Method and device for monitoring medication usage
AssigneeMarshfield Clinic
InventorsMichael E.M. Larson, Thomas M. Richards
Life of this patent
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Abstract
The present invention provides methods for detecting and quantifying metabolites in a biological sample by measuring the concentration of a test metabolite in the sample and comparing that concentration against the concentration of the reference metabolite; enabling accurate metabolite concentration measurements to determine aberrant drug usage patterns. Also disclosed is an analytical testing device and related computer-assisted products for detecting and quantifying metabolites in a biological sample efficiently and accurately.
Claims20
A method of determining a drug dose taken by a subject, the method comprising:
- (a) determining a concentration of a test metabolite and a reference metabolite in a biological sample obtained from a subject, wherein the test metabolite is the drug or a metabolite of the drug;
- (b) determining the normalized concentration of the test metabolite in the biological sample as a ratio of the concentration of the test metabolite to the concentration of the reference metabolite;
- and
- (c) determining the drug dose taken by the subject by using a database to determine the drug dose that is correlated with the normalized concentration of the test metabolite obtained in step (b), wherein the database comprises (i) dose of the drug taken by a reference population;
- (ii) reference metabolite concentration in a medium of biological sampling obtained from the reference population, and (iii) test metabolite concentration in the medium of biological sampling obtained from the reference population.
The method of claim 5, wherein concentration of the reference metabolite is determined using gas chromatography, tandem gas chromatography-mass spectroscopy, or a test strip.
An interindividual method of determining a drug dose taken by a subject, the method comprising:
- determining a concentration of a test metabolite and a concentration of a reference metabolite in a biological sample obtained from a subject, wherein the test metabolite is the drug or a metabolite of the drug;
- determining a normalized concentration of the test metabolite in the biological sample as a ratio of the concentration of the test metabolite to the concentration of the reference metabolite;
- and
- using the normalized concentration of the test metabolite to determine the drug dose taken by the subject, without accounting for any variations between individuals other than reference metabolite concentration.
A method of monitoring possible non-adherence to a prescribed medication regimen comprising the steps of:
- (a) determining a concentration of a reference metabolite and a concentration of a test metabolite in a biological sample from a patient receiving a prescribed medication regimen;
- (b) determining a normalized test metabolite concentration that is adjusted for changes in hydration status of the patient as a ratio of the test metabolite concentration to reference metabolite concentration in the biological sample;
- (c) using a database to determine a test metabolite/reference metabolite ratio that is correlated with the prescription medication dosage of the prescribed medication regimen, wherein the database comprises (i) prescription medication dosage administered to a reference population that is receiving the prescribed medication regimen;
- (ii) test metabolite concentration specific to a medium of biological sampling of the reference population, and (iii) reference metabolite concentration specific to a medium of biological sampling of the reference population,
- wherein a mismatch between the test metabolite/reference metabolite ratio that is correlated with the prescription medication dosage of the prescribed medication regimen as determined in step (c) and the normalized test metabolite concentration determined in step (b) indicates non-adherence to the prescribed medication regimen.
Dependencies are inferred from the claim text.