System and method for managing a patient treatment program including a prescribed drug regimen
First Claim
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1. A method of individualizing the treatment of a patient associated with a prescribed drug regimen comprising the steps of:
- developing a pharmacokinetic model, which predicts the drug concentration over time in the patient in response to the drug dosage history of the patient;
developing a pharmacodynamic model, which includes a predicted level of effectiveness for various levels of dosing and various degrees of deviation from prescribed dosing regimen;
prescribing a drug regimen for the patient, designed to achieve a desired pharmacological effect, based upon the pharmacokinetic model and the pharmacodynamic model;
monitoring the adherence of the patient to a prescribed dosing regimen including the degree of deviation;
measuring the pharmacological effect in the patient of the prescribed dosing regimen;
comparing the measured effect with the level of effectiveness, predicted by the pharmacodynamic model, after taking into account the adherence of the patient to the prescribed dosing regimen; and
if the measured effect deviates from the predicted level of effectiveness, performing additional tests to determine the actual drug concentration over time in the particular patient, adjusting the pharmacokinetic model based upon the actual determined drug concentration over time, and adjusting the prescribed drug regimen for the patient to account for adjustments in the pharmacokinetic model.
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Abstract
The present invention relates to a system and method for managing a patient treatment program including a prescribed dosing regimen. The system and method develops and/or makes use of a pharmacokinetic model and a pharmacodynamic model and the monitored adherence of the patient to determine if and when testing should be performed. The system and method further determines if the prescribed dosing regimen should be adjusted, based upon a comparison of the results of the one or more tests and the results predicted by the one or more models.
190 Citations
45 Claims
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1. A method of individualizing the treatment of a patient associated with a prescribed drug regimen comprising the steps of:
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developing a pharmacokinetic model, which predicts the drug concentration over time in the patient in response to the drug dosage history of the patient;
developing a pharmacodynamic model, which includes a predicted level of effectiveness for various levels of dosing and various degrees of deviation from prescribed dosing regimen;
prescribing a drug regimen for the patient, designed to achieve a desired pharmacological effect, based upon the pharmacokinetic model and the pharmacodynamic model;
monitoring the adherence of the patient to a prescribed dosing regimen including the degree of deviation;
measuring the pharmacological effect in the patient of the prescribed dosing regimen;
comparing the measured effect with the level of effectiveness, predicted by the pharmacodynamic model, after taking into account the adherence of the patient to the prescribed dosing regimen; and
if the measured effect deviates from the predicted level of effectiveness, performing additional tests to determine the actual drug concentration over time in the particular patient, adjusting the pharmacokinetic model based upon the actual determined drug concentration over time, and adjusting the prescribed drug regimen for the patient to account for adjustments in the pharmacokinetic model. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 44)
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12. A method of designing a clinical trial, which determines the effectiveness of a drug in producing a desired pharmacological effect over abroad range of patient adherence to a prescribed drug regimen comprising the steps of:
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prescribing a drug regimen for one or more patients;
monitoring the adherence of the one or more patients to the prescribed drug regimen;
measuring the pharmacological effect in the one or more patients at various intervals; and
relating the measured pharmacological effect to the patient adherence and the degree of deviation from the prescribed dosing regimen, if any. - View Dependent Claims (13, 14)
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15. A method of providing patient care comprising:
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prescribing a drug regimen for a patient directed to achieving and maintaining a predetermined level of wellness, when a predetermined level of patient compliance is met or exceeded;
monitoring the adherence of the patient to the prescribed drug regimen;
if the patient compliance level approaches or falls below the predetermined level of patient compliance, comparing the cost of subsequent corrective action in drug dosing, if necessary, to compensate for non-compliant patient behavior with the cost of intervening with the patient to encourage patient compliance, if it is more cost effective to compensate for non-compliant patient behavior by adjusting the drug regimen, than by adjusting the drug regimen, and if it is equally or more cost effective to intervene with the patient to encourage patient compliance, then intervening with the patient; and
if the patient compliance level meets or exceeds the predetermined level of patient compliance, and the predetermined level of wellness fails to be achieved and maintained, determining the need for change in the prescribed drug regimen. - View Dependent Claims (16, 17, 18, 19)
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20. A system for managing a patient treatment program comprising:
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one or more enclosures each containing medication subscribed as part of a prescribed drug regimen for a respective one of the one or more patients, each enclosure being adapted for monitoring the access of the respective patient to the prescribed medication; and
a patient health management computer comprising a communication unit for receiving the access information from each of the one or more enclosures, a processor for executing a plurality of prestored instructions and data including instructions and data for creating and maintaining a pharmacokinetic model, which predicts the drug concentration over time in the patients, based at least in part upon the access information received from the corresponding enclosures, instructions and data for creating and maintaining a pharmacodynamic model, which receives the drug concentration over time predicted by the pharmacokinetic model, and predicts the level of effectiveness for various levels of dosing and various degrees of deviation from the prescribed dosing regimen, and instructions and data for creating and maintaining a decision analytic model, which receives the dosing history, the predicted drug concentration over time in the respective patients, and the predicted levels of effectiveness, for recommending when at least one of one or more tests should be performed on a patient to determine the actual condition of at least one aspect of the patient, and for deciding when the prescribed dosing regimen should be changed, and an interface unit for communicating to a user the recommendation when a test should be performed, and for receiving the results of the tests performed. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 45)
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29. A method for managing an antiretroviral treatment program of a patient including one or more drugs comprising the steps of:
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prescribing a drug regimen for treating a viral infection, the severity of which is represented by a viral load;
if the condition of the patient, including the viral load, does not improve after a predetermined period of time monitoring the adherence of the patient to the prescribed drug regimen including a dosing history, executing a pharmacokinetic model, which receives the dosing history and predicts the drug concentration over time in the patient, executing a pharmacodynamic mode, which receives the drug concentration over time from the pharmacokinetic model and predicts the likelihood of emergence of a drug resistant virus, and executing a decision analytic model, which receives the dosing history, the drug concentration over time, and the likelihood of emergence of a drug resistant virus and determines when at least one of additional tests should be performed and when the prescribed drug regimen should be altered. - View Dependent Claims (30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43)
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Specification