Method of monitoring therapeutic agent consumption

• US 5,776,783 A
• Filed: 09/17/1996
• Issued: 07/07/1998
• Est. Priority Date: 11/02/1993
• Status: Expired due to Term

• Current Assignee: UD Testing Incorporated (U.D. Testing)
• Original Assignee: Private Clinic Laboratories, Inc.
• Inventors: Kell, Michael
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/715,016
• Time in Patent Office: 658 Days
• Field of Search: 436/111, 436/171, 436/808, 436/901
• US Class Current: 436/111
• CPC Class Codes: G01N 33/493 urine
• CPC Class Codes: G01N 33/94 involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
• CPC Class Codes: G01N 33/948 Sedatives, e.g. cannabinoids, barbiturates opiates G01N33/9486
• 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 436/173845 Amine and quaternary ammonium

Abstract

Quantitative compliance markers and associated methods for monitoring patient compliance with medication prescriptions associated with compliance markers have been found to eliminate the need for specific quantitative relationships for each new drug tested. Such compliance markers and methods for monitoring patient compliance utilize pharmacologically inert substances, namely the weak acids benzodiazepines, or non-metabolizable substances in association with an underlying drug at a measurable dosage, so as to correlate compliance marker concentration with underlying medication concentration to determine amount of actual medication ingested.

Claims

1. A method of monitoring compliance of a patient who has been placed on a medication maintenance program with a prescribed medication dosage, and with the method comprising the steps of:

(a) physically associating a compliance marker with a prescribed medication dosage prior to ingestion,

(b) obtaining a sample of the patient'"'"'s urine,

(c) measuring the concentration of the compliance marker and its metabolites in the urine and the urine specific gravity,

(d) calculating a normalized urine compliance marker and its metabolite concentration as a function of the measured compliance marker and its metabolite concentration in the urine and the urine specific gravity adjusted to account for the difference between the urine measured specific gravity and a preselected reference urine specific gravity,

(e) comparing the normalized urine compliance marker and its metabolite concentration with an expected normalized urine compliance marker and its metabolite concentration for the amount of compliance marker prescribed, as an indication of compliance or non-compliance.

2. The method of claim 1 further including the step:

(f) calculating the amount of prescribed medication actually ingested by multiplying the prescribed medication dose with the calculated normalized urine compliance marker and its metabolite concentration, and dividing the product by the expected normalized urine compliance marker and its metabolite concentration.

3. A method of monitoring compliance of a patient who has been placed on a medication maintenance program with a prescribed medication dosage and having a compliance marker physically associated with the medication at a predetermined dosage, and with the method comprising the steps of:

(a) obtaining a sample of the patient'"'"'s urine,

(b) measuring the concentration of the compliance marker and its metabolites in the urine and the urine specific gravity,

(c) calculating a normalized urine compliance marker and its metabolite concentration as a function of the measured compliance marker and its metabolite concentration in the urine and the urine specific gravity adjusted to account for the difference between the urine measured specific gravity and a preselected reference urine specific gravity,

(d) comparing the normalized urine compliance marker and its metabolite concentration with an expected normalized urine compliance marker and its metabolite concentration for the amount of compliance marker prescribed, as an indication of compliance or non-compliance.

4. The method of claim 3 further including the step:

(e) calculating the amount of prescribed medication actually ingested by multiplying the prescribed medication dose with the calculated normalized urine compliance marker and its metabolite concentration, and dividing the product by the expected normalized urine compliance marker and its metabolite concentration.

5. The method of claim 3 wherein step (c) the normalized urine compliance marker and its metabolite concentration is calculated in accordance with the equation

6. The method of claim 3 wherein step (b) the concentration of a benzodiazepine and its metabolites are measured.

7. The method of claim 6 wherein the benzodiazepine is diazepam.

8. The method of claim 6 wherein the benzodiazepine is alprazolam.

9. The method of claim 3 wherein step (b) the concentration of a barbiturate and its metabolites are measured.

10. The method of claim 9 wherein the barbiturate is phenobarbital.

19. A method of claim 3 wherein step (b) the concentration of a weakly acidic medication and its metabolites are measured.

11. A method of monitoring compliance of a patient who has been placed on a medication maintenance program with a prescribed medication dosage and having a compliance marker physically associated with the medication at a predetermined dosage, and with the method comprising the steps of:

(a) obtaining a sample of the patient'"'"'s urine,

(b) measuring the concentration of the compliance marker and its metabolites in the urine and the urine osmolality,

(c) calculating a normalized urine compliance marker and its metabolite concentration as a function of the measured compliance marker concentration and its metabolite in the urine and the urine osmolality,

(d) comparing the normalized urine compliance marker and its metabolite concentration with an expected normalized urine compliance marker and its metabolite concentration value prescribed, as an indication of compliance or non-compliance.

12. The method of claim 11 further including the step:

(e) calculating the amount of prescribed medication actually ingested by multiplying the prescribed medication dose with the calculated normalized urine compliance marker and its metabolite concentration, and dividing the product by the expected normalized urine compliance marker and its metabolite concentration.

13. The method of claim 11 wherein step (c) the normalized urine compliance marker and its metabolite concentration is calculated in accordance with the equation

14. The method of claim 11 wherein step (b) the concentration of a benzodiazepine and its metabolites are measured.

15. The method of claim 14 wherein the benzodiazepine is diazepam.

16. The method of claim 14 wherein the benzodiazepine is alprazolam.

17. The method of claim 11 wherein step (b) the concentration of a barbiturate compliance marker and its metabolites are measured.

18. The method of claim 17 wherein the barbiturate is phenobarbital.

20. A method of claim 11 wherein step (b) the concentration of a weakly acidic medication and its metabolites are measured.