WO2022131933A1 - Systèmes et méthodes pour fournir des recommandations relatives à des médicaments - Google Patents

Systèmes et méthodes pour fournir des recommandations relatives à des médicaments Download PDF

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Publication number
WO2022131933A1
WO2022131933A1 PCT/NZ2021/050220 NZ2021050220W WO2022131933A1 WO 2022131933 A1 WO2022131933 A1 WO 2022131933A1 NZ 2021050220 W NZ2021050220 W NZ 2021050220W WO 2022131933 A1 WO2022131933 A1 WO 2022131933A1
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patient
thc
information
medicine
cannabinoid
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PCT/NZ2021/050220
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English (en)
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Greg Charles Misson
Elizabeth Anne Plant
Shane RUTHERFURD
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Eqalis Group New Zealand Limited
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Publication of WO2022131933A1 publication Critical patent/WO2022131933A1/fr

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    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6813—Hybridisation assays
    • C12Q1/6827—Hybridisation assays for detection of mutation or polymorphism
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • 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
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • 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
    • 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
    • G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment
    • 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
    • G16H50/70—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other 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
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/40—ICT specially adapted for the handling or processing of medical references relating to drugs, e.g. their side effects or intended usage
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/106—Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/156—Polymorphic or mutational markers

Definitions

  • the present technology relates to systems and methods of providing medicine recommendations.
  • the technology may find particular application in providing recommendations for cannabis-based, or cannabinoid containing medicine prescriptions based on biological, pharmacogenetic and/or pharmacokinetic data. However, this should not be seen as limiting on the technology.
  • a medicine is to aid in the treatment of a medical condition, or the symptoms of the medical condition.
  • individual pharmacokinetics, therapeutic efficacy, potential side-effects and the severity of the side-effects vary across a population.
  • a medication may be suitable for use by an individual with an existing condition such as asthma, however when combined with other factors such as age, weight and ethnicity the likelihood of developing negative side-effects may increase significantly.
  • multiple medications can interact with one another e.g. affect metabolism, therapeutic efficacy and negative sideeffects. Requiring a doctor or prescribing physician to consider these factors can cause a paralysing effect where there is simply too much information to process.
  • a large number of contraindications or potential drug interactions may be flagged which can cause "alert fatigue", further affecting their ability to provide the best recommendations.
  • systems and methods for providing medicine recommendations based on at least one of biological, pharmacokinetic and pharmacogenetic data are provided.
  • systems and methods for providing medicine recommendations comprise: a list of formulations, said formulations comprising a first medicine containing a first active compound and a second medicine containing a second active compound, wherein the formulations of the first medicine include a first formulation having a first concentration of the first active compound and a second formulation having a second concentration of the first active compound, and further wherein the formulations of the second medicine include a third formulation having a first concentration of the second active compound and a fourth formulation having a second concentration of the second active compound, and wherein the systems and method provide a medicine recommendation which contains both of: one of the first formulation and the second formulation, and one of the third formulation and the fourth formulation.
  • a method of recommending a cannabinoid containing medicine to administer to a patient comprising the steps of: A) testing at least one genetic sample from the patient to determine the presence or absence of at least one single nucleotide polymorphism (SNP) associated with a risk factor for administration of a cannabinoid;
  • SNP single nucleotide polymorphism
  • a system configured to provide a recommendation on a cannabinoid containing medicine to administer to a patient
  • the system comprising: an input system for receiving at least one piece of genetic information, wherein the at least one piece of genetic information includes at least one single nucleotide polymorphism (SNP) associated with a risk factor for administration of a cannabinoid, and the patient's likely metabolism rate of at least one cannabinoid; and a processing system that is configured to provide an output indicative of a medicine recommendation for the patient based on the patient information.
  • SNP single nucleotide polymorphism
  • a system to generate prescriptions for administration of cannabinoid containing medicine to a patient comprising: an input system configured to receive patient information, wherein the patient information comprises patient metabolism information and patient risk information, a processing system configured to generate a medicine recommendation using the patient metabolism information in combination with the patient risk information, and an output system configured to generate a prescription containing a recomendation for a cannabinoid containing medicine to administer to the patient.
  • a device configured to generate prescriptions for administration of cannabinoid containing medicines to a patient
  • the device comprising: an input system configured to receive patient information, wherein the patient information comprises patient metabolism information and patient risk information, a processing system configured to generate a medicine recommendation using the patient information, and an output system configured to generate a prescription containing the medicine recommendation based on the patient metabolism information and the patient risk information.
  • a system to generate a recommendation for a cannabinoid containing medicine for administration to a patient comprising: an input system configured to receive patient information, a processing system configured to generate a recommendation for the cannabinoid containing medicine using the patient information, and an output system configured to generate a prescription containing the medicine recommendation based on the patient information.
  • a method of providing a recommendation for a cannabinoid containing medicine to administer to a patient comprising the steps of:
  • a system for providing a dosage recommendation for a cannabinoid containing medicine to administer to a patient comprising: an input system configured to receive patient information comprising physiological and genetic information; a processing system configured to generate a dosage recommendation for a cannabinoid containing medicine using at least one dosage factor and the patient information; and an output system configured to provide an output representing the dosage recommendation.
  • a device for providing a dosage recommendation for a cannabinoid containing medicine for administration to a patient comprising: an input system configured to receive patient information comprising physiological and genetic information; a processing system configured to generate a dosage recommendation for a medicine using at least one dosage factor and the patient information;
  • the present specification describes technology relating to medicines.
  • One application for the technology is cannabinoid containing medicines and reference will be made herein as such. However this should not be seen as limiting on the technology and other medicines as envisaged as being suitable for use with the present technology.
  • the cannabinoids include CBD and THC, CBC, CBG, CBDV, THCV, THC delta 8, THC delta 9, cannabinoid acids (CBDA, THCA) varin analgoues, endogenous counterparts and pharmaceutical equivalents e.g. synthetic cannabinoids.
  • CBDA cannabinoid acids
  • THCV cannabinoid acids
  • the disclosure herein may be inclusive, e.g. the cannabinoids include analogues and other compounds having the same or substantially similar metabolic pathways and biochemical actions.
  • CBD and CBDV and to the extent that CBDV has substantially the same biochemical action for treatment of a given treatment of a condition as CBD then CBDV will also be considered within the scope of the present technology.
  • the present technology may find application with any medicinalnce e.g. varin analogues, endogenous counterparts and pharmaceutical equivalents irrespective of whether the analoges have the same or substantially similar biochemical pathway to the compounds and single nucleotide polymorphisms (SNPs) described herein.
  • the foregoing statements refer to systems, methods and devices which use one or more single nucleotide polymorphisms (SNPs) which are associated with metabolism or a risk factor.
  • SNPs single nucleotide polymorphisms
  • the inventors envisage that in some embodiments of the technology, the systems, devices and methods described herein may be implemented using a subset of, i.e. only one of, the described SNPs.
  • these recommendations may be provided based on THC metabolism and possible psychosis risk alone, without considering CBD metabolism or possible neurocognitive impairment risk.
  • any combination of SNPs may be used without departing from the scope of the present technology.
  • reference to genetic information including at least one SNP should be understood to include information about the absence of the relevant SNPs.
  • the patient metabolism information inludes an assessment of at least one single nucleotide polymorphism (SNP) associated with metabolism of at least one active ingredient of a medicine.
  • SNP single nucleotide polymorphism
  • the SNP may be associated with the patient's metabolism rate of at least one of cannabinoid compound.
  • the patient metabolism information may include the patient's likely rate of metabolism of at least one of cannabidiol (CBD), CBDV and tetrahydrocannabinol (THC), THCV, THC delta 8, THC delta 9 or varin analogues thereof.
  • CBD cannabidiol
  • THC tetrahydrocannabinol
  • the patient risk information may include an assessment of at least one single nucleotide polymorphism SNP associated with the patient's possible psychosis risk.
  • SNP single nucleotide polymorphism
  • the possible psychosis risk may be due to administration of at least one of tetrahydrocannabinol THC, THCV, THC delta 8, THC delta 9 or varin analogues thereof.
  • the patient risk information may include an assessment of at least one single nucleotide polymorphism SNP associated with the patient's neurocognitive impairment risk.
  • the neurocognitive impairment risk may be due to administration of at least one of tetrahydrocannabinol (THC), THCV, THC delta 8, THC delta 9 or varin analogues thereof.
  • the patient risk information may include an assessment of at least one single nucleotide polymorphism (SNP) associated with the patient's potential addiction risk.
  • SNP single nucleotide polymorphism
  • the potential addiction risk may be due to administration of a compound e.g. a cannabinoid compound.
  • the present technology can use an assessment of single nucleotide polymorphism(s) to make decisions about patient medication recommendations.
  • Reference herein will therefore be made to the assessment of a single nucleotide polymorphism(s) in specific genes.
  • This assessment preferably involves determining the presence or absence of a SNP in a specific gene(s) - which is / are a pharmacogenetic indication of a patient's likely response to administration of a compound or active ingredient e.g. a cannabinoid.
  • the single nucleotide polymorphism(s) indicative of possible psychosis risk may be present in at least the patient's AKT1 gene.
  • the SNP may include any one or more of rsll30233 and rs2494732.
  • Other SNPs associated with psychosis risk may be known to those skilled in the art.
  • the SNP indicative of possible psychosis risk may be present in the COMT gene.
  • the single nucleotide polymorphism(s) indicative of metabolism rates, particularly for CBD and/or THC metabolism may be present in at least one of the patient's CYP2C9, CYP2C19, 2D6 and 3A4 genes.
  • the SNPs indicative of the patient's likely rate of metabolism of CBD are present in the CYP2C19, 2D6 or 3A4 genes, and the SNPs indicative of the patient's likely rate of metabolism of THC are present in the CYP2C9 gene.
  • the single nucleotide polymorphism(s) indicative of neurocognitive impairment may be present in at least one of the catechol-O-methyltransferase (COMT) genes.
  • the SNP may be rs4680 or any other SNP known to those skilled in the art.
  • the recommendations described herein may be based on full or partial genome mapping, including determining the presence or absence of single nucleotide polymorphisms in genes other than the CYP2C9, CPY2C19, AKT1 and COMT genes.
  • the single nucleotide polymorphism(s) indicative of addiction risk may be present in any gene that provides an indication of addiction risk.
  • the SNP may be present in at least the FAAH C385A gene.
  • the genetic sample(s) may consist of a saliva or blood sample.
  • a saliva or blood sample may be used.
  • other forms of genetic samples suitable for use with the present technology include blood, tissue, hair or amniotic fluid may be used.
  • genomic information regarding the presence and nature of any single nucleotide polymorphisms may be available and provided without requiring further testing.
  • the physiological information may comprise information relating to the patient's body and can include at least one of weight, age, renal function, hepatic function, and medical conditions.
  • the physiological information may also include other information e.g. medication already being taken.
  • the present technology may be configured to consider pathways for drug interactions to determine a dosage recommendation.
  • the dosage recommendations may consist of a starting dose and incremental step up to a maximum daily dose.
  • the dosage recommendation may consist of a set daily dose.
  • the first concentration of the first active compound may be different to the second concentration of the first active compound.
  • the first formulation may have a higher concentration of the first active compound than the second concentration or vice versa.
  • the first concentration of the second active compound may be different to the second concentration of the second active compound.
  • the input system comprises an electronic device.
  • the electronic device may include a smartphone, tablet, laptop, desktop or personal computer.
  • the input system may comprise at least one input device.
  • the input device may be a keyboard, touch-screen interface, touchpad or computer mouse.
  • the processing system may comprise a local application.
  • the local application may include machine readable code configured to be executed on a processor in an electronic device.
  • the processing system may further comprise at least one remote application configured to provide the medicine recommendations.
  • the remote application may be a cloud or web-based application.
  • the recommendation may comprise information about a / the medicine to be prescribed to the patient.
  • the recommendation may comprise a daily dosage of less than or equal to lmg of cannabinoids identified as producing psychotropic effects such as tetrahydrocannabinol (THC) or tetrahydrocannabivarin (THCV).
  • THC tetrahydrocannabinol
  • THCV tetrahydrocannabivarin
  • the candidate's risk of neurocognitive impairment may also be assessed, and the recommendation may comprise a non-zero daily dose of cannabinoids identified as producing psychotropic effects such as tetrahydrocannabinol (THC) or tetrahydrocannabivarin (THCV) or any formula containing other cannabinoids with psychotropic effects.
  • the non-zero daily dose may be determined to be one which is likely to have a low-risk of causing neurocognitive impairment.
  • the recommendation may comprise a cannabinoid containing composition containing substantially no cannabinoid having a psychotropic effect such as tetrahydrocannabinol (THC), cannabidol (CBN), THCV, THC delta 8, THC delta 9 or any formula containing other cannabinoids with psychotropic effects or varin analogues thereof.
  • THC tetrahydrocannabinol
  • CBN cannabidol
  • THCV tetrahydrocannabinol
  • THC delta 8 cannabidol
  • THC delta 9 any formula containing other cannabinoids with psychotropic effects or varin analogues thereof.
  • the dosage recommendation may be dependent on the patient's likely rate of metabolism of at least one active ingredient, such as a cannabinoid compound e.g. CBD and THC.
  • a cannabinoid compound e.g. CBD and THC.
  • the recommendation may comprise a prescription based on the indicated suitability for a cannabinoid containing medicine(s).
  • the graphical user interface may be provided on an electronic display.
  • the system may include at least one application programming interface (API) for receiving one or more pieces of information.
  • API application programming interface
  • the API may be configured to allow the system to receive patient information including genetic information.
  • the output system may comprise a display for presenting the recommendation.
  • the output system may comprise a printer for providing a printed prescription or electronic prescription.
  • the machine learning algorithm may comprise at least one neural network.
  • the systems, devices and methods according to the present technology may be configured to create or collect patient records and/or population data.
  • the patient records and/or population data may be used by the machine learning algorithms to improve the recommendations provided by the processing system.
  • the patient records and/or population data may be used to provide an improved medicine recommendation to a specific patient based only on that patient's patient record.
  • the dosage factors may include dosage factors for one or more of:
  • Organ function (such as kidney, or liver function, particularly relating to liver disease);
  • Fig. 1 shows a block diagram overview of a system according to the present technology.
  • Fig. 2 shows exemplary input systems according to the present technology.
  • Fig. 3 shows a flow diagram for validating patient credentials and obtaining medical information in accordance with the present technology.
  • Fig. 4a shows a device according to the present technology comprising a local application.
  • Fig. 4b shows a device configured to communicate with a remote application.
  • Fig. 4c shows a device comprising a local application configured to communicate with a remote application.
  • Fig. 5 shows a block diagram illustrating processing information structures according to the present technology.
  • Fig. 6 shows an exemplary user interface for a feedback system according to the present technology.
  • Fig. 7a shows an exemplary user interface for entering patient information in accordance with the present technology.
  • Fig. 7b shows a further exemplary user interface in accordance with Fig 7a.
  • Fig. 7c shows a further exemplary user interface in accordance with Fig 7a.
  • Fig. 7d shows a further exemplary user interface in accordance with Fig 7a.
  • Fig. 7e shows a further exemplary user interface in accordance with Fig 7a.
  • Fig. 8 shows a flow diagram for determining relative THC and CBD concentrations based on analysing single nucleotide polymorphisms in accordance with the present technology.
  • Fig. 1 is a flow chart which provides a high-level overview of a first embodiment of a system 100 for providing medicine recommendations according to the present technology.
  • the system 100 comprises an input system 102 configured to receive clinical information about a patient ("patient information").
  • patient information may include:
  • Organ function (such as kidney, or liver function-particularily liver disease)
  • Medical history e.g. one or more of diagnosis of schizophrenia, pyschoses, bipolar, suicide ideation or attempts, and diagnosis of Cannabis Use Disorder
  • One or more genetic markers indicating the patient likely response to a medicine e.g. one or more specific pharmacogenetic genotypes.
  • the input system 102 is configured to provide the patient information to a processing system 104.
  • the processing system 104 generates medicine recommendations based at least partially on the patient information.
  • Various processing systems 104 are described herein, and it should be appreciated that any one or more of the processing systems 104 described may be used in the examples provided.
  • the recommendation(s) generated by the processing system 104 are then provided to an output system 106.
  • the output system 106 is configured to output the recommendation(s) for medicines to be prescribed to the patient(s) to which the patient information relates.
  • the present technology could be used to provide a recommendation for a cannabinoid containing medicine which is likely to have positive therapeutic benefits, with a low-chance of negative side effects.
  • the output system 106 may be configured to provide the recommendation(s) to the physician who can review the recommendations and make a final decision of prescribing the medicine(s) to the patient.
  • the output system 106 may be configured to do at least one of the following: present the recommendations on an electronic device (such as a display), print the recommendations via a printer, send the recommendations to the physicians practise management system (PMS), or automatically generate a prescription for the medication (for example by interfacing with an electronic prescription system (EPS)).
  • PMS physicians practise management system
  • EPS electronic prescription system
  • the output system 106 may provide the recommendation(s) directly to the patient via an electronic device such as a display, via an email, or as printed information via a printer.
  • the system 100 may further comprise a feedback system 108.
  • the feedback system 108 is configured to enable data from one or more sources to be fed back into the input system 102.
  • the feedback system 108 may receive feedback from the patient.
  • This feedback may consist of subjective feedback such as feedback from the patient as to the therapeutic response or perceived efficacy of the medication due to their symptom control, or the presence and severity of any side-effects experienced. It is possible that the feedback may be provided using a known validated tool for assessing therapeutic effect as should be known to one skilled in the art e.g. available at https://www.practicalpain anagernent.com/sites/default/files/pain scales table.pdf.
  • the feedback may also comprise objective feedback such as clinical information on drug concentrations in the patient's body. It is also envisaged that the feedback may be provided by a clinician assessing efficacy of the medicinalation.
  • the patient may be tested to determine the drug concentrations present in the patient's system.
  • the patient's blood plasma may be tested to determine drug concentrations.
  • the patient's blood may be tested to determine CBD and or THC concentrations in blood plasma.
  • the patient's information can then be updated in the input system 102 and new recommendations generated by the processing system 104. For example, if testing shows a high drug concentration (such as CBD or THC concentration) in blood plasma (considering peak and trough levels), the processing system 104 may generate a medicine recommendation with a lower dose of the active ingredient (such as CBD or THC), or alternatively a lower dose of the same medication previously recommended.
  • the feedback information may be linked to the clinical information provided to the input system 102 and the recommended medication.
  • This allows the processing system 104 to create a population model linking clinical information feedback such as therapeutic efficacy, side effects experienced, metabolism rates (i.e. what drug concentrations remain in the patient's system after use) based on patient compliance with a prescription recommendation, therefore, the medicine recommendations provided by the present technology may be improved over time.
  • Yet a further advantage of the present technology is that it may assist development of formulations to better treat medical conditions or adapt to meet patient specific clinical requirements, or assist in meeting regulatory requriements by providing proof of efficacy.
  • FIG. 2 shows a representative input system 102 with multiple input devices configured to provide patient information and/or feedback information to the processing system 104.
  • the input system 102 is provided with one or more electronic devices such as smartphones
  • data can be input to an electronic device 110 using a touch-screen interface 112, keyboard 114, or pointing device 116 (such as a mouse or joystick).
  • a touch-screen interface 112 keyboard 114, or pointing device 116 (such as a mouse or joystick).
  • the input systems 102 may also be used to enter the feedback information to the feedback system 108.
  • a survey, questionnaire, or internationally recognised measurement tool (such as quality of life or pain scoring) may be presented to a patient via an electronic device 110a, b and / or c.
  • the electronic device 110a, b and / or c which is used to enter the feedback information may be different to the electronic device 110a, b and / or c which was used to input the clinical information about the patient.
  • clinical information may be entered into an electronic device 110 at a physician's office. Following a period of treatment, the patient may be emailed a feedback form which they can complete remotely, such as on their personal electronic devices 110a, b and / or c at home.
  • the input systems 102 described herein may comprise a User Interface (Ul) configured to prompt the patient to enter specific information. Examples of a suitable Ul is illustrated in Figs. 7a to 7e which are discussed in detail below.
  • Ul User Interface
  • the input system 102 is configured to receive clinical information which relates to the person seeking medicine recommendations. This clinical information may include medical history, biological, pharmacokinetic and/or pharmacogenetic information as described herein. In examples, the input system 102 may also be configured to receive information about the symptoms which the person is looking to treat. For example, the symptoms may include pain, anxiety, and depression. In examples the input system 102 may also be configured to receive information relating to the cause of the condition. For example, the information may contain information about a dislocated joint, hernia, or broken limb.
  • references herein to entering patient data may include someone acting on the patient's behalf.
  • a doctor, physician, nurse, or caregiver may in some examples enter the clinical information and/or feedback on the patient's behalf.
  • the electronic devices 110 may be configured to connect to a removable storage 118 device such as a USB mass storage device or compact disk (CD) in order to retrieve patient information.
  • a removable storage 118 device such as a USB mass storage device or compact disk (CD)
  • genome sequence information or medical history information may be provided on a removable storage device 118.
  • Other examples of retrieving patient information include via wired or wireless transmissions, such as ethernet, WiFi, Bluetooth or NFC.
  • the input system may also be configured to receive information from a network or cloud-based data storage 120.
  • a method for obtaining medical information is illustrated in Fig. 3.
  • the patient is prompted to provide identifying credentials. This could include a unique identifier, such as a National Health Index (NHI) number, an Accident Compensation Corporation (ACC) claim number, an individual healthcare identifier (IHI), Medicare number, or any other form of unique identifier.
  • a unique identifier such as a National Health Index (NHI) number, an Accident Compensation Corporation (ACC) claim number, an individual healthcare identifier (IHI), Medicare number, or any other form of unique identifier.
  • the patient is also prompted to provide their name, and date of birth, in order to confirm that the unique identifier is for the correct person.
  • identifying credentials are then validated against one or more databases such as a patient information database or practice management database. Providing that the credentials are valid, the system may obtain medical history about the patient including medical history, biological, pharmacokinetic and/or pharmacogenetic information.
  • the system 100 may comprise its own database of patient information, and the patient may provide sufficient identifying credentials, such as log-in information in order to access any previously saved information.
  • the processing system 104 is configured to provide recommendations on the best medicine to prescribe a patient, based at least partially on the information provided by the input system 102.
  • Dosing factors which can be used to determine whether the patient should be recommended a higher or lower dose of medication based on the information provided by the input system 102;
  • the processing system 104 comprises at least one processor, and a computer readable storage medium having computer readable program code which is executable by the at least one processor, the computer readable program code being configured to provide medicine recommendations as described herein. 6.3.1. APPLICATION ARCHITECTURE
  • FIG. 4a shows an example of the technology in which an electronic device 400 is configured to facilitate use of the technology by a patient.
  • the electronic device illustrated is a smartphone, however this should not be seen as limiting on the technology.
  • the electronic device 400 comprises an input system 102 configured to receive patient information. In use this would be provided by a touch screen interface or a connected peripheral such as a keyboard or mouse.
  • the patient information is provided to the processing system 104, which in this example comprises a local application 402 installed on the electronic device 400.
  • the local application 402 includes machine readable instructions which are configured to be executed on a processing unit (such as a Central Processing Unit (CPU) or Graphics Processing Unit (GPU)) within the electronic device 400.
  • the local application 402 processes the information provided by the input system 102 in order to provide medicine recommendations to the output system 106.
  • the output system 106 in this example is the display 404 of the electronic device. However, this should not be seen as limiting on the technology, and the recommendations may instead be sent to another device such as a printer, or a web server.
  • the electronic device 400 may be configured to communicate the recommendations via a wireless network connection such as cellular data or WiFi. Where cellular data or WiFi networks are unavailable, the electronic device 400 may be configured to store this information and transmit it once a suitable network connection has been re-established.
  • a wireless network connection such as cellular data or WiFi.
  • One advantage of using local applications 402 is the ability to provide medicine recommendations in areas having poor network coverage, such as in disaster relief regions.
  • the electronic device 400 includes the same input system 102 and output systems 106 as previously described.
  • the processing system 104 comprises a remote application 406 which is external to the electronic device 400.
  • the remote application 406 may be a web or cloud-based application.
  • the electronic device 400 is configured to communicate with the remote application using a web-browser 408 on the electronic device 400.
  • One advantage of using a remote application 406 is the ability to utilise remote processing power. Remotely processing the information can allow for faster results (particularly on slower devices) and reduced power consumption (particularly on battery powered devices).
  • the processing system 104 comprises a combination of local application(s) 402 and remote application(s) 406.
  • a local application 402 may facilitate the entry of some clinical information, and in some examples perform some processing of the information provided.
  • the local application 402 may calculate a Body Mass Index (BMI) based on height and weight data provided by the input system 102.
  • BMI Body Mass Index
  • the local application 402 may also provide a secure means for transmitting the patient information to the remote application 406.
  • the local application 402 may encrypt the information communicated to the remote application 406.
  • the local application 402 may be configured to communicate with the remote application 406 via one or more Application Programming Interfaces (API), a web browser, or using a file transfer methods such as a File Transfer Protocol (FTP) or SSH File Transfer Protocol (SFTP).
  • API Application Programming Interfaces
  • FTP File Transfer Protocol
  • SFTP SSH File Transfer Protocol
  • the processing system 104 includes one or more of the following sets of processing information 500 as illustrated in Fig. 5:
  • Medication coding data such as ULM (Universal medicines List) coding or equivalent SNOWMED compatible coding.
  • price and availability information 504 may not be available or used.
  • recommendations may be provided based on the best available medicine, irrespective of the price or availability of the medication.
  • the processing system 104 may provide a plurality of recommendations, and the patient or physician may select the appropriate medication based on the availability and/or price of the medication in the patient's local area.
  • the medication information 502 may include: The concentrations of active ingredients in the medication.
  • concentrations of active ingredients in the medication for example, for cannabis-based medications this may include the tetrahydrocannabinol (THC) and Cannabidiol (CBD) concentrations.
  • THC tetrahydrocannabinol
  • CBD Cannabidiol
  • the medicine may be intended for treatment of chronic pain, seizures, spasticity, nausea, headaches or inflammation.
  • Forms the medication is available in. For example, as a spray, tablet, oil, or as organic material.
  • any contraindications For example, a list of medicines which should not be used in combination with the medication, or a subset of the population for whom the medication is not suitable i.e. those who are pregnant/breastfeeding, history of psychosis, or have a serious heart condition, or liver disease.
  • the pricing and availability information 504 may include:
  • the dosage factor information 506 may include information relevant to the recommended dosages and concentrations of active ingredients recommended.
  • the dosage factor information 506 may include:
  • Age factors For example, containing preparations containing only CBD may be recommended for females under the age of 20 and for males under the age of 25.
  • Sex factors For example, a lower dose may be recommended for men or women.
  • Organ function For example, those with reduced kidney or liver function may require a lower dose.
  • Factors relating to other medications For example, a reduced or increased dosage may be required if the patient is currently a medication with a similar active ingredient.
  • a reduced or increased dosage may be required if the patient is currently a medication with a similar active ingredient.
  • there are known interactions between different drugs which need to be considered such as CBD reducing the metabolism rate of drugs such as clobazam resulting in high levels, and THC and CBD increasing the levels of warfarin).
  • Genotype factors For example, whether their genetic profile indicates that they may have a possible psychosis or impairment risk from THC containing medications or that due to slow metabolism rates they may need a dose reduction.
  • An incremental dosing regimen (This may be comprised of a starting dose and incremental step up to a maximum daily dose.
  • the system may enable a prescribing physician to override a recommendation due to clinical needs. This may be particularly useful in situations where a cost benefit assessment or clinical risk assessment suggests that the risk of potential adverse side affects are outweighed by the benefits e.g. in prescribing medicines containing THC for pain relief in males under 25 years and females under 20 years, or in treating autism and behavioural issues in children.
  • One advantage of the systems and methods described herein is the ability for the processing information 500 to be easily updated and maintained. For example, as new medicines are approved, the processing information 500 relating to these medicines can be added to the processing system 104 to improve the recommendations provided. In other examples, the processing system 104 may be updated based on feedback from the patient.
  • the remote application 406 may contain the master copy of the processing information 500.
  • the processing information 500 can be centrally managed. For example, a person or team of people may be tasked with manually updating the processing information 500 described herein as new information is made available.
  • processing information 500 may be automatically updated as information becomes available.
  • medication information 502 may be extracted from one or more publicly available registers (such as a universal list of medicines) using techniques known in the art such as API's, importing data structures such as database files, or by scraping content from one or more websites.
  • Similar techniques may be employed to update information relating to the price and availability information 504 as well as publicly known or published dosage factor information 506.
  • the dosage factor information 506 may be updated based on feedback provided by the feedback system 108. Accordingly, the dosage factor information 506 of the present technology may be more accurate than existing systems as it may be tailored to specific patient information such as medical history, biological, pharmacokinetic and/or pharmacogenetic information.
  • the factors relating to other medicines may be obtained by interfacing with an external reference resource such as "Stockley's Drug Interactions", British National Formulary (BNF), or New Zealand National Formulary (NZF) via means known to those in the art such as using one or more APIs.
  • an external reference resource such as "Stockley's Drug Interactions", British National Formulary (BNF), or New Zealand National Formulary (NZF)
  • BNF British National Formulary
  • NZF New Zealand National Formulary
  • processing information 500 may be updated by an artificial intelligence system as described herein.
  • the medication information 502, price and availability information 504 and/or the dosage factor information 506 may be updated using an artificial intelligence system such as machine learning. 6.3.4. PATIENT INFORMATION
  • the systems and methods described herein may be configured to generate, collect and / or store patient records.
  • the patient records may contain one or more of the following:
  • the patient records may be linked to specific patient log-in credentials, so that a patient can access their patient record at a later stage. For example, when providing feedback to the feedback system 108.
  • the patient may be automatically linked to their patient record when providing feedback information. For example, a patient may be asked to follow a link or URL to access a survey or questionnaire. The link or URL may contain sufficient identifying information to link the patient's feedback to their patient record.
  • a new patient record is generated.
  • the systems described herein may communicate with an external database, such as a practise management system (PMS).
  • PMS practise management system
  • the patient record (or a subset of information from the patient record) may be shared with the PMS in order to ensure that the PMS system is up-to-date.
  • Methods of communicating information between databases should be well known to those skilled in the art. For example using API's, web interfaces, importing files, or using file transfer methods.
  • the output system may include an electronic display, or printer.
  • the output system 106 may be configured to generate a file, such as an email or text document.
  • the output system 106 may be configured to generate a prescription for one or more of the recommended medications.
  • a prescription for one or more of the recommended medications For example, an electronic or paperbased prescription may be generated.
  • the prescription may be automatically generated as the recommendation is generated. In other examples the prescription may require input by a prescribing physician.
  • the output system 106 may be configured to interface with a medical centre's practice management software (PMS).
  • PMS medical centre's practice management software
  • the recommendation may be transferred to a PMS so that the medical centre has an automated record of the recommendation, as well as details of the prescription information (if applicable).
  • the prescription may be generated by the New Zealand electronic prescription service through an API to the dosing system.
  • One advantage of the present technology is the ability to update the processing system 104 to improve recommendations over time.
  • One method of achieving this is using the feedback system 108.
  • the feedback system 108 comprises questionnaire or survey-based feedback 600 as shown in Fig. 6.
  • a patient is prompted to provide identifying credentials, such as their name and a unique identifier e.g. a national health index number. These credentials are used to link the feedback to the patient information.
  • the feedback system 108 may automatically link the feedback to the medications that the patient is taking.
  • the patient may be prompted to enter information about the medication they are taking, and the dosages thereof. This may be particularly beneficial if the patient is taking a higher or lower dose than originally prescribed.
  • the patient is then prompted to provide feedback as to the therapeutic efficacy of the medication.
  • the medication was prescribed for treatment of pain, and accordingly the patient is prompted to provide feedback as to how well managed the pain systems are post-treatment.
  • the feedback system may populate a field which shows the patient how they rated their symptoms (pain in this case) prior to starting the treatment (for example using a validated pain score measurement tool).
  • the patient can then provide direct feedback as to whether the prescribed treatment has been effective, and quantify how effective the treatment has been.
  • the patient is also prompted to provide feedback as to whether they have experienced any side-effects while taking the medication, and if so, the severity of the side effects.
  • the feedback is then provided to the processing system 104 which records the feedback against the specific patient's clinical information, for example the feedback may be used to update a patient record as described herein. In this way, if another patient presents with similar patient information in the future, the processing system 104 can then tailor the recommendation based on whether the treatment was successful for similar candidates in the past.
  • the survey-based feedback system illustrated in Fig. 6 is shown on an electronic device, this should in no way been seen as limiting on the technology, and in other examples, the feedback may be obtained via a phone call, or by completing a paper questionnaire.
  • One advantage of the present technology is the ability to provide an improved medicine recommendation system for medicines containing cannabinoids. Note that these medicines may be referred to as cannabis-based medicines.
  • tests which can be used to provide additional information to a feedback system 108 in accordance with the present technology.
  • tests are available for determining concentrations of CBD and THC within a patient's body, such as blood plasma testing. Accordingly, dosage recommendations can be optimised by using pharmacogenetic information, and these recommendations can be optimised by subsequently testing for latent drug concentrations post-treatment.
  • SNPs single nucleotide polymorphisms
  • the present specification describes embodiments of the technology with reference to SNPs associated with metabolism, neurocognitive impairment, and psychosis risk for cannabinoid containing medicines, this should not be seen as limiting on the technology.
  • SNPs in the VKORC1, CYP3A4, CYP1A2 and CYP2C9 genes are known to affect the patient's response to the anticoagulant drug warfarin. Accordingly, the technologies described herein may be applied to any combinations of genetic and clinical information in order to provide improved medicine recommendations.
  • specific SNPs can be used to provide recommendations based on the patient's likely rate of metabolism of THC and CBD.
  • specific SNPs can be used to determine likely risk factors for psychosis and neurocognitive impairment which can improve medicine prescriptions, by reducing the likelihood or severity of related negative sideeffects.
  • CYP2C9 gene can be used to predict a patient's likely rate of metabolism of THC
  • CYP2C19 gene can be used to predict a patient's likely rate of metabolism of CBD
  • AKT1 gene can be used to predict a patient's likely psychosis risk as a result of consuming THC
  • COMT gene can be used to predict a patient's like chance of neurocognitive impairment as a result of consuming THC.
  • any one or more of the following CYP2C19 SNPs may have a negative effect on cannabinoid metabolism: rs4244285, rs4986893, rs28399504, rs56337013, rs72552267, rs72558186, rs41291556, rsl7884712, rs6413438, rsl92154563, rsl40278421, rsll8203757, rsll8203759, and rsl2769205.
  • rsl2248560 may have a positive effect on cannabinoid metabolism.
  • CYP2C9 SNPs may have a negative effect on cannabinoid metabolism: rsl799853, rsl057910, S56165452, rs28371686, rs9332131, rs7900194, rs28371685, rs9332239, rs72558187, rs72558190, rs72558188, and rs57505750.
  • CYP3A4 SNPs may have a negative effect on cannabinoid metabolism: rs55785340, rs72552799, rs67784355, rsl2721629, rs4986909, rsl2721627, rs4987161, rs67666821, rs35599367, and rsl38105638.
  • CYP1A2 is known to affect metabolism of certain drugs. For example individuals who carry one or more CYP1A2*1C alleles are "slow” caffeine metabolizers, whereas carriers of the variant CYP1A2*1F are "fast” caffeine metabolizers.
  • CYP2D6 is understood to be related to the metabolism of a large number of drugs including dextromethorphan.
  • the present technology can be used to determine a patient's risk for administration of a cannabinoid containing medicine. For example by testing for any one or more of the above SNPs, either alone or in combination with other SNPs, and providing a medicine recommendation accordingly.
  • the analysis of a user's genetic information can be used to determine or rule out potential sources of risk, or side effects.
  • the presence of one or more of the SNPs identified herein can be be used to indicate a low risk of the related risk factor.
  • the foregoing single nucleotide polymorphisms are provided by way of example only, and the systems and methods described herein are designed to incorporate further genotype information as their effects on pharmacokinetics and medicine use become known.
  • the inventors are developing representative base-line dosing factor information 506 for a range of clinical information in accordance with the present technology. It should be appreciated that these values may be updated over time in accordance with the present technology. Where specific values are not provided in the tables, the values may be inferred by interpolating between the values provided.
  • dosing levels described herein are based on the inventors' best knowledge and understanding. It should also be appreciated that a recommended dosage may be varied for some reason to account for patient specific clinical information. It should be understood that the dosage factors described herein may not be appropriate for all patients. It is recommended that patients consult a clinician before relying on the information described in this specification.
  • cannabinoid containing medicines are administered to a patient, and therefore recommended by the present technology and included in a prescription, as:
  • Table 1 provides an example of potential total daily limits for CBD and THC dosages to treat a range of medical conditions for a nominal patient. Also included are recommended starting dosages for both CBD and THC. These values are based on the inventors' current understanding.
  • a patient diagnosed with a medical condition such as those listed in Table 1, may be prescribed a medication comprising CBD and / or THC.
  • This medication is preferably administered in small doses, and gradually increased until the desired therapeutic effect is achieved.
  • an adult patient suffering from anxiety may be prescribed a medication comprising a 10:1 ratio of CBD to THC.
  • the patient may be administered a low-dosage of the medication, which is gradually increased, for example over a four week period until the desired therapeutic effect is achieved.
  • one or more of the total daily limits, starting doses and ratio of CBD to THC may be modified in accordance with clinical and or genetic information about the patient. For example, where a patient is found to have a low THC metabolism rate, the corresponding THC dosage should be reduced proportionally e.g. 40% thereof. For patients where multiple factors apply, each factor should be taken into account to calculate a recommended daily dosage e.g. each factor may be multiplied to the base-line dosage level to calculate the recommended dosage.
  • Table 2 provides example dosage factors for a nominal patient having a Single Nucleotide Polymorphism (SNP) in the listed genes.
  • SNP Single Nucleotide Polymorphism
  • Adenine (A), Thymine (T), Cytosine(C), and Guanine (G) nucleotide substitutions in a given gene may provide different information as to a patient's likely risk or metabolism rate for a given medication.
  • the dosage factor for that compound may be zero.
  • the dosage factor for a compound may be substantially zero if assessment of an SNP indicates the patient has an addiction risk form administration of that compound.
  • Table 3 provides example dosage factors for nominal patients that have previously been prescribed cannabinoid containing medications or who have consumed cannabinoid containing substances recreationally.
  • the THC and CBD concentrations in a patient's plasma can also be used to determine if the patient is metabolising a component of the cannabinoid containing medicine at a target rate during a course of medicine. For instance, that can be used to double check that metabolism is occurring as predicted according to the SNPs identified during a genetic test and which form part of the patient information. It can therefore be advantageous to feed these measurements to the feedback system 108 to optimise the recommendations provided by the processing system 104. .6.2.2. BASE BIOLOGICAL DOSAGE FACTORS
  • Table 4 provides example dosage factors based on representative biological factors for nominal patients.
  • Table 5 provides representative dosing factors for a patient who has reduced kidney or liver function.
  • the present technology may recommend administration to a patient of a specific ratio of two compounds due to the absence or presence of single nucleotide polymorphisms. This could be useful to optimise therapeutic efficacy and reduce or minimise adverse affects e.g. a patient having a lower rate of THC metabolism and a standard CBD metabolism rate would ideally be administered a medicine having less (or potentially zero) THC.
  • the present technology may recommend a medicine from a list of options. Exemplary formulations are provided in Table 6 below, in which the ratio of the actives varies between the formulations:
  • the present technology may provide a dosage recommendation for one of the formulations using the methods and systems described herein.
  • the exemplary formulations according to Table 6 may have a fixed concentration of one of the actives, and the concentration of the other may vary to provide the stated exemplary ratios.
  • the concentration of each active may vary between the exemplary formulations of Table 6 in addition to the ratio of actives.
  • the present technology may provide a medicine recommendation from a list of options.
  • exemplary formulations are provided in table 7 below, in which the ratio of actives is the same in each formulation but the concentration differs:
  • the present technology may provide recommendations on two or more medications and dosages of each.
  • the list of medicines may comprise one or more formulations having a first active compound, and one or more formulations containing a second active. Exemplary formulations for use in this embodiment are outlined in Table 8 below:
  • the technology is configured to provide a recommendation for a first medicine containing the first active and a second medicine containing the second active.
  • the recommendation may provide a specific dose of each of the first medicine and the second medicine.
  • the technology may recommend one or more of the following:
  • This approach to providing recommendations may provide greater flexibility in prescribing medications to patients. In addition, it may better assist in prescribing medications to meet an individual patient's medical needed e.g. according to genetic criteria, medical requirements, and other factors as described herein.
  • the present technology may be configured to update the recommendation for one of more of the first medication and the second medication e.g. based on patient feedback provided using the systems and method described herein, or an improved population model indicting that a recommendation or dosage could be improved.
  • One method of administering a medication to minimise the likelihood of negative side effects is to start with a low initial dose and gradually increase the dosage over time until the desired therapeutic effect is achieved. This may be particularly beneficial for prescribing and administering medications with a narrow therapeutic index i.e. a medication which has a narrow separation between the dosage which provides the desired therapeutic effect and the dosage which provides negative side effects.
  • a narrow therapeutic index i.e. a medication which has a narrow separation between the dosage which provides the desired therapeutic effect and the dosage which provides negative side effects.
  • Examples of medications with a narrow therapeutic index include (but are not limited to) Warfarin, Levothyroxine and Digoxin.
  • the present technology can partially or completely address the downsides of the prior art by applying the dosing factors described herein to provide improved medicine recommendations e.g. to optimise one or more of the initial dose recommendation, rate of dosage increase and maximum dosage in order to arrive at the therapeutic level faster.
  • population data or a population model as described herein may be used to predict an initial dose which is likely to provide the desired therapeutic effect. In this way the delay before receiving a therapeutic effect can be minimised, while maintaining a low chance of experiencing negative side effects.
  • the population data or model may suggest based on genetic and/or clinical information of similar patients that a given dosage would provide the desired therapeutic effect.
  • the initial dose can then be set at the recommended dosage or alternatively slightly below the recommended dosage to further reduce the likelihood of negative side effects developing.
  • the dosing factors and/or population data/models described herein may be used to optimise the medication recommended to a patient.
  • a patient suffers pain, such as neuropathic pain
  • pain such as neuropathic pain
  • the patient can be moved onto a second, third or fourth medication.
  • a patient may first be prescribed a treatment comprising paracetamol, and if the treatment is found to be ineffective, the prescription may be changed to a stronger medication such as codeine. This process can require trialling multiple medications until an appropriate therapeutic effect is achieved.
  • the present invention can reduce the trial and error approach to prescribing medications by using clinical and/or genetic information to recommend a medication which is mostly likely to provide the desired therapeutic effect in the first instance while minimising the likelihood of negative side effects occurring.
  • FIG. 7a to 7e An example of a user interface and method of interacting with a device 700 according to the present technology are illustrated in Figs. 7a to 7e.
  • Fig 7a shows an example credential validation interface for the present technology.
  • the interface prompts the patient to provide identifying credentials such as their name, date of birth, sex and a unique identifier (in this case a national health index number). These details are used to confirm the identity of the patient, and in some cases extract information about the patient from one or more databases.
  • the device 700 may be configured to communicate with a practise management system in order to extract details about the patient, such as their medical history.
  • the credentials may be used to access details on the device itself, or a server configured to track the patient's use of the recommendation system.
  • the patient may be prompted to provide log-in credentials, as should be familiar to those skilled in the art.
  • the patient is prompted to confirm that the details are correct before proceeding.
  • Fig. 7b shows a confirmation screen where the patient's medical history has been downloaded from a database. These details may be confirmed if correct, or modified if incorrect or incomplete. If the device 700 fails to download the patient's medical history, the patient may instead be prompted to enter a list of existing medical conditions as shown.
  • Fig. 7c shows an interface which prompts the patient to input details about the condition requiring treatment. This may include both the cause of the injury if applicable, the main symptom to be treated, as well as any additional symptoms requiring treatment.
  • the patient may select the symptoms to be treated only, particularly in situations where the underlying cause is unknown.
  • Fig 7d. shows a further interface prompting the patient to input additional information such as their height, weight, current medications, past cannabis usage history, genotype information (if known) and current CBD and THC blood plasma concentrations.
  • additional information such as their height, weight, current medications, past cannabis usage history, genotype information (if known) and current CBD and THC blood plasma concentrations.
  • One or more of the above fields may be automatically populated from the database the device connects to in Fig. 7b. It should be appreciated that some of the information shown may not be known. In these cases, the fields may be left blank.
  • genotype information is provided as a standalone file, it may be possible to import these files to extract the required information to populate the form.
  • Fig 7e shows an interface which provides a recommendation to the patient as to which medication should be taken to treat the specific medical condition disclosed.
  • This recommendation takes into consideration the clinical information provided to recommend a product or strain (when the recommendation related to cannabinoids containing medicines), as well as a specific dose of active ingredient.
  • administration route information is provided as the specific route affects pharmacokinetics of the drugs involved. Accordingly, administration route recommendations may be used to control blood plasma levels of CBD/THC in addition to simply varying the dosage strengths and relative concentrations.
  • the device 700 may be configured to automatically generate a prescription, or alternatively send a request for a prescription based on the recommendations provided.
  • the device 700 may also be configured to provide information to the prescriber, patient/user such as regulatory information, warnings, and/or prompt for informed consent.
  • the device 700 may be configured to provide information relating to medications which fall within section 29 of the New Zealand Misuse of Drugs Act 1975.
  • One method of recommending a cannabinoid containing medicine to administer to a patient comprising the steps of:
  • SNP single nucleotide polymorphism
  • steps A and B may be excluded, and a recommendation may be provided using the systems and methods described herein.
  • the patient may be asked to have genetic testing done in order to determine their suitability to receive medications containing cannabinoids.
  • the systems and methods described herein may be configured to provide medicine recommendations without any genetic information.
  • the processing system 104 may provide recommendations without any genetic information by comparing the outcomes of similar recommendations made in the past.
  • the processing system 104 may be configured to assume that where no genetic information is provided, the patient is likely to have the genetic composition which is most common among previous patients.
  • the processing system may be configured to assume worst-case SNP information (i.e. slow metabolism of CBD and/or THC, and high-risk factors for neurocognitive impairment or psychosis) to thereby provide conservative recommendations.
  • the technology provides recommendations based on genetic information provided by the patient or the patient's prescribing physician.
  • the present technology provides for systems and devices configured to provide a recommendation for a cannabinoid containing medicine for administration to a patient, comprising: a graphical user interface (GUI); an input system for receiving at least one piece of genetic information; wherein the at least one piece of genetic information includes one or more of the patient's possible psychosis risk due to at least one of administration of THC and the patient's neurocognitive impairment risk due to administration of THC; the patient's likely metabolism rate of at least one of cannabidiol (CBD) and tetrahydrocannabinol (THC); and a processing system that is configured to provide an output indicative of a medicine recommendation for the patient based on the patient's likely metabolism rate of at least one of CBD and THC in combination with one or more of the patient's possible psychosis risk and neurocognitive impairment risk.
  • GUI graphical user interface
  • systems configured to generate cannabinoid containing medicine recommendations for administration to a patient, the systems comprising: an input system for receiving at least one piece of genetic information; wherein the at least one piece of genetic information includes one or more of the patient's possible psychosis risk due to at least one of administration of THC and the patient's neurocognitive impairment risk due to administration of THC; and the patient's likely metabolism rate of at least one of cannabidiol (CBD) and tetrahydrocannabinol (THC); and a processing system that is configured to provide an output indicative of a medicine recommendation for the patient based on the patients likely metabolism rate of at least one of CBD and THC in combination with one or more of the patient's possible psychosis risk and neurocognitive impairment risk.
  • CBD cannabidiol
  • THC tetrahydrocannabinol
  • the present technology includes methods for providing a recommendation for a cannabinoid containing medicine to administer to a patient, the methods comprising the steps of:
  • a system to generate prescriptions for administration of cannabinoid containing medicines to a patient comprising: an input system configured to receive patient information, a processing system configured to generate medicine recommendations using the patient information; an output system configured to generate a prescription containing the medicine recommendation based on the patient information; and wherein the patient information comprises at least one single nucleotide polymorphism (SNP) associated with the patient's metabolism rate of at least one of cannabidiol (CBD) and tetrahydrocannabinol (THC) in combination with at least one SNP associated with the patient's possible psychosis risk and the patient's neurocognitive impairment risk due to administration of THC.
  • SNP single nucleotide polymorphism
  • CBD cannabidiol
  • THC tetrahydrocannabinol
  • a device configured to generate prescriptions for administration of cannabinoid containing medications to a patient
  • the device comprising: an input system configured to receive patient information; a processing system configured to generate a medicine recommendation using the patient information; an output system configured to generate a prescription containing the medicine recommendation based on the patient information; and wherein the patient information comprises at least one single nucleotide polymorphism (SNP) associated with associated the patient's metabolism rate of at least one of cannabidiol (CBD) and tetrahydrocannabinol (THC) in combination with at least one SNP associated with the patient's possible psychosis risk and the patient's neurocognitive impairment risk due to administration of THC.
  • SNP single nucleotide polymorphism
  • CBD cannabidiol
  • THC tetrahydrocannabinol
  • the present technology provides a system for providing cannabinoid containing medication dosage recommendations for administration to a patient, the system comprising: an input system configured to receive patient information comprising physiological and genetic information; a processing system configured to generate a dosage recommendation for a cannabinoid containing medicine using at least one dosage factor and the patient information; and an output system configured to provide an output representing the dosage recommendation.
  • composition recommendations i.e. CBD / THC compositions
  • the technology provides a device for providing cannabinoid containing medication dosage recommendations for administration to a patient, the device comprising: an input system configured to receive patient information comprising physiological and genetic information; a processing system configured to generate a dosage recommendation for a cannabinoid containing medicine using at least one dosage factor and the patient information; an output system configured to provide an output representing the dosage recommendation.
  • a system for providing medicine recommendations comprising: an input system consisting of at least one electronic device, configured to receive patient information; a processing system comprising at least one processor; a computer readable storage medium having computer readable program code embodied herewith and executable by the at least one processor; and the computer readable program code being configured to provide medicine recommendations based on the patient information and at least one dosage factor.
  • Fig. 8 shows a flow diagram for a further example of the technology, wherein THC and CBD dosage rates may be determined by analysing the COMT, AKT1, CYP2C9, CYP2D6, CYP3A4, CYP1A2 and CYP2C19 genes for single nucleotide polymorphisms (SNPs).
  • SNPs single nucleotide polymorphisms
  • the method involves determining whether the patient has a psychosis risk, preferably by assessing at least the AKT1 and COMT SNPs. If a high psychosis risk is identified, the processing system 104 is configured to recommend a cannabis dosage having no THC content. If a medium psychosis risk is identified, the processing system 104 is configured to recommend a cannabis dosage having a medium to low THC content.
  • SNPs are analysed to determine cognitive impairment risk, such as the COMT SNPs described herein. If a risk is identified, the processing system 104 is configured to recommend a low THC dose. In some examples, a cognitive impairment risk may be identified even where no corresponding SNP is identified, for example an elderly person may be considered to have a driving impairment risk from administration of THC, in which case a low to zero THC dose is recommended.
  • SNPs are analysed to determine a likely rate of THC metabolism.
  • the CYP2C9 SNP may be analysed as described herein. If a very low metabolism rate is detected, a low THC dose is recommended. If a low metabolism is detected, a medium THC dose is recommended. If a normal metabolism is detected, a normal THC dose is recommended.
  • the system looks at SNPs indicative of the patient's likely CBD metabolism rate, such as CYP2C19.
  • a high rate results in a high CBD dose
  • a normal rate results in a normal CBD dose
  • a low rate results in a low CBD dose
  • a very low or absent CBD metabolism results in a very low CBD dose.
  • the CYP2C19 SNP indicates that the patient is likely to be a superfast metaboliser of CBD an even higher dose may be administered.
  • one option is to recommend a low dose of THC comprising less than lmg of tetrahydrocannabinol per day.
  • the system may recommend up to three doses a day of a cannabinoid containing medicine comprising lmg of THC or less.
  • one or more single nucleotide polymorphisms can be assessed to determine whether a patent has a possible addition risk.
  • the gene encoding for fatty acid amide hydrolade (FAAH), or other SNP may be assessed to determine a patient's potential addiction risk due to administration of a compound(s). Where an addiction risk is identified, the system can recommend a zero dose of the compound(s) which may cause addiction.

Abstract

La technologie concerne des systèmes et des méthodes pour fournir des recommandations relatives à des médicaments sur la base de la présence ou de l'absence de polymorphismes mononucléotidiques (SNP). Dans des exemples de la technologie, les informations génétiques d'une personne sont analysées pour identifier des SNP se rapportant à des facteurs de risque potentiels pour l'administration d'un médicament contenant un cannabinoïde et/ou le métabolisme probable de médicaments contenant un cannabinoïde, et des recommandations relatives à des médicaments sont ensuite fournies.
PCT/NZ2021/050220 2020-12-14 2021-12-14 Systèmes et méthodes pour fournir des recommandations relatives à des médicaments WO2022131933A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019090421A1 (fr) * 2017-11-07 2019-05-16 MedReleaf Corp. Recommandations relatives au dosage et à la variété destinées au traitement d'états pathologiques à l'aide de cannabis
US20200211688A1 (en) * 2018-12-28 2020-07-02 Xing-Liang Liu Method and system for providing a personalized cannabinoid treatment regimen
US20200253921A1 (en) * 2017-10-30 2020-08-13 Endocanna Health, Inc. Cannabinoid Formulations

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200253921A1 (en) * 2017-10-30 2020-08-13 Endocanna Health, Inc. Cannabinoid Formulations
WO2019090421A1 (fr) * 2017-11-07 2019-05-16 MedReleaf Corp. Recommandations relatives au dosage et à la variété destinées au traitement d'états pathologiques à l'aide de cannabis
US20200211688A1 (en) * 2018-12-28 2020-07-02 Xing-Liang Liu Method and system for providing a personalized cannabinoid treatment regimen

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