Method and device for monitoring medication usage

• US 7,785,895 B2
• Filed: 08/03/2009
• Issued: 08/31/2010
• Est. Priority Date: 08/28/2003
• Status: Active Grant

• Current Assignee: Marshfield Clinic
• Original Assignee: Marshfield Clinic
• Inventors: Larson, Michael E. M., Richards, Thomas M.
• Primary Examiner(s): Hill, Jr.; Robert J
• Assistant Examiner(s): Gerido; Dwan A
• Application Number:
  US12/534,503
• Publication Number:
  US 20090291468A1
• Time in Patent Office: 393 Days
• Field of Search: 436/169, 436/171, 436/111, 436/808, 436/901, 436/96, 436/98
• US Class Current: 436/169
• CPC Class Codes: G01N 33/70 involving creatine or creatinine
• CPC Class Codes: G01N 33/94 involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
• CPC Class Codes: G01N 33/946 CNS-stimulants, e.g. cocaine, amphetamines
• CPC Class Codes: G01N 33/9486 Analgesics, e.g. opiates, aspirine
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/901 Drugs of abuse, e.g. narcotics, amphetamine
• CPC Class Codes: Y10T 436/141111 Diverse hetero atoms in same or different rings [e.g., alkaloids, opiates, etc.]
• CPC Class Codes: Y10T 436/145555 Hetero-N
• CPC Class Codes: Y10T 436/147777 Plural nitrogen in the same ring [e.g., barbituates, creatinine, etc.]
• CPC Class Codes: Y10T 436/173845 Amine and quaternary ammonium

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.

Claims

1. A method for quantifying at least one metabolite in at least one biological sample comprising the steps of:

(a) providing at least one biological sample obtained from a patient on a prescribed medication regimen, wherein the biological sample comprises at least one test metabolite;

(b) providing one set of known normative data specific to a reference metabolite, wherein the set of data is collected from a population that is on a prescribed medication regimen;

(c) contacting the biological sample with an analytical device;

(d) detecting the presence of at least one test metabolite in the biological sample with the device, wherein the device is capable of measuring the concentration of the test metabolite in the at least one biological sample;

(e) normalizing the biological sample to adjust for changes in the patient'"'"'s hydration status by determining the metabolite/creatinine ratio of the patient; and

(f) quantifying the concentration of at least one test metabolite in the biological sample by comparing a ratio between the concentration of the test metabolite from the patient to the set of known normative data specific to the reference metabolite concentration.

2. The method of claim 1, further comprising using the ratio between the concentration of the test metabolite to the set of known normative data to identify nonadherence to a prescribed medication regimen.

3. The method of claim 1, wherein the device is a test strip.

4. The method of claim 1, wherein the biological sample is selected from the group consisting of urine, blood, saliva, sweat, spinal and brain fluids.

5. The method of claim 1, wherein the metabolite to be quantified is selected from the group consisting of oxycodone, morphine, codeine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidone (EDDP), fentanyl, propoxyphene, hydrocodone, amphetamine, diazepam/temazepam, alphahydroxyalprazolam, and lorazepam.

6. A method of monitoring nonadherence to a prescribed medication regimen comprising the steps of:

(a) providing at least one biological sample obtained from a patient on a prescribed medication regimen, wherein the biological sample comprises at least one test metabolite;

(b) providing one set of known normative data specific to a reference metabolite, wherein the set of data is collected from a population that is on a prescribed medication regimen;

(c) contacting the biological sample comprising a test metabolite with an analytical device;

(d) detecting the presence of at least one test metabolite in a biological sample with the device, wherein the device is capable of measuring the concentration of the test metabolite in the at least one biological sample;

(e) normalizing the biological sample to adjust for changes in the patient'"'"'s hydration status by determining the metabolite/creatinine ratio of the patient; and

(f) quantifying the concentration of at least one test metabolite in the biological sample by comparing a ratio between the concentration of the test metabolite from the patient to the set of known normative data specific to the reference metabolite concentration determining non-adherence to a prescribed medication regimen, and wherein non-adherence is defined as overuse or underuse of the prescribed medication.

7. The method of claim 6, wherein the device is a test strip.

8. The method of claim 6, wherein the biological sample is selected from the group consisting of urine, blood, saliva, sweat, spinal and brain fluids.

9. The method of claim 6, wherein the test metabolite is selected from the group consisting of oxycodone, morphine, codeine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidone (EDDP), fentanyl, propoxyphene, hydrocodone, amphetamine, diazepam/temazepam, alphahydroxyalprazolam, and lorazepam.