JP2009522031A - Integrated medication compliance monitoring system using flexible conductive substrate - Google Patents

Abstract

An improved system is provided for monitoring patient compliance with a drug regimen. The system records when a unit dose of medication is dispensed to a patient and generates a signal each time a unit dose is dispensed (4, 6, 8, 10) and operates in response to the signal Possible signal processor (14). The apparatus physically supports and connects the detector (4, 6, 8, 10) and the processor (14) in an integral structure, and signals from the detector (4, 6, 8, 10) are processed by the processor. A flexible conductive substrate (12) conducting to (14); In a preferred embodiment, the flexible conductive substrate (12) employs a flexible conductive organic material.

Description

(Refer to related applications)
This application claims priority benefit over US Provisional Patent Application No. 60 / 757,109 (filed Jan. 6, 2006), the disclosure of which is incorporated herein by reference in its entirety. Is done.

(Technical field)
The present invention relates to a unit dose drug dispenser having a desired dosing schedule, and more particularly to a dispenser that collects and processes information relating to patient compliance with a desired dosing schedule.

  The primary cause of disease-related morbidity and mortality is poor patient compliance with drug regimens prescribed by physicians. The lack of an appropriate, reliable, simple and cost-effective way to measure patient compliance, doctors prescribe the patient's medication regimen most efficiently, Careful follow-up and prevention of optimization have resulted in sub-optimal treatment and recovery for patients and created significant additional costs for individuals and health care systems.

  The various previously proposed devices for measuring patient compliance are unreliable, do not adequately cover the duration of long dosing schedules, are cumbersome for patients, or are overly expensive, Proven to be inadequate.

  US Pat. No. 6,057,056 ("Pill Dispenser with Pil Actuated Time Indicator") is a fully mechanical that shows the last date and time when a tablet is scheduled to be taken and the next date and time that it is scheduled to be taken, according to a prescribed drug administration plan. The device is described. Because this device does not provide a means for knowing the actual time when the tablet was taken, or a means for storing or transmitting that information, this device remains essentially patient in terms of medication compliance. Dependent. Furthermore, this device requires that the appropriate dosage form be accurately loaded into the device. The tablet dispenser described in WO 3,079,959 ("Tablet Box") describes a system that overcomes this limitation of custom loading by utilizing a commercially available blister pack. The present invention provides an alarm clock that informs the patient of tablet removal and administration. Because the retrieval event is not recorded or transmitted, the physician is not informed about the patient's actual compliance with the prescribed treatment plan.

  This limitation is overcome in the apparatus described in US Pat. No. 5,099,096 ("Medication Compliance Monitoring Device Having Conductive Traces Up a Fraction Backing of a Medicament Compartment"). Individual blister packs with detectors based on conductive traces are detachable via multi-terminal connectors to electronic circuits that read the state of the conductive traces that indicate whether the traces were destroyed to access the compartment Connected. This event and its time are stored in electronic memory. During the patient visit, the stored information is accessed by connecting the blister electronics to the microcomputer. In principle, this system provides the information necessary for compliance monitoring, but the required attachment and detachment of the electronic circuit can be annoying to the patient, and compared to the manufacturing cost of the blister package itself, it is a standard electronic device. The use of is very expensive.

Thus, an improved device for monitoring patient compliance with a medication regimen prescribed by a physician such that the compliance monitoring device is available to a large number of patients for low cost and ease of use. There is a clear need for equipment.
US Pat. No. 3,871,551 US Pat. No. 4,616,316

  The main objective of the present invention is a new medication compliance that overcomes the disadvantages and deficiencies of known compliance monitoring and monitoring methods in terms of ease of use, reliability, low cost, miniaturization, effectiveness, and accuracy. A monitoring system and method is provided.

  A further object of the present invention is to collect and store data relating to patient medication administration, and optionally to communicate data relating to the stored medication administration event and its exact time over a wireless communication link and any electrical or mechanical contact. It is an object to provide an improved compliance monitoring system that can eliminate the need for the above.

  A further object of the present invention is to provide an improved medication compliance monitoring system comprising means for making information available to a patient, such as by employing a visual display such as an LCD array or LED array, employing an audible annunciator, etc. Is to provide.

  Another further object of the present invention is, for example, to measure environmental conditions such as temperature or humidity that may be associated with the patient's treatment process, or to provide a means for the patient to enter information or request feedback from the system. It is to provide an improved compliance monitoring system with additional sensor elements.

  The inventors have discovered an improved system for a compliance monitoring system for monitoring patient compliance with a drug regimen. These systems include a detector that provides a signal each time a unit dose of drug is dispensed to a patient. It also includes a processor that processes these signals into a more useful format, such as a storage format, a transmission format or a transmittable format, and encryption as necessary to ensure the confidentiality of patient information. The inventors have found that these systems are improved by including a flexible substrate that physically supports the detector and processor as an integrated system and conducts signals from the detector to the processor.

  Thus, in one form, the system of the present invention includes a detector for generating a signal each time a unit dose is dispensed to a patient and a signal processor operable in response to the generated signal. These systems also include a flexible substrate that physically supports the detector and processor in a unitary structure and conducts signals from the detector to the processor. Exemplary signal processors employed in these systems include at least one of the following. A) a memory for storing a signal with time information associated with the signal when it was generated, b) a transmitter for transmitting information related to the signal to a location remote from the system, c) generated A display or audible annunciator to provide the patient with information regarding patient compliance based on the signal, and / or patient compliance with a specific dosing regime associated with the detected medication event. These systems also include a power source that provides power to the detectors and / or other signal processing components. Other sensors and input devices may additionally be present on the flexible conductive substrate and thereby be integrated into a unitary structure.

  The signal conducted by the flexible substrate can be an electrical or optical signal. In the case of electrical signals, the monolithic substrate preferably consists of, contains or employs one or more flexible conductive organic materials, such as a flexible conductive polymer. In the case of optical signals, the flexible substrate preferably comprises a light guide and is preferably made of a flexible light guide organic material such as a light guide polymer, but also like quartz or glass fiber. It can also consist of a simple light-guiding inorganic material, and often a combination of organic layers or coatings.

  In other embodiments, the present invention may take the form of a method for monitoring and detecting patient compliance with a prescribed dosage regime, which employs the integrated system described above.

  In a preferred embodiment, the integrated medication monitoring system with a flexible conductive substrate takes the form of a label that is adaptable to the outer shape of the drug container to which the unit dose is dispensed due to the flexibility of the substrate. Is possible. The label can be essentially a two-dimensional shape having a substantial height and width, but less thickness. Such label-type flexibility monitoring systems generally have an adhesive layer for applying characteristically written (ie, printed) labeling information on one side and a drug container on the back side. And a conductor within the label body forming an integral system.

  In another preferred embodiment, the integrated medication compliance monitoring system provides a surface that at least partially defines one or more compartments each containing one or more unit doses of a physician-prescribed medication. A flexible conductive substrate may be included. Each of these compartments, when loaded, provides an initial signal that the system detects and conducts through the flexible signal conducting substrate. Each of these compartments provides a second signal or correction signal when a unit dose of drug is removed, which is detectably different from the initial signal and from which the unit dose of drug is removed. This is transmitted to the signal processor via a flexible substrate as an indicator that it is assumed that the patient has ingested it. The detector may include, for example, an electrical conduction path or optical waveguide path associated with the compartment that is disturbed or modified to provide a correction signal when a dose is removed from the compartment.

  Referring to FIG. 1, an active drug container 100 implementing an integrated medication compliance monitoring system according to the present invention most commonly contains or is made of a sheet of plastic material, preferably a conductive conjugated polymer. And comprises a section 2 comprising detector sections 4, 6, 8 and 10 formed in at least a part of a flexible light or electrically conducting organic substrate 12. The flexible conductive substrate 12 also connects the detector compartment and the processor 14 via conductors 16, 18, 20, 22, etc., so that when a medication event is detected, for example, detection Is conducted to the processor 14 including the instrument interface 24. These compartments 4, 6, 8 and 10 contain unit dosage forms of patient medication such as tablets or capsules. The compartment generally employs at least one fragile or ruptured surface, which may be the substrate layer 12 or another material. The dosage form can be dispensed from the compartment by applying force through the frangible surface. When this occurs, a detectable change occurs, such as by changing or blocking the electrical trace or light path. This detectable change can be a change in conductivity, a change in capacitance, or a change in resistance in the case of an electrical signal, and a change in light intensity or light wavelength in the case of an optical signal. . This signal is transmitted from each compartment 4, 6, etc. to the processor 14 via conductors 16, 18, etc. of the flexible conductive substrate 12, via a detector interface 24, etc.

  The processor 14 continuously or periodically monitors the optical or electrical signals received by the interface 24 from the detectors 4, 6, etc. and when a change is detected in one or more of these signals, The change is transmitted to the central processing unit 26 via the conductor 30 which is also part of the flexible substrate 12. The central processing unit 26 reads the appropriate time associated with the detected signal obtained from the time management circuit 32, such as via flexible substrate conductors 34, 34 ', and 34 ", and relates to the medication event. This time information is stored in the memory 28. The time resolution of this event recording is given by the accuracy of the time management circuit and the frequency at which the central processing unit examines the digital signal from the detector. Resolution should lead to meaningful data regarding patient compliance with or lack of dosing schedules.

  A small display 38 may be integrated on the flexible conductive support 12 of the integrated system 100 to provide information to the patient. This is optionally implemented as a display using a liquid crystal display (LCD), an inorganic light emitting diode (LED) or an organic polymer light emitting diode (PLED). This display is under the control of the central processing unit 26. Although it can be more complex, it is possible for the audible sound source to perform the same function.

  Additional sensor elements 40 may be integrated on the surface of the flexible substrate 12 to provide the system 100 with information regarding the patient's environment or condition. These can be, for example, temperature sensors that are realized as semiconductor diodes whose current-voltage characteristics vary with temperature, for detecting ambient temperature or patient body temperature. Another example is a humidity sensor implemented as a field effect transistor with a gate sensitized to measure humidity.

  It is also possible to obtain input from the patient from the patient's caregiver or other health care professional. This can be done, for example, by using a mechanical or capacitive touchpad (not shown) that is integrated with the system 100 directly on or within the flexible conductive substrate 12. Such touchpads can also be implemented as a combination of LEDs and photodiodes, as described, for example, in US Pat. No. 6,023,064 (“Optical Proximity Detector”).

  System 100 includes a power supply 44. The power supply 44 is optionally a flat battery that is easily integrated onto the flexible substrate 12. An alternative is to employ a combination of a photovoltaic cell and a capacitor in which electrical energy is stored for continuous operation in the dark. Such photovoltaic cells can be made cost-effective using amorphous silicon or organic semiconductors. Power is delivered from the power supply 44 to the rest of the system 100 via conductive traces 42, 42 ′, and 42 ″ that are also incorporated into the flexible substrate 12.

  In one embodiment, conductive traces such as 16, 18, 34, 42, 42 ', and 42 "incorporated into the flexible substrate 12, for example, are conductive organic polymers sold as Baytron®. It is mounted using a conductive organic material.

  The advantages of conductive polymers in this application can be deposited and patterned in or on flexible substrates by known cost-effective printing techniques such as silk screen printing, inkjet printing, or offset printing. That is. As an alternative, the circuit can be die-cut from a thin film sheet of conductive polymer.

  FIG. 2 shows a simple electronic circuit 200 where changes in electrical properties in the trace as defined by conductors 16 and 18 included in the substrate 12 of FIG. 1 can be detected by this circuit. One end of the electrical trace 16 is connected to a voltage source V, and the other end of the trace defined by the conductor 18 is connected to ground through a high resistance R. If the electrical trace is left as is, a small current I = V / R will flow through the trace and the detected voltage U is very close to V. If the trace is disturbed, such as by dispensing the dosage form 4, the detection voltage U will be very close to ground. This large voltage difference results in a digital signal indicating whether the dosage form 4 in a particular blister has been removed (U≈0) or whether the dosage form 4 is still in place (U≈V). Already represents.

  In another embodiment, the trace is implemented as an optical waveguide structure 300, as shown in FIG. In this embodiment, light from a light source such as LED 50 is carried to a detector such as photodiode 54 via conductor 52 included in substrate 12. As long as the trace 52 remains, light is detected by the photodiode 54. If the dosage of dosage form 4 interferes with or inhibits trace 52, the light intensity detected by photodiode 54 is reduced. The waveguide trace 54 can be realized as a ridge structure in the light-transmitting flexible photoconductive organic material constituting the substrate 12. Such a ridge structure can be made cost-effective using known copying techniques. Also, electrical signals such as can be generated by the photodetector 54 can be transmitted through the conductive polymer of the flexible substrate 12 as needed.

  Referring to FIG. 4, the integrated system 400 of the present invention is embodied as a flexible label. This label based on a flexible conductive substrate is suitable for application to drug administration containers such as tablet bottles or vials, inhalation dosers and the like. In system 400, the label body is defined by a flexible substrate 12 having many of the properties and components listed relative to those in the description of FIG. System 400 further includes a medication dosing event detector 62 that generates a signal when a single dose of medication is delivered to the patient. This signal is passed through conductors 64 and 66 embodied in flexible substrate 12 to dose detector interface 68 and then the rest of the processor, as generally described herein above. Sent to. The dose detector 62 can be any of the many types described above for recording dose delivery. This detection can be performed directly by recording changes in capacitance, resistance, light transmission, etc., accompanied by changes in the contents of the labeled drug delivery container. In other forms of direct detection, a signal can be detected based on the passage of the pharmaceutical dosage form from the container. As an alternative, the detector can record the dosage form delivery of the formulation, either speculatively or indirectly. Indirect or speculative detection can be done by recording the opening or closing of the container, or by recording the handling of a container that indicates medication, such as a quick inversion of the container.

  As shown in FIGS. 5 and 6, one such embodiment of the present invention is a system 500 that includes a label 70. The system 500 corresponds to the system 400 of FIG. 4, but further includes a secondary adhesive label 72 associated with the label 70 and the system 400 with the flexible conductive substrate 12. The secondary label 72 and the label 70 can be separated by tearing along the perforations 74. Secondary label 72 includes a magnetically detectable strip 76 that is detectable by detector 62 and conductors 64 and 66 all included in label 70 on substrate 12. As shown in FIG. 6, the system 500 can be affixed to a drug container 80/82, and the major portion of the system corresponding to the system 400 (ie, the label 70) is a rounded tablet container such as by conventional pressure sensitive adhesive. The secondary portion of the system that is affixed to the body 80 and defined by the secondary label 72 is affixed to the cap 82 of the tablet container. When the cap 82 is in place on the tablet bottle, the magnetic strip 76 is in the first position relative to the detector 62. When the bottle cap 72 is removed to open the container and access the drug dose contained therein, the strip 76 moves to a different position relative to the detector 62, which is different from the detector 62. And thus indirectly indicates to the system that a single dose has been taken by the patient.

  As shown, the label 70 is flexible and conforms to the circular outline of the bottle 80. Also, as shown, either an electrical or optical flexible conductor, embodied as a flexible conductive substrate 12 that couples the detector and processor to a single unitary body, is also applied to the container surface. Fits. The label 72 is also flexible and conforms to the outer shape of the cap 82.

  In a preferred embodiment, some or all of the electrical and optoelectronic circuits mounted on the flexible substrate utilize organic conductors and / or organic semiconductors. Organic materials can be incorporated as field effect transistors, diodes, LEDs, displays, photodiodes, photovoltaic cells, and the like, for example, EP Patent No. 1,376,697 ("Integrated Optical Microsystems Based on Organic Semiconductors"). ) Integration is possible. It has been demonstrated that such devices and circuits can be realized cost-effectively using known or modified printing techniques such as silk screen printing, inkjet printing, or offset printing. ing. The conductive polymer includes a conjugated polymer. These are described in, for example, “Chemical Innovation”, Vol. 30, no. 1, 14-22 (April 2000), and Business Communications Company, Inc. In a report titled “P-235 Conductive Polymers” by Mel Schetter published in October 2003. Typical conductive polymers are poly (aniline), poly (acetylene), poly (N-vinylcarbazole), poly (pyrrole), poly (thiophene), poly (2-vinylpyridine), poly (p-phenylene vinylene). ), Poly (naphthalene), and related derivatives. A part of the conductor can be formed of carbon fiber or the like as necessary. Photoconductors, including organic polymer photoconductors, are described in the book “Optical Network Design and Implementation” published in 2004 by Cisco Press. See especially the chapter “Fiber-Optic Technologies”. Exemplary polymeric materials for this application include polyester polymers such as poly (methyl methacrylate), and silica-polymer composites such as polymer clad glass and silica fibers. While these polymer-based materials are particularly useful in flexible substrates that combine the detector and processor into a single unitary structure, they do not need to be used exclusively and may be used in some applications In some cases, other conductors can be used as well.

  Within the system of the present invention, a processor conductively coupled to the detector via a flexible substrate is at least receiving a detected medication event signal, generally storing this event information, and detecting it. Or provide functional building blocks needed for sending information to external systems after storage.

  In these systems, the processor monitors a signal comparator for detecting these signal modifications, a time measurement and absolute time management circuit, and a detector signal circuit, and detects detected medication events along with the appropriate time. Central processing unit stored in memory cell, radio frequency or optical communication interface to transmit all this information to external system, optional sensor module such as temperature, touch sensor or other device for patient input And an optional display or annunciator module for providing visual or audible feedback to the patient, all powered by a power source such as a battery or photovoltaic cell, the detector and processor being a flexible conductive substrate Connected to the integrated system.

  The processor can also read the data provided by the detector and send it to a drug prescribing physician or an organization that collects and edits such data to present the data in a suitable format to the drug prescribing physician, An information retrieval and retransmission system may be provided. The conducting circuit or optical waveguide circuit in the detector is detectable when a single dose is removed.

  Such systems generally consist of a flexible conductive substrate made from a light or electrically conductive polymer or made from other plastic materials and including such a conductive polymer. This flexible substrate serves to define several compartments. Patient medication is loaded into these compartments. The flexible conductive substrate provides a first signal that is electrically or optically readable as each compartment is loaded with a drug. An electronic drug removal detection circuit monitors these first signals to determine a change in signal indicating that one or more formulations have been dispensed from one or more compartments.

  This detection depends on whether information about a particular individual dose is required (such as when the system monitors the administration of two or more drug doses on a single device). It can be specific to the form or can be based on the entire set of dosage forms. The processor obtains this information and combines it with the absolute or relative time stamp received from the clock generator and timing circuit, and the information can be stored in digital memory. The central processing unit can also be programmed with a medication regimen prescribed by the physician, reminding the patient of the time to retrieve and ingest the next dose, such as by a display or one or more colored light emitting diodes (LEDs). It is possible. This display or LED can also be contained on the same flexible substrate.

  Additional sensor elements, such as temperature or humidity sensors, can be integrated on a flexible substrate when monitoring of specific environmental conditions is important to ensure drug integrity. . It is also possible to provide a number of touch sensors to allow the patient to request specific information from the central processing unit and display it on an integrated display device.

  The system may also include a wireless communication module to allow the central processing unit to communicate drug removal events to the information retrieval and retransmission system. This process is implemented as a radio frequency or optical link, optionally using known infrared light on a television remote control.

  When the power supply is connected to the system, the clock generation module starts operation and the central circuit is activated. The absolute timing circuit resets itself to zero prior to continuous execution, or a long wave DCF 77 time signal (77.5 kHz) provided by the German Physical Science-Technique Bundesaltalt PTB, or It is possible to obtain an accurate absolute time from a radio station that emits a standard time signal, such as the WWVB time signal (60 kHz) provided by the US National Institute of Standards and Technology NIST.

  The drug removal event, along with its appropriate time stamp, is most commonly stored in digital memory by the central processing unit. This information can be read out and transmitted to an off-site information retrieval and retransmission system at any time. Because the distance between this information retrieval and retransmission system and the drug event detection system of the present invention is unknown, the detection system's wireless communication module should be provided with a very high level of transmitted RF or optical power. May be required.

  An alternative is to store all information in the integrated system processor memory until all of the unit dose of the drug has been dispensed or until the drug dosing schedule is complete. The patient then sends the used detector-processor unit together with its flexible substrate, for example, an effective transmission of data, such as a location in the patient's home that is coupled to an information retrieval and retransmission system. Can be placed in a container or container that is stored in a location that provides

  When the used detector-processor unit is placed in the container, the electronic circuitry in the container detects the presence of the arrival unit and sends it to the central processing unit on the blister pack, most commonly a wireless communication module. Request to download all drug retrieval information via. Since the distance between the wireless communication module and the receiver module of the information retrieval system is up to several centimeters, the emission power of the unit can be kept at a very low level. If the unit timing circuit did not disclose the exact time because it was set to zero when the power supply was connected, the relative time of the drug removal event is stored in the information retrieval system and the information retrieval system To process the information, the relative time is subsequently corrected to absolute time.

  Once the information retrieval and re-transmission system has obtained all the information from the used unit, this information is retransmitted to the drug prescribing physician or to the organization that collects and edits such data for presentation to the drug prescribing physician. Sent. This transmission can be a standard telephone line, a cable modem line, a wireless module according to one of the mobile phone standards such as GSM, a wireless local area network according to one of the IEEE standards such as 802.11, or any other communication means Can occur through.

  This allows one of the known systems to improve adherence to drug regimens, as disclosed, for example, in US Patent Publication No. US20051833653 ("System and Method for Improving and Promoting Compliance to a Therapeutic Regimen"). One can be implemented.

FIG. 1 is a schematic elevational view of a medication compliance monitoring system according to the present invention showing a detector mounted on a flexible conductive substrate and a representative processor building block to form an integrated system. FIG. 2 is a schematic diagram of a drug removal detector suitable for use in the system of FIG. 1, and detects a change in signal from the conductive trace adjacent to the dosage form and when the dosage form is dispensed. And an electronic circuit. FIG. 3 is a schematic diagram of an optoelectronic detector of a drug removal detector suitable for use in the system of FIG. 1, with an optical waveguide trace on or adjacent to the dosage form containing section, and a light generating device such as an LED. And a light detection device, such as a photodiode, that detects a change in the signal detected in the trace when the dosage form is removed. FIG. 4 is a schematic elevation view of a medication compliance monitoring system according to the present invention configured as a flexible label suitable for application to a tablet container or the like. The system employs a generic detector and a representative processor building block mounted on a flexible conductive substrate to form an integrated system. FIG. 5 is embodied as a flexible label suitable for application to a tablet container (bottle) and is configured to detect tablet dosing by a change in the relationship between the tablet bottle body and the tablet bottle cap. FIG. 5 is a schematic elevation view of a medication compliance monitoring system of the type shown in FIG. 4. 6 is a schematic perspective view of the medication compliance monitoring system of FIG. 5 disposed on a tablet bottle.

Claims (33)

A compliance monitoring system for monitoring patient compliance with a medication regimen by recording when a unit dose of medication is administered to a patient,
The system includes a detector for generating a signal each time a unit dose is dispensed, and a) a memory for storing the signal along with time information associated with the time at which the signal was generated, and b) A transmitter for transmitting information related to the signal to a location remote from the system; and c) displaying to the patient information regarding the patient's compliance with the dosing schedule based on the generated signal. A signal processor selected from at least one of: a display for: d) a power source for supplying power to the detector and / or other signal processing components;
The medication compliance monitoring system includes a flexible substrate that physically connects the detector and the processor to an integrated structure and conducts the signal from the detector to the processor. ,system.   The medication compliance monitoring system according to claim 1, wherein the signal processor includes a memory.   The medication compliance monitoring system according to claim 1, wherein the signal processor includes a transmitter.   The medication compliance monitoring system according to claim 1, wherein the signal processor includes a display.   The medication compliance monitoring system according to any one of claims 1 to 4, wherein the signal is an electrical signal.   The medication compliance monitoring system according to any one of claims 1 to 4, wherein the signal is an optical signal.   6. The medication compliance monitoring system according to claim 5, further comprising an electrical conductor for conducting the electrical signal from the detector to the processor, the electrical conductor being included in the flexible substrate.   The medication compliance monitoring system according to claim 5, further comprising an electrical conductor for conducting the electrical signal from the detector to the processor, the electrical conductor being the flexible substrate.   The medication compliance monitoring system according to claim 7 or 8, wherein the conductor is a conductive organic material.   The medication compliance monitoring system according to claim 7, 8, or 9, wherein the flexible substrate comprises an integral layer of the conductive organic material, the integral layer comprising the electrical conductor.   The medication compliance monitoring system of claim 10, wherein the monolithic layer of conductive organic material is patterned to provide a series of electrical conductors.   The medication compliance monitoring system according to claim 6, further comprising a photoconductor for conducting the optical signal from the detector to the processor, the photoconductor being included in the flexible substrate.   The medication compliance monitoring system according to claim 6, further comprising a photoconductor for conducting the optical signal from the detector to the processor, wherein the photoconductor is the flexible substrate.   The medication compliance monitoring system according to claim 12 or 13, wherein the photoconductor is an optical waveguide.   15. A medication compliance monitoring system according to claim 12, 13, or 14, wherein the flexible substrate comprises an integral layer of photoconductive organic material.   The medication compliance monitoring system of claim 15, wherein the monolithic layer of photoconductive organic material is patterned to provide a series of photoconductors.   The medication compliance monitoring system according to claim 1, wherein the substrate is configured as a label.   18. A medication compliance monitoring system according to claim 17, wherein the flexible monitoring device configured in the form of a label has a substantial length and width and a slight thickness so that it can fit on the container surface.   The medication compliance monitoring system according to claim 18, comprising a front surface, a back surface, and an adhesive layer on the back surface for bonding to the surface of the container.   20. The medication compliance monitoring system according to claim 19, further comprising a removable protective sheet that protects the adhesive layer prior to removal and adhesion to the container surface.   The medication compliance monitoring system according to claim 1, wherein the detector detects unit dose dosing from any unit dose compartment.   The medication compliance monitoring system of claim 1, wherein the detector detects a single unit dose medication from a particular unit dose compartment.   The medication compliance monitoring system according to claim 1 combined with the drug container.   24. A compliance monitoring system in combination with a container according to claim 23, wherein the signal is generated when a conductor is obstructed by a unit dose dispensed from the container.   25. The combination of claim 24, wherein the signal is an electrical signal and the disturbed conductor is an electrical conductor.   26. The combination of claim 25, wherein the signal is an optical signal and the disturbed conductor is a photoconductor.   27. A medication compliance monitoring system according to claim 6 or a combination according to claim 26, wherein the light signal is an infrared signal or a visible signal.   The medication compliance monitoring system according to claim 1, further comprising an information interface for inputting or requesting information from / to the system by the patient or a health care professional of the patient.   29. A medication compliance monitoring system according to claim 28, wherein the information interface is a keypad.   The medication compliance monitoring system according to claim 1, further comprising a sensor for sensing information related to the medication plan and generating an additional signal based on the information, wherein the flexible substrate further comprises: A system that physically connects the sensor and the processor to an integral structure and conducts the signal from the sensor to the processor.   An information interface for the additional signal for inputting or requesting information to / from the system by the patient or the patient's health care professional, wherein the flexible substrate further includes the information interface and the processor 32. The medication compliance monitoring system according to claim 30, wherein the signal is physically connected to the unitary structure and the signal is conducted from the information interface to the processor.   32. A medication compliance monitoring system according to claim 31, wherein the information interface is a keypad.   33. A method for monitoring a patient's medication use by employing a device for detecting and recording a medication event, wherein the medication compliance monitoring system according to any one of claims 1 to 32 is adopted as the device. Including improvements.

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