Oral electronic medical device

Abstract

A system for tracking consumer patient compliance with a pharmaceutical and dosage form includes a tracking device, a computer system, and a database. The tracking device is for processing a plurality of ingestible event marker (IEM) devices, wherein each IEM device includes an IEM storing an IEM identification code, and the tracking device can include a first capacitive plate, a second capacitive plate, and a structure for positioning each IEM device in proximity to the first capacitive plate and the second capacitive plate. The tracking device can be configured to interrogate each IEM via capacitive coupling as each IEM device passes through the structure. The computer system communicatively coupled to the tracking device can be configured to receive each IEM identification code read from each interrogated IEM, and the database tracking each IEM can be configured to link each received IEM identification code to additional information including an identifier of an active pharmaceutical / drug.

Description

BACKGROUND

[0001] Healthcare issues associated with pharmaceutical products include consumer patient error, misuse of medications, and lack of medication adherence. The present disclosure relates to methods, devices, and systems for tracking pharmaceutical products from manufacturer to consumer patient and monitoring medication adherence. SUMMARY

[0002] Proteus Digital Health, Inc. manufactures an ingestible event marker (IEM) that is programmed with an identification code (IEM identification code). The IEM can be incorporated into a placebo tablet. This form factor is referred to as a MIT (IEM in tablet). In one aspect, the IEM can be integrated directly into a pharmaceutical tablet / capsule or drug-containing capsule at the factory, at which point the dosage form becomes a drug-device combination product that requires additional FDA approval prior to marketing. In another aspect, the IEM can be co-encapsulated (CoE) with one or more pharmaceuticals / drugs by a licensed pharmacist upon a physician's prescription.

[0003] When the IEM is wet in the stomach, the IEM can activate its unique identification code and conduct through body tissue to a compatible receiver (e.g., a wearable sensor (WS) similar to a bandage). The WS records the detected IEM (e.g., and their corresponding identification codes) and can also track various physiological parameters (e.g., heart rate, activity, etc.). Data is periodically uploaded from the WS to a primary display of an external device (e.g., a smartphone or tablet). Once on the external device, the data can optionally be relayed to a cloud-based personal health record, other local application, or other data store depending on the use case.

[0004] The FDA has cleared the use of the Proteus Digital Health Feedback Device (PDHFD) including the IEM with the following statement in part: "When co-ingested with a medication, tracking and trending of the number of ingestions can be used as an adjunct to measure medication adherence." (c.f., K150494).

[0005] The Proteus IEM can be interrogated non-invasively after incorporation into a placebo tablet, pharmaceutical tablet / capsule, or drug-containing capsule. In one aspect, a wireless interrogator (WI) operates in the kV range by capacitively coupling an AC (50 kHz) signal to the IEM. This external signal powers the IEM, which then switches its internal antenna to be inside and outside the circuit, modulating the capacitance sensed by the WI, and thereby transmitting information. In this aspect, the unique identification code (e.g., IEM identification code) and configuration of each IEM can be read out at the time of manufacture or subsequently.

[0006] IEMs associated with pharmaceutical products can be used to confirm consumer-patient consumption of the appropriate drug and dosage form. The present disclosure relates to the technical challenges associated with mapping digital codes (individually programmed IEM identification codes) to specific dosing events (e.g., dosing events of a drug and dosage form, e.g., furosemide, 20 mg tablet) to monitor consumer-patient adherence to a prescribed medication regimen.

[0007] In one aspect of the present disclosure, a system for tracking consumer-patient adherence to a drug and dosage form is provided, comprising a tracking device, a computer system, and a database. The tracking device, for processing a plurality of ingestible event marker (IEM) devices, wherein each IEM device includes a stored IEM identification code, can include a first capacitive plate, a second capacitive plate, and a structure for positioning each IEM device in proximity to the first capacitive plate and the second capacitive plate. The tracking device can be configured to interrogate each IEM via capacitive coupling as each IEM device passes through the structure. The computer system communicatively coupled to the tracking device can be configured to receive each IEM identification code read from each interrogated IEM, and the database tracking each IEM can be configured to link each received IEM identification code to additional information including an identifier of an active drug / drug.

[0008] In another aspect of the present disclosure, a system for tracking consumer-patient adherence to a drug and dosage form is provided, the system comprising a computer system including an adherence application that identifies at least one active drug and dosage form associated with at least one ingestible event marker (IEM) identification code. The adherence application can be configured to: i) receive an IEM identification code associated with an ingested IEM, ii) detect whether the received IEM identification code is an unknown IEM identification code, iii) query an IEM tracking system database using the unknown IEM identification code to identify an active drug and dosage form associated with the ingested IEM, wherein the IEM tracking system database stores IEM data including a plurality of active drugs and dosage forms mapped to a plurality of IEM identification codes after production of the IEMs, and iv) receive from the IEM tracking system database the active drug and dosage form mapped to the unknown IEM identification code to confirm consumer-patient adherence associated with the active drug and dosage form.

[0009] In yet another aspect of the disclosure, a system for tracking consumer patient adherence to pharmaceuticals and dosage forms is provided, comprising a pharmacy system comprising a tracking device, a computer system, a database, and a transmission unit. The tracking device is for processing a plurality of ingestible event marker (IEM) devices, wherein each IEM device comprises an IEM storing an IEM identification code, and wherein each IEM is stably associated with a non-pharmaceutical composition co-encapsulated with an active pharmaceutical. The tracking device can comprise a first capacitive plate, a second capacitive plate, and a structure for positioning each IEM device proximate to the first capacitive plate and the second capacitive plate. The tracking device can be configured to interrogate each IEM via capacitive coupling as each IEM device passes through the structure. The computer system communicatively coupled to the tracking device can be configured to receive each IEM identification code read from each interrogated IEM, the database tracking each IEM can be configured to link each received IEM identification code to an identifier of the active pharmaceutical, and the transmission unit can be configured to transmit each received IEM identification code and the identifier of the active pharmaceutical linked to each received IEM identification code to an IEM tracking system database for tracking consumer patient adherence to at least one active pharmaceutical and dosage form.

[0010] In addition to the foregoing, various other methods and / or system and / or program product aspects are set forth in the teachings of the present disclosure, such as in the text of the specification (e.g., claims and / or detailed description) and / or the drawings.

[0011] The foregoing is a summary and thus can contain simplifications, generalizations, inclusions, and / or omissions of detail, so as to provide a working summary of the subject matter described herein. Those skilled in the art will appreciate the summary is illustrative only and is not intended to be in any way limiting. Other aspects, features, and advantages of the devices and / or processes described herein will become apparent in the teachings set forth herein.

[0012] In one or more various aspects, related systems include but are not limited to circuitry and / or programming for effecting the herein-referenced method aspects; the circuitry and / or programming can be virtually any combination of hardware, software, and / or firmware configured to affect the herein-referenced method aspects depending on the design choices of the system designer. In addition to the foregoing, various other methods and / or system aspects are set forth in the teachings of the present disclosure, such as in the text of the specification (e.g., claims and / or detailed description) and / or the drawings.

[0013] Further, it should be understood that any one or more of the following described forms, expressions of forms, examples can be combined with any one or more of the other following described forms, expressions of forms, and examples.

[0014] The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects and features described above, additional aspects and / or features will become apparent in connection with review of the drawings and the following detailed description. BRIEF DESCRIPTION OF DRAWINGS

[0015] The novel features of the various aspects described herein are set forth with particularity in the appended claims. These aspects can, however, be better understood in connection with the following description and the accompanying drawings.

[0016] Figure 1 An example IEM battery is shown in accordance with one aspect of the disclosure.

[0017] Figure 2 An example IEM circuit is shown in accordance with one aspect of the disclosure.

[0018] Figure 3A And Figure 3B A detailed view of a pill composition is shown.

[0019] Figure 4 Views of various IEM configurations are shown.

[0020] Figure 5 A flow diagram of IEM device life in accordance with one aspect of the disclosure is shown.

[0021] Figure 6 A tracking device usable in a commercial system in accordance with one aspect of the disclosure is shown.

[0022] Figure 7 A container that can be produced using a system in accordance with one aspect of the disclosure is shown. Figure 6

[0023] Figure 8 A tracking device usable in a commercial system in accordance with one aspect of the disclosure is shown.

[0024] Figure 9 A graphical representation of an IEM data framework in accordance with one aspect of the disclosure is provided.

[0025] Figure 10A A pharmaceutical product with an IEM that can be interrogated using capacitive coupling in accordance with one aspect of the disclosure is shown.

[0026] Figure 10B A pharmaceutical product with an IEM that can be interrogated using capacitive coupling in accordance with another aspect of the disclosure is shown.

[0027] Figure 10C ​A drug product with an IEM is shown that can be interrogated using capacitive coupling in accordance with another aspect of the disclosure.

[0028] Figure 10D An IEM that can be detected or interrogated using capacitive coupling in accordance with yet another aspect of the disclosure is shown.

[0029] Figure 10E A drug product with an IEM is shown that can be detected or interrogated using capacitive coupling with a coaxial probe / plate in accordance with yet another aspect of the disclosure.

[0030] Figure 11 An example circuit diagram for an IEM in accordance with an aspect of the disclosure is shown. Figures 10A-10E

[0031] Figure 11A An example diode bridge that can be used in an IEM in accordance with the disclosure is shown. Figure 11

[0032] Figure 11B A logic unit for an IEM in accordance with the disclosure is shown that communicates with a probe through a plate and conductive material, the probe associated with a device in accordance with the disclosure. Figure 11

[0033] A finite time period for power transfer cycles and information transfer cycles using capacitive coupling in accordance with the disclosure is shown. Figure 11C

[0034] An IEM device that passes through a tubular portion to confirm IEM device operation and program / record a unique IEM identification code in accordance with the disclosure is shown. Figure 12A

[0035] A specific time instance for an IEM device in accordance with the disclosure to pass between plates during interrogation / programming is shown. Figure 12B

[0036] An example unique IEM identification code associated with a 15-bit pattern in accordance with an aspect of the disclosure is shown. Figure 13

[0037] A digital code block concept in accordance with an aspect of the disclosure is shown. Figure 14

[0038] An example IEM data transfer between a business system and an IEM tracking system is shown. Figure 15

[0039] A flow diagram for dispensing an IEM device at a pharmacy system in accordance with an aspect of the disclosure is shown. Figure 16 DETAILED DESCRIPTION ​​​

[0040] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols and

[0041] Before explaining various aspects of the disclosure in detail, it is to be understood that the aspects disclosed herein are not limited in their application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. Rather, the disclosed aspects are capable of implementations or of being practiced in various ways. Thus, the aspects disclosed herein are to be considered as illustrative and not restrictive, and the scope of the aspects is not to be limited to the precise details of construction and arrangement set forth in the following description or shown in the accompanying drawings. Additionally, selected terms and expressions have been used throughout this document to describe aspects in the broadest terms possible in order to convey the scope and nature of the aspects. Furthermore, it should be understood that any one or more of the disclosed aspects, expressions of aspects, and / or examples thereof, can be combined with any one or more of the other disclosed aspects, expressions of aspects, and / or examples thereof, without limitation.

[0042] Also, in the following description, it is to be understood that terms such as front, back, inside, outside, top, bottom, and the like, are words of convenience and are not to be construed as limiting terms. Unless otherwise defined, the terms used herein are to be understood as common terms used in the art of the devices described herein, and can be attached or used in other contexts. Various aspects will be described in more detail with reference to the drawings.

[0043] Technical problem

[0044] Before delving into the following details, aspects of the present disclosure are intended to address various problems, including but not limited to: 1) problems related to code mapping, 2) problems related to code uniqueness and reuse, 3) problems related to manufacturing complexity and buffer inventory, and 4) problems related to regulatory risk.

[0045] With respect to code mapping, in order to be clinically helpful in measuring medication adherence, the identification of the IEM detected by the Proteus Digital Health Feedback Device (PDHFD) must be associated with the medication of interest. This mapping of the IEM digital code (individually programmed IEM identification code) to a specific dosing event (e.g., medication and dosage form, such as furosemide, 20 mg) creates technical and business challenges.

[0046] With respect to code uniqueness and reuse, IEM digital codes are limited in number. IEMs can be programmed during manufacturing to operate in one of three modes, each with a different data payload length. One form (i.e., the most common form) operates in a 15-bit mode (15b). Another form operates in a 30-bit mode (30b). Yet another form operates in a 43-bit mode (43b). The mode of operation determines the number of unique identification codes available for IEM programming. For example, in the 15-bit mode, there are 2 15

[0047] With respect to manufacturing complexity and buffer inventory, in one aspect of the disclosure, digital code blocks can be reserved for specific drug formulations (e.g., furosemide, 20 mg tablets), similar to the way area codes are used to reserve phone numbers for specific geographic areas. However, hard-coding with digital code blocks can cause a number of problems. For example, even if each of a plurality of MITs is physically identical (e.g., IEMs incorporated into placebo tablets), the plurality of physically identical MITs will effectively become a plurality of different products (e.g., separated by reserved digital code blocks). In this aspect, only a pharmacist required to dispense IEM devices to help track patient adherence to a specific drug product / drug can do so if there are already MITs hard-coded / programmed with digital codes within the predefined digital code blocks reserved for the specific drug product / drug. In theory, a pharmacist can use a multi-bottle (e.g., of MITs hard-coded / programmed with digital codes within predefined digital code blocks reserved for other drug products / drugs), but still be unable to fill the prescription. This division of physically identical MITs by predefined digital code blocks can create manufacturing scale inefficiencies, can greatly increase inventory requirements and supply chain complexity, and can increase the risk of not being able to meet customer demand.

[0048] With respect to regulatory risk, the FDA generally requires separate approval for medical devices that cite a specific drug product as a drug-device combination product. This has not been an issue with respect to manufacturing IEM devices (e.g., drug products containing IEMs in the form of tablets / pills or drug-containing capsules, etc.). In the case of Proteus, this can delay successfully implementing its existing clearance indication for PDHFD, which means being able to distinguish between different drug products taken by a patient (c.f., GlowCaps and other targeted adhesive devices and applications). In one aspect of the disclosure, the mapping of digital codes to drug products determined by the pharmacist is a way to avoid FDA classification in this manner.

[0049] ​Before describing various solutions to the above-described various problems, the present disclosure discusses topics including (as provided in the heading herein) IEM devices, manufacturing IEM devices, IEM systems, and communication modes. These topics cover various systems, devices, processes, etc. that support the pharmacy-level mapping and various other solutions disclosed herein.

[0050] IEM device

[0051] Various aspects of the present disclosure include ingestible event marker devices ("IEM devices"). In one aspect, an IEM device can include an IEM that is directly combined with a composition (e.g., one or more pharmaceuticals / drugs) at a source of manufacture of the composition (e.g., a manufacturer / producer of the pharmaceutical composition) to become a pharmaceutical-device combination. Such an IEM device can take the form of a tablet / pill or a drug-containing capsule. Such an IEM device can include an active agent composition having an IEM associated therewith. The active agent composition can include an active agent (e.g., a solid and / or liquid including an amount (e.g., a dose) of an active agent / pharmaceutical) and a pharmaceutically acceptable carrier / vehicle. The IEM itself can vary depending on the particular aspects of the composition and the intended application. In certain aspects, the IEM is a component that signals when activated by a stimulus (e.g., by interrogation, contact with a target physiological location, etc.). Thus, the IEM can signal when in contact with a target body physiological site. Additionally or alternatively, the IEM can signal when interrogated (e.g., by capacitive coupling, RFID, etc.).

[0052] In another aspect, the IEM device can include an IEM combined (e.g., co-encapsulated) by a licensed pharmacist with a composition (e.g., one or more pharmaceuticals / drugs) in a pharmaceutically acceptable carrier / vehicle (e.g., a capsule). In this aspect, the IEM itself can be combined (e.g., in the form of a placebo tablet or MIT, for example, to form a placebo / non-pharmaceutical IEM device) at the source of manufacture with another composition (e.g., a placebo / non-pharmaceutical composition, etc.) prior to co-encapsulation by the pharmacist. In an alternative aspect, the IEM itself can be coated with a protective layer composition at the source of manufacture prior to co-encapsulation by the pharmacist. In various aspects, the placebo, non-pharmaceutical, and / or protective layer composition can preserve the IEM and its composition prior to co-encapsulation by the pharmacist (e.g., after manufacture, during shipping to the pharmacy, during inventory, etc.). Again, the IEM can vary depending on the particular aspect and intended application of the composition. In certain aspects, the IEM is an assembly that signals when activated by stimulation (e.g., by interrogation, contact with a target physiological location, etc.). Thus, the IEM can signal when contacted with a target body physiological site. Additionally or alternatively, the IEM can signal when interrogated (e.g., by capacitive coupling, RFID, etc.).

[0053] In various aspects of the disclosure, the signal emitted by the IEM can be a unique signal (e.g., a signal that uniquely identifies in some manner the particular composition associated with the IEM that has contacted the target physiological site). This unique signal can be distinguishable from other signals emitted by IEMs associated with other compositions of the plurality of compositions at the target physiological site. In various aspects, the IEM can emit a signal that uniquely identifies a given unit dose in a given batch (even distinguishing other identical unit doses). Thus, in certain aspects, the IEM can emit a unique signal that distinguishes a given type of unit dose from other types of unit doses, e.g., a given drug from other types of drugs. In certain other aspects, the IEM can emit a unique signal that distinguishes a given unit dose from other unit doses of a defined population of unit doses, e.g., a prescription, batch, or lifetime production of a dosage formulation. In certain aspects, the IEM can emit a unique signal that is distinguishable from signals emitted by any other dosage formulation ever produced, where this signal can be considered a universally unique signal (e.g., like a human fingerprint, it is different from any other fingerprint of any other individual, thus uniquely identifying the individual at a universal level). In one aspect, the signal can either directly convey information about the composition or provide an identification code that can be used to retrieve information about the composition from a database (e.g., a database that links identification codes to compositions, such as the IEM tracking system database discussed herein).

[0054] An IEM can be any component or device that generates a detectable signal upon activation in response to a stimulus. In some aspects, the stimulus activates the IEM to signal once the component comes into contact with a physiological target site. For example, a patient may ingest an IEM device that includes an IEM, wherein the IEM generates a detectable signal upon contact with the gastrointestinal tract / gastric juice. Depending on the application, the target physiological site or location may vary. Examples of target physiological sites include, but are not limited to: locations within the gastrointestinal tract (e.g., mouth, esophagus, stomach, small intestine, large intestine, etc.); substitute sites within the body (e.g., parental sites, vascular sites, etc.); local sites, etc.

[0055] In some respects, the stimulus that activates the IEM can be an interrogation signal, such as a scan or other type of interrogation (see, for example, Figure 6 Examples include RFID coils; Figure 8 (e.g., capacitive coupling, magic wand / scanning tools, etc.). In these respects, stimulation activates the IEM, thereby emitting signals that are subsequently received and processed, for example, to identify components (e.g., directly or via a query in the IEM tracking system database).

[0056] IEMs can generate various types of signals, including but not limited to RF, magnetic, conductive (near field), and acoustic signals.

[0057] In one aspect, the IEM can be an IEM that is hard-coded / programmed during IEM manufacturing. In this aspect, multiple (e.g., hundreds / thousands) of individual integrated circuits (e.g., each associated with an IEM) can be present on the wafer during wafer fabrication. In this aspect, the wafer is moved to contact a probe card of wafer probes. When the microscopic probes of the probe card contact each integrated circuit, the wafer probes can test for functional defects in each integrated circuit during a testing phase and can program each integrated circuit during a programming phase. After testing and programming, each individual integrated circuit can be separated from the wafer using a dicing process. In one aspect of this disclosure, during the programming phase, the wafer probes can hard-code each integrated circuit with a unique identifier. In various aspects, the unique identifier can be stored in a memory component of the integrated circuit (e.g., non-volatile random access memory). In various aspects, as discussed herein, the unique identifier can include a digital code. In various aspects of this disclosure, the IEM manufacturer can transfer the hard-coded / programmed unique IEM identifier to an IEM tracking system (discussed herein).

[0058] In alternative aspects, the IEM can be a post-manufacturing programmable IEM, meaning the signals generated by the IEM can be determined after the IEM is produced. The IEM can be field-programmable, large-scale programmable, fuse-programmable, or even reprogrammable. An aspect where the IEM is first produced and then encoded to emit identification signals for the composition after being incorporated into the composition (e.g., an IEM device) is of interest. Any convenient programming technique can be employed. In some aspects, the programming technique employed is RFID technology (e.g., smart tag technology). Even after the IEM has been incorporated into the composition, entities (e.g., manufacturers, suppliers, pharmacies, etc.) can associate a unique identifier (e.g., an IEM identifier) ​​with a given IEM using RFID or other programming techniques. In some aspects, each individual or entity involved in handling the composition prior to use can import information into the IEM, for example, in the form of programming regarding the signals emitted by the IEM. See, for example, [link to relevant documentation]. Figure 5 Figure 518. However, this aspect may not be preferred. For example, if the IEM is programmable / reprogrammable after manufacturing, an entity (e.g., a patient) can program / reprogram a first IEM device (by programming / reprogramming an IEM stably associated with composition "A" (e.g., ibuprofen, placebo, etc.)) to simulate a second IEM device (e.g., an IEM stably associated with composition "B" (e.g., furosemide)). More specifically, for example, an entity can program / reprogram the IEM of the first IEM device using a unique identifier read from the IEM of the second IEM device in the patient's prescription. In this case, when the patient takes the first IEM device (e.g., including ibuprofen, placebo, etc.), the unique identifier of the second IEM device (e.g., associated with furosemide) will ultimately be transmitted to the IEM system. Without further safety measures, when a patient actually takes different compositions (e.g., ibuprofen, placebo, etc.), theoretically, the patient could induce the IEM system to determine that the patient has complied by taking their prescribed composition (e.g., furosemide).

[0059] In various aspects, it can be desirable for the IEM to be non-programmable / reprogrammable after manufacture (e.g., when monitoring drug / medication compliance). This aspect can be appropriate if fraudulent programming / reprogramming can occur. For example, with a non-programmable / reprogrammable IEM after manufacture, an entity (e.g., a patient) would be prohibited from programming / reprogramming a first IEM device to mimic a second IEM device that includes a drug / medication that the patient is prescribed to take. More specifically, the entity would not be able to program / reprogram the IEM of the first IEM device with another unique identifier (e.g., one that is read from the second IEM device in the patient's prescription). In this case, the unique identifier of the first IEM device is ultimately transmitted to the IEM system when the patient takes the first IEM device, and the unique identifier of the second IEM device is ultimately transmitted to the IEM system when the patient takes the second IEM device. When the patient actually takes different compositions (e.g., ibuprofen, placebo, etc.), the patient can trick the IEM system into determining that the patient has been compliant by taking their prescribed composition (e.g., furosemide).

[0060] In certain aspects, the IEM includes a memory element, where the memory element can vary in capacity. In certain aspects, the memory element has a capacity ranging from about 1 bit to 1 gigabyte or more (e.g., 1 bit to 1 megabyte), including from about 1 bit to about 128 bits. The particular capacity employed can vary depending on the application, e.g., where the signal is a coded signal, where the signal can be annotated with additional information (e.g., a unique patient identifier), etc.

[0061] According to aspects of the present disclosure, the IEM composition includes: (a) an activation component (e.g., battery completion) and (b) a signal generating component, where the signal generating component is activated by the activation component to produce an identification signal (e.g., as described above).

[0062] In one aspect of the present disclosure, the activation component can be completed by a battery. In this aspect, the battery includes a cathode, an anode, and an electrolyte when completed. When the IEM device (e.g., an IEM associated with active agent composition stability) is administered (e.g., taken) and passes through the esophagus, it proceeds into the stomach. The cathode and anode provided within the IEM do not constitute a complete battery. However, when the active agent composition dissolves to expose the cathode and anode of the IEM, the gastric fluid (e.g., hydrochloric acid and other digestive agents) acts as the electrolyte component of the battery. Thus, the added components of the gastric fluid complete the battery. Accordingly, when the IEM device (e.g., by passing into the stomach and dissolving to the point of cathode and anode exposure) contacts the target site, a power source is provided to activate the IEM, e.g., in a chip configuration. The data signal (e.g., as described herein) is then transmitted by the IEM identifier.

[0063] Figure 1 An IEM 100 is shown having a signal generating element 102 powered by reverse electrolysis. In one aspect, the signal generating element 102 includes electronic circuitry. The signal generating element 102 is electrically connected to metal electrodes 104 and 106, which are made of two different materials and are electrically insulated from each other. When the metal electrodes 104 and 106 are immersed in an ionic solution 108, a potential difference is created between them. For example, electrode 106 rises to a higher potential V+ while electrode 104 drops to a lower potential V-. This potential difference can be used to power the signal generating element / electronic circuitry 102. Two outputs of the electronic circuitry 102 are E0 110 and El 112, which are signal transmission electrodes on the top surface. In alternative aspects (not shown), the IEM can include signal transmission electrodes, e.g., output E0 110.

[0064] The electrodes 104 and 106 can be implemented in various ways; for example, a region on opposite surfaces of an integrated circuit (IC) chip can be coated with two different metals, and the entire IC chip can be placed in the ionic solution. The electrodes 104 and 106 can be made of any two materials suitable for the environment in which the IEM 100 is to operate. For example, in certain aspects, the ionic solution 108 includes gastric acid, and the electrodes 104 and 106 can be made of noble metals (e.g., gold, silver, platinum, palladium, etc.) so that they are not corroded prematurely. In alternative aspects, the electrodes 104 and 106 can be made of aluminum or any other electrically conductive material that has a sufficient survival time in the applicable ionic solution to allow the IEM 100 to perform its intended function.

[0065] Various different materials can be employed as the battery electrodes 104 and 106, (e.g., CuCI or CuI as the cathode; and Mg or Zn as the anode). In certain aspects, the electrode materials are selected to provide a voltage sufficient to drive the signal generating element 102 of the IEM when in contact with the target physiological site (e.g., the stomach). In certain aspects, the voltage provided by the electrode materials when in contact with the target physiological site is 0.001 V or more, including 0.01 V or more, e.g., 0.1 V or more, e.g., 0.3 V or more, including 0.5 V or more, and including 1.0 V or more. In certain aspects, the voltage ranges from about 0.001 to about 10 volts, e.g., from about 0.01 to about 10 V.

[0066] In certain aspects, the signal generating element 102 includes circuitry that produces or generates a signal, as developed in greater detail below. The type of circuitry selected depends at least in part on the driving power supplied by the power source / battery of the IEM. For example, when the driving power is 1.2 volts or above, standard CMOS circuitry can be employed. In other aspects, when the driving power ranges from about 0.7 to about 1.2 V, sub-threshold circuit design can be employed. For driving power of about 0.7 V or less, zero threshold transistor design can be employed.

[0067] In certain aspects, the signal generating element 102 includes a voltage controlled oscillator (VCO) that is capable of generating a digital clock signal in response to activation of the activation component. The VCO can be controlled by a digital control circuit that is assigned an address and can control the VCO with a control voltage. The digital control circuit can be embedded on an IC chip that includes the activation component and the oscillator. The address is encoded using amplitude modulation or phase shift keying, transmitting an identification signal.

[0068] Figure 2 is a block diagram of a signal generating element 200 of an IEM according to one aspect of the disclosure. In various aspects, the signal generating element 200 includes a transmitter. Referring to Figure 2 , the signal generating element 200 receives a signal M from an activation component that activates the signal generating element 200 to produce and emit a signal. The signal generating element 200 includes control logic 202, an oscillator 204, an electrode driver 206, and an antenna 208 (in this case, a pair of electrodes operating as an electric dipole antenna). In operation, the oscillator 204 generates an oscillating signal (e.g., a waveform) in response to a signal from the control logic 202. The signal from the control logic 202 can start or stop the oscillator, and in some aspects can also shape one or more aspects of the oscillating signal, such as amplitude, frequency, and / or phase. The oscillator 204 provides the waveform to the electrode driver 206, which drives a current or voltage on the antenna 208 to transmit a signal into the conductive medium of the body tissue and / or fluid.

[0069] According to a given aspect, the signal can or can not be modulated. For example, in certain aspects, the frequency of the signal can remain constant. Referring to Figure 2 , for example, the oscillator 204 can operate at a constant frequency. Receiving a constant frequency signal itself can provide useful information, such as the presence and operability of a remote device. In other aspects, the signal can be modulated in some manner (e.g., via a carrier-based modulation scheme, an ultra-wideband (or time-domain based) modulation scheme, etc.). For example, the oscillator 204 can modulate its signal to encode additional information.

[0070] Information can be encoded in various ways (usually by modulating (changing) some characteristics of the transmitted signal, such as frequency, amplitude, phase, or any combination thereof). Modulation techniques known in the art can be employed.

[0071] Generally, information can be transmitted using either analog or digital techniques. Analog techniques typically refer to modulation characteristics that vary to varying degrees, where the degree of variation is related to the value representing the information to be transmitted. For example, suppose signal generation element 200 is transmitting a signal. Oscillator 204 can be designed to operate within some frequency range. Digital techniques typically refer to representing the information to be transmitted as a sequence of binary numbers (bits) and modulating the signal based on a bit stream. For example, again suppose signal generation element 200 is using digital techniques to transmit a signal. Oscillator 204 can be designed to operate at at least two different frequencies, one frequency corresponding to bit value 0 and the other frequency corresponding to bit value 1. In aspects of this disclosure, information can be transmitted using either analog, digital, or a combination thereof. Furthermore, various types of modulation can be implemented.

[0072] In one aspect, frequency modulation can be used. Oscillator 204 can be a voltage-controlled oscillator (VCO), where the oscillation frequency of the oscillator circuit depends on the applied voltage. Control logic 202 provides an appropriate voltage (e.g., reflecting the value of the measured data, M), and the frequency of the signal indicates the value of the data. In another aspect, amplitude modulation can be used. For example, the drive signal can be changed. and / The amplitude can be controlled by changing the positive and negative rails (e.g., V+ and V-) of the drive circuit. In another aspect, phase modulation can be used. For example, in digital signal transmission, one phase corresponds to a bit value of 0, the opposite phase corresponds to a bit value of 1, and phase shift indicates a transition. Oscillator 204 may include a drive signal... and / Alternatively, the switching circuit can be directly or cross-connected to the input of the drive circuit. Combinations of frequency modulation, amplitude modulation, and / or phase modulation can also be used as needed.

[0073] In various aspects, the signal generating element 200 can transmit a "packet" that includes a unique identifier of the IEM (e.g., an IEM identification code, a numeric code, etc.), which in turn is used for a composition associated with the IEM. As discussed herein, such an IEM identification code can have been preprogrammed into the IEM at the time of manufacture of the IEM. The IEM identification code can also provide access to additional information located on a remote device (e.g., identification of active agent, annotation information). In one aspect, these additional information can be accessed by querying a remote IEM tracking system database using the IEM identification code transmitted in the packet. Other techniques for distinguishing between different signals can also be used, including: operating different transmitters in different frequency bands, allowing each transmitter to be identified by its frequency and / or configuring different transmitters to transmit at different (and known) numbers of times, allowing the transmitters to be identified when they transmit.

[0074] Figure 3A and Figure 3B A more detailed view of the tablet / pill composition 312 is provided. Figure 3A An IEM 300 is shown placed within a tablet / pill 302. The IEM 300 can exist as an integrated circuit (IC). See Figure 3A The bottom surface of the IEM 300 is at least partially coated with a first metal 304, and a portion of the top of the IEM 300 is coated with a different metal 306, allowing the IEM 300 to be powered by, for example, reverse electrolysis as described above. There are also two transmitter electrodes 308 and 310 on the top surface.

[0075] As described above, in one aspect, Figure 3A An IEM 300 can be depicted that is combined directly with a composition (e.g., one or more pharmaceuticals / drugs) at the source of manufacture of the composition (e.g., a manufacturer / producer of a pharmaceutical composition) to become a pharmaceutical-device composition (e.g., a tablet / pill). In this aspect, the "pharmaceutical" composition can dissolve in the stomach by a combination of mechanical action of the stomach and action of various chemical components in the stomach fluid (e.g., hydrochloric acid). In another aspect, Figure 3A An IEM can be depicted that is combined with a "first" composition (e.g., a placebo / inert composition, a non-pharmaceutical composition, and / or a protective layer composition, etc.) (e.g., in the form of a placebo tablet or MIT) at the source of manufacture. Such an IEM can then be combined (e.g., co-encapsulated) with a "pharmaceutical" composition (e.g., one or more pharmaceuticals / drugs) by a licensed pharmacist in a pharmaceutically acceptable carrier / vehicle (e.g., a capsule). See, for example, Figure 4, reference numerals 418 and 422. In this aspect, the pharmaceutically acceptable carrier / vehicle, the "drug product" composition, and the "first" composition can dissolve in the stomach through a combination of mechanical action of the stomach and action of various chemical components in the gastric fluid (e.g., hydrochloric acid).

[0076] When the tablet / pill composition 312 dissolves, the region of the IEM 300 is exposed to the gastric contents, which can be considered, for present purposes, to be an electrolyte solution. When the dissolution of the tablet / pill composition 312 exposes the metal layers 304 and 306, power is supplied to the IC of the IEM 300, which begins and continues to operate until the metal layers 304 and 306 or the circuitry itself is sufficiently dissolved by the digestive process and the acid to become non-functional. When powered, the IEM 300 can transmit its identification signal (e.g., IEM identification code) via the transmitter electrodes 308 and 310. Eventually, any remaining of the IEM 300 is naturally expelled from the body.

[0077] In alternative aspects, the IEM 300 can be attached to the tablet / pill 302 rather than encapsulated within the tablet / pill 302. For example, the IEM 300 can be placed at one end of the tablet / pill 302 in a soluble coating on the surface of the tablet / pill 302, etc. when the tablet / pill 302 is being prepared. In various aspects, the IEM 300 can be fully or partially exposed. In these aspects, the IC of the IEM 300 can begin to operate after the tablet / pill 302 enters the stomach rather than after the tablet / pill 302 dissolves. As above, when powered, the IEM 300 can transmit its identification signal (e.g., IEM identification code) via the transmitter electrodes 308 and 310.

[0078] Figure 3B is a block diagram of one aspect of the IC of the IEM 300. In this aspect, the IEM 300 is a transmitter configured / programmed to sequentially transmit a series of address (identifier) bits 326 using frequency shift keying, with a first oscillation frequency corresponding to a bit value of 0 and a second oscillation frequency corresponding to a bit value of 1. As described above, the metal layers 304 and 306 supply power to the IC of the IEM 300. Power is supplied to an oscillator 312, a counter 314, a readout circuit 316, and an electrode driver 318, which drives transmitter electrodes 320 and 322 to transmit a signal. The oscillator 312 can be a generally conventional design (e.g., a ring oscillator) and is advantageously configured to operate in the quasi-electrostatic frequency region. The oscillator 312 generates a drive signal and an inverse drive signal that is phase opposite to the drive signal In one aspect, oscillator 312 is a voltage controlled oscillator (VCO) in which the oscillation frequency depends on a control voltage provided on signal path 324. Counter 314 counts the oscillations of the drive signal and / or and provides the current count to readout circuit 316. In one aspect, counter 314 is an 8-bit counter of generally conventional design; other types of counters (including counters of different widths) can also be used. As noted above, readout circuit 316 is configured with a set of address (identifier) bits 326 that are fixed (e.g., at the time of manufacture of IEM 300). Further, as noted above, the bits can be unique to the particular instance of tablet / pill 302. In one aspect, pills containing the same particular drug formulation can be assigned a set of address (identifier) bits that include a numeric code associated with the particular drug formulation (discussed further below). Address bits 326 can be stored in non-volatile storage circuitry of generally conventional design, and any number of address bits can be provided (e.g., 8, 15, 16, 30, 32, 43, 48, etc.). Readout circuit 316 generates an oscillator control signal (e.g., a voltage) on line 324 that controls the frequency of VCO 312. In one aspect, readout circuit 316 is configured to select the current address bit, e.g., based on the current count provided by counter 314, and to generate a control signal on signal line 324 that selects a frequency corresponding to the value of that bit (i.e., "1" or "0"). After a certain number of cycles (as determined by counter 314), readout circuit 316 selects the next address bit and generates a corresponding control voltage on signal line 324. Various frequencies can be used to represent the address bit values "1" and "0". In one aspect, frequencies of 100 kHz and 200 kHz can be used to represent values "0" and "1", respectively. Other values (e.g., 1 MHz and 2 MHz or 1 kHz and 5 kHz) can also be used. The selected frequencies can be well below the absorption mode of human tissue, which is typically above 400 MHz. As noted above, VCO 312 generates a complementary signal signal Used to control electrode driver 318. It should be noted that since electrodes 304 and 306 are in contact with gastric fluid during IC operation of IEM 300, the near-field component is directly coupled into the conductive medium of the patient's body and can be detected by a suitably configured receiver (discussed below). In one aspect, the receiver is configured to record the address of the received data (e.g., a unique identifier, a digital code) and the time of receipt. The receiver can also be configured to retransmit this information to an external device (e.g., an IEM tracking system) in real time or while the patient is in a medical facility. It should be understood that the transmitter described herein is illustrative and can be changed and modified. For example, other encoding schemes can be used to transmit data; in one such aspect, phase-shift keying is used instead of frequency keying. In some aspects, multiple address bits can be encoded into a single symbol, which is transmitted using various keying schemes known in the art.

[0079] IEM signal generation elements (e.g., Figure 1 102. Figure 2 200 Figure 3A (300) is a structure that emits (e.g., can be received by a receiver) a detectable signal when activated by an activated component. The signal generating element in some aspects can be any convenient means capable of generating a detectable signal and / or modulating transduced broadcast power when activated by an activated component. Detectable signals of interest include, but are not limited to: conductive signals, acoustic signals, RF signals, etc. Representative types of signals of interest include, but are not limited to: frequency-shift coded signals; amplitude-modulated signals; frequency-modulated signals, etc.

[0080] Such IEM devices can be used to automatically detect and identify the pharmaceutical formulation that is actually delivered to the consumer patient's body. Various IEM devices including IEMs are discussed in U.S. Patent No. 8,847,766 entitled "Pharma-Informatics System," U.S. Provisional Application Serial No. 60 / 790,335 entitled "Pharma-Informatics System," U.S. Provisional Application Serial No. 60 / 713,680 entitled "Medical Diagnostic and Treatment Platform Using Near-Field Wireless Communication of Information Within a Patient's Body," U.S. Provisional Application Serial No. 60 / 694,078 entitled "Pharma-Informatics System," and U.S. Provisional Application Serial No. 60 / 676,145 entitled "Pharma-Informatics System," the entire disclosures of which are incorporated herein by reference.

[0081] Manufacturing an IEM device

[0082] Various systems / methods can be used to manufacture IEM devices. Example systems / methods include those discussed in U.S. Patent Application Publication No. 2012 / 0011699 entitled "High-Throughput Production of Ingestible Event Markers," the entire disclosure of which is incorporated herein by reference.

[0083] In one aspect, such manufacturing systems can include an assembly unit configured to stably associate an IEM with an active agent composition (active agent and medically acceptable carrier) to produce various configured IEM devices, such as Figure 4 shown (e.g., a pill / capsule or a drug-containing capsule). In this aspect, the IEM can be combined with the composition (e.g., one or more pharmaceuticals / drugs) at the manufacturing source of the composition (e.g., the manufacturer / producer of the pharmaceutical composition) to become a pharmaceutical-device combination.

[0084] In another aspect, such manufacturing systems can include an assembly unit configured to stably associate an IEM with a placebo / non-pharmaceutical composition to produce various configured placebo / non-pharmaceutical IEM devices, such as Figure 4The manufacturing system / process can be the same except for the substitution of placebo / non-drug composition for active agent composition (e.g., IEMs are not combined with active drug(s) / medicaments at the manufacturer). In this regard, the placebo / non-drug IEM devices can subsequently be combined (e.g., co-encapsulated) with active agents (e.g., one or more drugs / medicaments) by a licensed pharmacist in a pharmaceutically acceptable carrier / vehicle (e.g., a capsule).

[0085] In Figure 4 In the view of "IEM in tablet" 402, for example, IEM 406 (e.g., with cell 408 (e.g., two different materials and control devices) and current path extender ("skirt") 412) is present inside of tablet 404 (e.g., by incorporating or placing in a cavity provided by two half-tablets during tableting). Next, in "IEM on tablet" 414, IEM 406 (e.g., with cell 408 (e.g., two different materials and control devices) and current path extender ("skirt") 412) is communicatively associated with tablet 404. Coating 416, shown in partial form, partially or entirely covers IEM 406, and can cover at least a portion of the carrier (e.g., tablet 404). Next, in "IEM in capsule" 418, IEM 406 (e.g., with cell 408 (e.g., two different materials and control devices) and current path extender ("skirt") 412) is communicatively associated, e.g., inserted into capsule 420. Next, in "bimetallic tablet" 422, IEM 406 (e.g., with cell 408 (e.g., two different materials and control devices) and current path extender ("skirt") 412) is communicatively associated, e.g., placed within two half-tablets 404a and 404b, respectively, in cavities 424. Next, in "on capsule" 426, IEM 406 (e.g., with cell 408) is communicatively associated, e.g., attached to an external portion of capsule 420. Finally, in "IEM as carrier" 428, IEM 406 structure is a tablet or used as a drug storage matrix.

[0086] In one aspect of the disclosure, such a manufacturing system can include a programming device configured to program / reprogram circuit components of the IEM. (For example, the programming device discussed above in connection with FIG. 3.) Figure 3B - a set of address bits 326 that are fixed when the IEM is manufactured). Any convenient programming device can be employed. In one aspect of the disclosure, the manufacturing system can include a programming unit, wherein the programming unit is configured to confirm that the IEM is functional / operable, and wherein the programming unit is further configured to program / reprogram circuit components of the IEM (e.g., the control logic 202 of the signal generation element 200 in FIG. 2, Figure 2 the control logic 202 of the signal generation element 200 in FIG. 2, Figures 3A-3Bprogrammed. In this aspect, the programming unit can program / reprogram circuit components of the IEM before, during, and / or after determining that the IEM is functional / operable. In alternative aspects, the circuit components of the IEM can not be programmable / reprogrammable, as discussed herein.

[0087] Figure 5 A process flow diagram 500 of a system configured to program an IEM is shown. Process 500 begins with combining an IEM 502 with an active pharmaceutical agent (API) and a physiologically acceptable carrier 504 into a tablet IEM device 506. After tablet compression, the resulting tablet can be coated at stage 508, and any printing or labeling applied at stage 510 to produce the final IEM device. Next, the IEM device is sent to a bulk packaging stage 512, from which the bulk packaged IEM device is shipped to a pharmacy 516 at stage 514 for final sale to a customer. Block 518 illustrates an example of a point in the process at which information can be transmitted to the IEM and / or information can be received from the IEM. For example, in one aspect of the disclosure, programming information can be transmitted to the IEM at any of points 520, 522, 524, and 526. Alternatively and / or in addition to transmitting programming information to the IEM at any of points 520, 522, 524, and 526, identification information (e.g., a unique identification code) can be retrieved from the IEM at any of these points. In one aspect, this identification information can be sent to an IEM tracking system database (discussed below).

[0088] In alternative aspects, the tablet IEM device 506 can include a placebo / non-drug IEM device (e.g., the IEM is not combined with an active drug product at the manufacturer), as discussed herein. Similar to Figure 5 , the placebo / non-drug IEM device can be coated at stage 508, and any printing or labeling applied at stage 510. Next, the placebo / non-drug IEM device can be sent to a bulk packaging stage 512, from which the bulk packaged placebo / non-drug IEM device is shipped to a pharmacy 516 for subsequent co-encapsulation with an active drug product by a licensed pharmacist. Similar to Figure 5 , the IEM of the placebo / non-drug IEM device can or can not be programmed / reprogrammed at points 520, 522, 524, and 526. In various aspects, identification information (e.g., a unique identification code) can be retrieved from the IEM at any or all of points 520, 522, 524, and 526. In one aspect, this identification information can be sent to an IEM tracking system database (discussed below).

[0089] Figure 6A tracking device 600 that can be used in manufacturing, supply chain, and / or pharmaceutical systems (e.g., at points 520, 522, 524, and / or 526 in Figure 5 , for example) is shown. In Figure 6 , a hopper 602 can include a plurality of IEM devices 604. Here, it should be understood that the IEM devices 604 can include IEM devices that include active pharmaceuticals or placebo / non-pharmaceutical IEM devices as discussed herein. A funnel 606 dispenses the IEM devices 604 into a dispenser counter 608. In one aspect of the disclosure, a structure / tube 610 attached to the dispenser counter 608 can include a number of radio frequency identification (RFID) coils 612 configured to receive / transmit the IEM identification codes of the IEM devices 604 as they pass through the tube 610. In an alternative aspect of the disclosure, the tube 610 attached to the dispenser counter 608 can include a capacitive plate / probe (discussed below) configured to receive / transmit the IEM identification codes of the IEM devices 604 as they pass through the tube 610. (See Figures 12A-12B ). Generally, other capacitive elements shaped in different configurations can be used in addition to plates according to some embodiments, although embodiments are not so limited. Notably, the tube 610 is sized to dispense a single IEM device 604 at a time into a container 614 (e.g., a bulk packaging container, a patient consumer container, etc.) until the container 614 is filled to a desired number of identified IEM devices. In this aspect, the received (e.g., read) IEM identification codes can be sent to an IEM tracking system database (discussed below). In other aspects of the disclosure, the tracking device 600 can include a scanner (not shown, e.g., an integrated scanner, an attached hand-held scanner, etc.) configured to scan a container identifier of the container 614 (e.g., see Figure 7 , reference numerals 706 and / or 708). In this aspect, the tracking device 600 and / or a computer system (e.g., a manufacturing system, a supply chain system, a pharmaceutical system, etc.) in communication therewith is configured to link the container identifier of the container 614 with the received (e.g., read) IEM identification codes of the IEMs of the IEM devices 604 that passed through the tube 610 into the container 614. In this aspect, the tracking device 600 and / or the computer system can send this linking information to an IEM tracking system database (discussed below).

[0090] Figure 7 A container 700 according to one aspect of the disclosure is shown. The container 700 can be a bulk packaging container (e.g., filled by a manufacturer) or a consumer patient container (e.g., filled by a pharmacy). The container 700 includes a tracking device (e.g., Figure 6The container 700 identifies multiple IEM devices 704. It should be understood that IEM devices 704 may include IEM devices, which include active pharmaceutical / drug or placebo / non-pharmaceutical IEM devices as discussed herein. The container 700 further includes a cap 710 and at least one container identifier 706 and / or 708. Figure 6 Similarly, the tracking device may include a scanner configured to scan at least one container identifier 706 and / or 708 of container 700. In this aspect, the tracking device and / or computer system (e.g., a manufacturing system, supply chain system, pharmaceutical system, etc.) communicating therewith is configured to link at least one container identifier 706 and / or 708 to the IEM identification codes of a plurality of IEM devices 704 received / read by the tracking device. In this aspect, the tracking device and / or computer system may send such linking information to an IEM tracking system database (discussed below).

[0091] Figure 8 An alternative tracking device 800 from one aspect of this disclosure is shown. Figure 8 In this embodiment, the counting plate / tray 802 may include an integrated capacitor plate / probe 804 positioned at the product exit point 806. The integrated capacitor plate / probe 804 is configured to receive / transmit the IEM identification code of the IEM of the IEM device passing through the product exit point 806. In this aspect, the counting plate / tray 802 may further include circuitry (not shown) configured to receive the IEM identification code from the capacitor plate / probe 804 and transmit the IEM identification code (e.g., wirelessly) to a computer system (e.g., a pharmacy computer system). Additionally, in this aspect, the computer system may be configured to record the transmitted IEM identification codes. The computer system may be further configured to link each recorded IEM identification code (e.g., in a local database) with other information, including consumer patient container identifiers (e.g., ...). Figure 7The computer system may be further configured to send such linked information to the IEM tracking system database. In this respect, the counting plate / tray 802 is capable of tracking the IEM device in area 812 and dispensing it into the consumer patient container via product exit point 806. In this way, more than one consumer patient can share an IEM device from a single bulk container, but only the IEM device actually dispensed into the consumer patient container is associated with the consumer patient (e.g., the computer system can link the IEM identification code of the IEM device dispensed into the consumer patient container with the consumer patient identifier). Here, in the case of dispensing to a consumer patient, it should be understood that the tracked IEM device may include: an IEM device comprising an IEM combined by the manufacturer with an active pharmaceutical ingredient / drug; or an IEM device comprising a placebo / non-pharmaceutical IEM device (e.g., co-packaged) combined by a pharmacist with an active pharmaceutical ingredient / drug prior to dispensing.

[0092] In addition, Figure 8 In the view, the counting plate / tray 802 may include an integrated capacitor plate / probe 808 positioned at the product exit point 810. The integrated capacitor plate / probe 808 is configured to receive / transmit the IEM identification code of the IEM of the IEM device passing through the product exit point 810. In this aspect, the counting plate / tray 802 may further include circuitry (not shown) configured to receive the IEM identification code from the capacitor plate / probe 808 and transmit the IEM identification code (e.g., wirelessly) to a computer system (e.g., a pharmacy computer system). Furthermore, in this aspect, the computer system may be configured to confirm / verify IEM devices returned to the bulk packaging container (e.g., not allocated to a consumer patient). The computer system may be further configured to send this information to an IEM tracking system database. In this aspect, the counting plate / tray 802 is capable of tracking IEM devices injected into the injection area 814 and allocated to the bulk packaging container via the product exit point 810. In this way, more than one consumer patient can share an IEM device from a single large packaging container, while the system (e.g., a computer system, an IEM tracking system, etc.) keeps track of IEM devices that have not yet been distributed. It should be understood here that the tracked IEM devices can include: IEM devices comprising an IEM combined with an active pharmaceutical ingredient / drug by the manufacturer, or IEM devices comprising a placebo / non-pharmaceutical IEM device (e.g., co-packaged) combined with an active pharmaceutical ingredient / drug by a pharmacist prior to distribution.

[0093] Pharmacist co-encapsulation

[0094] As discussed in this article, manufacturers can produce a variety of configurations by stably associating the IEM with placebo / non-pharmaceutical components. Figure 4 For example, a placebo / non-pharmaceutical IEM device (reference numeral 402). Pharmacies may stock (e.g., from such manufacturers) multiple bulk containers, each containing multiple placebo / non-pharmaceutical IEM devices. As discussed herein, each placebo / non-pharmaceutical IEM device may be hardcoded / programmed at the manufacturer level with a unique IEM identifier. In other aspects of this disclosure, each placebo / non-pharmaceutical IEM device may be hardcoded / programmed at the manufacturer level with a unique IEM identifier including a digital code (e.g., reserved for a specific drug and dosage form).

[0095] In this environment, licensed pharmacists can obtain prescriptions from consumer patients. In various aspects of this disclosure, prescriptions can be made for IEM-based medications / dosages to consumer patients. The consumer patient's physician can write such prescriptions so that the physician and / or the consumer patient can (e.g., via an IEM tracking system) track whether the consumer patient has taken their prescribed dosage at the prescribed time (e.g., medication adherence).

[0096] As previously stated, in one aspect of this disclosure, each of the multiple placebo / non-drug IEM devices in a large packaging container can be hard-coded / programmed with a unique IEM identifier, which includes a digital code within a digital code block reserved for a specific drug and dosage form (e.g., furosemide, 20 mg tablets). In this regard, in response to a physician's prescription for an IEM-based drug / medication (e.g., a prescription for furosemide (20 mg tablets) with a total of 60 IEM system traceable entries), a licensed pharmacist can retrieve, for example, i) a bottle of prescription drug / medication (e.g., a bottle of furosemide, 20 mg tablets, counted in 100), ii) a placebo / non-drug IEM device in a large packaging container hard-coded / programmed with a unique IEM identification code, the IEM identification code including a digital code within a digital code block reserved for prescription drugs and dosage forms (e.g., a placebo / non-drug IEM device in a large packaging container hard-coded / programmed with a unique IEM identification code, the IEM identification code including a digital code within a digital code block reserved for furosemide (20 mg tablets), and iii) a number of pharmaceutically acceptable carriers / media for dispensing according to a prescription (e.g., 60 capsules). The pharmacist can then combine / co-encapsulate the prescription drug / medication (e.g., furosemide, 20mg tablets) with this placebo / non-drug IEM device in each pharmaceutically acceptable carrier / medium (e.g., capsule) to dispense the medication as prescribed. The pharmacist can then place the combined / co-encapsulated IEM-based drug / medication on the tracking device (e.g.,Figure 8 For example, the combined / co-encapsulated IEM-based drug / medication (e.g., in the area 814 of the counting tray / puck 802) is counted (e.g., by the counting tray / puck 802) and the combined / co-encapsulated IEM-based drug / medication (e.g., in the area 812) is dispensed into the consumer patient container (e.g., via the product outlet 806). As discussed above with reference to Figure 8 For example, the combined / co-encapsulated IEM-based drug / medication (e.g., in the area 814 of the counting tray / puck 802) is counted (e.g., by the counting tray / puck 802) and the combined / co-encapsulated IEM-based drug / medication (e.g., in the area 812) is dispensed into the consumer patient container (e.g., via the product outlet 806). As discussed above with reference to Figure 8 For example, the combined / co-encapsulated IEM-based drug / medication (e.g., in the area 814 of the counting tray / puck 802) is counted (e.g., by the counting tray / puck 802) and the combined / co-encapsulated IEM-based drug / medication (e.g., in the area 812) is dispensed into the consumer patient container (e.g., via the product outlet 806). As discussed above with reference to Figure 8 As discussed above with reference to the foregoing, the tracking device can facilitate the linking of each unique IEM identification code (e.g., including the numeric code within the numeric code block reserved for the prescribed drug and dosage form) of the dispensed IEM with other dispensing information (e.g., the identifier of the consumer patient container into which it was dispensed, the particular drug and dosage form that was dispensed, the identifier of the consumer patient to whom it was dispensed, etc.) and the transmission of this linked information to the IEM tracking system database. Notably, in this aspect, only placebo / non-drug IEM devices of the bulk packaging container that are hard-coded / programmed with unique IEM identification codes including the numeric code within the numeric code block reserved for the prescribed drug and dosage form can be utilized to fill a prescription. This can be required in situations where the tracking of the IEM-based drug / medication is particularly important / sensitive (e.g., a Class II drug).

[0097] As previously discussed, in another aspect of the disclosure, each placebo / non-drug IEM device of the plurality of placebo / non-drug IEM devices of the bulk packaging container can be hard-coded / programmed with a unique IEM identification code. In this aspect, there can be no numeric code block reserved for a particular drug and dosage form (e.g., furosemide, 20 mg tablets). In this aspect, in response to a physician's prescription for an IEM-based drug / medication (e.g., a prescription for a total of 60 IEM system traceable furosemide (20 mg tablets)), the pharmacist can retrieve, for example, i) a bottle of the prescribed drug / medication (e.g., a 100 count bottle of furosemide, 20 mg tablets), ii) placebo / non-drug IEM devices of the bulk packaging container that are hard-coded / programmed with unique IEM identification codes (e.g., 100 count bulk packaging container of placebo / non-drug IEM devices that are hard-coded / programmed with unique IEM identification codes), and iii) a number of pharmaceutically acceptable carriers / vehicles to fill the prescription (e.g., 60 capsules). The pharmacist can then combine / co-encapsulate the prescribed drug / medication (e.g., furosemide, 20 mg tablets) with this placebo / non-drug IEM device in each pharmaceutically acceptable carrier / vehicle (e.g., capsule) to fill the prescription. The pharmacist can then place the combined / co-encapsulated IEM-based drug / medication on the tracking device (e.g., Figure 8counted (e.g., placed into area 814 of the counting plate / tray 802), the combined / co-encapsulated IEM-based drug / medication is counted (e.g., via the product exit point 806) and dispensed into a consumer patient container. As discussed above with reference to Figure 8 Figure 8 Figure 8 As discussed above with reference to

[0098] IEM system

[0099] Various systems can be in data communication with the IEM. Such systems include those discussed in U.S. Patent Application entitled "Ingestible Event Marker Data Framework," Publication No. 2011 / 0009715, the entire disclosure of which is incorporated herein by reference.

[0100] See Figure 9 ​​IEM data framework 902 can include IEM data 904, hub 906, and one or more IEM data systems 908. Here, IEM data 904 includes data associated with an ingestion event (e.g., an ingestion action). For example, IEM data 904 can include an identification of an ingested substance (e.g., an IEM identification code, a numeric code, etc.). Hub 906 includes any hardware, software, and / or communication components in any combination / configuration that are generally used to communicate with IEM data 904. In one aspect, hub 906 is configured to communicate IEM data 904 to IEM data systems 908. For example, hub 906 can receive IEM data 904 from an IEM device and forward IEM data 904 to IEM data systems 908, either alone or in combination with other data from other sources. IEM data systems 908 provide discrete services and / or activities related to IEM data 904. Discrete services and / or activities include, for example, disseminating information, data, etc. to a particular user or group of users via various system components configurations, etc.

[0101] In one aspect of the disclosure, IEM data 904 can be communicated by an IEM that is attached to, embedded in, or otherwise integrated with a pharmaceutical product and dosage form (e.g., Figure 4 ). In another aspect of the disclosure, an IEM can be co-encapsulated with a pharmaceutical product and dosage form. Here, an IEM can be configured to communicate IEM data 904 via various methods (e.g., wireless methods, conduction methods via body tissue and / or fluids, etc.).

[0102] In one aspect of the disclosure, IEM data 904 can be communicated to, for example, received by a receiver. A receiver (e.g., hub 906) can be implemented in various ways, including an attachable device, an implantable device, a semi-implantable device (e.g., a subcutaneous device), and an externally applied device (e.g., a personal signal receiver). One example of a personal signal receiver is a "patch" receiver that can be removably affixed to an individual, clothing, etc. In one aspect, when such a receiver is affixed or otherwise associated with a consumer patient, the programming logic associated with the receiver can be configured to receive IEM data 904 (e.g., a unique IEM identification code, a numeric code, etc.) and communicate IEM data 904 to a computer-related device, e.g., IEM data systems 908. Various receivers can communicate with IEM devices. Such receivers include those discussed in U.S. Patent No. 9,439,599, entitled "Wearable Personal Body Associated Device with Various Physical Configurations," the entire disclosure of which is incorporated herein by reference.

[0103] In one aspect of the disclosure, hub 906 can include any hardware apparatus, software, and / or communication components, and combinations thereof, generally used in communicating IEM data 904, including receiving, storing, manipulating, displaying, processing, and / or transmitting IEM data 904. Communication of IEM data 904 with hub 906 includes any transmission means or carrier, and combinations thereof, including wireless, wired, RF, conductive, and the like. Here, hub 906 can include various types of devices (e.g., personal communication devices, base stations, mobile phones, and the like).

[0104] In one aspect of the disclosure, IEM data system 906 includes any hardware components, software components, and / or communication components, and networks, systems, and subsystems thereof, generally used in providing services, functions, activities, and the like, related to IEM data 904 (e.g., IEM identification codes). More specifically, IEM data system 908 can include components including computers, receivers, transmitters, applications, software modules, data storage media, relational databases, processors, memory components, and / or communication links, and IEM data system 908 can, for example, collect, manipulate, compute, transmit, receive, store, and / or otherwise communicate at least a portion of IEM data 904. Further, IEM data system 908 can integrate with, interoperate with, and / or communicate with one or more business systems, and can otherwise share or advance IEM data related activities with one or more business systems. Here, business systems can include manufacturer computer systems and / or pharmacy computer systems.

[0105] In one aspect of the disclosure, IEM data system 908 can include an IEM tracking system. The IEM tracking system can include software and an IEM tracking system database for processing and storing IEM data 904. More specifically, the IEM tracking system can track the life cycle of an IEM from manufacture to shipment, to pharmacy inventory, to delivery to a patient, to ingestion by a patient, and to excretion from a patient. Notably, in this aspect, the IEM tracking system can integrate with, interoperate with, communicate with, and otherwise share IEM data 904 (e.g., IEM identification code data) stored in its IEM tracking system database with one or more business systems, including manufacturer computer systems and / or pharmacy computer systems, in order to monitor consumer patient adherence to a prescribed medication regimen.

[0106] In one aspect of the disclosure, the IEM tracking system can be in communication with one or more business systems including at least one manufacturing system and / or at least one pharmacy system. As discussed herein, such manufacturing and / or pharmacy systems can communicate IEM data (e.g., IEM identification codes, etc.) to the IEM tracking system. In one exemplary aspect, IEM data from an IEM device can be recorded by the tracking device (see above Figure 6 and Figure 8 ). For example, the IEM tracking system can receive IEM data from a manufacturer computer system (e.g., a hard-coded / programmed IEM identification code read from an IEM device, information linked to the hard-coded / programmed IEM identification code via the tracking device). As another example, the IEM tracking system can receive IEM data from a pharmacy computer system (e.g., a hard-coded / programmed IEM identification code read from an IEM device, information linked to the hard-coded / programmed IEM identification code via the tracking device). In these aspects, the IEM tracking system is configured (e.g., via software, database applications, etc.) to store this IEM data in its IEM tracking system database.

[0107] In one exemplary aspect of the present disclosure, an IEM tracking system storing IEM data compiled from manufacturing systems and / or pharmacy systems can be queried to identify unknown IEM identification codes. Here, a plurality of IEM identification codes can be (e.g., wirelessly) relayed to a consumer-patient computer (e.g., a personal computer, a mobile phone, etc.) from / to a receiver / patch / hub that has logged a plurality of IEM identification codes (e.g., from IEM devices taken by a consumer-patient). In this aspect, the consumer-patient computer can include a compliance application (e.g., for monitoring the consumer-patient's adherence to a prescribed medication regimen) configured to identify unknown IEM identification codes. More specifically, the compliance application can be configured to query the IEM tracking system database for expected IEM identification codes (e.g., IEM identification codes stored as being associated with a medication and dosage form taken by the consumer-patient). In this aspect, the compliance application can be configured to compare these expected IEM identification codes to the plurality of relayed IEM identification codes to determine / detect any unknown IEM identification codes. Upon detection, the compliance application can be configured to register the unknown IEM identification code as a take event pending identification. In this aspect, the compliance application can be configured to query the IEM tracking system database for the medication and dosage form associated with the unknown IEM identification code. In one aspect, the compliance application can simply receive the identification of the medication and dosage form from the IEM tracking system. In another aspect, the compliance application can receive a patient container identifier linked to the unknown IEM identification code (e.g., uploaded to the IEM tracking system database from a pharmacy computer system that filled the medication and dosage form as discussed herein). In this aspect, the compliance application can be further configured to download all IEM identification codes associated with that patient container identifier (e.g., that prescription). This aspect can be desirable when the consumer-patient has begun taking / tracking a new medication / drug. By proactively downloading all such IEM identification codes (e.g., associated with the patient container identifier identified based on the detected unknown IEM identification code), the compliance application can more quickly recognize future IEM identification codes locally without having to query the IEM tracking system database again. In this way, the compliance application can learn the medications / drugs being tracked by the consumer-patient. Without this feature (e.g., until the compliance application is instructed to expect a new medication / drug), the compliance application would otherwise query the IEM tracking system database each time an IEM identification code associated with that patient container identifier is detected as an unknown IEM identification code.

[0108] Communication mode

[0109] In one aspect of the disclosure, communication with an IEM of an IEM device occurs via capacitive coupling. Capacitive coupling can be advantageous over other modes of communication (e.g., RFID) to ensure data integrity, privacy, etc. (e.g., close proximity between the capacitive probe / plate and the IEM device can facilitate / promote privacy aspects). Various systems / methods that implement capacitive coupling include those discussed in U.S. Patent Application Publication No. 2012 / 0220838, entitled "System for Supply Chain Management," the entire disclosure of which is incorporated herein by reference.

[0110] Referring to Figure 10A , the device 1010a (e.g., IEM) in the drug product 1012a (e.g., pill or tablet) is discussed in detail below, which is fully packaged and tested via a probe. According to various aspects of the disclosure, the device 1010a can be located within the product 1012a or affixed to the surface of the product 1012a, as contemplated within the scope of the disclosure. The device 1010a includes a control module for communication and a memory for storing information (e.g., IEM identification code) (see Figure 2 ). The probing of the device 1010a can be performed for a variety of purposes (e.g., to ensure that the device 1010a is operable to read the IEM identification code programmed within the device 1010a). The probing uses a capacitive coupling method (e.g., non-destructive interrogation method), in which a first probe capacitive plate 1020a is capacitively coupled with a first metal or material 1014a on one side of the device 1010a and a second probe capacitive plate 1030a is capacitively coupled with a second metal or material 1016a on the other side of the device 1010a. Although referred to as capacitive "plates" and / or "probes" in the disclosure, it is to be understood that any suitable capacitive element can be used to allow capacitive coupling between components. In one aspect of the disclosure, the first probe capacitive plate 1020a and the second probe capacitive plate 1030a are associated with a wireless interrogator (e.g., see Figure 6 and Figure 8). Notably, the capacitive pad 1020a is electrically isolated from the capacitive pad 1030a (not shown). Various methods of using capacitive coupling for detection can be implemented, such as metal, metal pads, etc. According to one aspect of the disclosure, for example, there is a capacitive coupling between the material 1014a and the capacitive pad 1020a and the material 1016a and the capacitive pad 1030a. The capacitive pads 1020a and 1030a can be probes that communicate with the device 1010a through capacitive coupling. The capacitive pads 1020a and 1030a are electrically connected to a system (e.g., a manufacturer system, a pharmacy system) that can receive information (e.g., an identification code of the device 1010a) from the capacitive pads 1020a and 1030a and process the information (e.g., transmit to an IEM tracking system). Further, according to various aspects of the disclosure, the drug product 1012a can be coated with a non-conductive material.

[0111] Referring to Figure 10B , according to one aspect of the disclosure, the device 1010b is shown as part of the product 1012b. The device 1010b includes a first material 1014b and a second material 1016b deposited on a surface of the device 1010b for forming a capacitive connection. The materials 1014b and 1016b are in communication with a control module of the device 1010b. Probes 1020b and 1030b are capacitively coupled to the materials 1014b and 1016b, respectively. Thus, when the probes 1020b and 1030b are energized with an AC voltage (e.g., in the kV range, a 50 kHz signal), the materials 1014b and 1016b are capacitively coupled to the probes 1020b and 1030b. Information associated with the device 1010b (e.g., an identification code of the device 1010b) stored in a memory of the device 1010b can be encoded by the control module of the device 1010b and communicated to the probes 1020b and 1030b using capacitive coupling. An external AC signal powers the device 1010b, which then switches its internal antenna to be in and out of circuit, modulating the capacitance sensed by a wireless interrogator (e.g., Figure 6 and Figure 8 ), and thereby conveying information. In this manner, the identification code and configuration of each device 1010b can be read out at the time of manufacture or subsequently.

[0112] Referring to Figure 10Cdepot 1018c. Further, the materials 1014c and 1016c are coupled to a control module of the device 1010c to allow communication from the control module of the device 1010c through capacitive coupling to allow identification of the device 1010c to be communicated to a system (e.g., a manufacturer system, a pharmacy system, etc.) through probes 1020c and 1030c. According to one aspect of the disclosure, the materials 1014c and 1016c are conductive inks, such as, for example, ingestible graphite or carbon-based inks or pastes. In this aspect, the probes 1020c and 1030c are powered by an AC source and, when in proximity to the materials 1014c and 1016c, the probes 1020c and 1030c can communicate with the device 1010c through capacitive coupling using the materials 1014c and 1016c, respectively. Further, according to another aspect of the disclosure, probes 1022c and 1032c are positioned to be in proximity to the materials 1014c and 1016c at different locations to allow for alternative positioning of the device 1010c or to provide detection of the device 1010c from another direction. Once the probes 1020c and 1030c are powered with an AC voltage and the device 1010c is in proximity to the probes 1020c and 1030c, the materials 1014c and 1016c can be used to transfer information between the device 1010c and a system (e.g., a manufacturer system, a pharmacy system, etc.) that is connected to the probes 1020c and 1030c through capacitive coupling.

[0113] Referring to Figure 10D device 1010d. The conductive material 1014d is deposited on a surface of a material 1019a associated with the device 1010d. The material 1019a and a material 1019b of the device 1010d are different materials and form part of a power source for the device 1010d. For example, the material 1019a can be CuCl and the material 1019b can be Mg. The device 1010d also includes a transistor at a connection 1019c that is capable of electrically connecting the composite material 1014d to either V-high or the material 1019b at the same potential as V-low. The device 1010d includes a composite material 1016d that is physically associated with the device 1010d and on top of an oxide layer 1017d. The material 1016d can be gold plated CuCl. Thus, when similar to Figures 10A-10CThe probes or plates discussed above are powered by an oscillating or AC voltage source and, when in proximity to the device 1010d, there is a capacitive coupling between the composite material 1014d and the composite material 1016d and the probes or plates. According to one aspect of the disclosure, when the voltage source is isolated, the energy transmitted to the material 1014d and the material 1016d changes accordingly and is stored on the device 1010d. When the voltage source is reduced to zero or quiet, then the device 1010d switches from receiving energy to transmitting energy to the probes using capacitive coupling. To create the oscillating energy source, a transistor 1019c is used to connect and disconnect the material 1014d between the material 1019b (representing V-low) and V-high. When the material 1014d changes the energy level from V-high to V-low, information (e.g., an identification code of the device 1010d) can be communicated to the probes. Thus, during a portion of the cycle when the power is off or quiet (as shown), the device 1010d is able to transfer energy to the probes, which energy includes information about the device 10d. Thus, using capacitive coupling, information communication can be made between the device 1010d and a system (e.g., a manufacturer system, a pharmacy system, etc.) connected to the probes in proximity to the device 1010d. Figure 11C

[0114] Referring to Figure 10E , according to another aspect of the disclosure, a coaxial probe is shown having two conductive probes / plates 1020e and 1030e spaced apart by an insulating material 1025e. The inner conductive probe or plate 1020e is surrounded by the insulating material 1025e, which is surrounded by the outer conductive probe or plate 1030e. The device 1010e is shown as part of a pharmaceutical product 1012e. The device 1010e includes a conductive material or ink 1015e deposited on the side opposite the coaxial probe. When the coaxial probe is positioned in proximity to the product 1012e, the probe 1020e is positioned over the center of the device 1010e and the probe 1030e is positioned over the outer edge of the device 1010e and in proximity to the material 1015e. Thus, as described above and with respect to Figure 11C , when the power source is isolated, energy is transferred from the coaxial probe to the device 1010e and when the power source is off or quiet, then energy is transferred from the device 1010e to a system (e.g., a manufacturer system, a pharmacy system, etc.) connected to the coaxial probe.

[0115] Referring to Figure 11 , the voltage source (e.g., an AC voltage or other isolated or alternative source 1140) can operate at a high frequency (e.g., 1 MHz). The voltage source is connected to the probes or plates. The device 1110 can include a control module 1150 and pads 1152, a material (e.g., Figure 10A ​1014a and 1016a) are coupled to the pads. According to one aspect of the disclosure, inside the device 1110 is a diode 1154, such as a Schottky diode or other type of diode that generates an internal power supply voltage, and a switch 1156 that has some impedance that changes the impedance of the device 1110. The change in impedance is used to communicate information about the identity of the device 1110 (e.g., an IEM identification code). The change in impedance allows the information associated with the device 1110 to be encoded and sent to a system (e.g., a manufacturer system, a pharmacy system, etc.) using capacitive coupling by the probes represented by capacitors 1158 and 1160. The information is captured by the system connected to the probes represented by the capacitors and read in the form of Vout by a sampling amplifier of the impedance labeled R-sample.

[0116] Once the control module 1150 is proximate to or exposed to the voltage source by the plate, energy is transferred by capacitive coupling and the device 1110 can generate an oscillating signal that can be detected. The oscillating signal contains information and the isolated signal can be encoded into, for example, a 1 MHz signal or similar frequency (e.g., 500 KHz), which can depend on the degree of capacitive coupling. The voltage of the source 1140 will determine how much capacitive coupling is achieved between the plate or probes (e.g., 1020a and 1030a) and their material (e.g., 1014a and 1016a). Figure 10A

[0117] Referring to Figures 11A-11B According to another aspect of the invention, a diode bridge is shown that is a circuit representation of the interaction between the plate (e.g., 1020a and 1030a) and the material (e.g., 1014a and 1016a) of the device (e.g., 1010a). The isolated voltage present at the plate (labeled "PLATE 1" and "PLATE 2") results in the transfer of energy in the form of high and low voltage to the device (e.g., 1010a). The device (e.g., 1010a) includes a control module that is part of a processor or logic unit. The logic unit can be a processor, microprocessor, multi-module device, or any form of integrated circuit. The logic unit communicates with the conductive material (e.g., 1014a and 1016a) and the plate (e.g., 1020a and 1030a, labeled "PLATE 1" and "PLATE 2"). When the plate (e.g., 1020a and 1030a) is powered with an AC source, the logic unit stores the energy and then uses the energy to send information.

[0118] Referring to Figure 11C ​, showing a power cycle with an active period and a quiet period, and showing a transfer cycle of the device (e.g., 1010a) as a transfer window. According to the present disclosure, the duration of the active period energy is transferred from the power source to the device. Then during the quiet phase, the energy stored by the device is used to transfer energy from the device to the system connected to the probe (e.g., 1020a and 1030a). In this way, information associated with the device can be transferred from the device to the system connected to the probe through the probe. According to various aspects of the present disclosure, the information sent from the device to the system from the probe during the quiet phase is based on information stored in the memory of the device. Thus, even though the transfer window or quiet phase of the power source shows "1", the information transferred during the quiet state or phase of the power source can be "0".

[0119] Referring to Figures 12A-12B According to various aspects of the present disclosure, the capacitive plate / probe and the system connected thereto to receive information can be integrated or otherwise associated with various structural components and other devices (e.g., as Figure 12AThe tubular structure 1260, shown with capacitive plates 1220 and 1230 associated therewith. To illustrate, an IEM device 1210 having an IEM can be introduced into the structure 1260. The IEM device 1210 can be introduced manually or automatically via an automated means. As the IEM device passes through the structure 1260, the IEM device 1210 is detected by the capacitive plates 1220 and 1230 in the structure 1260. In various aspects, other devices and / or components can be associated. In one example, a database can be associated with a local system (e.g., a manufacturer system, a supply chain system, a pharmacy system, etc.). This database can be configured to track each IEM read, where the database record includes the IEM identification code of each read IEM and data associated with the medication and dosage form of each read IEM. To continue the above illustration, once the entire or partial quantity of the IEM device 1210 (e.g., a pill) is detected or "read" via the system associated with the probes / plates 1220 and 1230, the system can communicate the read information to an IEM tracking system database via a transmission unit (e.g., wireless, wired, etc.) for further storage, display, manipulation, etc. In this manner, individual profiles, data, large amounts of data, etc. can be processed for various purposes. One such purpose can be, for example, to track medication in a supply chain application (e.g., during manufacturing, during pharmacy verification, during pharmacy prescription, etc.). In an alternative aspect of the present disclosure, a user can detect an IEM device (e.g., a pill or tablet including an IEM) using a simple hand-held reader (e.g., using an oscillating power source) and determine the IEM identification code of the IEM device (e.g., via capacitive coupling). This approach can enable medication and dosage information and control measures to propagate throughout the life cycle of an IEM. The life cycle includes, for example, medication manufacturing, supply chain management, pharmacy management, and patient usage management.

[0120] According to various aspects of the present disclosure, there are various components included as part of the devices 1010a-1010e. For example, the devices 1010a-1010e can be IEMs with unique identifiers that can be read using capacitive coupling pre-consumption and communicated using trans-impedance post-consumption. Various aspects of IEMs are disclosed in U.S. Patent No. 7,978,064, entitled "Communication System with Partial Power Source," the entire disclosure of which is incorporated herein by reference. For example, when an IEM is wet in the stomach, the IEM can activate its unique identifier and conduct through body tissue to a compatible receiver (e.g., a wearable sensor similar to a band-aid). The receiver can log the detected IEM and also track various physiological parameters (e.g., heart rate, activity). The data is periodically uploaded from the receiver to an external device (e.g., a smartphone or tablet). Once on the external device, the uploaded data can be relayed to a cloud-based personal health record, other local applications, data stores, IEM tracking system databases, etc. depending on the use case. Various IEM systems operable to use such information are disclosed in U.S. Patent No. 9,119,918, entitled "Probablistic Pharmacokinetic and Pharmacodynamic Modeling," the entire disclosure of which is incorporated herein by reference.

[0121] In other aspects of the present disclosure, other communication modes can replace or supplement the capacitive coupling methods described above. For example, the IEM devices can be multi-mode communication IEM devices. Such IEM devices can include those discussed in U.S. Patent Application Publication No. 2009 / 0256702, the entire disclosure of which is incorporated herein by reference. In this example aspect, the IEM devices can include a consumable assembly that includes a conductive communication module (e.g., conductive communication via body tissue and / or fluids) and at least one additional non-conductive communication module (e.g., wireless communication via RFID). Similar to above, the IEM devices are operable to communicate with various other devices, including transmitters / receivers associated with inventory control, pharmacy control, and internal and in-vivo devices.

[0122] The signal obtained from a particular IEM can be a unique signal (e.g., a signal that uniquely identifies a particular IEM from a plurality of IEMs) depending on the needs of the particular application. In one aspect of the disclosure, each IEM device of a batch of IEM devices emits a unique signal relative to all other IEM devices in the batch (e.g., in a bulk packaging container, in a consumer patient container). In another aspect, the IEM of each IEM device can emit a universally unique signal (similar to a human fingerprint). Specifically, each signal can provide an IEM identification code that can be used to retrieve information about the IEM from an IEM tracking system database. For example, the IEM tracking database of the present disclosure can link each IEM identification code with a particular drug product (e.g., a pharmaceutical and dosage form) and a particular consumer patient. In one aspect of the disclosure, the signals can be encrypted in a manner that provides control over access to the signals and their information content.

[0123] Pharmacy level mapping

[0124] As discussed herein, the IEMs can be hard-coded / programmed during their manufacture (e.g., wafer processing). In one aspect of the disclosure, the IEMs can be programmed to operate in a 15-bit mode. In the 15-bit mode, there are 2 15 or 32,768 unique identification codes available for programming (e.g., in a transistor memory, there are only two states, zero or one, so the numbers are encoded as binary values). In another aspect of the disclosure, the IEMs can be programmed to operate in a 30-bit mode. In the 30-bit mode, there are 2 30 or 1,073,741,824 unique identification codes available for programming. In yet another aspect of the disclosure, the IEMs can be programmed to operate in a 43-bit mode. In the 43-bit mode, there are 2 43 or 8,796,093,022,208 unique identification codes available for programming. Here, it should be understood that the present disclosure contemplates other bit modes (e.g., an x-bit mode with 2 x unique identification codes available for programming). Here, given a high production environment (see U.S. Patent Application Publication No. 2012 / 0011699, for example, 50,000 or more IEM devices per hour), it should be understood that re-use of unique identification codes can be a practical necessity (e.g., if operating in a 15-bit mode).

[0125] Figure 13A unique IEM identification code associated with a 15-bit pattern is shown. For example, during the manufacturing process, an IEM can be hard-coded / programmed with a unique IEM identification code spanning from 15 "0"s to 15 "1"s (e.g., sequential, random, etc.). Similarly, in other aspects, an IEM associated with a 30-bit pattern can be hard-coded / programmed with a unique IEM identification code spanning from 30 "0"s to 30 "1"s (e.g., sequential, random, etc.), and an IEM associated with a 43-bit pattern can be hard-coded / programmed with a unique IEM identification code spanning from 43 "0"s to 43 "1"s (e.g., sequential, random, etc.). Here, it should be appreciated that an IEM associated with an x-bit pattern can be hard-coded / programmed with a unique IEM identification code spanning from x "0"s to x "1"s (e.g., sequential, random, etc.).

[0126] Pharmacy-level mapping without digital code reservation

[0127] In various aspects of the present disclosure (e.g., when re-use of unique identification codes is not desired), an IEM can be hard-coded / programmed during the manufacturing process with a unique IEM identification code determined based on the bit pattern to be used (e.g., 30-bit, 43-bit, x-bit, etc.). In this aspect, after hard-coding / programming an IEM with a unique IEM identification code, an IEM manufacturer can transmit (e.g., via a manufacturer system) linking information (e.g., associating each hard-coded / programmed unique IEM identification code with a large pack container identifier) to an IEM tracking system. Further, in this aspect, each produced IEM can subsequently be used to manufacture, for example, i) an IEM device including an IEM combined with an active pharmaceutical drug, or ii) a placebo / non-pharmaceutical IEM device including an IEM combined with a placebo / non-pharmaceutical composition. Notably, such manufactured placebo / non-pharmaceutical IEM devices are not intended to reference a specific pharmaceutical drug, and thus can not require FDA individual approval as a pharmaceutical-device combination.

[0128] With respect to an IEM device including an IEM combined with an active pharmaceutical drug, an IEM device manufacturer can transmit (e.g., utilizing a manufacturer system and / or tracking device as discussed herein, for example, Figure 6 ) linking information (e.g., associating each hard-coded / programmed unique IEM identification code with a large pack container identifier and / or an identifier of the active pharmaceutical drug) to an IEM tracking system. Subsequently, at the pharmacy level, with respect to an IEM device including an IEM combined with an active pharmaceutical drug, a pharmacist can simply fill a prescription using the IEM device (including an IEM combined with the prescribed pharmaceutical drug) in accordance with the prescription (e.g., in response to a consumer patient prescription for an IEM-based pharmaceutical drug). Further, using a tracking device (e.g., Figure 6 ,Figure 8 The pharmacy system can generate additional mapping information (e.g., further associating each hard-coded / programmed unique IEM identifier with its bulk packaging container identifier, and / or with the consumer patient container identifier, and / or the consumer patient identifier), and send this additional mapping information to the IEM tracking system.

[0129] Regarding placebo / non-drug IEM devices that include an IEM in combination with a placebo / non-drug component, the IEM device manufacturer may transmit linking information (e.g., associating each hard-coded / programmed unique IEM identifier with a bulk packaging container identifier and / or a placebo / non-drug component identifier) ​​(e.g., using manufacturer systems and / or tracking devices as discussed herein, such as...). Figure 6 ( ) to an IEM tracking system. Subsequently, at the pharmacy level, regarding placebo / non-drug IEM devices that include an IEM in combination with a placebo / non-drug component, pharmacists may (e.g., in response to a consumer patient's prescription for a drug / medication based on an IEM) co-encapsulate the placebo / non-drug IEM device with the prescribed drug / medication in a pharmaceutically acceptable carrier (e.g., a capsule). Furthermore, using a tracking device (e.g., Figure 6 , Figure 8 The pharmacy system can generate additional mapping information (e.g., further associating each hard-coded / programmed unique IEM identifier with the identifier of the active pharmaceutical ingredient / drug specified in the prescription (e.g., drug and dosage form) as well as its bulk packaging container identifier, consumer patient container identifier and / or consumer patient identifier), and send the additional mapping information to the IEM tracking system.

[0130] Notably, in the absence of such pharmacy-level mapping of the hard-coded / programmed unique IEM identification code of the placebo / non-drug IEM device to the identifier of the active drug / medication prescribed, the IEM tracking system would not be able to associate the active drug / medication with the unique IEM identification code of the placebo / non-drug IEM device. For example, with such pharmacy-level mapping, a receiver / patch / hub associated with a consumer patient that records the unique IEM identification code associated with a placebo / non-drug IEM device that is co-packaged with a prescribed medication (e.g., drug "A") by a pharmacist and taken by the consumer patient can relay (e.g., wirelessly) the recorded unique IEM identification code to a consumer application of a computer patient computer (e.g., a mobile phone), the consumer application can query the IEM tracking system to identify the drug / medication associated with the relayed unique IEM identification code, the IEM tracking system can look up the queried unique IEM identification code in its IEM tracking database to find the pharmacy-level mapping of the unique IEM identification code to the identifier of the active drug / medication prescribed (e.g., drug "A"), then the IEM tracking system can transmit the identifier of the active drug / medication prescribed (e.g., drug "A") to the consumer application, and then the consumer application can confirm / validate the consumer patient's adherence to the prescribed medication based on the received identifier. In various aspects, when an IEM identification code is detected by a consumer patient's body, the particular drug and dosage form mapped to the IEM identification code can be obtained by querying the IEM tracking system database to confirm that the consumer patient has taken the particular drug and dosage form.

[0131] Pharmacy-level mapping with digital code reservation

[0132] In other aspects of the present disclosure, a block of digital codes can be reserved (e.g., by an entity in the supply chain, e.g., a manufacturer, a pharmacy, etc.) for a particular drug and dosage form. Here, reserving a block of digital codes can be analogous to reserving a block of phone numbers for a particular geographic region by area code. In this case, a unique IEM identification code (e.g., analogous to a phone number) that includes a digital code (e.g., analogous to an area code) can be reserved for a particular drug and dosage form (e.g., furosemide, 20 mg tablet). Figure 14 An example block of digital codes reserved according to this aspect of the present disclosure is shown. In this example, a block of digital codes that includes a unique IEM identification code that includes the digital code "100" can be reserved for furosemide, 20 mg tablet 1402; a block of digital codes that includes a unique IEM identification code that includes the digital code "101" can be reserved for furosemide, 40 mg tablet 1404; and a block of digital codes that includes a unique IEM identification code that includes the digital code "111" can be reserved for furosemide, 80 mg tablet 1406. In this example, the unique IEM identification code for furosemide, 20 mg tablet 1402 is "100-1234567890" (e.g., the unique IEM identification code includes the digital code "100" and a serial number "1234567890"), the unique IEM identification code for furosemide, 40 mg tablet 1404 is "101-9876543210" (e.g., the unique IEM identification code includes the digital code "101" and a serial number "9876543210"), and the unique IEM identification code for furosemide, 80 mg tablet 1406 is "111-5432109876" (e.g., the unique IEM identification code includes the digital code "111" and a serial number "5432109876"). Figure 14In the example 15-bit pattern, each reserved numeric code block defines a unique IEM identification code that includes a respective 3-digit numeric code (e.g., "100," "101," and "111") combined with a balance of twelve digits that span from twelve "0"s to twelve "1"s. Numeric code blocks can similarly be reserved in other bit patterns (e.g., x-bit, 30-bit, 43-bit, etc.). It should be appreciated that, Figure 14 The example numeric codes are for illustrative purposes and the present disclosure contemplates numeric codes located at any specified position within an IEM identification code that include any number and / or series of digits.

[0133] In various aspects of the present disclosure (e.g., when reuse of unique identification codes is anticipated), numeric code blocks can be reserved. In this aspect, during manufacture of the IEMs, each IEM can be hard-coded / programmed with a unique IEM identification code determined based on a bit pattern (e.g., x-bit, 15-bit, etc.), where each hard-coded / programmed unique IEM identification code includes a numeric code associated with a reserved numeric code block. In this aspect, after the IEMs are hard-coded / programmed with unique IEM identification codes from the reserved numeric code blocks, the IEM manufacturer can transmit (e.g., via a manufacturer system) linking information (e.g., associating each hard-coded / programmed unique IEM identification code from the reserved numeric code blocks with a bulk packaging container identifier) to an IEM tracking system. Notably, at this stage, it can not be desirable to associate the produced IEMs with a particular drug and dosage form. For example, if the produced IEMs are designated for a particular drug and dosage form (e.g., furosemide, 20 mg), subsequent IEM device manufacturers can encounter supply chain issues (e.g., there can be a limited supply of IEMs, the IEM manufacturer can not be able to produce enough IEMs that include unique IEM identification codes that include numeric codes associated with the numeric code blocks designated for the particular drug and dosage form) and / or inventory issues (e.g., the IEM device manufacturer can have IEMs in inventory, but can not be able to use them because the hard-coded / programmed unique IEM identification codes of the IEMs in inventory do not include numeric codes associated with the numeric code blocks designated for the particular drug and dosage form that the IEMs are to be combined with, which can result in increased inventory requirements and / or increased complexity of the supply chain to avoid the risk of not being able to meet the needs of pharmacies). In this aspect, each produced IEM can subsequently be used to manufacture, for example, i) an IEM device that includes the IEM combined with an active drug, or ii) a placebo / non-drug IEM device that includes the IEM combined with a placebo / non-drug composition. Notably, such manufactured placebo / non-drug IEM devices are not intended to reference a particular drug and, as such, can not require separate FDA approval as a drug-device combination.

[0134] With respect to IEM devices that include IEMs in combination with active pharmaceuticals / drugs, the IEM device manufacturer can transmit (e.g., using a manufacturer system and / or tracking device as discussed herein, e.g., Figure 6 ) link information (e.g., associating each hard-coded / programmed unique IEM identification code that includes a digital code associated with a reserved digital code block with a large package container identifier and / or an active pharmaceutical / drug identifier) to an IEM tracking system. In this regard, each hard-coded / programmed unique IEM identification code that includes a digital code associated with a reserved digital code block now has meaning (e.g., the digital code "101" means "furosemide 40 mg," etc.). Subsequently, at the pharmacy level, with respect to IEM devices that include IEMs in combination with active pharmaceuticals / drugs, the pharmacist can simply use the IEM device (including the IEM in combination with the prescribed active pharmaceutical / drug) to fill a prescription as prescribed (e.g., in response to a consumer patient prescription for an IEM-based pharmaceutical / drug). In addition, using a tracking device (e.g., Figure 6 , Figure 8 etc.), the pharmacy system can generate additional mapping information (e.g., further associating each hard-coded / programmed unique IEM identification code that includes a digital code associated with a reserved digital code block with its large package container and / or consumer patient container identifier and / or consumer patient identifier) and send this additional mapping information to the IEM tracking system.

[0135] With respect to placebo / non-pharmaceutical IEM devices that include IEMs in combination with placebo / non-pharmaceutical compositions, the IEM device manufacturer can transmit (e.g., using a manufacturer system and / or tracking device as discussed herein, e.g., Figure 6to the IEM tracking system. Notably, with respect to placebo / non-drug IEM devices, at this stage, it can not be desirable to associate the manufactured placebo / non-drug IEM devices with a particular drug and dosage form. For example, if the manufactured placebo / non-drug IEM devices are designated for a particular drug and dosage form (e.g., furosemide, 20 mg), the pharmacy can encounter supply chain issues (e.g., there can be a limited supply of placebo / non-drug IEM devices, the IEM device manufacturer can not be able to produce enough placebo / non-drug IEM devices that include a unique IEM identification code that includes a numeric code associated with the numeric code block designated for the particular drug and dosage form to be filled) and / or inventory issues (e.g., the pharmacy can have inventory of placebo / non-drug IEM devices, but can not be able to use them because the hard-coded / programmed unique IEM identification code of the placebo / non-drug IEM devices in inventory does not include a numeric code associated with the numeric code block designated for the particular drug and dosage form to be filled, which can result in increased inventory requirements and / or increased complexity of the supply chain to avoid the risk of not being able to meet the needs of the consumer patient). Subsequently, at the pharmacy level, with respect to placebo / non-drug IEM devices that include an IEM in combination with a placebo / non-drug composition, the pharmacist can co-encapsulate the placebo / non-drug IEM device with the prescribed drug in a pharmaceutically acceptable carrier (e.g., a capsule) (e.g., in response to a consumer patient prescription for an IEM-based drug). Here, such co-encapsulation is generally considered to be a form of compounding. Further, using tracking devices (e.g., RFID tags, bar codes, etc.), the pharmacy system can generate additional mapping information (e.g., further associating each hard-coded / programmed unique IEM identification code that includes a numeric code associated with the retained numeric code block with the identifier of the active drug of the prescription (e.g., the drug and dosage form) and its large package container identifier, consumer patient container identifier, and / or consumer patient identifier) and send the additional mapping information to the IEM tracking system. In this regard, each hard-coded / programmed unique IEM identification code that includes a numeric code associated with the retained numeric code block now has meaning (e.g., the numeric code "101" means "furosemide 40 mg," etc.). Figure 6 , Figure 8 etc.), the pharmacy system can generate additional mapping information (e.g., further associating each hard-coded / programmed unique IEM identification code that includes a numeric code associated with the retained numeric code block with the identifier of the active drug of the prescription (e.g., the drug and dosage form) and its large package container identifier, consumer patient container identifier, and / or consumer patient identifier) and send the additional mapping information to the IEM tracking system. In this regard, each hard-coded / programmed unique IEM identification code that includes a numeric code associated with the retained numeric code block now has meaning (e.g., the numeric code "101" means "furosemide 40 mg," etc.).

[0136] Notably, in the absence of such pharmacy-level mapping of the hard-coded / programmed unique IEM identification code of the placebo / non-drug IEM device that includes the digital code associated with the reserved digital code block to the identifier of the active drug / medication prescribed, the IEM tracking system would not be able to associate the active drug / medication with the unique IEM identification code of the placebo / non-drug IEM device that includes the digital code associated with the reserved digital code block. For example, with such pharmacy-level mapping, the receiver / patch / hub associated with the consumer patient that records the unique IEM identification code that includes the digital code associated with the reserved digital code block associated with the placebo / non-drug IEM device that is co-packaged by the pharmacist with the prescribed medication (e.g., drug "B") and taken by the consumer patient can (e.g., wirelessly) relay the recorded unique IEM identification code that includes the digital code associated with the reserved digital code block to the consumer application program of the computer patient computer (e.g., mobile phone), the consumer application program can query the IEM tracking system to identify the drug / medication associated with the relayed unique IEM identification code that includes the digital code associated with the reserved digital code block, the IEM tracking system can look up the queried unique IEM identification code that includes the digital code associated with the reserved digital code block in its IEM tracking database to find the pharmacy-level mapping of the unique IEM identification code that includes the digital code associated with the reserved digital code block to the identifier of the prescribed medication (e.g., drug "B"), then the IEM tracking system can transmit the identifier of the active drug / medication (e.g., drug "B") of the prescription to the consumer application program, and then the consumer application program can confirm / validate the consumer patient's adherence to the prescribed medication based on the received identifier. In various aspects, when the IEM identification code that includes the digital code associated with the reserved digital code block is detected through the consumer patient's body, the particular drug and dosage form mapped to the IEM identification code that includes the digital code associated with the reserved digital code block can be obtained by querying the IEM tracking system database to confirm that the consumer patient has taken the particular drug and dosage form.

[0137] Pharmacy-level mapping with IEM reprogramming

[0138] In alternative aspects of the present disclosure, the IEM of the IEM device can be programmable / reprogrammable. More specifically, in accordance with Figure 5IEMs of IEM devices can be programmed / reprogrammed at the pharmacy level (e.g., reference numeral 526). Programmable / reprogrammable IEMs can be desirable in the absence of fraud or deception involving the IEM tracking system (as discussed herein). In this regard, each IEM can or can not be programmed with an IEM identification code during the manufacturing process, or can be programmed with a generic / non-specific IEM identification code. Similar to other aspects of the present disclosure, each produced IEM can subsequently be used to manufacture, for example, i) an IEM device comprising an IEM in combination with an active pharmaceutical drug, or ii) a placebo / non-pharmaceutical IEM device comprising an IEM in combination with a placebo / non-pharmaceutical composition. Notably, such manufactured placebo / non-pharmaceutical IEM devices are not intended to reference a specific pharmaceutical drug, and thus can not require FDA individual approval as a pharmaceutical-drug combination.

[0139] At the pharmacy level, with respect to IEM devices comprising IEMs in combination with active pharmaceutical drugs, a pharmacist can simply use the IEM device (comprising an IEM in combination with a prescribed pharmaceutical drug) to fill a prescription as prescribed (e.g., in response to a consumer-patient prescription for an IEM-based pharmaceutical drug). Here, the pharmacy system (e.g., tracking device of Figure 6 , Figure 8 etc.) can be further configured to program / reprogram each IEM of each IEM device at the time of counting (e.g., as it passes through tube 610 or product exit point 806, etc.). In one aspect of the present disclosure, the IEMs can be programmed / reprogrammed using unique IEM identification codes comprising a numeric code associated with a block of numeric codes reserved for a prescribed pharmaceutical drug. Here, the block of reserved numeric codes can be identified in a field (e.g., same as manufacturer, see, for example, Figure 15 , 1504 and 1506, i.e., numeric code "100" reserved for furosemide, 20 mg tablets). In another aspect of the present disclosure, any subset of possible unique IEM identification codes can be used to program / reprogram the IEMs. (See, for example, Figure 15 , 1508 and 1510, e.g., numeric code "101" reserved for furosemide, 40 mg tablets at the manufacturer level, and numeric code "110" reserved for furosemide, 40 mg tablets at the pharmacy level). In yet another aspect, the IEMs can be programmed / reprogrammed using a general / arbitrary subset of unique IEM identification codes. In this aspect, only a small number of unique IEM identification codes are needed (e.g., based on the count of IEM-based prescribed pharmaceutical drugs). Moreover, the tracking device (e.g., Figure 6 , Figure 8Using the tracking device (e.g., a pharmacy system such as a pharmacy system 1000 of FIG. 10, etc.), the pharmacy system can generate mapping information (e.g., associating each programmed / reprogrammed unique IEM identification code with an identifier of an active drug / medication of the prescription (e.g., drug and dosage form) and a large pack container identifier, a consumer patient container identifier, and / or a consumer patient identifier) and send this mapping information to the IEM tracking system. In this regard, each programmed / reprogrammed unique IEM identification code (e.g., with or without a number code) now has meaning (e.g., the number code "101" means "furosemide 40 mg," etc.).

[0140] At the pharmacy level, with respect to a placebo / non-drug IEM device that includes an IEM in combination with a placebo / non-drug composition, a pharmacist can co-encapsulate the placebo / non-drug IEM device with the prescription drug / medication in a pharmaceutically acceptable carrier (e.g., a capsule) (e.g., in response to a consumer patient prescription for an IEM-based drug / medication). Here, such co-encapsulation is generally considered to be a composite form. Here, similar to above, a pharmacy system (e.g., a pharmacy system 1000 of FIG. 10, etc.) can further be configured to program / reprogram each IEM of each IEM device at the time of counting (e.g., as it passes through a tube 610 or a product exit point 806, etc.). In addition, using a tracking device (e.g., a pharmacy system such as a pharmacy system 1000 of FIG. 10, etc.), the pharmacy system can generate mapping information (e.g., associating each programmed / reprogrammed unique IEM identification code with an identifier of an active drug / medication of the prescription (e.g., drug and dosage form) and a large pack container identifier, a consumer patient container identifier, and / or a consumer patient identifier) and send this mapping information to the IEM tracking system. Similar to above, each programmed / reprogrammed unique IEM identification code (e.g., with or without a number code) now has meaning (e.g., the number code "101" means "furosemide 40 mg," etc.). Figure 6 、 Figure 8 In this regard, similar to above, a pharmacy system (e.g., a pharmacy system 1000 of FIG. 10, etc.) can further be configured to program / reprogram each IEM of each IEM device at the time of counting (e.g., as it passes through a tube 610 or a product exit point 806, etc.). In addition, using a tracking device (e.g., a pharmacy system such as a pharmacy system 1000 of FIG. 10, etc.), the pharmacy system can generate mapping information (e.g., associating each programmed / reprogrammed unique IEM identification code with an identifier of an active drug / medication of the prescription (e.g., drug and dosage form) and a large pack container identifier, a consumer patient container identifier, and / or a consumer patient identifier) and send this mapping information to the IEM tracking system. Similar to above, each programmed / reprogrammed unique IEM identification code (e.g., with or without a number code) now has meaning (e.g., the number code "101" means "furosemide 40 mg," etc.). Figure 6 、 Figure 8 In this regard, similar to above, a pharmacy system (e.g., a pharmacy system 1000 of FIG. 10, etc.) can further be configured to program / reprogram each IEM of each IEM device at the time of counting (e.g., as it passes through a tube 610 or a product exit point 806, etc.). In addition, using a tracking device (e.g., a pharmacy system such as a pharmacy system 1000 of FIG. 10, etc.), the pharmacy system can generate mapping information (e.g., associating each programmed / reprogrammed unique IEM identification code with an identifier of an active drug / medication of the prescription (e.g., drug and dosage form) and a large pack container identifier, a consumer patient container identifier, and / or a consumer patient identifier) and send this mapping information to the IEM tracking system. Similar to above, each programmed / reprogrammed unique IEM identification code (e.g., with or without a number code) now has meaning (e.g., the number code "101" means "furosemide 40 mg," etc.).

[0141] It is worth noting that without this pharmacy-level mapping between the unique IEM identifier of the IEM device (programmed / reprogrammed) and the identifier of the prescription drug / medication, the IEM tracking system will not be able to associate the active drug / medication with the unique IEM identifier of the IEM device. For example, through this pharmacy-level mapping, a receiver / patch / hub associated with a consumer patient can record a unique IEM identifier associated with an IEM device taken by the consumer patient. The receiver / patch / hub can (e.g., wirelessly) relay the recorded unique IEM identifier to a consumer application on the patient's computer (e.g., a mobile phone). The consumer application can query the IEM tracking system to identify the drug / medication associated with the relayed unique IEM identifier. The IEM tracking system can look up the queried unique IEM identifier in its IEM tracking database to find a pharmacy-level mapping of the unique IEM identifier to an identifier for a prescription drug (e.g., drug "C"). The IEM tracking system can then transmit the identifier for the prescription drug (e.g., drug "C") to the consumer application, and the consumer application can then confirm / verify the consumer patient's adherence to the prescription drug based on the received identifier. In various aspects, when an IEM identifier is detected through the consumer patient's body, the specific drug and dosage form mapped to the IEM identifier can be retrieved by querying the IEM tracking system database to confirm that the consumer patient has taken the specific drug and dosage form.

[0142] Pharmacy dispensing of IEM devices

[0143] See Figure 16 This illustrates an example flowchart of dispensing an IEM device at the pharmacy level according to one aspect of this disclosure. When dispensing / according to its formulation 1602 for an IEM-based drug / medication, it can first be determined whether a bulk package of the IEM device is available 1604. If not, a bulk package of the IEM device can be ordered (e.g., from the manufacturer / supplier, automatically via a pharmacy system, etc.) 1606. If available, it can be determined 1608 whether the bulk package includes i) an IEM device comprising an IEM in combination with an active drug / medication, or ii) a placebo / non-drug IEM device comprising an IEM in combination with a placebo / non-drug component.

[0144] exist Figure 16 In the first aspect, if the bulk packaging includes an IEM device, said IEM device comprising an IEM (e.g., with or without a digital code) 1610 in combination with the active pharmaceutical ingredient / drug, then the bulk packaging identifier (e.g., Figure 7 706 and / or 708 Figure 15, 1516) can be scanned / manually entered 1612. For example, a pharmacist can scan / manually enter the large package's identifier into their pharmacy computer system. This can be accomplished, for example, using a scanning tool, a keyboard, a mobile application, a web browser, and / or other software (e.g., the dispenser application). Next, it can be optionally determined whether the entered large package identifier has been linked to a particular active pharmaceutical product (e.g., furosemide, 20 mg). This can be determined, for example, by querying the IEM tracking system database. As discussed herein, the IEM device manufacturer can have transmitted this information (e.g., linking the large package identifier to a particular active pharmaceutical product) to the IEM tracking system. Next, the tracking device (e.g., Figure 8 ) can be used to count the IEM devices into the consumer patient container 1614 (e.g., and read their respective IEMs). Next, the software (e.g., the dispenser application) can be used to map the counted IEM devices' (e.g., Figure 15 , 1518) IEMs to the scanned large package identifier (e.g., Figure 15 , 1516) in the pharmacy system, the consumer patient container identifier (e.g., Figure 15 , 1520, e.g., scanned via a scanning tool, manually entered, etc.), and / or the consumer patient identifier (e.g., Figure 15 , 1522, e.g., manually entered, previously stored in the dispenser application, etc.) 1616. The prescription can then be dispensed to the consumer patient, and the pharmacy system can upload / transmit the pharmacy-level mapping ( Figure 15 , 1512) to the IEM tracking system for storage in its IEM tracking database 1618.

[0145] In a second aspect of Figure 16 , if the large package includes placebo / non-pharmaceutical IEM devices that include IEMs in combination with placebo / non-pharmaceutical compositions (e.g., with or without a digital code) 1620, the large package's identifier (e.g., Figure 7 , 706 and / or 708, Figure 15, 1516) can be scanned / manually entered 1622. For example, a pharmacist can scan / manually enter the identifier of a large package into their pharmacy computer system. This can be accomplished, for example, using a scanning tool, a keyboard, a mobile application, a web browser, and / or other software (e.g., a dispenser application). Next, it can be determined (e.g., by querying an IEM tracking system database) whether the entered large package identifier has previously been mapped to a particular active drug product / medication (e.g., furosemide, 20 mg). With respect to placebo / non-drug IEM devices, this can occur when the pharmacy system is dispensing an IEM-based drug treatment pursuant to another prescription. If so, it can be determined whether the active drug product associated with the entered large package identifier is the same as the active drug product / medication that is currently being dispensed pursuant to the prescription 1626. If they are not the same active drug product / medication, the pharmacist must select another available large package 1628 and begin the process again 1604. If they are the same active drug product / medication, or the entered large package identifier has not previously been mapped to a particular active drug product / medication 1624, the practicing pharmacist can co-encapsulate the placebo / non-drug IEM devices from the large package with the prescription drug product / medication in a pharmaceutically acceptable carrier (e.g., a capsule) 1630. Next, a tracking device (e.g., Figure 8 ) can be used to count the IEM devices into a consumer patient container 1632 (e.g., and read their respective IEMs). Next, software (e.g., a dispenser application) can be used to map the IEMs of the counted IEM devices (e.g., Figure 15 , 1518) to the prescription active drug product / medication in the pharmacy system, the scanned large package identifier (e.g., Figure 15 , 1516), the consumer patient container identifier (e.g., Figure 15 , 1520, e.g., scanned via a scanning tool, manually entered, etc.), and / or the consumer patient identifier (e.g., Figure 15 , 1522, e.g., manually entered, previously stored in the dispenser application, etc.) 1634. The prescription can then be dispensed to the consumer patient, and the pharmacy system can upload / transfer the pharmacy-level mappings ( Figure 15 , 1512) to the IEM tracking system for storage in its IEM tracking database 1618. Furthermore, the pharmacy system can upload / transfer additional information (e.g., Figure 8 , IEMs of IEM devices, etc., that are returned to the large package through the product exit point 810) 1636. In one aspect of the disclosure, any remaining placebo / non-drug IEM devices mapped to the large package identifier will be used to dispense a prescription for the same associated active drug product / medication.

[0146] Under this second aspect, each large package can be mapped / dispensed at the pharmacy level at the required time. Here, it should be appreciated that multiple large packages can be processed in this manner, and that pools of placebo / non-drug IEM devices from multiple large packages can be dispensed and combined to fill a consumer patient's prescription for IEM-based drugs / medications (see, e.g., Figure 15 , 1516, i.e., the IEM device pools from "Pkg 113" and "Pkg 114" (both linked to furosemide, 20 mg tablets) can be combined to fill the consumer patient's prescription). Further, it should be appreciated that more than one consumer patient can share IEM devices from a single large package, but that each consumer patient will receive a subset of the unique IEM identification codes from a single large package.

[0147] Here, in accordance with Figure 16 It should be appreciated that a prescription for an IEM-based drug / medication can be formulated from both IEM devices 1610 that include IEMs in combination with active drugs / medications, and placebo / non-drug IEM devices 1620 that include IEMs in combination with placebo / non-drug compositions, the placebo / non-drug IEM devices being co-encapsulated with the active drugs / medications by a licensed pharmacist. In either case, when an IEM identification code is detected by the consumer patient via conductive detection, the particular drug and dosage form linked to the IEM identification code can be obtained by querying the IEM tracking system database to confirm that the consumer patient has taken the particular drug and dosage form. In this regard, further relevant information (e.g., consumer patient identifier, consumer patient container identifier, and / or large package identifier, etc.) can be used to confirm that a particular consumer patient has taken a particular drug and dosage form.

[0148] In an alternative aspect of the present disclosure, it can be determined that a large package includes i) IEM devices that include programmable / reprogrammable IEMs in combination with active drugs / medications, or ii) placebo / non-drug IEM devices that include programmable / reprogrammable IEMs in combination with placebo / non-drug compositions. Here, in addition to the above-described processes, a pharmacist can program each programmable / reprogrammable IEM with a unique IEM identification code as discussed above (e.g., from a subset of a digital code block, a unique identifier, etc.).

[0149] Traditionally, when a licensed pharmacist dispenses a prescription drug and dosage form, prescription processing software has been used for various reasons (e.g., to process third party insurance claims on behalf of the consumer-patient, to check for possible drug interactions, to check for possible allergies, to document the prescription drug, etc.). In one aspect of the disclosure, the above-mentioned functionality can be seamlessly integrated with such prescription processing software. In another aspect of the disclosure, the above-mentioned functionality can be a stand-alone dispensing application. In yet another aspect of the disclosure, the above-mentioned functionality can be partially integrated with such prescription processing software and partially integrated with this dispensing application.

[0150] 43-bit pattern example

[0151] In one aspect of the disclosure, an IEM can be programmed to operate in a 43-bit mode. In the 43-bit mode, there are 2 43 or 8,796,093,022,208 unique identification codes available for programming. Thus, the reservation of digital code blocks discussed herein is not really necessary. However, there is still a need to associate other specific information with the active drug / drug of interest. Here, in accordance with the above-mentioned "pharmacy-level mapping without digital code reservation" section, the IEM manufacturer and / or IEM device manufacturer (e.g., which can be the same or different manufacturing entities) can transmit linking information (e.g., associating each hard-coded / programmed unique IEM identification code with further identifying information discussed above) to the IEM tracking system. In addition, the pharmacy system can transmit additional mapping information (e.g., associating each hard-coded / programmed unique IEM identification code with additional identifying information discussed above) to the IEM tracking system. Subsequently, the consumer-patient computer's consumer application can utilize this information (e.g., stored in the IEM tracking system database) to identify the active drug / drug of interest (e.g., version discussed herein) associated with the unique IEM identification code detected / recorded by the consumer-patient's receiver / patch / hub after ingestion of the IEM device. More specifically, the consumer application can confirm / validate whether the consumer-patient complied with their prescription medication based on the identification of the active drug / drug of interest retrieved from the IEM tracking system database.

[0152] Further, in this aspect, and similar to that discussed previously herein, it can be desirable to use a wireless interrogator during manufacturing to record the unique IEM identification codes (e.g., contained in the MIT or blister pack) and store in the IEM tracking system database (e.g., associating each set of IEM identification codes with a corresponding large pack identifier). At the time of dispensing, the pharmacist can scan the large pack identifier (or manually enter such code) using a mobile application, web browser, or other software. At this time, if the large pack identifier has not already been assigned, it can be assigned to map to a particular drug and dosage form (e.g., furosemide, 20 mg). At this time, the remaining IEM devices within that particular large pack will be reserved for future prescriptions using the same assigned drug and dosage form. In this way, the pharmacist can have a pool of IEM devices in separate large packs (e.g., bottles) that can be dispensed at any time as needed for any drug. Subsequently, when the patient-facing application first detects an unknown IEM identification code uploaded from a wearable sensor, it can register it as an unknown ingestion event waiting for identification. When possible, a query from the computer or smartphone can check the IEM identification code against the backend database (IEM system tracking database). The query will report the corresponding large pack identifier and cause the patient's device to download all IEM identification codes associated with that large pack. This enables rapid local identification of all future IEM devices that can be associated with the prescription. More than one consumer patient can share IEM devices from a single bottle, but each consumer patient's IEM identification codes will be a unique subset of the IEM identification codes contained within the large pack assigned by the pharmacist to a particular drug dosage form. There are other ways to uniquely associate the ID with a particular prescription and consumer patient. For example, the wireless interrogator can be miniaturized so that each unique IEM identification code can be identified as it passes from the pharmacist's counting board through an electronic hopper into the consumer patient's pill bottle. This approach would associate each IEM identification code separately with a particular drug dosage form and patient identifier at the server database level, obviating the need to track large pack identifiers.

[0153] 15-bit pattern example

[0154] In another aspect of the disclosure, the IEM can be programmed to operate in a 15-bit mode. In accordance with the above, in the 15-bit mode, there are 2 15or 32,768 unique identification codes can be available for programming. In this regard, it should be appreciated that re-use of unique identification codes can be desirable. Thus, it can be practical to reserve digital code blocks as discussed herein. Here, in accordance with the "Pharmacy Level Mapping with Digital Code Reservations" section above, the IEM manufacturer and / or IEM device manufacturer (e.g., which can be the same or different manufacturing entities) can transmit link information (e.g., associating each hard-coded / programmed unique IEM identification code that includes a digital code associated with a reserved digital code block with the further identification information discussed above) to the IEM tracking system. Additionally, the pharmacy system can transmit additional mapping information (e.g., associating each hard-coded / programmed unique IEM identification code that includes a digital code associated with a reserved digital code block with the additional identification information discussed above) to the IEM tracking system. Subsequently, the consumer application on the consumer patient computer can utilize this information (e.g., stored in the IEM tracking system database) to identify the active pharmaceutical / drug (e.g., version discussed herein) associated with a unique IEM identification code that includes a digital code associated with a reserved digital code block detected / recorded by the consumer patient's receiver / patch / hub after taking the IEM device. More specifically, the consumer application can query the IEM tracking system database (e.g., via a Boolean "AND") for the particular pharmaceutical and dosage form mapped to the IEM identification code that includes a digital code associated with a reserved digital code block and the unique consumer patient identifier (e.g., consumer patient mobile phone number, patient MAC address, IMEA, etc.). This approach greatly reduces the number of unique digital code blocks required within the 15-bit pattern. Rather than reserving a digital code block for each possible pharmaceutical and dosage form, only the number of unique digital code blocks need be reserved for the number of pharmaceuticals and dosage forms being tracked for each consumer patient (e.g., 5 or 6 digital code blocks reserved at the patient level). In one aspect, for example, one hypothetical digital code "A-10" can map to a 20 mg furosemide for one consumer patient and a 200 mg ibuprofen for another consumer patient. It should be appreciated that this approach is also applicable to other bit patterns (e.g., x-bit patterns). Under this approach, the consumer application can confirm / validate whether the consumer patient is adhering to their prescribed medication based on the identifier of the active pharmaceutical / drug retrieved from the IEM tracking system database.

[0155] Further, in this aspect, similar to the above, a challenging use case is where limited unique IDs are available. One solution is to perform a Boolean AND of the digital code and some form of consumer patient unique identifier, such that a particular digital code maps to a particular active pharmaceutical / drug only when a particular consumer patient is using it at any time. This approach greatly reduces the total demand for unique digital code blocks. We now only need a unique digital code that is sufficient for the total number of consumer patients' drugs (and dosage strengths) being tracked at the same time, rather than a digital code for each pharmaceutical and dosage form (e.g., type and strength). According to this procedure (e.g., valid for 43b and other high address space modes as well), the pharmacist will assign a digital code according to the consumer patient specific identifier (e.g., mobile phone number, MAC address, IMEA) and the drug of interest (e.g., furosemide, 20 mg). The drug mapping downloaded to the consumer patient's mobile device is only for that consumer patient. Thus, one hypothetical digital code "A-10" can map to a consumer patient's 20 mg furosemide and another consumer patient's 200 mg ibuprofen. According to this aspect, more than one manufactured product (MITs separated by digital codes) is still needed, but the total number of such digital code SKUs will be reduced, possibly significantly. Further, in this aspect, the pharmacist must know and enter the consumer patient facing unique identifying information. However, using the very common mobile phone number will result in a trivial change in traffic. Finally, in this aspect, the pharmacist can assign any active pharmaceutical / drug of interest to any digital code. This greatly simplifies the process of scaling the number of available "digital drugs" (i.e., active pharmaceuticals / drugs that can be tracked for adherence by taking the associated IEM device).

[0156] While various details have been set forth in the foregoing description, it will be appreciated that various aspects of the technology can be practiced without these specific details. Those skilled in the art will recognize or be able to ascertain such equivalents, further, where a term is provided in the written description as an example, the

[0157] Moreover, although several forms have been explained and described, the applicant does not wish to be limited or confined to the details set forth, but intends to cover all modifications, variations, changes, alternatives, combinations, and equivalents thereof which fall within the scope of the disclosure. Further, the structure of each element associated with the described forms can alternatively be described as means for providing the function performed by the element. Also, for certain components disclosed, other materials can be used. Therefore, it is to be understood that the foregoing description and the appended claims are intended to cover all such modifications, combinations, and variations as falling within the scope of the disclosed forms. The appended claims are intended to cover all such modifications, variations, changes, alternatives, modifications, and equivalents.

[0158] For the sake of brevity and clarity, some aspects of the disclosure above are presented in terms of diagrams rather than details. Certain portions of the detailed description provided herein can be presented in terms of instructions that operate on data that is stored in one or more computer memories or one or more data storage devices (e.g., floppy disks, hard drives, compact disks (CDs), digital video disks (DVDs), or digital tapes). Those skilled in the art will recognize that these descriptions and representations are the means used by those skilled in the art to most effectively convey the substance of their work to others skilled in the art. An algorithm is here, and generally, conceived to be a self- consistent sequence of steps leading to a desired result, where a "step" refers to a manipulation of physical quantities, possibly although not necessarily, in the form of electrical or magnetic signals, and / or of binary digits, where the quantity is transformed from one state to another, for example, changing from 0 to 1, or vice versa. Commonly, the terms used in this specification, and especially, the functional ones, are associated with the corresponding physical quantities per se.

[0159] Unless specifically stated otherwise, as apparent from the above disclosure, it is appreciated that throughout the specification the use of terms such as "processing" or "computing" or "calculating" or "determining" or "displaying" or the like, refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system memories or registers into other data similarly represented as physical quantities within the computer system memories or registers or other information storage, transmission or display devices.

[0160] In general, those skilled in the art will recognize that the individual aspects described herein, which can be implemented separately and / or collectively by a wide variety of hardware, software, firmware, or combinations thereof, can be viewed as being comprised of various types of "circuitry." Therefore, as used herein "circuitry" includes, but is not limited to, electrical circuitry having at least one discrete electrical circuit, electrical circuitry having at least one integrated circuit, electrical circuitry having at least one application specific integrated circuit, electrical circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program which at least partially implements the processes and / or devices described herein, or a microprocessor configured by a computer program which at least partially implements the processes and / or devices described herein), electrical circuitry forming a memory device (e.g., forms of random access memory), and / or electrical circuitry forming a communications device (e.g., a modem, a communications switch, or an optical-electrical device). Those skilled in the art will recognize that the subject matter described herein can be implemented in an analog or digital form, or some combination thereof.

[0161] The above detailed description has shown, described, and pointed out, by using various forms of diagrams, flowcharts, and / or examples, various forms of apparatus and / or process. As will be recognized by those skilled in the art after a

[0162] In some cases, the expressions "coupled" and "connected" and variations thereof, can be used. It will be understood that these terms are not intended to be synonymous with each other. For example, the term "connected" can be used to indicate that two or more elements are in direct physical or electrical contact with each other. In another example, the term "coupled" can be used to indicate that two or more elements are in direct physical or electrical contact with each other. However, the term "coupled" can also mean that two or more elements are not in direct contact with each other, but yet still co-operate or interact with each other. It will be understood that the architectures depicted herein are merely examples and that, in fact, many other architectures can be implemented which achieve the same functionality. In conceptual terms, any arrangement of components that achieves the same functionality is effectively "associated" such that the desired functionality is achieved. Hence, any two components herein combined to achieve a particular functionality can be seen as "associated with" each other such that the desired functionality is achieved, irrespective of architectures or intermediate components. Likewise, any two components so associated can also be viewed as being "operably connected," or "operably coupled," to each other to achieve the desired functionality, and any two components capable of being so associated can also be viewed as being "operably couplable," to each other to achieve the desired functionality. Specific examples of operably couplable include but are not limited to physically mateable and / or physically interacting components, and / or wirelessly interactable and / or wirelessly interacting components, and / or logically interacting and / or logically interactable components, and / or electrically interacting components, and / or electrically interactable components, and / or optically interacting components, and / or optically interactable components.

[0163] In other instances, one or more components can be referred to herein as being "configured to," "configurable to," "operable / operable to," "adapted to / adaptable to," "capable of," "compliant with / complying with," etc. Those skilled in the art will recognize that "configured to" can include active- and / or inactive- and / or standby-state components unless context requires otherwise.

[0164] While specific aspects of the disclosure have been shown and described in detail, to be sure, it will be understood, by those skilled in the art, that changes and modifications can be made without departing from the subject matter described herein and its broader aspects, and thus, the appended claims are to cover all such changes and modifications which fall within the true scope of the subject matter described herein. It should be understood by those skilled in the art that, in general, the terms used herein (and particularly in the appended claims (e.g., the body of the appended claims)) are generally intended as "open-ended" terms (e.g., the term "comprising" should be considered as "comprising but not limited to," the term "having" should be considered as "having at least one," the term "including" should be considered as "including but not limited to," etc.). It should further be understood by those skilled in the art that, if a specific number of an introduced claim is intended, such an intent will be explicitly recited in the claim, and in the absence of such a recitation, no such intent exists. For example, to aid understanding, the following appended claims can contain introductory phrases such as "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be taken to imply that the recitations of claims introduced by indefinite articles "a" or "an" are limited to only those claims containing a single such recitation, even when the same claim includes introductory phrases such as "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and / or "an" should typically be interpreted to mean "at least one" or "one or more"); the same applies to the use of definite articles to introduce claim recitations.

[0165] Further, even if the specific number of an introduced claim recitation is explicitly recited, one of skill in the art will recognize that such recitation should typically be interpreted to mean at least the minimum number of the recited number (e.g., the recitation of "two antennas" typically means at least two antennas, or two or more antennas). Additionally, the conjugation "at least one of A, B, and C" or other similar language for similar purposes can connote that the group comprising members A, B, and C exists in the description, or that the group, in some manner, includes at least one of A, B, or C. In this regard, the conjunctive sense of "at least one of A, B, and C" or other similar language for similar purposes should only be construed in a manner consistent with the context of the description.

[0166] With respect to the appended claims, one of skill in the art will recognize that the operations recited therein typically are performed in any order. Also, although various operational flows are presented in a sequence(s), it should be understood that the various operations can be performed in other orders than those which are illustrated, or can be performed concurrently, unless otherwise indicated herein below. Furthermore, certain of the processes, operations, or methods described herein can be performed in any order, unless otherwise specified and / or except where this can be impractical, the processes, operations, or methods described herein being performed as single operations, or in a single arrangement, but can be implemented by hardware, software, firmware, or a combination of these, unless otherwise indicated herein below. Moreover, in some instances, the acts recited can be carried out in particular orders, unless otherwise indicated herein, and some acts can be combined, separated, executed in other orders, omitted, and / or added.

[0167] It is noted that any reference to something hereinafter "encompassing," "including," "containing," or "comprising," means that the item includes the specified item, but that the item can additionally include other items not specified. It is further noted that any reference to "one aspect," "an aspect," "one form," or "a form" means that a particular feature, structure, or characteristic described in connection with that aspect is included in at least one aspect. Thus, appearances of the phrases "in one aspect," "in an aspect," "in one form," or "in a form" in various places in the specification are not necessarily all referring to the same aspect. Further, where a particular feature, structure, or characteristic is stated to be included in one or more aspects, it will be understood that the particular features, structures, or characteristics can be combined in any suitable manner in one or more aspects.

[0168] With respect to essentially any plural and / or singular terms used herein, a skilled artisan can translate from plural to singular and / or from singular to plural, as appropriate, depending on the context and / or application. For clarity, various singular / plural combinations are not specifically addressed.

[0169] In some cases, even though components are not present here, use of a system or method can occur. For example, in the case of a distributed computing environment, use of a distributed computing system can occur, even though components of system are not present here (e.g., relays, servers, processors, signal-bearing media, transmitting computers, receiving computers, etc. are not present here).

[0170] Likewise, sale of a system or method can occur even though components of the system or method are not present here and / or are used outside of here. Additionally, implementation of at least a portion of a system for performing a method in here can not preclude use of the system in another location.

[0171] All of the above-referenced U.S. Patents, U.S. Patent Application Publications, U.S. Patent Applications, foreign Patents, foreign Patent Applications, non-patent publications, and / or other publications referenced herein are incorporated herein by reference to the extent that the incorporated material is not inconsistent with that described herein and for all purposes to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. To the extent there is a conflict or inconsistency between incorporated material and that described herein, the description herein will control. In the event that any restrictions on the use of the incorporated material are too narrow to encompass the full scope of the incorporated material, the restrictions are deemed relaxed to the maximum extent possible.

[0172] In closing, many of the advantages of the present application are anticipated to be apparent from the foregoing description. For purposes of illustration and description, one or more forms are set forth above. The foregoing description is not intended to be exhaustive or to limit the precise form disclosed. Modifications or variations are possible in light of the above teachings. The one or more forms are selected and described above on the basis of what is believed to be the most practical and preferred aspects of the technology, and thus other forms can be selected and utilized equally effectively by one skilled in the art. It is intended that the claims define the overall scope of the technology.

Claims

1. A system for tracking consumer patient adherence to a pharmaceutical product and dosage form, the system comprising: a tracking device comprising at least one capacitive element and a structure that positions an IEM device in proximity to the at least one capacitive element, the IEM being an ingestible event marker, the IEM device being an ingestible event marker device, the tracking device configured to: process a plurality of the IEM devices, wherein each IEM device comprises a pharmaceutical composition, wherein the pharmaceutical composition is co-packaged with an IEM at a pharmacy according to a prescription obtained from a consumer patient, the IEM capable of storing an IEM identification code and either being programmed with no IEM identification code or being programmed with a generic IEM identification code during manufacturing, at a pharmacy level, program each of the plurality of IEM devices with a unique identification code that distinguishes each IEM device from the plurality of IEM devices via the capacitive element; the tracking device configured to program / reprogram each IEM of each IEM device at a pharmacy level at the time of counting; interrogate each IEM via capacitive coupling as each IEM device passes through the structure; the tracking device configured to generate mapping information at the pharmacy level and transmit the mapping information to a database; the database that records a mapping of the unique identification codes and links each received IEM identification code to additional information, wherein the additional information comprises at least one of a corresponding pharmaceutical product that it is co-packaged with the IEM or a prescription of a consumer patient; a computer system communicatively coupled with the tracking device, wherein the computer system is configured to receive each unique IEM identification code read from each interrogated IEM; and store each unique IEM identification code and at least one of a corresponding pharmaceutical product that it is co-packaged with the IEM or a prescription into the database.

2. The system of claim 1, wherein, the computer system further comprising a transmission unit configured to transmit each received IEM identification code and additional information linked to each received IEM identification code to an IEM tracking system for storage in an IEM tracking system database.

3. The system of claim 1, wherein, the computer system is a pharmacy computer system, wherein the tracking device is a counting plate, and wherein the at least one capacitive element is positioned at a location that is away from the counting plate after each IEM device is counted.

4. The system of claim 1, wherein, the structure comprises a cylindrical portion, and wherein the at least one capacitive element is positioned within the cylindrical portion.

5. The system of claim 1, wherein, each IEM comprises a first material and a second material, and wherein the at least one capacitive element comprises a first capacitive plate configured to capacitive couple the first material of each IEM and a second capacitive plate configured to capacitive couple the second material of each IEM.

6. The system of claim 1, wherein, each IEM is either stably associated with a pharmaceutical composition or stably associated with a non-pharmaceutical composition.

7. The system of claim 1, wherein, The computer system is an IEM device manufacturer computer system, wherein each IEM is stably associated with a pharmaceutical composition, and wherein the database is configured to link each received IEM identification code to an active pharmaceutical product identifier.

8. The system of claim 1, wherein, The computer system is a pharmacy computer system, wherein each IEM is stably associated with a non-pharmaceutical composition that is co-encapsulated with an active pharmaceutical product, and wherein the database is configured to link each received IEM identification code to an identifier of the active pharmaceutical product.

9. The system of claim 8, wherein, Each IEM has been encoded by the manufacturer with a unique IEM identification code that is capable of being reprogrammed at a pharmacy.

10. The system of claim 8, wherein, Each IEM has been hard-coded by the manufacturer with a unique IEM identification code that includes a block of numbers associated with a reserved block of numbers.

11. The system of claim 1, wherein, Each IEM is programmed to operate in one of a 15-bit mode, a 30-bit mode, or a 43-bit mode.

12. The system of claim 1, wherein, The additional information includes at least one of a specific pharmaceutical product and dosage form, a consumer patient container identifier, or a consumer patient identifier.

13. The system of claim 1, further comprising a scanner configured to scan at least one of a case pack identifier or a consumer patient container identifier, wherein, The database is further configured to link each received IEM identification code to at least one of the large package identifier or the consumer patient container identifier.

14. A system for tracking consumer patient compliance with a pharmaceutical product and dosage form, the system comprising: a computer system comprising: a compliance application configured to identify at least one active pharmaceutical product and dosage form associated with at least one ingestible event marker (IEM) identification code, wherein the compliance application is further configured to: receive an IEM identification code associated with an ingested IEM; detect whether the received IEM identification code is an unknown IEM identification code by comparing the received IEM identification code to a plurality of expected IEM identification codes stored in an IEM tracking system database, and determining that the received IEM identification code does not match any of the plurality of expected IEM identification codes, wherein the IEM tracking system database stores IEM data including a plurality of active pharmaceutical products and dosage forms mapped to a plurality of expected IEM identification codes, wherein the IEM tracking system database further receives mapping information generated at a pharmacy level by a tracking device; wherein the tracking device is configured to program / reprogram each IEM at a pharmacy level at the time of counting, and generate and transmit mapping information to the IEM tracking system database at the pharmacy level; query the mapping information generated at the pharmacy level in the IEM tracking system database using the unknown IEM identification code to identify an active pharmaceutical product and dosage form associated with the ingested IEM; and receive the active pharmaceutical product and dosage form mapped to the unknown IEM identification code from the IEM tracking system database to confirm consumer patient compliance associated with the active pharmaceutical product and dosage form.

15. The system of claim 14, wherein, The computer system comprises a cell phone or personal computer associated with the consumer patient.

16. The system of claim 14, wherein, receiving the IEM identification code from a receiver associated with the consumer patient, wherein the receiver detects a signal that includes the IEM identification code conductively transmitted from the ingested IEM through the consumer patient.

17. The system of claim 14, wherein, The plurality of IEM identification codes stored in the IEM tracking system database have been mapped to the plurality of active pharmaceutical products and dosage forms using at least one of a manufacturer computer system of the tracking device, a supply chain computer system, or a pharmacy computer system.

18. The system of claim 14, wherein, The unknown IEM identification code is further linked to a large package identifier in the IEM tracking system database, and wherein the adherence application is further configured to download all other IEM identification codes associated with the large package identifier from the IEM tracking system database.

19. The system of claim 18, wherein, The adherence application is further configured to compare a subsequently detected unknown IEM identification code to the downloaded IEM identification codes to identify an active pharmaceutical product and dosage form associated with the subsequently detected unknown IEM identification code prior to querying the IEM tracking system database.

20. A system for tracking adherence of a consumer patient to a pharmaceutical product and dosage form, the system comprising: a pharmacy system comprising: a tracking device comprising at least one capacitive element and a structure to position an IEM device proximate to the at least one capacitive element, the IEM being an ingestible event marker, the IEM device being an ingestible event marker device, the tracking device configured to: process a plurality of the IEM devices, wherein each IEM device comprises a pharmaceutical composition, wherein the pharmaceutical composition is co-packaged with an IEM at a pharmacy according to a prescription obtained from a consumer patient, the IEM capable of storing an IEM identification code, and either not programmed with an IEM identification code during manufacturing, or programmed with a generic IEM identification code, program each of the plurality of IEM devices at a pharmacy level with a unique identification code that distinguishes each IEM device from the plurality of IEM devices via the capacitive element, the tracking device configured to program / reprogram each IEM of each IEM device at a pharmacy level at the time of counting; and interrogate each IEM via capacitive coupling as each IEM device passes through the structure; the tracking device configured to generate mapping information at a pharmacy level and transmit the mapping information to a database; the database recording the mapping of the unique identification codes and linking each received IEM identification code to additional information, wherein the additional information includes at least one of a corresponding pharmaceutical product co-packaged therewith or a prescription of a consumer patient; a computer system communicatively coupled with the tracking device, wherein the computer system is configured to: receive each unique IEM identification code read from each interrogated IEM; and store each unique IEM identification code and at least one of a corresponding pharmaceutical product co-packaged therewith or a prescription into the database; and a transmission unit configured to transmit each received unique IEM identification code and the identifier of the drug composition linked to each received unique IEM identification code to an IEM tracking system database for tracking consumer patient compliance with at least one active drug and dosage form.

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