US 12,462,914 B2
Systems and methods for dispensing a statin medication over the counter
James Blasetto, Chadds Ford, PA (US); Judy Firor, Landenberg, PA (US); David Guiga, West Chester, PA (US); William Mongan, Malvern, PA (US); Robert Prybolsky, West Chester, PA (US); and Richard L. Skelly, Flourtown, PA (US)
Assigned to ASTRAZENECA UK LIMITED, Cambridge (GB)
Filed by ASTRAZENECA UK LIMITED, Cambridge (GB)
Filed on May 23, 2024, as Appl. No. 18/672,436.
Application 18/672,436 is a continuation of application No. 17/898,115, filed on Aug. 29, 2022, granted, now 12,002,558.
Application 17/898,115 is a continuation of application No. 17/132,731, filed on Dec. 23, 2020, granted, now 11,430,555, issued on Aug. 30, 2022.
Application 17/132,731 is a continuation of application No. 16/872,251, filed on May 11, 2020, granted, now 10,910,091, issued on Feb. 2, 2021.
Application 16/872,251 is a continuation in part of application No. 16/791,745, filed on Feb. 14, 2020, granted, now 11,031,104, issued on Jun. 8, 2021.
Application 16/791,745 is a continuation of application No. 15/385,747, filed on Dec. 20, 2016, granted, now 10,600,502, issued on Mar. 24, 2020.
Prior Publication US 2025/0140360 A1, May 1, 2025
This patent is subject to a terminal disclaimer.
Int. Cl. G16H 20/10 (2018.01); A61K 31/505 (2006.01); G16H 50/30 (2018.01)
CPC G16H 20/10 (2018.01) [A61K 31/505 (2013.01); G16H 50/30 (2018.01)] 20 Claims
OG exemplary drawing
 
1. A computer system for qualifying a human subject for delivery of a statin pharmaceutical composition over the counter to lower cholesterol, 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 thereby obtaining a first plurality of survey results from the subject, wherein the first plurality of survey results comprises:
a gender of the subject,
an age of the subject,
when the subject is a female, whether the subject is pregnant or breastfeeding,
whether the subject is taking one or more compositions that interact with the statin pharmaceutical composition,
whether the subject has ever had a cardiac event,
a total cholesterol level of the subject,
a low-density lipoprotein (LDL) cholesterol level of the subject,
a high-density lipoprotein (HDL) cholesterol level of the subject,
a triglyceride level of the subject,
a systolic blood pressure of the subject,
a diastolic blood pressure of the subject,
whether the subject has a liver condition,
an alcohol consumption status of the subject, and
whether the subject has had an adverse reaction to a cholesterol lowering composition; and
b) applying a process to the first plurality of survey results, wherein the process comprises:
i) running all or a portion of the first plurality of survey results against a first plurality of filters wherein, when a respective filter in the first plurality of filters is fired, the process is terminated, and wherein the first plurality of filters comprises:
an age filter that is fired at least when the first information set indicates the age of the subject fails to satisfy an age threshold for receiving the statin pharmaceutical composition,
when the subject is a female, a pregnancy filter that is fired at least when the first information set indicates the subject is pregnant or breastfeeding,
a severe drug interaction filter that is fired at least when the first information set indicates the subject is taking one or more compositions that interact with the statin pharmaceutical composition, wherein the one or more compositions are each contraindicated for co-administration with the statin pharmaceutical composition,
a cardiac event filter that is fired at least when the first information set indicates the subject has had a documented cardiac event,
a total cholesterol filter that is fired at least when the first information set indicates the subject has a total cholesterol level that fails to satisfy a ceiling total cholesterol level threshold,
a LDL cholesterol filter that is fired at least when the first information set indicates the subject has a LDL cholesterol level that fails to satisfy a ceiling LDL cholesterol level threshold,
a HDL cholesterol filter that is fired at least when the first information set indicates the subject has a HDL cholesterol level that fails to satisfy a ceiling HDL cholesterol level threshold,
a triglyceride filter that is fired at least when the first information set indicates the subject has a triglyceride level that fails to satisfy a ceiling triglyceride level threshold,
a blood pressure filter that is fired at least when the first information set indicates (i) the systolic blood pressure of the subject fails to satisfy a ceiling systolic blood pressure threshold or (ii) the diastolic blood pressure of the subject fails to satisfy a ceiling diastolic blood pressure threshold,
an atherosclerotic cardiovascular disease (ASCVD) risk pooled cohort equation filter that is fired at least when an ASCVD risk derived from the first information set indicates the ASCVD risk of the subject fails to satisfy a ceiling ASCVD risk threshold, and
a liver condition filter that is fired at least when the first information set indicates the subject has a liver condition;
ii) running all or a portion of the first plurality of survey results against a second plurality of filters 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:
an alcohol consumption filter that is fired at least when the alcohol consumption status of the subject in the first information set fails to satisfy a ceiling alcohol consumption threshold,
a first adverse reaction filter that is fired at least when the first information set indicates the subject has had an adverse reaction to a cholesterol-lowering drug, and
a moderate drug interaction filter that is fired at least when the first information set indicates the subject is taking one or more compositions that interact with the statin pharmaceutical composition, wherein the one or more compositions are each associated with a warning, but are not contraindicated, for co-administration with the statin pharmaceutical composition;
iii) obtaining acknowledgment from the subject confirming that the subject has discussed the risk factor associated with each warning issued to the subject by any filter in the second plurality of assessment filters with a physician; and
iv) proceeding with the process when (a) no filter in the first plurality of assessment filters has been fired and (b) the subject has acknowledged each warning associated with each filter in the second plurality of assessment filters that was fired, wherein the fulfillment process comprises, wherein the process further comprises:
storing an indication in a subject profile of an initial order for the statin pharmaceutical composition,
communicating an over the counter drug facts label for the statin 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 provision of the statin pharmaceutical composition to the subject,
wherein the statin pharmaceutical composition is administered to the subject after the authorizing to lower cholesterol.