Pharmaceutical quality control system and method using terminal apparatus with built-in temperature sensor
By using a terminal device with a built-in temperature sensor to directly manage medicine temperatures, the system addresses indirect temperature control issues, reducing waste and enhancing pharmaceutical quality control and information management.
Patent Information
- Application Number
- JP2024092727
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-06-08
- Filing Date
- 2024-06-07
- Publication Date
- 2024-12-19
AI Technical Summary
Conventional temperature control in cold storage for valuable medicines in medical facilities is complex and indirect, leading to potential quality deterioration and unnecessary disposal, contrary to the Sustainable Development Goals (SDGs).
A terminal device with a built-in temperature sensor, such as an RFID tag or beacon, is attached to a medicine box to directly measure and manage the temperature of the medicines, allowing for direct quality control and information management, including identification, usage details, and temperature monitoring.
This system enables easier and more direct temperature management of medicines, reducing wasteful disposal and contributing to SDGs by ensuring quality compliance, while providing valuable information for pharmaceutical manufacturers.
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Figure 2024177143000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to a pharmaceutical quality control system and a quality control method using a terminal device with a built-in temperature sensor. [Background technology]
[0002] 2. Description of the Related Art Thermostatic chambers capable of controlling temperature like a refrigerator are known as storage cabinets for storing medicines and the like in a cooled state (see, for example, Patent Document 1).
[0003] In particular, in medical facilities such as hospitals, they are widely used as pharmaceutical refrigerators for storing valuable medicines and the like. [Prior art documents] [Patent documents]
[0004] [Patent Document 1] Patent No. 6408731 Summary of the Invention [Problem to be solved by the invention]
[0005] In the medical facilities mentioned above, precious medicines are very expensive, and strict quality control in the refrigerator is necessary. However, the conventional temperature control in the refrigerator is complicated, and does not directly control the temperature of the medicine itself, but indirectly controls the quality of the medicine from the temperature of the refrigerator. Therefore, the possibility of deterioration of the quality of the medicine cannot be denied, and it is difficult to return the medicine to the pharmaceutical wholesaler from which it was delivered, so that medicines that have passed a certain period of time are uniformly disposed of. This results in waste of medicines, which is also contrary to the Sustainable Development Goals (SDGs) of recent years.
[0006] Therefore, the objective of the present invention is to provide a pharmaceutical quality control system and a quality control method that can easily evaluate whether the quality of pharmaceuticals is guaranteed to withstand returns by constantly controlling the temperature of the pharmaceuticals, thereby significantly reducing the waste of pharmaceuticals and contributing to the SDGs.
[0007] Furthermore, the present invention has an objective of providing an information management system and information management method that manages information related to used pharmaceuticals, i.e., information related to the pharmaceutical identification number, date of use, time of use, place of use and / or institution of use, thereby not only reducing the waste of pharmaceuticals but also contributing to the management of information useful for planning marketing strategies of pharmaceutical manufacturers and other suppliers of pharmaceuticals. [Means for solving the problem]
[0008] In order to solve the above problems, the present invention has the following configuration. [1] A pharmaceutical quality control system comprising a terminal device with a built-in temperature sensor arranged to be in contact with a medicine box containing pharmaceuticals, and characterized in that the temperature sensor provided in the terminal device measures the temperature of the medicine box at an appropriate sampling rate. [2] The pharmaceutical quality control system described in [1], wherein the terminal device is attached to the medicine box with an adhesive member and brought into contact with the medicine box. [3] The pharmaceutical quality control system described in [1], wherein the terminal device is placed in a packaging body together with the medicine box to bring the terminal device into contact with the medicine box. [4] A pharmaceutical quality control system according to any one of [1] to [3], wherein temperature measurements by the terminal device are performed at intervals of 5 to 15 minutes. [5] The pharmaceutical quality control system described in any one of [1] to [4], wherein the terminal device is an RFID tag. [6] The pharmaceutical quality control system according to any one of [1] to [4], wherein the terminal device is a beacon. [7] A pharmaceutical quality control system as described in [5] or [6], which is configured to obtain the date, time and / or location at which the temperature was measured from the RFID tag or beacon that was in contact with the medicine box containing the medicine and collected after use of the medicine. [8] A pharmaceutical quality control system described in any of [1] to [7], which determines that the pharmaceuticals contained in the pharmaceutical box can be returned if all measured temperatures are within a predetermined range as a result of temperature measurement of the pharmaceutical box. [9] An information management system comprising a terminal device arranged to come into contact with a medicine box containing medicines, a collection box for collecting the terminal device after the medicines have been used, and a server that receives information related to the medicines from the terminal device via a repeater provided in the collection box, wherein when the terminal device is inserted into the collection box, the repeater pairs with the terminal device and receives information related to the medicine's identification number, date of use, time of use, place of use and / or institution of use, and transmits it to the server.
[10] The information management system described in [9], wherein the server generates aggregated information based on the information received from the repeater.
[11] The information management system described in
[10] , wherein the aggregated information is information relating to the optimal supply amount, supply frequency and / or supply location of the pharmaceutical.
[12] A pharmaceutical quality control method comprising the step of measuring the temperature of a pharmaceutical box containing pharmaceuticals at an appropriate sampling rate using a temperature sensor provided on a terminal device arranged to be in contact with the pharmaceutical box.
[13] The pharmaceutical quality control method described in
[12] , wherein the terminal device is attached to the pharmaceutical box with an adhesive member and brought into contact with the pharmaceutical box.
[14] A pharmaceutical quality control method as described in
[12] , wherein the terminal device is brought into contact with the pharmaceutical box by being placed in a packaging body together with the pharmaceutical box.
[15] The pharmaceutical quality control method according to any one of
[12] to
[14] , wherein the temperature measurement by the terminal device is performed at intervals of 5 to 15 minutes.
[16] The pharmaceutical quality control method according to any one of
[12] to
[15] , wherein the terminal device is an RFID tag.
[17] The pharmaceutical quality control method according to any one of
[12] to
[15] , wherein the terminal device is a beacon.
[18] A pharmaceutical quality control method as described in
[16] or
[17] , comprising a step of recovering the RFID tag or beacon that was in contact with the pharmaceutical box in which the pharmaceutical was stored in a recovery box after the pharmaceutical has been used, and a step of determining the date, time and / or location of temperature measurement related to the pharmaceutical box.
[19] A pharmaceutical quality control method according to any one of
[12] to
[18] , comprising a step of determining that the pharmaceuticals contained in the pharmaceutical box are returnable if all measured temperatures are within a predetermined range as a result of temperature measurement of the pharmaceutical box.
[20] An information management method comprising the steps of: arranging a terminal device so as to come into contact with a medicine box containing a medicine; inserting the terminal device into a collection box after using the medicine; a repeater provided in the collection box pairing with the terminal device; the repeater receiving information relating to the medicine's identification number, date of use, time of use, place of use and / or institution of use from the terminal device; and the repeater transmitting the information to a server.
[21] The information management method according to
[20] , further comprising a step of the server generating aggregated information based on the information received from the repeater.
[22] The information management method described in
[21] , wherein the aggregated information is information relating to the optimal supply amount, supply frequency and / or supply location of the pharmaceutical. Effect of the Invention
[0009] According to the present invention, for example, a strip-shaped terminal device with a built-in temperature sensor is arranged so as to come into contact with a medicine box containing medicines, and the temperature of the medicine box is measured at any sampling time by the temperature sensor embedded in the terminal device, and information related to the temperature is collected and stored in a memory embedded in the terminal or a gateway, etc. In other words, by bringing the terminal device into contact with the medicine box containing medicines, the temperatures measured over time can be checked all at once by a wireless receiving device such as a smartphone or gateway.
[0010] This allows for simpler and more direct management of medicines compared to storing medicines in a refrigerator and managing the temperature of the refrigerator by sequentially measuring the temperature of the refrigerator, etc. As a result, it is possible to easily and immediately determine whether the medicine satisfies the return requirements by grasping the temperature state of the medicine, and it is possible to provide a medicine quality control system and quality control method that significantly reduces the disposal of unnecessary medicines and contributes to the SDGs.
[0011] In addition, according to the present invention, when a used terminal device is collected in a collection box, the terminal device and a repeater installed in the collection box are paired to exchange information regarding the identification number of the used medicine, the date of use, the time of use, the place of use and / or the institution of use, and this information can be transmitted from the repeater to a server.
[0012] This will not only reduce the waste of medicines, but will also enable pharmaceutical manufacturers, who are the suppliers of medicines, to manage and generate aggregated information that is useful for formulating marketing strategies. [Brief description of the drawings]
[0013] [Figure 1] FIG. 1 is a diagram showing an example of a pharmaceutical quality control system using the RFID tag of the present invention. [Diagram 2] FIG. 11 is a diagram showing another example of a pharmaceutical quality control system using the RFID tag of the present invention. [Diagram 3] FIG. 1 is a diagram illustrating an example of an information management system according to the present invention. [Figure 4] FIG. 1 is a diagram illustrating an example of an information management system according to the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0014] Hereinafter, the present invention will be described based on an embodiment. (First embodiment) Fig. 1 is a diagram showing an example of a pharmaceutical quality control system using an RFID tag as a terminal device of the present invention. As shown in Fig. 1, a pharmaceutical quality control system 10 using an RFID tag of the present invention includes a pharmaceutical box 11 in which pharmaceuticals are stored, and a strip-shaped RFID tag 12 arranged so as to be in contact with the pharmaceutical box 11. Pharmaceuticals are stored in a bottle such as an ampule (not shown), and a plurality of ampoules can be set upright in the pharmaceutical box 11, or other tablets or powdered pharmaceuticals can be stored in a state of being filled in a pouch, and the form is not particularly limited.
[0015] The RFID tag 12 may be a general-purpose one, and includes an antenna, a memory, a temperature sensor, a battery, and the like (not shown).
[0016] In this example, the size of the RFID tag 12, i.e., the length and width, etc., are smaller than the size of the medicine box 11, i.e., the length and width, etc., that define the medicine box 11. Therefore, in order to bring the RFID tag 12 into contact with the medicine box 11, the RFID tag 12 is affixed to the medicine box 11 with an affixing member 13 such as a security tape, as shown in FIG.
[0017] In this example, an RFID tag 12 is disposed so as to come into contact with a medicine box 11 containing medicines, the temperature of the medicine box 11 is measured over time by a temperature sensor embedded in the RFID tag 12, and information relating to the temperature is stored in a memory embedded in the RFID tag 12. In other words, by bringing the RFID tag 12 into contact with the medicine box 11 containing medicines, the temperatures measured over time can be checked all at once by a wireless receiving device such as a smartphone.
[0018] In this way, pharmaceuticals can be managed more simply and directly than when the pharmaceuticals are stored in a refrigerator and the temperature of the refrigerator is measured periodically, etc. As a result, it is possible to provide a pharmaceutical quality control system and a pharmaceutical quality control method that easily controls the temperature of pharmaceuticals and significantly reduces pharmaceutical waste, thereby contributing to the SDGs.
[0019] However, this does not exclude the use of a refrigerator for storing the medicine box 11, i.e., medicines, and in cases where the medicine storage temperature cannot be maintained without using a refrigerator, it may be used in combination as appropriate. The present invention does not exclude the use of a refrigerator itself, but eliminates the temperature control work involved.
[0020] From the viewpoint of properly managing the storage conditions of the medicine, it is preferable to measure the temperature of the medicine box 11 using the RFID tag 12 at intervals of 5 to 15 minutes, and more preferably at intervals of 15 minutes. In such a case, the battery in the RFID tag 12 will be exhausted in about 50 days, and the RFID tag 12 will reach the end of its life, so it is preferable to clearly indicate the expiration date (date and time when it can be used) on the surface of the RFID tag 12.
[0021] If the medicine box 11, i.e., the medicine, is always kept within a specified temperature range that satisfies the return requirements during the period of use of the RFID tag 12, it can be determined that the efficacy of the medicine is maintained, and the seller, etc. can accept the return of the unused remaining medicine. On the other hand, if the medicine box 11, i.e., the medicine, is not kept within the specified temperature range, for example, if the deviation is large, it will be discarded, but if the deviation is small, it may be determined that it can be sold depending on the set conditions.
[0022] In addition, since the RFID tag 12 is used for temperature management, the information from the memory in the RFID tag 12 can be checked all at once using a wireless receiving device such as a smartphone.
[0023] Second embodiment Fig. 2 is a diagram showing another example of a pharmaceutical quality control system using the RFID tag of the present invention. As shown in Fig. 2, the pharmaceutical quality control system 10 of the present invention includes a pharmaceutical box 11 containing pharmaceuticals, and a strip-shaped RFID tag 12 arranged so as to be in contact with the pharmaceutical box 11. As in the above example, the pharmaceuticals can be contained in a bottle such as an ampule (not shown) and arranged so that a plurality of ampules are erected in the pharmaceutical box 11, or else, a tablet or powder pharmaceutical can be arranged in a state of being filled in a pouch, and the form is not particularly limited.
[0024] The RFID tag 12 may be a general-purpose one, and may have the configuration as described above.
[0025] In this example, the size of the RFID tag 12, i.e., the length and width, etc., are larger than the size of the medicine box 11, i.e., the length and width, etc., that define the medicine box 11. Therefore, in order to bring the RFID tag 12 into contact with the medicine box 11, the medicine box 11 and the RFID tag 12 are stored in a packaging body 23 such as a vinyl bag or a polybag, as shown in FIG.
[0026] In this example, too, a strip-shaped RFID tag 12 is disposed so as to come into contact with a medicine box 11 containing medicines, and the temperature of the medicine box 11 is measured over time by a temperature sensor embedded in the RFID tag 12, and the temperature is stored in a memory embedded in the RFID tag 12. In other words, by bringing the RFID tag 12 into contact with the medicine box 11 containing medicines, the temperatures measured over time can be checked all at once by a wireless receiving device such as a smartphone.
[0027] Therefore, pharmaceuticals can be managed more simply and directly than when the pharmaceuticals are stored in a refrigerator and the temperature of the refrigerator is measured periodically, etc. As a result, it is possible to provide a pharmaceutical quality control system and a pharmaceutical quality control method that easily controls the temperature of pharmaceuticals and significantly reduces pharmaceutical waste, thereby contributing to the SDGs.
[0028] As in the above example, this does not exclude the use of a cooler, but excludes the temperature control of the cooler.
[0029] From the viewpoint of properly managing the storage conditions of the medicine, it is preferable to measure the temperature of the medicine box 11 using the RFID tag 12 at intervals of 5 to 15 minutes, and more preferably at intervals of 15 minutes. In such a case, the battery in the RFID tag 12 will be exhausted in about 50 days, and the RFID tag 12 will reach the end of its life, so it is preferable to clearly indicate the expiration date (date and time when it can be used) on the surface of the RFID tag 12.
[0030] If the medicine box 11, i.e., all of the medicine, is within the specified temperature range during the usage period of the RFID tag 12, the efficacy of the medicine is maintained, and any unused medicine remaining can be returned to the distributor, etc. On the other hand, if the medicine box 11, i.e., the medicine, is not within the specified temperature range, for example, if the deviation is large, it will be discarded, but if the deviation is small, it may be possible to sell it.
[0031] In addition, since the RFID tag 12 is used for temperature management, the information from the memory in the RFID tag 12 can be checked all at once using a wireless receiving device such as a smartphone.
[0032] Third embodiment This embodiment is a modification of the first embodiment, and uses a beacon instead of an RFID tag. The beacon 31 can be a general-purpose one, and is a terminal device capable of communicating with a nearby repeater (gateway) via Bluetooth or the like, and has the advantage of being low cost and consuming less power than an RFID tag.
[0033] In this example, too, a beacon 31 is provided so as to come into contact with a medicine box 11 containing medicines, the temperature of the medicine box 11 is measured over time by a temperature sensor embedded in the beacon 31, the temperature is received by a gateway 32 provided in a showcase or the like, and the temperature is stored and managed in the cloud 33. In other words, the beacon 31 is provided in contact with the medicine box 11 containing medicines, and the temperature measured over time can be checked all at once by a receiving device such as the gateway 32.
[0034] Therefore, pharmaceuticals can be managed more simply and directly than when the pharmaceuticals are stored in a refrigerator and the temperature of the refrigerator is measured periodically, etc. As a result, it is possible to provide a pharmaceutical quality control system and a pharmaceutical quality control method that easily controls the temperature of pharmaceuticals and significantly reduces pharmaceutical waste, thereby contributing to the SDGs, as described above.
[0035] In addition, if the medicine box, i.e., the medicine itself, is not within the specified temperature range, for example, if the deviation is significant, it will be discarded, but if the medicine box is unopened and the deviation is minor, it may be returned and available for sale.
[0036] Furthermore, the used beacon 31, i.e., the beacon 31 that has been in contact with the medicine box after the medicine box has been opened and the medicine has been used, is collected in the collection box 34. When the beacon 31 is put into the collection box 34, the gateway 32 disposed in the collection box 34 pairs with the beacon 31 and receives information related to the identification number of the medicine with which the beacon 31 has been in contact. Furthermore, information related to the date and / or time of use of the medicine is obtained from the date and time when the beacon 31 was put into the collection box 34. Also, information related to the place and / or institution of use of the medicine is obtained from the location information of the gateway 32 that has been paired with the beacon 31. The gateway 32 transmits the information related to the medicine thus obtained, i.e., information related to the identification number, date and time of use, place and / or institution of use of the medicine, to the cloud 33, and the cloud 33 can accumulate and manage the information. Furthermore, the gateway 32 can be installed in any manner as long as it is capable of pairing with the beacon 31 dropped into the collection box 34; it may be installed inside or outside the collection box 34, or it may be installed as an integral part of the collection box 34.
[0037] The cloud 33 can also generate aggregate information based on the information related to the drug received from the gateway 32. For example, the cloud 33 can generate aggregate information on the optimal supply amount and supply frequency of the drug for each use location, etc., by calculating the amount of the drug used within a predetermined period for each use location and / or use institution of the drug. Alternatively, the cloud 33 can generate aggregate information on the optimal supply location, etc., by identifying the use location, etc., where a large amount of the drug was used within a predetermined period. The cloud 33 can also transmit the aggregate information to a PC, mobile terminal, or any other terminal device provided at the drug manufacturer, etc., which is the manufacturer of the drug. At this time, the cloud 33 can be arbitrarily configured to transmit the aggregate information only to terminals that satisfy conditions such as payment of a predetermined fee, or to transmit the aggregate information in real time. This allows the drug manufacturer, etc., to not only suppress waste of drugs, but also to obtain information useful for planning a marketing strategy.
[0038] The other features and effects are the same as those of the above embodiment, and therefore will not be described. The present embodiment does not exclude the use of a refrigerator, but excludes the temperature control of the refrigerator, as in the above embodiment.
[0039] Furthermore, the use of beacons (and gateways, etc.) instead of RFID tags can be applied not only to the modified example of the first embodiment, but also to the modified example of the second embodiment.
[0040] Although some embodiments of the present invention have been described above, these are merely examples and are not intended to limit the technical scope of the present invention. These novel embodiments can be implemented in various other forms, and various omissions, substitutions, and modifications can be made without departing from the spirit of the invention. These embodiments and their modifications are included in the scope and gist of the invention, and are included in the scope of the invention and its equivalents described in the claims. [Explanation of symbols]
[0041] 10. Pharmaceutical quality control system using RFID tags 11 Medicine Box 12 RFID tags 13 Attachment material 23 Encapsulating body 31 Beacon 32 Gateway 33 Server (Cloud) 34 Collection Box
Claims
1. A pharmaceutical quality control system comprising a terminal device with a built-in temperature sensor arranged to be in contact with a pharmaceutical box containing pharmaceuticals, and measuring the temperature of the pharmaceutical box at an appropriate sampling rate using the temperature sensor provided in the terminal device.
2. The pharmaceutical quality control system according to claim 1 , wherein the terminal device is attached to the pharmaceutical box with an adhesive member and is in contact with the pharmaceutical box.
3. The pharmaceutical quality control system according to claim 1 , wherein the terminal device is in contact with the pharmaceutical box by being placed in a package together with the pharmaceutical box.
4. The pharmaceutical quality control system according to any one of claims 1 to 3, wherein the temperature measurement by the terminal device is performed at intervals of 5 to 15 minutes.
5. The pharmaceutical quality control system according to any one of claims 1 to 4, wherein the terminal device is an RFID tag.
6. The pharmaceutical quality control system according to any one of claims 1 to 4, wherein the terminal device is a beacon.
7. A pharmaceutical quality control system as described in claim 5 or 6, which is configured to obtain the date, time and / or location at which the temperature was measured from the RFID tag or beacon that was in contact with the medicine box that contained the medicine and was collected after the medicine was used.
8. A pharmaceutical quality control system as described in any one of claims 1 to 7, which determines that the pharmaceuticals contained in the pharmaceutical box can be returned if all measured temperatures are within a predetermined range as a result of temperature measurement of the pharmaceutical box.
9. An information management system comprising: a terminal device arranged to be in contact with a medicine box containing medicines; a collection box for collecting the terminal device after use of the medicines; and a server for receiving information related to the medicines from the terminal device via a repeater provided in the collection box, An information management system characterized in that when the terminal device is placed in the collection box, the repeater pairs with the terminal device and receives information related to the medicine's identification number, date of use, time of use, place of use and / or institution of use, and transmits it to the server.
10. The information management system according to claim 9 , wherein the server generates aggregate information based on the information received from the repeater.
11. The information management system according to claim 10 , wherein the collected information is information relating to an optimal supply amount, supply frequency and / or supply location of the medicine.
12. A pharmaceutical quality control method comprising the step of measuring the temperature of a pharmaceutical box containing pharmaceuticals at an appropriate sampling rate using a temperature sensor provided in a terminal device arranged to be in contact with the pharmaceutical box.
13. The pharmaceutical quality control method according to claim 12, wherein the terminal device is attached to the pharmaceutical box with an adhesive member and brought into contact with the pharmaceutical box.
14. The pharmaceutical quality control method according to claim 12, wherein the terminal device is brought into contact with the pharmaceutical box by being placed in a package together with the pharmaceutical box.
15. The pharmaceutical quality control method according to any one of claims 12 to 14, wherein the temperature is measured by the terminal device at intervals of 5 to 15 minutes.
16. The pharmaceutical quality control method according to any one of claims 12 to 15, wherein the terminal device is an RFID tag.
17. The pharmaceutical quality control method according to any one of claims 12 to 15, wherein the terminal device is a beacon.
18. The pharmaceutical quality control method according to claim 16 or 17, further comprising a step of recovering the RFID tag or beacon that has been in contact with the pharmaceutical box containing the pharmaceutical after use in a recovery box, and a step of determining the date, time and / or location of temperature measurement relating to the pharmaceutical box.
19. A pharmaceutical quality control method according to any one of claims 12 to 18, further comprising a step of determining that the pharmaceuticals contained in the pharmaceutical box are returnable if all measured temperatures are within a predetermined range as a result of temperature measurement of the pharmaceutical box.
20. placing a terminal device in contact with a medicine box containing medicines; inserting the terminal device into a collection box after use of the medicine; A step of pairing a repeater provided in the collection box with the terminal device; receiving information related to the identification number, date of use, time of use, place of use, and / or institution of use of the medicine from the terminal device by the relay device; and a step of the repeater transmitting the information to a server.
21. 21. The information management method according to claim 20, further comprising a step of the server generating compiled information based on the information received from the repeater.
22. The information management method according to claim 21 , wherein the collected information is information relating to an optimal supply amount, supply frequency and / or supply location of the medicine.
Citation Information
Patent Citations
Digital parallel / serial converter
JP1989008731A
