Methods For Delivering Drugs Utilizing a Patient-Controlled Device and For Regulating and Monitoring Same

Abstract

Aspects and embodiments of the present invention generally include a device for patient self-administration of a prescribed medication. The total quantity of doses to be contained in the device, the quantity of prescribed medication comprising each individual dose, and the dosing schedule, collectively referred to as prescription parameters, are determined and controlled solely by a health care provider. In accordance with a prescribed dosing schedule, the device makes available for administration the precise quantity of prescribed medication constituting an individual dose. Patient access to the medication as well as patient control of the device is limited solely to the aspects of the device necessary to administer the available dose. The device also has a monitored subassembly which detects and transmits relevant device information to a remote management system accessible to the HCP, including detected attempts to alter, access, control or otherwise tamper with the device beyond its prescribed use.

What is claimed is: 
     
         1 . A method for managing administration of a single dose of a medication to a patient utilizing a remotely regulated and monitored patient-controlled drug delivery device configured to store a plurality of medication doses, the method comprising:
 ensuring one or more prerequisite requirements set by the HCP have been fulfilled;   making available to a delivery interface of the device responsive to patient control actions a single dose of the plurality of medication doses conditioned on said prerequisite requirements fulfillment indication;   delivering, via the delivery interface, the available single dose of medication to the patient upon the reception of the patient control actions; and   receiving treatment feedback related to said self-administration of the single dose of medication.   
     
     
         2 . The method of  claim 1 , wherein said ensuring one or more prerequisite requirements have been fulfilled comprises:
 successful passing of a user identification test by the patient.   
     
     
         3 . The method of  claim 2 , wherein said passing of a user identification test by the patient comprises:
 receiving confirmation that the data from a biometric sensor affirmatively identifies the patient.   
     
     
         4 . The method of  claim 3 , wherein said biometric sensor is a fingerprint scanner. 
     
     
         5 . The method of  claim 2 , wherein said passing of a user identification test by the patient comprises:
 receiving confirmation that the data from a camera affirmatively identifies the patient.   
     
     
         6 . The method of  claim 1 , wherein said ensuring one or more prerequisite requirements have been fulfilled comprises:
 agreeing to policies by the patient.   
     
     
         7 . The method of  claim 1 , wherein said ensuring one or more prerequisite requirements have been fulfilled comprises:
 confirming the patient's readiness and ability to use the device to self-administer the medication.   
     
     
         8 . The method of  claim 1 , wherein said ensuring one or more prerequisite requirements have been fulfilled comprises:
 successful passing of a health status test by the patient.   
     
     
         9 . The method of  claim 8 , wherein said at least one health status test comprises:
 use of at least one survey by the patient.   
     
     
         10 . The method of  claim 8 , wherein said at least one health status test comprises:
 use of at least one external sensor by the patient.   
     
     
         11 . The method of  claim 10 , wherein said use of at least one external sensor by the patient comprises:
 use of at least one test by the patient to indicate the presence of at least one substance within the body.   
     
     
         12 . The method of  claim 11 , wherein said at least one test by the patient to indicate the presence of at least one substance within the body comprises:
 blowing into a breathalyzer by the patient.   
     
     
         13 . The method of  claim 1 , wherein said ensuring one or more prerequisite requirements have been fulfilled comprises:
 the absence of a detected tamper event.   
     
     
         14 . The method of  claim 1 , wherein said treatment feedback comprises:
 confirming successful self-administration of the single dose of medication by the patient.   
     
     
         15 . The method of  claim 1 , wherein said treatment feedback comprises:
 data collected by the use of at least one survey by the patient.   
     
     
         16 . The method of  claim 15 , wherein said data collected by the use of at least one survey by the patient comprises:
 data regarding health status.   
     
     
         17 . The method of  claim 16 , wherein said data regarding health status comprises:
 data regarding potential medication side-effects.   
     
     
         18 . A method for delivering a single dose of a medication to a patient by a remotely regulated and monitored patient-controlled drug delivery device configured to store a plurality of medication doses, the method comprising:
 receiving prescription parameters including dose schedule;   receiving an indication that one or more prerequisite requirements set by the HCP have been fulfilled;   making available to a delivery interface of the device responsive to patient control actions a single dose of the plurality of medication doses in accordance with said dose schedule and conditioned on said prerequisite requirements fulfillment indication;   alerting the patient that the single dose of medication is available for self-administration;   delivering, via the delivery interface, the available single dose of medication to the patient upon the reception of the patient control actions; and   transmitting an indication that delivery of the available single dose of medication has been detected.   
     
     
         19 . The method of  claim 18 , wherein the delivery interface is a nasal spray device, and wherein said patient control actions comprise:
 one or more depressions of an actuator of the nasal spray delivery interface.   
     
     
         20 . The method of  claim 18 , wherein said receiving an indication that one or more prerequisite requirements have been fulfilled comprises:
 receiving data indicating the absence of a detected tamper event.