US20210027307A1 - Apparatus, System and Method for Facilitating Tracking of Consumable Pharmaceutical Articles - Google Patents
Apparatus, System and Method for Facilitating Tracking of Consumable Pharmaceutical Articles Download PDFInfo
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- US20210027307A1 US20210027307A1 US16/976,467 US201916976467A US2021027307A1 US 20210027307 A1 US20210027307 A1 US 20210027307A1 US 201916976467 A US201916976467 A US 201916976467A US 2021027307 A1 US2021027307 A1 US 2021027307A1
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Definitions
- the present disclosure relates to facilitating the tracking of the chain of custody of individual consumable articles. More particularly, the present disclosure relates to an apparatus, system and method for applying unique identifiers to individual pharmaceutical articles at a point of sale.
- the opioid overdose crisis has reached epidemic levels. Nearly half of all opioid deaths involved prescription opioids. More people currently die from overdoses than they do from guns and cars. What is needed are new, more effective, cost-effective solutions for fighting the growing opioid crisis.
- inventions of a new apparatus, system and method for implementation partially or entirely within a pharmaceutical point-of-sale location.
- Such apparatus, system and method involve application of indelible identifiers onto, for example, tablets and capsules at the point of sale or dispensation (e.g., pharmacies and clinics).
- indelible identifiers may include, for example, text, bar codes, an image of the patient's face, an RFID tag, a combination thereof or the like.
- This technology allows unique identifiers to be applied on each pharmaceutical article (e.g., pill, tablet or capsule) at the time it is dispensed, without damaging the originally-manufactured article, thereby providing for prescription and patient traceability, and a tool to help curb drug counterfeiting and drug overdose.
- a unique identification e.g., patient name, prescription number, etc.
- imprinting a unique identification on each opioid dosage could allow local and federal law enforcement, through the use of a database, to identify and trace each prescription back to the original patient and their prescribing doctor.
- FIG. 1 is a diagrammatic perspective view of one non-limiting example of a portable point-of-sale marking apparatus in accordance with the present disclosure, wherein all or portions of the control electronics and network communication element are disposed externally of the enclosure;
- FIG. 2 illustrates various non-limiting examples of discreet consumable pharmaceutical articles with indelible identifiers in accordance with the present disclosure
- FIG. 3 is a diagrammatic perspective view of one non-limiting example of a tray element with pockets in accordance with the present disclosure
- FIG. 4 is a diagrammatic perspective view of one non-limiting example of a tray element in accordance with the present disclosure being transported between a loading position and an application position;
- FIG. 5 is a diagrammatic partial front view of the apparatus of FIG. 1 , wherein the tray element is shown in an application position;
- FIG. 6 is a diagrammatic cross-sectional side view of another non-limiting example of a portable point-of-sale marking apparatus in accordance with the present disclosure, wherein the control electronics and network communication element are disposed internally of a unitary enclosure, and the apparatus is shown in electrical communication with a patient camera and a remote database;
- FIG. 7 is a schematic view of one non-limiting example of a system and method for facilitating tracking of consumable pharmaceutical articles in accordance with the present disclosure
- FIG. 8 is a diagrammatic partial cross-sectional side view of one non-limiting example of an apparatus in accordance with the present disclosure, wherein the tray element includes a funnel portion and is upwardly-rotatable with respect to a shuttle element;
- FIG. 9 is a diagrammatic partial cross-sectional side view similar to that of FIG. 8 , but wherein the tray element is shown transported to the loading position by way of the shuttle element;
- FIG. 10 is a diagrammatic partial cross-sectional side view similar to that of FIG. 9 , but wherein the tray element is shown in an upwardly-rotated position thereby enabling consumable articles to be transported from respective pockets to a funnel portion by way of gravity;
- FIG. 11 is a diagrammatic plan view taken along direction 11 of FIG. 10 ;
- FIG. 12 is a diagrammatic partial cross-sectional side view of one non-limiting example of an apparatus in accordance with the present disclosure, wherein the transport subsystem includes a shuttle element slidable with respect to the enclosure and configured to releasably support the tray element, and the transport subsystem includes a spring element for resiliently biasing the shuttle element toward placing the tray element in the loading position;
- FIG. 13 is a diagrammatic partial cross-sectional view similar to that of FIG. 12 , but wherein the shuttle element is shown in an extended position so as to place the tray element in the loading position, and the removability of the tray element from the shuttle element is illustrated;
- FIG. 14 is a diagrammatic partial cross-sectional top view of one non-limiting example of an apparatus in accordance with the present disclosure; wherein the shuttle element is rotatable with respect to the enclosure in turntable fashion to move the tray element between the loading position and the application zone;
- FIG. 15 is a diagrammatic side view of one non-limiting example of a tray element in accordance with the present disclosure, wherein the tray element is a pre-packaged blister pack housing a plurality of consumable articles in hermetically-sealed configuration, at least one side of the blister pack having a translucent or transparent layer through which the indelible identifier application is achievable without compromising the hermetic seal;
- FIG. 16 is a diagrammatic cross-sectional view of one non-limiting example of a consumable article in accordance with the present disclosure, comprising a layer of digestible material deposited onto a precursor OEM-manufactured pharmaceutical article by way of an apparatus in accordance with the present disclosure;
- FIG. 17 is a diagrammatic cross-sectional view of another non-limiting example of a consumable article in accordance with the present disclosure, wherein the article is a precursor OEM-manufactured pharmaceutical article encapsulated with a respective sensor sleeve by way of a presently-disclosed apparatus, the sensor sleeve having a sensor imbedded therein;
- FIG. 18 is a diagrammatic cross-sectional view of a further non-limiting example of a consumable article in accordance with the present disclosure, wherein the article is a precursor OEM-manufactured pharmaceutical article with one or more layers of a marking substrate composition deposited onto the article by way of a presently-disclosed apparatus;
- FIG. 19 is a diagrammatic perspective view of one non-limiting example of a randomized article marking system in accordance with the present disclosure.
- FIG. 20 is a diagrammatic cross-sectional view of portions of the example marking system of FIG. 19 ;
- FIG. 21 is a diagrammatic top view of an inspection camera a field of view of a randomized article marking system in accordance with the present disclosure, such as the system of FIG. 19 , wherein any overlapping articles in the application zone have been detected and then agitated to become non-overlapping;
- FIG. 22 is a diagrammatic top view of an inspection camera field of view similar to that of FIG. 21 , but wherein the application zone is illuminated in such a way as to produce hotspots which may undesirably hinder accurate detection of the shapes of each of the articles within the application zone;
- FIG. 23 is a diagrammatic top view of an inspection camera field of view similar to that of FIG. 22 , but wherein the application zone is illuminated without hotspots (e.g., by way of diffused lights, filters, and/or software tools) in order to facilitate accurate identification of the shape of each article within the application zone;
- hotspots e.g., by way of diffused lights, filters, and/or software tools
- FIG. 24 is a diagrammatic top view of a portion of an inspection camera field of view similar to that of FIG. 22 , but wherein a software process is used to find an origin and orientation of each article within the application zone;
- FIG. 25 is a diagrammatic flow chart of one example implementation of a method for facilitating tracking of consumable pharmaceutical articles in accordance with the present disclosure.
- a portable point-of-sale marking apparatus 100 for applying indelible identifiers 106 onto discreet consumable pharmaceutical articles 104 may comprise an enclosure 108 , a transport subsystem 110 , an identifier application subsystem 112 and an inspection element 114 .
- the transport subsystem 110 may have a tray element 116 transportable between a loading position (see, for example, FIG. 9 ) and an application position (see, for example, FIG. 8 ).
- the tray element 116 may have a multiplicity of pockets 118 each configured to receive a respective said article 104 , wherein (a) when the tray element 116 is in the application position (see, for example FIG. 6 ), its pockets 118 are located within an application zone 120 internal to the enclosure 108 , and (b) when the tray element 116 is in the loading position (see, for example, FIG. 4 ), its pockets 118 are located externally to the enclosure 108 .
- the identifier application subsystem 112 may be positioned within the enclosure 108 for applying an indelible identifier 106 onto each said article 104 within the application zone 120 .
- the inspection element 114 may be positioned within the enclosure 108 and may be configured to verify the quality of the indelible identifier 106 applied onto each respective article 104 .
- the inspection element 114 may be, or may include, an inspection camera.
- the identifier application subsystem 112 may include a transmission element 122 (e.g., a laser transmission element) configured to direct a steered beam 124 (e.g., of UV laser energy) toward the application zone 120 for marking an indelible image 106 onto each said article 104 within the application zone 120 .
- the identifier application subsystem 112 may further include a beam optics element 182 optically disposed between the laser transmission element 122 and a beam scanning element 180 .
- Control electronics 186 may be programmed to control and receive data from some or all of the electronic components of the apparatus 100 , such as the laser transmission element 122 , beam scanning element 180 and inspection element 114 .
- a debris vacuum hose 184 may be in debris-evacuating communication between the application zone 120 and the ambient environment external to the enclosure 108 .
- the enclosure 108 may be unitary, meaning it may define a single cavity within which all of the components of the apparatus 100 are housed.
- the cavity may or may not be partitioned, for example, to provide internal mounting structures or airflow channels.
- the enclosure may include a lift handle portion 218 to facilitate movement of the apparatus 100 within the point-of-sale location 102 by, for example, one person.
- the transport subsystem 110 may include a handle portion 188 by which the tray element 116 is manually transportable between the loading position and the application position.
- the transport subsystem 110 may include a shuttle element 126 slidable with respect to the enclosure 108 and configured to releasably support the tray element 116 .
- the apparatus 100 may include a tray identification reader 128 , and the tray element may include a tray identification element 130 readable by the tray identification reader 128 .
- the apparatus or system may include a plurality of tray elements 116 .
- the pockets 118 of each of said plurality of tray elements 116 may have a different size (e.g., width, length, diameter or a combination thereof) compared to the pockets 118 of the other tray elements 116 in the same plurality.
- the shuttle element 116 may be axially slidable with respect to the enclosure 108 . Such axial slidability may be along a slide axis 190 .
- the transport subsystem 110 may include a spring element 134 for resiliently biasing the shuttle element 126 toward placing the tray element 116 in the loading position.
- the transport subsystem 110 may include a latch element 136 for releasably retaining the tray element 116 in the application position.
- the shuttle element 126 may be rotatable with respect to the enclosure 108 in turntable fashion so as to transport one or more tray elements 116 into and out of the application zone 120 .
- the tray element 116 includes a funnel portion 138 ; (b) the tray element 116 is upwardly-rotatable with respect to the shuttle element 126 when releasably supported thereby; and (c) the upward rotation 140 is configured to enable consumable articles 104 to be transported from respective said pockets 118 to the funnel portion 138 by way of gravity.
- the tray element 116 may include a rotation handle element 142 to manually facilitate the upward rotation.
- the enclosure 108 may include an application zone window portion 144 disposed between the application zone 120 and the loading position.
- the application zone window portion 144 may be configured to enable a naked eye of a human to view the occurrence of the application (e.g., involving transmission of laser energy) from a viewpoint 146 outward of the enclosure 108 without causing damage to the eye.
- particular preferred embodiments of the apparatus 100 may further comprise a network communication element 148 configured to be placed in network communication with a remote database element 150 .
- the remote database element 150 may be configured to be in data-receiving communications with a pharmaceutical manufacturer 176 or distributor 176 , thereby collectively forming an embodiment of a tracking system 178 in accordance with the present disclosure.
- the remote database element 150 may be placed (or configured to be placed) in network communication with a law enforcement scanning tool 156 , thereby collectively forming an alternate embodiment of a system 178 in accordance with the present disclosure.
- Such scanning tool 156 may be configured to read the indelible identifier 106 and indicate whether the indelible identifier corresponds to the patient to whom the respective article was legitimately prescribed and sold.
- the indelible identifier 106 may include article identifier data unique to the article 104 upon which it is applied.
- the article identifier data may include patient data for identifying a patient 220 to whom the respective article was prescribed and sold.
- the article identifier data may include prescriber data for identifying a prescriber 132 by whom the respective article was prescribed.
- the article identifier data may include prescription data for identifying the prescription number under which the respective article was sold.
- certain embodiments of the apparatus 100 may further comprise a layer-depositing element 158 for depositing one or more layers 160 of digestible material into the articles 104 .
- the one or more layers 160 may be configured to indicate whether and when the articles 104 have been consumed by a patient.
- the identifier application subsystem 112 may include a sleeve-encapsulation element 162 for encapsulating each of the articles 104 with a respective sensor sleeve 164 , the sensor sleeves 164 each having a sensor 166 imbedded therein.
- the identifier application subsystem 112 may include a marking layer applicator 168 by which the indelible identifier 106 is applied onto each said article within the application zone.
- the marking layer applicator 168 may be configured to deposit one or more layers of a marking substrate composition 170 onto each said article 104 within the marking zone 120 .
- the marking substrate composition 170 may comprise, for example, Titanium Dioxide or the like.
- the deposition may be by way of, for example, a spraying operation. Referring to FIG.
- the identifier application subsystem 112 may include a laser transmission element 122 configured to direct a steered beam 124 of UV laser energy toward the application zone 120 for marking an indelible image 106 onto the marking substrate composition 170 deposited onto each said article within the application zone 120 .
- the indelible identifiers 106 may be or include optically-viewable indelible images.
- each indelible image may include a facial image 172 of the respective patient 220 to whom the article was prescribed.
- the apparatus 100 may include or be configured to be placed in communication with a patient camera subsystem 174 for obtaining the facial image 172 at the point-of-sale location 102 .
- the indelible identifier 106 may include an RFID tag and the inspection element 114 may include an RFID reader.
- the discrete consumable articles 104 are defined as each comprising a precursor electrically-conductive layer prior to coming into contact with the apparatus 100 ; and (b) the application subsystem 112 includes a laser transmission element 122 configured to direct a steered beam of laser energy 124 toward the application zone 120 for (i) marking an indelible image 106 onto each said article within the application zone 120 ; and (ii) etching into the precursor electrically-conductive layer to form an RFID tag.
- the tray element 116 may be or include an original equipment manufactured (OEM) pre-packaged blister back housing a plurality (e.g., an array) of said articles 104 in hermetically-sealed configuration, at least one side of the blister pack having a translucent or transparent layer 192 through which the indelible identifier application is achievable without compromising (e.g., breaking) the hermetic seal.
- the transport subsystem 110 may also include a shuttle element 126 slidable with respect to the enclosure 108 and configured to releasably support the tray element (e.g., as shown in FIG. 13 ).
- a system and method in accordance with the present disclosure may facilitate or comprise a series of steps.
- a manufacturer 176 of pharmaceutical articles e.g., opioid drugs
- may supply the drug information e.g., manufacturing date, lot, expiration date, shipping date, etc.
- the database element 150 may also receive information from any distribution point between the manufacturer 176 and the point-of-sale 102 (e.g., dispensing pharmacy or clinic). This step may operate, for example, similarly to a conventional courier tracking system.
- the pharmacy 102 may upload all the relevant data (e.g., prescribing physician 132 and patient names, addresses, drug quantity, etc.) into the same database element 150 .
- the dispensing pharmacy 102 may then use the apparatus 100 to mark every solid dosage form (e.g., article 104 ) with a unique indelible identifier 106 linked to (associated with) the prescription.
- such indelible identifier 106 may be, for example, a picture, a 2D code, an alphanumerical code, a cipher or any other combination of visible and/or invisible information (e.g., RFID).
- the dispensing pharmacy may then upload the identifier into the database element 150 , thereby completing the cycle.
- the method may include an option for an automated subprocess whereby, for example, a prescribing physician enters a prescription into the database which randomly generates the UNIQUE ID, and the pharmacy then uses the apparatus 100 to mark this ID on every tablet/capsule while filling the prescription.
- the end user e.g., patient
- other authorized personnel e.g., nurse in the hospital, policemen on the street
- can scan the tablet ID with an appropriate scanning device 156 e.g., a cell phone
- an appropriate scanning device 156 e.g., a cell phone
- a database element 150 as described herein may comprise one or more processor elements, and one or more corresponding database components or memory storage devices, each of which may be located geographically remotely from one another.
- one or more of the portable point-of-sale marking apparatuses 100 in accordance with the present disclosure may be configured to incorporate a randomized article marking system 200 in which a plurality of articles 104 can be randomly placed on the tray element 116 (e.g., by hand or by hopper mechanism) having a tray coordinate system 202 , and then analyzed and marked by the system 200 in situ (i.e., without requiring the articles to be organized in an ordered array prior to marking).
- a randomized article marking system 200 in which a plurality of articles 104 can be randomly placed on the tray element 116 (e.g., by hand or by hopper mechanism) having a tray coordinate system 202 , and then analyzed and marked by the system 200 in situ (i.e., without requiring the articles to be organized in an ordered array prior to marking).
- an inspection camera 114 may obtain a first inspection image of the marking zone 120 within its field of view 206 .
- the preliminary inspection image may then be analyzed (e.g., via one or more software modules) to determine various characteristics of the articles 104 .
- the first inspection image e.g., the image shown in FIG.
- each article 104 present within the marking zone 120 may be used assign a unique article identifier (e.g., alphanumeric) to each article 104 present within the marking zone 120 , and to determine the respective article's X-Y position 210 , angular orientation 212 (e.g., within the X-Y plane), shape, size, color and/or texture. These characteristics may then be stored as unique article datasets (e.g., in a dataset storage memory element), wherein each article dataset corresponds to a different article 104 within the marking zone 120 during the same inspection/marking cycle.
- a unique article identifier e.g., alphanumeric
- the article dataset may then be used to produce a field marking image (e.g., by way of a respective marking image software module) to determine where and how the marking beam 124 should be activated and steered within the marking zone 120 in order to apply the proper markings (e.g., by way of laser transmission element 122 , beam optics element 182 , and beam scanning element 180 ) to each respective article 104 .
- the inspection camera 114 may be configured to obtain a second inspection image to verify that each of the articles within the marking zone 120 were correctly marked and that the number of marked articles present within the applications/marking zone 120 (i.e., a batch) are counted.
- This article count may be recorded in a memory element configured to be in communication with or forming part of the control electronics 186 . Additionally, or in the alternative, the article count may be recorded in a memory element configured to be in communication with or forming part of the remote database 150 . Moreover, depending upon the particular embodiment of the apparatus 100 , the inspection camera 114 may be configured or directed (i.e., by the control electronics 186 ) to obtain a count of the total number of articles 104 present within the application/marking zone 120 , before, during and/or after the marking of all of the articles 104 present in the application/marking zone 120 has occurred. The apparatus 100 may be configured such that the article count corresponding to a particular batch of articles 104 may be printed onto a container in which the batch of marked articles will be placed for storage within the pharmacy or dispensing to the patient or the patient's care facility.
- embodiments of a randomized article marking system 200 may include one or more agitation elements 204 to ensure that none of the articles within the marking zone 120 overlap.
- Such agitation elements 204 may include, for example, a laterally-moving or circularly-moving blade or brush configured to sweep over the articles at a pre-determined height, or (as shown in FIG. 20 ) a vibration element 204 for momentarily vibrating the tray element 116 .
- these agitation elements may be employed as a matter of course regardless of whether an overlapping of the articles 104 has initially been detected.
- embodiments of the system 200 may be configured to obtain a preliminary inspection image (e.g., preceding the first inspection image mentioned above) to determine any of the articles 104 in the marking zone 120 appear to be overlapping with another article 104 (see, e.g., overlapping/elevated article 104 a ). If it is determined that overlapping has or may have occurred, agitation element 204 may then be activated. A post-agitation image may also be obtained in order to verify that no instances of overlapping remain (see, e.g., FIG. 21 ) within the marking zone 120 .
- a lateral boundary wall 214 may be provided to retain the articles on the tray 116 during, for example, agitation. The boundary wall be an integral part of the tray 116 , or may be a separate component positioned in proximity to the periphery of the tray 116 .
- the application/marking zone 120 may be illuminated by a field illumination element 208 .
- the illumination element 208 may include diffused lights, filters, and/or software tools, in order to facilitate accurate identification of the shape of each article 104 within the application zone.
- a software process may be used to determine an X-Y origin 210 and orientation 212 of each article 104 within the application zone.
- a randomized article marking system 200 may be configured to mark multiple different shapes and types of articles within the same marking or application zone 120 during the same inspection/marking cycle.
- the system 200 may be capable of using the first inspection image to identify pharmaceutical tablets 104 of different types based on their shape, color and/or texture. This information may then be compared to a database (internal or external to the system 200 ) to allow the system 200 to identify the pharmaceutical composition of the respective tablets 104 . This pharmaceutical composition information may then be used as a factor in controlling what indelible identifier 106 is marked into the respective article 104 .
- a remote database element 150 may be provided which is configured to be in network communication with a marking apparatus 100 located in a pharmaceutical dispensary 102 .
- the pharmaceutical dispensary 102 may be a point-of-sale location at which the patient is dispensed the prescribed quantity of articles 104 (e.g., a pharmacy or hospital).
- a remote database element 150 may acquire drug information pertaining to each of a manufactured quantity of consumable pharmaceutical articles.
- the remote database element 150 may receive prescription data defined by a prescription issued from a prescriber 132 to a respective patient.
- This prescription data may include, for example, (a) a prescription quantity defining the number of said consumable pharmaceutical articles prescribed to the respective patient; and (b) a patient identifier (e.g., the patient's name) uniquely corresponding to the respective patient.
- the step of receiving may be by way of network communication between the prescriber 132 and the remote database element 150 .
- the prescription quantity of articles would typically comprise a subset of the manufactured quantity of articles.
- the remote database element 150 may record a digital image of an indelible identifier 106 applied by way of the marking apparatus 100 to each of the consumable pharmaceutical articles 104 in the prescription quantity.
- the digital image may preferably be recorded in correspondence with some or all of the prescription data.
- the digital image may be generated by the marking apparatus 100 and obtained by the remote database element 150 prior to the step of recording.
- the digital image may be, for example, a graphical reproduction of the indelible identifier (e.g., as raster or vector image data) or some other optically-readable or signal-readable data format that informationally mirrors the indelible identifier.
- the indelible identifier 106 may be configured to be readable by a scanning tool 156 configured to thereby display some or all of the prescription data associated with the respective consumable pharmaceutical article 104 .
- the indelible identifier 106 may preferably be an alpha-numeric code, photo image (e.g., the face of the patient), a bar code, a QR code, a cipher, an RFID code some combination thereof or the like.
- the indelible identifier 106 is preferably uniquely associated with the respective prescription.
- the drug information may include one or more of the following: manufacturing date, a lot number, an expiration date and a shipping date.
- the drug information may be acquired from a distributor or manufacturer 176 of the manufactured quantity by way of network communication with the remote server element 150 .
- the prescription data may further include one or more of the following: name of the prescriber 132 , name of the patient 220 , address of the patient, location of the pharmaceutical dispensary, prescription number, article dosage (e.g., strength) and article expiration date.
- the remote database element 150 may generate the digital image.
- the remote database element 150 may then provide the digital image to the marking apparatus 100 for application of the indelible identifier onto or within the articles 104 .
- the remote database element 150 may be configured to be placed in network communication with the scanning tool 156 to thereby provide the prescription data to the scanning tool for the display of the prescription data.
Abstract
Description
- This application claims the benefit of U.S. Provisional Application No. 62/636,819 filed Feb. 28, 2018, and U.S. Provisional Application No. 62/714,089 filed Aug. 3, 2018, the contents of each of which are incorporated by this reference in their entireties for all purposes as if fully set forth herein.
- The present disclosure relates to facilitating the tracking of the chain of custody of individual consumable articles. More particularly, the present disclosure relates to an apparatus, system and method for applying unique identifiers to individual pharmaceutical articles at a point of sale.
- The opioid overdose crisis has reached epidemic levels. Nearly half of all opioid deaths involved prescription opioids. More people currently die from overdoses than they do from guns and cars. What is needed are new, more effective, cost-effective solutions for fighting the growing opioid crisis.
- Certain deficiencies of the prior art are overcome by the provision of embodiments of a new apparatus, system and method for implementation partially or entirely within a pharmaceutical point-of-sale location. Such apparatus, system and method involve application of indelible identifiers onto, for example, tablets and capsules at the point of sale or dispensation (e.g., pharmacies and clinics). Examples of indelible identifiers may include, for example, text, bar codes, an image of the patient's face, an RFID tag, a combination thereof or the like. This technology allows unique identifiers to be applied on each pharmaceutical article (e.g., pill, tablet or capsule) at the time it is dispensed, without damaging the originally-manufactured article, thereby providing for prescription and patient traceability, and a tool to help curb drug counterfeiting and drug overdose. Preferably, imprinting a unique identification (e.g., patient name, prescription number, etc.) on each opioid dosage, could allow local and federal law enforcement, through the use of a database, to identify and trace each prescription back to the original patient and their prescribing doctor.
- Further advantages of the present invention may become apparent to those skilled in the art with the benefit of the following detailed description of the preferred embodiments and upon reference to the accompanying drawings in which:
-
FIG. 1 is a diagrammatic perspective view of one non-limiting example of a portable point-of-sale marking apparatus in accordance with the present disclosure, wherein all or portions of the control electronics and network communication element are disposed externally of the enclosure; -
FIG. 2 illustrates various non-limiting examples of discreet consumable pharmaceutical articles with indelible identifiers in accordance with the present disclosure; -
FIG. 3 is a diagrammatic perspective view of one non-limiting example of a tray element with pockets in accordance with the present disclosure; -
FIG. 4 is a diagrammatic perspective view of one non-limiting example of a tray element in accordance with the present disclosure being transported between a loading position and an application position; -
FIG. 5 is a diagrammatic partial front view of the apparatus ofFIG. 1 , wherein the tray element is shown in an application position; -
FIG. 6 is a diagrammatic cross-sectional side view of another non-limiting example of a portable point-of-sale marking apparatus in accordance with the present disclosure, wherein the control electronics and network communication element are disposed internally of a unitary enclosure, and the apparatus is shown in electrical communication with a patient camera and a remote database; -
FIG. 7 is a schematic view of one non-limiting example of a system and method for facilitating tracking of consumable pharmaceutical articles in accordance with the present disclosure; -
FIG. 8 is a diagrammatic partial cross-sectional side view of one non-limiting example of an apparatus in accordance with the present disclosure, wherein the tray element includes a funnel portion and is upwardly-rotatable with respect to a shuttle element; -
FIG. 9 is a diagrammatic partial cross-sectional side view similar to that ofFIG. 8 , but wherein the tray element is shown transported to the loading position by way of the shuttle element; -
FIG. 10 is a diagrammatic partial cross-sectional side view similar to that ofFIG. 9 , but wherein the tray element is shown in an upwardly-rotated position thereby enabling consumable articles to be transported from respective pockets to a funnel portion by way of gravity; -
FIG. 11 is a diagrammatic plan view taken alongdirection 11 ofFIG. 10 ; -
FIG. 12 is a diagrammatic partial cross-sectional side view of one non-limiting example of an apparatus in accordance with the present disclosure, wherein the transport subsystem includes a shuttle element slidable with respect to the enclosure and configured to releasably support the tray element, and the transport subsystem includes a spring element for resiliently biasing the shuttle element toward placing the tray element in the loading position; -
FIG. 13 is a diagrammatic partial cross-sectional view similar to that ofFIG. 12 , but wherein the shuttle element is shown in an extended position so as to place the tray element in the loading position, and the removability of the tray element from the shuttle element is illustrated; -
FIG. 14 is a diagrammatic partial cross-sectional top view of one non-limiting example of an apparatus in accordance with the present disclosure; wherein the shuttle element is rotatable with respect to the enclosure in turntable fashion to move the tray element between the loading position and the application zone; -
FIG. 15 is a diagrammatic side view of one non-limiting example of a tray element in accordance with the present disclosure, wherein the tray element is a pre-packaged blister pack housing a plurality of consumable articles in hermetically-sealed configuration, at least one side of the blister pack having a translucent or transparent layer through which the indelible identifier application is achievable without compromising the hermetic seal; -
FIG. 16 is a diagrammatic cross-sectional view of one non-limiting example of a consumable article in accordance with the present disclosure, comprising a layer of digestible material deposited onto a precursor OEM-manufactured pharmaceutical article by way of an apparatus in accordance with the present disclosure; -
FIG. 17 is a diagrammatic cross-sectional view of another non-limiting example of a consumable article in accordance with the present disclosure, wherein the article is a precursor OEM-manufactured pharmaceutical article encapsulated with a respective sensor sleeve by way of a presently-disclosed apparatus, the sensor sleeve having a sensor imbedded therein; -
FIG. 18 is a diagrammatic cross-sectional view of a further non-limiting example of a consumable article in accordance with the present disclosure, wherein the article is a precursor OEM-manufactured pharmaceutical article with one or more layers of a marking substrate composition deposited onto the article by way of a presently-disclosed apparatus; -
FIG. 19 is a diagrammatic perspective view of one non-limiting example of a randomized article marking system in accordance with the present disclosure; -
FIG. 20 is a diagrammatic cross-sectional view of portions of the example marking system ofFIG. 19 ; -
FIG. 21 is a diagrammatic top view of an inspection camera a field of view of a randomized article marking system in accordance with the present disclosure, such as the system ofFIG. 19 , wherein any overlapping articles in the application zone have been detected and then agitated to become non-overlapping; -
FIG. 22 is a diagrammatic top view of an inspection camera field of view similar to that ofFIG. 21 , but wherein the application zone is illuminated in such a way as to produce hotspots which may undesirably hinder accurate detection of the shapes of each of the articles within the application zone; -
FIG. 23 is a diagrammatic top view of an inspection camera field of view similar to that ofFIG. 22 , but wherein the application zone is illuminated without hotspots (e.g., by way of diffused lights, filters, and/or software tools) in order to facilitate accurate identification of the shape of each article within the application zone; -
FIG. 24 is a diagrammatic top view of a portion of an inspection camera field of view similar to that ofFIG. 22 , but wherein a software process is used to find an origin and orientation of each article within the application zone; and -
FIG. 25 is a diagrammatic flow chart of one example implementation of a method for facilitating tracking of consumable pharmaceutical articles in accordance with the present disclosure. - Referring now to the drawings, like reference numerals designate identical or corresponding features throughout the several views.
- With reference to the several drawings, a portable point-of-
sale marking apparatus 100 for applyingindelible identifiers 106 onto discreet consumablepharmaceutical articles 104 may comprise anenclosure 108, atransport subsystem 110, anidentifier application subsystem 112 and aninspection element 114. - The
transport subsystem 110 may have atray element 116 transportable between a loading position (see, for example,FIG. 9 ) and an application position (see, for example,FIG. 8 ). Referring toFIGS. 3, 4, 8 and 9 thetray element 116 may have a multiplicity ofpockets 118 each configured to receive a respective saidarticle 104, wherein (a) when thetray element 116 is in the application position (see, for exampleFIG. 6 ), itspockets 118 are located within anapplication zone 120 internal to theenclosure 108, and (b) when thetray element 116 is in the loading position (see, for example,FIG. 4 ), itspockets 118 are located externally to theenclosure 108. With reference toFIG. 6 , theidentifier application subsystem 112 may be positioned within theenclosure 108 for applying anindelible identifier 106 onto each saidarticle 104 within theapplication zone 120. Theinspection element 114 may be positioned within theenclosure 108 and may be configured to verify the quality of theindelible identifier 106 applied onto eachrespective article 104. Theinspection element 114 may be, or may include, an inspection camera. - Referring to
FIGS. 6 and 19 , in certain preferred embodiments of theapparatus 100 andsystem 200, theidentifier application subsystem 112 may include a transmission element 122 (e.g., a laser transmission element) configured to direct a steered beam 124 (e.g., of UV laser energy) toward theapplication zone 120 for marking anindelible image 106 onto each saidarticle 104 within theapplication zone 120. Theidentifier application subsystem 112 may further include abeam optics element 182 optically disposed between thelaser transmission element 122 and abeam scanning element 180.Control electronics 186 may be programmed to control and receive data from some or all of the electronic components of theapparatus 100, such as thelaser transmission element 122,beam scanning element 180 andinspection element 114. Adebris vacuum hose 184 may be in debris-evacuating communication between theapplication zone 120 and the ambient environment external to theenclosure 108. - Referring to
FIG. 6 for example illustration, in particular embodiments of theapparatus 100, theenclosure 108 may be unitary, meaning it may define a single cavity within which all of the components of theapparatus 100 are housed. The cavity may or may not be partitioned, for example, to provide internal mounting structures or airflow channels. Moreover, the enclosure may include alift handle portion 218 to facilitate movement of theapparatus 100 within the point-of-sale location 102 by, for example, one person. - Referring to
FIGS. 1, 5 and 6 for example illustration, in certain embodiments of theapparatus 100, thetransport subsystem 110 may include ahandle portion 188 by which thetray element 116 is manually transportable between the loading position and the application position. - Referring to
FIGS. 8-10 and 12-14 for example illustration, in particular embodiments of theapparatus 100, thetransport subsystem 110 may include ashuttle element 126 slidable with respect to theenclosure 108 and configured to releasably support thetray element 116. - Referring to
FIG. 6 for example illustration, theapparatus 100 may include atray identification reader 128, and the tray element may include atray identification element 130 readable by thetray identification reader 128. In this or other embodiments of theapparatus 100 orsystem 200, the apparatus or system may include a plurality oftray elements 116. In such case, thepockets 118 of each of said plurality oftray elements 116 may have a different size (e.g., width, length, diameter or a combination thereof) compared to thepockets 118 of theother tray elements 116 in the same plurality. - Referring to
FIGS. 8 and 9 , theshuttle element 116 may be axially slidable with respect to theenclosure 108. Such axial slidability may be along aslide axis 190. Referring toFIGS. 12 and 13 for example illustration, thetransport subsystem 110 may include aspring element 134 for resiliently biasing theshuttle element 126 toward placing thetray element 116 in the loading position. Thetransport subsystem 110 may include alatch element 136 for releasably retaining thetray element 116 in the application position. Alternatively, or in addition, as illustrated inFIG. 14 for example, theshuttle element 126 may be rotatable with respect to theenclosure 108 in turntable fashion so as to transport one ormore tray elements 116 into and out of theapplication zone 120. - Referring to
FIGS. 8-11 for example illustration, in certain preferred embodiments of the portable, point-of-sale marking apparatus 100, (a) thetray element 116 includes afunnel portion 138; (b) thetray element 116 is upwardly-rotatable with respect to theshuttle element 126 when releasably supported thereby; and (c) theupward rotation 140 is configured to enableconsumable articles 104 to be transported from respective saidpockets 118 to thefunnel portion 138 by way of gravity. In such an apparatus embodiment, thetray element 116 may include arotation handle element 142 to manually facilitate the upward rotation. - Referring to
FIG. 6 for example illustration, in certain preferred embodiments of theapparatus 100, theenclosure 108 may include an applicationzone window portion 144 disposed between theapplication zone 120 and the loading position. The applicationzone window portion 144 may be configured to enable a naked eye of a human to view the occurrence of the application (e.g., involving transmission of laser energy) from aviewpoint 146 outward of theenclosure 108 without causing damage to the eye. - Referring to
FIGS. 6 and 7 for example illustration, particular preferred embodiments of theapparatus 100 may further comprise anetwork communication element 148 configured to be placed in network communication with aremote database element 150. Theremote database element 150 may be configured to be in data-receiving communications with apharmaceutical manufacturer 176 ordistributor 176, thereby collectively forming an embodiment of atracking system 178 in accordance with the present disclosure. Alternatively, or in addition, theremote database element 150 may be placed (or configured to be placed) in network communication with a lawenforcement scanning tool 156, thereby collectively forming an alternate embodiment of asystem 178 in accordance with the present disclosure.Such scanning tool 156 may be configured to read theindelible identifier 106 and indicate whether the indelible identifier corresponds to the patient to whom the respective article was legitimately prescribed and sold. - The
indelible identifier 106 may include article identifier data unique to thearticle 104 upon which it is applied. The article identifier data may include patient data for identifying apatient 220 to whom the respective article was prescribed and sold. Alternatively, or in addition, the article identifier data may include prescriber data for identifying aprescriber 132 by whom the respective article was prescribed. Alternatively, or in addition, the article identifier data may include prescription data for identifying the prescription number under which the respective article was sold. - Referring to
FIGS. 6 and 16 , certain embodiments of theapparatus 100 may further comprise a layer-depositingelement 158 for depositing one ormore layers 160 of digestible material into thearticles 104. The one ormore layers 160 may be configured to indicate whether and when thearticles 104 have been consumed by a patient. - Referring to
FIGS. 6 and 17 , theidentifier application subsystem 112 may include a sleeve-encapsulation element 162 for encapsulating each of thearticles 104 with arespective sensor sleeve 164, thesensor sleeves 164 each having asensor 166 imbedded therein. - Referring to
FIG. 6 , theidentifier application subsystem 112 may include amarking layer applicator 168 by which theindelible identifier 106 is applied onto each said article within the application zone. Referring toFIG. 18 , themarking layer applicator 168 may be configured to deposit one or more layers of a markingsubstrate composition 170 onto each saidarticle 104 within the markingzone 120. The markingsubstrate composition 170 may comprise, for example, Titanium Dioxide or the like. The deposition may be by way of, for example, a spraying operation. Referring toFIG. 6 , theidentifier application subsystem 112 may include alaser transmission element 122 configured to direct a steeredbeam 124 of UV laser energy toward theapplication zone 120 for marking anindelible image 106 onto the markingsubstrate composition 170 deposited onto each said article within theapplication zone 120. - Referring to
FIG. 2 for example illustrations, theindelible identifiers 106 may be or include optically-viewable indelible images. In such case, each indelible image may include afacial image 172 of therespective patient 220 to whom the article was prescribed. Moreover, referring toFIG. 6 , in such embodiment, theapparatus 100 may include or be configured to be placed in communication with apatient camera subsystem 174 for obtaining thefacial image 172 at the point-of-sale location 102. - In particular embodiments of the apparatus, the
indelible identifier 106 may include an RFID tag and theinspection element 114 may include an RFID reader. - In particular embodiments of the a portable, point-of-
sale marking apparatus 100, (a) the discreteconsumable articles 104 are defined as each comprising a precursor electrically-conductive layer prior to coming into contact with theapparatus 100; and (b) theapplication subsystem 112 includes alaser transmission element 122 configured to direct a steered beam oflaser energy 124 toward theapplication zone 120 for (i) marking anindelible image 106 onto each said article within theapplication zone 120; and (ii) etching into the precursor electrically-conductive layer to form an RFID tag. - Referring to
FIG. 15 for example illustration, in particular embodiments of the portable, point-of-sale marking apparatus 100, thetray element 116 may be or include an original equipment manufactured (OEM) pre-packaged blister back housing a plurality (e.g., an array) of saidarticles 104 in hermetically-sealed configuration, at least one side of the blister pack having a translucent ortransparent layer 192 through which the indelible identifier application is achievable without compromising (e.g., breaking) the hermetic seal. In such an embodiment, thetransport subsystem 110 may also include ashuttle element 126 slidable with respect to theenclosure 108 and configured to releasably support the tray element (e.g., as shown inFIG. 13 ). - Referring to
FIG. 7 , a system and method in accordance with the present disclosure may facilitate or comprise a series of steps. By way of a non-limiting example, amanufacturer 176 of pharmaceutical articles (e.g., opioid drugs) may supply the drug information (e.g., manufacturing date, lot, expiration date, shipping date, etc.) to thedatabase element 150. Thedatabase element 150 may also receive information from any distribution point between themanufacturer 176 and the point-of-sale 102 (e.g., dispensing pharmacy or clinic). This step may operate, for example, similarly to a conventional courier tracking system. When thepharmacy 102 fills the prescription for a specific patient, that pharmacy may upload all the relevant data (e.g., prescribingphysician 132 and patient names, addresses, drug quantity, etc.) into thesame database element 150. The dispensingpharmacy 102 may then use theapparatus 100 to mark every solid dosage form (e.g., article 104) with a uniqueindelible identifier 106 linked to (associated with) the prescription. Referring toFIG. 2 , suchindelible identifier 106 may be, for example, a picture, a 2D code, an alphanumerical code, a cipher or any other combination of visible and/or invisible information (e.g., RFID). The dispensing pharmacy may then upload the identifier into thedatabase element 150, thereby completing the cycle. The method may include an option for an automated subprocess whereby, for example, a prescribing physician enters a prescription into the database which randomly generates the UNIQUE ID, and the pharmacy then uses theapparatus 100 to mark this ID on every tablet/capsule while filling the prescription. Finally, the end user (e.g., patient) or other authorized personnel (e.g., nurse in the hospital, policemen on the street) can scan the tablet ID with an appropriate scanning device 156 (e.g., a cell phone) in network communication with thedatabase element 150 and can determine what solid dosage form is under consideration and what it is intended for (e.g. date of manufacture, point of sale, physician and patient names, expiration date, etc.). - In one alternate embodiment of the method, the need for a database and scanning device may be eliminated and the dispensing pharmacy can just print, for example, a picture ID on each tablet. Other intermediate scenarios with incomplete or just local (e.g. hospital) databases are also possible. Notably, a
database element 150 as described herein may comprise one or more processor elements, and one or more corresponding database components or memory storage devices, each of which may be located geographically remotely from one another. - With reference to
FIGS. 19 and 20 , one or more of the portable point-of-sale marking apparatuses 100 in accordance with the present disclosure, or larger production-scale marking apparatuses with some or all of the same features and components as the portable version, may be configured to incorporate a randomizedarticle marking system 200 in which a plurality ofarticles 104 can be randomly placed on the tray element 116 (e.g., by hand or by hopper mechanism) having a tray coordinatesystem 202, and then analyzed and marked by thesystem 200 in situ (i.e., without requiring the articles to be organized in an ordered array prior to marking). Once a plurality ofarticles 104 are placed on thetray element 116, aninspection camera 114 may obtain a first inspection image of the markingzone 120 within its field ofview 206. The preliminary inspection image may then be analyzed (e.g., via one or more software modules) to determine various characteristics of thearticles 104. By way of example, referring toFIG. 24 , for eacharticle 104 present within the markingfield 120, the first inspection image (e.g., the image shown inFIG. 23 ) may be used assign a unique article identifier (e.g., alphanumeric) to eacharticle 104 present within the markingzone 120, and to determine the respective article's X-Y position 210, angular orientation 212 (e.g., within the X-Y plane), shape, size, color and/or texture. These characteristics may then be stored as unique article datasets (e.g., in a dataset storage memory element), wherein each article dataset corresponds to adifferent article 104 within the markingzone 120 during the same inspection/marking cycle. The article dataset may then be used to produce a field marking image (e.g., by way of a respective marking image software module) to determine where and how the markingbeam 124 should be activated and steered within the markingzone 120 in order to apply the proper markings (e.g., by way oflaser transmission element 122,beam optics element 182, and beam scanning element 180) to eachrespective article 104. Finally, theinspection camera 114 may be configured to obtain a second inspection image to verify that each of the articles within the markingzone 120 were correctly marked and that the number of marked articles present within the applications/marking zone 120 (i.e., a batch) are counted. This article count may be recorded in a memory element configured to be in communication with or forming part of thecontrol electronics 186. Additionally, or in the alternative, the article count may be recorded in a memory element configured to be in communication with or forming part of theremote database 150. Moreover, depending upon the particular embodiment of theapparatus 100, theinspection camera 114 may be configured or directed (i.e., by the control electronics 186) to obtain a count of the total number ofarticles 104 present within the application/marking zone 120, before, during and/or after the marking of all of thearticles 104 present in the application/marking zone 120 has occurred. Theapparatus 100 may be configured such that the article count corresponding to a particular batch ofarticles 104 may be printed onto a container in which the batch of marked articles will be placed for storage within the pharmacy or dispensing to the patient or the patient's care facility. - Referring to
FIGS. 19 and 20 , embodiments of a randomizedarticle marking system 200 may include one ormore agitation elements 204 to ensure that none of the articles within the markingzone 120 overlap.Such agitation elements 204 may include, for example, a laterally-moving or circularly-moving blade or brush configured to sweep over the articles at a pre-determined height, or (as shown inFIG. 20 ) avibration element 204 for momentarily vibrating thetray element 116. In particular embodiments of thesystem 200, these agitation elements may be employed as a matter of course regardless of whether an overlapping of thearticles 104 has initially been detected. Alternatively, or in addition, embodiments of thesystem 200 may be configured to obtain a preliminary inspection image (e.g., preceding the first inspection image mentioned above) to determine any of thearticles 104 in themarking zone 120 appear to be overlapping with another article 104 (see, e.g., overlapping/elevated article 104 a). If it is determined that overlapping has or may have occurred,agitation element 204 may then be activated. A post-agitation image may also be obtained in order to verify that no instances of overlapping remain (see, e.g.,FIG. 21 ) within the markingzone 120. Alateral boundary wall 214 may be provided to retain the articles on thetray 116 during, for example, agitation. The boundary wall be an integral part of thetray 116, or may be a separate component positioned in proximity to the periphery of thetray 116. - Referring to
FIG. 23 , in certain embodiment of a randomizedarticle marking system 200, the application/marking zone 120 may be illuminated by afield illumination element 208. In order to limit or prevent hotspots from being introduced in the image when the first inspection image is obtained (for example, the hotspot shown at 216 inFIG. 22 ), theillumination element 208 may include diffused lights, filters, and/or software tools, in order to facilitate accurate identification of the shape of eacharticle 104 within the application zone. Referring toFIG. 24 , a software process may be used to determine an X-Y origin 210 andorientation 212 of eacharticle 104 within the application zone. - Notably, preferred embodiments of a randomized
article marking system 200 may be configured to mark multiple different shapes and types of articles within the same marking orapplication zone 120 during the same inspection/marking cycle. By way of example, thesystem 200 may be capable of using the first inspection image to identifypharmaceutical tablets 104 of different types based on their shape, color and/or texture. This information may then be compared to a database (internal or external to the system 200) to allow thesystem 200 to identify the pharmaceutical composition of therespective tablets 104. This pharmaceutical composition information may then be used as a factor in controlling whatindelible identifier 106 is marked into therespective article 104. - Referring to
FIGS. 7 and 25 , particular preferred embodiments of amethod 250 for facilitating tracking of consumablepharmaceutical articles 104 are disclosed herein. For example, atblock 252, aremote database element 150 may be provided which is configured to be in network communication with amarking apparatus 100 located in apharmaceutical dispensary 102. Thepharmaceutical dispensary 102 may be a point-of-sale location at which the patient is dispensed the prescribed quantity of articles 104 (e.g., a pharmacy or hospital). - At
block 254, aremote database element 150 may acquire drug information pertaining to each of a manufactured quantity of consumable pharmaceutical articles. Atblock 256, theremote database element 150 may receive prescription data defined by a prescription issued from aprescriber 132 to a respective patient. This prescription data may include, for example, (a) a prescription quantity defining the number of said consumable pharmaceutical articles prescribed to the respective patient; and (b) a patient identifier (e.g., the patient's name) uniquely corresponding to the respective patient. In certain embodiments of the method, the step of receiving may be by way of network communication between theprescriber 132 and theremote database element 150. The prescription quantity of articles would typically comprise a subset of the manufactured quantity of articles. - At
block 258, theremote database element 150 may record a digital image of anindelible identifier 106 applied by way of themarking apparatus 100 to each of the consumablepharmaceutical articles 104 in the prescription quantity. The digital image may preferably be recorded in correspondence with some or all of the prescription data. In certain embodiments of the method, the digital image may be generated by the markingapparatus 100 and obtained by theremote database element 150 prior to the step of recording. Notably, the digital image may be, for example, a graphical reproduction of the indelible identifier (e.g., as raster or vector image data) or some other optically-readable or signal-readable data format that informationally mirrors the indelible identifier. - The
indelible identifier 106 may be configured to be readable by ascanning tool 156 configured to thereby display some or all of the prescription data associated with the respective consumablepharmaceutical article 104. Theindelible identifier 106 may preferably be an alpha-numeric code, photo image (e.g., the face of the patient), a bar code, a QR code, a cipher, an RFID code some combination thereof or the like. Theindelible identifier 106 is preferably uniquely associated with the respective prescription. - The drug information may include one or more of the following: manufacturing date, a lot number, an expiration date and a shipping date. The drug information may be acquired from a distributor or
manufacturer 176 of the manufactured quantity by way of network communication with theremote server element 150. - The prescription data may further include one or more of the following: name of the
prescriber 132, name of thepatient 220, address of the patient, location of the pharmaceutical dispensary, prescription number, article dosage (e.g., strength) and article expiration date. - In particular preferred embodiments of the method, prior to the step of recording, the
remote database element 150 may generate the digital image. Theremote database element 150 may then provide the digital image to themarking apparatus 100 for application of the indelible identifier onto or within thearticles 104. - In certain preferred embodiments of the method, the
remote database element 150 may be configured to be placed in network communication with thescanning tool 156 to thereby provide the prescription data to the scanning tool for the display of the prescription data. - While embodiments of the invention have been illustrated and described, it is not intended that these embodiments illustrate and describe all possible forms of the invention. Rather, the words used in the specification are words of description rather than limitation, and it is understood that various changes may be made without departing from the spirit and scope of the invention.
Claims (30)
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WO2019169196A1 (en) | 2019-09-06 |
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