Combination and method including a visual marker for determining compliance with a medication regimen

Abstract

A method and combination including a visual marker for monitoring a patient to determine compliance with a medication regimen. An orally administrable medication composition is provided in combination with a visual marker. When the combination is orally ingested, the marker causes a coloration or discoloration of the oral and / or pharyngeal cavity of a subject. By visually observing the oral and / or pharyngeal cavity of the subject, one can determine whether medication has been ingested based upon the presence or absence of the coloration / discoloration.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a divisional of and claims priority to U.S. application Ser. No. 09 / 765,151 by Gilbert R. Gonzales, entitled “Combination and Method Including a Visual Marker for Determining Compliance with a Medication Regimen,” filed on Jan. 17, 2001, the disclosure of which is hereby incorporated by reference in its entirety.FIELD OF INVENTION [0002] The present invention relates generally to monitoring therapeutic drug ingestion, and more particularly to a method and composition used for monitoring a patient to determine compliance by the patient with a medication regimen. BACKGROUND OF THE INVENTION [0003] The term “compliance” in the practice of medicine, and specifically in pharmacotherapy, is defined as the “extent to which the patient's behavior coincides with the clinical prescription” (Litt, I. F. and Chuskey, W. R., Compliance with medical regimens during adolescence, Pediatric Clin North Am, 27:3, 1980). [0004] When sel...

AI Technical Summary

Benefits of technology

The solution provides a rapid, inexpensive, and non-intrusive method for monitoring medication compliance, reducing the time, effort, and complexity of prior art methods, enabling caregivers to verify ingestion and adjust medication delivery accordingly, thereby improving compliance and reducing noncompliant behavior.

Problems solved by technology

If a medication must be taken more than once a day, compliance becomes the most important factor in selecting a drug because the pharmacologic efficacy of the medication will be more adversely affected if the medication is not taken as directed.

The problem of noncompliance with a prescribed regimen has become so serious that, in response to such a problem, the pharmaceutical industry has developed long-acting forms of many medications.

The problems with noncompliance are particularly pronounced among certain groups of patients.

Accordingly, noncompliance is a problem that is widespread in society.

The proportion of those that do not ingest their prescribed medication is greatest when social and cultural barriers, such as a language difficulty, exist, or when a decline in cognitive understanding, such as memory loss, interferes with carrying out instructions.

Therefore, noncompliance is a major problem in medicine in general, and in several diseases in particular.

Clinical observation, however, is time consuming and, therefore, expensive.

Furthermore, it is dependent on the physician's subjective opinion, and therefore is subject to potential errors.

However, whether qualitative or quantitative, several drawbacks exist in these analytical methods.

First, these analytical methods and tests are time and labor-intensive, often requiring the use of complex equipment in the analysis, and thus are not particularly useful when the time period between medication dosages is short.

Second, these methods generally require a trained technician to perform the analysis.

Third, the analysis is often performed at a location remote to the site where the sample is obtained.

Finally, the sample collection itself, for example, obtaining a urine sample, involves a heightened degree of intrusiveness for the patient.

As a result, these methods are not amenable to a rapid, generally non-intrusive, on-site assessment of compliance.

However, these methods still require that the urine or stool of a subject be examined by a trained professional to detect the presence of the marker.

Thus, while reducing some of the time and complexity involved, these tests are still not useful as a “home” test, still require some heightened degree of time, labor and expense, and do nothing to reduce the intrusiveness experienced by the patient.

While providing useful information relative to patient status and treatment compliance, the clinical monitoring methods described above have distinct drawbacks which limit their usefulness in determining compliance.