Systems and methods for medication monitoring

• US 6,822,554 B2
• Filed: 01/13/2003
• Issued: 11/23/2004
• Est. Priority Date: 01/11/2002
• Status: Active Grant

• Current Assignee: Aardex Group
• Original Assignee: Hexalog SA
• Inventors: Urquhart, John, De Klerk, Erik, Vrijens, Bernard, Metry, Jean-Michel
• Primary Examiner(s): Hofsass, Jeffery
• Assistant Examiner(s): Stone, Jennifer
• Application Number:
  US10/342,655
• Publication Number:
  US 20030135392A1
• Time in Patent Office: 680 Days
• Field of Search: 340/309.16, 340/309.15, 340/309.4, 340/531, 340/534, 340/539.12, 340/3.1, 340/3.3, 340/3.31, 340/3.32, 340/3.34, 706/924, 368/1, 368/10, 128/920, 128/923, 177/25.19, 221/2, 221/8
• US Class Current: 340/309.16
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: Y10S 706/924 Medical

Abstract

The present invention relates to a method and system of medication monitoring which includes analyzing data on the clinical consequences of variable patient compliance with prescribed drug regimens, communicating to caregivers and/or patients the compliance-dependent probabilities of two clinically important transitions in health status: substantive improvement in the patient'"'"'s health status and substantive deterioration in the patient'"'"'s health status, defining acceptable levels of the respective probabilities of deterioration and of improvement, and intervening when appropriate to improve the patient'"'"'s compliance, in order to achieve mutually-agreed upon maintenance, improvement, or avoidance of deterioration in health status.

Claims

1. A method of medication monitoring comprising:

analyzing data on the clinical consequences of variable patient compliance with a prescribed drug regimen to determine the compliance-dependent probabilities of (i) substantive improvement in the patient'"'"'s health status, and (ii) substantive deterioration in the patient'"'"'s health status;

communicating the compliance-dependent probabilities to caregivers and patients;

defining acceptable levels of the probabilities of improvement and deterioration;

prescribing a drug regimen for the patient;

measuring patient compliance with the prescribed drug regimen with a medication dispenser having a recorder for recording dosing events; and

intervening with the patient to improve compliance with an intensity and urgency based on the defined acceptable levels of probabilities.

2. The method of claim 1, wherein the analysis of data on the clinical consequences of variable patient compliance involves the calculation of cubic distance or Timing Error from the variations in intervals between dosages, and which has explanatory power for clinical outcomes superior to that provided by other parameters derived from patients'"'"' dosing histories.

3. The method of claim 1, wherein step of intervening involves warning the patient with a graduating warning system including different colored lights on the medication dispenser.

4. The method of claim 1, wherein the step of intervening involves warning the patient by a remote warning center after communication between the remote warning center and electronics associated with the medication dispenser.

5. The method of claim 1, wherein substantive improvement and deterioration in the patient'"'"'s health status occurs when a measurement of a patient'"'"'s health indicator changes between predetermined levels of the health indicator.

6. The method of claim 5, wherein the patient'"'"'s health indicator is the viral load and the predetermined levels each include a range of viral loads.

7. A method of medication monitoring comprising the steps of:

identifying a patient with a condition treatable with a prescribed drug regimen;

prescribing a drug regimen for the patient;

defining an acceptable level of compliance with the prescribed drug regimen, based on an analysis of clinical compliance data involving the calculation of a parameter, cubic distance or Timing Error, from the variations in intervals between dosages;

monitoring compliance of the patient with the prescribed drug regimen with a medication dispenser having a recorder for recording dosing events; and

warning the patient with a graduated warning system that is based on the defined acceptable level of compliance.

8. The method of claim 7, wherein the patient is warned with a graduating warning system including differently colored lights on the medication dispenser.

9. The method of claim 7, wherein the patient is warned by a remote warning center after communication between the remote warning center and electronics associated with the medication dispenser.

10. The method of claim 7, wherein the step of defining an acceptable level of compliance involves accessing the clinical compliance data for the particular drug regimen, wherein the clinical compliance data includes both a probability of improvement in patient health and a probability of deterioration in patient health.

11. The method of claim 7, wherein the step of defining an acceptable level of compliance involves accessing the clinical compliance data for the particular drug regimen, wherein the clinical compliance data is broken down into categories based on patient health status.

12. The method of claim 7, comprising a step of compiling a drug dosing history from the recorded dosing events and reviewing the defined acceptable level of compliance based on the drug dosing history.

13. A method of medication monitoring comprising:

analyzing data on the clinical consequences of variable patient compliance with a prescribed drug regimen to determine the compliance-dependent probabilities of (i) substantive improvement in the patient'"'"'s health status, and (ii) substantive deterioration in the patient'"'"'s health status;

defining patient acceptable levels of the probabilities of improvement and deterioration;

measuring patient compliance with the prescribed drug regimen with a medication dispenser having a recorder for recording dosing events; and

intervening with the patient to improve compliance when the defined acceptable levels of probabilities are exceeded.

14. The method of claim 13, wherein the analysis of data on the clinical consequences of variable patient compliance involves the calculation of cubic distance or Timing Error from the variations in intervals between dosages, and which has explanatory power for clinical outcomes superior to that provided by other parameters derived from patients'"'"' dosing histories.

15. The method of claim 13, wherein step of intervening involves warning the patient with a graduating warning system including different colored lights on the medication dispenser.

16. The method of claim 13, wherein the step of intervening involves warning the patient by a remote warning center after communication between the remote warning center and electronics associated with the medication dispenser.

17. The method of claim 13, wherein substantive improvement and deterioration in the patient'"'"'s health status occurs when a measurement of a patient'"'"'s health indicator changes between predetermined levels of the health indicator.

18. The method of claim 17, wherein the patient'"'"'s health indicator is the viral load and the predetermined levels each include a range of viral loads.

19. The method of claim 13, comprising a step of compiling a drug dosing history from the recorded dosing events and reviewing the defined acceptable level of compliance based on the drug dosing history.

20. A system for medication monitoring comprising:

a computer readable medium containing executable code for;

analyzing data on the clinical consequences of variable patient compliance with a prescribed drug regimen to determine the compliance-dependent probabilities of (i) substantive improvement in the patient'"'"'s health status, and (ii) substantive deterioration in the patient'"'"'s health status; and

communicating the compliance-dependent probabilities to caregivers and patients; and

a medication dispenser having a recorder for recording dosing events a warning system for warning the patient of non-compliance with an intensity and urgency based on defined acceptable levels of probabilities.

21. The system of claim 20, wherein the analysis of data on the clinical consequences of variable patient compliance involves calculation of cubic distance or Timing Error from the variations in intervals between dosages.

22. The system of claim 20, wherein the medication dispenser comprises a graduating warning system including different colored lights.

23. The method of claim 20, wherein the medication dispenser delivers a signal to a remote warning center.