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

[0014] In use, shortly after ingestion of the inventive combination, inspection would be carried out by visually observing the oral and / or pharyngeal cavity for a coloration or discoloration that is characteristically evoked by the marker. After the passage of time following ingestion, the visually apparent coloration or discoloration could evanesce leaving no significant coloration of a portion of the oral and / or pharyngeal cavity. In that way, multiple dosages could be monitored without the coloration from a previous dose significantly interfering with the next, subsequent dose.

[0017] In accordance with another aspect of the present invention, multiple markers are utilized in the combination, and the multiple markers have different coloration qualities for providing further indication of compliance. In one embodiment of the invention, one of the multiple markers causes a coloration of a portion of the oral and / or pharyngeal cavity for a longer time than another of the markers. That is, the coloration caused by one marker has a greater duration and may be visually detected, either under natural light, or fluorescent light, longer than the coloration from another marker. In that way, the presence or absence of particular colorations may be determined in order to determine a time frame in which the combination was ingested. In another embodiment of the invention, one marker may cause a different coloration than another marker. The different color markers also have different durations, such that detecting one coloration more strongly than another may indicate the length of time since the ingestion of the last dosage of the medication composition and may help establish a time frame of the last dosage.

[0019] The use of an orally ingested and visible marker provides a qualitative determination of a patient's compliance with a medication regimen. In providing for this determination rapidly, visually, and without intrusion of the patient's privacy, the present invention reduces and eliminates various of the drawbacks of the prior art. The marker can be directly visually detected soon after oral administration of the medication and also may be detected some time later by flourescing the marker in the oral and / or pharyngeal cavity.

[0020] The marker indicates to a primary caregiver, guardian, or family member whether the medication was orally ingested during a recent period of time. The presence of coloration of the oral and / or pharyngeal cavity caused by the marker is the specific information to notify the caregiver that the medication was actually orally ingested. The physical act of checking on the compliance of the medication delivery associated with the invention will also improve medication delivery.

[0022] By virtue of the foregoing, there is thus provided a method and combination composition for monitoring the compliance of a patient in following a medication regimen while reducing and / or eliminating the problems associated with monitoring methods of the prior art. The present invention reduces the time, effort, complexity, cost, and intrusiveness of prior art monitoring methods. These and other objects and advantages of the present invention shall be apparent from the accompanying Detailed Description of the Invention.

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.