JP2010211538A - Medicine information integrated management system and information management method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To construct a system allowing management of a flow of medicine to dosage to a patient in a medical institution from production in a drug company in each individual article. <P>SOLUTION: In this medicine information integrated management system, a drug company information system and a medical institution information system are connected via a network, at least an individual article identification ID is written in an electronic tag in the drug company, an in-medical-institution identification ID for identifying an administration unit to the patient is created in the medical institution, a unique ID is created from the individual article identification ID and the in-medical-institution identification ID, and is registered in the medical institution information system, and the in-medical-institution identification ID is written in the electronic tag. By the created unique ID, information to the dosage of the medicine in the medical institution from shipment of the medicine in the drug company can be unified in management in each individual article of the medicine. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to an information management system and an information management method for integrating and managing information from shipment from a pharmaceutical company to medication to a patient for each individual drug product.

In recent years, it has become necessary to ensure traceability from the time of manufacture to the time of final sale of products that are consumed by the human body, such as foods and pharmaceuticals. In addition, medical institutions may have serious consequences if prescription drugs are not properly administered to patients, and countermeasures have been required to prevent misadministration. In addition, as a countermeasure against influenza, the type and amount of medicines consumed may vary greatly depending on the time, such as the consumption of vaccines during the vaccination period, and the need for more antibiotics during the epidemic. There is also a need to optimize drug inventory at institutions.
In order to meet such a demand, for example, Patent Document 1 has an electronic tag attached to a medicine, and medicine identification information such as a medicine identification code, medicine name, or medicine capacity is stored in an IC card. It is proposed to verify whether or not medicines have been used properly.

JP 2003-95440 A

In the case where a defect occurs in a medicine, it is not sufficient to accurately track the medicine only by managing the medicine with a product code (GTIN code) in order to ensure the traceability of the medicine.
In the event that a defect occurs, follow-up surveys on how the product with the defect was distributed, and in order to collect all defective items remaining in the inventory, distribution process, medical institution, etc. Management is required. In addition, the presence or absence of side effects caused by pharmaceuticals and the degree of influence of side effects are not determined solely by the amount and frequency of use of pharmaceuticals, but are greatly influenced by the constitution of the patient to be administered and the physical condition at the time of administration. Therefore, there is a strong need for information on how pharmaceuticals are administered to specific patients on an individual basis.

  In a pharmaceutical company, if an electronic tag is attached to an individual product of a pharmaceutical product and an individual product identification ID is given to the electronic tag, the pharmaceutical product can be managed for each individual product. On the other hand, in a medical institution, when a medicine is delivered (withdrawn) based on a doctor's order, an in-medical institution identification ID is assigned and managed for each unit of administration to a patient. Therefore, it is important to solve the problem that information management of individual pharmaceutical products and pharmaceutical management based on order information at a medical institution are performed independently and independently of each other.

  The present invention forms a unique ID from an in-medical institution identification ID and an individual product identification ID that are newly given to each medicine at the time of delivery of the medicine in the medical institution, and registers the unique ID in the medical institution information system. , Associate the individual product ID given to the individual product of the drug by the pharmaceutical company with the in-medical institution ID assigned to each individual product of the drug by the pharmacy of the medical institution, and determine the patient attribute from the individual product information of the drug. The information and the medication information for the patient are centrally managed.

That is, the present invention is as follows.
[1] An electronic tag attached to each individual pharmaceutical product;
A pharmaceutical company information system for managing pharmaceutical information;
A medical institution information system for managing at least drug entry / exit information, prescription information, electronic medical record and patient attribute information;
A pharmaceutical information integrated management system having a network connecting at least a pharmaceutical company information system and a medical institution information system,
The pharmaceutical company information system includes a first reader / writer, writes at least an individual product identification ID, a product code, a serial number, and an expiration date on an electronic tag, sets overwriting prohibition,
The medical institution information system includes a second reader / writer, receives the read individual identification ID via the second reader / writer,
When a medical institution identification ID for identifying a dosage unit for a patient is input to the medical institution information system,
The medical institution information system writes the in-medical institution identification ID into the empty area of the electronic tag via the second reader / writer, and constructs a unique ID from the read individual product identification ID and in-medical institution identification ID,
A pharmaceutical information integrated management system that allows a medical institution information system to centrally manage everything from individual product information to patient attribute information and medication information to a patient via a unique ID.
[2] A medical institution information system includes a medical institution computer, and the medical institution computer receives an in-medical institution identification ID for identifying an administration unit to a patient in the medical institution; An individual product identification ID receiving unit that receives an individual product identification ID read via the second reader / writer, a unique ID configuration unit that constitutes a unique ID from the medical institution identification ID and the individual product identification ID; The pharmaceutical information integrated management system according to [1], further including an in-medical institution identification ID assigning unit that assigns an in-medical institution identification ID to an electronic tag using a reader / writer.
[3] The medical institution information system has a use result survey data creation function,
When there is a request from the pharmaceutical company information system for usage-results survey data for a pharmaceutical product with an individual product identification ID,
The medical institution information system was created by using the individual product identification ID as a key to identify the drug use result information accumulated in the medical institution information system and using the use result investigation data creation function to create the use result investigation data. The pharmaceutical information integrated management system according to the above [1] or [2], which provides use result survey data to a pharmaceutical company information system.
[4] The medical institution information system has an effectiveness survey data creation function,
When there is a request from the pharmaceutical company information system for efficacy survey data for a pharmaceutical product having an individual product identification ID,
The medical institution information system was created by identifying the drug use information accumulated in the medical institution information system using the individual product identification ID as a key, and creating the efficacy survey data using the efficacy survey data creation function. The pharmaceutical information integrated management system according to the above [1] or [2], wherein the efficacy survey data is provided to the pharmaceutical company information system.
[5] The medical institution information system has a medical institution terminal, and the medicine information stored in the pharmaceutical company information system can be acquired from the medical institution terminal using the in-medical institution identification ID as a key. [4] The pharmaceutical information integrated management system according to any one of [4].
[6] A distribution base information system that is installed at a distribution base that mediates pharmaceuticals from a pharmaceutical company to a medical institution, is connected to at least the pharmaceutical company information system via a network, and includes a reader / writer. The pharmaceutical product according to any one of [1] to [5] above, wherein entry / exit information for each individual pharmaceutical product is written in an electronic tag or registered in a distribution base computer. Integrated information management system.
[7] The pharmaceutical information integrated management system according to any one of [1] to [6], wherein the pharmaceutical is a biological product or a specific biological product.
[8] An electronic tag attached to each individual pharmaceutical product;
A pharmaceutical company information system that has a computer and a database and manages pharmaceutical information;
A medical institution information system having a computer and a database, and managing at least drug entry / exit information, prescription information, electronic medical records and patient attribute information;
An information management method applied to a pharmaceutical information integrated management system having a network connecting a pharmaceutical company information system and a medical institution information system,
The pharmaceutical company information system writes at least the individual product identification ID, the product code, the serial number and the expiration date on the electronic tag based on the pharmaceutical information stored in the database, and sets the overwriting prohibition;
When a medicine is issued from a medical department of a medical institution, the computer of the medical institution information system configures a unique ID from the in-medical institution identification ID and the individual product identification ID for identifying the administration unit to the input patient. And registering with the medical institution information system,
The computer of the medical institution information system has a step of writing the medical institution identification ID on the electronic tag,
An information management method characterized by identifying drug use information stored in a medical institution information system using an individual product identification ID as a key, and providing necessary information from the medical institution information system to the pharmaceutical company information system.
[9] Drug use information is drug use results survey data,
The medical institution information system has a function to create usage data.
From the pharmaceutical company information system to the medical institution information system, requesting the use result survey data of the medicine having the individual product identification ID;
The medical institution information system activates the use result survey data creation function, specifies the drug use result information accumulated in the medical institution information system using the individual product identification ID as a key, and creates use result data;
The information management method according to [8], further including a step of the medical institution information system transmitting the created drug use result survey data to the pharmaceutical company information system.
[10] The drug use information is drug efficacy survey data,
The medical institution information system has a function to create efficacy survey data.
From the pharmaceutical company information system to the medical institution information system, requesting the efficacy survey data of the medicine having the individual product identification ID;
The medical institution information system activates the efficacy survey data creation function, specifies the drug use result information accumulated in the medical institution information system using the individual product identification ID as a key, and creates efficacy data;
The information management method according to [8], further including a step in which the medical institution information system transmits the created drug effectiveness survey data to the pharmaceutical company information system.
[11] A step in which the computer of the medical institution information system constructs a second unique ID from the new institution identification ID and the individual item identification ID when the unused medicine returned to the pharmacy is reissued; The information management method according to the above-mentioned [8], further comprising: overwriting a new medical institution identification ID on an electronic tag attached to the individual drug product.
[12] At the time of co-administration administration of a plurality of medicines, the computer of the medical institution information system for each given medicine institution ID identifies, for each of the plurality of medicines, an institution ID and an individual product identification ID. The information management method according to [8], further including a step of configuring and recording a unique ID.
[13] The information management method according to any one of [8] to [12], wherein the pharmaceutical is a biological product or a specific biological product.
[14] The above-mentioned [1] to [1], wherein an overwrite prohibition area and a writable area are provided, and an individual product identification ID, a product code, a manufacturing number, and an expiration date are recorded in the overwrite prohibition area. 7] An electronic tag used for the pharmaceutical information integrated management system according to any one of [7].
[15] A pharmaceutical packaging unit equipped with the electronic tag according to [14] above.
Here, the drug refers to a drug administered to a patient based on a doctor's prescription, more specifically, a drug administered to a patient by a medical worker such as a doctor or a nurse.
In addition, the individual product is a dispensing package unit for pharmaceutical products such as an ampule injection, a vial injection, a cartridge injection, a syringe injection, and a bag infusion.
The individual product identification ID may be a completely unique identification ID for identifying each dispensing packaging unit. For example, Ucode of Ubiquitous ID Center, EPC Global Inc. The serial ID of EPC can be given.
On the other hand, the identification ID within the medical institution only needs to be able to identify the unit of administration to the patient within one medical institution, and complete uniqueness including the outside of the medical institution is not necessarily required. It may have a thickness.
A medical institution refers to an institution that performs medical activities on patients, such as hospitals and clinics, regardless of the number of beds of patients.
Patient attribute information refers to information about the patient himself / herself regarding the patient's name, address, gender, age, height, weight, disease name, etc., and medication information to the patient refers to the administration date and dose of the drug to the patient. Information on the administration of pharmaceuticals to patients, such as the number of administrations.
As a method for prohibiting overwriting of information written in an electronic tag, a method known in the technical field of the electronic tag can be applied. For example, write prohibition for each block by a write lock command of ISO15693, The tamper-proof Lock command proposed in the Hibiki / Secure RFID tag project can be used.

A unique ID is composed of the individual product identification ID given to the individual product of the drug by the pharmaceutical company and the intra-medical institution identification ID given to each patient administration unit in the pharmacy of the medical institution, and medical treatment is performed on the electronic tag. By writing the in-engine identification ID, the following effects can be obtained.
Through the unique ID, each item of drug (or drug) is associated with the electronic medical record of the patient used, so the usage status is clarified for each item and the drug traceability is greatly improved.
The GTIN code of the electronic tag attached to each medicine and the medical product name code (including GTIN code and JAN code) written in the prescription order are matched and the medical institution identification ID is recorded. Since it is easy and reliable to collate pharmaceutical information with prescription information and patient attribute information on the side, it is effective in preventing the occurrence of medication errors in the medical field.
Through the unique ID, it is possible to associate drug information from pharmaceutical companies with information from electronic medical records from medical institutions. Therefore, investigation of drug use results and efficacy studies that were not possible before (such as post-marketing clinical trials) ) Becomes easy.
In lot-based management, when a mixed medicine is dispensed in the dispensing room, it moves within the medical institution in the unit of administration to the mixed patient, so it is difficult to trace the original medicine. By registering the unique ID for each administration unit associated with the item, it becomes easy to associate with the individual pharmaceutical product even after mixed injection.
When a prescription order code is used as a medical institution identification ID, when a medicine that has not been used is returned to the pharmacy, it only needs to be overwritten on the electronic tag on the order code that was previously dispensed. In addition, it is accurate and easy to manage the delivery of medicines.
When using a conventional barcode, it is necessary to bring the barcode close to the optical device so that the barcode portion can be read optically in order to read the information of individual items. The electronic tag can be read and written to the electronic tag in a non-contact manner, which reduces the burden of reading work and eliminates the need for optical reading. It is possible to read and write information on the dispensing packaging unit (ie, individual product). In addition, since there is no need for optical reading, the occurrence of reading troubles due to the appearance process in the distribution process and medical institutions is reduced.

FIG. 1 is a block diagram illustrating a pharmaceutical information integrated management system according to an embodiment of the present invention. FIG. 2 is a block diagram illustrating a pharmaceutical company information system according to an embodiment of the present invention. FIG. 3 is a block diagram illustrating a medical institution information system according to an embodiment of the present invention. FIG. 4 is a block diagram illustrating a medical institution computer according to an embodiment of the present invention. FIG. 5 is a flowchart for explaining an information management method according to an embodiment of the present invention. FIG. 6 is a block diagram illustrating a medical institution information system according to an embodiment of the present invention. FIG. 7 is a chart of traceability information output results according to an embodiment of the present invention. FIG. 8 is a flowchart for explaining an outline of a method in which the pharmaceutical company information system obtains use result survey data from the medical institution information system in the pharmaceutical information integrated management system according to the embodiment of the present invention. FIG. 9 is a chart of output results of usage result survey information according to an embodiment of the present invention. FIG. 10 is a flowchart for explaining information processing in the return processing in the medical institution information system according to the embodiment of the present invention. FIG. 11 is a flowchart for explaining information processing in mixed injection in the medical institution information system according to an embodiment of the present invention.

  Hereinafter, the present invention will be specifically described with reference to the drawings. In addition, this invention is not limited only to the following embodiment.

  As shown in FIGS. 1 to 4, the pharmaceutical information integrated management system of the present invention includes a pharmaceutical company information system 100 including one or more terminals 101 and a medical institution information system 200 including one or more terminals 201. The pharmaceutical company information system 100 and the medical institution information system 200 are connected via a network 300. Between the pharmaceutical company information system 100 and the medical institution information system 200, a distribution base information system 400 including one or a plurality of terminals 401 may be provided via the network 300.

  The pharmaceutical company information system 100 includes a first reader / writer 110 for electronic tags, a display 120, a pharmaceutical company computer 130, a database 140, and a transmission / reception device 150.

  The first reader / writer 110 is a device that can write signals to and read signals from the electronic tag 500 mounted on an individual pharmaceutical product. When the electronic tag 500 uses a radio frequency (RF) of 13.56 MHz, a signal can be read / written in a contactless manner at a distance of several tens of centimeters from the electronic tag 500. A commercially available reader / writer can be used as such a reader / writer. For example, an RFID reader / writer (part numbers FTRF-T110, FTRF-T121) manufactured by Fujitsu, which conforms to the RFID standard of ISO15693 can be used.

  The pharmaceutical company computer 100 acquires an individual product identification ID corresponding to each electronic tag 500 attached to the pharmaceutical product, and stores the individual product identification ID in the database 140. At the same time, drug information is written in the electronic tag 500. The pharmaceutical information to be written includes at least an individual product identification ID, a product code, a production number, and an expiration date for each dispensing unit. Further, the pharmaceutical company computer 100 has overwriting prohibition means in the CPU, and after overwriting information on the individual product identification ID, product code, serial number and expiration date on the electronic tag 500 of the present invention, overwriting is prohibited. The means has a feature that the information is set to prohibit overwriting. Another feature of the electronic tag of the present invention is that a free area is provided for a medical institution, and the memory area is set so that the medical institution can freely write.

  Of the information written in the electronic tag, the product code includes a GTIN code and a JAN code. The JAN code is obtained by removing the first digit (distribution identification code) of the GTIN code which is an international standard commodity identification code. In the case of GTIN code, the original packing unit has 2 before the JAN code, the sales packaging unit has 1 before the JAN code, and the dispensing packaging unit has 0 before the JAN code. . Therefore, the sales packaging unit and the dispensing packaging unit have the same JAN code, but in the case of the GTIN code, the first digit is different. In addition, when an electronic tag is used, the GTIN code and JAN code of the dispensing packaging unit can be collectively read from the outside of the package, which is a feature that is not found in a barcode. Further, as the individual product identification ID, the “ucode” specification of the ubiquitous ID center or EPC (Electronic Product Code) of EPC Global Inc. can be used.

  Since the amount of information increases, the detailed attribute data of the medicine may be stored in the database 140 without being written in the electronic tag so that it can be referred to from the individual product identification ID or the product code. For example, when an electronic tag 500 having a memory usage area of 112 bytes is used, the above information can be written by using 91 bytes at the time of manufacture. Also, 16 bytes are secured as a memory area that can be used later in a medical institution. Further, when using the electronic tag 500 having a memory use area of 196 bytes, a pharmaceutical company can use 43 bytes for assigning an individual product identification ID and provide 20 bytes of free area for writing in a medical institution. The electronic tag 500 is preferably a passive type from the viewpoint of cost, small size, etc., but an active type may be used. As a specific example of a commercially available ISO / IEC15693 ISO 18000-3 model 1 compliant electronic tag, for example, TS-L series (102LU, 102JC, 102CC, 102DC) manufactured by Lintec Corporation having a communication frequency of 13.56 MHz. ) And the like. Note that the communication frequency of the electronic tag is not limited to 13.56 MHz, and an electronic tag using a communication frequency in the UHF band (950 MHz) or the microwave band (2.45 GHz) may be used.

  The transmission / reception device 150 transmits / receives information among the pharmaceutical company information system 100, the medical institution information system 200, and the distribution base information system 400.

  As shown in FIG. 3, the medical institution information system 200 includes a second reader / writer 210 for electronic tags, a display 220, a medical institution computer 230, a database 240, and a transmission / reception device 250. The medical institution information system 200 does not need to be provided in the medical institution and may be installed outside the medical institution. Further, it may be an information system in which a plurality of, for example, affiliated medical institutions are bundled. Furthermore, the functions performed by the medical institution information system can be partially substituted on the network (or on the Internet).

  In a medical institution, in addition to the receipt and delivery of medicines, the use (administration) of medicines, and return of goods, information such as patient attribute information, prescription information, and electronic medical records is stored in the database 240, and these are related to each other. A plurality of information to be intertwined in a complicated way. In the medical institution, the flow of medicines from delivery from the pharmacy etc. to bedside medication (medicine) is identified within the medical institution given to the unit of administration to each patient based on the doctor's order. Managed by ID. The identification ID within the medical institution may be an ID that can identify the administration unit within the medical institution. For example, a serial ID unique to the medical institution corresponding to the administration unit to the patient, a prescription order code (hereinafter referred to as order) Code)). Here, as the prescription order code, one order code is generated each time a doctor in the medical institution prescribes a predetermined medicine to a specific patient from a terminal of the medical institution. In the present invention, from the identification ID in the medical institution and the individual identification ID given to the electronic tag by the pharmaceutical company, by configuring a unique ID, from the individual drug information to the patient attribute number and the medication information to the patient. It is characterized by centrally managing.

  Next, as an embodiment, a specific method for constructing a unique ID from an order code and an individual product identification ID using an order code as a medical institution identification ID will be exemplified.

  Now, assuming that the order code is (AAAA) and the individual product identification ID of the medicine is (111111), a unique ID (111111AAAAA) can be constructed from these two IDs. This unique ID (111111AAAAA) may be written in the electronic tag as one new code. However, in this embodiment, only the order code (AAAAA) is recorded in the medical institution writing area and read out by the computer in advance. The individual product identification ID (111111) written by the company and the order code (AAAAA) are combined and recognized as a unique ID (111111AAAAA), for example. Note that the form of combination at this time is not limited to the form in which the order code is combined with (111111AAAAA) after the individual product identification ID, and may be the opposite (AAAAA111111) or other combinations.

  FIG. 4 shows a system for generating and managing a unique ID based on order information in a medical institution computer. When the doctor orders a medicine from the terminal 201 of the medical institution, the medical institution identification ID receiving unit 231 receives the order and simultaneously generates an order code. On the other hand, the individual product identification ID read from the second reader / writer 210 is received by the individual product identification ID receiving unit 232. The order code generated by the medical institution identification ID reception unit 231 and the individual product identification ID received by the individual product identification ID reception unit 232 are transmitted to the unique ID configuration unit 233, and the individual product identification ID, the order code, Is a unique ID. Further, the order code is transmitted to the medical institution identification ID assigning unit 234, and is written in the empty area of the electronic tag (16 bytes in the above example) via the second reader / writer 210. On the other hand, the unique ID is recorded and stored in the database 240 in association with the order code and the individual product identification ID. Information regarding the unique ID may be transmitted from the transmission / reception device 250 to the pharmaceutical company information system 100 and the distribution base information system 400 via the network 300.

Next, with reference to FIG. 5, a method according to an embodiment for managing drug information by the drug information integrated management system of the present invention will be described. In the present embodiment, a flow from shipment to administration of a plasma fraction preparation Venoglobulin (registered trademark) -IH _Yoshitomi (hereinafter abbreviated as VG agent) as a pharmaceutical will be described. First, a pharmaceutical company records an individual product identification ID, a product code, a production number, and an expiration date on an electronic tag, sets overwriting prohibition, and attaches an electronic tag to each medicine (S101). The electronic tag (also referred to as an IC tag) used in this embodiment is a type that can be read / written with an electromagnetic wave of 13.56 MHz, and the dimensions of the tag are 30 mm wide × 20 mm long. The memory usage area of the electronic tag is 112 bytes, and the pharmaceutical company uses 91 bytes.

  The mounting format of the electronic tag varies depending on the form of the pharmaceutical product. Since the VG agent used in this embodiment is contained in a vial container, an electronic tag is attached to the bottom of the container. In the case of an infusion solution enclosed in a bag, it may be attached to the side of the bag. In order to record the information of the electronic tag in association with the medication information to the patient, etc., and to enable tracing up to the dosage stage to the patient, the electronic tag must be attached to the drug until the stage of administration to the patient. I must. Therefore, it is necessary to attach directly to a pharmaceutical bottle, bottle or bag, or at least to a single package. If it is an adhesive label type electronic tag, it can be directly attached to a container or a soft bag. For the purpose of lot management or the like, an electronic tag may be further attached to an assembly box packed in a plurality of individual packaging units or an original packaging.

  A medicine with an electronic tag attached to each item passes through a distribution base such as a wholesaler, and passage information is registered (S102), and then delivered to a medical institution. The passing information at the distribution base may be written in an electronic tag, recorded in the distribution base information system, or transmitted to the pharmaceutical company information system. In the medical institution, the individual product identification ID of the pharmaceutical is read using a reader / writer (S103) and registered in the medical institution information system (S104). Note that a serial ID unique to a medical institution corresponding to an individual drug product may be given when entering the medical institution drug department (S105). When the doctor decides to administer the VG agent to a specific patient and inputs the delivery order of the VG agent (S106), an order code corresponding to the order is generated (S107). Next, a unique ID is constructed from the previously received individual product identification ID and order code, and is registered in the medical institution information system (S108). The unique ID configured in this way plays a role of centrally managing information on the VG agent held by the pharmaceutical company and information until the VG agent is administered to the patient at the medical institution. The VG agent is delivered after the order code is written on the attached electronic tag (S109). At the bedside, the patient ID and the medicine order code are collated, and then the patient is dispensed (S110), and the medication record is registered in the medical institution information system (S111). In this way, an electronic tag is attached to each container of the VG agent, and the individual product identification ID, product code, production number, and expiration date are written on the electronic tag, so that the appropriateness of the medicine can be instantaneously and at the bedside, and It can be determined accurately. At the same time, traceability of pharmaceuticals can be ensured because a detailed history of individual medicines shipped from a pharmaceutical company can be listed until they are administered to a patient.

  Next, an application example of the unique ID configured as described above will be described below. FIG. 6 shows an outline of an embodiment of a medical institution information system. The medical institution information system 200 includes a medical image network system (PACS) 2200, an electronic medical record system 2300, an ordering system 2400, a reception system 2500, and other systems 2600, which are medical institution computers. Processed and controlled at 230. Each of these systems may have a CPU and a microcomputer, and may share the processing and control of the medical institution computer 230. The medical institution computer 230 also stores and controls the processed data in order to store and control the patient attribute database 2710, the electronic medical record database 2710, the PACS database 2730, the traceability database 2740, the usage result survey database 2750 in the database (DB) 2700, and Utilize the effectiveness survey database 2760. Note that the usage record survey DB 2750 and the effectiveness survey DB 2760 may be independent DBs, or may be a specific storage area in the database 2700, or the electronic medical record DB 2720 may be the use record survey DB 2750 and the validity. A survey DB 2760 may be included. Also, the electronic medical record system 2300 replaces the paper medical chart, in which the doctor / dentist has entered the progress of the medical treatment, with an electronic system, edits and manages the medical record collectively as electronic information, and records it in the database In this embodiment, it includes patient attribute information, prescription information, medication information, and examination information. Further, the electronic medical record system 2300 has a use result survey data creation function and an effectiveness survey data creation function, as will be described later.

  As described above, the process from the delivery at the pharmaceutical company to the medication to the patient is related and centrally managed through the unique ID. Now, when order information 2800 based on a doctor's order input is given, a unique ID is created by the ordering system 2400 and stored in the electronic medical record DB 2720 in association with the electronic medical record system 2300 or the like.

  Since the order information 2800 is associated with a unique ID, for example, by inputting a product code (GTIN code), a manufacturing number (lot number), and an inspection classification from a terminal of a pharmaceutical company, a part of them is shown in FIG. As shown, a data list can be easily obtained. The form shown in FIG. 7 shows prescription ID, nurse in addition to drug information such as name (venoglobulin IH), GTIN code, lot number, expiration date, and individual identification code (ucode). Information in the medical institution such as ID and presence / absence of medication is listed. Thus, according to the present invention, easy and accurate traceability can be ensured.

  As a kind of medicine suitable for applying the pharmaceutical information integrated management system and information management method of the present invention, a medicine that is managed in individual units and used under a prescription is preferable. For example, a biological product or a specific biological product may be used. These products have record retention obligations, and pharmaceutical companies are required to store and manage sales record information including product names and serial numbers for 30 years. Medical institutions are required to store product names, serial numbers, It is necessary to store and manage the patient's name / address and administration date for 20 years. Therefore, traceability for each individual product is particularly important for these drugs. An example of a pharmaceutical form to which the present invention is preferably applied is an injection. The injection includes both cases where the pharmaceutical is liquid and solid. It can also be applied to prefilled syringes. Injection forms include ampoules and vials (intravenous, intravenous, intramuscular, subcutaneous, and topical injection), cartridges (self-injection and subcutaneous injection), and syringes (local, intravenous, intraarterial, subcutaneous, and subcutaneous) Self-injection / subcutaneous injection), soft bags, and others (kit formulations).

FIG. 8 shows an embodiment of a flow for obtaining usage result survey information from a pharmaceutical company. In addition, it is only necessary to be within the scope of the inventive concept that the pharmaceutical company information system and the medical institution information system centrally manage information through the unique ID, and the acquisition of use result survey information according to the present invention is limited to the following flow. It is not done.
First, a password (PW) or the like is input from the terminal 101 of the pharmaceutical company information system 100 (S201). When access to the medical institution information system 200 is permitted (S202), the "use result survey" column is selected from the menu screen (not shown) of the terminal 101, and the individual identification ID of the pharmaceutical to be investigated is input. Then, the medical institution information system 200 is requested for use result survey data of the medicine (S203).
The medical institution computer 230 inquires of the electronic medical record system whether or not the use result survey data of the inputted individual product identification ID has been created (S204), and if created, reads the data from the use result survey database 2750. Data is transmitted to the pharmaceutical company information system 100 via the network 300 (S205).
On the other hand, if not created, the medical institution computer 230 issues a use result survey data creation command to the electronic medical record system 2300 (S206). Upon receiving the request, the electronic medical record system 2300 activates the usage record survey data creation function in the electronic medical record system 2300 (S207). The medical institution computer 230 collates the individual product identification ID of the medicine to be investigated input from the terminal 101 with the unique ID (S208), and calls the medical institution identification ID through the unique ID (S209).
The medical institution computer 230 determines whether or not the drug contains an adverse event (S210), collects related information in the electronic medical record system 2300 using the identification ID in the medical institution as a key, and responds to the presence or absence of the adverse event Then, for each medicine, use result survey data is created for a patient to whom the medicine is actually administered (S211).
The medical institution computer 230 stores the newly created usage-results survey data in the usage-results survey database 2750 (S212) and transmits data to the pharmaceutical company information system 100 via the network 300 (S213).
The newly created usage record data may be temporarily stored in the use record database 2750 and then transmitted to the pharmaceutical company information system 100. Before storage, for example, a memory in the electronic medical record system 2300 may be used. The data accumulated in can be directly transmitted to the pharmaceutical company information system 100. In addition, the electronic medical record system 2300 itself may control the processing between S207 and S212 after the medical institution computer 230 issues a use result survey data creation command to the electronic medical record system 2300.
The content of usage-results survey data varies from drug to drug. For example, patient anonymized information (name initials, address, age, gender, height, weight, disease name, etc.), drug administration status ( Administration date / time, dosage, number of administrations, etc.), administration status of concomitant drugs, test data, and the like. In addition, when there are adverse events, test data after the occurrence of the adverse event is added in addition to them. FIG. 9 shows an example in which a part of a form created by collecting the usage result survey data collected in this way is printed.

  Even when the efficacy survey data is collected, the medical institution information system 200 is accessed from the terminal 101 of the pharmaceutical company and the efficacy survey data is obtained via the electronic medical record system 2300 in the same procedure as in FIG. can do. Here, efficacy survey data is data obtained by digitizing the results of post-marketing clinical trials, etc., including information on the quality, efficacy and safety of pharmaceuticals, and data that overlaps with use-results survey data There are many items. However, the examination data of the patient before the medication and the examination data after 7 days after the medication are added. In addition, findings by doctors may be described. Effectiveness investigation data can be collectively recorded and stored in the effectiveness investigation DB 2760.

Next, the flow of returning a pharmaceutical product will be described with reference to FIG. When a medicine with a specific individual identification ID (111111) enters the pharmacy of a medical institution (S301) and an order for delivery by a doctor is issued (S302), the order code (AAAAA) and the individual identification ID A unique ID (111111AAAAA) is constructed from (111111), and the medicine with the electronic tag with the order code (AAAAA) attached is paid out (shipped) (S303). At the bedside, whether or not the medicine can be administered is determined according to the condition of the patient A (S304). When the medicine is stopped, the medicine is returned to the pharmacy (S305). When the returned medicine is reordered (S306), the unique ID (111111BBBB) is composed of the new order code (BBBB) and the individual product identification ID (111111), and the order tag (BBBB) is overwritten. The drug with affixed is reissued (S307), and if necessary, the presence or absence of medication is determined, and the medication record is recorded in the prescription of patient A (or patient B) (S308).
For pharmaceutical products, an electronic tag is used for each individual product. At the first delivery, an order code (AAAAA) is written to the electronic tag, and a unique ID (111111AAAAA) is registered in the medical institution information system. Further, at the time of re-issue (S307), the newly created order code (BBBB) is overwritten on the electronic tag on the previously written order code (AAA), and in the medical institution information system, The unique ID (111111AAAAA) is deleted, and the unique ID (111111BBBB) is registered. By doing in this way, the information of the individual drug product and the information of the patient who is finally administered are associated and recorded through the unique ID. That is, based on the finally stored unique ID, it can be clearly determined without error whether the medicine has been administered to the patient A or the patient B.

  Next, the flow of information processing when drugs are mixedly injected will be described with reference to FIG. For the medicines A, B, and C with individual product identification IDs, a mixed injection order (order code: AAAA) is issued by the doctor (S404), and the medicines A (111111), B (111110), and C (111101) has a unique ID corresponding to each mixed injection order: [(111111AAAAA), (111110AAAAA), (111101AAAAA)] and is registered in the medical institution information system. The medicine is mixed in the container of the medicine A with the electronic tag to which the code is added (S405). When the medication of the mixed medicine is completed, the medication records for the medicines A, B, and C are recorded on the electronic medical record together with the medication information to the patient based on the information of the electronic tag attached to the container of the medicine A. The In this way, in the case of mixed injection, the unique ID composed of the individual product identification ID and the mixed order code is configured for each of the pharmaceutical products A, B, and C, so that the individual product information of the pharmaceutical product and the patient who has been dosed It is possible to centrally manage the results of use of the medicine, so that it is possible to accurately grasp what kind of medicine has been mixed.

  As described above, the pharmaceutical information integrated management system and information management method of the present invention can be suitably applied to pharmaceuticals that require traceability. Already, it can be used in combination with drugs with barcodes attached. In addition, as long as an electronic tag reader / writer is provided, the present invention can be applied to facilities and private residences via the Internet.

DESCRIPTION OF SYMBOLS 100 Pharmaceutical company information system 101 Terminal of pharmaceutical company information system 200 Medical institution information system 201 Terminal of medical institution information system 300 Network 400 Distribution base information system 401 Terminal of distribution base information system 500 Electronic tag 110 Reader / writer 120, 220 Display 130 Pharmaceutical company computer 140 Database 150 Transmission / reception device 110, 210 Reader / writer 230 Medical institution computer 240 Database 250 Transmission / reception device 231 Medical institution identification ID reception unit 232 Individual product identification ID reception unit 233 Unique ID creation unit 234 Medical institution identification ID assignment Part 2200 PACS
2300 Electronic Medical Record System 2400 Ordering System 2500 Receipt System 2600 Other System 2700 Database 2710 Patient Attribute Database 2720 Electronic Medical Record Database 2730 PACS Database 2740 Traceability Database 2750 Usage Result Survey Database 2760 Effectiveness Survey Database 2800 Order Information

Claims (15)

An electronic tag attached to each individual pharmaceutical product;
A pharmaceutical company information system for managing pharmaceutical information;
A medical institution information system for managing at least drug entry / exit information, prescription information, electronic medical record and patient attribute information;
A pharmaceutical information integrated management system having a network connecting at least a pharmaceutical company information system and a medical institution information system,
The pharmaceutical company information system includes a first reader / writer, writes at least an individual identification ID, a product code, a serial number, and an expiration date on the electronic tag, and sets overwriting prohibition.
The medical institution information system includes a second reader / writer, and receives the read individual identification ID via the second reader / writer.
When a medical institution identification ID for identifying a unit of administration to a patient is input to the medical institution information system,
The medical institution information system writes the medical institution identification ID into an empty area of the electronic tag via the second reader / writer, and from the read individual item identification ID and the medical institution identification ID. Configure a unique ID,
The medical institution information integrated management system in which the medical institution information system can centrally manage everything from individual drug information to patient attribute information and patient medication information via the unique ID.   The medical institution information system includes a medical institution computer, and the medical institution computer receives an in-medical institution identification ID for identifying an administration unit to a patient in the medical institution, An individual item identification ID receiving unit that receives an individual item identification ID read via the second reader / writer, a unique ID configuration unit that constitutes a unique ID from the in-medical institution identification ID and the individual item identification ID, The pharmaceutical information integrated management system according to claim 1, further comprising a medical institution identification ID assigning unit that assigns the medical institution identification ID to the electronic tag using a second reader / writer. The medical institution information system has a use result survey data creation function,
From the pharmaceutical company information system, when there is a request for use result survey data of a medicine having the individual product identification ID,
The medical institution information system specifies drug use result information accumulated in the medical institution information system using the individual product identification ID as a key, and creates use result investigation data using the use result investigation data creation function. The pharmaceutical information integrated management system according to claim 1 or 2, wherein the created usage record survey data is provided to a pharmaceutical company information system. The medical institution information system has an effectiveness survey data creation function,
From the pharmaceutical company information system, when there is a request for the efficacy investigation data of the medicine having the individual product identification ID,
The medical institution information system specifies drug use information stored in the medical institution information system using the individual product identification ID as a key, and creates efficacy survey data using the efficacy survey data creation function. The pharmaceutical information integrated management system according to claim 1 or 2, wherein the created efficacy investigation data is provided to a pharmaceutical company information system.   The medical institution information system has a medical institution terminal, and medicine information stored in the pharmaceutical company information system can be acquired from the medical institution terminal using the in-medical institution identification ID as a key. 5. The pharmaceutical information integrated management system according to any one of 4 above.   A distribution base information system installed in a distribution base that mediates pharmaceuticals from a pharmaceutical company to a medical institution, connected to at least the pharmaceutical company information system via a network, and provided with a reader / writer; The medicine according to any one of claims 1 to 5, wherein entry / exit information for each individual medicine is written in the electronic tag or registered in the distribution base computer. Integrated information management system.   The pharmaceutical information integrated management system according to any one of claims 1 to 6, wherein the medicine is a biological product or a specific biological product. An electronic tag attached to each individual pharmaceutical product;
A pharmaceutical company information system that has a computer and a database and manages pharmaceutical information;
A medical institution information system having a computer and a database, and managing at least drug entry / exit information, prescription information, electronic medical records and patient attribute information;
An information management method applied to a pharmaceutical information integrated management system having a network connecting the pharmaceutical company information system and the medical institution information system,
The pharmaceutical company information system writes at least an individual product identification ID, a product code, a serial number and an expiration date on the electronic tag based on drug information stored in a database, and sets overwriting prohibition;
A unique ID from the medical institution identification ID and the individual product identification ID used by the computer of the medical institution information system to identify the unit of administration to the patient when the medicine is delivered from the drug department of the medical institution And registering with the medical institution information system,
The computer of the medical institution information system has a step of writing the medical institution identification ID into the electronic tag,
An information management method characterized in that drug use information stored in a medical institution information system can be specified using the individual product identification ID as a key, and necessary information can be provided from the medical institution information system to the pharmaceutical company information system. The drug use information is drug use result survey data,
The medical institution information system has a use result survey data creation function,
From the pharmaceutical company information system to the medical institution information system, requesting the use result survey data of the medicine having the individual product identification ID;
The medical institution information system activates the use result survey data creation function, specifies the drug use result information stored in the medical institution information system using the individual product identification ID as a key, and creates use result data And steps to
The information management method according to claim 8, further comprising: the medical institution information system transmitting the created drug use result survey data to the pharmaceutical company information system. The drug use information is drug efficacy survey data,
The medical institution information system has an effectiveness survey data creation function,
Requesting from the pharmaceutical company information system to the medical institution information system the efficacy survey data of the medicine having the individual product identification ID;
The medical institution information system activates the effectiveness survey data creation function, specifies the drug use result information stored in the medical institution information system using the individual product identification ID as a key, and creates efficacy data And steps to
The information management method according to claim 8, further comprising the step of the medical institution information system transmitting the created drug efficacy survey data to the pharmaceutical company information system.   When the unused medicine returned to the pharmacy is reissued, the computer of the medical institution information system forms a second unique ID from the new medical institution identification ID and the individual product identification ID; The information management method according to claim 8, further comprising the step of overwriting the new medical institution identification ID on an electronic tag attached to an individual pharmaceutical product.   At the time of co-administration of a plurality of pharmaceuticals, the computer of the medical institution information system for each given medical institution identification ID uses the medical institution identification ID and the individual product identification ID for each of a plurality of medicines. The information management method according to claim 8, further comprising a step of configuring and recording a unique ID.   The information management method according to any one of claims 8 to 12, wherein the medicine is a biological product or a specific biological product.   8. An overwriting prohibited area and a writable area, wherein an individual product identification ID, a product code, a serial number, and an expiration date are recorded in the overwriting prohibited area. An electronic tag used in the pharmaceutical information integrated management system according to item 1. A pharmaceutical packaging unit equipped with the electronic tag according to claim 14.

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