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The American Pharmacists Association's (APhA) 2014 assessment of pharmacists’ patient care environment concluded that: "pharmacists’ services are expanding; confidence in pharmacists to deliver these services continues to grow; pharmacists are improving access to care, reducing gaps in patient care, and improving performance for health plans." [Shomer 2015] Similarly, the Joint Commission of Pharmacy Practitioners (JCPP) consensus on the patient care process states, "The profession of pharmacy is continuing its evolution from a principal focus on medication product distribution to expanded clinically-oriented patient care services." [JCCP 2014] As readers are aware, pharmacists collaborate with other providers on the health care team to optimize patient health and medication outcomes and to provide patient-centered care. [JCCP 2014] An essential first step is the establishment of a patient–pharmacist relationship that supports engagement and effective communication with patients, families, and caregivers throughout the process. Anaphylaxis—a severe, sudden systemic allergic reaction—is a setting that affords pharmacists an opportunity to use their skills and training to reduce gaps in care and improve outcomes for those who have experienced, or are at risk for, anaphylaxis.

Anaphylaxis Overview

Anaphylaxis can occur within minutes of exposure to an allergen. The reaction typically involves two or more organs/systems (e.g., skin, airways, lungs, stomach, heart or blood pressure). A first episode of anaphylaxis is almost always unanticipated. [Arnold 2011][Wood 2014]

The sudden release of mast cell- and basophil-derived mediators into a patient's circulation during anaphylaxis manifests as acute, multisystem reactions. [Sampson 2006][Kemp 2015] The World Allergy Organization (WAO) classifies anaphylaxis as immunologic or non-immunologic, depending upon the involvement of immunoglobulins. [Johansson 2004][Lockey 2012][Kemp 2015]

• Immunologic anaphylaxis:
  • Immunoglobulin E (IgE)-mediate reactions
  • Immunoglobulin G (IgG)-mediated reactions
  • Immune complex/complement-mediated reactions
• Non-immunologic anaphylaxis (also called non-allergic anaphylaxis): caused by agents or events that induce sudden, massive mast cell or basophil degranulation in the absence of immunoglobulins

Anaphylaxis may be mild, moderate-to-severe, or severe. While most cases of anaphylaxis are mild, any episode is a potentially life-threatening medical emergency that requires immediate treatment with adrenaline injection. In severe cases, delayed recognition and treatment may lead to death; reactions such as airway obstruction or vascular collapse can be fatal. Common triggers include allergies to foods, medications, insect bites/stings and latex; in some individuals, exercise can be a trigger. [Arnold 2011][Wood 2014]

Symptoms may include: difficulty breathing; rashes, hives or swelling of the lips, tongue or skin; vomiting; loss of blood pressure; or, even loss of consciousness. (Table 1) In a 2013 study by the Asthma and Allergy Foundation of America (AAFA), physicians reported the most common symptoms associated with anaphylaxis were respiratory symptoms (73%), followed by skin (61%), cardiovascular (24%), neurological (15%), and gastrointestinal (7%). A patient survey portion of the study reported similar findings. [Wood 2014]

Table 1. Manifestation of anaphylaxis in different body systems.
Body System	Area Involved	Signs and Symptoms
General	Adult Overall Involvement	Anxiety, feeling of impending doom, metallic taste, numbness in extremities, malaise, weakness
	Pediatric Overall Involvement	Sudden behavior changes, irritability, cessation of playing behavior
Dermatological
	Eyes	Swelling around the eyes, erythema, tears
	Mouth/Oral Mucosa	Angioedema around the tongue and lips
	Skin	Itching and flushing, urticarial rash, morbilliform rash, angioedema
Respiratory
	Lower Airway	Bronchospasm accompanied by wheezing or cough, chest tightness, increase in respiration, decreased expiratory flow, cyanosis, respiratory arrest
Cardiovascular
	Early Involvement	Fast heart rate (tachycardia), sweating, delayed capillary refill, hypotension
	Late Involvement	Slowed heart rate (bradycardia), shock, T-wave inversion and ST segment depression in multiple lead on the EKG, cyanosis, cardiac arrest
Gastrointestinal
	GI Tract	Nausea, vomiting, diarrhea, abdominal cramps
Neurological
	Central Nervous System	Throbbing headache, dizziness, lightheadedness, confusion, tunnel vision, loss of consciousness
Table adapted from Arnold JJ, Williams PM. Anaphylaxis: Recognition and Management. Am Fam Physician. 2011;84(10):1111-1118.

According to the AAFA, "There is no cure or preventative treatment for most causes of anaphylaxis, so immediate use of a prescription epinephrine auto-injector at the first sign of a severe allergic reaction is the standard-of-care for adults and children. Patients at risk for anaphylaxis should be prescribed epinephrine auto-injectors to keep on-hand at all times and ready to use if an emergency occurs." [Wood 2014]

It is important to keep in mind that anaphylaxis is not a one-time event – a majority of patient respondents in the AAFA survey reported 2 or more anaphylactic reactions in their lifetime and 19% reported experiencing 5 or more. All patients at risk of recurrent anaphylaxis should be educated about the appropriate use of prescription epinephrine auto-injectors. [Wood 2014]

Epidemiology and Evolving Trends

The exact incidence of anaphylaxis in the US is not known. The AAFA study described above found anaphylaxis to be common; it very likely occurs in nearly 1-in-50 Americans (1.6%), and survey respondents believed the rate was probably higher, closer to 1-in-20 (5.1%). [Wood 2014]

According the group FARE (Food Allergy Research and Education), "teenagers and young adults with food allergies are at the highest risk of fatal food-induced anaphylaxis" and "individuals with food allergies who also have asthma may be at increased risk for severe/fatal food allergy reactions." [FARE 2016][Bock 2007][Bock 2001][Sampson 1992]

Contributors to an increase in anaphylaxis may include the fact that the incidence of food allergies is increasing, contrast media is being used more often in diagnostic and clinical situations, and chemotherapy and monoclonal antibodies are being administered more often in outpatient clinics. As the use of monoclonal antibodies increases and biosimilar monoclonal antibodies become available in the US, the incidence of anaphylaxis associated with their use can also be expected to increase. [Grissinger 2015] Hospital admissions for anaphylaxis are also increasing nationally; the highest rates are found among children 4 years old or younger with food-induced anaphylaxis. [Simons 2015]

Insights into Patient Behavior and Care Needs

Among the 1059 patients with a history of allergic reactions within the prior 10 years who participated in the AAFA study, anaphylaxis occurred most commonly at home, and in the majority of cases treatment was sought in less than 30 minutes—although 6.4% received no treatment. With respect to treating anaphylaxis, 34% of respondents went to the hospital, 27% self-administered an antihistamine, 11% self-administered epinephrine, and 10% called 911. Most respondents with a history consistent with anaphylaxis had not been provided with an emergency care plan. In addition to the low rate of epinephrine use and lack of an emergency care plan, other factors that could increase the risk of an anaphylactic reaction were identified: only 32% of respondents planned to use epinephrine with future reactions, 52% had never received a prescription for self-injectable epinephrine, and 60% did not currently have self-injectable epinephrine available. [Wood 2014]

Recommendations: Diagnosis and Management

Multiple recommendations have been published during the past two decades for the diagnosis and management of anaphylaxis. WAO guidelines were published in 2011 and have been continually revisited and updated, most recently in 2015. [Simons 2015] Box 1 describes the three diagnostic criteria for anaphylaxis, each representing a different clinical presentation. [Simons GL 2011][Simons Summary 2011][Simons Diagnosis 2013]

Box 1. Criteria for Anaphylaxis
Anaphylaxis is HIGHLY likely when any ONE of the following THREE criteria are met
Criterion 1
Sudden onset of an illness (minutes to several hours) with the involvement of the skin, mucosal tissue, or both (e.g., generalized hives, itching or flushing, swollen lips-tongue-uvula)
AND at least ONE of the following
Sudden respiratory symptoms and signs (e.g., shortness of breath, wheeze, cough, stridor, hypoxemia) Sudden reduced blood pressure or symptoms of end-organ dysfunction (e.g., hypotonia, incontinence)
OR Criterion 2
Two or more of the following occur suddenly after exposure to a likely allergen or other trigger* for that patient (minutes to several hours) Sudden skin or mucosal symptoms and signs (e.g., generalized hives, itch-flush, swollen lips-tongue-uvula) Sudden respiratory symptoms (e.g., shortness of breath, wheeze, cough, stridor, hypoxemia) Sudden reduced blood pressure or symptoms of end-organ dysfunction (e.g., hypotonia, incontinence) Sudden gastrointestinal symptoms (e.g., crampy abdominal pain, vomiting)
OR Criterion 3
Reduced blood pressure (BP) after exposure to a known allergen** for that patient (minutes to several hours)
Infants/children	Low systolic BP (age-specific) or greater than 30% decrease in systolic BP 1 month – 1 year: <70 mm Hg 1 – 10 years: <(70 mm Hg + [2 x age]) 11 – 17 years: <90 mm Hg Normal heart rate: 1-2 years: 80-140 beats/min 3 years: 80-120 beats/min >3 years: 70-115 beats/min
Adults	Systolic BP <90 mm Hg or greater than 30% decrease from that person's baseline
* For example, immunologic but Ig-E independent, or non-immunologic (direct mast cell activation)
** For example, after an insect sting, reduced BP might be the only manifestation of anaphylaxis; or, after allergen immunotherapy, generalized hives might be the only initial manifestation of anaphylaxis
*** Low systolic BP for children
Source: Simons FE, Ardusso LR, Bilò BM, et al. World Allergy Organization anaphylaxis guidelines: summary. J Allergy Clin Immunol. 2011;127(3):587-593.

In addition, a practice parameter for emergency departments (ED) was released by the Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma and Immunology (AAAAI), the American College of Allergy, Asthma and Immunology (ACAAI); and the Joint Council of Allergy, Asthma and Immunology. This practice parameter outlined an algorithm for diagnosis and management of anaphylaxis in the ED. [Campbell 2014]

Guidelines and practice parameters all emphasize the use of epinephrine for first-line treatment. However, management of anaphylaxis does not end with administration of epinephrine and other medications and supportive care. Previous and current guidelines recommend that a patient with anaphylaxis be observed for 4-6 hours due to the risk of a biphasic anaphylaxis reaction. Biphasic reactions are categorized as the recurrence of anaphylaxis symptoms after resolution of the initial episode without additional exposure to the trigger. [Sampson 2006][Lieberman 2010][Simons 2011][Manivannan 2014] Patients at risk for more severe future episodes, especially those who are refractory to therapy, should be observed longer than 4-6 hours.

Box 2 describes the components of a tool kit for managing acute anaphylaxis in an outpatient setting.

Box 2: Recommended Equipment for Outpatient Management of Acute Anaphylaxis

Commercially made epinephrine auto-injector (child and adult version) or aqueous epinephrine (1:1,000 dilution vials), auto-injector preferred

Injectable histamine H1 receptor antagonists

Injectable or oral corticosteroids

Intravenous start kit: tourniquets, large-bore catheters, alcohol swipes

Normal saline

Oxygen setup with different sized masks

Peak flow meter

Stethoscope and appropriately sized blood pressure cuff

Source: Arnold JJ, Williams PM. Anaphylaxis: Recognition and Management. Am Fam Physician. 2011;84(10):1111-1118.

"In the absence of high-quality evidence, management decisions rely to a greater extent on physician or other health care provider experience and patient circumstances. Where appropriate, patients should be given the opportunity to express their values and preferences and participate in the medical decision-making process." [Lieberman 2015]

According to current WAO guidelines, optimal follow-up after acute treatment for anaphylaxis comprises 3 parts, which touch on multiple aspects of the pharmacists’ role in the prevention of anaphylaxis: discharge management, trigger confirmation, and trigger avoidance (Box 3). [Simons Summary 2011]

Box 3. Three Aspects of Care Following Anaphylaxis

1. Discharge Management Following an Acute Anaphylaxis Episode

Epinephrine injector and training for use Anaphylaxis emergency action plan, education Medical identification

2. Confirm Anaphylaxis Trigger(s)

Allergen skin tests at follow-up visit to allergist/specialist (e.g., 3-4 weeks after acute episode) Allergen-specific serum IgE levels

3. Avoidance and Immunomodulation

Avoid known triggers Medication desensitization Stinging insect venom immunotherapy

Source: Simons FE, Ardusso LR, Bilò BM, et al. World Allergy Organization anaphylaxis guidelines: summary. J Allergy Clin Immunol. 2011;127(3):587.

Role of the Pharmacist in Anaphylaxis

In the setting of anaphylaxis, the pharmacist provides education to patients and caregivers including basic information related to the condition, strategies such as trigger avoidance for preventing anaphylaxis, proper device usage and storage, prompt symptom recognition, and components of emergency preparedness. Pharmacists should also counsel patients to inspect their auto-injectors to verify that they are not outdated, and that they are not exposed to extreme hot or cold conditions. [Prescott 2015][Packey 2012]

Pharmacists may be involved in any or all of the following:

• Collect information to understand relevant medical/medication history and current clinical status
• Evaluate comorbidities and concomitant medications
• Identify potential sources of allergic reaction triggers
  • Refer patients with food allergies to dietitians
• Discuss lifestyle modifications and other tactics to avoid known triggers
• Recognize symptoms of allergic response that may progress to anaphylaxis
• Emergency preparedness (patient and caregivers)
  • Provide training on correct injection technique
  • Carry at least one epinephrine auto-injector
  • Review the need for a written anaphylaxis emergency action plan
  • Use medical identification
    • Medical Alert ID bracelets or tags
    • Medical information stored in smart phones or mobile apps

Topics that require counseling for patients with anaphylaxis include:

• Avoiding known allergens and recognizing the symptoms of a life-threatening allergic reaction
• The potential for a biphasic reaction that could result in a need for multiple epinephrine injections
• Training on the use of the epinephrine auto-injector
• Strongly consider training family and friends on the use of the auto-injector, in the event that assistance is needed
• Need for emergency medical attention even with the use of an auto-injector
• Importance of a follow-up appointment with their allergist/immunologist following usage of an auto-injector

Other points of education include how to store epinephrine auto-injectors properly and the importance of keeping epinephrine auto-injectors on hand wherever they may be needed (e.g., home, car, office). Patients should also be instructed to regularly check the expiration date on all epinephrine auto-injectors and to have a yearly date where a new prescription is obtained and filled (e.g., an anniversary, January 1^st).

By counseling patients on avoidance of known allergens, proper device usage, prompt symptom recognition, and appropriate device storage, pharmacists can help improve outcomes during emergency medical situations involving anaphylaxis.

As the rate of anaphylaxis has increased, so has the demand for epinephrine auto-injectors and their resultant costs. The ability to access epinephrine auto-injectors has the potential to reduce fatal outcomes; however as identified, a great number of patients do not obtain them. According to Westermann-Clark et al. the cost of epinephrine auto-injectors has been rising substantially since 1990. [Westermann-Clark; 2012]. The Kaiser Health System in California conducted a study of refill history that theorized the high cost of epinephrine might prevent or discourage a patient from obtaining refills. [Kaplan 2011] Therefore, in addition to patient education, the pharmacist may be called on to help the patient to understand the extent of their insurance coverage, and to engage in discussions with insurance and healthcare providers to ensure there is no lapse in coverage.

If pharmacists identify cost as a barrier when educating patients, the next step would be to assess insurance plan coverage for an auto-injector; in some instances the generic auto-injector may be covered. It is important for pharmacists to identify that the generic epinephrine auto-injector has a B/X rating and cannot be automatically substituted as a generic equivalent. [EOB 2016] Additionally, some products may also require a preauthorization for obtainment. Prompt communication with the ordering provider with recommendations for an agent that is covered or with information for a prior authorization may help the patient obtain their epinephrine auto-injector in a timely manner. Lastly, pharmacists can also help direct patients for whom cost remains an issue to the manufacturer directly to determine if they have a patient prescription program that may help with financial obtainment; it should be noted that this process is usually lengthy and may result in a delay in obtainment.

As integral members of the healthcare team, pharmacists can be involved in many ways; main areas of focus are highlighted in Box 4.

Box 4. Ways in Which Pharmacists Can Improve Anaphylaxis Care Provide education about anaphylaxis, including An overview of anaphylaxis Strategies for trigger avoidance to prevent future episodes Recommend seeing a dietician for patients with food allergies Symptoms of anaphylaxis and importance of knowing how to promptly identify them Review proper device utilization and storage There are three devices on the market and they are all used differently, so knowing how to use one device does not translate to knowing how to use them all Have a trainer device on hand that can be reviewed with patients when they are picking up their prescriptions If the pharmacy does not have trainers, you can contact each manufacturer directly and they may be able to provide your pharmacy with trainer devices for demonstration Some items also have a trainer with their 2-pack prescription Review all the steps on administration of the epinephrine auto-injector AND the importance of calling 911 AFTER the medication is administered Review positioning of the patient after epinephrine is administered while awaiting emergency services Lay the person flat and raise their legs or on their side Review when to give a second dose of epinephrine If the patient's symptoms are not improving or if symptoms return within 5 minutes after the initial dose, a second dose of epinephrine should be administered. Educate the patient/family not to hesitate to administer the second dose if the patient requires it. [Arnold 2012] Education on storage and refill recommendations Auto-injectors should not be exposed to extreme heat or cold conditions Educate patients on the importance of preventing outdating of product Auto reminders Refilling yearly on a specific date such as the first of the year, birthday, etc. Review the importance of creating an anaphylaxis emergency care plan (can be done when patients pick up their initial prescription or refills) Educate and review the importance of the family/caregivers having an emergency action plan created and available for those who will be overseeing the care of the patient. Guide patients to sources of examples of these action plans (See Table 2)

Auto-Injection Technique

Three brands of auto-injectors are available in the US, but they are not interchangeable with respect to training and the way they are used. Pharmacists should be aware of the differences in how to use these products individually in order to educate patients on their respective use. Pharmacists can access videos online for each type of injector that highlight the key action steps for use. These videos can also be shared with patients and their families during education. Pharmacists can also use the links below to request a trainer device directly from each manufacturer. These trainer devices may also be kept at the pharmacy for demonstration sessions with patients and their families.

• EpiPen® [http://www.epipen.com/]
  • Every EpiPen 2-Pak^® and EpiPen Jr 2-Pak^® carton includes a needle-free, epinephrine-free EpiPen^® Trainer.
• Adrenaclick® [http://www.epinephrineautoinject.com/]
• Epinephrine injection [http://www.epinephrineautoinject.com/]

Creating an Anaphylaxis Action Plan

Because there is not much time to react, all patients should be encouraged to create an emergency action plan soon after they become aware that they are at risk for anaphylaxis. This plan should be shared with schools, caregivers, work, or anyone who may be taking care of the patient with allergies. An anaphylaxis emergency plan is written ahead of time and clearly identifies what needs to happen in the event the patient experiences an anaphylactic reaction. These plans should also be reviewed and signed by the patient’s healthcare provider.

Emergency action plans may vary, but there are key components to these plans including: [Simons 2009][Simons 2006])

1. Patient’s name
2. Type of allergy/allergen
3. Current medications (if applicable)
4. Overall symptoms of anaphylaxis
5. Epinephrine device and dose recommendations
6. Information to call 911 AFTER epinephrine administered
7. How to position the patient when awaiting for emergency responders
8. Emergency contact information for the family/caregivers
9. Healthcare provider’s signature
10. Patient’s/caregiver’s signature

The easiest way to create an anaphylaxis emergency plan is to use a pre-made template. You can find examples of templates that may be downloaded and shared with patients at the websites below. (Table 2) Once the patient identifies the action plan they prefer, they should be encouraged to bring it to their healthcare provider for review and signature. Action plans should be stored where they can be easily accessed. This may include not just school, daycare home and work environments, but also in the patient’s purse, wallet or backpack. In addition patients can also be encouraged to wear a medical alert bracelet or tag that can alert emergency responders or medical personal that the patient has allergies. [Lieberman 2015]

Table 2. Action plan templates that can be downloaded and printed.
Organization	Website
Allergy and Asthma Information Association	http://www.aaia.ca/en/Anaphylaxis_Emergency_Plan_with_EpiPen_instructions.pdf
American Academy of Allergy and Asthma Immunology	https://www.aaaai.org/aaaai/media/medialibrary/pdf%20documents/libraries/anaphylaxis-emergency-action-plan.pdf
Asthma and Allergy Foundation of America	http://www.aafa.org/media/asthma-action-plan-aafa.pdf
National Institute of Allergy and Infectious Disease	http://www.niaid.nih.gov/topics/foodallergy/clinical/documents/faguidelinespatient.pdf

Summary

Anaphylaxis is a condition that is often misunderstood, underrecognized, underdiagnosed, and undertreated. The pharmacist’s role in patient care is expanding and in an acute anaphylaxis situation, patients may have easier access to pharmacists than to other healthcare professionals. As such, pharmacists must be able to provide education that will help patients better understand their condition and the importance of having self-administered treatment available at all times, show them how to use auto-injectors, and help them identify and avoid allergy triggers and better manage their episodes.

Practice Pearls

• Provide education about anaphylaxis including recognizing symptoms of anaphylaxis and strategies for trigger avoidance
• Demonstrate how to use the epinephrine auto-injector AND the importance of calling 911 AFTER the medication is administered
• Educate the patient/family not to hesitate to administer the second dose if the patient requires it
• Provide education on storage and refill recommendations (e.g., annually on an easy-to-remember date)
• Create and review an anaphylaxis emergency care plan (can be done when patients pick up their initial prescription or refills)

Additional Resources

World Allergy Organization. WAO Anaphylaxis Resources Online. Available at http://www.worldallergy.org/anaphylaxis/

References

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