A drug-induced disease active monitoring and reporting system

Abstract

The present application relates to a kind of drug-induced disease active monitoring reporting system, for the monitoring of patient clinical treatment process information, to drug adverse events and medication error classification early warning, active reporting, after monitoring the medication risk information, according to the risk degree, output classification early warning, simultaneously, based on patient treatment process information, to the backtracking and continue monitoring, determine the correlation between adverse reactions and suspected drugs, active reporting drug adverse events, effectively prevent medication risk, improve the reporting rate and reporting accuracy of adverse events.

Description

Technical Field

[0001] This invention relates to the field of medical technology, specifically to an active monitoring and reporting system for drug-induced diseases. Background Technology

[0002] Adverse drug events (ADEs) and medication errors (MEs) are among the leading causes of drug-induced diseases. Therefore, monitoring ADEs and MEs is an important measure to reduce the incidence of adverse events in healthcare institutions. Currently, the main methods for monitoring ADEs include adverse event case review and voluntary reporting systems. These methods collect information on the occurrence of ADEs through case review and voluntary reporting. However, the quality and detection capability of these reports depend on the reporting awareness and cooperation of healthcare institutions, leading to issues such as false reporting, missed reporting, and post-event reporting. Furthermore, current ADE monitoring is a passive, "post-event" monitoring method, lacking proactive prevention.

[0003] The main problems currently existing in the monitoring and reporting of adverse drug events are: 1. The current ADE / ME monitoring system has problems such as false alarms, missed alarms, low reporting rate, low reporting accuracy, and inconsistent evaluation standards for the correlation between suspected drugs and adverse events. Therefore, it cannot reflect the true occurrence level of ADE or ME. This further results in small sample size, low sample quality, and poor timeliness of the original data for adverse drug event research, which brings inconvenience to clinical drug safety supervision and drug quality feedback.

[0004] 2. Some ADE / ME can be avoided or detected early, but current ADE / ME monitoring systems are mostly reactive and lack early warning mechanisms. The lack of early warning causes clinical treatment to miss the best intervention time for ADE, increasing the incidence and severity of ADE.

[0005] 3. ADE reporting requires accuracy and a certain amount of time for evidence-based verification, while ADE early warning requires timeliness and early warning of potential ADE risks. Current ADE / ME monitoring systems cannot simultaneously meet the requirements of accurate reporting and timely early warning.

[0006] Therefore, designing an active monitoring and reporting system for drug-induced diseases to provide timely early warning and accurate reporting of adverse drug events is a technical problem that urgently needs to be solved by those skilled in the art. Summary of the Invention

[0007] An active surveillance and reporting system for drug-induced diseases includes: a knowledge base for drug-induced diseases, inpatient and outpatient medical record modules, an intelligent monitoring module, an ADE / ME report management module, and a statistics module; The drug-induced disease knowledge base is used to provide medication risk information, including: a literature knowledge base, an information knowledge base, a drug instruction manual database, and a potential medication risk module; The intelligent monitoring module obtains medication risk information from the drug-induced disease knowledge base and patient treatment process information from the inpatient and outpatient medical record module based on the patient's medication situation. It monitors the medication risk information appearing in the patient's treatment process information in real time and provides real-time early warning and proactive reporting of adverse drug events and medication errors. The proactive reporting operation includes at least the following: when an adverse drug event occurs, the intelligent monitoring module detects medication risk information and immediately issues an early warning, and based on the patient's treatment process information, it continues to monitor backward and forward, and after determining the correlation between the adverse event and the suspected drug, it proactively reports the adverse drug event.

[0008] The potential medication risk module is used to integrate medication risk information corresponding to each drug in the literature knowledge base, information knowledge base, and drug instruction database using standardized data tables. The medication risk information corresponding to each drug includes the following sub-items: contraindications, dosage range and route of administration, adverse event set, ADE / ME intervention set, high-risk population, and high-alert drug attributes.

[0009] In the drug-induced disease knowledge base, the literature knowledge base includes drug safety and adverse event columns in various pharmaceutical and clinical medical academic journals, the information knowledge base includes the drug adverse event database in the drug supervision and management website, and the drug instruction manual database includes various drugs including precautions, risk warning boxes, and adverse event columns in the instruction manual.

[0010] The adverse event set is divided into a high-risk set and a non-high-risk set according to the severity of the consequences; the high-risk set includes serious adverse drug events and life-threatening adverse drug events; the non-high-risk set includes mild adverse events and moderate adverse events; the ADE / ME intervention set includes discontinuation, dosage reduction or administration of rescue drugs in response to adverse events or medication errors; The high-alert drug attribute indicates whether the drug belongs to the high-alert drug category; the high-alert drug is a drug with high toxicity and is likely to cause serious adverse events, and all high-alert drugs constitute a high-alert drug list; The potential medication risk module can output the corresponding medication risk information by inputting the drug name. After inputting the patient's current physical condition information, the potential medication risk module outputs the patient's corresponding medication risk information, including: a list of prohibited drugs and a list of high-risk drugs for the patient under the current physical condition; the list of prohibited drugs includes drugs that the patient is prohibited from using under the current physical condition based on the prohibited items for each drug; the patient's high-risk drug list includes: drugs containing the patient in the high-risk population sub-item, and high-alert drugs not on the patient's prohibited drug list; the high-alert drugs other than the patient's prohibited drugs are obtained by taking the difference between the high-alert drug list and the patient's prohibited drug list.

[0011] The intelligent monitoring module includes: (1) a patient medication risk warning module, which is used to analyze the patient's potential medication risks based on the patient's physical condition before medication and provide pre-medication risk warnings; (2) a medication error monitoring module, which is used to monitor medication errors that will occur and medication errors that have already occurred during the entire process of patient medication; (3) a monitoring parameter construction module, which is used to determine the monitoring parameters of adverse drug events based on the clinical manifestations and laboratory test indicators of adverse drug events and the intervention methods for adverse events; (4) a medication process monitoring and early warning module, which is used to monitor the patient's treatment process information and provide graded early warnings for adverse drug events and medication errors that occur during the process; (5) an active reporting module, which is used to determine the correlation between adverse drug events and suspected drugs and to actively report adverse drug events and medication errors. The patient medication risk warning module extracts information closely related to the analyzed patient's physical condition from the inpatient and outpatient medical record modules in real time, including: underlying disease information, age information, gender information, liver function information, kidney function information, pregnancy information, allergy information, and surgical history information, to form the analyzed patient's current physical condition information; the physical condition information is input into the potential medication risk module to obtain the patient's current prohibited drug list and high-risk drug list; during the patient's treatment, the current prohibited drug list and high-risk drug list are updated in real time as the patient's treatment process information in the inpatient and outpatient medical record modules changes, forming the latest patient's current prohibited drug list and high-risk drug list, and are sent to the attending physician and pharmacist in the form of medication precautions for clinical medication reference; The medication error monitoring module is used to determine whether the patient's current medication is incorrect. For the patient's current medication, based on the list of prohibited medications output by the patient's medication risk warning module, it determines whether the medication is a contraindicated drug for the patient. The medication is then input into the potential medication risk module, and the dosage range and route of administration of the patient's current medication are compared with the corresponding dosage range and route of administration of the medication in the potential medication risk module to determine whether the dosage range and route of administration are correct. If the medication is a contraindicated drug for the patient, or the dosage range and route of administration are incorrect, then a medication error exists; otherwise, no medication error exists. The monitoring parameter construction module is used to construct adverse event monitoring parameters before executing medication orders, so as to conduct targeted monitoring of medication risk information appearing in the patient's treatment process information during medication administration. The patient's treatment process information is obtained from the inpatient and outpatient medical record modules. The medication to be executed is input into the potential medication risk module, and the adverse event set and ADE / ME intervention set corresponding to the medication are extracted. Adverse event monitoring parameters are constructed based on the adverse event set and ADE / ME intervention set. The adverse event monitoring parameters include adverse event indication parameters and adverse event intervention parameters. The adverse event indication parameters include: clinical manifestations corresponding to the adverse event and laboratory test indications corresponding to the adverse event. The intervention parameters include discontinuation, reduction, and administration of rescue drugs for the medication to be executed. The adverse event indications are further divided into high-risk indications and non-high-risk indications. The indications corresponding to adverse events in the high-risk set are high-risk indications, and the indications corresponding to adverse events in the non-high-risk set are non-high-risk indications.

[0012] The medication process monitoring and early warning module includes: (1) a graded early warning submodule, which is used to output different levels of early warning for suspected adverse drug events, medication errors that are about to occur, and medication errors that have already occurred; (2) a prescription medication monitoring submodule, which is used to investigate medication errors when prescription medications are issued but not executed, and to provide preventive early warning for medication errors that are about to occur; (3) a high-risk medication monitoring submodule, which is used to monitor and provide early warning for high-risk medications; and (4) a non-high-risk medication monitoring submodule, which is used to monitor and provide early warning for non-high-risk medications. The hierarchical early warning mechanism of the hierarchical early warning submodule is as follows: The monitored medication risk information is divided into five categories according to the risk level from high to low: Category I events, Category II events, Category III events, Category IV events, and Category V events, which are respectively output as black warning, red warning, orange warning, yellow warning, and blue warning. Among them, the first type of event includes: (1) medication error that is about to occur, (2) medication error that has occurred but has not been intervened, and (3) medication error that has occurred but has not been reversed; a black warning is issued for the first type of event to remind the physician to intervene in a timely manner; The second type of event includes: adverse events that may occur within the high-risk set and are currently in an uninterrupted state; for the second type of event, a red alert is issued, prompting physicians to intervene promptly and continuously; The three types of events include: adverse events that may occur within the high-risk set, which have been intervened for but not reversed; for these three types of events, an orange alert is issued to remind physicians that continued intervention is necessary; The four types of events include: adverse events that are likely to occur within a non-high-risk cluster; a yellow alert will be issued for these four types of events, and physician intervention is recommended; The five categories of events include: adverse events that may occur outside the high-risk group; a blue alert will be issued for these five categories of events, and physicians are advised to strengthen their observation. The medication monitoring submodule is used to monitor patients' medication orders in real time. For the medication to be ordered, the name, dosage and route of administration of the medication to be ordered are input into the medication error monitoring module to determine whether there is a medication error. If there is, the associated graded early warning submodule outputs a black warning to alert patients of the medication error, until the medication order with the error is cancelled. Once it is detected that a patient has used medication, the system determines whether the use of the medication is considered high-risk under the patient's current physical condition, based on the patient's high-risk medication list. If it is considered high-risk, monitoring is performed using the high-risk medication monitoring submodule; otherwise, monitoring is performed using the non-high-risk medication monitoring submodule. The high-risk medication monitoring submodule is used for the following process: Based on adverse event monitoring parameters, the patient treatment process information in the inpatient and outpatient medical record modules is monitored; after a positive indication is detected, the name of the medication, dosage range, and route of administration are first input into the medication error monitoring module to check for medication errors; if a medication error is found, the graded early warning module is associated, and a black warning is continuously output according to the first type of event to indicate that a medication error has occurred. The ADE / ME intervention set for the medication is also pushed to the physician and pharmacist. The warning is cleared after subsequent monitoring shows that the intervention has been implemented and the detected positive indication turns negative. Positive indicators are clinical manifestations or laboratory test results corresponding to adverse events; The high-risk medication monitoring submodule includes a high-risk indication monitoring and early warning submodule and a non-high-risk indication monitoring and early warning submodule. After ruling out medication errors, it determines whether any of the detected positive indications are high-risk. If high-risk indications are present, monitoring is performed based on the high-risk indication monitoring and early warning submodule within the high-risk medication monitoring submodule. If all detected positive indications are non-high-risk, monitoring is performed based on the non-high-risk indication monitoring and early warning submodule within the high-risk medication monitoring submodule. The non-high-risk medication monitoring submodule is used for processing as follows: Based on adverse event monitoring parameters, the patient treatment process information in the inpatient and outpatient medical record modules is monitored; after a positive indication is detected, the name of the medication, dosage range, and route of administration are first entered into the medication error monitoring module to check for medication errors; if a medication error is found, the graded early warning module is associated, and a black warning is continuously output according to the first type of event to indicate that a medication error has occurred. The ADE / ME intervention set for the medication is also pushed to the physician and pharmacist. The warning is cleared after subsequent monitoring shows that the intervention has been implemented and the detected positive indication turns negative. The non-high-risk medication monitoring submodule includes a high-risk indication monitoring and early warning submodule and a non-high-risk indication monitoring and early warning submodule. After ruling out medication errors, it is determined whether any of the detected positive indications are high-risk indications. If high-risk indications are present, monitoring is performed based on the high-risk indication monitoring and early warning submodule within the non-high-risk medication monitoring submodule. If all detected positive indications are non-high-risk indications, monitoring is performed based on the non-high-risk indication monitoring and early warning submodule within the non-high-risk medication monitoring submodule. In both the high-risk medication monitoring submodule and the non-high-risk medication monitoring submodule, the high-risk indication monitoring and early warning submodule processes the following: after detecting a positive high-risk indication, it is associated with the graded early warning module, which issues an early warning for Category II events, continuously outputting a red warning to inform physicians and pharmacists that an adverse event within the high-risk set of the drug may have occurred and intervention is necessary. The drug's ADE / ME intervention set is also pushed to physicians and pharmacists. If the drug intervention parameter is subsequently detected as positive, it is downgraded to a Category III event, and an orange warning is continuously output until the indication turns negative and the warning is removed. The high-risk medication monitoring submodule and the non-high-risk medication monitoring submodule both process the following: when all detected positive indicators are non-high-risk indicators, they are judged according to conditions 1 and 2 respectively, and the warning level is obtained. The warning is then output according to the highest warning level obtained from the judgment of conditions 1 and 2. Condition 1: Within a certain time window t1 after medication, k non-high-risk indicators corresponding to adverse events are simultaneously detected as positive. If 0 < k ≤ n, that is, within a certain period of time after medication, a small number of non-high-risk indicator parameters are concurrently positive, an early warning is issued for a category 5 event, a blue early warning is continuously output to remind the physician to pay attention to observation; If k > n, that is, within a certain period of time after medication, multiple non-high-risk indicator parameters are concurrently positive, the hierarchical early warning module is associated, an early warning is issued for a category 4 event, a yellow early warning is continuously output, the ADE / ME intervention set of the drug is pushed to physicians and pharmacists, and intervention is recommended; Said n is the sensitivity concurrency threshold in non-high-risk indicator monitoring and early warning; Condition 2: After medication, there is at least one non-high-risk indicator that remains continuously positive within time T; If T > q, that is, after medication, there is at least one non-high-risk indicator that remains continuously positive for a long time, an early warning is issued for a category 4 event, a yellow early warning is continuously output, the ADE / ME intervention set of the drug is pushed to physicians and pharmacists, and intervention is recommended; If T ≤ q, that is, after medication, there is at least one non-high-risk indicator that remains continuously positive for a short time, an early warning is issued for a category 5 event, a blue early warning is continuously output to remind the physician to pay attention to observation; Said q is the sensitivity time threshold in non-high-risk indicator monitoring and early warning; In the high-risk monitoring sub-module, the sensitivity concurrency threshold and the sensitivity time threshold of the non-high-risk indicator monitoring sub-sub-module are n1 and q1 respectively; In the non-high-risk monitoring sub-module, the sensitivity concurrency threshold and the sensitivity time threshold of the non-high-risk indicator monitoring sub-sub-module are n2 and q2 respectively; Wherein, n1 < n2, q1 < q2; that is, for the monitoring and early warning of non-high-risk indicators, the high-risk medication monitoring sub-module is more sensitive than the non-high-risk medication monitoring sub-module.

[0013] Said active reporting module comprises: a medication error reporting module and an adverse event reporting module; after the medication process monitoring and early warning module detects a positive indicator and gives an early warning of an occurred medication error or a possible adverse event, the medication error reporting module and the adverse event reporting module actively report the medication error and the drug adverse event respectively; The adverse event reporting module is configured to: determine the correlation between the adverse event and the suspected drug causing the adverse event based on the treatment process information before and after the occurrence of the patient's positive adverse event indicator, so as to achieve accurate graded reporting of adverse events; the period before and after the occurrence of the patient's positive adverse event indicator is three days before and after; The adverse event reporting module includes: a correlation scoring module, a correlation grading module, a suspected drug correlation ranking module, and a report generation module. The correlation scoring module is used to score the correlation between suspected drugs that cause adverse events and the adverse events. The correlation grading module classifies the correlation between suspected drugs and adverse events into four levels: certain, very likely, possible, and suspected, based on the score output by the correlation scoring module, so as to facilitate tiered reporting. The suspected drug correlation ranking module ranks suspected drugs that may produce the same adverse event when used in combination with other drugs, assisting physicians in determining the main causes of adverse events. The correlation scoring module, for multiple suspected drugs corresponding to positive indicators, scores each item based on patient treatment process information in the inpatient and outpatient medical record modules, according to the following scoring items, and sums them to obtain the correlation score of adverse drug events caused by various suspected drugs; the scoring items include: Scoring Item 1: Does the adverse event corresponding to the positive indication belong to a clearly defined adverse event of the drug? Yes, get 1 point; no, get 0 points; unknown, get 0 points. Scoring item 2: Whether the positive indicator was detected after medication. If yes, get 2 points; if no, get -1 point; if unknown, get 0 points. Item 3: Whether the adverse event indicators turn negative after discontinuation or administration of the rescue drug. 1 point for yes, 0 points for no, and 0 points for unknown. Scoring item 4: After a period of discontinuation, if the medication is resumed, do adverse event indicators reappear? 2 points for yes, -1 point for no, and 0 points for unknown. Scoring item 5: Are there any other factors that could have triggered a positive indicator of this adverse event? If yes, score -1 point; if no, score 2 points; if unknown, score 0 points. Scoring item 6: Does the drug concentration in the patient's body exceed the toxic dose? 1 point for yes, 0 points for no, 0 points for unknown. Item 7: Is the severity of adverse event indicators positively correlated with the drug dosage? 1 point for yes, 0 points for no, and 0 points for unknown. Scoring item 8: Does the patient have a history of adverse events related to this drug or similar drugs? If yes, get 1 point; if no, get 0 points; if unknown, get 0 points. The correlation grading module classifies the correlation between suspected drugs and adverse events into four levels based on the scoring results of the correlation scoring module: certain, very likely, possible, and suspected. For adverse event C corresponding to a positive indication and the suspected drug Msi that may cause adverse event C: If the correlation score is greater than or equal to 7, the correlation level between the drug Msi and adverse event C is considered positive. If the correlation score is 4-6, the correlation between the drug Msi and adverse event C is considered to be highly probable. If the correlation score is 1-3, the correlation level between the drug Msi and adverse event C is considered to be probable. If the correlation score is less than 1, the correlation level between the drug Msi and adverse event C is considered suspicious. The suspected drug correlation ranking module ranks suspected drugs that may produce the same adverse event when used in combination with other drugs. For adverse events corresponding to positive indicators, all drugs in the patient's medication records that may cause adverse events constitute a suspected drug list. The suspected drugs are then sorted according to their correlation scores to form a suspected drug correlation ranking list. The information in the suspected drug correlation ranking list includes the name of the suspected drug, the correlation score between the suspected drug and the adverse event, the correlation level between the suspected drug and the adverse event, and the adverse event corresponding to the positive indicator. The suspected drug correlation ranking list is sorted in descending order of correlation score and pushed to clinicians to assist them in making targeted decisions on the next medication or treatment. The report generation module generates a drug adverse event report based on the classification results of the correlation classification module, the ranking list of suspected drug correlations, and the patient treatment process information related to adverse events in the inpatient and outpatient medical record modules, and inputs the drug adverse event report into the ADE / ME report management module.

[0014] The medication error reporting module is used to report medication errors that have occurred. When the medication process monitoring and early warning module detects a positive sign and the medication error monitoring module determines it to be a medication error event, the medication error reporting module generates a medication error report based on the patient's treatment process information from the inpatient and outpatient medical record modules, and inputs the medication error report into the ADE / ME report management module. The medication error report includes: the time when the medication error occurred, the medication involved in the error, the details of the error, and the extent of harm caused to the patient by the error. The ADE / ME report management module will report medication error reports to the Food and Drug Adverse Event Monitoring Center or the Drug-Induced Disease Monitoring Network. The statistics module is used to summarize the adverse drug event reports and medication error reports submitted by the ADE / ME report management module, providing basic clinical data for the statistical analysis of adverse drug events and medication errors.

[0015] Compared with the prior art, the beneficial effects of the present invention are as follows: (1) For the monitoring of drug-induced diseases, the present invention adopts real-time monitoring of the medication risk information that appears in the patient's treatment process, timely warning and proactive reporting of adverse drug events and medication errors, changing post-event handling to pre-event warning, and changing voluntary post-event reporting to proactive reporting as soon as it occurs, effectively strengthening the management and control of clinical medication risks.

[0016] (2) The potential medication risk module integrates medication risk information derived in real time from literature, consultation, and instructions for use for each drug using standardized data tables. This facilitates quick retrieval of medication risks during clinical use, using drug information or patient health information as the index entry point. When constructing the potential drug risk model, risks are classified based on patient health information and the severity of adverse events, facilitating subsequent graded management of medication risks. Furthermore, this module is updated along with the aforementioned literature knowledge base, information knowledge base, and drug instructions for use, ensuring the accuracy of medication risk information.

[0017] (3) This invention forms a two-tiered prevention and control system for controllable medication risks. The first tier is: before the medication order is executed, the patient medication risk warning module pushes medication precautions, including a list of currently prohibited and high-risk medications, to the attending physician in real time based on the patient's current physical condition, accurately reminding the physician of the current medication risks. The second tier is: the patient medication order monitoring module conducts preventive screening for medication errors before the medication order is executed, alerting clinicians and pharmacists in advance that a medication error is about to occur, thus achieving pre-emptive intervention.

[0018] (4) The present invention sets up a dedicated medication error monitoring module to prevent medication errors throughout the entire process before and during medication administration. Preferably, before medication administration, the medication error monitoring module checks for medication errors in the medical orders to be executed. During the entire monitoring process, based on positive indicators, it conducts real-time screening for medication error events and outputs early warnings according to the highest sensitivity and risk level, prompting physicians to intervene in the medication errors that have occurred as soon as possible, effectively controlling the harm of the medication errors that have occurred.

[0019] (5) This invention sets up a medication process monitoring and early warning module and an active reporting module to resolve the contradiction between the timeliness of early warning and the accuracy of reporting. Specifically, the medication process monitoring and early warning module, upon detecting a positive indication, immediately outputs different levels of early warning based on different risk levels, prompting physicians to observe or intervene. The active reporting module, after an early warning occurs, continues monitoring backward and forward based on the patient's treatment process information, automatically searching for clinical evidence to determine the correlation between adverse events and suspected drugs, thereby achieving accurate reporting.

[0020] (6) The medication process monitoring and early warning module in this invention provides differentiated risk warnings based on the degree of danger of positive indicators. For high-risk indicators, a high-sensitivity, high-risk level early warning method is adopted, and an early warning is issued as soon as a positive parameter is detected, and intervention is mandatory to minimize the harm caused by adverse events.

[0021] (7) The medication process monitoring and early warning module in this invention adjusts the sensitivity and risk level of the early warning by setting a threshold for non-high-risk indications, thus avoiding interference with clinical medication caused by too many high-risk warnings while ensuring the effectiveness of the early warning. By setting an observation time window, concurrent and continuous positive indications within the time window are captured, and the early warning level is upgraded in a timely manner to indicate highly suspected adverse events, thereby achieving early proactive warning of adverse events.

[0022] (8) This invention differentiates the warning sensitivity settings for the high-risk medication submodule and the non-high-risk medication monitoring submodule, specifically the non-high-risk indication warning submodule. For high-risk medications where adverse events are prone to worsen or develop rapidly, a warning is issued in the early stages when non-high-risk indications are concentrated and persistent. For non-high-risk medications, the occurrence of non-high-risk indications is tolerated to a greater extent, avoiding unnecessary high-level warnings and intervention suggestions that could affect normal treatment and medication use. This achieves classified risk management of medications with different risks, providing more targeted risk warnings for clinical medication.

[0023] (9) The adverse event reporting module in this invention, based on the positive indicators detected by the medication process monitoring and early warning module, traces back and continues to monitor the patient's treatment process information to find clinical evidence of suspected drug-induced adverse events. By integrating multiple clinical evidences and based on objective scoring criteria, the correlation between positive indicators of adverse events and clinical medication is determined, providing an objective and unified standard for adverse event reporting, improving the accuracy of adverse event reporting, and providing high-quality clinical sample data for drug adverse event supervision and research.

[0024] (10) In cases of multiple drugs being used together with similar adverse events, the suspected drug correlation ranking module in this invention determines the main pathogenic drug of the adverse event based on the correlation ranking, providing an accurate reference for clinical drug use. Attached Figure Description Figure 1 This describes the working process of the medication monitoring and early warning module and the adverse event reporting module within the intelligent monitoring module. Figure 2 This is a medication monitoring and early warning module that monitors medication use for different risks. Figure 3 This defines the internal working logic of the high-risk medication monitoring submodule and the non-high-risk medication monitoring submodule. Detailed Implementation

[0025] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0026] Therefore, the following detailed description of embodiments of the present invention is not intended to limit the scope of the claimed invention, but merely illustrates some embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0027] It should be noted that, unless otherwise specified, the embodiments and features and technical solutions in the present invention can be combined with each other.

[0028] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0029] In the description of this invention, it should be noted that the terms "upper," "lower," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of this invention is in use, or the orientation or positional relationship commonly understood by those skilled in the art. These terms are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention. In addition, the terms "first," "second," etc., are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0030] An active monitoring and reporting system for drug-induced diseases includes: a knowledge base of drug-induced diseases, inpatient and outpatient medical record modules, an intelligent monitoring module, an ADE / ME report management module, and a statistics module.

[0031] The drug-induced disease knowledge base is used to provide medication risk information, including: a literature knowledge base, an information knowledge base, a drug instruction manual database, and a potential medication risk module.

[0032] The inpatient and outpatient medical record module is used to record and store patient treatment process information, including: patient medication and previous medication information, outpatient or inpatient laboratory and examination records, and outpatient or inpatient medical orders and prescription records.

[0033] The intelligent monitoring module retrieves medication risk information from the drug-induced disease knowledge base and patient treatment process information from the inpatient and outpatient medical record modules based on the patient's medication history. It monitors the medication risk information appearing in the patient's treatment process information in real time, providing real-time warnings and proactive reporting of adverse drug events and medication errors. The medication risk information is closely related to adverse drug events or medication errors, including: medication risk information corresponding to the drug and medication risk information corresponding to the patient. The proactive reporting operation includes at least the following: when an adverse drug event occurs, the intelligent monitoring module immediately issues a warning upon detecting medication risk information, and based on the patient's treatment process information, it continues to monitor backward and forward to determine the correlation between the adverse event and the suspected drug, and then proactively reports the adverse drug event.

[0034] The ADE / ME report management module generates standard reports based on the proactive reports output by the intelligent monitoring module, after manual review, in the form of adverse drug events or medication errors, and submits them to the Food and Drug Adverse Event Monitoring Center or the Drug-Induced Disease Monitoring Network.

[0035] The statistics module is used to summarize the adverse drug event reports and medication error reports finally reported by the ADE / ME report management module.

[0036] The beneficial effects of this invention compared to existing technologies are as follows: For the monitoring of drug-induced diseases, this invention monitors medication risk information in real time during the patient's treatment process, providing timely warnings and proactively reporting adverse drug events and medication errors. It transforms post-event handling into pre-event warning, and voluntary post-event reporting into proactive reporting upon occurrence, effectively strengthening the management of clinical medication risks.

[0037] Preferably, in the drug-induced disease knowledge base, the literature knowledge base includes drug safety and adverse event columns from various pharmaceutical and clinical medical academic journals; the information knowledge base includes a drug adverse event database from drug regulatory websites; and the drug instruction manual database includes various drugs, including precautions, risk warning boxes, and adverse event columns in the instruction manuals. The potential drug risk module is used to integrate drug risk information corresponding to each drug from the literature knowledge base, information knowledge base, and drug instruction manual database using standardized data tables. The drug risk information corresponding to each drug includes the following sub-items: contraindications, dosage range and route of administration, adverse event set, ADE / ME intervention set, high-risk populations, and high-alert drug attributes.

[0038] The adverse event set is divided into a high-risk set and a low-risk set according to the severity of the consequences. The classification criteria are as follows: The high-risk group includes serious adverse drug events and life-threatening adverse drug events. Preferably, the life-threatening adverse drug events endanger the patient's life and require emergency treatment. These serious adverse drug events result in hospitalization or prolonged hospitalization, or reduce the patient's ability to live independently.

[0039] The non-high-risk group includes mild adverse events and moderate adverse events. Preferably, mild adverse events are asymptomatic, minor, and treatment-free adverse events. Moderate adverse events are adverse events requiring minor, localized, or non-invasive treatment.

[0040] The ADE / ME intervention set includes discontinuation, dose reduction, or administration of rescue drugs in response to adverse events or medication errors.

[0041] The "high-alert" drug attribute indicates whether the drug is classified as a high-alert drug. High-alert drugs are those with high toxicity and a high risk of causing serious adverse events; all high-alert drugs constitute a high-alert drug list.

[0042] The potential medication risk module allows you to input the drug name and output the corresponding medication risk information, including: contraindications, dosage range and route of administration, adverse event set, ADE / ME intervention set, high-risk populations, and high-alert drug attributes.

[0043] The potential medication risk module, after inputting the patient's current physical condition information, outputs the patient's corresponding medication risk information, including: a list of prohibited medications and a list of high-risk medications for the patient under the current physical condition. The list of prohibited medications includes medications that the patient is prohibited from using under the current physical condition, determined based on the contraindications for each medication. The patient's high-risk medication list includes: medications containing the patient within the high-risk population sub-item, and high-alert medications not included in the patient's prohibited medication list. The high-alert medications other than the patient's prohibited medications are obtained by taking the difference between the high-alert medication list and the patient's prohibited medication list.

[0044] surface Example of a standardized form in the Potential Medication Risk Module Drug Name Disabled items High-risk groups Dosage range, route of administration Non-dangerous sets High-risk cluster ADE / ME Intervention Strategies High-alert drug properties warfarin Contraindicated in patients with impaired liver or kidney function, severe hypertension, coagulation disorders with bleeding tendency, active ulcers, trauma, threatened abortion, recent surgery, and during pregnancy. elderly people or women during menstruation For oral administration, the usual adult dose is as follows: To avoid shock therapy, take 3-4 mg on days 1-3 (half the dose is sufficient for elderly, frail, and diabetic patients). After 3 days, a maintenance dose of 2.5-5 mg per day can be given (the dose can be adjusted according to the clotting time to achieve an INR value of 2-3). Ecchymosis, purpura, bleeding gums, epistaxis, persistent bleeding from wounds, excessive menstrual bleeding, nausea, vomiting, diarrhea, itchy rashes, and mild bleeding from the urinary and digestive systems. Bilateral breast necrosis, microangiopathy or hemolytic anemia, extensive skin gangrene, intestinal wall hematoma, subacute intestinal obstruction, subdural intracranial hematoma, moderate to severe bleeding in the urinary or digestive system; INR>3 Reduce dosage, discontinue medication, administer vitamin K intravenously yes Ibuprofen Cross-sensitivity may occur in individuals allergic to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). This product may also be indicated for asthmatic patients allergic to aspirin, pregnant women, and breastfeeding women. Patients with gastrointestinal diseases Adults take the following dosage orally: (1) For rheumatism, take 0.4g to 0.6g once, 3 to 4 times a day. The dosage for rheumatoid arthritis is higher than that for osteoarthritis. (2) For mild to moderate pain and dysmenorrhea, take 0.2g to 0.4g once, every 4 to 6 hours. The maximum adult dosage is generally 2.4g per day. 2. Children take the following dosage orally: Take 5mg / kg to 10mg / kg of body weight each time, 3 times a day. Gastrointestinal symptoms include indigestion, heartburn, stomach pain, nausea, vomiting, stomach ulcers, headache, drowsiness, dizziness, and tinnitus. Ulcer perforation, liver and kidney dysfunction, gastrointestinal bleeding Reduce dosage, discontinue medication no The beneficial effects of this invention compared to existing technologies are as follows: The potential medication risk module, for each drug, integrates medication risk information derived from literature, information, and instructions into a standardized data table. This facilitates quick retrieval of medication risks during clinical use, using drug information or patient health information as the index entry point. When constructing the potential drug risk model, risk classification is based on patient health information and the severity of adverse events, facilitating subsequent graded management of medication risks. Furthermore, this module can be updated along with the literature knowledge base, the information knowledge base, and the drug instructions, ensuring the accuracy of the medication risk information.

[0045] The intelligent monitoring module includes: (1) a patient medication risk warning module, which is used to analyze the patient's potential medication risks based on the patient's physical condition before medication and provide pre-medication risk warnings. (2) a medication error monitoring module, which is used to monitor medication errors that will occur or have already occurred during the entire medication process. (3) a monitoring parameter construction module, which is used to determine the monitoring parameters of adverse drug events based on the clinical manifestations and laboratory test indicators of adverse drug events and the intervention methods for adverse events. (4) a medication process monitoring and early warning module, which is used to monitor the patient's treatment process information and provide graded early warnings for adverse drug events and medication errors that occur during the process. (5) an active reporting module, which is used to determine the correlation between adverse drug events and suspected drugs and to actively report adverse drug events and medication errors.

[0046] The patient medication risk warning module extracts information closely related to the analyzed patient's physical condition from the inpatient and outpatient medical record modules in real time, including: underlying disease information, age information, gender information, liver function information, kidney function information, pregnancy information, allergy information, and surgical history information, forming the analyzed patient's current physical condition information. This physical condition information is input into the potential medication risk module to obtain the patient's current prohibited drug list and high-risk drug list. During the patient's treatment, the current prohibited drug list and high-risk drug list are updated in real time according to changes in the patient's treatment process information in the inpatient and outpatient medical record modules, forming the latest current prohibited drug list and high-risk drug list, which are sent to the attending physician and pharmacist in the form of medication precautions for clinical medication reference.

[0047] Example 1: For patients over 65 years of age with a history of falls or fractures, the high-risk medication list includes: midazolam, diazepam, alprazolam, diazepam, nitrazepam, clonazepam, lorazepam, sulpiride, flupentixol, melitracen, risperidone, clozapine, and fluperidone.

[0048] The list of contraindicated medications includes: sulpiride, flupentixol, melitracen, risperidone, clozapine, and droperidol. This list can be sent to the patient's attending physician to remind them of the risks associated with these medications.

[0049] Example 2: When the patient in Example 1 develops new symptoms of heart failure, the list of drugs to be added to the patient's list of prohibited drugs should include: cilostazol and nonsteroidal anti-inflammatory drugs.

[0050] The beneficial effects of this invention compared to the prior art are as follows: the patient medication risk warning module can output the latest list of prohibited drugs and high-risk drugs based on the patient's real-time physical condition, and send them to the attending physician and pharmacist in the form of a medication precautions list, providing accurate and timely reference for clinical medication and forming the first level of pre-emptive risk prevention and control.

[0051] The medication error monitoring module is used to determine whether the patient's current medication is incorrect. Preferably, for the patient's current medication, it determines whether the medication is a contraindicated drug based on the patient's current list of prohibited drugs output by the patient medication risk warning module. The medication is input into the potential medication risk module, and the dosage range and route of administration of the patient's current medication are compared with the corresponding dosage range and route of administration of the medication in the potential medication risk module to determine whether the dosage range and route of administration are correct. If the medication is a contraindicated drug, or the dosage range and route of administration are incorrect, then a medication error exists; otherwise, no medication error exists.

[0052] The medication error monitoring module can be invoked at any time during the entire medication process to quickly identify medication errors, so as to strictly prevent medication errors throughout the entire medication process.

[0053] The monitoring parameter construction module is used to construct adverse event monitoring parameters before executing medication orders, so as to conduct targeted monitoring of medication risk information appearing in the patient's treatment process information during medication administration. The patient's treatment process information is obtained from the inpatient and outpatient medical record modules. Preferably, the medication to be executed is input into the potential medication risk module, and the corresponding adverse event set and ADE / ME intervention set are extracted. Adverse event monitoring parameters are constructed based on the adverse event set and ADE / ME intervention set. The adverse event monitoring parameters include adverse event indication parameters and adverse event intervention parameters. The adverse event indication parameters include: clinical manifestations corresponding to the adverse event and laboratory test indications corresponding to the adverse event. The intervention parameters include discontinuation or reduction of the medication to be executed and administration of rescue drugs for the medication to be executed. The adverse event indications are further divided into high-risk indications and non-high-risk indications. The indications corresponding to adverse events in the high-risk set are high-risk indications, and the indications corresponding to adverse events in the non-high-risk set are non-high-risk indications.

[0054] Example 3: The adverse events in the ibuprofen adverse event cluster include: liver injury. The parameters for liver injury-related adverse events include: (1) two consecutive tests of ALT > 40 U / L (upper limit of normal) and TB > 1 × ULN (upper limit of normal), (2) a single test of ALT > 2 × ULN (twice the upper limit of normal) and TB > 2 × ULN (upper limit of normal). The parameters for ADE / ME intervention for ibuprofen-induced liver injury include: (1) discontinuation or reduction of ibuprofen, (2) administration of glutathione, thioproline, glycyrrhizic acid preparations, and polyene phosphate choline.

[0055] The medication process monitoring and early warning module includes: (1) a graded early warning submodule, which is used to output different levels of early warning for suspected adverse drug events, medication errors that are about to occur, and medication errors that have already occurred. (2) a prescription medication monitoring submodule, which is used to investigate medication errors when prescription medications are issued but not executed, and to provide preventive early warning for medication errors that are about to occur. (3) a high-risk medication monitoring submodule, which is used to monitor and provide early warning for high-risk medications. (4) a non-high-risk medication monitoring submodule, which is used to monitor and provide early warning for non-high-risk medications.

[0056] The hierarchical early warning mechanism of the hierarchical early warning submodule is as follows: The monitored medication risk information is divided into five categories according to the risk level from high to low: Category I events, Category II events, Category III events, Category IV events, and Category V events, which are respectively output as black warnings, red warnings, orange warnings, yellow warnings, and blue warnings.

[0057] The first category of events includes: (1) medication errors that are about to occur, (2) medication errors that have occurred but have not been intervened in, and (3) medication errors that have occurred but have not been reversed. A black warning is issued for each of the first category of events, prompting physicians to intervene in a timely manner.

[0058] The second type of event includes adverse events that may occur within the high-risk set and are currently uninterrupted. For the second type of event, a red alert is issued, prompting physicians to intervene promptly and continuously.

[0059] The three types of events include: adverse events that may occur within the high-risk group, which have been intervened for but not reversed. For each of these three types of events, an orange alert is issued, indicating that physicians must continue to intervene.

[0060] The four types of events include: adverse events that are highly likely to occur within a non-high-risk cluster. A yellow alert is issued for each of these four types of events, and physician intervention is recommended.

[0061] The five categories of events include: adverse events that may occur outside the high-risk group. A blue alert will be issued for each of these five categories of events, and physicians are advised to increase their monitoring.

[0062] The medication monitoring submodule is used to monitor patients' medication orders in real time. For medications to be ordered, the name, dosage, and route of administration of the medications to be ordered are input into the medication error monitoring module to determine whether there is a medication error. If there is, the associated graded early warning submodule outputs a black warning to alert patients of the medication error, until the medication order with the medication error is cancelled.

[0063] The beneficial effects of this invention compared to the prior art are as follows: the medication monitoring submodule conducts preventive screening of medication error events before the medication is administered, and alerts clinicians and pharmacists to patients about an impending medication error as soon as the medication is prescribed, thus achieving pre-emptive intervention and forming a second level of pre-emptive risk control.

[0064] Once medication use is detected, the system determines whether the patient's current medication use constitutes high-risk medication use based on the patient's high-risk medication list. If it is high-risk, monitoring is performed using the high-risk medication use monitoring submodule; otherwise, monitoring is performed using the non-high-risk medication use monitoring submodule.

[0065] The high-risk medication monitoring submodule is used for processing as follows: Based on adverse event monitoring parameters, patient treatment process information within the inpatient and outpatient medical record modules is monitored. Upon detecting a positive indication, the drug name, dosage range, and route of administration are first input into the medication error monitoring module to investigate medication errors. If a medication error is found, a tiered early warning module is associated, and a black alert is continuously output according to the event category, indicating that a medication error has occurred. The ADE / ME intervention set for the drug is also pushed to physicians and pharmacists. The alert is cleared after subsequent monitoring shows that intervention has been implemented and the detected positive indication turns negative.

[0066] Preferably, a positive indicator is a clinical manifestation or laboratory test result corresponding to an adverse event.

[0067] The high-risk medication monitoring submodule includes a high-risk indication monitoring and early warning submodule and a non-high-risk indication monitoring and early warning submodule. After ruling out medication errors, it determines whether any of the detected positive indications are high-risk. If high-risk indications are present, monitoring is performed based on the high-risk indication monitoring and early warning submodule within the high-risk medication monitoring submodule. If all detected positive indications are non-high-risk, monitoring is performed based on the non-high-risk indication monitoring and early warning submodule within the high-risk medication monitoring submodule.

[0068] The non-high-risk medication monitoring submodule is used for processing as follows: Based on adverse event monitoring parameters, patient treatment process information within the inpatient and outpatient medical record modules is monitored. Upon detecting a positive indication, the drug name, dosage range, and route of administration are first input into the medication error monitoring module to investigate medication errors. If a medication error is found, a tiered early warning module is associated, and a black alert is continuously output according to the event category, indicating that a medication error has occurred. The ADE / ME intervention set for the drug is also pushed to physicians and pharmacists. The alert is cleared after subsequent monitoring shows that intervention has been implemented and the detected positive indication turns negative.

[0069] The non-high-risk medication monitoring submodule includes a high-risk indication monitoring and early warning submodule and a non-high-risk indication monitoring and early warning submodule. After ruling out medication errors, it is determined whether any of the detected positive indications are high-risk. If high-risk indications are present, monitoring is performed based on the high-risk indication monitoring and early warning submodule within the non-high-risk medication monitoring submodule. If all detected positive indications are non-high-risk, monitoring is performed based on the non-high-risk indication monitoring and early warning submodule within the non-high-risk medication monitoring submodule.

[0070] The beneficial effects of this invention compared to the prior art are as follows: For adverse drug events, risk monitoring is carried out by classifying and categorizing them according to the degree of harm. Throughout the monitoring process, based on positive indicators, medication error events are investigated in real time, and early warnings are output according to the highest sensitivity and risk level, so as to prompt physicians to intervene in the medication errors that have occurred in the first instance, and effectively control the degree of harm of the medication errors that have occurred.

[0071] In both the high-risk medication monitoring submodule and the non-high-risk medication monitoring submodule, the high-risk indication monitoring and early warning submodule processes the following: After a positive high-risk indication is detected, it is associated with the graded early warning module and warned as a Class II event, continuously outputting a red warning to indicate that a high-risk adverse event may have occurred within the drug's high-risk set and intervention is necessary. The drug's ADE / ME intervention set is also pushed to the physician and pharmacist. If a positive result is subsequently detected for the drug intervention parameter, it is downgraded to a Class III event, and an orange warning is continuously output until the indication turns negative and the warning is removed.

[0072] Example 4: For Patient A older than 65 years old who is administered warfarin, if the high-risk medication list of Patient A includes warfarin, this falls into high-risk medication. The high-risk indication parameters of warfarin include INR > 3 and moderate gastrointestinal bleeding. ADE / ME intervention measures include dosage reduction of warfarin, discontinuation of warfarin and administration of vitamin K. After medication, when it is monitored that the parameter INR > 3 is positive, or moderate gastrointestinal bleeding occurs, a red warning is continuously output. Thereafter, when it is detected that warfarin dosage has been reduced, warfarin has been discontinued or vitamin K has been administered, but INR > 3 or moderate gastrointestinal bleeding is still detected, the warning is changed to continuous output of an orange warning until it is detected that both the parameters INR > 3 and bleeding are negative, and then the warning is eliminated.

[0073] The beneficial effects achieved by the present invention over the prior art lie in: differentiated risk early warning is performed according to the risk degree of positive indications, a high-sensitivity and high-risk-level early warning method is adopted for high-risk indications, an early warning is issued as long as there is a positive parameter, and intervention is mandatory, so that the harm caused by adverse events is minimized to the greatest extent.

[0074] In the high-risk medication monitoring submodule and the non-high-risk medication monitoring submodule, the processing performed by the non-high-risk indication monitoring and early warning submodule is all: when all the detected positive indications are non-high-risk indications, discrimination of conditions 1 and 2 is performed respectively to obtain an early warning level, and an early warning is output according to the highest early warning level obtained by discrimination according to the conditions 1 and 2.

[0075] Preferably, condition 1: within a time window t1 of a certain length after medication, it is simultaneously detected that k non-high-risk indications corresponding to adverse events are positive.

[0076] If 0 < k ≤ n, that is, within a certain period of time after medication, a small number of non-high-risk indication parameters are concurrently positive, an early warning for a category 5 event is issued, a blue early warning is continuously output to remind the physician to pay attention to observation.

[0077] If k > n, that is, within a certain period of time after medication, a plurality of non-high-risk indication parameters are concurrently positive, the hierarchical early warning module is associated, an early warning for a category 4 event is issued, a yellow early warning is continuously output, the ADE / ME intervention set of the drug is pushed to physicians and pharmacists, and intervention is suggested.

[0078] Wherein n is the sensitivity concurrency threshold in non-high-risk indication monitoring and early warning.

[0079] Condition 2: after medication, there is at least one non-high-risk indication that remains continuously positive within T time.

[0080] If T > q, that is, after administration of the drug, there is at least one non-high-risk indication that remains continuously positive for a long time, an early warning for a category 4 event is issued, a yellow early warning is continuously output, the ADE / ME intervention set of the drug is pushed to physicians and pharmacists, and intervention is suggested.

[0081] If T£q, that is, after the administration of the drug, there is at least one non-high-risk indication that is positive for a short duration, a level-5 event warning is issued, and a blue warning is continuously output to remind the physician to pay attention to observation.

[0082] The q described is the sensitivity time threshold in non-high-risk indication monitoring and warning.

[0083] The sensitivity concurrency threshold and sensitivity time threshold of the non-high-risk indication monitoring sub-submodule in the high-risk monitoring submodule are n1 and q1, respectively.

[0084] The sensitivity concurrency threshold and sensitivity time threshold of the non-high-risk indication monitoring sub-submodule in the non-high-risk monitoring submodule are n2 and q2, respectively.

[0085] Wherein, n1<n2, q1<q2. That is, for the monitoring and warning of non-high-risk indications, the high-risk medication monitoring submodule is more sensitive than the non-high-risk medication monitoring submodule.

[0086] Example 5: Patient B has a history of gastrointestinal ulcer, and uses the drug ibuprofen. Ibuprofen is included in Patient B's high-risk medication list, so this is a high-risk medication. The non-high-risk indications of ibuprofen include: nausea, vomiting, anorexia, indigestion, heartburn, and abdominal pain. The high-risk indications of ibuprofen include: gastrointestinal bleeding. The sensitivity concurrency threshold and sensitivity time threshold of the non-high-risk indication monitoring sub-submodule in the high-risk medication monitoring submodule are n1=2, q1=2d. Within a certain time window after medication, if the patient has concurrent nausea, vomiting, anorexia, or abdominal pain for 3 days, the hierarchical warning submodule outputs a yellow warning. If the gastrointestinal bleeding parameter in the high-risk indication parameters is detected to be positive during the subsequent medication process, the warning is upgraded to a red warning, prompting the physician to perform immediate intervention. After it is detected that the drug withdrawal and dose reduction parameters in the ADE / ME intervention parameter are positive, and the gastrointestinal bleeding parameter is still positive, the warning is downgraded to an orange warning, indicating that continuous intervention is required until the gastrointestinal bleeding parameter becomes negative and the warning is cleared.

[0087] Example 6: Patient C has no gastrointestinal disease and uses the drug ibuprofen, which is a non-high-risk medication. The non-high-risk indications of ibuprofen include: nausea, vomiting, anorexia, indigestion, heartburn, and abdominal pain. The sensitivity concurrency threshold and sensitivity time threshold of the non-high-risk indication monitoring sub-submodule in the non-high-risk medication monitoring submodule are n1=4, q1=5d. Within a certain time window after medication, if the patient has concurrent nausea, vomiting, anorexia, or abdominal pain for 3 days, the hierarchical warning submodule outputs a blue warning to remind the physician to strengthen observation.

[0088] The beneficial effects of this invention compared to existing technologies are as follows: For non-high-risk indications, by setting thresholds, the sensitivity and risk level of the early warning are adjusted, ensuring the effectiveness of the early warning while avoiding interference from excessive high-risk warnings on clinical medication. By setting observation time windows, concurrent and persistent positive indications within the time window are captured, and the early warning level is promptly upgraded to indicate highly suspected adverse events, achieving early proactive warning of adverse events. The sensitivity of the warning sub-module for non-high-risk indications in the high-risk and non-high-risk medication monitoring sub-modules is differentiated. For high-risk medications where adverse events are prone to worsening or rapid development, warnings are issued at the initial stage of concentrated and persistent non-high-risk indications. For non-high-risk medications, the occurrence of non-high-risk indications is tolerated to a greater extent, avoiding unnecessary high-level warnings and intervention suggestions from affecting normal treatment medication, achieving classified risk management of medications with different risks, and providing more targeted risk warnings for clinical medication.

[0089] The proactive reporting module includes a medication error reporting module and an adverse event reporting module. After the medication process monitoring and early warning module detects a positive indication and issues an early warning of a medication error or a possible adverse event, the medication error reporting module and the adverse event reporting module proactively report the medication error and adverse event, respectively.

[0090] The adverse event reporting module is used to: determine the correlation between adverse events and suspected drugs that caused them, based on treatment process information before and after the occurrence of positive adverse event indicators in patients, so as to achieve accurate classification and reporting of adverse events. Preferably, the period before and after the occurrence of positive adverse event indicators in patients is three days.

[0091] The adverse event reporting module includes: a correlation scoring module, a correlation grading module, a suspected drug correlation ranking module, and a report generation module. The correlation scoring module scores the correlation between suspected drugs that trigger adverse events and the adverse events themselves. The correlation grading module, based on the scores output by the correlation scoring module, categorizes the correlation between suspected drugs and adverse events into four levels: certain, very likely, possible, and suspected, for tiered reporting. The suspected drug correlation ranking module ranks suspected drugs that may produce the same adverse event when used in combination with other drugs, assisting physicians in determining the primary cause of the adverse event.

[0092] Preferably, the correlation scoring module, for multiple suspected drugs corresponding to positive indicators, scores each item based on patient treatment process information in the inpatient and outpatient medical record modules according to the following scoring items, and sums them to obtain a correlation score for adverse drug events caused by various suspected drugs. The scoring items include: Scoring Item 1: Does the adverse event corresponding to the positive indication belong to a clearly defined adverse event of the drug? Yes, get 1 point; no, get 0 points; unknown, get 0 points. Scoring item 2: Whether the positive indicator was detected after medication. If yes, get 2 points; if no, get -1 point; if unknown, get 0 points. Item 3: Whether the adverse event indicators turn negative after discontinuation or administration of the rescue drug. 1 point for yes, 0 points for no, and 0 points for unknown. Scoring item 4: After a period of discontinuation, if the medication is resumed, do adverse event indicators reappear? 2 points for yes, -1 point for no, and 0 points for unknown. Scoring item 5: Are there any other factors that could have triggered a positive indicator of this adverse event? If yes, score -1 point; if no, score 2 points; if unknown, score 0 points. Scoring item 6: Does the drug concentration in the patient's body exceed the toxic dose? 1 point for yes, 0 points for no, 0 points for unknown. Item 7: Is the severity of adverse event indicators positively correlated with the drug dosage? 1 point for yes, 0 points for no, and 0 points for unknown. Scoring item 8: Does the patient have a history of adverse events related to this drug or similar drugs? If yes, get 1 point; if no, get 0 points; if unknown, get 0 points.

[0093] The correlation grading module classifies the correlation between suspected drugs and adverse events into four levels based on the scoring results of the correlation scoring module: certain, very likely, possible, and suspected.

[0094] For adverse event C corresponding to a positive indication and the suspected drug Msi that may cause adverse event C: If the correlation score is greater than or equal to 7, the correlation level between the drug Msi and adverse event C is considered positive. If the correlation score is 4-6, the correlation between the drug Msi and adverse event C is considered to be highly probable. If the correlation score is 1-3, the correlation level between the drug Msi and adverse event C is considered to be probable. If the correlation score is less than 1, the correlation level between the drug Msi and adverse event C is considered suspicious.

[0095] The suspected drug correlation ranking module ranks suspected drugs that may cause the same adverse event when used in combination with other drugs. For an adverse event C corresponding to a positive indication, all drugs in the patient's medication record that may cause adverse event C constitute a suspected drug list Ms={Ms1,Ms2,Ms3,…,Ms nThe suspected drugs are sorted according to their correlation scores to form a suspected drug correlation ranking list. The information in the suspected drug correlation ranking list includes the suspected drug name, the correlation score between the suspected drug and the adverse event, the correlation level between the suspected drug and the adverse event, and the adverse event corresponding to the positive indication. The suspected drug correlation ranking list is sorted in descending order of correlation score and pushed to clinicians to assist them in making targeted decisions regarding further medication or treatment.

[0096] Example 7: Clinically, the acceptable range for INR is 2-3. If the INR value is higher than the above range, the patient is more likely to bleed. Abnormal INR value is a known adverse event of the drug warfarin.

[0097] Patient D had a history of adverse bleeding events caused by warfarin, no underlying gastrointestinal diseases, and no other medications that could easily cause bleeding. On day 7 after starting warfarin, Patient D experienced an INR of 3.8 and gastrointestinal bleeding. The medication was discontinued, and the patient was given the antidote vitamin K. On day 14, the INR was 2.1, and the gastrointestinal bleeding symptoms disappeared. On day 21, warfarin was started at 90% of the initial dose. On day 28, the INR was 3.2, and no bleeding occurred. The patient continued taking warfarin at 80% of the initial dose. On day 35, the INR was 2.5.

[0098] Table 2. Correlation between abnormal D INR and warfarin in patients. Patient's condition description Score Rating Item 1 Abnormal INR indicators are clearly adverse events associated with warfarin. +1 Rating Item 2 The abnormal INR was detected after taking warfarin. +2 Rating item 3 After discontinuing the medication and administering the antidote vitamin K, the INR returned to normal. +1 Rating item 4 After discontinuing warfarin for a period of time, the INR became abnormal again upon re-intake. +2 Rating item 5 The patient has no other factors that could cause an abnormal INR. +2 Rating item 6 The drug concentration in the patient's body is unknown. 0 Rating item 7 INR values ​​increase with warfarin dosage +1 Rating item 8 The patient has a history of adverse events related to warfarin and similar drugs. +1 If the correlation score for warfarin-induced INR abnormalities is 10 points or greater than 7 points, and the correlation level is positive, then it can be determined that warfarin caused an adverse event with abnormal INR.

[0099] Example 8: Gastrointestinal bleeding is one of the adverse events of the drug ibuprofen, and also one of the adverse events of the drug warfarin.

[0100] Patient E had a history of peptic ulcer disease but no history of adverse gastrointestinal events caused by ibuprofen. The patient started taking warfarin on day 1. On day 3, the patient took ibuprofen to relieve joint pain. On day 7, the joint pain was relieved and ibuprofen was discontinued. On day 8, gastrointestinal bleeding symptoms appeared, and warfarin was discontinued. On day 12, the bleeding symptoms disappeared. On day 20, the original dose of warfarin was resumed. On day 27, gastrointestinal bleeding recurred.

[0101] Table 3. Correlation Score Table between Gastrointestinal Bleeding and Warfarin in Patients (E) Patient's condition description Score Rating Item 1 Gastrointestinal bleeding is a known adverse event associated with warfarin. +1 Rating Item 2 Gastrointestinal bleeding was detected after taking warfarin. +2 Rating item 3 After discontinuing warfarin, the symptoms of gastrointestinal bleeding disappeared. +1 Rating item 4 After stopping the medication for a period of time, warfarin was ingested again, resulting in renewed gastrointestinal bleeding. +2 Rating item 5 Ibuprofen taken by patients can also cause gastrointestinal bleeding. -1 Rating item 6 The drug concentration in the patient's body is unknown. 0 Rating item 7 The correlation between the severity of adverse events and drug dosage is unknown. 0 Rating item 8 The patient has no history of adverse events related to warfarin or similar drugs. 0 Table 4. Correlation Score between Gastrointestinal Bleeding and Ibuprofen in Patient E Patient's condition description Score Rating Item 1 Gastrointestinal bleeding is a known adverse event associated with ibuprofen. +1 Rating Item 2 Gastrointestinal bleeding was detected after taking ibuprofen. +2 Rating item 3 After discontinuing ibuprofen, the symptoms of gastrointestinal bleeding disappeared. +1 Rating item 4 Ibuprofen was not taken again after a period of discontinuation. +0 Rating item 5 Warfarin can also cause gastrointestinal bleeding in patients. -1 Rating item 6 The drug concentration in the patient's body is unknown. 0 Rating item 7 The correlation between the severity of adverse events and drug dosage is unknown. 0 Rating item 8 The patient has a history of adverse events related to ibuprofen and similar drugs. 0 Tables 3 and 4 show that the correlation scores for warfarin and ibuprofen, the suspected drugs that caused gastrointestinal bleeding in patient E, were 5 and 3 points respectively, with a correlation level of "probably" and "likely". In the list of suspected drugs causing gastrointestinal bleeding, warfarin ranks higher than ibuprofen, meaning that patient E's gastrointestinal bleeding was more likely caused by warfarin use.

[0102] The beneficial effects of this invention compared to existing technologies are as follows: The adverse event reporting module in this invention, based on positive indicators detected by the medication process monitoring and early warning module, retrospectively and subsequently monitors patient treatment process information to find clinical evidence of suspected drug-induced adverse events. By integrating multiple clinical evidences and based on objective scoring criteria, it determines the correlation between positive indicators of adverse events and clinical medication use, providing an objective and unified standard for adverse event reporting, improving the accuracy of adverse event reporting, and providing high-quality clinical sample data for drug adverse event monitoring and research. Furthermore, for multiple drugs used concurrently with similar adverse events, it identifies the main causative drug for the adverse event based on correlation ranking, providing accurate reference for clinical medication use.

[0103] The report generation module generates a drug adverse event report based on the classification results of the correlation classification module, the ranking list of suspected drug correlations, and the patient treatment process information related to adverse events in the inpatient and outpatient medical record modules, and inputs the drug adverse event report into the ADE / ME report management module.

[0104] The adverse event report includes: (1) patient name, gender, original disease, and name of adverse event; (2) adverse event course information including symptoms, signs, and clinical test results; and (3) suspected drugs with adverse event correlation classification results of definite, very likely, or possible.

[0105] Preferably, the ADE / ME reporting management module reports adverse drug events to the Food and Drug Adverse Event Monitoring Center or the Drug-Induced Disease Monitoring Network.

[0106] The medication error reporting module is used to report medication errors that have occurred. When the medication process monitoring and early warning module detects a positive indication, and the medication error monitoring module determines it to be a medication error event, the medication error reporting module generates a medication error report based on the patient's treatment process information from the inpatient and outpatient medical record modules, and inputs the medication error report into the ADE / ME report management module.

[0107] The medication error report includes: the time when the medication error occurred, the medication involved, the details of the medication error, and the extent of harm caused to the patient by the medication error.

[0108] Preferably, the ADE / ME report management module will report medication error reports to the Food and Drug Adverse Event Monitoring Center or the Drug-Induced Disease Monitoring Network.

[0109] The statistics module is used to summarize the adverse drug event reports and medication error reports submitted by the ADE / ME report management module, providing basic clinical data for the statistical analysis of adverse drug events and medication errors.

[0110] The above embodiments are only used to illustrate the present invention and are not intended to limit the technical solutions described herein. Although the present invention has been described in detail with reference to the above embodiments, the present invention is not limited to the specific embodiments described above. Therefore, any modifications or equivalent substitutions to the present invention, as well as all technical solutions and improvements that do not depart from the spirit and scope of the invention, are covered within the scope of the claims of the present invention.

Claims

1. An active surveillance and reporting system for drug-induced diseases, comprising: Drug-induced disease knowledge base, inpatient and outpatient medical record module, intelligent monitoring module, ADE / ME report management module, and statistics module; The drug-induced disease knowledge base is used to provide medication risk information, including: a literature knowledge base, an information knowledge base, a drug instruction manual database, and a potential medication risk module; The intelligent monitoring module obtains medication risk information from the drug-induced disease knowledge base and patient treatment process information from the inpatient and outpatient medical record module based on the patient's medication situation. It monitors the medication risk information appearing in the patient's treatment process information in real time and provides real-time early warning and proactive reporting of adverse drug events and medication errors. Its features are: The proactive reporting operation includes at least the following: when an adverse drug event occurs, the intelligent monitoring module detects medication risk information and issues an early warning, and based on the patient's treatment process information, it continues to monitor backward and forward, and after determining the correlation between the adverse event and the suspected drug, it proactively reports the adverse drug event; The intelligent monitoring module includes: The patient medication risk warning module is used to analyze the patient's potential medication risks based on the patient's physical condition before medication and to provide pre-medication risk warnings. The medication error monitoring module is used to monitor medication errors that are about to occur and medication errors that have already occurred throughout the entire process of patient medication administration. The monitoring parameter construction module is used to determine the monitoring parameters of adverse drug events based on the clinical manifestations and laboratory test indicators of adverse drug events and the intervention methods for adverse events. The medication process monitoring and early warning module is used to: monitor patient treatment process information and provide graded early warnings for adverse drug events and medication errors that occur during the process; The proactive reporting module is used to determine the correlation between adverse drug events and suspected drugs, and to proactively report adverse drug events and medication errors. The patient medication risk warning module extracts information closely related to the analyzed patient's physical condition from the inpatient and outpatient medical record modules in real time, including: underlying disease information, age information, gender information, liver function information, kidney function information, pregnancy information, allergy information, and surgical history information, to form the analyzed patient's current physical condition information; the physical condition information is input into the potential medication risk module to obtain the patient's current prohibited drug list and high-risk drug list; during the patient's treatment, the current prohibited drug list and high-risk drug list are updated in real time as the patient's treatment process information in the inpatient and outpatient medical record modules changes, forming the latest patient's current prohibited drug list and high-risk drug list, and are sent to the attending physician and pharmacist in the form of medication precautions for clinical medication reference; The medication error monitoring module is used to determine whether the patient's current medication is incorrect. For the patient's current medication, based on the list of prohibited medications output by the patient's medication risk warning module, it determines whether the medication is a contraindicated drug for the patient. The medication is then input into the potential medication risk module, and the dosage range and route of administration of the patient's current medication are compared with the corresponding dosage range and route of administration of the medication in the potential medication risk module to determine whether the dosage range and route of administration are correct. If the medication is a contraindicated drug for the patient, or the dosage range and route of administration are incorrect, then a medication error exists; otherwise, no medication error exists. The monitoring parameter construction module is used to construct adverse event monitoring parameters before executing medication orders, so as to conduct targeted monitoring of medication risk information appearing in the patient's treatment process information during medication administration. The patient's treatment process information is obtained from the inpatient and outpatient medical record modules. The medication to be executed is input into the potential medication risk module, and the adverse event set and ADE / ME intervention set corresponding to the medication are extracted. Adverse event monitoring parameters are constructed based on the adverse event set and ADE / ME intervention set. The adverse event monitoring parameters include adverse event indication parameters and adverse event intervention parameters. The adverse event indication parameters include: clinical manifestations corresponding to the adverse event and laboratory test indications corresponding to the adverse event. The intervention parameters include discontinuation, reduction, and administration of rescue drugs for the medication to be executed. The adverse event indications are further divided into high-risk indications and non-high-risk indications. The indications corresponding to adverse events in the high-risk set are high-risk indications, and the indications corresponding to adverse events in the non-high-risk set are non-high-risk indications. The medication administration process monitoring and early warning module includes: The graded early warning submodule is used to output different levels of early warning for suspected adverse drug events, impending medication errors, and medication errors that have already occurred. The medication monitoring submodule is used to identify medication errors when medications are prescribed but not administered, and to provide preventative warnings for potential medication errors. The high-risk medication monitoring submodule is used to monitor and issue early warnings for high-risk medication use. The non-high-risk medication monitoring submodule is used to monitor and provide early warnings for non-high-risk medication use. The hierarchical early warning mechanism of the hierarchical early warning submodule is as follows: The monitored medication risk information is divided into five categories according to the risk level from high to low: Category I events, Category II events, Category III events, Category IV events, and Category V events, which are respectively output as black warning, red warning, orange warning, yellow warning, and blue warning. One type of event includes: An impending medication error; Medication errors that have occurred but were not addressed; Medication errors that have occurred but cannot be reversed; A black alert is issued for a certain type of event, prompting doctors to intervene in a timely manner; The second type of event includes: adverse events that may occur within the high-risk set and are currently in an uninterrupted state; for the second type of event, a red alert is issued, prompting physicians to intervene promptly and continuously; The three types of events include: adverse events that may occur within the high-risk set, which have been intervened for but not reversed; for these three types of events, an orange alert is issued to remind physicians that continued intervention is necessary; The four types of events include: non-high-risk adverse events that are very likely to occur within the cluster; a yellow warning will be issued for the four types of events, and physician intervention is recommended; The five categories of events include: adverse events that may occur outside the high-risk group; a blue alert will be issued for these five categories of events, and physicians are advised to strengthen their observation. The medication monitoring submodule is used to monitor patients' medication orders in real time. For the medication to be ordered, the name, dosage and route of administration of the medication to be ordered are input into the medication error monitoring module to determine whether there is a medication error. If there is, the associated graded early warning submodule outputs a black warning to alert patients of the medication error, until the medication order with the error is cancelled. Once it is detected that a patient has used medication, the system determines whether the use of the medication is considered high-risk under the patient's current physical condition, based on the patient's high-risk medication list. If it is considered high-risk, monitoring is performed using the high-risk medication monitoring submodule; otherwise, monitoring is performed using the non-high-risk medication monitoring submodule. The high-risk medication monitoring submodule is used for the following process: Based on adverse event monitoring parameters, the patient treatment process information in the inpatient and outpatient medical record modules is monitored; after a positive indication is detected, the name of the medication, dosage range, and route of administration are first input into the medication error monitoring module to check for medication errors; if a medication error is found, the graded early warning module is associated, and a black warning is continuously output according to the first type of event to indicate that a medication error has occurred. The ADE / ME intervention set for the medication is also pushed to the physician and pharmacist. The warning is cleared after subsequent monitoring shows that the intervention has been implemented and the detected positive indication turns negative. Positive indicators are clinical manifestations or laboratory test results corresponding to adverse events; The high-risk medication monitoring submodule includes a high-risk indication monitoring and early warning submodule and a non-high-risk indication monitoring and early warning submodule. After ruling out medication errors, it determines whether any of the detected positive indications are high-risk. If high-risk indications are present, monitoring is performed based on the high-risk indication monitoring and early warning submodule within the high-risk medication monitoring submodule. If all detected positive indications are non-high-risk, monitoring is performed based on the non-high-risk indication monitoring and early warning submodule within the high-risk medication monitoring submodule. The non-high-risk medication monitoring submodule is used for processing as follows: Based on adverse event monitoring parameters, the patient treatment process information in the inpatient and outpatient medical record modules is monitored; after a positive indication is detected, the name of the medication, dosage range, and route of administration are first entered into the medication error monitoring module to check for medication errors; if a medication error is found, the graded early warning module is associated, and a black warning is continuously output according to the first type of event to indicate that a medication error has occurred. The ADE / ME intervention set for the medication is also pushed to the physician and pharmacist. The warning is cleared after subsequent monitoring shows that the intervention has been implemented and the detected positive indication turns negative. The non-high-risk medication monitoring sub-module includes a grandchild module for high-risk indication monitoring and early warning and a grandchild module for non-high-risk indication monitoring and early warning; after excluding medication errors, it is determined whether there are any high-risk indications among the detected positive indications. If high-risk indications exist, monitoring is performed based on the grandchild module for high-risk indication monitoring and early warning in the non-high-risk medication monitoring sub-module. If all detected positive indications are non-high-risk indications, monitoring is performed based on the grandchild module for non-high-risk indication monitoring and early warning in the non-high-risk medication monitoring sub-module; In both the high-risk medication monitoring sub-module and the non-high-risk medication monitoring sub-module, the specific processing performed by the grandchild module for high-risk indication monitoring and early warning is as follows: after a positive high-risk indication is detected, the module is associated with the hierarchical early warning module, an early warning is issued for a Category II event, a red early warning is continuously output to remind physicians and pharmacists that an adverse event in the high-risk drug set may have occurred and intervention is mandatory, and the ADE / ME intervention set for the drug is pushed to physicians and pharmacists. After a positive drug intervention parameter is detected in subsequent monitoring, the early warning is downgraded to a Category III event, and an orange early warning is continuously output until the indication turns negative and the early warning is canceled; In the high-risk medication monitoring sub-module and the non-high-risk medication monitoring sub-module, the processing performed by the grandchild module for non-high-risk indication monitoring and early warning is as follows: when all detected positive indications are non-high-risk indications, the judgments of condition 1 and condition 2 are performed respectively to obtain an early warning level, and the highest early warning level obtained from the judgments of condition 1 and condition 2 is used for early warning output; Condition 1: Within a certain length of time window t1 after medication, non-high-risk indications corresponding to k adverse events are simultaneously detected as positive; If 0 < k ≤ n, that is, within a certain period of time after medication, a small number of non-high-risk indication parameters test positive concurrently, an early warning is issued for a Category V event, and a blue early warning is continuously output to remind the physician to pay attention to observation; If k > n, that is, within a certain period of time after medication, multiple non-high-risk indication parameters test positive concurrently, the module is associated with the hierarchical early warning module, an early warning is issued for a Category IV event, a yellow early warning is continuously output, the ADE / ME intervention set for the drug is pushed to physicians and pharmacists, and intervention is recommended; The n is a sensitivity concurrency threshold in non-high-risk indication monitoring and early warning; Condition 2: After medication, there is at least one non-high-risk indication that remains continuously positive for T time; If T > q, that is, after medication, there is at least one non-high-risk indication that remains continuously positive for a long time, an early warning is issued for a Category IV event, a yellow early warning is continuously output, the ADE / ME intervention set for the drug is pushed to physicians and pharmacists, and intervention is recommended; If T ≤ q, that is, after medication, there is at least one non-high-risk indication that remains continuously positive for a short time, an early warning is issued for a Category V event, a blue early warning is continuously output to remind the physician to pay attention to observation; The q is a sensitivity time threshold in non-high-risk indication monitoring and early warning; The sensitivity concurrency threshold and sensitivity time threshold of the grandchild module for non-high-risk indication monitoring in the high-risk monitoring sub-module are n1 and q1 respectively; The sensitivity concurrency threshold and sensitivity time threshold of the grandchild module for non-high-risk indication monitoring in the non-high-risk monitoring sub-module are n2 and q2 respectively; wherein, n1<n2 and q1<q2; that is, for monitoring and early warning of non-high-risk indications, the high-risk medication monitoring sub-module is more sensitive than the non-high-risk medication monitoring sub-module.

2. The active monitoring and reporting system for drug-induced diseases as described in claim 1, characterized in that: the potential medication risk module is configured to integrate the medication risk information corresponding to each drug in the document knowledge base, information knowledge base and drug specification database by using a standardized data table; the medication risk information corresponding to each drug includes the following sub-items: contraindications corresponding to each drug, dosage range and administration route, adverse event set, ADE / ME intervention measure set, high-risk groups, and high-alert medication attributes.

3. The active monitoring and reporting system for drug-induced diseases as described in claim 2, characterized in that: in the drug-induced disease knowledge base, the document knowledge base comprises medication safety and adverse event columns in pharmaceutical and clinical medical academic journals, the information knowledge base comprises a drug adverse event database on drug supervision and administration websites, and the drug specification database comprises precautions, risk warning boxes and adverse event columns in specifications of various drugs.

4. The active monitoring and reporting system for drug-induced diseases as described in claim 3, characterized in that, the adverse event set is divided into a high-risk set and a non-high-risk set according to the severity of consequences; the high-risk set comprises serious adverse drug events and life-threatening adverse drug events; the non-high-risk set comprises mild adverse events and moderate adverse events; the ADE / ME intervention measure set comprises drug withdrawal, dose reduction or administration of antidotes for adverse events or medication errors; the high-alert medication attribute characterizes whether the drug belongs to a high-alert medication; the high-alert medication is a drug with great toxicity and is prone to cause serious adverse events, and all high-alert medications form a high-alert medication list; the potential medication risk module can output the corresponding medication risk information of the drug after inputting the drug name; after inputting the patient's current physical condition information, the potential medication risk module outputs the patient's corresponding medication risk information, which comprises: a list of contraindicated drugs and a list of high-risk medications for the patient under the current physical condition; the contraindicated drug list comprises drugs prohibited for the patient under the current physical condition determined according to contraindication items of each drug; the patient's high-risk medication list comprises: drugs that contain the patient in the high-risk group sub-item, and high-alert medications other than the patient's contraindicated drug list; the high-alert medications other than the patient's contraindicated drugs are obtained by taking the difference set between the high-alert medication list and the patient's contraindicated drug list.

5. The active monitoring and reporting system for drug-induced diseases as described in claim 4, characterized in that: the active reporting module comprises: a medication error reporting module and an adverse event reporting module; after the medication process monitoring and early warning module monitors a positive indication and gives an early warning of an occurred medication error or a possible adverse event, the medication error reporting module and the adverse event reporting module respectively perform active reporting for the medication error and the adverse drug event; the adverse event reporting module is configured to: determine the correlation between the adverse event and the suspicious drug causing the adverse event based on the treatment process information before and after the occurrence of the patient's positive adverse event indication, so as to realize accurate graded reporting of the adverse event; the period before and after the occurrence of the patient's positive adverse event indication is three days before and three days after; The adverse event reporting module includes: a correlation scoring module, a correlation grading module, a suspected drug correlation ranking module, and a report generation module. The correlation scoring module is used to score the correlation between suspected drugs that cause adverse events and the adverse events. The correlation grading module classifies the correlation between suspected drugs and adverse events into four levels: certain, very likely, possible, and suspected, based on the score output by the correlation scoring module, so as to facilitate tiered reporting. The suspected drug correlation ranking module ranks suspected drugs that may produce the same adverse event when used in combination with other drugs, assisting physicians in determining the main causes of adverse events. The correlation scoring module, for multiple suspected drugs corresponding to positive indicators, scores each item based on patient treatment process information in the inpatient and outpatient medical record modules, according to the following scoring items, and sums them to obtain the correlation score of adverse drug events caused by various suspected drugs; the scoring items include: Scoring Item 1: Does the adverse event corresponding to the positive indication belong to a clearly defined adverse event of the drug? Yes, get 1 point; no, get 0 points; unknown, get 0 points. Scoring item 2: Whether the positive indicator was detected after medication. If yes, get 2 points; if no, get -1 point; if unknown, get 0 points. Item 3: Whether the adverse event indicators turn negative after discontinuation or administration of the rescue drug. 1 point for yes, 0 points for no, and 0 points for unknown. Scoring item 4: After a period of discontinuation, if the medication is resumed, do adverse event indicators reappear? 2 points for yes, -1 point for no, and 0 points for unknown. Scoring item 5: Are there any other factors that could have triggered a positive indicator of this adverse event? If yes, score -1 point; if no, score 2 points; if unknown, score 0 points. Scoring item 6: Does the drug concentration in the patient's body exceed the toxic dose? 1 point for yes, 0 points for no, 0 points for unknown. Item 7: Is the severity of adverse event indicators positively correlated with the drug dosage? 1 point for yes, 0 points for no, and 0 points for unknown. Scoring item 8: Does the patient have a history of adverse events related to this drug or similar drugs? If yes, get 1 point; if no, get 0 points; if unknown, get 0 points. The correlation grading module classifies the correlation between suspected drugs and adverse events into four levels based on the scoring results of the correlation scoring module: certain, very likely, possible, and suspected. For adverse events corresponding to positive indicators and suspected drugs that may cause adverse events: If the correlation score is greater than or equal to 7, the correlation between the drug and the adverse event is considered positive. If the correlation score is 4-6, the correlation between the drug and the adverse event is considered to be highly probable. If the correlation score is 1-3, the correlation between the drug and the adverse event is considered to be probable. If the correlation score is less than 1, the correlation between the drug and the adverse event is considered suspicious. The suspected drug correlation ranking module ranks suspected drugs that may produce the same adverse event when used in combination with other drugs. For adverse events corresponding to positive indicators, all drugs in the patient's medication records that may cause adverse events constitute a suspected drug list. The suspected drugs are then sorted according to their correlation scores to form a suspected drug correlation ranking list. The information in the suspected drug correlation ranking list includes the name of the suspected drug, the correlation score between the suspected drug and the adverse event, the correlation level between the suspected drug and the adverse event, and the adverse event corresponding to the positive indicator. The suspected drug correlation ranking list is sorted in descending order of correlation score and pushed to clinicians to assist them in making targeted decisions on the next medication or treatment. The report generation module generates a drug adverse event report based on the classification results of the correlation classification module, the ranking list of suspected drug correlations, and the patient treatment process information related to adverse events in the inpatient and outpatient medical record modules, and inputs the drug adverse event report into the ADE / ME report management module.

6. The active monitoring and reporting system for drug-induced diseases as described in claim 5, characterized in that: The medication error reporting module is used to report medication errors that have occurred. When the medication process monitoring and early warning module detects a positive sign and the medication error monitoring module determines it to be a medication error event, the medication error reporting module generates a medication error report based on the patient's treatment process information from the inpatient and outpatient medical record modules, and inputs the medication error report into the ADE / ME report management module. The medication error report includes: the time when the medication error occurred, the medication involved in the medication error, the details of the medication error, and the extent of harm caused to the patient by the medication error; The ADE / ME report management module will report medication error reports to the Food and Drug Adverse Event Monitoring Center or the Drug-Induced Disease Monitoring Network. The statistics module is used to summarize the adverse drug event reports and medication error reports submitted by the ADE / ME report management module, providing basic clinical data for the statistical analysis of adverse drug events and medication errors.

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