WO2013142801A2 - Procédés, systèmes, et appareil d'optimisation des effets d'un traitement médicamenteux en utilisant des profils d'observance médicamenteuse - Google Patents

Procédés, systèmes, et appareil d'optimisation des effets d'un traitement médicamenteux en utilisant des profils d'observance médicamenteuse Download PDF

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Publication number
WO2013142801A2
WO2013142801A2 PCT/US2013/033523 US2013033523W WO2013142801A2 WO 2013142801 A2 WO2013142801 A2 WO 2013142801A2 US 2013033523 W US2013033523 W US 2013033523W WO 2013142801 A2 WO2013142801 A2 WO 2013142801A2
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medication
patient
treatment
data
monitor
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PCT/US2013/033523
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English (en)
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WO2013142801A3 (fr
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Steven Mayer
David Kravitz
Tracey MAYER
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I.D. Therapeutics Llc
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Priority claimed from US13/427,389 external-priority patent/US20120203573A1/en
Application filed by I.D. Therapeutics Llc filed Critical I.D. Therapeutics Llc
Publication of WO2013142801A2 publication Critical patent/WO2013142801A2/fr
Publication of WO2013142801A3 publication Critical patent/WO2013142801A3/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0076—Medicament distribution means
    • A61J7/0084—Medicament distribution means for multiple medicaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4833—Assessment of subject's compliance to treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/30—Compliance analysis for taking medication
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00—General identification or selection means
    • A61J2205/60—General identification or selection means using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0418—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with electronic history memory
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0427—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system
    • A61J7/0436—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system resulting from removing a drug from, or opening, a container
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/80—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for detecting, monitoring or modelling epidemics or pandemics, e.g. flu
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
    • Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Definitions

  • the disclosure relates to methods, systems, and apparatus for monitoring patient medication usage, determining medication compliance patterns, and establishing and adjusting medication regimens.
  • the disclosure further relates to methods, systems, and apparatus for monitoring, storing, and analyzing patient medication usage data and
  • compliance patterns associating the compliance patterns with medication properties data and patient history data, and determining a correlation between medication compliance patterns and the other data.
  • Medications may include potent chemical and/or biological elements designed to induce a specific ameliorative effect on a patient's disease state or medical condition.
  • Medication manufacturers, prescribing physicians, and caretakers have limited information about a given medication that typically includes only basic guidelines for safely and effectively prescribing very powerful substances to patients.
  • Poor or unexpected medication treatment regimen compliance is a medical problem that poses risks to patient health and potentially increases health care costs.
  • a patient who has undergone an organ transplant may be prescribed a regimen of immunosuppressive medications to protect the patient's transplanted organ from being rejected by the patient's immune system. If a patient takes too much or too little of these medications, or takes them at incorrect time intervals, then the patient's body may experience a cascade of biochemical reactions that may result in the transplanted organ being rejected or other diseases being acquired, or other complications.
  • Methods, systems, and apparatus are needed that provide robust checks and balances for establishing medication regimens, adjusting medication regimens, and caring for patients who are taking medications. Further, methods, systems, and apparatus are needed that permit monitoring, analysis, and recording of medication usage data and regimen compliance patterns for individual patients and patient populations. Further still, methods and systems are needed that permit analysis of medication regimen compliance patterns in view of patient history data to enable, for example, medication manufacturers and/or prescribing caretakers to safely and efficaciously establish and adjust treatment regimens.
  • Embodiments of methods, systems, and apparatus described herein fulfill needs for readily accessible data concerning medication regimen compliance and patient history data, for individual patients or populations of patients.
  • Methods, systems, and apparatus provide access to medication usage data and compliance patterns.
  • Methods, systems, and apparatus permit analysis of associated medication compliance patterns, outcomes data, medicine interaction data, biomarker data and establishment and adjustment of medication dosage regimens.
  • embodiments of methods permit optimizing effects of treatment with medication by establishing medication regimens based on medication compliance patterns.
  • the medication compliance patterns are determined by performing statistical analysis on medication usage data using a processor.
  • Embodiments include systems for optimizing the effects of treatment with medication that may have a medication monitor, a receiving system, and a compliance data processor that processes medication usage data to produce one or more medication compliance pattern.
  • Embodiments include systems that may have a storage system for storing at least one of medication compliance pattern, medication properties data, outcomes data, biomarker data, and patient history data.
  • the systems may include a treatment regimen processor that establishes a treatment regimen based on at least one of the medication compliance pattern, medication properties data, outcomes data, biomarker data, a
  • the systems may include a biomarker device that is configured to output the biomarker data to the treatment regimen processor or some other device.
  • Embodiments include a monitor that may include a housing body defining an opening that accommodates insertion and removal of medication that may be contained by the monitor.
  • the housing body may include a plurality of housings each configured to accommodate a specific shape of a pre-filled medication insert.
  • the monitor may include a lid that slideably covers and uncovers the opening, and a sensor for determining when the opening is uncovered.
  • the monitor may be equipped with a processor for determining medication compliance patterns based on medication usage data sensed by the monitor by way of, for example, sensing the covering and uncovering of the opening by the lid.
  • the monitor may include a sensor to detect, for example, an origin of manufacture of the pre- filled medication insert.
  • Each pre-filled medication insert may have a barcode, RFID tag or other identifier that relays the origin of manufacture data and other data to verify authenticity of the medication.
  • the monitor may include a reader such as a barcode reader, an RFID label reader or other information detector that verifies that the medication is not counterfeit at the time the monitor is loaded and/or at the time of use by the patient.
  • the RFID information may also be sent to a receiving system such as a remote server, which verifies, and may send a signal to the monitor and/or another receiver, regarding whether the medication is authentic.
  • the monitor may also or instead include a sensor to detect a specific shape of a medication, the specific shape of the pre-filled medication insert, a medication made by a unique manufacturing process, or an orientation of the medication within the housing body.
  • Embodiments include methods that may accommodate optimizing treatment of a transplant recipient.
  • Methods may include providing a patient with a medication monitor that can provide usage data regarding the patient's compliance with an immunosuppressant treatment regimen.
  • Methods may include collecting the usage data at a central server over a predetermined period of time, and determining over the predetermined period of time a patient's compliance pattern with the treatment regimen.
  • methods may include obtaining a diagnostic test or biomarker result indicative of a level of immunosuppression of the patient, comparing the patient's compliance pattern with the diagnostic results, and, based on the comparison, outputting a recommendation of replacing an immunosuppressant medication used in the treatment with a different medication, changing a dosage amount and/or frequency of an immunosuppressant medication, or not changing the regimen.
  • FIG. 1 is a flow diagram of a method of establishing a treatment regimen in accordance with an exemplary embodiment
  • FIG. 2 is a flow diagram of a method of establishing a treatment regimen in accordance with an exemplary embodiment
  • FIG. 3 is a flow diagram of a method of establishing a treatment regimen in accordance with an exemplary embodiment
  • FIG. 4 is a diagrammatical view of a medication usage monitoring system in accordance with an exemplary embodiment
  • FIGs. 5a-5b are perspective views of a medication monitor in accordance with an exemplary embodiment.
  • FIG. 6 is a perspective view of a medication monitor cartridge compartment in accordance with an exemplary embodiment
  • Embodiments include one or more medication monitors having a housing and/or container for holding one or more types of medication for one or more patients.
  • a monitor may include a sensor for sensing medication usage data such as a time, a date, a location of medication insertion, usage, dispensing, consumption, or the like.
  • the monitor may include one or more sensors for sensing patient medication usage by way of, for example, sensing the position of a lid that covers or uncovers a cavity, housing, cartridge, chamber, or other opening, closing, filling, refilling, or dispensing structure.
  • the monitor may include a processor that enables the apparatus to monitor, record, and generate, for example, medication usage data such as time, date, and/or location of medication
  • the location of medication consumption may determined with a medication monitor that is equipped with, for example, global positioning satellite technology ("GPS") and/or wireless communication technology such as cell phone technology.
  • the processor may enable the apparatus to monitor and record usage data such as the amount of medication remaining in one or more containers.
  • the monitor may be constructed to accept, contain, and dispense one or more medications by containing medications separately, in prescription pharmacy containers, bottles, blisterpacks, and/or by way of cartridges or chambers.
  • the monitor may include a display, and may be constructed to dispense contained medication.
  • the identity of one or more medications may be determined with a medication monitor that is equipped with, for example, an RFID sensor.
  • a medication monitor may include a compliance pattern processor that determines compliance patterns based on statistical analysis or other now known or later developed systems.
  • the medication monitor may include a treatment regimen processor that determines a treatment regimen based on the compliance pattern.
  • the medication monitor may include a processor that provides an output that suggests alternatives in view of medication compliance patterns, medication properties data, outcomes data, biomarker data, and/or patient history data.
  • processors may be in separate apparatus (e.g., in one or more remote servers).
  • the medication monitor may be constructed to communicate with one or more receiving systems, such as a remote computer, another medication monitor, a cellular or landline telephone, or other receiving or remote communications device, for example of a patient, central repository, server, healthcare facility, caretaker, or family member.
  • the medication monitor may be constructed to include a port for connecting and communicating with a separate receiving system by way of a universal serial bus connection or a cable connection.
  • the medication monitor may include a transmitter for communicating wirelessly.
  • the medication monitor may be located on the same network as a receiving system, or on a different network.
  • the medication monitor may communicate data to a receiving system for presentation or storage.
  • the receiving system may communicate with, or may include, a storage system for storing the medical usage data, compliance pattern, or regimen data. Further, the receiving system may include a computer program for analyzing and organizing the usage data or compliance pattern, and for formatting the information for presentation to a patient, health care provider, medication researcher, developer or
  • the receiving system may not be limited to merely receiving data from the medication monitor, but may also transmit signals and data to the medication monitor.
  • the receiving device may request that the medication monitor send data, or may transmit data to the monitor such as software updates, new software, or new adjusted dosage regimens.
  • Information such as new adjusted dosage regimens, a time, an amount of remaining medication, a reminder, and/or a warning may be communicated to a patient by way of a display located on or in communication with the monitor.
  • Other messages for example messages targeted to specific patients or populations of patients, could be disseminated though the monitor.
  • monitors associated with a certain medication can be targeted with information or inquiries about that medication (e.g., recall notices or commercial or educational information) or generally about the type of medication or related health conditions. Because of the transmission capability of the monitor, such features could be used for two-way communications such as surveys. This capability may preferably be associated with a switch or programming choice to enable or disable such communications, particularly incoming commercial information.
  • the receiving system may be in communication with one or more medication monitors.
  • the receiving system may communicate with a gateway of a network of medication monitors.
  • the network may be a wide area network or a local area network.
  • the networks may be of any topology now known or later developed, including tree, mesh, or star.
  • the networks may be peer-to-peer or server/client.
  • the receiving system may be located on the same network as or a different network from the one or more medication monitors.
  • the receiving system may receive and/or communicate with medication monitors on more than one network.
  • the receiving system may also be configured to receive patient history data that includes, for example, a historical record of deleterious and/or ameliorative effects of a medication on a patient or population of patients, optionally correlated to particular patient medication usage compliance patterns.
  • patient history data includes, for example, a historical record of deleterious and/or ameliorative effects of a medication on a patient or population of patients, optionally correlated to particular patient medication usage compliance patterns.
  • the receiving system may also be configured to receive medication properties data related to, for example, the effects of an interaction between a prescribed medication and another medication.
  • the receiving system may be a remote server.
  • the receiving system may be configured to store and present received data upon demand from an interested party using a storage system and/or a reporting system. In this manner, the receiving system may function to communicate warnings based on an analysis of monitored patient medication usage data, medication compliance patterns, and medication interaction data. Further, the receiving system may be configured with a computer program for analyzing the patient medication compliance pattern, outcomes data, and medication interaction data to organize the data for presentation, and/or to determine a correlation therebetween.
  • the receiving device may be configured with a computer program for analyzing a correlation between the patient medication compliance pattern and the outcomes data in view of a treatment regimen, and that outputs one or more predictions pertaining to the effects on the patient of the treatment regimen, or the effects of potential treatment regimens, and present the output.
  • the receiving device may include a computer program for ranking the data, or otherwise assigning values to highlight particular aspects of the data for presentation to an interested party.
  • Embodiments include methods for monitoring patient medication usage and generating corresponding compliance patterns for at least one patient.
  • embodiments include methods for monitoring patient medication usage and generating compliance patterns for one or more population of patients. Exemplary populations of patients could be defined, for example, based on treatment-related or treatment-unrelated characteristics.
  • certain populations may be determined to share compliance characteristics— e.g., populations above or below a certain age or suffering from certain conditions (e.g., Alzheimers), may be more forgetful; populations with certain lifestyle attributes (e.g., alcoholics, drug addicts) may be less rigorous, more forgetful and/or more oppositional to treatment; gender-based populations may have different compliance characteristics with respect to certain types of medications (e.g., contraceptives, erectile dysfunction medications) than with respect to other types of medications (e.g., blood pressure control medications).
  • certain types of medications e.g., contraceptives, erectile dysfunction medications
  • other types of medications e.g., blood pressure control medications
  • the usage data and compliance patterns may relate to more than one monitored medication.
  • the monitoring may be, hut does not have to be, accomplished by using a medication monitor as described herein.
  • Embodiments include using a medication monitor for monitoring at least one of a time, a date, and a location of medication usage. Also, embodiments include monitoring the time and/or date that a dosage of medication is removed from a monitored medication container.
  • a method for patient medication usage monitoring may include transmitting medication usage data to a remote monitoring server, receiving the usage data, and storing the medication usage data and/or compliance pattern, whether on the server, or on another device that is in communication with the medication monitor and/or system.
  • Embodiments include methods, systems, and apparatus wherein medication usage data may be used to determine a medication compliance pattern for the one or more patients to which the usage data pertains or for other patients. Medication compliance patterns may be stored, whether on the receiving device or on another device in
  • a compliance pattern is a statistical pattern derived from a plurality of data points of medication usage data gathered over a period of time, such as not less than one week, four weeks, three months, six months or a year or more.
  • the pattern could reflect, for example, percentage of doses missed, taken early (optionally including an indication of how early), taken late (optionally including an indication of how late), or taken on time.
  • Embodiments include methods for establishing a medication dosage regimen including receiving medication usage data from one or more patients using one or more patient medication momtor. Methods include determining a medication compliance pattern based on the received usage data, wherein the compliance pattern relates to a pre-established treatment regimen. Embodiments include methods for adjusting a pre-established treatment regimen or establishing an entirely new (i.e., initial) treatment regimen based on patient medication compliance patterns.
  • methods include receiving medication properties and/or patient history data pertaining to the positive and/or negative effects of a medication on a patient's health. This data may be received from a patient, a health care provider, a drug developer/manufacturer, a private database, and/or a central repository. Methods may further include receiving medication interaction data regarding the effects of interactions between the medication and other medications that a patient has taken or is taking.
  • the medication interaction data may relate to one patient or a population of patients.
  • the medication interaction data may be analyzed with patient medication usage data or a medication compliance pattern determined based on the patient medication usage data.
  • the data may be stored, and may be organized for presentation to an interested party.
  • Fig. 1 shows methods involving medication usage monitoring, and determining a medication compliance pattern in accordance with an exemplary embodiment.
  • the methods may be carried out using a medication monitor and treatment optimization system as described herein.
  • a patient may be given a medication and a treatment regimen associated therewith that the patient is instructed to follow.
  • the patient's usage of the medication is monitored to generate patient medication usage data.
  • the patient medication usage data may be received at SI 10 at or from, for example, a medication monitor as described herein.
  • the medication monitor may be constructed to contain a single medication or multiple medications.
  • the patient medication usage data may relate to the single medication or the multiple medications.
  • the patient medication usage data may relate to a single patient, or the patient medication usage data may relate to a population of patients.
  • the usage data may concern the doses of one or more medications in a container, and may concern the time, date, and/or location at which medication is added to or removed from the container.
  • the usage data may be based on the patient taking active medication or a placebo administered to establish a compliance pattern before active medication is administered or to help determine what, if any, active medication(s) may safely and/or effectively (and/or cost- effectively) be administered.
  • the term "medication" may include a placebo unless otherwise indicated by the context.
  • the patient medication usage data may be analyzed to determine a patient medication compliance pattern as shown at SI 20 of Fig. 1.
  • the patient medication compliance pattern may be determined by way of a processor, using, for example, a computer-run algorithm that causes the processor to execute statistical analysis of the usage data.
  • the usage data may be organized for presentation in a manner that accommodates determining a patient medication compliance pattern by way of, for example, graphical, diagrammatical or other representations of the usage data.
  • the patient medication usage data may be sensed by a medication monitoring apparatus, which may communicate the usage data to a receiving system, such as a remote monitoring server that is connected to a display.
  • the receiving system may analyze the usage data, and organize the data in a presentation format for display to an interested party.
  • the interested party may rely on the display of organized patient medication usage data to understand actual patient compliance patterns and associate them with patient history data, including outcomes data associated with the compliance patterns, for informed treatment regimen establishment and adjustment, and compliance monitoring.
  • Compliance patterns may be determined based on patient medication usage data from a patient who, for example, is pre-therapy, wherein the medication is a placebo. Further, compliance patterns may be determined based on patient usage data from a patient who is pre-therapy, wherein an active medication has been previously prescribed.
  • Compliance patterns may also be determined based on patient medication usage data from a patient who is undergoing therapy and has been prescribed medications. Compliance patterns may be used to establish a treatment regimen, or for other purposes, such as for input to a compliance incentive program. For example, external rewards such as money, food, discounts, services, etc. may be provided to a patient or population of patients based on their compliance patterns. These rewards may be used as incentives to promote compliance, and/or to reflect the effects of different levels of compliance. For example, insurance premiums can be adjusted based on compliance patterns, as an incentive and/or as a financial protection for the insurance provider. Notifications can be provided to incentive program staff, patients and other interested parties to provide positive or negative feedback when compliance patterns are improving, maintaining or deteriorating.
  • Fig. 1 shows a step of establishing a treatment regimen.
  • the treatment regimen may be a standardized treatment regimen or an individual patient treatment regimen.
  • a treatment regimen may be established in view of the patient medication compliance pattern determined at SI 20.
  • the treatment regimen may be established so as to maximize efficacy and safety, which may be determined in part by way of the patient medication compliance pattern.
  • the determined medication compliance pattern may be correlated with health variables of the monitored patient to predict the effects of medication intake, and to enable a caretaker to actively monitor and adjust an individual patient's medication intake by changing a dosing frequency and/or dosage amount.
  • Health variables may include individual patient data such as physical or physiological data regarding weight, body mass index, gender, and data related to other medications or other substances (e.g., alcohol, tobacco) that the patient is taking or has taken.
  • the determined medication compliance pattern may be analyzed in view of medication properties such as toxicity levels, and half-life of a particular medication.
  • Exemplary techniques include traditional statistical methods, multiple linear regression models, simple mixed logistic regression analysis, generalized linear mixed effects models, marginal models and generalized estimating equations, models for longitudinal data analysis, support vector machines, neural networks, K-nearest neighbor interpolation, non-linear methods, and other methods.
  • the algorithms may effect, in part, the step of establishing a treatment regimen at S130, and/or the step of determining a medication compliance pattern at SI 20. Further the algorithms may provide a result at SI 99 of providing warnings or messages to interested parties such as patients, family, caretakers, and support organizations. The algorithms may output status reports to patients and health care providers, or result in the change or establishment of a treatment regimen, whether by frequency of dosing or dosage amount, or the type and/or number of medications and/or other treatments prescribed.
  • the algorithms may output orders for specific tests or measures, or data upon which decisions to request such orders may be based.
  • Fig. 2 shows a method of establishing a treatment regimen in accordance with an exemplary embodiment.
  • the method may be carried out using a medication monitor and/or medication usage monitoring system as described herein.
  • a patient may be given a medication and a dosing regimen associated therewith that the patient is instructed to follow, and with which the patient may use a medication monitor to monitor the patient's usage of the medication and to generate patient medication usage data.
  • the patient medication usage data may be received at S210 at or from a medication monitor as, for example, described herein.
  • the medication monitor may hold a single medication, or may be constructed to hold multiple medications.
  • the patient medication usage data may relate to the single medication or the multiple medications.
  • the patient medication usage data may relate to a single patient, or the patient medication usage data may relate to a population of patients.
  • the usage data may concern the number of doses in a monitor at a given time, and may concern a time, a date, and/or a location at which a medication is dispensed, added to, or removed from the monitor.
  • the patient medication usage data may be analyzed to determine a medication compliance pattern as shown at S220 of Fig. 2.
  • the medication compliance pattern may be determined by way of a processor, using, for example, a computer-run algorithm.
  • the patient medication usage data may be organized and formatted for presentation in a manner that accommodates determining a patient medication compliance pattern by way of, for example, graphical and/or diagrammatical representations of patient medication usage data.
  • the patient medication usage data may be sensed and communicated by a medication monitor, which may communicate usage data to a receiving system or storage system, such as a remote monitoring server that is connected to a display.
  • the remote server may analyze the usage data, and organize the data for display to an interested party, for example, a health care provider.
  • the health care provider may rely on the display of organized patient medication usage data to determine a compliance pattern(s).
  • the analysis may take into account patient travel and time zone changes, for example by basing the analysis on options of keeping the same dosing time as in an original time zone or adjusting the dosing time to the new time zone.
  • Medication properties data may include measures of safety and/or efficacy. Such measures may take into account, for example, such information relating to ongoing treatment regimens or "take-as-needed" (e.g., "PRN") regimens. For example, a take-as- needed regimen compliance pattern may particularly address toxicity issues such as overdosing patterns.
  • the medication properties data may include recorded side effects, and recorded ameliorative and/or deleterious effects of medication usage on a patient or population of patients. Medication properties data may also include medication interactions data and/or biomarker data. If medication properties data are available, the data are received at S240.
  • the medication properties data may be received from a repository or database of medication properties data.
  • Fig. 2 shows a method of establishing a treatment regimen.
  • a treatment regimen may be established in view of the determined patient medication compliance pattern.
  • the treatment regimen may be established so as to maximize efficacy and safety, which may be determined by way of the patient medication compliance pattern and medication properties data.
  • the treatment regimen may also be established in view of patient history data.
  • the determined medication compliance pattern may be correlated with a health status of the monitored patient, and/or outcomes data, to predict the effects of medication intake, and to enable a caretaker to actively monitor and adjust an individual patient's medication intake by changing a dosing frequency and/or dosage amount.
  • the outcomes data may include data output by a biomarker device (described below) that may be implanted in the patient and/or provided external to the patient.
  • Various algorithm techniques may be employed for analyzing the patient medication compliance pattern data, medication properties data, and patient history data.
  • Exemplary techniques include traditional statistical methods, multiple linear regression models, simple mixed logistic regression analysis, multiple regression analysis, Quadratic Discriminant Analysis, Classification and Regression Trees, generalized linear mixed effects models, marginal models and generalized estimating equations, Analysis of Variance (ANOVA), Analysis of Co-Variance (ANCOVA) models for longitudinal data analysis, Principle Component Analysis (PCA), Linear Discriminant Analysis (LDA), support vector machines, neural networks, K-nearest neighbor interpolation, non-linear methods, and other methods.
  • ANOVA Analysis of Variance
  • ANCOVA Analysis of Co-Variance
  • PCA Principle Component Analysis
  • LDA Linear Discriminant Analysis
  • Analysis may be undertaken using software including but not limited to: SAS Version 8.02 or more recent version, ViSta (The Visual Statistics System), MATLAB, S+, STATA, MATLAB SVM, RapidMiner, Shogun, ACMB, Chronux, OpenEpi, SPSS, PSPP, SciPy, CRM114, and other software.
  • ViSta The Visual Statistics System
  • MATLAB S+
  • STATA STATA
  • MATLAB SVM RapidMiner
  • Shogun ACMB
  • Chronux Chronux
  • OpenEpi OpenEpi
  • SPSS PSPP
  • SciPy SciPy
  • CRM114 and other software.
  • the algorithms may effect in part the step of establishing a treatment regimen at S250, and/or the step of determining a medication compliance pattern at S220. Further the algorithms may provide a result at S299 of providing warnings, messages, treatment options, or adjusted regimens to interested parties. The algorithms may output status reports to interested parties, or result in the change of a dosage regimen, whether in frequency or amount of dosage, or the type and/or number of medications prescribed.
  • the algorithms may output orders for specific tests or measures.
  • Fig. 3 shows a method of establishing a medication treatment regimen in accordance with an exemplary embodiment.
  • the method may be carried out using a medication monitor and/or medication usage monitoring system as described herein.
  • a system or apparatus may monitor the patient's or a population's usage of a medication to generate patient medication usage data.
  • the patient medication usage data may be received at S310 at or from a medication monitor as described herein.
  • the medication monitor may hold and monitor a single medication, or multiple medications.
  • the patient medication usage data may relate to the single medication or to multiple medications.
  • the patient medication usage data may relate to a single patient, or the patient medication compliance pattern data may relate to a population of patients.
  • the usage data may concern the amount of dosage forms in a container at a given time, and may concern the time, date, and/or location at which a medication is removed from the container.
  • methods, systems, and apparatus may be directed to non-prescription or prescription applications including but not limited to immunosuppressant, steroid, prednisone, microbicide, yeast infection, depression, schizophrenia, bipolar, anxiety, panic, mood stabilizer, schizophrenia, sleep apnea, epilepsy and other treatment regimens.
  • applications may include but are not limited to thyroid, contraceptive, diabetes Type I and Type II, heart failure, injectable medication, hypertension, acute myocardial infarction, anticoagulation, antibiotic, oncology, renal failure, tuberculosis, rheumatoid arthritis, post-surgery, geriatric, obesity, Alzheimer, HIV, lipid and cholesterol lowering, pain therapy, gastro-esophageal reflux disease, duodenal ulcer and H.
  • Pilori asthma, rhinitis and allergy, prostate, ADD, ADHD, ophthalmic, overactive bladder, gout, erectile dysfunction, vitamin, osteoporosis, smoking cessation, migraine, angina, and/or alcoholism treatment regimens.
  • the patient medication usage data may be organized for presentation in a format that accommodates determining a patient medication compliance pattern by way of, for example, graphical and/or diagrammatical representations of patient medication usage data.
  • the patient medication usage data may be analyzed to determine a patient medication compliance pattern as shown at S320 of Fig. 3.
  • the patient medication compliance pattern may be determined by way of a processor, using, for example, a computer-run algorithm.
  • the established treatment regimen may be a regimen previously prescribed for the monitored patient, or may be a recommended treatment regimen that has not previously been prescribed for the patient. If an established treatment regimen is available, the established treatment regimen is received at S340.
  • the established treatment regimen may be received, for example, from a medication supplier, patient's caregiver, e.g., by way of a personal computer, a handheld device, or a centralized database. If established treatment regimen data is received at S340, then the established treatment regimen may be adjusted to maximize efficacy and safety, which may be determined by comparing the patient medication compliance pattern determined at S320 and the established treatment regimen received at S340.
  • the patient medication compliance pattern determined at S320 and the established treatment regimen received at S340 may be compared at S350. Outcomes data and medication properties data may also be received, analyzed, and/or stored. The comparison may be carried out by way of a processor and computer-run software.
  • patient medication compliance pattern data and outcomes data may be organized and formatted for presentation to a health care provider, caretaker or other interested party such as a family member. This may include ranking or assigning values to various aspects of the data to emphasize such aspects to caretakers or other interested parties.
  • Exemplary techniques include traditional statistical methods, multiple linear regression models, simple mixed logistic regression analysis, generalized linear mixed effects models, marginal models and generalized estimating equations, models for longitudinal data analysis, support vector machines, neural networks, -nearest neighbor interpolation, non-linear methods, and other methods as discussed above.
  • the algorithms may effect in part the step of establishing a new treatment regimen at S335, and/or the step of establishing a treatment regimen by adjusting an established treatment regimen at S360. Further the algorithms may provide a result at S398 or S399 of providing warnings, messages, and/or information to patients, family, caretakers, support organizations, medication developers or other interested parties. The algorithms may output status reports to interested parties, or result in a recommendation for the adjustment of a treatment regimen, e.g., in frequency and/or amount of dosage, and/or the type and/or number of medications prescribed. The status reports may include warnings,
  • a remote communication device, receiving system, and/or medication container may receive warning messages.
  • the status reports may be output from the algorithms. Further, the algorithms may output orders for specific tests or measures, or may output data upon which requests for such orders may be placed.
  • Fig. 4 shows a treatment regimen compliance monitoring system having a medication monitor 401, and a receiving system 410.
  • the receiving system 410 may be in communication with a storage system such as, for example, a server 420.
  • the receiving system 410 may also be in communication with, for example, a reporting system 430.
  • the receiving system 410 may also be in communication with a biomarker device 440. Any or all of the receiving system 410, the medication monitor 401, the server 420, the biomarker device 440, and the reporting system 430 may communicate by a wireless connection, wired connection, or a combination thereof, over the internet, local area network, PSTN, or the like.
  • the biomarker device 440 is preferably configured to output diagnostic test data related to a treatment regimen.
  • Exemplary embodiments of the biomarker device 440 may include a microchip that is implanted into the patient, a weight scale, a blood pressure monitor, or a patch provided on the surface of the patient's skin.
  • an ultrasonic pressure monitor or a patch provided on the surface of the patient's skin.
  • the biomarker device 440 may include a device that is configured to receive a biological sample and then be plugged into an analysis device, for example a component of a cell phone or some other device such as the reporting system 430.
  • an analysis device for example a component of a cell phone or some other device such as the reporting system 430.
  • Each of the previously mentioned embodiments of the biomarker device 440 may communicate by a wireless connection (such as through an RFID tag), wired connection, or a combination thereof, over the internet, local area network, PSTN, or the like.
  • U.S. Patent Application Publication No. 2005/0033133 Al discloses an example of an implantable microchip that can detect and wirelessly transmit diagnostic test results. The disclosure of U.S. Patent Application
  • the biomarker device 440 When the biomarker device 440 is implanted into the patient, the biomarker device 440 may be exposed to a source of bodily fluids such as blood in a vein, capillary, small artery or another fluid source such as urine or lymph fluid.
  • the biomarker device 440 may detect, for example, blood glucose levels or an amount of medication in the blood and then may wirelessly transfer that information to the receiving system 410 and/or the reporting system 420.
  • Medication monitor 401 may include a lid 405 having a transparent window 408.
  • the transparent window 408 may enable viewing of a medication contained by the medication container 401.
  • medication monitor 401 may be constructed to house multiple medications separately or together, and may be configured to separately monitor each of the housed medications.
  • Medication monitor 401 may be constructed to house one or more medications in various dosage forms. For example, medication monitor 401 may be constructed to house and dispense oral suspension, injection, inhalation, gel, cream, and/or solid dosage forms.
  • the medication monitor 401 may include a display 400.
  • the display 400 may be, for example, a liquid crystal display that functions to present data generated or received by the medication monitor 401, or other information.
  • Lid 405 may alternatively or additionally include a display 400.
  • the lid 405 may be constructed to slideably and/or hingedly move between an open state and a closed state to accommodate access to and closure of one or more compartments of the medication monitor 401, thereby enabling a user to view the display while viewing and/or accessing at least one compartment of the medication monitor 401.
  • the medication container 401 may be battery powered, may include a SIM card, and/or may be GPS enabled.
  • Medication container 401 may be a micro-electronic "smart" pill box that accepts a unique compartmentalized pill container insert that can either be hand-loaded with individual dosage forms of medications, or alternatively, the pill box can accept a custom designed, pre-filled cartridge.
  • the pre-filled cartridge may include RFID labels that the medication container 401 can read to confirm the identity and/or amount of the medication contained in the pre-filled cartridge as an anti-counterfeiting measure to determine whether the pre-filled cartridge is authentic.
  • Medication container 401 may be constructed to contain one or more types of medications that are each compartmentalized for ease of patient identification, dispensing, and refilling.
  • the medication container 401 may, for example, be constructed of aesthetically and economically designed injection molded thermoplastic.
  • the medication container itself and/or a cartridge/magazine for it may be childproof or tamperproof, and/or the monitor may be usable with childproof and/or tamperproof containers.
  • the childproof/tamperproof features may be mechanical, electronic,
  • electromechanical or other may involve one or more biometric identification features, such as a fingerprint recognition lock, and/or electronic codes, and may optionally include time lock features to help control untimely or excess access to the contained medication.
  • biometric identification features such as a fingerprint recognition lock, and/or electronic codes
  • time lock features to help control untimely or excess access to the contained medication.
  • Fig. 5A shows a preferred medication usage monitor 501 having a body 510.
  • the body 510 may include a housing 515.
  • the housing 515 may include one or more compartments 520.
  • the medication usage monitor 501 may include a lid 502.
  • the lid 502 may include a display 508.
  • the display 508 may be, for example, a liquid crystal display, or any other suitable display now known or later developed.
  • the lid 502 may be attached to the body 510 with a pivot 525 whereby the lid 502 may slideably move to cover or uncover the housing 515 of the body 510.
  • Fig. 5B shows medication monitor 501, which may include a lid 502.
  • the lid 502 may include a display 508.
  • the display may be, for example, a liquid crystal display, or any other suitable display now known or later developed.
  • the lid 502 may be attached to the body 510 by a hinge 528 so that the lid 502 may be lifted upward with respect to the body 510 to provide access to the housing 515 and one or more compartments 520 located therein.
  • the housing 515 may be constructed to receive and retain medication dosage forms, medication containers, medication cartridges that are factory refilled and/or refillable by consumers, and/or blister packs containing medication.
  • One or more sensor may be provided to determine when medication is removed from the housing; such sensors may be specific to opening of or dosage removal from a single compartment, or from any of several
  • the medication monitor 501 may serve as a periodic dispensing device.
  • the medication monitor 501 may also serve as a monitor for determining medication refill needs and communicating related messages.
  • the medication monitor 501 may be one unit or multiple units, and may include multiple containers or compartments for organizing multiple medications. If multiple units are provided to a single patient, they preferably are capable of communicating, and programmed to communicate, with one another to ensure integrated reporting of usage data.
  • the medication monitor 501 may be sized to fit in a pocket, or a purse, or may be larger.
  • the medication monitor 501 may be constructed to hold and organize portable medication monitors. It may optionally include one or more processors as described above.
  • Fig. 6 shows a medication cartridge.
  • the medication cartridge may be constructed to be inserted into and/or removed from the medication monitor.
  • the medication cartridge may be pre-filled with medication and/or refillable.
  • the cartridge may accommodate any dosage form.
  • 610 is a spring or other mechanism that keeps pushing the stacked pills up so that one or more pills can be removed at a time when the cartridge is opened.
  • 610 is a mechanism with an opening that allow one or more pills to be removed from the medication monitor.
  • the spring or other mechanism may be contained in the package or magazine of stacked of pills. Either mechanism may also contain a sensor (optic or other) that senses when a pill is removed from the magazine or cartridge.
  • a pre-filled medication cartridge 615 is illustrated in Fig. 6.
  • the pre-filled medication cartridge 615 may have a specific shape to match a specific shape of a housing of the medication monitor.
  • the monitor may include a sensor to detect, for example, an origin of manufacture and/or identity of contents of the pre-filled medication insert 615.
  • Each pre- filled medication insert 615 may have a barcode, an RFID tag, or other information source that relays the origin of manufacture data and/or other data, for example to verify authenticity and/or identity of the medication.
  • the monitor may also include a sensor to detect a specific shape of a medication, the specific shape of the pre-filled medication insert 615, a medication made by a unique manufacturing process, or an orientation of the medication within the housing body as a way of protecting against counterfeiting and/or misuse of medication.
  • the monitor may also include a barcode reader, an RFID label reader, or another information detector that allows for verifying whether the medication is counterfeit and/or the correct medication at the time of loading of the monitor and/or at the time of use by the patient.
  • the monitor may also send the information read by the reader to a receiving system such as a remote server, preferably the same remote server as discussed above, to verify whether the medication is authentic and/or the correct medication.
  • the receiving system may compare the information received to the information in a database, and report issues to the patient and/or family, caretakers, support organizations, health care providers, etc.
  • the medication monitor may have one or more cartridges, which may or may not be separable as shown in Fig. 6. These multiple cartridges may hold the same drug (for example if higher doses or multiple pills are needed at a dose time) or different drugs.
  • there may be a mechanical mechanism in the medication monitor which slides past 610 of each cartridge, removing one or more pill (the pills can be different thicknesses and/or can he dispensed in groups) from each cartridge; the mechanism may be controlled mechanically or electromechanically.
  • the magazine may be packaged with pills of existing shape and design, or pills may be designed with specific dimensions and characteristics allowing for pills to interface properly with packaging magazines, cartridges and/or medication monitors.
  • the medication monitor may be configured to detect whether the pills provided in the magazine are authentic, for example, by detecting any one or a combination of size, shape, color, unique manufacturing process of the pills, or unique manufacturing process of the pre-filled cartridge, as a barrier to counterfeiting or improper filling (e.g., with an incorrect medication).
  • the outer housing of the pre-packed magazine of pills may have vapor or other barrier properties necessary to maintain the stability of the medication contained in them.
  • the medication container 401 may include on-board micro-processing technology.
  • the on-board micro-processing technology may function to record and/or report at least one of a time, a date, and a location of when a medication is inserted or removed, or a pre-loaded cartridge is inserted or removed, and/or other information as discussed herein.
  • the micro-processing technology may function to record the number of medications or dosage forms in a specific medication compartment at any given time.
  • the micro-processing technology may record a date, a location, and/or a time when the lid 408 is opened, and the date, the location, the time, and/or the amount when specific medication is removed or inserted.
  • the micro-processing technology may function to determine medication compliance patterns, establish or recommend adjustment of treatment regimens in view of compliance data, medication properties data, and patient history data, and determine correlations between compliance data and patient history data, or those functions may be performed at a remote location.
  • Medication container 401 may include a transmitter 412 that effects communication of medication usage data or compliance patterns or other information discussed herein generated by the medication container 401.
  • the transmitter may effect communication to at least one of the receiving device 410 and the server 420.
  • the communication may comprise the information recorded by the micro-processing technology of the medication monitor 401 , a biomarker device, and/or other information input by a patient or caregiver.
  • Medication monitor 401 may include a port for communicating data, for example, wirelessly or by a Universal Serial Bus connection.
  • Information may be transmitted from the monitor 401 to a receiving system 410.
  • the receiving system 410 may include a communications port such as a transceiver for receiving information and transmitting information to the reporting system 430 and/or the server 420,
  • the receiving system 410 may include, for example, a port for communicating wirelessly or over a Universal Serial Bus connection.
  • the receiving system 410 may include a remote storage system that receives and stores information from at least one of the medication monitor 401 and the receiving system 410.
  • the receiving system 410 and/or remote storage device may implement algorithms to analyze information such as medication usage data, established treatment regimen data, medication properties data, and patient history data, including outcomes data.
  • Outcomes data may be received by receiving system 410 from, for example, server 420 or a healthcare provider, whether private or publicly accessible.
  • a monitored patient's attending physician, healthcare system representative, or laboratory information system, a data collection center, or the like may electronically provide a patient's outcomes data to the receiving system.
  • Medication properties data such as medication interaction data may be received from a central database or other repository of medication interaction data.
  • the algorithms used in methods, apparatus and systems described herein may be designed to determine a medication compliance pattern, or to analyze a medication compliance pattern received from the medication monitor 401. Further, the algorithms may be designed to correlate one or more patient medication compliance patterns with outcomes data, which also may be analyzed by way of the algorithms. Still further, the algorithms may analyze medication interaction data in view of outcomes data and medication compliance patterns to accommodate treatment regimen establishment and/or adjustment. Algorithms may also organize outcomes data, medication usage data, treatment regimen compliance patterns, and/or a combination thereof for presentation to a caretalcer or other interested party. The organization may be effected by a ranking system in which values are attributed to aspects of the data to signify a level of importance to a caretalcer or other interested party.
  • an output of an algorithm executed in accordance with an exemplary embodiment may be a warning that may be sent to at least one of a medication monitor 401 , receiving system 410, server 420, and reporting system 430.
  • the presentation may be textual, graphical, auditory, and/or diagrammatic.
  • the data may be presented, for example, on a laptop, desktop or workstation computer display, or may be presented on a handheld device such as reporting system 430.
  • an exemplary algorithm for methods, systems, and apparatus may include inputting a starting dosing regimen of a medication for treatment of a particular condition. Then, compliance patterns may be input. Medication properties data and patient history data may also be input. The algorithm may output, based on compliance patterns, medication properties data, and/or patient history data a new regimen or report.
  • the algorithm may include the step of inputting a starting dosing regimen of cyclosporin A at x mg per day to provide post kidney transplant
  • the compliance pattern may be input, which may indicate that the patient has a pattern of high compliance with very few missed doses.
  • the medication properties data and patient history data including patient physical data (e.g., weight, body mass index, gender, etc.), patient cyclosporin A measurements, and other data, may be input.
  • the algorithm may also consider malignancy and infection risk data linked to population compliance patterns. Taking these variables into account, the algorithm may then output a new treatment regimen that includes lowering a dose amount of the medication to y mg per day. Alternatively, the treatment regimen may be changed to one that is not correlated with malignancy or infection in view of the duration of the given patient's high compliance pattern.
  • the database is populated with information from patients who have had malignancies or infections correlatable to variations among their individual compliance patterns. Specific compliance patterns that have a high probability of resulting in malignancies or infections are identified and are included in the algorithm.
  • the algorithm routinely assesses each individual's ongoing compliance pattern. When an individual pattern is developing a correlation with a malignancies- or infections-related pattern, the algorithm outputs an appropriate and/or pre-established dose reduction and/or other treatment regimen change,
  • the algorithm may utilize models or subroutines in addition to assessing direct relationships between compliance patterns and malignancies or infections. For example, if individual drug levels (from therapeutic drug monitoring) are available, pharmacokinetic models (single compartment and others) can be utilized to project the resulting dynamic drug levels for the specific individual based on the specific individual's compliance pattern, allowing intervention to be engaged prior to a malignancy or infection event when projected drug exposure is too high. This approach can also be utilized with appropriate P and/or ADME models when the patient is also prescribed other medications that may have drug-drug interactions such as inducing or inhibiting drug metabolism.
  • the algorithm may establish relationships between individual compliance patterns and resulting changes in these biomarkers, allowing for the engagement of interventions (e.g., dose reduction) prior to a malignancy or infection event.
  • a compliance pattern may show that a patient occasionally misses doses but takes medication consistently.
  • the patient history data may show chronic rejection risk associated with the compliance pattern, and also show chronic allograft nephropathy data indicating histological tubulointestinal fibrosis and tubular atrophy.
  • the algorithm may output a new dosing regimen that increases the dose, and/or the treatment regimen may be changed to one that is not correlated with chronic rejection with the given patient's specific compliance pattern.
  • the database is populated with information from patients who have had chronic rejection correlatable to variations among their individual compliance patterns. Specific compliance patterns that have a high probability of resulting in chronic rejection are identified and are included in the algorithm.
  • the algorithm routinely assesses each individual's ongoing compliance pattern. When an individual pattern is developing a correlation with a chronic rejection-related pattern, the algorithm outputs an appropriate and/or pre-established dose increase and/or other treatment regimen change.
  • the algorithm may utilize models or subroutines in addition to assessing direct relationships between compliance patterns and chronic rejection. For example, if individual drug levels (from therapeutic drug monitoring) are available, pharmacokinetic models (single compartment and others) can be utilized to project the resulting dynamic drug levels for the specific individual based on the specific individual's compliance pattern, allowing intervention to be engaged prior to the chronic rejection.
  • the intervention may be a behavioral intervention to change the individual's compliance pattern and/or dose amount and/or other treatment regimen changes (e.g., prohibiting administration of certain types of medications).
  • the algorithm may establish relationships between individual compliance patterns and resulting changes in these biomarkers, allowing for the engagement of interventions (e.g., dose increase) prior to a rejection event.
  • a patient with a risk of acute rejection may be given a starting dosing regimen of a drug for post kidney transplant immunosuppression.
  • a compliance pattern that is input may show that the patient has had many missed doses and periods of missed doses.
  • Medication properties data and patient history data may be input.
  • the medication properties data, patient history data, and compliance pattern may be analyzed to determine and output an intervention prior to acute rejection of the transplanted kidney.
  • the intervention may be warning messages to the patient, family, support organizations; change of medications; change of dosage timing and/or amounts; and the like.
  • the database is populated with information from patients who have undergone acute rejection correlatable to variations among their individual compliance patterns. Specific compliance patterns that have a high probability of resulting in acute rejection are identified and are included in the algorithm.
  • the algorithm routinely assesses each individual's ongoing compliance pattern. When an individual pattern is developing a correlation with an acute rejection-related pattern, the algorithm outputs an appropriate and/or pre-established intervention.
  • the algorithm may utilize models or subroutines in addition to assessing direct relationships between compliance patterns and acute rejection. For example, if individual drug levels (from therapeutic drug monitoring) are available, pharmacokinetic models (single compartment and others) can be utilized to project the resulting dynamic drug levels for the specific individual based on the specific individual's compliance pattern, allowing intervention to be engaged prior to the acute rejection event, for example when the drug exposure is too low or too intermittent. As the database expands and includes existing and future biomarkers of acute rejection, the algorithm may establish relationships between individual compliance patterns and resulting changes in these biomarkers, allowing for the engagement of interventions prior to an acute rejection event.
  • the medication usage data, medication interaction data, outcomes data, and medication compliance pattern(s) analyzed by the algorithms of the receiving system 410 may be made available to a patient's physician or other interested party by way of a secure website.
  • a healthcare provider may understand a patient's individual medication compliance patterns and thereby perform informed establishment and/or adjustment of the patient's treatment regimen.
  • pattern data forms a registry that can provide profound insights into the relationship between patient medication compliance patterns and treatment regimens with individual patient medical outcomes or population medical outcomes.
  • a database of patients with common disease indications can be a profound resource for improving public health and lowering the cost of medicine in specific disease states.
  • ADME data for any of the drugs patient takes
  • AD ME data for any of the drugs patient takes
  • CNI Calcineurin Inhibitors
  • CSA cyclosporine 1. e.g., initially, levels in the range of 10-20 ng/mL, but, after 3 months, levels are kept lower (5-10 ng/mL) to reduce the risk of nephrotoxicity.
  • MMF Mycophenolate mofetil
  • Kidney Injury Marker KIM 1
  • Markers for adverse effects including hyperkalemia, hypomagnesemia, nausea, vomiting, diarrhea, hypertrichosis, hirsutism, gingival hyperplasia, hyperlipidemia, glucose intolerance, infection, malignancy, and hyperuricemia
  • MCA Mycophenolate acid
  • Markers for adverse effects including hyperkalemia, hypomagnesemia, hyperlipidemia, hypertriglyceridemia, leucopenia, anemia, impaired wound healing, and joint pain
  • cytokine release syndrome ie, fever, dyspnea, wheezes, headache, hypotension
  • pulmonary edema fever, chills
  • thrombocytopenia leucopenia
  • hemolysis respiratory distress, serum sickness, and anaphylaxis
  • IF/TA Interstitial fibrosis and tubular atrophy
  • Monocyte data (CD40,CD80,CD4, CD68,CD154, CD86, other markers) ty variables
  • BKV BK polymavirus infection and nephropathy develops in 5% (1-10%) of kidney transplants and can lead to loss of graft in 50% i. BKV-specific T-cell activity
  • NMSC Non-melanoma skin cancers
  • AML Acute myeloid leukemia
  • MDS Myelodysplastic syndromes
  • Cyclosporine (Sandimmune®, Neoral, Gengraf, SangCya) ii. azathioprin (Imuran) iii. steroids or prednisone (Deltasone, Kedral, Medrol, Orasone, Prelone, Sterapred DS)
  • cyclosporine A promotes carcinogenesis by TGF beta and VEGF, while mTOR inhibitors are antiproliferative.
  • Azathioprine photosensitizes to UVA and enables UVA to damage DNA directly.
  • hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineral corticoids ii. Congenital adrenal hyperplasia
  • Rheumatoid arthritis including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
  • Neoplastic Diseases For palliative management of:
  • Drug-induced secondary adrenocortical insufficiency may be
  • Vaginal candidiasis vaginal yeast infections due to Candida.
  • Anti-depressant Psychiatry, Obstetrics and Gynaecology, Family Practice, General Practice, Geriatric
  • SSRIs Selective serotonin reuptake inhibitors
  • fluoxetine hydrochloride PROZAC®
  • paroxetine Paxil
  • sertraline Zoloft
  • citalopram Celexa
  • fluvoxamine Livox
  • escitalopram Livox
  • Venlafaxine (Effexor), duloxetine (Cymbalta) 1 , Mirtazapine (Remeron) iii. Atypical antidepressants
  • nefazodone (Serzone), trazodone (Desyrel), and bupropion
  • TCAs Tricyclic antidepressants
  • LAMICTAL lamotrigine
  • RISPERDAL® can be administered once or twice daily. Initial dosing is generally 2 mg/day. Dose increases should then occur at intervals not less than 24 hours, in increments of 1-2 mg/day, as tolerated, to a recommended dose of 4-8 mg/day.
  • a potentially fatal symptom complex sometimes referred to as
  • NMS Neuroleptic Malignant Syndrome
  • MS Neuroleptic Malignant Syndrome
  • PROZAC® fluoxetine hydrochloride
  • LAMICTAL lamotrigine
  • AMRTX® cyclobenzaprine hydrochloride
  • AMRIX is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
  • Antiepileptic drugs including Neurontin, increase the risk of suicidal thoughts or behavior in patients
  • the levothyroxine sodium dose is generally adjusted in 12.5-25 meg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized
  • timing of daily dose is critical for efficacy
  • ACTOS® pioglitazone hydrochloride
  • LANTUS® insulin glargine [rDNA origin] injection
  • Micronase® (glyburide)
  • the usual maintenance dose is in the range of 1 ,25 to 20 mg daily, which may be given as a single dose or in divided doses. Dosage increases should be made in increments of no more than 2.5 mg at weekly intervals based upon the patient's blood glucose response.
  • Safety system and algorithm address when compliance pattern is
  • PRTNIVIL (Lisinopril), a synthetic peptide derivative, is an oral long- acting angiotensin converting enzyme inhibitor
  • VASOTEC® (enalapril maleate)
  • Lopressor® metoprolol tartrate
  • LANOXIN® digoxin
  • PRINIV1L (Lisinopril), a synthetic peptide derivative, is an oral long- acting angiotensin converting enzyme inhibitor
  • Lopressor® metoprolol tartrate
  • Apresazide Hydralazine HCI and hydrochlorothiazide
  • NORVASC® amlodipine besylate
  • KLOR-CON® potassium chloride
  • Benicar starting dose of Benicar is 20 mg once daily when used as monotherapy in patients who are not volume-contracted.
  • the dose of Benicar may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
  • NORVASC® amlodipine besylate
  • Gastrointestinal System Reactions hepatic encephalopathy in
  • Clonidine Withdrawal a. Sudden cessation of clonidine treatment has, in some cases,
  • Acute Myocardial infarction (Cardiovascular, Geriatric, General Practice, Family Practice)
  • PPJNIVIL® (lisinopril) a synthetic peptide derivative, is an oral long- acting angiotensin converting enzyme inhibitor
  • NORVASC® amlodipine besylate
  • PRINIVIL is indicated for the treatment of hemodynamically stable
  • Plavix (clopidogrel bisulfate)
  • iii COUMADIN® TABLETS (warfarin sodium)
  • thromboembolic events such as stroke or systemic embolization after myocardial infarction.
  • Treatment of each patient is a highly individualized matter.
  • COUMADIN Warfarin Sodium
  • index a narrow therapeutic range
  • Dosage should be controlled by periodic determinations of prothrombin time (PT)/International Normalized Ratio (1NR).
  • TTP Thrombotic thrombocytopenic purpura
  • Augmentin® (amoxicillin/clavulanate potassium)
  • Acute short course treatment of patients with mild to moderate infections ii. Acute bacterial exacerbations of chronic obstructive pulmonary disease iii. Acute bacterial sinusitis
  • Fluoroquinolones including LEVAQUIN®, are associated with an increased risk of tendonitis and tendon rupture
  • GLEEVEC imatinib mesylate
  • Tasigna® (nilotinib) 3. Other (CAPECITABINE, CYCLOPHOSPHAMIDE, ETOPOSIDE, IDARUBICIN, VIN ORELB INE)
  • GIST Gastrointestinal stromal tumor
  • ALL Acute Lymphoblastic Leukemia
  • MDS/MPD Myelodysplastic/Myeloproliferative Diseases
  • ASM Aggressive Systemic Mastocytosis
  • HES Hypereosinophilic Syndrome
  • EOS Chronic Eosinophilic
  • CEL Leukemia
  • GLEEVEC imatinib mesylate
  • nilotinib The bioavailability of nilotinib is increased with food. Tasigna should not be taken with food. No food should be taken at least 2 hours before and at least one hour after the dose is taken. Grapefruit products and other foods that are known to inhibit CYP3A4 should be avoided.
  • the risk factors for acquiring TB include close-contact situations, alcohol and IV drug abuse, and certain diseases (for example, diabetes, cancer, and HIV) and occupations (for example, health-care workers)).
  • Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal
  • CV cardiovascular
  • Geriatric Geriatric, Family Practice, General Practice,
  • Patient groups Heart failure, Syncope, Chronic seizures or epilepsy, Deiirium, Dementia and cognitive impairment, Parkinson's disease, Insomnia, Chronic constipation, Chronic kidney disease
  • Oral meds for obesity Orlistat (Xenical), Topiragen, diethylpropion, sibutramine, phendimetrazine
  • Alzheimer (Geriatric, Family Practice, Psychiatry)
  • the recommended starting dose of Namenda is 5 mg once daily.
  • the recommended target dose is 20 mg/day.
  • the dose should be increased in 5 mg increments to 10 mg/day (5 mg twice a day), 1 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice a day).
  • the minimum recommended interval between dose increases is one week. ii. Safety (system and algorithm address when compliance pattern is
  • Cardiovascular Conditions Because of their pharmacological action, cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes. This effect may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of ARICEPT®.
  • RTIs nucleoside reverse transcriptase inhibitors
  • NRTIs non-nucleoside reverse transcriptase inhibitors
  • Kaletra (lopinavir and ritonavir)
  • VYTORIN ezetimibe/simvastatin
  • PRAVACHOL® (pravastatin sodium)
  • x. AMRIX® cyclobenzaprine hydrochloride
  • SOMA carisoprodol
  • Gastroesophageal Reflux Disease GFD
  • Duodenal Ulcer H. Pylori
  • PREVACID lansoprazole
  • ADVAIR DISKUS 100/50 fluticasone propionate 100 meg and salmeterol 50 meg
  • Long-term control asthma medications include:
  • Corticosteroids The inhaled form is the anti-inflammatory drug of choice for persistent asthma.
  • Theophylline (a bronchodilator used along with an anti- inflammatory drug to prevent nighttime symptoms) 5.
  • Leukotriene modifiers an alternative to steroids and mast cell
  • Rhinitis and allergy Pulmonary, Pediatrics, Otorhinolaryngology, General Practice, Family Practice
  • ALLEGRA® farnesoidine hydrochloride
  • BPH prostrate
  • BPH benign prostatic hyperplasia
  • Indications i. Efficacy (system and algorithm address when compliance pattern is not adequate to maintain intended efficacy)
  • ADHD Psychiatry, Pediatrics, Family Practice, General Practice
  • CONCERTA® methylphenidate HC1
  • ADHD Attention Deficit Hyperactivity Disorder
  • Glaucoma d. Glaucoma
  • Overactive bladder (Urology, Nephrology, Family Practice, OB/GYN, Geriatric) a. Medications
  • Gout (Rheumatology, General Practice, Family Practice, Geriatric, Endocrine and Metabolism)
  • VIAGRA® sidenafil citrate
  • NAION Eye non-arteritic anterior ischemic optic neuropathy
  • Alfacalcidol 1-alpha-hydroxycholecalciferol, 1 alpha (OH)D3.
  • Calcitriol 1 ,25-DHCC, 1,25-dihydroxycholecalciferol, 1,25- dihydroxyvitamin D3, 1,25-diOHC, l,25(OH)2D3.
  • Cholecalciferol Activated 7-dehydrocholesterol, colecalciferol, Vitamin D3.
  • Ergocalciferol Activated ergosterol, Calciferol, Ergocalciferolum, Irradiated ergosterol, Viosterol, Vitamin D2.
  • CHANTIX 1 mg twice daily following a 1-week titration as follows:
  • Migraine (Neurology, Family Practice, General Practice, Psychiatry) a. Medications
  • ISMO isosorbide mononitrate

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Primary Health Care (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Data Mining & Analysis (AREA)
  • Databases & Information Systems (AREA)
  • Pathology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medical Treatment And Welfare Office Work (AREA)

Abstract

La présente invention concerne des procédés, des systèmes et un appareil de surveillance de données relatives à l'usage de médicaments pour un patient ou une population de patients, lesdites données pouvant être traitées pour déterminer des profils d'observance. Ces procédés et systèmes peuvent associer, analyser, organiser et présenter des données relatives à l'usage de médicaments, des profils d'observance, et des corrélations entre les données relatives aux profils d'observance et aux résultats cliniques pour une analyse électronique ou une analyse par le personnel soignant. Ces procédés, systèmes, et appareils permettent l'analyse des profils d'observance pour permettre, par exemple, d'établir ou d'ajuster des régimes thérapeutiques sûrs et efficaces, et peuvent comprendre des systèmes rétroactifs pour assurer l'authenticité des médicaments et/ou des effets des médicaments sur un patient.
PCT/US2013/033523 2012-03-22 2013-03-22 Procédés, systèmes, et appareil d'optimisation des effets d'un traitement médicamenteux en utilisant des profils d'observance médicamenteuse WO2013142801A2 (fr)

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US13/427,389 US20120203573A1 (en) 2010-09-22 2012-03-22 Methods, systems, and apparatus for optimizing effects of treatment with medication using medication compliance patterns
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014143805A1 (fr) * 2013-03-15 2014-09-18 I.D. Therapeutics Llc Appareil et procédés d'optimisation de traitement utilisant des schémas d'observance thérapeutique et capteur de glucose

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US20090134181A1 (en) * 2005-07-13 2009-05-28 Vitality, Inc. Medication dispenser with automatic refill
WO2007129318A2 (fr) * 2006-05-06 2007-11-15 Irody Inc Appareil et procede pour obtenir une identification de medicaments pour ameliorer la securite
CA3000256A1 (fr) * 2010-03-09 2011-09-15 Perceptimed, Inc. Dispositif d'authentification, procede d'authentification et programme
WO2012013723A1 (fr) * 2010-07-29 2012-02-02 Dsm Ip Assets B.V. Distributeur de produits pharmaceutiques
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014143805A1 (fr) * 2013-03-15 2014-09-18 I.D. Therapeutics Llc Appareil et procédés d'optimisation de traitement utilisant des schémas d'observance thérapeutique et capteur de glucose
US10572627B2 (en) 2013-03-15 2020-02-25 I.D. Therapeutics Llc Apparatus and method for optimizing treatment using medication compliance patterns and glucose sensor

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