Abstract

Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. This condition, often caused by certain foods, insect bites or stings, and some medications, affects an estimated 2% of people worldwide, according to the World Allergy Organization (WAO), although cases are often under-reported and under-recognized, and prevalence appears to be increasing. To manage the condition, people at risk should be properly educated about anaphylaxis and carry an epinephrine autoinjector, which can be used in an emergency to reverse the potentially fatal symptoms.While epinephrine can save lives when used promptly in cases of anaphylaxis, its use is not as widespread as it could be. WAO cited a study published in Clinical & Experimental Allergy that found that "only 14% of 164 people with fatal anaphylaxis had received epinephrine before cardiorespiratory arrest."■Pharmacists may be able to use a proposed FDA initiative to expand access to some prescription drugs.■Prescription epinephrine is one case where pharmacists can help.Pharmacists can helpEpinephrine autoinjectors require a prescription in the United States, which is one potential reason for underutilization. FDA's proposed Nonprescription Safe Use Regulatory Expansion (NSURE) Initiative seeks to address this access issue for certain medications, including emergency medications such as epinephrine, under specific conditions of safe use that would be approved by the agency.In 2012, APhA launched the Anaphylaxis Screening and Protection Program (ASAP), an innovative practice model advancement project to test a potential model similar to the concepts included in FDA's NSURE program that integrates pharmacists and technology to ensure conditions of safe use. Through ASAP, systems have been created to screen patients who may be at potential risk and enable a patient's pharmacist to take steps to obtain, through the patient's physician, an epinephrine prescription, if deemed appropriate. ASAP also enables patients to complete a knowledge assessment to determine how well they understand when and how to use a prescribed epinephrine autoinjector.In a presentation at the Brookings Institution, APhA Associate Vice President for Practice & Science Affairs James Owen, BSPharm, PharmD, BCPS, discussed anaphylaxis as a test case for pharmacists to use the NSURE framework to expand patient access, bring back and refer patients to the health care system, and communicate and collaborate with other health professionals.In ASAP, Owen explained, patients are directed to a Web-based risk assessment (www.asapmyrisk.com) that can be completed onsite at a pharmacy or at home on the patient's own computer. If the pharmacist determines that an auto- injector is indicated for the patient, the pharmacist can obtain a prescription through a collaborative drug therapy management agreement, if available, or through direct physician consultation.All about ASAPThe ASAP pilot program, undertaken by APhA through an unrestricted educational grant from Mylan Specialty L.P., has launched at 14 pharmacies. The program began with a no-cost 90-minute CPE program for all site pharmacists. The participating pharmacies will display ASAP signage, distribute patient information sheets, and direct and assist patients with the online assessment tool. Pharmacists will also have the opportunity to consult with patients and monitor their refills to encourage adherence. The program includes coupons and free patient consultations and assessments.According to Owen's presentation, ASAP offers the potential to increase access to needed therapy, reduce burden for both patients and pharmacists, increase the consistency of patient assessments, and simplify the assessment process.Alex EgervaryManaging Editor, Pharmacy TodayASAP screening questions■Have you ever had a prescription for an epinephrine autoinjector?■Do you have a family history of allergies?■Are you currently receiving immunotherapy (e.g., allergy shots), or have you received immunotherapy within the last 5 years?■Are you currently under a doctor's care for asthma, atopic dermatitis or eczema, heart disease, allergic rhinitis, or any other conditions?■Are you allergic to any triggers?■How many allergic reactions to any of these triggers have you had in your lifetime?■When did the most severe allergic reaction occur?■Which symptoms did you experience during your most severe allergic reaction?■Following your most severe allergic reaction, when did the symptoms begin?■How long did your most severe allergic reaction last?■Did you experience additional symptoms after the initial allergic reaction was over?■What course of action did you take for your most severe allergic reaction? Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. This condition, often caused by certain foods, insect bites or stings, and some medications, affects an estimated 2% of people worldwide, according to the World Allergy Organization (WAO), although cases are often under-reported and under-recognized, and prevalence appears to be increasing. To manage the condition, people at risk should be properly educated about anaphylaxis and carry an epinephrine autoinjector, which can be used in an emergency to reverse the potentially fatal symptoms. While epinephrine can save lives when used promptly in cases of anaphylaxis, its use is not as widespread as it could be. WAO cited a study published in Clinical & Experimental Allergy that found that "only 14% of 164 people with fatal anaphylaxis had received epinephrine before cardiorespiratory arrest."■Pharmacists may be able to use a proposed FDA initiative to expand access to some prescription drugs.■Prescription epinephrine is one case where pharmacists can help. ■Pharmacists may be able to use a proposed FDA initiative to expand access to some prescription drugs.■Prescription epinephrine is one case where pharmacists can help. ■Pharmacists may be able to use a proposed FDA initiative to expand access to some prescription drugs.■Prescription epinephrine is one case where pharmacists can help. Pharmacists can helpEpinephrine autoinjectors require a prescription in the United States, which is one potential reason for underutilization. FDA's proposed Nonprescription Safe Use Regulatory Expansion (NSURE) Initiative seeks to address this access issue for certain medications, including emergency medications such as epinephrine, under specific conditions of safe use that would be approved by the agency.In 2012, APhA launched the Anaphylaxis Screening and Protection Program (ASAP), an innovative practice model advancement project to test a potential model similar to the concepts included in FDA's NSURE program that integrates pharmacists and technology to ensure conditions of safe use. Through ASAP, systems have been created to screen patients who may be at potential risk and enable a patient's pharmacist to take steps to obtain, through the patient's physician, an epinephrine prescription, if deemed appropriate. ASAP also enables patients to complete a knowledge assessment to determine how well they understand when and how to use a prescribed epinephrine autoinjector.In a presentation at the Brookings Institution, APhA Associate Vice President for Practice & Science Affairs James Owen, BSPharm, PharmD, BCPS, discussed anaphylaxis as a test case for pharmacists to use the NSURE framework to expand patient access, bring back and refer patients to the health care system, and communicate and collaborate with other health professionals.In ASAP, Owen explained, patients are directed to a Web-based risk assessment (www.asapmyrisk.com) that can be completed onsite at a pharmacy or at home on the patient's own computer. If the pharmacist determines that an auto- injector is indicated for the patient, the pharmacist can obtain a prescription through a collaborative drug therapy management agreement, if available, or through direct physician consultation. Epinephrine autoinjectors require a prescription in the United States, which is one potential reason for underutilization. FDA's proposed Nonprescription Safe Use Regulatory Expansion (NSURE) Initiative seeks to address this access issue for certain medications, including emergency medications such as epinephrine, under specific conditions of safe use that would be approved by the agency. In 2012, APhA launched the Anaphylaxis Screening and Protection Program (ASAP), an innovative practice model advancement project to test a potential model similar to the concepts included in FDA's NSURE program that integrates pharmacists and technology to ensure conditions of safe use. Through ASAP, systems have been created to screen patients who may be at potential risk and enable a patient's pharmacist to take steps to obtain, through the patient's physician, an epinephrine prescription, if deemed appropriate. ASAP also enables patients to complete a knowledge assessment to determine how well they understand when and how to use a prescribed epinephrine autoinjector. In a presentation at the Brookings Institution, APhA Associate Vice President for Practice & Science Affairs James Owen, BSPharm, PharmD, BCPS, discussed anaphylaxis as a test case for pharmacists to use the NSURE framework to expand patient access, bring back and refer patients to the health care system, and communicate and collaborate with other health professionals. In ASAP, Owen explained, patients are directed to a Web-based risk assessment (www.asapmyrisk.com) that can be completed onsite at a pharmacy or at home on the patient's own computer. If the pharmacist determines that an auto- injector is indicated for the patient, the pharmacist can obtain a prescription through a collaborative drug therapy management agreement, if available, or through direct physician consultation. All about ASAPThe ASAP pilot program, undertaken by APhA through an unrestricted educational grant from Mylan Specialty L.P., has launched at 14 pharmacies. The program began with a no-cost 90-minute CPE program for all site pharmacists. The participating pharmacies will display ASAP signage, distribute patient information sheets, and direct and assist patients with the online assessment tool. Pharmacists will also have the opportunity to consult with patients and monitor their refills to encourage adherence. The program includes coupons and free patient consultations and assessments.According to Owen's presentation, ASAP offers the potential to increase access to needed therapy, reduce burden for both patients and pharmacists, increase the consistency of patient assessments, and simplify the assessment process. The ASAP pilot program, undertaken by APhA through an unrestricted educational grant from Mylan Specialty L.P., has launched at 14 pharmacies. The program began with a no-cost 90-minute CPE program for all site pharmacists. The participating pharmacies will display ASAP signage, distribute patient information sheets, and direct and assist patients with the online assessment tool. Pharmacists will also have the opportunity to consult with patients and monitor their refills to encourage adherence. The program includes coupons and free patient consultations and assessments. According to Owen's presentation, ASAP offers the potential to increase access to needed therapy, reduce burden for both patients and pharmacists, increase the consistency of patient assessments, and simplify the assessment process. Alex EgervaryManaging Editor, Pharmacy TodayASAP screening questions■Have you ever had a prescription for an epinephrine autoinjector?■Do you have a family history of allergies?■Are you currently receiving immunotherapy (e.g., allergy shots), or have you received immunotherapy within the last 5 years?■Are you currently under a doctor's care for asthma, atopic dermatitis or eczema, heart disease, allergic rhinitis, or any other conditions?■Are you allergic to any triggers?■How many allergic reactions to any of these triggers have you had in your lifetime?■When did the most severe allergic reaction occur?■Which symptoms did you experience during your most severe allergic reaction?■Following your most severe allergic reaction, when did the symptoms begin?■How long did your most severe allergic reaction last?■Did you experience additional symptoms after the initial allergic reaction was over?■What course of action did you take for your most severe allergic reaction? Managing Editor, Pharmacy TodayASAP screening questions■Have you ever had a prescription for an epinephrine autoinjector?■Do you have a family history of allergies?■Are you currently receiving immunotherapy (e.g., allergy shots), or have you received immunotherapy within the last 5 years?■Are you currently under a doctor's care for asthma, atopic dermatitis or eczema, heart disease, allergic rhinitis, or any other conditions?■Are you allergic to any triggers?■How many allergic reactions to any of these triggers have you had in your lifetime?■When did the most severe allergic reaction occur?■Which symptoms did you experience during your most severe allergic reaction?■Following your most severe allergic reaction, when did the symptoms begin?■How long did your most severe allergic reaction last?■Did you experience additional symptoms after the initial allergic reaction was over?■What course of action did you take for your most severe allergic reaction? ■Have you ever had a prescription for an epinephrine autoinjector?■Do you have a family history of allergies?■Are you currently receiving immunotherapy (e.g., allergy shots), or have you received immunotherapy within the last 5 years?■Are you currently under a doctor's care for asthma, atopic dermatitis or eczema, heart disease, allergic rhinitis, or any other conditions?■Are you allergic to any triggers?■How many allergic reactions to any of these triggers have you had in your lifetime?■When did the most severe allergic reaction occur?■Which symptoms did you experience during your most severe allergic reaction?■Following your most severe allergic reaction, when did the symptoms begin?■How long did your most severe allergic reaction last?■Did you experience additional symptoms after the initial allergic reaction was over?■What course of action did you take for your most severe allergic reaction? ■Have you ever had a prescription for an epinephrine autoinjector?■Do you have a family history of allergies?■Are you currently receiving immunotherapy (e.g., allergy shots), or have you received immunotherapy within the last 5 years?■Are you currently under a doctor's care for asthma, atopic dermatitis or eczema, heart disease, allergic rhinitis, or any other conditions?■Are you allergic to any triggers?■How many allergic reactions to any of these triggers have you had in your lifetime?■When did the most severe allergic reaction occur?■Which symptoms did you experience during your most severe allergic reaction?■Following your most severe allergic reaction, when did the symptoms begin?■How long did your most severe allergic reaction last?■Did you experience additional symptoms after the initial allergic reaction was over?■What course of action did you take for your most severe allergic reaction?

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