WO2007077224A2

WO2007077224A2 - Unitary medication compliance monitoring system using a flexible conductive substrate

Info

Publication number: WO2007077224A2
Application number: PCT/EP2007/000073
Authority: WO
Inventors: Jean-Michel MÉTRY; Peter Seitz; Pierre-Alain Gaillard
Original assignee: Aardex Ltd.
Priority date: 2006-01-06
Filing date: 2007-01-05
Publication date: 2007-07-12
Also published as: JP2009522031A; WO2007077224A3; EP1981466A2

Abstract

Improved systems for monitoring patient compliance with medication regimens are provided. The systems note when unit doses of medication are dispensed to a patient and include a detector (4, 6, 8, 10) for generating a signal each time a unit dose is dispensed as well as a signal processor (14) which can act upon the signal. The devices include a flexible conductive substrate (12) physically supporting and connecting the detector (4, 6, 8, 10) and the processor (14) into a unitary structure and conducting the signal from the detector (4, 6, 8, 10) to the processor (14). In preferred embodiments the flexible conductive substrate (12) employs flexible conductive organic materials.

Description

UNITARY MEDICATION COMPLIANCE MONITORING SYSTEM USING A FLEXIBLE CONDUCTIVE SUBSTRATE

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to United States Provisional Application Serial No. 60/757,109 filed January 6, 2006, the disclosures of which are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

This invention relates to dispensers of unit dose medications having a desired dispensing regimen and, in particular, to such dispensers which gather and process information on patient compliance with the desired dispensing regimen.

BACKGROUND OF THE INVENTION

A major cause of disease-related morbidity and mortality is poor compliance of patients with the medication regimen prescribed by their physician. The lack of a suitable, reliable, simple and cost-effective method of measuring a patient's medication compliance prevents physicians from most effectively prescribing, closely following and optimizing a patient's medication regimen, causing sub-optimum treatment and recovery of the patient, as well as significant additional cost to the individual and the health care system.

A variety of previously proposed devices for measuring medication compliance of patients have proven to be unsatisfactory because they are not reliable, they do not properly cover the extended time spans of the dosing regimens, they are unwieldy for the patient, or they are overly expensive.

United States Patent No. 3,871,551 ("Pill Dispenser with Pill Actuated Time Indicator") describes a fully mechanical device, which indicates the last time a pill was taken and the next time one is due, according to the prescribed medication regimen. Since this device does not provide any means to know about the actual time a pill was taken or any means to store or transmit this information, it still depends essentially on the patient for medication compliance. In addition, it necessitates proper loading of the device with the appropriate drug dosage forms. The pill dispenser described in WO Patent No. 3,079,959 ("Tablet Box") describes a system which overcomes this restriction of custom loading by making use of commercially available blister packs. This invention provides an alarm clock for reminding the patient that a pill should be removed and administered. Since the removal events are neither recorded nor transmitted, the physician is not informed about the patient's actual compliance to the therapeutic regimen which was prescribed.

This limitation is overcome in the device described in United States Patent No. 4,616,316 ("Medication Compliance Monitoring Device Having Conductive Traces Upon a Frangible Backing of a Medication Compartment"), by means of electrically conductive traces over the compartments of a blister pack. The separate blister pack, with its conductive trace- based detector is detachably connected via a multi-terminal connector to an electronic circuit reading out the status of the conductive traces which indicate whether a trace was ruptured to access a compartment. This event and its time are stored in an electronic memory. During the patient's follow-up visit, the stored information is accessed by connecting the blister's electronic circuit to a microcomputer. This system provides, in principle, the required information for compliance monitoring, but the required plugging and unplugging of electronic circuits renders it cumbersome to the patient, and the use of standard electronic devices makes it rather expensive, in comparison with the manufacturing cost of the blister package, itself.

Accordingly, there is a definite need for an improved device for monitoring the compliance of patients with medication regimens prescribed by their physicians at such low cost and ease of use that this compliance monitoring device becomes accessible to a large number of patients. SUMMARY OF THE INVENTION

It is a principal object of this invention to provide novel medication compliance monitoring systems and methods which overcome the disadvantages and deficiencies of the known compliance monitors and monitoring methods, in terms of ease of use, reliability, low cost, compactness, effectiveness and accuracy.

A further object of the invention is to provide improved medication compliance monitoring systems that can gather data concerning patient dosing of medications and store and optionally communicate the data concerning stored medication dosing events and their precise time with a wireless communication link, obviating the need for any electrical or mechanical contacts.

A further object of the invention is to provide improved medication compliance monitoring systems with means of making information available to the patient, by employing a visible display such as an LCD array or an LED array, by employing an audio enunciator or the like.

A still further object of the invention is to provide improved medication compliance monitoring systems with additional sensor elements, for example for measuring environmental conditions such as temperature or humidity which may be relevant to the patient's course of treatment, or for giving the patient a means to input information or request feedback from the system.

We have now discovered an improvement to medication compliance monitoring systems for monitoring patient compliance with medication regimens. These systems include a detector which provides a signal each time a unit dose of medication is dispensed to the patient. They also include a processor which processes these signals into a more usable form, such as a stored form, or a transmitted or transmittable form, encrypted as necessary for the purpose of assuring confidentiality of patients' information, or the like. We have found that these systems are improved by the inclusion of a flexible substrate which physically supports the detector and the processor as a unitary system and which conducts the signals from the detector to the processor. Thus, in one form, the systems of this invention include a detector for generating a signal each time a unit dose is dispensed to a patient as well as a signal processor which can act upon the signal so generated. These systems also include a flexible substrate physically supporting and connecting the detector and the processor into a unitary structure and conducting the signal from the detector to the processor. Representative signal processors employed in these systems include at least one of the following: a.) a memory for storing the signal together with time information related to when the signal was generated, b.) a transmitter for transmitting information related to the signal to a location distant from the system, and c.) a display or audio enunciator or the like for providing to the patient information concerning the dispensing of the unit dose to the patient and/or patient's compliance with the particular dosing regimen to which the detected dosing event relates based upon the generated signal. These systems also include a power supply to power the detector and/or other signal- processing components. Other sensors and input devices can additionally be present upon and joined together into the unitary structure by the flexible conductive substrate.

The signals conducted by the flexible substrate can be electrical or optical signals. In the case of electrical signals the unitary substrate preferably is made from or includes or employs one or more electrically-conducting flexible organic materials such as flexible electrically-conducting polymers. In the case of optical signals, the flexible substrate preferably contains a light waveguide, preferably made of light-conducting flexible organic material such as light-conducting polymers but also possibly made of light-conducting inorganic materials such as quartz or glass fiber, also often in combination with organic layers or coatings .

In other embodiments this invention can take the form of a method for monitoring and detecting patient compliance with a prescribed drug dosing regimen which method employs the unitary systems just described.

In one preferred embodiment, the unitary medication monitoring systems with their flexible conductive substrates can take the form of a label which, because of the flexibility of the substrate, can conform to the contours of a container for the medication from which the unit doses are dispensed. This label can be essentially two dimensional with a substantial height and width but a less significant thickness. Such label-formatted flexible monitoring systems will generally contain typical written (i.e. printed) labeling information on one side and a layer of adhesive on the other for affixing to a medication container and will include conductors within the body of the label forming the unitary system.

In another preferred embodiment, this unitary medication compliance monitoring system may include a flexible conductive substrate providing a surface which defines, at least in part, one or more compartments each containing one or more unit doses of physician- prescribed medication. Each of these compartments, when loaded, provides an initial signal which the system detects and conducts through the signal-conductive flexible substrate. Each of these compartments, when the unit dose of medication is removed, provides a second or modified signal, which differs detectably from the initial signal and which is transmitted through the flexible substrate to the signal processor as an indication that the unit dose of medication from that compartment has been removed and by inference ingested by the patient. The detector can include, for example, electrically conducting or optically wave guiding paths associated with the compartments that are interfered with or modified to provide a modified signal when a dose is removed from a compartment.

DETAILED DESCRIPTIONOF THE INVENTION

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a schematic elevational view of a medication compliance monitoring system according to the present invention, showing a detector and representative processor building blocks mounted on a flexible conductive substrate to form a unitary system.

Figure 2 is a schematic view of a medication removal detector suitable for use in the system of Figure 1 which includes an electrically-conducting trace adjacent to a medication dosage form and an electronic circuit that detects a change in signal from that trace when the dosage form is dispensed.

Figure 3 is a schematic view of an optoelectronic detector in a medication removal detector suitable for use in the system of Figure 1 which includes an optical wave-guiding trace over or adjacent to a medication dosage form-containing compartment, a light generating device such as an LED and a light detecting device such as a photodiode that detects a change in the signal detected in the trace when the medication dosage form is removed. Figure 4 is a schematic elevational view of a medication compliance monitoring system according to the present invention configured as a flexible label suitable for affixing to a pill container, or the like. This system employs a general detector and representative processor building blocks mounted on a flexible conductive substrate to form a unitary system.

Figure 5 is a schematic elevational view of a medication compliance monitoring system of the type shown in Figure 4 that is embodied as a flexible label suitable for affixing to a pill container (bottle), configured to detect pill dispensing by changes in the relationship between the pill bottle body and the pill bottle cap.

Figure 6 is a schematic perspective view of the medication compliance monitoring system of Figure 5, deployed on a pill bottle.

DESCRIPTION OF PREFERRED EMBODIMENTS

Referring to Figure 1, an active drug container 100 that implements a unitary medication compliance monitor system according to the present invention consists of a section 2 with detector compartments 4, 6, 8 and 10 that are formed at least in part of a flexible light- or electricity-conductive organic substrate 12, most typically a sheet of plastic material, preferably containing or made up of electrically-conductive conjugated polymer. This flexible conductive substrate 12 also connects the detector compartments to a processor 14 via conductors 16, 18, 20, 22 and the like so that dispensing events, when detected, are conducted to the processor 14 which includes, for example, a detector interface 24. These compartments 4, 6, 8 and 10 contain the patient's medication in unit dosage form such as pills or capsules. The compartments commonly employ at least one frangible or disruptable surface which may be the substrate layer 12 or may be another material. A dosage form can be dispensed from the compartment by being forced through the frangible surface. When this occurs, a detectable change takes place such as by changing or breaking an electrical trace or an optical path. This detectable change can be a change in conductivity, a change in capacitance or a change in resistance, in the case of electrical signals, or it can be a change in optical intensity or optical wavelength in the case of optical signals. This signal is transmitted through conductors 16, 18 etc in the conductive flexible substrate 12 from each compartment 4, 6 etc to the processor 14, such as through the detector interface 24. The processor 14 continuously or periodically monitors the optical or electrical signals from the detectors 4, 6 etc as received by interface 24, and when a change in one or more of these signals is detected it is transmitted to central processor 26 via conductors 30, also part of the flexible substrate 12. Central processor 26 reads the appropriate time associated with the detected signal as obtained from the time keeping circuit 32 such as via flexible substrate conductors 34 and 34' and 34", and this time information related to the dosing event is stored in the memory 28. The time resolution of this event record is given by the accuracy of the time-keeping circuit and the frequency with which the central processor inspects the digital signals from the detector. The time resolution should be such as to lead to meaningful data concerning the patient's compliance with the dosing regimen or lack thereof.

In order to provide the patient with information, a small display 38 can be integrated on the flexible conductive support 12 of the unitary system 100. This is preferentially implemented as a liquid crystal display (LCD), a display using inorganic light emitting diodes (LEDs) or organic polymer light-emitting diodes (PLEDs). This display is under the control of the central processor 26. Although likely more complex, an audible information source can serve the same function.

In order to provide the system 100 with information about the patient's environment or condition, additional sensor elements 40 can be integrated on the surface of the flexible substrate 12. These can be temperature sensors, realized as semiconductor diodes whose current- voltage characteristics change as a function of temperature for detecting ambient temperatures or the patient's body temperature, for example. Another example is a humidity sensor realized as field effect transistors with a gate that is sensitized to measure humidity.

It is also possible to obtain input from the patient or from the patient's care givers or other healthcare professionals. This can be done, for example by using mechanical or capaci- tive touch pads (not shown) integrated into system 100 directly onto or into the flexible conductive substrate 12. Such touch pads can also be realized as combinations of LEDs and photodiodes, as described for example in United States Patent No. 6,023,064 ("Optical Proximity Detector").

System 100 includes a power supply 44. The power supply 44 is preferentially a flat battery that is easily integrated onto the flexible substrate 12. An alternative is to employ a combination of photovoltaic cells and a capacitor in which electrical energy is stored for continuous operation in darkness. Such photovoltaic cells can be fabricated cost-effectively using amorphous silicon or organic semiconductors. The power is transmitted from power supply 44 to the remainder of the system 100 via conductive traces 42, 42' and 42" which are incorporated into the flexible substrate 12 as well.

In one embodiment, the conductive traces such as 16, 18, 34, and 42, 42' and 42" for example which are incorporated into the flexible substrate 12 are implemented using an electrically-conducting organic material such as the conductive organic polymer marketed as Baytron™.

The advantage of conductive polymers in this application is that they can be deposited and patterned in or on the flexible substrate with known cost-effective printing techniques such as silk-screen printing, ink-jet printing or offset printing. Alternatively circuits can be stamped out of thin- film sheets of the conductive polymer.

Figure 2 illustrates a simple electronic circuit 200 with which the change in the electrical characteristics in a trace such as defined by conductors 16 and 18 present in substrate 12 in Figure 1 can be detected: One end of the electric trace 16 is connected to a voltage source V, the other end of the trace defined by conductor 18 is connected through a high resistance R to ground. If the electrical trace is intact, a small current I = V / R flows through the trace, and the detection voltage U is very close to V. If the trace is interrupted such as by dispensing dosage form 4, the detection voltage U is very close to ground. This large voltage difference already represents the digital signal indicating whether the medication dosage form 4 in the particular blister has been removed (U≤O) or, the medication dosage form 4 is still in place (UsV).

In another embodiment, shown in Figure 3, this trace is implemented as an optical waveguide structure 300. hi this embodiment light from a source such as an LED 50 is transported via conductor 52 present in substrate 12 to a detector such as a photodiode 54. As long as the trace 52 is intact, light is detected by the photodiode 54; if the trace 52 is interrupted or otherwise disturbed by the dispensing of medication dosage form 4, the light intensity detected by the photodiode 54 is reduced. This waveguide trace 54 can be realized as a ridge structure in an optically transparent, optically-conductive flexible organic material making up the substrate 12 . Such ridge structures can be fabricated cost-effectively using known replication techniques. Electrical signals such as would be generated by photodetector 54 can also be transmitted via electrically-conductive polymers in the flexible substrate 12, as desired.

Turning to Figure 4, a unitary system 400 of this invention is embodied as a flexible label. This label, based on its flexible conductive substrate, is suitable for fixation to a drug dose container such as a pill bottle or vial, inhalation dose dispenser, or the like. In System 400, the body of the label is defined by flexible substrate 12 having the characteristics and many of the components enumerated for it in the description of Figure 1. System 400 additionally includes a medication dispensing event detector 62 which produces a signal when a dose of medication is delivered to a patient. This signal is transmitted via conductors 64 and 66 which are embodied in flexible substrate 12 as generally described herein above, to dose detector interface 68 and then to the remainder of the processor . Dose detector 62 can be any of the many types of devices described heretofore for noting dose delivery. This detection can be carried out directly, such as by noting a change in capacitance, resistance, optical transmit- tance or the like accompanying a change in the content of a drug dosage container to which the label is affixed. In other forms of direct detection, a signal can be detected based upon the passage of a drug dosage form from the container. Alternatively, the detector can note the delivery of a dosage form of drug inferentially or indirectly. Indirect or inferential detection can take place by noting an opening or an opening and a closing of the container, or by noting a handling of the container indicative of drug dispensing, such as a rapid inverting of he container, or the like.

As shown in Figures 5 and 6, one such embodiment of this invention is system 500 which includes label 70. System 500 corresponds to system 400 in Figure 4 but further includes a secondary adhesive label 72 associated with label 70 and system 400 by flexible conductive substrate 12. Secondary label 72 and label 70 are separable such as by tearing along perforations 74. Secondary label 72 includes magnetically detectable strip 76 which is detectable by detector 62 and conductors 64 and 66 all present in label 70 on substrate 12. As shown in Figure 6, system 500 can be affixed to drug container 80/82 with the main portion of the system corresponding to system 400 (that is label 70) being affixed, such as by conventional pressure sensitive adhesive to the rounded body 80 of the pill container and the secondary portion of the system defined by secondary label 72 affixed to the cap 82 of the pill container. When the cap 82 is in place on the pill bottle, magnetic strip 76 is in a first position relative to detector 62. When the bottle cap 72 is removed to open the container and gain access to a drug dose contained therein, strip 76 is moved to a different position relative to detector 62, which different position is distinguishable by detector 62 and thus provides an indirect indication to the system that a dose has been taken by the patient.

As can be seen, the label 70 is flexible and conforms to the rounded contours of the bottle 80. A can also be seen, the flexible conductors, whether electrical or optical, embodied in the flexible conductive substrate 12 which joins the detector and processor into a single unitary body also conform to the container surface. Label 72 is also flexible and conform to the contours of the cap 82.

hi preferred embodiments, some or all of the electrical and optoelectronic circuits mounted on the flexible substrate make use of organic conductors and/or organic semiconductors. The organic materials can be incorporated as field effect transistors, diodes, LEDs, displays, photodiodes and photovoltaic cells and the like and can be integrated, as described for example in EP Patent No. 1,376,697 ("Integrated Optical Microsystems Based on Organic Semiconductors"). It has been demonstrated that such devices and circuits can be realized cost-effectively, employing known or modified printing techniques such as silk-screen printing, ink-jet printing or offset printing. Conductive polymers include conjugated polymers. These are described, for example at, Chemical Innovation, Vol. 30, No. 1, 14-22 (April 2000), and in the repot entitled "P -235 Conductive Polymers" by Mel Schlecter, published October 2003 by Business Communications Company, Inc. Representative conductive polymers include poly(aniline), poly(acetylene), poly(N-vinylcarbazole), poly(pyrrole), poly(thiophene), poly(2-vinylpyridine), poly(p-phenylenevinylene), poly(naphthalene) and related derivatives. Some of the conductors can be formed of carbon fibers and the like, if desired. Optical conductors, including organic polymeric optical conductors, are described in the book Optical Network Design and Implementation, Cisco Press, 2004. See especially the chapter "Fiber-Optic Technologies". Representative polymeric materials for this application include polyester polymers such as polymethylmethacrylate) as well as silica-polymer composites such as polymer-clad glass and silica fibers. While these polymer-based materials are particularly usefiil in the flexible substrate which joins the detector and processor into a single unitary structure, they need not be use exclusively and in some portions of some applications other conductors can be used, as well.

In the systems of this invention the processor, which is conductively connected to the detector through the flexible substrate, provides the functional building blocks that are required for at least the reception of the detected dispensing event signals and generally the storage of this event information and the transmission of the information, as detected or after storage, to an outside system.

In these systems, the processor can include signal comparators for detecting these signal modifications, clocking and absolute time-keeping circuits, a central processor that monitors the detector signaling circuits and stores detected dispensing events together with their time in appropriate memory cells, a wireless radio-frequency or optical communication interface for transmitting all this information to an outside system, optional sensor modules such as temperature, touch sensing or other devices for patient input, an optional display or enuncia- tor module for providing visual or audible feedback to the patient, all powered by the power- supply such as a battery or photovoltaic cell, with this detector and processor connected into a unitary system via the flexible conductive substrate.

This processor can also provide an information retrieval and retransmission system that can read the data provided by the detector and transmit it either to the medication- prescribing physician or to an organization that collects and compiles such data in order to present the data to the medication-prescribing physician in appropriate form. Electrically- conducting or optically-wave-guiding circuits in the detector can detect when a dose is removed.

Such a system consists of a flexible conductive substrate, typically made of a light- or electrically-conductive polymer or made of other plastic materials and including such a conductive polymer. This flexible substrate serves to define a number of compartments. The patient's medication is loaded into these compartments. The flexible conductive substrate provides an electrically- or optically-readable first signal for each compartment when loaded with drug. An electronic drug removal detection circuit monitors these first signals to determine a change in signal indicative of dispensing of one or more drug dosage forms from one or more compartments. This detection can be specific for individual dosage forms or it can be based on the overall collection of dosage forms, depending upon whether or not information concerning specific individual doses is needed (as would likely be the case if the system were monitoring the dispensing of doses of more than one drug with a single device). The processor obtains this information, combines it with an absolute or relative time stamp that is received from a clock generator and timing circuit, and the information can be stored in a digital memory. The central processor can also be programmed with the physician-prescribed medication regimen, and it can remind the patient with a display or with one opr more colored light-emitting diodes (LEDs) or the like of the time to remove and ingest the next dose. This display or the LEDs can also be contained on the same flexible substrate.

It is possible to integrate additional sensor elements such as a temperature or humidity sensor on the flexible substrate, if monitoring certain environmental conditions is important to ensure the integrity of the medication. It is also possible to provide a multitude of touch sensors, giving the patient the freedom to request certain information from the central processor, to be shown on the integrated display device.

The system can also contain a wireless communication module, with which the central processor can communicate the medication removal events to the information retrieval and retransmission system. This process is implemented either as a radio-frequency or an optical link, preferentially using infrared light as known from television remote controls.

Once the power supply is connected to the system, the clock generation module begins to operate and the central circuit is initialized. The absolute timing circuit either resets itself to zero before running continuously, or it can obtain the correct, absolute time from a radio station emitting standard time signals, such as the long-wave DCF77 time signal (77.5 kHz) provided by the German Physikalisch-Technische Bundesanstalt PTB or the WWVB time signal (60 kHz) provided by the US National Institute of Standards and Technology NIST.

The medication removal events together with their appropriate time stamps are most commonly stored by the central processor in the digital memory. This information can be read out and transmitted from time to time to an offsite information retrieval and retransmission system. Since the distance between this information retrieval and retransmission system and the medication event detection system of this invention is not known, there might be the need to provide the detection systems' wireless communication module with quite a high level of transmitted RF or optical power.

An alternative is to store all information in the unitary system processor memory until all of the unit doses of medication have been dispensed or the medication regimen has come to a close. The patient can then place the used detector-processor unit together with its flexible substrate into a container or receptacle which is stored at a location conducive to effective transmission of data, such as for example a location in the patient's home, which is combined with the information retrieval and retransmission system.

Once the used detector/processor unit is placed into this container, electronic circuitry within the container detects the presence of the arriving unit, and it requests the central processor on the blister pack to download all medication removal information most commonly over a wireless communication module. Since the distance between the wireless communication module and the receiver module of the information retrieval system is at most a few centimeters, the emitted power of the unit can be kept at very low levels. If the timing circuit of the unit did not disclose the accurate time because it was set to zero when the power supply was connected, the relative time of the medication removal events are stored in the information retrieval system, and they are subsequently corrected to the absolute time since the information retrieval system disposes of this information.

When the information retrieval and retransmission system has obtained the full information from a used unit, this information is retransmitted either to the medication-prescribing physician or to an organization that collects and compiles such data, in order to present them to the medication-prescribing physician. This transmission can occur either through a standard telephone line, a cable modem line, a wireless module according to one of the mobile telephone standards such as GSM, a wireless local area network according to one of the IEEE standards such as 802.11 or any other means of communications.

This makes it possible, for example, to implement one of the known systems for improving compliance with a medication regimen, as disclosed for instance by United States Patent Application Publication Number US2005183653 ("System and Method for Improving and Promoting Compliance to a Therapeutic Regimen").

Claims

WHAT IS CLAIMED IS:

1. A medication compliance monitoring system for monitoring patient compliance with a medication regimen by noting when unit doses of medication are dispensed to the patient, said system comprising a detector for generating a signal each time a unit dose is dispensed, a signal processor selected from at least one of: a.) a memory for storing the signal together with time information related to when the signal was generated, b) a transmitter for transmitting information related to the signal to a location distant from the system, c) a display for displaying to the patient information concerning the patient's compliance with the regimen based upon the generated signal, and d) a power supply to power the detector and/or other signal processing components, characterized in that the medication compliance monitoring system comprises a flexible substrate physically connecting the detector and the processor into a unitary structure and conducting the signal from the detector to the processor.

2. The medication compliance monitoring system of claim 1 wherein the signal processor includes a memory.

3. The medication compliance monitoring system of claim 1 wherein the signal processor includes a transmitter.

4. The medication compliance monitoring system of claim 1 wherein the signal processor includes a display.

5. The medication compliance monitoring system of any of claims 1-4 wherein the signal is an electrical signal.

6. The medication compliance monitoring system of any of claims 1-4 wherein the signal is an optical signal.

7. The medication compliance monitoring system of claim 5 additionally comprising an electrical conductor for conducting the electrical signal from the detector to the processor and wherein said electrical conductor is contained within the flexible substrate.

8. The medication compliance monitoring system of claim 5 additionally comprising an electrical conductor for conducting the electrical signal from the detector to the processor and wherein said electrical conductor is the flexible substrate.

9. The medication compliance monitoring system of claim 7 or 8 wherein said conductor is an electrically conductive organic material.

10. The medication compliance monitoring system of claim 7, 8 or 9 wherein the flexible substrate comprises a unitary layer of the electrically conductive organic material with said unitary layer comprising the electrical conductor.

11. The medication compliance monitoring system of claim 10 wherein the unitary layer of electrically conductive organic material is patterned to provide a series of electrical conductors.

12. The medication compliance monitoring system of claim 6 additionally comprising an optical conductor for conducting the optical signal from the detector to the processor and wherein said optical conductor is contained within the flexible substrate.

13. The medication compliance monitoring system of claim 6 additionally comprising an optical conductor for conducting the optical signal from the detector to the processor and wherein said optical conductor is the flexible substrate.

14. The medication compliance monitoring system of claim 12 or 13 wherein said optical conductor is an optical waveguide.

15. The medication compliance monitoring system of claim 12, 13 or 14 wherein the flexible substrate comprises a unitary layer of optically conductive organic material.

16. The medication compliance monitoring system of claim 15 wherein the unitary layer of optically conductive organic material is patterned to provide a series of optical conductors.

17. The medication compliance monitoring system of claim 1 wherein the substrate is configured as a label.

18. The medication compliance monitoring system of claim 17 wherein the label-configured flexible monitor has a substantial length and width and an insubstantial thickness such that it can conform to a surface of a container.

19. The medication compliance monitoring system of claim 18 having a front and a back side and a layer of adhesive on the back side for adherence to the surface of the container.

20. The medication compliance monitoring system of claim 19 additionally comprising a removable protective sheet protecting the layer of adhesive prior to removal and prior to adhering it to the surface of the container.

21. The medication compliance monitoring system of claim 1 wherein the detector detects the dispensing of a unit dose from any unit-dose compartment.

22. The medication compliance monitoring system of claim 1 wherein the detector detects the dispensing of a single unit dose from a specific, unit-dose compartment.

23. The medication compliance monitoring system of claim 1 in combination with a container for the medication.

24. The medication compliance monitoring system in combination with a container of claim 23 wherein the signal is generated when a conductor is disrupted by the dispensing of a unit dose from the container.

25- The combination of claim 24 wherein the signal is an electrical signal and the disrupted conductor is an electrical conductor.

26. The combination of claim 25 wherein the signal is an optical signal and the disrupted conductor is an optical conductor.

27. The medication compliance monitoring system of claim 6 or the combination of claim 26 wherein the optical signal is an infrared or a visible signal.

28. The medication compliance monitoring system of claim 1 additionally comprising an information interface for use by the patient or the patient's health care professional to input or request information into/from the system. ^;

29. The medication compliance monitoring system of claim 28 wherein the information interface is a keypad.

30. The medication compliance monitoring system of claim 1 additionally comprising a sensor for sensing information relevant to the regimen and generating an additional signal

5 based on said information wherein the flexible substrate additionally physically connects the sensor and the processor into a unitary structure and conducting the signal from the sensor to the processor.

31. The medication compliance monitoring system of claim 30 wherein the additional signal information interface for use by the patient or the patient's health care professional to input or io request information into/from the system, wherein the flexible substrate additionally physically connects the information interface and the processor into a unitary structure and conducting the signal from the information interface to the processor.

32. The medication compliance monitoring system of claim 31 wherein the information interface is a keypad.

15 33. In a method for monitoring patient drug dose consumption employing a device to detect and record drug dosing events, the improvement comprising employing a medication compliance monitoring system of any of claims 1-32 as said device.