CA2769851C - Methods, systems and apparatuses for medication management and storage - Google Patents

Abstract

The present invention relates to systems, methods, and apparatuses for the management, dispensing, and administration of over-the-counter and prescription medications through use of a pharmaceutical container labeling system and an optional integrated computer-based or online management system. In certain aspects, the invention relates to a pharmaceutical container (100) comprising a hollow body (110), a child-resistant cap (120), and a specialized information label (410a) affixed to the hollow body.

Description

METHODS, SYSTEMS AND APPARATUSES FOR MEDICATION MANAGEMENT
AND STORAGE
RELATED APPLICATIONS
This application is related to US Provisional Application No. 61/233,426, filed August 12, 2009, and US Provisional Application No. 61/233,781, filed August 13, 2009.
FIELD OF THE INVENTION
The present invention relates generally to medication management and storage.
BACKGROUND OF THE INVENTION
Studies consistently show that patients have limited "health literacy." In other words, patients, generally speaking, have limited understanding of the role they should play in their own health care, and more specifically, how to take and manage their medications.
Limited patient health literacy results in limited use of preventive services, delayed diagnoses, lack of understanding of medical conditions, failure to adhere to medical instructions, poor self-management skills, increased risk of hospitalization, poor physical and mental health, increased mortality risk, and greater healthcare costs. Some studies have shown these costs to range between $106 and $223 billion per year. What is needed is a comprehensive system enabling patients, physicians and pharmacists to more effectively communicate, and for patients to gain a greater understanding of their own health care and medication management.
The present invention solves these and other problems involved in the current state of the art, as will be explained below.
BRIEF SUMMARY OF THE INVENTION
The present disclosure is best understood with reference to the claims, the entire specification, and the drawings submitted herewith, which describe the systems, methods, and apparatuses of the present disclosure in greater detail. The summary is merely intended to convey aspects of illustrative embodiments.

The present disclosure relates to systems, methods, and apparatuses for the management, dispensing, and administration of over-the-counter and prescription medications through use of a pharmaceutical container labeling system and an optional integrated computer-based or online management system.
In certain aspects, the invention relates to a pharmaceutical container comprising a hollow body, a child-resistant cap, and a specialized information label affixed to the hollow body. In certain embodiments, the hollow body may have a squared form that has a rectangular longitudinal shape and a rectangular or square cross-section, with one corner cut across.
In certain embodiments, the specialized information label may be configured such that, upon being affixed to the hollow body, one side of the hollow body is visible, such that that medication is easily visible though the label. In addition, in certain embodiments, the label may provide extra space for relevant information by providing fold-out panels.
In certain aspects, information printed on the specialized label may be correlated or linked with a computerized or online management system, such as an interactive website to keep patients, pharmacists, physicians and other interested parties organized and informed with respect to all of a patient's prescribed and over-the-counter medications.
In certain embodiments, there is provided a pharmaceutical container comprising: a hollow body having a top portion, a bottom portion and side portions extending between the top and bottom portions to enclose the hollow body; wherein the top portion of the hollow body further includes a neck having threads; wherein the side portions of the hollow body are configured such that one or more corners, edges, or select portions of the cross-sectional form are cut-off at an angle to create one or more longitudinal flat portions; a cap having a top portion, a bottom portion and side portions extending between the top and .. bottom portions, and configured so as to correspond in cross-sectional shape with the hollow body such that the cap includes one or more longitudinal flat portions that align with the one or more longitudinal flat portions of the hollow body when the cap is secured to the hollow body; wherein the cap includes a socket having threads generally corresponding to the threads

2 of the neck of the hollow body so as to engage and secure closure of the cap to the neck of the hollow body; wherein the hollow body and the cap further include interlocking tab portions to provide a child resistant closure mechanism; a specialized information label affixed to the hollow body; wherein the specialized information label comprises multiple information panels including a panel having visual, pictorial administration instructions and a fold-out information panel, and wherein the information panel having visual, pictorial administration instructions comprises: two or more divided areas separated into multiple corresponding subareas, one of the divided areas including a pictorial representation in each of the corresponding subareas indicating the timeframe in which a medication may be administered, and a second divided area including, in the corresponding subareas, a pictorial representation of the amount of medication to be taken during that particular timeframe; and wherein the two or more divided areas are configured to display visual alignment of the amount of the medication taken in each timeframe across a next pharmaceutical container also having an affixed specialized information label, when the pharmaceutical container and the next pharmaceutical container are arranged with the two or more divided areas facing outwards in the same direction, and wherein each timeframe is aligned horizontally or vertically.
Additional objects, advantages and novel features of this invention will be set forth in part in the detailed description that follows, and in part will become apparent to those skilled in the art upon examination of the following description, or may be learned by practicing the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
In the accompanying drawings that form a part of the specification and are to be read in conjunction therewith, the present invention is illustrated by way of example and not limitation, with like reference numerals referring to like elements, wherein:
FIG. 1 is a top right perspective view of a squared pharmaceutical container with the cap attached according to one embodiment.
FIG. 2 is a top right perspective view of a prescription container with the cap detached according to one embodiment.
2a FIGS. 3A-3B illustrate bottom front and right perspective views of a cap according to embodiments.
FIG. 4 is a rear and left side view of a prescription container with a specialized label attached and folded out according to one embodiment.
FIG. 5A-5B illustrates front and rear views of a label detached from a prescription container and folded out according to embodiments.
FIG. 6 illustrates a front view of an alternative label detached from a prescription container and folded out according to an embodiment.
FIG 7A-7I describes and illustrates an exemplary interactive medication management system according to an embodiment.
2b DETAILED DESCRIPTION
In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of embodiments of the disclosure. In other instances, well known structures, interfaces, and processes have not been shown in detail, as they are understood by those of skill in the art. It is intended that no part of this specification be construed to effect a disavowal of any part of the full scope of the disclosure.
The present invention relates to systems, methods, and apparatuses for the management, dispensing, and administration of over-the-counter and prescription medications through use of a pharmaceutical container labeling system and an optional integrated computer-based or online management system.
In certain aspects, the invention relates to a pharmaceutical container comprising a hollow body, a child-resistant cap, and a specialized information label affixed to the hollow body. In certain embodiments, the hollow body may have a squared form that has a rectangular longitudinal shape and a rectangular or square cross-section, with one corner cut .. across.
More particularly, the cap and the neck of the hollow body provide a unique child-resistant mechanism. In certain embodiments, the mechanism is tabbed, requiring a user to press the corners of the hollow body instead of the sides. This closure provides the spring mechanism required to reposition the tab after it has been reassembled onto the container.
In one embodiment, as illustrated in Figurel, the hollow body 110 of the pharmaceutical container 100 has a squared form. In one particular embodiment, the squared form may have a rectangular longitudinal shape. In an alternative embodiment, the squared form may have a square cross-section shape. However, the disclosure is not so limited and alternative forms of the hollow body are within the scope of the present disclosure, e.g., round, triangular, etc.
With reference to Figure 1, hollow body 110 and cap 120 including one or more flat surfaces 130 may be preferred, as opposed to hollow forms including solely curved surface (e.g., a round bottle). However, any suitable hollow form may be used. In certain embodiments, the hollow body may have a square form, triangular form, round form, etc., except that one or more corners, edges, or select portions of the cross-sectional form is cut off at an angle to create a flat side(s) 130 (the "Flat", see., e.g., Fig. 1). In certain aspects, the Flat 130 may be used to accommodate a unique label feature, printed information, organizing information, etc.

3 In certain embodiments, the hollow body may be round in form with one or more portions of the cross-sectional form cut off at an angle to create one or more flat side(s). In other embodiments, the hollow body may be triangular in form with one or more corners of the cross-sectional form cut off at an angle to create one or more flat side(s). In yet other embodiments, the hollow body may be square or rectangular in form with one or more edges or corners cut off at an angle to create one or more flat side(s).
Figure 2 illustrates pharmaceutical container 100 with cap 120 in a detached position from hollow body 110, exposing a container neck 140 and threads or locking protrusions 142 (which generally correspond to threads or locking grooves 144 of cap socket 146, see Fig.
3A-3B).
In one embodiment, multi-lead threads 142 of various sizes and configuration on the neck 140 of the hollow body 110, for which the bottle cap 120 is correspondingly grooved 144, ensure that the closure can be applied in only one position. Again, in certain embodiments, a locking mechanism may be including, such as tab 150 on hollow body 110 and corresponding locking tab 152 on cap 120, requiring a user to press the corners of the hollow body 110 to disengage locking tab 152. This closure provides the spring mechanism required to reposition the tab after it has been reassembled onto the container.
In certain embodiments, non-uniform spacing of the thread configuration may prevent the closure from being cross-threaded, preventing the threads from engaging in the wrong location or position. By way of example, as shown in Figures 3A-3B, three non-uniformly spaced threads may be incorporated to ensure proper functioning. The shape of the thread "bottoms" at the thread lead-in may be flat so that the thread, while disengaged, will ride around the ledge on the bottle finish until the proper thread engagement is aligned. The size and spacing may be used to ensure that the closure is stable prior to engagement and to prevent improper engagement and cross-threading.
Generally, with reference to Figures 1 and 3, the hollow body 110 includes a top portion 110a, a bottom portion 110b and side portions 110c extending between the top and bottom portion to enclose the hollow body. The top portion 110a of the hollow body further includes a neck 140 having threads 142, and the side portions 110c of the hollow body 110 are configured such that one or more corners, edges, or select portions of the cross-sectional form is cut-off at an angle to create one or more longitudinal flat portion(s) 130. The cap 120 generally includes a top portion 120a, a bottom portion 120b and side portions 120c extending between the top and bottom portions, and configured so as to correspond in shape with the hollow body. The cap 120 includes a socket 146 having threads144 generally

4 corresponding to the threads142 of the neck 140 of the hollow body 110 so as to engage and secure closure of the cap 120 to the neck 140. The hollow body 110 and the cap 120 further include interlocking tab porti0ns150, 152 to provide a child resistant closure mechanism.
In another aspect, a specialized label is provided, which may be adhered to the hollow body. The specialized label is generally designed to make it easier for a consumer to understand medicament administration instructions and information. The specialized label may be configured in any suitable manner so as to accommodate the hollow body.
More particularly, in certain embodiments, the specialized label may be configured to include multiple panels sufficient in number to align with surfaces of the hollow body. In certain embodiments, the label may wrap around three sides of the hollow body (plus the Flat(s)) or a portion of the body, leaving the remaining side or portion unlabeled, to thereby leave a side or portion of the hollow body available for viewing of the contents of the hollow body (e.g., pills or liquid remaining in the pharmaceutical container).
As depicted in Figure 4 and explained in further detail herein, in one embodiment, the label may have multiple panels secured to the hollow body of the pharmaceutical container, e.g., three and one quarter outer panels (not shown, see FIG. 5A), two inner panels 410a and an expandable feature 410b to store additional information on the reverse, or inside, side.
As shown in Figures 5A-5B, in one embodiment of the invention, a specialized label (not secured to a hollow body) is illustrated, wherein the first outer panel 510a may list drug, pharmacy and patient information. A second outer panel 510b may list dosing instructions and primary warnings associated with taking the medication. A third outer panel 510c may show visual, pictorial administration instructions, e.g., a MedChart. The third outer panel 510c may also include the first name of the consumer/patient in large, bold type. This feature allows the consumer to immediately recognize which medications belong to him or her.
In certain embodiments, the MedChart may have two or more vertical columns or multiple divided areas (e.g., horizontal divided areas, diagonal, etc.), separated into multiple rows or subareas. In the first column or divided area, an icon or pictorial representation may listed in each corresponding row or subarea for a medication administration timeframe, such as morning, noon, evening, bed time, meal time (breakfast, lunch, dinner, snack time), etc.
The second column or divided area may call out (e.g., through pictorial representation), in the corresponding row or subarea, the amount of medication to be taken during that particular time frame. This MedChart provides several benefits to the consumer. First, it is a quick iconic reference for someone to see their exact dosage during the correct time frame. It is also beneficial for people who do not read English well. Third, if the consumer arranges

5 multiple bottles with the MedChart facing outwards, it is possible to see at a glance when multiple medications must be taken. In certain aspects, prescriber pads could be integrated with the MedChart, wherein the prescriber provides clear information to the pharmacist/dispenser in a format similar to the MedChart regarding dosage administration in the appropriate time frame, e.g., AM, Noon, Eve, Bed, meal time, etc.
A fourth outer panel 510d may include the name of the medication in large, bold type, as well as measurement markers for liquid medications. This feature allows an individual to immediately determine the contents of the bottle. The fourth out panel, in certain embodiments, may be configured to be aligned with the Flat 130 of the hollow body upon securing to the pharmaceutical container.
An expandable feature of the label 510e, configured to fold out from the hollow body upon securing to the pharmaceutical container (see, e.g., Fig. 4, 410b) provides for one or more inner panels, 510e-1, 510e-2, that can include useful information, e.g., for user administration, medicament usage and warnings, etc..
With reference to Figure 5B, in one embodiment, the specialized label may optionally be printed in a double sided manner. By way of example, first 512a and second 512b inner panels may display relevant advice and secondary precautions for the prescribed medication.
If desired (depending on the size of the expandable feature), third and fourth inner panels may display patient information, drug information, common uses of the medication, pharmacy information and provider information. The patient and drug information can be repeated on inner and outer panels so it is always visible.
In an alternative embodiment, e.g., as illustrated in Figure 6, a single sided specialized label may be desired. As shown, a first outer panel 610a may list drug, pharmacy and patient information. A second outer panel 610b may list dosing instructions and primary warnings associated with taking the medication. A third outer panel 610c may show visual, pictorial administration instructions, e.g., a MedChart as described above. The third outer panel 610c may also include the first name of the consumer/patient in large, bold type.
This feature allows the consumer to immediately recognize which medications belong to him or her.
A fourth outer panel 610d may include the name of the medication in large, bold type, as well as measurement markers for liquid medications. This feature allows an individual to immediately determine the contents of the bottle. The fourth out panel, in certain embodiments, may be configured to be aligned with the Flat 130 of the hollow body upon securing to the pharmaceutical container.

6

7 PCT/US2010/045388 An expandable feature of the label 610e, configured to fold out along 610e-3 from the hollow body upon securing to the pharmaceutical container (see, e.g., Fig. 4, 410b) provides for one or more inner panels, 610e-1, 510e-2, that can include useful information, e.g., for user administration, medicament usage and warnings, etc.
An optional feature may be included which allows for a clear view window, 610h. In certain embodiment, panel 610h may be configured with a die-cut window 610h-1 that may be removed prior to, upon application, or following application to a pharmaceutical container, to thereby allow visual access to the container.
The pharmaceutical containers described herein provide a variety of benefits.
Without intending to be limited, in certain embodiments, storing the bottles is simple: all bottles can be organized with the "front" facing outwards, so that relevant information is easily legible. This is convenient both for pharmacists and consumers. The configuration and sizing allows for more information to be conveyed on the specialized label. Further, the configuration and shape may improve ease of use. Child resistant caps are usually troublesome to push and twist even for the most skilled set of hands. The unique shape of the container, combined with the novel form of child resistant cap, provides an additional point of leverage making the container easy to grip and open. In certain embodiments, the Flat may provide a convenient surface on the closure for a thumb or finger while pressing inward to release the child resistant tab from the latch on the bottle.
In yet another aspect, the specialized label described herein may link users (e.g., pharmacists, prescribers, patients, etc.) to an interactive medication management system where users can get assistance in monitoring medications, dosing regimens, as well as accurately track current and past medications. In certain embodiments, the interactive medication management system may be a stand-alone computer system, a networked computer system, an on-line computer system, a website, etc.
In certain embodiments, the MedChart of the specialized label may be replicated on and linked to the interactive medication management system. By way of example, the specialized label may include information which directs patients to a website, where patients may view information concerning medication related to the MedChart, input additional medication information, organize and keep track of their medications, as well as share their information with other authorized users, including authorized family members, authorized prescribers, authorized pharmacists, etc. Further, the website may connect the patient with his or her prescribers, dispensers, and other health professionals to improve communication across these lines of health care, assuring proper understanding around medication regimens and promoting adherence.
In one embodiment of the invention, the interactive medication management system may include one or more of the following types of interactive online content:
a "home" page providing an overview of the medication management system (see Figure 6A);
a "tour" page providing a more comprehensive explanation of how the interactive management system works (not shown);
an encrypted registration page and portal for consumers to enter their 1) personal health history, 2) daily/weekly/monthly medication regimen, and 3) provider profiles (pharmacy, physicians). "Sign up" may, in some embodiments, be driven by the pharmacy or the physician (see Figures 6B-6D);
a resources page to direct patients to useful web links and local community resources (not shown); a "medical organizer" page which pulls together all pertinent information and displays any necessary alerts, such as "Your medication X has been recalled,"
or "You have a prescription ready at the pharmacy." This page may also provide options for adding and organizing medications (both over-the-counter and prescription) and user preferences, such as alert notifications (see Figures 6E-6F);
a "medical reminder" page, which provides adherence support to consumers by providing options for consumers to receive electronic reminders to take medicine, order a refill, or go to a medical appointment via social networking sites (such as Facebook, MySpace, Twitter, etc.) or via email, SMS, text, etc. (see Figure 6G); and a "medical share" page, which provides an option to share personal medication information and communicate with pharmacists, health care providers, caregivers, and/or family members (see Figure 6H).
By way of non-limiting example, an illustrative map of online content of an interactive medication management system is shown in Figure 61. As will be generally recognized by those of skill in the art, information for use in connection with the interactive medication management system may be stored in one or more database(s), displayed via one or more user interfaces, and communicated over any suitable technology (e.g., intranet, extranet, intemet, cellular networks, etc). Data and information may be uploaded, stored, input, etc. into databases in any known manner, and interactive online content may be displayed in any known manner (websites, VPN networks, intranets, etc.).

8 The interactive medication management system may also provide an option for an on-line viewable and/or computer printable pictorial management service. By way of example, the on-line viewable and/or computer printable pictorial management service may provide an option to view and/or print dosing and/or appointment calendars, e.g., pocket calendars, desk calendars, etc., including daily, weekly, monthly, etc. dosing instructions (e.g., MedChart information), refill reminders, appointment reminders, etc.
The interactive medication management system provides numerous benefits for users, such as reducing the need for in-person or telephone interactions with medical providers, assisting the patient in adhering to a schedule, organizing medications, providing reminders, sharing information, and tracking side effects. The interactive system can also consolidate all of the patient's medications, whether over-the-counter or prescribed. It may generate a complete MedChart which gives a visual indicator of medication schedules and may be linked to the MedChart shown on each label. The interactive system may also provide for comprehensive information sharing; by patient invitation, the system may allow healthcare providers access to medical record and to be notified when the patient fills or refills a medication. It may also allow a patient to share information with family members or friends.
The system may further provide links for medication information, such as medical references, the FDA website, or insurance education websites. It may also include a forums, where users can discuss health issues or consult with physicians or pharmacists about concerns.
The interactive system also provides benefits for physicians. The website provides a medication reconciliation tool, which serves as a master list of all medications taken by each patient, including over-the-counter medications and medications prescribed by other providers. This may prevent harmful interactions not caught at the pharmacy.
The system also provides adherence follow-up information, such as a confirmation of whether the patient filled or refilled medications at the right times. It may assist in early intervention, by increasing communication and counseling with patients through a chat room or emailed questions.
The system further provides benefits for pharmacists and dispensers. It may serve as the "Medication Therapy Management" component under Medicare Part D, which allows pharmacies to include counseling over medications as part of the dispensing fee. The system may direct patient communication; if a patient is late on refills or if important updates are issues for a medication precaution, these issues are easy to address. The system may serve a bridging function for medical and pharmacy technology. Further, the system may encourage efficiency, by allowing for easier and faster refill orders, and ensuring that these occur at the

9 proper time by the ability to notify patients that they need to call in refill, or even allow for 'opt out' function.
What has been described and illustrated herein is a preferred embodiment of the invention along with some of its variations. The terms, descriptions and figures used herein are set forth by way of illustration only and are not meant as limitations.
Those skilled in the art will recognize that many variations are possible within the spirit and scope of the invention, which is intended to be defined by the following claims, in which all terms are meant in their broadest reasonable sense unless otherwise indicated therein.

Claims (7)

CLAIMS:

1. A pharmaceutical container comprising:
a hollow body having a top portion, a bottom portion and side portions extending between the top and bottom portions to enclose the hollow body;
wherein the top portion of the hollow body further includes a neck having threads;
wherein the side portions of the hollow body are configured such that one or more corners, edges, or select portions of the cross-sectional form are cut-off at an angle to create one or more longitudinal flat portions;
a cap having a top portion, a bottom portion and side portions extending between the top and bottom portions, and configured so as to correspond in cross-sectional shape with the hollow body such that the cap includes one or more longitudinal flat portions that align with the one or more longitudinal flat portions of the hollow body when the cap is secured to the hollow body;
wherein the cap includes a socket having threads generally corresponding to the threads of the neck of the hollow body so as to engage and secure closure of the cap to the neck of the hollow body;
wherein the hollow body and the cap further include interlocking tab portions to provide a child resistant closure mechanism;
a specialized information label affixed to the hollow body;
wherein the specialized information label comprises multiple information panels including a panel having visual, pictorial administration instructions and a fold-out information panel, and wherein the information panel having visual, pictorial administration instructions comprises:
two or more divided areas separated into multiple corresponding subareas, one of the divided areas including a pictorial representation in each of the corresponding subareas indicating the timeframe in which a medication may be administered, and a second divided area including, in the corresponding subareas, a pictorial representation of the amount of medication to be taken during that particular timeframe; and wherein the two or more divided areas are configured to display visual alignment of the amount of the medication taken in each timeframe across a next pharmaceutical container also having an affixed specialized information label, when the pharmaceutical container and the next pharmaceutical container are arranged with the two or more divided areas facing outwards in the same direction, and wherein each timeframe is aligned horizontally or vertically.

2. The pharmaceutical container of claim 1, wherein the hollow body comprises a squared cross-section shape with one or more edges or corners cut across to form the one or more longitudinal flat portions of the hollow body.

3. The pharmaceutical container of claim 1, wherein the hollow body has a rectangular or square cross-section.

4. The pharmaceutical container of claim 2, wherein the specialized information label is affixed to the hollow body so as to leave one side of the hollow body visible.

5. The pharmaceutical container of claim 1, wherein the hollow body comprises a round form with one or more portions cut across to form the one or more longitudinal flat portions of the hollow body.

6. The pharmaceutical container of claim 1, wherein the fold-out information panel of the specialized label includes one or more inner panels configured to display information when the fold-out information panel is in a fold-out configuration.

7. The pharmaceutical container of claim 1, wherein the interlocking tab portions of the cap and hollow body are configured and located such that the tab portions are disengaged to release the cap from the hollow body upon pressing on the longitudinal flat portion of the cap.