Clinical test pharmacy management system and method based on traceable label

Abstract

According to the clinical test pharmacy management system and method based on the traceable labels, the medicines are coded according to the item numbers and the medicine numbers to generate the unique labels, traceable management is carried out on warehousing, storage and distribution of the medicines through the labels, and the defects that clinical test medicines are non-standardized, and the efficiency is high are overcome. According to the invention, the problems that the clinical experiment project and the medicine are bound and the medication state of the project is effectively managed and monitored by establishing project management and medicine dictionaries are solved, the prescription error and the middle manpower communication cost are reduced, the working efficiency of pharmacists is improved, and the clinical experiment project management system is suitable for the pharmacy. And the human resource cost and the time cost are greatly saved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical information management, and in particular to a clinical trial pharmacy management system and method based on traceable labels. Background Art

[0002] Clinical trials are systematic studies conducted on humans to evaluate the efficacy and safety of new drugs. They are an important part of the new drug development process and an indispensable step before new drugs are officially launched on the market. As the core of the entire clinical trial, whether the experimental drugs are managed in a standardized manner plays a vital role in ensuring the safety of the subjects and the reliability of the test results.

[0003] The Good Clinical Practice (GCP) pharmacy is also called the central pharmacy. It is a pharmacy established by the clinical trial center in accordance with the Good Clinical Practice (GCP) pharmacy for storing trial drugs. The establishment of the central pharmacy not only reduces the problems in the management of trial drugs, but also plays a certain role in the quality control of drug clinical trials. In order to facilitate unified management, more and more clinical trial institutions adopt the model of centralized drug management in the central pharmacy. However, there is currently no fixed model or relevant guiding principles for the management of central pharmacies, and the following problems may exist in the management process: First, trial drugs use drug codes as their unique identity codes. The drug codes in the same clinical trial are often one drug per code, or multiple drugs per code. Drug managers distribute drugs based on the drug codes in the prescriptions, which places higher requirements on the accuracy of drug managers; second, the trial drugs themselves do not contain drug traceability codes. If drug managers are still responsible for the process management of each link such as receipt, storage, distribution, and recovery of trial drugs and still use handwritten records, they will not be able to track or query the real-time status of the trial drugs; third, prescriptions and records of clinical trial drugs are mostly filled out manually, which is prone to irregular writing, high error rates, cumbersome processes, incomplete records, and other problems; finally, clinical trial drugs are stored in multiple refrigerators, which takes up a lot of space and has low efficiency, and requires temperature management and monitoring records for multiple refrigerators.

[0004] The existing clinical trial pharmacy management usually includes room temperature drug storage and low temperature drug storage, and is equipped with trained drug management personnel who hold GCP training certificates, who are responsible for different experimental projects. Drug management personnel are responsible for process management of experimental drug reception, storage, distribution, recovery and other links. Compared with common pharmacy management, the management of clinical trial pharmacy has its own particularity: First, most of the drugs used in clinical trials are unlisted drugs or drugs come from different pharmaceutical factories and are uniformly managed by CRO companies, so unlike drugs circulating in the market, they can not be traced by barcodes. Secondly, the specifications, packaging, names, etc. of clinical trial drugs are not uniform, and the drugs are bound to the projects and change with the change of projects. They cannot be displayed by the initials AZ like normal pharmacies. Thirdly, the prescriptions and records of clinical trial drugs are mostly filled in manually, which is prone to problems such as irregular writing, missing information, and filling in wrong information. If they are not changed to the correct information in time, it is easy to have problems such as missing test information, untraceable drugs and wrong drugs, thus affecting the integrity and smooth progress of the trial. Finally, clinical trial drugs have strict temperature management requirements. Even if each clinical center is equipped with complete cold chain equipment and monitoring systems, the experimental drugs are prone to excessive temperature and humidity due to various factors. The main factors that lead to this problem include equipment failure in the refrigerator, excessive temperature due to opening the refrigerator door when collecting and taking drugs, and excessive humidity due to problems with the drug storage location. Therefore, a clinical trial pharmacy management system is needed that can traceably manage drug project establishment, acceptance, storage, distribution, and recycling. Summary of the invention

[0005] The purpose of the present invention is to provide a clinical trial pharmacy management system based on traceable labels, and to provide an intelligent management system that can trace the entire process of clinical trial drugs.

[0006] In order to achieve the above object, the present invention provides a clinical trial pharmacy management system based on traceable labels, comprising:

[0007] The project management module is used to establish clinical trial projects, import and manage project information, and export the forms required for the project. The project information at least includes the unique project number of the project, and imports the drug information corresponding to the project from the drug dictionary module; the exported forms required for the project include the drug storage and distribution record form and the drug recovery return handover record form;

[0008] A drug dictionary module, which imports drug data and establishes a drug file based on the drug data, wherein the drug file includes at least one drug information associated with the corresponding clinical trial project, and the drug information includes at least a unique drug number of the drug. The drug dictionary module generates a traceable drug label based on the project number and the drug number, and records the full process status of the drug;

[0009] The drug storage management module selects a drug box to place the drugs that need to be stored. The drug box has a unique box number. The drug box is bound to the clinical trial project based on the box number. The drug is bound to one or more drug boxes based on the drug number. After the binding is completed, the manipulator is controlled to transfer the drug box with the drug bound to a fixed location in the warehouse for storage;

[0010] The prescription management module receives and reviews the electronic prescription, and dispenses the electronic prescription according to the review result. The medication dispensing obtains the bound medicine box number through the medicine number, controls the manipulator to take the medicine box out of the warehouse, and performs the medicine dispensing operation and records the completed prescription;

[0011] The drug recovery management module receives the recovery prescription information, verifies the drugs recovered to the pharmacy according to the drug number, remaining drug quantity, and empty package information in the recovery prescription, and records the completed drug recovery.

[0012] Furthermore, the project management module provides a project management page, in which information management operations, warehousing operations, prescription management and recovery operations are performed on the project information and its associated drug information.

[0013] Furthermore, the drug file includes the drug name, specification, dosage form, unit, drug length, width and height, storage temperature, manufacturer and inventory, and the drug information includes batch number, scheme number, project number, drug number, quantity, expiration date and status.

[0014] Furthermore, the drug dictionary module classifies the drugs according to their length, width and height to generate built-in drug information, wherein the built-in drug information includes a drug box matched according to the length, width and height of the drugs and the number of drugs placed in the drug box.

[0015] Furthermore, after receiving the warehousing operation instruction, the drug storage management module selects a matching medicine box for warehousing operation according to the built-in information of the medicine, and determines whether the medicine box is full according to the number of medicines placed. If it is not full, other medicine boxes bound to the medicine are selected for warehousing operation.

[0016] Furthermore, the warehousing management module includes a prescription review unit, which receives and reviews electronic prescriptions through the HIS system to verify that the electronic prescriptions have been confirmed by the physician, pharmacist, and recipient. Prescriptions that have passed the review will have their status changed to pending medication. If the review fails, the system will send a text message to the prescribing physician to confirm the prescription information and change the prescription status to rejected for review.

[0017] Furthermore, the prescription management module includes a prescription dispensing unit, which obtains the corresponding electronic prescription to be dispensed based on scanning the barcode on the paper prescription, obtains the storage location of the medicine box based on the binding information of the electronic prescription to be dispensed, takes out the medicine box through a robotic arm, scans the traceable drug label of the drug to verify the accuracy of the drug, and then changes the prescription status to dispensed.

[0018] Furthermore, the prescription management module includes a prescription dispensing module, which reviews the dispensed prescription, scans the traceable drug label of the drug for secondary verification of the drug, and changes the prescription status to dispensed after the system verifies that the drug is accurate.

[0019] Furthermore, if the medicine to be dispensed requires intravenous preparation, the prescription dispensing module will print the corresponding bottle label, which has a drug label. After the dispensing is completed, the prescription dispensing module obtains the scan result of the drug label on the label for dispensing verification. After the dispensing is completed, it enters the drug review and dispensing stage.

[0020] Furthermore, the drug recovery prescription includes the recovery date, subject number, drug name, specification, batch number, drug number, quantity, and person returning the drug. The drug recovery management module receives the scan code verification result of the recovered drug, completes the drug recovery operation and archives it.

[0021] Furthermore, the system also includes an automated pharmacy, which includes a drug receiving area, a drug dispensing area, and a storage area. The storage area includes a cool area and a refrigerated area. Robotic arms are provided in the cool area and the refrigerated area. The medicine boxes are placed in corresponding fixed positions according to the box numbers.

[0022] On the other hand, the present invention also provides a clinical trial pharmacy management method based on traceable labels, comprising the following steps:

[0023] Project management, establishing clinical trial projects, importing and managing project information, and exporting forms required for the project. The project information at least includes the unique project number of the project, and imports the drug information corresponding to the project from the drug dictionary module; the forms required for the exported project include the drug in and out warehouse issuance record form and the drug recovery return handover record form;

[0024] A drug dictionary, importing drug data, and establishing a drug file based on the drug data, wherein the drug file includes at least one drug information associated with the corresponding clinical trial project, and the drug information includes at least the unique drug number of the drug, and the drug dictionary module generates a traceable drug label based on the project number and drug number, and records the full process status of the drug;

[0025] Drug storage management: select a drug box to place the drugs that need to be stored. The drug box has a unique box number. The drug box is bound to the clinical trial project based on the box number. The drug is bound to one or more drug boxes based on the drug number. After the binding is completed, the robot is controlled to transfer the drug box with the drug bound to a fixed location in the warehouse for storage;

[0026] Prescription management: receiving electronic prescriptions and reviewing them, dispensing the electronic prescriptions according to the review results, obtaining the bound medicine box number through the medicine number, controlling the manipulator to take the medicine box out of the warehouse, dispensing the medicine after the prescriptions are completed and recording them;

[0027] Drug recycling management, receiving recycling prescription information, verifying the drugs recycled to the pharmacy according to the drug number, remaining drug quantity, and empty package information in the recycling prescription, and recording after completing the drug recycling.

[0028] The present invention has the following technical advances and beneficial effects:

[0029] The present invention provides a clinical trial pharmacy management system and method based on traceable labels, which encodes drugs according to project numbers and drug numbers to generate unique labels, and the warehousing, storage, and issuance of drugs are all traceably managed through labels, overcoming the problem that clinical trial drugs are non-standardized and customized and difficult to manage in an informationized manner, and by establishing a project management and drug dictionary, clinical trial projects and drugs are bound, the status of project medication is effectively managed and monitored, and prescription errors and intermediate human communication costs are reduced. The present invention improves the work efficiency of pharmacists and greatly saves human resource costs and time costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0031] Figure 1 This is a schematic diagram of the structure of the automated pharmacy according to an embodiment of the present invention.

[0032] Figure 2 This is a system structure diagram of the automated pharmacy according to an embodiment of the present invention.

[0033] Figure 3 The present invention is a flowchart of a method for managing a clinical trial pharmacy according to an embodiment of the present invention. DETAILED DESCRIPTION

[0034] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] In the following description, reference is made to “some embodiments”, which describe a subset of all possible embodiments, but it will be understood that “some embodiments” may be the same subset or different subsets of all possible embodiments and may be combined with each other without conflict.

[0036] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application belongs. The terms used herein are only for the purpose of describing the embodiments of this application and are not intended to limit this application.

[0037] The present invention provides a clinical trial pharmacy management system and method based on traceable labels, which encode drugs according to project numbers and drug numbers to generate unique labels, and the warehousing, storage and issuance of drugs are all traceably managed through the labels, overcoming the problem that clinical trial drugs are non-standardized and customized and difficult to manage informatization. By establishing a project management and drug dictionary, clinical trial projects and drugs are bound, the status of project medication is effectively managed and monitored, and prescription errors and intermediate human communication costs are reduced. The present invention improves the work efficiency of pharmacists and greatly saves human resource costs and time costs.

[0038] In an embodiment of the present invention, a clinical trial pharmacy management system based on traceable labels performs traceable management of drug warehousing, storage, project establishment, drug collection, drug dispensing, distribution, and recycling based on an automated pharmacy. Figure 1 The structural design diagram of the automated pharmacy of Example 1 of the present invention is as follows Figure 1 The automated pharmacy shown includes a drug receiving area 1, a drug dispensing area 2, an intelligent storage area 3, an intravenous drug preparation room 4, and a waiting area 5. The waiting area 5 is also provided with a recycling area 5-2 for placing recycled medicine boxes, drug delivery boxes, and drugs to be returned temporarily.

[0039] Specifically, the drug receiving area 1 is used to receive qualified drugs. The waiting area 5 is located outside the drug receiving area 1. A preparation table 2-2 is provided in the drug dispensing area 2. Drugs are prepared at the preparation table 2-2. Qualified drugs are placed on the preparation table for coding verification and label printing. The intelligent storage area 3 includes a cool area 3-1 and a cold storage area 3-2. The temperature in the cool area 3-1 is 15 to 25°C, which is used to store common drugs. The temperature in the cold storage is 2 to 8°C, which is used to store special drugs, such as biological agents. Shelves are placed in the cool area 3-1 and the cold storage area 3-2. The intravenous drug preparation room 4 is equipped with a dressing and disinfection area, and is equipped with a label scanning system to verify the configured drugs. The intelligent storage area 3 adopts an intelligent manipulator to grab drugs. The manipulator has a 180° rotation and can grab any medicine storage box. The replenishment and retrieval of drugs are independently designed without interfering with each other.

[0040] The present invention provides a clinical trial pharmacy management system based on traceable labels, which automatically allocates drug storage containers through pre-input project information / project plan (frequency of patient follow-up, dosage, etc.) and drug information (drug storage temperature, drug packaging size), and traces drugs through drug QR codes, eliminating the need for pharmacists to manually search for drugs and record drug storage locations.

[0041] Figure 2 : is a system architecture diagram of a clinical trial pharmacy management system according to an embodiment of the present invention. Figure 2 As shown, a clinical trial pharmacy management system based on traceable labels of the present invention includes: a project management module 101, a drug dictionary module 102, a drug storage management module 103, a prescription management module 104 and a drug recovery management module 105.

[0042] Specifically, the project management module is used to establish clinical trial projects, import and manage project information, and export project forms. The project management module imports project communication forms through the HIS system with one click. The imported content includes project name, protocol number, ward, sponsor, investigator (PI), research nurse, contact number, sponsor manager, contact number, project start date, expected number of patients, and project end date.

[0043] The project information at least includes the unique project number of the project and the drug information corresponding to the project imported from the drug dictionary module. The project management module displays all project information through the management page. The project information can be sorted, filtered, and searched according to the department or the associated drug name or PI. Each project information displays the project name, ward / department, sponsor manager, file creation time, and the number of drugs under development (based on the same drug number).

[0044] Double-click the name of the project information to open the detailed information of the drug file. The drug information belonging to this project will be displayed in the subordinate page. The drug information includes drug name, specification, dosage form, unit, storage temperature, manufacturer, batch number, number, quantity (inventory), and drug status. The drug status includes received, shipped / pending, shipped / pending, and recovered.

[0045] Specifically, the drug dictionary module imports the project communication record form through the HIS system with one click to establish a drug file. The drug file includes: drug name, specification, dosage form, unit, length, width and height of the drug, storage temperature, manufacturer, and inventory. The drug file includes at least one drug information associated with the clinical trial project to which it belongs, and the drug information includes at least the unique drug number of the drug. The drug dictionary module generates a traceable drug label based on the project number and drug number, and records the full process status of the drug. After the drug file is established, you can check the drug in the management page and print the drug label. After the drug label is printed, the drug status is recorded as printed.

[0046] It should be noted that each drug in the drug dictionary is associated with its corresponding unique item, and an item can be associated with multiple drugs. Drugs can be categorized according to length, width and height and built-in information can be calculated. The built-in information is used to determine which drug box the drug can be placed in and how many drugs can be placed in a drug box.

[0047] Specifically, the drug storage management module selects a drug box to place the drugs that need to be stored, the drug box has a unique box number, the drug box is bound to the clinical trial project based on the box number, and the drug is bound to one or more drug boxes based on the drug number. After the binding is completed, the manipulator is controlled to transfer the drug box with the drug binding to a fixed location in the warehouse for storage;

[0048] The drug storage management module receives and reviews the electronic prescription, and dispenses the drug according to the review results. The drug dispensing module obtains the bound drug box number by scanning the drug label, controls the robot to take the drug box out of the warehouse, and dispenses the drug after the prescription is dispensed and records the drug status as stored.

[0049] The prescription management module includes a prescription review unit. The prescription review unit receives and reviews electronic prescriptions through the HIS system to verify that the electronic prescriptions have been confirmed by the physician, pharmacist, and recipient. Prescriptions that have passed the review will have their status changed to pending medication. If the review fails, the system will send a text message to the prescribing physician to confirm the prescription information and change the prescription status to rejected for review.

[0050] The prescription management module includes a prescription dispensing unit. The prescription dispensing unit obtains the corresponding electronic prescription to be dispensed based on scanning the barcode on the paper prescription, obtains the storage location of the medicine box based on the binding information of the electronic prescription to be dispensed, takes out the medicine box through the robotic arm, scans the traceable drug label of the drug to verify the accuracy of the drug, and then changes the prescription status to dispensed.

[0051] The prescription management module includes a prescription dispensing module, which reviews the dispensed prescription, scans the traceable drug label of the drug for secondary verification of the drug, and changes the prescription status to dispensed after the system verifies that the drug is accurate.

[0052] Preferably, if the medicine to be dispensed requires intravenous preparation, the prescription dispensing module prints the corresponding bottle label, which has a medicine label. After the dispensing is completed, the prescription dispensing module obtains the scan result of the medicine label on the label for dispensing verification. After the dispensing is completed, the medicine review and dispensing link is entered.

[0053] The drug recovery management module receives the recovery prescription information, obtains the drug box number according to the drug number in the recovery prescription, controls the robot to take the drug box out of the warehouse, and records it after the drug recovery is completed.

[0054] Preferably, the drug recovery prescription includes the recovery date, subject number, drug name, specification, batch number, drug number, quantity, and person returning the drug. The drug recovery management module receives the scan code verification result of the recovered drug, completes the drug recovery operation and archives it.

[0055] Figure 3 : is a method flow chart of the clinical trial pharmacy management method according to an embodiment of the present invention, such as Figure 3 As shown, the present invention provides a clinical trial pharmacy management method based on traceable labels, including:

[0056] Project management: establish clinical trial projects, import and manage project information, and export the required forms for the project (including 1. Drug in / out warehouse distribution record form, 2. Drug recovery return handover record form). The project information at least includes the unique project number of the project, and imports the drug information corresponding to the project from the drug dictionary module;

[0057] A drug dictionary, importing drug data, and establishing a drug file based on the drug data, wherein the drug file includes at least one drug information associated with the corresponding clinical trial project, and the drug information includes at least the unique drug number of the drug, and the drug dictionary module generates a traceable drug label based on the project number and drug number, and records the full process status of the drug;

[0058] Drug storage management: select a drug box to place the drugs that need to be stored. The drug box has a unique box number. The drug box is bound to the clinical trial project based on the box number. The drug is bound to one or more drug boxes based on the drug number. After the binding is completed, the robot is controlled to transfer the drug box with the drug bound to a fixed location in the warehouse for storage;

[0059] Prescription management: receiving electronic prescriptions and reviewing them, dispensing the electronic prescriptions according to the review results, obtaining the bound medicine box number through the medicine number, controlling the manipulator to take the medicine box out of the warehouse, dispensing the medicine after the prescriptions are completed and recording them;

[0060] Drug recovery management: receive recovery prescription information, obtain the drug box number according to the drug number in the recovery prescription, control the robot to take the drug box out of the warehouse, and record it after the drug recovery is completed

[0061] Although the embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and cannot be understood as limiting the present invention. A person of ordinary skill in the art can change, modify, replace and modify the above embodiments within the scope of the present invention. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A clinical trial pharmacy management system based on traceable labels, characterized in that: The system is based on an automated pharmacy, which includes: a drug receiving area, a drug dispensing area, and a storage area. The storage area includes a cool area and a refrigerated area. Both the cool area and the refrigerated area are equipped with robotic arms. The drug boxes are placed in corresponding fixed positions according to the box numbers. The clinical trial pharmacy management system includes: A project management module is used to establish clinical trial projects, import and manage project information, and export forms required for the project. The project information at least includes the unique project number of the project, and imports drug information corresponding to the project from the drug dictionary module; A drug dictionary module, which imports drug data and establishes a drug file according to the drug data, wherein the drug file includes at least one drug information associated with the corresponding clinical trial project, wherein the drug information includes at least a unique drug number of the drug, and the drug dictionary module generates a traceable drug label based on the project number and the drug number, and records the full process status of the drug; The drug storage management module selects a drug box to place the drugs that need to be stored. The drug box has a unique box number. The drug box is bound to the clinical trial project based on the box number. The drug is bound to one or more drug boxes based on the drug number. After the binding is completed, the manipulator is controlled to transfer the drug box with the drug bound to a fixed location in the warehouse for storage; The prescription management module receives and reviews the electronic prescription, and dispenses the electronic prescription according to the review result. The medication dispensing obtains the bound medicine box number through the medicine number, controls the manipulator to take the medicine box out of the warehouse, and performs the medicine dispensing operation and records the completed prescription; The drug recovery management module receives the recovery prescription information, verifies the drugs recovered to the pharmacy according to the drug number, remaining drug quantity, and empty package information in the recovery prescription, and records the completed drug recovery.

2. A clinical trial pharmacy management system based on traceability labels as claimed in claim 1, characterized in that: The project management module provides a project management page, in which information management operations, warehousing operations, prescription management and recovery operations are performed on project information and its associated drug information.

3. A clinical trial pharmacy management system based on traceability labels as claimed in claim 1, characterized in that: The drug file includes the drug name, specification, dosage form, unit, length, width and height of the drug, storage temperature, manufacturer and inventory, and the drug information includes batch number, scheme number, project number, drug number, quantity, expiration date and status.

4. A clinical trial pharmacy management system based on traceability labels as claimed in claim 3, characterized in that: The drug dictionary module classifies the drugs according to their length, width and height to generate built-in drug information, wherein the built-in drug information includes a drug box matched according to the length, width and height of the drugs and the quantity of drugs placed in the drug box.

5. A clinical trial pharmacy management system based on traceability labels as claimed in claim 4, characterized in that: After receiving the storage operation instruction, the drug storage management module selects a matching drug box for storage operation according to the built-in information of the drug, and determines whether the drug box is full according to the number of drugs placed. If it is not full, other drug boxes bound to the drug are selected for storage operation.

6. A clinical trial pharmacy management system based on traceability labels as claimed in claim 5, characterized in that: The warehousing management module includes a prescription review unit, which receives and reviews electronic prescriptions through the HIS system to verify that the electronic prescriptions have been confirmed by the physician, pharmacist, and recipient. Prescriptions that have passed the review are changed to pending medication. If the review fails, the system sends a text message to the prescribing physician to confirm the prescription information and changes the prescription status to rejected for review.

7. A clinical trial pharmacy management system based on traceability labels as claimed in claim 6, characterized in that: The prescription management module includes a prescription dispensing unit, which obtains the corresponding electronic prescription to be dispensed based on scanning the barcode on the paper prescription, obtains the storage location of the medicine box based on the binding information of the electronic prescription to be dispensed, takes out the medicine box through a robotic arm, scans the traceable drug label of the drug to verify the accuracy of the drug, and then changes the prescription status to dispensed.

8. A clinical trial pharmacy management system based on traceability labels as claimed in claim 7, characterized in that: The prescription management module includes a prescription dispensing module, which reviews the dispensed prescription, scans the traceable drug label of the drug for secondary verification of the drug, and changes the prescription status to dispensed after the system verifies that the drug is accurate.

9. A clinical trial pharmacy management system based on traceability labels as claimed in claim 8, characterized in that: If the medicine to be dispensed requires intravenous preparation, the prescription dispensing module will print the corresponding bottle label, which has the prescription information and the drug label. After the dispensing is completed, the prescription dispensing module obtains the scan result of the drug label on the bottle label for dispensing verification. After the dispensing is completed, the drug review and dispensing link will be entered.

10. A clinical trial pharmacy management system based on traceability labels as claimed in claim 1, characterized in that: The drug recovery prescription includes the recovery date, subject number, drug name, specification, batch number, drug number, remaining drug quantity, remaining empty package quantity, and the person returning the drug. The drug recovery management module receives the scan code verification result of the recovered drug, completes the drug recovery operation and archives it.

11. A clinical trial pharmacy management method based on traceable labels, characterized in that: The following steps are involved: Project management: establishing clinical trial projects, importing and managing project information, exporting forms required for the project, where the project information includes at least the unique project number of the project, and importing drug information corresponding to the project from the drug dictionary module; A drug dictionary, importing drug data, and establishing a drug file based on the drug data, wherein the drug file includes at least one drug information associated with the corresponding clinical trial project, and the drug information includes at least the unique drug number of the drug, and the drug dictionary module generates a traceable drug label based on the project number and drug number, and records the full process status of the drug; Drug storage management: select a drug box to place the drugs that need to be stored. The drug box has a unique box number. The drug box is bound to the clinical trial project based on the box number. The drug is bound to one or more drug boxes based on the drug number. After the binding is completed, the robot is controlled to transfer the drug box with the drug bound to a fixed location in the warehouse for storage; Prescription management: receiving electronic prescriptions and reviewing them, dispensing the electronic prescriptions according to the review results, obtaining the bound medicine box number through the medicine number, controlling the manipulator to take the medicine box out of the warehouse, dispensing the medicine after the prescriptions are completed and recording them; Drug recycling management, receiving recycling prescription information, verifying the drugs recycled to the pharmacy according to the drug number, remaining drug quantity, and empty package information in the recycling prescription, and recording after completing the drug recycling.

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