Abstract:
Disclosed herein is a packaging system to support a blister package in a substantially vertical orientation. Such a vertical orientation of a medication storage device is intended to raise the visual prominence of the medication storage device, and thus serve as a reminder to a patient to adhere to the prescribed dosing regimen relevant to that medication. Improved patient compliance is an intended goal. An example of a preferred embodiment is as follows:

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of provisional application No. 60/871,601, filed Dec. 22, 2006, which application is herein incorporated in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to a packaging system for pharmaceutical products. More particularly, the present invention relates to a packaging system designed to be prominently positioned in a location of the patient&#39;s choice, thus improving patient compliance with a recommended dosing regimen. 
       BACKGROUND 
       [0003]    Patient compliance with recommended dosing regimens is a major public health concern. The World Health Organization, in a report in 2003, called noncompliance a “worldwide problem of striking magnitude.” It is estimated that in developed nations, half of patients did not take medicines for chronic diseases in the prescribed manner. Studies have shown that noncompliance causes 125,000 deaths annually in the U.S. (Smith, D., Compliance Packaging: A Patient Education Tool, American Pharmacy, Vol. NS29, No. 2 Feb. 1989), leads to 10 to 25 percent of hospital and nursing home admissions, and is becoming an international epidemic. One study concluded that 23% of nursing home admissions were due to noncompliance (Standberg, L. R., Drugs as a Reason for Nursing Home Admissions, American Health care Association Journal, 10, 20, 1984). Another study concluded that 10% of hospital admissions were due to noncompliance (Schering Report IX, 
         [0004]    The Forgetful Patient: The High Cost of Improper Patient Compliance, March 1981.) It has also been estimated that about 50% of the prescriptions filled each year are not taken correctly (Hayes, R. B., NCPIE Prescription Month, October 1989). Thus, there is clearly a need for improved patient compliance. 
         [0005]    Pharmaceutical agents in the form of tablets and capsules are generally dispensed to users in packages of two types. The first type of packaging which has historically dominated the market is bulk packaging which generally takes the form of a small vial or bottle having a cap that either twists or pops away from the body of the containment article so as to provide access to the articles disposed therein. Such caps may include locking structures when engaged with the package body so as to prohibit access to the contents by children. 
         [0006]    One deficiency with bulk packaging is that the user is responsible for maintaining an independent record by human memory or other means as to whether or not the proper dosage has actually been administered. This deficiency is particularly problematic for users who suffer from weak short-term memory performance. Thus, one can easily take either too many or too few doses in a given period of time, thereby either reducing the efficiency of the medication, or in a more serious situation actually causing damage to one&#39;s system. 
         [0007]    In order to address the inherent deficiencies of traditional bulk storage containers, a second category of storage systems, referred to as blister packaging, has been developed. Such blister packaging typically consists of a set of individualized packets, one for each dose or fractional dose of the pharmaceutical agent, located together on a card. This card is printed with a designation of dosages and warnings. The tablets themselves are encased between two materials such as aluminum foil and polyvinyl chloride film such that the tablet can be pressed through the aluminum foil backing thereby leaving a broken blister indicating that that dose has been utilized. While the use of a blister pack solves the problem of one being unable to remember whether or not a dosage has been administered, a traditional blister packaging system with a necessarily easily opened foil barrier may be susceptible to damage due to tearing or child intrusion. In lieu of a push-through sheet, the backing may comprise a sheet of material designed to be pealed away from the packaging. 
         [0008]    Conventional bulk packaging and blister packaging systems suffer from the weakness that they may not be visually prominent to the patient, thus failing to provide a visual stimulus to trigger the patient&#39;s memory to administer the drug and thus facilitate compliance. Furthermore, by virtue of the fact that they are not in any way associated or anchored to any one location, they may be subject to being misplaced, possibly within reach of a child. 
         [0009]    The prior art reflects various attempts to remedy certain of these shortcomings. U.S. Pat. No. 5,927,500 provides a packaging material which includes a paperboard or polymer sheet stock reinforced with a fabric substrate layer, thereby providing a composite which is resistant to tearing. U.S. Pat. No. 6,273,260 is directed to a packaging system that incorporates external reminders for effectively dispensing medication on an irregular basis or lengthy periodic basis. This reference also suggests that packaging systems that can be oriented vertically may, through their prominence, assist in reminding patients of the need to comply with a dosing regimen regarding the pharmaceutical product contained within. 
         [0010]    However, there remains the need for pharmaceutical packaging systems that will further improve patient compliance. 
       SUMMARY OF THE INVENTION 
       [0011]    In some embodiments, the invention is directed to a packaging system for a pharmaceutical product comprising a blister package containing a plurality of medication dosages and a retaining device for attaching said blister package to a mounting surface, wherein said retaining device supports said blister package in a substantially vertical orientation. 
         [0012]    In some embodiments, the retaining device comprises a magnet disposed on the rear surface of said blister, wherein said magnet is suitable for suspending said blister package from a ferrous vertical mounting surface. 
         [0013]    In some embodiments, the retaining device comprises an adhesive disposed on the rear surface of said blister package, wherein said adhesive is suitable for suspending said blister package from a vertical mounting surface. In some embodiments, the adhesive is a repositionable adhesive. 
         [0014]    In some embodiments, the retaining device comprises a fastener suitable for supporting said blister package from a mounting surface, wherein said fastener is selected from the group consisting of hooks, pegs, clamps, clip springs, hook-and-loop strips, and suction cups. In some embodiments, the retaining device further comprises a magnetic base portion suitable for supporting said blister package from a ferrous mounting surface. In some embodiments, the retaining device further comprises a tether attached at one end to said blister package and at the other end to said fastener. 
         [0015]    In some embodiments, the blister package further comprises a ferrous surface disposed on the rear surface of said blister package, and said fastener comprises a magnet disposed to engage said ferrous surface. 
         [0016]    In some embodiments, the retaining device comprises a grooved retaining fastener adapted to supportingly engage an edge of said blister package. 
         [0017]    In some embodiments, the blister package is attached to said retaining device by a hinge joint allowing said blister package to pivot about said hinge joint. 
         [0018]    In some embodiments, the retaining device comprises a grooved retaining fastener for attaching said blister package to said mounting surface. 
         [0019]    In some embodiments, the invention is directed to a packaging system for a pharmaceutical product comprising a blister package containing a plurality of medication dosages and a stand suitable for supporting said medication storage device from a horizontal surface. In some embodiments, the stand is integral to said medication storage device. In some embodiments, the stand comprises at least one fold-out cross-member. In some embodiments, the stand comprises a horizontal fold-out base. 
         [0020]    In some embodiments, the invention is directed to a method of enhancing patient compliance comprising the use of the packaging system of claim  1  to store and display a pharmaceutical product. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0021]    The aforementioned and current features and objects of this invention will be better understood from the following detailed description in view of the drawings wherein: 
           [0022]      FIGS. 1A and 1B  illustrate a packaging system comprising a blister package on the rear surface of which are located, alternatively, either magnetic or adhesive pads, as edge-mounted strips; 
           [0023]      FIGS. 1C and 1D  illustrate a packaging system comprising a blister package on the rear surface of which are located, alternatively, either magnetic or adhesive pads, as buttons; 
           [0024]      FIGS. 2A and 2B  illustrate a packaging system comprising a blister package that is supported via a hinge joint to a mounting structure, the rear surface of which comprises, alternatively, either magnetic or adhesive buttons; 
           [0025]      FIGS. 2C and 2D  illustrate side views of a packaging system comprising a blister package that is supported via a hinge joint integral to a mounting structure; 
           [0026]      FIGS. 3A and 3B  illustrate a packaging system comprising a blister package that is mountable by a hook or pin; 
           [0027]      FIG. 3C  illustrates a packaging system comprising a blister package that is mounted by a hook; 
           [0028]      FIGS. 4A ,  4 B and  4 C illustrate alternate embodiments of a packaging system comprising a blister package suspended from a grooved retaining fastener; 
           [0029]      FIGS. 4D and 4E  illustrate side views of alternative embodiments of a grooved retaining fastener; 
           [0030]      FIGS. 5A ,  5 B and  5 C illustrate embodiments of a packaging system comprising a blister package supported from its top edge by a retention component that comprises, alternatively, a clamp or spring clip; 
           [0031]      FIGS. 6A ,  6 B and  6 C illustrate embodiments of a packaging system comprising a blister package supported from a side edge by a retention component that comprises a base and, alternatively, a clamp or spring clip, and a tether; 
           [0032]      FIGS. 7A and 7B  illustrate a packaging system comprising a blister package supported by a freestanding base; 
           [0033]      FIGS. 7C and 7D  illustrate a packaging system comprising a blister package supported by an interlocking cross-member; 
           [0034]      FIGS. 7E and 7F  illustrate a packaging system comprising a blister package supported by integral fold-out cross-members; and, 
           [0035]      FIGS. 7G and 7H  illustrate a packaging system comprising a blister package supported by an integral horizontal fold-out base. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0036]    The present invention will now be described more fully herein with reference to the accompanying drawings in which preferred embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. As will be appreciated by one skilled in the art, the present invention may be embodied as a packaging system or method. 
         [0037]    The present invention is directed to a pharmaceutical packaging system comprising a substantially planar medication storage device from which one or more doses of a drug may be dispensed. In particular, this invention is directed to such packaging systems that maintain the storage device in a substantially vertical orientation, and thus provide a visually prominent display to a patient. Such a vertically-oriented, visually prominent display of the storage device is intended to provide the patient with a visual cue that will serve to remind him or her of the need to comply with the prescribed dosing regimen associated with the medication, and thus reduce the incidence of noncompliance. This invention encompasses a variety of embodiments in which a medication storage device is supported in its vertical orientation from any direction, i.e., from the rear surface or front surface, from the top edge, or from either side edge, a bottom edge, or a corner. 
         [0038]    The many options included within the scope of the invention are intended to provide the degree of flexibility in selection of mounting location required to achieve both visual prominence and convenience to the patient, while also being out of the reach of any children who may be present, thus avoiding potential pediatric overdoses. All embodiments provide for attachment of the storage device to a mounting location that is intended to remain constant during the course of administration of the doses contained therein. This is intended to encourage the patient to return the storage device to the same mounting location after each administration, and thus avoid potential mislocation of the storage device. In some embodiments, the storage device is physically anchored or tethered to the mounting location, thus providing a tangible reminder to the patient of the association between the storage device and the mounting location and further reducing the possibility of misplacement. 
         [0039]    The storage device is attached to the mounting surface by a retaining device. The retaining device comprises a mounting surface attachment feature and a storage device attachment feature, either or both of which attachment features may include the use of adhesive, magnet, or a fastener such as a hook, peg, clamp, clip spring, a hook-and-loop system, base, suction cup and the like. The fastener(s) must be fixed to a suitable location on the surface (herein referred to as the “mounting location”). The fastener(s) may be so fixed to the mounting location on the surface of choice by use of fastening hardware including one or more screws, nails, brads, staples, etc. Where the chosen mounting location comprises a ferrous metal, the fastener(s) may include a magnet in its base of suitable size to support the fastener and the storage device supported therefrom. In the case of a clamp or spring clip, the spring load of the fastener must be sufficient to retain the storage device at rest, but not so great as to hinder removal and replacement of the storage device by the patient. Where the fastener is a hook or peg, there must be a hole suitably sized and located in the storage device to allow the hook or peg to pass therethrough, thus allowing the storage device to suspend vertically therefrom. Alternatively in the case of a hook, the hook may be sized and disposed to engage a wire or loop appropriately disposed from the rear surface or edge of the storage device, similar to a conventional picture-hanging arrangement. 
         [0040]    The storage device may alternatively be fastened to the mounting location by use of a hook-and-loop fabric system, such as that which goes by the tradename of Velcro®. The fabric backing of the two opposed hook-and-loop strips can be attached to the mounting surface and the rear surface of the storage device or mounting structure by means of adhesive. 
         [0041]    When adhesive is used to bond the storage device directly to the mounting surface, the adhesive selected must be capable of retaining the storage device on the mounting surface after repeated cycles of application to and removal from the mounting surface. Assuming the storage device is removed from the mounting surface once each time a dosage is administered, and only one dosage is administered at a time, the minimum number of such cycles to be expected will be the number of medication dosages contained in the blister pack when new. Thus, for a fourteen-dose blister pack, the adhesive must be able to retain the blister pack to the mounting surface after at least fourteen cycles of application and removal. Adhesives suitable for this sort of service include those categorized as “repositionable adhesives.” Such repositionable adhesives are described and exemplified in the literature, e.g., U.S. Pat. No. 5,795,636. Ultrastik® is an example of a repositionable adhesive. 
         [0042]    The adhesive used to bond the storage device to the mounting surface may be disposed on a pad that is raised from the remainder of the adjacent surface of the storage device. The pad may be integral to the storage device, or may be a distinct component, which is itself permanently bonded to the storage device. Such a pad may have a relatively soft surface that will conform to any irregularities in the mounting surface, and thus maximize the effective bonding area. 
         [0043]    A patient may choose to locate the medication storage device in any number of locations in the home, at work, etc. In the home, it may be desirable to locate the storage device on a convenient and visually accessible vertical surface, for example a wall or a side of a medicine cabinet, vanity, or refrigerator.  FIGS. 1A ,  1 B,  1 C, and  1 D illustrate a number of preferred embodiments of this invention in which magnets or adhesive pads are fixed to the rear surface of a blister package. Of course, magnets will only retain the storage to ferrous surfaces, while the adhesive pads can be used for most flat surfaces, whether ferrous or non-ferrous. 
         [0044]    As illustrated, the magnets or adhesive may be disposed on raised pads on the rear surface of the blister package locally at corners and/or at mid-points or other locations near the edges. The surface area of the magnets or surfaces to which adhesive is applied should be designed to sufficiently retain the storage device when loaded with the maximum number of medication doses. Alternatively, the magnets or adhesive may be disposed on raised strips that extend for a portion of, or substantially the entirety of the length, of an edge of the blister package on the rear surface. In alternate embodiments, greater portions of the rear surface of the blister package, up to the entirety of the surface, are used to dispose a magnet or adhesive. 
         [0045]    Alternatively, the rear surface of the blister package may have one or more ferrous surfaces attached or incorporated therein. One or more magnetic pads can then be used to detachably engage the ferrous surface on the rear surface of the blister pack, while being more strongly attached to the mounting surface by adhesive or a mechanical fastener, such as a bolt. 
         [0046]      FIGS. 2A and 2B  illustrate embodiments of the storage device in which a blister package is supported from a mounting structure through a hinge arrangement arranged, alternatively, horizontally or vertically.  FIGS. 2C and 2D  are side views of a horizontally mounted hinged packaging system. The mounting structure may be a flat panel that mounts directly to the mounting surface by adhesive, fastener, or magnet. The hinge joint allows the blister package to pivot away from the mounting structure, thus allowing access to the rear surface of the blister package and removal of a dosage form therefrom, without physically detaching the blister package from the mounting structure. This is an example of an embodiment in which the storage device is physically anchored to the mounting location. 
         [0047]    In yet another set of embodiments, the blister package is suspended from a surface mounted fastener such as a hook or a peg. The blister package has at least one hole sized to accommodate the hook or peg. The fastener may be mounted to the mounting surface via a magnet or adhesive.  FIGS. 3A ,  3 B and  3 C illustrate embodiments in which a blister package is suspended from one or two hooks. 
         [0048]    In yet another set of embodiments, the blister package is suspended from a grooved retaining fastener which features a lip or groove sized and located to accommodate a surface edge of the blister pack.  FIGS. 4A ,  4 B and  4 C illustrate the use of a rectangular grooved retaining fastener that has a lip disposed on its top edge. The lip is dimensioned to accommodate the upper edge of the cut out central area of the blister pack, and when so disposed, to support the blister pack against the vertical surface. The groove may be dimensioned to allow the blister pack to be easily lifted out. In the embodiment illustrated in  FIG. 4B , the blister pack is open at one end, allowing for its removal by laterally sliding it across the mounting surface. The grooved retaining fastener may be fixed to the mounting surface by magnet, adhesive clamp, spring clip, hook-and-loop system or other fastening device, as described above. A tether may be used to tie the blister package to the grooved retaining fastener. These embodiments have the added advantage of providing a prominent surface on the grooved retaining fastener to display information of value to the patient, such as dosing instructions, warnings, or merely, a reminder to replace the blister package after each administration of the dosage form. 
         [0049]    In some embodiments, the storage device may be suspended from a horizontal surface, to which a fastener is attached either permanently or detachably. The horizontal surface may be, for example, a ceiling or a lower surface of a shelf or a cabinet and the fastener may be a magnet, adhesive clamp, spring clip, hook-and-loop system or other fastening device, as described above.  FIGS. 5A ,  5 B and  5 C illustrate embodiments of the suspension of a blister package from a horizontal surface by use of, alternatively, a clamp or a spring clip. 
         [0050]    In other embodiments, the storage device is suspended by one of its vertical edges. This arrangement allows the storage device to be very prominently suspended from the edge of a cabinet, refrigerator, or wall, for example. This embodiment may include the use of adhesive, one or more magnets, spring clip, clamp or other fastener disposed on the vertical surface at the mounting surface and suitable for supportingly engaging an edge of the storage device.  FIGS. 6A ,  6 B and  6 C illustrate embodiments in which the fastener comprises, alternatively, a clamp or a spring clip, and the blister package is attached to the fastener by means of a tether. The tether is long enough to allow sufficient access to the blister package to allow removal of a dosage but prevents the patient from removing the blister package to a distance beyond its length. This is another example of an embodiment in which the storage device is physically anchored to the mounting location. 
         [0051]    In yet other embodiments, the medication storage device is supported in its vertical orientation by a stand that reposes on a horizontal surface, such as a table top or a counter top. The medication storage device may be vertically supported by a stand that is either integral to, or distinct from, the storage device. 
         [0052]    In embodiments wherein the stand is distinct to the dispensing product, the stand may clip or pinch the base of the dispensing product. The stand may freely rest on the horizontal surface without any fixity thereto, or alternatively, may be fixed to the mounting surface by any of the fasteners mentioned above.  FIGS. 7A and 7B  illustrate an embodiment of a blister package supported from a horizontal surface by a stand that is distinct to the blister package.  FIGS. 7C and 7D  illustrate an embodiment in which the bottom edge of the blister package has a vertical notch dimensioned to accommodate a distinct cross-member that has a matching vertical notch. When assembled as shown in the figures, the blister package and cross-member interlock to form a base. 
         [0053]    In embodiments wherein the stand is integral to the storage device, supporting members may fold out from the base of the storage device to provide lateral stability, and maintain the vertical orientation of the storage device. The supporting members may be flaps that are integrally bonded or otherwise attached to the lower part of the storage device. Alternatively, the cross-members may be formed by perforated segments of the lower edge of the blister package that can be folded outward, as shown in  FIGS. 7E and 7F . In yet another embodiment, the base can be formed by appropriately folding the lower edge of the blister package at horizontal locations, as shown in  FIGS. 7G and 7H . The fold locations may be marked and of lesser cross-section or stiffness to facilitate folding. 
         [0054]    As stated above, the present invention is directed to pharmaceutical storage systems designed to maintain an essentially planar medication storage device in a vertical orientation. In many preferred embodiments, the medication storage device is a conventional blister-pack card. A typical blister pack card comprises a translucent sheet and a rupturable or pealable backing, and is mounted atop a sheet having a plurality of cutouts, each cutout defining an opening having an area large enough for one dose of medication to pass through. The cutouts can be perforated or non-perforated. A translucent sheet is placed over a portion of the first sheet, essentially overlapping it. The translucent sheet forms a plurality of blisters and is preferably manufactured from clear plastic, but can be manufactured from any other comparable material or combination of materials known to those skilled in the art. Each blister has a hollow cavity upon which one dose of medication is stored. A rupturable or pealable backing seals the hollow cavity so as to prevent contamination of dose of medication, each backing positioned to overlap each opening. In the case of a rupturable backing, the backing is preferably manufactured using a flexible, rupturable material such as a thin metallic sheet, however it can be manufactured using plastic or any other comparable material or combination of materials known to those skilled in the art. The rupturable backing is sandwiched in between the translucent sheet and the first sheet. When a user wishes to take dose of medication from the packaging system, all the user must do is apply pressure against the blister, causing a dose of the medication to break the rupturable backing and exit the packaging system through the opening. 
         [0055]    While in the foregoing specification this invention has been described in relation to certain preferred embodiments thereof, and many details have been set forth for purpose of illustration, it will be apparent to those skilled in the art that the invention is susceptible to additional embodiments and that certain of the details described herein can be varied considerably without departing from the basic principles of the invention.