Methods, systems, and apparatus for optimizing effects of treatment with medication using medication compliance patterns

Abstract

Methods, systems, and apparatus monitor medication usage data for one patient or a population of patients, which can be processed to determine compliance patterns. Such methods and systems can associate, analyze, organize and present medication usage data, compliance patterns, and correlations between compliance patterns and outcomes data for electronic analysis or analysis by a caretaker, Such methods, systems, and apparatus permit analysis of compliance patterns to enable, for example, establishment or adjustment of safe and effective treatment regimens, and may include feedback systems for ensuring authenticity of medication and/or effects of medication on a patient.

1 . A method of optimizing treatment of a medication recipient patient, comprising:
 providing the patient with a medication monitor capable of providing usage data regarding the patient's compliance with a medication treatment regimen;   collecting the usage data at a central server over a predetermined period of time;   determining the patient's pattern of compliance with the treatment regimen;   obtaining diagnostic test results from a biomarker device, the diagnostic test results being indicative of a response of the patient to the medication treatment regimen over the predetermined period of time;   correlating the patient's pattern of compliance with the diagnostic test results from the biomarker device; and   outputting at least one recommendation selected from the group consisting of:   replacing at least one medication used in the treatment regimen with at least one different medication, changing at least one dosage of at least one medication used in the treatment regimen, changing the timing of recommended usage of at least one medication in the treatment regimen, and not changing the treatment regimen.   
     
     
         2 . The method of  claim 1 , wherein the biomarker device is implanted in the patient so as to obtain the diagnostic test results, the biomarker device including a wireless transmitter that outputs the diagnostic test results. 
     
     
         3 . The method of  claim 2 , wherein the diagnostic test results relate to one or more of blood glucose levels and concentration of medication in the patient's bloodstream. 
     
     
         4 . The method of  claim 1 , wherein the biomarker device is a device that is external to the patient. 
     
     
         5 . The method of  claim 4 , wherein the biomarker device is one of a weight scale, a blood pressure monitor, a patch provided on skin of the patient, and a detection device that can be inserted into a mobile transmitter device. 
     
     
         6 . The method of  claim 1 , wherein the biomarker device communicates wirelessly to the medication monitor. 
     
     
         7 . The method of  claim 1 , wherein the diagnostic test results are provided to the central server. 
     
     
         8 . The method of  claim 6 , wherein the diagnostic test results are provided to the central server by the medication monitor. 
     
     
         9 . The method of  claim 1 , wherein the patient is a transplant recipient, and the medication comprises an immunosuppressant. 
     
     
         10 . The method of  claim 1 , wherein the patient is a heart treatment patient, and the medication comprises a diuretic. 
     
     
         11 . The method of  claim 1 , wherein the patient is a psychiatric patient, and the medication(s) comprises a psychiatric treatment medication(s). 
     
     
         12 . The method of  claim 1 , wherein the patient is a contraceptive recipient, and the medication comprises a contraceptive medication. 
     
     
         13 . The method of  claim 1 , wherein the patient is a Allergy & Immunology patient, and the medication(s) comprises a Allergy & Immunology treatment medication(s). 
     
     
         14 . The method of  claim 1 , wherein the patient is a Cardiovascular Disease patient, and the medication(s) comprises a Cardiovascular Disease treatment medication(s). 
     
     
         15 . The method of  claim 1 , wherein the patient is a Dermatology patient, and the medication(s) comprises a Dermatology treatment medication(s). 
     
     
         16 . The method of  claim 1 , wherein the patient is an Endocrine and Metabolism patient, and the medication(s) comprises an Endocrine and Metabolism treatment medication(s). 
     
     
         17 . The method of  claim 1 , wherein the patient is a Family Practice patient, and the medication(s) comprises a Family Practice treatment medication(s). 
     
     
         18 . The method of  claim 1 , wherein the patient is a Gastroenterology patient, and the medication(s) comprises a Gastroenterology treatment medication(s). 
     
     
         19 . The method of  claim 1 , wherein the patient is a General Practice patient, and the medication(s) comprises a General Practice medication(s). 
     
     
         20 . The method of  claim 1 , wherein the patient is a Geriatric Medicine patient, and the medication(s) comprises a Geriatric Medicine treatment medication(s). 
     
     
         21 . The method of  claim 1 , wherein the patient is an Obstetrics or Gynecology patient, and the medication(s) comprises an Obstetrics or Gynecology treatment medication(s). 
     
     
         22 . The method of  claim 1 , wherein the patient is a Hematology patient, and the medication(s) comprises a Hematology treatment medication(s). 
     
     
         23 . The method of  claim 1 , wherein the patient is an Infectious Disease patient, and the medication(s) comprises an Infectious Disease treatment medication(s). 
     
     
         24 . The method of  claim 1 , wherein the patient is an Internal Medicine patient, and the medication(s) comprises an Internal Medicine treatment medication(s). 
     
     
         25 . The method of  claim 1 , wherein the patient is a Nephrology patient, and the medication(s) comprises a Nephrology treatment medication(s). 
     
     
         26 . The method of  claim 1 , wherein the patient is a Neurology patient, and the medication(s) comprises a Neurology treatment medication(s). 
     
     
         27 . The method of  claim 1 , wherein the patient is an Oncology patient, and the medication(s) comprises an Oncology treatment medication(s). 
     
     
         28 . The method of  claim 1 , wherein the patient is a Surgery patient, and the medication(s) comprises a Surgery treatment medication(s). 
     
     
         29 . The method of  claim 1 , wherein the patient is a Otorhinolaryngology patient, and the medication(s) comprises a Otorhinolaryngology treatment medication(s). 
     
     
         30 . The method of  claim 1 , wherein the patient is a Pediatrics patient, and the medication(s) comprises a Pediatrics treatment medication(s). 
     
     
         31 . The method of  claim 1 , wherein the patient is a Preventative Medicine patient, and the medication(s) comprises a Preventative Medicine treatment medication(s). 
     
     
         32 . The method of  claim 1 , wherein the patient is a Pulmonary Disease patient, and the medication(s) comprises a Pulmonary Disease treatment medication(s). 
     
     
         33 . The method of  claim 1 , wherein the patient is a Rheumatology patient, and the medication(s) comprises a Rheumatology treatment medication(s). 
     
     
         34 . The method of  claim 1 , wherein the patient is a Sports Medicine patient, and the medication(s) comprises a Sports Medicine treatment medication(s). 
     
     
         35 . The method of  claim 1 , further comprising:
 correlating the patient's pattern of compliance and diagnostic test results with patterns of compliance and diagnostic test results from a population of patients; and   outputting the at least one recommendation based on both the patient's pattern of compliance and diagnostic test results and the patterns of compliance and diagnostic test results from the population of patients.   
     
     
         36 . The method of  claim 1 , wherein the treatment regimen is a standardized treatment regimen. 
     
     
         37 . The method of  claim 1 , wherein the treatment regimen is an individual patient treatment regimen. 
     
     
         38 . A medication monitor for storing medication or medication packaging and producing medication usage data, the medication monitor comprising:
 a housing body that includes a housing for containing medication or medication packaging, the housing body defining an opening to accommodate insertion and removal of medication or medication packaging;   a lid that slides or opens to removably cover the opening;   a medication sensor that is configured to sense identity of the medication;   a removal sensor that senses medication or medication packaging removal or device opening;   a processor that produces medication usage data based on the sensed removal; and   a communications port configured to communicate the medication usage data.   
     
     
         39 . The medication monitor of  claim 38 , wherein the medication sensor is configured to sense an indicium of origin of manufacture of the medication to verify authenticity of the medication. 
     
     
         40 . The medication monitor of  claim 39 , wherein the indicium of origin is provided by an information source associated with a pre-filled medication cartridge that is insertable into said opening. 
     
     
         41 . The medication monitor of  claim 40 , wherein the information source is at least one member selected from the group consisting of an RFID chip, a barcode, and a shape of the cartridge. 
     
     
         42 . The medication monitor of  claim 39 , wherein the information source is at least one member selected from the group consisting of size, shape and color of the medication. 
     
     
         43 . The medication monitor of  claim 40 , the housing body including a plurality of housings for containing a plurality of pre-filled medication cartridges. 
     
     
         44 . The medication monitor of  claim 43 , wherein a shape of each of the plurality of housings is configured to match a specific shape of each pre-filled medication insert. 
     
     
         45 . The medication monitor of  claim 38 , wherein the communications port is configured to wirelessly communicate the medication usage data. 
     
     
         46 . A system for optimizing effects of treatment with medication, the system comprising:
 a medication monitor configured to monitor medication usage and output medication usage data;   a biomarker device configured to detect and output medication treatment outcomes data; and   a data processor that processes the medication usage data and the medication treatment outcomes data to determine a medication regimen using statistical analysis.   
     
     
         47 . The system of  claim 46 , wherein the biomarker device is implantable in a patient so as to obtain the medication treatment outcomes data, and the biomarker device includes a wireless transmitter configured to output the medication treatment outcomes data for use by the data processor. 
     
     
         48 . The system of  claim 47 , wherein medication treatment outcomes data relate to at least one member selected from the group consisting of blood glucose levels and a concentration of medication in the patient's bloodstream. 
     
     
         49 . The system of  claim 46 , wherein the biomarker device is at least one of a weight scale, a blood pressure monitor, a patch configured to be provided on the skin of the patient, and a detection device that can be inserted into a mobile transmitter device to transmit the medication treatment outcomes data. 
     
     
         50 . The system of  claim 46 , wherein the biomarker device comprises a wireless transmitter configured to wirelessly output the medication treatment outcomes data to an external device. 
     
     
         51 . The system of  claim 50 , wherein the external device is the medication monitor. 
     
     
         52 . The system of  claim 50 , wherein the external device is the data processor. 
     
     
         53 . The system of  claim 46 , the medication monitor further comprising:
 a housing for containing a medication;   a sensor for sensing medication usage; and   a communications port for outputting the medication usage data based on the sensed medication usage.   
     
     
         54 . A method of establishing a regimen for treatment with medication, comprising establishing a treatment regimen using a processor, wherein the processor determines the treatment regimen based on a correlation of (a) a medication compliance pattern determined by performing statistical analysis on medication usage data and (b) outcomes data transmitted from at least one biomarker device. 
     
     
         55 . The method of  claim 54 , wherein the at least one biomarker device is implanted in at least one patient so as to obtain the outcomes data, the at least one biomarker device including a wireless transmitter that outputs the outcomes data. 
     
     
         56 . The method of  claim 54 , wherein the at least one biomarker device is provided in a monitor that is external to a patient. 
     
     
         57 . The method of  claim 56 , wherein the treatment regimen is established based on usage data from the monitor. 
     
     
         58 . The method of  claim 54 , wherein the compliance pattern and the outcomes data relate to a population of patients. 
     
     
         59 . The method of  claim 54 , wherein the compliance pattern and the outcomes data relate to an individual patient. 
     
     
         60 . The method of  claim 54 , wherein the medication usage data is from a patient or a first population of patients and the outcomes data is from the patient or a second population of patients. 
     
     
         61 . The method of  claim 60 , wherein the first population of patients is the same population as the second population of patients. 
     
     
         62 . The method of  claim 60 , wherein the first population of patients overlaps in part with the second population of patients.