Communications: electrical – Systems – Timer control
Reexamination Certificate
2003-01-13
2004-11-23
Hofsass, Jeffery (Department: 2632)
Communications: electrical
Systems
Timer control
C340S003100, C221S002000, C221S008000, C706S924000, C368S001000
Reexamination Certificate
active
06822554
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to a system and method of monitoring patient compliance with a prescribed drug regimen and warning or prompting the patient based on calculated probabilities of improvement or deterioration of the patient's health.
BACKGROUND OF THE INVENTION
It is now well-established, and well-known to those skilled in the art, that electronic medication event monitoring, also known in the medical literature as MEMS® Monitoring, is the best available method of measuring and compiling the drug dosing histories of ambulatory patients (1-4). Medication dispensers which monitor deviations from a prescribed dosing regimen are described in U.S. Pat. Nos. 4,725,997 and 4,748,600 which are incorporated herein by reference in their entirety.
It is also well-established in the medical literature, and well-known to those skilled in the art, that the actions of prescription drugs depend upon the amount (dose) of drug taken and the time-intervals that separate successive doses of drug. The specifics of the dose- and time-dependent actions of drugs vary, not only from one drug to another, but within the same drug, depending upon how it is formulated (5). Thus, each pharmaceutical product in use poses the question of how best to define its dynamic relations between the history of its dosing and the clinical consequences attributable to the drug's dose- and time-dependent actions. A variety of methods exist to ascertain these dynamic relations, but their applications are in some instances limited by ethical constraints on experimentation with humans and/or by limitations in one's ability to measure appropriate clinical variables. In general, however, one seeks the most robust dynamic model for projecting the clinical effects of the patient's variable exposure to the drug, wherein ‘exposure’ means not only the quantity of drug ingested, but also the time-intervals separating individual doses.
REFERENCES
The following publications are cited in parenthesis in this application. All of the following references are herein incorporated by reference in their entirety to the same extent as if each individual reference was specifically and individually indicated to be incorporated herein by reference in its entirety.
1. Liu H, Golin C E, Miller L G, Hays R D, Beck C K, Sanandaij S, Christian J, Maldonado T, Duran D, Kaplan A, Wenger N S. A comparison study of multiple measures of adherence to HIV protease inhibitors. Ann Inter Med 2001; 134:968-77.
2. Arnsten J, Demas P, Farzadegan H, Grant R, Gourevitch M, Chang C, Buono D, Eckholt H, Howard A, Schoenbaum E. Antiretroviral therapy adherence and viral suppression in HIV-infected drug users: comparison of self-report and electronic monitoring. Clinical Infectious Diseases 2001; 33:1417-23.
3. Cramer J A. Microelectronic system for monitoring and enhancing patient compliance with medication regimens. Drugs 49:321-7, 1995.
4. Urquhart J, de Klerk E. Contending paradigms for the interpretation of data on patient compliance with therapeutic drug regimens. Stat Med 17:251-267, 1998.
5. Urquhart J. Controlled drug delivery: pharmacologic and therapeutic aspects. J Internal Med 248:357-76, 2000.
6. Paterson D L, Swindells S, Mohr J, Brester M, Vergis E N, Squier C, Wagener M M, Singh N. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Int Med 133:21-30, 2000.
7. Gross R, Friedman H M, Bilker W B, Strom B L. Adherence to nelfinavir: magnitude and patterns associated with HIV suppression. Poster presentation at the 40
th
Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, Canada, Poster 790, Sept 17-20, 2000.
8. Urquhart J. Ascertaining how much compliance is enough with outpatient antibiotic regimens. Postgrad Med J 68 (suppl 3): S49-59, 1992.
9. U.S. Pat. No. 4,725,997 to Urquhart J. and Elgie H. assigned to APREX Corp.
10. U.S. Pat. No. 4,748,600 to Urquhart J. assigned to APREX Corp.
11. Turner B J, Hecht F M. Improving on a coin toss to predict adherence to medications. Ann Int Med 134:1004-6, 2001.
SUMMARY OF THE INVENTION
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.
In accordance with one aspect of the present invention, a method of medication monitoring includes the steps of 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.
In accordance with another aspect of the present invention, a method of medication monitoring includes 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, referred to as 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.
In accordance with a further aspect of the present invention, a method of medication monitoring includes the steps of 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.
In accordance with an additional aspect of the present invention, a system for medication monitoring includes a computer-readable medium containing executable code, and a medication dispenser having a recorder for recording dosing events, and a warning system for warning the patient of non-compliance with an intensity and urgency based on a defined acceptable levels of probabilities of treatment-dependent change in health status. The executable code is provided 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 proba
De Klerk Erik
Metry Jean-Michel
Urquhart John
Vrijens Bernard
Hexalog SA
Hofsass Jeffery
Stone Jennifer
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