Population-based medication risk stratification and personalized medication risk score

Abstract

Embodiments of the invention relate to a system and method for population-based medication risk stratification and for generating a personalized medication risk score. The system and method may pertain to a software that relates pharmacological characteristics of medications and patient's drug regimen data into algorithms that (1) enable identification and/or prognosis of high-risk patients for adverse drug events within a population distribution, and (2) allow computation of a personalized medication risk score which provides personalized, evidence-based information for safer drug use to mitigate medication risks.

1 .- 9 . (canceled) 
     
     
         10 . A method of reducing a risk of an adverse drug event in a patient diagnosed with insomnia, wherein the patient has been prescribed a drug regimen that includes at least an anticholinergic for treating insomnia and a second drug, the method comprising:
 calculating, by a computing device, a quantitative personalized medication total risk score for multi-drug interaction for the patient that is representative of the patient's risk for an adverse drug event by:
 (a) aggregating and weighting risk factor scores for risk factors associated with the patient's drug regimen including at least the anticholinergic for treating insomnia and the second drug onto a common scale to produce aggregated risk factor scores, wherein the risk factors include:
 1) Factor 1: relative odds ratio for one or more side effects of the patient's drug regimen including at least the anticholinergic for treating insomnia and the second drug, wherein a relative odds ratio risk factor score is representative of Factor 1; 
 2) Factor 2: anticholinergic burden of the drug regimen including at least the anticholinergic for treating insomnia and the second drug, wherein an anticholinergic burden risk factor score is representative of Factor 2; 
 3) Factor 3: sedative burden of the drug regimen including at least the anticholinergic for treating insomnia and the second drug, wherein a sedative burden risk factor score is representative of Factor 3; 
 4) Factor 4: QT-interval prolongation risk of the drug regimen including at least the anticholinergic for treating insomnia and the second drug, wherein a QT-interval prolongation risk factor score is representative of Factor 4; and 
 5) Factor 5: competitive inhibition of the drug regimen including at least the anticholinergic for treating insomnia and the second drug, wherein a competitive inhibition risk factor score is representative of Factor 5; and 
 
 (b) calculating, by the computing device, a quantitative personalized medication total risk score for multi-drug interaction as a function of: the relative odds ratio risk factor score, the anticholinergic burden risk factor score, the sedative burden risk factor score, the QT-interval prolongation risk factor score, and the competitive inhibition risk factor score to yield a total numerical value used to identify the calculated quantitative personalized medication total risk score as falling within a low-risk group or within a high-risk group; 
   generating a prognosis for the patient as a high-risk patient for an adverse drug event based on the patient's calculated quantitative personalized medication total risk score falling within the high-risk group; and   adjusting the high-risk patient's drug regimen including at least the anticholinergic for treating insomnia and the second drug to decrease the patient's calculated quantitative personalized medication total risk score such that the high-risk patient's risk of an adverse drug event is reduced; and such that treatment of the patient's insomnia is improved by performing one or more steps of:
 (a) reordering which of the anticholinergic for treating insomnia and the second drug is taken first by the patient; 
 (b) changing timing of when the anticholinergic for treating insomnia and/or the second drug are taken by the patient; 
 (c) changing time of day when the anticholinergic for treating insomnia and/or the second drug are taken by the patient; 
 (d) replacing the anticholinergic for treating insomnia and/or the second drug of the patient's drug regimen with one or more alternate drugs of the same class and/or category as the anticholinergic for treating insomnia and/or the second drug; 
 (e) reducing a dosage of the anticholinergic for treating insomnia and/or the second drug from an initial dosage to a reduced dosage; 
 (f) increasing a dosage of the anticholinergic for treating insomnia and/or the second drug from an initial dosage to an increased dosage; 
 (g) adding at least a third drug to the patient's drug regimen including at least the anticholinergic for treating insomnia and the second drug; and 
   (h) replacing the anticholinergic for treating insomnia and/or the second drug of the patient's drug regimen including at least the anticholinergic for treating pain and the second drug with one or more alternate drugs of a different class and/or category as the anticholinergic for treating pain and/or the second drug; and   administering to the high-risk patient the adjusted drug regimen to decrease the patient's calculated quantitative personalized medication total risk score such that the high-risk patient's risk of an adverse drug event is reduced; and such that treatment of the patient's insomnia is improved.   
     
     
         11 . The method according to  claim 10 , wherein the calculated quantitative personalized medication total risk score for the patient is identified as falling within a high-risk group if the total numerical value is 20 or greater on a weighted scale of 53. 
     
     
         12 . The method according to  claim 10 , wherein adjusting the patient's drug regimen causes the patient's calculated quantitative personalized medication total risk score to decrease. 
     
     
         13 . The method according to  claim 10 , wherein the second drug is selected from an anticholinergic, an antihypertensive, a diuretic, a bladder antispasmodic, an antidepressant, a tricyclic antidepressant, an antipsychotic, a beta-blocker, an opioid, an anti-inflammatory agent, an anti-platelet agent, a benzodiazepine, a barbiturate, a muscle relaxant, a first-generation antihistamine, an antiarrhythmic medication, triamterene, indapamide, erythromycin, cisapride, diphenhydramine, thioridazine, droperidol, sildenafil, domperidone, pimozide, risperidone, olanzapine, bupropion, rosuvastatin, and mianserin. 
     
     
         14 . A method of diagnosing a patient having depression as a high-risk patient for an adverse drug event due to multi-drug interactions, wherein the patient has been prescribed a drug regimen that includes at least an antidepressant and a second drug, the method comprising:
 calculating, by a computing device, a quantitative personalized medication total risk score for multi-drug interaction for the patient that is representative of the patient's risk for an adverse drug event by:
 (a) aggregating and weighting risk factor scores for risk factors associated with the patient's drug regimen including at least the antidepressant and the second drug onto a common scale to produce aggregated risk factor scores, wherein the risk factors include:
 1) Factor 1: relative odds ratio for one or more side effects of the patient's drug regimen including at least the antidepressant and the second drug, wherein a relative odds ratio risk factor score is representative of Factor 1; 
 2) Factor 2: anticholinergic burden of the drug regimen including at least the antidepressant and the second drug, wherein an anticholinergic burden risk factor score is representative of Factor 2; 
 3) Factor 3: sedative burden of the drug regimen including at least the antidepressant and the second drug, wherein a sedative burden risk factor score is representative of Factor 3; 
 4) Factor 4: QT-interval prolongation risk of the drug regimen including at least the antidepressant and the second drug, wherein a QT-interval prolongation risk factor score is representative of Factor 4; and 
 5) Factor 5: competitive inhibition of the drug regimen including at least the antidepressant and the second drug, wherein a competitive inhibition risk factor score is representative of Factor 5; and 
 
 (b) calculating, by the computing device, a quantitative personalized medication total risk score by as a function of: the relative odds ratio risk factor score, the anticholinergic burden risk factor score, the sedative burden risk factor score, the QT-interval prolongation risk factor score, and the competitive inhibition risk factor score to yield a total numerical value used to identify the calculated quantitative personalized medication total risk score as falling within a low-risk group or within a high-risk group; 
   generating a prognosis for the patient as a high-risk patient for an adverse drug event based on the patient's calculated quantitative personalized medication total risk score falling within the high-risk group; and   administering, to the identified high-risk patient for an adverse drug event, a treatment to reduce the high-risk patient's calculated quantitative personalized medication total risk score such that treatment of the patient's depression is improved by performing one or more steps of:
 (a) reordering which of the antidepressant and the second drug is taken first by the patient; 
 (b) changing timing of when the antidepressant and/or the second drug are taken by the patient; 
 (c) changing time of day when the antidepressant and/or the second drug are taken by the patient; 
 (d) replacing the antidepressant and/or the second drug of the patient's drug regimen with one or more alternate drugs of the same class and/or category as the antidepressant and/or the second drug; 
 (e) reducing a dosage of the antidepressant and/or the second drug from an initial dosage to a reduced dosage; 
 (f) increasing a dosage of the antidepressant and/or the second drug from an initial dosage to an increased dosage; 
 (g) adding at least a third drug to the patient's drug regimen; and 
 (h) replacing the antidepressant and/or the second drug of the patient's drug regimen with one or more alternate drugs of a different class and/or category as the antidepressant and/or the second drug. 
   
     
     
         15 . The method according to  claim 14 , wherein the calculated quantitative personalized medication total risk score for the patient is identified as falling within a high-risk group if the total numerical value is 20 or greater on a weighted scale of 53. 
     
     
         16 . The method according to  claim 14 , wherein adjusting the patient's drug regimen causes the patient's calculated quantitative personalized medication total risk score to decrease. 
     
     
         17 . The method according to  claim 14 , wherein the second drug is selected from an anticholinergic, an antihypertensive, a diuretic, a bladder antispasmodic, an antidepressant, a tricyclic antidepressant, an antipsychotic, a beta-blocker, an opioid, an anti-inflammatory agent, an anti-platelet agent, a benzodiazepine, a barbiturate, a muscle relaxant, a first-generation antihistamine, an antiarrhythmic medication, triamterene, indapamide, erythromycin, cisapride, diphenhydramine, thioridazine, droperidol, sildenafil, domperidone, pimozide, risperidone, olanzapine, bupropion, rosuvastatin, and mianserin. 
     
     
         18 . A method of reducing a risk of an adverse drug event in a patient diagnosed with pain, wherein the patient has been prescribed a drug regimen that includes at least a benzodiazepine for treating pain and a second drug, the method comprising:
 calculating, by a computing device, a quantitative personalized medication total risk score for multi-drug interaction for the patient that is representative of the patient's risk for an adverse drug event by:   (a) aggregating and weighting risk factor scores for risk factors associated with the patient's drug regimen including at least the benzodiazepine for treating pain and the second drug onto a common scale to produce aggregated risk factor scores, wherein the risk factors include:
 1) Factor 1: relative odds ratio for one or more side effects of the patient's drug regimen including at least the benzodiazepine for treating pain and the second drug, wherein a relative odds ratio risk factor score is representative of Factor 1; 
 2) Factor 2: anticholinergic burden of the drug regimen including at least the benzodiazepine for treating pain and the second drug, wherein an anticholinergic burden risk factor score is representative of Factor 2; 
 3) Factor 3: sedative burden of the drug regimen including at least the benzodiazepine for treating pain and the second drug, wherein a sedative burden risk factor score is representative of Factor 3; 
 4) Factor 4: QT-interval prolongation risk of the drug regimen including at least the benzodiazepine for treating pain and the second drug, wherein a QT-interval prolongation risk factor score is representative of Factor 4; and 
 5) Factor 5: competitive inhibition of the drug regimen including at least the benzodiazepine for treating pain and the second drug, wherein a competitive inhibition risk factor score is representative of Factor 5; and 
   (b) calculating, by the computing device, a quantitative personalized medication total risk score for multi-drug as a function of: the relative odds ratio risk factor score, the anticholinergic burden risk factor score, the sedative burden risk factor score, the QT-interval prolongation risk factor score, and the competitive inhibition risk factor score to yield a total numerical value used to identify the calculated quantitative personalized medication total risk score as falling within a low-risk group or within a high-risk group;   generating a prognosis for the patient as a high-risk patient for an adverse drug event based on the patient's calculated quantitative personalized medication total risk score falling within the high-risk group; and   adjusting the high-risk patient's drug regimen including at least the benzodiazepine for treating pain and the second drug to decrease the patient's calculated quantitative personalized medication total risk score such that the high-risk patient's risk of an adverse drug event is reduced; and such that treatment of the patient's pain is improved by performing one or more steps of:   (a) reordering which of the benzodiazepine for treating pain and the second drug is taken first by the patient;   (b) changing timing of when the benzodiazepine for treating pain and/or the second drug are taken by the patient;   (c) changing time of day when the benzodiazepine for treating pain and/or the second drug are taken by the patient;   (d) replacing the benzodiazepine for treating pain and/or the second drug of the patient's drug regimen with one or more alternate drugs of the same class and/or category as the benzodiazepine for treating pain and/or the second drug;   (e) reducing a dosage of the benzodiazepine for treating pain and/or the second drug from an initial dosage to a reduced dosage;   (f) increasing a dosage of the benzodiazepine for treating pain and/or the second drug from an initial dosage to an increased dosage;   (g) adding at least a third drug to the patient's drug regimen including at least the benzodiazepine for treating pain and the second drug; and   (h) replacing the benzodiazepine for treating pain and/or the second drug of the patient's drug regimen including at least the benzodiazepine for treating pain and the second drug with one or more alternate drugs of a different class and/or category as the benzodiazepine for treating pain and/or the second drug; and   administering to the high-risk patient the adjusted drug regimen to decrease the patient's calculated quantitative personalized medication total risk score such that the high-risk patient's risk of an adverse drug event is reduced; and such that treatment of the patient's pain is improved.   
     
     
         19 . The method according to  claim 18 , wherein the calculated quantitative personalized medication total risk score for the patient is identified as falling within a high-risk group if the total numerical value is 20 or greater on a weighted scale of 53. 
     
     
         20 . The method according to  claim 18 , wherein adjusting the patient's drug regimen causes the patient's calculated quantitative personalized medication total risk score to decrease. 
     
     
         21 . The method according to  claim 18 , wherein the second drug is selected from an anticholinergic, an antihypertensive, a diuretic, a bladder antispasmodic, an antidepressant, a tricyclic antidepressant, an antipsychotic, a beta-blocker, an opioid, an anti-inflammatory agent, an anti-platelet agent, a benzodiazepine, a barbiturate, a muscle relaxant, a first-generation antihistamine, an antiarrhythmic medication, triamterene, indapamide, erythromycin, cisapride, diphenhydramine, thioridazine, droperidol, sildenafil, domperidone, pimozide, risperidone, olanzapine, bupropion, rosuvastatin, and mianserin.