Medication management device, medication management system, pump, medication management method, and program

Abstract

This medication management device comprises an acquisition unit, a storage unit, and a control unit. The acquisition unit acquires drug administration information including an administration amount and an administration time of a drug for a patient. The storage unit stores past drug administration information of the patient as drug administration history information. The control unit estimates an in-vivo drug concentration of the patient on the basis of the drug administration history information, and executes, on the basis of the estimated in-vivo drug concentration of the patient, a process determined from a plurality of different processes.

Description

Medication management device, medication management system, pump, medication management method, and program

[0001] The present invention relates to a drug dispensing management device, a drug dispensing management system, a pump, a drug dispensing management method, and a program.

[0002] Patent Document 1 discloses an invention for a medication management device that supports patients in taking their medication voluntarily. In this medication management device, information on the drug and the changes in blood concentration after taking the drug are stored in a memory unit in an associated manner. As a result, this medication management device estimates the blood concentration of the drug based on the time the patient takes the drug and displays information indicating the blood concentration of the drug on a patient terminal that the patient can access. Patent Document 2 discloses an invention for a future-predictive anesthesia monitoring device related to inhaled anesthetic gases, for knowing the metabolic status of anesthetic gases in the patient's body. This device detects the concentration of inhaled anesthetic gases, performs a simulation based on the detected inhaled anesthetic concentration, compares it with a comparative value, and outputs the patient's internal anesthetic gas concentration at an appropriate stage of the simulation.

[0003] JP-A-2023-3946 JP-A-3-136666

[0004] Conventional technologies only estimate the drug concentration in the body of a patient receiving drug administration through simulation. In areas such as pain management during and after surgery, it is preferable to be able to manage appropriate drug administration based on past drug administration history information, such as analgesics.

[0005] Therefore, the purpose of this disclosure, which focuses on these points, is to improve the technology for administering drugs based on the patient's drug administration history information.

[0006] A medication management device in one aspect of the present disclosure is a medication management device comprising: (1) an acquisition unit that acquires medication administration information including the amount and time of administration of a patient's medication; a storage unit that stores the patient's past medication administration information as medication administration history information; and a control unit that estimates the patient's internal drug concentration based on the medication administration history information and executes a process determined from a plurality of different processes based on the estimated internal drug concentration of the patient.

[0007] As one embodiment of the present disclosure, (2) in the drug management device described in (1) above, the control unit preferably estimates the drug concentration in the body using a pharmacokinetic / pharmacodynamic (PK / PD) model.

[0008] As one embodiment of the present disclosure, (3) in the medication management device of (1) or (2) above, the control unit preferably sets at least one threshold for the concentration of the drug in the body and determines the process to be executed from the plurality of different processes based on the relationship between the estimated concentration of the drug in the body of the patient and the at least one threshold.

[0009] As one embodiment of the present disclosure, (4) in the medication management device described in (3) above, the at least one threshold includes a first threshold, and the control unit preferably displays a message on a screen displayed to the patient to confirm the administration of the drug when the estimated drug concentration in the patient's body is lower than the first threshold.

[0010] In one embodiment of the present disclosure, (5) in the medication management device described in (4) above, the control unit is configured to receive a request from the patient for the administration of the drug, and the control unit preferably sets the first threshold value based on the drug concentration in the patient's body when it previously received a request from the patient for the administration of the drug.

[0011] In one embodiment of the present disclosure, (6) in any of the medication management devices described in (3) to (5) above, the at least one threshold includes a second threshold, and the control unit preferably prohibits the administration of the drug to the patient when the estimated drug concentration in the patient's body is higher than the second threshold.

[0012] In one embodiment of the present disclosure, (7) in any of the medication management devices described in (3) to (6) above, the at least one threshold includes a third threshold, and the control unit preferably automatically administers the drug to the patient when the estimated drug concentration in the patient's body is lower than the third threshold.

[0013] As one embodiment of the present disclosure, (8) In any of the medication management devices described in (1) to (7) above, the control unit preferably generates image information showing the time-series changes in the concentration of the drug in the patient's body, and displays an image based on the image information on a predetermined display device.

[0014] A drug dispensing management system as one aspect of the present disclosure is a drug dispensing management system comprising (9) a drug dispensing management device as described in any of (1) to (8) above, and a pump, wherein the acquisition unit of the drug dispensing management device acquires the drug administration information from the pump.

[0015] One aspect of the present disclosure is a pump that is equipped with a drug dispensing control device as described in any of (1) to (8) above.

[0016] One aspect of the present disclosure is a medication management method, which is a medication management method performed by a medication management device, and includes: acquiring medication administration information including the amount and time of administration of a patient's medication; storing the patient's past medication administration information as medication administration history information; estimating the patient's internal drug concentration based on the medication administration history information; and performing a process determined from a plurality of different processes based on the estimated internal drug concentration of the patient.

[0017] One aspect of the present disclosure is a program that causes a computer to perform the following processes: (12) acquire drug administration information including the dosage and time of administration of a patient's drug; store the patient's past drug administration information as drug administration history information; estimate the patient's internal drug concentration based on the drug administration history information; and perform a process determined from a plurality of different processes based on the estimated internal drug concentration of the patient.

[0018] According to this disclosure, the control unit estimates the drug concentration in the patient's body based on drug administration history information, enabling it to perform appropriate processing from multiple different processes according to the patient's drug concentration. This improves the technology for administering drugs.

[0019] This is a block diagram illustrating the schematic configuration of a pump incorporating a medication management device according to one embodiment of this disclosure. This is a diagram showing a three-compartment model, which is an example of a pharmacokinetic / pharmacodynamic (PK / PD) model used by the estimation unit in Figure 1 when estimating the drug concentration in the body. This is a diagram showing the time change between the amount of drug administered by bolus administration and the drug concentration in the patient's body. This is a diagram showing an example of the change in drug concentration in the body due to repeated drug administration to a patient. This is a diagram showing an example of an image displayed on the display screen. This is a diagram showing an example of a text screen displayed for healthcare professionals. This is a diagram showing an example of a text screen displayed for patients. This is a diagram illustrating the processing of the medication management device in the first stage (during surgery). This is a diagram illustrating the processing of the medication management device in the second stage (after surgery). This is a diagram illustrating the processing of the medication management device in the second stage (after surgery). This is a diagram showing an example of a display screen when the drug concentration in the body falls below the drug concentration at the time of the previous drug administration. This is a flowchart illustrating the medication management method according to one embodiment. This is a flowchart illustrating the processing of the first stage in Figure 12. This is a flowchart illustrating the processing of the second stage in Figure 12. This is a block diagram illustrating the schematic configuration of a medication management system according to one embodiment.

[0020] The embodiments of this disclosure will be described below with reference to the drawings.

[0021] (Pump Configuration) Figure 1 shows a pump 10 according to one embodiment. Pump 10 is a pump for administering liquid medication to a patient. Pump 10 is, for example, a syringe pump or an infusion pump. Pump 10 has the function of a PCA (Patient Controlled Analgesia) pump. To support pain relief therapy, the PCA pump can administer additional medication to the patient in a set dose via bolus administration. Bolus administration is a method of administering a predetermined amount of drug in a short period of time.

[0022] A PCA pump is a pump that allows patients to administer a certain amount of narcotic or analgesic themselves to relieve pain after surgery or from illnesses such as cancer. PCA pumps generally have the following problems: (1) It is difficult to confirm the degree of effect of the administered drug. (2) Pain is a subjective value for the patient, making it difficult to determine the appropriate dosage of the drug. (3) Because the patient administers the drug themselves, there is a possibility of overdose. (4) It is difficult for a physician to intervene at the appropriate time. The embodiment of this invention addresses these problems by estimating and visualizing the changes in the drug concentration in the patient's body and the drug concentration when the patient administers the drug themselves, and by performing appropriate control, as described below.

[0023] The pump 10 in Figure 1 includes a medication management device 20. The medication management device 20 has the function of estimating the drug's effective level and concentration in the body using a pharmacokinetic / pharmacodynamic (PK / PD) model. The concentration of the drug in the patient's body is referred to as "body drug concentration" below. The medication management device 20 performs various displays and processes using the estimated body drug concentration. In particular, the medication management device 20 sets one or more thresholds for the body drug concentration and determines and executes one of several different processes based on the relationship between the estimated body drug concentration and the threshold.

[0024] As shown in Figure 1, the pump 10 includes a liquid delivery unit 11, a display unit 12, an operation unit 13, a pump control unit 14, and a medication management device 20.

[0025] The fluid delivery unit 11 injects the drug into the patient's vein or other location via a fluid delivery tube. The fluid delivery unit 11 includes a drive mechanism for fluid delivery. For example, if the pump 10 is a syringe pump, the drug is injected into the patient's body by pushing out the inner cylinder of the syringe containing the drug using a stepping motor or the like, while the outer cylinder of the syringe is fixed in place. If the pump 10 is an infusion pump, the pump 10 is installed in the middle of the fluid delivery tube. The pump 10 supplies a set flow rate of drug into the patient's body by moving a set of protrusions called fingers attached to the tube.

[0026] The display unit 12 displays information related to the operation of the pump 10, information on the content of operations received through the control unit 13, and notifications to the patient or medical personnel, including doctors and nurses. The display unit 12 may be, for example, a liquid crystal display (LCD), an organic electroluminescent (EL) display, or an inorganic EL display. The display unit 12 may be provided on the main body of the pump 10, or it may be provided outside the pump 10 via a cable. The display unit 12 may display information such as the name of the drug, the dosage, and the administration rate. The display unit 12 may also display the estimated drug concentration in the patient's body.

[0027] The control unit 13 receives operations on the pump 10 by a healthcare professional or a patient. The control unit 13 may be, for example, a touch panel integrated with the display unit 12. Healthcare professionals can set the administration time, dosage, and administration rate of medication to the patient using the control unit 13. The control unit 13 may include operation switches for making various settings. In particular, the control unit 13 may include a switch for the patient to instruct the pump 10, which is acting as a PCA pump, to administer analgesics. This switch will be referred to as the PCA switch below. The PCA switch is, for example, a button switch connected to the main body of the pump 10 by a cable. The control unit 13 may further include a switch to turn the power of the pump 10 on / off, and a switch to enable / disable medication administration by the patient themselves.

[0028] The pump control unit 14 includes one or more processors. The processors include a general-purpose processor that loads a specific program and executes a specific function, and a dedicated processor specialized for a specific process. The pump control unit 14 or the processor may include memory for storing programs for various processes and information during calculations. The pump control unit 14 controls the overall operation of the pump 10. The pump control unit 14 drives the fluid delivery unit 11 according to instructions input via the operation unit 13.

[0029] The medication management device 20 includes an acquisition unit 21, a storage unit 22, and a control unit 23. The medication management device 20 does not need to be an independent component within the pump 10. The medication management device 20 may be composed of components that are partially common with the pump control unit 14. Furthermore, the functions of the medication management device 20 as a whole may be included in the pump control unit 14.

[0030] The acquisition unit 21 acquires drug administration information, including the amount and time of drug administration to the patient, from the pump control unit 14.

[0031] The storage unit 22 includes at least one semiconductor memory, at least one magnetic memory, at least one optical memory, or at least two combinations thereof. The semiconductor memory is, for example, RAM (random access memory) or ROM (read-only memory). The RAM is, for example, SRAM (static random access memory) or DRAM (dynamic random access memory). The ROM is, for example, EEPROM (electrically erasable programmable read-only memory). The storage unit 22 stores information necessary for processing performed by the medication management device 20, and information generated as a result of processing performed by the medication management device 20. For example, the storage unit 22 stores past drug administration information of a patient acquired via the acquisition unit 21 as drug administration history information.

[0032] The control unit 23, like the pump control unit 14, is configured to include at least one processor. The processor of the control unit 23 may be the same as or different from the processor of the pump control unit 14. The control unit 23 performs various processes based on the drug administration history information stored in the storage unit 22. The control unit 23 includes the components of the estimation unit 24, the display control unit 25, and the determination unit 26. The components of the estimation unit 24, the display control unit 25, and the determination unit 26 may be hardware modules or software modules. The operations described below as processes performed by each component can be rephrased as operations performed by the control unit 23.

[0033] The estimation unit 24 estimates the drug concentration in the patient's body over time based on the drug administration history information stored in the storage unit 22. The estimation unit 24 may estimate the drug concentration in the patient's body at each time point at a predetermined time interval. The predetermined time interval may be, for example, 1 second, 3 seconds, or 10 seconds.

[0034] The estimation unit 24 estimates the drug concentration in the patient's body by simulation using a pharmacokinetics / pharmacodynamics (PK / PD) model. As an example, the estimation unit 24 estimates the drug concentration in the body using the three-compartment model shown in FIG. 2. This model is used in simulations with a target-controlled infusion (TCI) pump. The TCI pump is a syringe pump that automatically changes the continuous infusion rate of the drug when the target blood concentration of the drug is set and administers it.

[0035] In FIG. 2, a "compartment" is a site in the human body that is assumed to have a certain volume and a constant drug concentration therein. The first compartment 31 is the blood into which the drug is injected. The second compartment 32 may be a site with a large blood flow, and the third compartment 33 may be a site with a small blood flow. The compartment e (effect site) 34 is the site where the drug exhibits the desired effect, that is, it means the effect site. In this model, the movement of the drug between each compartment is expressed by the following simultaneous differential equations (Equations (1) to (4)).

[0036]

[0037] Here, I(t) indicates the infusion rate of the drug into the patient's body. The volume V １ , V ２ and V ３ indicate the volumes of the first compartment 31, the second compartment 32, and the third compartment, respectively. The drug amounts a １ , a ２ , a ３ and a ｅ indicate the drug amounts in the first compartment 31, the second compartment 32, the third compartment 33, and the compartment e (effect site) 34, respectively. The coefficient k ｉｊ(where i and j are any of 1 to 3) indicates the rate of drug transfer from the i-th compartment to the j-th compartment. The coefficient k ｅ０ indicates the rate of drug transfer from the blood to the effect site. The coefficient k １０ indicates the rate of drug excretion from the first compartment 31.

[0038] The estimation unit 24 analyzes or approximately solves this system of simultaneous differential equations to estimate the drug amounts a １ a ２ a ３ and a ｅ The estimation unit 24 estimates the blood drug concentration Cp and the drug concentration Ce at the effect site by the following mathematical formulas (5) and (6). Cp = a １ / V １ (5) Ce = a ｅ / V １ (6) The blood drug concentration Cp and the drug concentration Ce at the effect site are included in the in-vivo drug concentration. In the present application, the in-vivo drug concentration is used in the sense of both the blood drug concentration Cp and the drug concentration Ce at the effect site, or either one of them.

[0039] In the mathematical formulas (1) to (4), the coefficients k ｉｊ (i, j are 1 to 3), k ｅ０ k １０ are determined based on a pharmacokinetics / pharmacodynamics (PK / PD) model corresponding to the administered drug and attributes such as the patient's height, weight, age, and gender. Drugs and models that can be used in the pump 10 which is a PCA pump include, for example, the following.

[0040]

[0041] For example, as shown in FIG. 3, when a bolus injection of a drug (for example, fentanyl) is performed at the administration time T, the in-vivo drug concentration by simulation gradually decreases according to the model.

[0042] As an example, in the following description, analgesics are administered to the patient using pump 10 from the first stage of surgery to the second stage of surgery. During the first period P1, which is the period during the first stage of surgery, pump 10 intermittently administers analgesics to the patient. In the second period P2, which is the period after the second stage of surgery, pump 10 accepts PCA administration of analgesics by the patient themselves. For example, pump 10 is programmed to administer a bolus of 2 μg / kg of fentanyl at the start of surgery, and then intermittently administer 1 μg / kg of fentanyl four times every 30 minutes during the surgery. However, if the patient's drug concentration in the body decreases, the drug may be administered earlier than the scheduled time. Also, pump 10 is to administer fentanyl to the patient in the ward after surgery at a PCA rate of 0.5 μg / kg per dose. All drug administrations are bolus administrations. In this case, the changes in the body drug concentration estimated by the estimation unit 24 will be as shown in Figure 4 as an example. At the start of the surgery and during the elapsed time t1 to t4, pump 10 intermittently administers analgesics to the patient. During the elapsed time t5 to t7 after the surgery, pump 10 administers PCA (pain-controlled analgesic) to the patient.

[0043] The estimation unit 24 sequentially stores the estimated drug concentration in the body at each point in time in the storage unit 22. When the patient operates the PCA switch on the operation unit 13, the estimation unit 24 records the estimated drug concentration in the body at the time of that operation.

[0044] The display control unit 25 generates image data for the medication management device 20 to display on the display screen 40 of the display unit 12. The display control unit 25 displays the generated image data on the display screen 40 of the display unit 12. As shown in Figure 5, the display control unit 25 can display on the display screen 40 an image that graphs the estimated changes in the patient's internal drug concentration up to the present time. This allows healthcare professionals to visually grasp the changes in the patient's internal drug concentration and take appropriate action.

[0045] Furthermore, the display control unit 25 may display information related to drug administration as a text image, as shown in Figures 6 and 7. The text image display screen 40 may include a drug administration mode display area 41, a drug name display area 42, a drug administration status display area 43, and a message display area 44. The drug administration mode display area 41 displays "intermittent administration" or "PCA administration," indicating the drug administration method. The drug name display area 42 displays the name of the drug being administered. The drug administration status display area 43 shows information such as the drug administration status, dosage, and administration time. The message display area 44 displays messages based on the drug concentration in the patient's body.

[0046] Figure 6 shows an example of a display for healthcare professionals when intermittent drug administration is being performed on a patient during the first period P1. In the example in Figure 6, the drug administration status display area 43 displays the blood drug concentration and the drug concentration at the site of action. Additionally, if necessary, a message is displayed in the message display area 44 indicating that healthcare professionals should check the patient's condition. Figure 7 shows an example of a display for patients when PCA (Patient-Controlled Allocation) administration of drug is being performed on a patient during the second period P2. In the example in Figure 7, the drug administration status display area 43 displays the amount and duration of drug administration. Additionally, if necessary, a message is displayed in the message display area 44 prompting the patient to administer the drug.

[0047] The decision unit 26 determines the process to be executed by the medication management device 20 based on the estimated drug concentration in the patient's body. The decision unit 26 determines the process to be executed by the medication management device 20 from among a plurality of processes based on one or more predetermined thresholds. The control unit 23 executes the process determined by the decision unit 26.

[0048] For example, as shown in Figure 8, a first comparison value CV1 may be predetermined as the lower limit of the drug concentration in the body during the first period P1 of surgery. The first comparison value CV1 is a third threshold. When the current drug concentration Dp, which indicates the current drug concentration in the body, is equal to or greater than the first comparison value CV1, the decision unit 26 decides that the display control unit 25 should display a graph of the trend of the drug concentration in the body, as shown in Figure 5, on the display unit 12. When the drug concentration in the body falls below the first comparison value CV1, the decision unit 26 may display a message, as shown in Figure 6, on the display unit 12 for healthcare professionals. This allows healthcare professionals to administer the drug to the patient at the appropriate time. Alternatively, when the drug concentration in the body falls below the first comparison value CV1, the decision unit 26 may decide to automatically administer the drug to the patient without instructions from healthcare professionals or the patient. This allows for an appropriate reduction in the pain experienced by the patient during surgery.

[0049] In Figure 8, since the internal drug concentration from the present time onward has not been estimated, when the display unit 12 of the pump 10 actually displays a graph of the internal drug concentration, only the graph to the left of the current drug concentration Dp in Figure 8 is displayed. In Figure 8, for explanatory purposes, graphs of the internal drug concentration for the entire period of the first period P1 and the second period P2 are shown. The same applies to Figures 9 and 10.

[0050] Furthermore, as shown in Figure 9, for example, a second comparative value CV2 may be predetermined as the upper limit of the internal drug concentration that can be additionally administered during the second postoperative period P2. The second comparative value CV2 is a second threshold. The decision unit 26 decides to prohibit the patient from administering the drug when the internal drug concentration is higher than the second comparative value CV2. In this case, for example, the decision unit 26 may, via the display control unit 25, display a message such as "Analgesic administration is not possible at this time" in the message display area 44 of the display screen 40. The decision unit 26 may also, via the pump control unit 14, disable the operation of the PCA switch on the operation unit 13 by the patient. In this way, the medication management device 20 can prevent the pump 10 from administering an excessive amount of drug to the patient.

[0051] Furthermore, as shown in Figure 10, for example, in the second postoperative period P2, the determination unit 26 may determine a third comparison value CV3 based on the drug concentration in the patient's body when the patient previously operated the PCA switch of the operation unit 13, which is stored in the memory unit 22. The third comparison value CV3 is the first threshold. The third comparison value CV3 may be, for example, the drug concentration in the patient's body when the patient operated the PCA switch immediately before. Alternatively, the third comparison value CV3 may be the average value of the drug concentrations in the patient's body when the patient operated the PCA switch multiple times in the past.

[0052] When the drug concentration in the body is lower than CV3, the decision unit 26 displays a message on the display screen 40, which is displayed to the patient via the display control unit 25, to confirm drug administration. For example, as shown in Figure 11, the message display area 44 of the display screen 40 may display a message inquiring about the patient's condition, such as "Are you in pain?". Furthermore, the message display area 44 may display a button widget for the administration start button 45 to initiate bolus administration. In this way, the medication management device 20 can confirm drug administration with the patient at the same time as when the drug concentration in the body has decreased to the same level as in previous drug administrations. The patient can also easily start drug administration by simply pressing the administration start button 45 on the display screen 40.

[0053] The thresholds set for the drug concentration in the body are not limited to the three comparison values ​​CV1 to CV3 described above; two or more thresholds may be set. Furthermore, the processing performed by the control unit 23 in response to the drug concentration in the body is not limited to those described above. For example, the control unit 23 may perform various different processes, such as notifying healthcare professionals, in response to the estimated drug concentration in the patient's body.

[0054] In Figure 1, the medication management device 20 is shown to be built into the pump 10, but the medication management device 20 may be a separate information device from the pump 10. In this case, the medication management device 20 may be connected to the pump 10 via wired or wireless communication means.

[0055] (Medication management method by medication management device) The medication management method performed by the control unit 23 of the medication management device 20 of this embodiment will be described below with reference to Figures 12 to 14. The medication management device 20 may be configured to implement the processes described below by reading a program recorded on a non-temporary computer-readable medium. The non-temporary computer-readable medium includes, but is not limited to, magnetic storage media, optical storage media, magneto-optical storage media, and semiconductor storage media.

[0056] As shown in Figure 12, in this embodiment, the medication management device 20 performs a first stage of processing during surgery (step S101), and then performs a second stage of processing after surgery (step S102). The medication management device 20 may perform only one of the first stage or the second stage of processing. The first stage and the second stage of processing may be switched by a medical professional operating a switch provided on the operation unit 13 of the pump 10. Alternatively, the switching between the first stage and the second stage of processing may be incorporated in advance into a program executed by the control unit 23 of the medication management device 20.

[0057] The details of the first stage of processing (step S101) are shown in Figure 13. First, a healthcare professional operates the control unit 13 to set information such as the drug dosage and administration time. The control unit 23 of the drug management device 20 acquires information on the first drug administration via the acquisition unit 21 (step S201). The control unit 23 stores the information on the first drug administration in the storage unit 22.

[0058] The control unit 23 estimates the drug concentration in the body based on information such as the type of drug, the amount of drug administered, and the administration rate (step S202).

[0059] The control unit 23 generates image data of information to be displayed on the display screen 40 of the display unit 12 based on the estimated drug concentration in the body, and displays it on the display unit 12 (step S203). The control unit 23 may also display a graph showing the trend of drug concentration in the body on the display screen 40.

[0060] The control unit 23 checks whether the time scheduled for additional drug administration has elapsed (step S204). If the time scheduled for drug administration has not elapsed (step S204: No), the control unit 23 proceeds to the next step S205. The control unit 23 checks whether the drug concentration in the patient's body is lower than the first comparison value CV1 (step S205).

[0061] If the scheduled administration time has elapsed in step S204 (step S204: Yes), or if the patient's drug concentration in the body is lower than the first comparison value CV1 in step S205 (step S205: Yes), the control unit 23 proceeds to step S206. In step S206, the control unit 23 notifies the pump control unit 14 of the pump 10 to start bolus administration of the drug to the fluid delivery unit 11 (step S206). Furthermore, the control unit 23 updates the drug administration history information by adding the drug administration information related to the drug administered this time to the drug administration history stored in the storage unit 22 (step S207).

[0062] If the patient's drug concentration in step S205 is equal to or greater than the first comparative value CV1 (step S205: Yes), or after step S207, the control unit 23 proceeds to step S208. While the first stage of processing is still ongoing (step S208: No), the control unit 23 returns to step S202 and repeats the processes of steps S202 to S208. The control unit 23 may have a built-in clock and insert a process to wait for time to pass between step S208 and step S202, so that the process of step S202 is performed at predetermined time intervals. The predetermined time can be set to any time including, for example, 1 second, 3 seconds, or 10 seconds. When the surgery is completed and the first stage of processing is finished (step S208: Yes), the control unit 23 returns to the flowchart in Figure 13 and proceeds to step S102.

[0063] As described above, the control unit 23 can automatically administer the drug to the patient during surgery when the scheduled drug administration time arrives, or when the drug concentration in the body falls below the first comparative value CV1. This reduces the burden on medical personnel during surgery and allows the drug to be administered to the patient at the appropriate time.

[0064] Next, the details of the second stage of processing (step S102) are shown in Figure 14. Assume that the patient has finished surgery and has been moved to a hospital room with the pump 10 still attached. The control unit 23 continues to estimate the drug concentration in the body (step S301).

[0065] The control unit 23 checks whether the estimated drug concentration in the body is lower than the third comparison value CV3 (step S302). If the drug concentration in the body is not lower than the third comparison value CV3 (step S302: No), the control unit 23 displays a normal display on the display screen 40, such as the drug concentration trend graph shown in Figure 5. If the drug concentration in the body is lower than the third comparison value CV3 (step S302: Yes), the control unit 23 displays a pain confirmation message on the display screen 40, as shown in Figure 11 (step S304).

[0066] Next, the control unit 23 determines whether or not there is an input from the patient indicating an instruction to administer a drug (step S305). If the patient operates the PCA switch on the operation unit 13, or if the patient presses the administration start button 45 on the display screen 40, the control unit 23 determines that there has been an input from the patient indicating an instruction to administer a drug (step S305: Yes).

[0067] If the patient gives an input indicating an instruction to administer medication (step S305: Yes), the control unit 23 determines whether the patient's internal drug concentration is at a level where the medication can be administered (step S306). If the patient's internal drug concentration is higher than the second comparison value CV2, the control unit 23 determines that the medication cannot be administered (step S306: No). In that case, the control unit 23 proceeds to step S310 without administering the medication. At this time, the control unit 23 may display on the display screen 40 that the medication cannot be administered. A result of No in step S306 is when the patient spontaneously operates the PCA switch on the operation unit 13 without going through step S304.

[0068] In step S306, if the patient's internal drug concentration is lower than the second comparison value CV2 and the drug is at an administerable concentration (step S306: Yes), the control unit 23 records the patient's current internal drug concentration in the storage unit 22 (step S307). This internal drug concentration is then used to calculate the third comparison value CV3, which is used in step S302. Subsequently, the control unit 23 notifies the pump control unit 14 to start bolus administration of the drug (step S308). Furthermore, the control unit 23 updates the drug administration history information by adding the drug administration information related to the drug administered this time to the drug administration history stored in the storage unit 22 (step S309).

[0069] If the patient does not input drug administration in step S305 (step S305: No), if the patient's internal drug concentration is not sufficient for drug administration in step S306 (step S306: No), or after step S309, the control unit 23 proceeds to step S310. While the second stage processing is ongoing (step S310: No), the control unit 23 returns to step S301 and repeats the processing in steps S301 to S310. Similar to step S202 in Figure 13, the control unit 23 may perform the processing in step S301 at predetermined time intervals. When the second stage processing is completed, such as when a medical professional operates the control unit 13 to end the operation of the pump 10 (step S310: Yes), the control unit 23 returns to the flowchart in Figure 12 and terminates the processing.

[0070] As described above, with the pump 10 incorporating the medication management device 20 according to this embodiment, the control unit 23 estimates the drug concentration in the patient's body, making it possible to estimate the current effect of the drug on the patient. This allows the control unit 23 to determine and execute the appropriate process from among multiple processes. This improves the technique of administering drugs.

[0071] For example, the medication management device 20 can prevent healthcare professionals from overlooking information and / or making mistakes in situational judgment by issuing messages to healthcare professionals based on the estimated drug concentration in the patient's body. Furthermore, the medication management device 20 controls the effectiveness or ineffectiveness of the patient's actions to instruct drug administration based on the estimated drug concentration in the patient's body, thereby preventing patients from overdosing. Additionally, the medication management device 20 can support patients in receiving medication at the appropriate time by displaying messages to confirm their willingness to receive medication in appropriate situations.

[0072] Furthermore, the medication management device 20 stores the drug concentration in the patient's body in the memory unit 22 when the patient administers the drug by operating the PCA switch, etc., thereby enabling a correlation between the effectiveness of the drug and the degree of pain experienced by the patient, and supporting the decision-making of healthcare professionals.

[0073] In this embodiment, a first comparative value CV1 is set during the first period P1 in surgery, and second and third comparative values ​​CV2 and CV3 are set during the second period P2 after surgery. However, each comparative value CV1 to CV3 may be set individually or simultaneously under any circumstances. For example, in the second period P2, the first comparative value CV1 may be set together with the second and third comparative values ​​CV2 and CV3. In this case, if the drug concentration in the patient's body falls below the first comparative value CV1, the drug will be automatically administered to the patient's body without the patient having to operate the PCA switch.

[0074] (Medication Management System) Figure 15 is a block diagram showing the configuration of a medication management system 1 according to another embodiment. The medication management system 1 includes one or more pumps 50 and a medication management device 60. The medication management device 60 can be an independent device that is communicatively connected to one or more pumps 50. The medication management device 60 may be, for example, a general-purpose PC (Personal Computer) or a dedicated computer. The functions of the medication management device 60 may be distributed across multiple hardware devices rather than a single hardware device.

[0075] The medication management system 1 may include a pump 50 and a medication management device 60, as well as a display device 70 dedicated to displaying information, which may be placed in a nurse's station or the like. The pump 50, medication management device 60, and display device 70 are configured to communicate with each other via a wired and / or wireless network 80. The network 80 is, for example, a LAN (Local Area Network) within a medical institution, but the network 80 may also be connected via a wide-area network such as the Internet to connect remote locations.

[0076] The pump 50 is comprised of a liquid delivery unit 51, a display unit 52, an operation unit 53, a pump control unit 54, and a communication unit 55. The liquid delivery unit 51, display unit 52, operation unit 53, and pump control unit 54 may be configured in the same way as the liquid delivery unit 11, display unit 12, operation unit 13, and pump control unit 14 of the pump 10 in Figure 1. The communication unit 55 is equipped with a communication interface corresponding to the communication method of the network 80 and transmits and receives data with the communication unit 61 of the drug management device 60.

[0077] The medication management device 60 includes a communication unit 61, a storage unit 62, a control unit 63, a display unit 67, and an input unit 68. The communication unit 61 is equipped with a communication interface corresponding to the communication method of the network 80 and can acquire various types of information, including drug administration information, from the pump 50. Therefore, the communication unit 61 functions as an acquisition unit. The communication unit 61 can transmit data for the display screen to be displayed on the display unit 52 and the display device 70 of the pump 50, according to instructions from the display control unit 65, to the pump 50 and the display device 70.

[0078] The storage unit 62, the control unit 63, and the estimation unit 64, display control unit 65, and determination unit 66 included in the control unit 63 may be configured in the same way as the storage unit 22, control unit 23, estimation unit 24, display control unit 25, and determination unit 26 of the medication management device 20 in Figure 1. The storage unit 62 may store drug administration history information for each of the multiple pumps 50. The control unit 63 may process the information for each of the multiple pumps 50, or collectively. The display control unit 65 may control not only the display unit 52 of the pump 50, but also the images displayed on the display unit 67 of the medication management device 60 and / or the display device 70.

[0079] The display unit 67 is a display device including, for example, a liquid crystal display, an organic EL display, or an inorganic EL display. The display control unit 65 may display information for multiple pumps 50 together on the display unit 67. The input unit 68 may receive instructions for the pumps 50 from medical personnel, including instructions for drug administration.

[0080] With the configuration described above, healthcare professionals can centrally manage the drug concentrations in the bodies of multiple patients fitted with pumps 50 using the medication management device 60. Furthermore, by placing the display device 70 in a nurse's station or similar location, healthcare professionals can monitor the status of drug administration by multiple pumps 50 from a single location.

[0081] While embodiments relating to this disclosure have been described based on the drawings and examples, it should be noted that those skilled in the art will find it easy to make various modifications or alterations based on this disclosure. Therefore, it should be noted that these modifications or alterations are included within the scope of this disclosure. For example, the functions included in each component or step can be rearranged in a logically consistent manner, and multiple components or steps can be combined into one or divided. While embodiments relating to this disclosure have been described primarily in terms of apparatus, embodiments relating to this disclosure can also be realized as methods including steps performed by each component of the apparatus. Embodiments relating to this disclosure can also be realized as methods, programs, or storage media recording programs executed by a processor in the apparatus. These should also be understood to be included within the scope of this disclosure.

[0082] 1 Medication Management System 10 Pump 11 Fluid Delivery Unit 12 Display Unit 13 Operation Unit 14 Pump Control Unit 20 Medication Management Device 21 Acquisition Unit 22 Storage Unit 23 Control Unit 24 Estimation Unit 25 Display Control Unit 26 Determination Unit 31 First Compartment 32 Second Compartment 33 Third Compartment 34 Area of ​​Effect 40 Display Screen 41 Drug Administration Mode Display Area 42 Drug Name Display Area 43 Medication Status Display Area 44 Message Display Area 45 Start Administration Button 50 Pump 51 Fluid Delivery Unit 52 Display Unit (Display Device) 53 Operation Unit 54 Pump Control Unit 55 Communication Unit 60 Medication Management Device 61 Communication Unit (Acquisition Unit) 62 Storage Unit 63 Control Unit 64 Estimation Unit 65 Display Control Unit 66 Determination Unit 67 Display Unit (Display Device) 68 Input Unit 70 Display Device 80 Network T Administration Time P1 First Period (During Surgery) P2 Second Period (Post-Surgery) t1-t7 Elapsed Time Dp Current Drug Concentration in Body CV1 First Comparison Value (Third Threshold) CV2 Second Comparison Value (Second Threshold) CV3 Third Comparison Value (First Threshold)

Claims

1. A medication management device comprising: an acquisition unit that acquires medication administration information including the dosage and time of administration of a patient's medication; a storage unit that stores the patient's past medication administration information as medication administration history information; and a control unit that estimates the patient's internal drug concentration based on the medication administration history information and executes a process determined from a plurality of different processes based on the estimated internal drug concentration of the patient.

2. The drug management device according to claim 1, wherein the control unit estimates the concentration of the drug in the body using a pharmacokinetic / pharmacodynamic (PK / PD) model.

3. The drug dispensing management device according to claim 1, wherein the control unit sets at least one threshold for the concentration of a drug in the body and determines the process to be executed from the plurality of different processes based on the relationship between the estimated concentration of the drug in the patient and the at least one threshold.

4. The medication management device according to claim 3, wherein the at least one threshold includes a first threshold, and the control unit causes a message to be displayed on a screen to the patient to confirm the administration of the drug when the estimated drug concentration in the patient's body is lower than the first threshold.

5. The drug administration management device according to claim 4, wherein the control unit is configured to receive a request from the patient for the administration of the drug, and the control unit sets the first threshold based on the concentration of the drug in the patient's body when it previously received a request from the patient for the administration of the drug.

6. The medication management device according to claim 3, wherein the at least one threshold includes a second threshold, and the control unit prohibits the administration of the drug to the patient when the estimated concentration of the drug in the patient's body is higher than the second threshold.

7. The medication management device according to claim 3, wherein the at least one threshold includes a third threshold, and the control unit automatically administers the drug to the patient when the estimated concentration of the drug in the patient is lower than the third threshold.

8. The medication management device according to any one of claims 1 to 7, wherein the control unit generates image information showing the time-series changes in the concentration of the drug in the patient's body, and displays an image based on the image information on a predetermined display device.

9. A medication management system comprising the medication management device described in claim 1 and a pump, wherein the acquisition unit of the medication management device acquires the drug administration information from the pump.

10. A pump equipped with the medication management device described in claim 1.

11. A medication management method performed by a medication management device, comprising: acquiring medication administration information including the dosage and time of administration of a patient's medication; storing the patient's past medication administration information as medication administration history information; estimating the patient's internal drug concentration based on the medication administration history information; and performing a process determined from a plurality of different processes based on the estimated internal drug concentration of the patient.

12. A program that causes a computer to perform a process that includes: acquiring drug administration information including the dosage and time of administration of a patient's medication; storing the patient's past drug administration information as drug administration history information; estimating the patient's internal drug concentration based on the drug administration history information; and executing a process determined from a plurality of different processes based on the estimated internal drug concentration of the patient.

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