GB2539215A

GB2539215A - Dispensers and methods of use thereof

Info

Publication number: GB2539215A
Application number: GB1509977.3A
Authority: GB
Inventors: Howieson Graham; Khan Farid; Burnstone James
Original assignee: Elucid Mhealth Ltd
Current assignee: Elucid Mhealth Ltd
Priority date: 2015-06-09
Filing date: 2015-06-09
Publication date: 2016-12-14
Also published as: GB201509977D0

Abstract

A device has two arms 20, 24 movable towards each other and means 18 for logging this movement. One arm could by U, Y or O shaped to form an aperture 22 and the other could have a convex, isosceles trapezium projection 30 adjacent this aperture to push a tablet 44 out of a blister pack 46 through the aperture. The device could include a reader to identify the drug via coded indicia on the blister pack. The dispensing could be sensed by measuring a change in impedance of a foil layer of the blister pack. The device can alert the user when a dose is due. It can communicate with a remote server via a smart phone to issue reminders, record dispensing, log errors, prohibit dispensing or to update the optimal dispensing schedule. Activation of the device can be prevented more than once in a given time period. One arm could be hinged relative to the other so that it moves along a single plane. A blister pack containing pills has data about the pills encoded upon it.

Description

DISPENSERS AND METHODS OF USE THEREOF

Technical Field of the Invention

The invention relates to dispensers for use with blister packaged products, to blister packages and systems and methods of dispensing blister packaged products, such as pharmaceuticals.

Background to the Invention

Products, such as pharmaceuticals and dietary supplements can be dangerous if incorrectly administered. Most medicines need to be administered under a particular regimen to be effective. However, some patients take two does of the medicine if they have missed a previous dose which could be extremely harmful. There are issues with patient dose compliance which is often hard to establish by physicians and can lead to further unnecessary investigations and treatments.

It has been well recognized that medication which has not been taken at the right time and at the correct dosage leads to a poor clinical outcome. The underlying reasons of why patients do not follow a medication regime or are 'non-adherent' are complex.These are often due to a number of factors including age, mental health, disabilities (e.g. vision impairment, limited dexterity), the number of other medications being taken, lack of organizational skills, environmental setting and the patient relationship with health care professionals.

An estimated 50% of patients are non-adherent which in 2013 cost the US healthcare system $105 billion in terms of medicine wastage plus costs arising from increased demands for healthcare due to sub-optimal medication use. Similar costs have been observed in Europe. An additional problem is that prescribers frequently alter doses assuming 100% adherence. This results in patients receiving doses which are higher than required which is both expensive to the healthcare system, wasteful and increases the likelihood of adverse events. 60% of non- -2 -adherence is believed to be unintentional; arising from forgetfulness/confusion, lack of understanding and inability to access the medicine from its packaging.

Blister packaging presently accounts for approximately 75% of all solid oral dosage form packaging yet some 17% of patients experience difficultly with removing medication from blister strips and this proportion is substantially greater within the older population and those with impaired manual dexterity such as diagnoses of Parkinson's disease and rheumatoid arthritis.

Devices have been proposed to assist in the dispensing of pharmaceutical tablets from blister packaging. For example, US5791513 discloses pill dispensing device for use in dispensing a capsule from a blister pack which comprises hingedly connected members which when moved push the capsule through the blister package to be dispensed. However, such devices do not actively provide or promote patient dose compliance or enable dose consumption to be monitored.

An object of the present invention is to address one or more of the above issues. It is also an object of the present invention to provide for a dispenser and/or system which can enable blister pack medicines to be dispensed more easily and with improved dose compliance.

It would also be advantageous if the dispenser and/or system additionally provided for the monitoring of the dispensation of one or more doses of medicine.

Summary of the Invention

In accordance with a first aspect of the present invention, there is provided a tablet dispensing device for use in dispensing a tablet from a blister pack containing tablets in individual blister cells, the device comprising two arms configured to receive a portion of the blister pack therebetween, the arms being arranged such that at least one arm is capable of moving towards another arm so as to move between an open configuration and a tablet dispensing configuration, where in use, the open configuration enables the portion of the blister pack to be placed between the arms and the tablet dispensing configuration enables at least one arm to be brought towards the other arm so as to exert a force on the blister pack enabling -3 -a tablet to be dispensed from a blister cell, and wherein the tablet dispensing event is recorded, and optionally communicated, by the device for dose monitoring.

The term "tablet" and "pharmaceutical tablet" may be used interchangeably and is intended to mean a sold or liquid dose product in the shape or configuration of a tablet or lozenge and which incorporates a pharmaceutical, nutraceutical, nutritional or dietary active substance.

The device will preferably further comprise one or more sensors or readers for detecting an identification code or identification signature applied to, associated with or incorporated in the blister pack and/or assigned to an individual blister cell and/or tablet. Such identification code or identification signature may comprise any one of the following: a bar code; a smart code; an image; a letter code; a number code; a pattern; a colour; and a fluorescence profile. The sensors may comprise one or more selected from: a code reader, a radio frequency identification (RFID) reader, an optical reader, a camera, a colormetric; and a fluorometric detector. It will be apparent to the skilled addressee that other identification means and related sensors could also be employed in conjunction with the present invention.

Alternatively, one or more tablets dispensing events may be detected by measuring changes in the physical characteristics of the blister pack. This could be achieved using a number of methods. For example, the cells of the blister pack may be overlaid with a rupturable foil backing layer and the device detects one or more tablet dispensing events by measuring an impedance value of a portion of the foil backing layer and comparing the value to control impedance value.

Preferably, the tablet dispensing event is communicated to a remote server. The communication to a remote server can be achieved either directly or indirectly. The communication could be directly from the device or via an intermediary communication means such as a smart phone. The term "smart phone" of "phone" can be used interchangeably and -4 -are intended to be used to describe mobile communication devices which are capable of communicating wirelessly with between the device a remote server.

The device may further comprise a notification arrangement for notification of a pre-set event to a user. The pre-set event may comprise one or more of the following: a dose reminder; registration of the device over and around a blister cell; confirmation of a successful tablet dispensing event; an unsuccessful tablet dispensing event; and prohibition of a further tablet dispensing event. The notification arrangement may comprise a visual and/or sound and/or vibration notification. It will be apparent to the skilled addressee that such notifications could be those commonly used in the art, such as a red light to indicate an unsuccessful tablet dispensing event or prohibition of a further tablet dispensing event and a green light to indicate a dose reminder, registration of the device over and around a blister cell or confirmation of a successful tablet dispensing event. The light could flash and be used in conjunction with a audible tone or vibration sequence to differentiate between different states.

So as to assist in dose compliance, the device may be pre-set with a dispensing regime associated with a medicament contained in the blister pack tablets. Alternatively, such a dispensing regime may be communicated to device from a remote server, and optionally, via a smart phone. Notification arrangements as mentioned above could be used to notify the user of the dose regime.

If desired, the device may be prohibited from moving to the tablet dispensing configuration if sufficient time has not elapsed between pre-set dosage times and/or tablet dispensing would contravene a pre-set dosage regime. Such instances may be useful for time critical medicaments or for dispensing certain pharmaceutical products such as drug rehabilitation medicines like methadone.

The device may employ a micro-switch arrangement which is mechanically attached to the one arm capable of moving towards another arm so as to prohibit the movement of the arm when the device is prohibited from dispensing a tablet. -5 -

In its construction, the device may comprise a first fixed arm and a second movable arm. The second movable arm may be hingably attached to the first fixed arm or to a housing to which the first fixed arm is attached. Alternatively, the second movable arm may be adapted to move towards and away from the first fixed arm along a single plane.The distal portion of one arm may comprise an inwardly facing protuberance for contacting with the exterior surface of a blister cell and the corresponding distal portion of the other arm comprises a supporting surface for contacting with the exterior surface of a backing layer of a blister pack and extending at least partly around the adjacent area of the backing layer which is to be ruptured. Preferably, the inwardly facing protuberance is substantially convex or is substantially a isosceles trapezium in cross-section. Preferably, the supporting surface is in the form of a U-, a Y-or 0-shaped portion. The supporting surface may form an aperture portion, through which the tablet can be dispensed into either a lower compartment or void so as to enable the tablet to taken after being dispensed. Of course, other shapes and configurations of the distal portions of the arms will also be envisaged and contemplated.

In order to help with aligning the device to be placed over the blister pack at the correct depth for dispensing a tablet, the device may comprise a housing from which the arms are attached and the housing may be formed with a slot in a portion between the two arms which is capable of accommodating a portion of the edge of a blister pack. To further assist in aligning the device with the blister the slot may have an interior shape which is complementary to the shaped edge of the blister pack so as to enable the user to correctly align the device with a blister cell. The edge of the blister pack may be a number of shapes and profiles. Preferably, the edge of the blister pack is undulating, castellated or slotted.

In accordance with a second, but related, aspect of the present invention, there is provided a pharmaceutical tablet blister pack for use in dose monitoring comprising: a) a blister tray having a plurality of open ended blister cell compartments opening to a common planar surface for holding pharmaceutical tablets therein; -6 -b) one or more pharmaceutical tablets deposited in one or more blister cell compartments; c) a rupturable blister sheet overlying the planar surface of the blister tray and closing the open ends of the blister cell compartments so as to seal the pharmaceutical tablets therein; and wherein the blister pack has an identification code or identification signature applied to, associated with or incorporated with the pack and/or assigned to an individual blister cell and/or tablet, said identification code or identification signature being capable of being read or sensed by a blister pack tablet dispensing device so that the tablet dispensing event can be recorded, and optionally communicated, by the device for dose monitoring.

It will be apparent to the skilled addressee that existing pharmaceutical tablet blister packs may be retro-fitted to incorporate an identification code or identification signature applied to, associated with or incorporated with the pack and/or assigned to an individual blister cell and/or tablet, said identification code or identification signature being capable of being read or sensed by a blister pack tablet dispensing device so that the tablet dispensing event can be recorded, and optionally communicated, by the device for dose monitoring.

The identification code or identification signature may comprise any one of the following: a bar code; a smart code; an image; a letter code; a number code; a pattern; a colour; and a fluorescence profile. The identification code or identification signature may be: a. embedded in a RFID tag located on or within the blister pack and/or adjacent to or in the region of each individual blister cell; b. formed by different portions of the rupturable blister sheet corresponding to each individual blister cell with different colours or patterns; -7 -c. formed by providing substantially transparent blister cell compartments and/or backing sheet and providing differently coloured tablets or differently fluorescing tablets The backing sheet may be formed of an electrically conductive material whose change in impedance can be measured when one or more portions of the sheet have been ruptured.

Preferably, the edge of the blister pack will have registration features such as an undulating, castellated or slotted shape/profile.

The blister pack as herein above described will of course be suitable for use with the tablet dispensing device as described with reference to the first aspect.

In accordance with a third aspect of the present invention, there is provided a pharmaceutical dose monitoring kit comprising a tablet dispensing device in accordance with the first aspect of the present invention and a blister pack in accordance with the second aspect of the present invention.

In accordance with a fourth aspect of the present invention, there is provided a pharmaceutical dose monitoring and/or compliance system comprising: a. a tablet dispensing device for dispensing a tablet from a blister pack containing tablets in individual blister cells, the device comprising two arms configured to receive a portion of the blister pack therebetween, the arms being arranged such that at least one arm is capable of moving towards another arm so as to move between an open configuration and a tablet dispensing configuration, the device further comprising one or more sensors or readers for detecting an identification code or identification signature applied to, associated with or incorporated in the blister pack and/or assigned to an individual blister cell and/or tablet, where in use, the open configuration enables the portion of the blister pack to be placed between the arms and the tablet dispensing configuration enables at least one -8 -arm to be brought towards the other arm so as to exert a force on the blister pack enabling a tablet to be dispensed from a blister cell, and wherein the tablet dispensing event is recorded, and optionally communicated, by the device; and b. a blister tray having a plurality of open ended blister cell compartments opening to a common planar surface for holding pharmaceutical tablets therein, one or more pharmaceutical tablets deposited in one or more blister cell compartments, a rupturable blister sheet overlying the planar surface of the blister tray and closing the open ends of the blister cell compartments so as to seal the pharmaceutical tablets therein; and wherein the blister pack has an identification code or identification signature applied to, associated with or incorporated with the pack and/or assigned to an individual blister cell and/or tablet.

The system may further comprise a communication device for relaying tablet dispensing event to a remote computer and/or database. Preferably, the communication device comprises an electronic communication arrangement incorporated in the tablet dispensing device or used in conjunction with the tablet dispensing device. The electronic communication arrangement used in conjunction with the tablet dispensing device may comprise a smart phone.

The system may comprise a tablet dispensing device in accordance with the first aspect of the present invention and a blister pack in accordance with the second aspect of the present invention.

It will be apparent to the skilled addressee that the a number of compatible features will exist between the various aspects of the invention as described and therefore such compatible features will be interchangeable with one another.

Detailed Description of the Invention

Embodiments of the present invention will now be described, by way of example only, with reference to the following examples and accompanying figures, in which: -9 -Figure 1A shows a perspective view of a blister dispenser in accordance with the present invention; Figure 1B shows a view of the base of the blister dispenser as shown in Figure 1A; Figure 2A shows a side view of the blister pack as shown in Figure 1A, where the blister dispenser has been placed around a blister cell of a blister card package and is in an open configuration; Figure 2B shows a side view of the blister dispenser as shown in Figure 1 B, but where the dispenser is in a tablet dispensing configuration so as to push a pharmaceutical tablet through the backing film of the blister card package; Figure 3A shows the blister dispenser as shown in Figure 1A at a position remote from a blister card package and is in an open configuration; Figure 3B shows a blister dispenser as shown in Figure 1A, where the blister dispenser has been placed over a blister cell of a blister card package and is in an open configuration; Figure 3C shows the blister dispenser as shown in Figure 1A, where the blister dispenser has been used to push a pharmaceutical tablet through the backing film of the blister card package and is shown in a tablet dispensing configuration; Figure 4 shows a blister card package having a backing film having different coloured portions overlaying individual blister cells; Figure 5 shows a blister card package having a backing film in which an RFID tag has been attached to the backing film overlaying individual blister cells; Figure 6 shows a blister card packaging which is overlayed with a backing film comprising an electrically conductive material whose impedance is affected by the rupturing of one or more portions of the backing film by one or more tablets being dispensed; -10 -Figure 7 shows a blister card packaging which has a substantially transparent backing layer and where the individual cells contain pharmaceutical tablets having optically distinct characteristics; Figure 8 shows a blister card packaging where the backing layer has portions containing unique barcodes in areas overlaying individual blister cells; Figure 9 shows a blister card package having RFID tags located adjacent to rupturable areas of the backing film overlaying individual blister cells; Figure 10 shows a schematic flow diagram of how a system or method employing the blister dispenser and blister package is implemented; Figure 11 shows a perspective view of another embodiment of a blister dispenser in accordance with the present invention; Figure 12 shows a cut-away perspective view of the blister dispenser as shown in Figure 11; Figure 13A shows a cut-away side view of a blister dispenser shown in Figure 11 which has been placed around a blister cell of a blister card package and is in an open configuration; Figure 13B shows a cut-away side view of the blister dispenser shown in Figure 13A in a tablet dispensing configuration; Figure 14 shows a perspective view of yet a further blister dispenser embodiment in accordance with the present invention; Figure 15 shows a cut-away perspective view of the blister dispenser as shown in Figure 14; Figure 16A shows a cut-away side view of the blister dispenser as shown in Figure 14, where the blister dispenser has been placed around the blister cell of a blister card package and is in an open configuration; and -11 -Figure 16B shows a cut-away side view of the blister dispenser as shown in Figure 14, where the blister dispenser has been placed over a blister cell of a blister card package and is in a tablet dispensing configuration.

Referring to Figures 1A-2B, there is shown a blister dispenser 10. At one end of the blister dispenser 10, there is provided a housing 12 which incorporates an actuation button 14, a visual indicator 16 (in the form of a light or LED which can flash and change colour), a battery cover 18 (covering a battery and battery compartment (not shown)). An upper arm 20 extends from the housing 12 and terminates at a distal end with an aperture 22 which is large enough to enable a pharmaceutical tablet to pass therethrough. A lower arm 24 extends in a direction which is substantially parallel to that of the upper arm 20. The upper arm 20 is unitarily formed with the housing 12 and is in a fixed position. However, the lower arm 24 is pivotally attached to the base of the housing 12 by means of an integral hinge 26. The lower arm 24 may be moved from an "open" position (or open configuration) where the upper arm 20 and lower arm 24 extend in a substantially parallel and equidistant configuration from one another, and a "closed" position (or a tablet dispensing configuration) whereby the distal end of the lower arm 24 is brought into close proximity with the distal end of the upper arm 20 in the direction denoted by the arrow 25 in Figure 2B). On the interior face 28 of the lower arm 24, extends a substantially convex raised portion 30 adapted for contacting and applying pressure to an exterior surface of a blister cell 32. In order to enable the blister dispenser 10 to be configured (with pre-determined dosage regimes, communication and security protocols etc.) and the rechargeable batteries (not shown) re-charged (where appropriate), a USB socket 34 is provided on a surface of the housing.

As can be seen in Figures 2A and 2B, at the point in which the upper arm 20 attaches to the housing 12, there is provided a slot 36 adapted to receive a portion of the exterior edge 38 of a blister card pack. Furthermore, the interior of the slot 36 has a pointed or toothed shape (not shown) which facilitates the correct registration of the blister dispenser 10 in-line with a blister cell 32 of the blister card pack. The interior shape is configured so as to enable the -12 -blister dispenser 10 to be in registration with a corresponding slot 40 on the exterior edge 38 of a blister card pack by means of the complementary mating surfaces.

As can be seen in Figures 2A and 2B, a pharmaceutical tablet 42 is housed in a blister cell 32. In Figure 2B, the left hand blister cell has been ruptured and a pharmaceutical tablet 44 shown to have been dispensed.

Depending upon how the blister dispenser 10 is configured, the housing 12 will typically accommodate a communication system (such as Wi-Fi or Bluetooth®) for communicating with and relaying and receiving information from a remote server/database. The remote server/database provides dosage and/or patient information and relays dispensing event information to track compliance (and calculates dose times and cycles where appropriate).

Furthermore, additional sensors may be provided within the housing or on (or within) the upper arm 20 and/or the lower arm 24, and such sensors may comprise barcode readers, RFID readers, colorimetric of fluorometric analytical devices, electrodes, electrical conductance or impedance measuring devices, for example.

With reference to Figures 3A-3C, there is shown a blister dispenser 10 at different stages of dispensing a pharmaceutical tablet. In Figure 3A, the blister dispenser 10 is not in contact with a blister card pack 46, whereas in Figure 3B, the exterior edge 38 of the blister card pack has been inserted between the upper arm 20 and lower arm 24 of the blister dispenser and lastly in Figure 3C, the lower arm 24 has been pivotally moved towards the upper arm 20 so that a pharmaceutical tablet 42 has ruptured the backing layer of the blister pack to dispense the tablet. In practice, the blister dispenser 10 is configured either by the user or at the pharmacy by loading data onto the blister dispenser using the USB socket 34 or by means of wireless communication. The blister dispenser 10 can be pre-set with a number of dose protocols. For example, one protocol may be that the dispenser 10 prevents the hinge 26 from pivoting until a pre-determined time has lapsed between dispensing actions so as to prohibit multiple tablets being dispensed at the same time, or to ensure adherence to set dosage regimes. Secondly, the blister dispenser timer could be configured with a protocol that simply -13 -records when the dispenser has been placed over a blister card pack and the hinge activated so as to dispense a pharmaceutical tablet 42 from a blister cell 32. In both protocol instances, the blister dispenser 10 would relay the information about how many tablets have been dispensed to a remote computer for data collection and/or compliance monitoring and/or re-ordering of stock. As mentioned earlier, the blister dispenser 10 may also incorporate additional sensors which may identify individual blister card packs 46 and/or identify individual pharmaceutical tablets and/or individual blister cells and/or number of pharmaceutical tablets 42 which have been dispensed from the overall blister pack so as to provide a more comprehensive data set to the remote computer or database.

In use, the blister dispenser 10 self-aligns within a given slot 40 located on the exterior edge 38 of a blister card pack when the blister card pack is inserted between the upper and lower arms as the exterior edge 38 as it is received by the slot 36 located beneath the upper arm 20 and the housing 12. As shown in Figure 3B, the aperture 22 formed at the distal end of the upper arm 20 has a dimension which is slightly larger than the dimensions of a pharmaceutical tablet 44 to be dispensed through the ruptured backing film of a blister card pack 46 and the exterior edges of the aperture 22 form a surface against which the backing film around a blister cell 32 can abut. Additionally, the exterior edge of the aperture 22 can act as a gripping surface when the lower arm 24 is pivotally moved towards the upper arm so as to press against the exterior surface of the blister cell and which in turn presses the pharmaceutical tablet 42 against the backing layer so as to rupture the backing layer substrate and permit the tablet to be dispensed (as illustrated in Figure 3C) from the packaging through the aperture 22. After the tablet 44 has been dispensed (as shown in Figure 3C) the blister dispenser 10 stores the dispensing event information and communicates this to a remote computer.

When a further pharmaceutical tablet 42 is to be dispensed, the blister dispenser 10 is simply moved along the exterior edge 38 of the blister card pack so that the aperture 22 is aligned with another blister cell and surrounds the backing layer of an adjacent or next blister -14 -cell and the lower arm 24 actuated to push the tablet through the backing layer of the blister pack 46.

The actuation button 14 can be used to turn the device on and off, or indeed to switch the blister dispenser between 'stand-by' and 'on' modes. The visual indicator 16 may be configured to change colour depending on whether the next tablet is ready for dispensing and can also provide an alert to the user to remind them to take a tablet in accordance with a predetermined dosage regime. Further alerting methods may also be incorporated into the blister dispenser 10, such as an audible or vibrating notification which may also be used in conjunction with the visual indicator. The visual indicator 16 may employ different colours and/or flashing programs depending on what function or, what status is to be conveyed to the user. For example, a red flashing light may denote that the lower arm 24 has been locked in the position so that no further tablets can be dispensed until the correct time has elapsed between doses. The visual indicator 16 may flash green to denote that the next dose is ready to be taken.

Figures 4-9 show a range of blister card packs which could be employed with the blister dispenser 10 in order to help monitor or force the compliance of a patient with a pharmaceutical treatment regime. One or more identification features can be incorporated on the blister card packs to enable identification of a pharmaceutical tablet being dispensed from a pack.

With reference to Figure 4, there is shown a blister card pack 100 which relies on a coloured or patterned backing layer to enable the blister dispenser 10 to identify which blister cell has been dispensed. The blister card pack 100 also contains a barcode 102 which can be initially read by the blister dispenser 10 (so as to initially identify the batch and/or type of medicine) and when the upper arm 22 is placed around the dispensing area of the backing film an optical sensor is capable of reading the pattern or coloured portion associated with each blister cell. As the blister dispenser is able to identify each individual blister cell, and each individual dispensing action can be recorded by the device and relayed back to the remote computer. As shown in Figure 4, there are 6 patterned areas such as criss-crosses 104, small dots 106, horizontal stripes 108, vertical stripes 110, large dots 112 and circles 114 etc. -15 -Turning to Figure 5, there is a blister card pack 200 shown which relies on RFID technology to enable the blister dispenser to identify the blister. Rather than relying on a bar-code, a RFID tag 202 which can be read by a RFID reader (not shown) incorporated in the blister dispenser 10 and when the blister dispenser is positioned over an individual blister cell and a tablet dispensed from each blister cell, the tablet dispensing event is recorded and relayed back to the remote database/computer.

Turning to Figure 6, there is provided a blister card pack 300 which relies on the sensing of the difference in impedance of an electrically conductive backing layer 304 which correlates to the number of ruptured areas of the backing layer. Again, a barcode 302 is provided on the blister card pack so as to enable the blister dispenser 10 to initially identify the blister pack.

When the blister dispenser 10 is placed on the blister card pack, impedance sensors (not shown) located on the device pass a low voltage electrical current between two points of the electrically conductive backing layer and the number of ruptured blister cells determined by the impedance value and the dispensing event or accumulative dispensing events relayed back to a remote computer.

With reference to Figure 7, there is provided a blister card pack 400 which relies on colorimetric or fluorometric analysis of each pharmaceutical tablet located within a blister cell. The backing layer of the blister card pack is made from a transparent substrate and the blister dispenser 10 contains colorimetric or fluorometric analytical apparatus which illuminates a pharmaceutical tablet and can analyse the resultant spectral wavelength. As each pharmaceutical tablet 402, 404, 406 and 408 is manufactured with different coloured coatings, then the dispensing event of any individual pharmaceutical tablet can be recorded and relayed to the remote server.

Turning to Figure 8, there is shown a blister card pack 500 where a unique barcode (or smartcode) have been printed onto portions of the backing layer which overlay individual blister cells. When the blister dispenser 10 is placed over the blister card pack, a barcode reader -16 -located on the upper arm 20 reads the unique barcode 502, 504, 506, 508 and after a tablet has been dispensed, the dispensing event of an individual tablet is relayed to a remote computer.

Turning now to Figure 9, there is shown a blister card pack 600 utilising similar technology to that shown in Figure 5, but instead of only having one RFID tag, individual RFID tags 602, 604, 606, 608 are located between the blisters and the exterior edge of the blister card pack. The blister dispenser 10 incorporates and RFID reader which can read an RFID tag located near to a given blister cell and when a blister cell has been ruptured, the RFID tag details are logged and the dispensing event of an individual tablet is relayed to a remote computer.

With reference to Figure 10 there is shown a schematic diagram of a system 700 of monitoring and improving adherence to a dosage regime. The system comprises a electronic blister pack dispenser 702, a blister pack 704 containing a number of pharmaceutical tablets houses within individual blister cells, a smart phone 706, a remote computer 708, a remote database 710, a storage facility 712 housing extra supplies of blister packs, a delivery service 714 and lastly a patient 716.

In use, the patient 716 will have been assigned a dosage regime of a medicine by a physician. The medicine is in the form of a tablets or lozenges individually sealed into blister cells of the blister pack 704. When the patient has been prescribed the medicine, they are also given a blister pack dispenser 702 which is assigned to them to monitor compliance of the patient with the set dosage regime and also try and force adherence in some circumstances.

The patient will be directed to download and install software on to their smart phone 706 for communicating (indicated with arrow 718) with the blister pack dispenser 702. Once the software is installed on the smart phone 706, the blister pack dispenser 702 is paired with it for communication purposes and tablet dispensing events recorded by the dispenser 702 can be communicated 718 to the phone 706 which can in turn communicate the information to a remote computer 708 via communication route 720 and/or remote database 710 via communication route 722 for compliance monitoring purposes. Alternatively, the remote computer 708 may -17 -relay the tablet dispensing event directly to the remote database 710 via communication route 724. The remote database may be based on the internet or a cloud based server and it is envisaged that all communication routes will be encrypted using standard or enhanced security protocols.

Additionally, a storage facility 712 can be notified via communication route 726 if the remote database 710 determines that the patient 716 requires new stock in the form of one or more new blister packs 704. If new stock is required, then one or more blister packs are placed into a delivery service 714 for delivering 728 new stock to the patient 716.

The patient 716 can use 730 and interact with the dispenser 702 in a number of ways.

The dispenser can identify the blister pack by means of reading an RFID tag 732 located within the pack. If the dose of the tablets is time dependent and/or more than one dose should not be taken at once, then the dispenser can be pre-programed to only permit the dispensation of a tablet at certain time periods and prohibit or discourage the patient from dispensing another tablet. For example, the dispenser 702 may mechanically prevent the dispensing of a tablet, or a light 734 may flash or change colour to red to indicate that another tablet is not yet due.

Conversely, when a dose is required, the dispenser 702 may actively encourage the patient to take the next dose by making an audible alert and the light 734 may flash green. Furthermore, dose information and reminders may also be displayed on the phone 706.

It will of course be apparent to the skilled addressee that the dispenser 702 and blister pack 704 may be the same and/or include similar or identical features of the dispenser and blister packs as described in earlier embodiments.

The dispenser has many advantages. It can be formed as a portable hand-held device which fits over any conventional blister pack and allows an audible 'ping' and LED light flash on dispensation of a pill from a single blister. The dispenser can be activated by moving the arms together if desired. This dispensing action can allow for the wireless monitoring of the -18 -medication (dosage, time, date and location) to a smart phone, which in turn can sends out reminders to the patient to take the next dosage.

With reference to Figures 11-13B, there is shown an alternative blister dispenser 800 which has a similar construction and appearance of a paper stapler. The blister dispenser 800 has a lower fixed arm 802 and a movable upper arm 804 which pivots at one end by means of an axis 806. Internally a spring 808 is located between the fixed lower arm 802 and the movable upper arm 804 so as to bias the arms away from each other in an open configuration (as shown in Figures 11 and 13A), such that both arms extend parallel to one another in a longitudinal direction. Batteries 810 power an electrical circuit which in turn controls a micro switch 812. The micro switch 812 is arranged so as to prevent the movable upper arm 804 from being brought towards the fixed lower arm 802 if the blister dispenser 800 is not permitted to dispense a tablet 814 from a blister pack 816. The fixed lower arm 802 forms a cavity 818 into which the tablet 814 can be held after being dispensed from the blister pack 816. In order to enable an individual to remove a tablet 814 from the cavity 818, there is an aperture 820 provided at the distal end of the exterior facing surface of the fixed lower arm 802.

At the distal end of the movable upper arm 804 is a convex protuberance 821 which is adapted to contact the exterior of a blister cell in a blister cell pack 816 and push the tablet 814 through the backing layer. So as to enable the tablet 814 to enter the cavity 818 in the fixed lower arm 802 there is provided an aperture 822 located opposite and adjacent with the protuberance 821 on the movable upper arm 804. In use, the blister dispenser 800 works in a similar manner as to previous embodiments as shown in, and illustrated in Figures 1A-10 in that a blister pack 816 is placed in a position between the fixed lower arm 802 and the movable upper arm 804 and depending upon whether the blister dispenser 800 is permitted to dispense a tablet from the blister pack 816, the micro switch 812 permits the movable upper arm 804 to rotate about the axis 806 so as to be brought together with the fixed lower arm 802 so that the protuberance 821 can contact the exterior surface of the blister cell of the blister pack and push the tablet 814 through the backing layer, the aperture 822 and into the cavity 818 of the fixed -19 -lower arm 802 to allow an individual to remove the tablet 814 from the blister dispenser 800. It will be apparent to the skilled addressee, that the device may be connected to a remote server and/or be able to identify individual blister packs as described with reference to earlier embodiments or enable adherence and/or recording tablet dispensing events. Should the blister dispenser 800 not be permitted to dispense a tablet 814 from a blister pack 816, the micro switch 812 prevents (or locks the) movement of the movable upper arm 804 towards the fixed lower arm 802 and therefore prevent over prescription or unauthorised dispensation of a tablet 814.

With reference to Figures 14-16B, there is provided a blister dispenser 900 sharing a number of similar features to the embodiment shown in Figures 11-13B. The blister dispenser 900 has a fixed lower arm 902 which extends in a longitudinal direction that is parallel to a movable upper arm 904. However, in contrast to the embodiment shown in Figures 11-13B, the arms of the blister dispenser 900 do not pivot around an axis, but rather are capable of moving towards one another along a linear path, such movement being facilitated by means of a pin 906 which is attached to the fixed lower arm 902 riding within a channel 907 of the movable upper arm 904. The movable upper arm 904 is urged away from the fixed lower arm 902 by means of a spring 908 which is part-located around the shank of the pin 906 with one end contacting part of the fixed lower arm 902 and the other end contacting the exterior of the outer rim of the channel 907 of the movable upper arm 904.

Batteries 910 are also provided within the fixed lower arm 902 which in turn power circuitry that actuates a micro switch 912 that controls whether or not the movable upper arm 904 can be moved towards the fixed lower arm so as to dispense a tablet 914 from a blister pack 916. Within the fixed lower arm 902 there is provided a cavity 918 for receiving the tablet 914 after it has been dispensed from the blister pack, such cavity being easy to access by an individual so that they can remove a tablet and can consume the pharmaceutical. Directly above the cavity 918 is an aperture 920 through which the tablet 914 passes when it has been forced through the backing layer of the blister pack 916. Directly above the aperture 920 on the -20 -movable upper arm 904 is a flat-topped protuberance 921 which is adapted to contact the exterior surface of a blister cell which can push a tablet 914 through the aperture 920 into the cavity 918 so as to enable a tablet to be removed from the cavity by means of an exterior facing aperture 922.

When in use, the blister dispenser 900 operates in a similar manner as to the blister dispenser 800 shown in Figures 11-13B. As mentioned previously, the blister dispenser of Figures 14-16B do not have arms which are connected by means of an axis, but rather has a fixed lower arm 902 and a movable upper arm 904 which can be brought together along a linear path in a similar operation to that of as a stamp or hole-punch. Again, the mode of action for the blister dispenser 900 will be similar to that of previous embodiments, so that the dispenser has the ability to identify a given blister pack 916 and/or permit or prevent the dispenser from dispensing a tablet 914 from a blister pack 916 depending on the dosage regime and/or an authorisation code. When a tablet 914 is dispensed from the dispenser 900, the dispensing event can be recoded and/or transmitted on to a remote database for monitoring purposes. In use, the fixed lower arm 902 and the movable upper arm 904 are in a spaced-apart configuration which allows for a cell of a blister pack 916 being inserted between the arms such that a blister cell would be aligned with the protuberance 921. If the micro switch 912 is programmed to permit the movable upper arm from being pressed down towards the fixed lower arm, such movement of travel is facilitated by the pin 906 which is attached to the fixed lower arm 902 riding inside the channel 907 of the movable upper arm 904. If the micro switch 912 is programmed to prevent movement of the movable upper arm 904 towards the fixed lower arm 902, then the upper arm is prevented from being pressd towards the fixed lower arm and no tablet 914 is permitted from the blister pack 916. However, when the micro switch 912 permits movement of the movable upper arm 904 towards the fixed lower arm 902, then the exterior surface of the protuberance 921 is brought into contact with the exterior surface of the blister cell of the blister pack 916 so as to exert a pressure on the blister cell and tablet 914 contained therein so as to push the tablet through the backing layer of the blister pack, through -21 -the aperture 920 in the fixed lower arm and enable it to fall into the cavity 918 so that an individual can remove the tablet via the exterior facing aperture 922 located at the base of the fixed lower arm 902.

The dispenser (and related system) is also an enabling device which assists in the de-blistering of medicines and allows the patient to monitor their own adherence to medication without the reliance of memorizing or recording when they took their last dose or indeed when to take the next dose. The dispenser is able to alert patients, carers and family when medication is not taken on time. It also permits the re-ordering of repeat prescriptions in time before the 'running out of tablets'. This invention will serve to improve outcomes by increasing adherence levels and will empower patients by giving them confidence in timely management of their medicines unobtrusively in their own homes or within healthcare environments.

The synchronization of the dispenser with the generation of a wireless signal to the smart phone could be used to avoid false logging due to the inadvertent use of the device. The dispenser may be 'locked' so that it cannot be utilised without a blister pack being inserted first.

It may also be equipped with a low energy Bluetooth® module to provide sufficient battery life.

The system will monitor adherence, provide an audible reminder and facilitate medication dispensation from its packaging. The system is inclusive of all patients and particularly supportive for those with limited dexterity and impaired memory.

Advantageously, potentially new medicines could be prescribed by physicians who may have been previously concerned about a patient's ability to correctly self-administer their medication when living at home without access to a care professional. The dispenser and system can also be used on the hospital wards or in care homes to monitor patients who are self-administering their medicines or used by care workers to record medication administration activity. Furthermore, the dispenser, blister and system may be purchased by patients who would appreciate a regular reminder to take their medicines and support in de-blistering their -22 -medicines. It can be utilised with existing blister packs or retrofitted to existing blister packs if desired.

The configuration of the blister packages and dispensers described above can of course be interchanged depending upon the precise application and therefore the foregoing embodiments are not intended to limit the scope of the protection afforded by the claims, but rather to describe examples of how the invention may be put into practice.

Claims

-23 -Claims 1. A tablet dispensing device for use in dispensing a tablet from a blister pack containing tablets in individual blister cells, the device comprising two arms configured to receive a portion of the blister pack therebetween, the arms being arranged such that at least one arm is capable of moving towards another arm so as to move between an open configuration and a tablet dispensing configuration, where in use, the open configuration enables the portion of the blister pack to be placed between the arms and the tablet dispensing configuration enables at least one arm to be brought towards the other arm so as to exert a force on the blister pack enabling a tablet to be dispensed from a blister cell, and wherein the tablet dispensing event is recorded, and optionally communicated, by the device for dose monitoring.
2. A device as claimed in claim 1, wherein the device further comprises one or more sensors or readers for detecting an identification code or identification signature applied to, associated with or incorporated in the blister pack and/or assigned to an individual blister cell and/or tablet.
3. A device as claimed in claim 2, wherein the identification code or identification signature comprises any one of the following: a bar code; a smart code; an image; a letter code; a number code; a pattern; a colour; and a fluorescence profile.
4. A device as claimed in either claim 2 or 3, wherein the sensors comprises one or more selected from: a code reader, a radio frequency identification (RFID) reader, an optical reader, a camera, a colormetric; and a fluorometric detector.
5. A device as claimed in any preceding claim, wherein one or more tablets dispensing events detected by measuring changes in the physical characteristics of the blister pack.
6. A device as claimed in claim 5, wherein the cells of the blister pack are overlaid with a rupturable foil backing layer and the device detects one or more tablet dispensing events -24 -by measuring an impedance value of a portion of the foil backing layer and comparing the value to control impedance value.
7. A device as claimed in any preceding claim, wherein the tablet dispensing event is communicated to a remote server.
8. A device as claimed claim 7, where the device communicates to a remote server via a smart phone.
9. A device as claimed in any preceding claim, wherein the device further comprises a notification arrangement for notification of a pre-set event to a user.
10. A device as claimed in claim 9, wherein the pre-set event comprises one or more of the following: a dose reminder; registration of the device over and around a blister cell; confirmation of a successful tablet dispensing event; an unsuccessful tablet dispensing event; and prohibition of a further tablet dispensing event.
11. A device as claimed in any one of claims 9 or 10, wherein the notification arrangement comprises a visual and/or sound and/or vibration notification.
12. A device as claimed in any preceding claim, wherein the device is pre-set with a dispensing regime associated with a medicament contained in the blister pack tablets.
13. A device as claimed in any preceding claim, wherein a dispensing regime associated with a medicament contained in the blister pack tablets is communicated to device from a remote server, and optionally, via a smart phone.
14. A device as claimed in either claim 12 or 13, when dependent upon claims 10 and 11, wherein the notification arrangement notifies the user of the dose regime.
15. A device as claimed in any preceding claim, wherein the device is prohibited from moving to the tablet dispensing configuration if sufficient time has not elapsed between -25 -pre-set dosage times and/or tablet dispensing would contravene a pre-set dosage regime.
16. A device as claimed in any preceding claim, wherein the device comprises a first fixed arm and a second movable arm.
17. A device as claimed in claim 15, wherein the second movable arm is hingably attached to the first fixed arm or to a housing to which the first fixed arm is attached.
18. A device as claimed in claim 15, wherein the second movable arm is adapted to move towards and away from the first fixed arm along a single plane.
19. A device as claimed in any preceding claim, where the distal portion of one arm comprises an inwardly facing protuberance for contacting with the exterior surface of a blister cell and the corresponding distal portion of the other arm comprises a supporting surface for contacting with the exterior surface of a backing layer of a blister pack and extending at least partly around the adjacent area of the backing layer which is to be ruptured.
20. A device as claimed in claim 19, wherein the inwardly facing protuberance is substantially convex or is substantially a isosceles trapezium in cross-section.
21. A device as claimed in claim 19 or 20, wherein the supporting surface is in the form of a U-, a Y-or 0-shaped portion.
22. A device as claimed in claim 19 or 20 wherein the supporting surface forms an aperture portion, through which the tablet can be dispensed.
23. A device as claimed in any preceding claim, wherein the device comprises a housing from which the arms are attached and the housing is formed with a slot in a portion between the two arms which is capable of accommodating a portion of the edge of a blister pack.
24. A device as claimed in claim 23, wherein the slot has an interior shape which is complementary to the shaped edge of the blister pack so as to enable the user to correctly align the device with a blister cell.
25. A device as claimed in claim 24, wherein the edge of the blister pack is undulating, castellated or slotted.
26. A pharmaceutical tablet blister pack for use in dose monitoring comprising: a) a blister tray having a plurality of open ended blister cell compartments opening to a common planar surface for holding pharmaceutical tablets therein; b) one or more pharmaceutical tablets deposited in one or more blister cell compartments; c) a rupturable blister sheet overlying the planar surface of the blister tray and closing the open ends of the blister cell compartments so as to seal the pharmaceutical tablets therein; and wherein the blister pack has an identification code or identification signature applied to, associated with or incorporated with the pack and/or assigned to an individual blister cell and/or tablet, said identification code or identification signature being capable of being read or sensed by a blister pack tablet dispensing device so that the tablet dispensing event can be recorded, and optionally communicated, by the device for dose monitoring.
27. A blister pack as claimed in claim 26, wherein the identification code or identification signature comprises any one of the following: a bar code; a smart code; an image; a letter code; a number code; a pattern; a colour; and a fluorescence profile.
28. A blister pack as claimed in either claim 26 or 27, wherein the identification code or identification signature is: -27 -a. embedded in a RFID tag located on or within the blister pack and/or adjacent to or in the region of each individual blister cell; b. formed by different portions of the rupturable blister sheet corresponding to each individual blister cell with different colours or patterns; c. formed by providing substantially transparent blister cell compartments and/or backing sheet and providing differently coloured tablets or differently fluorescing tablets.
29. A blister pack as claimed in either claim 26 or 27, wherein the backing sheet is formed of a electrically conductive material whose change in impedance can be measured when one or more portions of the sheet have been ruptured.
30. A blister pack as claimed in any one of claims 26 to 29, wherein the edge of the blister pack is undulating, castellated or slotted.
31. A blister pack as claimed in any one of claims 26 to 29 for use with a tablet dispensing device as claimed in any one of claims 1 to 25.
32. A pharmaceutical dose monitoring kit comprising a tablet dispensing device as claimed in any one of claims 1 to 25 and a blister pack as claimed in any one of claims 26 to 30.
33. A pharmaceutical dose monitoring and/or compliance system comprising: a. a tablet dispensing device for dispensing a tablet from a blister pack containing tablets in individual blister cells, the device comprising two arms configured to receive a portion of the blister pack therebetween, the arms being arranged such that at least one arm is capable of moving towards another arm so as to move between an open configuration and a tablet dispensing configuration, the device further comprising one or more sensors or readers for detecting an identification code or identification signature applied to, associated with or incorporated in the blister pack and/or assigned to an individual blister cell and/or tablet, where in -28 -use, the open configuration enables the portion of the blister pack to be placed between the arms and the tablet dispensing configuration enables at least one arm to be brought towards the other arm so as to exert a force on the blister pack enabling a tablet to be dispensed from a blister cell, and wherein the tablet dispensing event is recorded, and optionally communicated, by the device; and b. a blister tray having a plurality of open ended blister cell compartments opening to a common planar surface for holding pharmaceutical tablets therein, one or more pharmaceutical tablets deposited in one or more blister cell compartments, a rupturable blister sheet overlying the planar surface of the blister tray and closing the open ends of the blister cell compartments so as to seal the pharmaceutical tablets therein; and wherein the blister pack has an identification code or identification signature applied to, associated with or incorporated with the pack and/or assigned to an individual blister cell and/or tablet.
34. A system as claimed in claim 33, wherein the system further comprises a communication device for relaying tablet dispensing event to a remote computer and/or database.
35. A system as claimed in claim 34, wherein the communication device comprises an electronic communication arrangement incorporated in the tablet dispensing device or used in conjunction with the tablet dispensing device.
36. A system as claimed in claim 35, wherein the electronic communication arrangement used in conjunction with the tablet dispensing device comprises a smart phone.
37. A system as claimed in any one of claims 33 to 36, wherein the tablet dispensing device comprises a device as claimed in any one of claims 2 to 25 and a pharmaceutical tablet blister pack as claimed in any one of claims 26 to 30.