Method of monitoring patient compliance with medications prescriptions

• US 5,908,788 A
• Filed: 08/19/1996
• Issued: 06/01/1999
• Est. Priority Date: 11/02/1993
• Status: Expired due to Term

• Current Assignee: UD Testing Incorporated (U.D. Testing)
• Original Assignee: UD Testing Incorporated (U.D. Testing)
• Inventors: Kell, Michael
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/697,063
• Time in Patent Office: 1,016 Days
• Field of Search: 436/63, 436/111, 436/171, 436/808, 436/901
• US Class Current: 436/111
• CPC Class Codes: G01N 33/493 urine
• CPC Class Codes: G01N 33/9486 Analgesics, e.g. opiates, aspirine
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/816 Alkaloids, amphetamines, and barbiturates
• CPC Class Codes: Y10S 436/901 Drugs of abuse, e.g. narcotics, amphetamine
• CPC Class Codes: Y10T 436/173845 Amine and quaternary ammonium

Abstract

A method of monitoring compliance of a patient that has been placed on a medication maintenance program with a prescribed medication dosage by determining a normalized urine methadone concentration. An unadulterated urine sample is obtained from the patient. The urine methadone concentration and urine specific gravity are measured. The normalized urine medication concentration is calculated as a function of the measured medication concentration in the urine and the urine specific gravity. The calculated normalized urine medication concentration is compared with an expected medication concentration value for the patient for the maintenance program prescribed to determine any significant differences therebetween as an indication of noncompliance. Alternatively, a urinary-parameter normalized urine medication concentration is calculated as a function of the measured medication concentration in the urine, the urine specific gravity and at least one selected pharmacokinetic parameter of the medication. The calculated urinary-parameter normalized urine medication concentration is compared with an expected medication concentration value for an average compliant patient for the maintenance program prescribed to determine any significant differences therebetween as an indication of noncompliance.

Claims

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

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

(b) measuring the concentration of the medication or its metabolites in the urine and the urine specific gravity,

(c) calculating a normalized urine medication concentration as the product of the measured medication concentration in the urine and a specific gravity factor, the specific gravity factor being a ratio of specific gravity of a typical morning void for the general population to the patient measured urine specific gravity, and

(d) comparing the normalized urine medication concentration with an expected medication concentration value for the patient for the maintenance program prescribed to determine any significant differences therebetween as an indication of noncompliance.

2. The method of claim 1 wherein the specific gravity of a typical morning void for the general population has a value of 1.030.

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

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

(b) measuring the concentration of the medication in the urine, the urine specific gravity and at least one selected pharmacokinetic parameter of the medication,

(c) calculating a urinary-parameter normalized urine medication concentration as the product of the measured medication concentration in the urine, a specific gravity factor and the at least one selected pharmacokinetic parameter, the specific gravity factor being a ratio of specific gravity of a typical morning void for the general population to the patient measured urine specific gravity, and

(d) comparing the urinary-parameter normalized urine medication concentration with an expected medication concentration value for an average compliant patient for the maintenance program prescribed to determine any significant differences therebetween as an indication of noncompliance.

4. The method of claim 3 wherein the specific gravity of a typical morning void for the general population has a value of 1.030.

5. A method of monitoring compliance of a patient that has been placed on a methadone maintenance program in accordance with claim 3 and wherein step (b) the concentration of methadone is measured.

6. The method of claim 5 wherein step (b) methadone dose, patient body weight and urine pH are measured as the selected pharmacokinetic parameters.

7. A method of monitoring compliance of a patient that has been placed on a methadone maintenance program which comprises the steps of

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

(b) measuring the concentration of methadone, the specific gravity and the pH value of the urine sample,

(c) calculating the concentration of methadone of the plasma as the product of the measured concentration of methadone of the urine, a specific gravity factor and urine pH, the specific gravity factor being a ratio of specific gravity of a typical morning void for the general population to the patient measured urine specific gravity, and

(d) comparing the calculated concentration of methadone of the plasma with an expected value for the maintenance program prescribed.

8. The method of claim 7 wherein the specific gravity of a typical morning void for the general population has a value of 1.030.