed. St Lousi (MO): Mosby, INC., 2002.

Neugut AI, Ghatak AT, Miller RL. Anaphylaxis in the United States: An Investigation Into Its Epidemiology. Arch Intern Med. 2001; 161:15-21.

References

Pumphrey R. Anaphylaxis: can we tell who is at risk of a fatal reaction? Curr Opin Allergy Clin Immunol 2004;4:285-

90. Resuscitation Council (2008) Emergency treatment of anaphylactic reactions. Guidelines for healthcare providers.

Available at: www.resus.org.uk/pages/reaction.pdf. Accessed: August 24,2012.

Sampson HA, Munoz-Furlong A, Campbell RL, Adkinson NF, Bock SA, Branum A, et. al. Second symposium on the definition and management of anaphylaxis: Summary report - Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin Immunol. 2006;117:391-7.

Sheikh A and Alves B. Age, sex, geographical and socio-economic variations in admissions for anaphylaxis: analysis of four years of English hospital data. Clinical and Experimental Allergy. 2001; 31: 157106.

Sheikh A, Shehata YA, Brown SGA, Simons FER. Adrenaline (epinephrine) for the treatment of anaphylaxis with and without shock (Review). The Cochrane Library 2012; 4: 1-16.

Simons FER, Peterson S, Black CD. Epinephrine dispensing patterns for an out of hospital population: A novel approach to studying the epidemiology of anaphylaxis. J Allergy Clin Immunol 2002;110:647-51.

Stumpf JL, Shehab N, Patel AC. Safety of Angeiotensin-Converting EnzymeInhibitors in Patients with Insect Venom Allergies. Ann Pharmacother 2006;40:699-703.

Walker S, Sheikh A. Managing anaphylaxis: effective emergency and long-term care are necessary. Clin Exp Allergy 2003; 33:1015-18.

References

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Go to www.pharmacist/com/live-activities and under the Live Activities list, select the Claim Credit link for: Anaphylaxis Screening and Protection

You will need to enter your pharmacist.com username and password.

Select “Add to Cart” or “Enroll Now” from the left navigation and successfully complete the Assessment (use Attendance Code provided during the webinar), Learning Evaluation and Activity Evaluation/ You will need to provide your NABP e-profile ID number to access your Statement of Credit.

Please visit www.pharmacist.com/cpe-monitor for any questions regarding your NABP e-profile ID number. Note that it may take up to 3 hours for your NABP e-profile ID number to become activated.

The filing deadline for this CPE activity is Tuesday, November 27, 2012. No credit will be issued after this date.

If you have any questions or require additional information to claim your credit, please contact Marcia Tomaselli, Senior Manager, Education Department at the American Pharmacists Association by calling 202-429-4125 or e-mailing [email protected].

How to Obtain Your CPE Credit