Methods and systems for managing the dispensing and treatment of food allergy oral immunotherapy medications

Abstract

Methods and systems for managing the dispensing of medications containing food allergens are described herein. Exemplary methods allow for registration of distributors, pharmacies, healthcare facilities, healthcare providers, and / or patients in a medication dispensing management database for the medication, where dispensing or provision of the medication is contingent upon securing one or more of the entities registered in the medication dispensing management database. Other methods for utilizing the medication dispensing management database are also described.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 62 / 938,180, filed on November 20, 2019, and U.S. Provisional Patent Application Serial No. 63 / 056,492, filed on July 24, 2020; the contents of each application are incorporated herein by reference in their entirety. Technical Field

[0003] A computer-implemented method for managing the dispensing of a medication containing a food allergen is described herein. Also described are electronic systems and devices for implementing this method. Also provided are methods for treating a patient with food allergies via oral immunotherapy, including managing the dispensing of a medication containing a food allergen, and related electronic devices and systems. Background Art

[0004] Food allergies are common, long-term conditions that typically develop in early childhood. Peanut allergy is the most common food allergy, affecting approximately 2% of children in the United States, and approximately 80% of children with peanut allergy will develop a lifelong peanut allergy. Because peanut protein is present in many foods and there are multiple contamination possibilities, allergic reactions from accidental peanut exposure are common. Peanut allergy is the most common cause of severe, potentially life-threatening anaphylaxis and fatal allergic reactions from food.

[0005] A recently developed pharmaceutical composition, PALFORZIA, contains peanut flour formulated with excipients and packaged into unit doses at carefully controlled dosage levels. TM [Peanut / Arachis hypogaea allergen powder - dnfp] has been developed for the purpose of treating peanut allergies in patients using oral immunotherapy. See, for example, U.S. Patent No. 9,198,869; U.S. Patent No. 9,492,535; U.S. Patent No. 10,086,068; and U.S. Patent No. 10,449,118; each of which is incorporated herein by reference for all purposes. The drug is formulated as an oral powder containing a characterized peanut allergen that is administered once daily by mixing the powder with food. The pharmaceutical composition is used as an oral immunotherapy to reduce the incidence and severity of allergic reactions (including anaphylaxis) after accidental exposure to peanuts in patients aged 4 to 17 years with a confirmed peanut allergy. Other oral immunotherapy pharmaceutical compositions containing formulated protein allergen powders have also been developed for other food allergies, such as egg white allergy or various tree nut allergies. See, for example, WO 2016 / 033094 and WO 2018 / 132733, each of which is incorporated herein by reference for all purposes.

[0006] The dosing regimen for oral immunotherapy drugs is usually administered in three phases: initial dose escalation, dosing, and maintenance. When monitoring the patient for allergic reactions, the initial dose escalation is administered as a series of smaller but gradually increasing doses of the drug. The dosing phase typically involves administering a set dose (i.e., level) of the drug daily for a period of time before administering a higher dose of the drug to the patient for a certain period of time. After the dosing phase, a set of maintenance doses of the drug is administered to the patient. Summary of the Invention

[0007] Described herein are computer-implemented methods for authorizing the dispensing of a medication that includes a food allergen for oral immunotherapy. Also described are electronic devices comprising a memory storing one or more programs for implementing the medication dispensing management method, a computer-readable medium storing one or more programs for implementing the medication dispensing management method, and a computer program that, when executed by a computer, implements the medication dispensing method. Also described herein are methods of dispensing medication or treating a patient with medication.

[0008] In some embodiments, a computer-implemented method for authorizing the provision of a medication containing a food allergen to a healthcare facility includes: (a) receiving, at a first electronic device communicatively coupled to a medication dispensing management database for the medication, a healthcare facility registration verification request and a patient registration verification request from a second electronic device associated with a pharmacy registered in the medication dispensing management database, the healthcare facility registration verification request including healthcare facility information of the healthcare facility and the patient registration verification request including patient information of the patient; (b) generating a healthcare facility registration status at the first electronic device, including (i) accessing the medication dispensing management database, (ii) comparing the healthcare facility information in the healthcare facility registration verification request with the registered healthcare facility information in the medication dispensing management database, and (iii) obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database, or obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database. (c) generating a patient registration status at the first electronic device, comprising (i) accessing the medication dispensing management database, (ii) comparing the patient information in the patient registration verification request with the registered patient information in the medication dispensing management database, and (iii) obtaining a positive patient registration status by identifying a match between the patient information in the patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the patient registration verification request and the patient information in the medication dispensing management database; and (d) sending the healthcare facility registration status and the patient registration status to the second electronic device, wherein receipt of the positive healthcare facility registration status and the positive patient registration status by the pharmacy authorizes the pharmacy to provide the healthcare facility with an initial dose escalation kit associated with the patient, the initial dose escalation kit including a plurality of different doses of the medication according to an initial dose escalation schedule.In some embodiments, step (a) further comprises receiving, at the first electronic device, a healthcare provider registration verification request from the second electronic device, the healthcare provider registration verification request comprising healthcare provider information of the healthcare provider; wherein the method further comprises the step of generating, at the first electronic device, a healthcare provider registration status, the step comprising (i) accessing the medication dispensing management database, (ii) comparing the healthcare provider information in the healthcare provider registration verification request with the registered healthcare provider information in the medication dispensing management database, and (iii) comparing the healthcare provider information in the healthcare provider registration verification request with the registered healthcare provider information in the medication dispensing management database by identifying the healthcare provider information in the healthcare provider registration verification request with the registered healthcare provider information in the medication dispensing management database. wherein step (d) further comprises transmitting the healthcare provider registration status to the second electronic device, wherein receipt by the pharmacy of each of the positive healthcare facility registration status, the positive patient registration status, and the positive healthcare provider registration status authorizes the pharmacy to provide the initial dose escalation kit associated with the patient to the healthcare facility.

[0009] In some embodiments, a computer-implemented method for authorizing the provision of a medication containing a food allergen to a healthcare facility or patient, the computer-implemented method comprising: (a) receiving, at a first electronic device communicatively coupled to a medication dispensing management database for the medication, a healthcare facility registration verification request and a patient registration verification request from a second electronic device associated with a pharmacy registered in the medication dispensing management database, the healthcare facility registration verification request including healthcare facility information of the healthcare facility and the patient registration verification request including patient information of the patient; (b) generating a healthcare facility registration status at the first electronic device, comprising (i) accessing the medication dispensing management database, (ii) comparing the healthcare facility information in the healthcare facility registration verification request with the registered healthcare facility information in the medication dispensing management database, and (iii) obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database, or obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database. (c) generating a patient registration status at the first electronic device, comprising (i) accessing the medication dispensing management database, (ii) comparing the patient information in the patient registration verification request with the registered patient information in the medication dispensing management database, and (iii) obtaining a positive patient registration status by identifying a match between the patient information in the patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the patient registration verification request and the patient information in the medication dispensing management database; and (d) sending the healthcare facility registration status and the patient registration status to the second electronic device, wherein receipt of the positive healthcare facility registration status and the positive patient registration status by the pharmacy authorizes the pharmacy to provide multiple doses of the medication at a single therapeutic dose level to the healthcare facility or the patient according to the oral immunotherapy dosing schedule.In some embodiments, step (a) further comprises receiving, at the first electronic device, a healthcare provider registration verification request from the second electronic device, the healthcare provider registration verification request comprising healthcare provider information of the healthcare provider; wherein the method further comprises generating, at the first electronic device, a healthcare provider registration status, comprising (i) accessing the medication dispensing management database, (ii) comparing the healthcare provider information in the healthcare provider registration verification request with registered healthcare provider information in the medication dispensing management database, and (iii) comparing the healthcare provider information in the healthcare provider registration verification request with the healthcare provider information registered in the medication dispensing management database by identifying the healthcare provider information in the healthcare provider registration verification request with the healthcare provider information in the medication dispensing management database. wherein the pharmacy receives the healthcare provider registration status from the pharmacy, ...

[0010] In some embodiments, a computer-implemented method for authorizing provision of a medication containing a food allergen to a patient includes: (a) receiving, at a first electronic device communicatively coupled to a medication dispensing management database for the medication, a healthcare provider registration verification request and a patient registration verification request from a second electronic device associated with a pharmacy registered in the medication dispensing management database, the healthcare provider registration verification request including healthcare provider information of a healthcare provider, the patient registration verification request including patient information of a patient; and (b) generating, at the first electronic device, a healthcare provider registration status, including (i) accessing the medication dispensing management database, (ii) comparing the healthcare provider information in the healthcare provider registration verification request with the registered healthcare provider information in the medication dispensing management database, and (iii) obtaining a positive healthcare provider registration status by identifying a match between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database, or obtaining a positive healthcare provider registration status by identifying no match between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database. (c) generating a patient registration status at the first electronic device, comprising (i) accessing the medication dispensing management database, (ii) comparing the patient information in the patient registration verification request with the registered patient information in the medication dispensing management database, and (iii) obtaining a positive patient registration status by identifying a match between the patient information in the patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the patient registration verification request and the patient information in the medication dispensing management database; and (d) sending the healthcare provider registration status and the patient registration status to the second electronic device, wherein receipt of the positive healthcare provider registration status and the positive patient registration status by the pharmacy authorizes the pharmacy to provide multiple doses of the medication at a single therapeutic dose level to the healthcare provider or the patient according to the oral immunotherapy dosing schedule. In some embodiments, the method further comprises repeating steps (a) through (d) at a plurality of different therapeutic dose levels, wherein the pharmacy is not authorized to simultaneously provide the drug at more than one therapeutic dose level for the patient.

[0011] In some embodiments of the above method, the method also includes receiving a patient registration request by the first electronic device, the patient registration request including patient information of the patient; and adding an entry including the patient information to the drug distribution management database at the first electronic device to register the patient in the drug distribution management database.

[0012] In some embodiments of the above method, the method also includes receiving a pharmacy registration request at the first electronic device, the pharmacy registration request including pharmacy information of the drug; and adding an entry including the pharmacy information to the drug distribution management database at the first electronic device to register the pharmacy in the drug distribution management database.

[0013] In some embodiments of the above method, the method also includes receiving a healthcare institution registration request at the first electronic device, the healthcare institution registration request including healthcare institution information of the healthcare institution; and adding an entry including the healthcare institution information to the drug distribution management database at the first electronic device to register the healthcare institution in the drug distribution management database.

[0014] In some embodiments of the above method, the method further includes receiving a healthcare provider registration request at the first electronic device, the healthcare provider registration request including healthcare provider information of the healthcare provider; and adding an entry including the healthcare provider information to the medication dispensing management database at the first electronic device to register the healthcare provider in the medication dispensing management database.

[0015] Also described herein is a computer program product comprising instructions which, when executed by a computer, cause the computer to perform the steps of any one of the methods described above.

[0016] In some embodiments, an electronic device includes one or more processors; a memory configured to store a medication dispensing management database for medications containing food allergens, the medication dispensing management database including an entry for a registered patient including registered patient information, an entry for a registered healthcare facility including registered healthcare facility information, and an entry for a registered pharmacy including registered pharmacy information; and one or more programs stored on the memory, the one or more programs configured to be executed by the one or more processors, the one or more programs including instructions for the following steps: (a) receiving a healthcare facility registration verification request and a patient registration verification request from a second electronic device associated with a pharmacy registered in the medication dispensing management database, the healthcare facility registration verification request including healthcare facility information of a healthcare facility, the patient registration verification request including patient information of a patient; (b) generating, by the one or more processors, a healthcare facility registration status, comprising (i) accessing the medication dispensing management database, (ii) comparing the healthcare facility information in the healthcare facility registration verification request with the healthcare facility information in the medication dispensing management database, and (iii) verifying that the healthcare facility information in the healthcare facility registration verification request is consistent with the healthcare facility information in the medication dispensing management database. and (iii) obtaining a positive healthcare institution registration status by identifying a match between the healthcare institution information in the healthcare institution registration verification request and the healthcare institution information in the medication dispensing management database, or obtaining a negative healthcare institution registration status if no match is identified between the healthcare institution information in the healthcare institution registration verification request and the healthcare institution information in the medication dispensing management database; and (c) generating a patient registration status by the one or more processors, including (i) accessing the medication dispensing management database, (ii) comparing the patient information in the patient registration verification request with the registered patient information in the medication dispensing management database, and (iii) comparing the patient information in the patient registration verification request with the registered patient information in the medication dispensing management database by identifying a match between the patient information in the patient registration verification request and the healthcare institution information in the medication dispensing management database. and (c) obtaining a positive patient registration status based on a match between the patient information in the patient registration verification request and the patient information in the medication distribution management database, or obtaining a negative patient registration status if no match is identified between the patient information in the patient registration verification request and the patient information in the medication distribution management database; and (d) sending the healthcare facility registration status and the patient registration status to the second electronic device, wherein receipt of the positive healthcare facility registration status and the positive patient registration status by the pharmacy authorizes the pharmacy to provide an initial dose escalation kit associated with the patient to the healthcare facility, the initial dose escalation kit including a plurality of different doses of the medication according to an initial dose escalation schedule.In some embodiments, the medication dispensing management database further includes an entry for a registered healthcare provider including registered healthcare provider information; wherein the instructions of (a) further include receiving, at the first electronic device, a healthcare provider registration verification request from the second electronic device, the healthcare provider registration verification request including healthcare provider information of the healthcare provider; wherein the one or more programs further include instructions for generating, at the first electronic device, a healthcare provider registration status, comprising (i) accessing the medication dispensing management database, (ii) comparing the healthcare provider information in the healthcare provider registration verification request with the registered healthcare provider information in the medication dispensing management database, and (iii) registering the healthcare provider by identifying the healthcare provider. wherein the instructions of (d) further comprise transmitting the healthcare provider registration status to the second electronic device, wherein receipt by the pharmacy of each of a positive healthcare facility registration status, a positive patient registration status, and a positive healthcare provider registration status authorizes the pharmacy to provide the healthcare facility with the initial dose escalation kit associated with the patient.

[0017] In some embodiments, an electronic device includes one or more processors; a memory configured to store a medication dispensing management database for medications containing food allergens, the medication dispensing management database including entries for registered patients including registered patient information, entries for registered healthcare providers including registered healthcare provider information, and entries for registered pharmacies including registered pharmacy information; and one or more programs stored on the memory, the one or more programs configured to be executed by the one or more processors, the one or more programs including instructions for: (a) receiving a medication from a patient associated with a food allergen; a second electronic device associated with a pharmacy registered in the medication dispensing management database receives a healthcare provider registration verification request and a patient registration verification request, wherein the healthcare provider registration verification request includes healthcare provider information of the healthcare provider and the patient registration verification request includes patient information of the patient; (b) generating a healthcare provider registration status at the first electronic device, comprising (i) accessing the medication dispensing management database, (ii) comparing the healthcare provider information in the healthcare provider registration verification request with the healthcare provider information registered in the medication dispensing management database, and (iii) identifying the healthcare provider in the healthcare provider registration verification request. and (c) generating a patient registration status at the first electronic device, comprising: (i) accessing the medication dispensing management database, (ii) comparing the patient information in the patient registration verification request with the registered patient information in the medication dispensing management database, and (iii) identifying the patient registration status by comparing the patient information in the patient registration verification request with the registered patient information in the medication dispensing management database. the pharmacy obtaining a positive patient registration status based on a match between the patient information in the patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the patient registration verification request and the patient information in the medication dispensing management database; and (d) sending the healthcare provider registration status and the patient registration status to the second electronic device, wherein receipt of the positive healthcare provider registration status and the positive patient registration status by the pharmacy authorizes the pharmacy to provide multiple doses of the medication at a single therapeutic dose level to the healthcare provider or the patient in accordance with the oral immunotherapy dosing schedule.

[0018] In some embodiments, an electronic device includes one or more processors; a memory configured to store a medication dispensing management database for medications containing food allergens, the medication dispensing management database including an entry for a registered patient including registered patient information, an entry for a registered healthcare facility including registered healthcare facility information, and an entry for a registered pharmacy including registered pharmacy information; and one or more programs stored on the memory, the one or more programs configured to be executed by the one or more processors, the one or more programs including instructions for the following steps: (a) receiving a healthcare facility registration verification request and a patient registration verification request from a second electronic device associated with a pharmacy registered in the medication dispensing management database, the healthcare facility registration verification request including healthcare facility information of a healthcare facility, the patient registration verification request including patient information of a patient; (b) generating, by the one or more processors, a healthcare facility registration status, comprising (i) accessing the medication dispensing management database, (ii) comparing the healthcare facility information in the healthcare facility registration verification request with the healthcare facility information in the medication dispensing management database, and (iii) registering a healthcare facility registration status by identifying the healthcare facility information in the healthcare facility registration verification request. the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database to obtain a positive healthcare facility registration status, or a negative healthcare facility registration status if no match is identified between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database; (c) generating, by the one or more processors, a patient registration status, comprising (i) accessing the medication dispensing management database, (ii) comparing the patient information in the patient registration verification request with the registered patient information in the medication dispensing management database, and (iii) obtaining a positive patient registration status by identifying a match between the patient information in the patient registration verification request and the patient information in the medication dispensing management database, or a negative patient registration status if no match is identified between the patient information in the patient registration verification request and the patient information in the medication dispensing management database; and (d) transmitting the healthcare facility registration status and the patient registration status to the second electronic device, wherein receipt by the pharmacy of the positive healthcare facility registration status and the positive patient registration status authorizes the pharmacy to provide multiple doses of the medication at a single therapeutic dose level to the healthcare facility or the patient according to the oral immunotherapy dosing schedule. In some embodiments, the one or more programs further comprise instructions for repeating steps (a) through (d) at a plurality of different therapeutic dose levels, wherein the pharmacy is not authorized to simultaneously provide the drug at more than one therapeutic dose level for the patient.In some embodiments, the medication dispensing management database further includes an entry for a registered healthcare provider including registered healthcare provider information; wherein the instructions of (a) further include receiving a healthcare provider registration verification request from the second electronic device associated with the pharmacy registered in the medication dispensing management database, the healthcare provider registration verification request including healthcare provider information of the healthcare provider; wherein the one or more programs further include instructions for generating, by the one or more processors, a healthcare provider registration status, comprising (i) accessing the medication dispensing management database, (ii) comparing the healthcare provider information in the healthcare provider registration verification request with the registered healthcare provider information in the medication dispensing management database, and (iii) registering the healthcare provider by identifying the healthcare provider. wherein the instructions of (d) further comprise transmitting the healthcare provider registration status to the second electronic device, wherein receipt by the pharmacy of each of the positive healthcare facility registration status, the positive patient registration status, and the positive healthcare provider registration status authorizes the pharmacy to provide the plurality of doses of the medication at a single therapeutic dosage level to the healthcare facility, the healthcare provider, or the patient.

[0019] In some embodiments of any of the above-mentioned electronic devices, the one or more programs also include instructions for the following steps: receiving a patient registration request by the one or more processors, the patient registration request including patient information of the patient; and adding an entry including the patient information to the medication distribution management database by the one or more processors to register the patient in the medication distribution management database.

[0020] In some embodiments of any of the above-mentioned electronic devices, the one or more programs also include instructions for the following steps: receiving a pharmacy registration request by the one or more processors, the pharmacy registration request including pharmacy information of the pharmacy; and adding an entry including the pharmacy information to the drug distribution management database by the one or more processors to register the pharmacy in the drug distribution management database.

[0021] In some embodiments of any of the above-mentioned electronic devices, the one or more programs also include instructions for the following steps: receiving a healthcare institution registration request by the one or more processors, the healthcare institution registration request including healthcare institution information for the healthcare institution; and adding an entry including the healthcare institution information to the drug distribution management database by the one or more processors to register the healthcare institution in the drug distribution management database.

[0022] In some embodiments of any of the foregoing electronic devices, the one or more programs further comprise instructions for: receiving, by the one or more processors, a healthcare provider registration request, the healthcare provider registration request comprising healthcare provider information of the healthcare provider; and adding, by the one or more processors, an entry comprising the healthcare provider information to the medication dispensing management database to register the healthcare provider in the medication dispensing management database.

[0023] In some embodiments, a non-transitory computer-readable storage medium storing one or more programs, the one or more programs including instructions that, when executed by one or more processors of an electronic device, cause the electronic device to: (a) receive a healthcare facility registration verification request and a patient registration verification request from a second electronic device associated with a pharmacy registered in a medication dispensing management database for medications containing food allergens, the healthcare facility registration verification request including healthcare facility information of the healthcare facility and the patient registration verification request including patient information of the patient; and (b) generate, by the one or more processors, a healthcare facility registration status by: (i) accessing the medication dispensing management database, (ii) comparing the healthcare facility information in the healthcare facility registration verification request with the healthcare facility information in the medication dispensing management database, and (iii) obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database, or obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database, or obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database. and (c) generating a patient registration status by the one or more processors by: (i) accessing the medication dispensing management database, (ii) comparing the patient information in the patient registration verification request with the registered patient information in the medication dispensing management database, and (iii) obtaining a positive patient registration status by identifying a match between the patient information in the patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the patient registration verification request and the patient information in the medication dispensing management database; and (d) sending the healthcare facility registration status and the patient registration status to the second electronic device, wherein receipt of the positive healthcare facility registration status and the positive patient registration status by the pharmacy authorizes the pharmacy to provide the healthcare facility with an initial dose escalation kit associated with the patient, the initial dose escalation kit including a plurality of different doses of the medication according to an initial dose escalation schedule.In some embodiments, step (a) further comprises receiving a healthcare provider registration verification request from the second electronic device, the healthcare provider registration verification request comprising healthcare provider information of a healthcare provider; wherein the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device, by the one or more processors, to generate the healthcare provider registration status by: (i) accessing the medication dispensing management database, (ii) comparing the healthcare provider information in the healthcare provider registration verification request with the registered healthcare provider information in the medication dispensing management database, and (iii) identifying the healthcare provider information in the healthcare provider registration verification request. wherein step (d) further comprises transmitting the healthcare provider registration status to the second electronic device, wherein receipt by the pharmacy of each of the positive healthcare facility registration status, the positive patient registration status, and the positive healthcare provider registration status authorizes the pharmacy to provide the initial dose escalation kit associated with the patient to the healthcare facility.

[0024] In some embodiments, a non-transitory computer-readable storage medium storing one or more programs comprising instructions that, when executed by one or more processors of an electronic device, causes the electronic device to: (a) receive a healthcare provider registration verification request and a patient registration verification request from a second electronic device associated with a pharmacy registered in a medication dispensing management database for medications containing food allergens, the healthcare provider registration verification request including healthcare provider information of a healthcare provider, the patient registration verification request including patient information of a patient; and (b) generate, by the one or more processors, a healthcare provider registration status by: (i) accessing the medication dispensing management database, (ii) comparing the healthcare provider information in the healthcare provider registration verification request with the healthcare provider information in the medication dispensing management database, and (iii) obtaining a positive healthcare provider registration status by identifying a match between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database, or obtaining a positive healthcare provider registration status by identifying a match between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database, or obtaining a positive healthcare provider registration status by identifying a match between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database. (c) generating, by the one or more processors, a patient registration status by: (i) accessing the medication dispensing management database, (ii) comparing the patient information in the patient registration verification request with the registered patient information in the medication dispensing management database, and (iii) obtaining a positive patient registration status by identifying a match between the patient information in the healthcare institution registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the patient registration verification request and the patient information in the medication dispensing management database; and (d) transmitting the healthcare provider registration status and the patient registration status to the second electronic device, wherein receipt of the positive healthcare provider registration status and the positive patient registration status by the pharmacy authorizes the pharmacy to provide multiple doses of the medication at a single therapeutic dose level to the healthcare provider or the patient according to the oral immunotherapy dosing schedule.

[0025] In some embodiments, a non-transitory computer-readable storage medium storing one or more programs, the one or more programs including instructions that, when executed by one or more processors of an electronic device, causes the electronic device to: (a) receive a healthcare facility registration verification request and a patient registration verification request from a second electronic device associated with a pharmacy registered in a medication dispensing management database for medications containing food allergens, the healthcare facility registration verification request including healthcare facility information of the healthcare facility, and the patient registration verification request including patient information of the patient; and (b) generate a healthcare facility registration status by the one or more processors by: (i) accessing the medication dispensing management database, (ii) comparing the healthcare facility information in the healthcare facility registration verification request with the healthcare facility information in the medication dispensing management database, and (iii) obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database, or obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database, or obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database. (c) generating a patient registration status by the one or more processors by: (i) accessing the medication dispensing management database, (ii) comparing the patient information in the patient registration verification request with the registered patient information in the medication dispensing management database, and (iii) obtaining a positive patient registration status by identifying a match between the patient information in the patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the patient registration verification request and the patient information in the medication dispensing management database; and (d) sending the healthcare facility registration status and the patient registration status to the second electronic device, wherein receipt of the positive healthcare facility registration status and the positive patient registration status by the pharmacy authorizes the pharmacy to provide multiple doses of the medication at a single therapeutic dose level to the healthcare facility or the patient according to the oral immunotherapy dosing schedule.In some embodiments, (a) further includes receiving a healthcare provider registration verification request from the second electronic device associated with the pharmacy registered in the medication dispensing management database, the healthcare provider registration verification request including healthcare provider information of a healthcare provider; wherein the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device, by the one or more processors, to generate a healthcare provider registration status, including (i) accessing the medication dispensing management database, (ii) comparing the healthcare provider information in the healthcare provider registration verification request with the registered healthcare provider information in the medication dispensing management database, and (iii) identifying the healthcare provider registration verification request by the healthcare provider registration verification request. wherein (a) receiving the healthcare provider registration status from the pharmacy and (b) receiving the healthcare provider registration status from the pharmacy and (c) receiving the healthcare provider registration status from the pharmacy and (d) receiving the healthcare provider registration status from the pharmacy; wherein (b) receiving the healthcare provider registration status from the pharmacy and (d) receiving the healthcare provider registration status from the pharmacy and (e) receiving the healthcare provider registration status from the pharmacy and (f) receiving the healthcare provider registration status from the pharmacy; wherein (c) receiving the healthcare provider registration status from the pharmacy and (f) receiving the healthcare provider registration status from the pharmacy and (f) receiving the healthcare provider registration status from the pharmacy; wherein (d ...; wherein (d) receiving the healthcare provider registration status from the pharmacy and (f) receiving the healthcare provider registration status from the pharmacy; wherein (d) receiving

[0026] In some embodiments of any one of the above-mentioned storage media, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive a patient registration request by the one or more processors, the patient registration request including patient information of the patient; and add an entry including the patient information to the medication distribution management database by the one or more processors to register the patient in the medication distribution management database.

[0027] In some embodiments of any one of the above-mentioned storage media, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive a pharmacy registration request by the one or more processors, the pharmacy registration request including pharmacy information of the pharmacy; and add an entry including the pharmacy information to the drug dispensing management database by the one or more processors to register the pharmacy in the drug dispensing management database.

[0028] In some embodiments of any one of the above-mentioned storage media, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive a healthcare institution registration request by the one or more processors, the healthcare institution registration request including healthcare institution information of the healthcare institution; and add an entry including the healthcare institution information to the drug distribution management database by the one or more processors to register the healthcare institution in the drug distribution management database.

[0029] In some embodiments of any of the foregoing storage media, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive, by the one or more processors, a healthcare provider registration request, the healthcare provider registration request including healthcare provider information of the healthcare provider; and add, by the one or more processors, an entry including the healthcare provider information to the medication dispensing management database to register the healthcare provider in the medication dispensing management database.

[0030] In some embodiments, a computer-implemented method for authorizing the provision of a medication containing a food allergen to a pharmacy includes: (a) receiving, at a first electronic device communicatively coupled to a medication dispensing management database for the medication, a pharmacy registration verification request from a second electronic device associated with a distributor registered in the medication dispensing management database, the pharmacy registration verification request including pharmacy information of the pharmacy; (b) generating a pharmacy registration status at the first electronic device, including (i) accessing the medication dispensing management database, (ii) comparing the pharmacy information in the pharmacy registration verification request with the registered pharmacy information in the medication dispensing management database, and (iii) obtaining a positive pharmacy registration status by identifying a match between the pharmacy information in the pharmacy registration verification request and the pharmacy information in the medication dispensing management database, or obtaining a negative pharmacy registration status if no match is identified between the pharmacy information in the pharmacy registration verification request and the pharmacy information in the medication dispensing management database; and (c) sending the pharmacy registration status to the second electronic device, wherein receipt of the positive pharmacy registration status authorizes the distributor to provide the medication to the pharmacy. In some embodiments, the method further includes: receiving a pharmacy registration request by the first electronic device, the pharmacy registration request including pharmacy information of the pharmacy; and adding an entry including the pharmacy information to the medication dispensing management database at the first electronic device to register the pharmacy in the medication dispensing management database. In some embodiments, the method further includes: receiving a distributor registration request by the first electronic device, the distributor registration request including distributor information of the distributor; and adding an entry including the distributor information to the medication dispensing management database at the first electronic device to register the distributor in the medication dispensing management database. In some embodiments, a computer program product includes instructions that, when the program is executed by a computer, cause the computer to perform the steps of the method.

[0031] In some embodiments, an electronic device includes one or more processors; a memory configured to store a medication dispensing management database for medications containing food allergens, the medication dispensing management database including entries for registered distributors including registered distributor information and entries for registered pharmacies including registered pharmacy information; and one or more programs stored on the memory, the one or more programs configured to be executed by the one or more processors, the one or more programs including instructions for the following steps: (a) receiving, by the one or more processors, a pharmacy registration verification request, the pharmacy registration verification request including pharmacy information of a pharmacy; and (b) generating, by the one or more processors, a pharmacy registration status. , comprising (i) accessing the medication dispensing management database, (ii) comparing the pharmacy information in the pharmacy registration verification request with the registered pharmacy information in the medication dispensing management database, and (iii) obtaining a positive pharmacy registration status by identifying a match between the pharmacy information in the pharmacy registration verification request and the pharmacy information in the medication dispensing management database, or obtaining a negative pharmacy registration status if no match is identified between the pharmacy information in the pharmacy registration verification request and the pharmacy information in the medication dispensing management database; and (c) sending the pharmacy registration status to a second electronic device associated with the distributor, wherein receiving the positive pharmacy registration status authorizes the distributor to provide the medication to the pharmacy. In some embodiments, the one or more programs further comprise instructions for the following steps: receiving, by the one or more processors, a pharmacy registration request, the pharmacy registration request including pharmacy information of the pharmacy; and adding, by the one or more processors, an entry including the pharmacy information to the medication dispensing management database to register the pharmacy in the medication dispensing management database. In some embodiments, the one or more programs also include instructions for the following steps: receiving a distributor registration request by the one or more processors, the distributor registration request including distributor information of the distributor; and adding an entry including the distributor information to the drug distribution management database by the one or more processors to register the distributor in the drug distribution management database.

[0032] In some embodiments, a non-transitory computer-readable storage medium storing one or more programs, the one or more programs including instructions that, when executed by one or more processors of an electronic device, causes the electronic device to: (a) receive, by the one or more processors, a pharmacy registration verification request, the pharmacy registration verification request including pharmacy information of a pharmacy; (b) generate, by the one or more processors, a pharmacy registration status by: (i) accessing a medication dispensing management database for medications containing food allergens, (ii) comparing the pharmacy information in the pharmacy registration verification request with the registered pharmacy information in the medication dispensing management database, and (iii) obtaining a positive pharmacy registration status by identifying a match between the pharmacy information in the pharmacy registration verification request and the pharmacy information in the medication dispensing management database, or obtaining a negative pharmacy registration status if no match is identified between the pharmacy information in the pharmacy registration verification request and the pharmacy information in the medication dispensing management database; and (c) sending the pharmacy registration status to a second electronic device associated with the distributor, wherein receiving the positive pharmacy registration status authorizes the distributor to provide the medication to the pharmacy. In some embodiments, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive, by the one or more processors, a pharmacy registration request, the pharmacy registration request including pharmacy information of the pharmacy; and add, by the one or more processors, an entry including the pharmacy information to the medication dispensing management database to register the pharmacy in the medication dispensing management database. In some embodiments, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive, by the one or more processors, a distributor registration request, the distributor registration request including distributor information of the distributor; and add, by the one or more processors, an entry including the distributor information to the medication dispensing management database to register the distributor in the medication dispensing management database.

[0033] A computer-implemented method for authorizing the distribution of an oral immunotherapy treatment kit comprising a plurality of doses of a medication including a food allergen at different dosing levels to a healthcare facility comprises: (a) receiving, at a first electronic device communicatively coupled to a medication distribution management database for the medication, a healthcare facility registration verification request from a second electronic device associated with a distributor registered in the medication distribution management database, the healthcare facility registration verification request including healthcare facility information of a healthcare facility; and (b) generating, at the first electronic device, a healthcare facility registration status comprising (i) accessing the medication distribution management database, (ii) comparing the healthcare facility information in the healthcare facility registration verification request with the healthcare facility information of the healthcare facility; The method further comprises: (i) comparing the healthcare institution information in the healthcare institution registration verification request with the healthcare institution information registered in the medication dispensing management database, and (ii) obtaining a positive healthcare institution registration status by identifying a match between the healthcare institution information in the healthcare institution registration verification request and the healthcare institution information in the medication dispensing management database, or obtaining a negative healthcare institution registration status if no match is identified between the healthcare institution information in the healthcare institution registration verification request and the healthcare institution information in the medication dispensing management database; and (iii) obtaining a positive healthcare institution registration status by identifying a match between the healthcare institution information in the healthcare institution registration verification request and the healthcare institution information in the medication dispensing management database; and (c) transmitting the healthcare institution registration status to the second electronic device, wherein receiving the positive healthcare institution registration status authorizes the distributor to provide the oral immunotherapy treatment kit to the healthcare institution. In some embodiments, the method further comprises: receiving a healthcare institution registration request by the first electronic device, the healthcare institution registration request including healthcare institution information of the healthcare institution; and adding an entry including the healthcare institution information to the medication dispensing management database at the first electronic device to register the healthcare institution in the medication dispensing management database. In some embodiments, the method further comprises: receiving a distributor registration request by the first electronic device, the distributor registration request including distributor information of the distributor; and adding an entry including the distributor information to the medication dispensing management database at the first electronic device to register the distributor in the medication dispensing management database. In some embodiments, a computer program product comprises instructions which, when executed by a computer, cause the computer to perform the steps of the described method.

[0034] In some embodiments, an electronic device includes one or more processors; a memory configured to store a medication distribution management database for medications containing food allergens, the medication distribution management database including entries for registered distributors including registered distributor information and entries for registered healthcare facilities including registered healthcare facility information; and one or more programs stored on the memory, the one or more programs configured to be executed by the one or more processors, the one or more programs including instructions for the following steps: (a) receiving, by the one or more processors, a healthcare facility registration verification request, the healthcare facility registration verification request including healthcare facility information of a healthcare facility; (b) generating, by the one or more processors, a healthcare facility registration status, including (i) accessing the medication distribution management database; The one or more programs further comprise instructions for: receiving, by the one or more processors, a healthcare institution registration request including healthcare institution information of the healthcare institution; and adding, by the one or more processors, an entry including the healthcare institution information to the medication dispensing management database to register the healthcare institution in the medication dispensing management database. In some embodiments, the one or more programs also include instructions for the following steps: receiving a distributor registration request by the one or more processors, the distributor registration request including distributor information of the distributor; and adding an entry including the distributor information to the drug distribution management database by the one or more processors to register the distributor in the drug distribution management database.

[0035] In some embodiments, a non-transitory computer-readable storage medium storing one or more programs, the one or more programs comprising instructions that, when executed by one or more processors of an electronic device, causes the electronic device to: (a) receive, by the one or more processors, a healthcare facility registration verification request, the healthcare facility registration verification request including healthcare facility information of a healthcare facility; (b) generate, by the one or more processors, a healthcare facility registration status by: (i) accessing a medication dispensing management database for medications containing food allergens, (ii) comparing the healthcare facility information in the healthcare facility registration verification request with the registered healthcare facility information in the medication dispensing management database, and (iii) obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database, or obtaining a negative healthcare facility registration status if no match is identified between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database; and (c) sending the healthcare facility registration status to a second electronic device associated with the distributor, wherein receipt of the positive healthcare facility registration status authorizes the distributor to provide the oral immunotherapy treatment kit to the healthcare facility. In some embodiments, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive, by the one or more processors, a healthcare institution registration request, the healthcare institution registration request including healthcare institution information of the healthcare institution; and add, by the one or more processors, an entry including the healthcare institution information to the medication distribution management database to register the healthcare institution in the medication distribution management database. In some embodiments, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive, by the one or more processors, a distributor registration request, the distributor registration request including distributor information of the distributor; and add, by the one or more processors, an entry including the distributor information to the medication distribution management database to register the distributor in the medication distribution management database.

[0036] In some embodiments, a computer-implemented method for managing the dispensing of a medication containing a food allergen, the computer-implemented method comprising: (a) authorizing the provision of an initial dose escalation kit, the initial dose escalation kit comprising a plurality of different doses of the medication according to an initial dose escalation schedule, comprising: (i) receiving, at a first electronic device communicatively coupled to a medication dispensing management database for the medication, a first healthcare facility registration verification request and a first patient registration verification request from a second electronic device associated with a pharmacy registered in the medication dispensing management database, the first healthcare facility registration verification request comprising healthcare facility information of a healthcare facility, the first patient registration verification request comprising patient information of a patient; (ii) generating, at the first electronic device, a first healthcare facility registration status, comprising: (1) accessing the medication dispensing management database, (2) comparing the healthcare facility information in the first healthcare facility registration verification request with the registered healthcare facility information in the medication dispensing management database, and (3) obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database, or ... (iii) generating a first patient registration status at the first electronic device, comprising (1) accessing the medication dispensing management database, (2) comparing the patient information in the first patient registration verification request with the registered patient information in the medication dispensing management database, and (3) obtaining a positive patient registration status by identifying a match between the patient information in the patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the patient registration verification request and the patient information in the medication dispensing management database; and (iv) transmitting the first healthcare facility registration status and the first patient registration status to the second electronic device, wherein receipt by the pharmacy of the positive first healthcare facility registration status and the positive first patient registration status authorizes the pharmacy to provide the healthcare facility with an initial dose escalation kit associated with the patient, the initial dose escalation kit including a plurality of different doses of the medication according to an initial dose escalation schedule;(b) authorizing the provision of multiple doses of the drug at a single therapeutic dose level according to an oral immunotherapy dosing schedule, comprising: (i) receiving, at the first electronic device, a second healthcare institution registration verification request and a second patient registration verification request from the second electronic device, the second healthcare institution registration verification request including healthcare institution information of the healthcare institution, and the second patient registration verification request including patient information of the patient; (ii) generating a second healthcare institution registration status at the first electronic device, comprising (1) accessing the medication dispensing management database, and (2) comparing the healthcare institution information in the second healthcare institution registration verification request with the registered healthcare institution information in the medication dispensing management database. comparing, and (3) obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the second healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database, or obtaining a negative healthcare facility registration status if no match is identified between the healthcare facility information in the second healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database; (iii) generating a second patient registration status at the first electronic device, comprising (1) accessing the medication dispensing management database, (2) comparing the patient information in the second patient registration verification request with the registered patient information in the medication dispensing management database, and (3) obtaining a positive patient registration status by identifying a match between the patient information in the second patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the second patient registration verification request and the patient information in the medication dispensing management database; and (iv) transmitting the second healthcare facility registration status and the second patient registration status to the second electronic device, wherein receipt by the pharmacy of the positive second healthcare facility registration status and the positive second patient registration status authorizes the pharmacy to administer the oral immunotherapy dosing schedule as a single treatment. (c) repeating step (b) at different therapeutic dose levels, wherein the pharmacy is not authorized to simultaneously provide the drug at more than one therapeutic dose level for the patient; and (d) authorizing provision of an oral immunotherapy treatment kit to a healthcare facility, the oral immunotherapy treatment kit comprising a plurality of doses of a drug for treating food allergies at different dosing levels, comprising: (i) receiving, at the first electronic device, a third healthcare facility registration verification request from a third electronic device associated with a distributor registered in the medication distribution management database, the third healthcare facility registration verification request comprising healthcare facility information of the healthcare facility;(ii) generating a third healthcare institution registration status at the first electronic device, comprising (1) accessing the medication dispensing management database, (2) comparing the healthcare institution information in the third healthcare institution registration verification request with the registered healthcare institution information in the medication dispensing management database, and (3) obtaining a positive healthcare institution registration status by identifying a match between the healthcare institution information in the third healthcare institution registration verification request and the healthcare institution information in the medication dispensing management database, or obtaining a negative healthcare institution registration status if no match is identified between the healthcare institution information in the third healthcare institution registration verification request and the healthcare institution information in the medication dispensing management database; and (iii) sending the third healthcare institution registration status to the third electronic device, wherein receiving the positive third healthcare institution registration status authorizes the distributor to provide the oral immunotherapy treatment kit to the healthcare institution. In some embodiments, the method further comprises receiving a patient registration request by the first electronic device, the patient registration request including patient information of the patient; and adding an entry including the patient information to the medication dispensing management database at the first electronic device to register the patient in the medication dispensing management database. In some embodiments, the method further includes: receiving a pharmacy registration request by the first electronic device, the pharmacy registration request including pharmacy information of the pharmacy; and adding an entry including the pharmacy information to the medication dispensing management database at the first electronic device to register the pharmacy in the medication dispensing management database. In some embodiments, the method further includes: receiving a healthcare institution registration request by the first electronic device, the healthcare institution registration request including healthcare institution information of the healthcare institution; and adding an entry including the healthcare institution information to the medication dispensing management database at the first electronic device to register the healthcare institution in the medication dispensing management database. In some embodiments, the method further includes: receiving a distributor registration request by the first electronic device, the distributor registration request including distributor information of the distributor; and adding an entry including the distributor information to the medication dispensing management database at the first electronic device to register the distributor in the medication dispensing management database. In some embodiments, a computer program product includes instructions that, when executed by a computer, cause the computer to perform the steps of the described method. ;

[0037] In some embodiments, a computer-implemented method for managing the dispensing of a medication containing a food allergen includes: (a) authorizing the provision of an initial dose escalation kit, the initial dose escalation kit including a plurality of different doses of the medication according to an initial dose escalation schedule, comprising: (i) receiving, at a first electronic device communicatively coupled to a medication dispensing management database for the medication, a first healthcare facility registration verification request, a first healthcare provider registration verification request, and a first patient registration verification request from a second electronic device associated with a pharmacy registered in the medication dispensing management database, the first healthcare facility registration verification request including healthcare facility information of the healthcare facility, the first healthcare provider registration verification request including healthcare provider information, and the first patient registration verification request including patient information of the patient; (ii) generating a first healthcare facility registration status at the first electronic device, comprising: (1) accessing the medication dispensing management database, (2) comparing the healthcare facility information in the first healthcare facility registration verification request with the registered healthcare facility information in the medication dispensing management database, and (3) identifying the healthcare facility by (iii) generating a first healthcare provider registration status at the first electronic device, comprising: (1) accessing the medication dispensing management database, (2) comparing the healthcare provider information in the first healthcare provider registration verification request with the registered healthcare provider information in the medication dispensing management database, and (3) obtaining a positive healthcare provider registration status by identifying a match between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database, or obtaining a negative healthcare provider registration status if no match is identified between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database;(iv) generating a first patient registration status at the first electronic device, comprising (1) accessing the medication dispensing management database, (2) comparing the patient information in the first patient registration verification request with the registered patient information in the medication dispensing management database, and (3) obtaining a positive patient registration status by identifying a match between the patient information in the patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the patient registration verification request and the patient information in the medication dispensing management database; and (v) sending the first healthcare facility registration status, the first healthcare provider registration status, and the first patient registration status to the second electronic device, wherein receipt of the positive first healthcare facility registration status, the positive healthcare provider registration status, and the positive first patient registration status by the pharmacy authorizes the pharmacy to provide an initial dose escalation kit associated with the patient to the healthcare facility or the healthcare provider, the initial dose escalation kit including a plurality of different doses of the medication according to an initial dose escalation schedule; b) authorizing provision of a plurality of doses of the medication at a single therapeutic dose level according to an oral immunotherapy dosing schedule, comprising: (i) receiving, at the first electronic device, a second healthcare provider registration verification request and a second patient registration verification request from the second electronic device, the second healthcare provider registration verification request including healthcare provider information of the healthcare provider and the second patient registration verification request including patient information of the patient; (ii) generating, at the first electronic device, a second healthcare provider registration status, comprising: (1) accessing the medication dispensing management database, (2) comparing the healthcare provider information in the second healthcare provider registration verification request with the registered healthcare provider information in the medication dispensing management database, and (3) obtaining a positive healthcare provider registration status by identifying a match between the healthcare provider information in the second healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database, or obtaining a negative healthcare provider registration status if no match is identified between the healthcare provider information in the second healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database;(iii) generating a second patient registration status at the first electronic device, comprising (1) accessing the medication dispensing management database, (2) comparing the patient information in the second patient registration verification request with the registered patient information in the medication dispensing management database, and (3) obtaining a positive patient registration status by identifying a match between the patient information in the second patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the second patient registration verification request and the patient information in the medication dispensing management database; and (iv) sending the second healthcare provider registration status and the second patient registration status to the second electronic device, wherein receipt by the pharmacy of the positive second healthcare provider registration status and the positive second patient registration status authorizes the pharmacy to provide multiple doses of the medication at a single therapeutic dose level according to the oral immunotherapy dosing schedule to the healthcare facility, the healthcare provider, or the patient; (c) repeating step (b) at different therapeutic dose levels, wherein the pharmacy is not authorized to simultaneously provide the medication at more than one therapeutic dose level for the patient; and (d) authorizing provision of an oral immunotherapy treatment kit to a healthcare facility, wherein the oral immunotherapy treatment kit An oral immunotherapy treatment kit includes multiple doses of medication for treating food allergies at different dosing levels, comprising: (i) receiving a second healthcare facility registration verification request at the first electronic device from a third electronic device associated with a distributor registered in the medication distribution management database, the second healthcare facility registration verification request including healthcare facility information of the healthcare facility; (ii) generating a second healthcare facility registration status at the first electronic device, comprising (1) accessing the medication distribution management database, (2) comparing the healthcare facility information in the second healthcare facility registration verification request with the registered healthcare facility information in the medication distribution management database, and (3) obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the second healthcare facility registration verification request and the healthcare facility information in the medication distribution management database, or obtaining a negative healthcare facility registration status if no match is identified between the healthcare facility information in the second healthcare facility registration verification request and the healthcare facility information in the medication distribution management database; and (iii) sending the second healthcare facility registration status to the third electronic device, wherein receiving the positive third healthcare facility registration status authorizes the distributor to provide the oral immunotherapy treatment kit to the healthcare facility. In some embodiments, the method further comprises: receiving, by the first electronic device, a healthcare provider registration request, the healthcare provider registration request including healthcare provider information of the patient;and adding, at the first electronic device, an entry including the healthcare provider information to the medication dispensing management database to register the healthcare provider in the medication dispensing management database. In some embodiments, the method further comprises receiving, by the first electronic device, a patient registration request, the patient registration request including patient information of the patient; and adding, at the first electronic device, an entry including the patient information to the medication dispensing management database to register the patient in the medication dispensing management database. In some embodiments, the method further comprises: receiving, by the first electronic device, a pharmacy registration request including pharmacy information of the pharmacy; and adding, at the first electronic device, an entry including the pharmacy information to the medication dispensing management database to register the pharmacy in the medication dispensing management database. In some embodiments, the method further comprises: receiving, by the first electronic device, a healthcare institution registration request, the healthcare institution registration request including healthcare institution information of the healthcare institution; and adding, at the first electronic device, an entry including the healthcare institution information to the medication dispensing management database to register the healthcare institution in the medication dispensing management database. In some embodiments, the method further includes: receiving, by the first electronic device, a distributor registration request, the distributor registration request including distributor information of the distributor; and adding, at the first electronic device, an entry including the distributor information to the medication distribution management database to register the distributor in the medication distribution management database. In some embodiments, a computer program product includes instructions that, when executed by a computer, cause the computer to perform the steps of the described method.

[0038] In some embodiments, an electronic device includes: one or more processors; a memory configured to store a medication dispensing management database for medications containing food allergens, the medication dispensing management database including an entry for a registered patient including registered patient information, an entry for a registered healthcare facility including registered healthcare facility information, an entry for a registered pharmacy including registered pharmacy information, and an entry for a registered distributor including registered distributor information; and one or more programs stored on the memory, the one or more programs configured to be executed by the one or more processors, the one or more programs including instructions for the following steps: (a) authorizing, by the one or more processors, provision of an initial dose escalation kit, the initial dose escalation kit including a plurality of different doses of the medication according to an initial dose escalation schedule, including: (i) receiving, by the one or more processors, a first healthcare facility registration verification request and a first patient registration verification request from a second electronic device associated with a pharmacy registered in the medication dispensing management database, the first healthcare facility registration verification request including healthcare facility information of the healthcare facility, the first patient registration verification request including patient information of the patient; (ii) generating, by the one or more processors, a first healthcare facility registration verification request. (iii) generating, by the one or more processors, a first patient registration status, comprising: (1) accessing the medication dispensing management database, (2) comparing the patient information in the first patient registration verification request with the registered patient information in the medication dispensing management database, and (3) obtaining a positive patient registration status by identifying a match between the patient information in the first patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the first patient registration verification request and the patient information in the medication dispensing management database; (iv) generating, by the one or more processors, a first patient registration status, comprising: (1) accessing the medication dispensing management database, (2) comparing the patient information in the first patient registration verification request with the registered patient information in the medication dispensing management database, and (3) obtaining a positive patient registration status by identifying a match between the patient information in the first patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the first patient registration verification request and the patient information in the medication dispensing management database;and (iv) sending the first healthcare facility registration status and the first patient registration status to the second electronic device, wherein receipt by the pharmacy of an affirmative first healthcare facility registration status and an affirmative first patient registration status authorizes the pharmacy to provide an initial dose escalation kit associated with the patient to the healthcare facility, the initial dose escalation kit comprising a plurality of different doses of the drug according to an initial dose escalation schedule; and (b) authorizing, by the one or more processors, a plurality of doses of the drug at a single therapeutic dose level according to an oral immunotherapy dosing schedule, comprising: (i) receiving, by the one or more processors, a second healthcare facility registration verification request and a second patient registration status from the second electronic device; (i) generating a second healthcare institution registration status by the one or more processors, comprising (1) accessing the medication dispensing management database, (2) comparing the healthcare institution information in the second healthcare institution registration verification request with the registered healthcare institution information in the medication dispensing management database, and (3) obtaining a positive healthcare institution registration status by identifying a match between the healthcare institution information in the second healthcare institution registration verification request and the healthcare institution information in the medication dispensing management database, or obtaining a positive healthcare institution registration status if no match is identified between the healthcare institution information in the second healthcare institution registration verification request and the healthcare institution information in the medication dispensing management database. (iii) generating, by the one or more processors, a second patient registration status, comprising (1) accessing the medication dispensing management database, (2) comparing the patient information in the second patient registration verification request with the registered patient information in the medication dispensing management database, and (3) obtaining a positive patient registration status by identifying a match between the patient information in the second patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status by not identifying a match between the patient information in the second patient registration verification request and the patient information in the medication dispensing management database. (c) repeating step (b) at different therapeutic dose levels, wherein the pharmacy is not authorized to simultaneously provide the medication at more than one therapeutic dose level for the patient;(d) authorizing, by the one or more processors, to provide an oral immunotherapy treatment kit to a healthcare facility, the oral immunotherapy treatment kit including a plurality of doses of medication for treating food allergies at different dosing levels, comprising: (i) receiving, by the one or more processors, a third healthcare facility registration verification request from a third electronic device associated with a distributor registered in the medication dispensing management database, the third healthcare facility registration verification request including healthcare facility information of the healthcare facility; (ii) generating, by the one or more processors, a third healthcare facility registration status, comprising: (1) accessing the medication dispensing management database, (2) comparing the healthcare facility information in the third healthcare facility registration verification request with the healthcare facility information in the medication dispensing management database; and comparing the registered healthcare institution information in the medication dispensing management database with the healthcare institution information in the third healthcare institution registration verification request, and (3) obtaining a positive healthcare institution registration status by identifying a match between the healthcare institution information in the third healthcare institution registration verification request and the healthcare institution information in the medication dispensing management database, or obtaining a negative healthcare institution registration status if no match is identified between the healthcare institution information in the third healthcare institution registration verification request and the healthcare institution information in the medication dispensing management database; and (iii) sending the third healthcare institution registration status to the third electronic device, wherein receiving the positive third healthcare institution registration status authorizes the distributor to provide the oral immunotherapy treatment kit to the healthcare institution. In some embodiments, the one or more programs further include instructions for the following steps: receiving, by the one or more processors, a pharmacy registration request, the pharmacy registration request including pharmacy information of the pharmacy; and adding, by the one or more processors, an entry including the pharmacy information to the medication dispensing management database to register the pharmacy in the medication dispensing management database. In some embodiments, the one or more programs further include instructions for the following steps: receiving, by the one or more processors, a distributor registration request, the distributor registration request including distributor information of the distributor; and adding, by the one or more processors, an entry including the distributor information to the medication distribution management database to register the distributor in the medication distribution management database. In some embodiments, the one or more programs further include instructions for the following steps: receiving, by the one or more processors, a patient registration request, the patient registration request including patient information of the patient; and adding, by the one or more processors, an entry including the patient information to the medication distribution management database to register the patient in the medication distribution management database. In some embodiments, the one or more programs further include instructions for the following steps: receiving, by the one or more processors, a healthcare institution registration request, the healthcare institution registration request including healthcare institution information of the healthcare institution;and adding, by the one or more processors, an entry including the healthcare institution information to the medication distribution management database to register the healthcare institution in the medication distribution management database. ;

[0039] In some embodiments, an electronic device includes: one or more processors; a memory configured to store a medication dispensing management database for medications containing food allergens, the medication dispensing management database including entries for registered patients including registered patient information, entries for registered healthcare facilities including registered healthcare facility information, entries for registered healthcare providers including registered healthcare provider information, entries for registered pharmacies including registered pharmacy information, and entries for registered distributors including registered distributor information; and one or more programs stored on the memory, the one or more programs configured to be executed by the The one or more programs are executed by one or more processors, the one or more programs including instructions for the following steps: (a) authorizing, by the one or more processors, provision of an initial dose escalation kit, the initial dose escalation kit including a plurality of different doses of the drug according to an initial dose escalation schedule, including: (i) receiving, by the one or more processors, a first healthcare facility registration verification request, a first healthcare provider registration verification request, and a first patient registration verification request from a second electronic device associated with a pharmacy registered in the medication dispensing management database, the first healthcare facility registration verification request including healthcare facility information of the healthcare facility, the first healthcare provider registration verification request including healthcare provider information, and the first patient registration verification request. The method further comprises: (i) generating, by the one or more processors, a first healthcare institution registration status, comprising: (1) accessing the medication dispensing management database, (2) comparing the healthcare institution information in the first healthcare institution registration verification request with the registered healthcare institution information in the medication dispensing management database, and (3) obtaining a positive healthcare institution registration status by identifying a match between the healthcare institution information in the first healthcare institution registration verification request and the healthcare institution information in the medication dispensing management database, or obtaining a positive healthcare institution registration status by not identifying a match between the healthcare institution information in the first healthcare institution registration verification request and the healthcare institution information in the medication dispensing management database. (iii) generating, by the one or more processors, a first patient registration status, comprising (1) accessing the medication dispensing management database, (2) comparing the patient information in the first patient registration verification request with the registered patient information in the medication dispensing management database, and (3) obtaining a positive patient registration status by identifying a match between the patient information in the first patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the first patient registration verification request and the patient information in the medication dispensing management database;and (iv) generating, by the one or more processors, a first healthcare provider registration status, comprising (1) accessing the medication dispensing management database, (2) comparing the healthcare provider information in the first healthcare provider registration verification request with the registered healthcare provider information in the medication dispensing management database, and (3) obtaining a positive healthcare provider registration status by identifying a match between the healthcare provider information in the first healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database, or obtaining a negative healthcare provider registration status if no match is identified between the healthcare provider information in the first healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database; and (v) transmitting the first healthcare facility registration status, the first healthcare provider registration status, and the first patient registration status to the second electronic device, wherein receipt by the pharmacy of the positive first healthcare facility registration status, the positive first healthcare provider registration status, and the positive first patient registration status authorizes the pharmacy to provide the healthcare facility or healthcare provider with an initial dose escalation kit associated with the patient, the initial dose escalation kit comprising a first dose escalation kit and a second dose escalation kit according to an initial dose escalation plan. (b) authorizing, by the one or more processors, the plurality of doses of the medication at a single therapeutic dose level according to the oral immunotherapy dosing schedule, comprising: (i) receiving, by the one or more processors, a second healthcare provider registration verification request and a second patient registration verification request from the second electronic device, the second healthcare provider registration verification request comprising healthcare provider information of a healthcare provider, the second patient registration verification request comprising patient information of a patient; (ii) generating, by the one or more processors, a second healthcare provider registration status, comprising: (1) accessing the medication dispensing management database, (2) comparing the healthcare provider information in the second healthcare provider registration verification request with the registered healthcare provider information in the medication dispensing management database, and (3) obtaining a positive healthcare provider registration status by identifying a match between the healthcare institution information in the second healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database, or obtaining a negative healthcare provider registration status if no match is identified between the healthcare provider information in the second healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database;(iii) generating, by the one or more processors, a second patient registration status, comprising (1) accessing the medication dispensing management database, (2) comparing the patient information in the second patient registration verification request with the registered patient information in the medication dispensing management database, and (3) obtaining a positive patient registration status by identifying a match between the patient information in the second patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the second patient registration verification request and the patient information in the medication dispensing management database; and (iv) transmitting the second healthcare provider registration status and the second patient registration status to the second electronic device, wherein receipt by the pharmacy of the positive second healthcare provider registration status and the positive second patient registration status authorizes the pharmacy to provide multiple doses of the medication at a single therapeutic dose level according to the oral immunotherapy dosing schedule to the healthcare facility, the healthcare provider, or the patient; and (c) repeating step (b) at different therapeutic dose levels, wherein the pharmacy is not authorized to simultaneously provide the medication at more than one therapeutic dose level for the patient. said medication; (d) authorizing, by the one or more processors, to provide an oral immunotherapy treatment kit to a healthcare facility, said oral immunotherapy treatment kit including a plurality of doses of medication for treating food allergies at different dosing levels, comprising: (i) receiving, by the one or more processors, a second healthcare facility registration verification request from a third electronic device associated with a distributor registered in the medication dispensing management database, said second healthcare facility registration verification request including healthcare facility information of a healthcare facility; (ii) generating, by the one or more processors, a second healthcare facility registration status, comprising (1) accessing the medication dispensing management database, (2) comparing the healthcare facility information in the second healthcare facility registration verification request with the registered healthcare facility information in the medication dispensing management database, and (3) obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the second healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database, or obtaining a negative healthcare facility registration status if no match is identified between the healthcare facility information in the second healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database;and (iii) sending the second healthcare institution registration status to the third electronic device, wherein receiving a positive second healthcare institution registration status authorizes the distributor to provide the oral immunotherapy treatment kit to the healthcare institution. In some embodiments, the one or more programs further include instructions for the following steps: receiving, by the one or more processors, a healthcare provider registration request, the healthcare provider registration request including healthcare provider information of the healthcare provider; and adding, by the one or more processors, an entry including the healthcare provider information to the medication dispensing management database to register the healthcare provider in the medication dispensing management database. In some embodiments, the one or more programs further include instructions for the following steps: receiving, by the one or more processors, a pharmacy registration request, the pharmacy registration request including pharmacy information of the pharmacy; and adding, by the one or more processors, an entry including the pharmacy information to the medication dispensing management database to register the pharmacy in the medication dispensing management database. In some embodiments, the one or more programs further include instructions for the following steps: receiving, by the one or more processors, a distributor registration request, the distributor registration request including distributor information of the distributor; and adding, by the one or more processors, an entry including the distributor information to the medication dispensing management database to register the distributor in the medication dispensing management database. In some embodiments, the one or more programs further include instructions for: receiving, by the one or more processors, a patient registration request, the patient registration request including patient information of the patient; and adding, by the one or more processors, an entry including the patient information to the medication dispensing management database to register the patient in the medication dispensing management database. In some embodiments, the one or more programs further include instructions for: receiving, by the one or more processors, a healthcare institution registration request, the healthcare institution registration request including healthcare institution information of the healthcare institution; and adding, by the one or more processors, an entry including the healthcare institution information to the medication dispensing management database to register the healthcare institution in the medication dispensing management database.

[0040] In some embodiments, a non-transitory computer-readable storage medium storing one or more programs, the one or more programs comprising instructions that, when executed by one or more processors of an electronic device, causes the electronic device to: (a) authorize, by the one or more processors, provision of an initial dose escalation kit comprising a plurality of different doses of the medication comprising a food allergen according to an initial dose escalation schedule by: (i) receiving, by the one or more processors, a first healthcare facility registration verification request and a first patient registration verification request from a second electronic device associated with a pharmacy registered in the medication dispensing management database, the first healthcare facility registration verification request comprising healthcare facility information of a healthcare facility, the first patient registration verification request comprising patient information of a patient; and (ii) generating, by the one or more processors, a first healthcare facility registration status comprising: (1) accessing the medication dispensing management database, (2) comparing the healthcare facility information in the first healthcare facility registration verification request with the registered healthcare facility information in the medication dispensing management database, and (3) obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the first healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database. (iii) generating, by the one or more processors, a first patient registration status, comprising (1) accessing the medication dispensing management database, (2) comparing the patient information in the first patient registration verification request with the registered patient information in the medication dispensing management database, and (3) obtaining a positive patient registration status by identifying a match between the patient information in the first patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the first patient registration verification request and the patient information in the medication dispensing management database; and (iv) transmitting the first healthcare facility registration status and the first patient registration status to the second electronic device, wherein receipt by the pharmacy of the positive first healthcare facility registration status and the positive first patient registration status authorizes the pharmacy to provide an initial dose escalation kit associated with the patient to the healthcare facility, the initial dose escalation kit comprising a plurality of different doses of the medication according to an initial dose escalation schedule;(b) the one or more processors authorizing a plurality of doses of the drug at a single therapeutic dose level according to the oral immunotherapy dosing schedule by: (i) receiving, by the one or more processors, a second healthcare institution registration verification request and a second patient registration verification request from the second electronic device, the second healthcare institution registration verification request including healthcare institution information of the healthcare institution, and the second patient registration verification request including patient information of the patient; (ii) generating, by the one or more processors, a second healthcare institution registration status, comprising (1) accessing the medication dispensing management database, (2) comparing the healthcare institution information in the second healthcare institution registration verification request with the registered healthcare institution information in the medication dispensing management database, and (iii) generating, by the one or more processors, a second patient registration status, comprising: (1) accessing the medication dispensing management database; (2) comparing the patient information in the second patient registration verification request with the patient information in the medication dispensing management database; and (3) obtaining a positive healthcare institution registration status by identifying a match between the healthcare institution information in the second healthcare institution registration verification request and the healthcare institution information in the medication dispensing management database, or obtaining a negative healthcare institution registration status if no match is identified between the healthcare institution information in the second healthcare institution registration verification request and the healthcare institution information in the medication dispensing management database; and (iii) generating, by the one or more processors, a second patient registration status, comprising: (1) accessing the medication dispensing management database; (2) comparing the patient information in the second patient registration verification request with the patient information in the medication dispensing management database; information in the second patient registration verification request and the patient information in the medication dispensing management database, and (3) obtaining a positive patient registration status by identifying a match between the patient information in the second patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the second patient registration verification request and the patient information in the medication dispensing management database; and (iv) sending the second healthcare facility registration status and the second patient registration status to the second electronic device, wherein receipt of the positive second healthcare facility registration status and the positive second patient registration status by the pharmacy authorizes the pharmacy to administer the oral immunotherapy dosing schedule at a single therapeutic dose level to the healthcare facility. (c) repeating step (b) at different therapeutic dose levels, wherein the pharmacy is not authorized to provide the drug at more than one therapeutic dose level for the patient simultaneously; and (d) authorizing, by the one or more processors, provision of an oral immunotherapy treatment kit to a healthcare facility, the oral immunotherapy treatment kit comprising multiple doses of a drug for treating food allergies at different dosing levels by: (i) receiving, by the one or more processors, a third healthcare facility registration verification request from a third electronic device associated with a distributor registered in the medication distribution management database, the third healthcare facility registration verification request comprising healthcare facility information of a healthcare facility;(ii) generating a third healthcare institution registration status by the one or more processors, including (1) accessing the drug distribution management database, (2) comparing the healthcare institution information in the third healthcare institution registration verification request with the registered healthcare institution information in the drug distribution management database, and (3) obtaining a positive healthcare institution registration status by identifying a match between the healthcare institution information in the third healthcare institution registration verification request and the healthcare institution information in the drug distribution management database, or obtaining a negative healthcare institution registration status if no match is identified between the healthcare institution information in the third healthcare institution registration verification request and the healthcare institution information in the drug distribution management database; and (iii) sending the third healthcare institution registration status to the third electronic device, wherein receiving the positive third healthcare institution registration status authorizes the distributor to provide the oral immunotherapy treatment kit to the healthcare institution. In some embodiments, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive, by the one or more processors, a pharmacy registration request, the pharmacy registration request including pharmacy information of the pharmacy; and add, by the one or more processors, an entry including the pharmacy information to the medication dispensing management database to register the pharmacy in the medication dispensing management database. In some embodiments, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive, by the one or more processors, a distributor registration request, the distributor registration request including distributor information of the distributor; and add, by the one or more processors, an entry including the distributor information to the medication dispensing management database to register the distributor in the medication dispensing management database. In some embodiments, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive, by the one or more processors, a patient registration request, the patient registration request including patient information of the patient; and add, by the one or more processors, an entry including the patient information to the medication dispensing management database to register the patient in the medication dispensing management database. In some embodiments, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive, by the one or more processors, a healthcare institution registration request, the healthcare institution registration request including healthcare institution information of the healthcare institution; and add, by the one or more processors, an entry including the healthcare institution information to the medication dispensing management database to register the healthcare institution in the medication dispensing management database.

[0041] In some embodiments, a non-transitory computer-readable storage medium storing one or more programs, the one or more programs comprising instructions that, when executed by one or more processors of an electronic device, cause the electronic device to: (a) authorize, by the one or more processors, provision of an initial dose escalation kit, the initial dose escalation kit comprising a plurality of different doses of the drug containing the food allergen according to an initial dose escalation schedule, by the one or more processors: (i) receive, by the one or more processors, a first healthcare facility registration verification request, a first healthcare provider registration verification request, and a first patient registration verification request from a second electronic device associated with a pharmacy registered in the medication dispensing management database, the first healthcare facility registration verification request comprising healthcare facility information of the healthcare facility, the first healthcare provider registration verification request comprising healthcare provider information, and the first patient registration verification request comprising patient information of the patient; and (ii) generate, by the one or more processors, a first healthcare facility registration status, comprising: (1) accessing the medication dispensing management database, (2) comparing the healthcare facility information in the first healthcare facility registration verification request with the healthcare facility information in the medication dispensing management database. and (iii) generating, by the one or more processors, a first patient registration status, comprising: (1) accessing the medication dispensing management database; (2) comparing the patient information in the first patient registration verification request with the registered patient information in the medication dispensing management database; and (3) obtaining a positive patient registration status by identifying a match between the patient information in the first patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the first patient registration verification request and the patient information in the medication dispensing management database;(iv) generating, by the one or more processors, a first healthcare provider registration status, comprising (1) accessing the medication dispensing management database, (2) comparing the healthcare provider information in the first healthcare provider registration verification request with the registered healthcare provider information in the medication dispensing management database, and (3) obtaining a positive healthcare provider registration status by identifying a match between the healthcare provider information in the first healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database, or obtaining a negative healthcare provider registration status if no match is identified between the healthcare provider information in the first healthcare provider registration verification request and the healthcare facility information in the medication dispensing management database; and (v) transmitting the first healthcare facility registration status, the first healthcare provider registration status, and the first patient registration status to the second electronic device, wherein receipt by the pharmacy of the positive first healthcare facility registration status, the positive first healthcare provider registration status, and the positive first patient registration status authorizes the pharmacy to provide the healthcare facility or healthcare provider with an initial dose escalation kit associated with the patient, the initial dose escalation kit comprising a plurality of medications according to an initial dose escalation schedule. different doses of the medication; and (b) authorizing, by the one or more processors, multiple doses of the medication at a single therapeutic dose level according to an oral immunotherapy dosing schedule by the following steps: (i) receiving, by the one or more processors, a second healthcare provider registration verification request and a second patient registration verification request from the second electronic device, the second healthcare provider registration verification request including healthcare provider information of a healthcare provider, and the second patient registration verification request including patient information of a patient; (ii) generating, by the one or more processors, a second healthcare provider registration status, comprising (1) accessing the medication dispensing management database, (2) comparing the healthcare provider information in the second healthcare provider registration verification request with the registered healthcare provider information in the medication dispensing management database, and (3) obtaining a positive healthcare provider registration status by identifying a match between the healthcare provider information in the second healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database, or obtaining a negative healthcare provider registration status if no match is identified between the healthcare provider information in the second healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database;(iii) generating, by the one or more processors, a second patient registration status, comprising (1) accessing the medication dispensing management database, (2) comparing the patient information in the second patient registration verification request with the registered patient information in the medication dispensing management database, and (3) obtaining a positive patient registration status by identifying a match between the patient information in the second patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the second patient registration verification request and the patient information in the medication dispensing management database; and (iv) sending the second healthcare provider registration status and the second patient registration status to the second electronic device, wherein receipt by the pharmacy of the positive second healthcare provider registration status and the positive second patient registration status authorizes the pharmacy to provide multiple doses of the medication at a single therapeutic dose level to the healthcare facility, the healthcare provider, or the patient in accordance with the oral immunotherapy dosing schedule; and (c) repeating step (b) at different therapeutic dose levels, wherein the pharmacy is not authorized to simultaneously provide the medication at more than one therapeutic dose level for the patient. (d) authorizing, by the one or more processors, provision of an oral immunotherapy treatment kit to a healthcare facility, the oral immunotherapy treatment kit including a plurality of doses of medication for treating food allergies at different dosing levels, by: (i) receiving, by the one or more processors, a second healthcare facility registration verification request from a third electronic device associated with a distributor registered in the medication dispensing management database, the second healthcare facility registration verification request including healthcare facility information of a healthcare facility; (ii) generating, by the one or more processors, a second healthcare facility registration status, comprising (1) accessing the medication dispensing management database, (2) comparing the healthcare facility information in the second healthcare facility registration verification request with the registered healthcare facility information in the medication dispensing management database, and (3) obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the second healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database, or obtaining a negative healthcare facility registration status if no match is identified between the healthcare facility information in the second healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database;and (iii) sending the second healthcare facility registration status to the third electronic device, wherein receiving a positive third healthcare facility registration status authorizes the distributor to provide the oral immunotherapy treatment kit to the healthcare facility. In some embodiments, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive, by the one or more processors, a healthcare provider registration request, the healthcare provider registration request including healthcare provider information of the healthcare provider; and add, by the one or more processors, an entry including the healthcare provider information to the medication dispensing management database to register the healthcare provider in the medication dispensing management database. In some embodiments, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive, by the one or more processors, a pharmacy registration request, the pharmacy registration request including pharmacy information of the pharmacy; and add, by the one or more processors, an entry including the pharmacy information to the medication dispensing management database to register the pharmacy in the medication dispensing management database. In some embodiments, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive, by the one or more processors, a distributor registration request, the distributor registration request including distributor information of the distributor; and add, by the one or more processors, an entry including the distributor information to the medication distribution management database to register the distributor in the medication distribution management database. In some embodiments, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive, by the one or more processors, a patient registration request, the patient registration request including patient information of the patient; and add, by the one or more processors, an entry including the patient information to the medication distribution management database to register the patient in the medication distribution management database. In some embodiments, the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receive, by the one or more processors, a healthcare institution registration request, the healthcare institution registration request including healthcare institution information of the healthcare institution; and add, by the one or more processors, an entry including the healthcare institution information to the medication distribution management database to register the healthcare institution in the medication distribution management database. ;

[0042] In some embodiments, a method for treating a patient with food allergies by oral immunotherapy comprises: (a) registering the patient or verifying the registration of the patient in a medication distribution management database for medications containing food allergens; (b) administering a dose of the medication at a first dosing level according to a dosing schedule to the registered patient at a healthcare facility registered in the medication distribution management database; (c) after administering the dose of the medication in step (b), monitoring the registered patient for an allergic reaction to the medication at the registered healthcare facility; (d) providing a first prescription requesting that the first prescription be administered at the medication distribution management database; (b) or (e) administering the medication at the first dosing level to the registered patient or registered healthcare facility; (c) administering the medication at the subsequent dosing level to the registered patient at the registered healthcare facility according to the dosing schedule; (d) monitoring the registered patient at the registered healthcare facility for an allergic reaction to the medication after the medication at the dose administered in step (e); and (e) providing a subsequent prescription requesting the registered pharmacy to administer the medication at the subsequent dosing level to the registered patient or registered healthcare facility. In some embodiments, the dosing of (b) or (e) is administered under the supervision of a healthcare provider registered in the medication dispensing management database. In some embodiments, the monitoring of (c) or (f) is under the supervision of a healthcare provider registered in the medication dispensing management database. In some embodiments, the method includes obtaining the dose of the drug administered to the registered patient in step (b) or step (e) from an oral immunotherapy treatment kit, the oral immunotherapy treatment kit including multiple doses of the drug at different dosing levels. In some embodiments, the oral immunotherapy treatment kit is received from a distributor registered in the drug distribution management database. In some embodiments, the method includes submitting a request to the registered distributor to provide the oral immunotherapy treatment kit to the registered healthcare institution, wherein the provision of the oral immunotherapy treatment kit to the registered healthcare institution is conditional on the registered distributor verifying the registration of the healthcare institution. In some embodiments, the method includes administering multiple different doses of the drug according to an initial dose escalation schedule to the registered patient in the registered healthcare institution before step (b). In some embodiments, the multiple different doses of the drug according to the initial dose escalation schedule are administered under the supervision of a healthcare provider registered in the drug distribution management database. In some embodiments, the method further comprises monitoring the enrolled patient at the enrolled healthcare facility for an allergic reaction to the drug after administration of each different dose of the drug according to the initial dose escalation schedule.In some embodiments, monitoring after administration of each different dose of the drug according to the initial dose escalation schedule is under the supervision of a healthcare provider registered in the drug distribution management database. In some embodiments, the multiple different doses of the drug according to the initial dose escalation schedule are obtained from an initial dose escalation kit assigned to the registered patient. In some embodiments, the method includes receiving the initial dose escalation kit from a registered pharmacy. In some embodiments, the method includes submitting a request to the registered pharmacy to provide the initial dose escalation kit to the registered healthcare institution, wherein the provision of the initial dose escalation kit to the registered healthcare institution is conditional on the registered pharmacy verifying (1) the patient's registration in the drug distribution management database and (2) the healthcare institution's registration. In some embodiments, another condition for providing the initial dose escalation kit to the registered healthcare institution is that the registered pharmacy verifies the registration of a healthcare provider in the drug distribution management database, wherein the healthcare provider is associated with the registered patient. In some embodiments, the present invention provides a medicament comprising a food allergen for use in treating a patient with food allergy by oral immunotherapy, wherein the medicament is administered to the patient according to the methods described above.

[0043] In some embodiments, a method for initiating treatment of a food allergy patient with oral immunotherapy comprises: (a) registering the patient or verifying the patient's registration in a medication distribution management database for medications containing food allergens; (b) administering a plurality of different doses of the medication according to an initial dose escalation schedule to the registered patient at the registered healthcare facility; and (c) monitoring the registered patient for an allergic reaction to the medication at the registered healthcare facility after each different dose of the medication according to the initial dose escalation schedule is administered in step (b). In some embodiments, the plurality of different doses of step (b) are administered under the supervision of a healthcare provider registered in the medication distribution management database. In some embodiments, the monitoring of step (c) is under the supervision of a healthcare provider registered in the medication distribution management database. In some embodiments, the plurality of different doses of the medication according to the initial dose escalation schedule is obtained from an initial dose escalation kit assigned to the registered patient. In some embodiments, the method comprises receiving the initial dose escalation kit from a pharmacy registered in the medication distribution management database. In some embodiments, the method comprises submitting a request to a registered pharmacy to provide the initial dose escalation kit to a registered healthcare facility, wherein providing the initial dose escalation kit to the registered healthcare facility is conditional upon the registered pharmacy verifying (1) the patient's registration in the medication dispensing management database and (2) the healthcare facility's registration. In some embodiments, providing the initial dose escalation kit to the registered healthcare facility is further conditional upon the registered pharmacy verifying the registration of a healthcare provider in the medication dispensing management database, wherein the healthcare provider is associated with the registered patient. In some embodiments, the present invention provides a medicament comprising a food allergen for treating a patient with food allergy by oral immunotherapy, wherein the medicament is administered to the patient according to the method described above.

[0044] In some embodiments, a method for continuing to treat a patient with food allergy by oral immunotherapy, the method comprising: (a) registering the patient or verifying the patient's registration in a medication distribution management database for medications containing food allergens; (b) administering a dose of the medication to the patient at a dose level higher than any previous dose level administered to the patient in the registered healthcare facility and after registering the patient or verifying the patient's registration in step (a); and (c) monitoring the patient for an allergic reaction to the medication in the registered healthcare facility after administering the medication in step (b). In some embodiments, the dose of step (b) is administered under the supervision of a healthcare provider registered in the medication distribution management database. In some embodiments, the monitoring of step (c) is under the supervision of a healthcare provider registered in the medication distribution management database. In some embodiments, the dose of the medication is obtained from an oral immunotherapy administration kit, which includes multiple doses of the medication at different dose levels. In some embodiments, the dose of medication obtained from the oral immunotherapy administration kit is administered only to patients registered in the medication distribution management database. In some embodiments, the dose of drug obtained from the oral immunotherapy dosing kit is not used to initiate treatment of a patient. In some embodiments, the oral immunotherapy treatment kit is received from a distributor registered in the drug distribution management database. In some embodiments, the method includes submitting a request to the registered distributor to provide the oral immunotherapy treatment kit to the registered healthcare facility, wherein providing the oral immunotherapy treatment kit to the registered healthcare facility is conditional on the registered distributor verifying the registration of the healthcare facility. In some embodiments, the present invention provides a medicament comprising a food allergen for treating a patient with food allergy by oral immunotherapy, wherein the medicament is administered to the patient according to the method as described above.

[0045] In some embodiments of any of the foregoing treatment methods, the method includes submitting a registration request to the healthcare facility and receiving registration verification from the healthcare facility. In some embodiments, the registration request confirms that the healthcare facility is equipped to identify and treat anaphylaxis. In some embodiments, the registration request confirms that the healthcare facility will monitor the patient for an allergic reaction to the drug after administering the drug to the patient. In some embodiments, the registration request confirms that the healthcare facility will register the patient in the medication distribution management database or verify the patient's registration in the medication distribution management database for each patient to be treated by the healthcare facility with the drug. In some embodiments, the registration request confirms that the healthcare facility will only use an initial dose escalation kit to initiate treatment for patients uniquely associated with the initial dose escalation kit.

[0046] In some embodiments of any of the aforementioned treatment methods, the method includes generating a record of each dose of the drug administered to the registered patient at the registered healthcare facility, wherein the record identifies the administration of the drug and the monitoring of the registered patient after administration of the drug.

[0047] In some embodiments of any of the aforementioned treatment methods, the method further comprises recommending to the patient that the patient receive treatment for the allergic reaction immediately available to the patient during the course of treatment. In some embodiments, the allergic reaction treatment comprises epinephrine. In some embodiments, the method comprises generating a record confirming that a recommendation has been made to the patient that the patient receive treatment for the allergic reaction immediately available to the patient during the course of treatment.

[0048] In some embodiments of any of the aforementioned methods of treatment, the method comprises recommending to the patient that the patient avoid dietary consumption of foods during the course of treatment. In some embodiments, the method comprises generating a record confirming that a recommendation has been made to the patient that the patient avoid dietary consumption of foods during the course of treatment.

[0049] In some embodiments of any of the aforementioned treatment methods, the method includes providing a patient status to a medication distribution management database manager after discontinuation of treatment for the patient or after transfer of the patient's care to a subsequent healthcare facility.

[0050] In some embodiments, the present invention provides a medicament comprising a food allergen for use in treating a patient with food allergy by oral immunotherapy, wherein the medicament is administered to the patient according to the methods described above.

[0051] In some embodiments, a method for providing a medication containing a food allergen to a healthcare facility or a patient includes: (a) receiving a request at a pharmacy registered in a medication dispensing management database for the medication to provide an initial dose escalation kit associated with an identified patient to the healthcare facility, the initial dose escalation kit including a plurality of different doses of the medication according to an initial dose escalation schedule; (b) verifying the registration of the identified patient in the medication dispensing management database; (c) verifying the registration of the healthcare facility in the medication dispensing management database; (d) providing the initial dose escalation kit associated with the identified patient to the healthcare facility; (e) receiving a prescription issued by the healthcare facility at the registered pharmacy to provide a plurality of doses of the medication at a dosing level or a plurality of doses of the medication at a maintenance level according to a dosing schedule; (f) repeating steps (b) and (c) after step (e); and (g) providing the plurality of doses of the medication at the dosing level or the plurality of doses of the medication at the maintenance level to the patient or the healthcare facility.

[0052] In some embodiments, a method for providing a medication containing a food allergen to a healthcare facility includes: (a) receiving a request at a pharmacy registered in a medication dispensing management database for the medication to provide the healthcare facility with an initial dose escalation kit associated with an identified patient, the initial dose escalation kit including a plurality of different doses of the medication according to an initial dose escalation schedule; (b) verifying the registration of the identified patient in the medication dispensing management database for the medication; (c) verifying the registration of the healthcare facility in the medication dispensing management database; and (d) providing the initial dose escalation kit associated with the identified patient to the healthcare facility.

[0053] In some embodiments, a method of providing a medication containing a food allergen to a patient or a healthcare facility includes: (a) receiving a prescription issued by the healthcare facility at a pharmacy registered in a medication dispensing management database for the medication to provide multiple doses of the medication at a dosing level or multiple doses of the medication at a maintenance level according to a dosing schedule; (b) verifying the registration of the identified patient in the medication dispensing management database for the medication; (c) verifying the registration of the healthcare facility in the medication dispensing management database; and (d) providing the multiple doses of the medication at the dosing level or the multiple doses of the medication at the maintenance level to the patient or the healthcare facility.

[0054] In some embodiments of the method of providing the above-described medication, the method includes submitting a registration request to the pharmacy and receiving a registration verification for the pharmacy.

[0055] In some embodiments of the method of providing the above-described medicament, the method includes generating a record for the patient, the record associating the provided multiple dose treatment levels with the identified patient, wherein the treatment level indicates the initial dose escalation level, the dosing level, or the maintenance dose level.

[0056] In some embodiments, a method for providing an oral immunotherapy treatment kit comprising multiple doses of a medication comprising a food allergen at different levels comprises: (a) receiving a request to provide the oral immunotherapy treatment kit to a healthcare facility at a distributor registered in a medication distribution management database for the medication; (b) verifying the healthcare facility's registration in the medication distribution management database for the medication; and (c) providing the oral immunotherapy treatment kit to the healthcare facility only if the healthcare facility is registered in the medication distribution management database. In some embodiments, the method comprises submitting a registration request to the distributor and receiving a registration verification for the distributor. In some embodiments, the method comprises generating a record identifying the healthcare facility to which the oral immunotherapy treatment kit has been provided. In some embodiments, the request to provide the oral immunotherapy treatment kit to the healthcare facility is made by the healthcare facility.

[0057] In some embodiments, a method for treating a patient with food allergies by oral immunotherapy comprises: (a) registering the patient or verifying the registration of the patient in a medication distribution management database for medications containing food allergens; (b) administering a dose of the medication at a first dosing level to the registered patient according to a dosing schedule, wherein the dose is administered under the supervision of a healthcare provider registered in the medication distribution management database; (c) after administering the dose of the medication in step (b), monitoring the registered patient for an allergic reaction to the medication under the supervision of the registered healthcare provider; and (d) providing a first prescription, wherein the first prescription request is registered in the medication distribution management database. The method further comprises administering to the registered patient or registered healthcare provider a plurality of doses of the medication at the first dosing level; (e) administering to the registered patient a dose of the medication at a subsequent dosing level according to the dosing schedule, wherein the dose is administered under the supervision of the healthcare provider; (f) monitoring the registered patient for an allergic reaction to the medication after the dose of the medication is administered in step (e); and (g) providing a subsequent prescription requesting the registered pharmacy to administer to the registered patient, the registered healthcare provider, or a healthcare facility registered in the medication distribution management database a plurality of doses of the medication at the subsequent dosing level. In some embodiments, the method further comprises advising the registered patient, wherein the advising is performed under the supervision of the registered healthcare provider. In some embodiments, the medication administered to the registered patient in step (b) or step (e) is administered at a healthcare facility registered in the medication distribution management database. In some embodiments, the method further comprises obtaining the dose of the drug administered to the registered patient in step (b) or step (e) from an oral immunotherapy treatment kit, the oral immunotherapy treatment kit comprising a plurality of doses of the drug at different dosing levels. In some embodiments, the oral immunotherapy treatment kit is received from a distributor registered in the drug distribution management database. In some embodiments, the method comprises submitting a request to the registered distributor to provide the oral immunotherapy treatment kit to the registered healthcare provider or the registered healthcare institution, wherein the provision of the oral immunotherapy treatment kit to the registered healthcare provider or the registered healthcare institution is conditional on the registered distributor verifying the registration of the healthcare provider if the oral immunotherapy treatment kit is to be provided to the healthcare provider, or verifying the registration of the healthcare institution if the oral immunotherapy treatment kit is to be provided to the healthcare institution. In some embodiments, the method further comprises, prior to step (b), administering to the registered patient a plurality of different doses of the drug according to an initial dose escalation schedule, wherein the administration is under the supervision of the registered healthcare provider.In some embodiments, the method further comprises monitoring the registered patient for an allergic reaction to the drug after administering each different dose of the drug according to the initial dose escalation schedule. In some embodiments, the multiple different doses of the drug according to the initial dose escalation schedule are obtained from an initial dose escalation kit assigned to the registered patient. In some embodiments, the method further comprises receiving the initial dose escalation kit from the registered pharmacy. In some embodiments, the method further comprises submitting a request to the registered pharmacy to provide the initial dose escalation kit to the registered healthcare provider, wherein the provision of the initial dose escalation kit to the registered healthcare provider is conditional on the registered pharmacy verifying (1) the patient's registration in the medication distribution management database and (2) the healthcare provider's registration. In some embodiments, another condition for providing the initial dose escalation kit to the registered healthcare provider is that the registered pharmacy verifies the healthcare facility's registration in the medication distribution management database, wherein the initial dose escalation kit will be administered to the registered patient at the registered healthcare facility. In some embodiments, the present invention provides a medicament comprising a food allergen for use in treating a patient with food allergy by oral immunotherapy, wherein the medicament is administered to the patient according to the methods described above.

[0058] In some embodiments, there is a method for initiating treatment of a patient with food allergy by oral immunotherapy, the method comprising: (a) registering the patient or verifying the registration of the patient in a medication distribution management database for medications containing food allergens; (b) administering a plurality of different doses of the medication according to an initial dose escalation schedule to the registered patient, wherein the administration is under the supervision of a healthcare provider registered in the medication distribution management database; and (c) monitoring the registered patient for an allergic reaction to the medication after each different dose of the medication according to the initial dose escalation schedule is administered in step (b). In some embodiments, the administration of step (b) is at a healthcare facility registered in the medication distribution management database. In some embodiments, the monitoring of step (c) is at a healthcare facility registered in the medication distribution management database. In some embodiments, the plurality of different doses of the medication according to the initial dose escalation schedule is obtained from an initial dose escalation kit assigned to the registered patient. In some embodiments, the method further comprises receiving the initial dose escalation kit from a pharmacy registered in the medication distribution management database. In some embodiments, the method comprises submitting a request to a registered pharmacy to provide the initial dose escalation kit to a registered healthcare provider or a healthcare facility registered in the medication distribution management database, wherein providing the initial dose escalation kit is conditioned on verifying the patient's registration in the medication distribution management database and: i) verifying the healthcare provider's registration in the medication distribution management database if the initial dose escalation kit is to be provided to the healthcare provider, or ii) verifying the healthcare facility's registration in the medication distribution management database if the initial dose escalation kit is to be provided to the healthcare provider. In some embodiments, the present invention provides a medicament comprising a food allergen for treating a patient with food allergy by oral immunotherapy, wherein the medicament is administered to the patient according to the method described above.

[0059] In some embodiments, a method for authorizing the provision of a medication containing a food allergen to a healthcare facility includes: (a) verifying the healthcare facility's registration in a medication dispensing management database; (b) verifying a patient's registration in the medication dispensing management database; (c) after the healthcare facility and the patient's registrations in the medication dispensing management database have been verified, authorizing a pharmacy to provide the healthcare facility with an initial dose escalation kit associated with the patient, the initial dose escalation kit including a plurality of different doses of the medication according to an initial dose escalation schedule; in some embodiments, the method further includes verifying a healthcare provider's registration in the medication dispensing management database, wherein step (c) occurs after the healthcare provider's registration in the medication dispensing management database has been verified.

[0060] In some embodiments, a method for authorizing the provision of a medication containing a food allergen to a healthcare facility includes: (a) receiving a healthcare facility registration verification request and a patient registration verification request; (b) generating a healthcare facility registration status, wherein the healthcare facility registration status indicates whether the healthcare facility associated with the healthcare facility registration verification request is registered in a medication dispensing management database; (c) generating a patient registration status, wherein the patient registration status indicates whether the patient associated with the patient registration verification request is registered in the medication dispensing management database; and (d) sending the healthcare facility registration status and the patient registration status to a pharmacy registered in the medication dispensing management database to authorize the pharmacy to provide an initial dose escalation kit associated with the patient to the healthcare facility, wherein the initial dose escalation kit includes multiple different doses of the medication according to an initial dose escalation schedule. In some embodiments, the method further comprises: receiving a healthcare provider registration verification request; generating a healthcare provider registration status, the healthcare provider registration status indicating whether the healthcare provider associated with the healthcare provider registration verification request is registered in the medication dispensing management database; and sending the healthcare provider registration status to the pharmacy registered in the medication dispensing management database to authorize the pharmacy to provide the initial dose escalation kit associated with the patient to the healthcare facility.

[0061] In some embodiments, a method of authorizing the provision of a medication containing a food allergen to a healthcare facility or patient comprises: (a) verifying a healthcare provider's registration in a medication distribution management database; (b) verifying a patient's registration in the medication distribution management database; and (c) after verifying the healthcare provider's and the patient's registrations in the medication distribution management database, authorizing a pharmacy to provide a plurality of doses of the medication at a single therapeutic dose level according to an oral immunotherapy dosing schedule to the healthcare facility or the patient. In some embodiments, the method further comprises verifying the healthcare facility's registration in the medication distribution management database, wherein step (c) occurs after verifying the healthcare facility's registration in the medication distribution management database.

[0062] In some embodiments, a method for authorizing the provision of a medication containing a food allergen to a healthcare facility or patient includes: (a) receiving a healthcare provider registration verification request and a patient registration verification request; (b) generating a healthcare provider registration status, the healthcare provider registration status indicating whether the healthcare provider associated with the healthcare facility registration verification request is registered in a medication dispensing management database; (c) generating a patient registration status, the patient registration status indicating whether the patient associated with the patient registration verification request is registered in the medication dispensing management database; and (d) sending the healthcare provider registration status and the patient registration status to a pharmacy registered in the medication dispensing management database to authorize the pharmacy to provide multiple doses of the medication at a single therapeutic dose level according to an oral immunotherapy dosing schedule to the healthcare facility or the patient. In some embodiments, the method further includes repeating steps (a) to (d) at multiple different therapeutic dose levels, wherein the pharmacy is not authorized to simultaneously provide the medication at more than one therapeutic dose level for the patient.

[0063] In some embodiments, a method for authorizing the provision of a medication containing a food allergen to a pharmacy includes: (a) verifying the pharmacy's registration in a medication distribution management database; and (b) authorizing a distributor to provide the medication to the pharmacy after the pharmacy's registration in the medication distribution management database has been verified.

[0064] In some embodiments, a method for authorizing the provision of a medication containing a food allergen to a pharmacy includes: (a) receiving a pharmacy registration verification request; (b) generating a pharmacy registration status, wherein the pharmacy registration status indicates whether the pharmacy associated with the pharmacy registration verification request is registered in a medication dispensing management database; and (c) sending the pharmacy registration status to a distributor registered in the medication dispensing management database to authorize the distributor to provide the medication to the pharmacy.

[0065] In some embodiments, a method for authorizing the distribution of an oral immunotherapy treatment kit comprising multiple doses of a medication including a food allergen at different dosing levels to a healthcare facility comprises: (a) verifying the healthcare facility's registration in a medication distribution management database; and (b) after the healthcare facility's registration in the medication distribution management database has been verified, an authorized distributor providing the oral immunotherapy treatment kit to the healthcare facility.

[0066] In some embodiments, a method for authorizing the distribution of an oral immunotherapy treatment kit comprising multiple doses of medication including food allergens at different dosing levels to a healthcare facility comprises: (a) receiving a healthcare facility registration verification request; (b) generating a healthcare facility registration status, wherein the healthcare facility registration status indicates whether the healthcare facility associated with the pharmacy registration verification request is registered in a medication dispensing management database; and (c) sending the healthcare facility registration status to a distributor registered in the medication dispensing management database to authorize the distributor to provide the oral immunotherapy treatment kit to the healthcare facility.

[0067] In some embodiments, a method for managing the dispensing of a medication containing a food allergen comprises: (a) authorizing the provision of an initial dose escalation kit comprising a plurality of different doses of the medication according to an initial dose escalation schedule, comprising: (i) verifying a healthcare provider's registration in a medication dispensing management database; (ii) verifying a patient's registration in a medication dispensing management database; (iii) authorizing a pharmacy to provide the initial dose escalation kit associated with the patient to the healthcare provider after the healthcare provider and the patient's registrations in the medication dispensing management database have been verified; (b) authorizing the provision of a plurality of doses of the medication at a single therapeutic dose level according to an oral immunotherapy dosing schedule, comprising: (i) verifying a healthcare provider's registration in the medication dispensing management database; (ii) verifying a patient's registration in the medication dispensing management database; (iii) authorizing the pharmacy to provide the plurality of doses of the medication at the single therapeutic dose level to the healthcare facility or the patient after verifying the healthcare provider and the patient's registration in the medication distribution management database; (c) repeating step (b) at different therapeutic dose levels, wherein the pharmacy is not authorized to simultaneously provide the medication at more than one therapeutic dose level for the patient; and (d) authorizing the provision of an oral immunotherapy treatment kit to the healthcare facility, the oral immunotherapy treatment kit comprising a plurality of doses of the medication for treating food allergies at different dosing levels, comprising: (i) verifying the healthcare facility's registration in the medication distribution management database; (ii) authorizing a distributor to provide the oral immunotherapy treatment kit to the healthcare facility after verifying the healthcare facility's registration in the medication distribution management database. In some embodiments, step (a) further comprises verifying the healthcare provider's registration in the medication distribution management database, wherein step (a)(iii) occurs after verifying the healthcare provider's registration in the medication distribution management database.

[0068] In some embodiments, a method for managing the distribution of a medication containing a food allergen includes: (a) authorizing the provision of an initial dose escalation kit, the initial dose escalation kit including multiple different doses of the medication according to an initial dose escalation schedule, including: (i) receiving a healthcare provider registration verification request and a patient registration verification request; (ii) generating a healthcare provider registration status, the healthcare provider registration status indicating whether the healthcare provider associated with the healthcare provider registration verification request is registered in the medication distribution management database; (iii) generating a patient registration status indicating whether the patient associated with the patient registration verification request is registered in the medication distribution management database; and (iv) sending the healthcare provider registration status and the patient registration status to a pharmacy registered in the medication distribution management database to authorize the pharmacy to provide the initial dose escalation kit associated with the patient to the healthcare provider; (b) authorizing the provision of multiple doses of the medication at a single therapeutic dose level according to an oral immunotherapy dosing schedule, including: (i) verifying that the healthcare provider has registered in the medication distribution management database (i) receiving a healthcare provider registration verification request; (ii) generating a healthcare provider registration status, the healthcare provider registration status indicating whether the healthcare provider associated with the pharmacy registration verification request is registered in the medication dispensing management database; and (iii) sending the healthcare provider registration status to a distributor registered in the medication dispensing management database to authorize the distributor to provide the oral immunotherapy treatment kit to the healthcare provider. In some embodiments, step (a) further comprises: receiving a healthcare provider registration verification request; generating a healthcare provider registration status indicating whether the healthcare provider associated with the healthcare provider registration verification request is registered in a medication dispensing management database; and sending the healthcare provider registration status to the pharmacy registered in the medication dispensing management database to authorize the pharmacy to provide the initial dose escalation kit associated with the patient to the healthcare facility.

[0069] In some embodiments of the above method, the method further comprises: receiving a pharmacy registration request, the pharmacy registration request comprising patient information of the patient; and registering the pharmacy in the medication distribution management database.

[0070] In some embodiments of the above method, the method further comprises: receiving a distributor registration request, the distributor registration request comprising the patient information of the patient; and registering the distributor in the medication distribution management database.

[0071] In some embodiments of the above method, the method further comprises: receiving a patient registration request, the patient registration request comprising patient information of the patient; and registering the patient in the medication distribution management database.

[0072] In some embodiments of the above method, the method further comprises: receiving a healthcare institution registration request, the healthcare institution registration request comprising patient information of the patient; and registering the healthcare institution in the medication distribution management database.

[0073] In some embodiments of the above method, the method further comprises: receiving a healthcare provider registration request, the healthcare provider registration request comprising patient information of the patient; and registering the healthcare provider in the medication dispensing management database. BRIEF DESCRIPTION OF THE DRAWINGS

[0074] Figure 1A An overview of an exemplary medication dispensing system for dispensing medication containing formulated allergenic materials for treating food allergies is shown.

[0075] Figure 1B An overview of another exemplary medication dispensing system for dispensing medication containing formulated allergenic materials for treating food allergies is shown.

[0076] Figure 2 An exemplary oral immunotherapy treatment regimen for treating peanut allergy using a drug comprising formulated peanut flour, which has been designed and successfully tested in clinical trials, is illustrated.

[0077] Figure 3A An exemplary initial dose escalation kit that can include doses for an initial dose escalation phase is illustrated. Figure 3B The interior of the initial dose escalation kit is shown.

[0078] Figure 4 An exemplary oral immunotherapy treatment kit is shown that may be owned by a healthcare facility registered with a medication distribution management database.

[0079] Figure 5An overview of exemplary dispensing controls for the medication dispensing methods described herein is provided.

[0080] Figure 6 An exemplary process for providing an initial dose escalation kit comprising a drug is shown.

[0081] Figure 7 An exemplary method for providing an oral immunotherapy treatment kit to a healthcare setting is illustrated.

[0082] Figure 8 An exemplary process for dispensing multiple doses of a medication at selected dosage levels by a pharmacy is shown.

[0083] Figure 9 An example of a computing device that may be used with the methods or systems described herein is illustrated.

[0084] Figure 10 Another overview of exemplary dispensing controls for the medication dispensing methods described herein is provided. DETAILED DESCRIPTION

[0085] Successful treatment of a patient's food allergy by oral immunotherapy (OIT) can desensitize the patient to the allergens in the food, which can reduce the risk of a systemic or severe allergic reaction (such as anaphylaxis) upon dietary consumption of the food. Completion of treatment may not result in absolute resolution of the allergic reaction, but generally increases the threshold amount of allergenic material required to induce a life-threatening reaction. Mild or moderate allergic reactions can be expected during the administration of a drug containing an allergenic protein for treating a patient's food allergy by oral immunotherapy. Occasionally, treatment can result in severe or systemic allergic reactions, such as anaphylaxis, a potentially life-threatening reaction to ingesting the allergenic composition. As further described herein, oral immunotherapy treatment regimens are further complicated by many administration phases and levels of administration, and it is important that the patient receives the correct dose at each administration to limit the risk of allergic reactions. Unregulated distribution or administration of drugs for oral immunotherapy can have potentially fatal consequences. The processes and systems described herein are implemented to carefully regulate the administration and distribution of the drug by requiring certain checkpoints during the administration or distribution process. As further described herein, systems and methods have been developed to carefully control the dispensing and administration of allergenic drugs for oral immunotherapy to mitigate the risks associated with allergic reactions to the drugs.

[0086] The distribution and administration of the drug can include multiple contact points between the manufacturer, distributor, pharmacy, healthcare institution, prescriber (such as healthcare provider) and the patient. In addition, the drug can be distributed or administered in different forms during oral immunotherapy, such as an initial dose escalation kit, an oral immunotherapy treatment kit for a healthcare institution, a medicated dosage form and a maintenance dosage form distributed or administered at different dosing levels. Any one or more of these dosage forms can be used to treat a patient during an oral immunotherapy treatment regimen, and the distribution and administration of the drug must be carefully controlled to ensure that the patient receives the correct amount of drug at the right time and in the correct setting. For example, the initial dose escalation, the administration of the first dose of each medicated level and the first maintenance dose are performed in a supervised healthcare institution. Only after the dose level is successfully administered to the patient can the drug at that level be distributed to authorized patients.

[0087] The methods and systems described herein allow for the registration of distributors, pharmacies, healthcare facilities, prescribers (such as healthcare providers), and / or patients to be registered in a medication distribution management database for medications. Registration of these entities in the medication distribution management database ensures that only authorized entities receive or distribute medications, which limits the risk of administering an incorrect dose of medication to a patient. Dispensing of medications is contingent upon ensuring registration of the dispensing entity, and registration of the receiving entity is contingent upon registration in the medication distribution management database.

[0088] definition

[0089] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0090] Reference herein to "about" a value or parameter includes (and describes) variations involving the value or parameter itself. For example, a description referring to "about X" includes a description of "X."

[0091] The term "desensitization" is used herein to refer to oral immunotherapy of a food allergen to which the subject's threshold for reaction is increased. Desensitization to a food allergen can be tested using methods known in the art, including oral food challenge. Desensitization can be partial, in which the subject tolerates increased amounts of the food allergen compared to before treatment, but still reacts to higher doses of the food allergen; or desensitization can be complete, in which the patient tolerates all tested doses of the food allergen.

[0092] Unless otherwise indicated, the terms "effective," "efficacy," or "effectiveness" are used herein to refer to the ability of a therapy to induce immunomodulation (such as desensitization) or to maintain a desired immune state (such as a desensitized state).

[0093] As used herein, an action performed or undertaken by a "healthcare institution" may be performed or undertaken by the health care institution itself or by a representative of the health care institution, such as a health care provider (e.g., a doctor, nurse, nursing assistant, etc.) associated with or acting on behalf of the health care institution. For example, "a prescription issued by a health care institution" encompasses a prescription issued by a health care provider associated with or acting on behalf of the health care institution.

[0094] The term "maintenance phase" refers to the phase of oral immunotherapy that involves administering a food allergen to the patient (ie, a maintenance dose) and occurs after the dosing phase is complete.

[0095] The term "mild allergic adverse event" or "mild allergic reaction" refers to an observed or experienced OIT treatment-related allergic adverse event that is associated with transient discomfort but does not require immediate medical intervention (such as hospitalization or epinephrine) and does not substantially interfere with daily activities.

[0096] The term "moderate allergic adverse event" or "moderate allergic reaction" refers to an observed or experienced allergic adverse event associated with OIT treatment that is associated with a degree of discomfort sufficient to interfere with daily activities and may indicate medical intervention and / or additional observation.

[0097] The term "severe allergic adverse event" or "severe anaphylaxis" refers to an observed or experienced OIT treatment-related allergic adverse event resulting in anaphylaxis requiring hospitalization and / or administration of epinephrine or other life-saving medical intervention.

[0098] The term "systemic allergic adverse event" or "anaphylaxis" refers to an observed or experienced allergic adverse event associated with OIT treatment that affects two or more body systems.

[0099] The terms "subject" or "patient" are used synonymously herein to describe a human of any age.

[0100] A subject "tolerates" a dose when the subject is administered the dose without any moderate or severe (ie, serious) allergic adverse events. A subject is considered to have tolerated the dose even if mild allergic adverse events are observed or experienced.

[0101] The terms "treat," "treating," and "treatment" are used synonymously herein to refer to any action that provides a benefit to a subject suffering from a disease state or condition, including ameliorating the condition by: alleviating, inhibiting, suppressing, or eliminating at least one symptom; delaying the progression of the disease; delaying the recurrence of the disease; inhibition of the disease; or partial or complete reduction in the response or reaction to an allergen.

[0102] A "dosing phase" refers to a phase of oral immunotherapy characterized by a series of increasing food allergen doses, starting with administration of a food allergen dose that is lower than the highest dose administered to the patient during oral immunotherapy and ending when the highest dose administered to the patient during oral immunotherapy is reached.

[0103] It should be understood that aspects and variations of the present invention described herein include "consisting of" and / or "consisting essentially of" aspects and variations.

[0104] When a range of values is provided, it is understood that each intervening value between the upper and lower limits of that range and any other specified or intervening values in that stated range are encompassed within the scope of the present disclosure. Where the stated range includes an upper or lower limit, ranges excluding any of those included limits are also encompassed within the present disclosure.

[0105] The section headings used herein are for organizational purposes only and should not be construed as limiting the subject matter described. This description is provided to enable one of ordinary skill in the art to make and use the invention and is provided in the context of a patent application and its requirements. Various modifications to the described embodiments will be apparent to those skilled in the art, and the general principles herein may be applied to other embodiments. Therefore, the present invention is not intended to be limited to the embodiments shown, but to conform to the broadest scope consistent with the principles and features described herein.

[0106] The disclosures of all publications, patents, and patent applications mentioned herein are hereby incorporated by reference in their entirety. To the extent any reference incorporated by reference conflicts with the present disclosure, the present disclosure controls.

[0107] Overview of Drug Distribution Management System

[0108] Patients, healthcare facilities, prescribers (such as healthcare providers), pharmacies, and distributors are registered in a medication distribution management database, and an entity that provides medication to another entity must ensure that the entity receiving the medication is registered in the medication distribution management database. The providing entity can submit a registration verification request that is received by an electronic device. The electronic device then accesses the medication distribution management database and compares the information provided in the registration verification request with the information in the medication distribution management database to determine whether the querying entity is registered in the medication distribution management database. If the querying entity is registered, a positive registration status is transmitted to the requesting entity, which authorizes the requesting entity to provide the medication to the querying entity. Additional details of these medication distribution management methods are provided herein.

[0109] Figure 1AAn overview of an exemplary medication distribution management system for treating food allergies (e.g., peanut allergies) containing formulated allergenic materials (such as allergenic peanut flour) is shown. An electronic system 101 includes a memory storing a medication distribution management database 102, which includes sub-databases, including a registered patient sub-database 103, a registered healthcare facility sub-database 104, a registered pharmacy database 105, and a registered distributor database 106. Registered patient sub-database 103 includes multiple entries for patients registered in the sub-database (these entries can be organized as lists, nodes, or other suitable formats), each of which contains patient information (such as one or more of the patient's name, registration number, address, date of birth, gender, telephone number, parent or guardian name, healthcare facility information identifying a healthcare facility that treats patients with food allergies, and / or a confirmation that the patient and / or guardian has read and / or understood the patient's certification regarding medication use). The registered healthcare facility sub-database 104 includes a plurality of entries for healthcare facilities registered in the sub-database (these entries may be organized as a list, node, or other suitable format), wherein each entry contains healthcare facility information (such as one or more of the healthcare facility name, registration number, names of one or more authorized representatives of the healthcare facility, names and / or medical license numbers of one or more healthcare providers associated with the healthcare facility, address, telephone number, a list of patients treated with medications by the healthcare facility, and / or confirmation that the authorized representative has read and / or understood the healthcare facility's certification regarding medication use). The registered pharmacy database 105 includes a plurality of entries for pharmacies registered in the sub-database (these entries may be organized as a list, node, or other suitable format), wherein each entry contains pharmacy information (such as one or more of the pharmacy name, registration number, address, telephone number, names of one or more authorized representatives of the pharmacy, pharmacy license number, and / or confirmation that the authorized representative has read and / or understood the pharmacy's certification regarding providing medications to another entity). The registered distributor sub-database 106 includes a plurality of entries for distributors registered in the sub-database (the entries may be organized as a list, nodes, or other suitable format), wherein each entry contains distributor information (such as one or more of the distributor's name, registration number, distributor license number, address, telephone number, the names of one or more authorized representatives of the distributor, and / or a confirmation that the authorized representative has read and / or understood the distributor's certification regarding the provision of a drug to another entity).

[0110] The healthcare institution 107 can be registered in the healthcare institution sub-database 104 by submitting a healthcare institution registration request to the medication dispensing management database manager. The healthcare institution registration request includes healthcare information, and the medication dispensing management database manager can approve the registration and / or create an entry for the healthcare institution 107 in the healthcare institution sub-database 104. Once the healthcare institution 107 is registered in the healthcare institution, the sub-database can submit a patient registration request containing patient information on behalf of the patient 108 to the medication dispensing management database manager, which can approve the registration and / or create an entry for the patient 108 in the patient sub-database 103. Optionally, the healthcare institution 107 can be authorized to create an entry for the patient 108 in the patient sub-database 103.

[0111] Pharmacies 109 may be registered in the pharmacy house database 105 by submitting a pharmacy registration request to the medication dispensing management database manager. The pharmacy registration request includes pharmacy information, and the medication dispensing management database manager may approve the registration and / or generate an entry for the pharmacy 109 in the pharmacy house database 105. Once the pharmacy 109 is registered in the pharmacy house database 105, the pharmacy may submit a patient registration verification request or a healthcare facility registration verification request to the electronic system 101 or the medication dispensing management database manager to verify the registration of the patient and / or healthcare facility. Pharmacies 109 registered in the pharmacy house database 105 are authorized to dispense medication to the healthcare facility 107 (for an initial dose escalation kit and / or a boosting dose at a selected level) or to the patient 108 (for a boosting dose at a selected level) only after the registrations of the patient 108 and healthcare facility 107 have been verified.

[0112] A distributor 110 may be registered in the distributor sub-database 106 by submitting a distributor registration request to the medication dispensing management database manager. The distributor registration request includes distributor information, and the medication dispensing management database manager may approve the registration and / or create an entry for the distributor 110 in the distributor sub-database 106. Once the distributor 110 is registered in the distributor sub-database 106, the distributor may submit a healthcare institution registration verification request to the electronic system 101 or the medication dispensing management database manager to verify the healthcare institution's registration. The distributor 110 registered in the distributor sub-database 106 is authorized to distribute the medication packaged in the oral immunotherapy treatment kit to the healthcare institution 107 only after the healthcare institution's 107 registration has been verified.

[0113] Figure 1BAn overview of another exemplary medication distribution management system for treating food allergies (e.g., peanut allergies) containing formulated allergenic materials (e.g., allergenic peanut flour) is shown. An electronic system 151 includes memory storing a medication distribution management database 152, which includes sub-databases, including a registered patient sub-database 153, a registered prescriber sub-database 154 (e.g., a registered healthcare provider sub-database), a registered healthcare facility sub-database 155, a registered pharmacy database 156, and a registered distributor database 157. Registered patient sub-database 153 includes multiple entries for patients registered in the sub-database (these entries can be organized as lists, nodes, or other suitable formats), each entry containing patient information (e.g., one or more of the patient's name, registration number, address, date of birth, gender, telephone number, parent or guardian name, healthcare facility information identifying the healthcare facility that treats patients with food allergies, and / or confirmation that the patient and / or guardian has read and / or understood the patient's certification regarding medication use). The registered prescriber sub-database 154 includes a plurality of entries for prescribers (e.g., healthcare providers) registered in the sub-database (these entries may be organized as a list, node, or other suitable format), wherein each entry contains prescriber information (such as the prescriber's name, registration number, identification number (e.g., national provider identifier, medical license number, etc.), address, telephone number, a list of patients treated by the prescriber with the medication, the name of the associated healthcare institution, and / or confirmation that the prescriber has read and / or understood the prescriber's certification regarding the use of the medication). The registered healthcare institution sub-database 155 includes a plurality of entries for healthcare institutions registered in the sub-database (these entries may be organized as a list, node, or other suitable format), wherein each entry contains healthcare institution information (such as the healthcare institution's name, registration number, the names of one or more authorized representatives of the healthcare institution, the names and / or medical license numbers of one or more healthcare providers associated with the healthcare institution, address, telephone number, a list of patients treated by the healthcare institution with the medication, and / or confirmation that the authorized representatives have read and / or understood the healthcare institution's certification regarding the use of the medication). The registered pharmacy database 156 includes multiple entries for pharmacies registered in the sub-database (the entries can be organized as a list, node, or other suitable format), where each entry contains pharmacy information (such as one or more of the pharmacy name, registration number, address, telephone number, the names of one or more authorized representatives of the pharmacy, the pharmacy license number, and / or confirmation that the authorized representative has read and / or understood the pharmacy's certification regarding the provision of medication to another entity).The registered distributor sub-database 157 includes a plurality of entries for distributors registered in the sub-database (the entries may be organized as a list, nodes, or other suitable format), wherein each entry contains distributor information (such as one or more of the distributor's name, registration number, distributor license number, address, telephone number, the names of one or more authorized representatives of the distributor, and / or a confirmation that the authorized representative has read and / or understood the distributor's certification regarding the provision of a drug to another entity).

[0114] The prescriber 159 may be registered in the prescriber sub-database 154 by submitting a prescriber registration request to the medication dispensing management database manager. The prescriber registration request includes prescriber information, and the medication dispensing management database manager may approve the registration and / or create an entry for the prescriber 159 in the prescriber sub-database 154.

[0115] A healthcare facility 158 may be registered in the healthcare facility sub-database 155 by submitting a healthcare facility registration request to the medication dispensing management database manager. The healthcare facility registration request includes healthcare facility information, and the medication dispensing management database manager may approve the registration and / or creation of an entry for the healthcare facility 158 in the healthcare facility sub-database 155. Once the healthcare facility 158 is registered in the healthcare facility, the sub-database may submit a patient registration request containing patient information on behalf of the patient 160 to the medication dispensing management database manager, which may approve the registration and / or creation of an entry for the patient 160 in the patient sub-database 153. Optionally, the healthcare facility 158 may be authorized to create an entry for the patient 160 in the patient sub-database 153.

[0116] A pharmacy 161 can be registered in the pharmacy house database 156 by submitting a pharmacy registration request to the medication dispensing management database manager. The pharmacy registration request includes pharmacy information, and the medication dispensing management database manager can approve the registration and / or create an entry for the pharmacy 161 in the pharmacy house database 156. Once the pharmacy 161 is registered in the pharmacy house database 156, the pharmacy can submit a patient registration verification request, a prescriber registration verification request, and / or a healthcare facility registration verification request to the electronic system 151 for the medication dispensing management database manager to verify the registration of the patient, prescriber, and / or healthcare facility. In some embodiments, a pharmacy 161 registered in the pharmacy house database 156 is authorized to dispense medication to a healthcare facility 158 or prescriber 159 (for an initial dose escalation kit and / or a boosting dose at a selected level) or a patient 160 (for a boosting dose at a selected level) only after the registrations of the patient 160, prescriber 159, and healthcare facility 158 have been verified. In some embodiments, a pharmacy 161 registered in the pharmacy database 156 is authorized to dispense medication to a healthcare facility 158 or prescriber 159 (for an initial dose escalation kit and / or a boosting dose at a selected level) or a patient 160 (for a boosting dose at a selected level) only after the registration of the patient 160 and prescriber 159 has been verified.

[0117] A distributor 162 may be registered in the distributor sub-database 157 by submitting a distributor registration request to the medication dispensing management database manager. The distributor registration request includes distributor information, and the medication dispensing management database manager may approve the registration and / or create an entry for the distributor 162 in the distributor sub-database 157. Once the distributor 162 is registered in the distributor sub-database 157, the distributor may submit a healthcare facility registration verification request to the electronic system 151 for the medication dispensing management database manager to verify the healthcare facility's registration. The distributor 162 registered in the distributor sub-database 157 is authorized to distribute the medication packaged in the oral immunotherapy treatment kit to the healthcare facility 158 only after the healthcare facility's 158 registration has been verified.

[0118] Patients treated

[0119] Patients with food allergies (such as peanut allergies) can be treated using the oral immunotherapy methods described in further detail herein. Briefly, treatment typically includes an initial dose escalation phase (which is omitted in some embodiments), a dosing phase (which includes periodic increases in the drug dose as a variety of different dose levels), and a maintenance phase. Patients are treated under the supervision of a healthcare provider associated with a healthcare facility. The medication delivery management system and methods described herein are designed to mitigate risks to patients by ensuring that they receive the correct amount of medication at the correct time during oral immunotherapy treatment.

[0120] Prior to treatment, the patient is registered in the patient sub-database of the medication distribution management database. For example, a patient registration request is submitted to the medication distribution system manager by a healthcare institution or an authorized representative of the healthcare institution (such as a healthcare provider (e.g., a prescriber)). The patient registration request can be in the form of electronic transmission (e.g., via a secure network, the Internet, an IP protocol, a network interface, a mobile application (e.g., a mobile phone or tablet application), an email, an electronic record transfer, a fax, or any other suitable electronic transmission). The patient registration request includes patient information, such as the patient's name, the patient's date of birth, the patient's gender, the patient's contact information (such as an address, telephone number, email address, etc.), the name of a parent or guardian, and / or the contact information of a parent or guardian. The patient registration request can also include a confirmation that the patient and / or guardian has read and / or understood the patient's certificate (this confirmation can be indicated, for example, by a signature or initials). Such patient certification may include, but is not limited to, any one or more of the following: (1) the patient has been instructed to immediately enter and / or undergo anaphylaxis treatment (such as epinephrine, albuterol, diphenhydramine, etc.) during the food allergy treatment process, (2) the patient has been instructed to avoid dietary consumption of foods associated with the food allergy for which the patient is being treated, (3) the patient has been informed of the signs and / or symptoms of an allergic reaction, (4) the patient consents to remain at the health care facility for a monitoring period (e.g., one hour) after receiving a dose of medication at the health care facility to monitor for an allergic reaction, (5) the patient consents to report the allergic reaction to the health care facility or an authorized representative of the health care facility, (6) the patient consents to notify the health care facility or an authorized representative of the health care facility if additional anaphylaxis treatment medication is needed, and / or (7) the patient consents to immediately enter and / or undergo anaphylaxis treatment during the food allergy treatment process. The patient information may also include information about the health care facility that treats the food allergy patient, such as the name of the health care facility, a registration number (such as a national provider identifier, a registration number, or other alphanumeric identifier), and / or contact information for the health care facility (e.g., an address, telephone number, fax number, and / or an email address).

[0121] A healthcare facility treating a patient may transmit a patient registration request to the medication dispensing management system manager. Once the entry for the patient is received by the medication dispensing management system manager, an entry for the patient may be created in a registered patient sub-database of the medication dispensing management database, the registered patient sub-database including patient information. Once the medication dispensing management system manager is registered in the patient sub-database, the medication dispensing management system manager may send a confirmation of registration to the healthcare facility and / or the patient.

[0122] In some embodiments, a prescriber (such as a healthcare provider) treating a patient, who may be associated with a healthcare organization, may transmit a patient registration request to the medication dispensing management system manager. Once the entry for the patient is received by the medication dispensing management system manager, an entry for the patient may be created in a registered patient sub-database of the medication dispensing management database, the registered patient sub-database including patient information. Once the medication dispensing management system manager is registered in the patient sub-database, the medication dispensing management system manager may send a confirmation of the registration to the prescriber (such as a healthcare provider) and / or the patient.

[0123] In some embodiments, the patient information in the patient sub-database of the drug distribution management database is updated to indicate the dosage level of the drug for treating the patient. The dosage level can be updated by a pharmacy registered in the drug distribution management database or by a healthcare institution registered in the drug distribution management database. For example, if a pharmacy provides an initial dose escalation kit to a healthcare institution (or prescriber, such as a healthcare provider) of a specific patient, the patient information of the patient can be updated to indicate that the initial dose escalation kit is being utilized to treat the patient. If a pharmacy distributes multiple doses of the drug (e.g., as specified by a healthcare institution or healthcare provider) at a selected dosage level, the patient information can be updated by the pharmacy to indicate the dosage level for treating the patient.

[0124] healthcare providers

[0125] Prescriber (also referred to as health care provider) treats food allergy patient and / or supervises the treatment to food allergy patient, and must register in the prescriber sub-database of the drug distribution management database before initiating treatment or receiving oral immunotherapy treatment kit or initial dose increment kit.The duties of health care provider are further described herein.In short, health care provider administers the dosage (including representative health care institution) (assuming that initial dose increment kit is used in optional oral immunotherapy scheme in some embodiments) contained in initial dose increment kit (this initial dose increment kit can be received from the pharmacy and once in the drug distribution management database, patient is specifically associated with patient, as further described herein) to patient.Between initial increment dose, health care provider monitors the allergic reaction of patient (including representative health care institution) during monitoring period.Health care provider is further responsible for administering the first dose (including representative health care institution) to patient under each dosage level.Health care provider administers the first dose (or supervises the administration of the first dose) under given dosage level, and monitors the allergic reaction (or supervises the monitoring of the allergic reaction to patient) of patient on behalf of health care institution.Health care provider can then prescribe the prescription of this dosage level to patient. To change the dose level, the patient must return to the healthcare provider at the associated healthcare facility, and the healthcare provider administers a dose of the subsequent dose level and monitors the patient for allergic reactions during a monitoring period. This process is repeated for each dose level during the dosing and maintenance phases of oral immunotherapy.

[0126] A healthcare provider (or healthcare organization) may transmit a healthcare provider registration request to the medication dispensing management database manager, and if approved, the medication dispensing management database manager may generate an entry in a prescriber sub-database of the medication dispensing management database, the prescriber sub-database including prescriber (i.e., healthcare provider) information for registering the healthcare provider in the medication dispensing management database. The healthcare provider registration request may be in the form of an electronic transmission (e.g., via a secure network, a web interface, email, electronic record transfer, fax, or any other suitable electronic transmission). The healthcare provider information may include one or more of the healthcare provider's name, an identification number (e.g., a national provider identifier, a license number, etc.), the healthcare provider's contact information (e.g., an address, telephone number, fax number, and / or email address), information about one or more healthcare organizations associated with the healthcare provider (e.g., healthcare organization address, telephone number, fax number, name, etc.), and / or confirmation of the healthcare provider's credentials (e.g., a signature). The healthcare provider certification may include, but is not limited to, one or more of the following: (1) confirmation that the healthcare provider will register each patient in the medication distribution management database (or confirm the patient's registration in the medication distribution management database) prior to initiation of treatment and / or prior to writing a prescription for the patient, (2) confirmation that the healthcare provider will provide the patient with a copy of the completed patient registration form prior to initiation of treatment and / or prior to writing a prescription for the patient, (3) confirmation that the healthcare provider will advise the patient of the need for immediate use of injectable epinephrine prior to initiation of treatment and / or prior to writing a prescription for the patient, and the need for monitoring during the initial dose escalation period (if part of an oral immunotherapy). (a) confirmation that the first dose of each dosing level requires monitoring, that peanuts need to be avoided in the diet on an ongoing basis, and how to recognize signs and symptoms of allergies; (4) confirmation that the healthcare provider will assess the patient's supply of injectable epinephrine before treatment is initiated and / or before a prescription is written for the patient and provide a prescription for epinephrine if necessary; (5) confirmation that the healthcare provider will assess the patient's tolerability of the previously administered level and the appropriateness of continuing dosing according to the oral immunotherapy regimen during treatment but before dispensing the first dose of each dosing level; and (6) confirmation that the healthcare provider will consistently report treatment discontinuations or transfers of care for patients to the healthcare management database manager.

[0127] health care institutions

[0128] The healthcare institution oversees the treatment of patients with food allergies and must register in the healthcare institution sub-database of the drug distribution management database before initiating treatment or receiving an oral immunotherapy treatment kit or an initial dose escalation kit. The responsibilities of the healthcare institution for treating patients are further described herein. In short, the healthcare institution administers the dose contained in the initial dose escalation kit (which can be received from a pharmacy and specifically associated with the patient once the patient is registered in the drug distribution management database, as further described herein) to the patient (assuming that the initial dose escalation kit is used in an optional oral immunotherapy regimen in some embodiments). Between the initial increasing doses, the healthcare institution monitors the patient's allergic reactions during the monitoring period. The healthcare institution is further responsible for administering the first dose to the patient at each dose level. As further described herein, the oral immunotherapy treatment kit at the healthcare institution includes multiple doses at each dose level used during oral immunotherapy. The healthcare institution (or authorized representative) administers the first dose at a given dose level and monitors the patient's allergic reactions. The healthcare institution can then prescribe the dosage level to the patient. To change the dose level, the patient must return to the healthcare facility, which administers a dose of the subsequent dose level and monitors the patient for allergic reactions during a monitoring period. This process is repeated for each dose level during the dosing and maintenance phases of oral immunotherapy.

[0129] The healthcare institution may transmit a healthcare institution registration request to the medication dispensing management database manager, and if approved, the medication dispensing management database manager may generate an entry in a healthcare institution sub-database of the medication dispensing management database, the healthcare institution sub-database including healthcare institution information for registering the healthcare institution in the medication dispensing management database. The healthcare institution registration request may be in the form of an electronic transmission (e.g., via a secure network, a web interface, email, electronic record transfer, fax, or any other suitable electronic transmission). The healthcare institution information may include one or more of the healthcare institution name, an identification number (e.g., a national provider identifier, a Drug Enforcement Agency (DEA) number, etc.), contact information for the healthcare institution (e.g., an address, telephone number, fax number, and / or email address, etc.), the name of an authorized representative, and / or confirmation of the healthcare institution's credentials (e.g., a signature). The health care facility certification may include, but is not limited to, one or more of the following: (1) confirmation that an authorized representative and / or treating health care provider has reviewed educational information regarding the use of medications to treat food allergies, (2) confirmation that patients who are administered a dose of medication at the health care facility will be monitored for allergic reactions during a monitoring period, (3) confirmation that the health care facility is equipped to treat patients for allergic reactions (such as anaphylaxis and / or anaphylaxis), (4) confirmation that the health care facility will establish practices for registering patients in a medication dispensing management database and / or verifying the registration of patients in a medication dispensing management database, (5) confirmation that the initial dose escalation kit received by the health care facility will be used only for the patient specifically associated with the initial dose escalation kit, (6) confirmation that the health care facility will have procedures to ensure that patients being treated for food allergies by the health care facility enter into allergic reaction treatment (such as epinephrine) during the course of food allergy treatment. , albuterol, diphenhydramine, etc.), (7) confirmation that the health care facility will instruct patients being treated for food allergies to avoid dietary consumption of foods associated with the food allergy being treated, (8) confirmation that the health care facility will instruct patients how to recognize signs and / or symptoms of an allergic reaction, (9) confirmation that the health care facility will notify the patient and / or the parent or guardian of the patient being treated that the patient will need to be monitored for allergic reactions during a monitoring period following administration of the medication in the health care facility, (10) confirmation that the health care facility will not distribute, transfer, loan, or sell medications, (11) confirmation that the health care facility will not distribute initial dose escalation kits for use outside of the health care facility, (12) confirmation that doses from the oral immunotherapy kit will not be administered to patients who are not registered in the medication distribution management system, and / or (13) confirmation that the health care facility will only use initial dose escalation kits to initiate treatment.

[0130] pharmacy

[0131] A pharmacy registered in a pharmacy house database of a medication dispensing management database distributes (1) an initial dose escalation kit associated with a specific patient registered in a patient sub-database of the medication dispensing management database to a healthcare facility registered in a healthcare facility sub-database of the medication dispensing management database and / or distributes (2) multiple doses of medication at a prescribed dose level to a patient registered in a patient sub-database of the medication dispensing management database or a healthcare facility registered in a healthcare facility sub-database. In some embodiments, before dispensing medication, the pharmacy is required to verify the registration of the patient and the healthcare facility in the medication dispensing management database. In some embodiments, before dispensing medication, the pharmacy is required to verify the registration of the patient and the healthcare provider (and / or the healthcare facility associated with the healthcare provider) in the medication dispensing management database. In some embodiments, before dispensing medication, the pharmacy is required to verify the registration of the patient, the healthcare facility, and the healthcare provider in the medication dispensing management database.

[0132] A pharmacy can be registered in the pharmacy house database by transmitting a pharmacy registration request to the drug distribution management database manager. The pharmacy registration request can be in the form of an electronic transmission (e.g., via a secure network, a network interface, an email, an electronic record transfer, a fax, or any other suitable electronic transmission). Once the drug distribution management database manager receives the registration request, the drug distribution management database manager can authorize the registration of the pharmacy in the pharmacy house database including information about the pharmacy and / or generate an entry for the pharmacy. The pharmacy registration request includes pharmacy information, such as the pharmacy name, an identification number (such as a national provider identifier, a national prescription drug committee program ID, a Drug Enforcement Agency (DEA) number, etc.), the pharmacy's contact information (such as an address, telephone number, fax number, and / or email address), the name or identification information of the pharmacy's authorized representative, and / or confirmation of the pharmacy's certification (such as a signature). The pharmacy certification may include, but is not limited to, one or more of the following: (1) confirmation that an authorized representative has reviewed the overview of the medication dispensing management system, (2) confirmation that the initial dose escalation kit will be associated with a specific patient registered in the patient sub-database of the medication dispensing management database, (3) confirmation that the initial dose escalation kit will only be provided to health care facilities registered in the health care facility sub-database, (4) confirmation that the pharmacy will establish a process to ensure that only a single dose level of the medication is dispensed to a patient at any given time, (5) confirmation that the pharmacy will verify the patient and health care facility registrations in the medication dispensing management database before dispensing the medication (as an initial dose escalation kit or as a booster or maintenance level) to the health care facility or patient, and / or (6) confirmation that the pharmacy will maintain records for the patient indicating the dose level of the medication administered to the patient.

[0133] The pharmacy may transmit a healthcare facility registration verification request and a patient verification request to the medication dispensing management database manager to ensure that the healthcare facility and the patient are registered in the medication dispensing management database. The pharmacy may also transmit a prescriber (such as a healthcare provider) registration verification request to the medication dispensing management database manager to ensure that the prescriber (such as a healthcare provider) is registered in the medication dispensing management database. The prescriber registration verification request may include prescriber (such as a healthcare provider) information, which is used to compare information with entries in the database and generate a registration status for the prescriber (such as a healthcare provider). The healthcare facility registration verification request may include healthcare facility information, and the patient registration verification request may include patient information, which is used to compare information with entries in the database and generate a registration status for the patient and healthcare facility. In some embodiments, a positive registration status for the patient and healthcare facility authorizes the pharmacy, which is also registered in the medication dispensing management database, to dispense medication to the patient and / or healthcare facility. In some embodiments, a positive registration status for the patient and prescriber authorizes the pharmacy, which is also registered in the medication dispensing management database, to dispense medication to the patient and / or healthcare facility. In some embodiments, affirmative registration status by the patient, prescriber, and healthcare facility authorizes that the pharmacy also be registered in the medication dispensing management database to dispense the medication to the patient and / or healthcare facility.

[0134] Distributor

[0135] A distributor registered in a distributor sub-database of a medication dispensing management database may provide an oral immunotherapy treatment kit to a healthcare facility registered in a healthcare facility sub-database of the medication dispensing management database, the oral immunotherapy treatment kit being used to provide a first dose at each dose level during a dosing phase of oral immunotherapy and a first maintenance dose during a maintenance phase of oral immunotherapy. The distributor may verify the healthcare facility's registration in the medication dispensing management database before providing the oral immunotherapy treatment kit to the healthcare facility.

[0136] A distributor can be registered in a distributor sub-database of a drug distribution management database by transmitting a distributor registration request to the drug distribution management database manager. Upon receiving the registration request, the drug distribution management database manager can authorize the registration of the distributor and / or generate energy for the distributor in the distributor sub-database including information about the distributor. The distributor registration request can be in the form of an electronic transmission (e.g., via a secure network, a network interface, an email, an electronic record transfer, a fax, or any other suitable electronic transmission). The distributor information included in the registration request can include, for example, one or more of a distributor name, a distributor identifier (e.g., a national provider identifier, a distributor drug prohibition agency number, or some other alphanumeric identifier), contact information about the distributor (such as an address, telephone number, fax number, and / or email address), and / or a confirmation of the distributor's certification (such as a signature). Distributor certification may include, for example, one or more of (1) confirmation that the distributor will verify the health care facility's registration before providing the drug to the health care facility, (2) confirmation that the distributor will verify the pharmacy's registration before providing the drug to the pharmacy, and / or (3) confirmation that the distributor will maintain records indicating that the drug was provided to the health care facility and / or pharmacy.

[0137] Before providing medication (such as an oral immunotherapy treatment kit) to a healthcare facility, a distributor is required to verify that the healthcare facility is registered in the healthcare facility sub-database of the medication distribution management database. The distributor transmits a healthcare facility registration verification request containing healthcare facility information to the medication distribution management database manager. The medication distribution management database manager can then compare the healthcare facility information included in the verification request with the healthcare facility information contained in the entry in the healthcare facility sub-database and generate a registration status that is transmitted to the distributor. A positive healthcare facility registration status received by the distributor authorizes the distributor to provide medication (e.g., an oral immunotherapy treatment kit) to the healthcare facility.

[0138] Oral immunotherapy

[0139] Patients with food allergies can be treated for food allergies by administering to the patient a series of doses of a drug comprising an allergenic protein formulated with one or more excipients according to a dosing schedule over the course of an oral immunotherapy treatment regimen, thereby desensitizing the patient to the food allergy. The oral immunotherapy treatment regimen is multi-phase and includes an initial dose escalation (IDE) phase (which, in some embodiments, can be omitted from the treatment regimen), a dosing phase, and a maintenance phase. Figure 2 An exemplary oral immunotherapy treatment regimen for treating peanut allergy using a drug comprising formulated peanut flour, which has been designed and successfully tested in clinical trials, is illustrated.

[0140] Oral immunotherapy can be initiated using an initial dose escalation phase, in which the patient is administered a series of increasing doses over the course of one or two days. The series of initial doses is administered in a healthcare facility so that the patient can be monitored for allergic reactions after the doses are ingested. A monitoring period follows the administration of each dose, and if the patient does not have a serious adverse reaction, subsequent doses can be administered and the patient monitored. Because administering a medication containing a food allergen to a patient who is allergic to that food carries the risk of an allergic reaction, the medication delivery management system described herein is designed to ensure that the initial dose escalation is administered only in a healthcare facility where the patient can be monitored. The initial dose escalation phase is discussed in further detail herein.

[0141] After the initial dose escalation phase (if included in the treatment regimen), the patient enters the dosing phase. During the dosing phase of oral immunotherapy, the dosage intensity (or "level") of the drug administered to the patient is periodically increased until the target dose level is reached. For example, during the dosing phase, the same amount of peanut protein composition may be administered to the patient daily for a period of time (e.g., 1 week, 2 weeks, 3 weeks, 4 weeks, or more weeks) before the dose level is increased. As increasing the amount of drug administered to the patient increases the risk of a severe allergic reaction, the medication delivery management system described herein is designed to ensure that the first dose of each increased level is administered in a healthcare facility so that the patient can be monitored. The dosing phase is discussed in further detail herein. Following the dosing phase, the patient is administered a maintenance dose, which maintains the patient's state of desensitization to the food allergen. The duration of treatment, such as the duration of the dosing phase and / or the maintenance phase, may vary based on factors such as the patient's age, health status, severity of peanut allergy, tolerance of the drug product, and / or complicating comorbidities or conditions. The dosage of the peanut protein composition administered during the dosing phase and the maintenance phase can be adjusted as needed based on the judgment of the patient's healthcare provider and / or the needs of the patient.

[0142] Patients undergoing oral immunotherapy for the treatment of food allergies typically have a known or suspected allergy to the food being treated. Methods for diagnosing food allergies are known in the art and include clinical history of allergic reactions following peanut ingestion, immunoassays (such as measuring peanut-specific IgE (ps-IgE) levels), skin prick testing, and food challenges. To diagnose food allergies by food challenge, patients typically receive increasing doses of the allergenic protein from the food, and an allergic reaction to the peanut protein observed during the food challenge indicates that the patient suffers from a food allergy.

[0143] Patients who undergo oral immunotherapy for peanut allergy may be treatment-naive, have never undergone peanut oral immunotherapy for food allergy, or may have previously been treated for food allergy by oral immunotherapy or another treatment approach. Patients diagnosed with food allergy by diagnostic exposure to an allergenic protein (such as in a food challenge) but with no history of other clinical exposure to the allergenic protein after the diagnostic exposure are still considered treatment-naive.

[0144] The patient receiving oral immunotherapy for food allergy is a human patient. In some embodiments, the patient is about 1 year old or older, such as between 1 year old and about 4 years old, between about 4 years old and about 12 years old, between about 12 years old and about 18 years old, between about 18 years old and about 26 years old, or between about 26 years old or older.

[0145] Figure 2 An exemplary oral immunotherapy dosing schedule for treating peanut allergy is shown. The oral immunotherapy shown begins with an optional initial escalation phase that includes oral administration of a series of increasing doses ranging from about 0.5 mg to about 6 mg of peanut protein, administered on the same day and spaced about 20 minutes to about 30 minutes apart. During this phase, the patient can be monitored under medical supervision for adverse events or allergenic reactions, and the medical caregiver can assess the patient's suitability for oral immunotherapy. After the optional initial escalation phase is completed, the patient begins the dosing phase of treatment. During the dosing phase, the subject receives a predetermined dose of a pharmaceutical composition comprising peanut protein each day. The same dose is administered daily for a period of time before the dose is increased. According to Figure 2 In the schedule illustrated in , the patient receives the same dose for two weeks before the dose is escalated. However, the two-week period can be longer (e.g., about 2 weeks to about 4 weeks), or can be shorter (e.g., about 1 week to about 2 weeks). The predetermined time period can be predetermined or can be adjusted based on the patient's response to the pharmaceutical composition. For example, if the patient experiences no allergic adverse events or only mild allergic adverse events, the time period may be two weeks before the dose is escalated. On the other hand, if the patient experiences moderate allergic adverse events or severe allergic adverse events, the oral immunotherapy dosing schedule can be adjusted to delay the dose escalation or reduce the dose. In addition to allergic adverse events, the dosing schedule can also be adjusted for other concurrent factors, such as infection, inflammation (e.g., due to surgery, trauma), menstruation, or other concurrent factors that may lead to increased sensitivity to peanut protein. In Figure 2In the example illustrated in FIG, the dosing phase includes doses of peanut protein of about 3 mg, about 6 mg, about 12 mg, about 20 mg, about 40 mg, about 80 mg, about 120 mg, about 160 mg, about 200 mg, about 240 mg, and about 300 mg, which are administered to the patient in an ascending manner. However, other suitable doses may be used during the dosing phase, and (as discussed above) the scheduled dose may be reduced based on the patient's condition. In a scheduled oral immunotherapy, the dosing phase is followed by a maintenance phase, which includes regular oral administration of a maintenance dose. In some embodiments, the maintenance dose is administered daily. The maintenance dose may be the same dose as the highest dose achieved during the dosing phase, but in some embodiments, the maintenance dose may be above or below the highest dose level. The maintenance phase is administered to the patient to maintain the desensitized state.

[0146] To administer a medicament comprising formulated allergenic materials, the composition is ingested orally. Although the pharmaceutical composition may be packaged in an edible dosage form (e.g., a capsule), the pharmaceutical composition is typically removed from the packaging to allow for adequate oral access. For example, the pharmaceutical composition may be mixed with a food carrier and consumed, such as oatmeal, pudding, applesauce, yogurt, or other semi-solid food.

[0147] Initial incremental phase

[0148] Oral immunotherapy may include an initial dose-escalation phase, preceded by a dosing phase, in which the patient is administered a series of increasing doses over the course of one or two days. The initial dose-escalation phase differs from the dosing phase in that it has a lower dose range, shorter intervals between dose increases, and typically closer monitoring by the patient's healthcare provider. For example, the two-day initial dose-escalation phase may include a series of doses of about 0.5 mg to about 6 mg of peanut protein, such as individual doses of about 0.5 mg, about 1 mg, about 1.5 mg, about 3 mg, and about 6 mg of peanut protein. The highest tolerated dose in the initial dose-escalation phase, or a dose lower than the highest tolerated dose in the initial dose-escalation phase, may be the first dose in the dosing phase. If a patient cannot tolerate at least a certain dose during the initial dose-escalation phase, the patient may be excluded from oral immunotherapy as unsuitable for treatment at that time. For example, if a patient experiences a severe allergic adverse event after administration of a 0.5 mg, 1 mg, or 1.5 mg dose of peanut protein, the patient may not be allowed to proceed to the dosing phase. The purposes of the initial ramp-up phase include calibrating the dosing for the up-regulation phase (eg, the initial dose for the up-regulation phase) and ensuring patient fitness to safely proceed into the up-regulation phase.

[0149] Doses for the initial dose escalation phase may be included in an initial dose escalation kit. Figure 3A and Figure 3BAn exemplary initial dose escalation kit that may include doses for an initial dose escalation phase is illustrated. The initial dose escalation kit is distributed by a pharmacy registered in a medication distribution management database to a healthcare facility registered in a medication distribution management database for use only in an initial dose escalation phase for a specific patient, who must also be registered in the medication distribution management database associated with the initial dose escalation kit. Figure 3A And in one embodiment, the initial dose escalation kit 300 can be a single-use (non-reusable) bifold folio made of card stock or other material. The front portion 302 of the initial dose escalation kit 300 can include identification information 304, including but not limited to product and / or company information 306 and space 308 for a pharmacy prescription label and / or patient information (e.g., the patient's name or other patient identifier). Figure 3B Is in open configuration Figure 3A 3. A front view of an initial dose escalation kit 300 is shown. As shown, the initial dose escalation kit 300 includes content information 310 on a first side 312 of an interior portion 314 of the kit 300. The content information 310 may include, for example, dosage preparation instructions 316, dosage form administration instructions 318, storage instructions 320, ingredients 322, and company / product identification information 324, among other information. A second side 326 of the interior portion 314 includes a series of dosage units 328, from a first minimum dose 330 to a maximum dose 332, which are releasably retained within the folio material. For example, the dosage units 328 can be retained within a separate foil package attached to or integrated with the second side 326 of the kit 300. During the initial escalation phase, the initial escalation kit 300 can be prescribed to the patient, wherein each of the dosage units 328 is administered to the patient within a healthcare facility at predetermined or physician-determined time intervals (e.g., according to an OIT protocol). For example, during an initial escalation phase, the patient may be administered a first minimum dose 330 to a maximum dose 332 depending on tolerability.

[0150] The initial ramp-up phase is administered under medical supervision (such as by a healthcare provider registered in the medication distribution management database) at a healthcare facility registered in the medication distribution management database. Patients are typically closely monitored by a medical caregiver (such as a healthcare provider), who may provide interventions such as epinephrine, albuterol, and diphenhydramine in the event of an allergic adverse reaction requiring intervention. The initial ramp-up phase of oral immunotherapy, if any, includes administering multiple small doses of the peanut protein composition to the patient. The small doses may be spaced out over a period of time, such as from about 10 minutes to about 60 minutes, and may include one, two, three, four, or five or more doses.

[0151] In one example, the initial escalation phase includes doses ranging from about 0.5 mg to about 6 mg of peanut protein, such as about 0.5 mg to about 1.5 mg of peanut protein, about 1.5 mg to about 3 mg of peanut protein, or about 3 mg to about 6 mg of peanut protein. In a non-limiting example, the initial escalation phase includes incremental increases from about 0.5 mg to a maximum of about 6 mg of peanut protein per day, with single doses of about 0.5 mg, about 1 mg, about 1.5 mg, about 3 mg, and about 6 mg of peanut protein, wherein tolerability of the 3 mg or 6 mg peanut protein dose indicates that the patient can safely proceed to the dosing phase of oral immunotherapy.

[0152] Dosing stage

[0153] The dosing phase comprises orally administering a series of increasing doses of the pharmaceutical composition to the patient daily, wherein the given dose is administered to the patient for at least a predetermined period of time before the dose is increased during the course of oral immunotherapy to reach the maximum dose administered to the patient. The length of the dosing phase can be adjusted according to the needs of the individual patient, but is typically completed within about 22 weeks to about 40 weeks. For some patients, the dosing phase may last up to 2 years or longer. For example, if the patient experiences an allergic adverse event after starting a higher dose in the dose series, the dosing phase may be extended.

[0154] During the dosing phase, the pharmaceutical composition administered to the patient is administered at a preset, gradually increasing dose level. The patient slowly increases the dose level under medical guidance (such as under the guidance of a healthcare provider) until a maximum dose (usually the same dose as the maintenance dose) is reached. The same dose level (i.e., the same dose of peanut protein) is administered to the patient for a period of time because the patient becomes desensitized to the amount before the dose level is increased. In some embodiments, the dosing phase includes a series of increasing doses of the pharmaceutical composition at about 5 different dose levels or more (e.g., 5 different dose levels to 15 different dose levels, such as 5 different dose levels, 6 different dose levels, 7 different dose levels, 8 different dose levels, 9 different dose levels, 10 different dose levels, 11 different dose levels, 12 different dose levels, 13 different dose levels, 14 different dose levels, or 15 different dose levels). In a non-limiting preferred embodiment, the dosing phase includes 11 different dose levels. For example, the dosing phase can include dosage levels of about 3 mg, about 6 mg, about 12 mg, about 20 mg, about 40 mg, about 80 mg, about 120 mg, about 160 mg, about 200 mg, about 240 mg, and about 300 mg of peanut protein.

[0155] The dosing phase of peanut OIT typically involves incrementally increasing the dose of peanut protein administered over a period of time (e.g., approximately every 1 to 4 weeks). A particular dose in the series is repeatedly administered to the patient (e.g., daily) until advancing to the next dose in the series. In some cases, such as when a patient does not tolerate a particular dose in the series or the patient experiences one or more allergic adverse events, the dose is reduced or the dose in the series is repeated for a period of time before advancing to the next dose in the series. The rate of dosing (e.g., the length of time over which individual doses in the series are administered or the size of the dose increments between doses in the series) can be adjusted based on one or more observed allergic adverse events.

[0156] The dosage applied to the patient during the dosing phase is usually applied every day for a period of time, such as from about 1 week to about 4 weeks, such as about 2 weeks. After completing the specific dose in the series for a period of time, treatment can be advanced to the higher dosage in the series. In some embodiments, the dosing phase for the treatment of comprises a series of different dosage levels between 5 and 15. If the patient tolerates a specific dosage level during the dosing phase for a period of time, the patient can be advanced to the next dosage level in a series of dosing phases. If the patient does not tolerate a specific dosage level during the dosing phase for a period of time, the patient can repeat the current dosage level in the series. Alternatively, if the patient tolerates a specific dosage level during the dosing phase for a period of time, the patient can return to the earlier dosage level in the series. Therefore, the duration of the dosing phase depends on the patient's specific reaction. The patient can repeat the dosage in the series as needed for many times to achieve the highest dose in the series. When the highest dose is tolerated for two weeks, the dosing phase ends.

[0157] For example, the dosage level of the drug administered during the dosing phase for oral immunotherapy for treating peanut allergy is typically between about 0.5 mg and about 1000 mg of peanut protein, such as about 0.5 mg to about 10 mg of peanut protein, about 10 mg to about 100 mg of peanut protein, about 100 mg to about 300 mg of peanut protein, about 300 mg to about 500 mg of peanut protein, or about 500 mg to about 1000 mg of peanut protein. In non-limiting exemplary embodiments, the dosage levels during the dosing phase include dosages of about 3 mg of peanut protein, about 6 mg of peanut protein, about 12 mg of peanut protein, about 20 mg of peanut protein, about 40 mg of peanut protein, about 80 mg of peanut protein, about 120 mg of peanut protein, about 160 mg of peanut protein, about 200 mg of peanut protein, about 240 mg of peanut protein, and about 300 mg of peanut protein, wherein each dosage level is administered daily for about 1 week to about 4 weeks (e.g., about 2 weeks) before being increased to the next highest dose.

[0158] The dosage administered to the patient during the dosing phase is adjusted periodically, such as between once a week and once every six weeks. In some embodiments, the dosing phase includes weekly dose adjustments, biweekly dose adjustments, three-weekly dose adjustments, four-weekly dose adjustments, five-weekly dose adjustments, six-weekly dose adjustments, or adjustments based on the judgment of the patient's medical caregiver. The dose can be increased to the next scheduled dose in the series, reduced to the previous one in the series in response to an allergic adverse event, maintained for another period of time at the current dose in the series, increased to a higher dose in the series based on the judgment of the patient's medical caregiver, or reduced to a lower dose in the series based on the judgment of the patient's medical caregiver. In some embodiments, the dosing phase can be adjusted at any time based on the judgment of the patient's medical caregiver, i.e., the patient is intolerant to the current dose in the series.

[0159] A first dose of any dosage level is administered to a patient at a healthcare facility registered in a medication distribution management database. The healthcare facility possesses an oral immunotherapy treatment kit (which can be distributed to the healthcare facility by a distributor registered in the medication distribution management database after verifying that the healthcare facility has registered in the medication distribution management database) that includes multiple doses at different dosage levels. A healthcare provider can extract a dose of the drug at a prescribed dosage level for administration to the patient in the healthcare facility. Once the dose has been administered to the patient, the patient is monitored for adverse reactions within the healthcare facility. After monitoring the patient, the healthcare provider can prescribe additional doses of the drug at the prescribed dosage level for the patient, and the pharmacy registered in the medication distribution management database can distribute those additional doses at the prescribed dosage level to the patient or healthcare facility. In some embodiments, a prescription for the dosage level is provided only when the patient has not experienced a clinically significant allergic reaction to the drug. In some embodiments, a prescription for the dosage level is provided only when the patient has not experienced a moderate or severe allergic reaction to the drug. In some embodiments, a prescription for the dosage level is provided only when the patient has not experienced a severe allergic reaction to the drug. In some embodiments, a prescription for that dosage level is provided only if the patient does not experience a systemic allergic reaction to the drug. The patient (or the patient's parent, guardian, or other healthcare provider) can then self-medicate at the prescribed dosage level for the prescribed period of time until the patient returns to the healthcare facility. Based on the patient's tolerance to the dosage level, the healthcare provider can then administer the drug at a higher dosage level, a lower dosage level, or the same dosage level in the healthcare facility before monitoring the patient for an allergic reaction in the healthcare facility.

[0160] Figure 4An exemplary oral immunotherapy treatment kit is shown that can be used by a healthcare institution registered in a medication distribution management database. For example, the oral immunotherapy treatment kit 400 can be used to store, organize, identify, and / or select appropriate dosage form levels during OIT administration. The illustrated oral immunotherapy treatment kit 400 includes a housing 402 having a base portion 412 having an inner cavity 414 that retains a plurality of dose containers 420a and 420b. Each dose container holds a plurality of single-dose packages 430a and 430b. Each single-dose package 430a and 430b contains a single dose of medication at an indicated dosage level. The single-dose packages within a given dosage container contain the same dosage form. For example, the dosage container 420a contains a plurality of single-dose packages 430a, each of which provides a first dosage level (e.g., 3 mg), and the dosage container 420b contains a plurality of single-dose packages 430b, each of which provides a second dosage level (e.g., 6 mg), wherein the first dosage level and the second dosage level are different. During normal use, the unit dose dispensing system including housing 402, dosage form container 420, and single dose package 430 is maintained in a physician's office or medical clinic and facilitates efficiency and dosage form accuracy during in-office patient OIT treatment.

[0161] The dosing phase advances until the patient realizes the final dose of the dosing series. In some embodiments, the dosing phase is about 1 month to about 6 months, such as about 1 month to about 3 months or about 3 months to about 6 months. In some embodiments, the dosing phase is about 6 months to about 2 years, such as about 6 months to about 1 year, about 1 year to about 18 months or about 18 months to about 2 years. In non-limiting exemplary embodiments, the dosing phase continues 22 weeks to 2 years, which depends on the quantity of dosage reduction and re-increase and dosage level repetition. In any one of the described embodiments, when the patient tolerates the predetermined dose of the final dose in a series of dosing phases of 2 weeks, the dosing phase terminates, and thus begins the maintenance phase.

[0162] Each dose in the series of dosing phases can be planned to last about 1 week, about 2 weeks, about 3 weeks, about 4 weeks, or values and ranges therebetween. Based on observations of allergic adverse events, the patient's caregiver may repeat the patient's current dose in the dosing series. A specific portion with a specific dose can be repeated as many times as needed, such as once, twice, three times, four times or more, to sufficiently desensitize the patient to the dose, such as when the patient no longer experiences a moderate allergic adverse event or a severe allergic adverse event upon accidental (or intentional) exposure to a food allergen.

[0163] Maintenance phase

[0164] The maintenance phase of oral immunotherapy begins after the dosing phase terminates. In any of the methods described herein, the maintenance phase includes orally administering multiple maintenance doses of the pharmaceutical composition to the patient. The maintenance phase can be initiated in a healthcare facility by administering the drug to the patient at a maintenance dose level (which maintenance dose level can, for example, be included in an oral immunotherapy treatment kit owned by a healthcare facility). After the maintenance dose is administered to the patient, the patient's allergic reactions are monitored before the healthcare provider prescribes the maintenance dose level for the user. The drugs registered in the medication distribution management database can then be distributed at the maintenance dose level to patients registered in the medication distribution management database or to healthcare facilities registered in the medication distribution management database.

[0165] The duration of the maintenance phase is typically about 20 weeks or longer and may last for the patient's entire life. For example, in some embodiments, the maintenance phase is about 20 weeks to about 24 weeks, about 24 weeks to about 28 weeks, about 28 weeks to about 32 weeks, about 32 weeks to about 36 weeks, about 36 weeks to about 40 weeks, about 40 weeks to about 44 weeks, about 44 weeks to about 48 weeks, about 48 weeks to about 52 weeks, about 52 weeks to about 60 weeks, about 60 weeks to about 72 weeks, about 72 weeks to about 80 weeks, or more than about 80 weeks, such as the patient's lifetime.

[0166] The dosage of peanut protein administered to the patient during the maintenance phase is between about 200 mg and about 1000 mg of peanut protein, unless the maintenance phase dose has been reduced, for example, according to the methods described herein, when the patient missed one or more consecutive doses. For example, in some embodiments, the dosage during the maintenance phase is between about 200 mg and about 300 mg of peanut protein, about 300 mg and about 500 mg of peanut protein, about 500 mg and about 1000 mg of peanut protein, or values and ranges therebetween, unless the maintenance phase dose has been reduced, for example, according to the methods described herein, when the patient missed one or more consecutive doses. The predetermined maintenance phase dose can be the same as or a higher dose than the dose administered during the final sub-phase of the dosing phase. In a non-limiting exemplary embodiment, the maintenance phase dose administered to the patient during the maintenance phase is about 300 mg of peanut protein. In some embodiments, the maintenance phase dose is administered daily.

[0167] Pharmaceutical composition

[0168] Medications for treating food allergies are specific for the food allergy being treated and include food allergens (such as allergenic proteins) commonly found in that food. For example, medications for treating peanut allergies can include allergenic peanut proteins (e.g., Ara h 1, Ara h 2, Ara h 6, etc.). In some embodiments, medications for treating peanut allergies include peanut powder formulated with one or more excipients. In another example, medications for treating egg allergies include allergenic egg proteins (e.g., ovalbumin, ovomucin, lysozyme, etc.). In some embodiments, medications for treating egg allergies include dried egg albumin powder formulated with one or more excipients.

[0169] The drug can be contained in an openable package, such as a sachet or an openable capsule (or "spray capsule"), in an amount according to the individually packaged dosage level. The package can be opened and the drug contents of the package poured into a semi-solid food (e.g., yogurt, applesauce, oatmeal, pudding, etc.) and mixed. The food mixed with the drug is then consumed by the patient. In some embodiments, the drug is formulated as a free-flowing powder, which allows the drug to be easily poured from the package.

[0170] Exemplary pharmaceutical compositions are described in U.S. Patent No. 9,198,869; U.S. Patent No. 9,492,535; U.S. Patent No. 10,086,068; and U.S. Patent No. 10,449,118; WO 2016 / 033094; and WO 2018 / 132733, each of which is incorporated herein by reference for all purposes.

[0171] In some embodiments, the pharmaceutical composition is peanut (Arachis hypogaea) allergen powder.

[0172] In some embodiments, the present invention provides a medicament comprising a food allergen for use in treating a patient with food allergy by oral immunotherapy, wherein the medicament is administered or provided to the patient according to any of the methods as described herein.

[0173] Food allergy treatment

[0174] Drugs used to treat food allergies contain allergenic proteins that induce an immune response in patients with food allergies. The immediate immune response is usually mild or not clinically apparent, but over time, due to changes in the immune system during treatment, the patient becomes desensitized to the allergenic protein. Occasionally, a clinically apparent (even severe or systemic) allergic reaction may occur after a patient is treated with the drug. Therefore, the distribution and administration controls described herein are used to minimize the risk to the patient.

[0175] Prior to treatment, the patient must be registered in the medication distribution management database. In some embodiments, the healthcare provider overseeing the patient's treatment must register the patient in the medication distribution management database or otherwise verify the patient's registration in the medication distribution management database for medications used to treat food allergies. In some embodiments, the prescriber overseeing the patient's treatment (such as a healthcare provider) registers the patient in the medication distribution management database or otherwise verifies the patient's registration in the medication distribution management database for medications used to treat food allergies. Once the patient is registered in the medication distribution management database (or the registration is otherwise verified), the healthcare provider (which must also be registered in the medication distribution management database) and / or the healthcare provider (which must also be registered in the medication distribution management database) submits a request for the initial dose escalation kit. The initial dose escalation kit is received by the healthcare provider at the pharmacy, which must also be registered in the medication distribution management database. In some embodiments, the pharmacy must verify the patient and healthcare provider's registration in the medication distribution management database before providing the initial dose escalation kit to the healthcare provider. In some embodiments, the pharmacy verifies the patient and healthcare provider's registration in the medication distribution management database before providing the initial dose escalation kit to the healthcare provider. In some embodiments, the pharmacy verifies the patient, healthcare provider, and healthcare facility's registration in the medication distribution management database before providing the initial dose escalation kit to the healthcare facility. The initial dose escalation kit is specific to the patient being treated. The initial dose escalation kit includes multiple escalating doses that are administered to the patient in the healthcare facility. The dose is administered to the patient at one time, and the patient is monitored for allergic reactions during a monitoring period in the healthcare facility.

[0176] After initiating treatment using the initial dose escalation kit, the dosing phase can begin. The drug is administered to the patient at an initial dose level, and the dose level is periodically increased based on patient response. Although the overall trajectory during the dosing phase is upward, there may be times when the healthcare provider treats the patient at a lower dose level or the same dose level after a certain level of dosing is complete.

[0177] In a healthcare facility, a first dose of a drug at any dosage level is administered to a patient, and the patient is monitored in the healthcare facility for allergic reactions to the drug. If the patient tolerates the drug at that dosage level, the treatment healthcare provider can prescribe multiple doses at that dosage level for the patient. Multiple doses at that drug dosage level can be obtained from a pharmacy, which can register in a medication distribution management database. In some embodiments, the pharmacy must verify the registration of the patient and the healthcare facility in the medication distribution management database. In some embodiments, the pharmacy verifies the registration of the patient and the healthcare provider in the medication distribution management database. In some embodiments, the pharmacy verifies the registration of the patient, the healthcare provider, and the healthcare facility in the medication distribution management database. After the multiple doses of drug are administered to the patient, the patient can return to the healthcare facility. At the healthcare facility, the patient is administered a dosage at a subsequent dosage level, and the patient is monitored for allergic reactions to the drug. The healthcare institution (and / or healthcare provider) can then provide a subsequent prescription for a subsequent level of the drug, which, in various embodiments, can be obtained from a pharmacy registered in the drug distribution management database after the pharmacy verifies the healthcare institution and the patient; the healthcare provider and the patient; or the healthcare institution, the healthcare provider and the patient are registered in the drug distribution management database. In some embodiments, a prescription for that dosage level is provided only when the patient does not experience a clinically significant allergic reaction to the drug. In some embodiments, a prescription for that dosage level is provided only when the patient does not experience a moderate or severe allergic reaction to the drug. In some embodiments, a prescription for that dosage level is provided only when the patient does not experience a severe allergic reaction to the drug. In some embodiments, a prescription for that dosage level is provided only when the patient does not experience a systemic allergic reaction to the drug. This process is repeated through the dosing phase and through maintenance level administration.

[0178] In some embodiments, a method for treating a patient with food allergy by oral immunotherapy includes (a) registering a patient or verifying registration of a patient in a medication dispensing management database for medication for treating food allergies; (b) administering a dose of the medication at a first dosing level according to a dosing schedule to the registered patient at a healthcare facility registered in the medication dispensing management database; (c) after administering the dose of the medication in step (b), monitoring the registered patient at the registered healthcare facility for an allergic reaction to the medication; and (d) providing a first prescription requesting a pharmacy registered in the medication dispensing management database to dispense a plurality of doses of the medication at the first dosing level to the registered patient or the registered healthcare facility. In some embodiments, administering the dose of the medication at the first dosing level according to the dosing schedule is under the supervision of a healthcare provider registered in the medication dispensing management database. In some embodiments, monitoring the registered patient is under the supervision of a healthcare provider registered in the medication dispensing management database.

[0179] In some embodiments, a method for treating a patient with food allergy by oral immunotherapy includes (a) registering a patient or verifying registration of a patient in a medication dispensing management database of medication for treating food allergies; (b) administering a dose of the medication to the registered patient at a first dosing level according to a dosing schedule at a healthcare facility registered in the medication dispensing management database; (c) after administering the dose of the medication in step (b), monitoring the registered patient at the registered healthcare facility for an allergic reaction to the medication; (d) providing a first prescription requesting a pharmacy registered in the medication dispensing management database to dispense multiple doses of the medication at the first dosing level to the registered patient or the registered healthcare facility; (e) administering a dose of the medication to the registered patient at a subsequent dosing level according to the dosing schedule at the registered healthcare facility; (f) after administering the dose of the medication in step (e), monitoring the registered patient at the registered healthcare facility for an allergic reaction to the medication; and (g) providing a subsequent prescription requesting the registered pharmacy to dispense multiple doses of the medication at subsequent dosing levels to the registered patient or the registered healthcare facility. In some embodiments, administration of the dose of the medication at the first dosing level to the registered patient according to the dosing schedule is under the supervision of a healthcare provider registered in the medication dispensing management database. In some embodiments, administration of the dose of the medication at the subsequent dosing level to the registered patient according to the dosing schedule is under the supervision of a healthcare provider registered in the medication dispensing management database. In some embodiments, the first prescription and / or the subsequent prescription are provided by a healthcare provider registered in the medication dispensing management database.

[0180] In some embodiments, a method for treating a patient with food allergy by oral immunotherapy comprises (a) registering a patient or verifying registration of a patient in a medication distribution management database for medications for treating food allergies; (b) administering a plurality of doses of the medication from an initial dose escalation kit to the registered patient at a healthcare facility registered in the medication distribution management database; (c) monitoring the registered patient for an allergic reaction to the medication at the registered healthcare facility after each dose of the medication is administered in step (b); (d) administering a dose of the medication at a first dosing level according to a dosing schedule to the registered patient at the healthcare facility registered in the medication distribution management database; and (e) administering the dose of the medication at a first dosing level after the dose is administered in step (d). In some embodiments, the administration of the multiple doses of the drug from the initial dose escalation kit to the registered patient is under the supervision of a healthcare provider registered in the medication dispensing management database. In some embodiments, the administration of the multiple doses of the drug from the initial dose escalation kit to the registered patient is under the supervision of a healthcare provider registered in the medication dispensing management database. In some embodiments, the administration of the multiple doses of the drug from the initial dose escalation kit to the registered patient is under the supervision of a healthcare provider registered in the medication dispensing management database. In some embodiments, the administration of the multiple doses of the drug from the initial dose escalation kit to the registered patient is under the supervision of a healthcare provider registered in the medication dispensing management database. In some embodiments, a healthcare provider registered with the medication dispensing management database provides a first prescription. In some embodiments, administration of a dose of medication at subsequent dosing levels according to a dosing schedule to a registered patient is under the supervision of a healthcare provider registered with the medication dispensing management database. In some embodiments, subsequent prescriptions are provided by healthcare providers registered with the medication dispensing management database.

[0181] In some embodiments, a method of treating a patient with food allergy by oral immunotherapy comprises (a) registering a patient or verifying registration of a patient in a medication dispensing management database of a medication for treating food allergy; (b) administering a dose of the medication at a first dosing level to the registered patient according to a dosing schedule, wherein the dose is administered under the supervision of a healthcare provider registered in the medication dispensing management database; (c) after administering the dose of the medication in step (b), monitoring the registered patient for an allergic reaction to the medication under the supervision of the registered healthcare provider; (d) providing a first prescription requesting that the patient be registered in the medication dispensing management database. (e) administering a dose of the medication at a subsequent dosing level to the registered patient according to a dosing schedule, wherein the dose is administered under the supervision of the healthcare provider; (f) monitoring the registered patient for an allergic reaction to the medication after the dose of the medication is administered in step (e); and (g) providing a subsequent prescription requesting the registered pharmacy to administer a plurality of doses of the medication at a subsequent dosing level to the registered patient, the registered healthcare provider, or the healthcare institution registered in the medication dispensing management database.

[0182] Drug distribution

[0183] As discussed herein, the distribution and administration of medications are tightly controlled to minimize risk to patients and ensure that patients receive the correct amount of medication at the appropriate stage of treatment. These controls include controls over the distribution and / or administration of medications by various involved entities (such as distributors, pharmacies, healthcare facilities, and patients).

[0184] Figure 5 An overview of exemplary dispensing controls for the medication dispensing methods described herein is provided. Figure 5The roles of a prescriber 501, a patient (or a patient's parent or guardian) 502, a healthcare facility 503, a pharmacy 504, a distributor 505, and a medication dispensing management database manager 506 are shown. Prescriber 501 manages the treatment of food allergies for patient 502 and is preferably associated with healthcare facility 503. An electronic system 507 (including a memory storing a medication dispensing management database 508 and one or more processors 509 configured to access the memory and execute one or more programs accessing information in the medication dispensing management database 508) is used to manage the authorization of medication dispensing. Medication dispensing management database 508 includes a registered patient sub-database 510, a registered healthcare facility sub-database 511, a registered pharmacy database 512, and a registered distributor sub-database 513. Prescriber 501 provides pharmacy 504 with a prescription or request 514 for a specific patient 502's healthcare facility 503 to provide an initial dose escalation kit. The initial dose escalation kit is specific to patient 502 and should not be used to initiate treatment for a different patient. At 515, the pharmacy receives the prescription or request 514 and verifies that the patient 502 is registered in the patient sub-database 510 and the healthcare facility 503 is registered in the healthcare facility sub-database 511 by sending a verification request to the medication dispensing management database manager 506. In some embodiments, verification occurs automatically; for example, the verification request can be received by a computer system communicatively connected to the medication dispensing management database, which automatically accesses the computer system to compare the information in the verification request with the information in the database. If a match is determined between the information in the verification request and the information in the database, a registration status can be automatically generated. In some embodiments, the registration status is automatically transmitted to the pharmacy in response to receiving the request. Once the pharmacy 504 has received the positive registration verification, the pharmacy 504 provides the healthcare facility 503 with the patient-specific initial dose escalation kit (as indicated at 516). Before or after receiving the initial dose escalation kit but before initiating treatment for the patient, the healthcare facility 503 verifies the patient's registration in the patient sub-database 510 at step 517. Verification of the registration of patient 502 in the patient sub-database may be performed by reviewing a record in which a patient registration request has been transmitted to medication dispensing management database manager 506 and a registration confirmation has been received from medication dispensing management database manager 506, or by sending a registration verification request to medication dispensing management database manager 506 for patient 502. Upon receiving the registration verification request, medication dispensing management database manager 506 may compare the patient information in the request with the patient information in patient sub-database 510 to verify the registration of patient 502, and medication dispensing management database manager may then transmit a positive registration verification of patient 502 to healthcare facility 503.In some embodiments, verification occurs automatically; for example, a verification request can be received by a computer system communicatively connected to a medication dispensing management database, which can automatically access the computer system to compare the information in the verification request with the information in the database. If a match is determined between the information in the verification request and the information in the database, a registration status can be automatically generated. In some embodiments, the registration status is automatically transmitted to the healthcare provider in response to receiving the request. Once the healthcare provider 503 has confirmed the registration of the patient 502 in the patient sub-database 510, at step 518, the medication can be administered to the patient 502 from the initial dose escalation kit according to the initial dose escalation schedule.

[0185] Treatment of food allergies using medication through oral immunotherapy during the administration phase includes two sub-steps at each administration level. The first sub-step includes administering a first dose of the medication at a selected administration level to a patient 502 in a healthcare facility 503. The second sub-step includes administering multiple doses of the medication at the same dose level (e.g., one dose per day) over a period of time, which the patient 502 can receive from a pharmacy 504 and administer in an unsupervised setting (i.e., at a location outside the healthcare facility). The healthcare facility 503 extracts the first dose of each dose level from the oral immunotherapy treatment kit for administration to the patient 502. At step 519, the prescriber 501 requests the distributor 505 to provide the oral immunotherapy treatment kit to the healthcare facility 503. The distributor 505 transmits a registration verification request containing healthcare facility information to the medication distribution management database manager. The medication distribution management database manager compares the information contained in the registration verification request with the healthcare facility information in the healthcare facility sub-database 511. If healthcare facility 503 is registered in the healthcare facility sub-database, medication dispensing management database manager 506 can transmit a positive registration verification to distributor 505, authorizing the distributor to provide the oral immunotherapy treatment kit to healthcare facility 503, as indicated by 521. In some embodiments, verification occurs automatically; for example, a verification request can be received by a computer system communicatively connected to the medication dispensing management database, which automatically accesses the computer system to compare the information in the verification request with the information in the database. If a match is determined between the information in the verification request and the information in the database, a registration status can be automatically generated. In some embodiments, the registration status is automatically transmitted to the healthcare facility in response to receiving the request. Healthcare facility 503 can then use the medication dose in the oral immunotherapy treatment kit to administer a first dose of the medication at a selected level to patient 502, as indicated by 522. Patient 502 is monitored at healthcare facility 503 before prescriber 501 provides a prescription to pharmacy 504 or requests 523 to provide patient 502 with multiple doses of the medication at the same dosage level. Pharmacy 504 receives prescription or request 523 and may provide multiple doses of medication to healthcare facility 503 (at 524) or patient 502 (at 525) only after verifying the healthcare facility 503's registration in healthcare facility sub-database 511 and the patient 502's registration in patient sub-database 510, as indicated by 526. The pharmacy may submit a healthcare facility registration request containing healthcare facility information and a patient registration verification request containing patient information to medication dispensing management database manager 506. Medication dispensing management database manager 506 may compare the received information with information in medication dispensing management database 508 and may provide registration verification to pharmacy 504, which authorizes pharmacy 504 to provide medication to patient 502 or healthcare facility 503.In some embodiments, verification occurs automatically; for example, a verification request can be received by a computer system communicatively connected to a medication dispensing management database, which can automatically access the computer system to compare the information in the verification request with the information in the database. If a match is determined between the information in the verification request and the information in the database, a registration status can be automatically generated. In some embodiments, the registration status is automatically transmitted to the pharmacy in response to receiving the request. The pharmacy 504 should only provide a single dosage level of the medication for any given patient 502 at a time.

[0186] Figure 10 An additional overview of exemplary dispensing controls for the medication dispensing methods described herein is provided. Figure 10The diagram illustrates the roles of a prescriber (also referred to herein synonymously as a healthcare provider) 1001, a patient (or a patient's parent or guardian) 1002, a healthcare facility 1003, a pharmacy 1004, a distributor 1005, and a medication dispensing management database manager 1006. Prescriber 1001 manages treatment for food allergy patient 1002 and is preferably associated with healthcare facility 1003. An electronic system 1007 (including a memory storing a medication dispensing management database 1008 and one or more processors 1009 configured to access the memory and execute one or more programs accessing information in the medication dispensing management database 1008) is used to manage the authorization of medication dispensing. The medication dispensing management database 1008 includes a registered prescriber sub-database 1010, a registered patient sub-database 1011, a registered healthcare facility sub-database 1012, a registered pharmacy database 1013, and a registered distributor sub-database 1014. Prescriber 1001 provides pharmacy 1004 with a prescription or request 1015 for an initial dose escalation kit to healthcare provider 1003 for a specific patient 1002. The initial dose escalation kit is specific to patient 1002 and should not be used to initiate treatment for a different patient. At 1016, pharmacy receives prescription or request 1015 and verifies that patient 1002 is registered in patient sub-database 1011, prescriber 1001 is registered in prescriber sub-database 1010, and, in some embodiments, healthcare provider 1003 is registered in healthcare provider sub-database 1012 by sending a verification request to medication dispensing management database manager 1006. In some embodiments, verification occurs automatically; for example, the verification request may be received by a computer system communicatively connected to the medication dispensing management database, which automatically accesses the computer system to compare the information in the verification request with the information in the database. If a match is determined between the information in the verification request and the information in the database, a registration status may be automatically generated. In some embodiments, the registration status is automatically transmitted to the pharmacy in response to receiving the request. Once the pharmacy 1004 has received the positive registration verification, the pharmacy 1004 provides the patient-specific initial dose escalation kit to the healthcare facility 1003 (as indicated at 1017). Either before or after receiving the initial dose escalation kit but before initiating treatment for the patient, the healthcare facility 1003 verifies the patient's registration in the patient sub-database 1011 at step 1018. Verification of the patient's 1002 registration in the patient sub-database can be performed by reviewing a record that a patient registration request has been transmitted to the medication dispensing management database manager 1006 and a registration confirmation has been received from the medication dispensing management database manager 1006, or by sending a registration verification request to the medication dispensing management database manager 1006 for the patient 1002.Upon receiving the registration verification request, medication dispensing management database manager 1006 may compare the patient information in the request with the patient information in patient sub-database 1011 to verify patient 1002's registration. The medication dispensing management database manager may then transmit a positive registration verification of patient 1002 to healthcare provider 1003. In some embodiments, verification occurs automatically; for example, the verification request may be received by a computer system communicatively connected to the medication dispensing management database, which may automatically access the computer system to compare the information in the verification request with the information in the database. If a match is determined between the information in the verification request and the information in the database, a registration status may be automatically generated. In some embodiments, the registration status is automatically transmitted to the healthcare provider in response to receiving the request. Once healthcare provider 1003 has confirmed patient 1002's registration in patient sub-database 1011, medication may be administered to patient 1002 from the initial dose escalation kit according to the initial dose escalation schedule at step 1019.

[0187] Treatment of food allergies using oral immunotherapy medication during the administration phase includes two sub-steps at each dosing level. The first sub-step includes administering a first dose of the medication at a selected dosing level to a patient 1002 at a healthcare facility 1003 by a prescriber 1001. The second sub-step includes administering multiple doses of the medication at the same dose level (e.g., one dose per day) over a period of time. Patient 1002 can receive the medication from a pharmacy 1004 and administer the medication in an unsupervised setting (i.e., at a location outside the healthcare facility). Healthcare facility 1003 extracts the first dose of each dose level from an oral immunotherapy treatment kit for administration to patient 1002. At step 1020, prescriber 1001 requests the oral immunotherapy treatment kit from distributor 1005 to be provided to healthcare facility 1003. At step 1021, distributor 1005 receives request 1020 and transmits a registration verification request containing healthcare facility information to the medication distribution management database manager. The medication distribution management database manager compares the information contained in the registration verification request with the healthcare facility information in the healthcare facility sub-database 1012. If the healthcare facility 1003 is registered in the healthcare facility sub-database, the medication dispensing management database manager 1006 can transmit a positive registration verification to the distributor 1005, which authorizes the distributor to provide the oral immunotherapy treatment kit to the healthcare facility 1003, as indicated at 1022. In some embodiments, the verification occurs automatically; for example, the verification request can be received by a computer system communicatively connected to the medication dispensing management database, which automatically accesses the computer system to compare the information in the verification request with the information in the database. If a match is determined between the information in the verification request and the information in the database, a registration status can be automatically generated. In some embodiments, the registration status is automatically transmitted to the healthcare facility in response to receiving the request. The healthcare facility 1003 (such as by the prescriber 1001) then uses the drug dosage in the oral immunotherapy treatment kit to administer a first dose of the drug at the selected level to the patient 1002, as indicated at 1023. The patient 1002 is monitored at the healthcare facility 1003 (such as by the prescriber 1001) before the prescriber 1001 provides the pharmacy 1004 with a prescription or request 1024 to provide multiple doses of the medication at the same dosage level for the patient 1002. The pharmacy 1004 receives the prescription or request 1024 and may provide the multiple doses of the medication to the healthcare facility 1003 (at 1025) or the patient 1002 (at 1026) only after verifying the patient 1002's registration in the patient sub-database 1011 and either: i) the healthcare facility 1003's registration in the healthcare facility sub-database 1012 and the prescriber 1001's registration in the prescriber sub-database 1010, or ii) the prescriber 1001's registration in the prescriber sub-database 1010, as indicated at 1027.The pharmacy may submit a healthcare facility registration request containing healthcare facility information, a prescriber registration request containing prescriber information, and / or a patient registration verification request containing patient information to the medication dispensing management database manager 1006. The medication dispensing management database manager 1006 may compare the received information with information in the medication dispensing management database 1008 and provide the registration verification to the pharmacy 1004, authorizing the pharmacy 1004 to provide the medication to the patient 1002 or healthcare facility 1003. In some embodiments, the verification occurs automatically; for example, the verification request may be received by a computer system communicatively connected to the medication dispensing management database, which may automatically access the computer system to compare the information in the verification request with the information in the database. If a match is determined between the information in the verification request and the information in the database, a registration status may be automatically generated. In some embodiments, the registration status is automatically transmitted to the pharmacy in response to receiving the request. The pharmacy 1004 should only provide a single dose level of the medication for any given patient 1002 at a time.

[0188] Additional embodiments of drug delivery and treatment methods are described below.While the following discussion includes headings, it should be understood that the headings are provided for organizational purposes only and that various aspects of the described methods can be combined with various aspects of other described methods.

[0189] Initial dose escalation kit

[0190] The initial dose escalation kit is provided by the pharmacy to the healthcare facility so that the healthcare facility can initiate treatment for the food allergy patient (such as by a prescriber / healthcare provider). Each of these entities (pharmacies, healthcare providers, healthcare facilities, and patients) must be registered in the medication distribution management database before the initial dose escalation kit is provided by the pharmacy to the healthcare facility. In addition, the initial dose escalation kit is provided for the specific patient associated with the initial dose escalation kit, and the healthcare facility (and / or healthcare provider) should not use the initial dose escalation kit associated with one patient to initiate treatment for another patient.

[0191] exist Figure 6An exemplary process for providing an initial dose escalation kit containing a drug, which may be a computer-implemented process, is shown in FIG. At step 602, a pharmacy, which must be registered in a drug distribution management database, receives a request to provide an initial dose escalation kit associated with an identified patient to a healthcare facility. A healthcare provider (which may be associated with a healthcare facility) may generate a prescription for the initial dose escalation kit. The prescription may be provided to the patient for provision to the pharmacy, or may be provided directly to the pharmacy. The prescription should include patient information for the patient to be treated, healthcare facility information for the healthcare facility that will treat the patient, and an indication that the initial dose escalation kit should be provided.

[0192] Once the pharmacy receives a prescription or request for an initial dose escalation kit at step 602, the pharmacy must be authorized to distribute the initial dose escalation kit before providing the initial dose escalation kit to the healthcare institution. To obtain authorization, at step 604, the pharmacy must verify that the patient identified in the request and the healthcare institution identified in the request are each registered in the medication distribution management database. In another embodiment, the pharmacy must verify that the prescriber (such as a healthcare provider) who also registers the patient in the medication distribution management database at step 604. The pharmacy can transmit a registration verification request containing patient information (i.e., a patient registration verification request) and a registration verification request containing healthcare institution information (i.e., a healthcare institution registration verification request) to the medication distribution management database manager. The pharmacy can also transmit a registration verification request containing prescriber information (i.e., a prescriber registration verification request, also referred to as a healthcare provider registration verification request). The registration verification request can be transmitted, for example, by telephone, fax, email, or another suitable electronic device.

[0193] For example, a computer-implemented method for verifying the registration of a patient and a healthcare facility in a medication dispensing management database may include transmitting, at an electronic device associated with a pharmacy registered in the medication dispensing management database for a medication, a healthcare facility registration verification request and a patient registration verification request to a second electronic device communicatively coupled to the medication dispensing management database. The pharmacy must be registered with the medication dispensing management system and may have unique credentials that allow the pharmacy to make the request. The second electronic device communicatively coupled to the medication dispensing management database may receive the registration verification request from a first electronic device associated with the pharmacy and may generate a registration status for each of the healthcare facility and the patient. For example, the second electronic device may access the medication dispensing management database, compare healthcare facility information in the healthcare facility registration verification request with healthcare facility information in the medication dispensing management database, and obtain a positive healthcare facility registration status by identifying a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database (or alternatively, obtain a negative healthcare facility registration status by failing to identify a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database). Similarly, the second electronic device can access the medication dispensing management database, compare the patient information in the patient registration verification request with the patient information in the medication dispensing management database, and obtain a positive patient registration status by identifying a match between the patient information in the patient registration verification request and the patient information in the medication dispensing management database (or alternatively, obtain a negative patient registration status by failing to identify a match between the patient information in the patient registration verification request and the patient information in the medication dispensing management database). The second electronic device can then send the healthcare facility registration status and the patient registration status to an electronic device associated with the pharmacy, wherein receiving the positive healthcare facility registration status and the positive patient registration status authorizes the pharmacy to dispense the initial dose escalation kit. In some embodiments, the verification occurs automatically; for example, the verification request can be received by a computer system communicatively connected to the medication dispensing management database, and the computer system is automatically accessed to compare the information in the verification request with the information in the database. If a match is determined between the information in the verification request and the information in the database, a registration status can be automatically generated. In some embodiments, the registration status is automatically transmitted to the pharmacy in response to receiving the request.

[0194] By way of example, a computer-implemented method for verifying the registration of a patient, a healthcare provider, and a healthcare facility in a medication dispensing management database may include transmitting, at an electronic device associated with a pharmacy registered in the medication dispensing management database for a medication, a healthcare facility registration verification request, a healthcare provider registration verification request, and a patient registration verification request to a second electronic device communicatively coupled to the medication dispensing management database. The pharmacy must be registered with the medication dispensing management system and may have unique credentials that allow the pharmacy to make requests. The second electronic device communicatively coupled to the medication dispensing management database may receive the registration verification request from a first electronic device associated with the pharmacy and may generate a registration status for each of the healthcare facility, the healthcare provider, and the patient. For example, the second electronic device may access the medication dispensing management database, compare healthcare facility information in the healthcare facility registration verification request with healthcare facility information in the medication dispensing management database, and obtain a positive healthcare facility registration status by identifying a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database (or alternatively, obtain a negative healthcare facility registration status by failing to identify a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database). Similarly, the second electronic device can access the medication dispensing management database, compare the patient information in the patient registration verification request with the patient information in the medication dispensing management database, and obtain a positive patient registration status by identifying a match between the patient information in the patient registration verification request and the patient information in the medication dispensing management database (or alternatively, obtain a negative patient registration status by failing to identify a match between the patient information in the patient registration verification request and the patient information in the medication dispensing management database). In addition, the second electronic device can access the medication dispensing management database, compare the healthcare provider information in the healthcare provider registration verification request with the healthcare provider information in the medication dispensing management database, and obtain a positive healthcare provider registration status by identifying a match between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database (or alternatively, obtain a negative healthcare provider registration status by identifying a match between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database). The second electronic device can then send the healthcare facility registration status, healthcare provider status, and patient registration status to an electronic device associated with the pharmacy, wherein receipt of a positive healthcare facility registration status, a positive healthcare provider registration status, and a positive patient registration status authorizes the pharmacy to dispense the initi...

Claims

1. An electronic device, comprising: one or more processors; a memory configured to store a medication dispensing management database for medications containing food allergens, the medication dispensing management database including an entry for a registered patient including registered patient information, an entry for a registered healthcare facility including registered healthcare facility information, and an entry for a registered pharmacy including registered pharmacy information; and One or more programs, the one or more programs stored on the memory, the one or more programs configured to be executed by the one or more processors, the one or more programs including instructions for the following steps: (a) receiving a healthcare institution registration verification request and a patient registration verification request from a second electronic device associated with a pharmacy registered in the medication distribution management database, the healthcare institution registration verification request including healthcare institution information of the healthcare institution, and the patient registration verification request including patient information of the patient; (b) generating, by the one or more processors, a healthcare facility registration status, comprising (i) accessing the medication dispensing management database, (ii) comparing the healthcare facility information in the healthcare facility registration verification request with the healthcare facility information in the medication dispensing management database, and (iii) obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database, or obtaining a negative healthcare facility registration status if no match is identified between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database; (c) generating, by the one or more processors, a patient registration status, comprising (i) accessing the medication dispensing management database, (ii) comparing the patient information in the patient registration verification request with the registered patient information in the medication dispensing management database, and (iii) obtaining a positive patient registration status by identifying a match between the patient information in the patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the patient registration verification request and the patient information in the medication dispensing management database; and (d) sending the healthcare institution registration status and the patient registration status to the second electronic device, wherein the pharmacy receives a positive healthcare institution registration status and a positive patient registration status to authorize the pharmacy to (i) providing the healthcare facility with an initial dose escalation kit associated with the patient, the initial dose escalation kit comprising a plurality of different doses of the drug according to an initial dose escalation schedule; (ii) providing a plurality of doses of said drug to a healthcare provider or said patient at a single therapeutic dose level according to an oral immunotherapy dosing schedule; or (iii) providing multiple doses of the drug to the healthcare facility or the patient at a single therapeutic dosage level according to an oral immunotherapy dosing schedule.

2. The electronic device according to claim 1, wherein the medication dispensing management database further includes an entry for a registered healthcare provider including registered healthcare provider information; wherein the instructions of (a) further comprise receiving, at the electronic device, a healthcare provider registration verification request from the second electronic device, the healthcare provider registration verification request including healthcare provider information of a healthcare provider; wherein the one or more programs further comprise instructions for generating a healthcare provider registration status at the electronic device, comprising (i) accessing the medication dispensing management database, (ii) comparing the healthcare provider information in the healthcare provider registration verification request with the registered healthcare provider information in the medication dispensing management database, and (iii) obtaining a positive healthcare provider registration status by identifying a match between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database, or obtaining a negative healthcare provider registration status if no match is identified between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database; wherein the instructions of (d)(i) further comprise sending the healthcare provider registration status to the second electronic device, wherein receipt by the pharmacy of each of a positive healthcare facility registration status, a positive patient registration status, and a positive healthcare provider registration status authorizes the pharmacy to provide the healthcare facility with the initial dose escalation kit associated with the patient.

3. The electronic device according to claim 1: wherein the medication dispensing management database further includes an entry for a registered healthcare provider including registered healthcare provider information; wherein the instructions of (a) further comprise receiving a healthcare provider registration verification request from the second electronic device associated with the pharmacy registered in the medication dispensing management database, the healthcare provider registration verification request including healthcare provider information of a healthcare provider; wherein the one or more programs further comprise instructions for generating, by the one or more processors, a healthcare provider registration status, including (i) accessing the medication dispensing management database, (ii) comparing the healthcare provider information in the healthcare provider registration verification request with registered healthcare provider information in the medication dispensing management database, and (iii) obtaining a positive healthcare provider registration status by identifying a match between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database, or obtaining a negative healthcare provider registration status if no match is identified between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database; wherein the instructions of (d)(iii) further comprise sending the healthcare provider registration status to the second electronic device, wherein receipt by the pharmacy of each of a positive healthcare facility registration status, a positive patient registration status, and a positive healthcare provider registration status authorizes the pharmacy to provide the plurality of doses of the medication at a single therapeutic dosage level to the healthcare facility, the healthcare provider, or the patient.

4. An electronic device according to claim 3, wherein the one or more programs further include instructions for repeating steps (a) to (d) at multiple different therapeutic dosage levels, wherein the pharmacy is not authorized to provide the drug at more than one therapeutic dosage level for the patient at the same time.

5. The electronic device according to any one of claims 1 to 4, wherein the one or more programs further comprise instructions for the following steps: receiving, by the one or more processors, a patient registration request, the patient registration request including patient information of the patient; and An entry including the patient information is added, by the one or more processors, to the medication delivery management database to register the patient in the medication delivery management database.

6. The electronic device according to any one of claims 1 to 4, wherein the one or more programs further comprise instructions for the following steps: receiving, by the one or more processors, a pharmacy registration request, the pharmacy registration request including pharmacy information of the pharmacy; and An entry including the pharmacy information is added, by the one or more processors, to the medication dispensing management database to register the pharmacy in the medication dispensing management database.

7. The electronic device according to any one of claims 1 to 4, wherein the one or more programs further comprise instructions for the following steps: receiving, by the one or more processors, a healthcare facility registration request, the healthcare facility registration request including healthcare facility information of the healthcare facility; and An entry including the healthcare facility information is added, by the one or more processors, to the medication dispensing management database to register the healthcare facility in the medication dispensing management database.

8. A non-transitory computer-readable storage medium storing one or more programs comprising instructions that, when executed by one or more processors of an electronic device, cause the electronic device to: (a) receiving a healthcare institution registration verification request and a patient registration verification request from a second electronic device associated with a pharmacy registered in a medication dispensing management database for medications containing food allergens, the healthcare institution registration verification request including healthcare institution information of the healthcare institution and the patient registration verification request including patient information of the patient; (b) generating, by the one or more processors, a healthcare facility registration status by (i) accessing the medication dispensing management database, (ii) comparing the healthcare facility information in the healthcare facility registration verification request with the healthcare facility information in the medication dispensing management database, and (iii) obtaining a positive healthcare facility registration status by identifying a match between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database, or obtaining a negative healthcare facility registration status if no match is identified between the healthcare facility information in the healthcare facility registration verification request and the healthcare facility information in the medication dispensing management database; (c) generating, by the one or more processors, a patient registration status by (i) accessing the medication dispensing management database, (ii) comparing the patient information in the patient registration verification request with the registered patient information in the medication dispensing management database, and (iii) obtaining a positive patient registration status by identifying a match between the patient information in the patient registration verification request and the patient information in the medication dispensing management database, or obtaining a negative patient registration status if no match is identified between the patient information in the patient registration verification request and the patient information in the medication dispensing management database; and (d) sending the healthcare institution registration status and the patient registration status to the second electronic device, wherein the pharmacy receives a positive healthcare institution registration status and a positive patient registration status to authorize the pharmacy to (i) providing the healthcare facility with an initial dose escalation kit associated with the patient, the initial dose escalation kit comprising a plurality of different doses of the drug according to an initial dose escalation schedule; (ii) providing a plurality of doses of said drug to a healthcare provider or said patient at a single therapeutic dose level according to an oral immunotherapy dosing schedule; or (iii) providing multiple doses of the drug to the healthcare facility or the patient at a single therapeutic dosage level according to an oral immunotherapy dosing schedule.

9. The storage medium according to claim 8, wherein step (a) further comprises receiving a healthcare provider registration verification request from the second electronic device, the healthcare provider registration verification request including healthcare provider information of the healthcare provider; wherein the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device, by the one or more processors, to generate the healthcare provider registration status by: (i) accessing the medication dispensing management database, (ii) comparing the healthcare provider information in the healthcare provider registration verification request with the registered healthcare provider information in the medication dispensing management database, and (iii) obtaining a positive healthcare provider registration status by identifying a match between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database, or obtaining a negative healthcare provider registration status if no match is identified between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database; wherein step (d)(i) further comprises sending the healthcare provider registration status to the second electronic device, wherein receipt by the pharmacy of each of a positive healthcare facility registration status, a positive patient registration status, and a positive healthcare provider registration status authorizes the pharmacy to provide the initial dose escalation kit associated with the patient to the healthcare facility.

10. The storage medium according to claim 8: wherein (a) further comprises receiving a healthcare provider registration verification request from the second electronic device associated with the pharmacy registered in the medication dispensing management database, the healthcare provider registration verification request including healthcare provider information of a healthcare provider; wherein the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device, by the one or more processors, to generate a healthcare provider registration status comprising (i) accessing the medication dispensing management database, (ii) comparing the healthcare provider information in the healthcare provider registration verification request with registered healthcare provider information in the medication dispensing management database, and (iii) obtaining a positive healthcare provider registration status by identifying a match between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database, or obtaining a negative healthcare provider registration status if no match is identified between the healthcare provider information in the healthcare provider registration verification request and the healthcare provider information in the medication dispensing management database; wherein (d)(iii) further comprises sending the healthcare provider registration status to the second electronic device, wherein receipt by the pharmacy of each of a positive healthcare facility registration status, a positive patient registration status, and a positive healthcare provider registration status authorizes the pharmacy to provide the plurality of doses of the medication at a single therapeutic dosage level to the healthcare facility, the healthcare provider, or the patient.

11. A storage medium according to claim 10, wherein the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to repeat steps (a) to (d) at multiple different therapeutic dose levels, wherein the pharmacy is not authorized to provide the drug at more than one therapeutic dose level for the patient at the same time.

12. The storage medium according to any one of claims 8 to 11, wherein the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receiving, by the one or more processors, a patient registration request, the patient registration request including patient information of the patient; and An entry including the patient information is added, by the one or more processors, to the medication delivery management database to register the patient in the medication delivery management database.

13. The storage medium according to any one of claims 8 to 11, wherein the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receiving, by the one or more processors, a pharmacy registration request, the pharmacy registration request including pharmacy information of the pharmacy; and An entry including the pharmacy information is added, by the one or more processors, to the medication dispensing management database to register the pharmacy in the medication dispensing management database.

14. The storage medium according to any one of claims 8 to 11, wherein the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receiving, by the one or more processors, a healthcare facility registration request, the healthcare facility registration request including healthcare facility information of the healthcare facility; and An entry including the healthcare facility information is added, by the one or more processors, to the medication dispensing management database to register the healthcare facility in the medication dispensing management database.

15. The storage medium according to any one of claims 9 to 11, wherein the instructions, when executed by the one or more processors of the electronic device, further cause the electronic device to: receiving, by the one or more processors, a healthcare provider registration request, the healthcare provider registration request including healthcare provider information of the healthcare provider; and An entry including the healthcare provider information is added, by the one or more processors, to the medication dispensing management database to register the healthcare provider in the medication dispensing management database.

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