JP2020184237A - Medicine quality control system and medicine quality control method - Google Patents

Abstract

To provide technology with which it is possible to confirm the temperature of content of a medicine under a deviation environment.SOLUTION: A medicine quality control system of the present invention comprises: storage condition environment means for maintaining the environment temperature of an approved storage condition of a medicine; substance temperature detection means for detecting the substance temperature of content of the medicine; deviation environment means for maintaining a deviation environment temperature deviating from the environment temperature of the approved storage condition of the medicine; and determination means for determining whether or not the medicine exposed to the deviation environment in the circulation process of the medicine is usable. The determination means determines whether or not the medicine exposed to the deviation environment is usable, on the basis of history information relating to the substance temperature of content of a medicine for test after being accommodated in the storage condition environment means and moved to the deviation environment means while being maintained at the environment temperature of the approved storage condition.SELECTED DRAWING: Figure 5

Description

The present invention is a drug quality control system capable of simulating a temperature environment for the contents of a drug exposed to a deviation environment in the distribution process, and a quality that can determine whether or not the drug can be used using the drug quality control system. Regarding management method.

Conventionally, in pharmaceutical products, the stability of quality may be impaired by external factors such as temperature, light, and humidity. Therefore, pharmaceutical products are stored in accordance with the storage conditions approved by the competent ministry, Ministry of Health, Labor and Welfare. There is. For example, if storage conditions such as "2-8 ° C, shading" are specified in the package insert of the drug, distributors and medical institutions will use a refrigerator or a refrigerator to meet the storage conditions specified in the package insert. The drug is stored in the refrigerator. In this way, maintaining the quality of pharmaceutical products has become an important responsibility for distributors and medical personnel who handle the pharmaceutical products.

In domestic drug distribution, good distribution practice (GDP) is aimed at preventing the contamination of counterfeit drugs that are intentionally or fraudulently misrepresented with respect to their uniqueness, composition or origin, and improving the management of distribution channels. Guidelines were put in place in 2018, and distributors are required to have a high level of quality assurance. In particular, special attention is required for drugs that require special storage conditions as shown in the above guidelines. For example, medicines that require these special storage conditions are, in principle, not allowed to be returned to sellable inventory and are subject to approved storage conditions for the entire period of time. Documented evidence that it was there is needed.

On the other hand, in medical institutions and insurance pharmacies as well, in order to safely administer drugs to patients, pay attention to the quality of drugs in all processes such as storage in the pharmacy, in-hospital transportation, and preparation. Is required. In recent years, due to the increase in high-priced drugs such as orphan drugs and biopharmacy, prevention of drug disposal due to neglect of proper management is required of distributors, medical institutions and insurance pharmacies. is there.

However, in the drug distribution process, for example, at the stage of transferring a drug transported from a manufacturer / distributor under cold storage conditions to a distributor's cold storage, and at medical institutions and insurance pharmacies, for preparation for multiple patients. In some cases, such as when stocking multiple medicines, the approved storage conditions may be unavoidably deviated. In such a deviant environment, at present, there is no means for confirming whether or not the temperature of the contents of the drug maintains the approved storage temperature, and a means for determining whether or not the drug can be used. In addition, since the medical environment and management resources of individual medical institutions and insurance pharmacies are limited, whether or not the approved storage temperature is maintained for drugs placed in the above-mentioned deviant environment, or whether or not they are maintained. It is extremely difficult to conduct tests to determine the applicability of drugs in deviant environments.

Japanese Patent No. 6235650

The present invention has been made to solve the above problems, and an object of the present invention is to provide a technique capable of confirming the temperature of the contents of a pharmaceutical product in a deviant environment. Then, it is possible to determine whether or not the drug exposed to the deviant environment can be used.

The present invention has been made to solve the above problems, and is characterized by the following points. That is, this drug quality control system
Storage conditions to maintain the environmental temperature of approved storage conditions for pharmaceutical products Environmental means and
A substance temperature detecting means for detecting the substance temperature of the contents of the drug and
Deviation environmental means for maintaining the deviation environmental temperature deviating from the environmental temperature of the approved storage conditions of the drug, and
In the distribution process of the drug, a determination means for determining whether or not the drug exposed to the deviant environment can be used is provided.
The determination means is the content of the test drug after moving the test drug in a state of being housed in the storage condition environmental means and maintained at the environmental temperature of the approved storage condition to the deviant environmental means. It is characterized in that it is determined whether or not the drug exposed to the deviant environment can be used based on the historical information regarding the actual temperature of the object.

That is, in the present invention, the storage condition environmental means for maintaining the environmental temperature of the approved storage condition of the drug, the body temperature detecting means for detecting the body temperature of the contents of the drug, and the approved storage condition of the drug. Deviations deviating from the environmental temperature Provided with deviating environmental means for maintaining the environmental temperature. Then, the content of the test drug after the determination means in the present invention is accommodated in the storage condition environmental means and the test drug in a state of being maintained at the environmental temperature of the approved storage conditions is moved to the deviant environmental means. Based on the historical information about the actual temperature of the object, it is judged whether or not the drug exposed to the deviant environment can be used in the distribution process.

With such a configuration, it is possible to objectively confirm whether or not the temperature of the contents of the drug placed in the deviant environment maintains the approved storage temperature. Then, it becomes possible to determine whether or not a drug exposed to a deviant environment can be used with a clear basis from the viewpoint of quality maintenance. This makes it possible for distributors and medical institutions to reuse high-priced drugs such as orphan drugs and biopharmacy, and to reduce waste due to disposal of drugs due to neglect of proper management. it can.

Further, in the present invention, the determination means is subjected to the deviation environment based on the morphological information regarding the heat conduction of the drug exposed to the deviation environment and the history information regarding the test drug having the morph information. The availability of the exposed drug may be determined.

According to such a configuration, the test drug can be provided with morphological information regarding the heat conduction of the drug exposed to the deviant environment, so that the temperature state of the contents of the drug handled in the distribution process under the deviant environment can be determined. , The judgment accuracy for judging whether or not the approved storage temperature is maintained can be improved more accurately.

Further, in the present invention, the morphological information regarding the heat conduction of the drug is at least information about the contents of the drug, information about the capacity of the contents, information about the material of the direct container in which the contents are housed, secondary. It may include information on either packaging or exterior.

According to such a configuration, the influence of heat transfer from the deviant environment on the contents of the drug in the distribution process when exposed to the deviant environment from the environmental temperature of the approved storage conditions is determined. It becomes possible to make a judgment in consideration of morphological information regarding heat conduction. By considering the morphological information regarding the heat conduction of the drug, it is possible to improve the judgment accuracy for judging whether or not the drug can be used for the drug exposed to the deviant environment.

Further, in the present invention, the determination means changes the determination criteria for determining whether or not the drug exposed to the deviant environment can be used according to the morphological information regarding the heat conduction of the drug. May be good. With such a configuration, the accuracy of judgment for confirming whether or not the temperature state of the contents of the medicines handled in the distribution process in the deviant environment maintains the approved storage temperature is further improved. Can be done.

In addition, in the quality control method for pharmaceutical products, which is one aspect of the present invention, storage condition environmental means for maintaining the environmental temperature of the approved storage conditions for pharmaceutical products
A substance temperature detecting means for detecting the substance temperature of the contents of the drug and
Deviant environmental means for maintaining the deviant environmental temperature deviating from the environmental temperature of the approved storage conditions of the drug.
It is a determination method for determining whether or not the drug exposed to the deviant environment can be used in the distribution process of the drug.
Concerning the actual temperature of the contents of the test drug after the test drug contained in the storage condition environmental means and maintained at the environmental temperature of the approved storage condition is moved to the deviant environmental means. Based on the historical information, it may be determined whether or not the drug exposed to the deviant environment can be used.

The present invention can be specified as a drug quality control system including at least a part of the above means and treatment, or a drug quality control method. The above processes and means can be freely combined and carried out as long as there is no technical contradiction.

According to the present invention, it is possible to provide a technique capable of confirming the temperature of the contents of a pharmaceutical product in a deviant environment. In addition, it becomes possible to determine whether or not a drug exposed to a deviant environment can be used. As a result, it is possible to suppress the disposal of orphan drugs, biopharmacy, vaccines, blood products, and other products that require special storage conditions and regenerative medicine products at distributors and medical institutions.

It is a figure which shows the mode of distribution of the conventional drug to which the drug quality control system in Example 1 of this invention applies. It is a figure for demonstrating the system structure of the pharmaceutical quality control system in Example 1 of this invention. It is a figure for demonstrating the form of the pharmaceutical quality test in Example 1 of this invention. It is a figure which shows an example of the form information in Example 1 of this invention. It is a figure which shows an example of the determination information of the approval condition holding time in Example 1 of this invention. This is an example of a flowchart showing the flow of the determination process in the first embodiment of the present invention.

Hereinafter, the pharmaceutical quality control system according to the embodiment will be described with reference to the drawings. The configuration of the following embodiments is an example, and the drug quality control system is not limited to the configuration of the embodiment.

<Example 1>
FIG. 1 is a diagram showing a mode of distribution of a conventional drug to which the drug quality control system in this embodiment is applied. In FIG. 1, block 1 indicates a drug manufacturer, block 2 indicates a distributor, and block 3 indicates a medical institution such as a hospital or an insurance pharmacy. The "distributor" includes all the distributors who intervene between the drug manufacturer 1 and the medical institution 3, such as the drug wholesaler and the carrier, and depending on the distribution form, the drug manufacturer 1, the medical institution, etc. 3 It can be itself. Here, since strict temperature control is required for the drug 5 that requires special storage conditions specified in the guidelines for proper distribution of drugs (GDP), it is stored in a cold storage container 6 that can control the temperature during movement. It is purchased by the distributor 2 in a state of being. Further, in the distributor 2, the drug 5 is stored in a refrigerated storage 7 or the like in a temperature-controlled state until it is sold. Then, when the medical institution or the like 3 to be sold is determined, the product is taken out from the refrigerated storage 7 or the like and transported to the medical institution or the like 3 in a state of being stored in the cold storage container 16 again. Then, in the medical institution 3 or the like, the drug 5 is taken out from the cold storage container 16 and stored and stored in the refrigerated storage 17 or the like in a state where the temperature is controlled. When the drug 5 stored in the refrigerated storage 17 or the like and under temperature control is used by a patient, it is taken out of the refrigerated storage and administered.

In the distribution mode of the drug 5 shown in FIG. 1, the identification element 5a on which the ID of the drug is recorded is attached to the drug 5, for example, the drug itself or the package of the drug. Further, a reading sensor 6a capable of detecting the identification information of the drug 5 by the identification element 5a and a temperature sensor 6b capable of acquiring the internal temperature history information are attached to the cold storage container 6. Then, the output signals of the reading sensor 6a and the temperature sensor 6b are transmitted to the information management device 8 by wireless communication and recorded as necessary. As a result, information on whether or not the drug 5 having a predetermined ID is stored in the cold storage container 6 related to movement and temperature history information which is the storage environment of the drug 5 in the cold storage container 6 can be recorded in real time. It has become. The same applies to the movement of the drug 5 from the distributor 2 to the medical institution 3 by the cold storage container 16. As a result, it becomes possible to detect that the drug 5 is reliably stored in the cold storage containers 6 and 16 while the drug 5 is being moved from the drug manufacturer 1 to the distributor 2 and from the distributor 2 to the medical institution 3 and the like. The temperature history in the cold storage containers 6 and 16 related to the movement of 5 can be recorded.

Further, in FIG. 1, the reading sensors 7a and 17a and the temperature history information capable of detecting the identification information of the drug 5 by the identification element 5a also in the refrigerating storages 7 and 17 provided in the distributor 2 and the medical institution 3 and the like. Temperature sensors 7b and 17b that can acquire the above temperature sensors 7b and 17b are attached. Then, the output signals of the reading sensors 7a and 17a and the temperature sensors 7b and 17b are transmitted to the information management device 8 in real time by wireless communication and recorded. As a result, information on whether or not the drug 5 having a predetermined ID is stored in the refrigerated storages 7 and 17 and temperature history information in the storage environment in the refrigerated storages 7 and 17 can be recorded in real time. It has become.

In FIG. 1, the actual distribution route of the drug 5 is shown by a solid line, and the information route is shown by a broken line. In the information management device 8 of FIG. 1, a core server 8a and an intermediate server 8b are provided as servers for managing information related to the distribution of the drug 5 by the distributor 2. The core server 8a manages information on processing from the ordering of the drug 5 from the medical institution 3 by the distributor 2 to the delivery of the drug 5 to the medical institution, information on the inventory of the medical institution 3, and information on billing processing. It is a server to do. In addition, the core server 8a also manages information regarding automatic replenishment, payment request, etc. regarding returns from medical institutions and the like 3.

The intermediate server 8b is a server that manages the sales information (selling price, customer information, etc.) of the distributor 2, as well as the information from the cold storage container server 8c and the cold storage server 8d. In the intermediate server 8b, information on the ID, location or existence (including those by warehousing and withdrawal) of the drug 5 and temperature history information from the cold storage container server 8c and the refrigerated storage server 8d, and the return / re-return of the drug 5 Information related to the processing of sales is processed. Further, the intermediate server 8b exchanges sales information including customer information and selling prices with the core server 8a.

Further, the intermediate server 8b provides information to the drug maker 1 as needed. For example, information on the ID, location or existence (including those by warehousing and withdrawal) of the drug 5 and temperature history information from the cold storage container server 8c and the refrigerated storage server 8d are between the intermediate server 8b and the drug maker 1. Shared by.

The cold storage container server 8c is a server that collects information from the cold storage containers 6 and 16, and receives and stores output signals from the reading sensors 6a and 16a and the temperature sensors 6b and 16b in real time. The refrigerated storage server 8d is a server that collects information from the refrigerated storages 7 and 17, and receives and stores output signals from the reading sensors 7a and 17a and the temperature sensors 7b and 17b in real time. The information stored in the cold storage container server 8c and the cold storage server 8d is transmitted to the intermediate server in response to a command from the intermediate server 8b.

The place where each server in the information management device 8 is installed is not particularly limited. For example, the servers 8a to 8d constituting the information management device 8 may be installed in the facility of the distributor 2, and the cold storage container server 8c is installed in the facility of the management company of the cold storage containers 6 and 16 and refrigerated. The storage server 8d may be installed in the management company of the refrigerated storages 7 and 17. Further, each server in the information management device 8 may be connected by an original line, or may be connected by an Internet line or a telephone line. Further, each server in the information management device 8 may have all or a part of the servers installed on the cloud.

Here, the identification element 5a may be, for example, an IC tag or RFID (including both active and passive systems and may be a temperature sensor integrated type), and in this case, reading sensors 6a and 16a. , 7a, 17a may be RFID readers. Further, the identification element 5a and the reading sensors 6a, 16a, 7a, 17a may be configured by a device capable of short-distance wireless communication such as Bluetooth (registered trademark). Further, the identification element 5a may be a device that emits a magnetic field or light that can identify the ID of the drug 5, and in this case, the reading sensors 6a, 16a, 7a, 17a are magnetic sensors or optical sensors. You may. Further, the identification element 5a does not have to actively transmit signals such as an electromagnetic field and light, and is, for example, a label on which a two-dimensional code such as a barcode or a QR code (registered trademark) is printed. May be good. In this case, the reading sensors 6a, 16a, 7a17a may be a two-dimensional code reader such as a barcode reader or a QR code reader.

As described above, each reading sensor and each temperature sensor has a communication function, and the ID and location information of the drug 5 and the temperature history information are transmitted in real time to the connected information management device 8, respectively. Information may be recorded, but each reading sensor itself and the temperature sensor itself may be provided with a storage function so that each acquired information can be independently recorded and stored. Further, the cold storage containers 6 and 16 or the refrigerating storages 7 and 17 may be provided with a storage function, and each information transmitted from each reading sensor and each temperature sensor may be independently recorded and stored.

According to the configuration shown in FIG. 1, the distribution process from the drug manufacturer 1 to the distributor 2, the storage process in the distributor 2, and the distribution after the drug 5 is manufactured and shipped by the drug manufacturer 1 (purchased by the distributor 2). In the distribution process from the trader 2 to the medical institution 3 and the storage process in the medical institution 3, the drug 5 is surely stored in the cold storage containers 6 and 16 or the cold storage 7 and 17, and appropriate temperature control is performed. It becomes possible to confirm whether or not it is.

In the conventional mode of distribution of pharmaceuticals shown in FIG. 1, for example, at the stage of transferring the pharmaceutical product 5 transported from the pharmaceutical manufacturer 1 in the cold storage container 6 to the refrigerator storage 7 of the distributor 2, the cold storage container is temporarily used. There is a period of deviation from the temperature control by 6 and the refrigerated storage 7. Further, in the medical institution, etc. 3, when a plurality of medicines 5 stored in the refrigerated storage 7 are paid out for preparation for patients, the temperature is temporarily controlled by the refrigerated storage 7. There is a period of deviation. Therefore, if the temperature is deviated from the temperature control by the cold storage container 6 or the refrigerated storage 7, it indicates that the condition for returning to the sellable inventory, that is, the storage condition approved for the entire period was met. It becomes difficult.

When such storage conditions are unavoidably deviated, it becomes unclear whether or not the temperature of the contents of the drug 5 placed in the deviating environment maintains the approved storage temperature, for example. It has been difficult to determine the possibility of using the drug 5 in a deviant environment.

Next, the drug quality control system in this embodiment will be described. FIG. 2 is a diagram for explaining the system configuration of the pharmaceutical quality management system 50. The pharmaceutical quality management system 50 shown in FIG. 2 cooperates with the information management device 8 of FIG. 1 or constitutes a part of the system including the information management device 8. Then, the drug quality management system 50 objectively determines whether or not the temperature of the contents of the drug 5 placed in the deviant environment maintains the approved storage temperature, and the drug quality management system 50 determines, for example, whether or not the temperature of the contents of the drug 5 maintains the approved storage temperature. It is a system that can determine whether or not it can be used. In addition, such a system may be operated individually by each of one or more drug manufacturers 1, distributors 2, medical institutions, etc. 3 in the distribution of drug 5, and any combination of any of the above 1 or more organizations. It may be jointly operated by. In addition, it may be operated by a specific contractor entrusted by each of the above 1 or more organizations or a jointly operated organization by a combination of the 1 or more organizations, and the organization entrusted by the competent ministry related to the approval of the drug 5 may operate. It may be operated. In the following, the drug quality management system 50 cooperates with the information management device 8, for example, the storage temperature at which the temperature of the contents of the drug 5 placed in the deviation environment is approved in response to the request from the intermediate server 8b. It will be described as determining whether or not the drug is maintained and whether or not the drug can be used.

In FIG. 2, the drug quality control system 50 includes a drug testing device 51 and an information management device 58 in its configuration. The information management device 58 includes a data server 58b in which various data including test data are stored, and a quality control server 58a that manages the quality of the drug 5 handled in the distribution process. The information management device 58 has a communication function and is connected to the information management device 8 through a communication line. Communication lines include original lines composed of wireless lines, wired lines, etc., Internet lines, and telephone lines.

The drug testing device 51 is approved as a refrigerated storage 52 for exposing the drug 55 for testing (including the use of the actual drug for testing) at an environmental temperature of approved storage conditions for a period of time. The configuration includes a refrigerated storage 53 for exposure at a deviation environmental temperature deviating from the environmental temperature of the storage conditions. Here, the refrigerated storage 52 is not limited to the refrigerated storage, as long as it can control the environmental temperature of the approved storage conditions of the drug 55, and can be controlled by an ultra-low temperature freezer, a cold storage container, a constant temperature bath, and temperature control. It may be indoors or outdoors. The same applies to the refrigerated storage 53, and if it is possible to measure the deviation environmental temperature that deviates from the environmental temperature of the approved storage conditions of the drug 55, an ultra-low temperature freezer, a cold storage container, a constant temperature bath, and temperature control are possible. It may be indoors or outdoors.

In this embodiment, the refrigerated storage 52 has the same configuration as the refrigerated storage 7, and is attached with a temperature sensor 52b capable of acquiring history information of the internal storage condition environmental temperature with the passage of time. The refrigerating storage 52 has an external communication means 52c, and is configured so that the output signal of the temperature sensor 52b is transmitted and recorded in real time to the data server 58b of the information management device 58 connected through the external communication means. Will be done. The temperature sensor 52b of the refrigerated storage 52 constitutes a storage condition environmental temperature detecting means, and the external communication means 52c and the data server 58b constitute a storage condition environmental temperature recording means. The refrigerating storage 52 may be provided with a storage function such as a memory, and may be configured to record and store historical information of the storage condition environmental temperature detected through the temperature sensor 52b. In this case, a storage function such as a memory provided in the refrigerating storage 52 constitutes a storage condition environmental temperature recording means.

Further, the refrigerating storage 52 has an internal communication means 52a, and is configured to receive drug temperature history data transmitted from a plurality of drugs 55 connected through the internal communication means. Then, the refrigerating storage 52 is configured to transmit and record the drug temperature history data received from the plurality of drugs 55 through the internal communication means 52a to the data server 58b. As a result, in the data server 58b of the information management device 58, the history information of the storage condition environmental temperature and the drug temperature history data of the plurality of drugs 55 stored in the refrigerator storage 52 are associated with the recording device ID. It is possible to record. In addition, when a plurality of refrigerated storages 52 are provided to imitate the approved storage condition environment, a refrigerated storage ID for individually identifying each refrigerated storage is assigned, and the refrigerated storage is assigned. It can be configured to identify various data recorded in the data server 58b according to the ID.

The refrigerated storage 53 in the present embodiment also has the same configuration as the refrigerated storage 7, and is equipped with a temperature sensor 52b capable of acquiring historical information on the storage condition environmental temperature with the passage of time inside. Further, the refrigerating storage 53 has an external communication means 53c, and is configured so that the output signal of the temperature sensor 53b is transmitted and recorded in real time to the data server 58b connected through the external communication means. The temperature sensor 53b of the cold storage 53 constitutes a deviation environment temperature detecting means, and the external communication means 53c and the data server 58b constitute a deviation environment temperature recording means. The refrigerated storage 53 may also be provided with a storage function such as a memory constituting the deviation environment temperature recording means, and may record and store the history information of the deviation environment temperature detected through the temperature sensor 53b.

Further, the refrigerating storage 53 has an internal communication means 53a, and is configured to receive drug temperature history data at a deviation environmental temperature transmitted from a plurality of drugs 55 connected through the internal communication means. The refrigerated storage 53 is also configured to transmit and record the drug temperature history data under the deviant environmental temperature of the plurality of drugs 55 received through the internal communication means 53a to the data server 58b. As a result, in the data server 58b, the history information of the deviation environmental temperature exposed by the refrigerating storage 53 and the drug temperature history data of the plurality of drugs 55 stored in the refrigerating storage 53 correspond to the recording device ID. It is attached and can be recorded. When a plurality of refrigerating storages 53 for exposing the deviant environmental temperature to the medicines 55 stored inside are provided, a refrigerating storage ID for individually identifying each refrigerating storage is assigned to each. Can be granted. In the data server 58b, various data recorded through each refrigerated storage 53 can be identified based on the refrigerated storage ID. Each refrigerating storage 53 associates the refrigerating storage ID assigned to its own device with the history information of the deviation environmental temperature and the drug temperature history data of the plurality of drugs 55 stored in the own device in the data server 58b. You can send it to.

In the drug testing apparatus 51, as will be described later, the drug 55 for testing is stored in the refrigerated storage 52 and temporarily stored under the environmental temperature under the approved storage conditions. Then, the drug stored in the temperature environment of the approved storage conditions is discharged from the refrigerated storage 52, moved to the refrigerated storage 53, and stored. In the refrigerated storage 53, the drug 55 stored under the environmental temperature of the approved storage conditions is exposed at a deviating environmental temperature deviating from the environmental temperature of the approved storage conditions. In the test drug 55, the actual temperature of the contents changes from the temperature state under the approved storage conditions due to heat transfer from the deviant environmental temperature.

The drug testing device 51 measures the temperature change of the contents of the drug 55 exposed to the deviant environmental temperature over time. For example, the pharmaceutical testing apparatus 51 measures the temperature change in the period until the actual temperature of the content that changes due to heat transfer from the deviation environmental temperature reaches a temperature that deviates from the environmental temperature under the approved storage conditions. To do.

The measurement result of the temperature change of the test drug 55 with the passage of time in the deviation environment of the contents is stored in the data server 58b as objective test data showing the temperature transition in the deviation environment. In the quality control server 58a, for example, when receiving a request from the information management device 8 and determining whether or not a drug placed in an environment deviating from the environment of the approved storage conditions can be used, the data is accumulated. Refer to the test data for each drug to determine whether or not to use the drug to be judged.

FIG. 3 is a diagram illustrating a form of a drug quality test in a deviation environment in this example. In FIG. 3, the drug 55 is a drug for drug quality testing in a deviant environment. The drug 55 is, for example, a drug 5 provided by any of the drug manufacturer 1, the distributor 2, the medical institution, and the like 3 and handled in the distribution process. However, drugs 5 that require special storage conditions specified in the Guidelines for Proper Distribution of Drugs (GDP) include orphan drugs, biopharmacy, vaccines, and other high-priced drugs. Therefore, the drug 55 may be a pseudo-drug capable of confirming the temperature change of the drug 5 handled in the distribution process in a deviant environment. The pseudo-pharmaceutical product is provided with, for example, as will be described later, the content imitating the morphological information of the drug 5 handled in the distribution process, the capacity of the content, the material of the direct container, the secondary packaging, and the exterior. The morphological information of the drug is information on the heat conduction of the drug.

The drug 55 for testing is registered in the data server 58b in association with the drug ID of the drug 5 handled in the distribution process. Information such as the name of the drug, the serial number, the rod number, the date of manufacture, the manufacturer ID, the attached document, and the interview form is associated with the drug ID. In addition, morphological information on heat conduction of the drug, for example, information such as the type of contents, the capacity of the contents, the material of the direct container in which the contents are stored, the presence / absence or type of secondary packaging, the presence / absence or type of exterior Is registered in association with the drug ID.

FIG. 4 is a diagram showing an example of morphological information registered in the data server 58b. In FIG. 4, morphological information having each field such as a large item, a medium item, and a small item, which are distinguished by a record number in a table format, is exemplified. The major items store information indicating form items such as the contents, the capacity of the contents, the material of the direct container, the secondary packaging, and the exterior. In the middle item, information indicating a more detailed form item corresponding to the large item is stored. For example, when a major item is a content, information indicating the physical aspect of the content such as gas, liquid, or solid is stored. Similarly, in the content volume, information indicating the content volume such as 1 mL, 2 mL, and 3 mL is stored. In the direct container material, information indicating the material of the container in which the contents such as plastic and glass are stored is stored. In the secondary packaging and exterior, information indicating the presence or absence of the packaging is stored. In the sub-item, information indicating a more detailed form item corresponding to the middle item is stored. For example, when the middle item is a liquid, information indicating a material such as water or ethylene glycol is stored. When the major item is secondary packaging or exterior, information indicating the materials constituting the secondary packaging or exterior such as aluminum, plastic, and paper is stored.

The pseudo-pharmaceutical product can be provided with the form of the drug 5 handled in the distribution process by imitating the form information in the distribution process registered in association with the drug ID. Therefore, the drug testing device 51 can confirm the temperature change of the contents exposed to the deviant environment with the passage of time through the pseudo drug. The morphological information associated with the drug ID and registered in the data server 58b can include morphological information relating to heat conduction of the contents other than the items illustrated in FIG.

As shown in FIGS. 2 and 3, the pharmaceutical material 55 has a temperature sensor 54a capable of detecting the temperature of the contents under a storage condition environment or a deviation environment, and a time lapse of the contents detected by the temperature sensor 54a. A recording device 54b capable of recording temperature history information in a predetermined period of temperature change accompanying the temperature change is attached.

Examples of the temperature sensor 54a include a thermocouple buried or brought into contact with the contents, a resistance temperature device (RTD), a thermistor, and the like. However, the temperature sensor 54a may be a non-contact type device such as an infrared sensor. The detection signal detected by the temperature sensor 54a is output to the recording device 54b, and is acquired at a constant sampling cycle of minutes or seconds such as 1 minute. The recording device 54b records the detection signal sampled at regular periodic intervals together with the information indicating the time. The recording device 54b is given a recording device ID associated with the drug ID of the drug 55. In the recording device 54b, the actual temperature of the contents of the drug 55 detected via the temperature sensor 54a is recorded as temperature history information together with the recording device ID. The recording device 54b has a communication function, and as will be described later, the recorded drug temperature history data is stored in the refrigerated storage 52 or the refrigerated storage 53 in which the test drug 55 is stored. It is transmitted at regular intervals. The temperature sensor 54a constitutes a means for detecting the actual temperature of the contents of the drug 55, and the recording device 54b constitutes a means for recording the actual temperature of the contents.

In the drug quality test of this embodiment, the drug 55 in the test state 54 to which the temperature sensor 54a and the recording device 54b are attached is stored in the refrigerated storage 52 capable of temperature control under the approved storage condition environment. In the refrigerated storage 52, the temperature of the stored drug 55 is controlled according to the approved storage condition environmental temperature. Approved storage conditions The environmental temperature is specified in the package insert registered on the data server 58b associated with the drug ID of the drug 55. Then, the drug 55 in the test state 54 stored in the refrigerated storage 52 is exposed to the storage condition environmental temperature for a certain period of time (for example, the period until the actual temperature of the contents reaches the storage condition environmental temperature). It is taken out, moved to a refrigerated storage 53 capable of temperature control under a deviation environment, and stored. In the refrigerated storage 53, temperature control deviating from the approved storage condition environmental temperature is performed, and the temperature change of the actual temperature of the contents of the drug 55 exposed to the deviating environmental temperature with the passage of time is measured.

The approved storage condition environmental temperature specified in the attached document has a predetermined temperature range (for example, 2 to 8 ° C, 1 to 30 ° C, 15 to 25 ° C, etc.). Therefore, in the drug testing device 51, the temperature at which the contained drug 55 is exposed may be changed within the temperature range of the approved storage conditions. For example, when the temperature range of the approved storage conditions is 2 to 8 ° C, the unit temperature for varying 1.0 ° C is 2.0 ° C, 3.0 ° C, 4.0 ° C, 5. The temperature of the storage environment to be exposed is changed, such as 0 ° C, 6.0 ° C, 7.0 ° C. Then, for each storage environment temperature, the drug 55 is exposed at a deviation environmental temperature of the same temperature (for example, 20 ° C.), and the temperature change of the actual temperature of the contents of the drug is measured. In the above measurement of the temperature change, the drug 55 whose temperature has been measured by being exposed to the deviant environmental temperature is housed in the refrigerated storage 52 again and exposed to the changed storage environment temperature for a certain period of time. , It may be moved to the cold storage 53 to measure the temperature change under the deviant environmental temperature.

In the drug quality management system 50, measurement data in a deviant environment can be accumulated for drugs 55 stored at different storage temperatures within the approved temperature range. This is to confirm whether or not the temperature state of the contents of the drug 5 handled in the distribution process under the deviant environment maintains the approved storage temperature based on the environmental temperature at the time of storage. Judgment accuracy can be improved.

Further, in the pharmaceutical testing apparatus 51, the deviant environmental temperature to be exposed can be changed within the deviant temperature range. For example, if the temperature range of the approved storage conditions is 2-8 ° C, the deviation environmental temperature is 5 ° C, such as 10 ° C, 15 ° C, 20 ° C, 25 ° C, 30 ° C, 35 ° C. Can be changed as a variable unit temperature. Then, the drug 55 stored at a constant storage environment temperature (for example, 3.0 ° C.) is exposed at each of the above-mentioned changed deviation environmental temperatures, and the temperature change of the actual temperature of the contents is measured. In the measurement of the temperature change as well, the drug 55 whose temperature change of the actual temperature has been measured by being exposed to the deviation environmental temperature is stored in the refrigerated storage 52 again, exposed to the predetermined storage environment temperature for a certain period of time, and then. The drug 55 may be moved to the refrigerated storage 53 and the temperature change under the changed deviation environmental temperature may be measured.

In the pharmaceutical quality management system 50, measurement data for each deviant environmental temperature can be accumulated for the pharmaceutical 55 exposed to different deviant environmental temperatures within the deviant temperature range. Thereby, based on the environmental temperature at the time of deviation, a judgment for confirming whether or not the temperature state of the contents of the drug 5 handled in the distribution process under the deviation environment maintains the approved storage temperature. The accuracy can be improved.

According to the drug quality test of this example, when a drug stored at an approved storage condition environmental temperature is delivered and exposed to a deviant environment, the transitional change of the actual temperature of the contents with the passage of time is continuous. It becomes possible to measure. In addition, it is possible to measure the transition change of the actual temperature of the contents with the passage of time for each unit temperature within the approved storage condition environmental temperature range and for each unit temperature within the deviation range of the deviation environmental temperature. The measurement results are stored in the data server 58b, and are objective for determining whether or not the temperature of the contents of the drug 5 placed in the deviant environment maintains the approved storage temperature in the distribution process. Data can be acquired.

In the pharmaceutical quality management system 50 of this embodiment, the approval conditions for determining whether or not the approval conditions for the contents under the deviation environment are maintained based on the measurement data recorded and accumulated in the data server 58b. Information indicating the holding time is registered. Such information is registered for each drug ID.

FIG. 5 is a diagram showing an example of determination information of the approval condition holding time registered in the data server 58b. In FIG. 5, determination information of the approval condition holding time represented in a table format is exemplified. The approval condition holding time determination information shown in FIG. 5 is, for example, an example of a drug having an approved storage condition environmental temperature of 2 ° C to 8 ° C. The determination information of the approval condition holding time of FIG. 5 has each field of the temperature of the contents and the external environment temperature. The storage temperature under the storage condition environment is stored in the temperature of the contents. The external environment temperature has a plurality of subfields, and the deviation temperature under the deviation environment is stored in a plurality of subfields.

In FIG. 5, in the field where the temperature of the contents and the external environmental temperature intersect, the period until the temperature deviates from the approved storage condition environmental temperature obtained by analyzing the data measured in the drug quality test. Information indicating that is stored. Here, the information stored in the field where the temperature field of the contents and the external environment temperature field intersect is information indicating a judgment criterion for judging whether or not the drug exposed to the deviant environment can be used. .. Such information can be expressed in time units such as minutes and seconds. In addition, the information indicating the period until the temperature deviates from the approved storage condition environmental temperature may include measured test data. The test data is assigned, for example, an identification number that identifies the data.

In the example of FIG. 5, when the temperature of the contents is "4.0 ° C" and the external environmental temperature is "20 ° C", the period until the temperature deviates from the approved storage condition environmental temperature is "B2". Minutes "are stored. Further, "DATbbbbbb2" is stored as an identification number of the measured test data. In this example, when the storage temperature of the drug 5 handled in the distribution process is "4.0 ° C" and it is exposed to a deviation environment of "20 ° C", the content of the drug is "B2 minutes". It is shown that the actual temperature of the object deviates from the approved storage condition environmental temperature. In addition, "DATbbbbbb2" is the test data showing the temperature change of the contents over time when the drug stored at the environmental temperature of "4.0 ° C" is exposed to the deviation environment of "20 ° C". It is shown that there is.

In the drug quality control system 50 of this embodiment, the quality control server 58a receives a request from the interlocking intermediate server 8b, and the temperature of the contents of the drug 5 placed in the deviation environment is set to the approved storage temperature. Determine if it is maintained.

FIG. 6 is an example of a flowchart showing the flow of the determination process performed by the quality control server 58a. In FIG. 6, the start of processing is the acceptance of a determination request from the interlocking intermediate server 8b whether or not the temperature of the contents of the drug 5 placed in the deviant environment maintains the approved storage temperature. Time is illustrated. In step S101, information on the drug 5 to be determined is acquired. For example, through the intermediate server 8b, information such as a drug ID, a storage environmental temperature, an environmental temperature at the time of deviation, and a deviation time is acquired for the drug 5 to be determined. Next, in step S102, information indicating the form of the drug 5 to be determined regarding heat conduction is acquired. For example, referring to the data server 58b, the type of contents, the capacity of the contents, the type of the direct container, the presence / absence or type of secondary packaging, the presence / absence of exterior, etc., which are registered in association with the drug ID, are shown in FIG. Form information such as type is acquired.

Next, in step S103, the approval condition holding time table of the contents under the deviation environment is specified. For example, referring to the data server 58b, an exemplary approval condition retention time table, which is registered in association with the drug ID, is specified in FIG. Then, in step S104, it is determined whether or not the drug 5 to be determined can be used based on the specified approval condition holding time table.

In step S104, for example, based on the storage environment temperature of the drug 5, the temperature field of the content of the approval condition holding time table in which the corresponding temperature is stored is specified. Further, based on the environmental temperature at the time of deviation, the external environmental temperature field in the approval condition holding time table in which the corresponding temperature is stored is specified. Then, in the approval condition holding time table, information indicating the period until the approved storage condition environmental temperature is deviated, which is stored in the field where the temperature field of the corresponding content and the external environmental temperature field intersect, is acquired. To. Then, the deviation time obtained in step S101 when the drug 5 was exposed to the deviation environment is compared with the information indicating the period until the drug 5 deviates from the approved storage condition environmental temperature, and the availability of the drug is compared. To judge.

In step S105, the result of the comparison is determined. That is, when the deviation time of the drug 5 to be determined is within the period until the deviation time deviates from the approved storage condition environmental temperature (step S105, “Yes”), the temperature of the contents is the approved storage temperature. Is judged to be maintained. Then, it is determined that the drug can be used, and the process proceeds to step S106. On the other hand, when the deviation time of the drug 5 to be determined is equal to or longer than the period until the deviation from the approved storage condition environmental temperature (step S105, “No”), the temperature of the contents is the approved storage temperature. Is judged not to be maintained. Then, it is determined that the drug cannot be used, and the process proceeds to step S107.

In step S106, the intermediate server 8b is notified as a response to the determination request that the drug 5 to be determined can be used. Further, in step S107, the intermediate server 8b is notified as a response to the determination request that the drug 5 to be determined cannot be used. In steps S106 and S107, the test data which is the basis for determining the availability may be notified. The quality control server 58a presents objective data indicating whether or not the temperature (substantive temperature) of the contents placed in the deviant environment maintains the approved storage temperature for the drug 5 to be judged. it can.

As described above, according to the present embodiment, it is objective whether or not the temperature (substance temperature) of the contents of the drug 5 placed in the deviant environment maintains the approved storage temperature. The temperature can be confirmed. Such temperature confirmation is performed according to the storage environment temperature of the drug 5, the environmental temperature at the time of deviation, the deviation time, and the morphological information regarding heat conduction. Then, it becomes possible to determine whether or not a drug exposed to a deviant environment can be used with a clear basis from the viewpoint of quality maintenance. This makes it possible for distributors and medical institutions to reuse high-priced drugs and vaccines such as orphan drugs and biopharmacy, and waste due to the disposal of drugs due to neglect of proper management. Can be reduced.

<Modification example>
The present invention may be applied when the environmental conditions required for the management of the pharmaceutical product 5 are other conditions. For example, the present invention may be applied to the case where humidity, illuminance, shock, vibration, atmospheric pressure, or a combination of these conditions including temperature is used as the environmental conditions required for the management of the drug 5.

Further, the processing in the above-described embodiment may be systematically automatically processed by each of the above-mentioned servers based on a predetermined program as much as possible, but the present invention describes the above-mentioned embodiment. The purpose is to include an invention as a method of manually executing the processing according to the above by human resources.

The subject to which the present invention is applied includes products such as anticancer agents, hemophilia therapeutic agents, plasma fractionation preparations, vaccine preparations, companion diagnostics, regenerative medicine, etc., in addition to orphan drugs and biopharmacy. .. In addition, the subject to which the present invention is applied may be drugs, medical materials, medical devices, quasi-drugs other than drugs that require special storage conditions shown in the guidelines for proper distribution of drugs.

1 Pharmaceutical manufacturer 2 Distributor 3 Medical institution 5, 55 Pharmaceutical 5a Identification element 6, 16 Refrigerated container 7, 17 Refrigerated storage 8 Information management device 8b Intermediate server 50 Pharmaceutical quality control system 51 Pharmaceutical testing device 52, 53 Refrigerated storage 52a, 53a Internal communication means 52b, 53b Temperature sensor 52c, 53c External communication means 54a Temperature sensor 54b Recording device 58 Information management device 58a Quality control server 58b Data server

Claims (8)

Storage conditions to maintain the environmental temperature of approved storage conditions for pharmaceutical products Environmental means and
A substance temperature detecting means for detecting the substance temperature of the contents of the drug and
Deviation environmental means for maintaining the deviation environmental temperature deviating from the environmental temperature of the approved storage conditions of the drug, and
In the distribution process of the drug, a determination means for determining whether or not the drug exposed to the deviant environment can be used is provided.
The determination means is the content of the test drug after moving the test drug in a state of being housed in the storage condition environmental means and maintained at the environmental temperature of the approved storage condition to the deviant environmental means. A drug quality control system, characterized in that it determines whether or not the drug exposed to the deviant environment can be used based on historical information regarding the actual temperature of the object. The determination means of the drug exposed to the deviation environment is based on the morphological information regarding the heat conduction of the drug exposed to the deviation environment and the history information regarding the test drug having the morph information. The pharmaceutical quality control system according to claim 1, wherein the propriety of use is determined. The morphological information regarding heat conduction of the drug is at least information about the contents of the drug, information about the capacity of the contents, information about the material of the direct container in which the contents are housed, information about the secondary packaging, information about the exterior. The pharmaceutical quality management system according to claim 2, further comprising any of the above information. 2. The determination means is characterized in that the determination criteria for determining whether or not the drug exposed to the deviant environment can be used is changed according to the morphological information regarding the heat conduction of the drug. The pharmaceutical quality management system according to 3. Storage conditions to maintain the environmental temperature of approved storage conditions for pharmaceutical products Environmental means and
A substance temperature detecting means for detecting the substance temperature of the contents of the drug and
Deviant environmental means for maintaining the deviant environmental temperature deviating from the environmental temperature of the approved storage conditions of the drug.
It is a determination method for determining whether or not the drug exposed to the deviant environment can be used in the distribution process of the drug.
Concerning the actual temperature of the contents of the test drug after the test drug contained in the storage condition environmental means and maintained at the environmental temperature of the approved storage condition is moved to the deviant environmental means. A method for quality control of a drug, which comprises determining whether or not the drug exposed to the deviant environment can be used based on historical information. Based on the morphological information regarding the heat conduction of the drug exposed to the deviant environment and the historical information regarding the test drug having the morphological information, it is determined whether or not the drug exposed to the deviant environment can be used. The method for quality control of a pharmaceutical product according to claim 5, wherein the method is to be used. The morphological information regarding heat conduction of the drug is at least information about the contents of the drug, information about the capacity of the contents, information about the material of the direct container in which the contents are housed, information about the secondary packaging, information about the exterior. The method for quality control of a pharmaceutical product according to claim 6, which comprises any of the above information. The determination method is characterized in that the determination criteria for determining whether or not to use the drug exposed to the deviant environment is changed according to the morphological information regarding the heat conduction of the drug. The method for quality control of pharmaceutical products according to 7.

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