EP3061438A1 - Electronic drug packaging for improved compliance - Google Patents

Electronic drug packaging for improved compliance Download PDF

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Publication number
EP3061438A1
EP3061438A1 EP15156720.3A EP15156720A EP3061438A1 EP 3061438 A1 EP3061438 A1 EP 3061438A1 EP 15156720 A EP15156720 A EP 15156720A EP 3061438 A1 EP3061438 A1 EP 3061438A1
Authority
EP
European Patent Office
Prior art keywords
blister pack
processing unit
unit
switches
electric circuit
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP15156720.3A
Other languages
German (de)
French (fr)
Inventor
Rajesh Mishra
Vikrant MESTA
Abhilash Balasubramanian
Jithin AMBUJAN
Shripad Jathar
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Healthcare Pvt Ltd
Original Assignee
Abbott Healthcare Pvt Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Abbott Healthcare Pvt Ltd filed Critical Abbott Healthcare Pvt Ltd
Priority to EP15156720.3A priority Critical patent/EP3061438A1/en
Priority to PCT/EP2016/054115 priority patent/WO2016135306A1/en
Publication of EP3061438A1 publication Critical patent/EP3061438A1/en
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0481Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers working on a schedule basis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035Blister-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers

Definitions

  • the present invention concerns an electronic drug packaging for improved compliance.
  • a packaging system for medicaments includes an exchangeable blister pack including a plurality of pockets for each housing a unit of medicament.
  • the system further includes a processing unit.
  • the blister pack includes a first electric circuit that is wiredly connected to the processing unit.
  • the blister pack includes a second electric circuit that is wirelessly connected to the processing unit.
  • the processing unit is arranged for wirelessly retrieving information representative of a prescribed dosage pattern of the units from the second electric circuit.
  • the processing unit is arranged for wiredly retrieving information representative of actual taking of a unit from the blister pack from the first electric circuit.
  • the exchangeable blister pack can contain a plurality of units of a medicament, such as pills, tablets capsules or the like.
  • the exchangeable blister pack can be a single use packaging that is to be discarded after taking all of the units initially included in the blister pack. It will be appreciated that the exchangeable blister pack of the system can be replaced by another, e.g. full, blister pack e.g. after depletion of the former blister pack.
  • the exchangeable blister pack can include a first sheet, e.g. a plastic sheet, including the plurality of pockets for holding the units.
  • the exchangeable blister pack can include a second sheet, e.g. an aluminum sheet or laminate sheet, closing the pockets. The second sheet is breakable so as to allow removal of the units from the pockets.
  • the second sheet includes the first electric circuit.
  • the first electric circuit can include a plurality of switches, each pocket of the first sheet having a switch of the plurality of switches associated therewith, such that removal of a unit from its pocket opens the associated switch.
  • the processing unit then can be wiredly connected to the switches, the processing unit being arranged for determining opening of a switch.
  • a switch may include a frangible electric conductor. Opening of the switch may include breaking of the frangible electric conductor. The opening of a switch is representative of an actual taking of a unit from the blister pack.
  • the second electric circuit can include a memory storing the information representative of the prescribed dosage pattern of the units.
  • the prescribed dosage pattern can e.g. include prescribed intervals between the taking of a unit of the medicament.
  • the prescribed dosage pattern can include prescribed moments, such as prescribed clock times, for the prescribed taking of a unit of the medicament.
  • the information representative of the prescribed dosage pattern can include timing data, such as intervals or moments.
  • the information representative of the prescribed dosage pattern can include a code, the code being representative of the dosage pattern. The code can be recognized by the processing unit and linked to an actual dosage pattern. A plurality of codes and associated dosage patterns may be stored in a memory associated with the processing unit.
  • the second electric circuit can include a communication section, such as an antenna for communicating the information to the processing unit.
  • the second electric circuit can e.g. be arranged to communicate through radio frequency identification (RFID), e.g. according to ISO/IEC 18000-3, and/or near field communication (NFC), e.g. according to ISO/IEC 18092, ECMA-340, ISO/IEC 21481 and/or ECMA-352.
  • RFID radio frequency identification
  • NFC near field communication
  • the second electric circuit can include an, unpowered, NFC chip, sometimes also referred to as a tag.
  • the processing unit being arranged for both wiredly and wirelessly retrieving information from the blister pack provides several advantages.
  • the wiredly retrieving of information representative of actual taking of a unit from the blister pack allows for cheap and robust retrieval of information. Also, as this retrieval of information is performed wiredly it ensures physical connection between the blister pack and the processing unit. This may prevent tampering or misreading of information.
  • the wirelessly retrieving of information representative of a prescribed dosage pattern of the units allows for retrieval of complex information without the need for a complex physical interface between the blister pack and the processing unit. This too may prevent misreading of the information and/or reduce the risk of malfunction. Also current wireless information retrieval technologies, such as for example NFC, allow for cheap storage and retrieval of information, which is of great importance if the blister pack is to be a disposable.
  • each pocket of the plurality of pockets has a switch of the plurality of switches associated therewith, such that removal of a unit from its pocket opens the associated switch, wherein each switch has an electrical resistance.
  • the switches are electrically connected in parallel and the blister pack includes a first contact electrically conductively connected to a first sides of the switches and a second contact electrically conductively connected to a second side of the switches. This allows for a very simple wired interface between the processing unit and the first and second contacts of the blister pack.
  • the opening of a switch results in a change of the resistance of the first electric circuit between the first and second contacts.
  • the processing unit can be arranged to detect a change in resistance between the first and second contacts.
  • the first sheet includes more than one pluralities of pockets.
  • the first electric circuit can then include a first plurality of switches electrically connected in parallel, and a second plurality of switches electrically connected in parallel, each plurality of parallel switches being arranged for wired connection to the processing unit.
  • the blister pack can include a plurality of pluralities of pockets, the first electric circuit including a plurality of pluralities of switches, wherein the switches within each plurality of switches are electrically connected in parallel.
  • each switch has a different resistance.
  • each switch has a different resistance. Then the opening of an individual switch has a different effect on the effective resistance of the first electric circuit between the first and second contacts than the opening of an other switch.
  • the processing unit can be arranged for determining which switches of the plurality of switches are open on the basis of the determined electric resistance.
  • the processing unit includes a memory arranged for storing the information representative of actual taking of a unit from the blister pack.
  • the processing unit includes a clock, such as a real time clock.
  • the processing unit can be arranged for storing an indication of time, such as a timestamp, at which a unit was taken from the blister pack.
  • the processing unit includes an alarm unit arranged for, according to the prescribed dosage pattern, indicating to a user that a unit of medicament has to be taken.
  • the alarm unit can for instance be a buzzer, a loudspeaker or a light source.
  • the processing unit is arranged to determine an alternative dosage pattern on the basis of the prescribed dosage pattern and on the basis of a time of an actual taking of a unit of medication. For instance, if a unit of medication has been taken too late, it may be desirable that the processing unit can calculate a suitable delay time for the next unit. It is possible that information relating to allowability of an alternative dosage pattern and/or relating to the alternative dosage pattern is stored in the memory of the second electric circuit.
  • the processing unit includes a communications unit arranged for communicating with an external data processor.
  • the communications unit can include a physical connector, such as a USB connector, for wiredly connecting the processing unit to the external data processor, such as a personal computer.
  • the communications unit can be arranged for wirelessly communicating with the external data processor, such as via Bluetooth, Wifi, Zigbee or the like.
  • the processing unit can e.g. communicate the information representative of the actual taking of a unit of medicament from the blister pack to the external data processor. Then a reviewer, such as a medical professional, can review adherence to the prescribed dosage pattern.
  • the packaging system further includes a housing arranged for housing the blister pack when wiredly and wirelessly connected to the processing unit.
  • the housing can e.g. be substantially rigid.
  • the housing can be dimensioned such that the blister pack is housed entirely within the housing.
  • the housing can protect the blister pack from damage.
  • the housing includes a cover movable between an opened state allowing taking of a unit and a closed state preventing taking of a unit.
  • the housing is provided with a lock, such as a child-safe and/or senior-friendly lock.
  • the system further includes a switch arranged for switching the processing unit in a power save mode when the cover is in the closed state.
  • the invention also relates to a blister pack including a first sheet including a plurality of pockets for each housing a unit of medicament and a second sheet closing the pockets, the second sheet being breakable for removing the units from the pockets.
  • the second sheet includes a first electric circuit including a plurality of switches.
  • Each pocket of the first sheet has a switch of the plurality of switches associated therewith, such that removal of a unit from its pocket opens the associated switch.
  • the switches are electrically conductively connected to one or more contacts.
  • the contacts can be wiredly connected to a processing unit.
  • the switches are electrically connected in parallel.
  • the blister pack may include a first contact electrically conductively connected to a first sides of the switches and a second contact electrically conductively connected to a second side of the switches.
  • each switch has a different resistance.
  • the blister pack includes a second electric circuit including a wireless communication circuit including a memory storing information associated with the units.
  • the wireless communication circuit is a passive wireless communication circuit, such as a near field communication circuit.
  • the invention also relates to a method for improving medicament intake.
  • the method includes providing an exchangeable blister pack including a plurality of pockets each housing a unit of medicament, and a processing unit.
  • the blister pack includes a first electric circuit that is wiredly connected to the processing unit.
  • the blister pack includes a second electric circuit that is wirelessly connected to the processing unit.
  • the processing unit is arranged for wirelessly retrieving information representative of a prescribed dosage pattern of the units from the second electric circuit, and for wiredly retrieving information representative of actual taking of a unit from the blister pack from the first electric circuit.
  • the method further includes providing an indication that a unit of medication needs to be taken, on the basis of the information representative of the prescribed dosage pattern and the information representative of the actual taking of a unit of medication.
  • the method further includes determining an alternative dosage pattern on the basis of the prescribed dosage pattern and on the basis of a time of an actual taking of a unit of medication.
  • Figure 1 shows a schematic representation of an example of a packaging system 1 according to the invention.
  • the system 1 includes an exchangeable blister pack 2.
  • the system 1 further includes a processing unit 4.
  • the system 1 further includes a housing 5.
  • the exchangeable blister pack 2 includes a first sheet 6 and a second sheet 8.
  • the first sheet 6 includes plurality of pockets 10 each holding a pill 12, also see Figures 2 and 3 .
  • the first sheet is a plastic sheet.
  • the second sheet 8 closes the pockets 10.
  • the second sheet 8 is arranged to easily break when a pill 12 is pushed from the side of the pocket 10, so as to allow easy removal of a pill 12 from its pocket 10.
  • the exchangeable blister pack 2 is a single use packaging that is to be discarded after all pills 12 have been taken from their pockets 10. It will be appreciated that the exchangeable blister pack 2 of the system 1 can be replaced by another exchangeable blister pack 2.
  • the processing unit 4 and the housing 5 in this example is re-usable by refilling with another blister pack 2.
  • the second sheet 8 includes an electrically non-conducting sheet 8a, such as a paper sheet.
  • the electrically non-conducting sheet 8a may be laminated to an electrically conducting sheet 8b, such as an aluminium foil.
  • the second sheet 8 further includes a first electric circuit 14, see Figures 4 and 10 .
  • the first electric circuit 14 may be included in or on the nonconducting sheet 8a, or on further sheet 8c.
  • the first electric circuit 14 includes a plurality of switches 16.
  • the switch 16 includes a frangible electric conductor 18 overlying the pocket 10 holding the pill 12. It will be appreciated that expelling the pill 12 from its pocket 10 results in opening of the switch 16 by breaking of the frangible electric conductor 18.
  • each pocket 10 of the blister pack 2 has its own switch 16.
  • each switch 16 has a predetermined electrical resistance 19. In the examples of Figures 4, 5 and 7 the resistance of each switch 16 is 5.1 kOhms.
  • each switch 16 differs from the electrical resistances of the other switches of the group.
  • the resistors of a group can have values close to or equal to, 5100, 2550, 1700, 1275, 1020, 850, 728.57, and 637.5 Ohms, respectively.
  • the effective resistance of the group can be made to be unique for each combination of opened switches. Then, it can be determined from the measured voltage (or measured resistance) which switches are opened and which switches are closed, i.e. which pockets contain a pill, and which pockets are empty.
  • each group 17.i the switches 16 are connected in parallel by first and second tracks 20.i, 22.i.
  • the first track 20.i electrically conductively connects first sides of the switches 16 to a first contact 24.i.
  • the second track 22.i electrically conductively connects second sides of the switches 16 to a second contact 26.i.
  • the first and second contacts 24.i, 26.i form part of a blister pack connector 27.
  • the first and second tracks 20.i, 22.i are optimized to have minimum track length. It will be appreciated that the second contact 26.i of the all groups 17.i in this example is a common contact.
  • the first electric circuit 14 is printed on a non-conducting sheet 8c using conductive ink.
  • Silver ink is used to print the tracks 20.i, 22.i and conductors 18 in this example.
  • Carbon ink is used to print resistors 19 in this example.
  • a coat of lamination 21 is used to block UV rays and moisture from coming into contact with the first electric circuit 14.
  • the non-conducting sheet 8c may be attached to the first sheet to close 6 the pockets. Alternatively the non-conducting sheet 8c may be attached to a sheet 8a or 8b already closing the pockets.
  • the first electric circuit 14 may be printed on the non-conducting sheet 8c prior to attaching the non-conducting sheet.
  • the blister pack 2 further includes a second electric circuit 28.
  • the second electric circuit 28 includes a memory 30.
  • the memory 30 stores information representative of a prescribed dosage pattern of the pills 12.
  • information representative of the prescribed dosage pattern includes information representative of prescribed intervals between the taking of a pill, such as eight hours between pills.
  • the information representative of prescribed dosage pattern can include information representative of prescribed moments, such as prescribed clock times, for the prescribed taking of a pill, such as 7:00 AM.
  • the second electric circuit 28 includes a communication section 32.
  • the communication section is an antenna 34 for communicating with an interrogating electric field, e.g. at a frequency of 13.56 MHz.
  • the second electric circuit 28 is arranged to communicate over near field communication, NFC, e.g. according to ISO/IEC 18092, ECMA-340, ISO/IEC 21481 and/or ECMA-352.
  • NFC near field communication
  • the second electric circuit 28 is included in a tag 29, e.g. a sticker, attached to the blister pack 2.
  • both the first electric circuit 14 and the second electric circuit 28 are passive circuits. Therefore, there is no need for a power source in the blister pack 2.
  • the processing unit 4 includes a processing unit connector 31, see Figures 5 , 6 and 7 .
  • the processing unit connector 31 is arranged to mate with the blister pack connector 27.
  • the processing unit connector 31 includes a slot 32 for insertion of a side area of the blister pack.
  • the processing unit connector includes third contacts 34.i and fourth contacts 36.i.
  • the third contacts 34.i form a wired connection to the first contacts 24.i of the first electric circuit 14.
  • the fourth contacts 36.i form a wired connection to the second contacts 26.i of the first electric circuit 14.
  • the processing unit 4 includes a processor 38.
  • the processor 38 is arranged for determining a resistance of the first electric circuit 14. Thereto the processor 38 is arranged for measuring the electrical resistance between the third and fourth contacts 34.i, 36.i.
  • a measurement unit 39 of the processor 38 here an analog-to-digital converter, ADC, may thereto be arranged to determine a voltage difference between the third and fourth contacts 34.i, 36.i when a current is known.
  • the processing unit 4 includes resistors 40.i connected between the third and fourth contacts 34.i, 36.i. Therefore, when all switches 16 of the blister pack 2 are opened, the processor 38 measures a resistance between the third and fourth contacts equal to the resistance of the resistor 40. When one or more switches are closed the processor 38 can determine whether one or more switches are opened and which one or more switches are opened, based on the measured resistance and based on the predetermined different electrical resistances of the switches 16.
  • the processing unit 4 includes a clock 42, such as a real time clock.
  • the processing unit 4 includes a memory 44.
  • the processing unit is arranged for storing in the memory 44 an indication of time, such as a timestamp, at which a pill 12 was taken from its pocket 10.
  • the processing unit 4 includes a wireless information retrieval unit 46.
  • the wireless information retrieval unit 46 is a near field communication unit arranged for arranged near field communication, NFC, e.g. according to ISO/IEC 18092, ECMA-340, ISO/IEC 21481 and/or ECMA-352.
  • the wireless information retrieval unit 46 is arranged for interrogating the second electric circuit 28.
  • the wireless information retrieval unit is arranged for retrieving information stored in the memory 30 of the second electric circuit 28.
  • the wireless information retrieval unit 42 is arranged for retrieving information representative of the prescribed dosage pattern of the pills 12.
  • the memory 30 can also store other information such as the predetermined different electrical resistances of the switches 16, information relating to the manufacturer of the blister pack and/or of the medication, an expiry date, etc. All such information can also be retrieved by the wireless information retrieval unit 46. The information retrieved by the wireless information retrieval unit can be stored in the memory 44 of the processing unit 4.
  • the processing unit 4 includes an alarm unit 48.
  • the processing unit 4 is arranged for activating the alarm unit 48 for indicating to a user that a pill 12 has to be taken from the blister pack 2.
  • the processing unit 4 can activate the alarm unit 48 according to the prescribed dosage pattern as retrieved from the second electric circuit 28.
  • the alarm unit 48 includes a loudspeaker 50 and a light source 52.
  • the processing unit 4 can also be arranged to activate the alarm unit when the blister pack 2 included in the housing 5 is depleted.
  • the alarm unit 48 thereto includes a separate, second light source 53.
  • the housing 5 houses both the blister pack 2 and the processing unit 4. As can be seen from Figure 1 , the blister pack 2 is housed entirely within the housing 5.
  • the housing is rigid, e.g. manufactured from plastic.
  • the housing 5 includes a tray 5a in which the blister pack 2 is mainly housed.
  • the tray 5a can include first grooves 56 into which the blister pack 2 can be slidingly inserted.
  • the housing 5 includes a head 5b, 5c in which the processing unit 4 is housed.
  • the shells of the head 5b, 5c may be interconnected, e.g. through fasteners 5e
  • the head 5b, 5c connects to the tray 5a.
  • the head 5b, 5c snap-fits to the tray 5a.
  • the housing 5 further includes a blister lock 5d which locks the blister pack 2 to the head 5b, 5c, so that the blister pack connector 27 remains connected to the processing unit connector 31.
  • the housing 5 also includes a cover 58.
  • the cover 58 is slidingly held in second grooves 60, see Figure 3 .
  • the cover 58 can be slid from an opened state allowing taking of a pill 12 to a closed state preventing taking of a pill 12, and vice versa.
  • the cover 58 includes an upper cover part 58a and a lower cover part 58b. Hence, the cover can be slid from an closed state to a partially opened state to a fully opened state, see figure 2 .
  • the housing 5 is provided with a lock 62, see Figures 8A and 8B .
  • the lock 62 includes a lip 64 that can be hooked in a recess 66.
  • the cover further includes a hook 65 arranged for preventing the cover 58 to be detached from the body of the housing 5.
  • the recess 66 is positioned in a movable stopper 66a. The movable stopper 66a is biased towards a position in which the recess 66 grips the lip 64, see Figure 8A .
  • the movable stopper 66a is pressed against the biasing force of a biasing element 66b at a tip 66b projecting through the head part 5b, the recess 66 is moved to release the lip, see figure 8B . Then the cover 58a, 58b can be slid aside to access the pockets 10.
  • the cover 58 further includes a gripping area 67 having a surface structure enabling easy sliding of the cover by the use of a finger or thumb.
  • the cover 58 is transparent to allow visual inspection of the blister pack 2 without necessitating to open the cover.
  • the housing 5 includes a support structure 69 underneath the blister pack 2.
  • the support structure 69 includes a plurality of opening 71 for allowing the taking of the pills 12.
  • the processing unit 4 includes four buttons 54. It will be appreciated that in general one or more buttons 54 can be included. The buttons are connected to the processor 38. In this example each button is associated with a predetermined symptom, such as drowsy, nauseous, headache, neutral, feeling cold, feeling hot, feeling better, or the like. When a button 54 is pressed, the processing unit 4 stores information representative of the associated symptom, preferably together with a timestamp representative of the moment of pressing the button 54.
  • a predetermined symptom such as drowsy, nauseous, headache, neutral, feeling cold, feeling hot, feeling better, or the like.
  • the housing 5 houses both the blister pack 2 and the processing unit 4.
  • the blister pack 2 is housed entirely within the housing 5.
  • the housing is rigid, e.g. manufactured from plastic.
  • the housing includes first grooves 56 into which the blister pack 2 can be slidingly inserted.
  • the housing also includes a retainer 57 for preventing the blister pack 2 from unintentionally being expelled from the housing 5.
  • the retainer includes grips 59 for allowing to exert enough force to remove the retainer 57 by hand.
  • the housing 5 also includes a cover 58.
  • the cover 58 is slidingly held in second grooves 60.
  • the cover 58 can be slid from an opened state allowing taking of a pill 12 to a closed state preventing taking of a pill 12, and vice versa.
  • the housing 5 is provided with a lock 62.
  • the lock 62 includes a lip 64 that can be hooked in a recess 66.
  • the cover further includes a hook 65 arranged for preventing the cover 58 to be detached from the body of the housing 5.
  • the cover 58 further includes a gripping area 67 having a surface structure enabling easy sliding of the cover by the use of a finger or thumb.
  • the system 1 further includes a switch 68 arranged for switching the processing unit 4 in a power save mode when the cover 58 is in the closed state.
  • the cover 58 is transparent to allow visual inspection of the blister pack 2 without necessitating to open the cover.
  • the housing 5 includes a support structure 69 underneath the blister pack 2.
  • the support structure 69 includes a plurality of opening 71 for allowing the taking of the pills 12.
  • the processing unit 4 further includes a connector 70, such as a USB connector, miniUSB connector, or microUSB connector.
  • the connector 70 allows for wiredly connecting the processing unit 4 to an external data processor, such as a personal computer.
  • the processing unit can include a wireless communications unit 72 arranged for wirelessly communicating with the external data processor, such as via Bluetooth, Wifi, Zigbee or the like.
  • the processing unit 4 can e.g. communicate the information representative of the actual taking of a pill 12 from the blister pack 2 to the external data processor.
  • the processing unit can also communicate additional data to the external data processor, such as data related to events of pressing a button 54. Then a reviewer, such as a medical professional, can review adherence to the prescribed dosage pattern and other data.
  • the processing unit also includes a battery 55, such as a 3.3V battery. In this example, the battery is rechargeable through the connector 70.
  • the packaging system 1 according to the invention can be used as follows.
  • the doctor prescribes a medication.
  • proper adherence to a prescribed dosage pattern is important.
  • the patient goes to the pharmacist to obtain the medication.
  • the pharmacist provides the medication, wherein units of the medication (such as pills, tablets or capsules) are included in a blister pack 2 as described above.
  • the blister pack 2 has the near field communication, NFC, circuit 28.
  • the circuit 28 can be included in the blister pack 2 during packaging of the medication in the blister pack, e.g. at a factory.
  • the pharmacist can apply the tag 29 including the circuit 28 to the blister pack 2.
  • the tag 29 can e.g. be a self-adhesive tag.
  • the NFC circuit 28 has inbuilt memory to store information related to the prescribed dosage pattern.
  • a computer based application can be used, this application can be used to transmit data to the NFC circuit through an NFC transceiver device connected to the computer.
  • the patient obtains, or already possesses, a processing unit 4 as described above.
  • the patient may e.g. obtain or possess an assembly including the processing unit 4 and the housing 5 as described above.
  • the blister pack 2 is inserted into the housing 5.
  • the blister pack 2 can e.g. be slid into the first grooves 56 of the housing 5.
  • the blister pack connector 27 mates with the processing unit connector 31. Thereby the first contacts 24.i are brought in electrically conductive connection with the third contacts 34.i and the second contacts 26.i are brought in electrically conductive connection with the fourth contacts 36.i.
  • the blister pack 2 now is wiredly connected to the processing unit 4.
  • the head 5b, 5c is connected to the tray 5a, or the retainer 57 is positioned to prevent inadvertent expulsion of the blister pack 2 from the housing 5.
  • the wireless information retrieval unit 46 reads information stored in the memory 30 of the second electric circuit 28.
  • the processor 38 retrieves the information representative of a prescribed dosage pattern of the pills 12 and stores it in the memory 44.
  • the processing unit 4 determines moments when a pill 12 has to be taken on the basis of the prescribed dosage pattern. For example, the processing unit determines moments when a pill 12 has to be taken on the basis of a timestamp of a taking of a first pill from the blister pack, and on the basis of a prescribed time interval in between two takings of a pill. For example the processing unit determines moments when a pill has to be taken on the basis of predetermined times defined in the prescribed dosage pattern, e.g. at 7:00 AM and at 5:00 PM.
  • the cover 58 After inserting the blister pack 2 in the housing 5 the cover 58 is closed. Putting the cover 58 in the closed state can bring the system 1 in sleep mode. In sleep mode circuitry of the processing unit 4 for retrieving information from the first and/or second electric circuit is disabled. In this example the system is re-activated only when the cover is opened. Nevertheless, in this example the alarm unit 48 and the optional input buttons 54 are also functional in sleep mode. The cover 58 also prevents false trigger and recording of medication administration.
  • the processing unit 4 determines that the time indicated by its clock 42 corresponds to a moment when a pill has to be taken, the processing unit 4 activates the alarm unit 48.
  • the alarm unit 48 includes an LED light source 52 and a loudspeaker 50. When activated the LED will flash green and the loudspeaker will generate a sound. Reminders through multiple modes, here both auditory and visual, ensures that the compliance adherence is maximized.
  • the patient When reminded by the alarm unit 48 the patient opens the cover 58. This may end the sleep mode and render the system 1 fully operational.
  • the patient takes one pill 12 from its pocket 10 and administers the pill 12 as required. Taking the pill from its pocket 10 opens the associated switch 16. This is detected as a change in electrical resistance between the third and fourth contacts 34.i, 36.i by the processing unit.
  • the processing unit 4 polls an analog-to-digital converter, ADC, at predetermined time intervals, of e.g. 10 ms, to determine a change in voltage between the third and fourth contacts 34.i, 36.i.
  • the processing unit stores the event of taking the pill and the time associated with it. In this example, from the electrical resistance measured between the third and fourth contacts 34.i, 36.i the processing unit 4 determines which switch 16 has been opened, viz. which pill has been taken. The processing unit also stores which pill has been taken with the event.
  • the processing unit 4 activates the alarm unit 48 again and the process is repeated.
  • the processing unit may determine that the blister pack 2 is depleted. The processing unit may then activate the alarm unit to indicate depletion, and required replenishment, of the blister pack to the patient.
  • the alarm unit 48 thereto activates the second light source 53.
  • the first light source 52 may be activate to flash, e.g. red, to indicate depletion of the blister pack.
  • the patient may experience symptoms associated with the use of the medication.
  • the patient experiences such symptom he or she can press the associated button 54 on the processing unit 4.
  • the processing unit 4 then stores an event indicating the time and the symptom experienced.
  • the patient After, or during, the medication, the patient carries the system 1 to the physician in his or her next visit.
  • the physician can inspect the medication history of patient by connecting the system 1 to his computer with the connector 70 or wireless communications unit 72.
  • the data stored in the memory 44 can be displayed, e.g. in the form of graphs or tables, on a graphical user interface.
  • the blister pack can be manufactured as follows.
  • the first sheet 6 including a plurality of pockets 10 is provided. In each pocket 10 a unit of medication is placed. The pockets are closed with a sheet of aluminium foil 8b.
  • the first electric circuit 14 is printed on a first side of an electrically non-conductive sheet 8c, such as a paper sheet.
  • branding and labeling information is printed on the other side of the non-conducting sheet.
  • the first side of the non-conductive sheet 8c is provided with an adhesive layer.
  • the non-conductive sheet 8c is adhered to the aluminium foil sheet 8b.
  • a further non-conductive sheet 8a is interposed between the sheets 8b and 8c.
  • the non-conductive sheet 8c may be covered with a lamination 21.
  • the non-conductive sheet 8c is provided with a transfer sheet to allow storage of the non-conductive sheet prior to attachment to the blister pack.
  • a plurality of the non-conductive sheets is stored on a roll.
  • the processing unit activates the alarm unit according to the prescribed dosage pattern retrieved from the second electric circuit. It is also possible that the processing unit is arranged to determine an alternative dosage pattern in case the actual taking of a unit of medication was not according to the prescribed dosage pattern.
  • the second electric circuit may store additional data such as minimum time between takings of a unit of the medication, allowability of taking forgotten units of the medication, earliest allowable taking times, latest allowable taking times, etc..
  • the processing unit can retrieve such additional data from the second electric circuit. For example if a pill has to be taken daily at 8:00 AM, but the previous pill was not taken until 4:00 PM it might be advisable to postpone activating the alarm for the taking of the next pill until after 8:00 AM, e.g. until 11:30 AM.
  • the blister pack is provided with the first electric circuit and the second electric circuit. It will be appreciated that a blister pack provided with the first electric circuit, but not with the second electric circuit can also be used to advantage in certain applications. It will be appreciated that a blister pack provided with the second electric circuit, but not with the first electric circuit can also be used to advantage in certain applications. A processing unit arranged for cooperating with such blister packs can also be manufactured.
  • the information stored in the memory of the second electric circuit can be encoded and/or encrypted.
  • the information stored in the memory of the second electric circuit includes information on a vendor and/or manufacturer of the medication.
  • the information stored in the memory of the second electric circuit includes information representative of prescribed intervals between the taking of a pill or information representative of prescribed moments, such as prescribed clock times, for the prescribed taking of a pill. It will be appreciated that it is also possible that the memory of the second electric circuit includes one or more codes representative of a prescribed dosage pattern. A plurality of codes and associated dosage patterns may also be stored in the memory of the processing unit, so that after readout the processing unit can determine the prescribed dosage pattern associated with the read out code(s).
  • the processing unit can wirelessly communicate with the external data processor, such as via Bluetooth, Wifi, Zigbee or the like. It will be appreciated that it is also possible that the processing unit wirelessly communicates with a further device, such as a mobile communications device, such as a mobile phone, e.g. via Bluetooth, SMS, GSM, or the like. The processing unit can then transmit a warning signal to the mobile communications device, such that the mobile communications device warns the user to take a medication.
  • a further device such as a mobile communications device, such as a mobile phone, e.g. via Bluetooth, SMS, GSM, or the like.
  • the processing unit can then transmit a warning signal to the mobile communications device, such that the mobile communications device warns the user to take a medication.
  • the device further includes a display, such as an LCD display, for conveying information to a user.
  • a display such as an LCD display
  • information can e.g. include one or more of a current time, a planned time for the next medication dose, a nature of the medication, a battery status, an imminent need for replenishment of medication, or the like.
  • processing unit can be embodied as dedicated electronic circuits, possibly including software code portions.
  • the processing unit, or part thereof can also be embodied as software code portions executed on, and e.g. stored in, a memory of, a programmable apparatus such as a computer.
  • the embodiments of the invention described with reference to the drawings comprise computer apparatus and processes performed in computer apparatus, the invention also extends to computer programs, particularly computer programs on or in a carrier, adapted for putting the invention into practice.
  • the program may be in the form of source or object code or in any other form suitable for use in the implementation of the processes according to the invention.
  • the carrier may be any entity or device capable of carrying the program.
  • the carrier may comprise a storage medium, such as a ROM, for example a CD ROM or a semiconductor ROM, or a magnetic recording medium, for example a floppy disc or hard disk.
  • a storage medium such as a ROM, for example a CD ROM or a semiconductor ROM, or a magnetic recording medium, for example a floppy disc or hard disk.
  • the carrier may be a transmissible carrier such as an electrical or optical signal which may be conveyed via electrical or optical cable or by radio or other means, e.g. via the internet or cloud.
  • the carrier When a program is embodied in a signal which may be conveyed directly by a cable or other device or means, the carrier may be constituted by such cable or other device or means.
  • the carrier may be an integrated circuit in which the program is embedded, the integrated circuit being adapted for performing, or for use in the performance of, the relevant processes.
  • any reference signs placed between parentheses shall not be construed as limiting the claim.
  • the word 'comprising' does not exclude the presence of other features or steps than those listed in a claim.
  • the words 'a' and 'an' shall not be construed as limited to 'only one', but instead are used to mean 'at least one', and do not exclude a plurality.
  • the mere fact that certain measures are recited in mutually different claims does not indicate that a combination of these measures cannot be used to an advantage.

Abstract

Packaging system for medicaments. The system includes an exchangeable blister pack including a plurality of pockets each housing a unit of medicament. The system includes a processing unit. The blister pack includes a first electric circuit that is wiredly connected to the processing unit. The blister pack includes a second electric circuit that is wirelessly connected to the processing unit. The processing unit is arranged for wirelessly retrieving information representative of a prescribed dosage pattern of the units from the second electric circuit. The processing unit is arranged for wiredly retrieving information representative of actual taking of a unit from the blister pack from the first electric circuit.

Description

    FIELD OF THE INVENTION
  • The present invention concerns an electronic drug packaging for improved compliance.
  • BACKGROUND TO THE INVENTION
  • Electronic drug packagings for improving an adherence to a prescribed dosage pattern of a medication are known per se. These packagings often suffer from being complicated to use. This makes the packaging less suitable for certain groups of people. Other packagings suffer from being too fragile, unable to withstand daily use.
  • SUMMARY OF THE INVENTION
  • In general it is desirable to improve adherence to a prescribed dosage pattern of a medication. It is also desirable to provide a system that can be used at low costs. It is also desirable to provide a system that is rugged.
  • According to the invention is provided a packaging system for medicaments. The system includes an exchangeable blister pack including a plurality of pockets for each housing a unit of medicament. The system further includes a processing unit. The blister pack includes a first electric circuit that is wiredly connected to the processing unit. The blister pack includes a second electric circuit that is wirelessly connected to the processing unit. The processing unit is arranged for wirelessly retrieving information representative of a prescribed dosage pattern of the units from the second electric circuit. The processing unit is arranged for wiredly retrieving information representative of actual taking of a unit from the blister pack from the first electric circuit.
  • The exchangeable blister pack can contain a plurality of units of a medicament, such as pills, tablets capsules or the like. The exchangeable blister pack can be a single use packaging that is to be discarded after taking all of the units initially included in the blister pack. It will be appreciated that the exchangeable blister pack of the system can be replaced by another, e.g. full, blister pack e.g. after depletion of the former blister pack. The exchangeable blister pack can include a first sheet, e.g. a plastic sheet, including the plurality of pockets for holding the units. The exchangeable blister pack can include a second sheet, e.g. an aluminum sheet or laminate sheet, closing the pockets. The second sheet is breakable so as to allow removal of the units from the pockets.
  • Optionally, the second sheet includes the first electric circuit. The first electric circuit can include a plurality of switches, each pocket of the first sheet having a switch of the plurality of switches associated therewith, such that removal of a unit from its pocket opens the associated switch. The processing unit then can be wiredly connected to the switches, the processing unit being arranged for determining opening of a switch. A switch may include a frangible electric conductor. Opening of the switch may include breaking of the frangible electric conductor. The opening of a switch is representative of an actual taking of a unit from the blister pack.
  • The second electric circuit can include a memory storing the information representative of the prescribed dosage pattern of the units. The prescribed dosage pattern can e.g. include prescribed intervals between the taking of a unit of the medicament. Alternatively, or additionally, the prescribed dosage pattern can include prescribed moments, such as prescribed clock times, for the prescribed taking of a unit of the medicament. The information representative of the prescribed dosage pattern can include timing data, such as intervals or moments. Alternatively, or additionally, the information representative of the prescribed dosage pattern can include a code, the code being representative of the dosage pattern. The code can be recognized by the processing unit and linked to an actual dosage pattern. A plurality of codes and associated dosage patterns may be stored in a memory associated with the processing unit. The second electric circuit can include a communication section, such as an antenna for communicating the information to the processing unit. The second electric circuit can e.g. be arranged to communicate through radio frequency identification (RFID), e.g. according to ISO/IEC 18000-3, and/or near field communication (NFC), e.g. according to ISO/IEC 18092, ECMA-340, ISO/IEC 21481 and/or ECMA-352. The second electric circuit can include an, unpowered, NFC chip, sometimes also referred to as a tag.
  • The processing unit being arranged for both wiredly and wirelessly retrieving information from the blister pack provides several advantages. The wiredly retrieving of information representative of actual taking of a unit from the blister pack allows for cheap and robust retrieval of information. Also, as this retrieval of information is performed wiredly it ensures physical connection between the blister pack and the processing unit. This may prevent tampering or misreading of information. The wirelessly retrieving of information representative of a prescribed dosage pattern of the units allows for retrieval of complex information without the need for a complex physical interface between the blister pack and the processing unit. This too may prevent misreading of the information and/or reduce the risk of malfunction. Also current wireless information retrieval technologies, such as for example NFC, allow for cheap storage and retrieval of information, which is of great importance if the blister pack is to be a disposable.
  • Optionally, each pocket of the plurality of pockets has a switch of the plurality of switches associated therewith, such that removal of a unit from its pocket opens the associated switch, wherein each switch has an electrical resistance. Optionally the switches are electrically connected in parallel and the blister pack includes a first contact electrically conductively connected to a first sides of the switches and a second contact electrically conductively connected to a second side of the switches. This allows for a very simple wired interface between the processing unit and the first and second contacts of the blister pack. The opening of a switch results in a change of the resistance of the first electric circuit between the first and second contacts. The processing unit can be arranged to detect a change in resistance between the first and second contacts.
  • It is also possible that the first sheet includes more than one pluralities of pockets. The first electric circuit can then include a first plurality of switches electrically connected in parallel, and a second plurality of switches electrically connected in parallel, each plurality of parallel switches being arranged for wired connection to the processing unit. The blister pack can include a plurality of pluralities of pockets, the first electric circuit including a plurality of pluralities of switches, wherein the switches within each plurality of switches are electrically connected in parallel.
  • Optionally, each switch has a different resistance. Optionally within each plurality of switches each switch has a different resistance. Then the opening of an individual switch has a different effect on the effective resistance of the first electric circuit between the first and second contacts than the opening of an other switch. The processing unit can be arranged for determining which switches of the plurality of switches are open on the basis of the determined electric resistance.
  • Optionally, the processing unit includes a memory arranged for storing the information representative of actual taking of a unit from the blister pack.
  • Optionally the processing unit includes a clock, such as a real time clock. The processing unit can be arranged for storing an indication of time, such as a timestamp, at which a unit was taken from the blister pack.
  • Optionally, the processing unit includes an alarm unit arranged for, according to the prescribed dosage pattern, indicating to a user that a unit of medicament has to be taken. The alarm unit can for instance be a buzzer, a loudspeaker or a light source.
  • Optionally, the processing unit is arranged to determine an alternative dosage pattern on the basis of the prescribed dosage pattern and on the basis of a time of an actual taking of a unit of medication. For instance, if a unit of medication has been taken too late, it may be desirable that the processing unit can calculate a suitable delay time for the next unit. It is possible that information relating to allowability of an alternative dosage pattern and/or relating to the alternative dosage pattern is stored in the memory of the second electric circuit.
  • Optionally, the processing unit includes a communications unit arranged for communicating with an external data processor. The communications unit can include a physical connector, such as a USB connector, for wiredly connecting the processing unit to the external data processor, such as a personal computer. Alternatively, or additionally, the communications unit can be arranged for wirelessly communicating with the external data processor, such as via Bluetooth, Wifi, Zigbee or the like. The processing unit can e.g. communicate the information representative of the actual taking of a unit of medicament from the blister pack to the external data processor. Then a reviewer, such as a medical professional, can review adherence to the prescribed dosage pattern.
  • Optionally, the packaging system further includes a housing arranged for housing the blister pack when wiredly and wirelessly connected to the processing unit. The housing can e.g. be substantially rigid. The housing can be dimensioned such that the blister pack is housed entirely within the housing. The housing can protect the blister pack from damage.
  • Optionally, the housing includes a cover movable between an opened state allowing taking of a unit and a closed state preventing taking of a unit. Thus, easy access to the blister pack can be provided. Optionally, the housing is provided with a lock, such as a child-safe and/or senior-friendly lock. Optionally, the system further includes a switch arranged for switching the processing unit in a power save mode when the cover is in the closed state.
  • The invention also relates to a blister pack including a first sheet including a plurality of pockets for each housing a unit of medicament and a second sheet closing the pockets, the second sheet being breakable for removing the units from the pockets. The second sheet includes a first electric circuit including a plurality of switches. Each pocket of the first sheet has a switch of the plurality of switches associated therewith, such that removal of a unit from its pocket opens the associated switch. The switches are electrically conductively connected to one or more contacts. The contacts can be wiredly connected to a processing unit. Optionally the switches are electrically connected in parallel. The blister pack may include a first contact electrically conductively connected to a first sides of the switches and a second contact electrically conductively connected to a second side of the switches. Optionally, each switch has a different resistance.
  • Optionally, the blister pack includes a second electric circuit including a wireless communication circuit including a memory storing information associated with the units. Optionally the wireless communication circuit is a passive wireless communication circuit, such as a near field communication circuit.
  • The invention also relates to a method for improving medicament intake. The method includes providing an exchangeable blister pack including a plurality of pockets each housing a unit of medicament, and a processing unit. The blister pack includes a first electric circuit that is wiredly connected to the processing unit. The blister pack includes a second electric circuit that is wirelessly connected to the processing unit. The processing unit is arranged for wirelessly retrieving information representative of a prescribed dosage pattern of the units from the second electric circuit, and for wiredly retrieving information representative of actual taking of a unit from the blister pack from the first electric circuit. The method further includes providing an indication that a unit of medication needs to be taken, on the basis of the information representative of the prescribed dosage pattern and the information representative of the actual taking of a unit of medication.
  • Optionally, the method further includes determining an alternative dosage pattern on the basis of the prescribed dosage pattern and on the basis of a time of an actual taking of a unit of medication.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • Embodiments of the present invention will now be described in detail with reference to the accompanying drawings in which:
    • Figure 1 is schematic representation of a plurality of views of a packaging system;
    • Figure 2 is a perspective view of a packaging system in three stages of opening;
    • Figure 3 is an exploded view of a packaging system;
    • Figure 4 is a schematic representation of a blister pack;
    • Figure 5 is a schematic representation of a blister pack and part of a processing unit;
    • Figure 6 is a schematic representation of a processing unit;
    • Figure 7 is a schematic representation of a system;
    • Figures 8A and 8B are schematic views of a lock;
    • Figures 9A and 9B are schematic view of taking of a unit;
    • Figure 10 is a schematic cross sectional view of a blister pack;
    • Figure 11 is a schematic view of a blister pack; and
    • Figure 12 is an exploded view of a packaging system.
    DETAILED DESCRIPTION
  • Figure 1 shows a schematic representation of an example of a packaging system 1 according to the invention. The system 1 includes an exchangeable blister pack 2. The system 1 further includes a processing unit 4. The system 1 further includes a housing 5.
  • The exchangeable blister pack 2 includes a first sheet 6 and a second sheet 8. The first sheet 6 includes plurality of pockets 10 each holding a pill 12, also see Figures 2 and 3. In this example the first sheet is a plastic sheet. The second sheet 8 closes the pockets 10. The second sheet 8 is arranged to easily break when a pill 12 is pushed from the side of the pocket 10, so as to allow easy removal of a pill 12 from its pocket 10.
  • In this example the exchangeable blister pack 2 is a single use packaging that is to be discarded after all pills 12 have been taken from their pockets 10. It will be appreciated that the exchangeable blister pack 2 of the system 1 can be replaced by another exchangeable blister pack 2. The processing unit 4 and the housing 5 in this example is re-usable by refilling with another blister pack 2.
  • In this example the second sheet 8 includes an electrically non-conducting sheet 8a, such as a paper sheet. The electrically non-conducting sheet 8a may be laminated to an electrically conducting sheet 8b, such as an aluminium foil.
  • The second sheet 8 further includes a first electric circuit 14, see Figures 4 and 10. The first electric circuit 14 may be included in or on the nonconducting sheet 8a, or on further sheet 8c. The first electric circuit 14 includes a plurality of switches 16. In this example the first electric circuit includes three groups 17.i (i=1, 2, 3) of switches 16. In this example the switch 16 includes a frangible electric conductor 18 overlying the pocket 10 holding the pill 12. It will be appreciated that expelling the pill 12 from its pocket 10 results in opening of the switch 16 by breaking of the frangible electric conductor 18. It is noted that each pocket 10 of the blister pack 2 has its own switch 16. In this example each switch 16 has a predetermined electrical resistance 19. In the examples of Figures 4, 5 and 7 the resistance of each switch 16 is 5.1 kOhms.
  • It will be appreciated that, alternatively, within each group 17.i the electrical resistance 19 of each switch 16 differs from the electrical resistances of the other switches of the group. For example, the resistors of a group can have values close to or equal to, 5100, 2550, 1700, 1275, 1020, 850, 728.57, and 637.5 Ohms, respectively. When each switch of a group has a different resistance, The effective resistance of the group can be made to be unique for each combination of opened switches. Then, it can be determined from the measured voltage (or measured resistance) which switches are opened and which switches are closed, i.e. which pockets contain a pill, and which pockets are empty.
  • In each group 17.i the switches 16 are connected in parallel by first and second tracks 20.i, 22.i. The first track 20.i electrically conductively connects first sides of the switches 16 to a first contact 24.i. The second track 22.i electrically conductively connects second sides of the switches 16 to a second contact 26.i. The first and second contacts 24.i, 26.i form part of a blister pack connector 27. In this example the first and second tracks 20.i, 22.i are optimized to have minimum track length. It will be appreciated that the second contact 26.i of the all groups 17.i in this example is a common contact.
  • In this example the first electric circuit 14 is printed on a non-conducting sheet 8c using conductive ink. Silver ink is used to print the tracks 20.i, 22.i and conductors 18 in this example. Carbon ink is used to print resistors 19 in this example. A coat of lamination 21 is used to block UV rays and moisture from coming into contact with the first electric circuit 14. The non-conducting sheet 8c may be attached to the first sheet to close 6 the pockets. Alternatively the non-conducting sheet 8c may be attached to a sheet 8a or 8b already closing the pockets. The first electric circuit 14 may be printed on the non-conducting sheet 8c prior to attaching the non-conducting sheet.
  • The blister pack 2 further includes a second electric circuit 28. The second electric circuit 28 includes a memory 30. In this example the memory 30 stores information representative of a prescribed dosage pattern of the pills 12. In this example information representative of the prescribed dosage pattern includes information representative of prescribed intervals between the taking of a pill, such as eight hours between pills. Alternatively the information representative of prescribed dosage pattern can include information representative of prescribed moments, such as prescribed clock times, for the prescribed taking of a pill, such as 7:00 AM.
  • The second electric circuit 28 includes a communication section 32. In this example the communication section is an antenna 34 for communicating with an interrogating electric field, e.g. at a frequency of 13.56 MHz. In this example the second electric circuit 28 is arranged to communicate over near field communication, NFC, e.g. according to ISO/IEC 18092, ECMA-340, ISO/IEC 21481 and/or ECMA-352. In this example the second electric circuit 28 is included in a tag 29, e.g. a sticker, attached to the blister pack 2.
  • In this example both the first electric circuit 14 and the second electric circuit 28 are passive circuits. Therefore, there is no need for a power source in the blister pack 2.
  • The processing unit 4 includes a processing unit connector 31, see Figures 5, 6 and 7. The processing unit connector 31 is arranged to mate with the blister pack connector 27. In this example the processing unit connector 31 includes a slot 32 for insertion of a side area of the blister pack. The processing unit connector includes third contacts 34.i and fourth contacts 36.i. The third contacts 34.i form a wired connection to the first contacts 24.i of the first electric circuit 14. The fourth contacts 36.i form a wired connection to the second contacts 26.i of the first electric circuit 14.
  • The processing unit 4 includes a processor 38. The processor 38 is arranged for determining a resistance of the first electric circuit 14. Thereto the processor 38 is arranged for measuring the electrical resistance between the third and fourth contacts 34.i, 36.i. A measurement unit 39 of the processor 38, here an analog-to-digital converter, ADC, may thereto be arranged to determine a voltage difference between the third and fourth contacts 34.i, 36.i when a current is known. In this example the processing unit 4 includes resistors 40.i connected between the third and fourth contacts 34.i, 36.i. Therefore, when all switches 16 of the blister pack 2 are opened, the processor 38 measures a resistance between the third and fourth contacts equal to the resistance of the resistor 40. When one or more switches are closed the processor 38 can determine whether one or more switches are opened and which one or more switches are opened, based on the measured resistance and based on the predetermined different electrical resistances of the switches 16.
  • The processing unit 4 includes a clock 42, such as a real time clock. The processing unit 4 includes a memory 44. In this example the processing unit is arranged for storing in the memory 44 an indication of time, such as a timestamp, at which a pill 12 was taken from its pocket 10.
  • The processing unit 4 includes a wireless information retrieval unit 46. In this example the wireless information retrieval unit 46 is a near field communication unit arranged for arranged near field communication, NFC, e.g. according to ISO/IEC 18092, ECMA-340, ISO/IEC 21481 and/or ECMA-352. The wireless information retrieval unit 46 is arranged for interrogating the second electric circuit 28. The wireless information retrieval unit is arranged for retrieving information stored in the memory 30 of the second electric circuit 28. In this example the wireless information retrieval unit 42 is arranged for retrieving information representative of the prescribed dosage pattern of the pills 12. It will be appreciated that the memory 30 can also store other information such as the predetermined different electrical resistances of the switches 16, information relating to the manufacturer of the blister pack and/or of the medication, an expiry date, etc. All such information can also be retrieved by the wireless information retrieval unit 46. The information retrieved by the wireless information retrieval unit can be stored in the memory 44 of the processing unit 4.
  • In this example the processing unit 4 includes an alarm unit 48. The processing unit 4 is arranged for activating the alarm unit 48 for indicating to a user that a pill 12 has to be taken from the blister pack 2. The processing unit 4 can activate the alarm unit 48 according to the prescribed dosage pattern as retrieved from the second electric circuit 28. In this example the alarm unit 48 includes a loudspeaker 50 and a light source 52. The processing unit 4 can also be arranged to activate the alarm unit when the blister pack 2 included in the housing 5 is depleted. Optionally the alarm unit 48 thereto includes a separate, second light source 53.
  • In this example the housing 5 houses both the blister pack 2 and the processing unit 4. As can be seen from Figure 1, the blister pack 2 is housed entirely within the housing 5. In this example the housing is rigid, e.g. manufactured from plastic.
  • In this example the housing 5 includes a tray 5a in which the blister pack 2 is mainly housed. The tray 5a can include first grooves 56 into which the blister pack 2 can be slidingly inserted. The housing 5 includes a head 5b, 5c in which the processing unit 4 is housed. The shells of the head 5b, 5c may be interconnected, e.g. through fasteners 5e The head 5b, 5c connects to the tray 5a. In this example the head 5b, 5c snap-fits to the tray 5a. Here the housing 5 further includes a blister lock 5d which locks the blister pack 2 to the head 5b, 5c, so that the blister pack connector 27 remains connected to the processing unit connector 31.
  • The housing 5 also includes a cover 58. The cover 58 is slidingly held in second grooves 60, see Figure 3. The cover 58 can be slid from an opened state allowing taking of a pill 12 to a closed state preventing taking of a pill 12, and vice versa. In this example, the cover 58 includes an upper cover part 58a and a lower cover part 58b. Hence, the cover can be slid from an closed state to a partially opened state to a fully opened state, see figure 2.
  • The housing 5 is provided with a lock 62, see Figures 8A and 8B. In this example the lock 62 includes a lip 64 that can be hooked in a recess 66. The cover further includes a hook 65 arranged for preventing the cover 58 to be detached from the body of the housing 5. In this example, the recess 66 is positioned in a movable stopper 66a. The movable stopper 66a is biased towards a position in which the recess 66 grips the lip 64, see Figure 8A. If the movable stopper 66a is pressed against the biasing force of a biasing element 66b at a tip 66b projecting through the head part 5b, the recess 66 is moved to release the lip, see figure 8B. Then the cover 58a, 58b can be slid aside to access the pockets 10.
  • The cover 58 further includes a gripping area 67 having a surface structure enabling easy sliding of the cover by the use of a finger or thumb.
  • In this example the cover 58 is transparent to allow visual inspection of the blister pack 2 without necessitating to open the cover. In this example the housing 5 includes a support structure 69 underneath the blister pack 2. The support structure 69 includes a plurality of opening 71 for allowing the taking of the pills 12.
  • In another example, see Figure 12, the processing unit 4 includes four buttons 54. It will be appreciated that in general one or more buttons 54 can be included. The buttons are connected to the processor 38. In this example each button is associated with a predetermined symptom, such as drowsy, nauseous, headache, neutral, feeling cold, feeling hot, feeling better, or the like. When a button 54 is pressed, the processing unit 4 stores information representative of the associated symptom, preferably together with a timestamp representative of the moment of pressing the button 54.
  • In this example the housing 5 houses both the blister pack 2 and the processing unit 4. As can be seen from Figure 12, the blister pack 2 is housed entirely within the housing 5. In this example the housing is rigid, e.g. manufactured from plastic. In this example the housing includes first grooves 56 into which the blister pack 2 can be slidingly inserted. The housing also includes a retainer 57 for preventing the blister pack 2 from unintentionally being expelled from the housing 5. In this example, the retainer includes grips 59 for allowing to exert enough force to remove the retainer 57 by hand.
  • The housing 5 also includes a cover 58. The cover 58 is slidingly held in second grooves 60. The cover 58 can be slid from an opened state allowing taking of a pill 12 to a closed state preventing taking of a pill 12, and vice versa. The housing 5 is provided with a lock 62. In this example the lock 62 includes a lip 64 that can be hooked in a recess 66. The cover further includes a hook 65 arranged for preventing the cover 58 to be detached from the body of the housing 5. The cover 58 further includes a gripping area 67 having a surface structure enabling easy sliding of the cover by the use of a finger or thumb.
  • The system 1 further includes a switch 68 arranged for switching the processing unit 4 in a power save mode when the cover 58 is in the closed state. In this example the cover 58 is transparent to allow visual inspection of the blister pack 2 without necessitating to open the cover. In this example the housing 5 includes a support structure 69 underneath the blister pack 2. The support structure 69 includes a plurality of opening 71 for allowing the taking of the pills 12.
  • In the examples the processing unit 4 further includes a connector 70, such as a USB connector, miniUSB connector, or microUSB connector. The connector 70 allows for wiredly connecting the processing unit 4 to an external data processor, such as a personal computer. Alternatively, or additionally, the processing unit can include a wireless communications unit 72 arranged for wirelessly communicating with the external data processor, such as via Bluetooth, Wifi, Zigbee or the like. The processing unit 4 can e.g. communicate the information representative of the actual taking of a pill 12 from the blister pack 2 to the external data processor. The processing unit can also communicate additional data to the external data processor, such as data related to events of pressing a button 54. Then a reviewer, such as a medical professional, can review adherence to the prescribed dosage pattern and other data. The processing unit also includes a battery 55, such as a 3.3V battery. In this example, the battery is rechargeable through the connector 70.
  • The packaging system 1 according to the invention can be used as follows.
  • A patient visits his or her doctor in event of illness. The doctor prescribes a medication. In order for the medication to have maximum effect, proper adherence to a prescribed dosage pattern is important. The patient goes to the pharmacist to obtain the medication. The pharmacist provides the medication, wherein units of the medication (such as pills, tablets or capsules) are included in a blister pack 2 as described above. The blister pack 2 has the near field communication, NFC, circuit 28. The circuit 28 can be included in the blister pack 2 during packaging of the medication in the blister pack, e.g. at a factory. Alternatively, the pharmacist can apply the tag 29 including the circuit 28 to the blister pack 2. The tag 29 can e.g. be a self-adhesive tag. The NFC circuit 28 has inbuilt memory to store information related to the prescribed dosage pattern. For NFC circuit programming with dosage details, a computer based application can be used, this application can be used to transmit data to the NFC circuit through an NFC transceiver device connected to the computer.
  • The patient obtains, or already possesses, a processing unit 4 as described above. The patient may e.g. obtain or possess an assembly including the processing unit 4 and the housing 5 as described above. The blister pack 2 is inserted into the housing 5. The blister pack 2 can e.g. be slid into the first grooves 56 of the housing 5. The blister pack connector 27 mates with the processing unit connector 31. Thereby the first contacts 24.i are brought in electrically conductive connection with the third contacts 34.i and the second contacts 26.i are brought in electrically conductive connection with the fourth contacts 36.i. The blister pack 2 now is wiredly connected to the processing unit 4. The head 5b, 5c is connected to the tray 5a, or the retainer 57 is positioned to prevent inadvertent expulsion of the blister pack 2 from the housing 5.
  • When the blister pack 2 is inserted into the housing 5 the wireless information retrieval unit 46 reads information stored in the memory 30 of the second electric circuit 28. In this example the processor 38 retrieves the information representative of a prescribed dosage pattern of the pills 12 and stores it in the memory 44. The processing unit 4 determines moments when a pill 12 has to be taken on the basis of the prescribed dosage pattern. For example, the processing unit determines moments when a pill 12 has to be taken on the basis of a timestamp of a taking of a first pill from the blister pack, and on the basis of a prescribed time interval in between two takings of a pill. For example the processing unit determines moments when a pill has to be taken on the basis of predetermined times defined in the prescribed dosage pattern, e.g. at 7:00 AM and at 5:00 PM.
  • After inserting the blister pack 2 in the housing 5 the cover 58 is closed. Putting the cover 58 in the closed state can bring the system 1 in sleep mode. In sleep mode circuitry of the processing unit 4 for retrieving information from the first and/or second electric circuit is disabled. In this example the system is re-activated only when the cover is opened. Nevertheless, in this example the alarm unit 48 and the optional input buttons 54 are also functional in sleep mode. The cover 58 also prevents false trigger and recording of medication administration.
  • When the processing unit 4 determines that the time indicated by its clock 42 corresponds to a moment when a pill has to be taken, the processing unit 4 activates the alarm unit 48. In this example, the alarm unit 48 includes an LED light source 52 and a loudspeaker 50. When activated the LED will flash green and the loudspeaker will generate a sound. Reminders through multiple modes, here both auditory and visual, ensures that the compliance adherence is maximized.
  • When reminded by the alarm unit 48 the patient opens the cover 58. This may end the sleep mode and render the system 1 fully operational. The patient takes one pill 12 from its pocket 10 and administers the pill 12 as required. Taking the pill from its pocket 10 opens the associated switch 16. This is detected as a change in electrical resistance between the third and fourth contacts 34.i, 36.i by the processing unit. In this example the processing unit 4 polls an analog-to-digital converter, ADC, at predetermined time intervals, of e.g. 10 ms, to determine a change in voltage between the third and fourth contacts 34.i, 36.i. The processing unit stores the event of taking the pill and the time associated with it. In this example, from the electrical resistance measured between the third and fourth contacts 34.i, 36.i the processing unit 4 determines which switch 16 has been opened, viz. which pill has been taken. The processing unit also stores which pill has been taken with the event.
  • After the patient has taken the pill 12, he or she closes the cover 58 again and the system goes into sleep mode again. When the next moment for taking a pill arises the processing unit 4 activates the alarm unit 48 again and the process is repeated.
  • After taking of the last pill of the blister pack, the processing unit may determine that the blister pack 2 is depleted. The processing unit may then activate the alarm unit to indicate depletion, and required replenishment, of the blister pack to the patient. In this example the alarm unit 48 thereto activates the second light source 53. Alternatively, the first light source 52 may be activate to flash, e.g. red, to indicate depletion of the blister pack.
  • During the course of taking the medication, the patient may experience symptoms associated with the use of the medication. When the patient experiences such symptom, he or she can press the associated button 54 on the processing unit 4. The processing unit 4 then stores an event indicating the time and the symptom experienced.
  • After, or during, the medication, the patient carries the system 1 to the physician in his or her next visit. The physician can inspect the medication history of patient by connecting the system 1 to his computer with the connector 70 or wireless communications unit 72. The data stored in the memory 44 can be displayed, e.g. in the form of graphs or tables, on a graphical user interface.
  • The blister pack can be manufactured as follows.
  • The first sheet 6 including a plurality of pockets 10 is provided. In each pocket 10 a unit of medication is placed. The pockets are closed with a sheet of aluminium foil 8b. The first electric circuit 14 is printed on a first side of an electrically non-conductive sheet 8c, such as a paper sheet. Optionally, branding and labeling information is printed on the other side of the non-conducting sheet. The first side of the non-conductive sheet 8c is provided with an adhesive layer. The non-conductive sheet 8c is adhered to the aluminium foil sheet 8b. Optionally a further non-conductive sheet 8a is interposed between the sheets 8b and 8c. The non-conductive sheet 8c may be covered with a lamination 21. Optionally, the non-conductive sheet 8c is provided with a transfer sheet to allow storage of the non-conductive sheet prior to attachment to the blister pack. Optionally, a plurality of the non-conductive sheets is stored on a roll.
  • Herein, the invention is described with reference to specific examples of embodiments of the invention. It will, however, be evident that various modifications and changes may be made therein, without departing from the essence of the invention. For the purpose of clarity and a concise description features are described herein as part of the same or separate embodiments, however, alternative embodiments having combinations of all or some of the features described in these separate embodiments are also envisaged.
  • In the above examples the processing unit activates the alarm unit according to the prescribed dosage pattern retrieved from the second electric circuit. It is also possible that the processing unit is arranged to determine an alternative dosage pattern in case the actual taking of a unit of medication was not according to the prescribed dosage pattern. Thereto the second electric circuit may store additional data such as minimum time between takings of a unit of the medication, allowability of taking forgotten units of the medication, earliest allowable taking times, latest allowable taking times, etc.. The processing unit can retrieve such additional data from the second electric circuit. For example if a pill has to be taken daily at 8:00 AM, but the previous pill was not taken until 4:00 PM it might be advisable to postpone activating the alarm for the taking of the next pill until after 8:00 AM, e.g. until 11:30 AM.
  • In the above examples the blister pack is provided with the first electric circuit and the second electric circuit. It will be appreciated that a blister pack provided with the first electric circuit, but not with the second electric circuit can also be used to advantage in certain applications. It will be appreciated that a blister pack provided with the second electric circuit, but not with the first electric circuit can also be used to advantage in certain applications. A processing unit arranged for cooperating with such blister packs can also be manufactured.
  • It will be appreciated that the information stored in the memory of the second electric circuit can be encoded and/or encrypted.
  • It is possible that the information stored in the memory of the second electric circuit includes information on a vendor and/or manufacturer of the medication.
  • In the examples the information stored in the memory of the second electric circuit includes information representative of prescribed intervals between the taking of a pill or information representative of prescribed moments, such as prescribed clock times, for the prescribed taking of a pill. It will be appreciated that it is also possible that the memory of the second electric circuit includes one or more codes representative of a prescribed dosage pattern. A plurality of codes and associated dosage patterns may also be stored in the memory of the processing unit, so that after readout the processing unit can determine the prescribed dosage pattern associated with the read out code(s).
  • In the examples, the processing unit can wirelessly communicate with the external data processor, such as via Bluetooth, Wifi, Zigbee or the like. It will be appreciated that it is also possible that the processing unit wirelessly communicates with a further device, such as a mobile communications device, such as a mobile phone, e.g. via Bluetooth, SMS, GSM, or the like. The processing unit can then transmit a warning signal to the mobile communications device, such that the mobile communications device warns the user to take a medication.
  • It is possible that the device further includes a display, such as an LCD display, for conveying information to a user. Such information can e.g. include one or more of a current time, a planned time for the next medication dose, a nature of the medication, a battery status, an imminent need for replenishment of medication, or the like.
  • It will be appreciated that the processing unit, or part thereof, can be embodied as dedicated electronic circuits, possibly including software code portions. The processing unit, or part thereof, can also be embodied as software code portions executed on, and e.g. stored in, a memory of, a programmable apparatus such as a computer.
  • Although the embodiments of the invention described with reference to the drawings comprise computer apparatus and processes performed in computer apparatus, the invention also extends to computer programs, particularly computer programs on or in a carrier, adapted for putting the invention into practice. The program may be in the form of source or object code or in any other form suitable for use in the implementation of the processes according to the invention. The carrier may be any entity or device capable of carrying the program.
  • For example, the carrier may comprise a storage medium, such as a ROM, for example a CD ROM or a semiconductor ROM, or a magnetic recording medium, for example a floppy disc or hard disk. Further, the carrier may be a transmissible carrier such as an electrical or optical signal which may be conveyed via electrical or optical cable or by radio or other means, e.g. via the internet or cloud.
  • When a program is embodied in a signal which may be conveyed directly by a cable or other device or means, the carrier may be constituted by such cable or other device or means. Alternatively, the carrier may be an integrated circuit in which the program is embedded, the integrated circuit being adapted for performing, or for use in the performance of, the relevant processes.
  • However, other modifications, variations, and alternatives are also possible. The specifications, drawings and examples are, accordingly, to be regarded in an illustrative sense rather than in a restrictive sense.
  • For the purpose of clarity and a concise description features are described herein as part of the same or separate embodiments, however, it will be appreciated that the scope of the invention may include embodiments having combinations of all or some of the features described. In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word 'comprising' does not exclude the presence of other features or steps than those listed in a claim. Furthermore, the words 'a' and 'an' shall not be construed as limited to 'only one', but instead are used to mean 'at least one', and do not exclude a plurality. The mere fact that certain measures are recited in mutually different claims does not indicate that a combination of these measures cannot be used to an advantage.

Claims (17)

  1. Packaging system for medicaments including:
    an exchangeable blister pack including a plurality of pockets each housing a unit of medicament; and
    a processing unit;
    wherein the blister pack includes a first electric circuit that is wiredly connected to the processing unit,
    wherein the blister pack includes a second electric circuit that is wirelessly connected to the processing unit,
    wherein the processing unit is arranged for wirelessly retrieving information representative of a prescribed dosage pattern of the units from the second electric circuit, and for wiredly retrieving information representative of actual taking of a unit from the blister pack from the first electric circuit.
  2. Packaging system according to claim 1 wherein the exchangeable blister pack has a first sheet including the plurality of pockets and a second sheet closing the pockets, the second sheet being breakable for removing the units from the pockets;
    wherein the second sheet includes the first electric circuit, the first electric circuit including a plurality of switches, each pocket of the first sheet having a switch of the plurality of switches associated therewith, such that removal of a unit from its pocket opens the associated switch, wherein the switches are electrically connected in parallel,
    wherein the blister pack includes a first contact electrically conductively connected to a first sides of the switches and a second contact electrically conductively connected to a second side of the switches,
    wherein the processing unit is wiredly connected to the first and second contacts, wherein the processing unit is arranged for determining the electric resistance of the switches between the first and second contacts and for determining which switches of the plurality of switches are open on the basis of the determined electric resistance.
  3. Packaging system according to claim 2, wherein each switch has a different electrical resistance.
  4. Packaging system according to claim 2 or 3, wherein the blister pack includes a plurality of pluralities of pockets, the first electric circuit including a plurality of pluralities of switches, wherein the switches within each plurality of switches are electrically connected in parallel.
  5. Packaging system according to any one of the preceding claims, wherein the second electric circuit includes a near field communication, NFC, circuit including a memory storing the information representative of the prescribed dosage pattern of the units.
  6. Packaging system according to any one of the preceding claims, wherein the processing unit is further arranged for storing the information representative of actual taking of a unit from the blister pack.
  7. Packaging system according to any one of the preceding claims, wherein the processing unit includes a clock and the information representative of actual taking of a unit from the blister pack includes a timestamp of the actual taking of the unit.
  8. Packaging system according to any one of the preceding claims, wherein the processing unit includes an alarm unit arranged for, according to the prescribed dosage pattern, indicating to a user that a unit of medicament has to be taken.
  9. Packaging system according to any one of the preceding claims, wherein the processing unit is arranged to determine an alternative dosage pattern on the basis of the prescribed dosage pattern and on the basis of a time of an actual taking of a unit of medication.
  10. Packaging system according to any one of the preceding claims, wherein the processing unit includes a communications unit arranged for communicating with an external data processor.
  11. Packaging system according to any one of the preceding claims, further including a housing arranged for housing the blister pack when wiredly and wirelessly connected to the processing unit.
  12. Packaging system according to claim 11, wherein the housing includes a cover movable between an opened state allowing taking of a unit and a closed state preventing taking of a unit, wherein the system optionally further includes a switch arranged for switching the processing unit in a power save mode when the cover is in the closed state.
  13. Blister pack including a first sheet including a plurality of pockets for each housing a unit of medicament and a second sheet closing the pockets, the second sheet being breakable for removing the units from the pockets;
    wherein the second sheet includes a first electric circuit including a plurality of switches, each pocket of the first sheet having a switch of the plurality of switches associated therewith, such that removal of a unit from its pocket opens the associated switch, the switches being electrically conductively connected to one or more contacts;
    wherein the blister pack includes a second electric circuit including a wireless communication circuit including a memory storing information associated with the units.
  14. Blister pack according to claim 13, wherein each switch has an electrical resistance, wherein the switches are electrically connected in parallel, wherein the blister pack includes a first contact electrically conductively connected to a first sides of the switches and a second contact electrically conductively connected to a second side of the switches.
  15. Blister pack according to claim 13 or 14, wherein each switch has a different electrical resistance.
  16. Method for improving medicament intake including:
    providing an exchangeable blister pack including a plurality of pockets each housing a unit of medicament; and a processing unit; wherein the blister pack includes a first electric circuit that is wiredly connected to the processing unit, wherein the blister pack includes a second electric circuit that is wirelessly connected to the processing unit, wherein the processing unit is arranged for wirelessly retrieving information representative of a prescribed dosage pattern of the units from the second electric circuit, and for wiredly retrieving information representative of actual taking of a unit from the blister pack from the first electric circuit;
    providing an indication that a unit of medication needs to be taken, on the basis of the information representative of the prescribed dosage pattern and the information representative of the actual taking of a unit of medication.
  17. Method according to claim 16, further including determining an alternative dosage pattern on the basis of the prescribed dosage pattern and on the basis of a time of an actual taking of a unit of medication.
EP15156720.3A 2015-02-26 2015-02-26 Electronic drug packaging for improved compliance Withdrawn EP3061438A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP15156720.3A EP3061438A1 (en) 2015-02-26 2015-02-26 Electronic drug packaging for improved compliance
PCT/EP2016/054115 WO2016135306A1 (en) 2015-02-26 2016-02-26 Electronic drug packaging for improved compliance

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP15156720.3A EP3061438A1 (en) 2015-02-26 2015-02-26 Electronic drug packaging for improved compliance

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