PEDIATRICS Vol. 105 No. 2 February 2000, pp. 359-362

Use Assessment of Self-Administered Epinephrine Among Food-Allergic Children and Pediatricians

Scott H. Sicherer, MD^*, Joel A. Forman, MD, and Sally A. Noone, RN, MSN^*

From the ^* Division of Allergy and Immunology, Jaffe Food Allergy Institute and the  Division of Ambulatory Pediatrics, Department of Pediatrics, Mount Sinai School of Medicine, New York, New York.

	ABSTRACT

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Background and Objectives.  Food allergy is a common cause of anaphylaxis, and early treatment with epinephrine can be life-saving. We sought to determine the ability of families with food allergic children and pediatricians to properly use self-injectable epinephrine.

Methods.  We enrolled families of consecutive, food-allergic pediatric patients newly referred to our allergy practice but previously prescribed epinephrine and a sampling of pediatricians. Parents or teenage patients answered a structured questionnaire concerning use of self-injectable epinephrine and demonstrated the use of devices with which they were familiar. Demonstrations were scored in a standard manner.

Results.  One hundred one families of food-allergic children (mean age of patients, 6.4 years) were enrolled. Self-injectable epinephrine was prescribed (mean of 2.7 years previously) primarily by pediatricians (n = 46) and allergists (n = 49). Patients were prescribed EpiPen (n = 93), EpiE-Z Pen (n = 11), and Ana-Kit (n = 3). Eighty-six percent of the families responded that they had the device with them "at all times," but only 71% of this group had epinephrine at the visit. Among those with the epinephrine, 10% had devices beyond the labeled expiration date. Thus, only 55% of the 101 families had unexpired epinephrine on-hand at the time of the survey. Among children in school, 77% had the medication available in school, and 81% stated that the school knew the indications for administration. Only 32% of the participants correctly demonstrated the use of the device. Twenty-nine attending pediatricians were enrolled (mean 14 yrs in practice; mean 4 epinephrine prescriptions/year). Familiarity with the devices was as follows: EpiPen (86%), EpiE-Z Pen (17%) and Ana-Kit (7%). Only 24% generally gave patients written materials concerning indications. Overall, 18% were familiar with and able to demonstrate correct use of at least 1 device (21% correctly demonstrated Epi-Pen). Seventeen pediatric residents were enrolled; 65% were familiar with the EpiPen; 36% demonstrated it correctly and only 1 resident was familiar with Ana-Kit.

Conclusions.  Many parents of severely food-allergic children, and food-allergic teenagers cannot correctly administer their self-injectable epinephrine and may not have the medication readily available. Pediatricians are not familiar with these devices and may fail to review their use with patients. Improved patient and physician education is needed to ensure proper use of this life-saving medication.  Key words:  anaphylaxis, food allergy, epinephrine.

Food allergy affects 6% to 8% of children,¹ and reactions can be severe² and potentially fatal.³ Food allergy is the most common cause of anaphylaxis in children outside of the hospital setting.⁴ Early administration of epinephrine for food-allergic reactions can be life-saving³ in delaying the progression of an anaphylactic reaction so that medical attention and additional treatment can be provided. Various devices for self-administration of epinephrine are available for patients with severe allergies to foods as well as for other causes of anaphylaxis. However, self-administered epinephrine is frequently underprescribed by^5,6 or unfamiliar to⁷ physicians and possibly misused⁸ by patients and their families. We undertook this study to assess patient and physician use of self-administered epinephrine. We administered a standard questionnaire and scored a demonstration with the devices among consecutive patients with food allergy previously prescribed epinephrine and among a convenience sample of pediatricians.

	METHODS

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Study Participants

Families of consecutive, newly referred, food-allergic pediatric patients previously prescribed epinephrine were enrolled in the study. A sampling of pediatricians were enrolled through unscheduled visits to the Mount Sinai Hospital pediatric ambulatory care facility (attending pediatricians and pediatric residents) and to 5 private pediatric office practices of physicians affiliated with the hospital with participation of all physicians available during the visits. The study was approved by the Mount Sinai Institutional Review Board and verbal informed consent was obtained.

Survey and Demonstration

A brief questionnaire (distinct for patients and physicians) was administered to obtain demographic information and details concerning the use of self-administered epinephrine. In families with a food allergic child, the parent deemed most likely to administer the drug was the subject for the study unless the child (>12 years old) was responsible for administering the medication. After completion of the questionnaire, the study participant was asked to demonstrate the use of the devices with which they were familiar using trainers (without needles or medication) supplied by the manufacturers. The demonstration was scored for accuracy of administration compared with instructions supplied by the manufacturer on a scale as follows: EpiPen/EpiPen-Jr and EpiE-Z Pen/EpiE-Z Pen-Jr (Dey, Napa, CA; the EpiE-Z Pens were subsequently recalled and discontinued). The 6 steps are as follows: 1) recognizes device without examining for clues of how to use; 2) remove cap; 3); select appropriate body site; 4) press correct end of device to body; 5) press to activate; and 6) hold in place for several seconds rather than punch and remove. The 9 steps for the Ana-Kit (Bayer Corporation, Spokane, WA) are as follows: 1) recognizes device without examining for clues of how to use; 2) presses plunger to remove air bubble; 3) twists plunger 1/4 turn to the right; 4) selects appropriate site for injection; 5) inserts needle before pressing plunger; 6) presses plunger; after instructed to give second injection; 7) twists plunger 1/4 to the right; 8) inserts needle; and 9) pushes plunger.

Statistics

² analysis was used.

	RESULTS

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One hundred one consecutive families of food allergic children (mean age 6.4 years) were enrolled. Surveys and demonstrations were completed by 95 parents and 6 patients. Self-injectable epinephrine had been prescribed a mean of 2.7 years previously (range, 1 week to 12 years) by pediatricians (n = 46), allergists (n = 49), both a pediatrician and an allergist (n = 3), emergency medicine physicians (n = 2), and a pulmonologist. The patients were prescribed EpiPen/EpiPen Jr (n = 93), EpiE-Z Pen/EpiE-Z Pen Junior (n = 11), and Ana-Kit (n = 3) with 6 families having more than 1 type of device. Epinephrine had been prescribed for previous severe reactions in 77 children, the remainder for potential severe reactions. The self-injectable epinephrine had been used by 15% of the patients for food-allergic reactions. Although 86% of the families responded that they had the device with them "at all times," only 71% had them during the physician visit. Of those with the device in hand, 10% were expired (not including recalled devices). Thus, only 55% of the group had nonexpired epinephrine with them.

Forty-nine percent of the parents of food-allergic children recalled that a physician demonstrated the use of the device for them and 80% stated that the use of the apparatus was explained verbally. Among children in school, 77% had the medication available in the school and only 81% of these had ensured that the school knew how and why to give the medication. If a suspected ingestion of the food occurred, 11% indicated that they would give epinephrine without any onset of symptoms, 19% would give epinephrine for isolated hives, and 93% for symptoms of breathing difficulty. All but 2 patients/parents indicated that they would seek emergency treatment after using the medicine. All knew that EpiPen should be stored at room temperature.

Twenty-nine attending pediatricians were enrolled. Their practice setting was academic (n = 13), private (n = 11), or combined (n = 5) with an average of 14 years in practice (range, 1-43 years). These physicians prescribed self-injectable epinephrine a mean of 4 times per year (range, 0-15); 17% of prescribers generally demonstrated the use of the device with a trainer, while all explained the use and indications verbally. Only 24% gave written materials concerning indications for using the device. Familiarity with the devices was as follows: EpiPen/EpiPen Jr (86%), EpiE-Z Pen/EpiE-Z Pen Jr (17%), and Ana-Kit (7%). Although the dose of epinephrine for treatment of anaphylaxis is 0.01 mg/kg, there is no specific recommendation from the manufacturer for using EpiPen Junior (0.15 mg) or EpiPen (0.3 mg) at particular weights. Eighty percent of the attending pediatricians answered that they would prescribe Epipen Junior to children weighing 10 kg, 100% for those 15 kg, 70% for 20 kg, and none would prescribe it for a 30-kg child. Four of the pediatricians familiar with EpiPen/EpiPen Jr thought incorrectly that it should be stored refrigerated (this could stiffen the spring). Seventeen pediatric residents (2 first year, 6 second year, and 9 third year) were enrolled in the study. The group prescribed self-injectable epinephrine a mean of 0.6 times per year (range, 0-3) and only 65% were familiar with EpiPen/EpiPen Jr, 1 resident was familiar with Ana-Kit.

The results of the Epi-Pen demonstration by patients/parents (93 study participants), pediatric attendings (n = 25) and pediatric residents (n = 11) familiar with the device are shown in Fig 1. The maneuvers accounting for the greatest number of mistakes were those involving removal of the safety cap, pressing to activate the needle (click) and holding the pen in place rather than punching and removing. Study participants selecting the wrong end of the device for placement generally would have injected the thumb, which can have adverse consequences for both the person administering the drug (vasoconstriction of blood vessels in the digit) as well as for the child who did not receive the medication. In considering those who performed all 6 steps correctly, 38% of patients/parents, 21% of attending pediatricians and 36% of residents correctly demonstrated the device. For patients/parents, correct use was related to having had the device >2.5 years (P = .0003), being a member of the lay organization, The Food Allergy Network (P = .007), with a trend toward having been prescribed the device by an allergist (P = .06); there was no relationship to reporting that physicians demonstrated the device in the office (P = .5).

View larger version (50K): [in this window] [in a new window]   Fig. 1.   Frequency of correct demonstration for each of 6 steps in using EpiPen among patients/families (n = 93), attending pediatricians (n = 25), and pediatric residents (n = 11) indicating they were familiar with the device. See text for description of each step.

Relatively few patients/parents or physicians were familiar with the EpiE-Z Pen/EpiE-Z Pen Jr and Ana-Kit. Among patients/parents, 45% (11 study participants tested) correctly demonstrated the EpiE-Z pen and none of 3 correctly used the Ana-Kit. Thus, considering all devices, only 32% of patients/parents could demonstrate the correct use of at least 1 of the devices they were prescribed. Among physicians, 4 of 5 study participants demonstrated the EpiE-Z pen correctly and 1 of 2 familiar with the Ana-Kit demonstrated it correctly. Considering the group of 29 attending physicians, only 18% were familiar with, and demonstrated correctly, at least 1 device. Of note, 1 attending pediatrician was familiar with all 3 devices and demonstrated all of them correctly.

	DISCUSSION

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In this study, we evaluated consecutive families with food-allergic children previously prescribed self-injectable epinephrine to determine their ability to demonstrate correct use of the device(s) they were prescribed. Only one third of the patients/parents could correctly demonstrate at least 1 of their devices. Furthermore, many families did not consistently have the medication available to them, including 23% who did not have the medication available at school. In a sampling of pediatricians, we found that many were not familiar with these devices and, for those who were, correct demonstration of technique for administering the medication was lacking.

Self-injectable epinephrine is indicated for patients with severe food and insect sting allergic reactions, as well as a number of other indications such as exercise-induced anaphylaxis, idiopathic anaphylaxis, systemic mastocytosis, and others. For children at risk for anaphylaxis, intramuscular injection may be the preferred route of administration as it provides peak concentrations rapidly in most children whereas subcutaneous injection results in variable and often delayed absorption.⁹

This study focused on children with food allergy for several reasons. In case series of anaphylaxis, food allergy is the major identifiable trigger, accounting for 34% to 57% of reactions^410-13 and food allergy is the most common cause of anaphylaxis in children outside of the hospital setting.⁴ In addition, early administration of epinephrine for food-allergic reactions can be life-saving,³ but underprescribing for food allergy has been recently reported.^5,14 It has also been noted that patients may not properly operate devices that administer medications, such as metered dose inhalers for asthma¹⁵ or EpiPens for anaphylaxis.⁸ Thus, in the present study we focused on food allergic children and pediatricians to determine a use assessment of self-injectable epinephrine, although there is no reason to suspect that the results would not apply to the other settings in which self-administered epinephrine is prescribed.

All of the devices that administer self-injectable epinephrine are relatively easy to use and packaged with instructions for the patients. All study participants were able to properly demonstrate the use of the devices after instruction by the investigators after each survey. Failure to demonstrate proper technique in patients/families was not related to having a physician demonstrate the device at the time of prescribing. However, successful demonstration was associated with factors relating to reviewing the use of the medication and food allergies (repeated prescriptions, membership in a lay organization for food allergy, having an allergist). Thus, efforts to encourage repeated review of the technique of administration and indications for these medications are warranted. For example, the authors encourage patients to review the use of the medication and to note the expiration date monthly in relation to some particular monthly event (paying a bill) to increase compliance.

A surprising proportion of attending physicians was not familiar with the devices or could not demonstrate proper technique. Two commented that they assumed the pharmacist reviewed the medication with the patients (although only 2 families indicated that this was how they learned about technique). Few provided written materials to their patients to reinforce instructions on indications for use. Individualizing instructions for a particular patient is often necessary based on their history of reactions (which should include an evaluation to confirm the presence of specific IgE to the causal food and consideration for referral to an allergist). For most patients, the authors use written materials, similar to those available through the Food Allergy Network (800-929-4040, www.foodallergy.org), to reinforce the indications for using medications (antihistamines and epinephrine) and to provide materials that are helpful to schools. There has not been a specific training session for using these devices aimed at residents in this pediatric program and this could account for the low familiarity with these devices noted in this group. Such training is now included in the curriculum.

Based on the results of this study, several recommendations can be made concerning the prescribing of self-administered epinephrine. Patients should be shown, using trainer devices, proper technique for administration and encouraged to review the technique often and to check for expired medication. This training could be facilitated with industry-provided trainers, perhaps packaged with the device, and instructional videos. Verbal and written instructions regarding the indications for using the medication should be reviewed. In addition, schools and caregivers should receive the same training and physicians should remind families about these issues. Including information concerning these devices in courses (continuing medical education) for physicians should be encouraged, trainers should be made available to prescribing physicians, and structured lectures that include the treatment of anaphylaxis with these devices should be a part of training for residents.

	ACKNOWLEDGMENTS

We thank Hugh A. Sampson, MD, for his thoughtful review of this manuscript and the families and physicians who kindly participated.

	FOOTNOTES

Received for publication Mar 8, 1999; accepted May 13, 1999.

Reprint requests to (S.H.S.) Division of Allergy/Immunology, Mount Sinai Hospital, Box 1198, One Gustave L Levy Pl, New York, NY 10029-6574. E-mail: scott.sicherer{at}mssm.edu

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