A system, method, device and medium for high-throughput identification of potential risks of drugs

By constructing a collection of identified risks for drugs and presetting potential risk level determination standards, high-throughput screening of massive spontaneous adverse reaction reporting data has been performed to solve the problem of potential drug risk identification, improve the coverage and accuracy of risk monitoring, and reduce drug costs. occurrence of harmful events.

CN115132374BActive Publication Date: 2025-01-21CHANGSHA FAMARK DATA TECH CO LTD
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Patent Information

Application Number
CN202210717041.7
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2022-06-23
Publication Date
2025-01-21
Estimated Expiration
2042-06-23

AI Technical Summary

Technical Problem

The prior art is difficult to quickly identify and monitor potential risks of drugs, resulting in drug damage incidents.

Method used

By constructing a collection of identified risks for drugs and presetting potential risk level determination standards, high-throughput screening of massive spontaneous adverse reaction reporting data is performed to quickly discover potential risks of drugs and take corresponding risk control measures.

Benefits of technology

It improves the coverage and accuracy of drug risk monitoring, enables rapid pharmacovigilance planning, and reduces the occurrence of drug-related incidents.

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Abstract

The present invention discloses a system, method, device and medium for high-throughput identification of potential risks of drugs, including obtaining drug instructions, constructing a collection of identified risks of drugs according to all adverse drug reactions in the drug instructions, presetting a potential risk level determination standard for drugs, obtaining adverse reactions of drugs from spontaneous adverse reaction reports and performing high-throughput matching with the collection of identified risks of drugs to obtain potential risks of drugs, matching the potential risks of drugs with the risk level determination standard to obtain the potential risk level of drugs, and taking corresponding risk control measures. The present invention realizes the rapid discovery of potential risks of drugs from complex spontaneous adverse reaction reports, improves the coverage and accuracy of risk monitoring, and can provide support for enterprises to quickly make drug vigilance plans and provide a basis for modifying drug instructions after listing, guide patients to use drugs healthily and rationally, and reduce the occurrence of drug-related incidents.
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Description

Technical Field

[0001] The present invention relates to the technical field related to high-throughput identification, and in particular to a system, method, device and medium for high-throughput identification of potential risks of drugs. Background Art

[0002] Potential risks of drugs are generally adverse reactions that exceed the drug instructions, drug investigator's manual or product characteristics summary, and their nature and severity are inconsistent with the labeled approved drug instructions, or they are unexpected adverse reactions. The harm of potential risks of drugs is far greater than the identified risks of drugs. Since the type and extent of risks are unknown, companies must focus on and formulate corresponding risk emergency measures. Therefore, it is very important to quickly identify potential risks of drugs.

[0003] According to data released by the Adverse Reaction Monitoring Center, in 2020, the National Adverse Drug Reaction Monitoring Network received a total of 1.67 million adverse reaction reports, indicating that my country's pharmaceutical companies' awareness and work of adverse reaction monitoring have greatly improved. At the same time, the effective use of huge data resources is of great research value. Summary of the invention

[0004] The present invention aims to at least solve the technical problems existing in the prior art. To this end, the present invention proposes a system, method, device and medium for high-throughput identification of potential risks of drugs, which performs high-throughput screening of a large amount of spontaneous adverse reaction reports through preset potential risk level judgment standards, so as to quickly discover the potential risks of drugs from complex spontaneous adverse reaction reports, improve the coverage and accuracy of risk monitoring, and provide support for enterprises to quickly make drug vigilance plans and provide a basis for the modification of drug instructions after listing, thereby reducing the occurrence of drug-related incidents.

[0005] In a first aspect of the present invention, a system for high-throughput identification of potential risks of drugs is provided, comprising the following steps:

[0006] A first condition setting module is used to construct a collection of identified risks of a drug based on all adverse reactions in the drug instructions;

[0007] The second condition setting module is used to pre-set the potential risk level determination criteria of the drug;

[0008] A risk capture module is used to obtain adverse reactions of the drug from spontaneous adverse reaction reports and perform high-throughput matching with the identified risk collection of the drug to obtain the potential risks of the drug;

[0009] A risk classification module, used to match the potential risk of the drug with the potential risk level determination criteria to obtain the potential risk level of the drug;

[0010] The measure implementation module is used to take corresponding risk control measures according to the potential risk level of the drug.

[0011] According to the embodiments of the present invention, there are at least the following technical effects:

[0012] This system obtains drug instructions, builds a collection of identified drug risks based on all adverse drug reactions in the drug instructions, pre-sets potential risk level determination standards for drugs, obtains adverse reactions of drugs from spontaneous adverse reaction reports, and performs high-throughput matching with the collection of identified drug risks to obtain the potential risks of drugs, matches the potential risks of drugs with the risk level determination standards to obtain the potential risk level of drugs, and takes corresponding risk control measures according to the potential risk level of drugs. This system uses the collection of identified adverse reactions and preset potential risk level determination standards to perform high-throughput screening on massive amounts of data from spontaneous adverse reaction reports, thereby quickly discovering potential risks of drugs from complex spontaneous adverse reaction reports, improving the coverage and accuracy of risk monitoring, and at the same time providing support for companies to quickly make drug vigilance plans and provide a basis for post-market drug instructions revisions, guiding patients to use drugs in a healthy and rational manner, and reducing the occurrence of drug-related injury incidents.

[0013] According to some embodiments of the present invention, the first condition setting module includes an identified risk collection module and an identified risk standardization module, the identified risk collection module is used to construct an identified risk collection of drugs according to all adverse drug reactions in the drug instructions; the identified risk standardization module is used to standardize the identified risk collection of drugs through MedDRA coding.

[0014] According to some embodiments of the present invention, the potential risk level determination criteria include important potential risks and general potential risks, and the medical severity of the important potential risks is a serious adverse event that causes death, disability, congenital abnormality or birth defect and meets the SAE standard;

[0015] The medical severity of the general potential risk is that the adverse reaction does not cause any harm to the patient's body and the adverse reaction disappears faster than a threshold.

[0016] According to some embodiments of the present invention, the risk capture module includes:

[0017] A risk matching module is used to obtain the adverse event name in the spontaneous adverse reaction report, and perform high-throughput matching between the adverse event name and the collection of identified risks of the drug. If the match is successful, it is classified as an identified risk; if the match fails, it is classified as a potential risk;

[0018] The risk classification module is used to obtain potential risks from the risk docking module, and match the potential risks of the drug with the risk level determination criteria to obtain the important potential risks and the general potential risks.

[0019] According to some embodiments of the present invention, if the potential risk level of the drug is a major potential risk, the risk control measures include taking restrictive measures on the use of the drug, suspending the production and sale of the drug, and recalling the product; if the potential risk level of the drug is a general potential risk, the measures include revising the drug instructions, labels, and packaging, changing the drug packaging specifications, changing the drug management status, conducting risk communication with medical personnel, providing doctors and patients with information on drug safety and precautions for use, registering patients who need to use the product for a long time, and closely monitoring adverse reactions that occur during the patient's medication process, wherein patient safety medication tips can be sent to patients along with the drugs or published through mass media.

[0020] A second aspect of the present invention provides a method for high-throughput identification of potential risks of drugs, which includes a system for high-throughput identification of potential risks of drugs as described in the first aspect of the present invention, and the method for high-throughput identification of potential risks of drugs includes:

[0021] Obtain drug instructions, and construct a collection of identified drug risks based on all adverse drug reactions in the drug instructions;

[0022] Pre-setting the potential risk level determination criteria for the drug;

[0023] Obtain adverse reactions of the drug from spontaneous adverse reaction reports and perform high-throughput matching with the identified risk collection of the drug to obtain the potential risks of the drug;

[0024] According to the potential risk of the drug, the potential risk level of the drug is obtained by matching the potential risk of the drug with the risk level determination standard;

[0025] Take corresponding risk control measures according to the potential risk level of the drug.

[0026] The method obtains drug instructions, constructs a collection of identified drug risks based on all drug adverse reactions in the drug instructions, pre-sets a standard for determining the potential risk level of the drug, obtains the adverse reactions of the drug from spontaneous adverse reaction reports, and performs high-throughput matching with the collection of identified drug risks to obtain the potential risk of the drug, matches the potential risk of the drug with the risk level determination standard to obtain the potential risk level of the drug, and takes corresponding risk control measures according to the potential risk level of the drug. The method uses the collection of identified adverse reactions and the preset potential risk level determination standard to perform high-throughput screening on a large amount of data from spontaneous adverse reaction reports, thereby quickly discovering the potential risks of the drug from complex spontaneous adverse reaction reports, improving the coverage and accuracy of risk monitoring, and at the same time providing support for companies to quickly make drug vigilance plans and provide a basis for modifying the drug instructions after listing, guiding patients to use drugs in a healthy and rational manner, and reducing the occurrence of drug-related injury incidents.

[0027] According to some embodiments of the present invention, the potential risk level determination criteria include important potential risks and general potential risks, and the medical severity of the important potential risks is a serious adverse event that causes death, disability, congenital abnormality or birth defect and meets the SAE standard;

[0028] The medical severity of the general potential risk is that the adverse reaction does not cause any harm to the patient's body and the adverse reaction disappears faster than a threshold.

[0029] According to some embodiments of the present invention, obtaining the adverse reaction of the drug from the spontaneous adverse reaction report and performing high-throughput matching with the identified risk collection of the drug to obtain the potential risk of the drug includes:

[0030] Obtain the adverse event name in the spontaneous adverse reaction report, perform high-throughput matching on the adverse event name with the collection of identified risks of the drug, and if the match is successful, classify it as an identified risk; if the match fails, classify it as a potential risk;

[0031] The potential risks of the drug are matched with the risk level determination criteria to obtain the important potential risks and the general potential risks.

[0032] The third aspect of the present invention provides an electronic device for high-throughput identification of potential risks of drugs, comprising at least one control processor and a memory for communicating with the at least one control processor; the memory stores instructions executable by the at least one control processor, and the instructions are executed by the at least one control processor to enable the at least one control processor to execute the above-mentioned method for high-throughput identification of potential risks of drugs.

[0033] A fourth aspect of the present invention provides a computer-readable storage medium storing computer-executable instructions for causing a computer to execute the above-mentioned high-throughput method for identifying potential risks of drugs.

[0034] It should be noted that the beneficial effects between the second to fourth aspects of the present invention and the prior art are the same as the beneficial effects between the above-mentioned high-throughput system for identifying potential risks of drugs and the prior art, and will not be described in detail here.

[0035] Additional aspects and advantages of the present invention will be given in part in the following description and in part will be obvious from the following description, or will be learned through practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The above and / or additional aspects and advantages of the present invention will become apparent and easily understood from the description of the embodiments in conjunction with the following drawings, in which:

[0037] Figure 1 This is a flow chart of a system for high-throughput identification of potential risks of drugs according to an embodiment of the present invention;

[0038] Figure 2 The present invention is a flowchart of a method for high-throughput identification of potential risks of drugs according to an embodiment of the present invention. DETAILED DESCRIPTION

[0039] Embodiments of the present invention are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and cannot be understood as limiting the present invention.

[0040] In the description of the present invention, if there is a description of first, second, etc., it is only for the purpose of distinguishing technical features, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features or implicitly indicating the order of the indicated technical features.

[0041] In the description of the present invention, it should be understood that descriptions involving orientation, such as orientation or positional relationship indicated as up, down, etc., are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0042] In the description of the present invention, it should be noted that, unless otherwise clearly defined, terms such as setting, installing, connecting, etc. should be understood in a broad sense, and technicians in the relevant technical field can reasonably determine the specific meanings of the above terms in the present invention in combination with the specific content of the technical solution.

[0043] Potential risks of drugs are generally adverse reactions that exceed the drug instructions, drug investigator's manual or product characteristics summary, etc., and their nature and severity are inconsistent with the adverse reactions of the labeled approved drugs, or they are unexpected adverse reactions. The harm of potential drug risks is far greater than the identified risks of drugs. Since the type and extent of the risks are unknown, companies must focus on and formulate corresponding risk emergency measures. Therefore, it is very important to quickly identify potential drug risks. According to data released by the Adverse Reaction Monitoring Center, in 2020, the National Adverse Drug Reaction Monitoring Network received a total of 1.67 million adverse reaction reports, indicating that my country's pharmaceutical companies' awareness and monitoring of adverse reaction monitoring have greatly improved. At the same time, the effective use of huge data resources is very valuable for research.

[0044] In order to solve the above technical defects, refer to Figure 1 One embodiment of the present invention provides a system for high-throughput identification of potential risks of drugs, including a first condition setting module 1100, a second condition setting module 1200, a risk capture module 1300, a risk classification module 1400 and a measure implementation module 1500, wherein:

[0045] The first condition setting module 1100 is used to obtain the drug instructions and construct a collection of identified drug risks based on all adverse drug reactions in the drug instructions.

[0046] The second condition setting module 1200 is used to pre-set the potential risk level determination criteria of the drug.

[0047] The risk capture module 1300 is used to obtain adverse reactions of drugs from spontaneous adverse reaction reports and perform high-throughput matching with the collection of identified risks of drugs to obtain potential risks of drugs.

[0048] The risk classification module 1400 is used to match the potential risk of the drug with the potential risk level determination criteria to obtain the potential risk level of the drug.

[0049] The measure implementation module 1500 is used to take corresponding risk control measures according to the potential risk level of the drug.

[0050] This system obtains drug instructions, builds a collection of identified drug risks based on all adverse drug reactions in the drug instructions, pre-sets potential risk level determination standards for drugs, obtains adverse reactions of drugs from spontaneous adverse reaction reports, and performs high-throughput matching with the collection of identified drug risks to obtain the potential risks of drugs, matches the potential risks of drugs with the risk level determination standards to obtain the potential risk level of drugs, and takes corresponding risk control measures according to the potential risk level of drugs. This system uses the collection of identified adverse reactions and preset potential risk level determination standards to perform high-throughput screening on massive amounts of data from spontaneous adverse reaction reports, thereby quickly discovering potential risks of drugs from complex spontaneous adverse reaction reports, improving the coverage and accuracy of risk monitoring, and at the same time providing support for companies to quickly make drug vigilance plans and provide a basis for post-market drug instructions revisions, guiding patients to use drugs in a healthy and rational manner, and reducing the occurrence of drug-related injury incidents.

[0051] In some embodiments, the first condition setting module includes an identified risk collection module and an identified risk standardization module. The identified risk collection module is used to construct an identified risk collection of drugs based on all adverse drug reactions in the drug instructions; the identified risk standardization module is used to standardize the identified risk collection of drugs through MedDRA coding.

[0052] In some embodiments, the potential risk level determination criteria include important potential risks and general potential risks, the medical severity of important potential risks being serious adverse events that lead to death, disability, congenital anomalies or birth defects and meet SAE standards;

[0053] The medical severity of general potential risks is that the adverse reaction does not cause harm to the patient's body and the adverse reaction disappears faster than a threshold.

[0054] In some embodiments, the risk capture module includes:

[0055] The risk matching module is used to obtain the adverse event names in the spontaneous adverse reaction reports, and perform high-throughput matching between the adverse event names and the collection of identified risks of the drug. If the match is successful, it is classified as an identified risk; if the match fails, it is classified as a potential risk;

[0056] The risk classification module is used to obtain potential risks from the risk docking module, and match the potential risks of drugs with risk level judgment criteria to obtain important potential risks and general potential risks.

[0057] In some embodiments, if the potential risk level of a drug is a significant potential risk, the risk control measures include taking restrictive measures on the use of the drug, suspending the production and sale of the drug, and recalling the product; if the potential risk level of the drug is a general potential risk, measures are taken to revise the drug instructions, labels, and packaging, change the drug packaging specifications, change the drug management status, conduct risk communication with medical personnel, provide doctors and patients with information on drug safety and precautions for use, register patients who need to use the product for a long time, and closely monitor adverse reactions that occur during the patient's use of the product. Among them, patient safety medication tips can be sent to patients along with the drugs or published through mass media.

[0058] In addition, refer to Figure 2 The present invention also provides a method for high-throughput identification of potential risks of drugs, comprising:

[0059] S100. Obtain the drug instructions and construct a collection of identified drug risks based on all adverse drug reactions in the drug instructions.

[0060] S200. Pre-set the potential risk level determination criteria for drugs.

[0061] S300, obtain adverse reactions of drugs from spontaneous adverse reaction reports and perform high-throughput matching with the collection of identified risks of drugs to obtain potential risks of drugs.

[0062] S400: Match the potential risk of the drug with the risk level determination standard to obtain the potential risk level of the drug.

[0063] S500. Take corresponding risk control measures according to the potential risk level of the drug.

[0064] In some embodiments, the potential risk level determination criteria include important potential risks and general potential risks, the medical severity of important potential risks being serious adverse events that lead to death, disability, congenital anomalies or birth defects and meet SAE standards;

[0065] The medical severity of general potential risks is that the adverse reaction does not cause harm to the patient's body and the adverse reaction disappears faster than a threshold.

[0066] In some embodiments, adverse reactions of drugs are obtained from spontaneous adverse reaction reports and high-throughput matched with the collection of identified risks of drugs to obtain potential risks of drugs, including:

[0067] Obtain the adverse event names from spontaneous adverse reaction reports, and perform high-throughput matching between the adverse event names and the collection of identified risks of the drug. If the match is successful, it is classified as an identified risk; if the match fails, it is classified as a potential risk;

[0068] Match the potential risks of drugs with the risk level determination criteria to obtain important potential risks and general potential risks.

[0069] The method obtains drug instructions, constructs a collection of identified drug risks based on all drug adverse reactions in the drug instructions, pre-sets a standard for determining the potential risk level of the drug, obtains the adverse reactions of the drug from spontaneous adverse reaction reports, and performs high-throughput matching with the collection of identified drug risks to obtain the potential risk of the drug, matches the potential risk of the drug with the risk level determination standard to obtain the potential risk level of the drug, and takes corresponding risk control measures according to the potential risk level of the drug. The method uses the collection of identified adverse reactions and the preset potential risk level determination standard to perform high-throughput screening on a large amount of data from spontaneous adverse reaction reports, thereby quickly discovering the potential risks of the drug from complex spontaneous adverse reaction reports, improving the coverage and accuracy of risk monitoring, and at the same time providing support for companies to quickly make drug vigilance plans and provide a basis for modifying the drug instructions after listing, guiding patients to use drugs in a healthy and rational manner, and reducing the occurrence of drug-related injury incidents.

[0070] It should be noted that the present method embodiment and the above-mentioned system embodiment are based on the same inventive concept, so the relevant contents of the above-mentioned method embodiment are also applicable to the present system embodiment and will not be repeated here.

[0071] The present application also provides an electronic device for high-throughput identification of potential risks of drugs, including: a memory, a processor, and a computer program stored in the memory and executable on the processor. When the processor executes the computer program, it implements: the method for high-throughput identification of potential risks of drugs as described above.

[0072] The processor and the memory may be connected via a bus or other means.

[0073] The memory, as a non-transient computer-readable storage medium, can be used to store non-transient software programs and non-transient computer executable programs. In addition, the memory may include a high-speed random access memory, and may also include a non-transient memory, such as at least one disk storage device, a flash memory device, or other non-transient solid-state storage device. In some embodiments, the memory may optionally include a memory remotely disposed relative to the processor, and these remote memories may be connected to the processor via a network. Examples of the above-mentioned network include, but are not limited to, the Internet, an intranet, a local area network, a mobile communication network, and combinations thereof.

[0074] The non-transient software program and instructions required to implement the method for high-throughput identification of potential risks of drugs in the above-mentioned embodiment are stored in the memory. When executed by the processor, the method for high-throughput identification of potential risks of drugs in the above-mentioned embodiment is executed, for example, the above-mentioned method is executed. Figure 2The method comprises steps S100 to S500.

[0075] The present application also provides a computer-readable storage medium storing computer-executable instructions, wherein the computer-executable instructions are used to execute: the high-throughput method for identifying potential risks of drugs as described above.

[0076] The computer-readable storage medium stores computer-executable instructions, which are executed by a processor or a controller, for example, by a processor in the above-mentioned electronic device embodiment, so that the above-mentioned processor can execute the high-throughput method for identifying potential risks of drugs in the above-mentioned embodiment, for example, executing the above-mentioned Figure 2 The method comprises steps S100 to S500.

[0077] It will be appreciated by those skilled in the art that all or some of the steps and systems in the disclosed method above may be implemented as software, firmware, hardware and appropriate combinations thereof. Some physical components or all physical components may be implemented as software executed by a processor, such as a central processing unit, a digital signal processor or a microprocessor, or may be implemented as hardware, or may be implemented as an integrated circuit, such as an application specific integrated circuit. Such software may be distributed on a computer-readable medium, which may include a computer storage medium (or a non-transitory medium) and a communication medium (or a temporary medium). As known to those skilled in the art, the term computer storage medium includes volatile and non-volatile, removable and non-removable media implemented in any method or technology for storing information (such as computer-readable instructions, data structures, program units or other data). Computer storage media include, but are not limited to, RAM, ROM, EEPROM, flash memory or other memory technologies, CD-ROM, digital versatile disks (DVD) or other optical disk storage, magnetic cassettes, magnetic tapes, disk storage or other magnetic storage devices, or any other medium that may be used to store desired information and may be accessed by a computer. Furthermore, it is well known to those skilled in the art that communication media generally contain computer readable instructions, data structures, program elements, or other data in a modulated data signal such as a carrier wave or other transport mechanism, and may include any information delivery media.

[0078] The embodiments of the present invention are described in detail above in conjunction with the accompanying drawings, but the present invention is not limited to the above embodiments, and various changes can be made within the knowledge scope of ordinary technicians in the relevant technical field without departing from the purpose of the present invention.

Claims

1. A high-throughput system for identifying potential risks of drugs, characterized in that: The system comprises: A first condition setting module is used to obtain a drug instruction sheet, and to construct a collection of identified drug risks according to all adverse drug reactions in the drug instruction sheet, wherein the first condition setting module includes an identified risk collection module and an identified risk standardization module, the identified risk collection module is used to construct a collection of identified drug risks according to all adverse drug reactions in the drug instruction sheet; the identified risk standardization module is used to standardize the collection of identified drug risks through MedDRA coding; The second condition setting module is used to pre-set the potential risk level determination standard of the drug, wherein the potential risk level determination standard includes important potential risks and general potential risks, the medical severity of the important potential risks is a serious adverse event that causes death, disability or congenital abnormality and meets the SAE standard; the medical severity of the general potential risks is that the adverse reaction does not cause damage to the patient's body and the disappearance speed of the adverse reaction is greater than a threshold; A risk capture module, used to obtain the adverse reaction of the drug from the spontaneous adverse reaction report and perform high-throughput matching with the collection of identified risks of the drug to obtain the potential risk of the drug, wherein the risk capture module includes a risk docking module, the risk docking module is used to obtain the name of the adverse event in the spontaneous adverse reaction report, perform high-throughput matching between the name of the adverse event and the collection of identified risks of the drug, if the match is successful, it is classified as an identified risk, if the match fails, it is classified as a potential risk; A risk classification module, used to match the potential risk of the drug with the potential risk level determination criteria to obtain the potential risk level of the drug; The measures implementation module is used to take corresponding risk control measures according to the potential risk level of the drug. If the potential risk level of the drug is a major potential risk, the risk control measures include taking restrictive measures on the use of the drug and suspending the production and sale of the drug and recalling the product; if the potential risk level of the drug is a general potential risk, the measures include revising the drug instructions, labels and packaging, changing the drug packaging specifications, changing the drug management status, conducting risk communication with medical staff, providing doctors and patients with information on drug safety and precautions for use, registering patients who need to use the drug for a long time, and closely monitoring adverse reactions that occur during the patient's use of the drug. Precautions for use of the drug can be sent to patients along with the drug or published through mass media.

2. A high-throughput method for identifying potential risks of drugs, characterized in that: The method is performed using a high-throughput system for identifying potential risks of drugs, wherein the high-throughput system for identifying potential risks of drugs comprises: A first condition setting module is used to obtain a drug instruction sheet, and to construct a collection of identified drug risks according to all adverse drug reactions in the drug instruction sheet, wherein the first condition setting module includes an identified risk collection module and an identified risk standardization module, the identified risk collection module is used to construct a collection of identified drug risks according to all adverse drug reactions in the drug instruction sheet; the identified risk standardization module is used to standardize the collection of identified drug risks through MedDRA coding; The second condition setting module is used to pre-set the potential risk level determination standard of the drug, wherein the potential risk level determination standard includes important potential risks and general potential risks, the medical severity of the important potential risks is a serious adverse event that causes death, disability or congenital abnormality and meets the SAE standard; the medical severity of the general potential risks is that the adverse reaction does not cause damage to the patient's body and the disappearance speed of the adverse reaction is greater than a threshold; A risk capture module, used to obtain the adverse reaction of the drug from the spontaneous adverse reaction report and perform high-throughput matching with the collection of identified risks of the drug to obtain the potential risk of the drug, wherein the risk capture module includes a risk docking module, the risk docking module is used to obtain the name of the adverse event in the spontaneous adverse reaction report, perform high-throughput matching between the name of the adverse event and the collection of identified risks of the drug, if the match is successful, it is classified as an identified risk, if the match fails, it is classified as a potential risk; A risk classification module, used to match the potential risk of the drug with the potential risk level determination criteria to obtain the potential risk level of the drug; The measures implementation module is used to take corresponding risk control measures according to the potential risk level of the drug. If the potential risk level of the drug is a major potential risk, the risk control measures include taking restrictive measures on the use of the drug and suspending the production and sale of the drug and recalling the product; if the potential risk level of the drug is a general potential risk, the measures include revising the drug instructions, labels and packaging, changing the drug packaging specifications, changing the drug management status, conducting risk communication with medical staff, providing doctors and patients with information on drug safety and precautions for use, registering patients who need to use the drug for a long time, and closely monitoring adverse reactions that occur during the patient's use of the drug. Precautions for use of the drug can be sent to patients along with the drug or published through mass media.

3. A high-throughput device for identifying potential risks of drugs, characterized in that: It includes at least one control processor and a memory for communicating with the at least one control processor; the memory stores instructions that can be executed by the at least one control processor, and the instructions are executed by the at least one control processor to enable the at least one control processor to execute the high-throughput method for identifying potential risks of drugs as described in claim 2.

4. A computer-readable storage medium, characterized in that: The computer-readable storage medium stores computer-executable instructions, and the computer-executable instructions are used to enable a computer to execute the high-throughput method for identifying potential risks of drugs as described in claim 2.

Citation Information

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