US20130161207A1 - Child Resistant Packaging for Multi-Prescription Order - Google Patents

Child Resistant Packaging for Multi-Prescription Order Download PDF

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Publication number
US20130161207A1
US20130161207A1 US13/710,176 US201213710176A US2013161207A1 US 20130161207 A1 US20130161207 A1 US 20130161207A1 US 201213710176 A US201213710176 A US 201213710176A US 2013161207 A1 US2013161207 A1 US 2013161207A1
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US
United States
Prior art keywords
pouches
child
patient
tablets
pouch
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.)
Abandoned
Application number
US13/710,176
Inventor
Robert A. Luciano, Jr.
Warren White
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.)
Edge Medical LLC
Original Assignee
Individual
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
Priority claimed from US11/241,783 external-priority patent/US8123036B2/en
Priority claimed from US11/796,125 external-priority patent/US9710866B2/en
Priority claimed from US11/796,123 external-priority patent/US7690173B2/en
Priority claimed from US11/796,124 external-priority patent/US8074426B2/en
Priority claimed from US11/923,321 external-priority patent/US8266878B2/en
Priority claimed from US12/418,436 external-priority patent/US20100089937A1/en
Priority claimed from US12/418,422 external-priority patent/US20100089936A1/en
Priority claimed from US12/418,418 external-priority patent/US20090294323A1/en
Priority claimed from US12/424,483 external-priority patent/US9245304B2/en
Priority claimed from US12/424,475 external-priority patent/US8146747B2/en
Priority claimed from US12/684,060 external-priority patent/US8789700B2/en
Priority claimed from US12/891,029 external-priority patent/US20130299381A9/en
Priority claimed from US12/891,042 external-priority patent/US20110101016A1/en
Priority claimed from US12/896,134 external-priority patent/US8712582B1/en
Priority claimed from US12/896,275 external-priority patent/US8914298B1/en
Priority claimed from US12/896,284 external-priority patent/US10315450B1/en
Priority claimed from US12/945,709 external-priority patent/US9141764B2/en
Priority claimed from US29/396,215 external-priority patent/USD675099S1/en
Priority claimed from US13/312,907 external-priority patent/US9015058B2/en
Priority claimed from US13/473,304 external-priority patent/US9334096B2/en
Priority claimed from US13/473,267 external-priority patent/US9238518B2/en
Priority claimed from US13/526,412 external-priority patent/US20120312714A1/en
Priority to US13/710,176 priority Critical patent/US20130161207A1/en
Application filed by Individual filed Critical Individual
Assigned to EDGE MEDICAL, LLC reassignment EDGE MEDICAL, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: WHITE, WARREN, LUCIANO, ROBERT A., JR.
Publication of US20130161207A1 publication Critical patent/US20130161207A1/en
Abandoned legal-status Critical Current

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D50/00Closures with means for discouraging unauthorised opening or removal thereof, with or without indicating means, e.g. child-proof closures
    • 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
    • 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
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B1/00Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B1/04Methods of, or means for, filling the material into the containers or receptacles
    • 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
    • A61J1/14Details; Accessories therefor
    • A61J1/1437Locking means requiring key or combination to open the container
    • 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
    • A61J7/0454Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers for dispensing of multiple drugs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B5/00Packaging individual articles in containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, jars
    • B65B5/06Packaging groups of articles, the groups being treated as single articles
    • B65B5/061Filled bags
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B63/00Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged
    • B65B63/04Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged for folding or winding articles, e.g. gloves or stockings

Definitions

  • the invention relates to a child-resistant container for a multi-prescription order. More particularly, the child resistant package is configured to hold a plurality of preliminary packages.
  • prepackage the multiple medications so that users can take the prepackaged medications at a predetermined time.
  • prepackaged medications are targeted to patients that lack mental capacity to take the correct medications at the correct time.
  • Some of the prepackaged medications are placed in a small plastic bag, which may be easily misplaced.
  • Other prepackaged medications are placed in sealed cups that are difficult to open.
  • Another complication of multiple medication regimens is that many patients may require variable doses of a given medication at different times. For example, many medications require titration when a patient begins taking them. This generally involves the patient taking gradually larger amounts of the drug until the desired dosage amount is reached. Still other regimens require that a given tablet be taken every other day, or that different dosages be taken on alternating days. These schedules make it even more difficult for a patient to comply with the medication regimen that has been prescribed or recommended.
  • multiple prescription filling systems are available, e.g. the McKesson PACMED system, these systems have limited capabilities. For example, these filling systems fail to assemble a multiple prescription order that can be easily transported and administered. Additionally, these filling systems fail to effectively organize the multiple prescription medications. Furthermore, the filling systems fail to organize the multiple prescription containers. Further still, the filling systems fail to provide a compliance packaging solution.
  • Child-resistant packaging is special packaging used to reduce the risk of children ingesting dangerous items, such as prescription drugs. This is often accomplished by the use of a special safety cap. Prepackaged medications in sealed cups also lack child-resistant compliance.
  • a child-resistant container that includes a receptacle, an open neck, a cap and a label.
  • the open neck projects from the receptacle and defines an opening.
  • the neck includes an outer surface and at least one thread formed on the outer surface of the neck.
  • the thread has a predetermined thickness along its length.
  • the cap is configured to interface with the neck of the receptacle.
  • the cap includes a top surface, a skirt, a second thread, and a sawtooth projection.
  • the skirt is adjacent to the top surface and defines an opening received by the neck of the receptacle.
  • the second thread is on an inner surface of the skirt for complementary engagement with the thread of the neck of the receptacle.
  • the sawtooth projection is on the inner surface of the skirt.
  • the cap is rotatably screwed onto the neck of the receptacle.
  • the receptacle receives preliminary packages, in which the preliminary package includes tablets associated with a multiple prescription order that indicates when the tablets are to be consumed.
  • the label is disposed on the receptacle and associated with the multiple prescription order.
  • the label includes a description of the plurality of tablets and a barcode associated with a particular patient consuming the plurality of tablets.
  • the preliminary packages include a plurality of pouches that form a strip of separably coupled pouches. Each pouch among the plurality of pouches may include a bar code for tracking medications within each pouch. Additionally, each pouch may include a pouch label with at least a name for each medication within the pouch and a dosage for each medication within the pouch. The illustrative label may include a particular dosing interval for consuming the medications within the pouch and information about the patient.
  • the child resistant container described above includes a locking mechanism, in which the sawtooth projections of the cap hold the thread of the neck of the receptacle.
  • a method for packaging a multiple prescription order includes receiving at a server an order for tablets that further includes an order for at least one type of prescription tablet and a selection of a child-resistant packaging.
  • the server then generates instructions for filling the pouches with a child resistant package.
  • the pouches are then filled by automated means with at least one type of prescription tablet. Labels are printed by automated means on the plurality of pouches. Each pouch label includes information indicating the time at which the contents of each pouches among the plurality of pouches are to be consumed.
  • the pouches are then packaged by automated means within the child-resistant package.
  • FIGS. 1A-1E illustrate a child-resistant container in accordance with an embodiment, the package including a push tab that is pushed down while turning the cap of the package to open the child-resistant container.
  • FIGS. 2A and 2B illustrate a top view and a bottom view of the child-resistant cap of a child-resistant container in accordance with an embodiment.
  • FIG. 3A illustrates a perspective view of a child-resistant container in accordance with an embodiment.
  • FIG. 3B illustrates a partial cross-sectional view of a child-resistant container holding a folded stack of a strip of pouches.
  • FIG. 3C shows a cross-sectional view of the cap.
  • FIG. 4A illustrates a detailed, partially broken view of a strip of pouches, including the tearable ribbons and cuts that separably couple the pouches.
  • FIG. 4B shows an illustrative sealed center cut pouches with three perforations and four tearable ribbons on each side of the center cut.
  • FIG. 4C shows an illustrative sealed center cut pouches with four perforations on each side of the center cut.
  • FIG. 4D shows an illustrative sealed center cut pouches with five perforations on each side of the center cut.
  • FIG. 5A illustrates a strip of pouches folded into a stack for packaging within a child-resistant container.
  • FIG. 5B illustrates a detailed label printed on a front of a pouch in accordance with an embodiment.
  • FIG. 5C illustrates a detailed label printed on a back of a pouch in accordance with an embodiment.
  • FIGS. 6A and 6B illustrate an arrangement of pouches associated with an individual regimen in accordance with an embodiment, the arrangement including a header, a prescription tablets pouches, and a non-prescription tablets pouches.
  • FIGS. 7A-7D illustrate a strip of stackable individual sealed cups in accordance with an embodiment.
  • FIGS. 8A-8D show the manner in which an illustrative strip of sealed cups may be folded from a flat configuration to a stacked configuration.
  • FIGS. 9A and 9B show a portion of one illustrative embodiment of a strip of pouches associated with an individual regimen of prescription and non-prescription tablets, including illustrative labeling information.
  • FIGS. 10A and 10B show one embodiment of the stackable individual medicament cups associated with an individual regimen of prescription and non-prescription tablets, including illustrative labeling information.
  • FIGS. 11A and 11B show an alternative embodiment of the stackable individual medicament cups associated with an individual regimen of prescription and non-prescription tablets, including illustrative labeling information.
  • FIGS. 12A-12D illustrate portions of strips of pouches representing configurations of filled packets and associated headers.
  • FIGS. 13A-13G show an alternative embodiment of a label included with a child-resistant container.
  • FIG. 14 shows an illustrative grouping for a 30-day tablet regimen for the patient management system packaged in child-resistant packaging.
  • FIG. 15 illustrates four child-resistant containers corresponding to the morning dosage period, with each container holding medications for one week.
  • FIG. 16 illustrates four child-resistant containers corresponding to different dosage periods in accordance with an embodiment.
  • FIG. 17 illustrates a secondary container for receiving four child-resistant containers in accordance with an embodiment.
  • FIGS. 18A and 18B show illustrative flowcharts of methods for compliance packaging for the patient medication management system.
  • FIGS. 19A-19E show a flat plan view of an illustrative label in accordance with an embodiment.
  • FIG. 20 shows an illustrative flowchart describing a method for packaging pharmaceutical and non-pharmaceutical tablets in accordance with an embodiment.
  • FIG. 21 shows an illustrative flowchart describing a method for inspecting the packing of pharmaceutical and non-pharmaceutical tablets in accordance with an embodiment.
  • the systems, apparatus and methods described herein provide the correct medications and dosages at the right time.
  • the packaging is designed with clear images and names to simplify the process of determining the appropriate medications to take at the appropriate time.
  • the patient medication management system and method described herein eliminates the worry of taking the wrong medication at the wrong time, and eliminates the need to manually open and organize prescriptions each week.
  • the system and method described herein gathers all the patient's medicines together in one package, and clearly shows the proper dosage time. Finally, the medicines are packaged in child-resistant packaging.
  • An embodiment is directed to a child-resistant container for holding a plurality of pouches associated with a multiple prescription order.
  • Each of the pouches holds a plurality of medications to be taken at a particular dosage time. For example, if a patient is to take medicines A-E in the morning (the dosage time), then each of the pouches is configured to include medicines A-E and configured to be labeled with the corresponding dosage time (i.e. morning).
  • the pouches may also be labeled with a written list of all of medications within the pouches (medicines A-E), with a picture of each of medicines A-E, the dosage associated with each of medicines A-E, patient information, among other information.
  • the labeling of the pouches thus enables the caretaker or patient to verify that the correct medicines are being taken at the appropriate time. After consuming the medicines, the opened and labeled pouches also serves as a record that the medicines were taken at the appropriate time in accordance with the prescribed regimen.
  • Child-resistant container and “child-resistant package” are used interchangeable in the present specification.
  • Child-resistant container/package is used to refer to a package used to reduce the risk of children ingesting dangerous items by including a closure mechanism that makes it difficult or prevents children from opening the container.
  • preliminary package includes, but is not limited to, packaging material such as a pouch, blister, vial, or any package that holds or houses a plurality of different medications.
  • a preliminary package may exist in a sealed preliminary package, e.g. pouches, or an unsealed preliminary package, e.g. blister.
  • the preliminary packages are then placed into a “final” package such as a child-resistant container or sleeve.
  • Embodiments of the child-resistant container are packaged to contain a plurality of pouches to be taken at the same dosage time. For example, if a patient is to take pills A and B in the morning for five weeks, and take pills C and D in the afternoon for three weeks, then the prescription can be packaged using a morning child-resistant container including pouches to be consumed in the morning for five weeks, and an afternoon child-resistant container including pouches to be consumed in the afternoon for three weeks. Thus, a container holds medications associated with a single dosage time among one or more dosage times of a prescription.
  • a single medication is packaged within a single container, with the user having to take the right amount of medication from the container at the various dosage times.
  • the user retrieves the appropriate amount of medication from the same container. This increases the risk of taking the wrong dosage if the dosage varies among the dosage times.
  • the multiple medications are usually packaged in separate containers. It is then the patient's (or caretaker's) responsibility to retrieve the right amount of medication from each of the containers at the various dosage times. That is, the patient must still retrieve the medication from the same containers at the various dosage times.
  • taking multiple medications compounds the risk of taking the wrong dosage.
  • Embodiments of the child-resistant container improve on traditional packaging of medications in that a single child-resistant container is associated with a single dosage time. That is, at a first dosage time, the patient retrieves medication from a first container, and at a second dosage time, the patient retrieves medication from a second container. This especially minimizes errors with multiple prescription orders and with prescribed regimens where dosage amounts vary over dosage times and over the prescribed time.
  • Embodiments also differ from prior medication containers in that multiple prescription orders are prepackaged in individual pouches, where each pouch holds a single dose.
  • the caretaker or patient simply takes an individual pouch and consumes the medicines within the individual pouches, without having to track complicated dosage regimens.
  • the prepackaging also avoids the need for the patient to have to sort out all of the medicines into a weekly pill organizer or some other type of organizer.
  • each child-resistant container hold only the pouches to be taken at the same particular dosage time, confusion is minimized since at a particular dosage time the user can simply take a pouch from the corresponding child-resistant container labeled with the particular dosage time.
  • FIG. 1A illustrates a child-resistant container 10 including a child-resistant cap 12 in accordance with an embodiment.
  • the receptacle 11 of the child-resistant container 10 is substantially cylindrical shaped, even though rectangular or alternatively shaped child-resistant containers may also be used with embodiments described herein.
  • the child-resistant container 10 includes a rim adjacent to the neck of the receptacle (not shown), the rim including a push tab 14 for opening the child-resistant container 10 .
  • Pushing the tab 14 while turning the cap 12 opens the child-resistant container 10 .
  • Alternative child-resistant mechanisms may be used.
  • the cap 12 may be pushed down while turning to open the container 10 .
  • Another mechanism includes pinching the cap 12 while turning to open the container 10 .
  • any child-resistant mechanism may be used for the packaging of multiple prescription orders described herein.
  • the illustrative container 10 may have an illustrative cap with a diameter of 2 inches or more. As the diameter of the container and corresponding cap increases, it becomes more difficult for a child's hands to effectively grip the cap, thus making it more challenging to open the container 10 .
  • the cap 12 includes side threads 16 on a raised portion 18 of the cap 12 .
  • the side threads 16 enable the cap 12 to be turned upside down and the cap 12 to be screwed into the mouth of the container 10 , thus closing the container 10 without child-resistant protection.
  • the label 20 of the container 10 may include patient information, such as the patient's name, a patient number associated with the patient or with the particular prescription, an order number, a list of medications included in the container 10 .
  • a bar code may associate the tablets in the child-resistant container 10 with a particular patient.
  • FIGS. 1B-1E illustrate in detail the label printed on the outside of the container 10 , with the label 20 including a list of medications and a list of precautions associated with the medications.
  • the list of medications may include the name of each drug, the dosage of each drug, the address of the patient, the information of the health provider prescribing the medications, information associated with the health provider, a picture of the patient, and pictures of each of the various medications included in the multi-prescription order.
  • FIG. 2A illustrates a top view of the container 10 with the cap 12 in the child-resistant position, with push tab 14 , the side threads 16 , and the raised portion 18 of the cap 12 on the outside of the container 10 .
  • FIG. 2B illustrates a top view of the container 10 with the cap 12 positioned without child-resistant protection.
  • the side grooves 16 are screwed to the inside of the mouth of the container 10 and the raised portion 18 is on the inside of the container 10 .
  • the cap 12 may engage the container 10 using alternative features.
  • FIG. 3A illustrates a perspective view of the container 10 with cap 12 removed.
  • the outside of the neck 22 of container 10 includes at least one thread 24 that fit with the at least one complementary thread (not shown) on the inside of cap 12 .
  • the side threads 16 of the cap 12 fit complementary threads (not shown) on the inside of the neck 22 of the container 10 .
  • FIG. 3A illustrates an example of a cap label 30 printed or attached to the top of the cap 12 .
  • the container also includes an open neck 22 projecting from the receptacle 11 (shown on FIG. 1A ), with rim 15 adjacent to the open neck 22 , including a push tab 14 .
  • the open neck includes an outer surface 23 with at least one thread 24 formed on the outer surface 23 of the open neck 22 .
  • the cap label 30 indicates the dosage time that all of the medications contained within container 10 are to be taken.
  • the container 10 may also include a second dosage label 32 printed or attached to the body of the container 10 also indicating the dosage time for the plurality of medications in the container 10 .
  • a first container would include all of the medications to be taken at the first dosage time
  • a second container would include all of the medications to be taken at the second dosage time, etc., with the cap label and/or the second dosage label including the corresponding dosage time.
  • the container 10 has dimensions to fit a plurality of preliminary packages, i.e. pouches, (not shown) arranged in various configurations.
  • the pouches can be stacked horizontally or vertically on the inside of container 10 .
  • the size of the container can be adjusted by the number of pouches per container. If the pouches are separably coupled into a strip of pouches, then the strip of pouches may be folded into a stack which can be inserted into the child-resistant container 10 .
  • FIG. 3B illustrates a partially cross-sectional view of the child-resistant container 10 , with the pouches 40 visible within the container 10 .
  • the receptacle 11 may be a clear plastic bottle, allowing the user to see the pouches 40 stored in the container 10 without having to open the container 10 .
  • the receptacle 11 may be a non-clear container, or may include a label that blocks from view the contents of the container.
  • the pouches with the individual dosages may be stacked horizontally.
  • the pouches may be individually separated, or they may consist of FIG.
  • 3C illustrates a cross-sectional view of the cap 12 , the cap having a top surface 52 and a skirt 50 adjacent to the top surface 52 that defines an opening.
  • the cap 12 also includes at least one second thread 56 on the inner surface of skirt 50 for complementary engagement with the thread 24 on the open neck 22 of the receptacle 11 .
  • the cap 12 further includes sawtooth projections 54 on the inner surface of skirt 50 that prevent the container 10 from being opened without engaging the push-tab 14 while unscrewing the cap 12 .
  • the system and method described herein also allows a patient or physician to seamlessly integrate OTC medications, vitamins, nutraceuticals and other beneficial supplements into a daily regimen. This can be particularly important in elderly patients. As people age, they tend to take an ever-growing number of medications, any of which can interact with another medicament or other substance they may ingest. For another regular regimen.
  • One such example is 81 mg aspirin, often recommended for patients to take daily to help prevent certain types of heart and/or cardiovascular disease.
  • the patient can have all pills in hand that need to be taken at one time without having to remember to open additional pill bottles and add extra pills to the regimen.
  • the child-resistant packaging can be configured to receive a plurality of pouches arranged and labeled to help avoid or diminish unwanted side effects of medications or food-medication interactions.
  • some breakfast foods are well-known to interact with some medications.
  • Grapefruit and/or grapefruit juice can slow elimination of certain types of drugs (such as benzodiazepines, like valium) from the body, while oatmeal can decrease absorption of digoxin to almost nothing. Since some medications including benzodiazepines are already eliminated more slowly by elderly patients, taking grapefruit juice or eating grapefruit while a large dose of medication is still in an elderly patient's system could be particularly dangerous.
  • the term “Dual Dispensing Tablet strip configuration” will be used to refer to a configuration of a strip of pouches including prescription medications, non-prescription medications, and an optional header label included within the strip of pouches. It is to be understood that the child-resistant packaging described herein can be used for the packaging of the Dual Dispensing Table strip configuration, as well as any configuration of strip of pouches, individual pouches, strip of sealed cups, or individual sealed cups. Finally, embodiments are not limited to containing a single strip of pouches, as multiple strips of pouches may be included within a single child-resistant container.
  • the Dual Dispensing Tablet strip configuration helps prevent the drug interaction problems described above by simply scheduling such drugs for a time other than “morning” or “breakfast time”.
  • Other timing-related complications that interfere with patient compliance with prescribed or recommended medication regimens include when the dosage of a given drug is not regular or when the frequency with which a drug should be taken is not regular. Certain tablets must be taken only every other day to maximize their benefit to the patient. It can be very difficult for patients to comply with such complicated regimens.
  • the Dual Dispensing Tablet strip configuration can aid those patients by providing the proper dose at the proper time. The patient is not required to tell the difference between two dosages of the same tablet, nor is he required to calculate the proper interval between dosages. All calculations and identification are done ahead of time, before the patient ever sees the prescription container.
  • Dual Dispensing Tablet strip configuration allows physicians or other health care providers to more closely monitor the non-prescribed pills that a patient may take each day, including vitamins, nutraceuticals, over-the-counter drugs or other pills. This can help prevent interactions between prescription medications and other pills.
  • aspirin can interact with blood thinners like Coumadin and/or antidepressants like Prozac to cause bleeding.
  • tablettes refer to medications, pharmaceuticals, nutriceuticals, vitamins, capsules, gel caps, pills and other such medicinal or nutritional preparations for oral use as would be appreciated by those of ordinary skill in the art of pharmacy.
  • prescription tablets refer to pills and other such medicinal or nutritional preparations for oral use that are prescribed to a patient by a physician or other health care provider, as would be appreciated by those of ordinary skill in the art of pharmacy.
  • non-prescription tablets refers to pills and other such preparations for oral use that may be obtained without a prescription.
  • the systems, apparatus and methods described herein provide assurances of the proper dosages at the proper period. Additionally, caregivers and patients get the assurance that the patient is getting the right medications and staying compliant with those medications. Furthermore, a time saving solution for dispensing tablets, medications and vitamins is described.
  • compliant packaging refers to packaging tablets so that they are administered in a manner that complies with one or more prescriptions. Additionally, compliant packaging may also refer to providing reminders for taking medications and/or recording that the medications have been consumed.
  • compliance packaging may include three elements: firstly, an action is initiated by a patient and/or caregiver with the compliance package; secondly, the compliance package dispenses at least one tablet as a result of the action taken by the patient and/or caregiver; and thirdly, the patient or caregiver records the dispensing of the tablet on the compliance package.
  • An illustrative example of a “compliance package” is the well-known birth control “dial pack” package, in which there are twenty-eight tablets in a blister package that are in a circular configuration (not shown). To consume the tablet, the patient pushes on the transparent plastic material and the tablet pierces a foil backing. After the tablet is dispensed from the dial package, a record is left on the dial pack package, i.e. a pressed plastic housing and pierced foil backing.
  • Compliant packaging may also include a compliant package having a plurality of different tablets corresponding to one or more prescriptions from one or more medical doctors.
  • the compliant package is consumed at a predetermined interval consistent with the prescription.
  • Some compliant packaging solutions may record that each of the tablets is consumed.
  • One of the illustrative patient medication systems described herein satisfies the requirements for a compliance package because an action is required by the patient or caregiver that requires identifying the appropriate dosage period, e.g. morning, and selecting the appropriate pouch or pouches.
  • the patient or caregiver records the consumption of the medication by removing the packet containing the appropriate medication from the container and consuming the medication. Since the packet is imprinted with a dosage time period and date for consumption, a patient or caregiver can tell at a glance whether the medication for the current date and dosage period has already been consumed or whether it remains to be taken.
  • Each pouch may be separably coupled with at least one other pouch so as to form a connected strip of pouches as illustrated in FIG. 4 .
  • the pouches in the strip may be torn or separated from the strip by tearing along the designated tear line.
  • the pouches may already be separated, thus requiring the caretaker or patient to simply pick out a particular pouch without having to separate or tear the pouches.
  • Any type of pouch material may be used for embodiments disclosed herein.
  • the pouch material may be plastic or other suitable material for holding a plurality of medications within the pouch.
  • the separable sealed pouches may be grouped into collections of seven pouches (for a child-resistant container holding medications for seven-days), twenty-eight pouches, thirty pouches or any other such combination.
  • a plurality of sealed pouches that are grouped is also referred to as a “strip,” and the terms “strip” and “group of pouches” is used interchangeably in this patent.
  • a typical strip includes seven pouches, twenty-eight pouches, or thirty pouches.
  • a reminder strip consists of seven pouches, followed by an empty pouch with printing on the pouches to remind the patient and/or caregiver to re-order, and two remaining pouches.
  • pouches there are twenty-eight pouches followed by an empty pouch with printing on the pouch to remind the patient and/or caregiver to re-order and two remaining pouches. It is to be understood that pouches may be grouped into strips of any particular number of pouches depending on the prescription order.
  • an illustrative strip 71 that includes a sealed center cut pouch 72 that is a pouch.
  • the illustrative pouch 72 is adjacent to pouches 74 and pouches 76 .
  • the illustrative pouch 72 comprises a sealed top end 78 , a sealed bottom end 80 , and two sides, in which at least one side is also sealed, e.g. side seal 82 , and the other side is folded over.
  • Each illustrative pouch includes different tablets corresponding to different medications, vitamins or other such medicinal or nutritional preparation for oral use.
  • the illustrative pouch is joined to an adjacent pouch by a plurality of tearable ribbons 84 a - 84 d adjacent to the first side cut 85 a adjacent the top end 78 .
  • a similar grouping of tearable ribbons is also adjacent to the second side cut 85 b adjacent to the top end.
  • Each sealed pouch comprises side cuts 85 a and 85 b on each side of the top end 78 and side cuts 85 c and 85 d on each side of bottom end 80 .
  • the illustrative embodiment shows a pouch with at least three perforations between each side cut and the center cut.
  • the first ribbon 84 a is disposed between the first side cut 85 a and the first perforation 86 a .
  • the second ribbon 84 b and third ribbon 84 c are each disposed between perforations 86 a , 86 b and perforations 86 b , 86 c , respectively.
  • the fourth ribbon 84 d is disposed between the third perforation 86 c and the center cut 87 a .
  • a similar configuration of perforations and ribbons surround the center cut 87 b that is adjacent to the bottom end 80 .
  • the ribbons have a width corresponding to the width of the u-shaped well.
  • the resulting pouches can be opened on either side and the center cut prevents tearing the existing pouches or the adjacent pouches.
  • the pouch described minimizes the number of tearable ribbons, thereby minimizing the likelihood of tearing the existing pouch or the adjacent pouches. Additionally, having the tearable ribbons at the edges of the pouches also minimizes the likelihood of tearing into the existing or adjacent pouches.
  • the resulting pouch will vary depending on the type of material being used, the thickness or weight of the material, the seal, the length of the cuts, the number of cuts, the length of the perforations, number of perforations, the width of the tearable ribbons, and the frequency of tearable ribbons.
  • FIG. 4B there is shown the illustrative sealed center cut pouches 72 described above with three perforations and four tearable ribbons on each side of the center cut.
  • FIG. 4C there is shown an illustrative sealed center cut pouch 88 with four perforations on each side of the center cut.
  • FIG. 4D depicts another illustrative sealed center cut pouch 89 with five perforations on each side of the center cut.
  • each pouch comprises a plurality of different tablets.
  • the separable sealed pouches have been grouped into a collection of fourteen pouches 90 that correspond to a seven day supply of medications.
  • a plurality of sealed pouches that is grouped is also referred to as a “strip,” and the terms “strip,” “group of pouches,” and “strip of pouches” is used herein interchangeably.
  • FIG. 5B there is shown an exploded view of the illustrative front side of one of the sealed center cut pouches 92 that contain prescription medication that is included in the strip of pouches 90 .
  • the exploded view shows that a variety of data fields are printed on the front of each pouch.
  • the data fields provide information corresponding to each tablet within the pouches.
  • the data fields include: the name of the patient 94 a , the date the tablets should be consumed 94 b , the time of day the tablets should be taken 94 c , the name of the prescribed medication 94 d , the name of the corresponding generic 94 e , the dosage 94 f , and the prescription number 94 g .
  • FIG. 5C there is shown an exploded view of the illustrative back side of the pouch 92 in FIG. 5B .
  • the data fields include: the name of patient 96 a , a bar code 96 b , the address of the facility that filled the pouch with tablets 96 c and the telephone number 96 d for additional information.
  • the illustrative bar code associates the tablets in the foldable box with a particular patient.
  • FIG. 6 illustrates a strip of pouches for the dual dispensing of prescription tablets and non-prescription tablets.
  • Header 802 does not contain any tablets. Instead, illustrative information is provided.
  • Pouch 804 represents a pouch containing tablets associated with one or more prescriptions associated with an illustrative individual regimen.
  • Pouch 806 represents a pouch containing non-prescription tablets associated with an illustrative individual regimen.
  • FIGS. 7A-7D there is shown a portion of the layout of a strip of sealed medicament cups that are associated with an illustrative individual regimen and which can also be packaged within the child-resistant container 10 .
  • FIGS. 7A-7D show the same strip portion in a variety of configurations.
  • FIG. 10B shows illustrative labeling including the name of the patient, the date the tablets should be consumed, the time of day the tablets should be taken, the name of the prescribed medication, the name of the corresponding generic, the dosage and the prescription number. Additionally, an expiration date may be included that identifies the medications that should not be taken after the expiration date.
  • the illustrative strip of medicament cups may then be folded to fit within child-resistant container 10 . Alternatively, the medicament cups may be separated into individual medicament cups, and the medicament cups may be arranged within the child-resistant container 10 .
  • the size and shape of the child-resistant container 10 may be selected based on the size, shape, and number of medicament cups to fit within the child-resistant container 10 .
  • FIGS. 12A-D portions of strips of pouches are shown to represent illustrative configurations of filled packets and associated headers.
  • FIGS. 12A and 12B the two packets that are to be consumed at the same time are located under a header that indicates the correct date and time period for administration.
  • FIG. 12C shows an illustrative reverse side of a “headerless” embodiment.
  • FIG. 12D shows the reverse side of an illustrative header where the header is the same size as the packets that hold medicaments and nutraceuticals.
  • Illustrative text that may appear on the reverse side of the illustrative embodiments of FIGS. 12A and 12B as well as 12 D is also included in FIG. 12D .
  • FIGS. 12A-12D The illustrative seven-day strips of FIGS. 12A-12D are placed in an illustrative seven-day container or in an illustrative 30-day container before being delivered to the patient.
  • Illustrative seven-day containers are presented in at least FIGS. 14-16 .
  • An illustrative 30-day container is presented in at least FIG. 17 .
  • embodiments are not limited to containing seven-day or 30-day strip.
  • the child-resistant container 10 may contain any arbitrary number of pouches based on the prescription assigned to the patient.
  • FIGS. 13A-13G illustrate an alternative label for the child-resistant container 10 .
  • the figures present the label 192 by presenting exploded view of various sections of the label 192 .
  • the label 192 may be affixed separately to the child-resistant container 10 or the label may be printed directly on a print area of the child-resistant container, or any combination thereof.
  • the label may also be affixed or printed on a box containing one or more child-resistant containers.
  • the illustrative label 192 comprises a plurality of printed text that may include: the patient's name 240 , the interval during which the medications are taken 252 , e.g. morning, a picture of the patient 242 , patient number 244 , order number 246 , a list of precautions 248 , a listing of the medications 250 , a prescription number 254 , quantity of tablets per prescription 256 , quantity of refills 258 , length of prescription 260 , the prescribing physician 262 , the manufacturer of the tablets 264 and the lot number 266 corresponding to each tablet. Additionally, a picture 268 of each tablet is provided and the dosage concentration 270 is provided for each medication. Information about the associated generic drug 272 is also provided. Furthermore, an expiration date may also be provided for each tablet or for each prescription. Further still, manufacturer information, corresponding “expiration dates,” personal contact information, physician contact information, insurance information, and other such information associated with the tablets in each container.
  • Each child-resistant container may include a plurality of daily indicators corresponding to a seven-day period that are disposed on the child-resistant container.
  • the daily indicators provide a means for recording that the medications in the pouches have been taken.
  • the label of the child-resistant container may include an indicator area where a user can mark with a pen or pencil when a pouches has been taken.
  • the indicator area can consist of a plurality of shapes, the days of the week, a numbered list, etc.
  • Each of the daily indicators is configured to indicate that the medications in the pouches have been taken, thereby providing a means for compliance packaging.
  • the sealed pouches associated with strips 302 , 304 , 306 and 308 include sealed pouches with a plurality of different tablets that correspond to different medications and/or vitamins.
  • the different medications are associated with at least one prescription and each tablet includes an appropriate dosage consistent with the prescription.
  • Each of the sealed pouches is labeled to show the medications or nutraceuticals in the pouches and labeled with a particular dosage period that includes at least one daily interval for consuming the medications in the pouches.
  • the child-resistant containers include a label on the top of the child-resistant cap and on the body of the container indicating that the contents of the containers are to be taken during the morning dosage time.
  • Each of the child-resistant containers includes the pouches to be taken on week 1, week 2, week 3, and week 4.
  • These child-resistant containers may then be packaged within a secondary container 340 , such as illustrated in FIG. 17 .
  • the secondary container 340 may be an assembled box made of cardboard material, even though an alternative material may also be suitable.
  • the secondary container 340 includes a lid 342 that may be rotatable about a back fold line.
  • the illustrative lid 342 includes a plurality of side flaps.
  • FIG. 17 illustrates a secondary container 340 for holding a plurality of different child-resistant containers corresponding to different dosage periods.
  • the secondary container 340 includes a divider creating four cells for receiving each of the child-resistant containers 330 , 332 , 334 , and 336 .
  • the secondary container 340 may be used to store any particular combination of child-resistant containers.
  • the size of the secondary container 340 and the size of the child-resistant containers may be adjusted to fit more or less of the child-resistant containers within the secondary container 340 .
  • the secondary container 340 may be sealed with a label that affixes the lid 342 to the body of the secondary container 340 .
  • the label may be label 20 , label 192 , or some other alternative label.
  • the label may include the patient's name and a general description that there are multiple prescription pouches 338 in the various child-resistant containers of secondary container 340 .
  • the label may also include additional information such as the dosing interval or dosing period, the prescribing physician, one or more bar codes, a patient serial number or additional information about the different medications, such as the type of prescriptions within the box 340 , the pharmacy that filled the prescription or any other such information.
  • the label is simply broken by the patient or caregiver and access is provided to the regimen in the child-resistant containers within the secondary container 340 .
  • a medication summary sheet 344 may also be included or housed by the secondary container 340 .
  • the medication summary sheet 344 provides detailed information about the tablets in each pouches.
  • the medication summary sheet 344 may include warnings, precautions, side effects, dosage, administration, clinical pharmacology, and pictures corresponding to each medication.
  • the medication summary sheet may include summaries of the various medications being taken and summaries of the side effects.
  • the medication summary sheet provides the patient with a detailed summary of the medications being taken.
  • the medication summary sheet 344 may also include the name of the patient, a bar code or other such identification means that ensures that the correct medication summary sheet 344 is associated with the corresponding prescription.
  • the method 1800 is initiated at block 1802 where a child-resistant container associated with the appropriate time interval or dosage period is selected. As described above, the illustrative dosage periods are morning, lunch, dinner and bedtime.
  • the patient or caretaker then proceeds to block 1804 where the patient opens the secondary container and selects the appropriate child-resistant container at block 1806 .
  • the child-resistant container is opened.
  • the appropriate multiple prescription pouches is selected at block 1810 and the patient may take or consume the tablets in the multiple prescription pouches.
  • the patient or caregiver then records that the pouches has been removed by marking on the appropriate marking area on the child-resistant container (if the child-resistant container includes a marking area). This recording step completes the compliance packaging process. Alternatively, the patient may take the tablets at block 1814 after marking on the appropriate marking area.
  • the patient or caregiver determines whether to place a new order.
  • the decision may be triggered by an empty pouches marked “Reorder,” as shown in FIG. 12D , which reminds the user that a new order or refill order should be placed or the decision may be triggered by the patient or caregiver taking their own initiative.
  • the order is then placed at block 1818 , where an illustrative refill order is placed.
  • the child-resistant container is closed and returned to the secondary container that is also closed.
  • the method then proceeds to decision diamond 1820 where the patient waits for the next time interval or dosage period. When the next dosage period arrives, the method returns to block 1802 and the entire cycle is repeated.
  • Compliant packaging may also include a compliant package having a plurality of different tablets corresponding to one or more prescriptions from one or more medical doctors.
  • the compliant package contents are consumed at a predetermined interval consistent with the prescription.
  • Some compliant packaging solutions may not record that each of the tablets is consumed. For example, an illustrative 30-day foldable box configured to receive the plurality of pouches is presented herein.
  • FIG. 18B there is shown an illustrative flowchart for using the patient medication management system described above.
  • the method 1830 is initiated at block 1832 where a secondary container associated with one of the illustrative weeks, such as week 1, is selected.
  • the patient then proceeds to block 1834 where the patient opens the secondary container.
  • the method then proceeds to selects the appropriate child-resistant container associated with the appropriate time interval or dosage period at block 1836 .
  • the illustrative dosage periods are morning, lunch, dinner and bedtime.
  • the child-resistant container is opened.
  • the appropriate multiple prescription pouches is selected at block 1840 and the patient may take or consume the tablets in the multiple prescription pouches.
  • the patient or caregiver then records that the pouches has been removed by marking on the appropriate marking area of the child-resistant container (if the child-resistant container includes such marking area). This recording step completes the compliance packaging process. Alternatively, the patient may take the tablets at block 1844 after marking the child-resistant container.
  • the patient or caregiver determines whether to place a new order.
  • the decision may be triggered by the empty pouches marked “Reorder,” as shown in FIG. 12D , which reminds the user that a new order or refill order should be placed or the decision may be triggered by the patient or caregiver taking their own initiative.
  • the order is then placed at block 1848 , where an illustrative refill order is placed.
  • the child-resistant container is closed and returned to the secondary container that is also closed.
  • the method then proceeds to decision diamond 1850 where the patient waits for the next time interval or dosage period. When the next dosage period arrives, the method returns to block 1832 and the entire cycle is repeated.
  • Compliant packaging may also include a compliant package having a plurality of different tablets corresponding to one or more prescriptions from one or more medical doctors.
  • the compliant package contents are consumed at a predetermined interval consistent with the prescription.
  • Some compliant packaging solutions may not record that each of the tablets is consumed.
  • FIGS. 19A-19E illustrate yet another embodiment of a label 500 that may be affixed to the child-resistant container 10 or to a secondary container storing child-resistant container 10 .
  • the label 500 may include, for example, patient and medication data such as patient name and number, names of prescribing physicians, medicine(s), dosage strength(s), medicine quantity(s), color images of the medicine(s), prescription number(s), NDA number(s), warning(s), dosage period(s), administration schedule(s), and the like.
  • the illustrative label strip is configured such that all information necessary for drug identification and administration is affixed to the child-resistant container 10 or to secondary container 340 .
  • the illustrative bar code 506 provides a means for associating the labels and pouches with a particular patient.
  • the means for associating the pouches may also include a radio-frequency identification (RFID) component, writing, or other such associative element capable of associating the labels, pouches, and particular package with a particular patient
  • RFID radio-frequency identification
  • the label 500 includes patient and dosage period information including time period 502 , patient name 504 , barcode 506 , patient number 508 , and order number 510 .
  • Some embodiments, particularly those embodiments suitable for use in a long-term care facility, may also include a photograph (not shown) of the patient in this portion of the label with other identifying information.
  • the label may include information about a variety of different prescriptions and medications associated with each of these different prescriptions.
  • the primary label may include an expiration date for each prescription.
  • the time period 502 refers to the particular time of day that the patient must take the tablets within the container. In this illustrative label, the time period is “Morning.” The numeral “1” next to the word “Morning” is another reference to the time period. In this case “Morning” is the first time period during which the illustrative patient must take medications.
  • a barcode 506 is printed on the illustrative label 500 .
  • a barcode may appear on each pouches, on each child-resistant container, or on the secondary container.
  • the barcodes for the pouches, the child-resistant container, and the secondary container may encode important information such as time period 502 , patient name 504 , patient number 508 and/or order number 510 .
  • the barcodes are associated with one another during container assembly and filling, improving order verification by ensuring that the appropriate pouches, having been filled with medicaments associated with a particular patient 504 and time period 502 , are placed in the appropriate container that is associated with the particular patient 504 and time period 502 .
  • Barcodes are also used to ensure that the appropriate label 500 is affixed to the appropriate container associated with a particular patient 504 and time period 502 .
  • the barcode may also be associated with a variety of different prescriptions and the corresponding expiration date for each prescription.
  • each drug precaution for each drug found within the container is present in the precautions section.
  • the precautions section may also include information on synergistic, agonist or antagonist effects that may occur among one or more medications in the order.
  • Each precaution 514 is associated with a numeral 512 A, or with another easy-to-interpret symbol. Each precaution applies to at least one drug in the order, but may apply to more than one drug.
  • the next column of label 500 contains another set of numerals 512 B that map to the numerals 512 A and thus to drug precautions 514 .
  • one of the drug precautions 514 instructs patients to refer to the Patient Info Booklet for additional cautions.
  • the 512 A number “6” is associated with the Patient Info Booklet precaution.
  • the 512 B number “6” is associated with several of the prescription tablets 518 (shown on FIG. 19D ). Other easily interpreted symbols could be used in place of numbers, but it is essential that the first set 512 A maps exactly to the second set 512 B.
  • the next part of the label 500 shows drug information, including color images 516 of each drug in the order and the name 518 of each drug in the order.
  • the numbers 512 B are grouped such that each ‘cell’ containing a group of numbers 512 B is associated with exactly one drug 518 .
  • the numbers 512 B show which listed precautions are associated with each prescription in the order.
  • each precaution 514 maps to exactly one number 512 A, but each precaution 514 and its corresponding number 512 B may apply to more than one drug in an order. That is, each number found in the set of numbers 512 A may appear associated with any or all drugs 518 in the order, depending on which group of numbers 512 B appears next to the drug image 516 and name 518 .
  • the first drug 518 listed on the label is “ARICEPT.” To the left of the word “ARICEPT” is shown the color image of the drug 516 . To the left of the color image of the drug 516 , the 512 B numbers “1, 2, 3, & 4” are listed. (See FIG.
  • the “Medication/Rx#” section of FIG. 19D includes the drug images 516 and the drug name 518 mentioned above, in addition to the unit dosage 520 , the drug format 521 and the prescription number 528 .
  • the prescriptions may also include different refill dates as indicated by the dates in column 522 , shown in FIG. 19E .
  • the color images 516 show both the front and the back of each tablet. The color images allow the patient or a caregiver to identify individual medications within each pouches by using the label 500 as a key.
  • the next column of text displays refill information 522 including the number of refills left on the prescription for that drug, the quantity of tablets that is supplied each time the prescription is filled and the date that the prescription expired.
  • the next column of text includes the prescribing practitioner's name 524 for each drug 518 and the last column includes manufacturer information 526 including the name of the manufacturer or other manufacturer data.
  • an illustrative flowchart 2000 describing the overall method for packaging pharmaceutical and non-pharmaceutical tablets.
  • the enrollment form is received from the new patient.
  • a prescription order is received at a server.
  • the order may, for example, be entered into the server by a patient or physician via an interface with the server.
  • the user interface can provide the patient or physician with a selection of package types, including child-resistant packages, and enable the patient and physician to specify whether a child-resistant package is desired.
  • an order for non-prescription tablets is received at the server.
  • the server may be associated with a front-end system such as PharmaServe.
  • the method then proceeds to block 2008 , where the prescription order is verified.
  • each order is now associated with a particular patient's individual regimen.
  • the prescription and non-prescription orders are grouped and treated as one order within the system. Any additional prescriptions that the patient may require in the future may be added to the patient's order when prescriptions are next filled.
  • the verified prescription order that is associated with a particular patient and corresponds to specific times for administration is forwarded to production and filled.
  • the user interface communicates with the back-end (filling) system, allowing the prescriptions to be grouped as an order during filling.
  • the filling process uses automated techniques. During the filling process, the tablets that are associated with the prescription order may be loaded into compliance containers that are configured for use with the system and methods described herein.
  • the method proceeds to printing of the header label.
  • the filled order is inspected.
  • the inspection process includes verifying that the tablets to be dispensed are properly associated with the particular patient and prescription order.
  • the inspection process also includes inspection of the filled packages to ensure that the distribution of the tablets within the containers is consistent with the patient's dosage regimen.
  • the labeling corresponding to a particular time period and specific dates for administration is associated with the pouches or cups that contain the associated tablets.
  • the header labeling associated with the order is also inspected and verified to be of legible print quality. Inspected strips are matched with the appropriate secondary container and the corresponding integrated labeling.
  • the strips are sealed within the appropriate child-resistant containers and all secondary containers corresponding to a complete order are placed into a shipping container.
  • a multiple inspection method that inspects packages filled with at least two different medications that are to be consumed by a particular patient.
  • the illustrative method is initiated at block 2102 when an order for multiple medications is received by the filling system.
  • a verified prescription order is received.
  • the verified prescription order is an order that has been verified according to local jurisdictional requirements, insurance requirements, co-pay requirements, transactional requirements, or a combination thereof. For example, in certain jurisdictions a verified prescription order may require a medical doctor's signature, and may have to be processed by a pharmacist. Additionally, a verified order may require approval from an insurance company, Medicare, or any such entity.
  • the only form of verification may include confirming that funds are available from the particular individual or organization charged, which satisfies transactional requirements.
  • verification of the availability of funds may include simply receiving authorization to charge a credit card and confirming that the credit card is a valid card.
  • an order may be received for supplements as described in patent application Ser. No. 12/945,709 entitled SYSTEM AND METHOD FOR ONLINE INTEGRATED MULTIPLE TABLET ORDERING.
  • the filling system starts to fill the multiple medication order.
  • Each package is filled with at least two different medications by the filling station.
  • the filling system is configured to associate at least one package with the patient.
  • the filling process includes placing the medications in a blister package that is unsealed or placing the medications in a pouches that is sealed. Additionally, the blister package may also be sealed in the filling machine.
  • the method then proceeds to select each package that is to be inspected.
  • the process control selects the package and the inspection process.
  • the process control module is communicatively coupled to the filling station.
  • the first inspection is initiated.
  • the first inspection may be qualitative or quantitative.
  • the illustrative first inspection step is a precision weighing process as shown in block 2108 .
  • the first automated inspection is initiated by examining the different medications with a first measurement device that is associated with a first inspection property. Subsequently, a comparison of a first expected inspection value with the first measurement result generates the first inspection result state.
  • the first inspection analysis is performed by an inspection control process at block 2110 .
  • the inspection control process module receives the measured medication value from the first inspection station. Additionally, the expected medication value is received by the inspection control process module. The inspection result state is then selected by the inspection control process module. The inspection control module compares the expected medication value to the measured medication value to generate the inspection result state, which includes a positive inspection result state, a negative inspection result state, and an inconclusive inspection result state.
  • the positive inspection result state corresponds to the measured medication value being within a range approximating the expected medication value.
  • the negative inspection result state corresponds to the measured medication value being outside a range approximating the expected medication value by a defined amount.
  • the inconclusive inspection result state corresponds to comparison between the measured medication value and the expected medication value being inconclusive and is outside the range approximating the expected medical value, but not so much that it can be determined to be a negative inspection result.
  • the second automated inspection is initiated by examining the different medications with a second measurement device that is associated with a second inspection property.
  • a second measurement result is generated.
  • the second inspection process is a visual inspection process.
  • the illustrative method then proceeds to block 2114 where the correct number of tablets is determined.
  • the correct number of tablets is a quantitative measurement result.
  • the illustrative method determines the color and shape of the tablets. The determination of color and shape is a qualitative measurement result.
  • a second inspection analysis is initiated at block 2118 .
  • the second inspection analysis generates a second automated inspection result by comparing a second expected inspection value with the second measurement result as described above.
  • a second measurement result is then generated.
  • the method then proceeds to determine a second automated inspection result state by comparing a second expected inspection value with the second measurement result.
  • the second inspection result state includes a positive inspection result state, a negative inspection result state, and an inconclusive inspection result state as described above.
  • Additional inspection steps may follow the second inspection as described herein.
  • a third inspection at a third inspection station may follow.
  • a fourth inspection at a final inspection station may also be performed.
  • the final inspection station may perform the scanning or identification of the bar codes for each preliminary package that is associated with the various labels and secondary container housing the preliminary packages.
  • a multi-inspection analysis is performed by an analytical module.
  • the analytical module compares and then analyzes the first automated inspection result and the second automated inspection result for at least one package. Based on this analysis, the analytical module selects one of a plurality of post-inspection states that are then communicated to the process control module.
  • the selected post-inspection state is communicated to the process control module that is communicatively coupled to the movement control module that controls the conveyance of the preliminary package to the appropriate post-inspection station.
  • the process control module may receive an instruction that a particular preliminary package was improperly filled and that the preliminary package is to be transferred to the manual inspection station, then correction station and finally to the assembly station.
  • the process control module receives an instruction that the package was filled improperly and the package is transferred to the correction station and then the assembly station. In yet another example, the process control module receives an instruction that the preliminary package was properly filled and the package is conveyed to the assembly station.
  • the assembly station begins the process of placing the preliminary packages in the illustrative box container.
  • the illustrative box container is configured to accommodate a 30-day supply of medication.
  • the box container is also configured to receive a label that indicates the time of day or interval during which the medications within the pouches are to be consumed, e.g. morning, noon, evening, or bedtime.
  • the illustrative box container is then glued or sealed.
  • the preliminary packages may be placed in a child-resistant container.
  • the final package is then assembled at block 2124 .
  • the final package includes three boxes, in which each box is associated with a particular time of day.
  • the illustrative time of day include morning, noon and evening.
  • the final package may include package inserts or a patient information sheet (PIS) and a detailed label that describes each of the medications.
  • PIS patient information sheet
  • the final package assembly may be performed by an automated means that reviews the prescription and labels, confirms that the appropriate inspections were performed for each preliminary package, confirms that the appropriate level of review by a pharmacist or technician has been performed, confirms that each container was sealed, and checks to see that the proper package insert was generated.
  • the package inserts have detailed information about indications, warnings, precautions, side effects, dosage, administration, and clinical pharmacology.
  • the package inserts may also include summaries of the various medications being taken, and summaries of the side effects, and the associated administration.
  • the package inserts are written primarily for a physician and pharmacist, the package inserts may be simplified so that they are easier for patients and caregivers to understand.
  • the final package may also include the PRN medications.
  • PRN medications are consumed on an as-needed basis. Most often PRN medications are analgesics such as Tylenol®, laxatives, sleeping aids, and similar medications.
  • the pouches further enable the reuse of rejected pouches in the process of FIG. 21 or medications unused by patients. That is, the distribution of medications in pouches enables tablets within unused pouches to be added back into a pharmacy's inventory to be redistributed.
  • An inspection station as described in patent application Ser. No. 13/473,304, entitled MULTIPLE INSPECTION SYSTEM AND METHOD THAT INSPECTS DIFFERENT MEDICATIONS that is hereby incorporated by reference, and associated with the inspection process of FIG. 21 , may be used for the processing of rejected medications.
  • pouches may be rejected during the various inspection processes performed during the automated filling of a multiple prescription order.
  • the inspection processes may be a manual process, where a pharmacist or other suitable personnel visually inspects the contents of pouches to verify that the pouches include the right medications, and that the medications are correctly associated with a particular patient.
  • a pouches may be rejected because it does not have the right medications or because it does not have the right dosage for the medications.
  • the illustrative inspection systems and methods described in copending patent application Ser. No. 13/473,304 include multiple inspection stations, in which each inspection station generates an inspection result state that is analyzed by a multi-inspection analytical module.
  • the multi-inspection analytical module is associated with an inspection control process module.
  • the inspection station compares the expected medication value to the measured medication value to generate an inspection result state.
  • the inspection result state includes a positive inspection result state, a negative inspection result state, and an inconclusive inspection result state.
  • the inspection result state may be associated with identifying that a tablet or medication is broken, compromised, or there are too many tablets being dispensed at one particular time in a particular package.
  • At least two inspection result states are then analyzed by the multi-inspection analytical module.
  • the multi-inspection analytical module then proceeds to select one of a plurality of post-inspection states that convey the package to one of a manual inspection station, a correction station, or an assembly station.
  • the systems and methods described herein reduce the uncertainty about the correctness of the container filling and improve accuracy.
  • the two or more inspection processes may be physically combined in the same housing or may operate as separate physical inspection stations.
  • the multiple inspection analysis operates by using a decision table to determine the post-inspection state.
  • the inspection may be conducted by measuring the physical characteristics of tablets using analytical methods, including but not limited to, 2D visual light sensor (camera or video), 3D visual light sensor, precision weighing, X-ray, near infrared, magnetic resonance imaging, ultrasound, laser excitation, raman spectroscopy, fluorescence spectroscopy, and other such analytical chemical methods. Additionally, precision counting systems that employ a sensor with a photo resistor to detect a light beam broken by a tablet may also be used as an inspection process. Furthermore, an inspection station may be dedicated to identifying RFID codes or other such machine readable representation of data associated with one or more medications or tablets.
  • analytical methods including but not limited to, 2D visual light sensor (camera or video), 3D visual light sensor, precision weighing, X-ray, near infrared, magnetic resonance imaging, ultrasound, laser excitation, raman spectroscopy, fluorescence spectroscopy, and other such analytical chemical methods. Additionally, precision counting systems that employ a sensor with a photo resistor to detect a light beam broken by
  • the illustrative inspection properties provide quantitative results or qualitative results.
  • Qualitative inspection properties ask the basic question of “what” is present.
  • Quantitative inspection properties ask the basic question of “how much” of each.
  • Qualitative analysis gives an indication of the identity of the chemical species in a sample.
  • Quantitative analysis determines the amount of each compound.
  • algorithmic processes can be applied to qualitative measurements that result in a quantitative value. For example, an optical system relying on visible light performs a quantitative analysis of tablet size, shape and color. An algorithm may then be applied that would count the number of tablets, thereby providing a quantitative measurement.
  • Pouches which fail to pass the various inspection processes may be directed to a correction station.
  • the rejected pouches may be corrected manually by a technician who may manually retrieve the correct medications and manually create a pouches with the correct medications.
  • the technician may also instruct the filling system to generate one or more additional pouches with the correct medications.
  • the pouches may be directed to a recycle station.
  • the recycle station may use automated means to open the rejected pouches, to pour the contents of the rejected packages into a sorting bin or chute, and to sort the contents of the sorting bin.
  • the sorting results in the medications being added to the pharmacy's inventory.
  • the sorting bin may use automated means to determine that the sorting bin includes medications A and B, and subsequently direct medications A and B to the pharmacy's stock of medications A and B so that these medications may be used for other prescriptions.
  • medications which were not consumed by a patient may be returned to the pharmacy. Since the medications are stored within individual sealed pouches or sealed cups, it serves as proof that the returned medications were not tampered with or came in contact with the patient. These pouches may then be directed to the recycle station to enable the medications to be reused for other prescriptions.

Abstract

A child-resistant container for dispensing pharmaceutical and non-pharmaceutical tablets is described. The child-resistant container includes a receptacle defining an opening, a neck that includes an outer surface and at least one thread formed on the outer surface of the neck. The child-resistant container further includes a rim adjacent to the neck having a push-tab locking device. The receptacle is configured to receive a plurality of pouches, wherein each pouch includes a plurality of tablets associated with a multiple prescription order that indicates when the tablets are to be consumed, and a label disposed on the receptacle and associated with the multiple prescription order. The child-resistant container is configured to hold a plurality of pouches, where each pouches contains at least one type of tablet. The child-resistant container includes a label with information about the contents of the pouches, patient information, and a bar code associating the medications with the patient.

Description

    CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
  • The present patent application is a continuation-in-part of design patent application No. 29/396,215, filed Oct. 25, 2011
  • this patent application is a continuation-in-part of patent application Ser. No. 13/566,052 filed on Aug. 3, 2012, and
  • this patent application is a continuation-in-part of patent application Ser. No. 13/473,267 filed on May 16, 2012, which claims the benefit of provisional patent application 61/486,427 filed on May 16, 2011, and
  • this patent application is a continuation-in-part of patent application Ser. No. 13/473,304 filed on May 16, 2012, which claims the benefit 61/420,436 filed on May 16, 2011, and
  • this patent application is a continuation-in-part of patent application Ser. No. 13/526,412 filed on Jun. 18, 2012, which claims the benefit of 61/498,489 and 61/420,436 both filed on Jun. 17, 2011, and
  • this patent application is a continuation-in-part of patent application Ser. No. 13/312,907 filed Dec. 6, 2011, which claims the benefit of provisional patent application 61/420,140 filed on Dec. 6, 2010, and
  • this patent application is a continuation-in-part of patent application Ser. No. 13/312,888 filed Dec. 6, 2011, which claims the benefit of provisional patent application 61/420,151 filed on Dec. 6, 2010, and
  • is a continuation-in-part of patent application Ser. No. 12/945,709 filed on Nov. 12, 2010 entitled SYSTEM AND METHOD FOR ONLINE INTEGRATED MULTIPLE TABLET ORDERING, and
  • is a continuation-in-part of patent application Ser. No. 12/896,284 filed on Oct. 1, 2010 entitled SYSTEM AND METHOD FOR GENERATING AN INTEGRATED LABEL FOR CONTAINER HOUSING MULTI-SCRIPT POUCHES that claims the benefit of provisional patent application 61/248,471 filed on Oct. 4, 2009, and
  • is a continuation-in-part of patent application Ser. No. 12/896,275 filed on Oct. 1, 2010 entitled SYSTEM AND METHOD FOR INTEGRATED VERIFICATION AND ASSEMBLY OF MULTI-SCRIPT POUCHES INTO A HOUSING CONTAINER that claims the benefit of provisional patent application 61/248,471 filed on Oct. 4, 2009, and
  • is a continuation-in-part of patent application Ser. No. 12/896,134 filed on Oct. 1, 2010 entitled SYSTEM AND METHOD FOR COMBING DIFFERENT TABLETS INTO A POUCH that claims the benefit of provisional patent application 61/248,471 filed on Oct. 4, 2009, and
  • is a continuation-in-part of patent application Ser. No. 12/891,042 filed on Sep. 27, 2010 entitled LOW VISION PATIENT COMPLIANT MEDICATION MANAGEMENT SYSTEM AND METHOD that claims the benefit of provisional patent application 61/245,912 filed on Sep. 25, 2009, and
  • is a continuation-in-part of patent application Ser. No. 12/891,029 filed on Sep. 27, 2010 entitled DUAL DISPENSING TABLET CONTAINER that claims the benefit of provisional patent application 61/245,899 filed on Sep. 25, 2009, and
  • is a continuation-in-part of patent application Ser. No. 12/696,884 filed on Jan. 29, 2010 entitled SYSTEM AND METHOD FOR VERIFYING AND ASSEMBLING A MULTIPLE PRESCRIPTION PACKAGE, and
  • is a continuation-in-part of patent application Ser. No. 12/684,640 filed on Jan. 8, 2010 entitled USER SELECTABLE MULTIPLE TABLET PACKAGE, and
  • is a continuation-in-part of patent application Ser. No. 12/684,664 filed on Jan. 8, 2010 entitled SYSTEM AND METHOD FOR PLACING A MULTIPLE TABLET ORDER, and
  • is a continuation-in-part of patent application Ser. No. 12/684,060 filed on Jan. 7, 2010 entitled SYSTEM AND METHOD FOR AUTOMATICALLY MANAGING INVENTORY IN A MULTIPLE TABLE PACKAGE which is a continuation-in-part of patent application Ser. No. 11/796,123 now U.S. Pat. No. 7,690,173, filed on Apr. 25, 2007 entitled MULTIPLE PRESCRIPTION PRODUCTION FACILITY, and
  • is a continuation-in-part of patent application Ser. No. 12/631,586 filed on Dec. 4, 2009 entitled MULTIPLE PRESCRIPTION PRODUCTION FACILITY, and
  • is a continuation-in-part of patent application Ser. No. 12/424,483 filed on Apr. 15, 2009 entitled MANUFACTURING SEPARABLE POUCHES WITH A CENTER CUT BLADE, and
  • is a continuation-in-part of patent application Ser. No. 12/424,475, now U.S. Pat. No. 8,146,747, filed on Apr. 15, 2009 entitled TABLET DISPENSING CONTAINER that claims the benefit of provisional patent applications 61/045,160 filed Apr. 15, 2008, provisional patent application 61/045,166 filed Apr. 15, 2008, provisional patent application 61/045,171 filed Apr. 15, 2008, and
  • is a continuation-in-part of patent application Ser. No. 12/418,436 filed on Apr. 3, 2009 entitled CHILD PROOF MEDICATION PACKAGING SYSTEM AND METHOD, and
  • is a continuation-in-part of patent application Ser. No. 12/418,418 filed on Apr. 3, 2009 entitled SPIRAL MEDICATION PACKAGING SYSTEM AND METHOD, and
  • is a continuation-in-part of patent application Ser. No. 11/796,125 filed on Apr. 25, 2007 entitled SYSTEM AND METHOD FOR PROCESSING A MULTIPLE PRESCRIPTION ORDER, and
  • is a continuation-in-part of patent application Ser. No. 12/418,422 filed on Apr. 3, 2009 entitled PATIENT COMPLIANT MEDICATION MANAGEMENT SYSTEM AND METHOD that claims the benefit of provisional patent application 61/042,262 filed Apr. 3, 2008 and provisional patent application 61/042,263 filed on Apr. 3, 2008, and
  • is a continuation-in-part of patent application Ser. No. 11/923,321, now U.S. Pat. No. 8,266,878, filed on Oct. 24, 2007 entitled METHOD FOR VERIFYING AND ASSEMBLING A MULTIPLE PRESCRIPTION PACKAGE that claims the benefit of provisional patent application 60/854,341 having a filing date of Oct. 24, 2006, and
  • is a continuation-in-part of patent application Ser. No. 11/796,124 now U.S. Pat. No. 8,074,426, filed Apr. 25, 2007 and entitled MULTIPLE PRESCRIPTION PACKAGE AND METHOD FOR FILING THE PACKAGE that claims the benefit of provisional patent application 60/795,370 filed on Apr. 26, 2006, provisional patent application 60/795,446 having a filing date of Apr. 26, 2006, provisional patent application 60/795,413 having a filing date of Apr. 26, 2006, and
  • is a continuation-in-part of patent application Ser. No. 11/241,783, now U.S. Pat. No. 8,123,036, filed Sep. 30, 2005 entitled PILL ASSEMBLY FOR PILL PACKAGING AND DELIVERY SYSTEMS that claims the benefit of provisional patent application 60/615,267 having a filing date of Oct. 1, 2004, and
  • all applications listed are hereby incorporated by reference.
  • FIELD OF THE INVENTION
  • The invention relates to a child-resistant container for a multi-prescription order. More particularly, the child resistant package is configured to hold a plurality of preliminary packages.
  • BACKGROUND
  • One of the major problems in taking prescribed daily medications comes from patients having to take more than one medication in the form of pills or tablets. A major concern is determining whether all medications are in compliance with the prescribed daily regimen. Many times this concern is compounded by the requirement that portions of the different medications must be taken at different times of the day.
  • One solution to the problem of taking multiple medications is to prepackage the multiple medications so that users can take the prepackaged medications at a predetermined time. Generally, prepackaged medications are targeted to patients that lack mental capacity to take the correct medications at the correct time. Some of the prepackaged medications are placed in a small plastic bag, which may be easily misplaced. Other prepackaged medications are placed in sealed cups that are difficult to open.
  • An added complication of multiple medication regimens is that often a particular patient may be advised to take one or more non-prescription medications, such as nutraceuticals, vitamins and/or other beneficial supplements in addition to his prescription medications. It would be beneficial to include any non-prescription pills to be consumed by that patient in compliance packaging to ensure that the patient is able to easily comply with his entire regimen, prescription and non-prescription alike. Additionally, it is even simpler and easier for the patient if both prescription and non-prescription regimens are integrated into one complete compliance package.
  • Another complication of multiple medication regimens is that many patients may require variable doses of a given medication at different times. For example, many medications require titration when a patient begins taking them. This generally involves the patient taking gradually larger amounts of the drug until the desired dosage amount is reached. Still other regimens require that a given tablet be taken every other day, or that different dosages be taken on alternating days. These schedules make it even more difficult for a patient to comply with the medication regimen that has been prescribed or recommended.
  • Although multiple prescription filling systems are available, e.g. the McKesson PACMED system, these systems have limited capabilities. For example, these filling systems fail to assemble a multiple prescription order that can be easily transported and administered. Additionally, these filling systems fail to effectively organize the multiple prescription medications. Furthermore, the filling systems fail to organize the multiple prescription containers. Further still, the filling systems fail to provide a compliance packaging solution.
  • Yet another complication of multiple medication regimens is that prepackaged medications that are placed in small plastic bags are not child-resistant. Child-resistant packaging is special packaging used to reduce the risk of children ingesting dangerous items, such as prescription drugs. This is often accomplished by the use of a special safety cap. Prepackaged medications in sealed cups also lack child-resistant compliance.
  • It would thus be desirable to have compliance packaging having a label associated with prescription and non-prescription tablets to be taken by a patient at a particular time, the label indicating the time at which the tablets are to be consumed. It would also be desirable to have containers for multiple prescription orders that are packaged in child-resistant packaging.
  • SUMMARY
  • A child-resistant container that includes a receptacle, an open neck, a cap and a label. The open neck projects from the receptacle and defines an opening. The neck includes an outer surface and at least one thread formed on the outer surface of the neck. The thread has a predetermined thickness along its length. The cap is configured to interface with the neck of the receptacle. The cap includes a top surface, a skirt, a second thread, and a sawtooth projection. The skirt is adjacent to the top surface and defines an opening received by the neck of the receptacle. The second thread is on an inner surface of the skirt for complementary engagement with the thread of the neck of the receptacle. The sawtooth projection is on the inner surface of the skirt. The cap is rotatably screwed onto the neck of the receptacle. The receptacle receives preliminary packages, in which the preliminary package includes tablets associated with a multiple prescription order that indicates when the tablets are to be consumed. The label is disposed on the receptacle and associated with the multiple prescription order.
  • In one illustrative embodiment, the label includes a description of the plurality of tablets and a barcode associated with a particular patient consuming the plurality of tablets. In another illustrative embodiment, the preliminary packages include a plurality of pouches that form a strip of separably coupled pouches. Each pouch among the plurality of pouches may include a bar code for tracking medications within each pouch. Additionally, each pouch may include a pouch label with at least a name for each medication within the pouch and a dosage for each medication within the pouch. The illustrative label may include a particular dosing interval for consuming the medications within the pouch and information about the patient.
  • In another embodiment, the child resistant container described above includes a locking mechanism, in which the sawtooth projections of the cap hold the thread of the neck of the receptacle.
  • A method for packaging a multiple prescription order is also presented. The method includes receiving at a server an order for tablets that further includes an order for at least one type of prescription tablet and a selection of a child-resistant packaging. The server then generates instructions for filling the pouches with a child resistant package. The pouches are then filled by automated means with at least one type of prescription tablet. Labels are printed by automated means on the plurality of pouches. Each pouch label includes information indicating the time at which the contents of each pouches among the plurality of pouches are to be consumed. The pouches are then packaged by automated means within the child-resistant package.
  • DRAWINGS
  • The present invention will be more fully understood by reference to the following drawings which are for illustrative, not limiting, purposes.
  • FIGS. 1A-1E illustrate a child-resistant container in accordance with an embodiment, the package including a push tab that is pushed down while turning the cap of the package to open the child-resistant container.
  • FIGS. 2A and 2B illustrate a top view and a bottom view of the child-resistant cap of a child-resistant container in accordance with an embodiment.
  • FIG. 3A illustrates a perspective view of a child-resistant container in accordance with an embodiment.
  • FIG. 3B illustrates a partial cross-sectional view of a child-resistant container holding a folded stack of a strip of pouches.
  • FIG. 3C shows a cross-sectional view of the cap.
  • FIG. 4A illustrates a detailed, partially broken view of a strip of pouches, including the tearable ribbons and cuts that separably couple the pouches.
  • FIG. 4B shows an illustrative sealed center cut pouches with three perforations and four tearable ribbons on each side of the center cut.
  • FIG. 4C shows an illustrative sealed center cut pouches with four perforations on each side of the center cut.
  • FIG. 4D shows an illustrative sealed center cut pouches with five perforations on each side of the center cut.
  • FIG. 5A illustrates a strip of pouches folded into a stack for packaging within a child-resistant container.
  • FIG. 5B illustrates a detailed label printed on a front of a pouch in accordance with an embodiment.
  • FIG. 5C illustrates a detailed label printed on a back of a pouch in accordance with an embodiment.
  • FIGS. 6A and 6B illustrate an arrangement of pouches associated with an individual regimen in accordance with an embodiment, the arrangement including a header, a prescription tablets pouches, and a non-prescription tablets pouches.
  • FIGS. 7A-7D illustrate a strip of stackable individual sealed cups in accordance with an embodiment.
  • FIGS. 8A-8D show the manner in which an illustrative strip of sealed cups may be folded from a flat configuration to a stacked configuration.
  • FIGS. 9A and 9B show a portion of one illustrative embodiment of a strip of pouches associated with an individual regimen of prescription and non-prescription tablets, including illustrative labeling information.
  • FIGS. 10A and 10B show one embodiment of the stackable individual medicament cups associated with an individual regimen of prescription and non-prescription tablets, including illustrative labeling information.
  • FIGS. 11A and 11B show an alternative embodiment of the stackable individual medicament cups associated with an individual regimen of prescription and non-prescription tablets, including illustrative labeling information.
  • FIGS. 12A-12D illustrate portions of strips of pouches representing configurations of filled packets and associated headers.
  • FIGS. 13A-13G show an alternative embodiment of a label included with a child-resistant container.
  • FIG. 14 shows an illustrative grouping for a 30-day tablet regimen for the patient management system packaged in child-resistant packaging.
  • FIG. 15 illustrates four child-resistant containers corresponding to the morning dosage period, with each container holding medications for one week.
  • FIG. 16 illustrates four child-resistant containers corresponding to different dosage periods in accordance with an embodiment.
  • FIG. 17 illustrates a secondary container for receiving four child-resistant containers in accordance with an embodiment.
  • FIGS. 18A and 18B show illustrative flowcharts of methods for compliance packaging for the patient medication management system.
  • FIGS. 19A-19E show a flat plan view of an illustrative label in accordance with an embodiment.
  • FIG. 20 shows an illustrative flowchart describing a method for packaging pharmaceutical and non-pharmaceutical tablets in accordance with an embodiment.
  • FIG. 21 shows an illustrative flowchart describing a method for inspecting the packing of pharmaceutical and non-pharmaceutical tablets in accordance with an embodiment.
  • DESCRIPTION
  • Persons of ordinary skill in the art will realize that the following description is illustrative and not in any way limiting. Other embodiments of the claimed subject matter will readily suggest themselves to such skilled persons having the benefit of this disclosure. It shall be appreciated by those of ordinary skill in the art that the apparatus and systems described herein may vary as to configuration and as to details. Additionally, the methods may vary as to details, order of the actions or other variations without departing from the illustrative method disclosed herein.
  • The systems, apparatus and methods described herein provide the correct medications and dosages at the right time. The packaging is designed with clear images and names to simplify the process of determining the appropriate medications to take at the appropriate time. Additionally, the patient medication management system and method described herein eliminates the worry of taking the wrong medication at the wrong time, and eliminates the need to manually open and organize prescriptions each week. Furthermore, the system and method described herein gathers all the patient's medicines together in one package, and clearly shows the proper dosage time. Finally, the medicines are packaged in child-resistant packaging.
  • An embodiment is directed to a child-resistant container for holding a plurality of pouches associated with a multiple prescription order. Each of the pouches holds a plurality of medications to be taken at a particular dosage time. For example, if a patient is to take medicines A-E in the morning (the dosage time), then each of the pouches is configured to include medicines A-E and configured to be labeled with the corresponding dosage time (i.e. morning). The pouches may also be labeled with a written list of all of medications within the pouches (medicines A-E), with a picture of each of medicines A-E, the dosage associated with each of medicines A-E, patient information, among other information. The labeling of the pouches thus enables the caretaker or patient to verify that the correct medicines are being taken at the appropriate time. After consuming the medicines, the opened and labeled pouches also serves as a record that the medicines were taken at the appropriate time in accordance with the prescribed regimen.
  • The terms “child-resistant container” and “child-resistant package” are used interchangeable in the present specification. Child-resistant container/package is used to refer to a package used to reduce the risk of children ingesting dangerous items by including a closure mechanism that makes it difficult or prevents children from opening the container.
  • The term preliminary package includes, but is not limited to, packaging material such as a pouch, blister, vial, or any package that holds or houses a plurality of different medications. A preliminary package may exist in a sealed preliminary package, e.g. pouches, or an unsealed preliminary package, e.g. blister. The preliminary packages are then placed into a “final” package such as a child-resistant container or sleeve.
  • Embodiments of the child-resistant container are packaged to contain a plurality of pouches to be taken at the same dosage time. For example, if a patient is to take pills A and B in the morning for five weeks, and take pills C and D in the afternoon for three weeks, then the prescription can be packaged using a morning child-resistant container including pouches to be consumed in the morning for five weeks, and an afternoon child-resistant container including pouches to be consumed in the afternoon for three weeks. Thus, a container holds medications associated with a single dosage time among one or more dosage times of a prescription.
  • In traditional packaging of prescriptions, a single medication is packaged within a single container, with the user having to take the right amount of medication from the container at the various dosage times. Thus, at the various dosage times, the user retrieves the appropriate amount of medication from the same container. This increases the risk of taking the wrong dosage if the dosage varies among the dosage times. Similarly, if the patient is prescribed multiple medications, the multiple medications are usually packaged in separate containers. It is then the patient's (or caretaker's) responsibility to retrieve the right amount of medication from each of the containers at the various dosage times. That is, the patient must still retrieve the medication from the same containers at the various dosage times. Thus, taking multiple medications compounds the risk of taking the wrong dosage.
  • Even when multiple medications are prepackaged in a plastic bag or a sealed cup, the plastic bags and the sealed cups are packaged within the same container regardless of the dosage time. Therefore, at the various dosage times, the user retrieves the appropriate plastic bag(s) or sealed cup(s) from the same container. Thus, similar to medications that are not prepackaged, the patient retrieving the medication from the same container increases the risk of the patient taking the wrong plastic bag(s) or sealed cup(s) at the wrong dosage time.
  • Embodiments of the child-resistant container improve on traditional packaging of medications in that a single child-resistant container is associated with a single dosage time. That is, at a first dosage time, the patient retrieves medication from a first container, and at a second dosage time, the patient retrieves medication from a second container. This especially minimizes errors with multiple prescription orders and with prescribed regimens where dosage amounts vary over dosage times and over the prescribed time.
  • Embodiments also differ from prior medication containers in that multiple prescription orders are prepackaged in individual pouches, where each pouch holds a single dose. By prepackaging the multiple prescription order in individual pouches, the caretaker or patient simply takes an individual pouch and consumes the medicines within the individual pouches, without having to track complicated dosage regimens. The prepackaging also avoids the need for the patient to have to sort out all of the medicines into a weekly pill organizer or some other type of organizer. Finally, by having each child-resistant container hold only the pouches to be taken at the same particular dosage time, confusion is minimized since at a particular dosage time the user can simply take a pouch from the corresponding child-resistant container labeled with the particular dosage time.
  • FIG. 1A illustrates a child-resistant container 10 including a child-resistant cap 12 in accordance with an embodiment. The receptacle 11 of the child-resistant container 10 is substantially cylindrical shaped, even though rectangular or alternatively shaped child-resistant containers may also be used with embodiments described herein. The child-resistant container 10 includes a rim adjacent to the neck of the receptacle (not shown), the rim including a push tab 14 for opening the child-resistant container 10.
  • Pushing the tab 14 while turning the cap 12 opens the child-resistant container 10. Alternative child-resistant mechanisms may be used. For example, the cap 12 may be pushed down while turning to open the container 10. Another mechanism includes pinching the cap 12 while turning to open the container 10. Thus, any child-resistant mechanism may be used for the packaging of multiple prescription orders described herein.
  • By way of example and not of limitation, the illustrative container 10 may have an illustrative cap with a diameter of 2 inches or more. As the diameter of the container and corresponding cap increases, it becomes more difficult for a child's hands to effectively grip the cap, thus making it more challenging to open the container 10.
  • The cap 12 includes side threads 16 on a raised portion 18 of the cap 12. The side threads 16 enable the cap 12 to be turned upside down and the cap 12 to be screwed into the mouth of the container 10, thus closing the container 10 without child-resistant protection.
  • The label 20 of the container 10 may include patient information, such as the patient's name, a patient number associated with the patient or with the particular prescription, an order number, a list of medications included in the container 10. A bar code may associate the tablets in the child-resistant container 10 with a particular patient. FIGS. 1B-1E illustrate in detail the label printed on the outside of the container 10, with the label 20 including a list of medications and a list of precautions associated with the medications. The list of medications may include the name of each drug, the dosage of each drug, the address of the patient, the information of the health provider prescribing the medications, information associated with the health provider, a picture of the patient, and pictures of each of the various medications included in the multi-prescription order.
  • FIG. 2A illustrates a top view of the container 10 with the cap 12 in the child-resistant position, with push tab 14, the side threads 16, and the raised portion 18 of the cap 12 on the outside of the container 10. FIG. 2B illustrates a top view of the container 10 with the cap 12 positioned without child-resistant protection. The side grooves 16 are screwed to the inside of the mouth of the container 10 and the raised portion 18 is on the inside of the container 10. In embodiments with alternative child-resistant mechanisms, the cap 12 may engage the container 10 using alternative features.
  • FIG. 3A illustrates a perspective view of the container 10 with cap 12 removed. The outside of the neck 22 of container 10 includes at least one thread 24 that fit with the at least one complementary thread (not shown) on the inside of cap 12. The side threads 16 of the cap 12 fit complementary threads (not shown) on the inside of the neck 22 of the container 10.
  • FIG. 3A illustrates an example of a cap label 30 printed or attached to the top of the cap 12. The container also includes an open neck 22 projecting from the receptacle 11 (shown on FIG. 1A), with rim 15 adjacent to the open neck 22, including a push tab 14. The open neck includes an outer surface 23 with at least one thread 24 formed on the outer surface 23 of the open neck 22. The cap label 30 indicates the dosage time that all of the medications contained within container 10 are to be taken. The container 10 may also include a second dosage label 32 printed or attached to the body of the container 10 also indicating the dosage time for the plurality of medications in the container 10. Thus, if the multiple prescription order of the patient required the patient to take medicines at two or more different dosage times, then a first container would include all of the medications to be taken at the first dosage time, a second container would include all of the medications to be taken at the second dosage time, etc., with the cap label and/or the second dosage label including the corresponding dosage time.
  • The container 10 has dimensions to fit a plurality of preliminary packages, i.e. pouches, (not shown) arranged in various configurations. The pouches can be stacked horizontally or vertically on the inside of container 10. The size of the container can be adjusted by the number of pouches per container. If the pouches are separably coupled into a strip of pouches, then the strip of pouches may be folded into a stack which can be inserted into the child-resistant container 10.
  • FIG. 3B illustrates a partially cross-sectional view of the child-resistant container 10, with the pouches 40 visible within the container 10. The receptacle 11 may be a clear plastic bottle, allowing the user to see the pouches 40 stored in the container 10 without having to open the container 10. Alternatively, the receptacle 11 may be a non-clear container, or may include a label that blocks from view the contents of the container. As illustrated in FIG. 3B, the pouches with the individual dosages may be stacked horizontally. The pouches may be individually separated, or they may consist of FIG. 3C illustrates a cross-sectional view of the cap 12, the cap having a top surface 52 and a skirt 50 adjacent to the top surface 52 that defines an opening. The cap 12 also includes at least one second thread 56 on the inner surface of skirt 50 for complementary engagement with the thread 24 on the open neck 22 of the receptacle 11. The cap 12 further includes sawtooth projections 54 on the inner surface of skirt 50 that prevent the container 10 from being opened without engaging the push-tab 14 while unscrewing the cap 12.
  • The system and method described herein also allows a patient or physician to seamlessly integrate OTC medications, vitamins, nutraceuticals and other beneficial supplements into a daily regimen. This can be particularly important in elderly patients. As people age, they tend to take an ever-growing number of medications, any of which can interact with another medicament or other substance they may ingest. For another regular regimen. One such example is 81 mg aspirin, often recommended for patients to take daily to help prevent certain types of heart and/or cardiovascular disease. Using the system and method described herein, the patient can have all pills in hand that need to be taken at one time without having to remember to open additional pill bottles and add extra pills to the regimen.
  • In one embodiment, the child-resistant packaging can be configured to receive a plurality of pouches arranged and labeled to help avoid or diminish unwanted side effects of medications or food-medication interactions. For example, some breakfast foods are well-known to interact with some medications. Grapefruit and/or grapefruit juice can slow elimination of certain types of drugs (such as benzodiazepines, like valium) from the body, while oatmeal can decrease absorption of digoxin to almost nothing. Since some medications including benzodiazepines are already eliminated more slowly by elderly patients, taking grapefruit juice or eating grapefruit while a large dose of medication is still in an elderly patient's system could be particularly dangerous. Ingestion of a large quantity of oatmeal before taking a dose of digoxin may be equally dangerous, because the patient believes he has received the beneficial effect of the drug since he has consumed the medication, when in reality, the drug was not absorbed by the body due to the effect of the oatmeal.
  • From herein, the term “Dual Dispensing Tablet strip configuration” will be used to refer to a configuration of a strip of pouches including prescription medications, non-prescription medications, and an optional header label included within the strip of pouches. It is to be understood that the child-resistant packaging described herein can be used for the packaging of the Dual Dispensing Table strip configuration, as well as any configuration of strip of pouches, individual pouches, strip of sealed cups, or individual sealed cups. Finally, embodiments are not limited to containing a single strip of pouches, as multiple strips of pouches may be included within a single child-resistant container.
  • The Dual Dispensing Tablet strip configuration helps prevent the drug interaction problems described above by simply scheduling such drugs for a time other than “morning” or “breakfast time”. Other timing-related complications that interfere with patient compliance with prescribed or recommended medication regimens include when the dosage of a given drug is not regular or when the frequency with which a drug should be taken is not regular. Certain tablets must be taken only every other day to maximize their benefit to the patient. It can be very difficult for patients to comply with such complicated regimens. The Dual Dispensing Tablet strip configuration can aid those patients by providing the proper dose at the proper time. The patient is not required to tell the difference between two dosages of the same tablet, nor is he required to calculate the proper interval between dosages. All calculations and identification are done ahead of time, before the patient ever sees the prescription container.
  • Another advantage of the Dual Dispensing Tablet strip configuration is that it allows physicians or other health care providers to more closely monitor the non-prescribed pills that a patient may take each day, including vitamins, nutraceuticals, over-the-counter drugs or other pills. This can help prevent interactions between prescription medications and other pills. For example, aspirin can interact with blood thinners like Coumadin and/or antidepressants like Prozac to cause bleeding.
  • The terms “tablets”, “medications” and “medicaments” as used herein to refer to medications, pharmaceuticals, nutriceuticals, vitamins, capsules, gel caps, pills and other such medicinal or nutritional preparations for oral use as would be appreciated by those of ordinary skill in the art of pharmacy. The terms “prescription tablets”, “prescription medications” and “prescription medicaments” refer to pills and other such medicinal or nutritional preparations for oral use that are prescribed to a patient by a physician or other health care provider, as would be appreciated by those of ordinary skill in the art of pharmacy. The term “non-prescription tablets” refers to pills and other such preparations for oral use that may be obtained without a prescription.
  • The systems, apparatus and methods described herein provide assurances of the proper dosages at the proper period. Additionally, caregivers and patients get the assurance that the patient is getting the right medications and staying compliant with those medications. Furthermore, a time saving solution for dispensing tablets, medications and vitamins is described.
  • One of the patient medication management systems provides a compliant packaging solution. For purposes of this patent, the term “compliant packaging” refers to packaging tablets so that they are administered in a manner that complies with one or more prescriptions. Additionally, compliant packaging may also refer to providing reminders for taking medications and/or recording that the medications have been consumed.
  • By way of example and not of limitation, compliance packaging may include three elements: firstly, an action is initiated by a patient and/or caregiver with the compliance package; secondly, the compliance package dispenses at least one tablet as a result of the action taken by the patient and/or caregiver; and thirdly, the patient or caregiver records the dispensing of the tablet on the compliance package. An illustrative example of a “compliance package” is the well-known birth control “dial pack” package, in which there are twenty-eight tablets in a blister package that are in a circular configuration (not shown). To consume the tablet, the patient pushes on the transparent plastic material and the tablet pierces a foil backing. After the tablet is dispensed from the dial package, a record is left on the dial pack package, i.e. a pressed plastic housing and pierced foil backing.
  • Compliant packaging may also include a compliant package having a plurality of different tablets corresponding to one or more prescriptions from one or more medical doctors. The compliant package is consumed at a predetermined interval consistent with the prescription. Some compliant packaging solutions may record that each of the tablets is consumed.
  • One of the illustrative patient medication systems described herein satisfies the requirements for a compliance package because an action is required by the patient or caregiver that requires identifying the appropriate dosage period, e.g. morning, and selecting the appropriate pouch or pouches. The patient or caregiver records the consumption of the medication by removing the packet containing the appropriate medication from the container and consuming the medication. Since the packet is imprinted with a dosage time period and date for consumption, a patient or caregiver can tell at a glance whether the medication for the current date and dosage period has already been consumed or whether it remains to be taken.
  • Each pouch may be separably coupled with at least one other pouch so as to form a connected strip of pouches as illustrated in FIG. 4. The pouches in the strip may be torn or separated from the strip by tearing along the designated tear line. Alternatively, the pouches may already be separated, thus requiring the caretaker or patient to simply pick out a particular pouch without having to separate or tear the pouches. Any type of pouch material may be used for embodiments disclosed herein. For example, the pouch material may be plastic or other suitable material for holding a plurality of medications within the pouch.
  • The separable sealed pouches may be grouped into collections of seven pouches (for a child-resistant container holding medications for seven-days), twenty-eight pouches, thirty pouches or any other such combination. A plurality of sealed pouches that are grouped is also referred to as a “strip,” and the terms “strip” and “group of pouches” is used interchangeably in this patent. A typical strip includes seven pouches, twenty-eight pouches, or thirty pouches. In one embodiment described in further detail below, a reminder strip consists of seven pouches, followed by an empty pouch with printing on the pouches to remind the patient and/or caregiver to re-order, and two remaining pouches. In another embodiment, there are twenty-eight pouches followed by an empty pouch with printing on the pouch to remind the patient and/or caregiver to re-order and two remaining pouches. It is to be understood that pouches may be grouped into strips of any particular number of pouches depending on the prescription order.
  • Referring now to FIG. 4A there is shown an illustrative strip 71 that includes a sealed center cut pouch 72 that is a pouch. The illustrative pouch 72 is adjacent to pouches 74 and pouches 76. By way of example and not of limitation, the illustrative pouch 72 comprises a sealed top end 78, a sealed bottom end 80, and two sides, in which at least one side is also sealed, e.g. side seal 82, and the other side is folded over. Each illustrative pouch includes different tablets corresponding to different medications, vitamins or other such medicinal or nutritional preparation for oral use.
  • Additionally, the illustrative pouch is joined to an adjacent pouch by a plurality of tearable ribbons 84 a-84 d adjacent to the first side cut 85 a adjacent the top end 78. A similar grouping of tearable ribbons is also adjacent to the second side cut 85 b adjacent to the top end. Each sealed pouch comprises side cuts 85 a and 85 b on each side of the top end 78 and side cuts 85 c and 85 d on each side of bottom end 80.
  • The illustrative embodiment shows a pouch with at least three perforations between each side cut and the center cut. The first ribbon 84 a is disposed between the first side cut 85 a and the first perforation 86 a. The second ribbon 84 b and third ribbon 84 c are each disposed between perforations 86 a, 86 b and perforations 86 b, 86 c, respectively. The fourth ribbon 84 d is disposed between the third perforation 86 c and the center cut 87 a. A similar configuration of perforations and ribbons surround the center cut 87 b that is adjacent to the bottom end 80. In the illustrative example, the ribbons have a width corresponding to the width of the u-shaped well.
  • The resulting pouches can be opened on either side and the center cut prevents tearing the existing pouches or the adjacent pouches. In general, the pouch described minimizes the number of tearable ribbons, thereby minimizing the likelihood of tearing the existing pouch or the adjacent pouches. Additionally, having the tearable ribbons at the edges of the pouches also minimizes the likelihood of tearing into the existing or adjacent pouches.
  • It shall be appreciated by those of ordinary skill in the art having the benefit of this disclosure that the resulting pouch will vary depending on the type of material being used, the thickness or weight of the material, the seal, the length of the cuts, the number of cuts, the length of the perforations, number of perforations, the width of the tearable ribbons, and the frequency of tearable ribbons. For example, in FIG. 4B there is shown the illustrative sealed center cut pouches 72 described above with three perforations and four tearable ribbons on each side of the center cut. In FIG. 4C there is shown an illustrative sealed center cut pouch 88 with four perforations on each side of the center cut. FIG. 4D depicts another illustrative sealed center cut pouch 89 with five perforations on each side of the center cut.
  • Referring to FIG. 5A there is shown a group of fourteen separable pouches, wherein each pouch comprises a plurality of different tablets. The separable sealed pouches have been grouped into a collection of fourteen pouches 90 that correspond to a seven day supply of medications. A plurality of sealed pouches that is grouped is also referred to as a “strip,” and the terms “strip,” “group of pouches,” and “strip of pouches” is used herein interchangeably.
  • Referring to FIG. 5B there is shown an exploded view of the illustrative front side of one of the sealed center cut pouches 92 that contain prescription medication that is included in the strip of pouches 90. The exploded view shows that a variety of data fields are printed on the front of each pouch. In general, the data fields provide information corresponding to each tablet within the pouches. The data fields include: the name of the patient 94 a, the date the tablets should be consumed 94 b, the time of day the tablets should be taken 94 c, the name of the prescribed medication 94 d, the name of the corresponding generic 94 e, the dosage 94 f, and the prescription number 94 g. Additionally, an expiration date 94 h is included that identifies that the medications should not be taken after the expiration date. If the pouch includes non-prescription medication, the data fields may also include the name of the non-prescription medication or nutraceutical, the scientific name or alternate common name of the medication or nutraceutical, the dosage, and indications or possible uses for the nutraceuticals.
  • Referring to FIG. 5C there is shown an exploded view of the illustrative back side of the pouch 92 in FIG. 5B. The data fields include: the name of patient 96 a, a bar code 96 b, the address of the facility that filled the pouch with tablets 96 c and the telephone number 96 d for additional information. The illustrative bar code associates the tablets in the foldable box with a particular patient.
  • The child-resistant container disclosed herein can also be used to hold a dual dispensing strip of pouches. FIG. 6 illustrates a strip of pouches for the dual dispensing of prescription tablets and non-prescription tablets. Referring to FIG. 6A there is shown an illustrative layout of pouches associated with all pills to be consumed by one individual at a particular date and time and associated with an illustrative individual regimen. Header 802 does not contain any tablets. Instead, illustrative information is provided. Pouch 804 represents a pouch containing tablets associated with one or more prescriptions associated with an illustrative individual regimen. Pouch 806 represents a pouch containing non-prescription tablets associated with an illustrative individual regimen.
  • Referring to FIG. 6B there is shown a portion of the layout of a strip of pouches associated with an illustrative individual regimen, showing that the header 802 a and the associated pouches 804 a and 806 a to be administered at one date and time are continuous with the header 802 b and pouches 804 b and 806 b for the subsequent date and time. As shown, a dosage unit comprising a header and at least one pouch may be continuous with one or more dosage units.
  • Referring to FIGS. 7A-7D there is shown a portion of the layout of a strip of sealed medicament cups that are associated with an illustrative individual regimen and which can also be packaged within the child-resistant container 10. FIGS. 7A-7D show the same strip portion in a variety of configurations.
  • FIGS. 8A-8D illustrate the manner in which a flat strip of medicament cups associated with an individual regimen may be folded into a stackable configuration for use with the child-resistant container 10.
  • FIGS. 9A and 9B show a portion of one illustrative embodiment of a strip of pouches, including illustrative labeling information associated with an individual regimen. As shown, in this embodiment, the header is associated with the two pouches that immediately follow it on the strip of pouches. As noted above, the pouches need not include the header associated with the prescription and non-prescription pouches. The strip of pouches illustrated in FIGS. 9A and 9B can be folded and/or stacked to fit within the child-resistant container 10.
  • FIGS. 10A and 10B show an illustrative labeling for one embodiment of a strip of medicament cups. FIG. 10A shows one illustrative layout of the strip of medicament containers, in which the header (material between cups) is configured to be printed with illustrative information about the individual integrated order and the associated patient and pill regimen. In this embodiment, the lids of the cups are marked with illustrative symbols to clearly indicate which cups hold the prescription medicaments and which cups hold the non-prescription tablets, such as nutraceuticals, vitamins and other beneficial supplements. Further, the header area is configured to be coupled to one of two adjacent cups that correspond to a single date and time for a particular individual to consume the tablets within and the header portion has information related to the contents of both adjacent cups.
  • FIG. 10B shows illustrative labeling including the name of the patient, the date the tablets should be consumed, the time of day the tablets should be taken, the name of the prescribed medication, the name of the corresponding generic, the dosage and the prescription number. Additionally, an expiration date may be included that identifies the medications that should not be taken after the expiration date. The illustrative strip of medicament cups may then be folded to fit within child-resistant container 10. Alternatively, the medicament cups may be separated into individual medicament cups, and the medicament cups may be arranged within the child-resistant container 10. The size and shape of the child-resistant container 10 may be selected based on the size, shape, and number of medicament cups to fit within the child-resistant container 10.
  • FIGS. 11A and 11B show illustrative container and illustrative labeling for another embodiment of a strip of medicament cups. FIG. 11A shows one illustrative layout of the strip of medicament containers, in which the header 1001 (material between cups) is configured to be printed with illustrative information about the individual integrated order and the associated patient and pill regimen. In this embodiment, the lids of the cups are marked with illustrative inverted colors to clearly indicate which cups hold the prescription medicaments and which cups hold the non-prescription medicaments, such as nutraceuticals, vitamins and other beneficial supplements. Further, the header area is configured to be coupled to each of two adjacent cups that correspond to a single date and time for a particular individual to consume the tablets within; the header portion has an additional perforation that allows each header portion to be separated from rest of the strip along with the corresponding medicament cup. FIG. 11B shows an illustrative header labeling including the date the tablets should be consumed, the time of day the tablets should be taken, the name of the prescribed medication and the dosage.
  • Referring now to FIGS. 12A-D, portions of strips of pouches are shown to represent illustrative configurations of filled packets and associated headers. In FIGS. 12A and 12B, the two packets that are to be consumed at the same time are located under a header that indicates the correct date and time period for administration. FIG. 12C shows an illustrative reverse side of a “headerless” embodiment. FIG. 12D shows the reverse side of an illustrative header where the header is the same size as the packets that hold medicaments and nutraceuticals. Illustrative text that may appear on the reverse side of the illustrative embodiments of FIGS. 12A and 12B as well as 12D is also included in FIG. 12D.
  • The illustrative seven-day strips of FIGS. 12A-12D are placed in an illustrative seven-day container or in an illustrative 30-day container before being delivered to the patient. Illustrative seven-day containers are presented in at least FIGS. 14-16. An illustrative 30-day container is presented in at least FIG. 17. As noted above, embodiments are not limited to containing seven-day or 30-day strip. The child-resistant container 10 may contain any arbitrary number of pouches based on the prescription assigned to the patient.
  • Referring to FIGS. 13A-13G in the illustrative embodiment, the child-resistant container 10 includes a label 192 with a description of the medications housed by the child-resistant container. If multiple containers are delivered as part of a box, then the label may be associated with the box. Additionally, the label 192 comprises a description of precautions corresponding to the medications as described in further detail below in reference to FIGS. 19A-19G.
  • FIGS. 13A-13G illustrate an alternative label for the child-resistant container 10. The figures present the label 192 by presenting exploded view of various sections of the label 192. The label 192 may be affixed separately to the child-resistant container 10 or the label may be printed directly on a print area of the child-resistant container, or any combination thereof. The label may also be affixed or printed on a box containing one or more child-resistant containers.
  • The illustrative label 192 comprises a plurality of printed text that may include: the patient's name 240, the interval during which the medications are taken 252, e.g. morning, a picture of the patient 242, patient number 244, order number 246, a list of precautions 248, a listing of the medications 250, a prescription number 254, quantity of tablets per prescription 256, quantity of refills 258, length of prescription 260, the prescribing physician 262, the manufacturer of the tablets 264 and the lot number 266 corresponding to each tablet. Additionally, a picture 268 of each tablet is provided and the dosage concentration 270 is provided for each medication. Information about the associated generic drug 272 is also provided. Furthermore, an expiration date may also be provided for each tablet or for each prescription. Further still, manufacturer information, corresponding “expiration dates,” personal contact information, physician contact information, insurance information, and other such information associated with the tablets in each container.
  • Further yet, a bar code 274 (illustrated in FIG. 13G) associates the medications in the child-resistant container 10 with a particular patient. Alternatively, the bar code 274 may be printed on a box or other container holding one or more child-resistant containers 10, with the bar code 274 associating the medications with the particular patient. Alternative means for associating the medications in the box to the patient include, by way of example but not of limitation, the patient's name, a serial number, a radio frequency identification (RFID) tag or any other such method for associating an individual with a particular item.
  • Referring to FIG. 14 there is shown a 30-day tablet regimen for the patient medication management system that uses the seven-day child-resistant container. A patient medication management system 300 provides a compliance packaging solution. The patient medication management system 300 described herein provides a compliance package because, firstly, an action is required by the patient or caregiver that requires identifying the appropriate dosage period, e.g. morning, and selecting the appropriate pouches. Secondly, the patient opens the appropriate pouch and consumes the medication. Thirdly, the patient or caregiver records the consumption of the medication by removing or pressing the circular cuts. Finally, access to the medication is restricted with the child-resistant container.
  • The patient medication management system 300 comprises a plurality of sealed pouches that are grouped into four separate strips 302, 304, 306 and 308. The first strip 302 is a seven day strip that covers the illustrative dates of Sep. 22, 2007 through Sep. 28, 2007 and the illustrative dosing period is the “morning.” In the illustrative embodiment, the dosage period is selected from the group of dosage period intervals consisting of a morning dosage interval, a noon dosage interval, an evening dosage interval or a bedtime dosage interval.
  • The first strip 302 is placed into the illustrative child-resistant container 310 that has the tablets corresponding to the first week of the 30-day regimen. The second strip 304 is a seven day strip that covers the illustrative dates of Sep. 29, 2007 through Oct. 5, 2007. The dosing period remains the same, i.e. morning. The second strip 304 is associated with child-resistant container 312 that houses the tablets corresponding to the second week of the 30-day regimen. The third strip 306 is a seven day strip that covers the illustrative dates of Oct. 6, 2007 through Oct. 12, 2007 and, again, the dosing period is the morning. The third strip 306 is associated with child-resistant container 314 that corresponds to the third week of the 30-day regimen.
  • The fourth strip 308 includes a seven day grouping of pouches 316 that covers the illustrative dates of Oct. 13, 2007 through Oct. 19, 2007; the dosing period remains the same, i.e. morning. Additionally, an empty pouches 318 is included with the fourth strip 308 that provides a reminder to place another order and an illustrative 800 number to assist in placing the refill order. Furthermore, a two day grouping of pouches 320 covers the illustrative dates of Oct. 20, 2007 through Oct. 21, 2007. The fourth strip 308 is associated with child-resistant container 322 that houses the tablets corresponding to the fourth week of the 30-day regimen. Thus, the fourth strip 308 includes nine pouches that complete the 30-day regimen.
  • Each of the strips 302, 304, 306 and 308 are placed in the corresponding child- resistant containers 310, 312, 314 and 322, respectively. Each child-resistant container is configured to receive at least seven pouches. Thus, each child-resistant container is configured to receive at least seven pouches that correspond to the particular dosage period, and the illustrative child-resistant container is labeled with the dosage period corresponding to the medications. Additionally, each child-resistant container may be labeled with the patient name and dosage period as described above.
  • Each child-resistant container may include a plurality of daily indicators corresponding to a seven-day period that are disposed on the child-resistant container. The daily indicators provide a means for recording that the medications in the pouches have been taken. For example, the label of the child-resistant container may include an indicator area where a user can mark with a pen or pencil when a pouches has been taken. For instance, the indicator area can consist of a plurality of shapes, the days of the week, a numbered list, etc. Each of the daily indicators is configured to indicate that the medications in the pouches have been taken, thereby providing a means for compliance packaging.
  • In the illustrative 30-day regimen, the sealed pouches associated with strips 302, 304, 306 and 308 include sealed pouches with a plurality of different tablets that correspond to different medications and/or vitamins. The different medications are associated with at least one prescription and each tablet includes an appropriate dosage consistent with the prescription. Each of the sealed pouches is labeled to show the medications or nutraceuticals in the pouches and labeled with a particular dosage period that includes at least one daily interval for consuming the medications in the pouches.
  • Referring to FIG. 15 there is shown the four illustrative child- resistant containers 310, 312, 314 and 322 described above. The child-resistant containers include a label on the top of the child-resistant cap and on the body of the container indicating that the contents of the containers are to be taken during the morning dosage time. Each of the child-resistant containers includes the pouches to be taken on week 1, week 2, week 3, and week 4. These child-resistant containers may then be packaged within a secondary container 340, such as illustrated in FIG. 17. The secondary container 340 may be an assembled box made of cardboard material, even though an alternative material may also be suitable. The secondary container 340 includes a lid 342 that may be rotatable about a back fold line. The illustrative lid 342 includes a plurality of side flaps.
  • FIG. 16 illustrates a different regimen for a patient, where child- resistant containers 330, 332, 334, and 336 include medications for a particular number of days, where each container holds the pouches associated with a particular dosage time among a plurality of dosage times. The plurality of dosage times include a morning dosing period corresponding to the “AM” secondary container 330, the lunch-time dosing period corresponding to the “Noon” secondary container 334, the dinner or evening dosage period associated with the “PM” secondary container 332, and the late night dosage period corresponding to the “Bedtime” secondary container 336. Rather than dividing the pouches into weekly periods, the containers 330, 332, 334, and 336 may include pouches for less than a week, or for more than one week. The four dosage times are presented for discussion purposes, as the actual dosage times may depend on the prescription for a particular patient.
  • FIG. 17 illustrates a secondary container 340 for holding a plurality of different child-resistant containers corresponding to different dosage periods. In particular, the secondary container 340 includes a divider creating four cells for receiving each of the child- resistant containers 330, 332, 334, and 336. As noted above, the secondary container 340 may be used to store any particular combination of child-resistant containers. The size of the secondary container 340 and the size of the child-resistant containers may be adjusted to fit more or less of the child-resistant containers within the secondary container 340.
  • In one embodiment, the secondary container 340 may be sealed with a label that affixes the lid 342 to the body of the secondary container 340. The label may be label 20, label 192, or some other alternative label. The label may include the patient's name and a general description that there are multiple prescription pouches 338 in the various child-resistant containers of secondary container 340. The label may also include additional information such as the dosing interval or dosing period, the prescribing physician, one or more bar codes, a patient serial number or additional information about the different medications, such as the type of prescriptions within the box 340, the pharmacy that filled the prescription or any other such information. To open the illustrative secondary container 340, the label is simply broken by the patient or caregiver and access is provided to the regimen in the child-resistant containers within the secondary container 340.
  • Additionally, a medication summary sheet 344 may also be included or housed by the secondary container 340. The medication summary sheet 344 provides detailed information about the tablets in each pouches. The medication summary sheet 344 may include warnings, precautions, side effects, dosage, administration, clinical pharmacology, and pictures corresponding to each medication. For example, the medication summary sheet may include summaries of the various medications being taken and summaries of the side effects. In general, the medication summary sheet provides the patient with a detailed summary of the medications being taken. The medication summary sheet 344 may also include the name of the patient, a bar code or other such identification means that ensures that the correct medication summary sheet 344 is associated with the corresponding prescription.
  • Referring to FIG. 18A there is shown an illustrative flowchart for using the patient medication management system described above. The method 1800 is initiated at block 1802 where a child-resistant container associated with the appropriate time interval or dosage period is selected. As described above, the illustrative dosage periods are morning, lunch, dinner and bedtime.
  • The patient or caretaker then proceeds to block 1804 where the patient opens the secondary container and selects the appropriate child-resistant container at block 1806. At block 1808, the child-resistant container is opened. Subsequently, the appropriate multiple prescription pouches is selected at block 1810 and the patient may take or consume the tablets in the multiple prescription pouches.
  • At block 1812, the patient or caregiver then records that the pouches has been removed by marking on the appropriate marking area on the child-resistant container (if the child-resistant container includes a marking area). This recording step completes the compliance packaging process. Alternatively, the patient may take the tablets at block 1814 after marking on the appropriate marking area.
  • At decision diamond 1816, the patient or caregiver determines whether to place a new order. The decision may be triggered by an empty pouches marked “Reorder,” as shown in FIG. 12D, which reminds the user that a new order or refill order should be placed or the decision may be triggered by the patient or caregiver taking their own initiative. The order is then placed at block 1818, where an illustrative refill order is placed.
  • If there is no need to place another order, the child-resistant container is closed and returned to the secondary container that is also closed. The method then proceeds to decision diamond 1820 where the patient waits for the next time interval or dosage period. When the next dosage period arrives, the method returns to block 1802 and the entire cycle is repeated. Those skilled in the art shall appreciate that various design parameters, requirements, rulings, orders and statutes may affect the precise method employed.
  • Compliant packaging may also include a compliant package having a plurality of different tablets corresponding to one or more prescriptions from one or more medical doctors. The compliant package contents are consumed at a predetermined interval consistent with the prescription. Some compliant packaging solutions may not record that each of the tablets is consumed. For example, an illustrative 30-day foldable box configured to receive the plurality of pouches is presented herein.
  • Referring to FIG. 18B there is shown an illustrative flowchart for using the patient medication management system described above. The method 1830 is initiated at block 1832 where a secondary container associated with one of the illustrative weeks, such as week 1, is selected.
  • The patient then proceeds to block 1834 where the patient opens the secondary container. The method then proceeds to selects the appropriate child-resistant container associated with the appropriate time interval or dosage period at block 1836. As described above, the illustrative dosage periods are morning, lunch, dinner and bedtime. At block 1838, the child-resistant container is opened. Subsequently, the appropriate multiple prescription pouches is selected at block 1840 and the patient may take or consume the tablets in the multiple prescription pouches.
  • At block 1842, the patient or caregiver then records that the pouches has been removed by marking on the appropriate marking area of the child-resistant container (if the child-resistant container includes such marking area). This recording step completes the compliance packaging process. Alternatively, the patient may take the tablets at block 1844 after marking the child-resistant container.
  • At decision diamond 1846, the patient or caregiver determines whether to place a new order. The decision may be triggered by the empty pouches marked “Reorder,” as shown in FIG. 12D, which reminds the user that a new order or refill order should be placed or the decision may be triggered by the patient or caregiver taking their own initiative. The order is then placed at block 1848, where an illustrative refill order is placed.
  • If there is no need to place another order, the child-resistant container is closed and returned to the secondary container that is also closed. The method then proceeds to decision diamond 1850 where the patient waits for the next time interval or dosage period. When the next dosage period arrives, the method returns to block 1832 and the entire cycle is repeated. Those skilled in the art shall appreciate that various design parameters, requirements, rulings, orders, and statutes may affect the precise method employed.
  • Compliant packaging may also include a compliant package having a plurality of different tablets corresponding to one or more prescriptions from one or more medical doctors. The compliant package contents are consumed at a predetermined interval consistent with the prescription. Some compliant packaging solutions may not record that each of the tablets is consumed.
  • FIGS. 19A-19E illustrate yet another embodiment of a label 500 that may be affixed to the child-resistant container 10 or to a secondary container storing child-resistant container 10. The label 500 may include, for example, patient and medication data such as patient name and number, names of prescribing physicians, medicine(s), dosage strength(s), medicine quantity(s), color images of the medicine(s), prescription number(s), NDA number(s), warning(s), dosage period(s), administration schedule(s), and the like. The illustrative label strip is configured such that all information necessary for drug identification and administration is affixed to the child-resistant container 10 or to secondary container 340.
  • The illustrative bar code 506 provides a means for associating the labels and pouches with a particular patient. By way of example and not of limitation, the means for associating the pouches may also include a radio-frequency identification (RFID) component, writing, or other such associative element capable of associating the labels, pouches, and particular package with a particular patient
  • Starting from the left side of FIG. 19A, the label 500 includes patient and dosage period information including time period 502, patient name 504, barcode 506, patient number 508, and order number 510. Some embodiments, particularly those embodiments suitable for use in a long-term care facility, may also include a photograph (not shown) of the patient in this portion of the label with other identifying information. In other illustrative embodiments, the label may include information about a variety of different prescriptions and medications associated with each of these different prescriptions. Furthermore, the primary label may include an expiration date for each prescription.
  • The time period 502 refers to the particular time of day that the patient must take the tablets within the container. In this illustrative label, the time period is “Morning.” The numeral “1” next to the word “Morning” is another reference to the time period. In this case “Morning” is the first time period during which the illustrative patient must take medications.
  • A barcode 506 is printed on the illustrative label 500. A barcode may appear on each pouches, on each child-resistant container, or on the secondary container. The barcodes for the pouches, the child-resistant container, and the secondary container may encode important information such as time period 502, patient name 504, patient number 508 and/or order number 510. The barcodes are associated with one another during container assembly and filling, improving order verification by ensuring that the appropriate pouches, having been filled with medicaments associated with a particular patient 504 and time period 502, are placed in the appropriate container that is associated with the particular patient 504 and time period 502. Barcodes are also used to ensure that the appropriate label 500 is affixed to the appropriate container associated with a particular patient 504 and time period 502. The barcode may also be associated with a variety of different prescriptions and the corresponding expiration date for each prescription.
  • Referring now to the “Precautions” section, as shown in FIGS. 19B and 19C, of the illustrative label 500, there is shown a list of drug precautions 514 associated with the medicaments in the illustrative order. Each drug precaution for each drug found within the container is present in the precautions section. The precautions section may also include information on synergistic, agonist or antagonist effects that may occur among one or more medications in the order. Each precaution 514 is associated with a numeral 512A, or with another easy-to-interpret symbol. Each precaution applies to at least one drug in the order, but may apply to more than one drug.
  • The next column of label 500 contains another set of numerals 512B that map to the numerals 512A and thus to drug precautions 514. For example, one of the drug precautions 514 instructs patients to refer to the Patient Info Booklet for additional cautions. The 512A number “6” is associated with the Patient Info Booklet precaution. In turn, the 512B number “6” is associated with several of the prescription tablets 518 (shown on FIG. 19D). Other easily interpreted symbols could be used in place of numbers, but it is essential that the first set 512A maps exactly to the second set 512B.
  • Referring now to FIGS. 19C and 19D, the next part of the label 500 shows drug information, including color images 516 of each drug in the order and the name 518 of each drug in the order. The numbers 512B are grouped such that each ‘cell’ containing a group of numbers 512B is associated with exactly one drug 518. The numbers 512B show which listed precautions are associated with each prescription in the order. As shown, each precaution 514 maps to exactly one number 512A, but each precaution 514 and its corresponding number 512B may apply to more than one drug in an order. That is, each number found in the set of numbers 512A may appear associated with any or all drugs 518 in the order, depending on which group of numbers 512B appears next to the drug image 516 and name 518.
  • For example, on the illustrative label 500, six precautions 514 are shown, each of which is in turn associated with exactly one number 512A. The first drug 518 listed on the label is “ARICEPT.” To the left of the word “ARICEPT” is shown the color image of the drug 516. To the left of the color image of the drug 516, the 512B numbers “1, 2, 3, & 4” are listed. (See FIG. 19B) This means that each precaution 514 associated with each of the 512A numbers “1”, “2”, “3”, and “4” applies to “ARICEPT.” Further, the number “4” appears in the groups of numbers 512B adjacent to three of the six illustrative drugs, and number “6” appears in the groups of numbers 512B adjacent to five of the six drugs listed, while the 512B number “5” is listed next to only one drug. This means that the precaution 514 associated with 512A number “5” applies only to one drug, while the precaution 514 associated with 512A number “6” applies to almost every drug in the order.
  • The “Medication/Rx#” section of FIG. 19D includes the drug images 516 and the drug name 518 mentioned above, in addition to the unit dosage 520, the drug format 521 and the prescription number 528. Thus, a variety of different prescriptions may be consolidated and integrated into the primary label 500. The prescriptions may also include different refill dates as indicated by the dates in column 522, shown in FIG. 19E. The color images 516 show both the front and the back of each tablet. The color images allow the patient or a caregiver to identify individual medications within each pouches by using the label 500 as a key. If a patient's medication must be changed in the middle of a 30-day prescription order, this allows the patient to keep taking medications from the current 30-day period by merely discarding tablets associated with any discontinued prescriptions or recommendations after opening the packet or pouches, and consuming the remaining medications.
  • The next column of text, shown in FIG. 19E, displays refill information 522 including the number of refills left on the prescription for that drug, the quantity of tablets that is supplied each time the prescription is filled and the date that the prescription expired. The next column of text includes the prescribing practitioner's name 524 for each drug 518 and the last column includes manufacturer information 526 including the name of the manufacturer or other manufacturer data.
  • Referring to FIG. 20, there is shown an illustrative flowchart 2000 describing the overall method for packaging pharmaceutical and non-pharmaceutical tablets. At optional block 2002, if the patient is a new patient, the enrollment form is received from the new patient. Proceeding to block 2004, a prescription order is received at a server. The order may, for example, be entered into the server by a patient or physician via an interface with the server. The user interface can provide the patient or physician with a selection of package types, including child-resistant packages, and enable the patient and physician to specify whether a child-resistant package is desired. At block 2006, an order for non-prescription tablets is received at the server. In some embodiments, the server may be associated with a front-end system such as PharmaServe. The method then proceeds to block 2008, where the prescription order is verified.
  • Once the patient and order information are entered into the server, each order is now associated with a particular patient's individual regimen. The prescription and non-prescription orders are grouped and treated as one order within the system. Any additional prescriptions that the patient may require in the future may be added to the patient's order when prescriptions are next filled.
  • Moving on to block 2010, the verified prescription order that is associated with a particular patient and corresponds to specific times for administration is forwarded to production and filled. The user interface communicates with the back-end (filling) system, allowing the prescriptions to be grouped as an order during filling.
  • The filling process uses automated techniques. During the filling process, the tablets that are associated with the prescription order may be loaded into compliance containers that are configured for use with the system and methods described herein.
  • Referring now to block 2012 of FIG. 20, the method proceeds to printing of the header label. Moving on to block 2014, the filled order is inspected. The inspection process includes verifying that the tablets to be dispensed are properly associated with the particular patient and prescription order. The inspection process also includes inspection of the filled packages to ensure that the distribution of the tablets within the containers is consistent with the patient's dosage regimen. Further, the labeling corresponding to a particular time period and specific dates for administration is associated with the pouches or cups that contain the associated tablets. The header labeling associated with the order is also inspected and verified to be of legible print quality. Inspected strips are matched with the appropriate secondary container and the corresponding integrated labeling.
  • Moving on to block 2016, the strips are sealed within the appropriate child-resistant containers and all secondary containers corresponding to a complete order are placed into a shipping container.
  • Referring to FIG. 21, there is shown a multiple inspection method that inspects packages filled with at least two different medications that are to be consumed by a particular patient. The illustrative method is initiated at block 2102 when an order for multiple medications is received by the filling system. In the illustrative embodiment, a verified prescription order is received. The verified prescription order is an order that has been verified according to local jurisdictional requirements, insurance requirements, co-pay requirements, transactional requirements, or a combination thereof. For example, in certain jurisdictions a verified prescription order may require a medical doctor's signature, and may have to be processed by a pharmacist. Additionally, a verified order may require approval from an insurance company, Medicare, or any such entity. In other jurisdictions, the only form of verification may include confirming that funds are available from the particular individual or organization charged, which satisfies transactional requirements. By way of example and not of limitation, verification of the availability of funds may include simply receiving authorization to charge a credit card and confirming that the credit card is a valid card. Alternatively, an order may be received for supplements as described in patent application Ser. No. 12/945,709 entitled SYSTEM AND METHOD FOR ONLINE INTEGRATED MULTIPLE TABLET ORDERING.
  • At block 2104, the filling system starts to fill the multiple medication order. Each package is filled with at least two different medications by the filling station. The filling system is configured to associate at least one package with the patient. The filling process includes placing the medications in a blister package that is unsealed or placing the medications in a pouches that is sealed. Additionally, the blister package may also be sealed in the filling machine.
  • The method then proceeds to select each package that is to be inspected. In the illustrative embodiment, the process control selects the package and the inspection process. The process control module is communicatively coupled to the filling station.
  • At block 2106, the first inspection is initiated. The first inspection may be qualitative or quantitative. By way of example of not of limitation, the illustrative first inspection step is a precision weighing process as shown in block 2108.
  • The first automated inspection is initiated by examining the different medications with a first measurement device that is associated with a first inspection property. Subsequently, a comparison of a first expected inspection value with the first measurement result generates the first inspection result state.
  • In the illustrative embodiment, the first inspection analysis is performed by an inspection control process at block 2110. The inspection control process module receives the measured medication value from the first inspection station. Additionally, the expected medication value is received by the inspection control process module. The inspection result state is then selected by the inspection control process module. The inspection control module compares the expected medication value to the measured medication value to generate the inspection result state, which includes a positive inspection result state, a negative inspection result state, and an inconclusive inspection result state.
  • The positive inspection result state corresponds to the measured medication value being within a range approximating the expected medication value. The negative inspection result state corresponds to the measured medication value being outside a range approximating the expected medication value by a defined amount. The inconclusive inspection result state corresponds to comparison between the measured medication value and the expected medication value being inconclusive and is outside the range approximating the expected medical value, but not so much that it can be determined to be a negative inspection result.
  • At block 2112, the second automated inspection is initiated by examining the different medications with a second measurement device that is associated with a second inspection property. A second measurement result is generated. By way of example and not of limitation, the second inspection process is a visual inspection process.
  • The illustrative method then proceeds to block 2114 where the correct number of tablets is determined. The correct number of tablets is a quantitative measurement result. At block 2116, the illustrative method determines the color and shape of the tablets. The determination of color and shape is a qualitative measurement result.
  • A second inspection analysis is initiated at block 2118. The second inspection analysis generates a second automated inspection result by comparing a second expected inspection value with the second measurement result as described above. A second measurement result is then generated. The method then proceeds to determine a second automated inspection result state by comparing a second expected inspection value with the second measurement result. Again, the second inspection result state includes a positive inspection result state, a negative inspection result state, and an inconclusive inspection result state as described above.
  • Additional inspection steps may follow the second inspection as described herein. Thus, a third inspection at a third inspection station may follow. Furthermore, a fourth inspection at a final inspection station may also be performed. For example the final inspection station may perform the scanning or identification of the bar codes for each preliminary package that is associated with the various labels and secondary container housing the preliminary packages.
  • At block 2120, a multi-inspection analysis is performed by an analytical module. At a minimum, the analytical module compares and then analyzes the first automated inspection result and the second automated inspection result for at least one package. Based on this analysis, the analytical module selects one of a plurality of post-inspection states that are then communicated to the process control module.
  • After the multi-inspection analysis, the selected post-inspection state is communicated to the process control module that is communicatively coupled to the movement control module that controls the conveyance of the preliminary package to the appropriate post-inspection station. For example, the process control module may receive an instruction that a particular preliminary package was improperly filled and that the preliminary package is to be transferred to the manual inspection station, then correction station and finally to the assembly station.
  • In another example, the process control module receives an instruction that the package was filled improperly and the package is transferred to the correction station and then the assembly station. In yet another example, the process control module receives an instruction that the preliminary package was properly filled and the package is conveyed to the assembly station.
  • At block 2122, the assembly station begins the process of placing the preliminary packages in the illustrative box container. In the illustrative embodiment, the illustrative box container is configured to accommodate a 30-day supply of medication. The box container is also configured to receive a label that indicates the time of day or interval during which the medications within the pouches are to be consumed, e.g. morning, noon, evening, or bedtime. The illustrative box container is then glued or sealed. Alternatively, the preliminary packages may be placed in a child-resistant container.
  • The final package is then assembled at block 2124. In the illustrative embodiment, the final package includes three boxes, in which each box is associated with a particular time of day. The illustrative time of day include morning, noon and evening. Additionally, the final package may include package inserts or a patient information sheet (PIS) and a detailed label that describes each of the medications.
  • The final package assembly may be performed by an automated means that reviews the prescription and labels, confirms that the appropriate inspections were performed for each preliminary package, confirms that the appropriate level of review by a pharmacist or technician has been performed, confirms that each container was sealed, and checks to see that the proper package insert was generated. By way of example and not of limitation, the package inserts have detailed information about indications, warnings, precautions, side effects, dosage, administration, and clinical pharmacology. The package inserts may also include summaries of the various medications being taken, and summaries of the side effects, and the associated administration. Although the package inserts are written primarily for a physician and pharmacist, the package inserts may be simplified so that they are easier for patients and caregivers to understand.
  • In certain instances, the final package may also include the PRN medications. PRN medications are consumed on an as-needed basis. Most often PRN medications are analgesics such as Tylenol®, laxatives, sleeping aids, and similar medications.
  • The pouches further enable the reuse of rejected pouches in the process of FIG. 21 or medications unused by patients. That is, the distribution of medications in pouches enables tablets within unused pouches to be added back into a pharmacy's inventory to be redistributed. An inspection station as described in patent application Ser. No. 13/473,304, entitled MULTIPLE INSPECTION SYSTEM AND METHOD THAT INSPECTS DIFFERENT MEDICATIONS that is hereby incorporated by reference, and associated with the inspection process of FIG. 21, may be used for the processing of rejected medications.
  • In one embodiment, pouches may be rejected during the various inspection processes performed during the automated filling of a multiple prescription order. The inspection processes may be a manual process, where a pharmacist or other suitable personnel visually inspects the contents of pouches to verify that the pouches include the right medications, and that the medications are correctly associated with a particular patient. A pouches may be rejected because it does not have the right medications or because it does not have the right dosage for the medications.
  • The illustrative inspection systems and methods described in copending patent application Ser. No. 13/473,304 include multiple inspection stations, in which each inspection station generates an inspection result state that is analyzed by a multi-inspection analytical module. In one embodiment, the multi-inspection analytical module is associated with an inspection control process module.
  • In general, the inspection station compares the expected medication value to the measured medication value to generate an inspection result state. The inspection result state includes a positive inspection result state, a negative inspection result state, and an inconclusive inspection result state. The inspection result state may be associated with identifying that a tablet or medication is broken, compromised, or there are too many tablets being dispensed at one particular time in a particular package.
  • At least two inspection result states are then analyzed by the multi-inspection analytical module. The multi-inspection analytical module then proceeds to select one of a plurality of post-inspection states that convey the package to one of a manual inspection station, a correction station, or an assembly station.
  • By analyzing two or more inspection processes, the systems and methods described herein reduce the uncertainty about the correctness of the container filling and improve accuracy. The two or more inspection processes may be physically combined in the same housing or may operate as separate physical inspection stations. In the illustrative embodiment, the multiple inspection analysis operates by using a decision table to determine the post-inspection state.
  • The inspection may be conducted by measuring the physical characteristics of tablets using analytical methods, including but not limited to, 2D visual light sensor (camera or video), 3D visual light sensor, precision weighing, X-ray, near infrared, magnetic resonance imaging, ultrasound, laser excitation, raman spectroscopy, fluorescence spectroscopy, and other such analytical chemical methods. Additionally, precision counting systems that employ a sensor with a photo resistor to detect a light beam broken by a tablet may also be used as an inspection process. Furthermore, an inspection station may be dedicated to identifying RFID codes or other such machine readable representation of data associated with one or more medications or tablets.
  • The illustrative inspection properties provide quantitative results or qualitative results. Qualitative inspection properties ask the basic question of “what” is present. Quantitative inspection properties ask the basic question of “how much” of each. Qualitative analysis gives an indication of the identity of the chemical species in a sample. Quantitative analysis determines the amount of each compound. Additionally, as described herein, algorithmic processes can be applied to qualitative measurements that result in a quantitative value. For example, an optical system relying on visible light performs a quantitative analysis of tablet size, shape and color. An algorithm may then be applied that would count the number of tablets, thereby providing a quantitative measurement.
  • Pouches which fail to pass the various inspection processes may be directed to a correction station. In the correction station, the rejected pouches may be corrected manually by a technician who may manually retrieve the correct medications and manually create a pouches with the correct medications. The technician may also instruct the filling system to generate one or more additional pouches with the correct medications.
  • In yet another embodiment, the pouches may be directed to a recycle station. The recycle station may use automated means to open the rejected pouches, to pour the contents of the rejected packages into a sorting bin or chute, and to sort the contents of the sorting bin. The sorting results in the medications being added to the pharmacy's inventory. For example, the sorting bin may use automated means to determine that the sorting bin includes medications A and B, and subsequently direct medications A and B to the pharmacy's stock of medications A and B so that these medications may be used for other prescriptions.
  • In yet another embodiment, medications which were not consumed by a patient may be returned to the pharmacy. Since the medications are stored within individual sealed pouches or sealed cups, it serves as proof that the returned medications were not tampered with or came in contact with the patient. These pouches may then be directed to the recycle station to enable the medications to be reused for other prescriptions.
  • It is to be understood that the detailed description of illustrative embodiments provided for illustrative purposes. The scope of the claims is not limited to these specific embodiments or examples. Various structural limitations, elements, details, and uses can differ from those just described, or be expanded on or implemented using technologies not yet commercially viable, and yet still be within the inventive concepts of the present disclosure. The scope of the invention is determined by the following claims and their legal equivalents.

Claims (20)

What is claimed is:
1. A child-resistant container comprising:
a receptacle;
an open neck projecting from the receptacle defining an opening, wherein the neck includes an outer surface and at least one thread formed on the outer surface of the neck, wherein the thread has a predetermined thickness along its length;
a cap configured to interface with the neck of the receptacle, the cap including,
a top surface;
a skirt adjacent to the top surface and defining an opening received by the neck of the receptacle;
a second thread on an inner surface of the skirt for complementary engagement with the thread of the neck of the receptacle;
a sawtooth projection is on the inner surface of the skirt;
wherein the cap is configured to be rotatably screwed onto the neck of the receptacle; and
a plurality of preliminary packages that are received by the receptacle, wherein each preliminary package includes a plurality of tablets associated with a multiple prescription order that indicates when the tablets are to be consumed; and
a label is disposed on the receptacle and associated with the multiple prescription order.
2. The child-resistant container of claim 1 wherein the label includes a description of the plurality of tablets and a barcode associated with a particular patient consuming the plurality of tablets.
3. The child-resistant container of claim 1 wherein the preliminary packages include a plurality of pouches that form a strip of separably coupled pouches.
4. The child-resistant container of claim 3 wherein each pouch among the plurality of pouches includes a bar code for tracking medications within each pouch.
5. The child-resistant container of claim 3 wherein each pouch includes a pouch label with at least a name for each medication within the pouch and a dosage for each medication within the pouch.
6. The child-resistant container of claim 5 wherein the label includes a particular dosing interval for consuming the medications within the pouch.
7. The child-resistant container of claim 5 wherein the label includes information about the patient.
8. A child-resistant container comprising:
a receptacle;
an open neck projecting from the receptacle defining an opening, wherein the neck includes an outer surface and at least one thread formed on the outer surface of the neck, wherein the thread has a predetermined thickness along its length;
a cap configured to interface with the neck of the receptacle, the cap including,
a top surface;
a skirt adjacent to the top surface and defining an opening received by the neck of the receptacle;
a second thread on an inner surface of the skirt for complementary engagement with the thread of the neck of the receptacle;
a sawtooth projection is on the inner surface of the skirt;
wherein when the cap is configured to be rotatably screwed onto the neck of the package;
a locking mechanism wherein the sawtooth projection of the cap holds the thread of the neck of the receptacle;
a plurality of preliminary packages that are received by the receptacle, wherein each preliminary package includes a plurality of tablets associated with a multiple prescription order that indicates when the tablets are to be consumed; and
a label is disposed on the receptacle and associated with the multiple prescription order.
9. The child-resistant container of claim 8 wherein the label includes a description of the plurality of tablets and a barcode associated with a particular patient consuming the plurality of tablets.
10. The child-resistant container of claim 8 wherein the preliminary packages include a plurality of pouches that form a strip of separably coupled pouches.
11. The child-resistant container of claim 10 wherein each pouch among the plurality of pouches includes a bar code for tracking medications within each pouch.
12. The child-resistant container of claim 10 wherein each pouch includes a pouch label with at least a name for each medication within the pouch and a dosage for each medication within the pouch.
13. The child-resistant container of claim 12 wherein the label includes a particular dosing interval for consuming the medications within the pouch.
14. The child-resistant container of claim 12 wherein the label includes information about the patient.
15. A method for packaging a multiple prescription order, the method comprising:
receiving at a server an order for tablets comprising an order for at least one type of prescription tablet and a selection of a child-resistant packaging;
generating with the server instructions for filling a plurality of pouches within the child-resistant packaging;
filling by automated means the plurality of pouches with the at least one type of prescription tablet;
printing by automated means a plurality of labels on the plurality of pouches, wherein each label includes information indicating the time at which the contents of each pouches among the plurality of pouches are to be consumed; and
packaging by automated means the plurality of pouches within the child-resistant packaging.
16. The method of claim 15, wherein the plurality of labels include a description of the plurality of tablets and a barcode associated with a particular patient consuming the order of tablets.
17. The method of claim 15, wherein each pouches among the plurality of pouches includes a bar code for tracking medications within each pouches.
18. The method of claim 15, wherein the plurality of labels include at least a name of each medication within each pouches and a dosage of each medication within each pouches.
19. The method of claim 15, wherein the plurality of labels include information about the patient.
20. The method of claim 15, wherein the plurality of pouches form a strip of separably coupled pouches, wherein the strip includes a prescription tablet pouches, a non-prescription tablet pouches, and a header label coupled to the prescription tablet pouches.
US13/710,176 2004-10-01 2012-12-10 Child Resistant Packaging for Multi-Prescription Order Abandoned US20130161207A1 (en)

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