Patent Publication Number: US-10769245-B1

Title: Systems and methods for monitoring medical adherence and compliance

Description:
BACKGROUND 
     The present disclosure generally relates to systems and methods for monitoring medical adherence and compliance. More particularly, and without limitation, the disclosed embodiments relate to smart packaging of medications allowing monitoring of a patient&#39;s use of medication. 
     Medication adherence is the act of timely filling or refilling prescriptions for medications. Medication compliance is the act of taking medication on schedule or as prescribed by a physician. According to the National Council on Patient Information and Education, poor medication adherence can lead to unnecessary disease progression and complications, reduced functional abilities and quality of life, additional medical costs and physician visits, increased use of expensive, specialized medical resources, and unneeded medication changes. Medication noncompliance can also lead to adverse effects—the average length of hospital stays due to medication noncompliance is 4.2 days. In the United States, 12 percent of people are 0% compliant (i.e., do not take their medication at all) even after they fill the prescription (i.e., are adherent). 
     There are a number of reasons why people are nonadherent and/or noncompliant with their medication regimen. The various factors that interfere with medication adherence and compliance include: social/economic-related factors such as age, race, economic status, literacy and costs; individual factors such as forgetfulness, treatment anxiety, misunderstood instructions and fear of addiction; medication-related factors such as the length or complexity of the treatment and the side-effects of the medication; and condition-related factors such as comorbidities and disabilities, and the overall severity of the condition. 
     By some estimates, up to 50% of patients are noncompliant to some extent, making it difficult for doctors to assess if a medication regimen is effective. If the patient is not accurately or truthfully reporting his or her compliance, doctors do not have a means of obtaining more accurate information. Furthermore, patient tracking of which medications to take and when can be cumbersome and can be confusing for some patients. 
     There are various techniques and systems for assisting patient adherence. For instance, processes are known for electronically transmitting prescriptions to a pharmacy, and the pharmacy automatically delivering the medication to the patient or sending reminders to the patient. Certain packaging is also known for aiding patient compliance, for example the PILLPACK available from PillPack, Inc. While these prior art approaches help the patient achieve compliance, doctors still do not know if the patient ever opens the package or takes the medication as prescribed. 
     SUMMARY 
     Embodiments of the present disclosure include systems and methods for monitoring medical adherence and compliance. Embodiments of this disclosure include, for example, pill packages with beacon transponders in a package of medication. 
     In some embodiments of the present disclosure, the beacon is a low-energy radio transponder. In an exemplary embodiment, the beacon is a BLUETOOTH Low Energy (BLE) transponder, such as a BLUETOOTH Smart or BLUETOOTH 4.0. Other protocols are also usable such as passive WiFi, ZIGBEE, 6LoWPAN or Z-Wave. In illustrative embodiments of the present disclosure, the beacon can be activated when a medication package is opened, and is programmed to transmit the contents of the package for a period of time to a smartphone or other device enabled to receive the beacon&#39;s signals. The smartphone or other enabled device can be detected by a beacon when it comes in range and open communications, using for example Proximity Beacon application program interface (API) and Eddystone protocol available from Google. As will be appreciated from this disclosure, other communication protocols may be utilized. 
     According to an example embodiment of the present disclosure, a medication package system is described having a packet bundle comprising a plurality of packets of medication, and a beacon system including a power source that powers at least one beacon, the beacon transmitting a signal when a packet of medication is separated from the packet bundle. 
     According to an additional example embodiment, a packet bundle is described having a plurality of individual sealed packets frangibly connected in a continuous arrangement, at least one of the plurality of sealed packets comprising a local power source; a central power source connected to one or more central power conductors extending across the plurality of packets; and a beacon connected to the local power source and the central power source; wherein, when one of the central power conductors is severed by separating a packet from the central power source, the beacon remains connected to the local power source and transmits a signal indicating that the packet has been separated from the packet bundle. 
     According to a still further example embodiment, a packet bundle is described having a plurality of individual sealed packets frangibly connected to one another in a continuous arrangement; a central power source connected to central power conductors extending across the plurality of packets; and a central beacon connected to the central power source, the central beacon being provided on at least one of the plurality of sealed packets; wherein, when one of the central power conductors is severed by separating a resistor from the central power source, the beacon transmits a signal indicating that a packet has been separated from the packet bundle based on a change of resistance. 
     According to a yet further example embodiment, a packet bundle is described having a plurality of individual sealed packets frangibly connected to one another in a continuous arrangement, a central power source connected to central power conductors extending across the plurality of packets; a local beacon provided on at least one of the plurality of sealed packets, the local beacon being connected to a local power source and the central power source; and a central beacon connected to the central power source; wherein, when one or more of the central power conductors are severed by separating a packet from the central power source, the local beacon remains connected to the local power source and the central beacon transmits a signal indicating that the packet has been separated from the packet bundle; and further wherein, when a frangible feature for detecting the packet seal has been broken is severed, the local beacon transmits a signal indicating that the packet has been opened. 
     According to a still further example embodiment according to the present disclosure, a method for monitoring use of a packet bundle of medication is described, the method including detecting when a packet of medication is separated from the packet bundle; and transmitting, based on the detection, a signal from a beacon that indicates the separation of the packet from the bundle. 
     According to further aspects of the present disclosure, the beacon may transmit a unique identifier that can be decoded to reveal the pill regimen, using a networked resource, or the entry of a proper key or password from the user. 
     According to an example embodiment, a small battery is included in the packaging to power a circuit to detect when a packet is opened and to transmit beacon signals. 
     Additional features and advantages of the disclosed embodiments will be set forth in part in the description that follows, and in part will be obvious from the description, or may be learned by practice of the disclosed embodiments. The features and advantages of the disclosed embodiments will be realized and attained by the elements and combinations particularly pointed out in the appended claims. 
     It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory only and are not restrictive of the disclosed embodiments as claimed. 
     The accompanying drawings constitute a part of this specification. The drawings illustrate several embodiments of the present disclosure and, together with the description, serve to explain the principles of the disclosed embodiments as set forth in the accompanying claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  depicts an exemplary medication packet bundle and package including beacon capability, according to aspects of the present disclosure. 
         FIG. 2  is a schematic representation of an exemplary medication packet bundle including individual packet beacons, consistent with the disclosed embodiments. 
         FIG. 3  is a schematic representation of an exemplary medication packet bundle including a central beacon, consistent with the disclosed embodiments. 
         FIG. 4  is a schematic representation of another exemplary medication packet bundle including beacons, consistent with the disclosed embodiments. 
         FIG. 5  is a flowchart representation of an exemplary process for obtaining compliance information from a medication packet bundle, consistent with the disclosed embodiments. 
     
    
    
     DETAILED DESCRIPTION 
     The disclosed embodiments relate to medication packages including beacons signaling when a medication package has been opened by a user. As a result, the beacon&#39;s signals can be monitored to indicate patient compliance with a medical regimen. 
     Reference will now be made in detail to embodiments of the present disclosure, examples of which are illustrated in the accompanying drawings. Where possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. 
       FIG. 1  depicts an example embodiment of a packet bundle  10  which in an illustrative embodiment is a segmented roll of individual packets  12  containing medication such as pill  14 . While shown as a continuous reel in  FIG. 1 , other continuous formats can be employed, including ammo-pack and fan-fold, as well as sheets having a plurality of packets  12 . Each packet  12  permits a beacon system to be employed to track when packet  12  is separated from packet bundle  10 . In the illustrative embodiment, beacon  16  is depicted associated with packet  12 , but other beacon features can take other configurations as discussed below. Each packet  12  is shown as being separable from bundle  10  by way of a frangible feature, which in an illustrative embodiment takes the form of tear line  18 . The tear line  18  may be perforated or otherwise prepared to enable separation of each packet  12  from bundle  10 . The packet bundle  10 , in the example embodiment in the form of a reel, can be received and stored in an outer packaging  20 . By way of example, outer packaging  20  may be implemented in the form of a carton or box. 
     Turning to  FIG. 2 , a schematic representation of packet bundle  10  according to an example embodiment of the present disclosure is shown. Packet bundle  10  is shown having a plurality of packets  12  in series. In an alternative embodiment, the packets could be arranged in an i×j matrix of strips. Seal margin  22  creates a sealed space  24  in the form of an envelope to contain medication  14 , comprising for example one or more pills, tablets, capsules, suppositories, ampoules, subpackets of powder, etc. 
     According to an illustrative embodiment, central power source  26 , which can take the form of a battery, is connected to central power conductors  30  that extend in parallel across packets  12 . Local power source  28 , which in illustrative embodiments is a battery, capacitor, or other power storage device, is operatively connected to beacon  16 . When connected to the packet bundle  10 , the beacon remains in low-power standby mode, but when the central power conductors  30  are severed by separating packet  12  along tear line  18 , an interrupt occurs causing beacon  16  to signal that it has been separated from the packet bundle  10  and central power source  26 . In an example embodiment, packet  12  has a packet periphery conductor  32 , which is illustrated taking the form of a conductive trace surrounding the sealed space  24 . When packet  12  is opened to access the medication  14 , for example by tearing, the periphery conductor  32  is broken, which is detected by beacon  16 , causing beacon to signal that packet  12  has been opened. This signal is received by a smartphone or other associated device, which can use the event as evidence that patient has taken the medication in compliance monitoring. 
     When a beacon  16  as disclosed herein broadcasts data, the data can be sent in advertising packets through one or more wireless advertising channels. The transmission of advertising packets takes place periodically during advertising events. Within an advertising event, the beacon can sequentially use each advertising channel for packet transmission. In some embodiments, an associated device scans these advertising channels for the presence of advertising packets from the beacon. The transmissions from the beacon to an associated device can also take place over a bidirectional data communication link. The creation of such a connection can include a beacon announcing over advertising channels that it is a connectable device, while the associated device listens for such advertisements. When the associated device finds a beacon, it may transmit a connection request message to the beacon, which establishes a point-to-point connection between the two devices. The packets for this connection can be identified by an access code for security. In other embodiments, the beacon can send advertising packets without connecting to an associated device. In this case, the transmissions are undirected and broadcast to all devices in a vicinity. 
     In some embodiments, beacon  16  can broadcast encrypted data. In some examples, packet bundle  10  and/or packets  12  can include an encryption key, such as a QR code. A smartphone, or other device, can be used to scan the code, otherwise receive the encryption key, and use the key to receive encrypted data from beacon  16 . In this way, only authorized devices may receive broadcasts from beacon  16 , which can increase security, for example when undirected transmissions are used. 
     Turning to  FIG. 3 , a schematic representation of packet bundle  10  with a central beacon, according to an example embodiment of the present disclosure is shown. Packet bundle  10  is shown having a plurality of packets  12 ′ and  12  in series. In an alternative embodiment, the packets could be arranged in an i×j matrix of strips. Seal margin  22  creates a sealed space  24  in the form of an envelope to contain medication  14 , comprising one or more pills, tablets, capsules, suppositories, ampoules, subpackets of powder, etc. 
     According to an illustrative embodiment, central power source  26 , which can take the form of a battery, is connected to central power conductors  30  that extend in parallel across packet  12 ′ and packets  12 . In packet  12 ′, a central beacon  34  is disposed. Each other packet  12  is provided with a resistor  36 . The resistors  36  are wired in parallel such that the total resistance of the packet bundle  10  is proportional to the number of packets. When the central power conductors  30  are severed by separating a packet  12  along tear line  18 , a change in the circuit resistance occurs causing central beacon  34  to signal that one or more packets  12  have been separated from the packet bundle  10  and central beacon  34 . This signal is received by a smartphone or other associated device, which can use the event as evidence that patient has taken the medication in compliance monitoring. 
     Turning to  FIG. 4 , a schematic representation of packet bundle  10  according to an example embodiment of the present disclosure is shown. Packet bundle  10  is shown having a plurality of packets  12 ′,  12 ,  12 ″ and  12  in series. In an alternative embodiment, the packets could be arranged in an i×j matrix of strips. Seal margin  22  creates a sealed space  24  in the form of an envelope to contain medication  14 , comprising one or more pills, tablets, capsules, suppositories, ampoules, subpackets of powder, etc. 
     According to an illustrative embodiment, central power source  26 , which can take the form of a battery, is connected to central power conductors  30  that extend in parallel across packet  12 ′ and packets  12 ,  12 ″, and  12 . In packet  12 ′, a central beacon  34  is disposed. Local power source  28 , which in illustrative embodiments is a battery, capacitor, or other power storage device, is operatively connected to beacon  16 . Beacon  16  is also connected to central power conductors  30 . Central power source  26  and local power source  28  are both therefore connected to beacon  16 . In an example embodiment, centralized beacon  34  can broadcast when the package is removed from the packet bundle  10  along tear line  18 , severing central power conductors  30 . In an example embodiment, packet  12  has a packet periphery conductor  32 , which is illustrated taking the form of a conductive trace surrounding the sealed space  24 . When packet  12  is opened to access the medication  14 , for example by tearing, the periphery conductor  32  is broken, which is detected by beacon  16 , causing beacon  16  to signal that packet  12  has been opened. These signals are received by a smartphone or other associated device, which can use the event as evidence that patient has taken the medication in compliance monitoring. Connection  38  of beacon  16  to central power supply  26  via the central power conductors  30  in an adjacent pack  12 ″ allows the beacon module to stay in low power mode until removed from the packet bundle  10 , without requiring communication from central beacon  34 . 
     The electrical components and electronic features of the exemplary embodiments can be laminated between layers of the packets  12 , or deposited on the inner or outer surfaces of packets  12 . 
       FIG. 5  shows an illustrative process  500  for obtaining compliance information from a bundle of medication packets, consistent with embodiments of the present disclosure. Process  500  may be implemented using any of the exemplary packet bundle embodiments described herein, including those illustrated and described with reference to  FIGS. 2-4 . 
     At step  502 , the removal of a packet from a bundle is detected, for example through the severing of frangible conductors as discussed above. At step  504 , a beacon signals removal of the packet. As discussed above, the beacon can be a central beacon connected to a plurality of packet, or a beacon associated with a single packet. Optionally, at step  506 , the system detects opening of a packet. In an illustrative embodiment, this occurs through the breaking of a conductor, which is detected and at step  508  signaled by a beacon associated with the packet. At step  510 , an associated device, such as a smartphone or other networked or wired device, detects beacon signals transmitted at steps  504  and optionally step  508 . At step  510 , one or more of the received beacon signals are processed to reveal information concerning the compliance of a patient, for example the time and date that the packet was removed, and optionally when the packet was opened, and the contents presumably taken. This information can advantageously be monitored for compliance with a medication regiment, as well as for adherence. For example, when no medication is indicated as having been taken for a period of time, it could be inferred that a prescription had not been filled. 
     In some embodiments, a smartphone or other device might be employed. The smartphone or device may include a controller. The controller may include one or more hardware processors, such as one or more central processing units (CPUs). The processor(s) may execute a set of instructions to perform operations, such as those of process  500  in  FIG. 5 . The set of instructions may be programmed and stored in one or more memory devices. Examples of memory devices include non-volatile memory (e.g., a flash memory), volatile memory (e.g., a random access memory (RAM)), and other memory components. In some embodiments, the controller may be configured run programmed instructions or software to execute operations, as described herein. The controller may also include one or more interfaces to communicate with beacons of packets or packet bundles. 
     The foregoing description has been presented for purposes of illustration. It is not exhaustive and is not limited to precise forms or embodiments disclosed. Modifications and adaptations of the embodiments will be apparent from consideration of the specification and practice of the disclosed embodiments. For example, the described implementations include hardware and software, but systems and methods consistent with the present disclosure can be implemented as hardware alone. In addition, while certain components have be described as being coupled to one another, such components may be integrated with one another or distributed in any suitable fashion. 
     Moreover, while illustrative embodiments have been described herein, the scope includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations and/or alterations based on the present disclosure. The elements in the claims are to be interpreted broadly based on the language employed in the claims and not limited to examples described in the present specification or during the prosecution of the application, which examples are to be construed as nonexclusive. Further, the steps of the disclosed methods can be modified in any manner, including reordering steps and/or inserting or deleting steps. 
     The features and advantages of the disclosure are apparent from the detailed specification, and thus, it is intended that the appended claims cover all systems and methods falling within the true spirit and scope of the disclosure. As used herein, the indefinite articles “a” and “an” mean “one or more.” Similarly, the use of a plural term does not necessarily denote a plurality unless it is unambiguous in the given context. Words such as “and” or “or” mean “and/or” unless specifically directed otherwise. Further, since numerous modifications and variations will readily occur from studying the present disclosure, it is not desired to limit the disclosure to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the disclosure. 
     Other embodiments will be apparent from consideration of the specification and practice of the embodiments disclosed herein. It is intended that the specification and examples be considered as example only, with a true scope and spirit of the disclosed embodiments being indicated by the following claims.