Abstract:
An article and method for recording dosing compliance is provided having compliance recordation indicia printed on a compliance recordation article and a mechanism for attaching the article to a container.

Description:
INDEX TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Patent Application No. 61/047,461, filed Apr. 24, 2008, the disclosure of which is incorporated herein by reference in its entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     Compliance when taking any product that is to be administered over a period of time is always a major concern. When the compliance relates to a patient compliance of a medical dosing regimen, the concerns for compliance are heightened. The present invention addresses the need for an effective article and method for assisting patient compliance. 
     BRIEF SUMMARY OF THE INVENTION 
     The present invention is a label configured to be secured to a prescription bottle or other container in which dosing and compliance are important. The label has indicia for specific days and times in which the medicine should be taken. 
     By way of example, if a patient has a prescription filled on Monday January 14 with instructions for the medicine to be taken three times a day for five days, the label may read as follows: 
     
       
         
               
               
               
               
             
               
               
               
               
               
             
           
               
                   
                   
               
               
                   
                 a.m. 
                 p.m. 
                 night 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Monday, Jan. 14, 2008 
                 
                      
                 
                 
                      
                 
                 
                      
                 
               
               
                   
                 Tuesday, Jan. 15, 2008 
                 
                      
                 
                 
                      
                 
                 
                      
                 
               
               
                   
                 Wednesday, Jan. 16, 2008 
                 
                      
                 
                 
                      
                 
                 
                      
                 
               
               
                   
                 Thursday, Jan. 17, 2008 
                 
                      
                 
                 
                      
                 
                 
                      
                 
               
               
                   
                 Friday, Jan. 18, 2008 
                 
                      
                 
                 
                      
                 
                 
                      
                 
               
               
                   
                   
               
             
          
         
       
     
     The area after each day would be for the patient to indicate or mark the dosage for that day and/or the time the dosage had been taken. 
     The indicia would change based on the dosing regimen prescribed and dates, but would be automatically generated for a label based upon the dosing regimen prescribed. 
     In a preferred embodiment the present invention is an article for recording dosing compliance comprising: 
     a. compliance recordation indicia printed on a compliance recordation article; and 
     b. attaching the article to a container. 
     The dosing regimen may be a prescription or non-prescription medicinal product, a nutraceutical, a nutritional supplement and the like. 
     The dosing regimen may be a schedule of taking a prescription or non-prescription medicinal product, a nutraceutical, a nutritional supplement and the like under the direction of a physician, health care provider, or as directed by a distributor or manufacturer of a product. 
     The article indicia are customizable to a dosing regimen. 
     The customization may include specific days and times. The indicia are configured for marking dose compliance. 
     The indicia are marked contemporaneously with the administration of a dose by a marking letter “x”, a circle, a square, and the like, other markings, and/or combinations thereof. 
     In one embodiment, the article is in a unitary configuration with a container label. That is, the label is affixed to the container and the article is a contiguous extension of the label. 
     Alternatively, the article may have a mechanism for attaching to a container which may be an adhesive that secures the article, in a permanent or substantially permanent manner to the container or to another label attached to the container. 
     In one embodiment, the article has a releasable adhesive on one portion of the article such that the article may be closed and conceal the recordation indicia. Preferably, the closing will be along a predefined fold line. 
     The present invention also comprises a method for recording dosing compliance comprising the steps of: 
     a. providing a compliance recordation article with compliance recordation indicia; 
     b. attaching the article to a container; 
     c. dispensing a dose from the container pursuant to a dosing regimen; 
     d. marking the compliance recordation article with a mark indicating a time a dose was taken. 
     The present invention also includes a method of producing a compliance recordation article having the steps of:
         a. providing a customizable computer readable medium unique for a patient and a medication;   b. operatively associating at least one user computer with said computer readable medium;   c. inputting dosage and medication information unique to a patient and into said user computer;   d. providing an output that produces a dosage compliance article;   e. affixing said dosage compliance article to a medicinal container;   f. providing said container to a patient.       

    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a front view of a prescription label with a compliance calendar label. 
         FIG. 2  is a rear view of a prescription label with a compliance calendar label. 
         FIG. 3  is perspective view of the front of a compliance label affixed to a container. 
         FIG. 4  is a cross section view of the prescription label of  FIGS. 1 and 2  with a fold line  16 . 
         FIG. 5  is a cross section view along line A-A from  FIG. 3 . 
         FIG. 6  is a cross section view of a compliance label on a container with an open tab. 
         FIG. 7  is a cross section view of a compliance label with the tab open. 
         FIG. 8  is a front view of a generic compliance label. 
         FIG. 9  is a front view of an alternate generic compliance label. 
         FIG. 10  is a front view of another alternate generic compliance label with a user marking. 
         FIG. 11  is a front view of a compliance label with dates and times. 
         FIG. 12  is a front view of an alternate compliance label with days and times. 
         FIG. 13  is a front view of an alternate compliance label with days and times with user markings. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present invention is a compliance calendar label for monitoring patient compliance and a dosing regimen. 
     Pharmaceutical label  10  is formed from a label sheet or roll as known in the art and has a front face  11 . Label  10  is an adhesive label, having a layer of adhesive  17  generally behind said label  10 . A silicon liner  20  provides a protective cover over said adhesive  17 . Silicon liner  20  has a rear label face  12 . 
     Front face  11  includes printed thereon a prescription in a prescription area  13  and a first compliance indicia area  15 . Rear face  12  includes printed thereon a second compliance indicia area  24 . Label  10  has a score line  14 . Said score line is also on liner  20 . In one embodiment, areas  15  and  24  have a fold line  16 . 
     Label  10  is affixed to a container  21  by removal of a portion of liner  20 , the portion  24   a  at score line  14 , and exposing adhesive  17  for affixing reverse side of label  10  circumferentially around container  21 . Said container  21  having a top rim  29  for receiving a closure cap not shown. Label  10  is constructed and arranged to be wrapped circumferentially around the perimeter of a desired container  21  starting at first end  19   a  of label  10  to second end  19   b  of label  10 . An informational tab  22  is formed approximately from score line  14  to the end of label  10  at tab end  19   c . Patient compliance indicia can be printed on one or both sides of tab  22  on compliance indicia areas  15  and  24 . Understandably, label  10  could be rearranged with the compliance indicia areas in different locations on label  10 . 
     The rear of label  10  includes a liner  24  that is typically scored at one or more locations. In at least a first location at the base of tab  22  at score line  14  and at a fold line  16  of tab  22 . Score  14  provides a fold line for face  11  and a tear line for face  12  to easily detach liner portion  24   a . Label  10 , as known in the art, and manufactured by Rx Technology Corporation, Joplin, Md. 64801, may be taken either from a label sheet that is passed through a printer and then removed or label  10  may be on a roll of labels attached end to end that are thermally printed and the label is then detached from the roll. 
     Tab  22  can be folded back onto itself as shown in  FIGS. 6 and 7 . Tab  22  folds in the directions—back and forth—depicted by arrow B such that a hinge is created at fold line  16  such that compliance indicia  24   a  folds back on itself. Edge portion of adhesive  17  releasably secures a first portion  24   b  of indicia area  24  against a second portion  24   c  of indicia area  24  one to the other. 
     In the compliance label embodiments of  FIGS. 9 ,  10  and  11  compliance indicia area  24  is surrounded at least on 2 side edges with adhesive  17  exposed such that compliance indicia area  24  when folded along fold line  16  as seen in  FIGS. 6 and 7  will fold against itself and is released by lifting tab end  19   c  at release points  33 . 
     The present invention provides for compliance indicia to be disposed on label  10  affixed to container  21  at the front face  11  and/or rear face  12 . Preferably, the compliance indicia are a compliance calendar disposed on tab  22  that extends outward from the perimeter of container  21  to which an incorporated label  10  is formed a part thereof or is attached. Compliance calendar labels in indicia areas  15  and/or  24  of the present invention are marked manually by a user. The user typically being the patient taking the medication or a person administering the medication for the patient. The marking does not require any electronics to keep track of dosing. The manual marking is by pencil, pen, hole puncher, combinations thereof, or any other appropriate marking mechanism. The compliance calendar to be marked is at the site of dispensing the medicine to the patient either by the patient directly or by a person administering it to the patient. 
     The compliance calendar is presented as either a generic listing of days and dosing times, as is shown in  FIGS. 8 ,  9 ,  10  and  12  or may be presented to a particular patient with days and times specific to a patient dosing regimen, as in  FIGS. 11 and 13 . 
     By way of example, and not limiting thereby, a patient is directed to take a particular medication twice a day, that has a prescription dispensed at a pharmacy beginning on Apr. 1, 2009 at 6 p.m. The patient would not have a morning dose but only an evening dose. As seen below, the morning dose on Apr. 1, 2009 has been marked indicating no morning dose. A personal compliance calendar that begins: 
     
       
         
               
               
               
               
             
           
               
                   
                   
               
             
             
               
                   
                 Apr. 1, 2009 
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                 p.m. 
               
               
                   
                 Apr. 2, 2009 
                 
                      
                 
                 
                      
                 
               
               
                   
                   
                 a.m. 
                 p.m. 
               
               
                   
                   
               
             
          
         
       
     
     The calendar would continue with subsequent dates until dosing regimen is completed. 
     The compliance calendar of the present invention will have indicia for particular start dates  26  and end dates  27  as applicable to a particular patient and medication, see  FIG. 12 . 
     In the above example, the personal compliance calendar indicates only one dosage to be taken on Apr. 1, 2009 with subsequent days if applicable (only April 2 nd  shown) to be taken morning and evening. The a.m. dosage of Apr. 1, 2009 is blocked out, thus indicating to the patient that no dosage be taken on that day and time. Similarly the calendars in  FIGS. 10 and 13  have been customized for the patient&#39;s prescribed dosing regimen. In  FIG. 10 , the Day 1 “a.m.” space has been blocked out indicating no dosage to be taken on that time. The first dosage called for at Day 1 “lunch.” In  FIG. 13 , the days and dates have been customized to a start date of noon on Tuesday March 31 st  (3/31). In the top row of the compliance calendar the days March 29 and 30 have been blocked out for the times a.m., noon, p.m. and bed when the compliance label was printed. Thus indicating the start time and day of noon March 31 st . Also shown in  FIG. 13 , are the markings by the user on March 31 for noon, p.m., bed and April 1 a.m. Said user markings indicate the compliance of the user in taking the “medicine use each time” taken. 
     In an example of ongoing dosing, such as, but not limited to blood pressure medication that is taken continually every day, the personal compliance calendar is presented to the patient with date and time indicia indicative of either an initial prescription, or date and time indicia indicative of when a previous prescription supply is exhausted and a new prescription supply begins. 
     By way of example only, a patient dispensed an initial 30 day supply of blood pressure medication on May 1, 2009 will receive a compliance calendar indicative of dosing starting on May 1, 2009. This patient calls a pharmacy for refill and typically requests a refill before the current supply is depleted. A patient may call in a refill on May 25, 2009, and the personal compliance calendar of the refill will have indicia beginning on May 31, 2009 i.e. the day the refill begins to replace the initial 30 day supply. 
     A particular dosing regimen, for example, a regimen given by a physician for a medicine, is indicated e.g. printed on compliance indicia areas  15  and/or  24 . In the embodiment of  FIG. 10 , as an example, the patient is to take a particular dosage three times a day (t.i.d—a medical abbreviation from the Latin phrase ter in die meaning a thrice-daily dosage) for five days. The patient is instructed to mark the label at the time of taking each individual dose. The present invention provides an easy way for the patient to mark the dosage taken on a particular day and time. Later, if a patient is unsure if they completed a particular dose, they need only look at label  10  on the specific container in question. As seen in  FIG. 10 , Day 1 “a.m.” has been marked with an x. 
     After review of the marked doses of label  10 , a patient will be able to proceed accordingly. A dose will be taken at a regimen specified time if there is no indication it had been taken. Conversely, the dose will be skipped if label  10  indicates the dose had been taken. 
     Although the figures show a particular embodiments with the indicia placed on one region of label  10 , the compliance information may be printed on the entire compliance indicia area  15  and/or  24  of label  10  in various manners and formats. Various manners and formats are shown in  FIGS. 8 to 13 . 
     The indicia would be specific for the dosing regimen. For example, if the dosing regime called for taking a particular dose two times the first day, and once a day for six more days, the label may appear as follows noting that the afternoons after day 1 are “marked out” indicating no dosage for that period: 
     
       
         
               
               
               
             
               
               
               
               
             
           
               
                   
                   
               
               
                   
                 a.m. 
                 p.m 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Start 
                   
                   
               
               
                   
                 Day 1 
                 
                      
                 
                 
                      
                 
               
               
                   
                 Day 2 
                 
                      
                 
                 X 
               
               
                   
                 Day 3 
                 
                      
                 
                 X 
               
               
                   
                 Day 4 
                 
                      
                 
                 X 
               
               
                   
                 Day 5 
                 
                      
                 
                 X 
               
               
                   
                 Day 6 
                 
                      
                 
                 X 
               
               
                   
                 Day 7 
                 
                      
                 
                 X 
               
               
                   
                 End 
               
               
                   
                   
               
             
          
         
       
     
     As seen in  FIG. 12 , label  10  has indicia to accommodate many doses dispensed from a single container. Label  10  of  FIG. 12  has indicia for four doses a day, seven days a week, for five weeks. This compliance calendar provides indicia for recordation of 140 individual doses of a medication from a single container. 
     The compliance calendars shown in  FIGS. 8 to 13  may be in either compliance indicia area  15  or  24  in any combination and where only a compliance calendar is placed in either  15  or  24  then the other area  15  or  24  without a compliance calendar may contain any other information. 
     While the invention has been described in its preferred form or embodiment with some degree of particularity, it is understood that this description has been given only by way of example and that numerous changes in the details of construction, fabrication, and use, including the combination and arrangement of parts, may be made without departing from the spirit and scope of the invention.