Abstract:
The medication compliance organizer takes the form of a magnetized panel that may be conveniently mounted on the front of an appliance such as a refrigerator, or alternatively conventionally hung on a wall or other suitable surface. The organizer includes a plurality of day and time based containers for organizing and releasably holding the medications, typically four vials in vertical columns for each day of the week, one for each prescription time interval, i.e. morning, noon, evening and bedtime. The individual containers are sufficiently large to handle the varying medication formats from tablets, elixirs and patches. The organizer further includes an open tray for holding other medications and peripheral supplies, a reminder area for writing reminders regarding specific medications or activities, and medical forms for reference by the patient, care givers and health care personnel.

Description:
GOVERNMENT RIGHTS 
     This invention was made with government support under Grant No. IR43 NR05021-01 awarded by the National Institutes of Health. The Government has certain rights in the invention. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to devices for increasing medication compliance and, in particular, to a comprehensive medication compliance organizing system for increasing the medication compliance of the elderly and impaired persons, and for documenting and communicating, at a single site, pertinent medical and emergency information between user, care givers, and health care providers. 
     BACKGROUND OF THE INVENTION 
     Non-compliance with medication regimens represents a significant health care problem to the elderly who, for proper treatment and health maintenance, require medications in a variety of forms to be dispensed at discrete times, and in differing combinations. It is estimated that 25-49% of all people taking prescribed medications are non-compliant (Ref. 1-4). At greater risk are the elderly where 50 to 75% are considered non-compliant (Ref. 3,5). Categorically, the elderly are at higher risk for non-compliance due to the number of medications they consume (Ref. 3,6). Whereas, the elderly represent about 13% of the total population, they purchase 31% of all prescription drugs (Ref. 9). In 1995 medication related incidences wherein non-compliance was an important factor, resulted in $76.6 billion in direct medical costs (Ref. 4,7). Furthermore, an estimated one-third of hospitalizations and one-half of nursing home admission for the elderly were linked to non-compliance or medication errors resulting in Medicare expenditures of $20.6 billion (Ref. 8). Indirect costs from non-compliance resulting from loss of productivity, lost time at work, emotional tolls, disability/morbidity, and loss of life are likewise significant. In addition to the afflicted individual, the families and care givers are also affected. Further, poor compliance attenuates benefits in evaluating drug efficacy and treatment outcomes (Ref. 2, 10). 
     Inasmuch as the elderly sector of the population is dramatically increasing, the foregoing problem will correspondingly increase. Many factors are associated with non-compliance by the elderly. With increasing age comes increased clinical problems associated with senescence and senility. Cognitive and physical functioning decline. Keeping the elderly healthy, safe, and independently functioning is not only beneficial to the individual for financial and quality of life reasons, but also to society as a whole by decreasing the care and financial burden on care givers and health care systems alike. It is recognized that decreasing the consequence of non-compliance may have a greater impact on health than any other treatment (Ref. 10). 
     In seeking to address the foregoing, various medication aids have been proposed including pill boxes, containers, calendars, identification cards, and electronic devices. While helpful to a degree, they do not provide a complete and flexible response to the numerous factors influencing non-compliance. Such approaches do not provide comprehensive organization of all medication components, focus the medications at a single site, or provide ongoing reminding of the medication regimen. Studies have revealed several disadvantages. Specialized pill boxes and containers are oftentimes difficult to open, prone to content spillage, non-accommodating of complex regimens, and difficult for observing and confirming contents and compliance. Calendars have similar limitations. Pharmacy filled and sealed containers provide increased visibility and flexibility, but are costly in terms of preparation time and packaging, and lack the ability to add or delete drugs once packaged (Ref. 6, 12). Electronic devices provide reminders, but lack specificity as to the medication and are not integrated with the organization and housing of the medications. Identification cards while providing identification and reminding do not organize the medications. Also the medications associated with emergency room visits for non-compliance are delivered in formats not accommodated by the foregoing memory aids including, for instance, insulin, phenytoin and meter-dosage inhalants (Ref. 7). 
     An example of the foregoing limitations is disclosed in U.S. Pat. No. 4,905,388 to Sinkow wherein a monthly calendar format provides a receptacle for each day of the month for containers holding tabular medications for the entire day. The device is limited to the pill format and does not provide for differing medicating times. A similar pill carrier is disclosed in U.S. Pat. No. 3,225,913 to Lee wherein a hinged lid may be pivoted to gain access to the table and capsule medications for each day of the month. 
     U.S. Pat. No. 5,032,937 to Nellhause discloses a weekly calendar wherein stamps are used for visually indicating the medications to be taken during the course of the day. The calendar does not handle multiple medications and is not housed therewith. 
     U.S. Pat. No. 4,889,237 to Brandon discloses a monthly calendar having daily panels to which a multi-compartment pill container is attached. The device is limited to small pills. 
     U.S. Pat. No. 6,041,932 to Holmberg discloses a device having sets of packets for each day of the week with a subset of packets for differing times of the day whereby tablets may be selected by the user. U.S. Pat. No. 4,749,085 to Denney discloses a similar pill holder wherein the individual pill cases can be removed and carried by the user. A further weekly device is disclosed in U.S. Pat. No. 4,318,477 to Kerpe wherein the individual containers are sized to receive differing medication formats. 
     U.S. Pat. No. 5,558,229 to Halbich discloses a medication holder wherein a single days supply of pills may be removed by the user. 
     BRIEF SUMMARY OF THE INVENTION 
     A medication compliance organizer in accordance with the present invention provides the user with a system for assisting individuals in taking medications as prescribed and, enhancing the flow of important medical information among individuals, care givers and health care providers. The organizer is a complete and comprehensive system for housing all room temperature medications and serves as a reminder for all other medications. The system&#39;s design features large and color coded components utilizing the user&#39;s visual senses for enhancing memory recognition, facilitates use by the visually and dexterity impaired, and enables users to have a single convenient location for all medications, information and reminders. The system houses two forms. One form outlines the prescribed medications in chart and written format, and the other contains emergency and medical information specific to the user. 
     The medication compliance organizer takes the form of a magnetized panel that may be conveniently mounted on the front of an appliance such as a refrigerator, or alternatively conventionally hung on a wall or other suitable surface. The organizer includes a plurality of day and time based containers for organizing and releasably holding the medications. Typically four vials are provided in seven vertical columns for each day of the week, and each prescription time interval, i.e. morning, noon, evening and bedtime. The individual containers are sufficiently large to handle the varying medication formats from tablets, elixirs and patches. Each organizer includes separate containers for handling each time interval of the prescribed medications for each day of the week. The organizer further includes an open tray for holding peripheral supplies and other medications such as drops, ointments and inhalers. The organizer also includes a reminder area for writing reminders regarding specific medications or activities, and removable patient and medical forms for reference by care givers and health care personnel. 
     The present invention thus overcomes the noted deficiencies of prior approaches by providing a simple and practical organizer that meets the needs of the elderly. The organizer is flexible, changeable, and comprehensive offering organization, single site housing of medications, and visually based reminders for even the most complicated drug regimens. The organizer is adapted for mounting in convenient accessible and visible locations such as a refrigerator or other frequently visited locations. 
     Assistance information is incorporated through removable forms disposed at the rear of the organizer. The forms identify medications in chart and written format and provide complete, accurate medical and emergency information on the user. The medication form is intended to assist the user or care giver in filling the organizer correctly. The emergency/medical form is intended for use by the user, care givers, and health care providers as a communication tool and for transport to medical appointments, emergency room visits, hospital admissions, or use in response to emergency calls. 
     Accordingly, it is an object of the present invention to provide an organizer for all medications that organizes daily medicine in all formats at a single site in a clear, visually relevant presentation. 
     Another object of the invention is to provide a medication device allocating prescribed medications in all common formats at a single site for clear identification by the user and for providing visual feedback to users and care givers regarding compliance with a medication regimen. 
     A further object of the invention is to provide a medication assembly having discrete containers for carrying all room temperature medication formats allocated and labeled in accordance with prescribed day and time. 
     Yet another object of the invention is to provide a medication organization, reminder and information product for convenient use by the elderly population notwithstanding visual, memory or dexterity limitations. 
     Yet a further object of the invention is to provide an area to write reminders to the user regarding all other medications not housed in the individual containers such as insulin injections, inhalers, ointments and drops as well as specifics about medications that are housed in the containers. 
    
    
     DESCRIPTION OF THE DRAWINGS 
     The above and other features and advantages of the present invention will become apparent upon reading the following detailed description taken in conjunction with the accompanying drawings in which: 
     FIG. 1 is a front perspective view of a medication compliance organizer in accordance with an embodiment of the invention; 
     FIG. 2 is a rear perspective view of the organizer illustrated in FIG. 1; 
     FIG. 3 is an enlarged fragmentary top view of the container slot; 
     FIG. 4 is a fragmentary longitudinal cross sectional view of the support panel assembly; 
     FIG. 5 is a fragmentary cross sectional view illustrating the mounting of the container racks; 
     FIG. 6 is a fragmentary rear view of the mounting slots for attaching the organizer to a vertical surface; 
     FIG. 7 is a front view of the medication form for the organizer; 
     FIG. 8 is a rear view of the medication form for the organizer; 
     FIG. 9 is a front view of the emergency/medical form for the organizer; 
     FIG. 10 is a rear view of the emergency/medical form for the organizer; and 
     FIG. 11 is a front perspective view of an embodiment of the organizer shown in FIG.  1 . 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring to the drawings for the purpose of describing the preferred embodiments of the present invention and not for limiting same, FIG. 1, there is shown a medication compliance organizer  10  for assisting patient users with taking their medications as prescribed and enhancing the dissemination of important medical information relative to the user among care givers, health care providers and emergency personnel. The organizer is a complete and comprehensive product designed to house, at a single location, all prescribed room temperature medications and provide visual reminders regarding other medications housed elsewhere. The organizer utilizes the visual senses of the user to enhance significantly memory, provides convenience and accessibility for the visually and dexterity impaired, and enables users to go to a single site for all medications and reminders. Information forms housed in the organizer describe medications in chart and written format, and emergency and medical information specific to the user. 
     More particularly, the organizer  10  comprises generally rectangular, vertically disposed support assembly  12  having a plurality of vertically spaced, horizontally extending container racks  14  adjustably connected to the front surface  16  thereof and releasably carrying a plurality of laterally spaced medication containers  18 . As illustrated, four racks  14  are provided, each carrying seven containers  18 . Thus for a week&#39;s supply of medications taken four times a day, twenty-eight containers are provided. Accordingly, each column represents a day of the week designated by indicia  20  and each row represents a time of day as represented by indicia  22 . Alternatively, the days of the week may be in horizontal rows and the time of day in vertical columns. Each indicia may be color coded, individually or collectively. Additionally, each container may individually carry indicia  24  designating the day and time of day for the user to take the contents thereof. Further, the organizer  10  included a walled supply tray  30  at a lower corner thereof and a reminder area  32  thereabove for inscribing with a suitable instrument reminders and information regarding the medication regimen. As shown in FIG. 2, a medication form  34  and an emergency/medical form  36  are removably carried at the rear of the plate  12 . 
     The containers  18  include a transparent cylindrical body  40  having a removable lid  42 . The containers  18  are appropriately sized to carry and dispense a variety of medication formats including pills, capsules, elixirs, patches and like room temperature medications. Inasmuch as patches are generally applied at the beginning of the day, the first row of racks may be disposed to carry a container sufficiently large to hold the patches, whereas the remaining rows may be sized for the reception of the other medication formats. Alternatively as shown in FIG. 11, the containers  18  may be similarly sized with slots  50  or other suitable apertures being provided for releasably holding the patches required for each day. A digital clock/calendar  43  may also be mounted on the organizer. 
     The container sizes may vary depending on need. The lids  42  may be of a child proof, pivotally or slidably attached, snap-on, twist-on or other variations convenient for the user. 
     The support assembly comprises a front panel  60 , a rear panel  62  laterally spaced by vertical slat  64  and base slat  66  to define vertically upwardly opening slots  67 ,  68  for slidably receiving the forms as described in greater detail below. Preferably the panels and slats are formed of a plastic material and adhesively or mechanically connected in assembly. 
     The supply tray  30  includes a forwardly extending base  70  surrounded by an upwardly extending peripheral rim  72  including side walls  74 ,  76  and a generally L-shaped front wall  78 . The base  70  is mechanically or adhesively connected to the front panel. The rim  72  is mechanically or adhesively connected to the front panel. The front wall  78  includes a left side wall portion aligned with the racks and containers and an enlarged right side portion below the reminder area  32  of the organizer. An intermediate wall  83  extends upwardly from the base  70  between the front panel  60  and the wall portion and establishes a supply receptacle disposed at the lower comer of the front plate and sized for carrying peripheral medical supplies or medications such as inhalers, drops or other “as-needed” medications, as well as a marker for inscribing instructions in the reminder area. The reminder area  32  is intended to display information related to medications not housed in the individual containers such as insulin, ointments, inhalers and the like. Reminders regarding proper ingestion and use of the medications contained in the individual containers may also be written in the reminders area. For plastic materials a dry erase marker may be used for such reminders and attached by flexible means to the organizer or carried in the tray or elsewhere. 
     The racks  14  are elongated one-piece plastic moldings having a horizontally extending vertically disposed base  80  engaging the front panel and a front ledge  81  having a plurality of forwardly projecting uniformly longitudinally spaced distal arms  82  defining therebetween generally U-shaped forwardly opening container receiving slots  84 . Referring to FIG. 3, the slots  84  are defined by a semi-circular cylindrical base wall  86 , side walls  88  and entry walls  90 . The base wall  86  and side walls have a diameter and spacing, respectively, that is slightly larger than the base of the container whereby the latter is loosely confined thereby in the stowed positions. The entry walls  90  are inwardly spaced from the side walls  88  at a distance providing a light interference fit with the base of the container, thereby providing limited resistance to insertion of the container to the stowed position and removal therefrom for use, while providing detenting against inadvertent movement during storage. 
     Referring to FIG. 1, the rear surface of the base  80  of the rack  14  engages the front surface  16  of the front panel  60 . A plurality of mounting holes  90  are aligned in laterally spaced vertical columns and horizontally spaced rows. The racks are mechanically fastened to the front panels by fasteners  92  disposed at the preformed holes. Accordingly, depending on the height of the containers desired for a daily dosage time, the racks may be appropriately vertically spaced. Referring to FIG. 1, the rack orientation provides for the tallest row of containers to be disposed for use in the morning dosage time thereby enabling storage of patches in the larger containers at the usual time for their application. The remaining racks provide for reception of ordinary containers for general pills, tablets and elixirs. 
     The medications information slot  67  and emergency/medical information slot  68  are configured to slidably receive and capture forms with a heading thereof projecting above the top of the front panel for identification purposes. As shown in FIGS. 7 and 8, the medication information form  34  comprises a front panel  102  and rear panel  104  both of which contain an upper header section  106  entitled “Medications”. The front panel provides an upper legend area  108  for entry of patient name and a numbered tabular section  110  for entering relevant information, such as drug name, dose, administration route, frequency, and relevant comments. The front panel includes a lower legend area  112  for entering information about other medications not carried in the container such as refrigerated medications, inhalers, drops, ointments and medications for occasional use and carried in the supply tray. The front panel also includes a verification section  113  for entry of the preparer&#39;s name and date prepared. 
     The rear panel  104  includes a similar header section  116  and a replication in tabular form  118  of the container layout setting forth week days and dosage times. For each day and each dosage time, the relevant information regarding the correctly prescribed medication is entered based on information on the front panel. This provides a convenient on site reference for filling the containers in chart format. 
     As shown in FIGS. 9 and 10, the Emergency/Medical form  36  includes a front panel  122  and a rear panel  124 . The front panel  122  includes a header section  123  entitled “Emergency/Medical”. Below the header section is a legend area  126  for entry of identifying information regarding the patient and emergency notification information. Below the legend area is a Medical Information legend  128  for entry of specific medical and surgical information relative to the patient. Provided below the medical information legend is a Medications table  130  for entering and updating medications prescribed for the patient and information relevant thereto. Below the medications table is a Doctors legend  132  for listing information regarding treating physicians for the patient. 
     The information on the front panel of the form is a particularly beneficial compilation for use by the patient, associated care givers, and health care providers as a communication tool. The panel provides complete and accurate medical and emergency information designed to streamline communication and enhance safe care. The form may be taken to medical appointments, emergency room visits, hospital admissions or used by emergency personnel in answering 911 calls. Patient safety is greatly enhanced as it communicates medical and emergency information in a succinct, accurate and concise formate thereby avoiding the need for patient recall of health history, treating physicians or current treatments. 
     The rear panel carries a similar header section  140  and a plurality of information legends  142  for entry of access information for reference by the patient or third parties, for general use and in case of emergency. Common numbers of emergency services are provided, utility information, family contacts, neighbors and personal requests by the patient provide invaluable information for handling emergency situations involving the patient. 
     The organizer  10  is intended for placement in a regularly visited, easily accessible place for the elderly or impaired person wherein the layout of medication containers, the day, the time of day, reminders and data panels can be readily viewed for use, status, compliance and information. The organizer  10 , as shown in FIGS. 1 and 2, is provided with a generally rectangular backing plate  62 . Adjacent the upper ends and symmetrically disposed between the sides, a pair of mechanical fastening apertures  150  are provided, each of which includes a circular base hole  154  and an inverted U-shaped shank slot  156 . These apertures permit mounting of the organizer  10  on a suitable vertical surface wherein horizontally aligned, appropriately spaced fasteners are inserted into the base hole  154  and the organizer shifted downwardly with the shank of the fastener residing in the shank slot  156 , all in a well known manner. The rear plate is also provided with three symmetrically disposed sheet magnets  160  adhesively adhered to the rear surface thereof. The magnets  160  have sufficient strength to enable the organizer to be supported on a vertical ferromagnetic surface such as a refrigerator door. 
     The hole patterns for the container racks permit selective vertical adjustment to permit containers of different lengths to be utilized. Such feature is extremely desirable inasmuch as it permits widely used patch medications to be stored in the containers along with tablet, capsule and elixirs. It has been found that most patch medications are adhered at the start of the day, i.e. morning. Accordingly it is preferred to dedicate three mounting hole arrays for fixed mounting of the racks for the noon, afternoon, and evening medications and permit the upper or morning rack to be shifted to the upper hole pattern for handling the larger containers suitable for housing such patches. 
     The aforementioned legends denoting the day of the week, time or dosage, and reminders may be provided by adhesive labels, integrally molded characters, providing space for hand entry, or the like. In particular, the time of dosage may comprise and integral part of the rack base or be a removably attached item. In the preferred embodiment, the legend is integral with the rack. It will be appreciated that those patients not on a four times a day medication regiment may remove unneeded racks thereby providing additional storage for peripheral items and medications on the lower tray. 
     As previously mentioned the containers are in two different sizes but may be of any suitable size or shape such as oval, rectangular, or square. Such container shapes and sizes are easily handled by the elderly and are sufficiently large to hold pills, tablets, capsules, elixirs, and patches.. Such containers are available with varying lid designs, including child-resistance lids and snap-on. The lids and the containers may also bear discrete indicia using labels or embossing designating by text, color and symbols the date and time of dosage for the days contents. 
     The medication organizer in controlled testing has demonstrated increased compliance and improved communication with medical professionals and caregivers. 
     Test 1—Medication Compliance 
     A cross over design study included 25 participants and compared the medication compliance organizer in accordance with the present investigation and a standardized pillbox. The participants ranged in age from 60 to 89 years with an average age of 75 years. 84% were female and 16% were male. 48% were Afro-American and 52% were Caucasian. All participants lived in rural eastern North Carolina. The majority of the participants were socio-economically disadvantaged. The participants were observed over a six week period on each device. The study determined the participants were 60% more compliant with organizer, 32% more compliant with the pillbox, and 8% showed no difference in compliance. Memory scores were evaluated against rates of compliance using Folstein&#39;s Mini Mental Exam. The study revealed that participants with lower memory scores did better using the organizer than with the pillbox indicating that those with mental deficits were assisted with the organizer. 
     Test 2—Information Formatting 
     The “Emergency/Medical” form housed in the organizer was evaluated for effectiveness in communicating pertinent medical information specific to the user. During the study, participants were asked to take their forms with them to all physician appointments, hospitalizations, and emergency room visits. Attending physicians were then sent a questionnaire requesting them to rate the form with respect to its accuracy in describing the participant&#39;s health status, usefulness in conveying medical information and ability to reveal useful information about the participant&#39;s health status. As to each category, the physicians rated the form extremely high thereby validating its efficacy as a communication adjunct in terms of health care and safety where clear communication between individuals, caregivers, and health care providers is paramount for effective and safe health care. 
     Surveys conducted with the participants, care givers and registered nurses involved in the study also demonstrated efficacy of the organizer for the visually impaired, i.e. macular degeneration and cataracts, improved handling for those with dexterity impairments, improved compliance with peripheral medications detailed in the reminder section of the organizer, and assistance in accurately filling the medication containers. 
     Having thus described a presently preferred embodiment of the present invention, it will now be appreciated that the objects of the invention have been fully achieved, and it will be understood by those skilled in the art that many changes in construction and widely differing embodiments and applications of the invention will suggest themselves without departing from the spirit and scope of the present invention. The disclosures and description herein are intended to be illustrative and are not in any sense limiting of the invention, which is defined solely in accordance with the following claims. 
     REFERENCES 
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     2. Urquart, J, Patient non-compliance with drug regimens: measurement, clinical correlates, economic impact, European Heart Journal, March 1996: 17 Suppl A:8-15. 
     3. Wandless I et al., Can drug compliance in the elderly be improved?, British Medical Journal, Feb. 5, 1977, 359-361. 
     4. Scott, L, Providers push for remedies to costly drug non-compliance, Modern Healthcare, April 1996, 44-50. 
     5. Blenkiron, P, The elderly and their medication: understanding and compliance in a family practice, Postgrad Med J, 1966, 72:671-676. 
     6. Ware, G J et al., Unit does calendar packaging and elderly patient compliance, New Zealand Medical Journal, November 1991, 495-7. 
     7. Dennehy, C E et al., Drug-related illness in emergency department patients, American Journal of Health-System Pharmacy, Jun. 15, 1996, 12: 1422-6. 
     8. Muirhead, G, New York pharmacists to work with nurses on compliance, Drug Topics, May 1996, 140 n 9:92-8. 
     9. Baum, C et al., Drug use in the United States in 1981, JAMA, 1984, 241(10), 1293-7. 
     10. Haynes, R B et al, Systematic review of randomized trials of interventions to assist patients to follow prescriptions for medications, Lancet Aug. 10, 1996, 348 (9024), 383-6. 
     11. Day, J C, Population of the United States by Age, Sex, Race, and Hispanic Origin: 1993-2050, United States Bureau of the Census, Current Population Reports, United States Printing Office, 1993. 
     12. Wong, B S W et al., Evaluation of a Novel Medication Aid, the Calendar Blister-Pak, and its effect on drug compliance in a geriatric outpatient clinic, JAGS, 1987, 35:21-6. 
     13. Craven County Chamber of Commerce, NC, phone interview. 
     14. Projected Population, May 1993, North Carolina Data Center. 
     15. North Carolina Comes of Age, County Profiles in Aging, CARES, Chapel Hill, NC, 1990.