CN114283913A - Active monitoring and reporting system for drug-induced diseases - Google Patents

Abstract

The invention relates to an active drug-induced disease monitoring and reporting system, which is used for carrying out graded early warning and active reporting on adverse events and medication errors of a medicine according to the monitoring of clinical treatment process information of a patient.

Description

Active monitoring and reporting system for drug-induced diseases

Technical Field

The invention relates to the technical field of medical treatment, in particular to an active monitoring and reporting system for drug-induced diseases.

Background

Adverse drug events (ads) and Medication Errors (ME) are one of the main causes of drug-induced diseases, and therefore, the development of Adverse Drug Event (ADE) and Medication Error (ME) monitoring is an important measure for reducing the incidence of adverse drug events in medical institutions. The main current ADE monitoring methods include adverse event medical record review method and voluntary report system method, the occurrence condition of ADE is collected through medical record review and voluntary report mode, the report number quality and signal detection capability of the mode depend on the report consciousness and the coordination degree of medical institutions, the problems of misinformation, missing report, after-the-fact report and the like exist, the true occurrence level of ADE or ME cannot be reflected, and the current ADE monitoring belongs to 'after-the-fact' passive monitoring and lacks of prior prevention.

The main problems in the prior art of monitoring and reporting adverse drug events are as follows:

1. the current ADE/ME monitoring system has the problems of false alarm, missing report, low report rate, low report accuracy, non-uniform association evaluation standard of suspicious drugs and adverse events and the like, so that the real occurrence level of ADE or ME cannot be reflected, the sample size of original data for researching the adverse events of drugs is small, the sample quality is low, the sample timeliness is poor, and inconvenience is brought to clinical medication safety supervision and drug quality feedback.

2. Some ADE/ME can be avoided or discovered in early stage, most of the current ADE/ME monitoring systems are disposed after the fact, a pre-warning mechanism is lacked, the clinical treatment misses the optimal intervention opportunity of ADE due to the lack of pre-warning, and the incidence rate and the severity of ADE are increased.

3. The ADE reports the requirement on accuracy, a certain time is needed for evidence-based review, the ADE early warning requirement on timeliness needs early warning of potential ADE risks, and the current ADE/ME monitoring system is difficult to meet the requirements on accuracy reporting and timely early warning at the same time.

Therefore, designing an active drug-induced disease monitoring and reporting system to early warn and accurately report adverse drug events in time is a technical problem to be solved urgently by those skilled in the art.

Disclosure of Invention

An active monitoring and reporting system for drug-induced diseases comprises: the system comprises a drug-induced disease knowledge base, an in-patient and out-patient medical record recording module, an intelligent monitoring module, an ADE/ME report management module and a statistical module;

the drug-induced disease knowledge base is used for providing drug use risk information and comprises a literature knowledge base, an information knowledge base, a drug specification database and a potential drug use risk module;

the intelligent monitoring module acquires medication risk information from the drug-induced disease knowledge base according to the medication condition of a patient, acquires treatment process information of the patient from an in-patient and out-patient medical record recording module, monitors the medication risk information appearing in the treatment process information of the patient in real time, and carries out real-time early warning and active reporting on adverse events and medication errors of a medicine;

the active reporting operation at least comprises: when a drug adverse event occurs, the intelligent monitoring module monitors that drug administration risk information immediately warns, and based on the treatment process information of the patient, the intelligent monitoring module backtracks forwards and continues to monitor backwards, and actively reports the drug adverse event after determining the relevance between the adverse event and the suspicious drug.

The potential medication risk module is used for integrating medication risk information corresponding to each medicine in the literature knowledge base, the information knowledge base and the medicine specification database by using a standardized data table; the medication risk information corresponding to each medicine comprises the following sub-items: contraindications, dosage range and administration route corresponding to each drug, adverse event set, ADE/ME intervention means set, high risk group and high warning drug attribute.

In the drug-induced disease knowledge base, the literature knowledge base comprises columns for drug safety and adverse events in various pharmacy and clinical medicine academic journals, the information knowledge base comprises a drug adverse event database in a drug supervision and management website, and the drug instruction book database comprises notes, risk warning frames and adverse event columns in various drugs including instructions.

The adverse event set is divided into a high-risk set and a non-high-risk set according to the critical degree of the consequence; the high risk set includes serious adverse drug events, life threatening adverse drug events; the non-high risk group comprises mild adverse events, moderate adverse events; the set of ADE/ME interventions includes the administration of drug withdrawal, decrement, or rescue medication for adverse events or medication errors;

the high alert drug attribute characterizes whether the drug belongs to a high alert drug; the high warning medicines are medicines which are high in medicine toxicity and easy to cause serious adverse events, and all the high warning medicines form a high warning medicine list;

the potential medication risk module inputs the name of the medicine, and then medication risk information corresponding to the medicine can be output;

after the current physical condition information of the patient is input, the potential medication risk module outputs medication risk information corresponding to the patient, and the medication risk information comprises: a list of forbidden medications and a list of high-risk medications for the patient under the current physical condition; the forbidden medicine list comprises medicines forbidden to be used by the patient under the current physical condition and determined according to each forbidden medicine item; the high risk medication list for the patient includes: the high-risk population sub-item comprises the medicine of the patient and high-warning medicines outside the forbidden medicine list of the patient; and the high warning medicines except the forbidden medicines of the patient are obtained by making a difference between a high warning medicine list and the forbidden medicine list of the patient.

The intelligent monitoring module comprises: (1) the patient medication risk prompting module is used for analyzing the potential medication risk of the patient according to the physical condition of the patient before medication, and prompting the risk before medication; (2) a medication error monitoring module for: monitoring the medication errors to be generated and the medication errors already generated in the whole medication process of a patient; (3) a monitoring parameter construction module for: determining monitoring parameters of adverse events of the medicines according to clinical performance indicators of the adverse events of the medicines, laboratory examination indicators and intervention means of the adverse events; (4) the medicine process monitoring and early warning module is used for: monitoring the treatment process information of the patient, and carrying out grading early warning on adverse events and medication errors of the medicine; (5) the active reporting module is used for determining the relevance between the adverse drug events and the suspicious drugs and actively reporting the adverse drug events and the medication errors;

the patient medication risk prompting module extracts information closely related to the physical condition of the analyzed patient from the in-patient and out-patient medical record recording module in real time, and comprises the following steps: basic disease information, age information, sex information, liver function information, renal function information, pregnancy information, allergy medicine information and operation history information form the current physical condition information of the analyzed patient; inputting the physical condition information into a potential medication risk module to obtain a currently forbidden medication list and a high risk medication list of the patient; in the treatment process of a patient, the current forbidden medicine list and the high-risk medicine list are updated in real time along with the change of the treatment process information of the patient in the in-patient and out-patient medical record module to form the latest current forbidden medicine list and the latest high-risk medicine list of the patient, and the latest current forbidden medicine list and the latest high-risk medicine list of the patient are sent to a doctor in charge and a pharmacist in the form of medication notice to serve as clinical medication references;

the medication error monitoring module is used for judging whether the current medication of the patient is wrong; for the currently used medicine of the patient, judging whether the medicine belongs to the contraindicated medicine of the patient according to the currently forbidden medicine list of the patient output by the patient medicine risk prompting module; inputting the medicine into the potential medication risk module, comparing the dosage range and the administration route of the current medication of the patient with the dosage range and the administration route corresponding to the medicine in the potential medication risk module, and judging whether the dosage range and the administration route of the medicine are correct or not; if the medicine belongs to contraindications of patients, or the dosage range and the administration route of the medicine are incorrect, medication errors exist, otherwise, the medication errors do not exist;

the monitoring parameter construction module is used for constructing adverse event monitoring parameters before executing medical advice medication so as to carry out targeted monitoring on medication risk information appearing in the treatment process information of the patient in the medication process, and the treatment process information of the patient is obtained from the medical record module in hospital and in clinic; inputting the to-be-executed medical advice drug into the potential medication risk module, and extracting an adverse event set and an ADE/ME intervention means set corresponding to the drug; constructing adverse event monitoring parameters based on the adverse event set and the ADE/ME intervention means set, wherein the adverse event monitoring parameters comprise adverse event indication parameters and adverse event intervention means parameters; the adverse event indicator parameters include: clinical performance indicators corresponding to adverse events, laboratory test indicators corresponding to adverse events; the intervention modality parameters include a deactivation of the prescribed medication to be administered, a decrement, and an administration of a rescue medication of the prescribed medication to be administered; the adverse event indicators are divided into high-risk indicators and non-high-risk indicators; the corresponding indication of the adverse events in the high-risk set is a high-risk indication, and the corresponding indication of the adverse events in the non-high-risk set is a non-high-risk indication.

The medication process monitoring and early warning module comprises: (1) the grading early warning sub-module is used for outputting early warnings of different grades for the monitored suspected adverse drug events, the medication errors to be generated and the medication errors to be generated; (2) the medical advice medication monitoring submodule is used for checking medication errors when the medical advice medicines are prescribed but not executed, and carrying out preventive early warning on the medication errors to be generated; (3) the high-risk medication monitoring submodule is used for monitoring and early warning high-risk medication; (4) the non-high-risk medication monitoring submodule is used for monitoring and early warning non-high-risk medication;

the grading early warning sub-module grading early warning mechanism is as follows: dividing the monitored medication risk information into the following items according to the risk grade from high to low: the first-class event, the second-class event, the third-class event, the fourth-class event and the fifth-class event respectively output a black early warning, a red early warning, an orange early warning, a yellow early warning and a blue early warning correspondingly;

wherein the event of the type comprises: (1) an impending medication error, (2) a medication error that has occurred but has not been intervened, (3) a medication error that has occurred but has not been reversed; outputting black early warning for a type of event, and prompting a doctor to intervene in time;

the two types of events include: adverse events within the high risk set may occur and be in an unpredicted state; for the second kind of events, red early warning is output to prompt a doctor to intervene timely and continuously;

the three types of events include: it is possible that adverse events within the high risk set have intervened but not reversed; for the three types of events, orange early warning is output to prompt a doctor to continuously intervene;

the four types of events include: non-high risk intra-set adverse events are likely to occur; outputting yellow early warning for the four types of events, and recommending a doctor to intervene;

the five types of events include: adverse events within non-high risk sets may occur; outputting blue early warning for the five types of events, and recommending doctors to carry out enhanced observation;

the medical advice medication monitoring submodule is used for monitoring medication of a patient medical advice in real time, inputting the name, the dosage and the medication route of the medicine to be administered to a medication error monitoring module for the medicine to be administered, judging whether medication errors exist, if so, outputting black early warning by the association grading early warning submodule, and warning the medication errors until the medication error medical advice is cancelled;

when the fact that the patient uses the medicine is monitored, whether the medicine used by the patient under the current physical condition is high-risk medicine or not is judged according to a high-risk medicine list of the patient; if the high-risk medication belongs to the high-risk medication, monitoring based on a high-risk medication monitoring submodule, and if the high-risk medication does not belong to the high-risk medication, monitoring based on a non-high-risk medication monitoring submodule;

the high-risk medication monitoring submodule is adopted for processing, and specifically comprises the following steps: monitoring the information of the treatment process of the patient in the medical record module for hospitalization and outpatient service based on the adverse event monitoring parameters; after the positive indication is monitored, firstly, inputting the medicine name, the dosage range and the administration route of the used medicine into an administration error monitoring module, and checking administration errors; if the medication error exists, the correlated grading early warning module continuously outputs black early warning according to a type of event to prompt that the medication error occurs, pushes the ADE/ME intervention means set of the medicine to doctors and pharmacists, and eliminates early warning after the follow-up monitoring shows that the intervention is performed and the monitored positive indication turns into negative;

positive indications are clinical performance indications or laboratory examination indications corresponding to adverse events;

the high-risk medication monitoring submodule comprises a high-risk indication monitoring and early warning sun module and a non-high-risk indication monitoring and early warning sun module; after medication errors are eliminated, judging whether the monitored positive indications have high-risk indications or not; if the high-risk indication exists, monitoring and early-warning by a high-risk indication monitoring and early-warning sun module in the high-risk medication monitoring sub-module, and if the positive indications are non-high-risk indications, monitoring and early-warning sun module in the high-risk medication monitoring sub-module;

the non-high-risk medication monitoring submodule is used for processing, and specifically, the information of the treatment process of the patient in the medical record module of the hospitalization and the outpatient clinic is monitored based on the adverse event monitoring parameter; after the positive indication is monitored, firstly, inputting the medicine name, the dosage range and the administration route of the used medicine into an administration error monitoring module, and checking administration errors; if the medication error exists, the correlated grading early warning module continuously outputs black early warning according to a type of event to prompt that the medication error occurs, pushes the ADE/ME intervention means set of the medicine to doctors and pharmacists, and eliminates early warning after the follow-up monitoring shows that the intervention is performed and the monitored positive indication turns into negative;

the non-high-risk medication monitoring submodule comprises a high-risk indication monitoring and early warning sun module and a non-high-risk indication monitoring and early warning sun module; after medication errors are eliminated, whether high-risk indications exist in the monitored positive indications is judged, if the high-risk indications exist, monitoring is carried out based on a high-risk indication monitoring and early warning sun module in a non-high-risk medication monitoring sub-module, and if the monitored positive indications are all non-high-risk indications, monitoring is carried out based on a non-high-risk indication monitoring and early warning sun module in a non-high-risk medication monitoring sub-module;

in the high-risk medication monitoring submodule and the non-high-risk medication monitoring submodule, the high-risk indication monitoring and early warning sun module processes the following steps: after the high-risk indication is monitored to be positive, the correlated grading early warning module carries out early warning according to the second type of event, continuously outputs red early warning to prompt doctors and pharmacists that adverse events in a high-risk set of medicines possibly occur and intervention is needed, pushes an ADE/ME intervention means set of the medicines to the doctors and the pharmacists, degrades the medicine to be the third type of event after the follow-up monitoring of the positive parameters of the medicine intervention means is carried out, continuously outputs orange early warning until the indication is monitored to be negative, and eliminates early warning;

the non-high-risk indication monitoring and early-warning sun module in the high-risk medication monitoring submodule and the non-high-risk medication monitoring submodule performs processing: when the monitored positive indications are all non-high-risk indications, judging conditions 1 and 2 respectively to obtain early warning levels, and outputting early warning according to the highest early warning level obtained by judging the conditions 1 and 2;

condition 1: in a time window t1 with a certain length after medication, non-high-risk indicators corresponding to k adverse events are monitored to be positive at the same time;

if k is more than 0 and less than or equal to n, a few non-high-risk indication parameters are concurrent and positive within a certain time period after the medicine is taken, and blue early warning is continuously output to remind doctors to observe according to five types of event early warning;

if k is larger than n, the multiple non-high-risk indication parameters are concurrent and positive within a certain time period after the medicine is taken, the correlated grading early warning module outputs yellow early warning continuously according to four types of event early warning, and an ADE/ME intervention means set of the medicine is pushed to doctors and pharmacists to recommend intervention;

the n is a sensitivity concurrency threshold value in non-high-risk finger monitoring and early warning;

condition 2: after administration, there were at least 1 non-high risk indications persistently positive within time T;

if T is greater than q, namely at least 1 long-time continuously positive non-high-risk indication exists after the medicine is used, yellow early warning is continuously output according to four types of event early warning, an ADE/ME intervention means set of the medicine is pushed to a doctor and a pharmacist, and intervention is recommended;

if T is less than q, namely after the medicine is used, at least 1 non-high-risk indication which is continuously positive for a short time exists, early warning is carried out according to five types of events, blue early warning is continuously output, and doctors are reminded to observe;

the q is a sensitivity time threshold in non-high-risk finger monitoring and early warning;

a non-high-risk indication monitoring sun module sensitivity concurrent threshold and a sensitivity time threshold in the high-risk monitoring submodule are respectively n1 and q 1;

a non-high-risk indication monitoring sun module sensitivity concurrent threshold and a sensitivity time threshold in the non-high-risk monitoring sub-module are n2 and q2 respectively;

wherein n1< n2, q1< q 2; the high-risk medication monitoring submodule is more sensitive than the non-high-risk medication monitoring submodule in monitoring and early warning of non-high-risk indications.

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 positive indications and early warns medication errors or possible adverse events, the medication error reporting module and the adverse event reporting module respectively report the medication errors and the adverse events actively;

the adverse event reporting module is used for: determining the relevance between the adverse event and suspicious drugs causing the adverse event based on the treatment process information before and after the positive adverse event indication of the patient occurs so as to realize accurate graded reporting of the adverse event; three days before and after the positive adverse event indication of the patient appears;

the adverse event reporting module comprises: the system comprises a relevance scoring module, a relevance grading module, a suspicious drug relevance ranking module and a report generating module; the relevance scoring module is used for scoring the relevance between the suspected medicine causing the adverse event and the adverse event; the relevance grading module divides the relevance of the suspicious drug and the adverse event into the following parts according to the score output by the relevance grading module: four levels of affirmation, high possibility, possibility and suspicion are carried out so as to be reported in a grading way; the suspicious drug relevance ranking module is used for carrying out relevance ranking on suspicious drugs which possibly generate the same adverse events under the condition of multi-drug combination, and assisting doctors to determine the main cause of the adverse events;

the relevance scoring module scores multiple suspicious drugs corresponding to the positive indications item by item according to the following scoring items based on the treatment process information of the patients in the in-patient and out-patient medical record recording module, and sums the scoring items to obtain relevance scores of adverse drug events caused by the suspicious drugs; the scoring items include:

whether the adverse events corresponding to the score item 1 and the positive indications belong to the definite adverse events of the medicines or not is judged, if so, 1 score is obtained, if not, 0 score is obtained,

the scoring item 2, whether the positive indication is monitored after the administration, if so, the score is 2, if not, the score is-1, if not, the score is 0,

scoring item 3, whether the adverse event indication turns negative after stopping taking or taking the rescue drug, if yes, scoring 1, if no, scoring 0,

scoring item 4, stopping taking the medicine for a period of time, and taking the medicine again, if the adverse event indication is positive, then obtaining score 2, if the adverse event indication is negative 1, if the adverse event indication is unknown, then obtaining score 0,

score 5, whether there are other factors that give rise to a positive indication of the adverse event, if a score of-1 is obtained, if a score of 2 is obtained, if a score of 0 is not known,

the scoring item 6, whether the concentration of the medicine in the body of the patient exceeds the toxic dose, if so, 1 score is obtained, if not, 0 score is obtained,

the score item 7, whether the severity of the adverse event indication is positively correlated with the dosage of the medicament, if so, 1 score is obtained, if not, 0 score is not known,

a scoring item 8, whether the patient has a history of adverse events for the drug or similar drugs, if so, a score of 1 is obtained, if not, a score of 0 is obtained, and if not, a score of 0 is obtained;

the relevance grading module divides the relevance of the suspicious drug and the adverse event into the following parts according to the scoring result of the relevance grading module: four levels of affirmation, high possibility, possibility and suspicion;

adverse event C for positive indications and suspected drug Msi that may cause adverse event C:

if the relevance score is greater than or equal to 7 points, the relevance grade of the medicine Msi and the adverse event C is considered to be positive;

if the relevance score is 4-6, the relevance of the medicine Msi and the adverse event C is considered to be high in degree possibly;

if the relevance score is 1-3, the relevance grade of the medicine Msi and the adverse event C is considered to be possible;

if the relevance score is less than 1 point, the relevance grade of the medicine Msi and the adverse event C is considered to be suspicious;

the suspicious drug relevance ranking module is used for carrying out relevance ranking on suspicious drugs which possibly generate the same adverse events under the condition of using multiple drugs together; for adverse events corresponding to the positive indications, all drugs which possibly cause the adverse events in the medication records of the patients form a suspicious drug list, and the drugs are sorted according to the relevance scoring results of the drugs in the suspicious drug list to form a suspicious drug relevance ranking list; the information in the list of the relevance ranking of the suspicious drugs comprises the names of the suspicious drugs, the relevance score of the suspicious drugs and the adverse events, the relevance grade of the suspicious drugs and the adverse events corresponding to the positive indications; the suspicious drug relevance ranking list is arranged in a descending order according to the relevance score value and is pushed to a clinician, so that the clinician is assisted to make next medication or treatment decision in a targeted manner;

and the report generation module forms a drug adverse event report according to the classification result of the relevance classification module, the relevance ranking list of the suspicious drugs and the treatment process information of the patients related to adverse events in the medical record module for hospitalization and outpatient service, and inputs the drug adverse event report into the ADE/ME report management module.

The medication error reporting module is used for reporting the occurred medication errors; when the medication process monitoring and early warning module monitors positive indications and a medication error event is judged by the medication error monitoring module, the medication error reporting module generates a medication error report based on the patient treatment process information of the in-patient and out-patient medical record recording module and inputs the medication error report into the ADE/ME report management module;

the medication error report includes: the occurrence time of medication errors, the medication errors relate to medicines, the content of the medication errors, and the condition of harm to patients caused by the medication errors;

the ADE/ME report management module reports the administration error report to a food and drug adverse event monitoring center or a drug-induced disease monitoring network;

the statistical module is used for summarizing the drug adverse event report and the medication error report reported by the ADE/ME report management module and providing basic clinical data for statistical analysis of the drug adverse event and the medication error.

Compared with the prior art, the invention has the beneficial effects that:

(1) for monitoring the drug-induced diseases, the invention monitors the drug-induced risk information appearing in the treatment process information of the patient in real time, and carries out early warning in time and actively reports adverse drug events and drug errors, namely, the early warning is carried out after treatment, and the active reporting is carried out when voluntary reporting is carried out after the treatment, so that the clinical drug risk management and control are effectively enhanced.

(2) The potential medication risk module integrates medication risk information obtained in real time according to documents, consultation and specifications by using a standardized data table aiming at each medicine, is convenient for retrieval by using medicine information or patient physical condition information as an index entry during clinical medication, and quickly inquires medication risk. When a drug potential risk model is constructed, risk classification is carried out based on physical condition information and adverse event severity of a patient, and subsequent drug administration risks are conveniently subjected to hierarchical management and control. Meanwhile, the module can be updated along with the literature knowledge base, the information knowledge base and the medicine specification, so that the accuracy of the medication risk information is ensured.

(3) The invention forms two stages of prevention and control in advance for the medicine taking risk which can be prevented and controlled, wherein the first stage of prevention and control is as follows: when the medical advice does not occur, the patient medication risk prompting module pushes medication cautionary items including the currently forbidden medication of the patient and the high-risk medication list to a doctor in charge in real time according to the current physical condition of the patient, and the doctor is accurately reminded of the current medication risk of the patient. The second-level prevention and control is as follows: the patient's medical advice monitoring module of using medicine carries out the preventive investigation of wrong incident of using medicine promptly before the execution of medicine of using medicine advice medicine, and the very first time suggestion clinician, pharmacist patient are about to take place the mistake of using medicine, accomplish the intervention in advance.

(4) The invention is provided with a special medication error monitoring module to prevent medication errors in the whole process before and during medication. Preferably, before medication, the medication error monitoring module checks medication errors in the planned execution medical orders, during the whole monitoring process, medication error events are checked in real time based on positive indications, early warning is output according to the highest sensitivity and the highest risk level, doctors are prompted to intervene in the occurred medication errors at the first time, and the harmfulness of the occurred medication errors is effectively controlled.

(5) The invention is respectively provided with a medication process monitoring and early warning module and an active reporting module, thereby solving the contradiction between early warning timeliness and reporting accuracy. And the medication process monitoring and early warning module immediately outputs early warnings of different grades according to different danger degrees after monitoring the positive indication, and prompts a doctor to pay attention to observation or intervene. And after the early warning occurs, the active reporting module traces back forwards and continues monitoring backwards based on the treatment process information of the patient, automatically searches clinical evidence and determines the relevance of adverse events and suspicious drugs so as to realize accurate reporting.

(6) The medicine taking process monitoring and early warning module carries out differential risk early warning according to the danger degree of the positive indication. And a high-sensitivity and high-risk-level early warning mode is adopted for high-risk indications, and positive parameters, namely early warning, are present, and intervention is forcibly required, so that the harm caused by adverse events is reduced to the maximum extent.

(7) According to the medicine taking process monitoring and early warning module, for non-high-risk indications, the threshold value is set, the early warning sensitivity degree and the risk level are adjusted, and on the premise that the early warning effect is guaranteed, the interference of excessive high-risk level early warning on clinical medicine taking is avoided. And a mode of setting an observation time window is adopted, concurrent and continuous positive indications in the time window are captured, the early warning level is upgraded in time to prompt highly suspected adverse events, and early active early warning of the adverse events is realized.

(8) According to the invention, the early warning sensitivity of the non-high-risk indication early warning sun module in the high-risk medication submodule and the non-high-risk medication monitoring submodule is set in a differentiated manner. The early warning prompt is carried out at the initial stage of centralized and continuous occurrence of non-high-risk indications when the high-risk medicine is used for the high-risk medicine with adverse events easy to deteriorate or rapidly develop. For non-high-risk medication, occurrence of non-high-risk indications is tolerated to a greater extent, unnecessary high-level early warning and intervention suggestions are avoided from influencing normal treatment medication, classified risk control of different risk medications is realized, and more targeted risk early warning is provided for clinical medication.

(9) The adverse event reporting module of the invention backtracks forwards and continues to monitor the treatment process information of the patient backwards according to the positive indications monitored by the medication process monitoring and early warning module, and searches clinical evidence of adverse events caused by suspicious drugs. The method integrates various clinical evidences, determines the correlation between the positive indication of the adverse event and clinical medication based on objective scoring criteria, provides objective and uniform standard for reporting the adverse event, improves the accuracy of reporting the adverse event, and provides high-quality clinical sample data for supervision and research of the adverse event of the medicine.

(10) For the situation of multiple drugs with similar adverse events, the relevance ranking module of the suspicious drugs determines the main pathogenic drugs of the adverse events based on the relevance ranking, and provides accurate reference for clinical medication.

Description of the drawings:

FIG. 1 shows the working processes of a medication process monitoring and early warning module and an adverse event reporting module in an intelligent monitoring module;

FIG. 2 shows a monitoring and early warning module for monitoring the medication process for different risks

FIG. 3 shows the internal working logic of the high-risk medication monitoring submodule and the non-high-risk medication monitoring submodule.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings. It is to be understood that the embodiments described are only a few embodiments of the present invention, and not all embodiments.

Thus, the following detailed description of the embodiments of the invention is not intended to limit the scope of the invention as claimed, but is merely representative of some embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

It should be noted that the embodiments of the present invention and the features and technical solutions thereof may be combined with each other without conflict.

It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.

In the description of the present invention, it should be noted that the terms "upper", "lower", and the like refer to orientations or positional relationships based on those shown in the drawings, or orientations or positional relationships that are conventionally arranged when the products of the present invention are used, or orientations or positional relationships that are conventionally understood by those skilled in the art, and such terms are used for convenience of description and simplification of the description, and do not refer to or imply that the devices or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like are used merely to distinguish one description from another, and are not to be construed as indicating or implying relative importance.

An active monitoring and reporting system for drug-induced diseases comprises: the system comprises a drug-induced disease knowledge base, an in-patient and out-patient medical record recording module, an intelligent monitoring module, an ADE/ME report management module and a statistical module.

The drug-induced disease knowledge base is used for providing drug use risk information and comprises a literature knowledge base, an information knowledge base, a drug specification database and a potential drug use risk module.

The in-patient and out-patient medical record recording module is used for recording and storing the treatment process information of the patient, and comprises the following components: the patient is in the information of medication and medication, the examination and examination record of outpatient or hospitalization, the doctor's order and prescription record of outpatient or hospitalization.

The intelligent monitoring module acquires medication risk information from the drug-induced disease knowledge base according to the medication condition of a patient, acquires treatment process information of the patient from the in-patient and out-patient medical record recording module, monitors the medication risk information appearing in the treatment process information of the patient in real time, and carries out real-time early warning and active reporting on adverse events and medication errors of drugs. The medication risk information is information closely related to adverse events or medication errors of the medicine, and the medication risk information comprises medication risk information corresponding to the medicine and medication risk information corresponding to the patient. The active reporting operation at least comprises: when a drug adverse event occurs, the intelligent monitoring module monitors that drug administration risk information immediately warns, and based on the treatment process information of the patient, the intelligent monitoring module backtracks forwards and continues to monitor backwards, and actively reports the drug adverse event after determining the relevance between the adverse event and the suspicious drug.

And the ADE/ME report management module generates a standard report in a drug adverse event form or a drug administration error form according to active report and manual audit output by the intelligent monitoring module and reports the standard report to a food and drug adverse event monitoring center or a drug-induced disease monitoring network.

And the statistical module is used for summarizing the adverse event report and the medication error report which are finally reported by the ADE/ME report management module.

Compared with the prior art, the invention has the beneficial effects that: for monitoring the drug-induced diseases, the invention monitors the drug-taking risk information appearing in the treatment process information of the patient in real time, and timely warns and actively reports adverse events and drug-taking errors of the drugs. The early warning is changed from post treatment to pre-warning, and the active reporting is changed from voluntary reporting to occurrence, so that the clinical medication risk management and control are effectively enhanced.

Preferably, in the drug-induced disease knowledge base, the literature knowledge base includes columns for drug safety and adverse events in various pharmaceutical and clinical medicine academic journals, the information knowledge base includes a drug adverse event database in a drug supervision and management website, and the drug instruction database includes columns for attention items, risk warning frames and adverse events in various drugs including instructions. The potential medication risk module is used for integrating medication risk information corresponding to each medicine in the literature knowledge base, the information knowledge base and the medicine specification database by using a standardized data table. The medication risk information corresponding to each medicine comprises the following sub-items: contraindications, dosage range and administration route corresponding to each drug, adverse event set, ADE/ME intervention means set, high risk group and high warning drug attribute.

And the adverse event set is divided into a high-risk set and a non-high-risk set according to the critical degree of the consequence. The division criterion is as follows:

the high risk set includes serious drug adverse events, life threatening drug adverse events. Preferably, the adverse event of the life-threatening drug is life-threatening to the patient and requires urgent treatment. The severe drug adverse event results in a prolonged or prolonged hospitalization of the patient, reducing the patient's ability to self-care.

The non-high risk group includes mild adverse events, moderate adverse events. Preferably, the mild adverse event is an asymptomatic, mild, non-treatment requiring adverse event. The moderate adverse event is an adverse event requiring minor, topical or non-invasive treatment.

The set of ADE/ME interventions includes the administration of drug withdrawal, decrement, or rescue medication for adverse events or medication errors.

The high alert drug attribute characterizes whether the drug belongs to a high alert drug. The high warning medicines are medicines which are high in medicine toxicity and easy to cause serious adverse events, and all the high warning medicines form a high warning medicine list.

The potential medication risk module inputs the name of the medicine, so that medication risk information corresponding to the medicine can be output, and the method comprises the following steps: contraindications, dosage range and administration route corresponding to the medicine, adverse event set, ADE/ME intervention means set, high risk group and high warning medicine attribute.

After the current physical condition information of the patient is input, the potential medication risk module outputs medication risk information corresponding to the patient, and the medication risk information comprises: a list of forbidden medications and a list of high-risk medications for the patient under the current physical condition. The forbidden drug list includes drugs that the patient is forbidden to use under the current physical condition determined according to the forbidden items of each drug. The high risk medication list for the patient includes: the high-risk population sub-item comprises the medicine of the patient and high-warning medicines outside the forbidden medicine list of the patient. And the high warning medicines except the forbidden medicines of the patient are obtained by making a difference between a high warning medicine list and the forbidden medicine list of the patient.

Watch (A)

Normalized form examples in a potential medication risk module

Medicine and food additive Name (R)

Forbidden item

Gao Feng People group

The dosage range of the compound is within the range of, route of administration

Non-dangerous collector

High-risk collector

ADE/ME Stem Set of forecasting methods

High warning Medicine belongs to Property of (2)

Hua Fang Forest (forest)

Liver and kidney function Can damage, Severe high Blood pressure and coagulation Blood function Disorder partner With bleeding Tendency and activity Mobility ulceration External ulcer Injury and premonitory organ Abortion and myopia Surgical operation The user is disabled to use the device, in gestation period Disable

Old age Human or Menstruation period Girl in the morning Property of (2)

Orally administered to adults The common usage amount is as follows: mosquito-repellent incense Non-impact therapy 1 st to 3 rd of oral administration 3-4 mg a day (old and infirm) And diabetes patients Half amount is And can) after 3 days Can give maintenance amount A day 2.5E 5mg (can refer to Blood coagulation time regulation The whole dose makes INR value up to 2 ℃ 3）

Ecchymosis and purple Vitiligo and gingiva Bleeding and nasal obstruction Non-traumatic and traumatic injuries Bleeding channel The disease can not be cured for a long time, amount of menstruation Excessive, aversion to Heart or vomiting Vomiting and abdomen Diarrhea and pruritus The skin rash caused by sex disease is shown, urinary system Promoting digestion Light system Severe hemorrhage

Bilateral breast necrosis Death and microangiopathy Or hemolytic anemia Blood and large range Gangrene around the skin, Hematoma of intestinal wall, ya The acute intestinal obstruction is caused by the intestinal obstruction, subdural intracranial Hematoma and urinary system Digestive system Moderate and severe acute gastritis Blood, INR>3

Decrease and stop Medicine and intravenous injection vitamin Biotin K

Is that

Bluo Fenfen (aromatic hydrocarbon)

Pair of toasts Forest or its Tafinasteride Medicine for treating body disease Yan Yao Ji (medicine for treating inflammation) The sensitive person is to The product can With a cross Allergy to Aspirin Forest allergy Of asthma The pregnant woman And breast-feeding Term women

Gastrointestinal tract Disease and disorder Patient's health

The dosage for adult Is administered orally. (1) Resist against Rheumatism for once 0.4g～ 0.6g, 3 days 4 class wind Wet arthritis ratio For osteoarthritis The amount is larger. (2) Light or medium Pain and aches The pain of the patient is relieved by the menstruation, once 0.2g & 0.4g, every 4 ℃ Once for 6 hours. The dosage for adults is the most A large amount of general Is administered every day 2.4 g. 2. Small Common metering orifice for children It is administered orally. Each time pressing Body weight 5mg/kg ～10mg/kg， 3 times a day

Alimentary canal Symptom bag Digestion by rubbing Stomach and stomach trouble Burning sensation, Stomach-ache and nausea Heart or vomiting Vomiting and gastric ulcer Ulcer and head Pain and addiction to disease Sleep and dizziness Dizziness and tinnitus

The perforation of the ulcer is carried out, impairment of liver and kidney function Harmfulness, gastrointestinal bleeding

Decrease and stop Medicine,

Whether or not

Compared with the prior art, the invention has the beneficial effects that: the potential medication risk module integrates medication risk information obtained according to documents, information and specifications by using a standardized data table aiming at each medicine. When clinical medication is convenient, drug information or patient physical condition information is used as an index entry for retrieval, and medication risk is quickly inquired. When a drug potential risk model is constructed, risk classification is carried out based on physical condition information and adverse event severity of a patient, and subsequent drug administration risks are conveniently subjected to hierarchical management and control. Meanwhile, the module can be updated along with the literature knowledge base, the information knowledge base and the medicine specification, so that the accuracy of the medication risk information is ensured.

The intelligent monitoring module comprises: (1) and the patient medication risk prompting module is used for analyzing the potential medication risk of the patient according to the physical condition of the patient before medication, and prompting the risk in advance of medication. (2) A medication error monitoring module for: the method monitors the medication errors to be generated and the medication errors to be generated in the whole process of the medication of the patient. (3) A monitoring parameter construction module for: and determining the monitoring parameters of the adverse drug events according to the clinical performance indication of the adverse drug events, the laboratory examination indication and the intervention means of the adverse drug events. (4) The medicine process monitoring and early warning module is used for: monitoring the treatment process information of the patient, and carrying out grading early warning on adverse events and medication errors of the medicine. (5) And the active reporting module is used for determining the relevance between the adverse drug events and the suspicious drugs and actively reporting the adverse drug events and the medication errors.

The patient medication risk prompting module extracts information closely related to the physical condition of the analyzed patient from the in-patient and out-patient medical record recording module in real time, and comprises the following steps: basic disease information, age information, sex information, liver function information, kidney function information, pregnancy information, allergy medicine information, and operation history information, and forms the current physical condition information of the analyzed patient. And inputting the physical condition information into a potential medication risk module to obtain a currently forbidden medication list and a high-risk medication list of the patient. During the treatment of the patient, the current forbidden drug list and the high-risk drug list are updated in real time along with the change of the treatment process information of the patient in the in-patient and out-patient medical record module, the latest current forbidden drug list and the latest high-risk drug list of the patient are formed, and the current forbidden drug list and the latest high-risk drug list are sent to a doctor in charge and a pharmacist in the form of drug attention items to serve as clinical drug references.

Example 1: for patients older than 65 years with a history of falls or fractures, the high risk medication list includes: midazolam, sulindac, alprazolam, diazepam, nitrazepam, clonazepam, lorazepam, sulpiride, flupentixol, melitracen, risperidone, clozapine, and droperidol.

The list of contraindicated drugs comprises the following traditional Chinese medicines: sulpiride, flupentixol, melitracen, risperidone, clozapine, and flupiride. The list may be sent to a patient supervisor physician to remind of medication risks.

Example 2: when the patient in example 1 had new heart failure symptoms, the new drugs in the contraindicated list of patients would include: cilostazol, and non-steroidal anti-inflammatory drug.

Compared with the prior art, the invention has the beneficial effects that: the patient medication risk prompting module can output the latest forbidden medicine list and the high-risk medication list based on the real-time physical condition of the patient, and sends the forbidden medicine list and the high-risk medication list to a doctor and a pharmacist in charge in a medication attention list form, so that accurate and timely reference is provided for clinical medication, and first-level prior risk prevention and control is formed.

And the medication error monitoring module is used for judging whether the current medication of the patient is wrong. Preferably, for the currently used medicine of the patient, whether the medicine belongs to the contraindicated medicine of the patient is judged according to the currently forbidden medicine list of the patient output by the patient medicine risk prompting module. Inputting the medicine into the potential medication risk module, comparing the dosage range and the administration route of the current medication of the patient with the dosage range and the administration route corresponding to the medicine in the potential medication risk module, and judging whether the dosage range and the administration route of the medicine are correct or not. If the medicine belongs to contraindications of patients, or the dosage range and the administration route of the medicine are incorrect, medication errors exist, otherwise, the medication errors do not exist.

The medication error monitoring module can be called at any time in the whole medication process, and medication errors can be rapidly checked, so that the medication errors can be strictly prevented in the whole medication process.

The monitoring parameter construction module is used for constructing adverse event monitoring parameters before executing medical advice medication so as to carry out targeted monitoring on medication risk information appearing in the patient treatment process information in the medication process, and the patient treatment process information is obtained from the in-patient and out-patient medical record recording module. Preferably, the to-be-executed medical orders and medicines are input into the potential medication risk module, and adverse event sets and ADE/ME intervention means sets corresponding to the medicines are extracted. And constructing adverse event monitoring parameters based on the adverse event set and the ADE/ME intervention means set, wherein the adverse event monitoring parameters comprise adverse event indication parameters and adverse event intervention means parameters. The adverse event indicator parameters include: clinical performance indicators corresponding to adverse events, laboratory examination indicators corresponding to adverse events. The intervention modality parameters include a deactivation of the prescribed medication to be administered, a decrement, and an administration of a rescue medication of the prescribed medication to be administered. The adverse event indicators are divided into high-risk indicators and non-high-risk indicators. The corresponding indication of the adverse events in the high-risk set is a high-risk indication, and the corresponding indication of the adverse events in the non-high-risk set is a non-high-risk indication.

Example 3: adverse events in the adverse event set of ibuprofen included: liver injury, the liver injury-related adverse event parameters include: (1) ALT > 40U/L (upper limit of normal), TB > 1 × ULN (upper limit of normal) were tested 2 consecutive times, and (2) ALT > 2 × ULN (2 times upper limit of normal), TB > 2 × ULN (upper limit of normal) were tested one time. ADE/ME intervention parameters for ibuprofen-induced liver injury include: (1) the non-use or reduction of ibuprofen, (2) the administration of glutathione, tiopronin, glycyrrhizic acid preparation, polyene phosphorylcholine.

The medication process monitoring and early warning module comprises: (1) and the grading early warning sub-module is used for outputting early warnings of different grades for the monitored suspected adverse drug events, the medication errors to be generated and the medication errors to be generated. (2) And the medical advice medication monitoring submodule is used for checking medication errors when the medical advice medicines are not executed after being prescribed, and carrying out preventive early warning on the medication errors to be generated. (3) And the high-risk medication monitoring submodule is used for monitoring and early warning high-risk medication. (4) And the non-high-risk medication monitoring submodule is used for monitoring and early warning non-high-risk medication.

The grading early warning sub-module grading early warning mechanism is as follows: dividing the monitored medication risk information into the following items according to the risk grade from high to low: the first-class event, the second-class event, the third-class event, the fourth-class event and the fifth-class event respectively output a black early warning, a red early warning, an orange early warning, a yellow early warning and a blue early warning correspondingly.

Wherein the event of the type comprises: (1) an impending medication error, (2) a medication error that has occurred but has not been intervened, (3) a medication error that has occurred but has not been reversed. And outputting black early warning for a type of event to prompt a doctor to intervene in time.

The two types of events include: adverse events within the high risk set may occur and be in an unpredicted state. And for the second type of events, red early warning is output to prompt a doctor to intervene timely and continuously.

The three types of events include: it is possible that adverse events within the high risk set have intervened but not reversed. For the three types of events, an orange warning is output, prompting the physician that continuous intervention is necessary.

The four types of events include: non-high risk intra-set adverse events are likely to occur. And outputting yellow early warning for the four types of events, and recommending a doctor to intervene.

The five types of events include: adverse events within the non-high risk set may occur. Blue warnings were output for five types of events, suggesting the physician to strengthen the observation.

The medical advice medication monitoring submodule is used for monitoring medication of a patient medical advice in real time, inputting the name, the dosage and the medication route of the medicine to be subjected to the medical advice to a medication error monitoring module for the medicine to be subjected to the medical advice, judging whether medication errors exist, if so, outputting black early warning by the association grading early warning submodule, and warning the medication errors until the medication error medical advice is cancelled.

Compared with the prior art, the invention has the beneficial effects that: the medical advice medication monitoring submodule performs preventive investigation on medication error events before medication advice medicine execution, prompts a clinician and a pharmacist for a patient to be about to have medication errors at the first time when medication advice is provided, performs prior intervention, and forms second-level pre-risk prevention and control.

And when the fact that the patient uses the medicine is monitored, judging whether the medicine used by the patient under the current physical condition is high-risk medicine or not according to a high-risk medicine list of the patient. If the high-risk medication belongs to high-risk medication, monitoring is carried out based on the high-risk medication monitoring submodule, and if the high-risk medication does not belong to high-risk medication, monitoring is carried out based on the non-high-risk medication monitoring submodule.

The high-risk medication monitoring submodule is adopted for processing, and specifically comprises the following steps: based on the adverse event monitoring parameters, the patient treatment process information in the in-patient and out-patient medical record modules is monitored. After the positive indication is monitored, the name, the dosage range and the administration route of the used medicine are input into the administration error monitoring module to check administration errors. And if the medication error exists, the correlated grading early warning module continuously outputs black early warning according to a type of event to prompt that the medication error occurs, pushes the ADE/ME intervention means set of the medicine to doctors and pharmacists, and eliminates early warning after the follow-up monitoring shows that the intervention is performed and the monitored positive indication turns into negative.

Preferably, a positive indication is a clinical performance indication or laboratory test indication corresponding to an adverse event.

The high-risk medication monitoring submodule comprises a high-risk indication monitoring and early warning sun module and a non-high-risk indication monitoring and early warning sun module. And after the medication error is eliminated, judging whether the monitored positive indications have high-risk indications. If the high-risk indication exists, monitoring is carried out based on a high-risk indication monitoring and early warning sun module in the high-risk medication monitoring sub-module, and if the positive indications are non-high-risk indications, monitoring is carried out based on a non-high-risk indication monitoring and early warning sun module in the high-risk medication monitoring sub-module.

The non-high-risk medication monitoring submodule is used for processing, and specifically, the information of the treatment process of the patient in the medical record module of the in-patient and out-patient is monitored based on adverse event monitoring parameters. After the positive indication is monitored, the name, the dosage range and the administration route of the used medicine are input into the administration error monitoring module to check administration errors. And if the medication error exists, the correlated grading early warning module continuously outputs black early warning according to a type of event to prompt that the medication error occurs, pushes the ADE/ME intervention means set of the medicine to doctors and pharmacists, and eliminates early warning after the follow-up monitoring shows that the intervention is performed and the monitored positive indication turns into negative.

The non-high-risk medication monitoring submodule comprises a high-risk indication monitoring and early warning sun module and a non-high-risk indication monitoring and early warning sun module. And after medication errors are eliminated, judging whether the monitored positive indications have high-risk indications, if so, monitoring based on a high-risk indication monitoring and early warning sun module in the non-high-risk medication monitoring submodule, and if the monitored positive indications are all non-high-risk indications, monitoring based on a non-high-risk indication monitoring and early warning sun module in the non-high-risk medication monitoring submodule.

Compared with the prior art, the invention has the beneficial effects that: and (3) carrying out classified risk monitoring on adverse drug use events according to the degree of harm, carrying out real-time troubleshooting on drug use error events based on positive indications in the whole monitoring process, outputting early warning according to the highest sensitivity and the risk grade, prompting a doctor to intervene on the occurred drug use errors at the first time, and effectively controlling the degree of harm of the occurred drug use errors.

In the high-risk medication monitoring submodule and the non-high-risk medication monitoring submodule, the high-risk indication monitoring and early warning sun module processes the following steps: and after the high-risk indication is monitored to be positive, the correlated grading early warning module carries out early warning according to the second type of event, continuously outputs red early warning to prompt doctors and pharmacists that adverse events in the high-risk set of the medicine are possible to occur and intervention is required, pushes the ADE/ME intervention means set of the medicine to the doctors and the pharmacists, degrades the medicine into the third type of event after the follow-up monitoring of the positive parameters of the medicine intervention means, continuously outputs orange early warning until the indication is monitored to be negative, and eliminates early warning.

Example 4: for patient A, the patient A is older than 65 years and uses warfarin, and the high-risk medication list of patient A contains warfarin, which belongs to high-risk medication. The high-risk index parameters of warfarin include INR >3 and moderate gastrointestinal hemorrhage. ADE/ME intervention includes warfarin decrement, inactivation, use of vitamin K. When the INR >3 parameter is positive or the gastrointestinal moderate bleeding is monitored after the medicine is taken, the red early warning is continuously output. And then, when the warfarin is monitored to reduce the dose, the warfarin is stopped or the vitamin K is used, the INR >3 or the moderate bleeding of the digestive tract is still monitored, the orange early warning is continuously output until the INR >3 and the bleeding parameters are all negative, and the early warning is eliminated.

Compared with the prior art, the invention has the beneficial effects that: and carrying out differential risk early warning according to the risk degree of the positive indication, adopting an early warning mode with high sensitivity and high risk level for the high-risk indication, carrying out early warning when positive parameters exist, and forcibly requiring intervention, so that the harm caused by bad events is reduced to the maximum extent.

In the high-risk medication monitoring submodule and the non-high-risk medication monitoring submodule, the non-high-risk indication monitoring and early warning sun module processes: and when the monitored positive indications are all non-high-risk indications, judging conditions 1 and 2 respectively to obtain early warning grades, and outputting early warning according to the highest early warning grade obtained by judging the conditions 1 and 2.

Preferably, condition 1: within a time window t1 of a certain length after the administration, positive non-high-risk indications corresponding to k adverse events were simultaneously monitored.

If k is less than 0 and less than n, a few non-high-risk indication parameters are concurrent and positive within a certain time period after the medicine is taken, and blue early warning is continuously output according to five types of event early warning to remind doctors to pay attention to observation.

If k is larger than n, the multiple non-high-risk indication parameters are concurrent and positive within a certain time period after the medicine is taken, the correlated grading early warning module outputs yellow early warning continuously according to four types of event early warning, and an ADE/ME intervention means set of the medicine is pushed to doctors and pharmacists to recommend intervention.

And n is a sensitivity concurrency threshold value in non-high-risk finger monitoring and early warning.

Condition 2: there were at least 1 non-high risk indications consistently positive at time T after dosing.

If T is greater than q, namely at least 1 non-high-risk indication which is continuously positive for a long time exists after the medicine is used, yellow early warning is continuously output according to four types of event early warning, and the ADE/ME intervention means set of the medicine is pushed to doctors and pharmacists to suggest intervention.

If T is less than q, namely after the medicine is used, at least 1 non-high-risk indication which is continuously positive in a short time exists, and blue early warning is continuously output according to five types of event early warning to remind doctors to pay attention to observation.

And q is a sensitivity time threshold in non-high-risk finger monitoring and early warning.

And a non-high-risk indication monitoring grandchild module sensitivity concurrency threshold and a sensitivity time threshold in the high-risk monitoring submodule are n1 and q1 respectively.

And the sensitivity concurrency threshold and the sensitivity time threshold of the non-high-risk indication monitoring grandchild module in the non-high-risk monitoring submodule are n2 and q2 respectively.

Wherein n1< n2, q1< q 2. The high-risk medication monitoring submodule is more sensitive than the non-high-risk medication monitoring submodule in monitoring and early warning of non-high-risk indications.

Example 5: patient B, with a history of peptic ulcer, used the drug ibuprofen, and included ibuprofen in the high-risk medication list of patient B, which belongs to high-risk medication. Non-high-risk indications for ibuprofen include: nausea, vomiting, anorexia, dyspepsia, heartburn, and abdominal pain. High risk indicators of ibuprofen include: bleeding of the digestive tract. And a non-high-risk indication monitoring sun module sensitivity concurrency threshold and a sensitivity time threshold in the high-risk medication monitoring submodule are respectively n1=2 and q1=2 d. Within a certain time window after the medicine is taken, the patient is suffered from nausea, vomit, anorexia or abdominal pain for 3 days, and the grading early warning submodule outputs yellow early warning. In the subsequent medicine taking process, if the digestive tract bleeding parameters in the high-risk indication parameters are monitored to be positive, the digestive tract bleeding parameters are upgraded to red early warning to prompt a doctor to immediately intervene, if the ADE/ME intervention means parameters are monitored to be positive, the digestive tract bleeding parameters are reduced to orange early warning after the digestive tract bleeding parameters are monitored to be still positive, and continuous intervention is prompted until the digestive tract bleeding parameters are negative and the early warning is eliminated.

Example 6: patient C, who had no digestive tract disease, used ibuprofen, a non-high risk medication. Non-high-risk indications for ibuprofen include: nausea, vomiting, anorexia, dyspepsia, heartburn, and abdominal pain. A non-high-risk indication monitoring sun module sensitivity concurrent threshold and a sensitivity time threshold in the non-high-risk medication monitoring submodule are respectively as follows: n1=4, q1=5 d. In a certain time window after the medicine is taken, and in a certain time window after the medicine is taken, the patient is suffered from nausea, vomit, anorexia or abdominal pain for 3 days, the grading early warning submodule outputs blue early warning to remind a doctor to strengthen the observation.

Compared with the prior art, the invention has the beneficial effects that: for non-high-risk indications, the sensitivity and risk level of early warning are adjusted by setting a threshold value, and on the premise of ensuring the early warning effect, the interference of excessive high-risk level early warning on clinical medication is avoided. And a mode of setting an observation time window is adopted, concurrent and continuous positive indications in the time window are captured, the early warning level is upgraded in time to prompt highly suspected adverse events, and early active early warning of the adverse events is realized. The early warning sensitivity of the non-high-risk indication early warning sun module in the high-risk medication and non-high-risk medication monitoring sub-module is set in a differentiated mode, high-risk medication which is easy to deteriorate or rapidly develop adverse events is carried out, early warning prompt is carried out at the initial stage when the non-high-risk indications are concentrated and continuously appear, for the non-high-risk medication, the occurrence of the non-high-risk indications is tolerated to a large extent, the influence of unnecessary high-level early warning and intervention suggestions on normal treatment medication is avoided, classified risk control of different risk medications is achieved, and more targeted risk early warning is provided for clinical medication.

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 positive indications and early warns medication errors or possible adverse events, the medication error reporting module and the adverse event reporting module respectively report the medication errors and the adverse events of the drugs actively.

The adverse event reporting module is used for: based on the treatment process information before and after the positive adverse event indication of the patient appears, the relevance between the adverse event and the suspicious drug causing the adverse event is determined, so that the adverse event can be reported accurately and hierarchically. Preferably, the patient has three days before and after an indication of a positive adverse event.

The adverse event reporting module comprises: the system comprises a relevance scoring module, a relevance grading module, a suspicious drug relevance ranking module and a report generating module. The relevance scoring module is used for scoring the relevance between the suspected drug causing the adverse event and the adverse event. The relevance grading module divides the relevance of the suspicious drug and the adverse event into the following parts according to the score output by the relevance grading module: and 4, four levels of affirmation, high possibility, possibility and suspicion are carried out so as to carry out classified reporting. And the suspicious drug relevance ranking module is used for carrying out relevance ranking on suspicious drugs which possibly generate the same adverse events under the condition of multi-drug combination, and assisting a doctor to determine the main cause of the adverse events.

Preferably, the relevance scoring module scores multiple suspicious drugs corresponding to the positive indications item by item according to the following scoring items based on the patient treatment process information in the in-patient and out-patient medical record recording module, and sums to obtain the relevance scoring of the adverse drug events caused by the suspicious drugs. The scoring items include:

whether the adverse events corresponding to the score item 1 and the positive indications belong to the definite adverse events of the medicines or not is judged, if so, 1 score is obtained, if not, 0 score is obtained,

the scoring item 2, whether the positive indication is monitored after the administration, if so, the score is 2, if not, the score is-1, if not, the score is 0,

scoring item 3, whether the adverse event indication turns negative after stopping taking or taking the rescue drug, if yes, scoring 1, if no, scoring 0,

scoring item 4, stopping taking the medicine for a period of time, and taking the medicine again, if the adverse event indication is positive, then obtaining score 2, if the adverse event indication is negative 1, if the adverse event indication is unknown, then obtaining score 0,

score 5, whether there are other factors that give rise to a positive indication of the adverse event, if a score of-1 is obtained, if a score of 2 is obtained, if a score of 0 is not known,

the scoring item 6, whether the concentration of the medicine in the body of the patient exceeds the toxic dose, if so, 1 score is obtained, if not, 0 score is obtained,

the score item 7, whether the severity of the adverse event indication is positively correlated with the dosage of the medicament, if so, 1 score is obtained, if not, 0 score is not known,

and 8, judging whether the patient has a history of adverse events for the medicine or the similar medicines, if so, judging that the score is 1, if not, judging that the score is 0, and if not, judging that the score is 0.

The relevance grading module divides the relevance of the suspicious drug and the adverse event into the following parts according to the scoring result of the relevance grading module: four levels of certainty, high probability, possibility, and suspicion.

Adverse event C for positive indications and suspected drug Msi that may cause adverse event C:

if the relevance score is greater than or equal to 7 points, the relevance grade of the medicine Msi and the adverse event C is considered to be positive;

if the relevance score is 4-6, the relevance of the medicine Msi and the adverse event C is considered to be high in degree possibly;

if the relevance score is 1-3, the relevance grade of the medicine Msi and the adverse event C is considered to be possible;

and if the relevance score is less than 1 point, the relevance grade of the medicine Msi and the adverse event C is considered to be suspicious.

The suspicious drug relevance ranking module performs relevance ranking on suspicious drugs which possibly generate the same adverse events under the condition of multi-drug combination. For adverse event C corresponding to a positive indication, all drugs in the patient's medication record that may cause adverse event C constitute a suspect drug listMs={Ms₁,Ms₂,Ms₃,…,Ms_nAnd sorting according to the relevance scoring results of the medicines in the suspicious medicine list to form a suspicious medicine relevance ranking list. The information in the list of the relevance ranking of the suspicious drugs comprises names of the suspicious drugs, relevance scores of the suspicious drugs and adverse events, relevance grades of the suspicious drugs and the adverse events and adverse events corresponding to positive indications. The suspicious drug relevance ranking list is arranged in a descending order according to the relevance score value and is pushed to a clinician, so that the clinician is assisted to make next medication or treatment decision in a targeted manner.

Example 7: clinically, the allowable range of INR is 2-3, the INR value is higher than the range, patients are easy to bleed, and abnormal INR value is a known adverse event of warfarin.

For patient D, there was a history of adverse events of warfarin-induced bleeding, no gastrointestinal underlying disease, and no other drugs that are likely to cause bleeding. Patient D monitored INR =3.8 on day 7 after warfarin administration, with concomitant gastrointestinal bleeding, withheld and given a rescue medication vitamin K anticaking agent, day 14, monitored INR =2.1, with disappearance of gastrointestinal bleeding symptoms, warfarin administered at 90% of the initial dose on day 21, no bleeding initiated at day 28, monitored INR =3.2, continued warfarin administration at 80% of the initial dose, and monitored INR =2.5 on day 35.

TABLE 2 Association of patient D INR abnormalities with warfarin scoring sheet

	Description of patient Condition	Score of
			Score item 1	The INR abnormality indication is warfarinCertain adverse events	+1
Score item 2	INR abnormalities are detected after warfarin administration	+2
			Score item 3	INR returns to normal after stopping taking medicine and administering rescue-relieving medicine vitamin K anticaking agent	+1
Score item 4	Warfarin is taken again after a period of withdrawal, INR is again abnormal	+2
			Score item 5	The patient does not have other factors causing INR abnormality	+2
Score item 6	The concentration of the drug in the patient is unknown	0
			Score item 7	The INR value increases with warfarin dosage	+1
Score 8	The patient has a history of adverse events to warfarin and its congeners	+1

And if the relevance score of the warfarin for inducing the INR abnormity is 10 points and is more than 7 points, and the relevance grade is positive, the warfarin can be determined to induce the INR abnormity adverse event.

Example 8: gastrointestinal bleeding is one of the adverse events of the drug ibuprofen and warfarin.

For patient E, there was a history of peptic ulcer, no history of adverse events in the digestive tract caused by ibuprofen, patients started taking warfarin on day 1, patients took ibuprofen on day 3 to relieve joint pain, patients took ibuprofen on day 7 to relieve joint pain, patients discontinued ibuprofen, patients had symptoms of digestive tract bleeding on day 8, patients discontinued warfarin, patients had no bleeding on day 12, patients recovered the original dose of warfarin on day 20, and patients had digestive tract bleeding again on day 27.

TABLE 3 patient E gastrointestinal hemorrhage and warfarin relevance scoring Table

	Description of patient Condition	Score of
			Score item 1	Digestive tract bleeding is a clear adverse event of warfarin	+1
Score item 2	Gastrointestinal bleeding was monitored after warfarin administration	+2
			Score item 3	The warfarin is stopped, and the hemorrhagic symptoms of the digestive tract disappear	+1
Score item 4	Stopping taking warfarin for a period of time, and bleeding digestive tract	+2
			Score item 5	Ibuprofen administered to patients may also trigger digestive tract bleeding	-1
Score item 6	The concentration of the drug in the patient is unknown	0
			Score item 7	The correlation between the severity of the adverse event indication and the dose is unknown	0
Score 8	Patient history of adverse events to warfarin and its analogues	0

TABLE 4 patient E gastrointestinal hemorrhage and ibuprofen correlation score sheet

	Description of patient Condition	Score of
			Score item 1	Digestive tract bleeding is a clear adverse event of ibuprofen	+1
Score item 2	Gastrointestinal bleeding was monitored after ibuprofen administration	+2
			Score item 3	Ibuprofen is stopped, and digestive tract hemorrhage disappears	+1
Score item 4	The ibuprofen is not taken again after stopping taking the medicine for a period of time	+0
			Score item 5	The patients taking warfarin can also cause the alimentary tract to bleed	-1
Score item 6	The concentration of the drug in the patient is unknown	0
			Score item 7	The correlation between the severity of the adverse event indication and the dose is unknown	0
Score 8	Patient to ibuprofenFenfen and its congeners have a history of adverse events	0

As can be seen from tables 3 and 4, the correlation scores of the suspected drugs warfarin and ibuprofen that induced the bleeding of the E digestive tract of the patient were: and 5 points and 3 points, and the relevance is graded as possible and probable. In the ranked list of suspected drugs that triggered gut bleeding, warfarin was ranked prior to ibuprofen, i.e., gut bleeding in patient E was more likely due to warfarin use.

Compared with the prior art, the invention has the beneficial effects that: the adverse event reporting module of the invention backtracks forwards and continues to monitor the information of the treatment process of the patient backwards according to the positive indications monitored by the medication process monitoring and early warning module, finds the clinical evidence of the adverse event caused by the suspected drug, synthesizes various clinical evidences, determines the correlation between the positive indications of the adverse event and the clinical medication based on the objective scoring criterion, provides objective and uniform standard for reporting the adverse event, improves the accuracy of reporting the adverse event, and provides high-quality clinical sample data for supervision and research of the adverse event of the drug. In addition, for the multi-drug combination with the same adverse events, the main pathogenic drugs of the adverse events are determined based on the relevance ranking, and accurate reference is provided for clinical drug administration.

And the report generation module forms a drug adverse event report according to the classification result of the relevance classification module, the relevance ranking list of the suspicious drugs and the treatment process information of the patients related to adverse events in the medical record module for hospitalization and outpatient service, and inputs the drug adverse event report into the ADE/ME report management module.

The adverse event report includes: (1) patient name, gender, original disease, adverse event name, (2) adverse event course information including symptoms, signs, clinical tests, (3) adverse event correlation grading result as positive, probable, possible suspicious drug.

Preferably, the ADE/ME report management module reports the drug adverse event report to a food and drug adverse event monitoring center or a drug-induced disease monitoring network.

And the medication error reporting module is used for reporting the occurred medication errors. When the medication process monitoring and early warning module monitors positive indications and a medication error event is judged by the medication error monitoring module, the medication error reporting module generates a medication error report based on the treatment process information of the patient of the in-patient and out-patient medical record recording module and inputs the medication error report into the ADE/ME report management module.

The medication error report includes: the occurrence time of medication errors, medication errors related to medicines, the content of medication errors and the condition of harm to patients caused by medication errors.

Preferably, the ADE/ME report management module reports the medication error report to a food and drug adverse event monitoring center or a drug-induced disease monitoring network.

The statistical module is used for summarizing the drug adverse event report and the medication error report reported by the ADE/ME report management module and providing basic clinical data for statistical analysis of the drug adverse event and the medication error.

The above embodiments are only used for illustrating the invention and not for limiting the technical solutions described in the invention, and although the present invention has been described in detail in the present specification with reference to the above embodiments, the present invention is not limited to the above embodiments, and therefore, any modification or equivalent replacement of the present invention is made; all such modifications and variations are intended to be included herein within the scope of this disclosure and the appended claims.

Claims (8)

1. An active monitoring and reporting system for drug-induced diseases comprises: the system comprises a drug-induced disease knowledge base, an in-patient and out-patient medical record recording module, an intelligent monitoring module, an ADE/ME report management module and a statistical module;

the drug-induced disease knowledge base is used for providing drug use risk information and comprises a literature knowledge base, an information knowledge base, a drug specification database and a potential drug use risk module;

the intelligent monitoring module acquires medication risk information from the drug-induced disease knowledge base according to the medication condition of a patient, acquires treatment process information of the patient from an in-patient and out-patient medical record recording module, monitors the medication risk information appearing in the treatment process information of the patient in real time, and carries out real-time early warning and active reporting on adverse events and medication errors of a medicine;

the method is characterized in that:

the active reporting operation at least comprises: when a drug adverse event occurs, the intelligent monitoring module monitors drug administration risk information, namely, early warning, and based on the treatment process information of the patient, the intelligent monitoring module backtracks forwards and continues monitoring backwards, and actively reports the drug adverse event after determining the relevance between the adverse event and the suspicious drug.

2. The active drug-induced disease monitoring and reporting system of claim 1, wherein: the potential medication risk module is used for integrating medication risk information corresponding to each medicine in the literature knowledge base, the information knowledge base and the medicine specification database by using a standardized data table; the medication risk information corresponding to each medicine comprises the following sub-items: contraindications, dosage range and administration route corresponding to each drug, adverse event set, ADE/ME intervention means set, high risk group and high warning drug attribute.

3. The active drug-induced disease monitoring and reporting system of claim 2, wherein: in the drug-induced disease knowledge base, the literature knowledge base comprises columns for drug safety and adverse events in pharmaceutical and clinical medicine academic journals, the information knowledge base comprises a drug adverse event database in a drug supervision and management website, and the drug instruction book database comprises various drugs including cautions, risk warning frames and adverse event columns in the instructions.

4. The active drug-induced disease monitoring and reporting system of claim 3, wherein the adverse event sets are classified into high-risk sets and non-high-risk sets according to the criticality of the consequence; the high risk set includes serious adverse drug events, life threatening adverse drug events; the non-high risk group comprises mild adverse events, moderate adverse events; the set of ADE/ME interventions includes the administration of drug withdrawal, decrement, or rescue medication for adverse events or medication errors;

the high alert drug attribute characterizes whether the drug belongs to a high alert drug; the high warning medicines are medicines which are high in medicine toxicity and easy to cause serious adverse events, and all the high warning medicines form a high warning medicine list;

the potential medication risk module inputs the name of the medicine, and then medication risk information corresponding to the medicine can be output;

after the current physical condition information of the patient is input, the potential medication risk module outputs medication risk information corresponding to the patient, and the medication risk information comprises: a list of forbidden medications and a list of high-risk medications for the patient under the current physical condition; the forbidden medicine list comprises medicines forbidden to be used by the patient under the current physical condition and determined according to each forbidden medicine item; the high risk medication list for the patient includes: the high-risk population sub-item comprises the medicine of the patient and high-warning medicines outside the forbidden medicine list of the patient; and the high warning medicines except the forbidden medicines of the patient are obtained by making a difference between a high warning medicine list and the forbidden medicine list of the patient.

5. The active drug-induced disease monitoring and reporting system of claim 4, wherein: the intelligent monitoring module comprises: (1) the patient medication risk prompting module is used for analyzing the potential medication risk of the patient according to the physical condition of the patient before medication, and prompting the risk before medication; (2) a medication error monitoring module for: monitoring the medication errors to be generated and the medication errors already generated in the whole medication process of a patient; (3) a monitoring parameter construction module for: determining monitoring parameters of adverse events of the medicines according to clinical performance indicators of the adverse events of the medicines, laboratory examination indicators and intervention means of the adverse events; (4) the medicine process monitoring and early warning module is used for: monitoring the treatment process information of the patient, and carrying out grading early warning on adverse events and medication errors of the medicine; (5) the active reporting module is used for determining the relevance between the adverse drug events and the suspicious drugs and actively reporting the adverse drug events and the medication errors;

the patient medication risk prompting module extracts information closely related to the physical condition of the analyzed patient from the in-patient and out-patient medical record recording module in real time, and comprises the following steps: basic disease information, age information, sex information, liver function information, renal function information, pregnancy information, allergy medicine information and operation history information form the current physical condition information of the analyzed patient; inputting the physical condition information into a potential medication risk module to obtain a currently forbidden medication list and a high risk medication list of the patient; in the treatment process of a patient, the current forbidden medicine list and the high-risk medicine list are updated in real time along with the change of the treatment process information of the patient in the in-patient and out-patient medical record module to form the latest current forbidden medicine list and the latest high-risk medicine list of the patient, and the latest current forbidden medicine list and the latest high-risk medicine list of the patient are sent to a doctor in charge and a pharmacist in the form of medication notice to serve as clinical medication references;

the medication error monitoring module is used for judging whether the current medication of the patient is wrong; for the currently used medicine of the patient, judging whether the medicine belongs to the contraindicated medicine of the patient according to the currently forbidden medicine list of the patient output by the patient medicine risk prompting module; inputting the medicine into the potential medication risk module, comparing the dosage range and the administration route of the current medication of the patient with the dosage range and the administration route corresponding to the medicine in the potential medication risk module, and judging whether the dosage range and the administration route of the medicine are correct or not; if the medicine belongs to contraindications of patients, or the dosage range and the administration route of the medicine are incorrect, medication errors exist, otherwise, the medication errors do not exist;

the monitoring parameter construction module is used for constructing adverse event monitoring parameters before executing medical advice medication so as to carry out targeted monitoring on medication risk information appearing in the treatment process information of the patient in the medication process, and the treatment process information of the patient is obtained from the medical record module in hospital and in clinic; inputting the to-be-executed medical orders and medicines into the potential medication risk module, and extracting an adverse event set and an ADE/ME intervention means set corresponding to the medicines; constructing adverse event monitoring parameters based on the adverse event set and the ADE/ME intervention means set, wherein the adverse event monitoring parameters comprise adverse event indication parameters and adverse event intervention means parameters; the adverse event indicator parameters include: clinical performance indicators corresponding to adverse events, laboratory test indicators corresponding to adverse events; the intervention modality parameters include a deactivation of the prescribed medication to be administered, a decrement, and an administration of a rescue medication of the prescribed medication to be administered; the adverse event indicators are divided into high-risk indicators and non-high-risk indicators; the corresponding indication of the adverse events in the high-risk set is a high-risk indication, and the corresponding indication of the adverse events in the non-high-risk set is a non-high-risk indication.

6. The active drug-induced disease monitoring and reporting system of claim 5, wherein: the medication process monitoring and early warning module comprises: (1) the grading early warning sub-module is used for outputting early warnings of different grades for the monitored suspected adverse drug events, the medication errors to be generated and the medication errors to be generated; (2) the medical advice medication monitoring submodule is used for checking medication errors when the medical advice medicines are prescribed but not executed, and carrying out preventive early warning on the medication errors to be generated; (3) the high-risk medication monitoring submodule is used for monitoring and early warning high-risk medication; (4) the non-high-risk medication monitoring submodule is used for monitoring and early warning non-high-risk medication;

the grading early warning sub-module grading early warning mechanism is as follows: dividing the monitored medication risk information into the following items according to the risk grade from high to low: the first-class event, the second-class event, the third-class event, the fourth-class event and the fifth-class event respectively output a black early warning, a red early warning, an orange early warning, a yellow early warning and a blue early warning correspondingly;

wherein the event of the type comprises: (1) an impending medication error, (2) a medication error that has occurred but has not been intervened, (3) a medication error that has occurred but has not been reversed; outputting black early warning for a type of event, and prompting a doctor to intervene in time;

the two types of events include: adverse events within the high risk set may occur and be in an unpredicted state; for the second kind of events, red early warning is output to prompt a doctor to intervene timely and continuously;

the three types of events include: it is possible that adverse events within the high risk set have intervened but not reversed; for the three types of events, orange early warning is output to prompt a doctor to continuously intervene;

the four types of events include: non-high risk intra-set adverse events are likely to occur; outputting yellow early warning for the four types of events, and recommending a doctor to intervene;

the five types of events include: adverse events within non-high risk sets may occur; outputting blue early warning for the five types of events, and recommending doctors to carry out enhanced observation;

the medical advice medication monitoring submodule is used for monitoring medication of a patient medical advice in real time, inputting the name, the dosage and the medication route of the medicine to be administered to a medication error monitoring module for the medicine to be administered, judging whether medication errors exist, if so, outputting black early warning by the association grading early warning submodule, and warning the medication errors until the medication error medical advice is cancelled;

when the fact that the patient uses the medicine is monitored, whether the medicine used by the patient under the current physical condition is high-risk medicine or not is judged according to a high-risk medicine list of the patient; if the high-risk medication belongs to the high-risk medication, monitoring based on a high-risk medication monitoring submodule, and if the high-risk medication does not belong to the high-risk medication, monitoring based on a non-high-risk medication monitoring submodule;

the high-risk medication monitoring submodule is adopted for processing, and specifically comprises the following steps: monitoring the information of the treatment process of the patient in the medical record module for hospitalization and outpatient service based on the adverse event monitoring parameters; after the positive indication is monitored, firstly, inputting the medicine name, the dosage range and the administration route of the used medicine into an administration error monitoring module, and checking administration errors; if the medication error exists, the correlated grading early warning module continuously outputs black early warning according to a type of event to prompt that the medication error occurs, pushes the ADE/ME intervention means set of the medicine to doctors and pharmacists, and eliminates early warning after the follow-up monitoring shows that the intervention is performed and the monitored positive indication turns into negative;

positive indications are clinical performance indications or laboratory examination indications corresponding to adverse events;

the high-risk medication monitoring submodule comprises a high-risk indication monitoring and early warning sun module and a non-high-risk indication monitoring and early warning sun module; after medication errors are eliminated, judging whether the monitored positive indications have high-risk indications or not; if the high-risk indication exists, monitoring and early-warning by a high-risk indication monitoring and early-warning sun module in the high-risk medication monitoring sub-module, and if the positive indications are non-high-risk indications, monitoring and early-warning sun module in the high-risk medication monitoring sub-module;

the non-high-risk medication monitoring submodule is used for processing, and specifically, the information of the treatment process of the patient in the medical record module of the hospitalization and the outpatient clinic is monitored based on the adverse event monitoring parameter; after the positive indication is monitored, firstly, inputting the medicine name, the dosage range and the administration route of the used medicine into an administration error monitoring module, and checking administration errors; if the medication error exists, the correlated grading early warning module continuously outputs black early warning according to a type of event to prompt that the medication error occurs, pushes the ADE/ME intervention means set of the medicine to doctors and pharmacists, and eliminates early warning after the follow-up monitoring shows that the intervention is performed and the monitored positive indication turns into negative;

the non-high-risk medication monitoring submodule comprises a high-risk indication monitoring and early warning sun module and a non-high-risk indication monitoring and early warning sun module; after medication errors are eliminated, whether high-risk indications exist in the monitored positive indications is judged, if the high-risk indications exist, monitoring is carried out based on a high-risk indication monitoring and early warning sun module in a non-high-risk medication monitoring sub-module, and if the monitored positive indications are all non-high-risk indications, monitoring is carried out based on a non-high-risk indication monitoring and early warning sun module in a non-high-risk medication monitoring sub-module;

in the high-risk medication monitoring submodule and the non-high-risk medication monitoring submodule, the high-risk indication monitoring and early warning sun module processes the following steps: after the high-risk indication is monitored to be positive, the correlated grading early warning module carries out early warning according to the second type of event, continuously outputs red early warning to prompt doctors and pharmacists that adverse events in a high-risk set of medicines possibly occur and intervention is needed, pushes an ADE/ME intervention means set of the medicines to the doctors and the pharmacists, degrades the medicine to be the third type of event after the follow-up monitoring of the positive parameters of the medicine intervention means is carried out, continuously outputs orange early warning until the indication is monitored to be negative, and eliminates early warning;

in the high-risk medication monitoring submodule and the non-high-risk medication monitoring submodule, the non-high-risk indication monitoring and early warning sun module processes: when the monitored positive indications are all non-high-risk indications, judging conditions 1 and 2 respectively to obtain early warning levels, and outputting early warning according to the highest early warning level obtained by judging the conditions 1 and 2;

condition 1: in a time window t1 with a certain length after medication, non-high-risk indicators corresponding to k adverse events are monitored to be positive at the same time;

if k is less than 0 and less than n, a few non-high-risk indication parameters are concurrent and positive within a certain time period after the medicine is taken, and blue early warning is continuously output according to five types of event early warning to remind doctors to pay attention to observation;

if k is larger than n, the multiple non-high-risk indication parameters are concurrent and positive within a certain time period after the medicine is taken, the correlated grading early warning module outputs yellow early warning continuously according to four types of event early warning, and an ADE/ME intervention means set of the medicine is pushed to doctors and pharmacists to recommend intervention;

the n is a sensitivity concurrency threshold value in non-high-risk finger monitoring and early warning;

condition 2: after administration, there were at least 1 non-high risk indications persistently positive within time T;

if T is greater than q, namely at least 1 long-time continuously positive non-high-risk indication exists after the medicine is used, yellow early warning is continuously output according to four types of event early warning, an ADE/ME intervention means set of the medicine is pushed to a doctor and a pharmacist, and intervention is recommended;

if T is less than q, namely after the medicine is used, at least 1 non-high-risk indication which is continuously positive for a short time exists, early warning is carried out according to five types of events, blue early warning is continuously output, and doctors are reminded to observe;

the q is a sensitivity time threshold in non-high-risk finger monitoring and early warning;

a non-high-risk indication monitoring sun module sensitivity concurrent threshold and a sensitivity time threshold in the high-risk monitoring submodule are respectively n1 and q 1;

a non-high-risk indication monitoring sun module sensitivity concurrent threshold and a sensitivity time threshold in the non-high-risk monitoring sub-module are n2 and q2 respectively;

wherein n1< n2, q1< q 2; the high-risk medication monitoring submodule is more sensitive than the non-high-risk medication monitoring submodule in monitoring and early warning of non-high-risk indications.

7. The active drug-induced disease monitoring and reporting system of claim 6, wherein: 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 positive indications and early warns medication errors or possible adverse events, the medication error reporting module and the adverse event reporting module respectively report the medication errors and the adverse events actively;

the adverse event reporting module is used for: determining the relevance between the adverse event and suspicious drugs causing the adverse event based on the treatment process information before and after the positive adverse event indication of the patient occurs so as to realize accurate graded reporting of the adverse event; three days before and after the positive adverse event indication of the patient appears;

the adverse event reporting module comprises: the system comprises a relevance scoring module, a relevance grading module, a suspicious drug relevance ranking module and a report generating module; the relevance scoring module is used for scoring the relevance between the suspected medicine causing the adverse event and the adverse event; the relevance grading module divides the relevance of the suspicious drug and the adverse event into the following parts according to the score output by the relevance grading module: four levels of affirmation, high possibility, possibility and suspicion are carried out so as to be reported in a grading way; the suspicious drug relevance ranking module is used for carrying out relevance ranking on suspicious drugs which possibly generate the same adverse events under the condition of multi-drug combination, and assisting doctors to determine the main cause of the adverse events;

the relevance scoring module scores multiple suspicious drugs corresponding to the positive indications item by item according to the following scoring items based on the treatment process information of the patients in the in-patient and out-patient medical record recording module, and sums the scoring items to obtain relevance scores of adverse drug events caused by the suspicious drugs; the scoring items include:

whether the adverse events corresponding to the score item 1 and the positive indications belong to the definite adverse events of the medicines or not is judged, if so, 1 score is obtained, if not, 0 score is obtained,

the scoring item 2, whether the positive indication is monitored after the administration, if so, the score is 2, if not, the score is-1, if not, the score is 0,

scoring item 3, whether the adverse event indication turns negative after stopping taking or taking the rescue drug, if yes, scoring 1, if no, scoring 0,

scoring item 4, stopping taking the medicine for a period of time, and taking the medicine again, if the adverse event indication is positive, then obtaining score 2, if the adverse event indication is negative 1, if the adverse event indication is unknown, then obtaining score 0,

score 5, whether there are other factors that give rise to a positive indication of the adverse event, if a score of-1 is obtained, if a score of 2 is obtained, if a score of 0 is not known,

the scoring item 6, whether the concentration of the medicine in the body of the patient exceeds the toxic dose, if so, 1 score is obtained, if not, 0 score is obtained,

the score item 7, whether the severity of the adverse event indication is positively correlated with the dosage of the medicament, if so, 1 score is obtained, if not, 0 score is not known,

a scoring item 8, whether the patient has a history of adverse events for the drug or similar drugs, if so, a score of 1 is obtained, if not, a score of 0 is obtained, and if not, a score of 0 is obtained;

the relevance grading module divides the relevance of the suspicious drug and the adverse event into the following parts according to the scoring result of the relevance grading module: four levels of affirmation, high possibility, possibility and suspicion;

adverse events corresponding to positive indications and suspected drugs that may cause adverse events:

if the relevance score is greater than or equal to 7 points, the relevance grade of the medicine and the adverse event is determined to be positive;

if the relevance score is 4-6, the relevance of the medicine and the adverse event is considered to be high in degree possibly;

if the relevance score is 1-3, the relevance grade of the medicine and the adverse event is considered to be possible;

if the relevance score is less than 1 point, the relevance grade of the medicine and the adverse event is considered to be suspicious;

the suspicious drug relevance ranking module is used for carrying out relevance ranking on suspicious drugs which possibly generate the same adverse events under the condition of using multiple drugs together; for adverse events corresponding to the positive indications, all drugs which possibly cause the adverse events in the medication records of the patients form a suspicious drug list, and the drugs are sorted according to the relevance scoring results of the drugs in the suspicious drug list to form a suspicious drug relevance ranking list; the information in the list of the relevance ranking of the suspicious drugs comprises the names of the suspicious drugs, the relevance score of the suspicious drugs and the adverse events, the relevance grade of the suspicious drugs and the adverse events corresponding to the positive indications; the suspicious drug relevance ranking list is arranged in a descending order according to the relevance score value and is pushed to a clinician, so that the clinician is assisted to make next medication or treatment decision in a targeted manner;

and the report generation module forms a drug adverse event report according to the classification result of the relevance classification module, the relevance ranking list of the suspicious drugs and the treatment process information of the patients related to adverse events in the medical record module for hospitalization and outpatient service, and inputs the drug adverse event report into the ADE/ME report management module.

8. The active drug-induced disease monitoring and reporting system of claim 7, wherein: the medication error reporting module is used for reporting the occurred medication errors; when the medication process monitoring and early warning module monitors positive indications and a medication error event is judged by the medication error monitoring module, the medication error reporting module generates a medication error report based on the patient treatment process information of the in-patient and out-patient medical record recording module and inputs the medication error report into the ADE/ME report management module;

the medication error report includes: the occurrence time of medication errors, the medication errors relate to medicines, the content of the medication errors, and the condition of harm to patients caused by the medication errors;

the ADE/ME report management module reports the administration error report to a food and drug adverse event monitoring center or a drug-induced disease monitoring network;

the statistical module is used for summarizing the drug adverse event report and the medication error report reported by the ADE/ME report management module and providing basic clinical data for statistical analysis of the drug adverse event and the medication error.

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