JP2018185636A - Adverse event management system and adverse event management program - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an adverse event management system and an adverse event management program capable of easily managing an adverse event grade of a patient according to a specific criterion.SOLUTION: An adverse event management system 10 acquires an adverse event grade by each patient's date according to a specific criterion in which a classification index of the adverse event grade is defined, makes an individual area A 133 corresponding to each combination of the date and a grade type of the adverse event displayed in a matrix manner, and makes the adverse event grade of the patient on each date displayed in the individual area A 133 corresponding to the grade.SELECTED DRAWING: Figure 9

Description

  The present invention relates to an adverse event management system and an adverse event management program capable of managing an adverse event of a patient.

  In general, a system capable of managing test results of various tests performed on a patient is known (see, for example, Patent Document 1). More specifically, in this type of system, the result of the inspection may be displayed as a graph in time series.

Japanese Patent Laid-Open No. 2015-069446

  By the way, a medical worker such as a pharmacist determines the grade of an adverse event for a patient taking a prescribed drug or a patient who has been administered a drug according to a regimen. Judgments may be made based on specific criteria such as Adverse Events).

  An object of the present invention is to provide an adverse event management system and an adverse event management program capable of easily managing the grade of an adverse event of a patient according to a specific standard.

  An adverse event management system according to the present invention includes an acquisition processing unit for acquiring a grade of an adverse event for each patient date according to a specific criterion in which a classification index of an adverse event grade is defined, the date and the adverse event A display processing unit for displaying individual areas corresponding to each combination with the grade type of the patient in a matrix and displaying the grade of the adverse event of the patient on each date in the individual area corresponding to the grade. Prepare.

  The adverse event management program according to the present invention includes obtaining an adverse event grade for each patient date according to a specific standard for which an adverse event grade classification index is defined, and the date and the adverse event grade. Causing the processor to display the individual areas corresponding to each combination with the type of the patient in a matrix and displaying the grade of the adverse event of the patient on each of the dates in the individual area corresponding to the grade. Adverse event management program for

  According to the present invention, an adverse event management system and an adverse event management program capable of easily managing the grade of an adverse event of a patient according to a specific standard are provided.

FIG. 1 is a block diagram showing a configuration of an adverse event management system according to an embodiment of the present invention. FIG. 2 is a diagram illustrating an example of an adverse event master used in the adverse event management system according to the embodiment of the present invention. FIG. 3 is a diagram showing an example of drug history data used in the adverse event management system according to the embodiment of the present invention. FIG. 4 is a diagram showing an example of regimen history data used in the adverse event management system according to the embodiment of the present invention. FIG. 5 is a diagram showing an example of test data used in the adverse event management system according to the embodiment of the present invention. FIG. 6 is a diagram showing an example of adverse event data used in the adverse event management system according to the embodiment of the present invention. FIG. 7 is a flowchart showing an example of an adverse event management process executed by the adverse event management system according to the embodiment of the present invention. FIG. 8 is an example of a display screen displayed by the adverse event management system according to the embodiment of the present invention. FIG. 9 is an example of a display screen displayed by the adverse event management system according to the embodiment of the present invention. FIG. 10 is a diagram illustrating an example of an adverse event master used in the adverse event management system according to the embodiment of the present invention. FIG. 11 is an example of a display screen displayed by the adverse event management system according to the embodiment of the present invention.

  Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings for understanding of the present invention. In addition, the following embodiment is an example which actualized this invention, Comprising: The thing of the character which limits the technical scope of this invention is not.

[Adverse event management system 10]
As shown in FIG. 1, an adverse event management system 10 according to an embodiment of the present invention includes a server 1, a client terminal 2, a printer 3, and the like. The server 1, the client terminal 2, and the printer 3 are connected via a communication network 4 so that they can communicate wirelessly or by wire. The communication network 4 is a LAN, a WAN, the Internet, an intranet, or the like. Further, a host system 5 is connected to the server 1 through the communication network 4.

  The host system 5 is, for example, an electronic medical record system, an ordering system, or a reception system. The host system 5 inputs into the server 1 prescription data related to prescription of medicines for patients, test data related to test results of various tests performed on patients, patient data indicating personal information of patients, and the like. The server 1 may be configured to actively read the prescription data, the examination data, the patient data, and the like from the host system 5. The prescription data includes preparation data in which a drug such as an anticancer drug is administered according to a preset therapy (regimen).

  For example, the prescription data includes patient information (patient ID, patient name, height, weight, body surface area, etc.), prescription date, preparation date, medication date, drug information (drug code, drug name, etc.), dose and usage, Includes therapy information. The therapy information includes therapy identification information that can identify therapy information such as a therapy name (regimen name), a therapy ID, or a therapy ID. In addition, the prescription data includes doctor information, types of drug containers (such as ampoules with drug solutions, vials with drug solutions, vials with powder drugs, or infusion bags), preparation content information (drug containers, syringes used for mixed injection work, Information such as type and number of injection needles) and preparation procedure information (work contents, dissolved drug, solvent, dissolved drug volume, solvent volume, sampling volume), medication date, prescription classification, clinical department, ward, etc. May be.

[Printer 3]
The printer 3 is a color printer or monochrome printer capable of executing a printing process for recording information included in print data input from the server 1 or the client terminal 2 via the communication network 4 on a sheet such as paper. This is an image forming apparatus. For example, in a medical institution such as a hospital or a pharmacy, a prescription based on the prescription data may be printed by the printer 3. The printer 3 may be used for printing information similar to a management screen P1 (see FIGS. 8 and 9) described later in the adverse event management system 10.

[Server 1]
The server 1 is a computer including a control unit 11, a storage unit 12, a communication I / F 13, a display device 14, an operation device 15, a drive device 16, and the like. The server 1 may be provided outside a medical institution such as a hospital or a pharmacy where the adverse event management system 10 is used. The server 1 may be an information processing apparatus such as a smartphone, a tablet terminal, or a laptop computer.

  The control unit 11 includes control devices such as a CPU, a ROM, a RAM, and an EEPROM (registered trademark). The CPU is a processor that executes various arithmetic processes. The ROM is a non-volatile storage unit in which information such as a control program for causing the CPU to execute various processes is stored in advance. The RAM is a volatile storage unit, and the EEPROM is a non-volatile storage unit. The RAM and the EEPROM are used as a temporary storage memory (working area) for various processes executed by the CPU. And the said control part 11 performs various processes according to the various control programs previously stored in the said ROM, the said EEPROM, or the said memory | storage part 12 using the said CPU.

  The storage unit 12 is a non-volatile storage unit such as a hard disk or an SSD that stores various control programs and various data executed by the control unit 11. The storage unit 12 includes a program storage unit 121, a master storage unit 122, and an information storage unit 123.

  The program storage unit 121 is a storage area for storing an adverse event management program for causing the control unit 11 to execute an after-mentioned adverse event management process (see FIG. 7). The program storage unit 121 also stores a program such as an operating system (OS).

  The master storage unit 122 is a storage area in which various types of master information such as a medicine master, a patient master, a clinical department master, a pharmacist master, a regimen master, and an adverse event master D1 are stored. For example, the chemical master includes a chemical code (YJ code, etc.), a chemical name, a JAN code, an RSS code, a vial code, a dosage form, a unit, a specific gravity, a chemical type, a composition change, and an excipient for various chemicals. , Information such as notes. The patient master includes information such as a patient name, patient ID, sex, age, alcohol consumption, smoking presence, and disease name for each patient. The medical department master includes information on various medical departments of a medical institution where the adverse event management system 10 is used.

  FIG. 2 is a diagram showing an example of the adverse event master D1. The data structure of the adverse event master D1 is not limited to that described here. For example, the adverse event master D1 may be stored in the master storage unit 1222 in a state in which the adverse event master D1 is divided and associated with a plurality of masters.

  As shown in FIG. 2, in the adverse event master D1, information such as an event ID, an event name, an examination ID, a grade condition, a numerical flag, a changeable flag, a related event, and a symptom type are stored in association with each other. . The event ID is identification information for identifying a preset adverse event, and the event name is information indicating the name of each adverse event. The examination ID is identification information for identifying an examination item used for determining the grade of the corresponding adverse event. The symptom type is information indicating whether the adverse event is an objective symptom or a subjective symptom. Here, the subjective symptom is a symptom that can be found by the patient, and the objective symptom is an objective symptom that can be found according to the result of a test performed on the patient.

  The grade condition is a classification index for classifying the grade of the adverse event according to a predetermined standard. Specifically, in the present embodiment, the specific criterion is an adverse event common term criterion (CTCAE: Common Termination Criteria for Adverse Events) in which a classification index of the adverse event grade is defined. The criteria registered in the adverse event master D1 are not limited to the original text defined in the adverse event common term criteria. For example, the control unit 11 can determine the grade based on the adverse event common term criteria. It may be a standard after being edited.

  In the present embodiment, the grade of the adverse event grade is determined in five stages from “0” to “4”, and is information indicating that the higher the numerical value, the more severe the symptom. The CTCAE also defines the grade “5”, but since the necessity for the grade “5” is low, the adverse event management system 1 according to the present embodiment does not use the grade “5”. And

  In the grade condition, a numerical range used as an index when each grade is determined numerically can be registered. For example, the control unit 11 may automatically extract and register a range corresponding to each grade from the criteria indicated in the CTCAE. Further, as described later, the control unit 11 may be able to register a range corresponding to each grade in the adverse event master D1 in accordance with a user operation on the master registration screen P2 (see FIG. 11). The changeability flag is information indicating whether or not the grade can be arbitrarily changed according to a user operation when the grade is automatically set by the control unit 11. When the numerical flag is “0”, the control unit 11 sets all the change enable / disable flags corresponding to each grade to “1 (possible)”.

  The numerical flag is information indicating whether or not at least a part of the grade of the adverse event can be determined according to a numerical value such as a test value or an arbitrarily input state value. For example, the control unit 11 sets the numerical flag to “1 (possible)” when a numerical value is input as range information in the grade condition. In addition, the control unit 11 can set the numerical flag according to a user operation. The related event is one or more for identifying one or a plurality of adverse events registered in advance as information to be displayed alongside or in the vicinity of the adverse event when the adverse event is displayed. Information including the event ID.

  For example, in the adverse event master D1, regarding “decrease in the number of platelets” that is an objective symptom among the adverse events, the adverse event of the patient is determined according to the test value of the test whose test ID is “0123455”. Grades can be classified, and in the grade conditions, the range of the inspection value corresponding to each grade is defined as a classification index. Specifically, grade “0” is “inspection value ≧ 158,000”, grade “1” is “158,000> inspection value ≧ 75,000”, and grade “2” is “75,000> inspection. Value ≧ 50,000 ”, grade“ 3 ”is“ 50,000> inspection value ≧ 25,000 ”, and grade“ 4 ”is“ 25,000> inspection value ”. The control unit 11 can arbitrarily change the range of test values set as grade conditions for each grade in the adverse event master D1 in accordance with a user operation. In addition, the range of the test value corresponding to each grade is set in advance for each gender of the patient, for example, and the control unit 11 determines the range of the test value used for the determination of the grade according to the gender of the patient. It is also possible to change.

  Further, in the adverse event master D1, the “fever” that is a subjective symptom among the adverse events is a grade of the patient regarding the adverse event according to a state value (for example, body temperature) indicating a state of the patient's fever. Classification is possible, and the body temperature corresponding to each grade is defined as a classification index in the grade conditions. On the other hand, in the adverse event master D1, regarding the numbness of the limbs that is a similar subjective symptom among the adverse events, the grade of the adverse event of the patient cannot be classified according to the numerical value. In the conditions, the severity of symptoms related to numbness of limbs corresponding to each grade is defined as a classification index.

  The regimen master includes therapy information indicating the contents of various regimens determined in advance. Specifically, the therapy information includes information related to the administration plan such as the name of the drug administered based on the therapy, the dose (per body surface area), the administration time, the administration date, and the length of one course. In addition, when the prescription data is generated in the host system 5, therapy identification information such as a therapy name for identifying the therapy information is given to the prescription data together with information such as medicine corresponding to the therapy.

  The control unit 11 can update various master information stored in the master storage unit as needed based on information acquired from the host system 5. In addition, the control unit 11 can edit various master information according to a user operation using the server 1 or the client terminal 2.

  The information storage unit 123 is a storage area in which various information such as the prescription data, drug history data D11, regimen history data D12, examination data D13, and adverse event data D14 are stored. The control unit 11 acquires the prescription data from the host system 5 and accumulates and stores it in the information storage unit 123.

  The drug history data D11 is information indicating a prescription history of the medicine for each patient, and the regimen history data D12 is information indicating a medication history of the medicine according to each patient's therapy. The control unit 11 updates the drug history data D11 and the regimen history data D12 based on the prescription data, for example. FIG. 3 is a diagram showing an example of the drug history data D11, and FIG. 4 is a diagram showing an example of the regimen history data D12.

  The drug history data D11 shown in FIG. 3 includes patient ID (patient identification information), patient name (patient identification information), prescription date, drug name (drug identification information), ward, usage / dose, medical department, Includes information such as physicians. Further, the control unit 11 may be able to arbitrarily update the drug history data D11 according to a user operation of the server 1 or the client terminal 2.

  The regimen history data D12 shown in FIG. 4 includes patient ID (patient identification information), patient name (patient identification information), administration date, therapy name (therapy identification information), ward, cool information, planning department, Includes information such as planners. Further, the control unit 11 may arbitrarily update the regimen history data D12 according to a user operation of the server 1 or the client terminal 2.

  The test data D13 is information including test results such as test values for each test item performed for each patient. FIG. 5 is a diagram showing an example of the inspection data D13. The examination data D13 shown in FIG. 5 includes patient ID (patient identification information), patient name (patient identification information), examination date, examination ID (examination identification information), examination item (examination identification information), examination Includes information such as results. The control unit 11 is based on patient examination data acquired from the host system 5 or patient examination data read from a recording medium such as a USB memory or a CD inserted into the server 1 or the client terminal 2. The inspection data D13 is updated.

  The adverse event data D14 is information indicating data of adverse events such as subjective symptoms and objective symptoms for each patient. FIG. 6 is a diagram showing an example of the adverse event data D14. The adverse event data D14 shown in FIG. 6 includes patient ID (patient identification information), patient name (patient identification information), date, adverse event ID (adverse event identification information), and event name (adverse event identification information). ), Including grade information. The control unit 11 is configured to obtain the adverse event data based on patient examination data acquired from the host system 5 or information on a patient's subjective symptoms arbitrarily input to the server 1 or the client terminal 2. D14 is updated. The control unit 11 can also update the adverse event data D14 in response to a user operation on a management screen P1 (see FIGS. 8 and 9) described later.

  The communication I / F 13 is a network card that performs data communication between the client terminal 2 and an external device such as the printer 3 via the communication network 4 in a wireless or wired manner according to a predetermined communication protocol. And the like.

  The display device 14 is a display unit such as a liquid crystal display or an organic EL display that displays various types of information in accordance with control instructions from the control unit 11. The operation device 15 is an operation unit operated by a user in order to input various kinds of information to the server 1. Specifically, the operation device 15 includes a keyboard and a mouse (pointing device) that accept input operations on various operation screens displayed on the display device 14. The operation device 15 may include a touch panel that accepts touch operations on various operation screens displayed on the display device 14 or a voice input device that accepts input of various information by voice recognition.

  The drive device 16 can read the adverse event management program from a computer-readable recording medium 161 in which the adverse event management program is recorded non-temporarily. The recording medium 161 is a CD, DVD, BD, or USB memory, and the drive device 16 is a CD drive, DVD drive, BD drive, USB port, or the like. In the server 1, the adverse event management program read from the recording medium 161 using the drive device 16 is installed in the program storage unit 121 of the storage unit 12 by the control unit 11.

  The control unit 11 of the server 1 includes an acquisition processing unit 111, a display processing unit 112, a first registration processing unit 113, and a second registration processing unit 114. Specifically, the control unit 11 executes various processes such as an adverse event management process (see FIG. 7) described later according to the adverse event management program, thereby obtaining an acquisition processing unit 111, a display processing unit 112, a first It functions as a registration processing unit 113 and a second registration processing unit 114. That is, in the present embodiment, the server 1 alone is an adverse event management system according to the present invention. Further, the server 1 may constitute a stand-alone adverse event management system that also serves as the client terminal 2 operated by a user. Note that some or all of the acquisition processing unit 111, the display processing unit 112, the first registration processing unit 113, and the second registration processing unit 114 may be configured by electronic circuits.

  In addition, it may be considered as another embodiment that part or all of the functions of the server 1 are provided in the client terminal 2. For example, a part or all of the adverse event management program is installed in the client terminal 2, and the control unit 21 of the client terminal 2 appropriately acquires necessary information from the server 1 to be described later. It is also conceivable to perform an adverse event management process (see FIG. 7). In this case, the client terminal 2 is an example of an adverse event management system according to the present invention. Furthermore, in the adverse event management system 10, the server 1 and the client terminal 2 may cooperate to execute an after-mentioned adverse event management process (see FIG. 7).

  The acquisition processing unit 111 can acquire an adverse event grade for each patient date according to a specific criterion such as the CTCAE in which a classification index of an adverse event grade is defined. Specifically, the acquisition processing unit 111 can acquire the grade of adverse event of each patient recorded in the adverse event data D14 from the adverse event data D14.

  The display processing unit 112 displays individual areas A133 (see FIG. 9) corresponding to each combination of the date and the grade of the adverse event in a matrix, and the adverse event of the patient on each of the dates. Can be displayed in the individual area A133 corresponding to the grade. The display by the display processing unit 112 is performed on the server 1 or the client terminal 2. In addition, the display processing unit 112 may omit the display of dates for which no data exists in both the examination data and the drug history data. Specifically, for the date for which there is no data in both the examination data and the drug history data, the display of the individual area A133 and the later-described drug history area A111 is omitted, and the individual area A133 for the date for which data exists. And the medicine history area A111 is displayed adjacently.

  The first registration processing unit 113 may register a grade of an objective symptom that can be classified into the grade according to a test result of a test item set in advance among the adverse events based on the test data of the patient. Is possible. That is, the first registration processing unit 113 automatically determines the grade of objective symptoms among the adverse events of each patient based on the examination data D13 and the adverse event master D1, and determines the adverse event data D14. Update. For example, the update timing of the adverse event data D14 by the first registration processing unit 113 is the time set in advance when the inspection data D14 is updated, or when there is a display request for a management screen P1 described later. When a preset time interval elapses or when an update operation is performed by the user.

  The second registration processing unit 114 registers the grade according to the numerical input for the first subjective symptom that can be classified according to the numerical input such as the state value indicating the patient's state among the adverse events. Is possible. The second registration processing unit 114 determines the grade based on the numerical value of the first subjective symptom and the adverse event master D1. The second registration processing unit 114 registers the grade corresponding to the individual area A133 according to the selection operation of the individual area A133 for the second subjective symptom excluding the first subjective symptom among the subjective symptoms. Is possible. That is, the second registration processing unit 114 responds to an operation of a user such as a pharmacist, according to an input of a subjective symptom grade or a numerical value that is an index of the grade among adverse events of each patient. The data D14 can be updated. More specifically, the second registration processing unit 114 can update the adverse event data D14 in response to a user operation on a management screen P1 described later.

[Client terminal 2]
The client terminal 2 is a personal computer including a control unit 21, a storage unit 22, a communication I / F 23, a display device 24, an operation device 25, a drive device 26, and the like. Each of the client terminals 2 is an operation terminal that is arranged in a medical institution where the adverse event management system 10 is used and is operated by a user such as a pharmacist. For example, the client terminal 2 is used by a pharmacist who prepares a medicine to be administered to a patient in the medical institution. The client terminal 2 may be an information processing apparatus such as a smartphone, a tablet terminal, or a laptop computer.

  The control unit 21 includes control devices such as a CPU, a ROM, a RAM, and an EEPROM. The CPU is a processor that executes various arithmetic processes. The ROM is a non-volatile storage unit in which information such as a control program for causing the CPU to execute various processes is stored in advance. The RAM is a volatile storage unit, and the EEPROM is a non-volatile storage unit. The RAM and the EEPROM are used as a temporary storage memory (working area) for various processes executed by the CPU. And the said control part 21 performs various processes according to the various control programs previously stored in the said ROM, the said EEPROM, or the said memory | storage part 22 using the said CPU.

  The storage unit 22 is a non-volatile storage unit such as a hard disk or an SSD in which various control programs executed by the control unit 21 and various data are stored. Specifically, the storage unit 22 includes a program storage unit 221 in which application programs such as an operating system (OS) and browser software are stored. The browser software displays various operation screens on the display device 24 by accessing the server 1 via the communication network 4, and performs an input operation on the operation screen using the operation device 25. Application software for transmission to the server 1. For example, when address information such as a URL (Universal Resource Locator) corresponding to the server 1 is input at a predetermined position on the operation screen displayed by the browser software, the control unit 21 is based on the address information. To access the server 1.

  The communication I / F 23 is a network card or the like that performs data communication between the server 1 and an external device such as the printer 3 via the communication network 4 in a wireless or wired manner according to a predetermined communication protocol. Is a communication interface.

  The display device 24 is a display unit such as a liquid crystal display or an organic EL display that displays various types of information in accordance with control instructions from the control unit 21. The operation device 25 is an operation unit operated by a user in order to input various information to the client terminal 2. Specifically, the operation device 25 includes a keyboard and a mouse (pointing device) that accept input operations on various operation screens displayed on the display device 24. The operation device 25 may include a touch panel that accepts touch operations on various operation screens displayed on the display device 24, or a voice input device that accepts input of various information by voice recognition.

  The drive device 26 can read the OS or the browser software from a computer-readable recording medium 261 on which the OS or the browser software is recorded. The recording medium 261 is a CD, DVD, BD, or USB memory, and the drive device 16 is a CD drive, DVD drive, BD drive, USB port, or the like. In the client terminal 2, the OS or the browser software read from the recording medium 261 using the drive device 26 is installed in the program storage unit 221 of the storage unit 22 by the control unit 21.

  In the adverse event management system 10, the server 1 sends various information such as a history of medication operations to patients and transitions of adverse events of the patient in accordance with the operation of the client terminal 2 by the user. It is displayed on the terminal 2. The client terminal 2 controls screen display based on data transmitted from the server 1, or controls screen display with reference to data stored in the storage unit 11 of the server 1. The server 1 can accept an operation input from the user to the client terminal 2. Specifically, in the present embodiment, a server client system is configured by the server 1 and the client terminal 2, and the server 1 executes processing such as display and printing in accordance with a user operation of the client terminal 2. The case will be described. Therefore, in this embodiment, “display”, “operation”, “selection”, and “input” described below are performed using the display device 24 and the operation device 25 of the client terminal 2. explain. Similar display and operation may be performed by the server 1.

  By the way, medical professionals such as pharmacists can determine the grade of adverse events based on specific criteria such as the Common Criteria for Adverse Events (CTCAE) for patients who have taken prescription drugs or who have been administered drugs according to therapy. Judgment may be made. On the other hand, the adverse event management system 10 according to the present embodiment can easily manage the grade of a patient's adverse event according to a specific standard.

[Adverse event management processing]
Hereinafter, an example of the adverse event management process executed by the control unit 11 of the server 1 will be described with reference to the flowchart of FIG. The control unit 11 uses the client terminal 2 to select the arbitrary patient as a target and perform the harmful event management program when a predetermined specific start operation for executing the adverse event management program is performed. Execute event management processing. The control unit 11 performs the adverse event management process corresponding to each of the client terminals 2 substantially in parallel when an execution start operation of the adverse event management program is performed from a plurality of the client terminals 2. Run. In addition, the adverse event management process may end in response to a predetermined end operation on the client terminal 2 even when the adverse event management process is being executed. The present invention may be regarded as an invention of an adverse event management method in which a part or all of the steps of the adverse event management process are executed by a computer such as the server 1.

<Step S1>
In step S1, the control unit 11 causes the client terminal 2 to display a management screen P1 for managing an adverse event for a patient selected as a target. The display processing in step S1 is executed by the display processing unit 112 of the control unit 11. Specifically, the control unit 11 causes the client device 2 to display the management screen P1 by transmitting display data of the management screen P1 to the client device 2. It is also conceivable that the control unit 11 transmits data necessary for displaying the management screen P1 to the client device 2, and the control unit 21 displays the management screen P1 based on the data. That is, the generation and update of the management screen P1 may be performed by either the server 1 or the client terminal 2.

  FIG. 8 shows an example of the management screen P1. As shown in FIG. 8, the management screen P1 displays a drug history display part A11, a regimen history display part A12, an adverse event display part A13, and the like. Note that the management screen P1 shown in FIG. 8 is not limited to the case where the entire screen is displayed at the same time. For example, the management screen P1 displays a vertical or horizontal scroll display according to a predetermined scroll operation or the like on the client terminal 2. It may be done.

  The medication history display unit A11 displays the patient's medication history based on the medication history data D11, and the regimen history display unit A12 displays the patient's regimen history based on the regimen history data D12. . Specifically, the control unit 11 causes the drug history display unit A11 and the regimen history display unit A12 to display a drug history region A111 corresponding to each combination of date and medicine or regimen type in a matrix. And the said control part 11 displays the presence or absence of the medicine administration according to the said medicine medication or the said regimen in the date corresponding to the said medicine history area | region A111 in each said medicine history area | region A111. When a user such as a pharmacist refers to the management screen P1, the purpose is often to refer to past data. Therefore, in the example shown in FIG. 8, the medicine history and regimen history of the patient are displayed in a range in which the date corresponding to today is displayed on the rightmost side.

  The adverse event display part A13 includes tabs T11, T12, and T13 that are different in information to be displayed. The control unit 11 corresponds to the tab among the information on the adverse event of the patient stored in the adverse event data D14 according to the selection of any of the tabs T11 to T13 according to the user operation. The information to be displayed is extracted and displayed on the adverse event display unit A13. Specifically, in the tab T11, information on objective symptoms among adverse events is displayed, and on the tab T12, information on subjective symptoms among adverse events is displayed. Further, in the tab T13, information on objective symptoms and subjective symptoms are displayed for adverse events. FIG. 8 shows a state where the tab T13 is selected.

  As shown in FIG. 8, the adverse event display unit A13 displays information on adverse events of the patient based on the adverse event data D14. When a user such as a pharmacist refers to the management screen P1, the purpose is often to refer to past data. Therefore, in the example shown in FIG. 8, the adverse event of the patient is displayed in the range in which the date corresponding to today is displayed on the rightmost side. The adverse event display section A13 may display information on events whose grades are not determined according to grade conditions.

  By the way, in the adverse event display part A13, when an adverse event corresponding to today's date is displayed at the right end, information such as the event name (or inspection item) of the adverse event and the grade judgment criterion (classification index) It becomes difficult to see away. Therefore, the control unit 11 displays information on adverse events corresponding to today's date in the vicinity of the event name and grade criteria of the adverse event. Specifically, in the example shown in FIG. 8, information on adverse events corresponding to today's date is located between the area where the grade condition is displayed and the oldest date, and is located on the left side of the oldest date. It is displayed in the display area A131.

  In addition, the control unit 11 causes the adverse event display unit A13 to display grade determination criteria corresponding to each grade defined in the adverse event master D1. By the way, it may be difficult to grasp the content of the grade determination standard defined in the adverse event common term standard at first glance. Therefore, as shown in FIG. 10, in the adverse event master D1, as the content of the grade condition corresponding to the grade determination criterion, the original character string of the common term for the adverse event criterion and the first criterion for medical staff It is conceivable that the character string and the second standard character string for the patient are registered in advance. The first criterion character string indicates the grade criterion in a simple manner that allows medical personnel such as doctors, nurses, and pharmacists to grasp the grade criterion. Further, the second criterion character string indicates the grade determination criterion in such a manner that the patient can grasp the grade criterion (for example, a character string including an explanation of the grade criterion). The control unit 11 can arbitrarily set the first standard character string and the second standard character string in accordance with a user operation.

  And when the said control part 11 displays the said management screen P1, the said 1st standard character string is displayed as a grade determination standard among the said grade conditions in the said adverse event master D1. As a result, on the management screen P1, the grade determination criteria can be displayed in a small display area that can be easily grasped by medical personnel. In addition, the controller 11 prints the second criterion as the grade criterion when printing the grade criterion on patient materials distributed to the patient, such as an questionnaire for obtaining an answer by the patient. Print a string. Thus, for example, the patient can easily grasp and answer the grade determination criteria by looking at the patient material.

  FIG. 11 is a diagram showing an example of a master registration screen P2 used for registering the adverse event master D1. The control unit 11 displays the master registration screen P2 on the client terminal 2 in response to a master registration start operation by a user. Then, the controller 11 displays the input contents on the master registration screen P2 when a predetermined registration operation is performed after various items are input in response to a user operation on the master registration screen P2. Based on this, the adverse event master D1 is updated. That is, the content displayed on the master registration screen P2 is information to be registered in the adverse event master D1.

  As shown in FIG. 11, a display order setting unit A21, a basic information setting unit A22, a grade condition setting unit A23, and the like are displayed on the master registration screen P2. The grade condition setting part A23 is displayed individually corresponding to each grade. The master registration screen P2 shown in FIG. 11 is not limited to the case where the entire screen is displayed at the same time. For example, the master registration screen P2 can be scrolled vertically or horizontally according to a predetermined scroll operation on the client terminal 2 or the like. Display may be performed.

  The display order setting unit A21 is an operation area for setting the display priority when each of the adverse events is displayed on the management screen P1. The control unit 11 changes the display priority of each adverse event according to a user operation for moving the adverse event up and down.

  The basic information setting unit A22 is an operation area for setting basic information of an adverse event being selected by the display order setting unit A21. Specifically, in the basic information setting unit A22, “display item name”, “determination value setting”, “determination criterion code”, “determination criterion name”, and the like can be input. In the basic information setting unit A22, “item name” and “annotation” of the adverse event indicated in the common adverse event common term standard are displayed.

  The grade condition setting unit A23 is an operation area for setting grade conditions for each grade of the adverse event being selected by the display order setting unit A21. Specifically, in the grade condition setting unit A23, an input operation can be performed on items such as “for medical workers”, “for patients”, and “range”. The control unit 11 registers the value input in the “range” field of the grade condition setting unit A23 as the value of the range of the grade condition in the adverse event master D1. As described above, the control unit 11 can also register the range of the grade condition for each gender according to the selection operation in the “determination value setting” field. The grade condition setting section A23 also displays the “original text” and “range (CTCAE)” of the grade determination criteria of the adverse event indicated in the common adverse event common term criteria.

  The control unit 11 determines whether or not the grade selection on the management screen P1 can be changed in accordance with whether or not the “change input allowed” column in the grade condition setting unit A23 is checked. It is possible to register with the master D1. For example, in the adverse event master D1 (see FIG. 2), for the adverse event “fever”, values in the same range are set as grade conditions of grades “3” and “4”. A grade “3” having a lower grade is automatically selected and registered in the grade information. On the other hand, in the setting screen P2, the adverse event “fever” is checked in the “change input possible” column of the grades “3” and “4”, and the grade selection on the management screen P1 can be changed. Suppose that it is set. In this case, the control unit 11 may arbitrarily select grades “3” and “4” for the adverse event “fever” on the management screen P1 according to a user operation and update the grade information D14. Is possible.

  The master registration screen P2 displays an operation key K21 that accepts an operation for supporting input of an explanatory note. When the operation key K21 is operated, the control unit 11 describes each grade of the adverse event currently selected in the display order setting unit A21 for each grade shown in the adverse event common term standard. The “original text” corresponding to is copied as an explanatory text in the “for medical staff” and “for patient” fields in the grade condition setting unit A23. This simplifies the user's input operation of the explanatory texts “for medical staff” and “for patients”.

<Step S2>
In step S2, the control unit 11 determines whether or not any tab switching operation of the tabs T11 to T13 has been performed in the adverse event display unit A13. If it is determined that the switching operation has been performed (S2: Yes), the process proceeds to step S3. If the switching operation has not been performed (S2: No), the process proceeds to step S4. .

<Step S3>
In step S3, the control unit 11 updates the display in the adverse event display unit A13 in accordance with the tab determined to have been operated in step S2. Specifically, when the tab T11 is operated, the control unit 11 causes the adverse event display unit A13 to display information about only objective symptoms among the adverse events. Further, when the tab T12 is operated, the control unit 11 causes the adverse event display unit A13 to display information on only subjective symptoms among the adverse events. Further, when the tab T13 is operated, the control unit 11 causes the adverse event display unit A13 to display information on both objective symptoms and subjective symptoms among the adverse events. 8 and 9 show a state where the tab T13 is selected, and the description of the display state when the tab T11 or the tab T12 is selected is omitted.

<Step S4>
In step S4, the control unit 11 determines whether or not an expansion switching operation has been performed for any of the adverse events displayed on the adverse event display unit A13. Specifically, an operation key K13 is displayed in the adverse event display area A13 in association with each adverse event. Then, when the operation key K13 is operated, the control unit 11 determines that a deployment switching operation has been performed for an adverse event corresponding to the operation key K13. If it is determined that the expansion switching operation has been performed (S4: Yes), the process proceeds to step S5. If the expansion switching operation has not been performed (S4: No), the process proceeds to step S6. Transition.

<Step S5>
In step S <b> 5, the control unit 11 switches presence / absence of expanded display for an adverse event for which the expansion switching operation has been performed among adverse events displayed on the adverse event display unit A <b> 13. Specifically, as shown in FIG. 8, when “+” is displayed on the operation key K13, an unexpanded state is displayed in which the adverse event corresponding to the operation key K13 is not expanded. is there. On the other hand, as shown in FIG. 9, when “−” is displayed on the operation key K13, the unfolded display is performed for the adverse event corresponding to the operation key K13. When the operation key K13 is operated in the unfolded state, the display of the adverse event corresponding to the operation key K13 is switched to the non-deployed state, and the operation key K13 is operated in the non-deployed state. The display of the adverse event corresponding to the operation key K13 is switched to the expanded state.

  Here, as shown in FIG. 8, in a state where no adverse event is expanded and displayed, the control unit 11 causes the event area corresponding to each combination of a date and the adverse event in the adverse event display unit A13. A132 is displayed. The event area A132 is displayed in a two-stage display, with the inspection value or state value used for the determination of the grade being displayed on the upper stage and the grade being described on the lower stage. The control unit 11 displays the background color or character color of the event area A132 in a color scheme set in advance corresponding to the adverse event grade.

  As shown in FIG. 9, when an adverse event is expanded and displayed, grade conditions for various grades of the adverse event are displayed. Specifically, the grades of the adverse events are displayed side by side from top to bottom in descending order. The grades of the adverse events may be displayed side by side from bottom to top in descending order. In addition, when the criteria of the adverse event grade are individually set by gender, the control unit 11 causes the adverse event display unit A13 to display a criterion corresponding to the gender of the patient, and based on the criterion Determine the grade.

  Then, as shown in FIG. 9, the control unit 11 is configured so that the adverse event displayed in the adverse event display unit A13 is an individual corresponding to each combination of a date and a grade type of the adverse event. The area A133 is displayed in a matrix. Further, the control unit 11 displays the grade of the adverse event of the patient on each date in the individual area A133 corresponding to the grade. For example, in the individual area A133, the grade of the adverse event of the patient on each date is displayed in characters. Thereby, the user can easily grasp the transition of the grade of the adverse event by referring to the position where the grade is described in the individual area A133.

  Further, the control unit 11 displays the background color or the character color of the individual area A133 in a color scheme set in advance corresponding to the grade of the adverse event. Thereby, the user can grasp the transition of the adverse event grade at a glance. The difference in the shaded display of the individual area A133 in FIG. 8 indicates the difference in color scheme. For example, the color scheme of the individual area A133 may be set so as to change from a cold color such as blue to a warm color such as red from a lower grade to a higher grade. In addition, when displaying the grade of the adverse event of the patient on each date in the color scheme to the individual area A133 corresponding to the grade, the display of characters indicating the grade type in the individual area A133 may be omitted. Good.

<Step S6>
In step S6, the control unit 11 determines whether or not an order change operation has been performed for any of the adverse events displayed on the adverse event display unit A13. Specifically, the adverse event display unit A13 displays operation keys K12 for selecting an adverse event in association with each adverse event. The adverse event display section A13 displays an operation key K11 for switching the display order of a plurality of adverse events. Then, when the operation key K11 is operated after the operation key K12 corresponding to any of the adverse events is operated and selected, the control unit 11 performs an order change operation for the adverse event. Judge that If it is determined that the order change operation has been performed (S6: Yes), the process proceeds to step S7. If the order change operation has not been performed (S6: No), the process proceeds to step S8. Transition. Note that the change of the display order of a plurality of adverse events is not limited to the case where the change is performed in the adverse event display unit A13. For example, a display master in which the display order of the adverse events in the adverse event display unit A13 can be registered in advance is stored in the storage unit 12, and the control unit 11 performs the display according to a specific editing operation by a user. The display order of the adverse events in the master may be registered in advance. And after that, when displaying the adverse event display unit A13, the control unit 11 displays the adverse events side by side based on the display master.

<Step S7>
In step S7, the control unit 11 sets the display position of the adverse event on which the rank changing operation is performed among the adverse events displayed on the adverse event display unit A13 according to the operation of the operation key K11. Change sequentially to lower order. In addition, when the operation key K11 is operated in a state where the plurality of the operation keys K12 are operated and selected, the control unit 11 performs an adverse event corresponding to the selected plurality of the operation keys K12. May be moved together. The display position changing method using the operation key K11 and the operation key K12 is merely an example. For example, the control unit 11 performs the drag-and-drop operation using a pointing device such as a mouse. The display position of the adverse event may be changed.

<Step S8>
In step S8, the control unit 11 has performed a synchronization presence / absence switching operation for switching presence / absence of synchronization of the date display range in the drug history display unit A11, the regimen history display unit A12, and the adverse event display unit A13. Judge whether or not. If it is determined that the synchronization presence / absence switching operation has been performed (S8: Yes), the process proceeds to step S9. If the synchronization presence / absence switching operation has not been performed (S8: No), the process proceeds to step S9. The process proceeds to S10.

  Specifically, the management screen P1 includes an operation unit K14 for changing a date display range of the drug history area A111 in the drug history display unit A11 and the regimen history display unit A12, and the adverse event display unit. An operation unit K15 for changing the date display range of the event area A132 in A13 is displayed. Furthermore, an operation key K16 for accepting the synchronization presence / absence switching operation is displayed on the management screen P1. And the said control part 11 changes the display range of the date of the said medication history area | region A111 in the said medication history display part A11 and the said regimen history display part A12 according to operation of the said operation part K14, and the said operation part K15 The date display range of the event area A132 in the adverse event display part A13 is changed according to the operation. The operation unit K16 is an operation unit for switching whether or not an operation on one of the operation unit K14 and the operation unit K15 is synchronized with the other operation. The control unit 11 determines that the synchronization presence / absence switching operation has been performed when the operation key K16 is operated.

  In the management screen P1, the scale of the date display range in the medicine history display part A11, the regimen history display part A12, and the adverse event display part A13 is unified. In addition, an operation key K17 for changing the scale of the display range is displayed on the management screen P1. The control unit 11 is preset with a scale of a date display range in the drug history display unit A11, the regimen history display unit A12, and the adverse event display unit A13 according to the operation of the operation key K17. Sequentially switching between at least two or more scales. For example, it is conceivable that the switching can be repeated sequentially on a scale of 1 week (7 days), 2 weeks, 1 month, or 3 months.

<Step S9>
In step S9, the control unit 11 displays the date display ranges of the drug history region A111 and the event region A132 in the drug history display unit A11, the regimen history display unit A12, and the adverse event display unit A13. Toggle synchronization. Specifically, when the synchronization is set to be present, the synchronization is changed to none, and when the synchronization is set to be absent, the synchronization is changed to presence. Is done.

  Then, when the synchronization is set to be present, the control unit 11 changes the date of either the drug history area A111 or the event area A132 by the operation of the operation unit K14 or the operation unit K15. When a display range changing operation is accepted, the operation is linked to the other operation. For example, when the date range of the medicine history area A111 to be displayed in the medicine history display part A11 and the regimen history display part A12 is changed by operating the operation part K14, the display in the adverse event display part A13 The display range is changed so that the date range of the target event area A132 is the same.

  When the synchronization is changed from “none” to “present” in the state where the date display ranges in the drug history display unit A11 and the regimen history display unit A12 and the adverse event display unit A13 are different, the control The unit 11 changes the display range of the other date based on the preset display range of one of the medication history display unit A11, the regimen history display unit A12, and the adverse event display unit A13. It is possible to do.

<Step S10>
In step S10, the control unit 11 determines whether or not a grade registration operation for registering a grade corresponding to a specific date for an adverse event displayed in the adverse event display unit A13 has been performed. Specifically, in the adverse event display unit A13, the control unit 11 inputs a numerical value to the event area A132 for the first subjective symptoms that can be classified into the grades according to the numerical value input among the adverse events. Accepted as the grade registration operation. Further, in the adverse event display unit A13, for the second subjective symptom excluding the first subjective symptom among the adverse events, the selection operation of the individual region A133 of the event region A132 is accepted as the grade registration operation. For example, the first subjective symptom is “fever”, “diarrhea” and the like, and the second subjective symptom is “vomiting”, “numbness of limbs” and the like. Note that the control unit 11 has the grade in the management screen P1 for the grade that has the change input possibility (“1”) in the adverse event master D1 even for the first subjective symptom. A selection operation is accepted as the grade registration operation. If it is determined that the grade registration operation has been performed (S10: Yes), the process proceeds to step S11. If the grade registration operation has not been performed (S10: No), the process proceeds to step S12. Transition.

<Step S11>
In step S11, the control unit 11 registers the grade of the adverse event according to the grade registration operation. Here, the registration process is executed by the second registration processing unit 114 of the control unit 11. Specifically, the control unit 11 determines the grade to which the numerical input belongs for the first subjective symptoms that can be classified according to the numerical input among the adverse events, according to the numerical input, The grade is displayed in the individual area A133 of the event area A132 and registered in the grade information D14. Further, the control unit 11 determines the grade corresponding to the individual area A133 according to the selection operation of the individual area A133 of the event area A132 for the second subjective symptom excluding the first subjective symptom among the subjective symptoms. Is registered in the grade information D14 as a grade corresponding to the date. Further, the control unit 11 determines the grades in the management screen P1 for the grades that have the change input possibility (“1”) in the adverse event master D1 even for the first subjective symptom. According to the selection operation, the grade is registered in the grade information D14 as a grade corresponding to the date. In addition, when the standard of the grade of the adverse event is set corresponding to each gender in the adverse event master D1, the control unit 11 determines the grade based on the standard corresponding to the sex of the patient.

<Step S12>
In step S12, the control unit 11 determines whether or not an execution end operation of the adverse event management process has been performed. When the execution end operation is performed (S10: Yes), the adverse event management process ends. If the execution end operation has not been performed (S10: No), the process returns to step S2.

  As described above, in the adverse event management system 10 according to the present embodiment, the grade of the adverse event of the patient according to a specific standard such as CTCAE determined based on the examination data of the patient is easily managed. It is possible.

[Additional Notes]
Hereinafter, the technical idea of the invention extracted from the above-described embodiment will be additionally described. Moreover, it is also possible to select and arbitrarily combine each configuration and each processing function to be described below.

[Appendix 1]
An acquisition processing unit for acquiring a grade of an adverse event for each patient date according to a specific criterion in which a classification index of an adverse event grade is defined;
The individual area corresponding to each combination of the date and the grade type of the adverse event is displayed in a matrix, and the adverse event grade of the patient on each date is displayed in the individual area corresponding to the grade. A display processing unit
Adverse event management system.

[Appendix 2]
The specific criteria are adverse event common term criteria,
The adverse event management system according to Appendix 1.

[Appendix 3]
The display processing unit causes the individual area to be displayed in a preset color scheme corresponding to the adverse event grade,
The adverse event management system according to appendix 1 or 2.

[Appendix 4]
The display processing unit displays the grade of the adverse event in the individual area in characters;
The adverse event management system according to any one of appendices 1 to 3.

[Appendix 5]
The display processing unit displays a first tab on which information corresponding to a preset objective symptom among the adverse events is displayed, and information corresponding to a preset subjective symptom among the adverse events. The second tab and the third tab on which information corresponding to the objective symptom and the subjective symptom among the adverse events can be switched and displayed.
The adverse event management system according to any one of appendices 1 to 4.

[Appendix 6]
The display processing unit can change the display order of a plurality of the adverse events according to a user operation,
The adverse event management system according to any one of appendices 1 to 5.

[Appendix 7]
The display processing unit displays a drug history area corresponding to each combination of the date and the type of drug taken by the patient or the type of drug administered to the patient in a matrix, and the date on each date The patient's medication or administration presence / absence is displayed in the drug history area corresponding to the drug,
The adverse event management system according to any one of appendices 1 to 6.

[Appendix 8]
The display processing unit is capable of switching the presence or absence of synchronization of the other date display range according to a change operation of the date display range for one of the individual area or the drug history area.
The adverse event management system according to appendix 7.

[Appendix 9]
A first registration processing unit capable of registering a grade of an objective symptom that can be classified according to a test result of a test item set in advance among the adverse events based on the patient's test data;
The adverse event management system according to any one of appendices 1 to 8.

[Appendix 10]
Among the adverse events, the first subjective symptom that can be classified into the grades according to the numerical input can be registered as the grade according to the numerical input, and the second subjective excluding the first subjective symptom among the adverse events The symptom includes a second registration processing unit capable of registering the grade corresponding to the individual area according to the selection operation of the individual area.
The adverse event management system according to any one of appendices 1 to 9.

[Appendix 11]
Obtaining a grade of adverse event by patient date according to specific criteria with a classification index of adverse event grade;
The individual area corresponding to each combination of the date and the grade type of the adverse event is displayed in a matrix, and the adverse event grade of the patient on each date is displayed in the individual area corresponding to the grade. And letting
Adverse event management program that causes the processor to execute.

1 Server 11 Control Unit 111 Acquisition Processing Unit 112 Display Processing Unit 113 First Registration Processing Unit 114 Second Registration Processing Unit 12 Storage Unit 13 Communication I / F
14 Operation device 15 Display device 16 Drive device 2 Client terminal 21 Control unit 22 Storage unit 23 Communication I / F
24 Operating device 25 Display device 26 Drive device 3 Printer 4 Communication network 5 Host system 10 Adverse event management system

Claims (11)

An acquisition processing unit for acquiring a grade of an adverse event for each patient date according to a specific criterion in which a classification index of an adverse event grade is defined;
The individual area corresponding to each combination of the date and the grade type of the adverse event is displayed in a matrix, and the adverse event grade of the patient on each date is displayed in the individual area corresponding to the grade. A display processing unit
Adverse event management system. The specific criteria are adverse event common term criteria,
The adverse event management system according to claim 1. The display processing unit causes the individual area to be displayed in a preset color scheme corresponding to the adverse event grade,
The adverse event management system according to claim 1 or 2. The display processing unit displays the grade of the adverse event in the individual area in characters;
The adverse event management system according to claim 1. The display processing unit displays a first tab on which information corresponding to a preset objective symptom among the adverse events is displayed, and information corresponding to a preset subjective symptom among the adverse events. The second tab and the third tab on which information corresponding to the objective symptom and the subjective symptom among the adverse events can be switched and displayed.
The adverse event management system according to any one of claims 1 to 4. The display processing unit can change the display order of a plurality of the adverse events according to a user operation,
The adverse event management system according to any one of claims 1 to 5. The display processing unit displays a drug history area corresponding to each combination of the date and the type of medicine or regimen in a matrix, and the medicine taken by the patient on each date or the medicine according to the regimen The presence or absence of administration is displayed in the drug history area corresponding to the drug,
The adverse event management system according to claim 1. The display processing unit is capable of switching the presence or absence of synchronization of the other date display range according to a change operation of the date display range for one of the individual area or the drug history area.
The adverse event management system according to claim 7. A first registration processing unit capable of registering a grade of an objective symptom that can be classified according to a test result of a test item set in advance among the adverse events based on the patient's test data;
The adverse event management system according to claim 1. Among the adverse events, the first subjective symptom that can be classified into the grades according to the numerical input can be registered as the grade according to the numerical input, and the second subjective excluding the first subjective symptom among the adverse events The symptom includes a second registration processing unit capable of registering the grade corresponding to the individual area according to the selection operation of the individual area.
The adverse event management system according to claim 1. Obtaining a grade of adverse event by patient date according to specific criteria with a classification index of adverse event grade;
The individual area corresponding to each combination of the date and the grade type of the adverse event is displayed in a matrix, and the adverse event grade of the patient on each date is displayed in the individual area corresponding to the grade. And letting
Adverse event management program that causes the processor to execute.

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