WO2022092286A1 - Système de gestion, procédé de gestion, et programme informatique - Google Patents

Système de gestion, procédé de gestion, et programme informatique Download PDF

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Publication number
WO2022092286A1
WO2022092286A1 PCT/JP2021/040111 JP2021040111W WO2022092286A1 WO 2022092286 A1 WO2022092286 A1 WO 2022092286A1 JP 2021040111 W JP2021040111 W JP 2021040111W WO 2022092286 A1 WO2022092286 A1 WO 2022092286A1
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WIPO (PCT)
Prior art keywords
information
drug
user
clinical trial
unit
Prior art date
Application number
PCT/JP2021/040111
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English (en)
Japanese (ja)
Inventor
洋 久保田
玲奈 宮崎
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藤森工業株式会社
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Publication of WO2022092286A1 publication Critical patent/WO2022092286A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06K—GRAPHICAL DATA READING; PRESENTATION OF DATA; RECORD CARRIERS; HANDLING RECORD CARRIERS
    • G06K19/00—Record carriers for use with machines and with at least a part designed to carry digital markings
    • G06K19/06—Record carriers for use with machines and with at least a part designed to carry digital markings characterised by the kind of the digital marking, e.g. shape, nature, code
    • G06K19/067—Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components
    • G06K19/07—Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components with integrated circuit chips
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06K—GRAPHICAL DATA READING; PRESENTATION OF DATA; RECORD CARRIERS; HANDLING RECORD CARRIERS
    • G06K19/00—Record carriers for use with machines and with at least a part designed to carry digital markings
    • G06K19/06—Record carriers for use with machines and with at least a part designed to carry digital markings characterised by the kind of the digital marking, e.g. shape, nature, code
    • G06K19/067—Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components
    • G06K19/07—Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components with integrated circuit chips
    • G06K19/077—Constructional details, e.g. mounting of circuits in the carrier
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/40—ICT specially adapted for the handling or processing of medical references relating to drugs, e.g. their side effects or intended usage

Definitions

  • the present invention relates to a technique for managing information about a drug.
  • This application claims priority based on Japanese Patent Application No. 2020-182638 filed in Japan on October 30, 2020, the contents of which are incorporated herein by reference.
  • One aspect of the present invention is a user identification information indicating a user of a clinical trial, a drug identification information indicating a drug subject to a clinical trial passed to the user, and a wireless tag provided in a drug package containing the drug.
  • a management assistance unit that records the tag identification information in association with each other, and a radio provided in the drug package containing the drug taken when the opening information indicating that the drug has been taken by the user is acquired.
  • a management system including a recording unit that records the tag identification information of the tag and the information indicating the timing at which the opening information is obtained in association with each other.
  • the recording unit can also adopt a configuration in which the biometric information of the user is further associated and recorded.
  • the recording unit may adopt a configuration in which the administrator identification information, which is the identification information indicating the administrator of the clinical trial, is further associated and recorded.
  • the present invention provides a management system including a notification unit for notifying the administrator of the clinical trial or the user of the abnormality so that information indicating the abnormality is output.
  • one aspect of the present invention includes user identification information indicating a user of a clinical trial, drug identification information indicating a drug subject to a clinical trial passed to the user, and a radio provided in a drug package containing the drug. It is provided in a management assist step for recording the tag identification information of the tag in association with each other, and for the drug packaging containing the drug taken when the opening information indicating that the drug has been taken by the user is acquired.
  • a management method including a recording step of recording the tag identification information of the wireless tag and the information indicating the timing at which the opening information is obtained in association with each other.
  • the present invention provides a management method including a notification step for notifying the administrator of the clinical trial or the user of the abnormality so that information indicating the abnormality is output.
  • one aspect of the present invention provides a computer program for operating a computer as the above-mentioned management system.
  • FIG. 1 is a schematic block diagram showing a system configuration of the management system 100 of the present invention.
  • the management system 100 is a system for appropriately managing the medication status of a person (user) who takes a drug to be investigated (hereinafter referred to as "investigative drug") for a clinical trial.
  • the management system 100 includes an information acquisition device 20, an administrator terminal 30, a medication system 2, and a clinical trial information management device 80.
  • the plurality of devices in the management system 1 are communicably connected via the network 90.
  • the network 90 may be a network using wireless communication or a network using wired communication.
  • the network 90 may be configured by combining a plurality of networks.
  • the information acquisition device 20 is provided in the filling facility 1.
  • the filling facility 1 is a facility for filling the drug package with the investigational drug.
  • the filling facility 1 is provided with a filling facility 10.
  • the filling facility 10 is a device for filling the drug package with the investigational drug.
  • the drug packaging contains a wireless tag that stores information about the investigational drug to be filled.
  • the information acquisition device 20 records information (hereinafter referred to as “drug packaging information”) regarding the investigational drug filled in the drug package in the filling facility 10.
  • the drug packaging information includes, for example, identification information of the wireless tag and information indicating the type of the drug packed in the drug package having the wireless tag.
  • the information acquisition device 20 transmits drug packaging information to the clinical trial information management device 80 via the network 90.
  • the administrator terminal 30 is a terminal device operated by a person who manages a clinical trial by a user (hereinafter referred to as "administrator").
  • the administrator terminal 30 communicates with other devices (for example, the monitoring terminal 40 and the clinical trial information management device 80) via the network 90.
  • the medication system 2 is a system for acquiring information on the user's medication.
  • the medication system 2 includes a monitoring terminal 40, a communication device 50, a drug package 60, and a biosensor 70.
  • the monitoring terminal 40 acquires and records information regarding the user's medication (hereinafter referred to as "medication information").
  • the monitoring terminal 40 transmits medication information to the clinical trial information management device 80 via the network 90. At this time, the monitoring terminal 40 may be connected to the network 90 via the communication device 50 included in the medication system 2.
  • the drug package 60 is a drug package filled with the investigational drug in the filling facility 1.
  • the monitoring terminal 40 acquires information on the investigational drug packed in the drug package 60 by communicating with the wireless tag included in the drug package 60.
  • the biosensor 70 is a sensor used by the user.
  • the biosensor 70 acquires the biometric information of the user.
  • the monitoring terminal 40 acquires the user's biometric information by communicating with the biosensor 70.
  • the clinical trial information management device 80 is a device that manages information related to a clinical trial conducted by one or a plurality of users.
  • the clinical trial information management device 80 receives drug packaging information from the information acquisition device 20 of the filling facility 1.
  • the clinical trial information management device 80 receives the medication information acquired by the monitoring terminal 40 of the medication system 2.
  • the clinical trial information management device 80 records the drug packaging information and the medication information received in this way.
  • the clinical trial information management device 80 determines whether or not an abnormality has occurred in the user's medication. When it is determined that an abnormality has occurred, the clinical trial information management device 80 transmits information regarding the abnormality to devices such as the administrator terminal 30 and the monitoring terminal 40.
  • FIG. 2 is a schematic block diagram showing a specific example of the functional configuration of the information acquisition device 20.
  • the information acquisition device 20 is configured by using an information device such as a smartphone, a tablet, a personal computer, a PLC (Programmable Logic Controller), or a dedicated device.
  • the information acquisition device 20 includes a wireless communication unit 21, a communication unit 22, a storage unit 23, and a control unit 24.
  • the wireless communication unit 21 wirelessly communicates with the wireless tag provided in the drug package in which the investigational drug is filled in the filling facility 10.
  • the wireless communication unit 21 receives the information recorded in the wireless tag by wirelessly communicating with the wireless tag.
  • the communication unit 22 is a communication device.
  • the communication unit 22 may be configured as, for example, a network interface.
  • the communication unit 22 performs data communication with another device via the network 90 according to the control of the control unit 24.
  • the communication unit 22 may be a device that performs wireless communication or a device that performs wired communication.
  • the storage unit 23 is configured by using a storage device such as a magnetic hard disk device or a semiconductor storage device.
  • the storage unit 23 stores the information acquired by the control unit 24.
  • the storage unit 23 may store, for example, drug packaging information.
  • the control unit 24 is configured by using a processor such as a CPU (Central Processing Unit) and a memory.
  • the control unit 24 functions as a reading unit 241, an information recording unit 242, and an information notification unit 243 by executing a program by the processor. All or part of each function of the control unit 24 may be realized by using hardware such as ASIC (Application Specific Integrated Circuit), PLD (Programmable Logic Device), and FPGA (Field Programmable Gate Array).
  • the above program may be recorded on a computer-readable recording medium.
  • Computer-readable recording media include, for example, flexible disks, magneto-optical disks, ROMs, CD-ROMs, portable media such as semiconductor storage devices (for example, SSD: Solid State Drive), hard disks and semiconductor storage built into computer systems. It is a storage device such as a device.
  • the above program may be transmitted over a telecommunication line.
  • the reading unit 241 reads information from the wireless tag by wireless communication by controlling the wireless communication unit 21.
  • the wireless tag may be configured by using, for example, an RFID (Radio Frequency IDentification) tag.
  • the reading unit 241 outputs the read information to the information recording unit 242.
  • the information recording unit 242 generates drug packaging information including information read from the wireless tag by the reading unit 241.
  • the information recording unit 242 records the generated drug packaging information in the storage unit 23.
  • the drug packaging information may be information including, for example, tag identification information recorded on a wireless tag, drug identification information indicating a drug to be packed in a drug package provided with the wireless tag.
  • the drug identification information may be input to the information acquisition device 20 by, for example, an operator in the filling facility 10, may be input to the information acquisition device 20 by communication from the filling facility 10, or may be input to the information acquisition device 20 by communication in another embodiment. It may be input to 20.
  • the drug packaging information includes information indicating the date and time of filling, information indicating the filling facility 10, information indicating the date and time when the drug packaging is shipped, and the shipping destination (or delivery destination) of the drug packaging. ) May be included in any one or more of the information.
  • the information transmission unit 243 transmits the drug packaging information to the clinical trial information management device 80 at a predetermined timing.
  • the drug packaging information to be transmitted may be the drug packaging information recorded in the storage unit 23, or may be the drug packaging information output from the information recording unit 242 to the information transmission unit 243.
  • FIG. 3 is a schematic block diagram showing a specific example of the functional configuration of the administrator terminal 30.
  • the administrator terminal 30 is configured by using information devices such as smartphones, tablets, personal computers, and dedicated devices.
  • the administrator terminal 30 includes a wireless communication unit 31, a communication unit 32, an input unit 33, an output unit 34, a storage unit 35, and a control unit 36.
  • the wireless communication unit 31 wirelessly communicates with the wireless tag provided in the drug package in which the investigational drug is filled in the filling facility 10.
  • the wireless communication unit 31 receives the information recorded in the wireless tag by wirelessly communicating with the wireless tag.
  • the communication unit 32 is a communication device.
  • the communication unit 32 may be configured as, for example, a network interface.
  • the communication unit 32 communicates data with another device via the network 90 under the control of the control unit 36.
  • the communication unit 32 may be a device that performs wireless communication or may be a device that performs wired communication.
  • the input unit 33 is configured by using an existing input device such as a keyboard, a pointing device (mouse, tablet, etc.), a button, and a touch panel.
  • the input unit 33 is operated by the administrator when inputting the administrator's instruction to the administrator terminal 30.
  • the input unit 33 may be an interface for connecting the input device to the administrator terminal 30. In this case, the input unit 33 inputs the input signal generated in response to the input of the administrator in the input device to the administrator terminal 30.
  • the input unit 33 may be configured by using a microphone and a voice recognition device. In this case, the input unit 33 voice-recognizes the wording spoken by the administrator, and inputs the character string information of the recognition result to the administrator terminal 30.
  • the input unit 33 may be configured in any way as long as the administrator's instructions can be input to the administrator terminal 30.
  • the output unit 34 may be configured by using an image display device such as a liquid crystal display or an organic EL (Electro Luminescence) display.
  • the output unit 34 may be an interface for connecting the image display device to the administrator terminal 30. In this case, the output unit 34 generates a video signal for displaying the image data, and outputs the video signal to the image display device connected to the output unit 34.
  • the output unit 34 may be configured by using an audio output device such as a speaker.
  • the output unit 34 may be configured in any way as long as it can output information to the administrator.
  • the storage unit 35 is configured by using a storage device such as a magnetic hard disk device or a semiconductor storage device.
  • the storage unit 35 stores the information acquired by the control unit 36.
  • the storage unit 35 may store, for example, management assistance information.
  • the control unit 36 is configured by using a processor such as a CPU and a memory.
  • the control unit 36 functions as a read unit 361 and a management auxiliary unit 362 when the processor executes a program.
  • all or a part of each function of the control unit 36 may be realized by using hardware such as ASIC, PLD and FPGA.
  • the above program may be recorded on a computer-readable recording medium.
  • Computer-readable recording media include, for example, flexible disks, magneto-optical disks, ROMs, CD-ROMs, portable media such as semiconductor storage devices (for example, SSD: Solid State Drive), hard disks and semiconductor storage built into computer systems. It is a storage device such as a device.
  • the above program may be transmitted over a telecommunication line.
  • the reading unit 361 reads information from the wireless tag by wireless communication by controlling the wireless communication unit 31.
  • the wireless tag may be configured using, for example, an RFID tag.
  • the reading unit 361 outputs the read information to the management auxiliary unit 362.
  • the management auxiliary unit 362 generates management auxiliary information including the information read from the wireless tag by the reading unit 361.
  • the management assistance unit 362 records the generated management assistance information in the storage unit 35.
  • the management auxiliary information may be information including, for example, tag identification information recorded on a wireless tag, and user identification information indicating a user to whom the drug package provided with the wireless tag is delivered.
  • the user identification information may be input to the administrator terminal 30 by, for example, the administrator operating the input unit 33, or the administrator terminal may be communicated from a device possessed by the user (for example, a monitoring terminal 40 or a biological sensor 70). It may be input to 30 or may be input to the administrator terminal 30 in other embodiments.
  • the management assistance information includes drug identification information indicating the drug in the drug package passed to the user, information indicating the date and time when the drug package was delivered to the user, and information passed to the user.
  • One or more of the clinical trial identification information indicating the clinical trial using the drug packaging and the identification information indicating the administrator who manages the clinical trial regarding the drug packaging given to the user (hereinafter referred to as "administrator identification information"). It may be included.
  • the administrator when the administrator gives a drug to a user for conducting a clinical trial, the administrator inputs user identification information, the date and time of delivery, and information indicating the method of taking the drug (timing and number of doses). It may be input to the administrator terminal 30 by operating the unit 33.
  • the management assisting unit 362 may further associate the input information with the tag identification information of the wireless tag acquired by the reading unit 361 via the wireless communication unit 31 and record it in the storage unit 35. ..
  • the management assistance unit 362 may output information for assisting the management of the clinical trial to the output unit 34 based on the information received from the clinical trial information management device 80. For example, when a notification indicating an abnormality is received from the clinical trial information management device 80, the management assistance unit 362 may output information indicating the content of the abnormality to the administrator via the output unit 34.
  • FIG. 4 is a schematic block diagram showing a specific example of the functional configuration of the monitoring terminal 40.
  • the monitoring terminal 40 is configured by using information devices such as smartphones, tablets, personal computers, game devices, and dedicated devices.
  • the monitoring terminal 40 includes a wireless communication unit 41, a communication unit 42, an input unit 43, an output unit 44, a storage unit 45, and a control unit 46.
  • the wireless communication unit 41 wirelessly communicates with the wireless tag provided in the drug package in which the investigational drug is filled in the filling facility 10.
  • the wireless communication unit 41 receives the information recorded in the wireless tag by wirelessly communicating with the wireless tag.
  • the communication unit 42 is a communication device.
  • the communication unit 42 may be configured as, for example, a network interface.
  • the communication unit 42 communicates with other devices according to the control of the control unit 46.
  • the communication unit 42 may perform data communication with another device via, for example, the network 90.
  • the communication unit 42 may go through the communication device 50 in the medication system 2.
  • the communication unit 42 may communicate with the communication device 50 by wireless communication such as WiFi (registered trademark), or may communicate with the communication device 50 by wired communication such as a wired LAN (Local Area Network). ..
  • the input unit 43 is configured by using an existing input device such as a keyboard, a pointing device (mouse, tablet, etc.), a button, and a touch panel.
  • the input unit 43 is operated by the user when inputting the user's instruction to the monitoring terminal 40.
  • the input unit 43 may be an interface for connecting the input device to the monitoring terminal 40. In this case, the input unit 43 inputs the input signal generated in response to the user's input in the input device to the monitoring terminal 40.
  • the input unit 43 may be configured by using a microphone and a voice recognition device. In this case, the input unit 43 voice-recognizes the wording spoken by the user and inputs the character string information of the recognition result to the monitoring terminal 40.
  • the input unit 43 may be configured in any way as long as the user's instruction can be input to the monitoring terminal 40.
  • the input unit 43 does not necessarily have to be operated by the user himself, and may be operated by another person.
  • the output unit 44 may be configured by using an image display device such as a liquid crystal display or an organic EL display.
  • the output unit 44 may be an interface for connecting the image display device to the monitoring terminal 40. In this case, the output unit 44 generates a video signal for displaying the image data, and outputs the video signal to the image display device connected to the output unit 44.
  • the output unit 44 may be configured by using an audio output device such as a speaker.
  • the output unit 44 may be configured in any way as long as it can output information to the user.
  • the storage unit 45 is configured by using a storage device such as a magnetic hard disk device or a semiconductor storage device.
  • the storage unit 45 stores the information acquired by the control unit 46.
  • the storage unit 45 may store medication information, for example.
  • the control unit 46 is configured by using a processor such as a CPU and a memory.
  • the control unit 46 functions as a read unit 461, a recording unit 462, and a notification unit 463 by executing a program by the processor.
  • all or a part of each function of the control unit 46 may be realized by using hardware such as ASIC, PLD and FPGA.
  • the above program may be recorded on a computer-readable recording medium.
  • Computer-readable recording media include, for example, flexible disks, magneto-optical disks, ROMs, CD-ROMs, portable media such as semiconductor storage devices (for example, SSD: Solid State Drive), hard disks and semiconductor storage built into computer systems. It is a storage device such as a device.
  • the above program may be transmitted over a telecommunication line.
  • the reading unit 461 reads the tag identification information from the wireless tag by wireless communication by controlling the wireless communication unit 41.
  • the wireless tag may be configured using, for example, an RFID tag.
  • the reading unit 461 outputs the read information to the recording unit 462. Further, the reading unit 461 may acquire information indicating that the drug has been taken out from the drug package 60 (hereinafter referred to as “opening information”) in response to wireless communication with the wireless tag of the drug package 60.
  • the reading unit 461 receives, for example, a detection result (opening information) indicating that the drug has been taken out from the wireless tag of the drug package 60 provided with a processor capable of detecting that the drug has been taken out by the user. May be good.
  • the reading unit 461 may detect that the drug has been taken out from the drug package 60, for example, in response to a change in communication that occurs in response to the drug being taken out by the user. More specifically, the antenna of the drug package 60 may be configured so that a part of the shape changes when the drug is taken out. In this case, the attributes such as the frequency of the radio signal change in the communication before and after the drug is taken out. The reading unit 461 may determine whether or not the drug has been taken out based on the change in the attribute of the radio signal, and may acquire the opening information.
  • the recording unit 462 generates medication information including the information read from the wireless tag by the reading unit 461.
  • the recording unit 462 records the generated medication information in the storage unit 45.
  • the medication information may be, for example, information including tag identification information recorded on the wireless tag and information indicating the date and time when the user took out the drug packed in the drug package 60 provided with the wireless tag. ..
  • the dosage information may be generated based on, for example, the opening information acquired by the reading unit 461. That is, the dosing information may be generated using the date and time when the opening information was obtained in the reading unit 461.
  • the dosage information may be input to the monitoring terminal 40, for example, by the user operating the input unit 33. Dosing information may be input to the monitoring terminal 40 by other embodiments.
  • the medication information may further include the biometric information of the user.
  • the biometric information may be, for example, information acquired by the biometric sensor 70.
  • the recording unit 462 may receive the biometric information transmitted from the biosensor 70 via the communication unit 42.
  • the recording unit 462 acquires biometric information at the timing when the user takes out the drug filled in the drug package 60, and records the biometric information in association with the dosing information including the tag identification information recorded in the wireless tag. You may.
  • the notification unit 463 transmits the medication information to the clinical trial information management device 80 at a predetermined timing.
  • the medication information to be transmitted may be medication information recorded in the storage unit 45, or may be medication information output from the recording unit 462 to the notification unit 463.
  • the radio tag may be contained in the drug package 60 in any manner.
  • a configuration in which the configuration of the wireless tag is sandwiched between the sheet of the drug package 60 and the lid may be adopted.
  • the circuit of the wireless tag may be formed on the sheet itself of the drug package 60.
  • the circuit of the wireless tag may be formed on the lid of the drug package 60 itself.
  • the mode of accommodating the wireless tag in the drug package 60 is not limited to the above-mentioned specific example.
  • the biosensor 70 is a sensor that acquires the biometric information of the user.
  • the biological sensor 70 acquires information such as a user's heart rate, body temperature, blood pressure, and amount of exercise.
  • the biosensor 70 transmits the acquired biometric information to the monitoring terminal 40.
  • FIG. 5 is a schematic block diagram showing a specific example of the functional configuration of the clinical trial information management device 80.
  • the clinical trial information management device 80 is configured by using information devices such as a personal computer, a server device, and a dedicated device.
  • the clinical trial information management device 80 includes a communication unit 81, a storage unit 82, and a control unit 83.
  • the communication unit 81 is a communication device.
  • the communication unit 81 may be configured as, for example, a network interface.
  • the communication unit 81 communicates with other devices according to the control of the control unit 83.
  • the communication unit 81 may perform data communication with another device via, for example, the network 90.
  • the communication unit 81 may be a device that performs wireless communication or may be a device that performs wired communication.
  • the storage unit 82 is configured by using a storage device such as a magnetic hard disk device or a semiconductor storage device.
  • the storage unit 82 stores the information acquired by the control unit 83.
  • the storage unit 82 may store, for example, clinical trial management information.
  • the control unit 83 is configured by using a processor such as a CPU and a memory.
  • the control unit 83 functions as an information acquisition unit 831, an abnormality determination unit 832, and a notification unit 833 when the processor executes a program.
  • all or a part of each function of the control unit 83 may be realized by using hardware such as ASIC, PLD and FPGA.
  • the above program may be recorded on a computer-readable recording medium.
  • Computer-readable recording media include, for example, flexible disks, magneto-optical disks, ROMs, CD-ROMs, portable media such as semiconductor storage devices (for example, SSD: Solid State Drive), hard disks and semiconductor storage built into computer systems. It is a storage device such as a device.
  • the above program may be transmitted over a telecommunication line.
  • the information acquisition unit 831 generates clinical trial management information by receiving information from other devices.
  • the clinical trial management information includes information necessary for clinical trials of the drug packed in the drug package 60.
  • the clinical trial management information is, for example, drug identification information indicating the type of drug being studied, user identification information indicating a user being tested, and identification information indicating an individual drug taken by the user (for example,).
  • the tag identification information of the wireless tag included in the drug package 60) and medication information are included.
  • the information acquisition unit 831 may receive drug packaging information from, for example, the information acquisition device 20. In this case, the information acquisition unit 831 may store the information included in the drug packaging information as a part of the clinical trial management information.
  • the information acquisition unit 831 may receive management assistance information from the administrator terminal 30, for example.
  • the information acquisition unit 831 may receive information included in the management assistance information (for example, administrator identification information) as a part of the clinical trial management information.
  • the information acquisition unit 831 may receive medication information from, for example, the monitoring terminal 40.
  • the information acquisition unit 831 may store the information included in the medication information as a part of the clinical trial management information.
  • the abnormality determination unit 832 performs abnormality determination processing based on the information acquired by the information acquisition unit 831. In the abnormality determination process, the abnormality determination unit 832 determines whether or not an abnormality has occurred in the behavior of the user in the clinical trial. The abnormality determination unit 832 records the result of the abnormality determination process in the storage unit 82.
  • the abnormality determination unit 832 may determine that an abnormality has occurred, for example, when information indicating that the user has taken the drug is not received at a predetermined timing.
  • the predetermined timing may be, for example, a preset date and time or time as an absolute standard, or may be a time or period since the user's previous dose as a relative standard. Such a determination may be made based on, for example, medication information.
  • the abnormality determination unit 832 may determine that an abnormality has occurred when the user has not taken a predetermined correct type of drug when taking the drug.
  • Information indicating which user should take which medicine may be set by, for example, the administrator terminal 30. Such information may be obtained, for example, by receiving the information transmitted from the administrator terminal 30 by the information acquisition unit 831. Further, the information indicating the type of the medicine taken by the user may be performed based on the tag identification information of the wireless tag included in the medicine taking information. Further, based on the drug packaging information, the tag identification information of the wireless tag and the type of the drug (drug identification information) packed in the drug package 60 having the wireless tag may be determined.
  • the abnormality determination unit 832 may determine that an abnormality has occurred when the user has not taken a predetermined correct number of medicines when taking the medicine.
  • Information indicating which user should take which medicine and how many medicines may be set by, for example, the administrator terminal 30. Such information may be obtained, for example, by receiving the information transmitted from the administrator terminal 30 by the information acquisition unit 831. Further, the information indicating the number of medicines taken by the user may be performed based on the tag identification information of the wireless tag included in the medicine taking information, the number of times the medicine taking information is received, and the like.
  • the abnormality determination unit 832 may determine that an abnormality has occurred when it is presumed that the user's physical condition is defective.
  • the criteria for estimating a user's illness may be set as a criteria common to multiple users, for example, or may be set according to the attributes of individual users (history, gender, age, etc.). good. Such estimation may be determined based on, for example, biometric information acquired by the biosensor 70.
  • the notification unit 833 transmits the result of the abnormality determination process to the administrator terminal 30.
  • the notification unit 833 transmits information indicating the occurrence of the abnormality to the administrator terminal 30.
  • the information indicating the occurrence of the abnormality may include user identification information of the user in which the abnormality has occurred and information indicating the content of the abnormality.
  • the notification unit 833 may transmit information indicating the occurrence of the abnormality or information instructing the resolution of the abnormality to the monitoring terminal 40.
  • the information instructing to resolve the abnormality may be registered in the storage unit 82 in advance in association with the content of the abnormality.
  • the information instructing the resolution of the abnormality may be, for example, information indicating that a predetermined type of drug should be taken immediately, or information instructing to consult with an administrator or a doctor. ..
  • Each terminal (administrator terminal 30 and monitoring terminal 40) that has received the above-mentioned notification from the notification unit 833 outputs a part or all of the notified information.
  • FIG. 6 is a sequence chart showing a specific example of the operation flow when the drug packaging 60 is shipped among the operation flows of the management system 100.
  • the information acquisition device 20 reads out the tag identification information from the wireless tag of the drug package filled with the drug (step S103).
  • the information acquisition device 20 records the drug packaging information including the read tag identification information (step S104).
  • the information acquisition device 20 acquires the shipping destination information to which the drug packaging to be processed is shipped, and records the information in association with the drug packaging information (step S105).
  • the information acquisition device 20 transmits the drug packaging information including the shipping destination information to the clinical trial information management device 80 (step S106).
  • the clinical trial information management device 80 When the clinical trial information management device 80 acquires drug packaging information from the information acquisition device 20 (step S107), the clinical trial information management device 80 records the acquired drug packaging information (step S108). By recording the drug packaging information, the clinical trial information management device 80 can record the correspondence between the tag identification information and the drug identification information. Further, the clinical trial information management device 80 can record the correspondence between the tag identification information and the shipping destination information by recording the drug packaging information.
  • FIG. 7 is a sequence chart showing a specific example of the operation flow of the management system 100 when the drug packaging 60 is passed from the administrator to the user of the clinical trial.
  • the administrator terminal 30 acquires the clinical trial identification information (step S201).
  • the clinical trial identification information may be input by, for example, the administrator operating the input unit 33 of the administrator terminal 30, or may be input to the administrator terminal 30 using an information input device such as a bar code reader (not shown). You may. In this case, for example, clinical trial identification information such as a barcode generated in advance for a clinical trial may be read out by the administrator terminal 30. Further, the clinical trial identification information may be issued from the clinical trial information management device 80 to the administrator terminal 30. Further, the clinical trial identification information may be generated in the administrator terminal 30 according to a predetermined rule according to the operation of the administrator.
  • the administrator terminal 30 acquires the user identification information (step S202).
  • the user identification information may be input by, for example, the administrator operating the input unit 33 of the administrator terminal 30, or may be input to the administrator terminal 30 by using an information input device such as a bar code reader (not shown). You may.
  • user identification information such as a barcode generated in advance for a clinical trial may be read out by the administrator terminal 30.
  • the user identification information may be issued from the clinical trial information management device 80 to the administrator terminal 30.
  • the user identification information may be generated in the administrator terminal 30 according to a predetermined rule according to the operation of the administrator.
  • identification information for example, SIM number, wireless tag identification information, identification information possessed by the installed clinical trial application recorded in advance on a mobile terminal or the like possessed by the user is used as user identification information. May be good.
  • the administrator terminal 30 reads the tag identification information from the wireless tag of the drug package given to the user (step S203).
  • the administrator terminal 30 generates management assistance information by associating the read tag identification information with the acquired clinical trial identification information and user identification information.
  • the administrator terminal 30 records the generated management assistance information (step S204). Then, the administrator terminal 30 transmits the management assistance information to the clinical trial information management device 80 (step S205).
  • the clinical trial information management device 80 acquires management assistance information from the administrator terminal 30 (step S206)
  • the clinical trial information management device 80 records the acquired management assistance information (step S207).
  • the clinical trial information management device 80 can record the correspondence between the tag identification information, the clinical trial identification information, the administrator identification information, and the user identification information. Therefore, it is possible to manage the history of the route taken by the drug used in the clinical trial to reach the user.
  • FIG. 8 is a sequence chart showing a specific example of the operation flow when the drug is taken out from the drug packaging 60 in the operation flow of the management system 100.
  • the monitoring terminal 40 does not perform any particular process until the opening information is acquired (step S301-NO).
  • the monitoring terminal 40 acquires the opening information (step S301-YES)
  • the monitoring terminal 40 acquires the output (biological information) of the biological sensor 70 at that time (step S302).
  • the monitoring terminal 40 generates medication information including the acquired biometric information, information indicating the date and time when the opening information was obtained, and tag identification information.
  • the monitoring terminal 40 records the generated medication information (step S303). Then, the monitoring terminal 40 transmits the medication information to the clinical trial information management device 80 (step S304).
  • the clinical trial information management device 80 When the clinical trial information management device 80 acquires medication information from the monitoring terminal 40 (step S305), the clinical trial information management device 80 records the acquired medication information (step S306). By recording the medication information, the clinical trial information management device 80 records the correspondence between the tag identification information, the information indicating the date and time when the drug was taken out by the user (information indicating the date and time when the drug was taken), and the biometric information of the user. Can be recorded.
  • FIG. 9 is a sequence chart showing a specific example of the operation flow when the occurrence of an abnormality is determined in the clinical trial information management device 80 among the operation flows of the management system 100.
  • the clinical trial information management device 80 waits for processing related to the abnormality until it is determined that the abnormality has occurred (step S401-NO).
  • step S401-YES information indicating that an abnormality has occurred in association with the user identification information of the user determined to have an abnormality.
  • Abnormal information is recorded (step S402).
  • the clinical trial information management device 80 transmits information indicating that an abnormality has occurred to the administrator terminal 30 (step S403).
  • the administrator terminal 30 When the administrator terminal 30 acquires abnormality information from the clinical trial information management device 80 (step S404), the administrator terminal 30 outputs the acquired abnormality information (step S405). This output allows the administrator to recognize that something is wrong with the user.
  • the administrator terminal 30 transmits abnormality information to the monitoring terminal 40 of the user who is determined to have an abnormality (step S406).
  • the monitoring terminal 40 When the monitoring terminal 40 acquires the abnormality information from the administrator terminal 30 (step S407), the monitoring terminal 40 outputs the acquired abnormality information (step S408). This output allows the user to recognize that something is wrong with them.
  • the management system 100 configured in this way, it becomes possible to more easily realize appropriate management in clinical trials. Specifically, it is as follows.
  • Information regarding the drug used in the clinical trial when it is passed from the administrator to the user for example, user identification information, drug identification information, and wireless tag identification information
  • information indicating the date and time when the user took the drug for example.
  • Tag identification information and date and time information are recorded respectively.
  • the recording may be performed on the monitoring terminal 40 and the administrator terminal 30, respectively, or may be performed on the clinical trial information management device 80. By making such a record, it becomes possible to easily perform various analyzes related to the clinical trial based on the recorded information.
  • information related to shipping information when the administrator gives it to the user, information indicating the date and time when the drug was taken by the user, the type of drug, and the amount thereof are information on the clinical trial information management device. Recorded at 80. Therefore, various analyzes related to the clinical trial can be easily performed based on the information recorded in the clinical trial management device 80 as needed.
  • the date and time when the drug was taken and the type of drug are recorded in the clinical trial management device 80, so that such information can be easily recorded.
  • a user of a clinical trial had to keep a record of taking the investigational drug by means such as a diary or a telephone, but such trouble can be reduced.
  • the clinical trial management device 80 may be configured by using a plurality of information processing devices.
  • the clinical trial management device 80 may be mounted with distributed functions in a plurality of information processing devices connected so as to be communicable via a network.
  • the abnormality determination unit 832 of the clinical trial management device 80 may be mounted on another device.
  • the abnormality determination unit 832 may be mounted on the administrator terminal 30 or the monitoring terminal 40.
  • the medication information generated by the monitoring terminal 40 may be transmitted to the clinical trial management device 80 via the administrator terminal 30.
  • the anomaly information generated by the clinical trial management device 80 may be transmitted directly to the monitoring terminal 40 instead of via the administrator terminal 30.

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  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Theoretical Computer Science (AREA)
  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Microelectronics & Electronic Packaging (AREA)
  • Computer Hardware Design (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Primary Health Care (AREA)
  • Epidemiology (AREA)
  • Toxicology (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Treatment And Welfare Office Work (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un système de gestion comprenant : une unité auxiliaire de gestion qui associe et enregistre des informations d'identification d'utilisateur indiquant un utilisateur dans un essai clinique, des informations d'identification de médicament indiquant un médicament testé dans l'essai clinique qui est administré à l'utilisateur, et des informations d'identification d'étiquette pour une étiquette sans fil appliquée à un emballage de médicament qui contient le médicament ; et une unité d'enregistrement qui, lorsqu'une information d'ouverture qui indique que le médicament a été pris par l'utilisateur est acquise, associe et enregistre les informations d'identification d'étiquette pour l'étiquette sans fil appliquée à l'emballage de médicament qui contient le médicament pris, et des informations indiquant l'instant auquel les informations d'ouverture ont été obtenues.
PCT/JP2021/040111 2020-10-30 2021-10-29 Système de gestion, procédé de gestion, et programme informatique WO2022092286A1 (fr)

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JP2007190140A (ja) * 2006-01-18 2007-08-02 Liti R & D:Kk 薬剤収納装置
WO2008117544A1 (fr) * 2007-03-28 2008-10-02 Nec Corporation Dispositif de gestion d'objet conditionné, appareil de fabrication de dispositif de gestion d'objet conditionné, procédé de fabrication de dispositif de gestion d'objet conditionné, et procédé de gestion d'objet conditionné
JP2009245255A (ja) * 2008-03-31 2009-10-22 Fujitsu Ltd 服用実績管理システム、情報処理装置及びコンピュータプログラム
JP2015018407A (ja) * 2013-07-11 2015-01-29 株式会社 日立産業制御ソリューションズ 治験支援装置、治験支援方法、治験支援プログラム及び携帯端末装置
JP2019013518A (ja) * 2017-07-07 2019-01-31 凸版印刷株式会社 薬剤利用管理システム、薬剤利用管理方法、および薬剤利用管理プログラム

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Publication number Priority date Publication date Assignee Title
JP3119049U (ja) * 2005-10-27 2006-02-16 古野電気株式会社 投薬監視システムおよび投薬監視装置
JP2007330677A (ja) * 2006-06-19 2007-12-27 Nikon Corp メモリ内蔵薬剤

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007175263A (ja) * 2005-12-28 2007-07-12 Vantec Liti Systems:Kk 試験薬服用情報収集器
JP2007190140A (ja) * 2006-01-18 2007-08-02 Liti R & D:Kk 薬剤収納装置
WO2008117544A1 (fr) * 2007-03-28 2008-10-02 Nec Corporation Dispositif de gestion d'objet conditionné, appareil de fabrication de dispositif de gestion d'objet conditionné, procédé de fabrication de dispositif de gestion d'objet conditionné, et procédé de gestion d'objet conditionné
JP2009245255A (ja) * 2008-03-31 2009-10-22 Fujitsu Ltd 服用実績管理システム、情報処理装置及びコンピュータプログラム
JP2015018407A (ja) * 2013-07-11 2015-01-29 株式会社 日立産業制御ソリューションズ 治験支援装置、治験支援方法、治験支援プログラム及び携帯端末装置
JP2019013518A (ja) * 2017-07-07 2019-01-31 凸版印刷株式会社 薬剤利用管理システム、薬剤利用管理方法、および薬剤利用管理プログラム

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