Oral immunotherapy unit dose dispensing systems and methods

Abstract

Systems and containers for organizing and administering an oral immunotherapy regimen to a patient are disclosed herein. One aspect of the present technology is directed systems for efficiently and safely identifying pre-packaged dose units to administer to a patient undergoing oral immunotherapy. Further aspects of the present technology are directed to reducing medical staff dosing errors when administering an oral immunotherapy regimen. In one embodiment, the system includes a plurality of dosage containers, wherein each dosage container includes dosage identification characteristics corresponding to dosage of an oral immunotherapy composition. Further aspects of the present technology are directed to methods of dispensing an oral immunotherapy composition to a patient in a manner that mitigates the risk of errors in oral immunotherapy dose administration.

What is claimed is: 
     
         1 . A system for administering an oral immunotherapy regimen to a patient, comprising:
 a plurality of dosage containers comprising a plurality of detached single dose packages comprising the same dosage of an oral immunotherapy composition,
 wherein the single dose packages in different dosage containers comprise different dosages of the oral immunotherapy composition, and 
 wherein the dosage containers comprises a dosage identifier that associates the dosage container with the dosage of oral immunotherapy composition contained by the single dose packages contained in the dosage container; and 
   a housing having an internal cavity that retains the plurality of dosage containers.   
     
     
         2 . The system of  claim 1 , wherein the single dose packages comprise the dosage identifier. 
     
     
         3 . The system of  claim 1  or  2 , wherein the dosage identifier is a dosage level of the oral immunotherapy composition. 
     
     
         4 . The system of any one of  claims 1 - 3 , wherein the dosage identifier comprises color-coding or shade-coding, and wherein each dosage is associated with a different color or shading. 
     
     
         5 . The system of any one of  claims 1 - 4 , wherein the dosage identifier comprises numeric coding, and wherein the numeric coding indicates an order in which the dosage levels increase or decrease. 
     
     
         6 . The system of any one of  claims 1 - 5 , wherein the dosage identifier comprises the dosage. 
     
     
         7 . The system of any one of  claims 1 - 6 , wherein the oral immunotherapy composition is a powder. 
     
     
         8 . The system of any one of  claims 1 - 7 , wherein the plurality of single dose packages comprise one or more capsules or tablets comprising the oral immunotherapy composition. 
     
     
         9 . The system of  claim 8 , wherein the one or more capsules or tablets are visible without opening the single does package. 
     
     
         10 . The system of  claim 9 , wherein the one or more capsules or tablets are arranged in a configuration associated with the dosage identifier for the dosage container. 
     
     
         11 . The system of  claim 10 , wherein the system further comprises a dosage configuration guide that associates the configuration to the dosage identifier. 
     
     
         12 . The system of any one of  claims 1 - 11 , wherein dosage containers comprise a plurality of supports spaced apart along a length of an inner wall of the dosage container, and wherein the dosage containers are configured to hold a single dose package in a substantially vertical orientation between the supports. 
     
     
         13 . The system of any one of  claims 1 - 12 , further comprising an initial escalation module containing a plurality of initial escalation folios comprising a plurality of dose units in increasing dosage levels. 
     
     
         14 . The system of any one of  claims 1 - 13 , further comprising a maintenance dosage container containing a plurality of maintenance dose units having the same dosage of the oral immunotherapy composition. 
     
     
         15 . The system of any one of  claims 1 - 14 , wherein the dosage containers are configured to be refilled with single dose packages. 
     
     
         16 . The system of any one of  claims 1 - 14 , wherein each dosage container is configured to be individually removed from the housing and replaced with a new dosage container. 
     
     
         17 . The system of any one of  claims 1 - 16 , wherein the system comprises 3, 4, 5, or 6 or more different dosage containers. 
     
     
         18 . The system of any one of  claims 1 - 17 , wherein the system comprises between 3 and about 100 different dosage containers. 
     
     
         19 . The system of any one of  claims 1 - 18 , wherein the oral immunotherapy composition comprises a peanut, tree nut, egg, dairy, or shellfish composition. 
     
     
         20 . The system of any one of  claims 1 - 19 , wherein the system further comprises an initial escalation folio comprising a series of escalating dose units comprising the oral immunotherapy composition. 
     
     
         21 . The system of  claim 20 , wherein the series of dose units comprises at least one dose unit with a dosage of the oral immunotherapy composition that is lower than the lowest dosage of the single dose packages in any of the dosage containers. 
     
     
         22 . The system of  claim 20  or  21 , wherein the escalating dose units are arranged in different configurations to identify different dosages. 
     
     
         23 . The system of any one of  claims 20 - 22 , wherein the initial escalation folio is contained within the housing. 
     
     
         24 . The system of  claim 23 , wherein the housing is configured to contain a plurality of initial escalation folios in a compartment of the housing. 
     
     
         25 . The system of any one of  claims 1 - 24 , further comprising a dosage folio comprising:
 a dosage identifier that associates the dosage folio to a dosage container within the plurality of dosage containers, and   a plurality of daily dose units comprising the oral immunotherapy composition associated with the dosage identifier.   
     
     
         26 . The system of  claim 25 , wherein the dosage folio comprises a patient log comprising a space identified for recording a date of administration of a daily dose unit. 
     
     
         27 . The system of  claim 25  or  26 , wherein the dosage folio comprises a patient log comprising a space identified for recording a reactive symptom following ingestion of the daily dose unit. 
     
     
         28 . The system of any one of  claims 25 - 27 , wherein the system comprises a plurality of dosage folios comprising different dosage identifiers, wherein the dosage folios comprise a plurality of daily dose units that correspond with the dosage identifier of the dosage folio. 
     
     
         29 . A dosage folio comprising:
 a plurality of daily dose units comprising an oral immunotherapy composition, wherein each daily dose unit is independently openable and comprises a plurality of capsules or tablets; and   a dosage identifier associated with the dosage of the daily dose units.   
     
     
         30 . The dosage folio of  claim 29 , further comprising a patient log, wherein the patient log comprises a space identified for recording a date of administration of a daily dose unit. 
     
     
         31 . The dosage folio of  claim 30 , wherein the patient log comprising a space identified for recording a reactive symptoms following ingestion of the daily dose unit. 
     
     
         32 . The dosage folio of any one of  claims 29 - 31 , further comprising pictorial instructions for administering the oral immunotherapy composition. 
     
     
         33 . The dosage folio of any one of  claims 29 - 32 , wherein the dosage identifier is a dosage level of the oral immunotherapy composition. 
     
     
         34 . The dosage folio of any one of  claims 29 - 33 , wherein the dosage identifier comprises a color code or a shade code. 
     
     
         35 . The dosage folio of any one of  claims 29 - 34 , wherein the dosage identifier comprises a numeric code. 
     
     
         36 . The dosage folio of any one of  claims 29 - 35 , wherein the dosage identifier comprises the dosage of the daily dose units. 
     
     
         37 . The dosage folio of any one of  claims 29 - 36 , wherein the oral immunotherapy composition is a powder. 
     
     
         38 . The dosage folio of any one of  claims 29 - 37 , wherein the daily dose units are arranged in a grid pattern and a grid pattern location associated with a first day lacks a daily dose unit. 
     
     
         39 . The dosage folio of  claim 29 - 38 , wherein the capsules or tablets are arranged in a configuration associated with the dosage identifier for the folio. 
     
     
         40 . The dosage folio of any one of  claims 29 - 39 , wherein the oral immunotherapy composition comprises a peanut, tree nut, egg, dairy, or shellfish composition. 
     
     
         41 . The dosage folio of any one of  claims 29 - 40 , wherein the dosage folio comprises about 7 to about 35 daily dose units. 
     
     
         42 . A method of dispensing a selected dosage of an oral immunotherapy composition to a patient, comprising:
 identifying a dosage container associated with a selected dosage of the oral immunotherapy composition using a dosage identifier on the dosage container, wherein the dosage container is identified from a plurality of different dosage containers comprising different dosage identifiers associated with different dosages of the oral immunotherapy composition;   removing a single dose package comprising the selected amount of the oral immunotherapy composition from the identified dosage container; and   dispensing the selected dosage of the oral immunotherapy composition to the patient.   
     
     
         43 . A method of retrieving a single dose package comprising a selected dosage of an oral immunotherapy composition, comprising:
 identifying a dosage container associated with the selected dosage of the oral immunotherapy composition using a dosage identifier on the dosage container, wherein the dosage container is identified from a plurality of different dosage containers comprising different dosage identifiers associated with different dosages of the oral immunotherapy composition; and   removing the single dose package comprising the selected amount of the oral immunotherapy composition from the identified dosage container.   
     
     
         44 . A method of retrieving a single dose package comprising a selected dosage of an oral immunotherapy composition, comprising:
 removing the single dose package comprising the selected amount of the oral immunotherapy composition from an identified dosage container, wherein the identified dosage container is identified using a dosage identifier on the dosage container that is associated with the selected dosage, and wherein the dosage container is identified from a plurality of different dosage containers comprising different dosage identifiers associated with different dosages of the oral immunotherapy composition.   
     
     
         45 . A method of dispensing a selected dosage of an oral immunotherapy composition to a patient, comprising:
 removing the single dose package comprising the selected amount of the oral immunotherapy composition from an identified dosage container, wherein the identified dosage container is identified using a dosage identifier on the dosage container that is associated with the selected dosage, and wherein the dosage container is identified from a plurality of different dosage containers comprising different dosage identifiers associated with different dosages of the oral immunotherapy composition; and   dispensing the selected dosage of the oral immunotherapy composition to the patient.   
     
     
         46 . A method of treating an allergy in a patient, comprising:
 identifying a dosage container associated with a selected dosage of an oral immunotherapy composition using a dosage identifier on the dosage container, wherein the dosage container is identified from a plurality of different dosage containers comprising different dosage identifiers associated with different dosages of the oral immunotherapy composition;   removing a single dose package comprising the selected amount of the oral immunotherapy composition from the identified dosage container; and   administering the selected dosage of the oral immunotherapy composition to the patient.   
     
     
         47 . A method of treating an allergy in a patient, comprising:
 removing a single dose package comprising a selected amount of the oral immunotherapy composition from an identified dosage container, wherein the identified dosage container is identified using a dosage identifier on the dosage container that is associated with the selected dosage, and wherein the dosage container is identified from a plurality of different dosage containers comprising different dosage identifiers associated with different dosages of the oral immunotherapy composition; and   administering the selected dosage of the oral immunotherapy composition to the patient.   
     
     
         48 . The method of  claim 46  or  47 , wherein the allergy is a food allergy. 
     
     
         49 . The method of any one of  claims 42 - 48 , wherein the plurality of dosage containers is contained within a housing. 
     
     
         50 . The method of any one of  claims 42 - 49 , wherein the oral immunotherapy composition comprises a peanut, tree nut, egg, dairy, or shellfish composition. 
     
     
         51 . The method of any one of  claims 42 - 50 , wherein the method is performed using the system of any one of  claims 1 - 28 . 
     
     
         52 . The method of any one of  claims 42 - 51 , wherein the method is performed in a medical clinic. 
     
     
         53 . The method of any one of  claims 42 - 52 , further comprising restocking the identified dosage container with single dose packages comprising an oral immunotherapy composition in the same amount as the removed single dose package. 
     
     
         54 . The method of any one of  claims 42 - 53 , further comprising replacing the identified dosage container with a new dosage container comprising the same dosage identification characteristic, wherein the new dosage container comprises a plurality of single dose packages. 
     
     
         55 . The method of any one of  claims 42 - 54 , wherein the dosage identifier comprises a color code, a shade code, or a number code associated with the selected dosage, and wherein identifying the dosage container comprises identifying the dosage container having the color code, the shade code, or the number code associated with the selected dosage. 
     
     
         56 . The method of any one of  claims 42 - 55 , wherein identifying the dosage container comprises using a dosage container position guide comprising the dosage identifier. 
     
     
         57 . The method of any one of  claims 42 - 56 , further comprising selecting the dosage of oral immunotherapy for the patient. 
     
     
         58 . The method of  claim 57 , wherein the dosage of oral immunotherapy is selected using a dosage identifier on a dosage folio previously provided to the patient. 
     
     
         59 . The method of  claim 57  or  58 , wherein the dosage of oral immunotherapy is selected based on a tolerability of a previously administered dose by the patient. 
     
     
         60 . The method of any one of  claims 42 - 59 , further comprising dispensing a series of escalating dose units comprising the oral immunotherapy composition. 
     
     
         61 . The method of  claim 60 , comprising administering the series of escalating dose units to the patient. 
     
     
         62 . The method of  claim 60  or  61 , comprising monitoring the patient for a period of time for a reactive symptom following ingestion of a first escalating dose unit prior to dispensing or administering a second escalating dose unit. 
     
     
         63 . The method of any one of  claims 60 - 62 , comprising monitoring the patient for a period of time for a reactive symptom following ingestion of each escalating dose unit. 
     
     
         64 . The method of  claim 62  or  63 , wherein the dosage of oral immunotherapy is selected based on a dosage of the escalating dose unit ingested prior to detection of a reactive symptom. 
     
     
         65 . The method of any one of  claims 42 - 64 , comprising dispensing a dosage folio to the patient for daily self-administration, wherein the dosage folio comprises a plurality of daily dose units comprising the selected dosage of the oral immunotherapy composition. 
     
     
         66 . The method of any one of  claims 42  and  45 - 64 , further comprising monitoring the patient for a period of time for a reactive symptom following dispensing or administering the selected dosage of the oral immunotherapy composition to the patient. 
     
     
         67 . The method of any one of  claims 42 - 66 , wherein the patient is a human. 
     
     
         68 . The method of any one of  claims 46 - 66 , wherein administering the selected dosage comprises mixing the oral immunotherapy composition with food. 
     
     
         69 . The method of  claim 68 , wherein one or more capsules or tablets containing the oral immunotherapy composition are opened prior to mixing the oral immunotherapy composition with food.