WO2018023167A1

WO2018023167A1 - Pharmaceutical storage system

Info

Publication number: WO2018023167A1
Application number: PCT/AU2017/050818
Authority: WO
Inventors: Barbara Joyce Perry; Donald Alexander Fraser; Christopher John Kayler-Thomson; Stuart George McKenzie
Original assignee: Barbara Joyce Perry
Priority date: 2016-08-04
Filing date: 2017-08-03
Publication date: 2018-02-08
Also published as: AU2017305104A1

Abstract

A medicine packaging article for storage and inventory control of medicine is disclosed. The article includes at least one compartment that is at least partially transparent for receiving a plurality of individual dosages of a medicine held within the original sub- packaging of the manufacturer, the compartment being sized and shaped to match the sub-packaging for the particular medicine. A hinged at least partially transparent releasable cover encloses the sub-packaged medicine within the compartments, and a display area is provided for attachment of a pharmaceutical label specific to the medicine contained within the packaging article. Attachment means allows a plurality of packaging articles to be joined together for storage and inventory control, and each individual dosage of medicine is visible for counting without opening of the compartment cover.

Description

Pharmaceutical storage system

Field of the invention

The present invention relates to a system for the storage and inventory control of medicine. It finds particular application for the secure handling of Schedule 8 and other prescription medicines or drugs of dependence.

Background of the invention

Schedule 8 drugs or drugs of dependence are prescription medicines that have a recognised therapeutic need but also have a high risk of misuse, abuse and dependence. Good management, as required by various legislation, requires the controlled distribution and storage of such drugs, including recordal of the authorised usage, as well as regular counting of inventory.

Patient prescribed Schedule 8 drugs and some Schedule 4 drugs are held in the facility safe and are managed by registered nursing staff who then have the obligation of strict inventory control. These drugs remain in their original manufacturers and pharmacy packaging, with patient and dosage information provided on a pharmacy label affixed to the outside surface of the box, as is standard practice. Typically multiple packets of the same drug, each being for a different patient, are held together with elastic bands. When it comes time for the nurse to count the individual tablets, each box is opened, the blister packs removed, individual tablets are counted and then the blister packs are replaced into the boxes. A record of the number of drugs is then made. This inventory counting of individual tablets occurs at the change-over of every shift, where the nursing staff responsible for the drugs going off shift and the nursing staff coming on shift must make the count together before responsibility for the drugs is transferred. The boxes are therefore opened and closed three times a day. The process of going through individual boxes is a very time-consuming process and often results in unpaid overtime by the nursing staff going off shift.

Of particular note is the common occurrence in hospitals and nursing homes that such drugs may be prescribed on an "as needed" basis. For drugs that have an infrequent use, the box of drugs may last a patient for a significant period of time. However, as the boxes are handled so frequently, at every changeover of shift, the boxes quickly degrade. This results in the closure flap breaking off from the box, which could result in blister packs falling out and going missing. Further, as the blister packs are regularly physically handled when they are removed from the box, the foil of the blister pack may degrade and be compromised. This results in tablets being discarded. It is therefore an aim of the present invention to provide a system of storage and inventory control of such medicines that overcomes or at least ameliorates the problems with existing handling, or provides a useful alternative that reduces time.

Reference to any prior art in the specification is not an acknowledgment or suggestion that this prior art forms part of the common general knowledge in any jurisdiction or that this prior art could reasonably be expected to be understood, regarded as relevant, and/or combined with other pieces of prior art by a skilled person in the art.

Summary of the invention

According to a first aspect, the present invention provides a medicine packaging article for storage and inventory control of medicine, the article including: at least one compartment that is at least partially transparent for receiving a plurality of individual dosages of a medicine held within the original sub-packaging of the manufacturer, the compartment being sized and shaped to match the sub- packaging for the particular medicine; at least one hinged releasable cover to enclose the sub-packaged medicine within the compartment(s), the cover being at least partially transparent; a display area for attachment of a pharmaceutical label specific to the medicine contained within the packaging article; attachment means to allow a plurality of packaging articles to be joined together for storage and inventory control; and wherein each individual dosage of medicine is visible for counting without opening of the compartment cover.

According to a second aspect, the present invention provides a system for the storage and inventory control of medicine, the system including: a base having mounting means; a plurality of medicine packaging articles each having: at least one compartment that is at least partially transparent for receiving a plurality of individual dosages of a medicine held within the original sub-packaging of the manufacturer, at least one hinged releasable cover to enclose the sub-packaged medicine within the compartment(s), the cover being at least partially transparent, and a display area for attachment of a pharmaceutical label specific to the medicine contained within the packaging article; each of the packaging articles having releasable attachment means for mounting the plurality of packaging articles to the base mounting means; wherein different packaging articles may have different compartment sizes to accommodate a variety of different medicines in different types and sizes of sub- packaging; and wherein the packaging articles are moveable with respect to the base to provide visibility to each successive packaging article and each individual dosage of medicine is visible for counting without opening of the compartment cover.

The compartment and the cover may be fully transparent. Alternatively, a portion of the compartment and/or cover may be transparent to allow full visibility of the contents within the compartment.

Preferably, a single compartment is specifically sized to receive only one item of sub-packaging, preventing the overlapping of sub-packaging and obscuring of individual doses. Medicine packaging articles may include two or more compartments, such that each sub-packaging is housed within a different compartment. In one embodiment of the invention there may be an additional compartment provided to house an individual dosage of a medicine. In such an embodiment this additional compartment will be sized and shaped to receive a single tablet, and would usually be used to securely hold a half tablet after being cut in half for administration of a half dosage.

The medicine packaging article preferably includes a rear sheet into which the one or more compartments are formed, with the hinged transparent releasable cover being hingedly attached along one edge of the rear sheet. The cover is preferably re- closable by incorporating a latch closure. The latch closure may be provided on an opposite edge to the hinge or alternatively on a top and/or lower edge, in one embodiment a latch closure may be provided on all of the unhinged edges.

The medicine packaging article is preferably made from plastic and may be semirigid. The stiffness of the material may differ between different articles. The material is preferably recyclable and may be food grade.

The display area may be provided on a rear sheet of the article below or adjacent a compartment. In some embodiments the display area may be on the cover; however it will not inhibit visibility for counting of the individual dosages of medicine. The display area is preferably a flat surface that is sized to accommodate a pharmaceutical label, which may be at least the minimum size requirements as set by the Therapeutic Goods Act (TGA), i.e. 80 mm x 40 mm.

The attachment means is preferably two spaced apart holes that can be fitted to the posts of an associated base, board or folder. Extending from the holes to the edge may be slits to allow flipping on and off of the articles from the posts without removal of overlying articles.

According to a third aspect, the present invention provides a method of storing and maintaining inventory control for a variety of different medicines, the method including: providing a plurality of medicine packaging articles mounted together, the packaging articles each having: at least one compartment for receiving a plurality of individual dosages of a medicine held within the original sub-packaging of the manufacturer, at least one transparent releasable cover to enclose the sub-packaged medicine within the compartment(s), and a display area with a pharmaceutical label specific to the medicine contained within the packaging article; each of the packaging articles being chosen to provide at least one compartment sized and shaped to receive the specific medicine and sub-packaging; as each dosage of medicine is required, identifying the correct packaging article via the pharmaceutical label, opening the compartment cover and dispensing the individual dosage, if any individual dosages remain in the sub-packaging, returning the sub-packaging to the compartment and closing the cover; as each dosage is dispensed, completing any associated documentation for inventory control; and periodically counting the individual dosages by viewing through the cover without opening the cover. Brief description of the drawings

Further aspects of the present invention and further embodiments of the aspects described in the preceding paragraphs will become apparent from the following description, given by way of example and with reference to the accompanying drawings, in which: Figure 1 is a representative side view of a system for the storage and inventory control of medicine;

Figures 2A, 2B and 2C are side, front and end views respectively of a base with mounting means;

Figures 3A, 3B and 3C are side, front and end views respectively of a medicine packaging article according to a first embodiment;

Figures 4A, 4B and 4C are side, front and end views respectively of a medicine packaging article according to a second embodiment;

Figures 5A, 5B and 5C are side, front and end views respectively of a medicine packaging article according to a third embodiment; Figures 6A, 6B and 6C are side, front and end views respectively of a medicine packaging article according to a fourth embodiment;

Figures 7A, 7B and 7C are side, front and end views respectively of a medicine packaging article according to a fifth embodiment;

Figure 8 is a representative cross-sectional end view of a medicine packaging article according to a sixth embodiment;

Figure 9 is a representative cross-sectional end view of a medicine packaging article according to a seventh embodiment; Figure 10 is a front view of a plurality of individual dosages of a medicine held within the original sub-packaging blister pack of the manufacturer; and

Figure 1 1 is a front view of a plurality of individual ampoules of a medicine held within the original sub-packaging of the manufacturer. Detailed description of the embodiments

Figure 1 shows a system for the storage and inventory control of medicine, particularly regulated drugs. Regulated controlled drugs are Schedule 8 substances that have additional restrictions placed on them due to their nature and potential toxicity. These drugs must be prescribed and are usually used for strong pain relief. Such drugs are restricted because of their dependence-forming nature and potential for abuse. Regulated restricted Schedule 4 substances are also dependence-forming and subject to abuse; they are also available only on prescription.

These regulated controlled drugs must be stored, documented, administered and disposed of in line with mandated legislation. Schedule 8 drugs must be stored in a safe or cupboard securely fastened to the premises; the key must be kept in the immediate personal property of the doctor or registered nurse responsible.

Whenever the responsibility for these drugs is handed over to another person, for example in the change of the nursing shift, the individual tablets or dosages need to be counted and documented, to ensure that each individual dosage is accounted for. The present invention provides a convenient system for storing these drugs that makes counting quicker and easier, improving efficiency for staff.

Figure 1 shows a system 10 for the storage and inventory control of medicine that includes a base board 12 having a mounting means in the form of a D-bar 14 that sits at the top of the base board 12. Five medicine packaging articles 16 are attach to the D-bar 14 such that they can be flipped through like a folder, with the D-bar 14 hinging backwards as the articles 16 are flipped with respect to the base board 12.

Figure 2 shows the base board 12 before being loaded with articles 16. It will be appreciated that any base board or folder system could be substituted, as long as it enabled the articles to be flipped through successively and provided visibility to both sides of the articles. The base board 12 illustrated is made of stainless steel and has a length of 210 mm and a width of 120 mm.

A variety of different medicine packaging articles 16 are provided to accommodate different types of drugs, as will be discussed below. A first example is shown in Figures 3A to 3C. Each of the articles 16 includes a rear sheet 18 of rigid or semi-rigid plastic having a generally rectangular shape. The overall size is typically 210 mm in length and 120 mm in width. Preferably the corners are curved to prevent injury. At the top end 20 there is provided attachment means in the form of two spaced apart holes 22 that are sized to fit over the posts of the D-bar 14. Slits (not shown) may extend from the holes 22 to the upper edge 20 to allow individual articles 16 to be removed when empty, without having to remove overlying articles. It also allows for new articles 16 to be inserted in the appropriate location.

The rear sheet 18 has a lower end 24 that has a generally planar upper surface 26. The planar upper surface 26 forms a display area sized to receive a pharmaceutical label 28 that includes prescribed patient details as well as drug and dosage information. Pharmaceutical labels have a minimum size specified by the Therapeutic Goods Act (TGA) of 80 mm by 50 mm.

Formed in the rear sheet 18 is a compartment 30 that has a transparent cavity extending rearwardly from the sheet 18. Extending over the front of the compartment 30 is a cover 32 that is hinged along the left side 34 of the rear sheet. The cover 32 may extend across the entire rear sheet 18 or it may only extend across the compartment 30 and not over the pharmaceutical label 28. The hinged cover 32 is transparent so that the contents of the compartment 30 and any underlying pharmaceutical label 28 are clearly visible without having to open the cover 32. The cover 32 is releasably closed along the edge 33 opposing the hinge 34 to securely fasten the compartment contents inside, as will be described further below. In an alternative embodiment (not shown) the rear sheet 18 may be tinted or non-transparent, whilst the cavity is fully transparent. This provides the ability to colour code for different drugs or types of drugs, whilst maintaining the ability for full visual inspection of the contained drugs. The embodiment of the article shown in Figures 3A to 3C has a compartment 30 sized and shaped to receive a plurality of individual dosages of a medicine held within the original sub-packaging of the manufacturer. In this instance the sub-packaging is a blister pack 31 containing individual dosage in the form of tablets 35 (as shown in Figure 10). The size of the compartment is such that it is only able to accommodate a single sub-packaging, with the depth of the compartment being such that two blister packs cannot be stacked on top of each other and allow the cover to be closed. This prevents stacking of multiple sub-packaging, which can obscure individual dosages and subsequently inhibit counting. In the embodiment shown in Figures 3A to 3C, the compartment is 140 mm in length, 1 10 mm in width and has a depth of 7 mm.

In the embodiment shown in Figures 4A to 4C the article 16 is generally similar to that shown in Figures 3A to 3C, with an additional transparent compartment 36. The additional compartment 36 is generally circular in shape (with a diameter of 18 mm) and has the same depth as the compartment 30 or a slightly shallower depth. This additional compartment 36 is for the storage of an individual dosage of medicine that has been removed from the manufacturer's sub-packaging. The reason this may occur is due to a half dosage being administered to the patient. Currently the other half of the tablet is generally discarded as it cannot be safely returned to the manufacturers packaging. The provision of this additional compartment 36 means a reduction in drug wastage and therefore cost.

The embodiment shown in Figures 5A to 5C contains two smaller compartments 30a, 30b, to hold two blister packs of a smaller size than that shown in the earlier embodiments. Compartments 30a and 30b are 67.5 mm in length and 1 10 mm wide. This enables an article 16 to hold two blister packs in separate compartments to prevent the overlapping that occurs when two blister packs are held within a single compartment, which inhibits the accurate counting of individual dosages without removal. Figures 6A to 6C illustrate another alternative article embodiment. The compartment 30c is of a greater depth (20 mm) than those designed to contain a blister pack. The compartment 30c is dimensioned to accommodate a number of ampoules that each contains an individual dosage of a liquid drug to be injected into a patient. An example of the ampoules is shown in Figure 1 1 , with five ampoules 38 being held within the original manufacturer's sub-packaging cradle 40. As ampoules 38 are typically made of fragile glass, the plastic used to create the articles for the ampoules may be stiffer and more rigid than for other drugs to provide additional protection to the contents.

Another embodiment is shown in Figures 7 A to 7C. This article 16 is configured to accommodate a plurality of medicated transdermal patches 42. The patches 42 are contained within the original manufacturer's per-patch packaging sachets, which are then placed individually into clear peel and seal envelopes 44. The envelopes illustrated are 150 mm in length and 105 mm wide. In this embodiment the compartment 30d includes an open slot 46 running along side 33, which is the side opposite the hinge 34. Within a lower corner of the compartment 30d is a post 48. Each of the envelopes 44 has an aperture to allow the envelopes to be stacked over the post and secured into the compartment with a pin 50. The slot 46 allows the envelopes 44 to be fanned outwards without opening the cover 32, permitting the counting of individual patches 42. An embodiment can be seen in Figure 8 of the post 48 being provided within the cavity 30d, whilst the pin 50 is provided on the cover 32. When a patch is to be removed from the article 16, the cover is opened, releasing the pin 50, thus allowing removal of the top most patch 42. The remainder of the patches are held on the post 48. In this embodiment the pharmacy label is provided on the top surface of the cover 32.

Alternatively, the cover could remain closed, and an envelope 44 fanned out to the side, where a patch sachet can be removed from the peel-and-seal envelop by cutting or tearing the end off. This allows for the post and pin to be permanently fixed once closed. In another alternative arrangement, the peel-and-seal envelopes may have a perforated corner adjacent the post hole to allow for the envelope to be torn off the corner.

Any number of different closure mechanisms could be incorporated into the present invention. One embodiment shown in Figure 9 incorporates a downturned flange 52 that extends along at least one side 33 of the rear sheet 18 opposite the hinge 34. The flange 52 includes a bulged ridge 54. On the same side of the cover 32 is a downturned flange 56 that incorporates an internal channel 58. When the cover 32 is closed, the cover flange 56 is forced over bulged ridge 54 until it sits within channel 58. It will be appreciated that in some embodiments the complimentary ridge and channel are provided at the top end 20 or the lower end 24, or a combination of both. In the embodiment shown in Figures 7A to 7C, the cover 32 may extend over the entire rear sheet 18, with complimentary ridges and channels provided at the top end 20 and at lower end 24, as well as partially up side edge 33. The latching does not overlie the slot 46, allowing the patches to be fanned out the slot 46 for counting.

The present invention has been designed so that a pharmacy can dispense the Schedule 8 and Schedule 4 drugs directly into the compartments 30 for delivery to a facility, such as a hospital. The pharmacist can secure the package with a tamper evident seal and the pharmaceutical label affixed directly to the display area. As additional security, special envelopes may be provided per article to enclose each individual article. The envelopes include a custom window to enable viewing of the pharmaceutical label. The closure would be on the same side as the window to give ready indication of any tampering. The articles can be filled by approved staff at a hospital or aged care facility if the pharmacy does not provide these services.

The articles 16 are preferably assembled on the base in the same order as the associated entries in the 'Schedule 8 Drug Administration Book'. This will result in faster access to drugs when required by a patient. This also enhances time savings and reduces possible errors during counting as the Book entries and drugs are in the same sequence.

There are a number of advantages that the present invention provides. For example, the system is capable of handling the full range of pharmaceutical product sub-packaging, including tablets, capsules, ampoules and patches. By maintaining the drugs in their original sub-packaging the integrity of the drugs are maintained. Prior systems are known that repackage individual dosages of drugs into multiple dosage cards. Repackaged drugs have a shortened expiry time. As the articles are semi-rigid, the contents are provided with a degree of physical protection. By providing compartments that are specifically designed for the different sub-packaging, the placing of multiple sub-packaging into a compartment is avoided, preventing overlapping that results in an unclear view of the individual dosages for counting.

The main advantage provided is the reduction in the time taken to count the individual dosages, as this system simply requires the flipping through of the articles, with each article providing a clear view of each individual dosage without having to remove the sub-packaging from the articles. It will be understood that the invention disclosed and defined in this specification extends to all alternative combinations of two or more of the individual features mentioned or evident from the text or drawings. All of these different combinations constitute various alternative aspects of the invention.

Claims

A medicine packaging article for storage and inventory control of medicine, the article including: at least one compartment that is at least partially transparent for receiving a plurality of individual dosages of a medicine held within the original sub- packaging of the manufacturer, the compartment being sized and shaped to match the sub-packaging for the particular medicine; at least one hinged releasable cover to enclose the sub-packaged medicine within the compartment(s), the cover being at least partially transparent; a display area for attachment of a pharmaceutical label specific to the medicine contained within the packaging article; attachment means to allow a plurality of packaging articles to be joined together for storage and inventory control; and wherein each individual dosage of medicine is visible for counting without opening of the compartment cover.

The medicine packaging article according to claim 1 , wherein the compartment and the cover are fully transparent.

The medicine packaging article according to claim 1 , wherein the cover is fully transparent to allow full visibility of the contents within the compartment.

The medicine packaging article according to claim 1 , 2 or 3, wherein a single compartment is specifically sized to receive only one item of sub-packaging, preventing the overlapping of sub-packaging and obscuring of individual doses.

The medicine packaging article according to any one of the preceding claims, wherein there are two or more compartments, such that more than one sub- packaging is housed within a different compartment in the same article.

The medicine packaging article according to any one of the preceding claims, wherein there is an additional compartment provided to house an individual dosage of a medicine.

The medicine packaging article according to any one of the preceding claims, further including a rear sheet into which the one or more compartments are formed, with the hinged transparent releasable cover being hingedly attached along one edge of the rear sheet.

8. The medicine packaging article according to claim 7, wherein the cover is recusable by incorporating a latch closure.

9. The medicine packaging article according to any one of the preceding claims, wherein the article is made from a semi-rigid plastic.

10. The medicine packaging article according to claim 7, wherein the display area is provided on the rear sheet of the article below or adjacent a compartment.

1 1 . The medicine packaging article according to any one of the preceding claims, wherein the display area is provided on the cover.

12. The medicine packaging article according to any one of the preceding claims, wherein the display area is a flat surface that is sized to accommodate a pharmaceutical label, being at least the minimum size requirements as set by the Therapeutic Goods Act (TGA).

13. A system for the storage and inventory control of medicine, the system including: a base having mounting means; a plurality of medicine packaging articles each having: at least one compartment that is at least partially transparent for receiving a plurality of individual dosages of a medicine held within the original sub-packaging of the manufacturer, at least one hinged releasable cover to enclose the sub- packaged medicine within the compartment(s), the cover being at least partially transparent, and a display area for attachment of a pharmaceutical label specific to the medicine contained within the packaging article; each of the packaging articles having releasable attachment means for mounting the plurality of packaging articles to the base mounting means; wherein different packaging articles may have different compartment sizes to accommodate a variety of different medicines in different types and sizes of sub-packaging; and wherein the packaging articles are moveable with respect to the base to provide visibility to each successive packaging article and each individual dosage of medicine is visible for counting without opening of the compartment cover.

14. The system of claim 13, wherein the attachment means is two spaced apart holes that can be fitted to the posts of the base.

15. The system of claim 14, wherein, the attachment means includes, extending from the holes to an edge, slits to allow flipping on and off of the articles from the posts without removal of overlying articles.

16. A method of storing and maintaining inventory control for a variety of different medicines, the method including: providing a plurality of medicine packaging articles mounted together, the packaging articles each having: at least one compartment for receiving a plurality of individual dosages of a medicine held within the original sub- packaging of the manufacturer, a transparent releasable cover to enclose the sub-packaged medicine within the compartment(s), and a display area with a pharmaceutical label specific to the medicine contained within the packaging article; each of the packaging articles being chosen to provide at least one compartment sized and shaped to receive the specific medicine and sub- packaging; as each dosage of medicine is required, identifying the correct packaging article via the pharmaceutical label, opening the compartment cover and dispensing the individual dosage, if any individual dosages remain in the sub-packaging, returning the sub-packaging to the compartment and closing the cover; as each dosage is dispensed, completing any associated documentation for inventory control; and periodically counting the individual dosages by viewing through the cover without opening the cover.