Method, system and apparatus for controlling patient access to medicaments

• US 20080228317A1
• Filed: 08/24/2007
• Published: 09/18/2008
• Est. Priority Date: 03/13/2007
• Status: Active Grant

• Current Assignee: MedicaSafe, Inc.
• Original Assignee: MedicaSafe, Inc.
• Inventors: Ervin, Matthew J.
• Granted Patent: US 7,996,106 B2
• Time in Patent Office: Days
• US Class Current: 700/231
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 80/00 ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring

Abstract

A method, system and apparatus for controlling patient access to medicaments are disclosed. A method, system and apparatus can include an interfacing system such as an IVR system that can receive identifying data from a user of a medicament dispensing device. The interfacing system can also communicate limited-use access authorization data to the user via a communicative intermediary. The limited-use access authorization data enables the dispensing device to dispense a medicament up to a certain limit in response to entering the access authorization data into the dispensing device. The dispensing device may not be connected to a network, but is capable of computing and storing a limited-use access authorization data as well as validating an inputted access authorization data.

Claims

1-19. -19. (canceled)

20. A method of enabling medicament access for a user comprising:

receiving identifying data from the user;

evaluating whether or not to provide access authorization data for medicaments based on the identifying data received and if a decision is made to grant access, then;

determining said access authorization data, wherein the access authorization data enables dispensing the medicaments up to a limit of use, and

communicating the access authorization data to the user.

21. The method of claim 20 wherein the identifying data includes one of information identifying the dispensing device, information describing the device, information associated with the device, information identifying the prescribed treatment regimen, information identifying the patient, information associated with the patient, information describing the patient, and device data including a status code indicating the pattern of medicament dispensing from the device.

22. The method of claim 20 wherein an interfacing server is provided that communicates with the user to receive identifying data and transmits the limited-use access authorization data to the user.

23. The method of claim 20 wherein communication of the access authorization data occurs via a communicative device which includes one of an interactive voice response (IVR) system, one or more web servers on the Internet and a networked personal computing device.

24. The method of claim 20 wherein the communication of identifying data and limited-use access authorization data occurs via a communicative intermediary, the communicative intermediary being one of a telephonic device, a computing device, a text-messaging device, and a face-to-face conversation.

25. The method of claim 20 wherein the limited-use access authorization data includes one of a passcode, a password, and a visual ticket.

26. The method of claim 20 wherein the access authorization data no longer provides normal access to the medicaments after a certain limit of use, the limit being one of a predetermined amount of usage, a predetermined period of time and a predetermined amount of usage during a predetermined amount of time.

27. The method of claim 20 wherein both the dispensing device and a computing device which decides whether or not to communicate the limited-use access authorization data to the user associated with the identifying data are both capable of determining the valid limited-use authorization data using one of computational calculation according to an algorithm and retrieving information from a data storage system.

28. The method of claim 20 wherein the session for communicating with the user to collect identifying data also includes communication of questions to the user,

whereby the communication session can be used to gather and record medically relevant information about a patient, including at least one of medical symptoms, activities, behaviors, attitudes, the dispensing history of the dispensing device, the times at which the user seeks access to medicaments, the effectiveness of the medicaments, issues related to medicament adherence, and issues related to health outcomes.

29. The method of claim 20 wherein more than one access authorization data are valid at the dispensing device at any one time, each access authorization data is associated with different limits of use, and the choice of which access authorization data to communicate to the user allows remotely controlling the level of access that the user has to the medicaments.

30. The method of claim 20 wherein data about dispensing, as derived from one of identifying data and the times when the user seeks access to the limited-use access authorization, is used to generate alerts to notify one or more interested persons when the user is seeking access to the medicaments in a pattern that suggests lack of adherence to a prescribed treatment regimen.

31. The method of claim 20 wherein data derived from one of identifying data and the times when the user receives access authorization data is used to generate outputs including one of a report and an alert.

32. A method of enabling access to medicaments comprising:

using a medicament dispensing device having the ability to receive access authorization data, said dispensing device also having the ability to evaluate whether or not said access authorization data is valid; and

inputting said access authorization data into the dispensing device; and

evaluating by said dispensing device said access authorization data and making a decision to allow access to medicaments in the device based on the validity of the access authorization data, and, if the decision is made to grant access, then,

enabling said dispensing device to dispense medicaments up to a certain limit of use, then, preventing access to additional medicaments once the limit of use has been reached.

33. The method of claim 32 wherein the access authorization data includes one of a passcode, a password, and a visual ticket.

34. The method of claim 32 wherein the access authorization data no longer enables access to the medicaments after a certain limit, the limit being one of a predetermined amount of usage, a predetermined period of time and a predetermined amount of usage during a predetermined amount of time.

35. The method of claim 32 wherein more than one access authorization data are valid at the dispensing device at any one time, each access authorization data has different limits of use, and the choice of which access authorization data to communicate to the user allows remotely controlling the level of access that the user has to the medicaments.

36. The method of claim 32 further comprising the step of using data about when the user is seeking access to the medicaments to generate an output including one of a report and an alert,

whereby it is possible to monitor overuse and underuse of the medicaments.

37. The method of claim 32 further comprising the steps of providing valid identifying data by a user before valid access authorization data is provided to the user in return, and

gathering additional relevant information before granting access to said medicaments, said additional information including one of user identity, user symptoms, device status, treatment status, and medicament usage information.

38. The method of claim 37 wherein communication of the identifying data and the access authorization data between the user and a separate system occurs via a communicative device including one of an interactive voice response (IVR) system, one or more web servers on the Internet and a networked personal computing device.

39. The method of claim 37 wherein the identifying data includes one of device identification information identifying the dispensing device, identification information identifying the prescribed treatment regimen, treatment information, information describing the patient, device information such as a status code indicating the pattern of medicament dispensing, patient symptoms, patient activity, device activity, and medicament usage information.

40. The method of claim 37 wherein the communication of identifying data and limited-use access authorization data occurs via a communicative intermediary, the communicative intermediary being one of a telephonic device, a computing device and a text-messaging device.

41. The method of claim 37 further comprising the step of using data derived from information including one of identifying data and the times when the user receives access authorization data to generate outputs including one of a report and an alert.

42. A method of providing access to medicaments comprising:

using a dispensing device, said dispensing device having the ability to provide access to medicaments up to a certain limit of use if valid access authorization data is entered into the dispensing device, and

communicating identifying data to an interfacing system separate from the dispensing device,

said interfacing system evaluating whether or not to grant access to the medicaments in the dispensing device based on the identifying data received, and if a decision is made to grant access, then,

determining using said interfacing system valid access authorization data, wherein input of said valid access authorization data into the dispensing device enables dispensing of the medicaments up to a limit of use;

communicating the access authorization data to the user,

inputting said access authorization data into the dispensing device,

said dispensing device evaluating whether or not to grant access to the medicaments based on the access authorization data entered, such that said device will not provide access to medicaments unless valid access authorization data is entered by a user, and once valid access authorization is entered,

dispensing the medicaments up to a certain limit of use,

once the limit of use has been reached, preventing additional dispensing of medicaments from the dispensing device unless additional valid access authorization data is acquired and input by the user,

whereby the time at which the access authorization data is acquired by the user of the dispensing device is indicative of a time of access to medicaments.

43. The method of claim 42 wherein more than one access authorization data are valid at the dispensing device at any one time, each access authorization data has different limits of use, and the choice of which access authorization data to communicate to the user allows remotely controlling the level of access that the user has to the medicaments.

44. The method of claim 42 further comprising the steps of providing valid access authorization data in response to a user providing valid identifying data, and

gathering additional relevant information before granting access to said medicaments, said additional information including one of user identity, user symptoms, device status, treatment status, and medicament usage information.

45. The method of claim 44 wherein data derived from one of identifying data and the times when the user seeks access to the limited-use access authorization is used to generate reports for one or more interested persons.

46. A system for access to medicaments comprising:

an interfacing system configured to interface with a communications intermediary;

a dispensing device for dispensing the medicaments, the dispensing device being capable of providing limited access to the medicaments in response to valid access authorization data, the access authorization data independently computable by both the dispensing device and the interfacing system and being of limited use,

whereby limited access to the medicaments is granted via communication of the valid limited-use authorization data from the interfacing system to a user via the communications intermediary.

47. The system of claim 46 wherein the interfacing system includes a web server and the communicative intermediary includes a client computing device having web capabilities.

48. The system of claim 46 wherein the interfacing system includes an interactive voice response (IVR) system and the communicative intermediary includes a telephonic device having telephone capabilities.

49. The system of claim 46 wherein the access authorization data includes one of a passcode, a password and a visual ticket.

50. The system of claim 46 wherein the access authorization data no longer provides access to the medicaments after a certain limit of use, the limit of use including one of a predetermined amount of usage, a predetermined period of time and a predetermined amount of usage during a predetermined amount of time.

51. The system of claim 46 wherein the dispensing device and the interfacing system are separately capable of computing and updating the valid limited-use authorization data using one of computational calculation according to an algorithm and retrieving the information from a data storage system.

52. The system of claim 46 wherein the interfacing system is interfaced with a data storage system populated by a plurality of data including one of dispensing device entries, information about prescribed treatment and information about users.

53. The system of claim 46 wherein the interfacing system compiles data about when the user is or is not seeking access to the medicaments and generates for interested persons an output including one of reports and alerts,

whereby it is possible to approximately monitor overuse and underuse of the medicaments.

54. The system of claim 46 wherein more than one access authorization data are valid at the dispensing device at any one time, each access authorization data has different limits of use, and the choice of which access authorization data to communicate to the user allows remote control of the rules for access to the medicaments in the device.

55. The system of claim 46 wherein the interfacing system includes one of a live person interface and a computer, and the communicative intermediary includes one of a face-to-face conversation and a known communication technology,

whereby the interfacing system includes one of an automated system and a manually operated system.

56. The system of claim 46 wherein valid identifying data is communicated by a user to the interfacing system before valid access authorization data is communicated to the user from said interfacing system,

whereby additional relevant infonnation is gathered before granting access to said medicaments, said additional information including at least one of user identity, user symptoms, device status, treatment status, and medicament usage information.

57. The method of claim 56 wherein the identifying data includes one of device identification information identifying the dispensing device, identification information identifying the prescribed treatment regimen, treatment information, information describing the patient, device information in the form of a status code indicating the pattern of medicament dispensing, patient symptoms, patient activity, device activity, and medicament usage information.

58. The system of claim 56 wherein data derived from at least one of identifying data and the times when the user is provided with limited-use access authorization data is used to generate an output including one of a report and an alert.

59. A medicament dispensing device comprising:

a dispensing unit containing a locking unit, such that the dispensing unit can be locked or unlocked and capable of dispensing medicaments only when unlocked,

the dispensing unit also including an input evaluation unit capable of accepting input data from a user, and capable of signaling the locking system to unlock when the input data is determined to be valid,

the dispensing unit also including a monitoring unit capable of monitoring dispensing of medicaments, and capable of signaling said locking unit to lock when dispensing has reached a certain limit of use associated with said valid input data,

whereby the device can be selectively unlocked and medicaments accessed only when the user provides valid input data, the medicaments being provided up to a certain limit of use associated with said input data.

60. The system of claim 59 wherein the access authorization data includes one of a passcode, a password and a visual ticket.

61. The system of claim 59 wherein the access authorization data no longer provides access to the medicaments after a certain limit of use, the limit including one of a predetermined amount of usage, a predetermined period of time and a predetermined amount of usage during a predetermined amount of time.

62. The system of claim 59 wherein more than one limited-use access authorization data are valid at the dispensing device at any one time, each limited-use access authorization data has different limits of use, and the choice of which access authorization data to communicate to the user allows remote control of the rules for access to the medicaments in the device.

63. The system of claim 59 wherein communication to the user of the access authorization information and communication by the user of any information necessary to receive said access authorization data occurs via one of a telephone, web interface, and a personal communication device.

64. The system of claim 59 wherein valid identifying data is communicated by a user before valid limited-use access authorization data is communicated to the user in return,

whereby it is possible to gather additional relevant information before granting access to said medicaments said additional relevant information including one of, user identity, user symptoms, device status, treatment status, medicament usage information.

65. The system of claim 64 wherein the identifying data includes one of device identification information identifying the dispensing device, identification information identifying the prescribed treatment regimen, treatment information, information describing the patient, device information including a status code indicating the pattern of medicament dispensing, patient symptoms, patient activity, device activity, and medicament usage information.

66. The system of claim 64 wherein data derived from one of identifying data and the times when the user seeks access to the limited-use access authorization is used to generate an output including one of a report and an alert.

67. A system for controlling access to medicaments comprising:

an interfacing system configured to interface with a communications intermediary, the interfacing system capable of receiving identifying data from a user via the communications intermediary;

the interfacing system containing an evaluation unit capable of evaluating the received data to determine whether or not to provide access authorization data for medicaments,

the interfacing system also containing a unit capable of computing access authorization data, said access authorization data being used to request access to medicaments up to a certain limit of use, and

the interfacing system having the ability to communicate valid access authorization data to the user via the communications intermediary.

68. The system of claim 67 wherein the access authorization data includes one of a passcode, a password, and a visual ticket.

69. The system of claim 67 wherein the access authorization data no longer enables access to the medicaments after a certain limit of use, the limit including one of a predetermined amount of usage, a predetermined period of time and a predetermined amount of usage during a predetermined amount of time.

70. The system of claim 67 wherein more than one access authorization data are valid at the dispensing device at any one time, each access authorization data has different limits of use, and the choice of which access authorization data to communicate to the user allows remote control of the level of access that the user has to the medicaments.

71. The system of claim 67 further including a reporting unit utilizing the data about when the user is or is not seeking access to the medicaments to generate one of reports and alerts,

whereby it is possible to monitor overuse and underuse of the medicaments.

72. The system of claim 67 wherein the communications intermediary includes one of a telephonic device, a computing device and a text-messaging device.

73. The system of claim 67 wherein the interfacing system collects identifying data from a user before valid access authorization data is provided to the user in return,

said identifying data including one of user identity, user symptoms, device status, treatment status, and medicament usage information.

74. The system of claim 73 wherein the communications intermediary includes one of an interactive voice response (IVR) system, one or more web servers on the Internet, and a networked personal computing device communicates the identifying data and the access authorization data to and from a user.

75. The system of claim 73 wherein the identifying data includes one of device identification information identifying the dispensing device, identification information identifying the prescribed treatment regimen, treatment information, information describing the patient, device information including a status code indicating the pattern of medicament dispensing, patient symptoms, patient activity, device activity, and medicament usage information.

76. The system of claim 73 further including a reporting unit such that data derived from one of identifying data and the times when the user receives access authorization data is used to generate one of a report and an alert.

77. A medicament provisioning system comprising:

a dispensing device for dispensing medicaments,

the dispensing device including a monitoring unit capable of tracking a time of dispensing of medicaments and a quantity of medicaments dispensed,

said dispensing device further including a locking unit such that the system can only enable access to medicaments only when unlocked,

said dispensing device further including an input unit and a computing unit capable of evaluating input information including access authorization data, such that input information can be evaluated and only certain input information can be considered valid for unlocking the device and enabling medicament access,

said computing unit capable of signaling to said locking unit to unlock when valid access authorization data is input, and further maintaining the device unlocked up to a certain limit of use associated by the computing unit with the valid access authorization data input,

said dispensing device communicating information about dispensed medicaments to the computing unit, and the computing unit then signaling to the locking unit to lock the device against further dispensing once the limit of use has been reached, and

the system further including an interfacing system configured to interface with a communications intermediary, the interfacing system capable of receiving identifying data from a user via the communications intermediary; and

the interfacing system including an evaluation unit capable of evaluating whether or not to grant access to medicaments based on the identifying data received,

the interfacing system also including a unit capable of computing access authorization data, and capable of communicating valid access authorization data to the user via said communications intermediary,

whereby monitoring times of communication of valid access authorization data to a user enables approximate tracking of the use of the medicaments within the medicament dispenser by the user.

78. The system of claim 77 wherein the identifying data includes one of device identification information identifying the dispensing device, identification information identifying the prescribed treatment regimen, treatment information, information describing the patient, device information including a status code indicating the pattern of medicament dispensing, patient symptoms, patient activity, device activity, and medicament usage information.

79. A method of providing improved adherence to medication treatment regimens, comprising:

using a medicament dispensing device having the ability to receive access authorization data, said dispensing device also having the ability to evaluate whether or not said access authorization data is valid; and

inputting said access authorization data into the dispensing device; and

, if the decision is made that the access authorization data is valid, then,

enabling said dispensing device to dispense medicaments in a normal mode up to a certain limit of use, then,

enabling said dispensing device to signal to the user that the limit of use has been reached.

80. The method of claim 79 wherein data about when the user is or is not seeking access to the medicaments is used to generate one of a report and an alert,

whereby it is possible to monitor overuse and underuse of the medicaments.

81. The method of claim 79 wherein valid identifying data is provided by a user before valid access authorization data is provided to the user in return, and further comprising the step of gathering additional relevant information before granting access to said medicaments, said additional information including one of user identity, user symptoms, device status, treatment status, and medicament usage information.

82. The method of claim 81 wherein communication of the identifying data and the access authorization data between the user and a separate system occurs via a communicative device including one of an interactive voice response (IVR) system, one or more web servers on the Internet and a networked personal computing device.

83. The method of claim 81 wherein the identifying data includes one of device identification information identifying the dispensing device, identification information identifying the prescribed treatment regimen, treatment information, information describing the patient, device information including a status code indicating the pattern of medicament dispensing, patient symptoms, patient activity, device activity, and medicament usage information.

84. The method of claim 81 wherein the communication of identifying data and limited-use access authorization data occurs via a communicative intermediary, the communicative intermediary including one of a telephonic device, a computing device and a text-messaging device.

85. The method of claim 81 wherein data derived from one of identifying data and the times when the user receives access authorization data is used to generate one of a report and an alert.

86. A medicament dispensing device comprising:

a dispensing unit containing an alerting unit, such that when active the alerting unit can alert a patient to act,

the dispensing unit also including an input evaluation unit capable of receiving access authorization data, and capable of signaling the alerting unit to cease alerts when valid access authorization data is input,

the dispensing unit also including a monitoring unit capable of monitoring dispensing of medicaments, and capable of signaling the alerting unit to initiate alerts when dispensing has reached a certain limit of use,

whereby the device can alert a user once the dispensing of medicaments has reached a certain limit of use.

87. The system of claim 86 wherein the access authorization data includes one of a passcode, a password and a visual ticket.

88. The system of claim 86 wherein the limit of use includes one of a predetermined amount of usage, a predetermined period of time and a predetermined amount of usage during a predetermined amount of time.

89. The system of claim 86 wherein valid identifying data is communicated by a user before valid limited-use access authorization data is communicated to the user in return,

whereby it is possible to gather additional relevant information before granting access to said medicaments, the additional relevant information including one of, user identity, user symptoms, device status, treatment status, and medicament usage information.

90. The system of claim 89 wherein data derived from one of identifying data and the times when the user seeks access to the limited-use access authorization is used to generate an output including one of a report and an alert.

91. A system for managing adherence to a medication treatment regimen comprising:

an interfacing system configured to interface with a communications intermediary;

a dispensing device for dispensing medicaments and including a monitoring unit to track the dispensing of medicaments,

the dispensing device including an alerting unit capable of achieving awareness by a user via an alert, said alerting unit being one of active and inactive,

the dispensing device including an input unit and an evaluation unit for receiving access authorization data and evaluating its validity,

the dispensing device capable of signaling the alerting device to be inactive in response to valid access authorization data,

the dispensing device capable of signaling the alerting unit to remain inactive until the limit of use has been reached, and further capable of signaling the alerting system to become active and alert the user once the limit of use has been reached.

92. The system of claim 91 wherein the access authorization data includes one of a passcode, a password and a visual ticket.

93. The system of claim 91 wherein the limit of use includes one of a predetermined amount of usage, a predetermined period of time and a predetermined amount of usage during a predetermined amount of time.

94. The system of claim 91 wherein valid identifying data is communicated by a user before valid limited-use access authorization data is communicated to the user in return,

whereby it is possible to gather additional relevant information before granting access to said medicaments the additional relevant information including one of, user identity, user symptoms, device status, treatment status, and medicament usage information.

95. The system of claim 94 wherein data derived from one of identifying data and the times when the user seeks access to the limited-use access authorization is used to generate one of a report and an alert.