ADMINISTRATION METHODS FOR ORAL MEDICATIONS

Methods for administering oral medications from a packaging are disclosed. The packaging includes a cover and a body with compartments each configured to hold at least one of the oral medications. The compartments have a circular arrangement on the body. The method may include at least partially detaching the cover from the body to access a separate opening to each of the compartments. In response to removing the cover, all of the oral medications may be removed from the compartments to empty the packaging.

BACKGROUND

The invention relates generally to packagings for oral medications and methods for administering oral medications from a packaging to a patient.

Prescription and non-prescription daily medications may be distributed to patients contained in a variety of different packages including conventional pill vials and blister cards. In many prescription dosing regimes, multiple oral medications are administered on a continuing basis to a patient at different times over the course of each day. The need to remove the oral medication from multiple different vials at specifically prescribed times each day can be confusing to a patient, especially senior patients. Patient confusion may contribute to partial prescription non-compliance or even complete prescription non-compliance if the patient fails to follow treatment directions.

Improved packagings and administration methods for oral medications are needed that can improve prescription compliance.

SUMMARY

In an embodiment of the invention, a packaging is provided for holding a plurality of oral medications. The packaging includes a cover and a body with a plurality of compartments each configured to hold at least one of the oral medications. The compartments have a circular arrangement relative to a point on the body.

In another embodiment of the invention, a method is provided for administering a plurality of oral medications from a packaging having a body with compartments holding the oral medications and a cover attached to the body for confining the oral medications in the compartments. The method may include at least partially detaching the cover from the body to access a separate opening to each of the compartments. In response to at least partially detaching the cover from the body, all of the oral medications may be removed from the compartments to empty the packaging.

DETAILED DESCRIPTION

With reference toFIGS. 1, 1B, and 2and in accordance with an embodiment of the invention, an oral medication packaging10includes a body12with a plurality of compartments14,16,18,20,22,24,26,28and a lidding sheet in the form of a cover30. The cover30is joined to the body12in order to seal closed the compartments14,16,18,20,22,24,26,28. In the representative embodiment, the number of compartments14,16,18,20,22,24,26,28is eight. Each of the compartments14,16,18,20,22,24,26,28may be configured to receive and hold a unit dose of an oral medication25(FIG. 8). After the oral medications25are placed into the compartments14,16,18,20,22,24,26,28and the cover30is attached to the body12to form the packaging10, the assembly (FIGS. 5 and 6) comprises a package that is sealed to prevent the ingress of environmental contaminants and that is in a state prepared for subsequent distribution to a patient.

Each of the oral medications25may be any type of ingestible substance capable of being categorized as an oral medication. The ingestible substance comprising each of the oral medications25may include, but is not limited to, one or more pharmaceuticals, medicaments, one or more compositions, one or more drugs, one or more vitamins, one or more mineral supplements, and one or more placebos, either alone or in combination and may be dispensed by prescription or over-the-counter. The oral medications25may be provided in various dosage forms such as pills, tablets, capsules, gel capsules, solids, etc. A unit dose is an amount of the ingestible substance that is administered to a patient in a single dose.

The compartments14,16,18,20,22,24,26,28are organized as a series of cavities arranged about a central region32of the body12that in the representative embodiment are triangular is cross-section (i.e., wedge-shaped). The compartments14,16,18,20,22,24,26,28are displaced in a radial direction slightly outward from central region32toward an outer perimeter33of the body12. The body12includes a plurality of corners34,36,38,40that are modified with a pattern of surface-area reducing features, generally indicated by reference numeral42, that consist of non-planar structures formed into the material of the body12. The compartments14,16,18,20,22,24,26,28are encircled by a polygonal shoulder44, which is inscribed inside the outer perimeter33of body12. Strips46, which extend radially from the central region32to the shoulder44, are present between adjacent pairs of the compartments14,16,18,20,22,24,26,28. A centerline of each of the strips46, if extended to reach a center45of the central region32, may intersect at the center45. The shoulder44is disposed between the compartments14,16,18,20,22,24,26,28and the outer perimeter33of the body12. The corners34,36,38,40are disposed between shoulder44and the outer perimeter33of the body12.

The surfaces of the central region32, shoulder44, and strips46are disposed in a common plane collectively defining a surface48of the body12. The surface48defined by the region32, shoulder44, and strips46is free of score lines, lines of weakening, perforated seams, and the like. This structural omission is permitted because the individual compartments14,16,18,20,22,24,26,28are not intended to be severed from the body12.

Because of the presence of the surface-area reducing features42, a fraction of the surface area of the body12in each of the corners34,36,38,40is likewise contained in the plane of surface48and another fraction of the surface area of corners34,36,38,40is not contained in the plane of surface48. The effective reduction in surface area in the corners34,36,38,40from the presence of the surface-area reducing features42functions to reduce the adhesion of the cover30to the body12at the corners34,36,38,40. The reduced adhesion permits the portion of the cover30overlying each of the corners34,36,38,40to be readily detached and lifted to form a corner pull tab39(FIG. 7) without immediately compromising the stronger adhesive bond between the rest of the cover30and the adjacent portion of the shoulder44. In an alternative embodiment, fewer than all of the corners34,36,38,40may include the surface-area reducing features42.

The body12of the packaging10includes a surface49that is opposite to surface48and that mirrors surface48with the exception of the absence of the surface-area reducing features42. The surfaces48,49converge at an edge extending about the outer perimeter33of the body12. The distance between the surfaces48,49defines the thickness of the body12, which is selected to lend a targeted degree of rigidity or semi-rigidity to the body12.

As best shown inFIG. 1B, the compartments14,16,18,20,22,24,26,28have a circular arrangement of positions or locations on the body12and are arranged about the circumference of a reference circle55. Specifically, a reference point on each of the compartments14,16,18,20,22,24,26,28or arc associated with each of the compartments14,16,18,20,22,24,26,28may be arranged on the circumference of the reference circle55. A center of the reference circle55may coincide with the center45of region32or, alternatively, with another point in region32of the body12. The reference point or arc may be a nominally equivalent location on each of the compartments14,16,18,20,22,24,26,28. In the representative embodiment, the reference point on the reference circle55for each of the compartments14,16,18,20,22,24,26,28is a respective position where the corner60(FIG. 1A) intersects the edge65(FIG. 1A) so that all corners60are equidistantly spaced from the center of the reference circle55with the same radius. However, other alternative reference arcs or points (e.g., the centroid to the opening58(FIG. 1A) associated with each of the compartments14,16,18,20,22,24,26,28) may be selected such that the diameter of the reference circle55is increased. One or more of the compartments14,16,18,20,22,24,26,28may have a different radial location relative to the center of the reference circle55so long as the circular arrangement is maintained.

Generally, the reference circle55characterizing the circular arrangement may be divided into a plurality of sectors. Each of the compartments14,16,18,20,22,24,26,28may be located within a unique sector characterized by a central angle having the center of the reference circle55as a vertex. The sides bounding the central angle for each of the compartments14,16,18,20,22,24,26,28may extend through an adjacent pair of the strips46. In one embodiment, the central angle for each of the unique sectors may be equal (e.g., 45°) so that the compartments14,16,18,20,22,24,26,28are uniformly spaced and distributed in the circular arrangement.

From a perspective normal to the surface48, the outer perimeter33of the body12may have a rectangular geometrical shape or, in a specific embodiment, may be square with side edges at the outer perimeter33of approximately equal length. In one embodiment, the body12may have a square geometrical shape with side edges measuring approximately4inches in length. This compact sizing permits the patient or caregiver to conveniently insert the assembled and filled packaging10into most shirt or blouse pockets.

The body12of the packaging10may include an indexing feature51in the representative form of a blind, hollow post that is disposed in the vicinity of corner34in the representative embodiment. Alternatively, the indexing feature51may be located in one of the other corners36,38,40. The indexing feature51projects away from the plane of surface48in the same direction as the compartments14,16,18,20,22,24,26,28. The indexing feature51may be utilized to rotationally orient the body12, for example, relative to tooling used to hold the packaging10for filling with the oral medications25. As a specific example, the body12of series of packagings10may be rotationally oriented such that the compartment14is consistently positioned at a known location. In this manner, the angular orientation of multiple different packagings10can be reproducibly established for positioning the compartments14,16,18,20,22,24,26,28at known and fixed positions during a filling operation.

As best shown inFIG. 1A, the compartment14, which is representative of the compartments14,16,18,20,22,24,26,28, includes a bottom wall50and side walls52,54,56that project from the surface48toward the bottom wall50. Side wall52physically joins or connects with side wall54at a corner60, side wall56physically joins or connects with side wall52at a corner62, and side wall56physically joins or connects with side wall54at a corner64. Similarly, the side walls52,54,56join the bottom wall50along respective corners. Side walls52,54extend parallel to the strips46toward the outer perimeter33of the body12. Side wall52and side wall54may have approximately equal lengths and each of the side walls52,54may be longer than side wall56.

The bottom wall50and side walls52,54,56of the compartment14have an interior surface63that contacts the oral medication25placed into compartment14and an exterior surface69separated from the oral medication25by the thickness of the walls50,52,54,56. The interior surface63, which joins surface48at an edge65, is continuous across the edge65with surface48. Edge65is bounded by the central region32on the inner radius relative to center45and the shoulder44on the outer radius, and is circumferentially bounded by an adjacent pair of strips46. The exterior surface69, which joins surface49, is continuous with surface49. The interior surface63of compartment14is recessed relative to the plane of surface48and the exterior surface69of compartment14projects away from the plane of surface49.

The corners60,62,64are inside corners on surface63and outside corners on surface69. Corner60is located closer to the central region32than corners62,64. Corner60is separated from corner62by the length of the side wall52and is separated from corner64by the length of the side wall54. Corners62,64are located more proximate to the outer perimeter33than corner60and are nominally distanced by the length of the side walls54,56from corner60. Corner60is characterized by an included or interior angle between the side walls52,54of, for example, 45°. The interior or included angles of the other corners62,64may be approximately equal. When viewed from a perspective normal to the bottom wall50, the side walls52,54,56of the compartment14have a triangular arrangement and the opening58is characterized by a triangular geometrical shape.

The open space inside the walls50,52,54,56is accessed through an opening58defined in the plane of surface48and peripherally bounded by edge65. The oral medications25are inserted and removed from the body12through the openings58. The opening58has a cross-sectional area assessed in the plane of surface48and the bottom wall50has a surface area that is slightly smaller than the cross-sectional area of the opening58. To accommodate the difference in areas, the corners60,62,64taper in width in a direction from surface48toward bottom wall50.

The width of the compartment14, which is measured as a distance or separation between the respective interior surfaces of the side walls52,54, narrows in a direction from corners62,64toward the center45of the region32with the minimum width occurring near the corner60. In one embodiment, the width of the compartment14may monotonically decrease with increasing distance from corner60. Compartment14includes a depth that is measured from the plane of surface48to the plane of the interior surface of the bottom wall50. In one embodiment, the depth of the compartment14may be uniform across the surface area in the plane of the interior surface of the bottom wall50. The depth and width of the compartment14are selected to receive and hold oral medications25of multiple different sizes and shapes. In various embodiments, the depth of the compartment14may range from thirteen (13) to seventeen (17) millimeters and the maximum width of the compartment14may range from twenty nine (29) millimeters to thirty three (33) millimeters.

Side wall56may include a denesting feature66represented by a small ridge that projects into the compartment14from side wall56. Before use, the bodies12of multiple packagings10may be stacked with the compartments14,16,18,20,22,24,26,28nested (i.e., fit inside each other). The denesting feature66functions to prevent the bodies12from tightly nesting so that they are difficult to separate and singulate from the stack. In one embodiment, the side wall56of each of the compartments14,16,18,20,22,24,26,28may include the denesting feature66. Alternatively, the denesting feature66may be provided on the side wall56of fewer than all of the compartments14,16,18,20,22,24,26,28. The denesting feature66is typically formed when the body12is formed and may represent a feature of the mold used to form body12.

With renewed reference toFIGS. 1 and 2, the compartments14,16,18,20,22,24,26,28may be marked with indicia70used to individually identify the compartments14,16,18,20,22,24,26,28. In the representative embodiment, each indicium70is a unique numerical digit or positive integer. More specifically, the indicia70of the representative embodiment are Arabic numerals ranging in value from one (1) to a number equal to the number of compartments14,16,18,20,22,24,26,28that, in the representative embodiment, is eight (8) compartments. In the representative embodiment, the value of the indicia70increments in a clockwise direction when surface49and the exterior surface69of compartments14,16,18,20,22,24,26,28is oriented to face the observer. However, the embodiments of the invention are not so limited as the indicia value may increment in a counterclockwise direction from this viewing perspective. Other labeling schemes can be used for the indicia70in order to individually and uniquely identify the compartments14,16,18,20,22,24,26,28with different alphanumeric characters.

In the representative embodiment, each indicium70is legible from the exterior of the packaging10. The orientation of the characters comprising indicia70may be chosen so that the indicia70are non-reversed when viewed from the exterior surface69of the bottom wall50of compartments14,16,18,20,22,24,26,28. Because the indicia70for the different compartments14,16,18,20,22,24,26,28are unique, the compartments14,16,18,20,22,24,26,28can be visually identified and distinguished relative to each other.

The indicia70may be physically formed into the material of the body12as permanent features that are not removable from the body12. This type of indicia70may be formed when the body12is formed and may be present as reverse features in the mold used to form body12. The indicia70may be raised relative to the plane of the interior surface63of the bottom wall50or may be recessed relative to the plane of the exterior surface69of the bottom wall50. The dimensions (e.g., line width, character height) of the indicia70are selected to promote legibility. Alternatively, the indicia70may be applied as stickers or labels to one of the surfaces63,69, preferably to the exterior surface69, of the compartments14,16,18,20,22,24,26,28or printed onto the surfaces63,69, preferably onto the exterior surface69.

The body12of the packaging10may be formed from a thin sheet composed of a polymer, such as polyvinyl chloride (PVC). The polymer comprising the thin sheet may be opaque, translucent, or transparent with regard to light transmission. The sheet may be molded or otherwise processed in a conventional manner to produce the compartments14,16,18,20,22,24,26,28. For example, the body12may be fabricated by a thermoforming process in which a thin-gauge sheet of thermoplastic polymer is pre-heated to a pliable forming temperature, formed to the specific shape in a mold, cooled to regain its rigidity, and trimmed to shape. The thin-gauge sheet used in the thermoforming process to form body12may be supplied to the thermoforming process from a roll of stock material.

With reference toFIGS. 3, 4, and 4A, the cover30has approximately the same geometrical shape and dimensions as the body12of the packaging10. The cover30has one surface80that is attached to the body12and a second surface82that is not attached to the body12. In particular, surface80of the cover30is attached to the surface48of the body12to seal the compartments14,16,18,20,22,24,26,28and to thereby seal the oral medications25in the compartments14,16,18,20,22,24,26,28. When the cover30is attached to the body12, the side walls52,54,56project in a direction away from the surface80of the cover30. When the packaging10is assembled, surface82is visible to an observer and exposed to environmental elements.

Surface80of cover30may include a coating84, as best shown inFIG. 4A, that is used to releasably attach the cover30to the shoulder44, strips46, and central region32of the body12. Surface82of the cover30is separated from the coating84on surface80by the thickness of the cover30. The second surface82is nominally free of the substance in the coating84, other than negligible amounts of stray residue that may be present as a result of the application process applying the coating84to surface80. Among other variables, the width of shoulder44, the width of strips46, and the area of central region32in the plane of surface48may be adjusted to set a level of adhesion and thereby set the resistance against removal of cover30.

In one embodiment, the coating84may be comprised of a pressure sensitive adhesive that is permanently tacky and is typically used in conjunction with a release paper covering. Alternatively, the coating84may be comprised of a cold seal adhesive that only adheres to itself; however, this embodiment may require also coating the surface48of the body12with the same of a compatible cold seal adhesive to provide an adhesive bond with the cold seal adhesive residing on surface80. In another alternative embodiment, the substance in the coating84on surface80may be a heat activated adhesive that must be heated for a defined period of time at an elevated temperature and/or in the presence of applied pressure in order to achieve final bonding strength.

The cover30of the packaging10may be formed from a thin sheet comprised of a composite material, such as a blend of paper with a polymer, such as polypropylene. The cover30is formed from a material with properties, such as thickness and stiffness, that provide rupture resistance to pressure indirectly applied through the material of the body12to one of the oral medications25in an attempt to push the oral medication25through the cover30. Preferably, the cover30is not rupturable over a wide range of applied forces applied to the oral medication inside of the compartments14,16,18,20,22,24,26,28. The single sheet design of the cover30differs from blister packs that include an impenetrable (e.g., paper) sheet and a penetrable (e.g., foil) sheet disposed between the blister body and the impenetrable sheet, and in which the impenetrable sheet is removed to reveal the penetrable sheet in preparation of forcing a medication to penetrate through the penetrable sheet.

In an alternative embodiment, the cover30of the packaging30may also comprise a peel foil and a heat-seal coating for the peel foil that includes two distinct laminated layers that are designed to separate from each other when peeled from the body12. When the card is sealed, an outermost layer of the heat-seal coating is permanently sealed to the body12. When the peel foil is peeled from the body12, an innermost seal layer of the heat-seal coating peels to release the peel foil and to uncover the compartments14,16,18,20,22,24,26,28, while the permanently-sealed portion of the outermost layer is retained on the surface48of body12.

The cover30is free of score lines, lines of weakening, perforated seams, and the like, which strengthens the resistance to cover punch-through in response to a force applied to the oral medication25. The cover30may be formed from roll stock to which the coating84is an adhesive (e.g., pressure sensitive adhesive) pre-applied as a coating across the full surface area of surface80. In one embodiment, the roll stock may be pressure sensitive label stock with the coating84and a removable liner or release paper (not shown) covering the coating84.

The coating84may be modified to selectively reduce the adhesiveness of the constituent substance or material. Specifically, if the coating84is comprised of an adhesive, a deadening material, such as a varnish, may be applied (e.g., by printing) over the entire surface area of surface80. The deadening material functions to adjust the adhesiveness of the coating84and the adhesion of cover30to the surface48of body12. This adjustment mechanism may be used to control the force that must be applied to separate the cover30from the body12, which may be a concern for the elderly who may exhibit a reduced physical strength.

In the representative embodiment, the deadening material may be patterned to form regions86a-hin the coating84that match the geometrical shape (e.g., triangular shape) and pattern of the openings58to the compartments14,16,18,20,22,24,26,28of the body12. The regions86a-hpreferably exhibit either no or negligible adhesiveness upon contact with the medications25. The regions86a-hare also provided in a circular arrangement on a center that matches the circular arrangement of the compartments14,16,18,20,22,24,26,28. The coating84of the cover30therefore exhibits different levels of adhesiveness at different positions across the surface area of surface82. When the cover30is joined to the body12(FIGS. 5, 6), the regions86a-hare aligned spatially with the locations of the opening58to each of the compartments14,16,18,20,22,24,26,28of the body12. In an alternative embodiment, the dispensing of the material constituting the coating84may be controlled such that the constituent material is not applied to surface80of cover30in regions86a-h.

Alternatively and as shown inFIG. 4B, if a release paper is present, the release paper may be die cut while resident on the cover30to define sections85. The sections85are permitted to remain adhered to the coating84on the cover30after the remainder of the release paper is removed in preparation of attaching the cover30to the body12. In the representative embodiment, the sections85have a triangular shape. The sections85function to block the coating84from adhering to the corners34,36,38,40of the body12when the cover30is attached to the body12. As a result, the sections85of the cover30may operate as pull tabs39. In the representative embodiment, each corner of the cover30includes one of the sections85of release paper. However, in an alternative embodiment, the sections85may be applied on fewer than all of the corners of the cover30. For example, only two corners may include one of the sections85. The sections85of release paper remain attached to the cover30when the cover30is at least partially detached to release the oral medications25for administration from the packaging10to a patient.

Sections (not shown) of release paper similar to sections85may be die cut in locations correlated with the location of the openings58to the compartments14,16,18,20,22,24,26,28of the body12. In one embodiment, these sections of release paper would match the shape and pattern of the openings58to the compartments14,16,18,20,22,24,26,28and therefore have an appearance similar or identical to regions86a-h. The presence of the release paper sections85would eliminate the need to completely deaden the coating84in regions86a-hor pattern the coating84so that the constituent substance is absent in regions86a-hbecause the sections of release paper would eliminate any adhesion of the medications25with the coating84. The presence of the release paper sections85may also eliminate the need for the surface-area reducing features42. The sections of release paper remain attached to the cover30and are removed from their respective locations over the openings58when the cover30is at least partially detached to release the oral medications25for administration from the packaging10to a patient.

Surface82of cover30may include information-containing data fields90,92,94,96and machine-readable markings98,100. The data fields90,92,94,96and machine-readable markings98,100are customized to be specific to the patient to whom the oral medications25are prescribed and, hence, may contain information pertinent to the packaging10, its contents of oral medications25, and the patient. Because the cover30is intact when removed to expose the openings58, the data fields90,92,94,96and machine-readable markings98,100can be presented on the surface82without consideration of obscuring the information by partial removal of the cover30.

Each of the data fields90,92,94,96may contain human-readable text such as simple text with any number and combination of alphanumeric characters, as well as optional symbols, grammatically formatted and arranged to be parsed and understood by a human reader and to convey information to the human reader.

The human-readable text in data field90may contain information relating to the patient, such as patient name, date of birth, sex, telephone number, and residential street address. This information may be used to verify that the named patient associated with the packaging10is correct.

The human-readable text in data field92may contain information that relates to the oral medications25inside the packaging10. The information in the data field92may include, but is not limited to, compartment number, oral medication name, strength, form, color, shape, and size. In particular, the data field92may include entries that correlate an alphanumeric representation of the unique indicia70on the body12with an alphanumeric identifier (e.g., oral medication name) for each of the oral medications25held the compartments14,16,18,20,22,24,26,28.

The human-readable text in data field94may contain information relating to the pharmacist or facility that filled the prescriptions. The human-readable text in data field96may contain time indicia, such as the day of the week, the calendar date, and a time of the day, that indicates a designated date and time (i.e., medication pass) at which the oral medications25(FIG. 8) in the packaging10are to be administered to the patient identified in data field90.

The machine-readable markings98,100may comprise a one-dimensional bar code or a two-dimensional bar code containing a light background and dark informational elements arranged in a pattern on the light background. The machine-readable markings98,100may be utilized by a machine, such as a smartphone, a vision system, or a bar code reader, equipped with suitable electronics capable of reading, imaging, or scanning the markings98,100and translating the resulting data into a digital form that is usable by the machine to track and/or verify each individual packaging10. The machine-readable markings98,100may encode information selected from one or more of the data fields90,92,94,96.

The data fields90,92,94,96and machine-readable markings98,100may be printed using conventional printing techniques or otherwise applied onto the surface82. For example, the data fields may be directly printed with a conventional printer (e.g., label printer) onto the surface82before the cover30is assembled with the body12.

With reference toFIGS. 5 and 6, the cover30is assembled with the body12to provide the packaging10that contains the medications25(FIG. 8). The assembly securely holds the oral medications25for distribution to a patient and stores the oral medications25until administered to the patient.

In use, one or more of the compartments14,16,18,20,22,24,26,28of the body12are filled with the requisite oral medications25(FIG. 8) at a pharmacy or other type of filling facility. Specifically, a single unit dose of each oral medication25can be inserted into each of the compartments14,16,18,20,22,24,26,28through the respective opening58and reside therein as best shown inFIG. 8. In one embodiment, each oral medication25inserted into one of the compartments14,16,18,20,22,24,26,28is a unit dose that is unique from the other unit doses. In an alternative embodiment, two or more of the compartments14,16,18,20,22,24,26,28may receive a unit dose of the same oral medication25. Alternatively, one or more of the compartments14,16,18,20,22,24,26,28may contain multiple unit doses of the same type of oral medication25. It is understood that one or more of the compartments14,16,18,20,22,24,26,28in the body12may remain unfilled and empty in the sealed condition. Each of the oral medications25may differ from the other oral medications25or, alternatively, two or more of the compartments14,16,18,20,22,24,26,28may contain the same type of oral medication.

After the compartments14,16,18,20,22,24,26,28are populated with the oral medications25, the cover30is joined to the body12, as best shown inFIGS. 5 and 6. The attachment (e.g., an adhesive bond) is established by the coating84disposed between the surface48of the body12and the surface80of the cover30. In the sealed condition, the packaging10is sealed closed against the entry of environmental contaminants and against the loss of the oral medications25. In the sealed condition, the compartments14,16,18,20,22,24,26,28are isolated from each other so that the oral medications25are confined and segregated to prevent commingling among the different oral medications25. The isolation of the oral medications25contrasts with conventional packages in which the oral medications25are not segregated and may commingle together.

The packaging10can be transferred from a medication filling facility to another location (e.g., delivered to a patient at the patient's residence or domicile) with the oral medications25secured inside the covered compartments14,16,18,20,22,24,26,28. The oral medications25are stored in each packaging10until administered to a patient.

At the location of the patient and in advance of oral consumption, the oral medications25can be removed from the compartments14,16,18,20,22,24,26,28through the same openings58used for filling. To that end, the packaging10is made available to a patient for whom the oral medications25contained in the packaging10were prescribed or by a caregiver for the patient. The patient or patient caregiver may grasp the packaging10in one hand with a finger inserted from below into the space between the compartments14,16,18,20,22,24,26,28of the body12and the palm of the hand contacting the surface69of at least some of the compartments14,16,18,20,22,24,26,28. With the opposite hand, the patient or patient caregiver lifts the portion of the cover30bonded to one of the corners34,36,38,40, which exhibits reduced adhesion due to the presence of the surface-area reducing features42or the release paper sections85, to form the corner pull tab39. The patient may use an object to provide assistance in forming the corner pull tab39.

The lifted portion of the cover30defines the corner pull tab39that the patient or caregiver can grasp and apply a manual force, which is diagrammatically indicated by the single-headed arrow101inFIG. 7, to the corner pull tab39that peels the cover30. After peeling is complete, the cover30may be only partially detached from the body12. Alternatively, the detachment may be complete so that the cover30is removed intact from the body12. This senior-friendly mode of opening the packaging10eliminates any type of punching action by applying pressure to each oral medication to push the oral medication through the lidding material as found in conventional blister packs.

After the cover30is peeled, the opening58at the entrance to each of the compartments14,16,18,20,22,24,26,28is revealed, as best shown inFIG. 8. The packaging10is then emptied of the oral medications25. For example, all of the oral medications25can be removed from the compartments14,16,18,20,22,24,26,28by manipulating the body12with one hand to empty the oral medications25into the other hand. The medication removal process contrasts with conventional blister packs that are reused by patients to dispense oral medications25at on multiple occasions (e.g., on different days and/or at different times during the same day).

The oral medications25are then administered to the patient. The patient or patient caregiver can conveniently dispose of the packaging10, which is non-reusable.

The consumption of the entire contents (i.e., all of the oral medications25in the compartments14,16,18,20,22,24,26,28) of the packaging10improves compliance because the patient has to exercise only minimal judgment in order to consume the oral medications25contained therein. The use of the packaging10eliminates potential confusion arising from the complexity of multiple prescriptions and administration instructions.

The packaging10is best suited for distributing oral medications25that are administered to a patient daily every month as part of long-term, maintenance care. Patients, such as elderly or senior patients, may daily dispense and consume oral medications25from the packaging10in medication passes at different time points during the day, such as breakfast, lunch, dinner, and bed time (or morning, noon, evening, and night) or at specifically designated times (e.g., 7 a.m., noon, 5 p.m., and 10 p.m.). A patient caregiver may participate in the use of the packaging10to dispense the oral medications25and the administration of the oral medications25to the patient for oral consumption. Each of the oral medications25may be administered to the patient by oral consumption once a day (QD), two times a day (BID), three times a day (TID), or four times a day (QID). Certain oral medications25should be administered to the patient by oral consumption during a specific medication pass (only at bed time or at breakfast). The number of daily doses and any time-of-day restrictions may be factors used to allocate the oral medications25to a specific packaging10designated for administration in a particular medication pass. Other types of oral medications that are administered to the patient when needed (PRN) may be supplied in a different type of packaging that permits separate access to each of the individual compartments.

The packaging10may be provided to a patient in a non-institutional (e.g., home or residential) setting. In one embodiment, the patient may be identified while in a transitional care facility, such as a hospital, rehabilitation center, or step-down care unit, and solicited to participate in a home/residence distribution service program following discharge from the transitional care facility. The oral medications25are prescribed by the patient's physician(s) and are filled by the service program provider with the oversight of a pharmacist. The service program provider is responsible for packaging the oral medications25into the packagings10and delivering the packagings10to the patient's domicile. In another embodiment, the patient may be solicited by direct advertising, by agreement with an organization to which the patient belongs, by agreement with a company that employs or that once employed the patent, etc.

Alternatively, the packagings10may be targeted for use by patients while resident in senior housing, such as assisted living facilities (ALF), skilled nursing facility facilities (SNF), and independent living facilities (ILF). At a skilled nursing facility, acute care and rehabilitation services are provided to each patient. Care is typically not provided to patients living at an independent living facility, which has the appearance of a multifamily setting with common meals, entertainment, and active senior life activities. An independent living facility also has the appearance of a multifamily setting but general assistance is provided for daily life activities.

With reference toFIGS. 9-11, a group of packagings10may be distributed to a patient in a carton120. For example, a one month or a fifteen (15) day supply of packagings10containing medications25for a unique medication pass may be placed inside the carton120and distributed to the patient for consumption, for example, at the patient's residence.

The carton120includes an outer casing118with end panels124,126and side panels128,130,132,134,136. The panels124,126,128,130,132,134,136are joined by various fold lines. The carton120is erected by folding a blank (FIG. 11) and securing the carton120in the folded shape with in a conventional manner, such as by adhesive bonding. End panel126folds to define a small platform that elevates the lowest packaging10off of the support surface to ease handling and removal. The carton120can be manufactured from a flat sheet of any of the grades or types of paperboard commonly used in folding carton manufacture. The blank used to form the carton120may be die cut from a flat sheet of the selected material.

The carton120can include instructions or other exteriorly-visible information, such as a month and a time of the day of the medication pass, that are related to the use of the packagings10inside the carton120. The information can, for example, include text and/or graphics, as desired. Furthermore, the carton120may include information that is related to a designation (e.g., a trademark or a trade name) of a product source, bar codes, or other artwork. Although the various items of information may be positioned on or in the carton120in any conventional way, the information can be printed on an exterior surface of the carton120.

Multiple packagings10, which have generally rectangular configuration in the representative embodiment, are placed into the interior space137inside the carton120with a horizontal orientation relative to a surface supporting the carton120. The packagings10are stacked in a single vertical tower or array within the interior space137and may be oriented such that the covers30of adjacent packagings10are separated from each other by the body12of one of the packagings10. The orientation may be such that the body12of each packaging10is located vertically between the respective cover30and the supporting surface for the carton120.

A removable slot cover138is defined in one of the panels128and has a perimeter defined by the perforations of a score line. The slot cover138is removed by tearing along the perforations to reveal a slot140. The slot cover138physically blocks the slot140, after filling, so that the packagings10are confined inside the carton120. The slot140provides access to the interior space136. The slot140includes a finger opening141that provides access to use fingers, typically the forefinger and thumb, to grasp the lowermost packaging10. The patient, patient caregiver, or other individual may visualize identifying indicia in at least data field96on the surface82of cover30of each packaging10through the slot140. Packagings10are horizontally retrieved in a sequential manner from the bottom of the vertical stack of packagings10and through the slot140by grasping a side edge of the packaging10. Panel126may define a ramp that lifts the lowermost packaging10above the support surface and thereby eases removal from the carton120. As each individual packaging10is withdrawn from the interior space137of carton120, the stack of packagings10drops downwardly to reposition another packaging10at the lowermost position for subsequent removal from the carton120. This procedure continues until the carton120is emptied of packagings10.

With reference toFIG. 10in which like reference numerals refer to like features inFIG. 9and in an alternative embodiment, packagings10may be distributed in a set of multiple cartons142,144,146,148each nominally identical to carton120(FIG. 9). Each of the cartons142,144,146,148may contain or house a set of packagings10with contents intended to be administered to the patient at nominally the same designated time on successive days of a month as identified by indicia in data field96. For example, the cartons142,144,146,148may contain respective stacks of packagings10sufficient to provide a one-month supply of oral medications25for administration at four different daily times (i.e., medication passes) each day in a given calendar month. Alternatively, an additional set of cartons like cartons142,144,146,148may be utilized to divide each respective stack of packagings10into two or more shorter stacks so that each specific medication pass is contained in two or more cartons. For example, one set of cartons142,144,146,148may hold the packagings10for days 1-15 and another set of cartons142,144,146,148may hold the packagings10for days 16-30 in order to distribute a one month supply of packagings10to the patient. In the representative embodiment, the cartons142,144,146,148may serve medication passes at different time points during the day, such as breakfast, lunch, dinner, and bed time. However, in an alternative embodiment, a smaller number of cartons may be distributed in which packagings10are held for different combinations and permutations of medication passes according to the medication needs of the patient. For example, only a pair of the cartons142,144may be filled and distributed that respectively hold a supply of packagings10designated for only two different medication passes (e.g., breakfast and dinner). As another example, only one carton142may be filled with packagings10and distributed to the patient.

The cartons142,144,146,148holding the packagings10may be delivered or shipped directly to the residential address of the patient each month through a commercial delivery or shipping service. The cartons142,144,146,148may be contained inside an outer shipping carton to provide protection during shipment. A patient's prescriptions may be automatically refilled each month by distributing a new group of packagings10. Additional non-unit dose items, such as injectables, patches, ointments and creams, intravenous therapy bags, etc., may be included in a separate carton shipped along with the cartons142,144,146,148to the patient.

The solitary units represented by the cartons142,144,146,148may be piecewise assembled together into a unit. The assemblage may be distributed as a unitary structure to the patient. After carton142is erected, filled and closed, a connector154is inserted into a slot155at the top of the carton142and another connector156is inserted into a slot157at the bottom of the carton142. The connectors154,156may be provided as removable portions of the blank used to form one or more of the cartons142,144,146,148. Preferably, approximately one half of each of the connectors154,156protrudes from its respective slot at the top and bottom of the carton142.

After carton144is erected, filled and closed, adhesive is applied to the exterior surface of a panel that, when the cartons142,144are juxtaposed in a side-by-side relationship, faces toward the panel of carton142with the inserted connectors154,156. Preferably, the cartons142,144are oriented such that the respective slots140face in the same direction. Carton144is guided such that the connectors154,156protruding from carton142are inserted the slots at the top and bottom of carton144, which are similar to slots155,157. Carton144is pressed against carton142in order to adhesively bond the mating panels of the cartons142,144together. The connectors154,156add rigidity to the assemblage and function to securely fasten the cartons142,144against top-to-bottom relative motion and front-to-back relative motion. The adhesive on the mated panels also adds rigidity to the assemblage and functions to securely fasten the cartons142,144against side-to-side relative motion. This process is continued to add additional cartons (e.g., carton146and/or carton148) to complete the assemblage.

Other types of machinable folding cartons may be used to store and distribute the groups of packagings10. For example, overwrap types of carton or knock-down cartons where either the end flaps or the top and bottom flaps are glued or folded may be used.

The filling of the prescriptions for the oral medications25dispensed in the packaging10may be supervised and coordinated by an advisor, such as a care coordinator, who operates as a patient interface. The care coordinator may also provide direction and oversight to the patient on all aspects of the acquisition, disposition, handling, storage, and administration of the oral medications25. For example, if one or more of the prescriptions change after the packagings10are distributed to the patient in carton120, the care coordinator may contact the patient or patient caregiver and instruct that person to halt the administration of the impacted oral medication25. After receiving the instructions, the recipient may determine how to best implement this instruction changing administration of the oral medications25. The correlation of the compartments14,16,18,20,22,24,26,28with the indicia70of body12and the mapping of the content of each of the compartments14,16,18,20,22,24,26,28with the data in data field92on cover30can be used to facilitate rapid and simple identification of the impacted oral medication. For example, the care coordinator can inform the patient or patient caregiver that the oral medication25contained in the compartment labeled with the number three (3) should not be consumed and, instead, should be discarded.

References herein to terms such as “vertical”, “horizontal”, “upper”, “lower”, “raise”, “lower”, etc. are made by way of example, and not by way of limitation, to establish a frame of reference. It is understood by persons of ordinary skill in the art that various other frames of reference may be equivalently employed for purposes of describing the embodiments of the invention.

It will be understood that when an element is described as being “attached”, “connected”, or “coupled” to or with another element, the element can be directly connected or coupled to the other element or, instead, one or more intervening elements may be present. In contrast, when an element is described as being “directly attached”, “directly connected”, or “directly coupled” to another element, there are no intervening elements present. When an element is described as being “indirectly attached”, “indirectly connected”, or “indirectly coupled” to another element, there is at least one intervening element present.