System for monitoring regulation of pharmaceuticals from data structure of medical and laboratory records

• US 20070033075A1
• Filed: 10/16/2006
• Published: 02/08/2007
• Est. Priority Date: 08/31/1999
• Status: Active Grant

• Current Assignee: Provantage Corporation, Express Scripts Strategic Development, Inc. (The Cigna Group)
• Original Assignee: Medco Health Solutions Incorporated (The Cigna Group)
• Inventors: Parr, Monique, Hoffman, Peter
• Granted Patent: US 7,853,458 B2
• Time in Patent Office: Days
• US Class Current: 705/3
• CPC Class Codes: G06F 16/00 Information retrieval; Database structures therefor; File system structures therefor
• CPC Class Codes: G06Q 10/00 Administration; Management
• CPC Class Codes: G06Q 30/02 Marketing; Price estimation or determination; Fundraising
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 70/60 relating to pathologies
• CPC Class Codes: Y10S 707/99931 Database or file accessing

Abstract

A system is provided that integrates of records of clinical laboratory services into the assessment and optimization of patient health care and, in particular, regulation of the use of pharmaceuticals. Laboratory test result records are used in conjunction with other health care benefits records to monitor regulation of use of pharmaceuticals by patients. The incorporation of laboratory tests and results into such a utilization system allows improvement in the management of a patient'"'"'s therapy based on a more precise picture of the patient'"'"'s level of illness as revealed by the laboratory test results. The system of the present invention also allows optimization of the selection of laboratory tests to be performed, and also provides an outcome assessment of the risk of hospitalization due to pharmaceutical treatments resulting in physician intervention, leading to a change in physician prescribing behavior and, accordingly, a decrease in drug induced hospitalizations and improved quality of patient care and savings of health care costs.

Claims

1. A system for reducing the risk of a drug therapy related illness in a patient, the system comprising:

at least one medical records database comprising;

i) drug therapy records, said drug therapy records including an indication of patient identification and an indication of prescribed drug therapy associated with said patient identification, and ii) laboratory test result records, said laboratory test result records including an indication of patient identification and an indication of laboratory test results associated with said patient identification;

a medical information database, said medical information database including criteria pertaining to;

i) interactions between a first drug and a second drug;

ii) a relationship between the first drug and a first disease; and

iii) administration of a laboratory test in connection with the administration of the first drug; and

a search and determination engine for reviewing said laboratory test result records, said drug therapy records and said medical information database criteria, and for determining an output for reducing the risk of the drug therapy related illness in the patient using said laboratory test result records, said drug therapy records and the medical information database criteria by determining a drug interaction indicating initiation of the first drug in a patient with current usage of the second drug, including;

(i) detecting the usage of the second drug concurrently with the first drug, (ii) monitoring for a laboratory report, (iii) generating an alert to the user of the system if such a report is not found, (iv) generating an alert to warn the user of the system about possible interaction effects between the first drug and the second drug;

or (v) generating an alert to warn the user of the system of the need for particular tests from the laboratory to monitor the levels of the first and/or second drugs, and said search and determination engine determining the output for reducing the risk of the drug therapy related illness in the patient (PATIENT1) using said laboratory test result records, said drug therapy records and said medical information database criteria by performing one or more of the following functions;

a monitor drug initiation function determining that PATIENT1 has been prescribed a first drug (DRUG A), detecting of initiation of DRUG A, monitoring for a first laboratory report (LAB1) within X days after initiation of DRUG A for duration period of Z days, and generating an alert is provided to the user if LAB1 indicates that no test has been run during the current period after initiation, and wherein the monitoring of lab testing after initiation of treatment with DRUG A provides information regarding level of DRUG A in patient and effectiveness of DRUG A as treatment;

a monitor drug frequency function determining that PATIENT1 has been provided two treatment phases of DRUG A including detecting of start of second treatment phase of DRUG A, monitoring for report from LAB1 every X days for duration period of Z days, and generating an alert to the user if LAB1 indicates that it has not run at least one test during each period of X days for duration period of Z days, or generating an alert to the user about the effectiveness of DRUG A for a second treatment phase for the disease indicated in the record, and wherein the monitoring of lab information regarding further treatment phases provides information about effectiveness of DRUG A as a treatment;

a monitor drug dosage changes function determining that PATIENT1 has been provided with a change in dosage level of greater than 50% of the previous dose of DRUG A including detecting of change in dosage level of DRUG A, monitoring for report from LAB1 every X days for duration period of Z days, and generating an alert to the user if LAB1 indicates that it has not run at least one test during the period of X days for duration period of Z days, or generating an alert about the level of dosage of DRUG A in the patient and the effectiveness of particular dosage levels of DRUG A for the treatment of the indicated disease;

a monitoring of disease function determining that PATIENT1 has DISEASE A including detecting of presence of DISEASE A, monitoring for report from LAB1 within X days after first indication of DISEASE A for duration period of Z days, and generating an alert to the user if such a report is not found or generating an alert about the effectiveness of particular drugs or the need for particular tests from the laboratory;

a drug discontinuation function determining discontinuation of a second drug (DRUG B) in PATIENT1 who is currently using DRUG A including detecting of discontinuation of DRUG B by user of DRUG A, monitoring for a report from LAB1 within X+30 days after the last use of DRUG B, and generating an alert to the user if the report is not found or generating an alert to the user about possible effects from the discontinuation of DRUG B;

a subtherapeutic drug dosage level function determining that LAB1 result is below the lower range indicating a subtherapeutic dosage of DRUG A including detecting of usage of DRUG A, monitoring for report from LAB1 within 30 days of first usage of DRUG A in order to monitor blood level, detecting of subtherapeutic dosage of DRUG A, and generating an alter to the user about the dosage level of DRUG A;

a toxic drug dosage level function determining that LAB1 result is above the normal range indicating a toxic dosage level of DRUG A including detection of usage of DRUG A, monitoring for report from LAB1 within 30 days of first usage of DRUG A in order to monitor blood level, detection of toxic dosage of DRUG A, and generating an alert to the user about the dosage level of DRUG A;

a disease (condition) reevaluation function determining that LAB1 result is below the lower range or above the upper range indicating a reevaluation of the diagnosis or condition as DISEASE A including detection of diagnosis of DISEASE A, and monitoring for report from LAB1 within 30 days of diagnosis for lab markers indicating correct diagnosis of disease;

a lab marker positives or negatives function determining that LAB1 result is positive or is negative suggesting a reevaluation of the diagnosis or condition as DISEASE A including detection of diagnosis of DISEASE A, and monitoring for report from LAB1 with lab markers indicating correct diagnosis of disease;

a false positives, false negatives or other result interference function determining that DRUG A or DISEASE A interferes with LAB1 and may lead to false positive, false negative, falsely elevated, falsely decreased or other improper influences on the results, and generating an alert to a user suggesting alternative test or other mechanism to minimize or eliminate the influence of DRUG A and/or DISEASE A on the results at LAB1;

a frequency of testing function determining normal or abnormal results obtained at LAB1, and generating an alert sent to user that abnormal result indicates that LAB1 test should be performed again or every X days, and generating an alert sent to user that normal result indicates that LAB1 test should be performed no more than every X days;

an inappropriate conditions function determining that use of LAB1 results in patients with DISEASE A is not valid, and generating an alert sent to user to modify conditions at LAB1 or use a second laboratory test (LAB2) for DISEASE A;

an obsolete tests function determining that LAB1 is using obsolete tests, and generating an alert to user; and

a duplicative tests function determining that LAB1 and LAB2 measure the same functional area and are considered duplicative, and generating an alert to user, and

wherein said system provides an output for the patient, to at least one of;

(1) a treatment provider of the patient;

or (2) a user of the system, wherein the output indicates the need for a laboratory test to be performed in connection with the care of said patient, and provides an alert to said treatment provider to prescribe said laboratory test, wherein said prescribing results in reducing the risk of a drug therapy related illness in said patient.

2. The system of claim 1 wherein said medical records database further comprises patient health records, said patient health records including an indication of a disease diagnosis associated with said patient identification.

3. The system of claim 1 wherein said search engine reviews said patient health records and said medical information database criteria, and provides an output indicating the potential for a false positive or false negative laboratory result, thereby indicating the need for a reevaluation of a diagnosis of disease.

4. The system of claim 1 wherein said drug therapy records include pharmaceutical benefit claims.

5. The system of claim 1 wherein said criteria in said medical information database comprises data pertaining to at least one of:

(1) drug treatment guidelines, (2) textbooks, (3) journals, (4) pharmaceutical manufacturer guidelines and (5) FDA requirements.

6. The system of claim 1 wherein said absence of the laboratory test pertains to a need for a laboratory test pursuant to a change in a prescribed dosage level of the prescribed drug.

7. The system of claim 1 wherein when the second drug comprises insulin, the first drug is in the sulfonylurea class, and the laboratory test referred to in the output pertains to the patient'"'"'s blood glucose level.

8. The system of claim 1 wherein said alert indicates a need to increase or decrease the dosage level of a prescribed drug which has been prescribed for the patient.

9. The system of claim 1 wherein the alert comprises a recommendation to perform a laboratory test, wherein the results of said laboratory test are useful in reducing the likelihood of a false positive output or a false negative output.

10. The system of claim 1 wherein said search engine review further includes:

detection of abnormal laboratory test results indicating the need for an additional laboratory test.

11. The system of claim 1 wherein said search engine review identifies conflicts between said prescribed drug therapy and said criteria for drug usage regulation, said conflicts being quantified by risk factors relating to risk of drug induced hospitalization.

12. The system of claim 1 wherein said risk factors include an assessment of factors relating to:

(1) patient age, (2) patient sex, (3) number of drugs prescribed to a patient, (4) number of physicians treating a patient, (5) number of pharmacies prescribing drugs to a patient, (6) number of laboratory tests, and (7) number of laboratory test triggering conflicts.

13. The system of claim 1 wherein said patients having said identified conflicts are prioritized based on risk of drug-induced hospitalization.

14. The system of claim 1, wherein the alert further includes an indication of a need for the patient to undergo a liver function test.

15. A system for detecting a subtherapeutic drug dosage or a toxic drug dosages in a patient receiving drug therapy, said system comprising:

at least one medical records database comprising;

i) drug therapy records, said drug therapy records including an indication of patient identification and an indication of prescribed drug therapy associated with said patient identification, and ii) laboratory test result records, said laboratory test result records including an indication of patient identification and an indication of laboratory test results associated with said patient identification;

a medical information database, said medical information database including criteria for drug usage regulation; and

a search and determination engine receiving a user query and reviewing at least a portion of said laboratory test result records and at least a portion of at least one of said drug therapy records and said criteria for drug usage regulation, and determining an output for detecting a subtherapeutic drug dosage or a toxic drug dosages in a patient receiving drug therapy, wherein said laboratory test result records, said drug therapy records and said medical information database criteria are used for the determining of the output, and said search and determination engine determines the output for reducing the risk of the drug therapy related illness in the (PATIENT1) using said laboratory test result records, said drug therapy records and said medical information database criteria by performing at least one of the following functions;

a monitor drug Initiation function determining that PATIENT1 has been prescribed a first drug (DRUG A), detecting of initiation of DRUG A, monitoring for a first laboratory report (LAB1) within X days after initiation of DRUG A for duration period of Z days, and generating an alert is provided to the user if LAB1 indicates that no test has been run during the current period after initiation, and wherein the monitoring of lab testing after initiation of treatment with DRUG A provides information regarding level of DRUG A in patient and effectiveness of DRUG A as treatment;

a monitor drug frequency function determining that PATIENT1 has been provided two treatment phases of DRUG A including detecting of start of second treatment phase of DRUG A, monitoring for report from LAB1 every X days for duration period of Z days, and generating an alert to the user if LAB1 indicates that it has not run at least one test during each period of X days for duration period of Z days, or generating an alert to the user about the effectiveness of DRUG A for a second treatment phase for the disease indicated in the record, and wherein the monitoring of lab information regarding further treatment phases provides information about effectiveness of DRUG A as a treatment;

a monitor drug dosage changes function determining that PATIENT1 has been provided with a change in dosage level of greater than 50% of the previous dose of DRUG A including detecting of change in dosage level of DRUG A, monitoring for report from LAB1 every X days for duration period of Z days, and generating an alert to the user if LAB1 indicates that it has not run at least one test during the period of X days for duration period of Z days, or generating an alert about the level of dosage of DRUG A in the patient and the effectiveness of particular dosage levels of DRUG A for the treatment of the indicated disease;

a monitoring of disease function determining that PATIENT1 has DISEASE A including detecting of presence of DISEASE A, monitoring for report from LAB1 within X days after first indication of DISEASE A for duration period of Z days, and generating an alert to the user if such a report is not found or generating an alert about the effectiveness of particular drugs or the need for particular tests from the laboratory;

a drug discontinuation function determining discontinuation of a second drug (DRUG B) in PATIENT1 who is currently using DRUG A including detecting of discontinuation of DRUG B by user of DRUG A, monitoring for a report from LAB1 within X+30 days after the last use of DRUG B, and generating an alert to the user if the report is not found or generating an alert to the user about possible effects from the discontinuation of DRUG B;

a subtherapeutic drug dosage level function determining that LAB1 result is below the lower range indicating a subtherapeutic dosage of DRUG A including detecting of usage of DRUG A, monitoring for report from LAB1 within 30 days of first usage of DRUG A in order to monitor blood level, detecting of subtherapeutic dosage of DRUG A, and generating an alter to the user about the dosage level of DRUG A;

a toxic drug dosage level function determining that LAB1 result is above the normal range indicating a toxic dosage level of DRUG A including detection of usage of DRUG. A, monitoring for report from LAB1 within 30 days of first usage of DRUG A in order to monitor blood level, detection of toxic dosage of DRUG A, and generating an alert to the user about the dosage level of DRUG A;

a disease (condition) reevaluation function determining that LAB1 result is below the lower range or above the upper range indicating a reevaluation of the diagnosis or condition as DISEASE A including detection of diagnosis of DISEASE A, and monitoring for report from LAB1 within 30 days of diagnosis for lab markers indicating correct diagnosis of disease;

a lab marker positives or negatives function determining that LAB1 result is positive (when DISEASE A should indicate negative) or is negative (when DISEASE A should indicate positive) suggesting a reevaluation of the diagnosis or condition as DISEASE A including detection of diagnosis of DISEASE A, and monitoring for report from LAB1 with lab markers indicating correct diagnosis of disease;

a false positives, false negatives or other result interference function determining that DRUG A or DISEASE A interferes with LAB1 and may lead to false positive, false negative, falsely elevated, falsely decreased or other improper influences on the results, and generating an alert to a user suggesting alternative test or other mechanism to minimize or eliminate the influence of DRUG A and/or DISEASE A on the results at LAB1;

a frequency of testing function determining normal or abnormal results obtained at LAB1, and generating an alert sent to user that abnormal result indicates that LAB1 test should be performed again or every X days, and generating an alert sent to user that normal result indicates that LAB1 test should be performed no more than every X days;

an inappropriate conditions function determining that use of LAB1 results in patients with DISEASE A is not valid, and generating an alert sent to user to modify conditions at LAB1 or use a second laboratory test (LAB2) for DISEASE A;

an obsolete tests function determining that LAB1 is using obsolete tests, and generating an alert to user; and

a duplicative tests function determining that LAB1 and LAB2 measure the same functional area and are considered duplicative, and generating an alert to user, and

wherein said system provides an output for the patient, wherein the output indicates at least one of;

i) an alert suggesting that a laboratory tests be performed to detect a toxic dosage of a drug that is being administered to the patient; and

ii) an alert suggesting that a laboratory test be performed to detect a subtherapeutic dosage of a drug that is being administered to the patient.

16. A computer-implemented and human-assisted method for identifying a risk of drug induced hospitalization, comprising:

providing a medical information database comprising criteria pertaining to;

i) at least one drug that is contraindicated in the presence of at least one disease;

ii) at least one-interaction between a first prescribed drug and a second prescribed drug, wherein the interaction renders one or both of the first and second drugs toxic or subtherapeutic;

iii) criteria for overutilization of a prescribed drug;

iv) criteria for underutilization of a prescribed drug;

v) laboratory test result records, said laboratory test result records including an indication of patient identification and an indication of laboratory test results associated with the patient identification; and

vi) criteria for use of a prescribed drug for an excessive time period;

providing a plurality of drug therapy records comprising a patient identification and a patient prescribed drug therapy;

comparing the drug therapy records and the medical information database to identify patients having at least one criteria as specified in the medical information database;

quantifying the risk of drug induced hospitalization by utilizing;

i) the criteria identified in said comparing step and ii) at least one patient attribute;

identifying patients having a clinically significant risk;

providing a communication to a medical provider, indicating patients having a clinically significant risk and informing the medical provider of the clinically significant risk; and

determining the output for reducing the risk of the drug therapy related illness in the patient (PATIENT1) using said laboratory test result records, said drug therapy records and said medical information database criteria by performing at least one of the following functions;

a monitor drug initiation function determining that PATIENT1 has been prescribed a first drug (DRUG A), detecting of initiation of DRUG A, monitoring for a first laboratory report (LAB1) within X days after initiation of DRUG A for duration period of Z days, and generating an alert is provided to the user if LAB1 indicates that no test has been run during the current period after initiation, and wherein the monitoring of lab testing after initiation of treatment with DRUG A provides information regarding level of DRUG A in patient and effectiveness of DRUG A as treatment;

a monitor drug frequency function determining that PATIENT1 has been provided two treatment phases of DRUG A including detecting of start of second treatment phase of DRUG A, monitoring for report from LAB1 every X days for duration period of Z days, and generating an alert to the user if LAB1 indicates that it has not run at least one test during each period of X days for duration period of Z days, or generating an alert to the user about the effectiveness of DRUG A for a second treatment phase for the disease indicated in the record, and wherein the monitoring of lab information regarding further treatment phases provides information about effectiveness of DRUG A as a treatment;

a monitor drug dosage changes function determining that PATIENT1 has been provided with a change in dosage level of greater than 50% of the previous dose of DRUG A including detecting of change in dosage level of DRUG A, monitoring for report from LAB1 every X days for duration period of Z days, and generating an alert to the user if LAB1 indicates that it has not run at least one test during the period of X days for duration period of Z days, or generating an alert about the level of dosage of DRUG A in the patient and the effectiveness of particular dosage levels of DRUG A for the treatment of the indicated disease;

a monitoring of disease function determining that PATIENT1 has DISEASE A including detecting of presence of DISEASE A, monitoring for report from LAB1 within X days after first indication of DISEASE A for duration period of Z days, and generating an alert to the user if such a report is not found or generating an alert about the effectiveness of particular drugs or the need for particular tests from the laboratory;

a drug discontinuation function determining discontinuation of a second drug (DRUG B) in PATIENT1 who is currently using DRUG A including detecting of discontinuation of DRUG B by user of DRUG A, monitoring for a report from LAB1 within X+30 days after the last use of DRUG B, and generating an alert to the user if the report is not found or generating an alert to the user about possible effects from the discontinuation of DRUG B;

a subtherapeutic drug dosage level function determining that LAB1 result is below the lower range indicating a subtherapeutic dosage of DRUG A including detecting of usage of DRUG A, monitoring for report from LAB1 within 30 days of first usage of DRUG A in order to monitor blood level, detecting of subtherapeutic dosage of DRUG A, and generating an alter to the user about the dosage level of DRUG A;

a toxic drug dosage level function determining that LAB1 result is above the normal range indicating a toxic dosage level of DRUG A including detection of usage of DRUG A, monitoring for report from LAB1 within 30 days of first usage of DRUG A in order to monitor blood level, detection of toxic dosage of DRUG A, and generating an alert to the user about the dosage level of DRUG A;

a disease (condition) reevaluation function determining that LAB1 result is below the lower range or above the upper range indicating a reevaluation of the diagnosis or condition as DISEASE A including detection of diagnosis of DISEASE A, and monitoring for report from LAB1 within 30 days of diagnosis for lab markers indicating correct diagnosis of disease;

a lab marker positives or negatives function determining that LAB1 result is positive (when DISEASE A should indicate negative) or is negative (when DISEASE A should indicate positive) suggesting a reevaluation of the diagnosis or condition as DISEASE A including detection of diagnosis of DISEASE A, and monitoring for report from LAB1 with lab markers indicating correct diagnosis of disease;

a false positives, false negatives or other result interference function determining that DRUG A or DISEASE A interferes with LAB1 and may lead to false positive, false negative, falsely elevated, falsely decreased or other improper influences on the results, and generating an alert to a user suggesting alternative test or other mechanism to minimize or eliminate the influence of DRUG A and/or DISEASE A on the results at LAB1;

a frequency of testing function determining normal or abnormal results obtained at LAB1, and generating an alert sent to user that abnormal result indicates that LAB1 test should be performed again or every X days, and generating an alert sent to user that normal result indicates that LAB1 test should be performed no more than every X days;

an inappropriate conditions function determining that use of LAB1 results in patients with DISEASE A is not valid, and generating an alert sent to user to modify conditions at LAB1 or use a second laboratory test (LAB2) for DISEASE A;

an obsolete tests function determining that LAB1 is using obsolete tests, and generating an alert to user; and

a duplicative tests function determining that LAB1 and LAB2 measure the same functional area and are considered duplicative, and generating an alert to user.