A dose safety adjustment method and system based on double confirmation

Abstract

The application relates to the field of medical information technology and discloses a dose safety adjustment method and system based on double confirmation, which comprises the following steps: performing basic medication confirmation on patient identity, medical order validity and medicine information; if the basic medication confirmation is inconsistent in identity, invalid in medical order or mismatched in medicine, a medication interception result is generated; risk conditions are generated based on clinical medication specifications; if there is drug interaction or dose over-limit, a prohibited administration result is generated; an efficacy evaluation index is the improvement degree of a symptom corresponding to a current drug treatment target, a safety evaluation index is the degree of adverse reactions, an incremental adjustment result, a maintenance adjustment result, a decremental adjustment result and an emergency drug withdrawal result are generated based on the efficacy evaluation index and the safety evaluation index, and the incremental adjustment result or the decremental adjustment result is subjected to safety adjustment based on a historical dose database. The application ensures the safety of dose adjustment.

Description

Technical Field

[0001] This invention relates to the field of medical information technology, and more specifically, to a method and system for safe drug dosage adjustment based on double confirmation. Background Technology

[0002] With the development of clinical medicine, dosage adjustment has become a crucial aspect of ensuring treatment effectiveness and reducing the incidence of adverse reactions. In scenarios such as chronic disease treatment, anti-infective therapy, tumor treatment, anticoagulation therapy, and intensive care, a patient's age, weight, liver and kidney function, comorbidities, and concurrent medication use all affect the efficacy and safety of drugs. Therefore, it is necessary to dynamically adjust the dosage based on the patient's actual condition.

[0003] Existing patent CN121789890A discloses a rational drug dosage method and device. By incorporating key factors affecting drug metabolism, such as genes and diet, it aims to make the dosage regimen more closely match the patient's actual metabolic characteristics. However, due to the lack of a medication confirmation mechanism regarding patient identity, prescription validity, and drug compatibility, subsequent dosage adjustments will still be necessary when patient identity is incorrect, prescription is invalid, or drug specifications are incompatible, thus increasing medication risks. Furthermore, the lack of consideration for drug interactions such as liver and kidney function during dosage adjustments leads to high-risk patients being treated with the same dosage adjustment logic as ordinary patients, thereby compromising the safety of dosage adjustments.

[0004] Therefore, it is necessary to design a dosage safety adjustment method and system based on double confirmation to solve the problems existing in the current technology. Summary of the Invention

[0005] In view of this, the present invention proposes a method and system for safe drug dosage adjustment based on dual confirmation, which aims to solve the problem that the existing technology lacks basic drug confirmation and individualized risk confirmation, and lacks consideration of drug interactions such as liver function and kidney function of patients, thus affecting the safety of drug adjustment.

[0006] This invention proposes a dosage safety adjustment method based on double confirmation, comprising: Obtain patient identity information, medical order information, and comprehensive drug information, and perform basic medication confirmation on patient identity, medical order validity, and drug information. If there is an inconsistency in identity, invalid medical order, or drug mismatch in the basic medication confirmation, a medication interception result is generated. If the basic medication is confirmed, patient body information and patient difference information are obtained, and risk conditions are generated based on clinical medication guidelines. If drug interactions or dosage exceedances exist, a prohibited drug administration result is generated. If the risk factors do not meet the risk conditions, a dosage adjustment analysis is performed. The dosage adjustment analysis includes obtaining efficacy evaluation indicators and safety evaluation indicators. The efficacy evaluation indicators are the degree of improvement of symptoms corresponding to the current drug treatment target, and the safety evaluation indicators are the degree of adverse reactions. Based on the efficacy evaluation indicators and safety evaluation indicators, incremental adjustment results, maintenance adjustment results, dosage reduction adjustment results and emergency discontinuation results are generated, and the incremental adjustment results or dosage reduction adjustment results are safely adjusted based on the historical dosage database.

[0007] Furthermore, when confirming basic medication use, this includes: The patient identity information includes the patient's name, age, medical record number, hospital number, bed number, and identification code, and the patient identity information is matched with the medical order information; The medical order information includes patient information, order status, order issuance time, issuing physician, route of administration, frequency of administration, single dose, and total daily dose, and the validity of the medical order is determined based on the issuing physician and / or the order status. The comprehensive drug information includes drug name, drug specifications, dosage form, batch number, expiration date, and storage status. The comprehensive drug information is then matched with the drugs in the medical order information.

[0008] Furthermore, when generating medication interception results, the following are included: If the patient's identity information is inconsistent with the patient information in the medical order, then an identity inconsistency is determined. If the status of the medical order is discontinued, revoked, or expired, and / or the authorizing physician's authority does not meet the drug prescribing authority, then it is determined that the medical order is invalid. If the drug name, drug specifications, or dosage form are inconsistent with the drug in the medical order information, then a drug mismatch is determined. If there are discrepancies in identity, invalid medical orders, or mismatched medications in the basic medication confirmation, a medication interception result will be generated, and the corresponding interception reason will be determined. If the basic medication confirmation confirms that the patient's identity matches, the doctor's order is valid, and the medication is compatible, then the basic medication confirmation is successful.

[0009] Furthermore, when acquiring patient body composition information and patient difference information, and generating individualized risk conditions based on clinical medication guidelines, this includes: The patient's physical information includes height and weight; The patient-specific information includes liver function information, kidney function information, pregnancy information, lactation information, allergy history information, and adverse reaction information. Based on the clinical medication guidelines, contraindications, precautions, and interactions are extracted and used as individualized risk conditions.

[0010] Furthermore, when acquiring patient body shape information and patient difference information, and generating individualized risk conditions based on clinical medication guidelines, the process also includes: If the medication in the medical order information is a weight-based medication, then the individual recommended dose is determined based on the weight and the unit weight dose of the clinical medication guidelines; If the medication in the medical order information is a medication administered based on body surface area, then the body surface area is determined based on the height and weight, and the individual recommended dose is determined based on the body surface area and the dose per unit body surface area in the clinical medication guidelines.

[0011] Furthermore, if drug interactions or dosage exceedances are present, a prohibition on dosing result is generated, including: Based on the comprehensive drug information, information on combined medication use is obtained, and the combined medication use information is matched with the interaction conditions; If the combined medication information contains drugs that are contraindicated for use with the medication prescribed, would enhance toxicity, enhance efficacy, or reduce safety, then a drug interaction is determined to exist. The single dose, total daily dose, and frequency of administration are compared with the upper limit of dose, upper limit of total daily dose, and upper limit of frequency in the clinical drug use guidelines, respectively. If any of the single dose, total daily dose, or frequency of administration exceeds the corresponding upper limit, it is determined that the dose exceeds the limit. If the drug interaction or dosage exceedance is present, a prohibition on dosing result is generated; If no drug interaction or dosage exceedance is found, a dosage adjustment analysis is performed.

[0012] Furthermore, the aforementioned dosage safety adjustment method based on double confirmation also includes: The efficacy evaluation indicators include at least blood pressure, blood glucose, body temperature, coagulation indicators, and imaging improvement; The safety evaluation indicators include at least blood routine, liver function, kidney function, electrolytes, and electrocardiogram QT interval; The efficacy evaluation indicators are compared with the preset efficacy targets to generate efficacy evaluation results, which include insufficient efficacy, efficacy achieved, and efficacy overflow. The safety evaluation indicators are compared with preset safety thresholds to generate safety evaluation results, which include normal safety and abnormal safety.

[0013] Furthermore, when generating incremental adjustment results, maintenance adjustment results, dose reduction adjustment results, and emergency discontinuation results based on the aforementioned efficacy evaluation indicators and safety evaluation indicators, the process includes: If the efficacy evaluation result is insufficient and the safety evaluation result is normal, then an incremental adjustment result is generated. If the efficacy evaluation result indicates that the efficacy target has been achieved, and the safety evaluation result indicates that the safety is abnormal, then a dose reduction adjustment result is generated. If the efficacy evaluation result is that the efficacy target has been achieved and the safety evaluation result is that the safety is normal, then a maintenance adjustment result is generated to maintain the individual recommended dose, the dosing frequency, the single dose, and the total daily dose. If the efficacy evaluation result is efficacy overflow and the safety evaluation result is safety abnormal, or if the efficacy evaluation result is efficacy insufficiency and the safety evaluation result is safety abnormal, then an emergency discontinuation result is generated and medication is stopped.

[0014] Furthermore, when making safety adjustments to the incremental or reduced dosage results based on the historical dosage database, the following steps are included: Obtain information on drugs with insufficient efficacy and their corresponding usage, or information on drugs with abnormal safety and their corresponding usage; The historical drug dosage database includes historical drug information, historical efficacy improvement results, historical response improvement results, and historical dosage information, and the historical drug information, historical efficacy improvement results, historical response improvement results, and historical dosage information correspond one-to-one; The drugs with insufficient efficacy or abnormal safety are traversed in the historical drug dosage database until historical efficacy improvement results are determined to improve insufficient efficacy to efficacy target, or historical response improvement results to improve abnormal safety to normal safety. The individual recommended dose, the single dose, the total daily dose, and the dosing frequency are adjusted based on the historical dosing information.

[0015] Compared with existing technologies, the beneficial effects of this invention are as follows: Firstly, basic medication confirmation is achieved through patient identity, valid medical orders, and drug matching, eliminating fundamental risks such as incorrect patient selection, invalid medical orders, and drug incompatibility before dosage adjustment. Secondly, individualized risk confirmation is achieved through patient body information, patient differences, clinical medication guidelines, drug interactions, and dosage exceeding limits, identifying individualized risks caused by allergy history, adverse reaction history, and concomitant medications before dosage adjustment. Thirdly, by jointly judging efficacy and safety evaluation indicators, dosage adjustment can be categorized into different outcomes: incremental adjustment, maintenance adjustment, dose reduction adjustment, and emergency discontinuation, avoiding blindly increasing the dosage based solely on insufficient efficacy and avoiding maintaining the original dosage when safety is abnormal. Fourthly, safe adjustments are made based on the results of incremental or dose reduction adjustments using a historical dosage database, utilizing past efficacy and adverse reaction improvement results as a reference for current dosage adjustments, thus improving the safety of dosage adjustment.

[0016] On the other hand, this application also provides a dosage safety adjustment system based on double confirmation, for applying the above-mentioned dosage safety adjustment method based on double confirmation, including: The first confirmation module is configured to obtain patient identity information, medical order information, and comprehensive drug information, and to perform basic medication confirmation on the patient identity, the validity of the medical order, and the drug information. If there is an inconsistency in identity, invalid medical order, or mismatch in drugs in the basic medication confirmation, a medication interception result is generated. The second confirmation module is configured to, if the basic medication confirmation is passed, acquire the patient's body posture information and patient difference information, and generate risk conditions based on clinical medication guidelines; if there is a drug interaction or dosage exceedance, generate a prohibition on drug administration result; if the risk factors do not meet the risk conditions, perform dosage adjustment analysis. The dosage adjustment module is configured to perform the dosage adjustment analysis by acquiring efficacy evaluation indicators and safety evaluation indicators. The efficacy evaluation indicators are the degree of improvement of symptoms corresponding to the current drug treatment target, and the safety evaluation indicators are the degree of adverse reactions. Based on the efficacy evaluation indicators and safety evaluation indicators, the module generates incremental adjustment results, maintenance adjustment results, dosage reduction adjustment results and emergency discontinuation results, and performs safety adjustments on the incremental adjustment results or dosage reduction adjustment results based on the historical dosage database.

[0017] It is understandable that the above-mentioned method and system for safe dosage adjustment based on double confirmation have the same beneficial effects, and will not be elaborated further here. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 A flowchart illustrating a dosage safety adjustment method based on dual confirmation, provided as an embodiment of the present invention; Figure 2 This is a flowchart illustrating the basic medication confirmation process for patient identity, medical order validity, and drug information, provided in an embodiment of the present invention. Figure 3 This is a functional block diagram of a drug dosage safety adjustment system based on dual confirmation, provided for an embodiment of the present invention. Detailed Implementation

[0020] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0021] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0022] See Figure 1-2 As shown in some embodiments of this application, a method for safe dosage adjustment based on double confirmation includes: S100: Obtain patient identity information, medical order information, and comprehensive drug information, and perform basic medication confirmation on patient identity, medical order validity, and drug information. If there is an inconsistency in identity, invalid medical order, or drug mismatch in the basic medication confirmation, a medication interception result will be generated. S200: If the basic medication is confirmed, patient body information and patient difference information are obtained, and risk conditions are generated based on clinical medication guidelines. If drug interactions or dosage exceedances exist, prohibited dosing results are generated. If the risk factors do not meet the risk conditions, dosage adjustment analysis is performed. S300: Dosage adjustment analysis includes obtaining efficacy evaluation indicators and safety evaluation indicators. The efficacy evaluation indicator is the degree of improvement of symptoms corresponding to the current drug treatment goal, and the safety evaluation indicator is the degree of adverse reaction. Based on the efficacy evaluation indicators and safety evaluation indicators, incremental adjustment results, maintenance adjustment results, dosage reduction adjustment results and emergency discontinuation results are generated, and safety adjustments are made to the incremental adjustment results or dosage reduction adjustment results based on the historical dosage database.

[0023] Specifically, the dosage safety adjustment method based on dual verification provided in this embodiment is applicable to hospital information systems, clinical medication auxiliary decision-making systems, inpatient pharmacy review systems, outpatient prescription review systems, nursing medication verification systems, and medical treatment scenarios requiring dynamic adjustment of patient medication dosages. Dosage safety adjustment, without deviating from medical order management and clinical medication guidelines, involves generating safety verification and adjustment suggestions for the current single dose, total daily dose, dosing frequency, or individual recommended dose of the medication based on patient identity, medical orders, medication, body condition, liver and kidney function, concomitant medications, changes in efficacy, and changes in adverse reactions.

[0024] The dual confirmation process includes a first level of basic medication confirmation and a second level of individualized risk confirmation. The first level of basic medication confirmation determines whether the patient can proceed to the next medication decision-making stage. This confirmation includes verifying patient identity consistency, the validity of the prescription, and whether the medication matches the prescription. The second level of individualized risk confirmation primarily determines whether the current patient is suitable to continue medication at the current dosage or according to the current prescription. This confirmation includes patient physical information, patient differences, clinical medication guidelines, drug interactions, upper dosage limits, upper frequency limits, and individual recommended dosages. The first level of confirmation avoids basic medication risks such as incorrect patient identification, continued execution of expired prescriptions, and incorrect medication specifications or dosage forms. The second level of confirmation avoids adjusting dosages based on the logic of treating ordinary patients when they have abnormal liver or kidney function, are pregnant, breastfeeding, allergic, have a history of adverse reactions, or have concomitant medication risks, thereby improving the safety and specificity of dosage adjustments.

[0025] In S100, patient identity information can be obtained from the hospital information system, wristband recognition devices, ID card recognition devices, bedside nursing terminals, and mobile ward round terminals. Patient identity information includes the patient's name, age, medical record number, hospital number, bed number, and identification code. The identification code can be a patient wristband barcode, QR code, RFID code, unique inpatient number, or unique outpatient number. Medical order information is obtained from the electronic medical record system, medical order system, prescription system, or pharmacy review system. Medical order information includes patient information, order status, order creation time, prescribing physician, route of administration, frequency of administration, single dose, and total daily dose. Patient information is used to match the order with patient identity information; order status determines whether the current order is executable; order creation time determines whether the order has exceeded its validity period or has been replaced by a new order; prescribing physician determines whether the order was issued by a physician with the appropriate authority; and route of administration, frequency of administration, single dose, and total daily dose are used for dose over-limit judgment and dosage adjustment analysis. The status of medical orders includes newly issued, reviewed, in progress, discontinued, revoked, and expired.

[0026] Comprehensive drug information can be obtained through drug barcode scanning and dispensing records from the medicine cabinet. This comprehensive information includes the drug name, specifications, dosage form, batch number, expiration date, and storage status. The drug name is used to determine if the dispensed drug matches the prescription; the specifications are used to determine if the content per tablet, vial, bottle, bag, or unit corresponds to the prescription; and the dosage form is used to determine if tablets, capsules, injections, eye drops, inhalers, and topical preparations match the route of administration. For drugs with the same name but different specifications, the same name but different dosage forms, or the same ingredients but different brand names, the comprehensive drug information should be matched together with the drug code, generic name, specifications, and dosage form in the prescription information to avoid the risk of misjudging a drug match based solely on similar names.

[0027] The system matches patient identification information with the patient information in the medical order information. If the patient's identification code, medical record number, or hospitalization number does not match the patient information in the medical order, an identity discrepancy is identified. If the patient's identification code, medical record number, or hospitalization number matches the patient information in the medical order, an identity match is identified, preventing medication from being delivered to the wrong patient. When determining the validity of a medical order, confirmation is based on the order status and the prescribing physician's authority. If the order status is discontinued, revoked, or expired, and / or the prescribing physician's authority does not meet the medication prescribing requirements (e.g., specially managed drugs, restricted antibiotics, high-alert drugs, chemotherapy drugs, or drugs requiring specialist prescribing authority are prescribed by an unauthorized physician), the medical order is determined to be invalid. When determining medication matching, the system matches the comprehensive medication information with the medication information in the medical order. Inconsistent drug names include discrepancies between the generic name, drug code, or drug approval information of the drug used and the prescription drug; inconsistent drug specifications include discrepancies between the unit content, concentration, packaging specifications, or conversion units of the drug and the prescription requirements; and inconsistent dosage forms include situations where the prescription requires oral tablets but the actual scan shows an injection, or the prescription requires a sustained-release dosage form but the actual product is a regular dosage form.

[0028] If any of the following issues arise during the basic medication confirmation process: inconsistency in patient identity, invalid prescription, or medication mismatch, a medication interception result is generated, and the corresponding reason for interception is determined. For inconsistencies in identity, the system prompts the user to re-verify the patient's identity and wristband information. For invalid prescriptions, the system prompts the user to contact the prescribing physician or re-examine the prescription. For medication mismatches, the system prompts the user to obtain the medication again or have a pharmacist confirm a replacement. After the medication interception result is generated, the dosage adjustment analysis process is not initiated to avoid continuing dosage calculations in cases of basic errors. If the identity is consistent, the prescription is valid, and the medication is compatible, the basic medication confirmation is successful, and a second level of individualized risk assessment is performed. Successful basic medication confirmation does not guarantee that the current medication is suitable for administration; it only indicates that the basic correspondence between the patient, prescription, and medication is correct. Whether the current dosage can be administered requires further judgment based on patient body information, patient differences, clinical medication guidelines, drug interactions, and dosage limits.

[0029] In S200, patient body information includes height and weight. Height and weight are obtained from admission assessment records, nursing records, and physical examination equipment. Weight is used to calculate the individual recommended dose for medications administered based on weight, while height and weight are used together to calculate the individual recommended dose for medications administered based on body surface area. Patient variability information includes liver function information, kidney function information, pregnancy information, lactation information, allergy history information, and adverse reaction information. Liver function information includes alanine aminotransferase, aspartate aminotransferase, total bilirubin, albumin, prothrombin time, or other information reflecting liver metabolic capacity. Kidney function information includes serum creatinine, estimated glomerular filtration rate, urine output, creatinine clearance, or dialysis status. Pregnancy and lactation information are used to determine whether the medication is contraindicated during pregnancy, should be used with caution during pregnancy, is contraindicated during lactation, or poses a risk during lactation. Allergy history information is used to determine whether the patient has an allergic risk to the current medication, similar medications, excipients, or related ingredients. Adverse reaction information is used to determine whether a patient has experienced skin rash, liver or kidney damage, hematological abnormalities, electrocardiographic abnormalities, or gastrointestinal reactions when using this drug or similar drugs in the past.

[0030] Clinical medication guidelines are derived from hospital medication rule databases, drug instruction manual databases, treatment guidelines, or internal review rules of medical institutions. Contraindications, precautions, and interactions are extracted from these guidelines and treated as individualized risk conditions. Contraindications are conditions under which a patient should not use the current medication or continue using the current dosing regimen, such as a known history of allergy, severe liver or kidney dysfunction, contraindication during a specific stage of pregnancy, or contraindications to specific concomitant medications. Precautions are conditions requiring a reduced dose, extended dosing interval, increased monitoring frequency, or use only after physician confirmation. Interactions are conditions that may lead to enhanced toxicity, excessive efficacy, reduced efficacy, or decreased safety between the current medication and concomitant medications.

[0031] For medications administered based on weight, the individual recommended dose is determined based on the patient's weight and the dose per unit weight as specified in clinical medication guidelines. Specifically, if the medication in the prescription is administered based on weight, the patient's current weight is read, and the weight is multiplied by the dose per unit weight to obtain the individual recommended dose. For medications administered based on body surface area (BSA), the body surface area is determined based on height and weight, and the individual recommended dose is determined based on the body surface area and the dose per unit BSA as specified in clinical medication guidelines. Body surface area (BSA) is the measured or calculated area of ​​the human body, commonly using formulas such as Hu Wensheng's formula and Du Bois' formula. If the medication in the prescription is administered based on BSA, the body surface area is multiplied by the dose per unit BSA to obtain the individual recommended dose.

[0032] When determining drug interactions, combined drug information is obtained based on comprehensive drug information, and this combined drug information is matched with interaction conditions. Combined drug information refers to the combination of all drugs involved in the prescription. Furthermore, combined drug information is not limited to drugs administered at the same time, but also covers drugs that may interact at other times. For example, some drugs, even after discontinuation, may still have a prolonged duration of action and could affect current drug metabolism, coagulation function, cardiac conduction, or liver and kidney function. If the combined drug information contains drugs that create contraindications with the prescription, enhance toxicity, increase efficacy, or reduce safety, a drug interaction is determined to exist.

[0033] Contraindicated combination therapy refers to combinations that are not recommended for use in clinical medication guidelines. Enhanced toxicity occurs when the combined use of two or more drugs may increase the risk of hepatotoxicity, nephrotoxicity, bone marrow suppression, bleeding, arrhythmia, or central nervous system depression. Enhanced efficacy occurs when the combined use of drugs results in excessively strong effects, potentially leading to hypotension, hypoglycemia, excessive coagulation, excessive sedation, or other excessive therapeutic effects. Reduced safety occurs when combined use of drugs, while not necessarily directly enhancing toxicity, may lead to a narrowing of the therapeutic window and increased monitoring difficulty. When determining dose exceedance limits, the single dose, total daily dose, and dosing frequency are compared with the upper limits for dose, total daily dose, and frequency in clinical medication guidelines, respectively. The single dose is the actual dose administered each time; the total daily dose is the cumulative dose administered within the same calendar day or dosing cycle; and the dosing frequency is the number of times the drug is administered per unit of time. If any single dose, total daily dose, or dosing frequency exceeds the corresponding upper limit, dose exceedance is determined. If drug interactions or dose exceedance are present, a prohibition on administration is generated. The prohibited dosing result includes the reason for the prohibition, the drug involved, and the relevant indicators. A prohibited dosing result is not equivalent to deleting the prescription; rather, it is used to interrupt the current dosing and adjustment process and prompt the physician, pharmacist, or nurse to review the medication, thereby improving the safety and specificity of dosage adjustments. If there are no drug interactions or dosage exceedances, the process proceeds to dosage adjustment analysis.

[0034] In S300, dosage adjustment analysis includes obtaining efficacy evaluation indicators and safety evaluation indicators. Efficacy evaluation indicators represent the degree of improvement in symptoms or objective indicators corresponding to the current drug treatment goal. These indicators include, but are not limited to, improvements in blood pressure, blood glucose, body temperature, coagulation parameters, and imaging findings. For antihypertensive therapy, efficacy evaluation indicators may include systolic blood pressure, diastolic blood pressure, mean arterial pressure, or blood pressure target achievement rate. For hypoglycemic therapy, efficacy evaluation indicators may include fasting blood glucose, postprandial blood glucose, random blood glucose, or glycated hemoglobin. For anti-infective therapy, efficacy evaluation indicators may include body temperature, white blood cell count, inflammatory markers, etiological results, or imaging improvements. For anticoagulation therapy, efficacy evaluation indicators may include coagulation parameters, thrombosis-related imaging changes, or clinical symptom improvement. The selection of efficacy evaluation indicators corresponds to the current drug treatment goal.

[0035] Safety evaluation indicators are objective indicators corresponding to the severity of adverse reactions. Safety evaluation indicators include at least complete blood count, liver function, kidney function, electrolytes, and QT interval on electrocardiogram, but are not limited to these indicators. For drugs that may cause bone marrow suppression, safety evaluation indicators may include white blood cells and neutrophils; for drugs that may affect liver function, they may include transaminases and bilirubin; for drugs that may affect kidney function, they may include serum creatinine, estimated glomerular filtration rate, urine output, and electrolytes. Efficacy evaluation indicators are compared with preset efficacy targets to generate efficacy evaluation results. Preset efficacy targets can be derived from medical orders, disease management goals, treatment guidelines, or physician-set expectations. Efficacy evaluation results include inadequate efficacy, efficacy achieved, and efficacy overflow. Inadequate efficacy means that the efficacy evaluation indicator has not reached the preset efficacy target, or the improvement trend is insufficient to support the continuation of the current dose. For example, blood pressure remains above the target range, blood glucose remains above the target range, body temperature has not decreased, coagulation indicators have not reached the treatment target, or imaging shows no improvement. Efficacy achieved means that the efficacy evaluation indicator has reached the preset efficacy target. Therapeutic spillover occurs when efficacy evaluation indicators exceed reasonable treatment goals and indicate that the drug effect is too strong, such as excessively low blood pressure, excessively low blood sugar, or excessive inhibition of coagulation function.

[0036] Safety evaluation indicators are compared with preset safety thresholds to generate safety evaluation results. Preset safety thresholds can be derived from clinical medication guidelines, drug instructions, medical institution warning rules, and pharmacist review rules. Safety evaluation results include "safe and normal" and "safe and abnormal." "Safe and normal" means that the current safety evaluation indicators do not reach the adverse reaction warning or prohibition level, and the patient has no record of new adverse reactions. "Safe and abnormal" means that the safety evaluation indicators exceed the preset safety level, or the patient experiences adverse reactions related to the current drug. When generating adjustment results based on efficacy and safety evaluation results, if the efficacy evaluation result indicates insufficient efficacy and the safety evaluation result indicates normal safety, an incremental adjustment result is generated. The incremental adjustment result indicates that the current prescribed drug is insufficiently effective even when safety indicators are not abnormal, and it is advisable to consider increasing the individual recommended dose, single dose, total daily dose, or adjusting the dosing frequency within the limits allowed by clinical medication guidelines. When generating incremental adjustment results, the dosage is not increased directly according to a fixed ratio. Instead, the remaining safety margin between the current dosage and the individual recommended dosage, dosage limit, daily total dosage limit, and frequency limit is first determined. The remaining safety margin can be determined according to the drug's instructions for use. For example, if the drug is prescribed three times a day, and the current prescription also specifies three times a day, if the current dosage has reached the point where there is no remaining safety margin, the dosage will not be increased even if the therapeutic effect is insufficient. Instead, the physician will be advised to evaluate and change the treatment plan. If there is still a remaining safety margin, the incremental adjustment results will be implemented accordingly.

[0037] If the efficacy evaluation result indicates that the therapeutic goal has been achieved and the safety evaluation result indicates that safety is within normal limits, a maintenance adjustment result is generated, which maintains the individual recommended dose, dosing frequency, single dose, and total daily dose. If the efficacy evaluation result indicates that the therapeutic goal has been achieved but the safety evaluation result indicates that safety is abnormal, a dose reduction adjustment result is generated. The dose reduction adjustment result indicates that although the current drug has achieved the therapeutic goal, safety risks have emerged. Therefore, it is necessary to reduce the single dose, reduce the total daily dose, extend the dosing interval, or reduce the dosing frequency accordingly. The dose reduction adjustment result considers the degree of correlation between the safety abnormality and the current drug. That is, if the safety abnormality is highly correlated with the current drug, the dose reduction can be relatively conservative to avoid the risk of a rapid decline in efficacy.

[0038] If the efficacy evaluation result indicates efficacy overflow and the safety evaluation result indicates safety abnormality, an emergency discontinuation result is generated, and medication is stopped. Emergency discontinuation results are applicable when the drug's efficacy is too strong and safety abnormalities occur simultaneously, such as when therapeutic indicators exceed the safe range and the patient experiences severe adverse reactions. When generating an emergency discontinuation result, information such as the efficacy indicator triggering discontinuation, the degree of abnormality, the most recent administration time, and the cumulative dose is recorded, and medical personnel are alerted to take emergency measures. For cases of efficacy overflow but a safety evaluation result indicating safety is normal, the medication can be reviewed according to the physician's orders, and the dosage can be adjusted based on the physician's recommendations. Similarly, for cases of insufficient efficacy and a safety evaluation result indicating safety abnormality, an emergency discontinuation result is generated, and medication is stopped.

[0039] After generating incremental or reduced dosage adjustment results, safety adjustments are made based on a historical dosage database. This database includes historical drug information, historical efficacy improvement results, historical response improvement results, and historical dosing information, with each category corresponding one-to-one. Historical drug information records the name, specifications, dosage form, route of administration, and indications of drugs used historically. Historical efficacy improvement results record whether insufficient efficacy has improved to the target level after historical dosage adjustments. Historical response improvement results record whether safety abnormalities have improved to normal levels after historical dosage adjustments. Historical dosing information records the corresponding single dose, total daily dose, dosing frequency, and individual recommended dose. Drugs with insufficient efficacy and their corresponding dosing information are retrieved and traversed through the historical dosage database until historical efficacy improvement results are found that have improved insufficient efficacy to the target level. The matching results do not directly replace clinical judgment but are used to determine the safe reference range for incremental adjustments. For example, if historical records show that a patient achieved the target level after a small incremental adjustment, the current incremental adjustment should not exceed that historically effective incremental adjustment. When adjusting dosage reduction results based on a historical dosage database, the system retrieves medications with safety abnormalities and their corresponding usage information. These medications are then traversed through the historical dosage database until historical usage information showing improved response results transforms the safety abnormality into a normal safety profile is identified. If historical records indicate that a certain dosage reduction can restore a safety abnormality to normal without loss of therapeutic efficacy, this historical usage information can be used as a reference for dosage reduction adjustments.

[0040] When adjusting individual recommended doses, single doses, total daily doses, and dosing frequency based on historical dosing information, these adjustments are subject to both clinical medication guidelines and current patient risk conditions. In other words, the historical dosage database provides a safety adjustment reference, not a basis for exceeding dosage limits. If the dosage corresponding to historical dosing information is higher than the current clinical medication guidelines' upper limit, that historical dosage should not be used as the current adjustment result.

[0041] In one specific embodiment, before drug administration, patient identity information is obtained. The patient's wristband identification code matches the patient information in the doctor's order, and the patient's name, hospital number, and bed number all match the doctor's order record. The doctor's order information is then obtained; the order status is "approved," indicating the prescribing physician has the authority to prescribe the drug. The drug's comprehensive information is then obtained through the drug barcode. If the drug name, specifications, and dosage form match the doctor's order information, basic medication confirmation is passed. Patient height, weight, liver function, kidney function, allergy history, and concomitant medication information are obtained, and the contraindications, precautions, and interactions corresponding to the current drug are extracted from clinical drug use guidelines. If it is determined that the patient has no history of allergy to the drug, no contraindicated concurrent medications, and the current single dose, total daily dose, and dosing frequency do not exceed the corresponding upper limits, then the dosage adjustment analysis begins. If the efficacy evaluation indicators corresponding to the current drug treatment target have not reached the preset efficacy target, and the safety evaluation indicators are still within the safe range, the efficacy evaluation result is insufficient, and the safety evaluation result is normal. An incremental adjustment result is then generated, and the historical dosage database is further queried. The historical drug dosage database contains past usage information for the same drug. Records show that, under the same route of administration, slightly increasing the single dose improved the therapeutic effect from insufficient to satisfactory, without any safety abnormalities. Therefore, this historical usage information can be used as a reference to make safe adjustments to the dosage, daily total dose, and frequency limits, provided they do not exceed the upper limits of clinical drug use guidelines.

[0042] In summary, the first layer of basic medication confirmation—confirming patient identity, medication order validity, and drug compatibility—can eliminate fundamental risks such as incorrect patient selection, invalid medication orders, and drug incompatibility before dosage adjustment. The second layer of individualized risk confirmation—confirming patient physical condition, patient differences, clinical medication guidelines, drug interactions, and dosage exceedances—can identify individualized risks arising from allergies, adverse reaction history, and concomitant medications before dosage adjustment. By jointly assessing efficacy and safety indicators, dosage adjustments can be categorized into incremental adjustments, maintenance adjustments, dose reduction adjustments, and emergency discontinuation, avoiding blindly increasing dosages based solely on insufficient efficacy and avoiding maintaining the original dosage when safety abnormalities occur. Utilizing historical dosage databases to conduct safe adjustments based on incremental or dose reduction results allows for reference of past efficacy and adverse reaction improvements, enhancing the safety of dosage adjustments.

[0043] Based on another preferred embodiment described above, see [link to preferred embodiment]. Figure 3 As shown, this embodiment provides a dosage safety adjustment system based on double confirmation, used to apply the above-described dosage safety adjustment method based on double confirmation, including: The first confirmation module is configured to obtain patient identity information, medical order information, and comprehensive drug information, and to perform basic medication confirmation on patient identity, medical order validity, and drug information. If there is an inconsistency in identity, invalid medical order, or drug mismatch in the basic medication confirmation, a medication interception result is generated. The second confirmation module is configured to obtain patient body information and patient difference information if the basic medication confirmation is passed, and generate risk conditions based on clinical medication guidelines. If there are drug interactions or dosage exceedances, a prohibition on drug administration result is generated. If the risk factors do not meet the risk conditions, a dosage adjustment analysis is performed. The dosage adjustment module is configured to perform dosage adjustment analysis, including obtaining efficacy evaluation indicators and safety evaluation indicators. The efficacy evaluation indicators are the degree of improvement of symptoms corresponding to the current drug treatment target, and the safety evaluation indicators are the degree of adverse reactions. Based on the efficacy evaluation indicators and safety evaluation indicators, it generates incremental adjustment results, maintenance adjustment results, dosage reduction adjustment results and emergency discontinuation results, and performs safety adjustments on the incremental adjustment results or dosage reduction adjustment results based on the historical dosage database.

[0044] It is understandable that the above-mentioned method and system for safe dosage adjustment based on double confirmation have the same beneficial effects, and will not be elaborated further here.

[0045] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that modifications or equivalent substitutions can still be made to the specific implementation of the present invention. Any modifications or equivalent substitutions that do not depart from the spirit and scope of the present invention should be covered within the scope of protection of the claims of the present invention.

Claims

1. A method for safe dosage adjustment based on double confirmation, characterized in that, include: Obtain patient identity information, medical order information, and comprehensive drug information, and perform basic medication confirmation on patient identity, medical order validity, and drug information. If there is an inconsistency in identity, invalid medical order, or drug mismatch in the basic medication confirmation, a medication interception result is generated. If the basic medication is confirmed, patient body information and patient difference information are obtained, and risk conditions are generated based on clinical medication guidelines. If drug interactions or dosage exceedances exist, a prohibited drug administration result is generated. If the risk factors do not meet the risk conditions, a dosage adjustment analysis is performed. The dosage adjustment analysis includes obtaining efficacy evaluation indicators and safety evaluation indicators. The efficacy evaluation indicators are the degree of improvement of symptoms corresponding to the current drug treatment target, and the safety evaluation indicators are the degree of adverse reactions. Based on the efficacy evaluation indicators and safety evaluation indicators, incremental adjustment results, maintenance adjustment results, dosage reduction adjustment results and emergency discontinuation results are generated, and the incremental adjustment results or dosage reduction adjustment results are safely adjusted based on the historical dosage database.

2. The dosage safety adjustment method based on double confirmation according to claim 1, characterized in that, When confirming basic medication use, the following should be included: The patient identity information includes the patient's name, age, medical record number, hospital number, bed number, and identification code, and the patient identity information is matched with the medical order information; The medical order information includes patient information, order status, order issuance time, issuing physician, route of administration, frequency of administration, single dose, and total daily dose, and the validity of the medical order is determined based on the issuing physician and / or the order status; The comprehensive drug information includes drug name, drug specifications, dosage form, batch number, expiration date, and storage status. The comprehensive drug information is then matched with the drugs in the medical order information.

3. The dosage safety adjustment method based on double confirmation according to claim 2, characterized in that, When generating medication interception results, the following are included: If the patient's identity information is inconsistent with the patient information in the medical order, then an identity inconsistency is determined. If the status of the medical order is discontinued, revoked, or expired, and / or the authorizing physician's authority does not meet the drug prescribing authority, then it is determined that the medical order is invalid. If the drug name, drug specifications, or dosage form are inconsistent with the drug in the medical order information, then a drug mismatch is determined. If there is an inconsistency in identity, invalid medical order, or mismatch in medication when confirming basic medication use, a medication interception result will be generated, and the corresponding interception reason will be determined. If the basic medication confirmation confirms that the patient's identity matches, the doctor's order is valid, and the medication is compatible, then the basic medication confirmation is successful.

4. The dosage safety adjustment method based on double confirmation according to claim 3, characterized in that, When acquiring patient body composition information and patient variation information, and generating individualized risk conditions based on clinical medication guidelines, this includes: The patient's physical information includes height and weight; The patient-specific information includes liver function information, kidney function information, pregnancy information, lactation information, allergy history information, and adverse reaction information. Based on the clinical medication guidelines, contraindications, precautions, and interactions are extracted and used as individualized risk conditions.

5. The dosage safety adjustment method based on double confirmation according to claim 4, characterized in that, When acquiring patient body shape information and patient difference information, and generating individualized risk conditions based on clinical medication guidelines, the following also applies: If the medication in the medical order information is a weight-based medication, then the individual recommended dose is determined based on the weight and the unit weight dose of the clinical medication guidelines; If the medication in the medical order information is a medication administered based on body surface area, then the body surface area is determined based on the height and weight, and the individual recommended dose is determined based on the body surface area and the dose per unit body surface area in the clinical medication guidelines.

6. The dosage safety adjustment method based on double confirmation according to claim 5, characterized in that, If drug interactions or dosage exceedances are present, a prohibition on dosing result will be generated, including: Based on the comprehensive drug information, information on combined medication use is obtained, and the combined medication use information is matched with the interaction conditions; If the combined medication information contains drugs that are contraindicated for use with the medication prescribed, or that enhance toxicity, efficacy, or safety, then a drug interaction is determined to exist. The single dose, total daily dose, and frequency of administration are compared with the upper limit of dose, upper limit of total daily dose, and upper limit of frequency in the clinical drug use guidelines, respectively. If any of the single dose, total daily dose, or frequency of administration exceeds the corresponding upper limit, it is determined that the dose exceeds the limit. If the drug interaction or dosage exceedance is present, a prohibition on dosing result is generated; If no drug interaction or dosage exceedance is found, a dosage adjustment analysis is performed.

7. The dosage safety adjustment method based on double confirmation according to claim 6, characterized in that, Also includes: The efficacy evaluation indicators include at least blood pressure, blood glucose, body temperature, coagulation indicators, and imaging improvement; The safety evaluation indicators include at least blood routine, liver function, kidney function, electrolytes, and electrocardiogram QT interval; The efficacy evaluation indicators are compared with the preset efficacy targets to generate efficacy evaluation results, which include insufficient efficacy, efficacy achieved, and efficacy overflow. The safety evaluation indicators are compared with preset safety thresholds to generate safety evaluation results, which include normal safety and abnormal safety.

8. The dosage safety adjustment method based on double confirmation according to claim 7, characterized in that, When generating incremental adjustment results, maintenance adjustment results, dose reduction adjustment results, and emergency discontinuation results based on the efficacy evaluation indicators and safety evaluation indicators, the following are included: If the efficacy evaluation result is insufficient and the safety evaluation result is normal, then an incremental adjustment result is generated. If the efficacy evaluation result indicates that the efficacy target has been achieved, and the safety evaluation result indicates that the safety is abnormal, then a dose reduction adjustment result is generated. If the efficacy evaluation result is that the efficacy target has been achieved and the safety evaluation result is that the safety is normal, then a maintenance adjustment result is generated to maintain the individual recommended dose, the dosing frequency, the single dose, and the total daily dose. If the efficacy evaluation result is efficacy overflow and the safety evaluation result is safety abnormal, or if the efficacy evaluation result is efficacy insufficiency and the safety evaluation result is safety abnormal, then an emergency discontinuation result is generated and medication is stopped.

9. The dosage safety adjustment method based on double confirmation according to claim 8, characterized in that, When making safety adjustments to the incremental or reduced dosage results based on the historical dosage database, the following are included: Obtain information on drugs with insufficient efficacy and their corresponding usage, or information on drugs with abnormal safety and their corresponding usage; The historical drug dosage database includes historical drug information, historical efficacy improvement results, historical response improvement results, and historical dosage information, and the historical drug information, historical efficacy improvement results, historical response improvement results, and historical dosage information correspond one-to-one; The drugs with insufficient efficacy or abnormal safety are traversed in the historical drug dosage database until historical efficacy improvement results are determined to improve insufficient efficacy to efficacy target, or historical response improvement results to safety abnormality to safety normal. The individual recommended dose, the single dose, the total daily dose, and the dosing frequency are adjusted based on the historical dosing information.

10. A dosage safety adjustment system based on double confirmation, used for applying the dosage safety adjustment method based on double confirmation as described in any one of claims 1-9, characterized in that, include: The first confirmation module is configured to obtain patient identity information, medical order information, and comprehensive drug information, and to perform basic medication confirmation on the patient identity, the validity of the medical order, and the drug information. If there is an inconsistency in identity, invalid medical order, or mismatch in drugs in the basic medication confirmation, a medication interception result is generated. The second confirmation module is configured to, if the basic medication confirmation is passed, acquire the patient's body information and patient difference information, and generate risk conditions based on clinical medication guidelines; if there is a drug interaction or dosage exceedance, generate a prohibition on drug administration result; if the risk factors do not meet the risk conditions, perform a dosage adjustment analysis. The dosage adjustment module is configured to perform the dosage adjustment analysis by acquiring efficacy evaluation indicators and safety evaluation indicators. The efficacy evaluation indicators are the degree of improvement of symptoms corresponding to the current drug treatment target, and the safety evaluation indicators are the degree of adverse reactions. Based on the efficacy evaluation indicators and safety evaluation indicators, the module generates incremental adjustment results, maintenance adjustment results, dosage reduction adjustment results and emergency discontinuation results, and performs safety adjustments on the incremental adjustment results or dosage reduction adjustment results based on the historical dosage database.

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