US2024006084A1PendingUtilityA1

Methods for treatment of hypertension with an angiotensin ii receptor blocker pharmaceutical composition

76
Assignee: ASTRAZENECA UK LTDPriority: Jun 14, 2018Filed: Apr 10, 2023Published: Jan 4, 2024
Est. expiryJun 14, 2038(~11.9 yrs left)· nominal 20-yr term from priority
G16H 70/40G16H 50/30G16H 20/10A61K 31/4245G16H 10/20G16H 50/20A61K 31/4178A61K 31/4184A61K 31/41A61P 9/12
76
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Claims

Abstract

A method is provided for lowering blood pressure in a subject in need thereof by administering an angiotensin II receptor blocker pharmaceutical composition to a subject qualified for over-the-counter access to the angiotensin II receptor blocker pharmaceutical composition. In some embodiments, the angiotensin II receptor blocker pharmaceutical composition includes azilsartan medoxomil, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, or valsartan. In some embodiments, the angiotensin II receptor blocker pharmaceutical composition comprises an active ingredient that is (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2′-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylate or a pharmaceutically acceptable salt thereof.

Claims

exact text as granted — not AI-modified
1 - 70 . (canceled) 
     
     
         71 . A non-transitory computer readable storage medium, wherein the non-transitory computer readable storage medium stores instructions, which when executed by a computer system, cause a computer system to perform a method of qualifying a human subject for over-the-counter delivery of an angiotensin II receptor blocker pharmaceutical composition for lowering blood pressure, the method comprising:
 a) obtaining a plurality of assessment survey results, wherein the plurality of assessment survey results comprises:
 whether the subject is one of (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant, 
 whether the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition, 
 a systolic blood pressure of the subject, 
 a diastolic blood pressure of the subject, 
 an age of the subject, 
 information required to calculate a risk of atherosclerotic cardiovascular disease for the subject, 
 whether the subject has ever had an abnormal electrolyte blood level, and 
 whether the subject has ever had a kidney problem; and 
   b) applying an algorithm to the plurality of assessment survey results, wherein the algorithm:
 i) runs all or a portion of the plurality of assessment survey results against a plurality of filters, wherein, when a respective filter in a first subset of the plurality of filters is fired, the subject is deemed not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, and when a respective filter in a second subset of the plurality of filters is fired the subject is provided with a warning corresponding to the respective filter, wherein the plurality of assessment filters comprises:
 a pregnancy assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject is pregnant or the subject is breastfeeding, 
 a drug interaction assessment filter that is fired at least when the plurality of assessment survey results indicate that the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition, 
 a blood pressure assessment filter that is fired at least when the plurality of assessment survey results indicates the subject is not hypertensive or the subject has severe hypertension, 
 an age assessment filter that is fired at least when the plurality of assessment survey results indicate the subject is too young to receive the angiotensin II receptor blocker pharmaceutical composition, 
 a pooled cohort equation assessment filter that is fired at least when the plurality of assessment survey results indicate that the subject has a risk for atherosclerotic cardiovascular disease that is below a floor threshold of risk or the subject has an incalculable risk for atherosclerotic cardiovascular disease, 
 an electrolyte blood level assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject has had an abnormal electrolyte blood level, and 
 a kidney problem assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject has had a kidney problem; 
 
 ii) obtains, when no filter in the plurality of filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, acknowledgment from the subject for each warning issued to the subject by any filter in the plurality of filters; and 
 iii) proceeds with a fulfillment process when (1) no filter in the plurality of filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition and (2) the subject has acknowledged each warning associated with each filter in the plurality of filters that was fired and that is associated with a warning, wherein the fulfillment process comprises:
 storing an indication in a subject profile of an initial order for the angiotensin II receptor blocker pharmaceutical composition, 
 communicating an over the counter drug facts label for the angiotensin II receptor blocker pharmaceutical composition to the subject, and 
 authorizing, upon confirmation from the subject that the over the counter drug facts label has been received and read, provision of the angiotensin II receptor blocker pharmaceutical composition to the subject, thereby providing the subject access to the angiotensin II receptor blocker pharmaceutical composition following the authorizing, for administration to lower blood pressure. 
 
   
     
     
         72 . The computer readable storage medium of  claim 71 , wherein the angiotensin II receptor blocker pharmaceutical composition comprises an active ingredient having the structure: 
       
         
           
           
               
               
           
         
         wherein R 1  is a group represented by the formula: 
       
       
         
           
           
               
               
           
         
         wherein R 2 , R 3 , R 4 , R 5 , R 6 , R 7 , and R 8  are each independently a hydrogen atom or a C1-6 alkyl, or a salt thereof. 
       
     
     
         73 . The computer readable storage medium of  claim 71 , wherein the angiotensin II receptor blocker pharmaceutical composition comprises an active ingredient that is (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2′-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylate or a pharmaceutically acceptable salt thereof. 
     
     
         74 . The computer readable storage medium of  claim 71 , wherein the angiotensin II receptor blocker pharmaceutical composition comprises an active ingredient that is azilsartan medoxomil or a pharmaceutically acceptable salt thereof. 
     
     
         75 . The computer readable storage medium of  claim 72 , wherein, upon confirmation from the subject that the over the counter drug facts label has been received and read, the subject is authorized for provision of a dosage of from 40 mg to 80 mg per day of the active ingredient of the angiotensin II receptor blocker pharmaceutical composition. 
     
     
         76 . The computer readable storage medium of  claim 71 , wherein the active ingredient of the angiotensin II receptor blocker pharmaceutical composition comprises an active ingredient selected from the group consisting of candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, and valsartan. 
     
     
         77 . The computer readable storage medium of  claim 71 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises candesartan, and   upon confirmation from the subject that the over the counter drug facts label has been received and read, the subject is authorized for provision of a dosage of from 4 mg to 32 mg of candesartan per day.   
     
     
         78 . The computer readable storage medium of  claim 71 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises candesartan,   the plurality of assessment survey results further comprises whether the subject has a liver problem, and   the plurality of assessment filters includes a liver problem assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject has advanced liver disease.   
     
     
         79 . The computer readable storage medium of  claim 71 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises eprosartan, and   upon confirmation from the subject that the over the counter drug facts label has been received and read, the subject is authorized for provision of a dosage of from 400 mg to 800 mg of eprosartan per day.   
     
     
         80 . The computer readable storage medium of  claim 71 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises irbesartan, and   upon confirmation from the subject that the over the counter drug facts label has been received and read, the subject is authorized for provision of a dosage from 75 mg to 300 mg of irbesartan per day.   
     
     
         81 . The computer readable storage medium of  claim 71 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises losartan, and   upon confirmation from the subject that the over the counter drug facts label has been received and read, the subject is authorized for provision of a dosage of from 25 mg to 100 mg of losartan per day.   
     
     
         82 . The computer readable storage medium of  claim 71 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises losartan,   the plurality of assessment survey results further comprises whether the subject is taking a potassium supplement or a salt substitute that includes potassium, and   the plurality of filters includes a potassium supplement assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject is taking a potassium supplement or a salt substitute that includes potassium.   
     
     
         83 . The computer readable storage medium of  claim 71 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises losartan,   the plurality of assessment survey results further comprises whether the subject has ever had a liver problem, and   the plurality of assessment filters includes a liver problem assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject has had a liver problem.   
     
     
         84 . The computer readable storage medium of  claim 71 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises olmesartan, and   upon confirmation from the subject that the over the counter drug facts label has been received and read, the subject is authorized for provision of a dosage of from 5 mg to 40 mg of olmesartan per day.   
     
     
         85 . The computer readable storage medium of  claim 71 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises colesevelam,   the plurality of assessment survey results further comprises whether the subject is taking colesevelam, and   the plurality of filters includes a colesevelam interaction assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject is taking colesevelam.   
     
     
         86 . The computer readable storage medium of  claim 71 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises telmisartan, and   upon confirmation from the subject that the over the counter drug facts label has been received and read, the subject is authorized for provision of a dosage of from 20 mg to 80 mg of telmisartan per day.   
     
     
         87 . The computer readable storage medium of  claim 71 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises telmisartan, and   the drug interaction assessment filter is fired when the plurality of assessment survey results indicates that the subject is taking digoxin.   
     
     
         88 . The computer readable storage medium of  claim 71 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises telmisartan, and   the plurality of assessment survey results further comprises whether the subject has ever had a liver problem, and   the plurality of filters includes a liver problem assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject has had a liver problem.   
     
     
         89 . The computer readable storage medium of  claim 71 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises telmisartan,   the plurality of assessment survey results further comprises whether the subject is taking a potassium supplement or a salt substitute that includes potassium, and   the plurality of filters includes a potassium supplement assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject is taking a potassium supplement or a salt substitute that includes potassium.   
     
     
         90 . The computer readable storage medium of  claim 71 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises telmisartan,   the plurality of assessment survey results further comprises whether the subject has ever had a heart failure, and   the plurality of filters includes a heart failure assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject has had a heart failure.   The computer readable storage medium of  claim 71 , wherein:   the angiotensin II receptor blocker pharmaceutical composition comprises valsartan, and   upon confirmation from the subject that the over the counter drug facts label has been received and read, the subject is authorized for provision of a dosage of from 40 mg to 320 mg of valsartan per day.   
     
     
         91 . The computer readable storage medium of  claim 71 , wherein the pregnancy assessment filter is also fired when the plurality of assessment survey results indicates that the subject is planning to become pregnant. 
     
     
         92 . The computer readable storage medium of  claim 71 , wherein the drug interaction assessment filter is fired when the plurality of assessment survey results indicates that the subject is taking a lithium medication. 
     
     
         93 . The computer readable storage medium of  claim 71 , wherein the drug interaction assessment filter is fired when the plurality of assessment survey results indicates that the subject is taking a non-steroidal anti-inflammatory medication. 
     
     
         94 . The computer readable storage medium of  claim 71 , wherein the drug interaction assessment filter is fired when the plurality of assessment survey results indicates that the subject is taking a high blood pressure medication. 
     
     
         95 . The computer readable storage medium of  claim 71 , wherein blood pressure that indicates the subject is not hypertensive, and is capable of firing the blood pressure assessment filter, is a systolic blood pressure of less than 130 mm Hg and a diastolic blood pressure of less than 80 mm Hg. 
     
     
         96 . The computer readable storage medium of  claim 71 , wherein blood pressure that indicates the subject has severe hypertension, and is capable of firing the blood pressure assessment filter, is a systolic blood pressure of at least 140 mm Hg or a diastolic blood pressure of at least 90 mm Hg. 
     
     
         97 . The computer readable storage medium of  claim 71 , wherein the performed method further comprises, when the plurality of assessment survey results indicates that the subject has elevated blood pressure but is not hypertensive:
 firing the blood pressure assessment filter; and   transmitting, to the subject, advice to manage their blood pressure by eating healthy and exercising.   
     
     
         98 . The computer readable storage medium of  claim 71 , wherein the performed method further comprises, when the plurality of assessment survey results indicates that the subject has stage two hypertension:
 firing the blood pressure assessment filter; and   transmitting, to the subject, advice to visit a doctor to discuss taking a prescription-strength blood pressure medication.   
     
     
         99 . The computer readable storage medium of  claim 71 , wherein the performed method further comprises, when the plurality of assessment survey results indicate that the subject is in hypertensive crisis:
 firing the blood pressure assessment filter; and   transmitting, to the subject, advice to seek emergency medical attention.   
     
     
         100 . The computer readable storage medium of  claim 71 , wherein the pooled cohort equation assessment filter is fired when the plurality of assessment survey results indicates that the subject has a 10-year risk for atherosclerotic cardiovascular disease, as determined using a pooled cohort equation, that is less than 10%. 
     
     
         101 . The computer readable storage medium of  claim 71 , wherein the pooled cohort equation assessment filter is fired when the plurality of assessment survey results indicates that the subject has an incalculable risk for atherosclerotic cardiovascular disease, as determined by one or more inputs of the pooled cohort equation, including:
 A) the subject is younger than forty years old,   B) a total cholesterol level of the subject is either less than 160 mg/dL or greater than 240 mg/dL,   C) a high density lipoprotein cholesterol level of the subject is less than 45 mg/dL or greater than 65 mg/dL,   D) an untreated systolic blood pressure of the subject is less than 100 mm Hg or greater than 140 mm Hg, or   E) a treated systolic blood pressure of the subject is less than 120 mm Hg or greater than 160 mm Hg.   
     
     
         102 . The computer readable storage medium of  claim 71 , wherein the method includes bypassing the firing of the pooled cohort equation assessment filter when the plurality of assessment survey results indicates that the subject has an incalculable risk for atherosclerotic cardiovascular disease but has an age that is above a risk threshold age. 
     
     
         103 . The computer readable storage medium of  claim 71 , wherein
 the plurality of assessment survey results further comprises:
 a gender of the subject, 
 a race of the subject, 
 a blood pressure medication status of the subject, 
 a smoking status of the subject, 
 a total cholesterol level of the subject, 
 a high density lipoprotein cholesterol level of the subject, 
 whether the subject has ever had an atherosclerotic cardiovascular history including an atherosclerotic cardiovascular event or a heart procedure, and 
 a diabetes status of the subject; and 
   the pooled cohort equation assessment filter incorporates the gender of the subject, the age of the subject, the race of the subject, the blood pressure medication status of the subject, the smoking status of the subject, the total cholesterol of the subject, the high density lipoprotein cholesterol level of the subject, the atherosclerotic cardiovascular history of the subject, and the diabetes status of the subject to derive the risk for atherosclerotic cardiovascular disease.   
     
     
         104 . The computer readable storage medium of  claim 71 , wherein the pooled cohort equation filter utilizes a pooled cohort equation implemented as a multivariable Cox proportional hazard regression. 
     
     
         105 . The computer readable storage medium of  claim 71 , wherein:
 the plurality of assessment survey results further comprises whether the subject is allergic to the angiotensin II receptor block pharmaceutical composition, and   the plurality of assessment filters includes an adverse reaction assessment filter that is fired when the plurality of assessment survey results indicates that the subject is allergic to the angiotensin II receptor blocker pharmaceutical composition.   
     
     
         106 . The computer readable storage medium of  claim 71 , wherein:
 the warning corresponding to a filter in the plurality of assessment filters comprises a prompt for the subject to indicate whether they have discussed the risk factor underlying the respective filter in the second plurality of assessment filters that was fired with a health care provider; and   acknowledgement is obtained from the subject when the subject indicates that they have discussed the risk factor underlying the filter that was fired with a health care provider.   
     
     
         107 . The computer readable storage medium of  claim 71 , wherein the fulfillment process further comprises:
 storing a destination associated with the subject in the subject profile.   
     
     
         108 . The computer readable storage medium of  claim 71 , wherein the fulfillment process further comprises:
 coordinating shipping of the angiotensin II receptor blocker pharmaceutical composition to a physical address associated with the subject.   
     
     
         109 . The computer readable storage medium of  claim 71 , wherein the lowering blood pressure is to treat or prevent a heart disease. 
     
     
         110 . A non-transitory computer readable storage medium, wherein the non-transitory computer readable storage medium stores instructions, which when executed by a computer system, cause a computer system to perform a re-fulfillment method comprising, responsive to receiving a re-order request from the subject for the angiotensin II receptor blocker pharmaceutical composition:
 (a) obtaining a plurality of reassessment survey results, wherein the plurality of reassessment survey results comprises:
 a systolic blood pressure of the subject, 
 a diastolic blood pressure of the subject, 
 whether the subject is one of (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant, 
 whether the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition, 
 whether the subject has experienced symptoms of hypotension since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, 
 whether the subject has developed an abnormal electrolyte blood level since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and 
 whether the subject has developed a kidney problem since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition; and 
   (b) applying an algorithm to the plurality of reassessment survey results, wherein the algorithm:
 i) runs all or a portion of the plurality of reassessment survey results against a plurality of reassessment filters, wherein, when a respective reassessment filter in a first subset of the plurality of reassessment filters is fired, the subject is deemed not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, and when a respective reassessment filter in a second subset of the plurality of reassessment filters is fired the subject is provided with a warning corresponding to the respective filter, wherein the plurality of reassessment filters comprises:
 a blood pressure reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject has hypertension, 
 a pregnancy reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject is pregnant or the subject is breastfeeding, 
 a drug interaction reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition, 
 a hypotension reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has experienced symptoms of hypotension since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, 
 an electrolyte blood level reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has developed an abnormal electrolyte blood level since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and 
 a kidney problem reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has developed a kidney problem since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition; 
 
 ii) obtains, when no filter in the plurality of reassessment filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, acknowledgment from the subject for each warning issued to the subject by any filter in the plurality of reassessment filters; and 
 iii) proceeds with a re-fulfillment process when (1) no filter in the plurality of reassessment filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition and (2) the subject has acknowledged each warning associated with each filter in the plurality of reassessment filters that was fired and that is associated with a warning, wherein the re-fulfillment process comprises:
 storing an indication in the subject profile of a re-order for the angiotensin II receptor blocker pharmaceutical composition, 
 communicating the over the counter drug facts label for the angiotensin II receptor blocker pharmaceutical composition to the subject, and 
 authorizing, upon confirmation from the subject that the over the counter drug facts label has been received and read, a re-order provision of the angiotensin II receptor blocker pharmaceutical composition to the subject, thereby providing the subject access to the angiotensin II receptor blocker pharmaceutical composition following the authorizing, for administration to lower blood pressure. 
 
   
     
     
         111 . The computer readable storage medium of  claim 110 , wherein the angiotensin II receptor blocker pharmaceutical composition is selected from the group consisting of azilsartan medoxomil, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, and valsartan. 
     
     
         112 . The computer readable storage medium of  claim 110 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises irbesartan,   the plurality of reassessment survey results further comprises whether the subject has experienced an impaired renal function since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and   the re-fulfillment process includes running all or a portion of the plurality of reassessment survey results against a renal function reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has experienced, since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, an impaired renal function, wherein when the renal function reassessment filter is fired, the subject is provided with a warning corresponding to the renal function reassessment filter.   
     
     
         113 . The computer readable storage medium of  claim 110 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises irbesartan,   the plurality of reassessment survey results further comprises whether the subject has experienced an abnormal potassium serum level since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and   the re-fulfillment process further comprises running all or a portion of the plurality of reassessment survey results against a potassium serum level reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has experienced, since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, an abnormal potassium serum level, wherein when the serum potassium level reassessment filter is fired, the subject is provided with a warning corresponding to the serum potassium level reassessment filter.   
     
     
         114 . The computer readable storage medium of  claim 110 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises losartan,   the plurality of reassessment survey results further comprises whether the subject has experienced an impaired renal function since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and   the re-fulfillment process includes running all or a portion of the plurality of reassessment survey results against a renal function reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has experienced, since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, an impaired renal function, wherein when the renal function reassessment filter is fired, the subject is provided with a warning corresponding to the renal function reassessment filter.   
     
     
         115 . The computer readable storage medium of  claim 110 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises losartan,   the plurality of reassessment survey results further comprises whether the subject has experienced an abnormal potassium serum level since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and   the re-fulfillment process further comprises running all or a portion of the plurality of reassessment survey results against a potassium serum level reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has experienced, since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, an abnormal potassium serum level, wherein when the serum potassium level reassessment filter is fired, the subject is provided with a warning corresponding to the serum potassium level reassessment filter.   
     
     
         116 . The computer readable storage medium of  claim 110 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises telmisartan,   the plurality of reassessment survey results further comprises whether the subject has experienced an impaired renal function since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and   the re-fulfillment process includes running all or a portion of the plurality of reassessment survey results against a renal function reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has experienced, since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, an impaired renal function, wherein when the renal function reassessment filter is fired, the subject is provided with a warning corresponding to the renal function reassessment filter.   
     
     
         117 . The computer readable storage medium of  claim 110 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises telmisartan,   the plurality of reassessment survey results further comprises whether the subject has experienced an abnormal potassium serum level since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and   the re-fulfillment process further comprises running all or a portion of the plurality of reassessment survey results against a potassium serum level reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has experienced, since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, an abnormal potassium serum level, wherein when the serum potassium level reassessment filter is fired, the subject is provided with a warning corresponding to the serum potassium level reassessment filter.   
     
     
         118 . The computer readable storage medium of  claim 110 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises valsartan,   the plurality of reassessment survey results further comprises whether the subject has experienced an impaired renal function since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and   the re-fulfillment process includes running all or a portion of the plurality of reassessment survey results against a renal function reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has experienced, since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, an impaired renal function, wherein when the renal function reassessment filter is fired, the subject is provided with a warning corresponding to the renal function reassessment filter.   
     
     
         119 . The computer readable storage medium of  claim 110 , wherein:
 the angiotensin II receptor blocker pharmaceutical composition comprises valsartan,   the plurality of reassessment survey results further comprises whether the subject has experienced an abnormal potassium serum level since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and   the re-fulfillment process further comprises running all or a portion of the plurality of reassessment survey results against a potassium serum level reassessment filter of the second category class that is fired at least when the plurality of reassessment survey results indicates that the subject has experienced, since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, an abnormal potassium serum level, wherein when the serum potassium level reassessment filter is fired, the subject is provided with a warning corresponding to the serum potassium level reassessment filter.   
     
     
         120 . The computer readable storage medium of  claim 110 , wherein the pregnancy reassessment filter is also fired when the plurality of reassessment survey results indicates that the subject is planning to become pregnant. 
     
     
         121 . The computer readable storage medium of  claim 110 , wherein the drug interaction reassessment filter is fired when the plurality of reassessment survey results indicates that the subject is taking a lithium medication. 
     
     
         122 . The computer readable storage medium of  claim 110 , wherein the drug interaction reassessment filter is fired when the plurality of reassessment survey results indicates that the subject is taking a non-steroidal anti-inflammatory medication. 
     
     
         123 . The computer readable storage medium of  claim 110 , wherein the drug interaction reassessment filter is fired when the plurality of reassessment survey results indicates that the subject is taking a high blood pressure medication. 
     
     
         124 . The computer readable storage medium of  claim 110 , wherein:
 the plurality of reassessment survey results further comprises whether the subject has experienced a side effect associated with the angiotensin II receptor blocker pharmaceutical composition since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and   the re-fulfillment process further comprises running all or a portion of the plurality of reassessment survey results against a side effect reassessment filter that is fired at least when plurality of reassessment survey results indicates that the subject has experienced, since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, a side effect selected from the group consisting of hypotension, dizziness, and faintness, wherein when the side effect reassessment filter is fired, the subject is provided with a warning corresponding to the side effect reassessment filter.   
     
     
         125 . The computer readable storage medium of  claim 110 , wherein the re-fulfillment process further comprises, when a respective filter in the plurality of reassessment filters is fired, storing a record associated with the firing of the respective filter in an adverse event profile comprising records of filter firing events associated with a plurality of subjects. 
     
     
         126 . The computer readable storage medium of  claim 110 , wherein the lowering blood pressure is to treat or prevent a heart disease. 
     
     
         127 . A computer system for qualifying a human subject for over-the-counter delivery of an angiotensin II receptor blocker pharmaceutical composition for lowering blood pressure, the computer system comprising one or more processors and a memory, the memory comprising non-transitory instructions which, when executed by the one or more processors, cause the computer system to perform a method comprising:
 a) obtaining a plurality of assessment survey results, wherein the plurality of assessment survey results comprises:
 whether the subject is one of (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant, 
 whether the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition, 
 a systolic blood pressure of the subject, 
 a diastolic blood pressure of the subject, 
 an age of the subject, 
 information required to calculate a risk of atherosclerotic cardiovascular disease for the subject, 
 whether the subject has ever had an abnormal electrolyte blood level, and 
 whether the subject has ever had a kidney problem; and 
   b) applying an algorithm to the plurality of assessment survey results, wherein the algorithm:
 i) runs all or a portion of the plurality of assessment survey results against a plurality of filters, wherein, when a respective filter in a first subset of the plurality of filters is fired, the subject is deemed not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, and when a respective filter in a second subset of the plurality of filters is fired the subject is provided with a warning corresponding to the respective filter, wherein the plurality of assessment filters comprises:
 a pregnancy assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject is pregnant or the subject is breastfeeding, 
 a drug interaction assessment filter that is fired at least when the plurality of assessment survey results indicate that the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition, 
 a blood pressure assessment filter that is fired at least when the plurality of assessment survey results indicates the subject is not hypertensive or the subject has severe hypertension, 
 an age assessment filter that is fired at least when the plurality of assessment survey results indicate the subject is too young to receive the angiotensin II receptor blocker pharmaceutical composition, 
 a pooled cohort equation assessment filter that is fired at least when the plurality of assessment survey results indicate that the subject has a risk for atherosclerotic cardiovascular disease that is below a floor threshold of risk or the subject has an incalculable risk for atherosclerotic cardiovascular disease, 
 an electrolyte blood level assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject has had an abnormal electrolyte blood level, and 
 a kidney problem assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject has had a kidney problem; 
 
 ii) obtains, when no filter in the plurality of filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, acknowledgment from the subject for each warning issued to the subject by any filter in the plurality of filters; and 
 iii) proceeds with a fulfillment process when (1) no filter in the plurality of filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition and (2) the subject has acknowledged each warning associated with each filter in the plurality of filters that was fired and that is associated with a warning, wherein the fulfillment process comprises:
 storing an indication in a subject profile of an initial order for the angiotensin II receptor blocker pharmaceutical composition, 
 communicating an over the counter drug facts label for the angiotensin II receptor blocker pharmaceutical composition to the subject, and 
 authorizing, upon confirmation from the subject that the over the counter drug facts label has been received and read, provision of the angiotensin II receptor blocker pharmaceutical composition to the subject, thereby providing the subject access to the angiotensin II receptor blocker pharmaceutical composition following the authorizing, for administration to lower blood pressure. 
 
   
     
     
         128 . A computer system for requalifying a human subject for over-the-counter delivery of an angiotensin II receptor blocker pharmaceutical composition for lowering blood pressure, the computer system comprising one or more processors and a memory, the memory comprising non-transitory instructions which, when executed by the one or more processor, perform a re-fulfillment method comprising, responsive to receiving a re-order request from the subject for the angiotensin II receptor blocker pharmaceutical composition:
 (a) obtaining a plurality of reassessment survey results, wherein the plurality of reassessment survey results comprises:
 a systolic blood pressure of the subject, 
 a diastolic blood pressure of the subject, 
 whether the subject is one of (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant, 
 whether the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition, 
 whether the subject has experienced symptoms of hypotension since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, 
 whether the subject has developed an abnormal electrolyte blood level since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and 
 whether the subject has developed a kidney problem since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition; and 
   (b) applying an algorithm to the plurality of reassessment survey results, wherein the algorithm:
 i) runs all or a portion of the plurality of reassessment survey results against a plurality of reassessment filters, wherein, when a respective filter in a first subset of the plurality of reassessment filters is fired the subject is deemed not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, and when a respective filter in a second subset of the plurality of reassessment filters is fired the subject is provided with a warning corresponding to the respective filter, wherein the plurality of reassessment filters comprises:
 a blood pressure reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject has hypertension, 
 a pregnancy reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject is pregnant or the subject is breastfeeding, 
 a drug interaction reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition, 
 a hypotension reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has experienced symptoms of hypotension since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, 
 an electrolyte blood level reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has developed an abnormal electrolyte blood level since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and 
 a kidney problem reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has developed a kidney problem since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition; 
 
 ii) obtains, when no filter in the plurality of reassessment filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, acknowledgment from the subject for each warning issued to the subject by any filter in the plurality of reassessment filters; and 
 iii) proceeds with a re-fulfillment process when (1) no filter in the plurality of reassessment filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition and (2) the subject has acknowledged each warning associated with each filter in the plurality of reassessment filters that was fired and that is associated with a warning, wherein the re-fulfillment process comprises:
 storing an indication in the subject profile of a re-order for the angiotensin II receptor blocker pharmaceutical composition, 
 communicating the over the counter drug facts label for the angiotensin II receptor blocker pharmaceutical composition to the subject, and 
 authorizing, upon confirmation from the subject that the over the counter drug facts label has been received and read, a re-order provision of the angiotensin II receptor blocker pharmaceutical composition to the subject, thereby providing the subject access to the angiotensin II receptor blocker pharmaceutical composition following the authorizing, for administration to lower blood pressure. 
 
   
     
     
         129 . A method for qualifying a human subject for over-the-counter delivery of an angiotensin II receptor blocker pharmaceutical composition for lowering blood pressure, the method comprising:
 a) obtaining a plurality of assessment survey results, via a computer system having a processor programed to receive the assessment survey results, wherein the plurality of assessment survey results comprises:
 whether the subject is one of (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant, 
 whether the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition, 
 a systolic blood pressure of the subject, 
 a diastolic blood pressure of the subject, 
 an age of the subject, 
 information required to calculate a risk of atherosclerotic cardiovascular disease for the subject, 
 whether the subject has ever had an abnormal electrolyte blood level, and 
 whether the subject has ever had a kidney problem; and 
   b) applying an algorithm to the plurality of assessment survey results, via a computer system having a processor programmed to perform the algorithm, wherein the algorithm:
 i) runs all or a portion of the plurality of assessment survey results against a plurality of filters, wherein, when a respective filter in a first subset of the plurality of filters is fired the subject is deemed not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, and when a respective filter in a second subset of the plurality of filters is fired the subject is provided with a warning corresponding to the respective filter, wherein the plurality of assessment filters comprises:
 a pregnancy assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject is pregnant or the subject is breastfeeding, 
 a drug interaction assessment filter that is fired at least when the plurality of assessment survey results indicate that the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition, 
 a blood pressure assessment filter that is fired at least when the plurality of assessment survey results indicates the subject is not hypertensive or the subject has severe hypertension, 
 an age assessment filter that is fired at least when the plurality of assessment survey results indicates the subject is too young to receive the angiotensin II receptor blocker pharmaceutical composition, 
 a pooled cohort equation assessment filter that is fired at least when the plurality of assessment survey results indicate that the subject has a risk for atherosclerotic cardiovascular disease that is below a floor threshold of risk or the subject has an incalculable risk for atherosclerotic cardiovascular disease, 
 an electrolyte blood level assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject has had an abnormal electrolyte blood level, and 
 a kidney problem assessment filter that is fired at least when the plurality of assessment survey results indicates that the subject has had a kidney problem; 
 
 ii) obtains, when no filter in the plurality of filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, acknowledgment from the subject for each warning issued to the subject by any filter in the plurality of filters; and 
 iii) proceeds with a fulfillment process when (1) no filter in the plurality of filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition and (2) the subject has acknowledged each warning associated with each filter in the plurality of filters that was fired and that is associated with a warning, wherein the fulfillment process comprises:
 storing an indication in a subject profile of an initial order for the angiotensin II receptor blocker pharmaceutical composition, 
 communicating an over the counter drug facts label for the angiotensin II receptor blocker pharmaceutical composition to the subject, and 
 authorizing, upon confirmation from the subject that the over the counter drug facts label has been received and read, provision of the angiotensin II receptor blocker pharmaceutical composition to the subject, wherein the authorization includes a destination associated with the subject, thereby providing the subject access to the angiotensin II receptor blocker pharmaceutical composition following the authorizing, for administration to lower blood pressure. 
 
   
     
     
         130 . A method for requalifying a human subject for over-the-counter delivery of an angiotensin II receptor blocker pharmaceutical composition for lowering blood pressure, the method comprising:
 (a) obtaining a plurality of reassessment survey results, via a computer system having a processor programed to receive the reassessment survey results, wherein the plurality of reassessment survey results comprises:
 a systolic blood pressure of the subject, 
 a diastolic blood pressure of the subject, 
 whether the subject is one of (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant, 
 whether the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition, 
 whether the subject has experienced symptoms of hypotension since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, 
 whether the subject has developed an abnormal electrolyte blood level since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and 
 whether the subject has developed a kidney problem since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition; and 
   (b) applying an algorithm to the plurality of reassessment survey results, via a computer system having a processor programmed to perform the algorithm, wherein the algorithm:
 i) runs all or a portion of the plurality of reassessment survey results against a plurality of reassessment filters, wherein, when a respective reassessment filter in a first subset of the plurality of reassessment filters is fired the subject is deemed not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, and when a respective reassessment filter in a second subset of the plurality of reassessment filters is fired the subject is provided with a warning corresponding to the respective reassessment filter, wherein the plurality of reassessment filters comprises:
 a blood pressure reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject has hypertension, 
 a pregnancy reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject is pregnant or the subject is breastfeeding, 
 a drug interaction reassessment filter that is fired at least when the plurality of reassessment survey results indicates the subject is taking a medication that interacts with the angiotensin II receptor blocker pharmaceutical composition 
 a hypotension reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has experienced symptoms of hypotension since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, 
 an electrolyte blood level reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has developed an abnormal electrolyte blood level since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition, and 
 a kidney problem reassessment filter that is fired at least when the plurality of reassessment survey results indicates that the subject has developed a kidney problem since receiving their last provision of the angiotensin II receptor blocker pharmaceutical composition; 
 
 ii) obtains, when no filter in the plurality of reassessment filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition, acknowledgment from the subject for each warning issued to the subject by any filter in the plurality of reassessment filters; and 
 iii) proceeds with a re-fulfillment process when (1) no filter in the plurality of reassessment filters has deemed the subject not qualified for delivery of the angiotensin II receptor blocker pharmaceutical composition and (2) the subject has acknowledged each warning associated with each filter in the plurality of reassessment filters that was fired and that is associated with a warning, wherein the re-fulfillment process comprises:
 storing an indication in the subject profile of a re-order for the angiotensin II receptor blocker pharmaceutical composition, 
 communicating the over the counter drug facts label for the angiotensin II receptor blocker pharmaceutical composition to the subject, and 
 authorizing, upon confirmation from the subject that the over the counter drug facts label has been received and read, a re-order provision of the angiotensin II receptor blocker pharmaceutical composition to the subject, thereby providing the subject access to the angiotensin II receptor blocker pharmaceutical composition following the authorizing, for administration to lower blood pressure.

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