- Email: [email protected]
Pharmacist use of the electronic medical record to identify adults at risk for anaphylaxis without epinephrine for self-administration
SCIENCE AND PRACTICE Journal of the American Pharmacists Association xxx (2017) 1e6
Contents lists available at ScienceDirect
Journal of the American Pharmacists Association journal homepage: www.japha.org
EXPERIENCE
Pharmacist use of the electronic medical record to identify adults at risk for anaphylaxis without epinephrine for self-administration Autumn Stewart*, Katherine Sulkowski a r t i c l e i n f o
a b s t r a c t
Article history: Received 15 July 2016 Accepted 28 January 2017
Objectives: To describe an innovative pharmacist-led approach, with the use of electronic medical record (EMR) data, to identify patients at risk of anaphylaxis in need of epinephrine auto-injector (EAI) for self-administration. Setting: An urban free health care center for an uninsured indigent adult population in Pittsburgh, PA. Practice innovation: In this pilot service, patients with allergy history fields containing the words “anaphylaxis,” “nut,” “bee,” or “shellfish” were screened for inclusion. Practice description: Patients were identified with the use of a report generated by the EMR vendor and were contacted via telephone by a clinical pharmacist. Using the patient-reported clinical history related to anaphylaxis and allergies, the pharmacist assessed the need for EAI, counseled the patient, and provided physician referral when appropriate. Evaluation: The service was evaluated with the use of a cross-sectional study of patients with electronic records at the health center during the time period studied. Data obtained from patient interviews were used to classify patients who were candidates for EAI and to assess prescribing and access to EAI. Demographic data and outcomes related to the availability of non-expired EAI were collected and analyzed using descriptive statistics. Results: Ninety-five patients were identified as potential candidates for the service, and 20 patients were able to be contacted via telephone. Fourteen participants provided consent for their data to be used in the program evaluation. A treatment gap likely existed for 11 of the 14 participants (79%) owing to history of anaphylaxis (57%) or history of systemic reaction (29%). The most common indication for EAI was anaphylaxis in response to bee stings. Conclusion: The findings from this project demonstrate that pharmacist use of EMR data, coupled with patient interview, may be an effective means for identifying treatment gaps in the long-term management of anaphylaxis and has the potential to ultimately improve management of anaphylaxis in patients within the community. © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
Anaphylaxis is an acute life-threatening systemic allergic reaction typically occurring suddenly; fatality can occur within minutes if untreated.1,2 In the general population, the estimated prevalence of anaphylaxis in the United States is 1.6%,
Disclosure: All authors and members of immediate family have no conflicts of interest or financial interests in any product or service affiliated with this research, including grants, employment, gifts, stock holdings, or honoraria. Previous presentation: Portions of this work were presented at the American Pharmacists Association Annual Meeting, San Diego, CA, March 28, 2015, and the Duquesne University Annual Undergraduate Research and Scholarship Symposium, April 9, 2015. * Correspondence: Autumn Stewart, PharmD, BCACP, CTTS, Associate Professor of Pharmacy Practice, Mylan School of Pharmacy, Duquesne University, 600 Forbes Avenue, Pittsburgh, PA 15282. E-mail address: [email protected] (A. Stewart).
and an estimated 16% of people may be “at risk” for anaphylaxis.1,3 In outpatient settings, food is the most common trigger, accounting for 30% of fatal cases of anaphylaxis.4 The most common foods to cause anaphylaxis are peanuts, tree nuts, fish, and shellfish, but other foods, such as milk, soy, and egg, also can be triggers.5 Medications, insect stings, and latex are also potential allergens that can cause anaphylaxis. The diagnosis for anaphylaxis is based on clinical findings and criteria developed by the World Allergy Organization. The identification of anaphylaxis is highly likely when any 1 of the following 3 criteria is fulfilled: (1) Sudden onset of an illness with involvement of the skin, mucosal tissue, or both and at least 1 of the following: sudden respiratory symptoms and signs, and sudden
http://dx.doi.org/10.1016/j.japh.2017.01.023 1544-3191/© 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
SCIENCE AND PRACTICE A. Stewart, K. Sulkowski / Journal of the American Pharmacists Association xxx (2017) 1e6
Key Points Background: Anaphylaxis is a potentially fatal allergic reaction prevalent in an estimated 1.6% of the United States' population. Guidelines endorse the prescribing of epinephrine auto-injector (EAI) for patients with a history of anaphylaxis and those at increased risk for anaphylaxis based on allergy history. However, the majority of patients who are candidates for EAI, never receive a prescription or have ready access to it. Lack of access to EAI represents a drug therapy related problem that pharmacists may have the potential to identify and resolve. Findings: A pharmacist-led assessment of components in the allergy history as documented in the electronic medical record was an effective strategy to identify patients at risk for anaphylaxis. Of the 14 subjects included in the evaluation, 93% had a definite or likely indication for EAI. Of the 8 subjects with a diagnosis of anaphylaxis, 7 participants (87.%) did not have a viable EAI in their possession. Of the 5 subjects identified as likely candidates for EAI, 4 (80%) had it in their possession. The positive results observed in this small sample support further implementation and the potential for adaptation to a variety of practice settings where pharmacists have access to electronic medical records.
reduced blood pressure or symptoms of end-organ dysfunction; (2) Two or more of the following that occur suddenly after exposure to a likely allergen or other trigger for that patient: sudden skin or mucosal symptoms and signs, sudden respiratory symptoms and signs, sudden reduced blood pressure or symptoms of end-organ dysfunction, and sudden gastrointestinal symptoms; or (3) Reduced blood pressure after exposure to a known allergen for that patient.2,6,7 The symptoms vary from patient to patient and from case to case, creating difficulty in the diagnosis of anaphylaxis. However, symptoms usually occur in 2 or more body systems. Common presentations of anaphylaxis include upper or lower airway obstruction, cardiovascular symptoms, and gastrointestinal symptoms.5 Epinephrine remains the first-line treatment of choice and should be administered at symptom onset. Studies estimate that 54% of anaphylactic reactions occur in the home; because symptoms can occur suddenly and progress rapidly, delays in administration are possible and are associated with an increased risk of fatality.1,3,8 To expedite access to treatment, epinephrine for self-administration by patients in the form of
2
epinephrine auto-injector (EAI) is recommended for patients with a history of anaphylaxis and in those at risk for anaphylaxis. Guidelines from the Joint Council of Allergy, Asthma, and Immunology recommend prescribing EAI for the following patient groups8: (1) History of anaphylaxis with possible exposure to the allergen. (2) History of a systemic allergic reaction. (3) IgE-mediated food allergy with concomitant asthma. (4) IgE-mediated allergy to specific high-risk food triggers (e.g., peanut, tree nuts, fish and shellfish). Despite these guidelines, as many as 52% of patients with a confirmed history of anaphylaxis never receive a prescription for EAI and 60% do not have EAI available.1 The Health Information and Technology for Economic and Clinical Health Act emphasizes the “meaningful use” of data within the electronic medical record (EMR) to administer optimal care and improve health outcomes, and mandates minimum population health initiatives.9 The potential role of EMR data on pharmacy practice and suggested means for integrating pharmacist-driven clinical services into EMR frameworks have been discussed previously.10,11 Allergy history and related information is routinely gathered by health care professionals in a variety of settings. When entered into specific fields within the EMR, these data become easily searchable, making the identification of individual patients with specific risk factors possible, such as the specific characteristics that place them at risk and as potential candidates for EAI. Pharmacists are uniquely trained as experts in the recognition and resolution of drug therapyerelated problems and work to ensure the appropriate and timely use of medications in the treatment of disease. Considering the gap in timely access to EAIs as a drug therapyerelated problem and potential access to allergy history fields in the EMR, pharmacists may be able to improve the long-term management of anaphylaxis in patients at risk. Objective To describe an innovative pharmacist-led approach, with the use of EMR data, to identify patients at risk of anaphylaxis in need of EAI for self-administration. Setting Located in the downtown area of Pittsburgh, PA, Catholic Charities Free Health Care Center is a free primary and specialty care provider for an uninsured adult population. Patients must demonstrate incomes below 200% of federal poverty limits before receiving care and are seen by volunteer medical providers by appointment only. Clinical pharmacy services were established in the practice, beginning in January 2008, with a focus on medication therapy management services, immunization needs assessments, and medication reconciliation. Practice innovation The pharmacy department also oversaw support related to medication access; medications were obtained through a
SCIENCE AND PRACTICE Identifying patients at risk for anaphylaxis
variety of means, including local $4 programs, manufacturersponsored patient assistance programs, discount cards, and samples. Periodically, the clinic would receive bulk donations of products through medical relief programs that received donations direct from manufacturers. A bulk donation of EAI created the impetus to identify patients who could benefit from the availability of this product. Patients could then be enrolled in a manufacturer assistance program for long-term access to EAI when samples became unavailable. The clinic used the Mylan Epipen Auto-Injector Patient Assistance Program, a free program for uninsured individuals with household incomes below 400% of the federal poverty limits. The application required completion by the patient and the prescriber and included documentation supporting the patient’s income and lack of insurance. Typically, once the patient was approved (within 1 week), the clinic would receive a shipment of free product to dispense to the patient as a sample. Patients were eligible to receive additional product as required and could re-enroll annually. Allergy histories were gathered and entered into the EMR by nurses during patient intake based on self-report at every medical appointment. The allergy fields consisted of a dropdown menu to choose the allergen and a separate dropdown menu to select a pre-populated list of reactions. If the allergen or response was not listed, text boxes permitted free-form typing. The clinic’s director of clinical pharmacy services worked with administrative support and the clinic’s EMR vendor, Practice Fusion, to develop a report specific to the clinic’s EMR that could search the pre-populated and free text fields within the allergy history section of the chart for any term. It was estimated that approximately 6000 individual patients in the EMR had visits completed where allergy histories were gathered. The director of clinical pharmacy services used the report to identify patients with any of the words “anaphylaxis,” “bee,” “nut,” or “shellfish” in the “allergen” or “reaction” fields within the allergy history. Terms were selected by the authors as likely to be present for patients with a previous diagnosis of an anaphylactic reaction or those at risk for anaphylaxis based on allergy history. The report generated an Excel spreadsheet with the patient name, medical record number, telephone number, date of birth, allergy, and reaction. Because anaphylaxis was a search term within the “reaction” field, some
patients with medication allergies alone were included on the generated list. Patients with a history of anaphylaxis to medications alone were not contacted, because guidelines recommend avoiding repeated exposure to the medication as opposed to prescribing EAI; an assessment for EAI need in those patients was not necessary.2 The remaining patients were contacted via telephone to have their risk factors for anaphylaxis assessed and to provide counseling. The telephone call consisted of an interview by a clinical pharmacist to gather additional information on the patient’s reported allergy history, nature of allergic response, and their use and access to viable EAI (e.g., unexpired). A general algorithm used for the service is presented in Appendix A. With the use of this information and with a physician consultation as necessary, the clinic’s clinical pharmacist assessed the patient’s need for EAI per guidelines and referred patients to a medical provider for follow-up when appropriate. Patients were considered to be EAI candidates if they reported a history of anaphylaxis or to be likely EAI candidates if they reported a systemic allergic reaction (defined as at least 2 sites involved in the response), food allergies with concomitant asthma, or allergies to high-risk foods (e.g., nuts or shellfish).8 Evaluation A cross-sectional study of patients with electronic records at the health center during the time period studied was used to describe the outcomes of the program. The Duquesne University Institutional Review Board required informed consent from participants and approved the program evaluation as research. The clinic’s privacy practices were followed during all interactions between the patients and the clinical pharmacist, and all data for the evaluation were collected in a de-identified manner consistent with the approved protocol. Inclusion criteria included adults with documentation of “bee,” “nut,” “shellfish,” or “anaphylaxis” in the allergy history fields of the EMR. Potential subjects with a history of anaphylaxis to medications alone were excluded because allergen avoidance is preferred over treatment with EAI. Patients unable to be reached by telephone or unwilling to provide informed consent also were excluded. Study enrollment procedures are summarized in Figure 1. Patients were invited to participate in the research study after the
Figure 1. Study enrollment: 95 potential subjects were identified, and 20 patients were contacted via telephone. Of the 20 patients that were contacted, 14 patients provided informed consent to participate in the study. Abbreviations used: EMR, electronic medical record; EAI, epinephrine auto-injector.
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Table 1 Summary of participant results Subject
a b c
Patient-reported allergen(s)
Patient-reported reaction(s)
EAI candidate?
EAI status
Potential treatment gap exists
1 2 3 4 5 6
Insect Insect Insect Insect Insect Insect
Likelyb Yesa Yesa Likelyb Yesa Likelyb
Expired Expired Never ordered Never ordered Never ordered Never ordered
Yes Yes Yes Yes Yes Yes
7 8 9
Yesa Unlikely Yesa
Expired Never ordered Never ordered
Yes No Yes
10 11 12 13
Insect (bee) Insect (bee) Food (egg); Insect (bee) Food (peanut) Insect (bee) Other (latex) Shellfish
Rash and facial swelling Anaphylaxis Anaphylaxis Full body swelling Anaphylaxis Rash, facial swelling, and difficulty breathing Anaphylaxis Swelling Anaphylaxis Mouth and tongue swelling Anaphylaxis Anaphylaxis Rash and breathing difficulty
Likelyc Yesa Yesa Likelyb,c
Yes Yes Yes No
14
Shellfish
Anaphylaxis
Yesa
Never ordered Never ordered Never ordered Unexpired EAI in possession Unexpired EAI in possession
(bee/wasp) (bee) (bee) (bee) (bee) (bee)
Self-reported previous diagnosis of anaphylaxis. Self-reported history of systemic allergic reaction. Self-reported allergy to specific high-risk food triggers.
pharmacist’s assessment of the patient’s need for EAI, and additional demographic data were collected on those providing informed consent to participate. The form used to collect data for program evaluation is presented in Appendix B. A treatment gap was considered to be present if the subject was an EAI candidate and did not have a viable EAI in their possession. Similarly, a likely treatment gap was defined as those who were likely EAI candidates without a viable EAI. Descriptive statistics were used (Microsoft Excel, 2013) to analyze the data to assess self-reported demographics and clinical characteristics of patients along with access to EAI. Results Of the 95 patients identified in the report, 31 were excluded because of medication-related allergy, and of the 64 eligible patients, 20 were reached by telephone and participated in the service, and 14 consented to participate in the program evaluation. The mean age of participants was 47 (range 33-65) years, and 50% of the subjects were female. A summary of the results for each participant is presented in Table 1. The most common allergy reported by patients was to bee stings (10, 71.4%); 4 subjects (28.6%) reported food allergies. Eight participants (57.1%) reported a history of anaphylaxis; those individuals were classified as having a known indication for the use of EAI. Of the remaining 6 subjects without a history of anaphylaxis, 3 were likely candidates for EAI based on a history consistent with a systemic allergic reaction in response to bee stings and 2 were likely candidates owing to a presumed allergic response to high-risk food triggers. These decisions were based on the patients’ self-reported allergic responses and the criteria outlined in the recommendations for EAI use as described previously.8 Of the 13 subjects with a clear or likely indication for EAI, 5 had been prescribed EAI in the past. Of those 5 with an EAI order, 2 had viable EAI in possession. The remaining 3 subjects possessed expired EAI. Overall, of the 14 participants, a treatment gap existed for 7 subjects (50%) with a 4
No
known indication for EAI and a likely treatment gap was present in 4 additional subjects (28.6%) with a likely indication for EAI. Discussion The use of allergy data from the EMR is an effective strategy to improve the identification of patients at risk for anaphylaxis. In the present study, 92.3% of the individuals assessed were definite or likely candidates for EAI based on patient-reported symptoms, demonstrating the potential of high sensitivity for this method of screening, a finding requiring confirmation through further study. This strategy was also applicable in identifying at-risk individuals for whom a gap in care exists and could be an innovative method for improving the EAI prescribing practices among high-risk patients. Allergy history is routinely gathered in primary care practices and community-based settings, including pharmacies. Implementation of screenings in these settings may help to improve management of anaphylaxis and access to EAI. This pilot study also demonstrates the importance of pharmacist access to EMRs, specifically allergy history fields. In this study, an alarming number of patients with an indication to receive EAI were without treatment, which further validates the need to identify patients as potential candidates for EAI based on the most recent evidence-based guidelines for managing anaphylaxis.6 This pilot program suggests that as pharmacist access to EMRs increases, there are growing opportunities for pharmacists to work collaboratively with patients and their health care providers in the long-term management of anaphylaxis. Improving access to EAI in these patients has the potential to reduce complications from anaphylaxis, which could ultimately decrease hospitalization rates and fatalities associated with anaphylaxis. This pilot study also further validates the need to identify patients as potential candidates for EAI, because 84.6% of subjects with a definite or likely need for EAI did not have viable EAI in their possession. This statistic is higher than previously
SCIENCE AND PRACTICE Identifying patients at risk for anaphylaxis
estimated.1 In addition, the results from this study may provide a more accurate estimate of EAI access among the uninsured. In the general population, fewer than one-half of patients receive a prescription for EAI after an anaphylactic reaction.1 In the present study, only 37.5% of those with a history of anaphylaxis had received an order for EAI. Therefore, it is important to realize that national estimates of EAI access may be overstated in certain patient groups, including those who are uninsured or of low income. More studies are needed to develop a better understanding of the management of anaphylaxis in low-income and uninsured adults. In addition, pharmacists and other health care providers should be aware of the different prescription assistance programs offered by various pharmaceutical manufacturers that are available for uninsured or low-income patients to improve access to epinephrine. Disparities in access among lower-income or indigent patients may exist, and that is an area for further exploration. The findings from the present study may also lend support to efforts that promote the classification of EAI as a preventive medication by the United States Preventive Services Task Force as a means for improving medication access.12 This pilot project also provides practices with strategies for incorporating population health initiatives into meaningful use of electronic health data across a variety of settings. Although any practice could potentially use the methods described herein, larger numbers of patients may be identified in those with patient populations at greater risk, such as asthma or allergy specialists. Because patients with a history of anaphylaxis may seek care in the emergency department, this service could be modified for the acute care setting to detect patients with diagnosis-related visits or admissions without EAI on discharge or for periodic follow-up to assess EAI viability and possession. These efforts could become part of transitions of care or value-added services, especially during spring or summer months when reactions to bee stings may be more likely. However, this approach will not identify all at-risk patients, especially those who are candidates for EAI based on history of IgE-mediated food allergies and concomitant asthma or high-risk food allergies. Those patients may be best identified through other points of interaction with the health care system (e.g., community pharmacies, urgent care clinics, etc.) where allergy histories are routinely documented. In all settings, pharmacists are able to assist in the evaluation and interpretation of patient-reported clinical histories and refer for further evaluation when needed. This study generated findings that promote further research to explore the impact of this model and the role of pharmacists on clinical and patient outcomes related to anaphylaxis treatment, EAI prescribing, and EAI access. This study also emphasizes the need for consistent and detailed allergy history fields with reactions noted in the EMR.
because diagnosis is beyond the scope of a pharmacist’s practice, the decision for EAI need was based on the consistency between the patient’s reported symptoms and the recommendations for EAI use listed previously.6 Nonetheless, this could have led to an overstatement in the need for EAI in those 6 patients. The higher incidence of lack of access to EAI may be the result of limitations related to the socioeconomic barriers in the population studied. Nonetheless, it is important to note that the clinic in the study had free access to EAI through manufacturer patient assistance programs, which suggests that barriers other than financial cost to the patient could have been present and contributed to the high treatment gap in this population. Concerns over the costs of EAI have recently come under intense public scrutiny; even the insured may lack access to EAI because of high deductibles and cost sharing.12 Thus, the findings from this study may be applicable to different socioeconomic groups, given the high cost associated with EAI for many patient populations, including those with insurance. Other limitations exist regarding the ability to generalize these findings owing to the population studied; however, this study also emphasizes the need for more studies to develop a better understanding of the management of anaphylaxis in low-income and uninsured adults. Despite having a large estimated number of records in the EMR, the use of data from a single center and the small incidence of anaphylaxis in the community were likely reasons for the small sample size, which also could affect the generalizability of these findings. The authors think that the description of the innovation will lead to further research in a larger and more diverse patient population. Only patients with documentation of “bee,” “nut,” “shellfish,” or “anaphylaxis” in the allergy history fields were identified; missing or incorrect data or selection bias could have prevented other allergies or triggers from being included as potential subjects in this pilot. The impact of this limitation is unknown and is an area for further research. Conclusion Pharmacist use of EMR technology is a novel strategy for identifying patients as potential candidates for EAI and patients without access to EAI. This innovation has the potential to be adapted for use in a variety of settings where pharmacists practice. This program also suggests that prescribing rates and access to EAI could be lower than national estimates among indigent patients with a previous diagnosis of anaphylaxis. This finding suggests the need for further research in a larger population. References
Limitations One limitation to the study was that assessment for EAI need was based on patient-reported recall of past clinical events, a method of data collection with inherent limitations. This determination was also based on a pharmacist’s assessment of the patient’s likely need for EAI for the 6 patients without an existing diagnosis of anaphylaxis. However,
1. Wood RA, Camargo CA, Lieberman P, et al. Anaphylaxis in America: the prevalence and characteristics of anaphylaxis in the United States. J Allergy Clin Immunol. 2014;133(2):461e467. 2. World Allergy Organization. Guidelines for the assessment and management of anaphylaxis. World Allergy Organ J. 2011;4(2):13e37. 3. Stoloff SW. Optimizing the clinical identification and management of patients at risk for anaphylaxis. J Fam Pract. 2010;59(8):S1eS8. 4. Lieberman P, Nicklas RA, Oppenheimer J, et al. The diagnosis and management of anaphylaxis practice parameter: 2010 update. J Allergy Clin Immunol. 2010;126(3):477e480.
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5. Simons FER. Anaphylaxis: recent advances in assessment and treatment. J Allergy Clin Immunol. 2009;124(4):625e636. 6. Simons FE, Ardusso LR, Dimov V, et al. World Allergy Organization anaphylaxis guidelines: 2013 update of the evidence base. Int Arch Allergy Immunol. 2013;162(3):193e204. MB, et al. 2012 update: World Allergy 7. Simons FE, Ardusso LR, Bilo Organization guidelines for the assessment and management of anaphylaxis. Curr Opin Allergy Clin Immunol. 2012;12(4):389e399. 8. Rudders SA, Banergi A. An update on self-injectable epinephrine. Curr Opin Allergy Clin Immunol. 2013;13(4):432e437. 9. Blumenthal D, Tavenner M. The “meaningful use” regulation for electronic health records. N Engl J Med. 2010;363(6):501e504. 10. Spiro RF, Gagnon JP, Knutson AR. Role of health information technology in optimizing pharmacists’ patient care services. J Am Pharm Assoc. 2010;50(1):4e8.
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11. Spiro R. The impact of electronic health records on pharmacy practice. Available at: http://www.pharmacyhit.org/pdfs/Article.pdf. Accessed January 20, 2016. 12. Fromer L. Prevention of anaphylaxis: the role of the epinephrine autoinjector. Am J Med. 2016;129(12):1244e1250. Autumn Stewart, PharmD, BCACP, CTTS, Associate Professor of Pharmacy Practice, Mylan School of Pharmacy, Duquesne University, Pittsburgh, PA, and Clinical Pharmacist, Heritage Valley Family Medicine Center, Beaver Falls, PA; at time of the research: Director of Pharmacy, Catholic Charities Free Health Care Center, Pittsburgh, PA Katherine Sulkowski, PharmD, Clinical Pharmacist, Gateway Health Plan, Pittsburgh, Pennsylvania; at time of the research: PharmD candidate, Mylan School of Pharmacy, Duquesne University, Pittsburgh, PA
SCIENCE AND PRACTICE Identifying patients at risk for anaphylaxis
Appendix A Pharmacist assessment process 1. Advise patient that clinic is offering a new service to identify patients who may be at risk for a serious allergic reaction and who may benefit by having a medication available to treat serious symptoms. 2. Conduct an individualized assessment of the patient’s history of anaphylaxis or risk factors for anaphylaxis,
for example: “Based on the allergy information in your chart it appears that you have an allergy to ___. What happens when you are exposed to ___? OR “Your chart says that you reported a history of anaphylaxis to ___. Is that correct? 3. Use algorithm below to assess patient and provide appropriate education and referral. Consult with available physician if needed. Document recommendation in pharmacy notes.
History
Sudden
History Two
OR
OR
Reduced
6.e1
SCIENCE AND PRACTICE A. Stewart, K. Sulkowski / Journal of the American Pharmacists Association xxx (2017) 1e6
Appendix B Data collection form 1. After completing the pharmacist assessment process, invite patient to participate in the research study by reading the “Consent to participate in a research study.” If patient declines, call will end. If patient accepts, document consent and complete the following data collection form. 2. Data Collection Form Patient Age: _____ Gender: , Male , Female Allergen: , Food ____________________________ , Insect ____________________________ , Other (if other, please specify) ____________________________ Reaction: , Anaphylaxis , Rash , Other (if other, please specify) ____________________________ Epinephrine access: , No EAI , Expired EAI , EAI available, but not in possession , EAI available and in possession
6.e2
Contents lists available at ScienceDirect
Journal of the American Pharmacists Association journal homepage: www.japha.org
EXPERIENCE
Pharmacist use of the electronic medical record to identify adults at risk for anaphylaxis without epinephrine for self-administration Autumn Stewart*, Katherine Sulkowski a r t i c l e i n f o
a b s t r a c t
Article history: Received 15 July 2016 Accepted 28 January 2017
Objectives: To describe an innovative pharmacist-led approach, with the use of electronic medical record (EMR) data, to identify patients at risk of anaphylaxis in need of epinephrine auto-injector (EAI) for self-administration. Setting: An urban free health care center for an uninsured indigent adult population in Pittsburgh, PA. Practice innovation: In this pilot service, patients with allergy history fields containing the words “anaphylaxis,” “nut,” “bee,” or “shellfish” were screened for inclusion. Practice description: Patients were identified with the use of a report generated by the EMR vendor and were contacted via telephone by a clinical pharmacist. Using the patient-reported clinical history related to anaphylaxis and allergies, the pharmacist assessed the need for EAI, counseled the patient, and provided physician referral when appropriate. Evaluation: The service was evaluated with the use of a cross-sectional study of patients with electronic records at the health center during the time period studied. Data obtained from patient interviews were used to classify patients who were candidates for EAI and to assess prescribing and access to EAI. Demographic data and outcomes related to the availability of non-expired EAI were collected and analyzed using descriptive statistics. Results: Ninety-five patients were identified as potential candidates for the service, and 20 patients were able to be contacted via telephone. Fourteen participants provided consent for their data to be used in the program evaluation. A treatment gap likely existed for 11 of the 14 participants (79%) owing to history of anaphylaxis (57%) or history of systemic reaction (29%). The most common indication for EAI was anaphylaxis in response to bee stings. Conclusion: The findings from this project demonstrate that pharmacist use of EMR data, coupled with patient interview, may be an effective means for identifying treatment gaps in the long-term management of anaphylaxis and has the potential to ultimately improve management of anaphylaxis in patients within the community. © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
Anaphylaxis is an acute life-threatening systemic allergic reaction typically occurring suddenly; fatality can occur within minutes if untreated.1,2 In the general population, the estimated prevalence of anaphylaxis in the United States is 1.6%,
Disclosure: All authors and members of immediate family have no conflicts of interest or financial interests in any product or service affiliated with this research, including grants, employment, gifts, stock holdings, or honoraria. Previous presentation: Portions of this work were presented at the American Pharmacists Association Annual Meeting, San Diego, CA, March 28, 2015, and the Duquesne University Annual Undergraduate Research and Scholarship Symposium, April 9, 2015. * Correspondence: Autumn Stewart, PharmD, BCACP, CTTS, Associate Professor of Pharmacy Practice, Mylan School of Pharmacy, Duquesne University, 600 Forbes Avenue, Pittsburgh, PA 15282. E-mail address: [email protected] (A. Stewart).
and an estimated 16% of people may be “at risk” for anaphylaxis.1,3 In outpatient settings, food is the most common trigger, accounting for 30% of fatal cases of anaphylaxis.4 The most common foods to cause anaphylaxis are peanuts, tree nuts, fish, and shellfish, but other foods, such as milk, soy, and egg, also can be triggers.5 Medications, insect stings, and latex are also potential allergens that can cause anaphylaxis. The diagnosis for anaphylaxis is based on clinical findings and criteria developed by the World Allergy Organization. The identification of anaphylaxis is highly likely when any 1 of the following 3 criteria is fulfilled: (1) Sudden onset of an illness with involvement of the skin, mucosal tissue, or both and at least 1 of the following: sudden respiratory symptoms and signs, and sudden
http://dx.doi.org/10.1016/j.japh.2017.01.023 1544-3191/© 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
SCIENCE AND PRACTICE A. Stewart, K. Sulkowski / Journal of the American Pharmacists Association xxx (2017) 1e6
Key Points Background: Anaphylaxis is a potentially fatal allergic reaction prevalent in an estimated 1.6% of the United States' population. Guidelines endorse the prescribing of epinephrine auto-injector (EAI) for patients with a history of anaphylaxis and those at increased risk for anaphylaxis based on allergy history. However, the majority of patients who are candidates for EAI, never receive a prescription or have ready access to it. Lack of access to EAI represents a drug therapy related problem that pharmacists may have the potential to identify and resolve. Findings: A pharmacist-led assessment of components in the allergy history as documented in the electronic medical record was an effective strategy to identify patients at risk for anaphylaxis. Of the 14 subjects included in the evaluation, 93% had a definite or likely indication for EAI. Of the 8 subjects with a diagnosis of anaphylaxis, 7 participants (87.%) did not have a viable EAI in their possession. Of the 5 subjects identified as likely candidates for EAI, 4 (80%) had it in their possession. The positive results observed in this small sample support further implementation and the potential for adaptation to a variety of practice settings where pharmacists have access to electronic medical records.
reduced blood pressure or symptoms of end-organ dysfunction; (2) Two or more of the following that occur suddenly after exposure to a likely allergen or other trigger for that patient: sudden skin or mucosal symptoms and signs, sudden respiratory symptoms and signs, sudden reduced blood pressure or symptoms of end-organ dysfunction, and sudden gastrointestinal symptoms; or (3) Reduced blood pressure after exposure to a known allergen for that patient.2,6,7 The symptoms vary from patient to patient and from case to case, creating difficulty in the diagnosis of anaphylaxis. However, symptoms usually occur in 2 or more body systems. Common presentations of anaphylaxis include upper or lower airway obstruction, cardiovascular symptoms, and gastrointestinal symptoms.5 Epinephrine remains the first-line treatment of choice and should be administered at symptom onset. Studies estimate that 54% of anaphylactic reactions occur in the home; because symptoms can occur suddenly and progress rapidly, delays in administration are possible and are associated with an increased risk of fatality.1,3,8 To expedite access to treatment, epinephrine for self-administration by patients in the form of
2
epinephrine auto-injector (EAI) is recommended for patients with a history of anaphylaxis and in those at risk for anaphylaxis. Guidelines from the Joint Council of Allergy, Asthma, and Immunology recommend prescribing EAI for the following patient groups8: (1) History of anaphylaxis with possible exposure to the allergen. (2) History of a systemic allergic reaction. (3) IgE-mediated food allergy with concomitant asthma. (4) IgE-mediated allergy to specific high-risk food triggers (e.g., peanut, tree nuts, fish and shellfish). Despite these guidelines, as many as 52% of patients with a confirmed history of anaphylaxis never receive a prescription for EAI and 60% do not have EAI available.1 The Health Information and Technology for Economic and Clinical Health Act emphasizes the “meaningful use” of data within the electronic medical record (EMR) to administer optimal care and improve health outcomes, and mandates minimum population health initiatives.9 The potential role of EMR data on pharmacy practice and suggested means for integrating pharmacist-driven clinical services into EMR frameworks have been discussed previously.10,11 Allergy history and related information is routinely gathered by health care professionals in a variety of settings. When entered into specific fields within the EMR, these data become easily searchable, making the identification of individual patients with specific risk factors possible, such as the specific characteristics that place them at risk and as potential candidates for EAI. Pharmacists are uniquely trained as experts in the recognition and resolution of drug therapyerelated problems and work to ensure the appropriate and timely use of medications in the treatment of disease. Considering the gap in timely access to EAIs as a drug therapyerelated problem and potential access to allergy history fields in the EMR, pharmacists may be able to improve the long-term management of anaphylaxis in patients at risk. Objective To describe an innovative pharmacist-led approach, with the use of EMR data, to identify patients at risk of anaphylaxis in need of EAI for self-administration. Setting Located in the downtown area of Pittsburgh, PA, Catholic Charities Free Health Care Center is a free primary and specialty care provider for an uninsured adult population. Patients must demonstrate incomes below 200% of federal poverty limits before receiving care and are seen by volunteer medical providers by appointment only. Clinical pharmacy services were established in the practice, beginning in January 2008, with a focus on medication therapy management services, immunization needs assessments, and medication reconciliation. Practice innovation The pharmacy department also oversaw support related to medication access; medications were obtained through a
SCIENCE AND PRACTICE Identifying patients at risk for anaphylaxis
variety of means, including local $4 programs, manufacturersponsored patient assistance programs, discount cards, and samples. Periodically, the clinic would receive bulk donations of products through medical relief programs that received donations direct from manufacturers. A bulk donation of EAI created the impetus to identify patients who could benefit from the availability of this product. Patients could then be enrolled in a manufacturer assistance program for long-term access to EAI when samples became unavailable. The clinic used the Mylan Epipen Auto-Injector Patient Assistance Program, a free program for uninsured individuals with household incomes below 400% of the federal poverty limits. The application required completion by the patient and the prescriber and included documentation supporting the patient’s income and lack of insurance. Typically, once the patient was approved (within 1 week), the clinic would receive a shipment of free product to dispense to the patient as a sample. Patients were eligible to receive additional product as required and could re-enroll annually. Allergy histories were gathered and entered into the EMR by nurses during patient intake based on self-report at every medical appointment. The allergy fields consisted of a dropdown menu to choose the allergen and a separate dropdown menu to select a pre-populated list of reactions. If the allergen or response was not listed, text boxes permitted free-form typing. The clinic’s director of clinical pharmacy services worked with administrative support and the clinic’s EMR vendor, Practice Fusion, to develop a report specific to the clinic’s EMR that could search the pre-populated and free text fields within the allergy history section of the chart for any term. It was estimated that approximately 6000 individual patients in the EMR had visits completed where allergy histories were gathered. The director of clinical pharmacy services used the report to identify patients with any of the words “anaphylaxis,” “bee,” “nut,” or “shellfish” in the “allergen” or “reaction” fields within the allergy history. Terms were selected by the authors as likely to be present for patients with a previous diagnosis of an anaphylactic reaction or those at risk for anaphylaxis based on allergy history. The report generated an Excel spreadsheet with the patient name, medical record number, telephone number, date of birth, allergy, and reaction. Because anaphylaxis was a search term within the “reaction” field, some
patients with medication allergies alone were included on the generated list. Patients with a history of anaphylaxis to medications alone were not contacted, because guidelines recommend avoiding repeated exposure to the medication as opposed to prescribing EAI; an assessment for EAI need in those patients was not necessary.2 The remaining patients were contacted via telephone to have their risk factors for anaphylaxis assessed and to provide counseling. The telephone call consisted of an interview by a clinical pharmacist to gather additional information on the patient’s reported allergy history, nature of allergic response, and their use and access to viable EAI (e.g., unexpired). A general algorithm used for the service is presented in Appendix A. With the use of this information and with a physician consultation as necessary, the clinic’s clinical pharmacist assessed the patient’s need for EAI per guidelines and referred patients to a medical provider for follow-up when appropriate. Patients were considered to be EAI candidates if they reported a history of anaphylaxis or to be likely EAI candidates if they reported a systemic allergic reaction (defined as at least 2 sites involved in the response), food allergies with concomitant asthma, or allergies to high-risk foods (e.g., nuts or shellfish).8 Evaluation A cross-sectional study of patients with electronic records at the health center during the time period studied was used to describe the outcomes of the program. The Duquesne University Institutional Review Board required informed consent from participants and approved the program evaluation as research. The clinic’s privacy practices were followed during all interactions between the patients and the clinical pharmacist, and all data for the evaluation were collected in a de-identified manner consistent with the approved protocol. Inclusion criteria included adults with documentation of “bee,” “nut,” “shellfish,” or “anaphylaxis” in the allergy history fields of the EMR. Potential subjects with a history of anaphylaxis to medications alone were excluded because allergen avoidance is preferred over treatment with EAI. Patients unable to be reached by telephone or unwilling to provide informed consent also were excluded. Study enrollment procedures are summarized in Figure 1. Patients were invited to participate in the research study after the
Figure 1. Study enrollment: 95 potential subjects were identified, and 20 patients were contacted via telephone. Of the 20 patients that were contacted, 14 patients provided informed consent to participate in the study. Abbreviations used: EMR, electronic medical record; EAI, epinephrine auto-injector.
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Table 1 Summary of participant results Subject
a b c
Patient-reported allergen(s)
Patient-reported reaction(s)
EAI candidate?
EAI status
Potential treatment gap exists
1 2 3 4 5 6
Insect Insect Insect Insect Insect Insect
Likelyb Yesa Yesa Likelyb Yesa Likelyb
Expired Expired Never ordered Never ordered Never ordered Never ordered
Yes Yes Yes Yes Yes Yes
7 8 9
Yesa Unlikely Yesa
Expired Never ordered Never ordered
Yes No Yes
10 11 12 13
Insect (bee) Insect (bee) Food (egg); Insect (bee) Food (peanut) Insect (bee) Other (latex) Shellfish
Rash and facial swelling Anaphylaxis Anaphylaxis Full body swelling Anaphylaxis Rash, facial swelling, and difficulty breathing Anaphylaxis Swelling Anaphylaxis Mouth and tongue swelling Anaphylaxis Anaphylaxis Rash and breathing difficulty
Likelyc Yesa Yesa Likelyb,c
Yes Yes Yes No
14
Shellfish
Anaphylaxis
Yesa
Never ordered Never ordered Never ordered Unexpired EAI in possession Unexpired EAI in possession
(bee/wasp) (bee) (bee) (bee) (bee) (bee)
Self-reported previous diagnosis of anaphylaxis. Self-reported history of systemic allergic reaction. Self-reported allergy to specific high-risk food triggers.
pharmacist’s assessment of the patient’s need for EAI, and additional demographic data were collected on those providing informed consent to participate. The form used to collect data for program evaluation is presented in Appendix B. A treatment gap was considered to be present if the subject was an EAI candidate and did not have a viable EAI in their possession. Similarly, a likely treatment gap was defined as those who were likely EAI candidates without a viable EAI. Descriptive statistics were used (Microsoft Excel, 2013) to analyze the data to assess self-reported demographics and clinical characteristics of patients along with access to EAI. Results Of the 95 patients identified in the report, 31 were excluded because of medication-related allergy, and of the 64 eligible patients, 20 were reached by telephone and participated in the service, and 14 consented to participate in the program evaluation. The mean age of participants was 47 (range 33-65) years, and 50% of the subjects were female. A summary of the results for each participant is presented in Table 1. The most common allergy reported by patients was to bee stings (10, 71.4%); 4 subjects (28.6%) reported food allergies. Eight participants (57.1%) reported a history of anaphylaxis; those individuals were classified as having a known indication for the use of EAI. Of the remaining 6 subjects without a history of anaphylaxis, 3 were likely candidates for EAI based on a history consistent with a systemic allergic reaction in response to bee stings and 2 were likely candidates owing to a presumed allergic response to high-risk food triggers. These decisions were based on the patients’ self-reported allergic responses and the criteria outlined in the recommendations for EAI use as described previously.8 Of the 13 subjects with a clear or likely indication for EAI, 5 had been prescribed EAI in the past. Of those 5 with an EAI order, 2 had viable EAI in possession. The remaining 3 subjects possessed expired EAI. Overall, of the 14 participants, a treatment gap existed for 7 subjects (50%) with a 4
No
known indication for EAI and a likely treatment gap was present in 4 additional subjects (28.6%) with a likely indication for EAI. Discussion The use of allergy data from the EMR is an effective strategy to improve the identification of patients at risk for anaphylaxis. In the present study, 92.3% of the individuals assessed were definite or likely candidates for EAI based on patient-reported symptoms, demonstrating the potential of high sensitivity for this method of screening, a finding requiring confirmation through further study. This strategy was also applicable in identifying at-risk individuals for whom a gap in care exists and could be an innovative method for improving the EAI prescribing practices among high-risk patients. Allergy history is routinely gathered in primary care practices and community-based settings, including pharmacies. Implementation of screenings in these settings may help to improve management of anaphylaxis and access to EAI. This pilot study also demonstrates the importance of pharmacist access to EMRs, specifically allergy history fields. In this study, an alarming number of patients with an indication to receive EAI were without treatment, which further validates the need to identify patients as potential candidates for EAI based on the most recent evidence-based guidelines for managing anaphylaxis.6 This pilot program suggests that as pharmacist access to EMRs increases, there are growing opportunities for pharmacists to work collaboratively with patients and their health care providers in the long-term management of anaphylaxis. Improving access to EAI in these patients has the potential to reduce complications from anaphylaxis, which could ultimately decrease hospitalization rates and fatalities associated with anaphylaxis. This pilot study also further validates the need to identify patients as potential candidates for EAI, because 84.6% of subjects with a definite or likely need for EAI did not have viable EAI in their possession. This statistic is higher than previously
SCIENCE AND PRACTICE Identifying patients at risk for anaphylaxis
estimated.1 In addition, the results from this study may provide a more accurate estimate of EAI access among the uninsured. In the general population, fewer than one-half of patients receive a prescription for EAI after an anaphylactic reaction.1 In the present study, only 37.5% of those with a history of anaphylaxis had received an order for EAI. Therefore, it is important to realize that national estimates of EAI access may be overstated in certain patient groups, including those who are uninsured or of low income. More studies are needed to develop a better understanding of the management of anaphylaxis in low-income and uninsured adults. In addition, pharmacists and other health care providers should be aware of the different prescription assistance programs offered by various pharmaceutical manufacturers that are available for uninsured or low-income patients to improve access to epinephrine. Disparities in access among lower-income or indigent patients may exist, and that is an area for further exploration. The findings from the present study may also lend support to efforts that promote the classification of EAI as a preventive medication by the United States Preventive Services Task Force as a means for improving medication access.12 This pilot project also provides practices with strategies for incorporating population health initiatives into meaningful use of electronic health data across a variety of settings. Although any practice could potentially use the methods described herein, larger numbers of patients may be identified in those with patient populations at greater risk, such as asthma or allergy specialists. Because patients with a history of anaphylaxis may seek care in the emergency department, this service could be modified for the acute care setting to detect patients with diagnosis-related visits or admissions without EAI on discharge or for periodic follow-up to assess EAI viability and possession. These efforts could become part of transitions of care or value-added services, especially during spring or summer months when reactions to bee stings may be more likely. However, this approach will not identify all at-risk patients, especially those who are candidates for EAI based on history of IgE-mediated food allergies and concomitant asthma or high-risk food allergies. Those patients may be best identified through other points of interaction with the health care system (e.g., community pharmacies, urgent care clinics, etc.) where allergy histories are routinely documented. In all settings, pharmacists are able to assist in the evaluation and interpretation of patient-reported clinical histories and refer for further evaluation when needed. This study generated findings that promote further research to explore the impact of this model and the role of pharmacists on clinical and patient outcomes related to anaphylaxis treatment, EAI prescribing, and EAI access. This study also emphasizes the need for consistent and detailed allergy history fields with reactions noted in the EMR.
because diagnosis is beyond the scope of a pharmacist’s practice, the decision for EAI need was based on the consistency between the patient’s reported symptoms and the recommendations for EAI use listed previously.6 Nonetheless, this could have led to an overstatement in the need for EAI in those 6 patients. The higher incidence of lack of access to EAI may be the result of limitations related to the socioeconomic barriers in the population studied. Nonetheless, it is important to note that the clinic in the study had free access to EAI through manufacturer patient assistance programs, which suggests that barriers other than financial cost to the patient could have been present and contributed to the high treatment gap in this population. Concerns over the costs of EAI have recently come under intense public scrutiny; even the insured may lack access to EAI because of high deductibles and cost sharing.12 Thus, the findings from this study may be applicable to different socioeconomic groups, given the high cost associated with EAI for many patient populations, including those with insurance. Other limitations exist regarding the ability to generalize these findings owing to the population studied; however, this study also emphasizes the need for more studies to develop a better understanding of the management of anaphylaxis in low-income and uninsured adults. Despite having a large estimated number of records in the EMR, the use of data from a single center and the small incidence of anaphylaxis in the community were likely reasons for the small sample size, which also could affect the generalizability of these findings. The authors think that the description of the innovation will lead to further research in a larger and more diverse patient population. Only patients with documentation of “bee,” “nut,” “shellfish,” or “anaphylaxis” in the allergy history fields were identified; missing or incorrect data or selection bias could have prevented other allergies or triggers from being included as potential subjects in this pilot. The impact of this limitation is unknown and is an area for further research. Conclusion Pharmacist use of EMR technology is a novel strategy for identifying patients as potential candidates for EAI and patients without access to EAI. This innovation has the potential to be adapted for use in a variety of settings where pharmacists practice. This program also suggests that prescribing rates and access to EAI could be lower than national estimates among indigent patients with a previous diagnosis of anaphylaxis. This finding suggests the need for further research in a larger population. References
Limitations One limitation to the study was that assessment for EAI need was based on patient-reported recall of past clinical events, a method of data collection with inherent limitations. This determination was also based on a pharmacist’s assessment of the patient’s likely need for EAI for the 6 patients without an existing diagnosis of anaphylaxis. However,
1. Wood RA, Camargo CA, Lieberman P, et al. Anaphylaxis in America: the prevalence and characteristics of anaphylaxis in the United States. J Allergy Clin Immunol. 2014;133(2):461e467. 2. World Allergy Organization. Guidelines for the assessment and management of anaphylaxis. World Allergy Organ J. 2011;4(2):13e37. 3. Stoloff SW. Optimizing the clinical identification and management of patients at risk for anaphylaxis. J Fam Pract. 2010;59(8):S1eS8. 4. Lieberman P, Nicklas RA, Oppenheimer J, et al. The diagnosis and management of anaphylaxis practice parameter: 2010 update. J Allergy Clin Immunol. 2010;126(3):477e480.
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5. Simons FER. Anaphylaxis: recent advances in assessment and treatment. J Allergy Clin Immunol. 2009;124(4):625e636. 6. Simons FE, Ardusso LR, Dimov V, et al. World Allergy Organization anaphylaxis guidelines: 2013 update of the evidence base. Int Arch Allergy Immunol. 2013;162(3):193e204. MB, et al. 2012 update: World Allergy 7. Simons FE, Ardusso LR, Bilo Organization guidelines for the assessment and management of anaphylaxis. Curr Opin Allergy Clin Immunol. 2012;12(4):389e399. 8. Rudders SA, Banergi A. An update on self-injectable epinephrine. Curr Opin Allergy Clin Immunol. 2013;13(4):432e437. 9. Blumenthal D, Tavenner M. The “meaningful use” regulation for electronic health records. N Engl J Med. 2010;363(6):501e504. 10. Spiro RF, Gagnon JP, Knutson AR. Role of health information technology in optimizing pharmacists’ patient care services. J Am Pharm Assoc. 2010;50(1):4e8.
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11. Spiro R. The impact of electronic health records on pharmacy practice. Available at: http://www.pharmacyhit.org/pdfs/Article.pdf. Accessed January 20, 2016. 12. Fromer L. Prevention of anaphylaxis: the role of the epinephrine autoinjector. Am J Med. 2016;129(12):1244e1250. Autumn Stewart, PharmD, BCACP, CTTS, Associate Professor of Pharmacy Practice, Mylan School of Pharmacy, Duquesne University, Pittsburgh, PA, and Clinical Pharmacist, Heritage Valley Family Medicine Center, Beaver Falls, PA; at time of the research: Director of Pharmacy, Catholic Charities Free Health Care Center, Pittsburgh, PA Katherine Sulkowski, PharmD, Clinical Pharmacist, Gateway Health Plan, Pittsburgh, Pennsylvania; at time of the research: PharmD candidate, Mylan School of Pharmacy, Duquesne University, Pittsburgh, PA
SCIENCE AND PRACTICE Identifying patients at risk for anaphylaxis
Appendix A Pharmacist assessment process 1. Advise patient that clinic is offering a new service to identify patients who may be at risk for a serious allergic reaction and who may benefit by having a medication available to treat serious symptoms. 2. Conduct an individualized assessment of the patient’s history of anaphylaxis or risk factors for anaphylaxis,
for example: “Based on the allergy information in your chart it appears that you have an allergy to ___. What happens when you are exposed to ___? OR “Your chart says that you reported a history of anaphylaxis to ___. Is that correct? 3. Use algorithm below to assess patient and provide appropriate education and referral. Consult with available physician if needed. Document recommendation in pharmacy notes.
History
Sudden
History Two
OR
OR
Reduced
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Appendix B Data collection form 1. After completing the pharmacist assessment process, invite patient to participate in the research study by reading the “Consent to participate in a research study.” If patient declines, call will end. If patient accepts, document consent and complete the following data collection form. 2. Data Collection Form Patient Age: _____ Gender: , Male , Female Allergen: , Food ____________________________ , Insect ____________________________ , Other (if other, please specify) ____________________________ Reaction: , Anaphylaxis , Rash , Other (if other, please specify) ____________________________ Epinephrine access: , No EAI , Expired EAI , EAI available, but not in possession , EAI available and in possession
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