METHODS OF NORMALIZING MEASURED DRUG CONCENTRATIONS AND TESTING FOR NON-COMPLIANCE WITH A DRUG TREATMENT REGIMEN
First Claim
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1. A method of detecting non-compliance with a prescribed opioid regimen in a subject, comprising:
- (a) providing a subject that is prescribed a daily dose of said opioid;
(b) determining a normalized level of said opioid in fluid of the subject;
(c) developing, in a population that does not include said subject, normalized reference opioid levels and confidence intervals corresponding to each of a plurality of daily doses of said opioid;
(d) comparing the normalized level of said opioid in the fluid of said subject to the normalized reference opioid level corresponding to the prescribed daily dose of said opioid;
(e) identifying the subject as non-compliant if the normalized level of said opioid in the fluid of said subject falls outside the confidence interval determined in step (c) corresponding to the subject'"'"'s prescribed daily dose.
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Abstract
Methods for monitoring subject compliance with a prescribed treatment regimen are disclosed. In one embodiment, the method comprises measuring a drug level in fluid of a subject and normalizing said measured drug level as a function of one or more parameters associated with the subject. The normalized drug level is compared to a reference value and associated confidence intervals or to a concentration range. The reference value and associated confidence intervals and/or the concentration range may be normalized based on one or more parameters associated with subjects in a reference population.
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Citations
61 Claims
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1. A method of detecting non-compliance with a prescribed opioid regimen in a subject, comprising:
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(a) providing a subject that is prescribed a daily dose of said opioid; (b) determining a normalized level of said opioid in fluid of the subject; (c) developing, in a population that does not include said subject, normalized reference opioid levels and confidence intervals corresponding to each of a plurality of daily doses of said opioid; (d) comparing the normalized level of said opioid in the fluid of said subject to the normalized reference opioid level corresponding to the prescribed daily dose of said opioid; (e) identifying the subject as non-compliant if the normalized level of said opioid in the fluid of said subject falls outside the confidence interval determined in step (c) corresponding to the subject'"'"'s prescribed daily dose. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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25. A method of detecting non-compliance with a prescribed opioid regimen in a subject, comprising:
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(a) identifying a subject'"'"'s prescribed daily dose of said opioid; (b) determining a steady state level of said opioid in urine of the subject; (c) normalizing said steady state level as a function of one or more parameters associated with the subject; (d) developing, in a secondary population that does not include said subject, normalized confidence intervals for urine opioid levels corresponding to each of a plurality of daily doses of said opioid; (e) comparing the normalized steady state level of said opioid in the urine of said subject to the normalized confidence intervals corresponding to each of said plurality of daily opioid doses; and (f) identifying the subject as non-compliant if the determined steady state level of said opioid in the urine of said subject does not fall within the normalized confidence intervals corresponding to the subject'"'"'s prescribed daily dose. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32)
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33. A method of determining a subject'"'"'s non-compliance with a prescribed treatment protocol comprising:
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measuring a drug concentration in fluid of the subject; measuring one or more parameters associated with the subject; calculating a normalized drug concentration for the subject as a function of the drug concentration and the one or more measured parameters; developing, in a population that does not include the subject, a normalized reference drug concentration range corresponding to the prescribed treatment protocol; comparing the normalized drug concentration of the subject to the normalized reference drug concentration range; and determining that the subject is non-compliant if the normalized drug concentration of the subject falls outside of the normalized reference drug concentration range. - View Dependent Claims (34, 35, 36, 37, 38, 39, 40, 41, 42, 43)
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44. A method of confirming a subject'"'"'s non-adherence to a chronic opioid therapy regimen comprising:
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prescribing to the subject a chronic opioid therapy regimen, said regimen comprising a daily dose of an opioid; determining, after a time sufficient to achieve steady state, an opioid concentration in the subject; normalizing said opioid concentration; developing, in a secondary population that does not include the subject, a normalized opioid range corresponding to the prescribed daily dose of the opioid; comparing the normalized opioid concentration in the subject to the normalized opioid range corresponding to the prescribed daily dose of the opioid; and determining the subject'"'"'s non-adherence to the chronic opioid therapy regimen if the normalized opioid concentration in the subject falls outside the confidence intervals corresponding to the prescribed daily dose of the opioid. - View Dependent Claims (45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61)
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Specification