WO2010008377A1 - Method, system and apparatus for controlling patient access to medicaments - Google Patents

Method, system and apparatus for controlling patient access to medicaments Download PDF

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Publication number
WO2010008377A1
WO2010008377A1 PCT/US2008/070038 US2008070038W WO2010008377A1 WO 2010008377 A1 WO2010008377 A1 WO 2010008377A1 US 2008070038 W US2008070038 W US 2008070038W WO 2010008377 A1 WO2010008377 A1 WO 2010008377A1
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WO
WIPO (PCT)
Prior art keywords
data
access
user
access authorization
device
Prior art date
Application number
PCT/US2008/070038
Other languages
French (fr)
Inventor
Matthew J. Ervin
Original Assignee
Medicasafe, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medicasafe, Inc. filed Critical Medicasafe, Inc.
Priority to PCT/US2008/070038 priority Critical patent/WO2010008377A1/en
Publication of WO2010008377A1 publication Critical patent/WO2010008377A1/en

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Classifications

    • GPHYSICS
    • G07CHECKING-DEVICES
    • G07FCOIN-FREED OR LIKE APPARATUS
    • G07F11/00Coin-freed apparatus for dispensing, or the like, discrete articles
    • G07F11/02Coin-freed apparatus for dispensing, or the like, discrete articles from non-movable magazines
    • G07F11/44Coin-freed apparatus for dispensing, or the like, discrete articles from non-movable magazines in which magazines the articles are stored in bulk
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0481Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers working on a schedule basis
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F19/00Digital computing or data processing equipment or methods, specially adapted for specific applications
    • G06F19/30Medical informatics, i.e. computer-based analysis or dissemination of patient or disease data
    • G06F19/34Computer-assisted medical diagnosis or treatment, e.g. computerised prescription or delivery of medication or diets, computerised local control of medical devices, medical expert systems or telemedicine
    • G06F19/3456Computer-assisted prescription or delivery of medication, e.g. prescription filling or compliance checking
    • G06F19/3462Computer-assisted distribution of medication from dispensers, i.e. making sure that medication is correctly delivered to patients
    • GPHYSICS
    • G07CHECKING-DEVICES
    • G07FCOIN-FREED OR LIKE APPARATUS
    • G07F11/00Coin-freed apparatus for dispensing, or the like, discrete articles
    • G07F11/002Coin-freed apparatus for dispensing, or the like, discrete articles where the dispenser is part of a centrally controlled network of dispensers
    • GPHYSICS
    • G07CHECKING-DEVICES
    • G07FCOIN-FREED OR LIKE APPARATUS
    • G07F17/00Coin-freed apparatus for hiring articles; Coin-freed facilities or services
    • G07F17/0092Coin-freed apparatus for hiring articles; Coin-freed facilities or services for assembling and dispensing of pharmaceutical articles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0427Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system
    • A61J7/0436Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system resulting from removing a drug from, or opening, a container
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0427Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system
    • A61J7/0445Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system for preventing drug dispensing during a predetermined time period
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A90/00Technologies having an indirect contribution to adaptation to climate change
    • Y02A90/10Information and communication technologies [ICT] supporting adaptation to climate change.
    • Y02A90/20Information and communication technologies [ICT] supporting adaptation to climate change. specially adapted for the handling or processing of medical or healthcare data, relating to climate change
    • Y02A90/22Information and communication technologies [ICT] supporting adaptation to climate change. specially adapted for the handling or processing of medical or healthcare data, relating to climate change for administrative, organizational or management aspects influenced by climate change adaptation
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A90/00Technologies having an indirect contribution to adaptation to climate change
    • Y02A90/10Information and communication technologies [ICT] supporting adaptation to climate change.
    • Y02A90/20Information and communication technologies [ICT] supporting adaptation to climate change. specially adapted for the handling or processing of medical or healthcare data, relating to climate change
    • Y02A90/26Information and communication technologies [ICT] supporting adaptation to climate change. specially adapted for the handling or processing of medical or healthcare data, relating to climate change for diagnosis or treatment, for medical simulation or for handling medical devices

Abstract

A method, system and apparatus for controlling and trackage 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 interlacing 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.

Description

METHOD, SYSTEM AND APPARATUS FOR CONTROLLING ACCESS TO MEDICAMENTS

BACKGROUND

[0001] Various medications are prescribed to combat illnesses and ailments. The use of prescribed medication, usually provided in pill farm, has increased as medical science has progressed. Likewise, advancements in medical science have increased the selection, application and potency of prescription medications. Moreover, various diseases, conditions and illnesses that once required or allowed a patient to opt for hospitalization are now commonly treated on an nut -patient basis through a prescribed medication regimen.

[0002] For the above reasons and more, many medications including many drugs in pill form are now regularly self-administered under little to no supervision. SeIf- adniintstration of medical ion increases the possibility that a patient will fail to comply with directions regarding such things as dosage and timing. Non-compliance can greatly diminish tlie effectiveness of the treatment as well as increase the likelihood of harm to the patient, neither of which are desirable. Further, non-compliance can increase healthcare costs and consume healthcare resources that could he allocated elsewhere but for the non-compliance.

[0003] Non-compliance includes such things as underdosing, overdosing, abuse and dependency, which typically affect a patient's overall health and. in many cases, can be life- threatening. Non-cotnpliance does not only direcl.lv affect the patient's health and economical welibeing. hut car) indirectly affect the health and economical wellbeing of family, friends and society as a whole. Overall, non-compliance on a national and worldwide scale is costly,

[0004] Underdosing and overdosing often occur by simple mistake or neglect, particularly, when a patient is required to self-administer a complex regimen of medications. Nevertheless, both underdosing and overdosing can be intentional. For example, underdosing may be attempted by a patient Iu lower healthcare costs. Overdosing may be an unsound attempt, to increase the therapeutic effectiveness of the medication or to cause self-inflicted harm as well as be the result of abuse or dependency.

[0005] Abuse such as recreational use or unauthorized distribution is always a societal concern.. Often abase is interrelated to dependency, The risk of dependency is of particular concern when the prescribed medication is known to be habit-forming or outright addictive. Although the risk of dependency is particularly acute when the patient is known to be high-risk (i.e. susceptible to abuse and addiction), dependency remains a risk with all patients.

[0006] Thus, the risks associated with non -compliance are a real concern for doctors, pharmacists and manufacturers, among others. As a result, doctors often under-prescribe certain medications, thereby, lessening the benefits of the medication. Doctors and other healthcare professionals are also forced to make dependency risk determinations about their patients, which can put the patient and the doctor in an uncomfortable, possibly, compromising situation,

SUMMARY

[0007] According in at least one embodiment, a method of managing and monitoring access to medicaments in a medicament dispensing device can include receiving identifying data from a user and evaluating whether or not to grant access to the medicaments based on the identifying data received. Identifying data can include data about the dispensing device, the status of the dispensing device, the identity of the patient, the treatment regimen prescribed, or the current condition of the patient. Jf a decision is made to grant access, cither by default or as a result of analyzing the identifying data provided, then limited-use

. 7 - access authorization data can be provided. Limited-use access authorization data enables the dispensing device in dispense the medicaments up to a certain limit of u.se. The iimited-use access authorization, data can be communicated to the user by & variety of means, including via the telephone.

[0008] hi another exemplary embodiment, a system for managing and monitoring access to medicaments can include an. interfacing system configured to interface with a communicative intermediary and a dispensing device for dispensing the medicaments. The dispensing device can he capable of providing limited access to the medicaments in response to valid access authorization data. The access authorization, data can. be independently computable by both the device and the interlacing system and can be of limited use. Thus, limited access to the medicaments can be granted via communication of the valid limited-use authorization data from the interlacing system to a user via a communicative intermediary. Moreover, the status and the dispensing history of the device can be ascertained from the user by requesting device status information via the communicative intermediary. This information is requested as part of identifying data, and valid identifying data can be required prior to communicating valid access authorization data to the user of the depending device, thus establishing a process whereby a user of the dispensing device has a strung incentive to communicate identifying information accurately and in a. timely manner.

[0009] In yet another exemplary embodiment, a method of managing and monitoring access to medicaments can include a means for inputting identifying data, a means for authorizing the inputted identifying data and a means for outputting access authorization data.

BRIEF DESCRIPTION OF THE FIGURES [001Oj Advantages of embodiments of the present invention will be apparent from the following detailed description of the exemplary embodiment thereof, which description should be considered in conjunction with the accompanying drawings in which:

[001 Ij Fig. 1 is an exemplary diagram of a computer network.

[0012] Rg. 2 is a flowchart showing an exemplary process for providing access authorization data via an interfacing system.

[0013] Pig. 3 is a flowchart showing an exemplary process for a storage system.

[0014] Hg. 4 is a database schema for an exemplary database implemented on a storage system.

[0015] Hg. 5 is a flowchart showing an exemplary process for processing access authorization data by a medicament dispensing device.

[00163 Hg. 6 is a figure showing an exemplary embodiment of a medicament dispensing device,

[0017] Fig. 7 is a figure showing another exemplary embodiment of a medicament dispensing device in a non-dispensing state.

[Θ018.1 Pig- 8 is a figure showing the medicament dispensing device of Fig. 7 in a dispensing state,

DETAILED DESCRIFfK)N

[0019] Aspects (ύ' the invention are disclosed in the following description and related drawings directed to specific embodiments of the invention. Alternate embodiments may be devised without departing from the spirit or the scope of the invention. Additionally, well- known elements of exemplary embodiments of the invention will not Ix described in detail or will be omitted so as not to obscure the relevant details of the invention. Further, to facilitate an understanding of the description discussion of several terms used herein follows. [ΘΘ20J The word "exemplary" is used herein to mean ''serving as an example, instance, or illustration." Any embodiment described herein as ''exemplary" Ls not necessarily to be construed as preferred or advantageous over other embodiments. Likewise, the term "embodiments of the invention" dues not require that all embodiments of die invention ineϊude the discussed feature, advantage or mode of operation.

(#0213 Further, many embodiments are described in terms of sequences of actions to be performed by, for example, elements of a computing device. It will be recognized that various actions described herein can be performed by specific circuits (e.g., application, specific integrated circuits (ASIC's)), by program instructions being executed by one or more processors, or by a combination, of both. Additionally, these sequences of actions described herein can be considered to be embodied entirely within any form of computer readable storage medium having stored therein a corresponding set of computer instructions that upon execution would cause an associated processor to perform the functionality described herein. Thus, the various aspects of the invention may be embodied in a number of different forms. all of which have been contemplated to be within the scope of the claimed subject matter. In addition, for cadi of the embodiments described herein, the corresponding form of any such embodiments may be described herein as, for example, "logic configured to" perform the described action.

[0022] Fig. 1 illustrates a computer system 1 1 1 upon which an embodiment of the present invention may be implemented. The computer system 1 1 1 includes a bus 1 12 or other communication mechanism for communicating information., and a processor 1 13 coupled with the bus i 12 for processing the information. The computer system 11 i also includes a main memory 1 14, such as a random access memory (RAM) or other dynamic storage device <e.g., dynamic RAM ΦRAM), static RAM (SRAM), and synchronous DRAM (SDRAM)), coupled to the bus 1 12 for storing information and instructions to he executed by

- > - processor 1 13. In addition, the main memory 1 14 may be used for storing temporary variables or other intermediate information during the execution of instructions by the processor 1 13. Hie computer system 1 1 1 further includes a read only memory {ROM} i 15 or other static storage device <e.g., programmable ROM (FROM), erasable PRC)M (EFROM), and electrically erasable PROM (EEPROM)) coupled to the bus 1 12 for storing static information and instructions for the processor 1 13.

[Θ023J "Hie computer system 111 also includes a disk controller 116 coupled to the bos 1.1.2 to control one or more storage devices for storing information and instructions, such as a magnetic hard disk ! 17, and a removable media drive 1.1.8 (e.g., floppy disk drive, readonly compact disc drive, read/write compact disc drive, compact disc jukebox, tape drive, and removable magneto-optical drive). The storage devices may be added to the computer system 1. 1. 1. using an appropriate device interface (e.g.. small computer system interlace (SCSI), integrated device electronics (IDE), enhanced-l.DE (E-IDE), direct memory access (DMA), or ultra-DMA.}.

[0024] Further, exemplary embodiments include or incorporate at least one database which may store software, descriptive data, system data, digital images and any other data item required by the other components necessary to effectuate any embodiment of the present .system and method known to use having ordinary skill in the art. The databases may be provided, for example, as a database management system (DBMS), a relational database management system (e.g., DB2, Oracle, SQL Server, My SQL, ACCBSS, etc), an object- oriented database management system (ODBMS), a file system or another conventional database package as a few non-limiting examples. The databases can be accessed via a Structure Query Language (SQL) or other tools known to one having skill in the art.

[0025] The computer system 1 1 S. may also include special purpose logic devices <e.g., application specific integrated circuits (ASICs)) or configurable logic devices (e.g., simple

- ft - programmable logic devices C'SFLDs), complex programmable logic devices (CFLJ)S), and field programmable gate arrays (FPGAs).).

[0026] Hie computer system 1 1 1 may also include a display controller 1 19 coupled to the bus 1 12 to control a display 120, such as a cathode ray tube (("RT), liquid crystal display (LCD) or any other type of display, for displaying information to a computer user. The computer system includes input devices, such as a keyboard 121 and a pointing device 122, for interacting with a computer user and providing inform af ion to the processor 113. Additionally, a touch screen could be employed in conjunction with display 1.20. The pointing device 122, for example, may be a mouse, a trackball, or a pointing stick for communicating direction information and command selections to the processor 1.13 and for controlling cursor movement on the display 120, Fn addition, a printer may provide printed listings of data stored and/or generated by the computer system 1 1 1.

[0027] The computer system 1 11 performs a portion or all of {.he processing steps of

(he invention in response to the processor 1 13 executing one or more, sequences of one or more, instructions contained in a memory, such as the main memory 1 14. Such instructions may be read into the main memory 1 14 from another computer readable medium, such as a hard disk 1 17 or a removable media drive 1 18, One or mure processors in a multi-processing arrangement may also be employed to execute the sequences of instructions contained in main memory 1 14. In alternative embodiments, hard- wired circuitry may be used in place of or in combination with software instructions. Thus, embodiments are not limited to any specific combination of hardware circuitry and software.

[0028] As stated above, the computer system 1 1 1 includes at least one computer readable medium or memory for holding instructions programmed according to the teachings of the invention and for containing data structures, tables, records, or other data described herein. Examples of computer readable media are compact discs, hard disks, floppy disks. tape, magneto-optical disks, PROMs (EPRC)M, EEPROM, flash EPROM), DRAM, SRAM5 SDRAM, or any other magnetic medium, compact discs (e.g., CD-ROM), or any other optical medium, punch cards, paper tape, or other physical medium with patterns of holes, a carrier wave (described below), or any other medium from which a computer can read,

[0029] Stored on any one or on a combination of computer readable media, the present invention includes software for controlling the computer system S. Ll, for driving a device or devices for implementing the invention, and for enabling the computer system 3 1 1 to interact with a human user. Such software may include, hut is not limited to, device drivers, operating systems, development tools, and applications software. Such computer readable media further includes the computer program product of the present invention for performing all or a portion (if processing is distributed) of the processing performed in implementing the invention.

[0030] The computer code devices of the present invention may he any iπierpretable or executable code mechanism, including bin not limited to scripts, inU'.rpretabJe programs, dynamic link libraries (DLLs), Java classes, and complete executable programs. Moreover, parts of the processing of the present invention may be distributed for better performance, reliability, and/or cost.

[0031.1 The term "'computer readable medium" a.s used herein refers to any medium that participates in providing instructions to the processor 113 for execution. A computer readable medium may take many forms, including but not limited to, non-volatile media, volatile media, and transmission, media. Non-volatile media includes, for example, optical magnetic disks, and magneto-optical disks, such as the hard disk 117 or the removable media drive 1 18. Volatile media includes dynamic memory, such as the main memory 1 14. Transmission media includes coaxial cables, copper wire and fiber optics, including the wires that make up the bus 112. Transmission media also may also take the Ions of acoustic or light waves, such as those generated during radio wave and infrared data communications,

[0032] Various forms of computer readable media may be involved in carrying out one or more sequences of one or more instructions to processor 1 13 for execution. For example, the instructions may initially be carried on a magnetic disk of a remote computer. The remote computer can load the instructions for implementing all or a portion, of the present invention remotely into a dynamic memory and send the instructions over a telephone line using a modem. A modem local to the computer system 1 1 1 may receive the data on the telephone line and use an infrared transmitter to convert, the data to an infrared signal. An infrared detector coupled to the bus 1 12 can receive the data carried in the infrared signal and place the data on the bus 1 12. The bus 1 12 carries the data to the main memory 1 14. from which the processor 1 13 retrieves and executes the instructions. The instructions received by the main memory 1 14 may optionally he stored on storage device i 17 or 1.1.8 either before or after execution by processor 1. 1.3.

[0033] The computer system 1 1 1 also includes at least one communication interface

123 (e.g. modem, telecom access card, etc) coupled to the bus 132. A communication interface 123 may provide a two-way data communication coupling to a network link 124 that i.s connected in, for example, a local area network (LAN) 125. or to another communications network 126 such a.s the "internet. The communication interface 123 may also include or serve as a telecom access device (e.g. if the communication interface is a telecom board), thus enabling the computer to act as an. IVK (Interactive Voice Response) system. One non-limiting example of such telecom access hardware is commercially available from. Dialogic, for example the Dialogic 480.1CT board. Further, the communication interface 123 may Ix; a network interface card to attach to any packet switched LAN. As another example, the communication interfaces 123 may be an asymmetrical digital subscriber line (ΛDSL) card, an integrated services digital network (ISDN) card or a modem tu provide a data communication connection to a corresponding type of communications line. Wireless links may also be implemented. In any such ijnp1em.enta.tion. the corn jnuni cation inter Spaces 123 may send and receive electrical electromagnetic or optical signals thai, carry digital data streams representing various types of information.

[Θ034J "Hie network link 124 typically provides data communication through one or more networks to other data or telecom devices. For example, the network link 124 may- provide a connection to another computer or remotely located presentation device through a local network 1.25 (e.g., a IAN) or through equipment operated by a service provider, which provides eomnionicaiion services through a communications network J 26, Fn preferred embodiments, the local network 124 and the communications network 126 preferably use eleeiricah electromagnetic, or optical signals that, cany digital data streams, The signals through the various networks and the signals on the network link 124 and through the communication interface 123, which carry the digital data to and from the computer system 1 1 1 , are exemplary forms of carrier waves transporting the information. The computer system 1 1 1 can transmit and receive data, including program code, through the network(.s) 125 and 126, the network link 124 and the communication interface 323. Moreover, the network link 124 may provide a connection through a LAN 125 to a mobile device 127 such as a personal digital assistant (PDA) laptop computer, or cellular telephone. The IAN communications network 125 and the communications network 126 both use electrical, electromagnetic or optical signals that carry digital data streams. The signals through the various networks and the signals on the network link 124 and through the communication interface 1.23, which carry the digital data to and from the system 1 1 1 , are exemplary forms of carrier waves transporting the information. The processor system 1 1 1 can transmit notifications and receive data, including program code, through the network(s), the network link 124 and the communication interface 123,

[0035] The exemplary embodiments below may use Interactive Voice Response

(JVR) systems. IVR systems may be computing devices which can: answer phone calls; play taaJio to the caller during a phone call such as "Please enter your ID number"; and accept input, from the caller, for example, via fouchtone input or speech input, and the like where the caller operates a telephone to signal to the !VR system. By playing audio to a caller and accepting input from the caller, the IVR system conducts a dialog.

[©036] Current IVR systems can include computers that can communicate with phone callers via a wide variety of telecom transmission protocols. Telecom protocols selected sometimes, hut not always, require (hat the computer contain a special physical telecom access card, .similar to a modem, for connecting to telecom systems and communicating audio via a telecom transmission protocol. Some new digital protocols, such as the Voice over Internet Protocol (VoIP), do not require a special additional modem-like communication subsystem, bin may have a communication device that can access a data network (a data card) and may use a program to control VoIP telecom calls. More traditional telephony systems aad protocols typically are connected to and controlled by commercially available telecom access cards,

[0037] Telecom access cards are specifically designed tu enable the computer to connect to a telecom system and contain means to allow the computer to prograinmalicalϊy control a dialog with one or more human beings on the other end of telecommunications connections (i.e., during phone calls). Telecom cards are commercially available such that, when installed in a computer, the computer can connect to and control voice calls over a variety of telecom protocols, including; analog lines, TDM. digital lines, ISDN digital lines. Voice over f P lines, etc. Thus, exemplary embodiments πf the below invention may use any of the telecom protocols and configurations described above.

[0038] In general, Figs, 2-8 are directed to aspects of at least one exemplary embodiment of a method, system and apparatus for administering medicaments to patients where the medicaments are dispensed in a controlled fashion from a dispensing device. Although many steps are described a>s being performed" by computer logic, a person of ordinary skill in the ail will understand that one or more of these steps can be performed by a human being. For example, a human being can answer a phone call from a user, request identifying data, determine whether authorization to a dispensing device is advisable, relay access authorization data to the user for accessing medicaments housed in a dispensing device, and the like,

[00393 According s.o at least one exemplary embodiment, a method and system of managing access to medicaments can communicate limited-use access authorization data to a user of" the drug dispensing device. The dispensing device can, in turn, utilize limited-use access authorization data to control access to medicaments. Embodiments can include using any dispensing device that .supports the utilization of limited-use access authorization data (e.g., a single -use passeode) to gain limited access to the medicaments within the dispensing device.

[0040] The term "access authorization data" is used throughout, and passcodes are but one example (ύ' such data. Valid passcodes are used in at least one exemplary embodiment to indicate to the drug dispensing device that access to some amount of medicaments has been authorized.

[0041] An important aspect of at least one exemplary embodiment can be considered to be the use of controlled communication of limited-use access authorization data where such access authorization data (a non-limiting example being a passcode) can then be used to enable limited access to medicaments in a drug dispensing device. Hence, control over communication of valid access authorization data to a user of the disposing device enables effective proxy control over ongoing access to medicaments in. the medicaments in that dispensing device. Access to medicaments can be granted for limited use {e.g.. the drug dispensing device only dispenses a certain quantity and/or dispenses over a certain period of time during which the passcode is valid) and at some point the access authorization data can expire. Thereafter, use of that access authorization data can fail to facilitate access Io the medicaments in. the drug dispensing device.

[0042] The access authorization data can be made to expire .for any number of reasons, such a.s if the medicaments are accessed too otten within a limited period of time. Once the access authorization data expires and is no longer valid, a user seeking access to further medicaments can seek new access authorization data (e.g. a new passcode) from an external resource (e.g. an external interfacing server via a communicative intermediary), "if new access authorization data is not soughs, the user can be left, without the ability So access the medicaments within the drug dispensing device. IJf the user requests new and valid access authorization data, this access data can be provided if the logic of the system controlling communication of the access authorization data deems it proper to do so. In at least one exemplary embodiment, the user is asked for identifying data as a. necessary step before the user can potentially receive new access authorization data. The identifying data provided can be evaluated and conclusions derived from the identifying data may affect whether to provide new valid access authorization data, or which access authorization data to provide, and selective denial of access authorization data is a possibility in at least one exemplary embodiment.

[0043] The phrase 'identifying data" is used throughout, and identifying data can. include one or more items such as a device identification number or name, device status information, a user name, a user identification number, a treatment identification number, treatment description, data about the medicament prescription, and similar data known to one having ordinary skill in the art. In particular, the identifying data could include information displayed on the device such as a status code that can be used to derive further information about the quantity and/or pattern of access to the medicaments during the intervening time since the last communication with the user.

[Θ044J hi at least one exemplary embodiment, the control of communicating valid access authorization data can be achieved by requiring a person (typically the user of the medicaments) to input identifying data to a.n interfacing server via a communicative intermediary before providing the user with valid access authorization data. A determination, can then be made as to whether or not it is advisable to provide valid access authorization data thereafter. In at least one exemplary embodiment, the identifying data collected contains information about the history of medicament, access, and this data can be used in a process to determine whether or not it is advisable to provide further access authorization data. In at least, one other exemplary embodiment, no direct data about, device dispensing history is collected as part of identifying data, but rather the time at which the user seeks access is used to infer whether the user is or is not complying with an acceptable treatment regimen, and based on this access authorization data is confirmed on denied,

[0045] The determination of whether access authorization data should be communicated to the user can be made programmaticalϊy, and the program can incorporate any algorithm/logic conceived to decide whether or not access should be authorized. Medical considerations that may be taken into account include concerns that the patient may be dispensing medicaments too frequently, and thus may Ix exhibiting signs of" drug addiction (and therefore medicament access should be curtailed). Also, the patient may not be taking the medicament at the rishl time Jo maximize the effectiveness of the medicament and access authorization data can be withheld until the appropriate time. 'The inputs to the determination could include data about when the user has sought access to medicaments in the past.

[0046] In at least one other exemplary embodiment, the dispensing device can be programmed by one with ordinary skill in the art to log the times at which medicaments were accessed in die device. This log data, or the most relevant information in this log, can be communicated by the user as identifying data. At least one exemplary embodiment described herein assumes that the time of dispensing is close to the time of the last communication of valid access authorization data. II. is possible for one skilled in the art. to identify and create a wide variety of dispensers thai are amenable to this tracking. A wide variety of sub systems can be conceived of that track when medicaments were removed from a dispenser, as will be known to one with ordinary skill in the art (e.g. a tray that rotates to reveals a pill in a discrete compartment, whereby that rotation can be monitored; A dispenser that pushes pills out from a cartridge, whereby that, removal from a cartridge can be monitored; Or an electro-optical detector that 'sees' when a pill is removed from a dispenser).

[0047] Data, collected by the device about the times of medicament access can condensed and encoded into a form, such as a status code, that could be communicated easily as by the user identifying data. As one non-limiting example, if the dispensing device is programmed to limit usage to no more than three, pills during a 48 hour period, the status code for such as 48 hour period could be designed as three 2 -digit numbers conjoined, each 2-dJgU number indicating the hour at which a medicament was dispensed during that 48 hour window. Status code 04 14 36 would indicate that pills were dispensed at hours 4, 14, and 36, while 05 05 00 would indicate that two pills were dispensed during hour 5 and none thereafter.

[0048] Various types of information collected by the dispensing device, including device status and dispensing history information, could be requested during any dialog with a user of the device. Anyone skilled at the ail could conceive of a variety of information that the dispensing device could log, and that a user could communicate, as part of identifying data.

[{K*49j in. at least one exemplary embodiment, the determination of whether or to provide access authorization data can include an algorithm that checks Jo see if sufficient time has passed since the last access authorization data was supplied. Such a relatively simple algorithm can be useful in controlling access to an addictive medicament, but the sirnplieiiy of this exemplary algorithm is not. intended to be limiting.

[MSOJ In at least one other exemplary embodiment, access authorization data is always communicated upon receipt of valid identifying data. While this embodiment does not. necessarily limit access to medicaments dispensed, it nonetheless enables remote monitoring of the pattern of medicament access, and could provide a process for collecting a variety of identifying data from a user.

[ΘΘ51] in addition to controlling and tracking access to medicaments in a dispensing device, various embodiments also serve as a practical mechanism for gathering information about when to remind users to take medicaments, in general, if a user fails to seek access authorization data within expected time expected, users are not following a treatment regimen in an appropriate manner. Anyone skilled in the art can act on this inferred data U) remind the user to do so by employing various types of reminder systems. Thus, at least one exemplary embodiment can remind the user to take the medicament if it can be inferred that they have not done so within a prescribed time frame,

[0052] Referring Jo Rg. 2, a process for accessing a medicament (or predetermined dosage quantity thereof) where a patient can receive access authorization data such as a passcode or password for operating a medicament, dispensing device is shown in accordance with at least one exemplary embodiment of the present invention. In at least one exemplary

. IS - embodiment, the access authorization data can be limited-use access authorization data such as single-use (i.e. "one-time") access authorization data. For instance, single-use access authorization data {a species of limited-use access authorization data) can require a patient, to request subsequent single-use access authorization data after the current single-use access authorization data has expired, for example, through a one-time use with the dispensing device and/or through the expiration of the designated lime period for use.

[0053] Limited-use access can describe access to a certain quantity of medicaments

(or dosages thereof) or can describe access to any number of medicaments over a range of time. Also, limited-use access can describe access to a certain quantity over a certain period of time. As such, limited-use access authorization data is intended to be broadly interpreted as information that can be used to provide access to medicaments based on limiting criteria. Limited-use access authorization data can provide access to a certain quantity of doses of a medicament or can provide access to medicaments over a certain period of time and any combination thereof (e.g., a Jimik'd-use passcode can be used up to three times during the next forty-eight hour period and thereafter the passcode will expire). After the limit of use has been reached, the liπiifed-use access authorization data will no longer enable access to medicaments.

[9054.1 Thus, the process shown in Fig. 2 can be repeated each time a patient requests access authorization data for dispensing a medicament and limited-use access authorization data can be provided each time it is determined to be medically advisable to provide such access authorization data. Exemplary embodiments are sometimes described herein, with reference to single-use access authorization data such as a single-use passcode. This is intended to be merely illustrative and not limiting as one of ordinary skill in the art will appreciate that limited-use access authorization data can be accommodated, in. other words, exemplary embodiments referring to single-use access authorization data can make use of limited-use access authorization data to also provide access to two or inure doses of medicaments. Hence exemplary embodiments making reference to single-use access authorization data can also serve as a guide to someone with ordinary skill in the art to create exemplary embodiments utilizing limited-use access to any arbitrary quantity of medicaments. In effect, all references herein Jo single-use access authorization data can be broadened and generalized as limited-use access authorization data. Limited use can be interpreted as open access to medicaments over any arbitrary quantity of lime, or for any quantity over any period ot time as well.

[©055] Still referring to Fig, 2. at step 202, a patient (or a person acting on behalf thereof) can operate a communicative intermediary such as a telephone and like devices having telephone functionality to interface with an interfacing system (e.g., a "remote master system") such as an IVR system. Alternatively, a patient can. operate a personal computing device such as a computer having webpage browsing capability to view a webpage requested from a web server that, provides a means for inputting identifying data such as an identification number for the dispensing device (which may also function as a patient, identification number or be associated therewith), as shown in step 204. Other non-limiting examples of identifying data may be a status code displayed on the device, prescription identification, etc. Moreover, in web-based embodiments, a secured Internet connection may¬ be used, as is well known in the art.

[0056] In other embodiments, the communicative intermediary can be a device with text "messaging functionality and the interfacing system can be one that can process text messages as one more non-limiting example. For example, a patient can transmit identifying data in text form over a mobile phone telecom system (e.g. "test message", such as in "texting information, to a five-digit short code" as is known in the art, and similar to "email"'.!. Another communicative intermediary could be an email system. [0057] Af step 204, the communicative intermediary can act to prompt a patient to input the identifying data. Fur example, embodiments having an fVR system can initiate a dialog and make audio requests through a telephone such as; "Please enter your identification number/1 or "Please enter your device ID number", or "Please enter the status code displayed on your device", and the like. Similarly, web- based embodiments can invite a patient to input the identifying data by providing a wehpage having a portion for inputting the identifying data. For instance, a webpage ean have a graphical user interface (GOl) widget such as a textbox for entering the identifying data,

[©058] In ai least one exemplary embodiment, identifying data can include a device identification ("device ID") number. That device can be associated in a database with a certain active patient and a certain active treatment regimen. If the device ID number is the identifying data, then a database (described below) can store an association between the device ID and She patient in possession of that device, information about, the medicaments in that device, information about the treatment regimen associated with that treatment and the like.

[Θ059J Nevertheless, identifying data can include any information known to one with skill in the art, such as information that enables identification of the device, identification of the patient, identification of the device status, identification of the device dispensing history, identification of the treatment regimen, any form of information about the quantify and times at which medicaments were dispensed from the device, etc. And identifying data could also Ix1 supplemented by a question and answer dialog, where the user responds with information that could be medically useful, such as information about pain levels, symptoms, etc. This identifying data serves as the key input to an algorithm for determining whether, when, and or which access authorization data should be allowed to Ix1 delivered to the user. [Θ06OJ After a patient inputs identifying data at .step 206, the inputted identifying data can be received at the interfacing computer system, At step 208, the interfacing computer .system can request authorization from & storage server system {i.e. which may he referred to as a ''roaster roediea! system'1), which may Ix; a database system having a database storing (and associating) data 212 such as patient biographical data, device data including device identification data and device status data, medical/treatment data pertaining to patients and their prescribed medicament regimens, access authorization data (including, e.g.. passeodes, passcode algorithms and the like), stored procedures for interpreting device status data, and the like known to one having ordinary skill in the art (see, e.g.. Fig. 4). As one non-limiting example, the database can be a relational database.

[0061] Notably, the interfacing and storage systems can be viewed as integral parts of an authorizing system including both operatively connected in accordance with at least one exemplary embodiment. The interfacing and storage systems can be implemented on a single computer, a central computer system or distributed.

[0062] In at least one exemplary embodiment, the interfacing server can collect identifying information from the caller and transmit that data to the storage system. The storage system can process the identifying data aad can execute algorithms to determine whether it is medically advisable to provide a medicament (or predetermined dosage quantity thereof) to the patient associated with the identifying data based on, for example, the treatment data stored within the storage system (e.g., a database thereof) and decision logic configured to process such data.

[0963] As will be readily understood by one having ordinary skill in the art. the determination of whether it. is medically advisable to provide a medicament can be based on the timing and dosage criteria of the treatment, regimen prescribed for the medicament in conjunction with inferred information about medicament access derived from the techniques forth herein. Such a decision can factor in data such as the la\t and previous

Figure imgf000023_0001
of access authorisation data to the patient, winch can be recorded within the storage system, and an> other device status information or patient information reported during the dialogue with the user. In the absence of detailed device status data, outputs of access authorization data can he considered e\ tdenee that the patient actually received their medicament dosage proximate the time the access authorization was requested. Ovexaih the storage s> stern can be used to track a patient's compliance with the prescribed treatment regimen as well as track v arious other indicators related io a patient's health.

[©064] ϊf it is determined to be medically advisable to dem the patient access to the medicament, then the storage system can transmit a denial io she interf acing system, alerting it thai access authorization data is not available for

Figure imgf000023_0002
iding so she patient. Λt step 210. the interfacing s\ stent can alert the patient (or a person acting on hehali thereof) that the access authorization data is nos av ailable (.or accessible; as this time through the communicative intermedial") . Kw example, an audio mexsage in embodiments having an IVK system can be played aleiung ol such or, alternative!) . in web-based embodiments, a weαpage showing that the request lor access authorization data has been denied and that the access authorization is not available can be displayed to a user ot a computing device.

100651 Il it is determined to be medkali) ad\ isable to pro\ ide the patient with access to the medicament according in the decision logic, then the storage system can transmit an authorization to the interfacing system to provide the requested access authorization data, which can be limited-use access authorization data such as a passcode. password, visual ticket and the like known to one

Figure imgf000023_0003
ing ordinary skill in the art. Upon authorization, the interfacing s>slem can compute or retrieve troπi the storage system the access authorization data at step 214 For example, the interlacing svsiem can compute or retrieve single-use access authorization data, such as a passcode based on a predetermined algorithm (or am known type of raftdom number generator), for generating seemingly random single-use passcode.s.

[0066] Alternatively, a password generator can be used as die generator for single-use passwords as one more non-limiting example. Exemplary embodiments described herein will generally be described in reference, to passαxles, algorithms and random number generators, which is illustrative and not intended to be limiting as will be appreeiaied by one having ordinary skill in the art

[0067] Still referring to Ing. 2, for example, a database of the storage system can store the algorithm where the interfacing system can query the algorithm and calculate the passcode. Alternatively, at step 2 ! 4, the access authorization data itself can be queried tram a database on the storage system where sets of access authorization data pertaining to each patient are stored for providing limited-use access authorization data in response to a parent's request. For example, the known results of a calculated passcode paUern for providing single-use passcodes can be stored in the database.

[0068] In at least one exemplary embodiment, if the patient fails to seek access authorization data lor the dispensing device within a predetermined time period or around a prescribed time, the interfacing system or aaother .system may alert the patient or a eoataet person (e.g., guardian, caregiver, relative, etc.) of the need to request access authorization data. These alerts can be of any type known to one having ordinary skill in the art including, for example, alerts transmitted through phone calls, text messages, emails and audible aad/or visual alarms. These alerts can also Ix1 communicated directly to the patient via the dispensing device. In at least one exemplary embodiment, the device may begin making a beeping sound when the limit of use has been reach. This will serve to remind the patient to take action, which could include the action of checking in to provide identifying data and receive new access authorization dafa. In at least one exemplary embodiment, this reminder capability is provided instead of providing a locking mechanism that prevents access to the medicaments. The reminder system, implemented by a beeping sound that continues until the patient, inputs new valid access authorization data, stimulates the act of checking in by proving to be an annoyance to the patient This reminder system can also be combined with the teachings herein for providing a locking mechanism on the device, and reminders can be programmatically designed to begin prior to the locking of the device. For example a reminder beep might begin 24 hours prior to the locking of iiie system implied by the limit of use associated with the initial access authorisation data. Hence the beeping would remind die patient to seek a new access authorization code prior to full lock. In another exemplary embodiment, one skilled in the art to use the principles described herein to create a medication management system that does not employ a lock on the medication dispenser, hut. instead employs limited use access authorization data thai, along with reminders that are initiated at the conclusion of that limit of use. This system might, be preferable for use with medications where locking the patient out for the medicaments is deemed undesirable, yet a mechanism is still required to stimulate regular patient check-in and collection of identifying data.

[§069] Also, in at least one exemplary embodiment, an alert can be transmitted to other parties including caregivers, family, or medical professionals such as doctors and pharmacists or their respective staff, that alert indicating to these parties that some sort of patient issue has been detected via the cnminunicatinn with the user described herein. The alert transmission to such parties can be made through the storage system or, alternatively, through the interfacing system as well as any other suitable system connected therewith. In particular, in at least one exemplary embodiment, an alert can be sent to interested parties if the patient is seeking access to a medicament in a pattern determined to be suggestive of addiction, abuse, misuse and the like. [ΘΘ70J At step 216, the interfacing system can transmit the liπiited-usc access authorization data, which may be single-use access authorization data, to the communicative intermediary. At step 218, the communicative intermediary can. relay the access authorization data to the patient (or a person, acting on. behalf" thereof). For example, an audio message in embodiments having an IVR system can be played relaying the access authorization data to the telephone user or, alternatively, in web-based embodiments, a webpage showing the access authorization data can be displayed on the computing device of the user.

[IMK? I] In relation to the process of .Fig, 2. one exemplary embodiment can include server code implemented to allow an IVR system s.o interact with a patient and provide, tor example, a current, passeode.

[0072] Exemplary code is provided herein for an exemplary embodiment that uses an

IVR system. This exempJaty code- consists of POP scripts, a common scripting language widely used by programmers skilled in the art of web programming, and VoieeXML code, a common scripting language widely used by programmers skilled in the art of IVR programming.

[0073] For instance, an exemplary code device configured to provide the basic IVR system menu can include:

heeler { "Content-type : text/xr.^"} ;

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[0074] Also, an exenipfary code device configured to enable a calier Io request, a new passcodc (where authorization is provided via a storage system having a database) can include:

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echo <«2HD

Figure imgf000031_0001
sssfcered your device id, -as; £>rint<;d on yo-.ir. device The 3y.5':B™ y?:.ll now I'ϊt-.ir.u t:o the rna:; Ti ΆBΏJ.

<./bicck>

< /for;:.> ≤Nb;

Tf;ys;q?._clo:se (} ; ? >

[0075.1 Moreover, emhoiiiincats of ihe present invenliun am include an exemplary code device configured to remind a caller of their current pa^scode if forgotten, which can. include:

B;;tio<"-?xrrύ v-er«iofi-\" 1.. OV ?>" ) ;

db_:τ. s i _c o π Ά e c t { }

< vx.T:_ v*s r s i CΏ~ " 2 , 1 '' >

Figure imgf000031_0002

{

$ae'/icsj id ~ S POST[11V- dssvice id*'j ;

Sqyery-" SELECT * "ROM Trc-st;π«;nt...I«fo WHERE ;FK..D<3vics__.ir>

' $'ievi-;'5mid1 AND Sti_iActive ~ 'i')"1;

Figure imgf000031_0003
echo <<<;KSD <pron-pt>

Xns system aoe-; :IG:; recogrsixe that Device ID. You eiiϊ<3ϊ<3d <'sάy-zs:

Figure imgf000032_0001
' ≤;a\ &3 > . Yc-; βhCΛild have erstε;:κci the device ID print β"! ovi your device. The ϊ7y£t.err wi .11 Ho«' r ζi t. Vi T Ti t.o T
Figure imgf000032_0002
IXVΓJΪΓ; r~er:u .

< Q' ot o r.÷s xt- — " ϊϊis 1 irit r o . P hp " / "» " j ;

KND

$treatτf;entm;.d - r^V3qimres;u:.t (5re:sui t , 0, "Tre.strent^JD")

Figure imgf000032_0003
;

$.T:i.πi:T;u:ϊ;mt isΛ,edift ~ ;;.vsaimri?sviit { '■ result , 0 , "Mini:T;j:r;mInterv-;;I" } ;

$paϊ.isnt...icJ ~ :uy;jq_...i8Si3l t (3r«ϊuit , 0, "?K...f «ti«nt....ID"}

St r&at;nern:...':-i!p" ~ :"v≤;ql...re:>:Ji ': f$re-3-;it,0/"Tr«!at^ent^Tyρe")'; ϊ query- "^ElSCT '' FROM Dev:.e;e_!nf o VtfiSRS (0evlce_I0 - '5OeVlCe-Jd1 j «;

;r;ycjq:...reault {?xsjsαltf i; , "P.sssco<i<s...C αrreritR-aπX'1} ;

$old...pacJCJCcάe ~ xr;yyql... result (Srssuit, 0, T*;j;jc:od<;...;;:jrr<sritfi } ;

Si: ow - Ti:;«sO ;

$t:.rre_requireJ - ($tlrr;emnezraccef;f; - $nc-«) if (5tiπ-emr*sq-oired <~ C } {

$ t iff^r eqy 1 rsd~0 ;

^no;;xs...ϊequ;. r&α 11 '5O Ϊ i S t: v"& .fϊϊO'vii :reci

<forrr i.a-"cail_b-ack_wh'sn">

<qxavsτ;ai: tγρe~"apρiicat ior:/x-- ":'swi" 1I i 2*'/qr-s;;i;"«.r> <:pro:ppt>

Ycur I-Λst passc;cd<a w^s; <say-a3 _yp«--"^crony.';:">SoId..p«εεcc-αfϊ</3ay-βsϊ. ,

Tt you ti«v& ij.ready -jsed that iast passccde, it will no longer work.

T D r ep f? <i 11 y o u r .. a 31 p « s s c c. d e w a :t < 3 « y ™ <i t" ■:yp«:-'f.;κ:.r;>riy:::">Solcϊ...ρ.;ts:s:co-i-5</3<)y-asr> ,

YCΛ! can -je.r a ti&w pass code in

echo ( "Sϊ;ours:....req-jiϊ«d ϊ;«ur≤; and $;::i n Ji:ej-;...r«qui.reα echo < «£N0

TG repeat , yojr l«st ρ-as scod«s ess <εay--as

■: yp«:

Tc repeat thi s in ferrat e on aga i n, pre;:s .1 . Jo ret .i rr; to the rruii n raerr..; , press 2 . < /prompt >

<wcto »szt~ "-!Fc«.ll back

Figure imgf000033_0001
/>

EMD;

< < <?;NO

<prerr:pt> ente red y. on ycυr a&vi ce Tne syst sr will now return to the main rr.sπυ. < /prc-:πpt > <octo »ezt~*';"si..

KND

Figure imgf000033_0002
! ; ?>

[M76] Now referring to Fig, 3, a process for inputting data, such as patient biographical data, device data including device identification data, medical/treatment data pertaining to patients and iheir prescribed medicament regimens and the like, into a storage system (i.e. the medical master system) is shown in accordance with at least one exemplary embodiment of" the present invention. At step 302, an operator can operate a terminal for a computing device for inputting such data into the storage system while, for example, at a workstation. The storage system can be remote and remotely accessible from the diem computing device through a network such as the Internet. [0077J The operator of such a computing device Ls envisioned, in accordance with at least one exemplary embodiment, to be an administrator for a medical provider. For example, the medical provider can be a hospital a doctor's office, a pharmacy and the like. An administrator can be any medical professional such as a doctor, pharmacist, psychiatrist and the like, as well as any staff (e.g.. a receptionist, nurse, technician, etc.), who also can be considered medical professionals depending on usage, working on. behalf thereof. Also, in at least one exemplary embodiment, the administrator can be an employee of a healthcare insurance company and the like. Moreover, in at least one embodiment it is envisioned that the operator will be the patient or a person acting on behalf thereof (e.g., guardian or caregiver) who is not an administrator for a medical provider or health insurance company.

[0078] Before inputting data at step 304, an operator may have to log in at sk'p 302 to gain, access to the storage system through any login means known to one having ordinary skill in the art. For example, logging in can be effectuated by providing a usemame and password to securely access the storage system via a secured Internet connection as is well known in the art. Customary procedures in the field of medical data can be used to determine the level of access granted to the operator.

[0079] At step 304, the operator can input data such as patient biographical data, device data including device identification data, medical/treatment data pertaining to patients and their prescribed medicament regimens and the like into the storage system, which can be stored and organized in a database (see, e.g., Fig, 4). As stated before, the storage system and any associated database can also include access authorization data and/or access authorization data algorithms for determining a limited-use access authorization data. The operator can input data via administrative screens for data entry such as webpage forms providing data entry means throush GUI widset.s. [Θ08OJ Fur instance, during patient enrollment, the operator can enter needed patient biographical data, needed treatment/medical data including treatment regimen, the quantity ul' medicaments disposed within, and housed by the dispensing device, dispensing device identification data (e.g., identification number) and the like known to one having ordinary skill in the art. Also, at this time, a patient can be provided with the medicament dispensing device as well as any needed information for contacting the interfacing system of an. authorizing system (see, e.g.. Fig.2) in order to receive access authorization data such as a limited-use passeode for gaining access to a dosage of the medicaments.

[ΘΘ8Ϊ] For example, an exemplary code device for providing a web form for inputting data regarding a new dispensing device can include:

beaαer ("Corv '-Yi'*'-

Sntsr 'ia::a X enroi.i. a :ist»; .tor :-ΪS «e ϊ-Λte </t. It"- B

Figure imgf000035_0001
" ;

<iJOd.V *

<?r>:i?-s

<forrr- anriorj-"" "6th->-i-"?>f:3-' ">

Fasscoάe 0:

Figure imgf000035_0002
typ«s" n):«:-:i: " :[;.arre""pa33co;}B...a"><b f >

Cvirrenr Passcoαe P.anλ: <inp-.it. type«"r.'?;χr "

Figure imgf000035_0003
<?php

- <:_JPGSΪ [ 'device^.d1 ] ;

Jϊϊe'fit — $ POST I ' oas seeds ci3£'£'*5πt. ' ; ;

SPascccde... uri-entRani - S..POST E 'pass ocde.. cur rent rank ID - 5..POSTt '«i9orith:r...id' j ;

y r FROK Device mϋo WfISRE

SDev.:.ce...JD' } " ) ; e c n o " 5B u^js & r " ;

Figure imgf000036_0001

(De ice....ID, Pasac;Gd<a...O, Pa33Coas...Ci3r rent , Pa33Coas...C-u rrentPsans., FK lg«rithn-;..JD) VAI"SS ( ' 5D*vice...rD ' ,

! 5Pa:s 3 ccd β* ,

Figure imgf000036_0002
' $Pa:53ccdemCurr6ntRank' ,

UPDATE Devi.c$ Xϊ'iio SET P^εsicoα*ϊ...0= ' Sf «ss£!CGd6...01 ,

.P-iι;:.ϊco-ie_C;jr rerjtp.srik- ' $Pa33Cc;de_Caj rrent.Ra.r.k ' , FK^igc.rithrr^ID- 1 ΪAigc;rithrrmID '

" } } { die (rrysqA merrcr f ) ) ; ! echo 'Overi dinc? dόta for exisfciftc? device . , , , " ;

} ™ nriy sql... query { " SSISCT * FPOM Devi o<5...I« f c KHSPE φevi ce...ID- ' $Device ..rD ' ) " ) ;

£ t f:™p_pa ;.~ .-s e.od-ϊ — my so lmre ;.~ u Ir. { ? rε

Figure imgf000036_0003
i t. r 0 , P a s s c.ode^C u r re n t } echo "Dat a for A Ke W Device 5Devi.cs__lD hss bsers ao;ded with c-j r rent p a β c c o ci e $ t e :T:p_p assc&ae . " ;

[00S2] Additionally, an exemplary code device for providing a web form for inputting patient-reiaied data (which could be further customized by one with ordinary skill in {he art to include additional patient, biographical data, treatment/medical data including certain treatment regimen data, the quantify of medicaments disposed within and housed by the dispensing device, dispensing device idenlif ϊcatiuα data and the like) can include;

Deader i *Ccτit<*:rc---::yϊ_ie; text/ht::^"i ;

< t i 11 s ^

≤fttt?i" data to enroll 0 ss'rf t re-At.Λ'.'snt i"e;/i;"srs for t:is Me die »5 ate svstss < / t i 1.1 θ ^

$teκ;!>-cJta_jϊ',.s'_._c.C!nnec!t (j ;

<iJOd.V *

(ϋεεet (6...PGST ?' submit ' j } } {

<forrr action-"" ;n&thod-"po3t ">

Pat is?nf._J.L> f ".eav» hi snk if Λftv? pat.ien1 <-:r,!-,'it t*. na^e-«patient_ld"xbr> i'ii'st ϊiaπ'a ; •cisifjut tγρe~"taxt" nas'≤- "firstmiiA.TA" ><);s Last Kaπiβ: < Ir;put tyρ<s- "tsjxt " r;-s;"e~"_«st...narae"><br> M«bi;.& Phoj-ie ; <input type-"tex':-" fsa;n«-":rob:π e...phone'' -<br> E:r;«ii Add ;:«««: <isip^ϊ ':ypsϊ-"t.&xt " Device ID

Figure imgf000037_0001
[Optional lP«s;t Fasscode; -'itsput typ«s"n!:«:-:i: " narr-.«!~ " p a « J; cc.-de ..p a 31 " > <h r. >

[Optional j Treatment Type: <inp«t type-"tsκt" na:T:e- "t rsat™er.t_type" ><b r >

Minimυ;n Iriterval {cc-.inutes) : <ir.put type~"tsxt" na:ϊ;t?-"mini~urnminvei:vόl'<><br>

Mazir.vjϊϊi Iπt srval (^i nut es) : <inp"ot. t.γpιs~"tsxt '' na~«a~ ''■r.-jιxi:::U.';:...i n . er v« i " > <br -^

vjjrt.™ " .-jijbTft.* t " r* ^"'S- " :'■ ubtci f " χ.'."; " u<s~ " 5' ubtr."l 1* ' '

<?php } e 1 s; <s

OPati^r»ϊ....II> - 3...POSi [ 'pa.iesst...id' j ;

$.l.a3tmNaxae ~ 5_PO5.'T [ ' .'. a^t^nar^^ ' j ; ?Mc.biie_Pnone ~ ?_POGT [ 'rr\obile_.ρhc;n& ' j ; $£:τ-3ii Ada re s s - S £OST s ' s~.a:. '.. addr^ss' i ; 5Davic*smID ~ :>mPOSX 1 ' ^vi-;em> } ; S P a s s c c ά s_j? A s t. — '■ mP O S T [ ' p a ;•" s c o d *s „ o a s t ' } ; OTreattcsns;...Tyρe ~ $...POST f ' tre«f:;ient...typ*ϊ ' 1 ;

Figure imgf000038_0001
~ ζδO* (0...POSTi
Figure imgf000038_0002
' ] ) ) ;
Figure imgf000038_0003
' 3 } } ; SSt:.:. LActive - TRl.'K;

$qικ:ry- "KhILSCT * VSOM D^vAce^^nro WKEKS { Devi ee_ID - ' 9Dev.i.cιe_.LVj' ! ";

SΪ s (SCΓJSΓV) / il

Figure imgf000038_0004
x'<33 -lit ) )

(ezit t

Figure imgf000038_0005
yet:,1

SSeϋult ^ :t;y3«I...query i" SELhICT - FROM ?atient...Tnf o JsHSFS ?ir3t...Narr;s-''^Firs;t...πa:^' AND L^s;t.J4a::^ - ' S La sst ...N-ame ' !1) ; if {

Figure imgf000038_0006
(5Rs?."5.3lt) ~~0} } J

™ y s CfI _q u e r y { " I N S E E T 'L R T 0 Patient _ϊ r; 1 o { ϊ' _, r s t _N s rr.e , L a s t _N a me , Mcbiie_Phorse, E:ΛaiImAddrscϊ:} VALvSS ( ' SFirϊ."t.Jϊa:::.*s ' , ' SLόst^N-aπ-e ' , ' 5Mobiie_Phone ' , ' $E;:.aiImAddreϊ;ϊ: ' } "} ;

Oo':Jcsxv ~ "SiSLSCT Pa'»:ic5π':- ID FPOM Patieπ':- Issfc KHSP.S ■3tmNaxf;e-1:?F;.r:st_Na^e' AND L.s;:t^a^e- - l SLaεt^fϊame"1;

0".VM~" {K-qM

Figure imgf000038_0007
, 0, "Pat..i.ent_::Vj" ! ; frchc "A Nev; Patient has b^en crsrated with IO ST'atiϊrϊit.Jf.r . " ;

{yirst_N«^e-'0.'-i.i'.3t_N3ir.e' AMD Last_J<ts-e = ' $L,ast_«a-;fi> ' ! ";

$Pati*snfcmIΪ,- ~ κycqimr*s:3vslt (Sresuit , 0, "Patient^ID") ;

'$F:'.1.5):...^«^= ' AHD La3i:...Na:;τιe-' $Las:t..n;s:;-e ' ) " ;

Figure imgf000038_0008
; echo "Tne psrient al-rea v nsd. a Patient_ID of $Pat ient_ID . Mobiis πujπbex and e^aii aααress nave been upd.at.sja.";

nofe'-Tiϊixe i ) ;

$query - "CPLATΪ Treatrrenrwlnrc SKT Gti';..':.Acιtive- 1O' κKER£ ' $Ds:Vicemir ' " ; (Squϋry) ; Sorύe∑y ~ "IIΪΞΪIRΪ INTO Trs-atπ-entmlnfc (FKmDsvicemI i"'Kmϊ-' βt lent 11 D , St.il 1 Act ivs , Mi r.i;T.vi:T;mI'fit s? rvai, Maxi;::;.iLT....I n Ie rv-ai , Treatccsn :; ...Type , Ti:i;e...N<jχ :; Acce a ε }

{ ' $Devi

Figure imgf000039_0001
' , te?:v.sl! , '$Jreatτf;ent...Typ«;' , '5now' ) ";

(:>q-jervi ;

Oq-jexy ™ "SSLSCT * FROK Tϊ««t:r&nt...l5if o

KSSRS {FK....P«ϊi^n::...TD-'$?it:ie!v:,..ID' AND FK...pev:: a.. Ih - ' $Dev:i ce...ID ' ^.ND St.:.llAci:::ve - ' i ' ) ";

$Tieat::τiBfit:...~D - rnv3ql...re« jit: f$ resu.: t , 0,

Figure imgf000039_0002
j ;

seho "Tne treat™sr;t information has beer, inserted with Treatment ID of $Ir*sat:r;entmID, " ;

! u ;

</bociy>

[<H>83] .Still referring to Fig.3, at step 306, the storage system < medical master

.system) can have customary procedures in the field of data processing configured k> pπxc-ss flie data (e.g., thai data including device and patient identification data, device sialus data, medical/treatment data, access authorization data, etc.) stored on the storage system . A variety of processing steps can occur, as will also be appreciated by one having ordinary skill in die an. .For example, the storage system can he used by someone wkh ordinary skill in ihe art to generate reports and oiupuf such reports at step 30X. which can be displayed. downloaded and/or printed by the operator. The reports can include a variety of information including information directed to when the paiient sought access to die dispensing device and presumably took a dosage of medicaments dispensed therefrom. These reports can be used by medical professionals to determine compliance with die treatment regimen and, thus, make decisions regarding {he prescribed treatment, as well as investigate any indicia of addiction, abuse, misuse and the like. [Θ0B4J Af step 308, alerts can also be ouipuffed (as previously discussed in conjunction with Fig. 2) to the patient, a caretaker, a medical professional and the like. These alerts can be of any type known to one having ordinary skill in the art. including, for example, alerts transmitted through phone calls, text messages, emails and audible and/or visual alarms on the dispensing device or via separate communication devices.

(#0853 Now referring to Fig, 4, which is an exemplary database schema, this figure illustrates the .structural aspects of an exemplary database that can be implemented on a server and form a storage system in accordance with at least one exemplary embodiment of the present invention. Fig. 4 has the following relational variables ("relvars"): Algorithm !. 402; Algorithms 404: Devieejnfo 406: TreatrnentJniO 408; Pat.iem.Jnfo 41.0; and Patient_$essions 412. As shown, each relvar has particular attributes where "PK" indicates that the attribute is a primary key and "FK" indicates that the attribute is a foreign key. The other attrihut.es are candidate keys, Note that this database structure is but one of many possible database structures thai one with ordinary skill in the art could conceive of for storing data related to the dispensing devices, patients, treatment regimens, device status, inferred information about the times and quantity uf medicament dispensing, etc.

[§§86] Referring to Fig. 5, a process tor enabling a medicament dispensing device to dispense a medicament in response to entering access authorization data is shown in accordance with at least one exemplary embodiment of the present invention. The dispensing device can house medicaments and provide access thereto in response to inputting a validated access authorization data. The dispensing device can be constructed so as to be secure when valid access authorization data has not been provided, preventing any sidestepping of the access authorization process. Thus, for example, the dispensing device may be securely sealed and tarnper-resistant, and can enable or deny access to the medicaments based on the access authorization data communicated to the drug dispensing device by the user. [Θ087J Notably, it is not necessary that the dispensing device be connected to a network at any time, ϊn particular, it dues not necessarily need to be networked with either the interfacing system or the storage system. The dispensing device can also independently compute and/or store current or subsequent access authorization data periodically and respond to enable or deny access based on current limited-use access authorization data being inputted. Thus, embodiments of the present invention such as IVR embodiments do not depend on a patient having Internet access, which may not be available to a patient for any of a variety of reasons,

[©088] Exemplary dispensing devices for use in conjunction with the process shown in Fig. 5 can include memory means such as various types of read only memory (''ROM") for storing instructions and data and processing means such as a central processing unit ("(TTf") for processing data. Also, the exemplary dispensing device can include input means such as a keypad, voice recognition system, touch screen, camera, wireless reader, and the like for inputting access authorization data, including all input mechanisms known to one having ordinary skill in the art. Moreover, exemplary dispensing devices can include means such as a display, playable audio files and the like for relaying information to an operator of the dispensing device, including ail output systems known to one having ordinary skill in the art, Exemplary dispensing devices can be designed that track the quantity of medicaments contained therein and the times at which the patient seeks access to those medicaments. The device can also implement logic that constrains access to the medicaments to a certain UmIl of use <e.g., no more than three doses within a 48 hour period). Exemplary devices can also display identifying data such as information reflecting medicament access times, either in an encoded format or in a format readable by a human.

[0089] Still referring to Fig, 5, at step 502, a patient U>r a person acting on behalf thereof} can input limited-use access authorization data such as a single-use passcodc, which may have been obtained from an authorizing system &\ described herein in conjunction w ith the process of Fig. 2. Once the access authorization data is inputted at step 502, ihe dispensing device can validate the access authorization data at .step 504. For example, the C TU can compare the access authorisation data inputted io a stored passcode and determine if the> match. If the inputted access authorization data does not match and. thus, is invalid/denied, then the dispensing dev ice can indicate such via the display (or by like means ) at step 506. For example, the dispensing

Figure imgf000042_0001
ice can display: "No Match"; "Invalid"; "Access Denied"; "Denied": and ihe hke.

[IMMH)] ϊf the inputted access authorization data does match and i.s there-fore validated. ihe CPI s can instruct the dispensing device io enable a dosage of a medicament to be dispensed at step 5OS. At siep 510, subsequent limited-use access authorization data such a\ ihe next single-use passcode can be computed based upon an algorithm or any random number generator known io one hav ing ordinary ?vk»li in the art,

[0091] A.s one non-limhing example, an algorithm can make use ni an initial live or

.seven digit number ihat is stored in an access number register such as memory forming part of a control mechanism such as a microcontroller. The first four digits of the five or seven digit number can be used as ihe initial siagle-use passcode to enable a medicament dispensing device. After which, the ine or seven digit number can be multiplied bv a random prime number that can also be stored in the access number register. The last seven or five numbers of the multiplication product can then Iv stored in ihe access auinber register. The f irst four digits of the multiplication product can be the next single-use passcode, As ΛUII be appreciated bv one hav ing skill in the ail, successive .single-use pa.sseodes can thus Ix* calculated ad injmintm. Such exemplary algorithms can produce seesninyh random stngle- use passcodes Table 1 K1Uw i.s a list oi seemingly random single-use passeodes used as the pa.sscodes for at least one exemplar) embodiment. Table 1 iteration 5-diqϊt product

1 23566

2 44334

3 33222

4 4621 1

5 22344

6 25446

7 32154

8 25442

9 51224

10 46165

11 32452

12 64352

13 55433

14 16325

15 34314

16 52254

17 24544

18 26152

19 43162

20 42153

21 13266

22 44422

- 4| - 23 26525

24 24151

25 56136

26 34531

27 61534

28 36212

29 36452

30 64562

31 55136

32 32364

33 34313

34 51145

35 13655

36 31561

37 22341

38 31311

39 34661

40 64413

41 63466

42 52454

43 61642

44 36226

45 26561

46 31231

47 42215 48 11634

49 14362

50 25565

[0092] Still referring to Pig. 5, at step 512, the access authorization data computed at step 510 such as the next, single-use passeode can be both stored in the memory of the dispensing device and stored in the storage system accessed by the interfacing server. Alternatively, an algorithm can be used Jo calculate and determine the next passcode, and the same algorithm should be used by both the interlacing server and the dispensing device to determine the next limited-use access authorization data. Also alternatively, both the device and the interfacing server can have access to separate but identical lists of valid access authorization data.

[0093] The limited-use access authorization data can be transmitted to a patient (or person acting on behalf thereof) by the interfacing system in conjunction with a storage system (medical master system). Importantly, the use of the same algorithm or same tables of access authorization data can allow independent calculation and storage of each limited- use access authorization data on both the dispensing device and the exemplary authorizing systcϊn of Fig, 2. Thus, it is not necessary that the dispensing device be networked with a storage system because it can have independent processing and storage capabilities for independently determining access authorization data.

[0094] In regard to access authorization data generation, particularly .single-use passcode generation in accordance with at lea,st one exemplary embodiment, single-use passcodcs can be set to change at any desired time, which may occur periodically and/or frequently. As stated above, at the dispensing device level, a microcontroller, as one non- limiting example, can prograrnmatieally change the passcode to follow a list of known passcodes, or in accordance with a random number generator such as an algorithm for such a purpose, In general, one with ordinary skill hi the art can conceive of a. variety of ways to implement a changing series of Hiniitjd-u.se access authorization data, and ensure that the same list of limited-use access authorization data can be simultaneously computable at both the drug dispensing device and at the interfacing server,

[0095] Alternative Iy j singularly or in conjunction;, the microcontroller can ensure that access authorization data is used for only a certain quantity of medicaments, or access to medicaments over a certain period of time, or a combination of quantity and time frame (e.g., a passcode unlocks the device until a user has dispensed medicaments three Lime or until twenty-four hours have passed, and thereafter the passcode expires). Also, the microcontroller can track the times al. which medicaments are accessed, store that information in memory, and consolidate that information into a status code which encodes information about the access history. It is possible to make this status code visible on a device display screen, for example in response to the pressing of certain keys on the key pad, and this device status data can be communicated as part of identifying data during the interaction between (he user and the interfacing server, such that device status data can be communicated to the interfacing server medical master system.

[§§96] In at least one exemplary embodiment in which the limit uf access is single use. the microcontroller can ensure that the access authorization data is used only once and is, thus, truly single-use. For example, the device can invalidate entered access authorization data after one use. Thus, multiple doses could not he dispensed over the designated period of time.

[0097] In ϊύ least one exemplary embodiment, the interfacing and storage systems can also be configured in parallel to the dispensing device (i.e. reproduce the process used by the dispensing device) so as to Ix1 able to provide the current and correct access authorization data, if available, when requested by a user (or person acting on behalf thereof.!. [0098.1 hi at least one exemplary embodiment, an access authorization data reset mechanism can be provided to address any situations where the dispensing device and authorizing system (i.e. interfacing and storage .systems) become out of sync or otherwise need reselling. The reset mechanism may function so as to reset the dispensing device to an initial or otherwise determinahle state where the access authorization data may be known or determined.

[0099] Also, in exemplary embodiments, two or more sets of access authorization data such as two or more single-use passeodes may be enabled or active during overlapping times. For example, if a first passcode is set to expire shortly after a patient contacts the authorizing system (e.g., a minute), then it may be desirable that the system provide the patient with a second passcode that is not set to expire until a later time (e.g., ten minutes) so that the patient has additional and/or sufficient time to access the needed dosage. As another example, the first passcode could enable access to at most three medicaments over the course of twelve hours, whereas an alternative passcode could enable access to at most four medicaments over the course of twenty-four hours. The interfacing server, in conjunction with the storage system, can follow an algorithm that enables that server to selectively communicate one or none of the valid pa.sscodes, depending on whether it is deemed medically advisable.

[00100] Figs, 6-8 generally show aspects and configurations for medicament dispensing devices in accordance with at least one exemplary embodiment of the present invention. Exemplary dispensing devices can dispense a dosage of medicaments without providing a patient with insecure access to all medicaments housed in the dispensing device. Dispensing devices can include control mechanisms that enable or disable dispensing activities, or, alternatively singularly or in conjunction, unlock or lock the dispensing devices. Λ varietv of such mechanisms are familiar to one with ordinary skill in the art. Further, exemplary embodiments may be capable of being connected to outside systems and sources, such as those that can be provided through the Internet via wired or wireless connections, although this is not a necessary feature in other exemplary embodiments as previously discussed.

[001011 Referring to Rg. 6. exemplary dispensing device 6(K) includes keypad 602 and display 604. Dispensing device 600 can also include CPU 608 that, is operafively connected to main memory 606 such as ROM and passcode storage memory 610. For example, passcode storage memory 610 can be in the form of IiFROM. Moreover, dispensing device 600 can include dispensing mechanism 612 for housing medicaments 614 where a medicament 614 can be dispensed by dispensing control mechanism 616 under the direction of CPU 608, In at least one exemplary embodiment. ROM 606 can primarily store instructions and data needed by CPU 608 for the operation, of display 604 and dispensing control mechanism 616 as well as for generally validating and computing access authorization data (e.g., the needed algorithm data). Passcode storage memory 61.0 can primarily be directed to storing passcode data needed by the CPU 608 fur validating inputted passcodes and computing subsequent passcodes,

[§§102] Referring to Figs, 7 and 8, another exemplary dispensing device is schematically depicted in accordance with at least one exemplary embodiment of the present invention, In Fig. 7, dispensing device 700 is in a locked/disengaged state where medicaments 702 can be securely housed in compartment 706 of housing 704. In at least one exemplary embodiment, the housing 704 of device 7(K) has a height of about.4,40 inches (vertical length as shown in Fig. 7} and a width of about 2,41 inches (horizontal length as shown in Fig. 7). In other embodiments, housing 704 can have any other suitable dimensions as will be appreciated by one having ordinary skill in the art. [00103] As shown, solenoid 708, which is in a de-energized state, can be operatively associated with lever 710. In turn, lever 7 U) can be operatively associated with dispensing wheel 712. A holding niche 714 tor capturing a dosage of medicaments 702 can. be defined in dispensing wheel 712, Spring 716 can. be attached to dispensing wheel 712 and be proximate lower boundary 718 of compartment 706.

[00104] Electronics package 720 can include control electronics including a processor

(e.g., a CPU) and memory means, a power source such as batteries, user interface electronics tor providing functionality to a user interface (e.g., a keypad / display) and the like known to one having ordinary skill in the art. The processor of electronics package 720 can be operatively connected to solenoid 708 tor energizing solenoid 708.

[00105] Upon validation of an access authorization data, a processor can energize solenoid 708 effectuating the engaged stale as shown in Hg. 8. The engaged (unlocked) slate is effectuated through solenoid 708 (powered by the processor) cooperating with lever 710 (hat, in turn, cooperates to unlock dispensing wheel 712 such (hat a patient can manually turn the wheel and dispense a dosage of medicaments 702.

[00106] For example, an exemplary code device for enabling a dispensing device to accept input of access authorization data, validate that data and provide a signal output to enable the dispensing device to provide access to medicaments, and thereafter require a new passcode to enable further access to medicaments can include the exemplary code device below:

X^diesS.* ie Prototype ?: (c.t MeaioaSsfs, ~"c;c.

Figure imgf000049_0001
•sf'iriclΛvd÷s "c[lcbai ,h'' //o'ioJ.iai setting-;:

#iftclυde <-;;vr/ infceϊϊ'jpt ,h> //inteϊϊ'jpt support. 1 ^1Sf ROM *'~incϊϋτvϊ ;w j tines (£oi

Figure imgf000050_0001

#: ncl -;de "t irierxS . h" //timei" library

^ i ΓΪ elude n rr^cii CΓJ β-T: iff? he Lp1^r . hn

/; ....v-- Function FictotypS';." ----v uO8 ch<3ck___code (vc-iαl ;

// ------ E!vi F;3(K5t:i«ϊi Prototype.; -- ---

#def:.;"ie CP£N..>'.SSSΛGS 2 faefir.e Ru''£T_KESGAGE 4

ines

/ , ....VJ-- tiODai. Va.iόOies ....,-.... uO6 g...r»«κ....key;

// 7 •• output, low (anode 2) // & - Ci3tp-ut, low (aϊiocis *) // ϊ, - output, ios imicάe 1} /./ 4 - ojϋput:, low (solenoid) // 3 - Input , p-sll.jp (εwi.tch €} // 2 -- input t puilyp (switch 2} // 1 -- input, puiiυp (switcn 1! C - input r pullup (switch 4) // DDRD: b?--0 -- ooooiiii - // PORID: JjV-O -- iiilpppp - OOOOIIii ■■ OxOF outh (DDRD, DzF0 ) ; <;-3>:b (POPTD, CxOF) ;

// r^DPC, PORTC:

././ 7 - input:, P'Ullup (no!

// 6 - λϊψ-ύrf p-jllup (nc)

// 1J -- input t puliyp (switch l)

// 4 - input, puiiυp. (svfitcn 'i\ ft 3 •• input,

Figure imgf000050_0002
(awitch &}

/ / 2 ■• mcjt, PuIi1Up (svfitc.1 J)

// 1 -- output, iϊign idiap o«:s)

// 0 " OJupiSt, LOW (αi3p is)

/ / DDPC * b''~0 — ^ ^ ^ Λ Λ -; ^, _ ooo^^^r^ 1^ — OxO > o\iV.hi DDP.'C, CxC.;); OUtfo(h:ORTC, 0S-.FZ) ;

// DORS, POSTS;

// ■"' •■ inpat, no pullup (xtai)

// S •• input, no pyllup (xt«i!

// S - <;j-:pjt:, low (o.i:φ olkj

// 4 - input, puiijp (no! 1 -- output, low (άisp sdi)

// 2 ■■ output f Lev (-inoie 6}

/' /' 1 -- output, ios {anode 3}

// C - ojϋput:, low {aiv>d<3 5>

GUtbfDDKS, Cx2F! ; ev;r.b{PORTB, 0x^.0} ;

"i£ϊLSϊϊr~ϊi:.t. {} ;

Λ'Jϊiie (66piO:i:....~3...X8ody () !~ 1} !

deIaym-s(i00) ;

Figure imgf000051_0001
; while ( ig_naxtmk«sy -- OzOO) I | {gmnestm>:ey ~~ Oxϊ'ϊ*} }

■1 :■ 3 p I a y _^.ε ε ε .s q e { E RROR^H?.' S 3 Α G .S ) ; } tv<rn_of f_3l I_anoαeε ( } ; delay_^f; {^.000} ;

J- O; -j*' j. -•:;; ;ι + + ) i dis;pi«.γ...::;κ;ssa9s (HS LlO..HS S SAGS) ;

// v---- Pr&gr-ft™ Variables --v---- uδo c-\irrent_code_di»it - 0; viOa pre?_sw_st?.te - C; υO8 ;;ctiv5m.'iey; "o 0 S A e γ_d o '.v rim r e ■? i s fc "5 Ϊ e d ;

Figure imgf000051_0002

// — v'~- Bssoiti .M.a.:.n Projiacr. Looj.' — v — while n.) f

yOo ciurrent...3B...slat« ~ ret^xn...s^it ch...states 0 ; if { icjϊϊK!tmcw__stite — — 0) ϋϋ (ρrevm3wmst όte ~~ O) ) {

} <slse ii ( (pr*sv...3w...3-ot« -- 0} -is.

Figure imgf000051_0003
; «08 i; fo~ { :.— 0; i< ζ; i-!-÷) { if icjrre;rιt_3>-/m3"rs"e & (OxO"; << i) ) { :5C!:i v «;...k<:: v ~ .1 ÷.". ;
Figure imgf000051_0004
Xey...dc»n...Iccr -\..c'c-u»"st — j.oo'p...ccur:t ; λnii if t t Up-'rev >-:at:« -- curreiv; «s* st,«t,&i *4
Figure imgf000051_0005
it' (
Figure imgf000052_0001
— — 0) ϋ {loop_';θL3fit ■■
Figure imgf000052_0002
) { if (active...key < 7) < entered ...code icun^ ■)■:... c«d«...d i.git j ™ a ct:! re ents?red...c:ode ■ current ___ocd<;:__.d:.git + i] "t e.lse ir f (active λev -- 7) && (current c;

~ ~ • '. ) *

J else if ((Active_Λey ~~ 7) ϋ {c.ui'_:ent_cocie_o;iτrii sstsifti ccd"5 ' c.jii'erjt corie diait] ~ 'b'; er.t^rsd^code [ cvjrr«sntmc.cdemdigit - i ] - 'u1; curr«rit...cods..oigit----; .■ el:se if i (act :.v<ϊ...X«y ~~ Sj && (&nter^d...c;od« fO ] !- aOS ch^ck^code^re-^-Jl" - check^code ( ) ; if {cιneβ'-c_cocift_.rftsru.':.t. —— 0) { c;urr-t;rir.__c.od.e__cii..γit. - G; j ei.se if i i rrict.jLve.m.'ζ.eγ —— o) ^^ {<sπf-eredmcc;ci& [^G j ^-

Key αcvixi

d.i sp i-?jy_st rin-? { enr ered_coae } ; - current _sv/_st«te;

Figure imgf000052_0003

pϋ03 *epro:::...by-:« - «&pro:r;...r':5ad...by t:«ζ0xC2) ; di.5pl«y...tru:rb*r {I , e^pr«;r;...byte} ; delay...rr;3 (.". ) ; {CxO3) ; ) ;

Figure imgf000052_0004
eeρro^:_byre - &&prorr_read_byts (0xQ4; ;
Figure imgf000052_0005
z"o,":...,oy c^ } ?

■i*siaymϊv.s (1) ;

«6prc-:i:....t>yt^ ~ eeprc:;"...read...by:;810 >; 0 J-- } ; di 3piay..;π-ϋ;"fcer { 4 , ^^pXcnX^bytel ;

Figure imgf000052_0006
{ CxOG) ; d:.;:play_n urc.be r ( 5, ssprorrubyts?) ;
Figure imgf000052_0007
«' '.. } ;
Figure imgf000052_0008
-• ••" u ') S c h e c k_c o >i«s f v o id) { **. fent
Figure imgf000053_0001
ζj «& i(::rste;re-i..ccdf? f 5 ] ~~ δ) } f for {λ^C; i<200; :.+•<■; f

fox (i^O; US; :!++) J

*"ϊ*iv" μ"^"ϊ" C5^i COG'S:1 I '" ! " T O T *

} return 0; w h i I e ( e e p r o rr;_:l 3 „ r s? r> o y ( ) ! ~ ."• } i

}

ύ*siaymrΛS ( S) ; υ 08 c VJ r r *s n tm c. c d e ~ se p r o ":„ r ■? a dmb v t s ( C x 0 Q ) ;

LiOS e<apro:n..oi"i"3«;'c ~ (6 * icurr«>n'c...ec:d«j-l ) } + 2; far <:>0; K1S; :1-Ϊ-Ϊ-) <

}

LiOS &eρro™_code__byte - eeρrorr;_i'ead_byts ( i + eeprorts cf rest 1 i.1 isjspro;τ:__.cc-de.._byt<3 ! - eiitercd..cod.<s [i] ) { return 1;

}

} far <:>0; K5C; i-i-÷) < } t υ r n__o f £ ma 11 ma ri c dec ( ) ; for {i~0; i<I00; i-i-i-j {

;v;vi^at8...so ;.eno:ld {) ; d&;. iy...:r;s (50) ;

Φsac;-: i <;at«...≤;olenoi d( } ; delav...rr;3 [5} ;

// for {i-0; i<255; i-i-i-j {

/ ' o;isplay_3trincf (&eprorr_τ.ode_bytsc) ; ror {i~0; i<€; i÷-O <

Figure imgf000053_0002
*fc ' ;

»

:. S (c:.ϊi"rent_cod!:: ~~ 1JC) i

<:: e p r o ΓΓ;_Λ' r :11 e mb y 16 ( 0 x 00 , .". ) ;

Figure imgf000053_0003
) ;

;<scαrii 0;

„ ^J „ Subroutines

# i f ride S MED.VCASI Ar'K...H£LP SR... H...

# i no 1 u ό €? " o'_ oba 1. ft "

JD3 g&t...s;wϊϊch...pϊ«ss ζvc id) ; uCS r<3':;.3xn...«w:.tc5i.....'Strtϊ<3.5 ( void) ; void 'ii-jpiay...string {uCS* strix;g...to....αi3piay > ;

void dispiay_r.«rr;foe_: {uiOS s&ven_seg_rvarr;ber, uO8 n«r rB= v o i '"i d i s o 1 a v _c h ■» r -a c t e r { ~o 0 S s Θ V e> rι_ce o'mr. ~o sis ΪΪ, 'j 0 ΪΓJ-ΛL -ΛC ;. t*sr uft' Oo.όcksd) vo i d c v c i Sm ri i s p 1 a v m c.1 c c k ( u 08 c _ o c k m c. v c.L&c) ; y«id turn...ρf f...all...afscd&≤; fvo:id) ; vo.-; d t;jrnmorim-iιrsoo;o (uO€ ancoe) ; void turn^of f^anooet^OS anode-} ;

Vwici act.i.vat

Figure imgf000054_0001
(vo.i.dj ; void deact ivate_.-so.l onoid (Vwici) ;

*1 AC ^ 1J c; e < r/ io , n c! , p. in n

#i ftcl υde < d ' > obai. / / c; i ob A _ s 1S 1.1 i xi a s

*i ttc 1 ud& " -'.or v P1

#ifsclud&

— v~ lϊfϊt vh_pro33 (void) t

OR ."^ V/

:at....s;wi,tcl scats ~

Figure imgf000054_0002
s ■s { 10 } ; ;orsα switc ^ -ate, 5 {)

(first swjtoh 3tatβ ~~ Si2>< ORd...3W

(first. W-; *.-:h — OxO,

Figure imgf000054_0003

. S {fir :51 3 w i t c h ε t .a t e ^^ OKO 3 fe'i t £h_ρ re ;:.ϊ

( f i r 3 v. a ): B s;vi.;.t.ch..]>:;e.5;j if { fi

Figure imgf000054_0004
;-5 wi t t?h_ρ re ;.- s if (first EKit s vrf 11 c. h_p r e s s

{ fiiαt...switch... state switch pie s s ( l'ii-εt...3is'i';.c;;j...atat& 3witon...presa if irst ...switch...stars -- 0x8 i'V^ -" t Ch D^^^^^ jp ∑s sc ;

Figure imgf000055_0001
uos -lata -=

.f (bit...is...cieόr (SW2...POΪ1T, SS2..PIN) ) data I- 0x02 .£ (bit is clear (SK2 FORT, GW3 FIKj } data I- 0x0<{

{ hi >: i « c Lear <3ϊ*f.. PORT, SN4...?~N} } I- 0x08 e«r(SK5...PORT, SWS..FIK) > data I=- OxIO

{b:'. ;.«« r{ S7A' δ... PORT, Si's ft..? T.N} } I- 0x20 fbit...is;...cieax-(Sw7...f ORT, GW7...FIN) > ci-Λta i~ {b:'.ϊ...i«...c;l««r{S7A'δ...PORT, SSS..PTJ!} } I rtvM αat;

Figure imgf000055_0002

// ----v Seven G«g::;ent Po.teriiϋ ~~y~~

■" / 0 K 90 i ,i:: τ 91 c

Figure imgf000055_0003
^π both " *'-h«;' *,

// 0>:?T, OxFF - b.1. ink

/.' ??, 0x40 - und«:r;:core uC8 nurftbs:r_s;egrr^nt3m3:i_b\jt_:.as;t [J 0; - [ft :.:■££, 0x28, CκCL, ft:-:f>D, 0x2B, Oz^"

Osϊ", 0x2", OxSF, Os&Fs ; uC8

Figure imgf000055_0004
33t [.1Oj - {0x77, 0x4i, Ox'S, 0x6Sf 0x4D, OxδE, Cx7S,

0x43, 0x7?, -izhF};

ΑάsύLue HELLO...K2SSA.GS i

st:αeii.ρ.<3 OFSH KSGGAGE 2

Adeline SPsPsOR MESSAGE 3

//uθδ helAo...3βg::τiBfit:j; [6] ~ i'Cx."..". , 0Λ54, 0X34, OXΛD, 0K:.:. [; uC8

Figure imgf000055_0005
[6] - |0HAB, 0XC7, QX'ZZ, OHCS, OXEE, OKOO}; uO8 oper._.3e^rtsente [ &j - {Qx££, OzSFr QxC7, QxAl, 0κ00r QxOOj; uCϊ errcr_ceoτrent.s [0] ~ (OxC'?, OxSI, OzSi, OxEl, 0x81, OzOOj;

vo:id cii.;play..;r&s:s:age (-jOς iTLej-;t;.;ig&...nvi:r:bev ) (

:. π {:r;e:5.;a9e...fsu^b&r == KSLIO.. MS3 SAGE) ξ

ir

Figure imgf000055_0006
=«=" OPEK_Mh:κSAGS) { shcw_ccreen (open_.3egmsr:ts} ; if {rαeas;agc...r!u::;b<sx -- SRROR..MESSAG2} i s h c Wm s c. Ϊ s? s? TJ I s r r o i „ s *s XTie at s ■ ; i^ (;:s33aqs ssu;τ-b6r ~~ FsSSET KSG GAGS) {

{uOS* st r:'. nσ_t.o_di spisy ! { unρackeci...oh«racter'5 E &i ; { i ^ 01 L < 6 } x "v "v } t if i«t:riΩg...to....α:i:φlay [ i : < 1.0} ξ display... £sis;^ber fi, 3ϊ.χi»g...t;c...di5:piay [1] } ; } eica if f st.rincjmto_aiϊ.play [ i ] -~ 'u' ) { if (i < 5} { di£jτjl«y...ch-aract'sr (i, 0z40} ; i € 1≤;& { diopLsy^character i i, 0x20} ;

! else Af <sr. ringmte_di3p:ay [ i ] -- 'b') ϊ

Figure imgf000056_0001
{ f a r i i ~ 0 ; i < 6 ; :14- 4- ) < dispi-ay_charactfi>r (i, pd-atήϋ]}; cieiaγ_^3 C) ;

i^ ^,0'Λ "" Xi*^ \ Display Pouting: Lc;vj-.'..ιsve.1 D^3plny Fc.xit i.ne.ϊ — v-

if (f;even_se-7mnurftbs:r ! =■ 5} dispi-ay_character (sevsn_seg_number , nα:ri?er...s;«:g."ient3...all...byt...i*εt E jiu;c.bssx...t c... display j } ;

» X ;5 « di 3p I a y ...ch-a r -Λ ct e x ( 3 ^ v& n..β <a g ...nu:;ύ>e x , nu::;b«M...3sc!rs«X;ts;....Ia;jt [n-sαi;8r...tG...dis;ρi.ay] } ;

Lspi-ay_character CuOS cever._.iseg_nυϊsfcsrr uO8

Figure imgf000056_0002

113 ~ Ti oi'έ si ,a xi c ds? s ( } ; D 1 S P _OE_P OP JaI (active-low DISP LS FOR1 U~ -..BV{π;rSF...LS...PLK) ; // de-a««ert i ^ ^ )

DI SF...SDl...PORT s" ...BV (Dl SF... SD .T ..PI^) ; i PiN) , c y c 1 e_a i s p i a y _c 1 o c k { 1 } ;

D^GP LE -ORT ^δ'v (DIS PmLEmf 2 N ! ; d^IayCO D 1 GP... LS... GRT ;<~ - ...Ev { DI SF...LS...F IH) ;

DISP OS... 'ORT &- mBV{Dl^P^mPIS; ; delay C_0); cy c.1 ;5...di .>play...c:Io<:k {2} ;

;:vcls d is; pi -a Y docki-iCS dock cvcl'ssj i fox Ii=O; i<clock...cyciet;; i+÷) {

- %4 -

Figure imgf000057_0001
; "i÷s 1 a v ( 10 ) ;

DI SP CLK PORT ;<~ -• BV(DISP CLK JIH) 1 d<51 a y i I U ) ;

1 . ~. ~. ^ ~ ~

Display Anode Control. Routine

AKOD F\ FORT d - BV(AHODSI FIN)

AKOD PORT -...BVΪAN0DS2...Piπ)

ANGD Fl3 PORT •..BV(AN0DF.3...?IN)

E4 PORT i ^^ v...BV(AM0D£4...Piπ)

ANGD PORT «^ •..BV(AN0DF.5...?IN)

ANOD PORT -^HV (ANODSC^PTKI)

cnmcnmarjoda (VJOB anode) { ϋ (-anode ^^ O) "ϊiODEl^PORT mBV(ANODH:lmPIN) ; X) AN0I>£4 POP." ..BV (AMODS4....P:Π) ,

AK0DS2 FORT ...BV(AH0DS2...PIN) ;

(aincde ^BV (ANODS ?^P JN) ; (anocis? 4) A5«DS3^PORT JSV!ANODH3___PIN) ;

(anode 51 «NODEf> PORT JiM (AtfODS6_PIN! ;

t-,;rn _a π sael \i Q 8 an o a e !

"HODEL...PORT "...Bv (AIJODEI ...F IN) ;

ANGUS 4..PORT -...EV{ΛN0DS4...Piπ) ; i. ■; (ano'i? ~~ 2)

Figure imgf000057_0002
...P ORT -...Ev{A?-J0DE2...f IH) ; it imicάe ~~ 3) ANODE 5...PORT -...BV f AHOD S ;>... P I ?\! ) ; if (anode — 4) ARODF.3...P0'RT --....BV { ANOL-S3...PIS5) ; if (aincde ANODS & PORT ~mB V ( AKOP S S\J? T N ) ;

Eric; Display Anccis Control Rouitinsβ

.// ----v is.sriCia Control Rovitiriec ----v y«id acti.vaϊe....;olefs«id (voi.α) f εθLSNOID...PORT I- ...EV ( SOLSKOID...F TK) ;

SOLϊ;tJOΪ.D_PORT Λ^ ~_JiV (^OLSKOIO_PIN) ; }

// ....■■-.... u;r!c; Solenoid Control. Roy torses ----■v----

[00107.1 In at least one other exemplary embodiment, an administrator such as a nurse can respond tn requests fur access authuiizaliun data from a patient (πr a person acting on behalf thereof). Λ patient may use a communicative intermediary Io contact the administrator. For example, it is eontemplated that the administrator can be a nurse employed by a call center for receiving requests for access authorization data. Also, a patient can place a phone eail that an administrator can receive, initiate a web-based corresfxrndenee

- *)*} - with an administrator, transmit a text message viewable by an administrator and the like fur requesting access authorization data. A patient can also correspond faee-to-faee with an administrator it" such an option is available.

[WlOS] in. such exemplary embodiments, ihe patient can provide identifying data to the administrator. Λs will be appreciated by one having ordinary skill in the art, access authorization, data can be authorized and/or determined through an administrator operating a computing device or be accomplished manually or a combination of the two. As one non- limiting example, the administrator can operate a computing device capable of authorizing identifying data and providing access authorization data. Alternatively, an administrator can view the medication regimen and a patient's access history and authorize additional access authentication data. As described above, the access1 authorization data can be used by a patient to access a dosage of medicaments from a dispensing device. Also, the access authorization can be limited-use access authorization data.

[Θ01OΦ] The administrator can communicate the access authorization data, if appropriate, to the patient via, for example, a communicative intermediary. Thus, an administrator may communicate the access authorization data over a telephone, through the internet, via a responsive text message and the like known to one having ordinary skill in the art.

[00110] The foregoing description and accompanying drawings illustrate the principles, preferred embodiments and modes of operation of the invention. However, the invention should not be construed as being limited to the particular embodiments discussed above. Additional variations of the embodiments discussed above will be appreciated by those skilled in the art.

PHH J J] Therefore, the above-described embodiments should be regarded as illustrative rather than restrictive. Accordingly, it should be appreciated that variations to those embodiments can be made b> those skilled in the art without deporting from the scope i if the πn emion as def incd

Figure imgf000059_0001
the follow in*, eianns.

Claims

CLAIMSWhat is claimed is:
1. Λ method of enabling medicament access for a user comprising: receiving identifying data iron's 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 dafa enables dispensing the medicaments up to a limit of use, and communicating the access authorisation data to the user,
2. The method of claim I 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,
3. The method uf claim 1 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,
4. The method of claim i wherein communication of the access authorization data occurs via a cotnmunicative 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.
5. The method of claim i 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-fo-faee conversation.
6. The method of claim ! wherein the limited-use access authorization data includes one of a passcode, a password, and a visual ticket.
7. The method of claim I. wherein the access authorization data no longer provides normal access to the medicaments after a certain limit of use. the limit being one ot a predetermined amount of usage, a predetermined period of time and a predetermined amount of usage during a predetermined amount of time,
8. The method of claim ! 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.
9. The method of claim I 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 Ix* 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 tiroes at which the user seeks access to medicaments, the effectiveness of the medicaments, issues related to medicament adherence, and issues related to health outcomes,
H), The method of claim ! 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 remotelv controlling the level of access that the user has to the medicaments.
1 1. The method of claim !. wherein data about dispensing, as derived from one of identifying data and siie 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,
12. The method of claim 1 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,
13. 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 inputing 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 giant 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,
.
14, The method of claim 13 wherein the access authorization data includes one of a passeode, a password, and a visual ticket,
15, The method of claim 1.3 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 amouπi of usage during a predetermined amount of time,
16. The method of claim 1.3 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.
.
17, The method of claim 13 further comprising the step of using data about when the user is seeking access to the medicaments \o generate an output intituling one of a report and an alert, whereby it. is possible to monitor overuse and underuse of the medicaments.
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18. The method of claim 13 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.
19. The method of claim 18 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 (TVR) system, one or more web servers on the Internet and a networked persona! computing device.
20. The method of claim 18 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.
21. The method of claim 18 wherein the communication of identifying data and limited- use access authorization data occurs via a communicative intermediary, the communicative intermediary being one ot a telephonic device, a computing device and a text-messaging device.
22. The method of claim 1 S further comprising the step of using data derived Iron) information including one of identifying data and the firaes when the user receives access authorization data Jo generate outputs including one of a report and an alert.
23. A method of providing access to medicaments comprising: using a dispensing device, said dispensing device having (he ability to provide access Jo 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, inputing 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 me access authorization data is acquired by the user of the dispensing device is indicative of a time of access to medicaments.
24. The method uf claim 23 wherein more than one access authorization data are valid at the dispensing device at any one {hue, each access authorization data has different limits of use, and the choice of which access authorization data to communicate Lo the user allows remotely controlling the level of access that the user has to the medicaments.
25. The method of claim 23 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.
26. The method of claim 25 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.
27. A system for access in 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 intermedial' v.
28. The system of claim 27 wherein the interfacing system includes a web server and the communicative intermediary includes a client computing device having web capabilities.
29. The system of claim 27 wherein ihe interfacing .system includes an interactive voice response ClVR) system and the communicative intermediary includes a telephonic device having telephone capabilities.
30. The system ot claim 27 wherein the access authorization data includes one of a passeode, a password and a visual ticket.
31. The system of claim 27 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.
32. The system of claim 27 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.
33. The system of claim 27 wherein the interfacing system k interfaced with a date storage system populated by a plurality of data including one of dispensing device entries, information about prescribed treatment and information about users.
34. The system of claim 27 wherein the interfacing system compiles data about when the user is or is not seeking access to the medicaments and generates fur interested persons an ouLput including one of reports and aierts, whereby it is possible to approximately monitor overuse and underuse of the medicaments.
35. The system of claim 27 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.
36. 'The system of claim 27 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.
37. The system of claim 27 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 information 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.
38. The method ^f claim 37 wherein the identifying data includes use 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.
39. The system ot claim 37 wherein data derived from at least one of identifying date and die 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,
40. 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.
41 . The system of claim 40 wherein the access authorization data includes one of a passeode, a password and a visual ticket.
42. The system of claim 40 wherein the access authorization data no longer provides access to the medicaments after a certain 1ira.il. of use, the limit including one of a predetermined amount of usage, a predetermined period of lime and a predetermined amount of usage during a predetermined amount of lime.
43. The system of claim 40 wherein more than one limited-use access authorization data are valid as. the dispensing device at any one time, each lim.is.ed-u.se 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.
44. The system of claim 40 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 persoaai communication device.
45. The system of claim 40 wherein valid identifying data is communicated by a user before valid limited-use access authori/.atiuu 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 syraptoras, device status, treatment status, jnedkaraent usage information.
46. The system of claim 45 w herein the identifying data includes one of device identification information identifying the dispensing device, identification information identitytng the prescribed treatment regimen, lrcalmenL information, information describing the patient, device inioπnation including a status code indicating the pattern of medicament dispensing, patient symptoms, patient activity. de\ ice activity , and medicament usage information.
47. The system oi claim 45 wherein data derived from one oi identifying daUi and the times w hen the user seeks access to the limited-use access authorization is used to generate an output including one oi a report and an alert,
48. Λ system for controlling access to medicaments comprising: a« interfacing system configured to interface with a communications intermediary, the interfacing s\ stem capable of receή ino identify ing, data from a usei via the Communications intermedial') ; tlie interfacing system containing an ev aluation unit capable of evaluating the reemed data to determine whether or not to provide access authorization data lor medicaments. the interfacing sj stem also containing a unit capable of computing acCfSs authorization data, said access authorization data being used to request access to medicaments up to a certain limit of use, and the mlerfaernμ system having tlie ability to communicate valid access authorization data to the user via the communications imermediarv.
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49. The system of claim 48 wherein the access authorization data includes one of a passcode, a password, and a visual ticket.
50. The system of claim 48 wherein the access authorization data no longer enables access to the medicaments after a certain 1ira.il. of use, the limit including one of a predetermined amount of usage, a predetermined period of lime and a predetermined amount of usage during a predetermined amount of time.
51. The .system of claim 48 wherein more than une access authorization data are valid at the dispensing device at any one time, each access authorization data has different limits of use, and the chuice 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,
52. The system of claim 48 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.
53. The system of claim 4S wherein the communications intermediary includes one of a telephonic device, a computing device and a text-messaging device.
54. The system of claim 48 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.
55. The system of claim 54 \\ herein the communications intermediary includes one of an interactive voice response UVR) system, one or more web servers on J he Internet, and a networked personal computing device communicates, the identifying data and the access authorization data to mά (rojn a user.
56 The system oi claim 54 wherein the identifying data includes one oi device identification information identifying the dispensing device, identification information idcatiiying the prescribed treatment regimen, treatment inf ormation, information describing the patient, device information including a status code indicating the pattern of medicament dispensing, patient symptoms, patient activity,
Figure imgf000073_0001
tee acm iij , and medicament usage information.
57. The system oi claim 54 further including a reporting unit such (hat data derived from one of identify ing data and the times when the user receives access authorization data K used to generate one of a report and an alert
58. A medicament provisioning system comprising; a dispensing device tor dispensing medicaments, the dispensing device including a monitoring unit capable ot tracking a time o! dispensing of medicaments and a quantity of medicaments dispensed. said dispensing device further including a locking uait such that the system can onl> 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 kicking unit to unlock when valid access authorization data is input, and further maintaining the device unlocked up in a certain limit of use associated by the computing unit with the valid access authorization data input, said dispensing deuce communicating information about dispensed medieamenus to the ctimputing unit, and the computing unit then signaling to the locking unit Jo lock the device against timber dispensing once tlie limit of use has been readied, and the s>sfeiu fun her including an interlacing s\ stent configured to interlace with a communications intermediary, the interfacing s> stent capable oi receiving kϊeniif\iog data from a user via the Communications intermediary: and the interlacing system including an evaluation unit capable of evaluating whether or not so Oi ant access so medicaments based on the identify ing data received. the interlacing system also including a unit capable of computing access authorization data, and capable of communicating \ aiid access authorization data So the user via said communications intermediary, whereby monitoring times of communication ol valid access authorization data to a user enables approximate tracking of the use of* the medicaments within the medicament dispenser by the user.
5*λ I'ht" s) stem of claim 58 wherein the identifying data includes one of device identif ication inf ormation identifying the dispensing device, identif ication 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 usaae information
60. A method of providing improved adherence to medication treatment regimens, comprising: using a medicament dispensing device having the ability to receive aecess authorization data, said dispensing deviee also having the ability to evaluate whether or not said access authorization data is valid; and imputing 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 deviee 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.
ήl . The method of claim 60 wherein data about when the user is or is not seeking access to (he medicaments is used to generate one of a report and an aieti, whereby it. is possible to monitor overuse and underuse of the medicaments.
62, The method of claim 60 wherein valid identifying data is provided by a user before valid access authorization dafa is provided Jo 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.
63. The method of claim 62 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 (JVR) system, one or more web servers on the Internet and a networked personal computing device.
64, The method of claim 62 wherein the identifying data includes one of device identification information identifying the dispensing device, identification information identifying {he prescribed treatment regimen, treatment ini.nrmai.ion, 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,
65. The method of claim 62 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,
6fi, The method of claim 62 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.
67, A medicament dispensing device coinprisi ng : 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.
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 Hm U of use includes one of a predetermined amount ot usage, a predetermined period of time and a predetermined amount of usage during a predet.ermi.ned amount of time.
7(1. The system of claim 67 wherein valid identifying data is communicated Hy a user before valid limited-use access authorization data i.s communicated l.o the user in return, whereby it. is possible ID 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.
71. The system of claim 70 wherein data derived from one of identifying data and the times when the user seeks access to the. limited-use access authurkatiun is used to generate. an output including one of a report and an alert.
72. 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 inpiα 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 1iin.it of use has been reached,
73. The. system of claim 72 wherein the access authorization data includes one of a passcode, a password and a visual ticket,
74. The system of claim 72 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.
75. The system of claim 72 wherein valid identifying data k 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. 76, The system of claim 75 w herein data derived ifom one of kiennf} tog data and the nines when the ikser seeks access u> ibe hnuted-itse access auihoπ/aiion is UMHI to generaie one of a repi)it and an alert.
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