Methods for lowering blood sugar with a metformin pharmaceutical composition

Abstract

A method is provided for lowering blood sugar in a subject in need thereof by administering a biguanide anti-hyperglycemic pharmaceutical composition to a subject qualified for over-the-counter access to the biguanide anti-hyperglycemic pharmaceutical composition. In some embodiments, the biguanide anti-hyperglycemic pharmaceutical composition includes N,N-dimethylimidodicarbonimidic diamide, or a pharmaceutically acceptable salt thereof. In some embodiments, the biguanide anti-hyperglycemic pharmaceutical composition includes metformin hydrochloride.

What is claimed is: 
     
         1 . A computer system for qualifying a human subject for over-the-counter delivery of a metformin pharmaceutical composition for lowering blood sugar, 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 method comprising:
 a) conducting a first survey of the subject thereby obtaining a first plurality of survey results, wherein the first plurality of survey results comprises:
 whether the subject is pregnant or breastfeeding, 
 whether the subject has a kidney problem, 
 a ketoacidosis status of the subject, 
 an alcohol consumption status of the subject, 
 an age of the subject, 
 a Type 1 diabetes status of the subject, 
 a lactic acidosis status of the subject, 
 a blood sugar level of the subject, 
 whether the subject has a liver problem, 
 whether the subject has ever had a heart attack, severe infection, or stroke, 
 a surgery status of the subject, 
 whether the subject has a history of dehydration, and 
 whether the subject is already taking a diabetes medication; 
   b) running all or a portion of the first plurality of survey results against a first plurality of filters of a first category class, wherein, when a respective filter in the first plurality of filters is fired, the subject is deemed not qualified for delivery of the metformin pharmaceutical composition and the method is terminated without delivery of the metformin pharmaceutical composition to the subject, wherein the first plurality of filters comprises:
 a first pregnancy filter that is fired at least when the first plurality of survey results indicates that the subject is pregnant or the subject is breastfeeding, 
 a kidney function filter that is fired at least when the first plurality of survey results indicates that the subject has a kidney problem, 
 a ketoacidosis filter that is fired at least when the first plurality of survey results indicates that the subject has ketoacidosis, 
 a first alcohol consumption filter, an age filter, 
 a Type 1 diabetes filter that is fired at least when the first plurality of survey results indicates that the subject has Type 1 diabetes, 
 a lactic acidosis filter that is fired at least when the first plurality of survey results indicates that the subject has lactic acidosis, and 
 a first blood sugar level filter that is fired at least when the first plurality of survey results indicates that the subject has a blood sugar level that is either (i) below a first baseline blood sugar level, or (ii) above a ceiling blood sugar level; 
   c) running all or a portion of the first plurality of survey results against a second plurality of filters of a second category class, wherein, when a respective filter in the second plurality of filters is fired, the subject is provided with a warning corresponding to the respective filter, and wherein the second plurality of filters comprises:
 a first liver disease filter that is fired at least when the first plurality of survey results indicates that the subject has a liver problem, 
 a first medical issue filter that is fired at least when the first plurality of survey results indicates that the subject has had a heart attack, the subject has had a severe infection, or the subject has had a stroke, 
 a first surgery filter that is fired at least when the first plurality of survey results indicates that the subject has recently undergone surgery, the subject is planning on undergoing surgery, or the subject is planning on having an x-ray procedure that includes injection of a contrast agent, 
 a first dehydration filter that is fired at least when the first plurality of survey results indicates that the subject has experienced a symptom of dehydration, and 
 a first diabetes medication filter that is fired at least when the first plurality of survey results indicates that the subject is taking a diabetes medication; 
   d) obtaining acknowledgment from the subject for the warning issued to the subject by any filter in the second plurality of filters; and   e) proceeding with a fulfillment process when (i) no filter in the first plurality of filters has been fired and (ii) the subject has acknowledged each warning associated with each filter in the second plurality of filters that was fired, wherein the fulfillment process comprises:
 storing an indication in a subject profile of an initial order for the metformin pharmaceutical composition, 
 communicating an over the counter drug facts label for the metformin 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 metformin pharmaceutical composition to the subject. 
   
     
     
         2 . The computer system of  claim 1 , wherein the metformin pharmaceutical composition comprises metformin hydrochloride. 
     
     
         3 . The computer system of  claim 1  or  2 , 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 500 mg to 1000 mg per day of metformin hydrochloride. 
     
     
         4 . The computer system of  claim 1  or  2 , 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 500 mg per day of metformin hydrochloride. 
     
     
         5 . The computer system according to any one of  claims 1 - 4 , wherein the first pregnancy filter is also fired when the first plurality of survey results indicates that the subject plans to become pregnant within a predetermined period of time. 
     
     
         6 . The computer system according to any one of  claims 1 - 5 , wherein the first alcohol consumption filter is fired when the first plurality of survey results indicates that the subject, on average, consumes at least a predetermined number of alcoholic drinks over a predetermined period of time. 
     
     
         7 . The computer system according to any one of  claims 1 - 6 , wherein the age filter is fired when the first plurality of survey results indicates that the subject is less than eighteen years old. 
     
     
         8 . The computer system according to any one of  claims 1 - 7 , wherein the first baseline blood sugar level used in the first blood sugar level filter is 6.5% glycated hemoglobin. 
     
     
         9 . The computer system according to any one of  claims 1 - 8 , wherein the ceiling blood sugar level used in the first blood sugar level filter is 7.5% glycated hemoglobin. 
     
     
         10 . The computer system according to any one of  claims 1 - 9 , wherein:
 the first plurality of survey results further comprises whether the subject is allergic to the metformin pharmaceutical composition, and   the first plurality of filters includes an adverse reaction filter that is fired when the first plurality of survey results indicates that the subject is allergic to the metformin pharmaceutical composition.   
     
     
         11 . The computer system according to any one of  claims 1 - 10 , wherein:
 the warning corresponding to a respective filter in the second plurality of filters comprises a prompt for the user to indicate whether they have discussed the risk factor underlying the respective filter in the second plurality of 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 respective filter in the second plurality of filters that was fired with a health care provider.   
     
     
         12 . The computer system according to any one of  claims 1 - 11 , wherein the fulfillment process further comprises:
 storing a destination associated with the subject in the subject profile.   
     
     
         13 . The computer system according to any one of  claims 1 - 12 , wherein the fulfillment process further comprises:
 coordinating shipping of the metformin pharmaceutical composition to a physical address associated with the subject.   
     
     
         14 . The computer system according to any one of  claims 1 - 13 , wherein the method further comprises:
 f) responsive to receiving a re-order request from the subject for the metformin pharmaceutical composition, performing a re-fulfillment procedure comprising:
 (i) conducting a second survey of the subject thereby obtaining a second plurality of survey results, wherein the second plurality of survey results comprises:
 whether the subject is pregnant or breastfeeding, 
 whether the subject has experienced a kidney problem since receiving their last provision of the metformin pharmaceutical composition, 
 an alcohol consumption status of the subject, 
 whether the subject has experienced a symptom of ketoacidosis since receiving their last provision of the metformin pharmaceutical composition, 
 whether the subject has experienced a symptom of lactic acidosis since receiving their last provision of the metformin pharmaceutical composition, 
 whether the subject has experienced an illness causing vomiting, diarrhea, or fever since receiving their last provision of the metformin pharmaceutical composition, 
 whether the subject has experienced a symptom of a liver problem since receiving their last provision of the metformin pharmaceutical composition, 
 whether the subject has experienced a heart attack, severe infection, or stroke since receiving their last provision of the metformin pharmaceutical composition, 
 a surgery status of the subject, 
 whether the subject has experienced a symptom of dehydration since receiving their last provision of the metformin pharmaceutical composition, 
 whether the subject is taking a diabetes medication, and 
 if the subject has been taking the metformin pharmaceutical composition for at least a predetermined period of time, a blood sugar level of the subject; 
 
 (ii) running all or a portion of the second plurality of survey results against a third plurality of filters of the first category class, wherein, when a respective filter in the third plurality of filters is fired, the subject is deemed not qualified for the metformin pharmaceutical composition and the re-fulfillment process is terminated without delivery of the metformin pharmaceutical composition to the subject, wherein the third plurality of filters comprise:
 a second pregnancy filter that is fired at least when the second plurality of survey results indicates that the subject is pregnant or the subject is breastfeeding, 
 a kidney disease filter that is fired at least when the second plurality of survey results indicates that the subject has experienced a kidney problem since receiving their last provision of the metformin pharmaceutical composition, 
 a second alcohol consumption filter, 
 a ketoacidosis symptom filter that is fired at least when the second plurality of survey results indicates that the subject has experienced a symptom of ketoacidosis since receiving their last provision of the metformin pharmaceutical composition, 
 a lactic acidosis symptom filter that is fired at least when the second plurality of survey results indicates that the subject has experienced a symptom of lactic acidosis since receiving their last provision of the metformin pharmaceutical composition, an illness filter that is fired at least when the second plurality of survey results indicates that the user has experienced an illness causing vomiting, diarrhea, or fever since receiving their last provision of the metformin pharmaceutical composition, and 
 a second blood sugar filter that is fired at least when:
 (i) the subject has been taking the metformin pharmaceutical composition for a threshold amount of time, and 
 (ii) the second plurality of survey results indicates that the subject has a blood sugar level of at least a second ceiling blood sugar level; 
 
 
 (iii) running all or a portion of the second plurality of survey results against a fourth plurality of filters of the second category class, wherein, when a respective filter in the fourth plurality of filters is fired, the subject is provided with a warning corresponding to the respective filter, and wherein the fourth plurality of filters comprises:
 a second liver disease filter that is fired at least when the second plurality of survey results indicates that the subject has experienced a liver problem since receiving their last provision of the metformin pharmaceutical composition, 
 a second medical issue filter that is fired at least when the second plurality of survey results indicates that the subject has had a heart attack, the subject has had a severe infection, or the subject has had a stroke since receiving their last provision of the metformin pharmaceutical composition, 
 a second surgery filter that is fired at least when the second plurality of survey results indicates that the subject has undergone surgery since receiving their last provision of the metformin pharmaceutical composition, the subject is planning on undergoing surgery, or the subject is planning on having an x-ray procedure that includes injection of a contrast agent since, 
 a second dehydration filter that is fired at least when the second plurality of survey results indicates that the subject has experienced, since receiving their last provision of the metformin pharmaceutical composition, a symptom of dehydration, and 
 a second diabetes medication filter that is fired at least when the second plurality of survey results indicates that the subject is taking a diabetes medication, and 
 
 (iv) obtaining acknowledgment from the subject for the warning issued to the subject by any filter in the fourth plurality of filters; and 
 (v) proceeding with the re-fulfillment process when (i) the re-fulfillment process is not already terminated by the firing of a filter in the third plurality of filters and (ii) the subject has acknowledged each warning associated with each filter in the third plurality of filers that was fired and that is associated with a warning, wherein the re-fulfillment process further comprises:
 storing an indication in the subject profile of a re-order for the metformin pharmaceutical composition, 
 communicating the over the counter drug facts label for the metformin 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 metformin pharmaceutical composition to the subject. 
 
   
     
     
         15 . The computer system of  claim 14 , wherein the second pregnancy filter is also fired when the second plurality of survey results indicates that the subject plans to become pregnant within a predetermined period of time. 
     
     
         16 . The computer system of  claim 14  or  15 , wherein the second alcohol consumption filter is fired when the first plurality of survey results indicates that the subject, on average, consumes at least a predetermined number of alcoholic drinks over a predetermined period of time. 
     
     
         17 . The computer system according to any one of  claims 14 - 16 , wherein a symptom of ketoacidosis, which is capable of firing the ketoacidosis filter, is selected from the group consisting of an increase of ketones in the blood of the subject, an increase of ketones in the urine of the subject, nausea, tiredness, vomiting, trouble breather, and abdominal pain. 
     
     
         18 . The computer system according to any one of  claims 14 - 17 , wherein a symptom of lactic acidosis, which is capable of firing the lactic acidosis symptom filter, is selected from the group consisting of cold feelings in the subject's hands or feet, dizziness, lightheadedness, slow or irregular heartbeat, feeling very weak or tired, unusual muscle pain, difficulty breathing, stomach pains, nausea, and vomiting. 
     
     
         19 . The computer system according to any one of  claims 14 - 18 , wherein the second baseline blood sugar level used in the second blood sugar filter is 7% glycated hemoglobin. 
     
     
         20 . The computer system according to any one of  claims 1 - 19 , wherein the lowering blood pressure is to treat Type 2 diabetes. 
     
     
         21 . A method for lowering blood sugar levels in a subject in need thereof, the method comprising:
 administering a biguanide anti-hyperglycemic pharmaceutical composition to a subject qualified for over-the-counter access to the metformin pharmaceutical composition.   
     
     
         22 . The method of  claim 21 , wherein the biguanide anti-hyperglycemic pharmaceutical composition comprises N,N-dimethylimidodicarbonimidic diamide, or a pharmaceutically acceptable salt thereof, as an active ingredient. 
     
     
         23 . The method of  claim 21 , wherein the biguanide anti-hyperglycemic pharmaceutical composition comprises metformin, or a pharmaceutically acceptable salt thereof, as an active ingredient. 
     
     
         24 . The method of  claim 21 , wherein the biguanide anti-hyperglycemic pharmaceutical composition comprises metformin hydrochloride, as an active ingredient. 
     
     
         25 . The method according to any one of  claims 22 - 24 , wherein the subject is administered from 500 mg to 1000 mg per day of the active ingredient. 
     
     
         26 . The method according to any one of  claims 22 - 24 , wherein the subject is administered 500 mg per day of the active ingredient.