Intelligent system and method for out-of-specification medication management
By establishing an off-label drug use database, integrating various diagnostic and treatment guidelines and data, identifying prescription orders and generating informed consent forms and alternative solutions, the management challenges of off-label drug use have been solved, and drug safety and compliance have been improved.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-12-07
- Publication Date
- 2026-03-10
AI Technical Summary
In the current technology, off-label drug use is common, which increases the incidence of adverse reactions and the risk of medical disputes, and there is a lack of effective management measures.
Establish a database of off-label drug use, integrate expert consensus data and international treatment guidelines, identify prescriptions through an interactive system, determine their legality using a judgment system, generate informed consent forms and alternative solutions, provide evidence for off-label drug use, and conduct registration and interception.
It enables intelligent management of off-label drug use, reduces adverse reactions and disputes, and improves drug safety and compliance.
Smart Images
Figure CN121641503A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The application relates to the technical field of off-label drug management, in particular to an intelligent system and method for off-label drug management. BACKGROUND
[0002] With the continuous progress of medical technology, off-label drug use is increasingly common in clinical treatment. Off-label drug use, also known as unregistered drug use, refers to the use of a drug in a way that is not recorded in the drug supervision and management department's approval of the drug instruction book, such as indications, dosage, course of treatment, route or population. Although off-label drug use may bring new treatment opportunities for patients, its potential risks cannot be ignored, and it is easy to increase the incidence of adverse reactions and cause medical disputes. SUMMARY
[0003] In view of the deficiencies of the prior art, the application provides an intelligent system and method for off-label drug management, which solves the problems in the background art.
[0004] To solve the above technical problems, according to one aspect of the application, more specifically, an intelligent system and method for off-label drug management, comprising an off-label drug database, characterized in that: the off-label drug database is provided with an interactive system, the interactive system identifies the prescription orders issued by his, the off-label drug database is internally provided with a judgment system, the judgment system is used to judge whether the off-label drug database has the prescription orders issued by his, the off-label drug database comprises expert consensus data, diagnosis and treatment specifications published by international authoritative academic associations or organizations, clinical diagnosis and treatment guideline data, foreign instruction book data, diagnosis and treatment specifications, clinical diagnosis and treatment guidelines, guiding principles and clinical pathway data published by national academic associations and recognized by the National Health Commission of the People's Republic of China, RCT system evaluation or Meta analysis literature data, randomized controlled clinical research data, monograph textbook data and case-control, cohort study data.
[0005] Further, after the judgment system judges that the prescription orders issued by his have the prescription orders, the prescription order information issued by his is transmitted to a doctor's department permission judgment module, and the doctor's department permission is used to judge whether the prescription orders issued by his have the permission.
[0006] Further, the doctor's department permission judgment module judges that the prescription orders issued by his have the permission, the system provides the drug use method of the prescription orders in the off-label drug database, generates patient information, warns the risk of drug use, then generates an informed consent form through a printing device, and archives after the doctor and the patient sign.
[0007] Further, the doctor department authority determination module determines that the prescription order issued by the his does not have authority, intercepts it, and prompts that the department or doctor has no authority to issue the prescription order.
[0008] Further, the determination system determines that the prescription order issued by the his has a replacement scheme.
[0009] Further, when the prescription order issued by the his has a replacement scheme, the system provides the replacement scheme and intercepts the prescription order issued by the his, and does not allow the off-label drug database to be used.
[0010] Further, when the prescription order issued by the his does not have a replacement scheme, the off-label drug database provides the corresponding off-label drug basis and drug risk to the doctor based on the off-label drug database, archives the off-label drug of the doctor, prompts the doctor to use after archiving, and intercepts the prescription order issued by the his this time.
[0011] Further, the off-label drug database internally detects whether the calculation formula of the prescription order issued by the his has: When r=1, the prescription order issued by the his has an archive in the off-label drug database. When r=-1, the prescription order issued by the his does not have an archive in the off-label drug database.
[0012] A use method of an intelligent system for off-label drug management, comprising the following steps: S1, input the prescription order issued by the his to the off-label drug database through the interactive system, and identify it; S2, identify the prescription order issued by the his in the off-label drug database, and determine whether the off-label drug database archives the off-label use; S2.1, if the off-label use has been archived, transmit the prescription order information issued by the his to the doctor department authority determination module; S2.1.1, if the doctor department authority determination module determines that the prescription order issued by the his has authority, the system provides the drug use of the prescription order in the off-label drug database, generates patient information, warns of drug risk, then generates an informed consent form through a printing device, and archives it after the doctor and patient sign it; S2.1.2, if the doctor department authority determination module determines that the prescription order issued by the his does not have authority, intercept it, and prompt that the department or doctor has no authority to issue the prescription order. S2.2, if the system determines that the prescription order with his is determined to have a replacement scheme, whether the prescription order with his has a replacement scheme; S2.2.1, if the prescription order with his has a replacement scheme, the system provides the replacement scheme, and intercepts the prescription order with his, and does not allow the off-label drug database to be used; S2.2.2, if the prescription order with his does not have a replacement scheme, the off-label drug database is used to provide the corresponding off-label drug basis and drug risk for the doctor, the off-label drug record is performed on the doctor, and the doctor is prompted to use after the record, and the prescription order with his is intercepted.
[0013] The beneficial effects of the intelligent system and method for off-label drug management of the application are: The expert consensus data, the diagnosis and treatment specification, the clinical diagnosis and treatment guideline data, the foreign specification data, the diagnosis and treatment specification, the clinical diagnosis and treatment guideline, the guiding principle and the clinical path data published by the national health commission, the RCT system evaluation or Meta analysis literature data, the randomized controlled clinical research data, the monograph textbook data and the case control, the cohort study data are imported into the database, and the rules are set in the off-label drug database, and the corresponding evidence-based basis is automatically popped up for the doctor, so that the doctor can record. BRIEF DESCRIPTION OF DRAWINGS
[0014] The application will be further described in detail below in combination with the drawings and specific implementation methods.
[0015] Figure 1 The structure diagram of the application.
[0016] Figure 2 The structure diagram of the database internal data of the application. DETAILED DESCRIPTION
[0017] The application will be further described in detail below in combination with the drawings and specific implementation methods.
[0018] As Figure 1As shown, according to one aspect of the present application, an intelligent system and method for off-label drug management are provided, which include an off-label drug database, the off-label drug database is provided with an interactive system, the interactive system identifies the prescription order issued by the HIS, the off-label drug database is internally provided with a judgment system, the judgment system is used to judge whether the off-label drug database has the prescription order issued by the HIS, and the off-label drug database includes expert consensus data, diagnosis and treatment specifications and guidelines published by international authoritative academic associations or organizations, clinical diagnosis and treatment guideline data, foreign specification data, diagnosis and treatment specifications and guidelines, clinical diagnosis and treatment guidelines, guiding principles and clinical pathway data recognized by the National Health Commission, RCT system evaluation or Meta analysis literature data, randomized controlled clinical research data, monograph textbook data, and case-control, cohort study data.
[0019] In this embodiment, after the judgment system judges that the prescription order issued by the HIS has the prescription order, the prescription order information issued by the HIS is transmitted to the doctor department permission judgment module, and the doctor department permission is used to judge whether the prescription order issued by the HIS has the permission.
[0020] In this embodiment, the doctor department permission judgment module judges that the prescription order issued by the HIS has the permission, the system provides the drug use method of the prescription order in the off-label drug database, generates patient informed information, warns the drug risk, then generates the informed consent form through the printing equipment, and archives after the doctor and patient sign.
[0021] In this embodiment, the doctor department permission judgment module judges that the prescription order issued by the HIS does not have the permission, intercepts it, and prompts the department or doctor that the prescription order issued by the HIS does not have the permission of the use method.
[0022] In this embodiment, after the judgment system judges that the prescription order issued by the HIS has the prescription order, whether the prescription order issued by the HIS has the alternative scheme.
[0023] In this embodiment, when the prescription order issued by the HIS has the alternative scheme, the system provides the alternative scheme and intercepts the prescription order issued by the HIS, and does not allow the use of the off-label drug database.
[0024] In this embodiment, when the prescription order issued by the HIS does not have the alternative scheme, the off-label drug database provides the corresponding off-label drug basis and drug risk for the doctor based on the off-label drug database, archives the off-label drug of the doctor, and prompts the doctor to use after archiving. The prescription order issued by the HIS is intercepted.
[0025] In this embodiment, the calculation formula for detecting whether the off-label drug database has the prescription order issued by the HIS is: In the formula, when r=1, the prescriptions issued by his are registered in the off-label drug use database; When r=-1, the prescriptions issued by his are not registered in the off-label drug use database.
[0026] A method for using an intelligent system and approach for managing off-label drug use includes the following steps: S1. Input the prescriptions issued by HIS into the off-label medication database through the interactive system and identify them; S2. Identify prescriptions issued by HIS in the off-label drug use database and determine whether the off-label drug use database has registered the off-label usage. S2.1 If the off-label use has been registered, the prescription information issued by HIS will be transmitted to the doctor's department permission determination module. S2.1.1 If the doctor's department permission determination module determines that the prescription issued by his has the authority, the system provides the drug usage information of the prescription in the off-label drug use database, generates informed information for the patient, warns of the drug use risks, and then generates an informed consent form through the printing device, and archives it after the doctor and patient sign it. S2.1.2 If the doctor's department permission determination module determines that the prescription order issued by HIS does not have the permission, it will block it and prompt the department or doctor that the prescription order issued by HIS does not have the permission to issue this usage. S2.2 If the system determines that there is a prescription issued by HIS, is there an alternative to the prescription issued by HIS? S2.2.1 If there is an alternative to the prescription issued by HIS, the system will provide the alternative and block the prescription issued by HIS, and will not allow the use of the off-label drug use database. S2.2.2 If there is no alternative to the prescription issued by HIS, the doctor will be provided with the corresponding off-label drug use basis and drug use risks based on the off-label drug use database, the doctor will be registered for off-label drug use, and the doctor will be prompted to use the drug after registration. Then the prescription order issued by HIS will be intercepted.
[0027] Of course, the above description is not a limitation of the present invention, and the present invention is not limited to the examples given above. Any changes, modifications, additions or substitutions made by those skilled in the art within the scope of the present invention are also within the protection scope of the present invention.
Claims
1. An intelligent system for off-label drug management, comprising an off-label drug database, characterized in that: The off-label drug database is provided with an interactive system that identifies the prescription order issued by the HIS, and the off-label drug database is internally provided with a judgment system for judging whether the off-label drug database has the prescription order issued by the HIS, and the off-label drug database includes expert consensus data, diagnosis and treatment specifications and guidelines published by international authoritative academic associations or organizations, clinical diagnosis and treatment guideline data, foreign specification data, diagnosis and treatment specifications and guidelines, clinical diagnosis and treatment guidelines, guiding principles and clinical pathway data recognized by the National Health Commission, RCT system evaluation or Meta analysis literature data, randomized controlled clinical research data, monograph textbook data, and case-control and cohort study data.
2. The intelligent system for managing off-label drug use according to claim 1, wherein: The judgment system judges that the HIS has issued the prescription order, and transmits the prescription order information issued by the HIS to the doctor's department authority judgment module, and the doctor's department authority is used to judge whether the prescription order issued by the HIS has authority.
3. The intelligent system for managing off-label drug use according to claim 2, wherein: The doctor's department authority judgment module judges that the HIS has the authority of the prescription order, the system provides the drug usage of the prescription order in the off-label drug database, generates patient informed information, and warns the risk of drug use, then generates an informed consent form through a printing device, and archives after the doctor and patient sign.
4. The intelligent system for managing off-label drug use according to claim 2, wherein: The doctor's department authority judgment module judges that the HIS does not have the authority of the prescription order, intercepts it, and prompts the department or doctor that the HIS does not have the authority to issue the prescription order.
5. The intelligent system for managing off-label drug use according to claim 1, wherein: The judgment system judges that the HIS has issued the prescription order, and whether the prescription order issued by the HIS has a replacement scheme.
6. The intelligent system for managing off-label drug use according to claim 5, wherein: When the HIS has a replacement scheme for the prescription order, the system provides a replacement scheme and intercepts the prescription order issued by the HIS, and does not allow the use of the off-label drug database.
7. The intelligent system for managing off-label drug use according to claim 5, wherein: When the HIS does not have a replacement scheme for the prescription order, the off-label drug database provides the corresponding off-label drug basis and drug use risk for the doctor based on the off-label drug database, and the doctor is recorded for off-label drug use, and the doctor is prompted to use after recording, and the HIS is intercepted for the prescription order.
8. The intelligent system for managing over-the-counter drug use according to claim 5, characterized in that: The calculation formula for detecting whether the HIS has the prescription order in the off-label drug database is: When r=1, the HIS has the prescription order in the off-label drug database. When r=-1, the HIS does not have the prescription order in the off-label drug database.
9. An intelligent system for off-label medication management, comprising a method of using an intelligent system for off-label medication management according to any one of claims 1-8, characterized in that, The steps include: S1, input the prescription order issued by the HIS into the off-label drug database through the interactive system, and identify it; S2, identify the prescription order issued by the HIS in the off-label drug database, and judge whether the off-label drug database has the off-label usage record; S2.1, if the off-label usage has been recorded, transmit the prescription order information issued by the HIS to the doctor's department authority judgment module; S2.1.1, if the doctor department authority determination module determines that the prescription order issued by his has authority, the system provides the internal drug usage of the prescription order in the off-label drug database, generates patient informed information, and warns of drug risks. Then, the informed consent form is generated by the printing device, and is filed after being signed by the doctor and the patient; S2.1.2, if the doctor department authority determination module determines that the prescription order issued by his does not have authority, the prescription order is intercepted, and it is prompted that the prescription order issued by his does not have the authority to be issued with the usage; S2.2, if the system determines that the prescription order issued by his has, whether the prescription order issued by his has a replacement scheme; S2.2.1, if the prescription order issued by his has a replacement scheme, the system provides the replacement scheme, and intercepts the prescription order issued by his, and does not allow the off-label drug database to be used; S2.2.2, if the prescription order issued by his does not have a replacement scheme, the off-label drug database is used to provide the corresponding off-label drug basis and drug risks for the doctor, the off-label drug record of the doctor is made, and it is prompted that the off-label drug record is used after the doctor records.