System and method for over-the-counter distribution of statins

Abstract

Systems and methods are provided for over-the-counter delivery of a statin to a subject. Results of five surveys from the subject are run against a first plurality of filters. The subject is deemed ineligible when a filter of the first plurality of filters is triggered. The survey results are also run against a second plurality of filters. The subject is provided with a corresponding warning when a respective filter of the second plurality of filters is triggered. When no filter of the first plurality of filters is triggered and the subject has confirmed each warning associated with each triggered filter of the second plurality of filters, the method proceeds to a fulfillment process. The fulfillment stores a composition order, transmits a drug facts label of the statin to the subject and authorizes the statin to be provided to the subject upon the subject confirming that the label has been read, the authorization including a destination associated with the subject.

Description

[0001] This application is a divisional application of application number 201780086608.2, filed on December 20, 2017, entitled "System and method for dispensing statin drugs over-the-counter". Technical Field

[0002] This disclosure generally relates to systems and methods for dispensing statin drug compositions for the treatment or prevention of atherosclerotic cardiovascular disease, for example by lowering cholesterol, to human subjects without a prescription. Background Technology

[0003] Globally, cardiovascular disease remains the leading cause of death, claiming more lives than all forms of cancer combined. It is projected that by 2030, cardiovascular deaths will increase to approximately 24 million annually. The total annual cost, both direct and indirect, exceeds $316 billion. This surpasses the total GDP of all countries in the world, excluding the top 30 countries by GDP.

[0004] For nearly three decades, statins have been a cornerstone of heart disease treatment. The evidence for their ability to reduce cardiovascular events is unparalleled among all medications. Statins remain the most commonly prescribed class of drugs.

[0005] Although many patent-expired statin drugs were generally available in the US and other markets by 2017, cardiovascular disease is expected to remain prevalent. That is, heart disease will persist. The next generation shows clear signs that they will develop cardiovascular disease at high prevalence levels and require assistance. While novel therapies are becoming a reality to address cardiovascular disease, these are expected to be in combination with statins, rather than as replacements for statins. Therefore, statins are expected to remain a cornerstone of cardiovascular disease treatment for the foreseeable future.

[0006] Unfortunately, long-term trends indicate that many people avoid using prescription medications, including statins. One way to make statins more accessible is to make them available without a prescription, for example, through over-the-counter (“OTC”) access. However, because statins can cause serious adverse reactions in some patients, the population receiving these medications should be carefully selected and monitored. Ramkumar S. et al., Acta Cardiol. Sin., 32(6):631-39 (2016). This is why statin dispensing has traditionally been managed through a proprietary prescription route. To ensure the safety of OTC dispensing of statins, prospective patients must effectively self-select the medication. However, recent studies have found that many prospective patients do not consistently follow the guidelines printed on OTC medication packaging to ensure safe and responsible use. PR Newswire Association, "Americans Should Pay More Attention to Over-the-Counter (OTC) Medicine Labels According to New Survey," October 15, 2015 (citing McNeil Consumer Healthcare research). According to these studies, 40% of potential patients simply treat the package insert as a guide, and 80% of patients do not reread the labels of OTC medications they have used before. More disturbingly, only 58% of the men surveyed felt that paying attention to the limitations on OTC labels was very important.

[0007] Previous attempts to improve self-selection and safe use of OTC statins have failed. For example, Pfizer announced in 2011 its intention to convert Lipitor from a prescription-only drug to an OTC product. See OTC Announcement, November 16, 2011, page 7. Pfizer abandoned its attempt to convert Lipitor from a prescription to an OTC (over-the-counter) product in the United States in 2014. Specifically, the Phase 3 “real-world use” trial, completed in December 2014, designed to simulate the OTC use of 10 mg Lipitor (atorvastatin calcium), failed to meet its primary objective because it did not achieve satisfactory results in patients adhering to the instructions to check their LDL-C levels and taking appropriate action based on their LDL-C levels after the test results.

[0008] Similarly, Merck applied to sell lovastatin over-the-counter at least three times in 2000, 2005, and 2007, but all applications were rejected by the FDA. In 2005, an FDA expert advisory panel rejected Merck's proposal to allow the over-the-counter sale of lovastatin. The panel focused on market research conducted to support the proposal, in which approximately one-third of the 3,316 customers who had the drug available over-the-counter decided to purchase it. After reviewing the data, the panel concluded that 45% of purchases were inappropriate for various reasons, including the age of the participants, their lack of understanding of their condition, and contraindications related to their condition. (Dyer O., *British Medical Journal (BMJ)*, 330(7484):164(2005).) In fact, statins have never been granted OTC status in the United States to date, and more than 15 years have passed since Bristol-Myers Squibb and Merck first failed in their attempts to convert pravastatin and lovastatin to OTC, respectively.

[0009] More than a third of American adults are eligible to take or are taking cholesterol-lowering medications according to current guidelines. However, according to a report by researchers at the Centers for Disease Control and Prevention (CDC) in the 2015 Morbidity and Mortality Weekly Report (MMWR), nearly half of this group is not eligible. Enabling 65% of this group of Americans to control their high LDL cholesterol levels by 2017 is one of the primary goals of the U.S. Department of Health and Human Services' Million Hearts initiative, which aims to prevent one million heart attacks and strokes.

[0010] Thus, the data shows that treatment rates have not significantly improved since 2011. In fact, it is expected that the situation may worsen as statins become off-brand and generic brands gain market share. With the loss of market share, it is unrealistic to expect that brand-name drug manufacturers will be able to maintain the level of support for hyperlipidemia that they have provided over the past three decades in terms of science, education, and marketing efforts. Generic manufacturers will not provide support for statins through education, science, or other means. Therefore, it is currently uncertain how the U.S. Department of Health and Human Services' Million Hearts Initiative goals will be achieved.

[0011] In light of the above background, what is needed in the art is a system and method for enabling human subjects to obtain over-the-counter delivery of statin drug compositions used, for example, to treat or prevent atherosclerotic cardiovascular disease by lowering cholesterol. Summary of the Invention

[0012] This disclosure addresses the need in the art for a system and method for the over-the-counter delivery of statin drug compositions for the treatment or prevention of atherosclerotic cardiovascular disease, for example, by lowering cholesterol. In this disclosure, a system and method for the over-the-counter delivery of statin drugs to a subject are provided. A survey is run against the subject against a first plurality of filters. When a filter in the first plurality of filters is activated, the subject is considered ineligible. The survey is also run against a second plurality of filters. When a corresponding filter in the second plurality of filters is activated, a corresponding warning is provided to the subject. When no filter in the first plurality of filters is activated and the subject has acknowledged each warning associated with each activated filter in the second plurality of filters, the method continues to a fulfillment process. The fulfillment of the stored composition order involves transmitting a drug fact label of the statin drug to the subject and authorizing delivery of the statin drug to the subject upon the subject's acknowledgment that the label has been read, the authorization including a destination associated with the subject.

[0013] Therefore, one aspect of this disclosure provides a computer system for qualifying human subjects for over-the-counter delivery of a statin drug composition for lowering cholesterol. The computer system includes one or more processors and a memory. The memory includes non-transitory instructions that, when executed by the one or more processors, perform a method. In the method, a first survey is conducted on the subject, thereby obtaining a first plurality of survey results.

[0014] In some embodiments, the first plurality of survey results include: the subject's sex; whether the subject is female and whether they are in one of the following states: (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant; whether the subject has or has had liver disease; the subject's age; the subject's total cholesterol level; the subject's HDL cholesterol count; the subject's systolic blood pressure; the subject's ethnicity; whether the subject is taking antihypertensive medication; whether the subject is taking one or more medications that interact with the statin drug composition, wherein the one or more medications contain cyclosporine; the subject's smoking status; the subject's diabetes status; the subject's alcohol consumption status; whether the subject has had an adverse reaction to cholesterol-lowering medications; and whether the subject has had an atherosclerotic cardiovascular event or undergone heart surgery.

[0015] The survey results, in whole or in part, are run against a first plurality of filters for the first category. When a corresponding filter among the first plurality of filters is activated, the subject is deemed ineligible for delivery of the statin composition, and the method terminates without delivery of the statin composition to the subject. In some embodiments, the first plurality of filters include a pregnancy filter, a cyclosporine filter, and a liver disease filter.

[0016] The method continues by running all or part of the survey results from the first plurality of survey results against a second plurality of filters for the second category. When a corresponding filter in the second plurality of filters is activated, a warning corresponding to that filter is provided to the subject. In some embodiments, the second plurality of filters include a total cholesterol level filter, a summary cohort equation filter, an age filter, a drug interaction filter, an alcohol consumption filter, an adverse reaction filter, and an atherosclerotic cardiovascular event filter.

[0017] In some embodiments, the aggregated cohort equation filter combines the subject's sex, ethnicity, age, total cholesterol level, HDL cholesterol count, systolic blood pressure, whether the subject is taking medications that interact with statins, smoking status, and diabetes status to extrapolate the risk of atherosclerotic cardiovascular disease. The aggregated cohort equation filter is considered activated when the risk meets a first threshold range or a first threshold value.

[0018] The method continues by obtaining confirmation from the subject of any warnings issued to the subject by any of the second plurality of filters.

[0019] The method continues by performing the process when (i) no filter in the first plurality of filters is activated and (ii) the subject has confirmed each warning associated with each activated filter in the second plurality of filters.

[0020] In some embodiments, the fulfillment process includes: storing an instruction for an initial order of the statin composition in a subject profile associated with the subject; transmitting an over-the-counter (OTC) drug fact label of the statin composition to the subject; and authorizing the delivery of the statin composition to the subject upon the subject's confirmation that the subject has received and read the OTC drug fact label, wherein the authorization includes a destination associated with the subject (e.g., where the statin composition should be delivered or which store the statin composition should be delivered to for the subject to obtain).

[0021] Another aspect of this disclosure provides a method for qualifying a person for over-the-counter delivery of a statin drug composition for lowering cholesterol. The method comprises: obtaining from the person a first set of information, the first set of information comprising one or more of the following: the person's sex; whether the person is female and whether the person is in one of the following states: (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant; whether the person has or has had liver disease; the person's age; the person's total cholesterol level; the person's HDL cholesterol count; the person's systolic blood pressure; the person's ethnicity; whether the person is currently receiving treatment for hypertension; whether the person is taking one or more compositions that interact with the statin drug composition, wherein the one or more compositions contain cyclosporine; the person's smoking status; the person's diabetes status; the person's alcohol consumption status; whether the person has had an adverse reaction to the cholesterol-lowering composition; and whether the person has had an atherosclerotic cardiovascular event or undergone heart surgery. In some embodiments, the first set of information comprises each of the features listed above.

[0022] The method further comprises: running all or a portion of the information set against a first plurality of filters of a first category, wherein when a corresponding filter among the first plurality of filters is activated, the person is deemed ineligible for delivery of the statin drug composition, and the method terminates if the statin drug composition is not delivered to the person. In some embodiments, the first plurality of filters includes one or more of the following: a pregnancy filter, a cyclosporine filter, and a filter for liver disease or allergic reaction to the statin drug composition. In some embodiments, the first plurality of filters includes all the filters listed above.

[0023] The method further comprises: running all or a portion of the first information set against a second plurality of filters of the second category, wherein when a corresponding filter among the second plurality of filters is activated, a warning corresponding to the corresponding filter is provided to the person. In some embodiments, the second plurality of filters comprises one or more of the following: a total cholesterol level filter; a summary cohort equation filter that combines the person's sex, the person's ethnicity, the person's age, the person's total cholesterol level, the person's high-density lipoprotein cholesterol count, the person's systolic blood pressure, whether the person is taking a combination that interacts with statins, the person's smoking status, and the person's diabetes status to infer the probability of atherosclerotic cardiovascular disease, wherein the summary cohort equation filter is considered activated when the probability meets a first threshold range or a first threshold; an age filter; a drug interaction filter; an alcohol consumption filter; an adverse reaction filter; and an atherosclerotic cardiovascular event filter. In some embodiments, the second plurality of filters comprises all of the filters listed above.

[0024] The method continues by obtaining confirmation from the person of any warning issued to the person by any of the second plurality of filters.

[0025] The method continues by performing the process when (i) no filter in the first plurality of filters is activated and (ii) the person has confirmed each warning associated with each activated filter in the second plurality of filters.

[0026] In some embodiments, the fulfillment process includes: storing an instruction for an initial order of the statin composition in a person profile; transmitting an over-the-counter drug label of the statin composition to the person; and authorizing the delivery of the statin composition to the person upon the person's confirmation that the over-the-counter drug label has been received and read, wherein the authorization includes a destination associated with the person.

[0027] In some embodiments, the first plurality of survey results may further include whether the subject has a family history of early-onset heart attack or stroke, such as a history of heart attack or stroke before the age of 45, 50, 55, 60, etc.

[0028] In some embodiments, the first plurality of survey results include the subject's hsCRP level.

[0029] In some embodiments, the first plurality of survey results further include whether the subject has ever had kidney disease. In some embodiments, the second plurality of filters in the second category include a kidney disease filter.

[0030] In some embodiments, the second plurality of filters in the second category includes an Asian ancestry filter. In some embodiments, the Asian ancestry filter is activated when the first plurality of survey results indicate that the subject is Asian.

[0031] In some embodiments, the atherosclerotic cardiovascular disease is coronary heart disease (e.g., myocardial infarction, angina pectoris, coronary artery stenosis, etc.), cerebrovascular disease (e.g., transient ischemic attack, ischemic stroke, carotid artery stenosis, etc.), peripheral artery disease (e.g., claudication) or aortic atherosclerotic disease (e.g., abdominal aortic aneurysm, descending thoracic artery aneurysm, etc.).

[0032] In some embodiments, the risk of the atherosclerotic cardiovascular disease is a lifetime risk, a three-year risk, a five-year risk, a ten-year risk, or a fifteen-year risk.

[0033] In some embodiments, the summary cohort equation is implemented in the form of a multivariate Cox proportional hazards regression.

[0034] In some embodiments, the statin composition includes lovastatin, fluvastatin, atorvastatin, rosuvastatin, simvastatin, pravastatin, or pitavastatin. For example, in some embodiments, the pharmaceutical composition is lovastatin, with a daily dose between 15 mg and 25 mg. In some embodiments, the pharmaceutical composition is fluvastatin, with a daily dose between 20 mg and 40 mg. In some embodiments, the pharmaceutical composition is atorvastatin, with a daily dose between 20 mg and 80 mg. In some embodiments, the pharmaceutical composition is rosuvastatin, with a daily dose between 2.5 mg and 15 mg. In some embodiments, the pharmaceutical composition is simvastatin, with a daily dose between 10 mg and 40 mg. In some embodiments, the pharmaceutical composition is pravastatin, with a daily dose between 10 mg and 80 mg. In some embodiments, the pharmaceutical composition is fluvastatin, with a daily dose of 70 mg to 90 mg. In some embodiments, the pharmaceutical composition is pitavastatin, with a daily dose of 1 mg to 4 mg.

[0035] In some embodiments, the over-the-counter drug fact label specifies that the statin composition includes rosuvastatin, and that the subject takes the statin composition at a predetermined daily dose between 4 mg and 15 mg.

[0036] In some embodiments, the over-the-counter drug fact label specifies that the statin composition includes rosuvastatin, and that the subject takes the statin composition at a predetermined daily dose between 4 mg and 11 mg.

[0037] In some embodiments, the over-the-counter drug fact label specifies that the statin composition comprises atorvastatin or simvastatin, and that the subject takes the statin composition at a predetermined daily dose between 10 mg and 25 mg.

[0038] In some embodiments, providing the statin composition to the subject includes shipping the statin composition to a physical address associated with the subject. In other embodiments, providing the statin composition to the subject includes shipping the statin composition to a pharmacy associated with the subject.

[0039] In some embodiments, the first pregnancy filter is activated when the first plurality of survey results indicate that the subject is pregnant.

[0040] In some embodiments, the age filter is activated when the first plurality of survey results indicate that the subject is a woman aged 49 or younger or 76 or older.

[0041] In some embodiments, the age filter is activated when the first plurality of survey results indicate that the subject is a male aged 39 years or younger or 66 years or older.

[0042] In some embodiments, the liver disease or allergic reaction filter to the statin composition is activated when the first plurality of survey results indicate that the subject has developed liver disease or an allergic reaction to the statin composition.

[0043] In some embodiments, the total cholesterol level filter is activated when the first plurality of survey results indicate that the subject's total cholesterol is less than 130 mg / dl or greater than 275 mg / dl. In some embodiments, the total cholesterol level filter is activated when the first plurality of survey results indicate that the subject's total cholesterol is less than 160 mg / dl or greater than 260 mg / dl.

[0044] In some embodiments, the risk of atherosclerotic cardiovascular disease is a 10-year risk, and the first threshold of the aggregated cohort equation filter is 7.5%.

[0045] In some embodiments, the Asian ancestry filter is activated when the first plurality of survey results indicate that the subject is Asian. In some embodiments, the Asian ancestry filter is not used.

[0046] In some embodiments, the drug interaction filter is activated when the first plurality of survey results indicate that the subject is currently taking cyclosporine, blood thinners, warfarin, HIV / AIDS drugs, colchicine, hepatitis drugs, cholesterol-lowering drugs, itraconazole, ketoconazole, or fluconazole. In some embodiments, the drug interaction filter is not used.

[0047] In some embodiments, the wine filter is activated when the first plurality of survey results indicate that the subject drinks an average of three or more servings of wine per day. In some embodiments, the wine filter is activated when the first plurality of survey results indicate that the subject drinks an average of two or more servings of wine per day. In some embodiments, the wine filter is activated when the first plurality of survey results indicate that the subject drinks an average of one or more servings of wine per day. In some embodiments, the wine filter is activated when the first plurality of survey results indicate that the subject drinks an average of four or more servings of wine per day. In some embodiments, the wine filter is activated when the first plurality of survey results indicate that the subject drinks an average of five or more servings of wine per day. In some embodiments, the wine filter is not used.

[0048] In some embodiments, when the risk derived from the aggregated cohort equation filter is within the first threshold range, the statin composition is provided to the subject during the course of treatment at a first predetermined daily dose; and when the risk derived from the aggregated cohort equation filter is within the second threshold range, the statin composition is provided to the subject during the course of treatment at a second predetermined daily dose. For example, in some embodiments, the statin composition comprises rosuvastatin, the risk of atherosclerotic cardiovascular disease is a 10-year risk, the first threshold range is between 5% and 7.5%, the first predetermined daily dose is between 4 mg and 8 mg, the second threshold range is between 7.5% and 10%, and the second predetermined daily dose is between 8 mg and 11 mg.

[0049] In some embodiments, the method further includes: in response to receiving a reorder request for the statin composition from the subject, performing a procedure including conducting a second survey on the subject to obtain a second plurality of survey results. The second plurality of survey results include: whether the subject has experienced muscle irregularities since taking the statin composition; whether the subject is pregnant; whether the subject is currently taking a drug that interacts with the statin composition; and whether the subject has had an atherosclerotic cardiovascular event (e.g., heart attack or stroke) or undergone heart surgery since the last order of the statin composition. The procedure further includes: running all or part of the survey results of the plurality of second survey results against a third plurality of filters, wherein when a corresponding filter in the third plurality of filters is activated, an action corresponding to the corresponding filter is triggered, and wherein the third plurality of filters includes the pregnancy filter, the muscle irregularity filter, the second drug interaction filter, and the atherosclerotic cardiovascular event filter. The reorder process further includes: obtaining from the subject confirmation of any warnings issued to the subject by any of the third plurality of filters.

[0050] The re-performance process continues further when (i) the activation of a filter in the third plurality of filters has not terminated the re-performance process and (ii) the subject has confirmed each warning associated with each of the activated and warning-associated filters in the third plurality of filters.

[0051] The re-fulfillment process further includes: storing an instruction to reorder the statin composition in a subject profile; transmitting an over-the-counter drug fact label of the statin composition to the subject; and authorizing the reordering of the statin composition to the subject upon the subject confirming that the subject has received and read the over-the-counter drug fact label, wherein the authorization includes the subject's destination.

[0052] In some embodiments, the muscle irregularity filter is activated when the second plurality of survey results indicate that the subject has experienced unexplained muscle spasms or muscle weakness since taking the statin composition; the pregnancy filter is activated when the second plurality of survey results indicate that the subject is pregnant, resulting in termination of the re-performance procedure; and the second drug interaction filter is activated when the second plurality of survey results indicate that the subject is currently taking cyclosporine, blood thinners, warfarin, HIV / AIDS drugs, or cholesterol-lowering drugs.

[0053] Another aspect of this disclosure provides a method for qualifying human subjects to receive over-the-counter delivery of a statin drug composition for lowering cholesterol. The method includes: conducting a first survey on the subject, thereby obtaining a first plurality of survey results. The first plurality of survey results include: (i) the subject's sex; whether the subject is female and whether they are: (a) pregnant, (b) breastfeeding, or (c) planning to become pregnant; (iii) whether the subject has or has had liver disease; (iv) the subject's age; (v) the subject's total cholesterol level; (vi) the subject's HDL cholesterol count; (vii) the subject's systolic blood pressure; (viii) the subject's ethnicity; (ix) whether the subject is taking antihypertensive medication; (x) whether the subject is taking one or more medications that interact with the statin combination, wherein the one or more medications contain cyclosporine; (xi) the subject's smoking status; (xii) the subject's diabetes status; (xiii) the subject's alcohol consumption status; (xiv) whether the subject has had an adverse reaction to cholesterol-lowering medications; and (xv) whether the subject has had an atherosclerotic cardiovascular event or undergone heart surgery. All or some of the survey results from the first plurality of survey results are run against the first plurality of filters of the first category. When a corresponding filter among the first plurality of filters is activated, the subject is deemed ineligible for delivery of the statin composition, and the method terminates without delivery of the statin composition to the subject. The first plurality of filters include a pregnancy filter, a cyclosporine filter, and a liver disease filter. All or part of the results from the first plurality of surveys are also run against a second plurality of filters of a second category. When a corresponding filter among the second plurality of filters is activated, a warning corresponding to the corresponding filter is provided to the subject. The second plurality of filters include: a total cholesterol level filter; and a summary cohort equation filter that combines the subject's sex, ethnicity, age, total cholesterol level, HDL cholesterol count, systolic blood pressure, whether the subject is taking medications that interact with the statin, smoking status, and diabetes status to extrapolate the risk of atherosclerotic cardiovascular disease, wherein the summary cohort equation filter is considered activated when the risk meets a first threshold range or a first threshold. The second plurality of filters further includes: an age filter, a drug interaction filter, an alcohol consumption filter, an adverse reaction filter, and an atherosclerotic cardiovascular event filter.The method proceeds to the subject when (i) no filter in the first plurality of filters is activated and (ii) the subject has confirmed each warning associated with each activated filter in the second plurality of filters. The procedure includes: storing an instruction for an initial order of the statin composition in a subject profile; transmitting an over-the-counter (OTC) drug fact label of the statin composition to the subject; and authorizing the delivery of the statin composition to the subject upon confirmation that the subject has received and read the OTC drug fact label, wherein the authorization includes a destination associated with the subject.

[0054] Another aspect of this disclosure provides a non-transitory computer-readable storage medium storing instructions that, when executed by a computer system, cause the computer system to perform any of the methods disclosed herein for qualifying a human subject for over-the-counter delivery of a statin drug composition for lowering cholesterol. Attached Figure Description

[0055] Figure 1 An exemplary system topology according to an embodiment of the present disclosure is shown, the exemplary system topology comprising: an over-the-counter (OTC) dispensing device for dispensing statin drug compositions for qualifying human subjects for over-the-counter delivery of statin drug compositions for lowering cholesterol; a data collection device for collecting subject data; one or more user devices associated with the human subjects; and one or more pharmacy destinations for dispensing statin drug compositions over the counter, wherein the above components are optionally interconnected via a communication network.

[0056] Figure 2 An example apparatus for qualifying human subjects for over-the-counter delivery of a statin drug composition for lowering cholesterol is shown according to embodiments of the present disclosure.

[0057] Figure 3 An example apparatus for qualifying a human subject for over-the-counter delivery of a statin drug composition for lowering cholesterol, according to embodiments of the present disclosure, is shown.

[0058] Figure 4A , 4B 4C, 4D, and 4E together provide a flowchart of a process for qualifying a human subject for over-the-counter delivery of a statin drug composition for lowering cholesterol, according to various embodiments of the present disclosure, wherein the elements in the dashed boxes are optional.

[0059] Figure 5A , 5B 5C, 5D, 5E, 5F, 5G, 5H, 5I, 5J, 5K, 5L, 5M, 5N, 5O, 5P, 5Q, 5R, 5S, 5T, 5U, and 5V together illustrate a first survey of subjects for obtaining a first plurality of survey results according to an embodiment of the present disclosure.

[0060] Figure 6 Feedback from a first survey is shown, based on embodiments of the present disclosure.

[0061] Figure 7 Evaluation results from a first survey are presented according to embodiments of the present disclosure.

[0062] Figure 8 A comparison of contraindications for various statin drugs is presented.

[0063] Throughout the various views in the accompanying drawings, similar reference numerals refer to the corresponding parts. Detailed Implementation

[0064] On one hand, this disclosure involves surveying subjects to obtain survey results that determine whether the subjects are eligible for access to over-the-counter (OTC) statin compositions for the treatment or prevention of atherosclerotic cardiovascular disease. The survey results are used as the basis for operating filters in a first category. If any trigger condition for a filter in the first category is activated, the subject is not eligible for access to the OTC statin composition. The survey results are also used as the basis for operating filters in a second category. If any trigger condition for a filter in the second category is activated, the subject is provided with a warning message associated with the activated filter in the second category. If no filter in the first category is activated and the subject successfully resolves the warning message associated with the activated filter in the second category, a fulfillment process for OTC delivery of the statin composition to the subject's associated destination is initiated.

[0065] Figure 1An example of an integrated system 48 is shown for surveying subjects to qualify them for OTC delivery of statin drug compositions and for delivering the statin drug compositions to destinations associated with eligible subjects. The integrated system 48 includes one or more connected user devices 102 for inputting survey data and requesting statin drug compositions; one or more pharmacy destination devices 104 for receiving instructions to provide statin drug compositions to eligible subjects; an OTC dispensing device 250 for statin drug compositions; and one or more data collection devices 200 for collecting subject data. Throughout this disclosure, for clarity only, the data collection device 200 and the OTC dispensing device 250 for statin drug compositions will be referred to as separate devices. That is, the disclosed functions of the data collection device 200 and the disclosed functions of the OTC dispensing device 250 for statin drug compositions are contained in separate devices, such as... Figure 1 As shown. However, it should be understood that, in fact, in some embodiments, the disclosed functions of the data collection device 200 and the disclosed functions of the statin drug composition OTC dispensing device 250 are contained in a single device.

[0066] Using the integrated system 48, survey results from the subjects are run against a first plurality of filters. When a filter in the first plurality of filters is activated for a corresponding subject, the corresponding subject is considered ineligible. The survey results are also run against a second plurality of filters. When a corresponding filter in the second plurality of filters is activated for a corresponding subject, a warning associated with that filter is provided to the corresponding subject. When no filter is activated in the first plurality of filters and the subject has confirmed or otherwise successfully resolved each warning associated with each activated filter in the second plurality of filters, the method enabled by the integrated system 48 continues to the fulfillment process. As part of the fulfillment process, a composition order is stored (e.g., stored in a user profile associated with the subject receiving the medication), a drug fact label for the statin is delivered to eligible subjects, and, after the subject confirms that the label has been read, authorization is granted to dispense the statin to the subject at a specific destination associated with the subject.

[0067] Reference will now be made in detail to embodiments, examples of which are illustrated in the accompanying drawings. Numerous specific details are set forth in the following detailed description to provide a thorough understanding of this disclosure. However, it will be apparent to those skilled in the art that this disclosure can be practiced without these specific details. In other instances, well-known methods, procedures, components, circuits, and networks have not been described in detail so as not to unnecessarily obscure aspects of the embodiments.

[0068] It should also be understood that while the terms first, second, etc., may be used herein to describe various elements, these elements should not be limited by these terms. These terms are used only to distinguish one element from another. For example, without departing from the scope of this disclosure, a first subject may be referred to as a second subject, and similarly, a second subject may be referred to as a first subject. Although both the first subject and the second subject are subjects, they are not the same subject. Furthermore, the terms "subject," "user," and "patient" are used interchangeably herein. The term insulin pen refers to an injection device suitable for administering discrete doses of insulin, wherein the injection device is adapted to record and transmit dose-related data.

[0069] The terminology used in this disclosure is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used in the specification and appended claims of this invention, the singular forms “a / an” and “the” are intended to equally include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used herein refers to and covers any and all possible combinations of one or more of the associated enumerations. It should be further understood that, when used in this specification, the term “comprises and / or comprising” specifies the presence of stated features, integers, steps, operations, elements, and / or components, but does not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0070] As used herein, depending on the context, the term "if" can be interpreted as "when," "upon," "in response to determination," or "in response to detection." Similarly, depending on the context, the phrase "if determination" or "if [the stated condition or event] is detected" can be interpreted as "when determination," "in response to determination," "when [the stated condition or event] is detected," or "in response to the detection of [the stated condition or event]."

[0071] As used herein, the term “over the counter” means, as disclosed herein, available for retail purchase without a prescription or license from a physician or medical practitioner.

[0072] As used herein, the term "contraindication" refers to a condition in which treatment is not appropriate, such as the over-the-counter use of statins. Contraindications include physical characteristics of the subject (e.g., pregnancy or liver disease) and concurrent drug use (e.g., cyclosporine use). In this context, based on some embodiments of the methods, systems, and software disclosed herein, identification of contraindications triggers a Class I filter that prevents authorization to provide statin drug compositions.

[0073] As used herein, the term "risk factor" refers to a condition that may preclude treatment, such as over-the-counter use of statins. Risk factors include the subject's physical characteristics (e.g., cholesterol levels) and concurrent medication use (e.g., use of blood thinners). In this context, based on some embodiments of the methods, systems, and software disclosed herein, identification of risk factors triggers a second-category filter that prevents authorization of the statin composition without confirmation that the subject has discussed the risk factors with a healthcare professional.

[0074] In the context of this disclosure, statin compositions that classify a condition as a contraindication or risk factor specific to a particular identity and dosage are authorized for over-the-counter use. The classification of a specific condition, such as concurrent cyclosporine use, may differ between different statin compositions (e.g., for a first statin, it may be classified as a contraindication; for a second statin, it may be classified as a risk factor; and / or for a third statin, it may be neither classified as a contraindication nor a risk factor). Similarly, for a specific statin used at a first over-the-counter dose, the specific condition may be classified as a contraindication; for the same specific statin used at a second (e.g., lower) over-the-counter dose, the specific condition may be classified as a risk factor; and / or for the same specific statin used at a third (e.g., lowest) over-the-counter dose, the specific condition may be neither classified as a contraindication nor a risk factor.

[0075] Reference Figure 1The statin composition OTC dispensing device 250 qualifies human subjects for over-the-counter delivery of statin compositions used to lower cholesterol. For this purpose, a data collection device 200 electrically connected to the statin composition OTC dispensing device 250 receives survey results originating from one or more user devices 102 associated with the subject. In some embodiments, the data collection device 200 receives such survey results directly from the user device 102. For example, in some embodiments, the data collection device 200 receives this data wirelessly via radio frequency signals. In some embodiments, such signals conform to 802.11 (WiFi), Bluetooth, or ZigBee standards. In some embodiments, the data collection device 200 directly receives such data, analyzes the data, and transmits the analyzed data to the statin composition OTC dispensing device 250.

[0076] In some embodiments, the data collection device 200 and / or the statin composition OTC dispensing device 250 are not close to the subjects and / or do not have wireless capabilities, or such wireless capabilities are not used for the purpose of obtaining survey results. In such embodiments, the communication network 106 can be used to transmit survey questions from the statin composition OTC dispensing device 250 to the user device 102 and to transmit responses to such survey questions from the user device 102 to the data collection device 200 and / or the statin composition OTC dispensing device 250. Further, in some embodiments, the communication network 106 is used to transmit authorization from the statin composition OTC dispensing device 250 for dispensing statin survey questions to the pharmacy destination device 104.

[0077] Examples of Network 106 include, but are not limited to, the World Wide Web (WWW), intranets and / or wireless networks (such as cellular telephone networks), wireless local area networks (LANs) and / or metropolitan area networks (MANs), and other devices that communicate wirelessly. Wireless communication optionally employs any of a variety of communication standards, protocols, and technologies, including, but not limited to: Global System for Mobile Communications (GSM), Enhanced Data GSM Environment (EDGE), High-Speed ​​Downlink Packet Access (HSDPA), High-Speed ​​Uplink Packet Access (HSUPA), Evolved Data Only (EV-DO), HSPA, HSPA+, Dual-Cell HSPA (DC-HSPDA), Long Term Evolution (LTE), Near Field Communication (NFC), Wideband Code Division Multiple Access (W-CDMA), Code Division Multiple Access (CDMA), Time Division Multiple Access (TDMA), Bluetooth, and Wi-Fi (e.g., IEEE 802.11a, IEEE 802.11ac, IEEE 802.11ax, IEEE 802.11b, IEEE 802.11g, and / or IEEE...). 802.11n), Voice over Internet Protocol (VoIP), Wi-MAX, email protocols (e.g., Internet Messaging Access Protocol (IMAP) and / or Post Office Protocol (POP)), instant messaging (e.g., Extensible Messaging and Presence Protocol (XMPP), Session Initiation Protocol for Instant Messaging and Presence Extensions (SIMPLE), Instant Messaging and Presence Service (IMPS)) and / or Short Message Service (SMS) or any other suitable communication protocol, including communication protocols that have not been developed as of the date of this disclosure.

[0078] Of course, other topologies of system 48 are possible. For example, the one or more user devices 102 and the one or more pharmacy destination devices 104 can communicate directly with the data collection device 200 and / or the statin drug composition OTC dispensing device 250, rather than relying on the communication network 106. Furthermore, the data collection device 200 and / or the statin drug composition OTC dispensing device 250 can be a portable electronic device, a server computer, or in fact constitute several computers linked together in a network, or may be a virtual machine in a cloud computing environment. Therefore, Figure 1 The exemplary topologies shown are merely for describing features of embodiments of this disclosure in a manner readily understood by those skilled in the art.

[0079] refer to Figure 2 In a typical embodiment, the statin drug composition OTC dispensing device 250 includes one or more computers. In order to... Figure 2As described herein, the statin drug composition OTC dispensing device 250 is represented as a single computer containing all the functions required to qualify a human subject for over-the-counter delivery of a statin drug composition for lowering cholesterol. However, this disclosure is not limited thereto. In some embodiments, the functions for qualifying a human subject for over-the-counter delivery of a statin drug composition for lowering cholesterol are distributed across any number of networked computers and / or reside on each of several networked computers and / or are hosted on one or more virtual machines located at a remote location and accessible via a communications network 106. Those skilled in the art will understand that any of the various computer topologies used in the application is applicable and all such topologies are within the scope of this disclosure.

[0080] Considering the foregoing, let's move on to... Figure 2 An exemplary statin drug composition OTC dispensing device 250 for optimizing the timing of short-acting insulin drug dosage in a prescribed insulin regimen for a subject includes one or more processing units (CPUs) 274, a network or other communication interface 284, a memory 192 (e.g., random access memory), one or more disk storage devices and / or permanent devices 290 optionally accessed by one or more controllers 288, one or more communication buses 213 for interconnecting the above components, a user interface 278 (including a display 282 and inputs 280 (e.g., keyboard, keypad, touchscreen)), and a power supply 276 for powering the above components. In some embodiments, well-known computing techniques such as caching are used to enable seamless sharing of data in memory 192 with non-volatile memory 290. In some embodiments, memory 192 and / or memory 290 includes a large-capacity storage device remotely located relative to one or more central processing units 274. In other words, some data stored in memory 192 and / or memory 290 can actually be hosted outside the statin composition OTC dispensing device 250 but can be accessed by the statin composition OTC dispensing device 250 via network interface 284 through the Internet, intranet, or other forms of network or electronic cable (in [the context of the OTC dispensing device 250]). Figure 2 (shown as element 106) on a computer that is accessed electronically.

[0081] In some embodiments, the memory 192 of the timed statin composition OTC dispensing device 250 for optimizing the dosage of short-acting insulin in a prescribed insulin regimen for a subject includes and stores the following:

[0082] Operating system 202, which contains programs for handling various basic system services;

[0083] Survey module 204;

[0084] The first survey 206 is used to qualify subjects to initially order statin drug compositions for the treatment or prevention of atherosclerotic cardiovascular disease, for example, by lowering cholesterol. The first survey includes a first plurality of survey questions 208.

[0085] The second investigation 210, which was used to qualify subjects to reorder statin drug compositions, included a second plurality of investigation questions 212;

[0086] The first plurality of filters 214 of the first category, each of the first plurality of filters 216 including one or more filter triggering conditions 218;

[0087] The second category of second plurality of filters 220, each of the second plurality of filters 222 including one or more filter trigger conditions 224 and one or more associated filter warnings 226;

[0088] Fulfillment module 228 is configured to perform a fulfillment process when (i) a filter 216 in the first plurality of filters 214 is not activated for the subject and (ii) the subject has acknowledged each warning associated with each filter 224 in the second plurality of filters 220 activated due to the subject's answer to the first survey 206 or the second survey 208, wherein the fulfillment process includes delivering an over-the-counter drug fact label 230 of a statin drug composition to the subject and receiving confirmation from the subject that the over-the-counter drug fact label has been received and read; and

[0089] Subject profile data storage device 232 includes a user profile 234 for each of a plurality of subjects, each corresponding user profile 234 containing information about the corresponding subject among the plurality of subjects, including the date and destination 236 of the initial order for the statin composition made by the corresponding subject using the statin composition OTC dispensing device 250 and the date and destination 238 of any reorder.

[0090] In some embodiments, the survey module 204 can be accessed within any browser (phone, tablet, laptop / desktop computer). In some embodiments, the survey module 204 runs on a local device framework and is available for download to a user device 102 running an operating system 102 such as Android or iOS.

[0091] In some embodiments, one or more of the data elements or modules identified above in the OTC dispensing device 250 for the over-the-counter delivery of a statin drug composition for lowering cholesterol, used to qualify human subjects, are stored in one or more of the previously described memory devices and correspond to a set of instructions for performing the functions described above. The data, modules, or programs (e.g., the set of instructions) identified above need not be implemented as separate software programs, processes, or modules, and therefore, in various embodiments, subsets of these modules can be combined or otherwise rearranged. In some embodiments, memory 192 and / or 290 optionally stores a subset of the modules and data structures identified above. Furthermore, in some embodiments, memory 192 and / or 290 stores additional modules and data structures not described above.

[0092] In some embodiments, the statin composition OTC dispensing device 250 for qualifying human subjects for over-the-counter delivery of the statin composition for lowering cholesterol is a smartphone (e.g., iPhone), laptop, tablet, desktop computer, or other form of electronic device (e.g., game console). In some embodiments, the statin composition OTC dispensing device 250 is non-movable. In some embodiments, the statin composition OTC dispensing device 250 is movable.

[0093] In some embodiments, the statin drug composition OTC dispensing device 250 is not a smartphone, but a tablet computer, desktop computer, emergency vehicle computer, or other form of wired or wireless networked device. For the sake of brevity and clarity, Figure 2 Only a few of the possible components of the statin composition OTC dispensing device 250 are shown in order to better highlight the additional software modules installed on the statin composition OTC dispensing device 250.

[0094] Figure 3 A description of a user device 102 that can be used with this disclosure is provided. Figure 3The user device 102 shown includes one or more processing units (CPUs) 274, a peripheral device interface 370, a memory controller 368, a network or other communication interface 284, a memory 192 (e.g., random access memory), a user interface 278 (which includes a display 282 and inputs 280 (e.g., a keyboard, keypad, touchscreen)), an optional accelerometer 317, an optional GPS 319, an optional audio circuitry 372, an optional speaker 360, an optional microphone 362, one or more optional intensity sensors 364 (e.g., touch-sensitive surfaces such as the touch-sensitive display system 282 of the user device 102) for detecting the intensity of contact on the user device 102, an optional input / output (I / O) subsystem 366, one or more optional optical sensors 373, one or more communication buses 213 for interconnecting the above components, and a power supply 276 for powering the above components.

[0095] In some embodiments, input 280 is a touch-sensitive display, such as a touch-sensitive surface. In some embodiments, user interface 278 includes one or more soft keyboard embodiments. The soft keyboard embodiments may include a standard (QWERTY) and / or non-standard symbol configuration on the displayed icons.

[0096] In addition to one or more accelerometers 317 Figure 3 The user device 102 shown optionally includes a magnetometer (not shown) and a GPS 319 (or GLONASS or other global navigation system) receiver, which are used to obtain information about the location and orientation (e.g., portrait or landscape) of the user device 102 and / or to determine the amount of physical exercise of the subject.

[0097] It should be understood that, Figure 3 The user device 102 shown is merely one example of a multifunctional device that can be used to conduct investigations in order to qualify for over-the-counter delivery of statin drug compositions for lowering cholesterol, and the user device 102 may optionally have more or fewer components than those shown, may optionally combine two or more components, or may optionally have different component configurations or arrangements. Figure 3 The components shown are implemented in hardware, software, firmware, or a combination thereof, and include one or more signal processing and / or application-specific integrated circuits.

[0098] Figure 3The memory 192 of the user device 102 shown optionally includes high-speed random access memory, and optionally also includes non-volatile memory, such as one or more disk storage devices, flash memory devices, or other non-volatile solid-state memory devices. Access to the memory 192 by other components of the statin drug composition OTC dispensing device 250, such as one or more CPUs 274, is optionally controlled by a memory controller 368.

[0099] In some embodiments, Figure 3 The memory 192 of the user device 102 shown optionally includes the survey module 204 described above for the OTC dispensing device 250 for combining statin drug compositions. Furthermore, in some embodiments, such as Figure 3 As shown, the first plurality of filters 214 includes a pregnancy filter 216-1, a cyclosporine filter 216-2, and a filter 216-3 for liver disease or allergic reactions to statin drug compositions. Furthermore, in some embodiments, such as Figure 3 As further shown, the second plurality of filters 220 includes a total cholesterol level filter 222-1, a summary cohort equation filter 222-2, an age filter 222-3, a drug interaction filter 222-4, an alcohol consumption filter 222-5, an adverse reaction filter 222-6, and an atherosclerotic cardiovascular event filter 222-7.

[0100] In some embodiments, optional accelerometer 317, optional GPS 319 and / or magnetometer (not shown) or such components of user device 102 are used to recommend one or more suitable destinations for the over-the-counter delivery of statins to an eligible subject.

[0101] Peripheral interface 370 can be used to couple the device's input and output peripherals to one or more CPUs 274 and memory 192. The one or more processors 274 run or execute various software programs and / or instruction sets stored in memory 192, such as survey module 204, to perform various functions of user device 102 and process data.

[0102] In some embodiments, the peripheral interface 370, one or more CPUs 274, and memory controller 368 are optionally implemented on a single chip. In other embodiments, they are implemented on separate chips.

[0103] The network interface's RF (radio frequency) circuitry system 284 receives and transmits RF signals, also known as electromagnetic signals. In some embodiments, this RF circuitry system is used to transmit survey module 204, survey questions 208 / 212, answers to survey questions 208 / 212, and / or over-the-counter drug fact labels 230. In some embodiments, the RF circuitry system 108 converts electrical signals to electromagnetic signals or vice versa, and communicates via electromagnetic signals with communication networks and other communication devices and / or data collection devices 200 and / or statin drug composition OTC dispensing devices 250. The RF circuitry system 284 optionally includes known circuitry systems for performing these functions, including, but not limited to, antenna systems, RF transceivers, one or more amplifiers, tuners, one or more oscillators, digital signal processors, codec chipsets, subscriber identity module (SIM) cards, memory, etc. The RF circuitry system 284 optionally communicates with communication network 106. In some embodiments, circuit system 284 does not include RF circuitry and is actually connected to network 106 via one or more hardwires (e.g., fiber optic cables, coaxial cables, etc.).

[0104] In some embodiments, audio circuitry 372, optional speaker 360, and optional microphone 362 provide an audio interface between the subject and user device 102. Audio circuitry 372 receives audio data from peripheral device interface 370, converts the audio data into electrical signals, and transmits the electrical signals to speaker 360. Speaker 360 converts the electrical signals into sound waves audible to humans. Audio circuitry 372 also receives electrical signals converted from sound waves by microphone 362. Audio circuitry 372 converts the electrical signals into audio data and transmits the audio data to peripheral device interface 370 for processing. Audio data is optionally retrieved from memory 192 and / or transmitted to RF circuitry 284 by peripheral device interface 370.

[0105] In some embodiments, power supply 276 optionally includes a power management system, one or more power sources (e.g., a battery, alternating current (AC)), a recharging system, a power failure detection circuit, a power converter or inverter, a power status indicator (e.g., a light-emitting diode (LED)), and any other components associated with the generation, management, and distribution of power in the portable device.

[0106] In some embodiments, the user device 102 optionally further includes one or more optical sensors 373. The one or more optical sensors 373 optionally include charge-coupled devices (CCDs) or complementary metal-oxide-semiconductor (CMOS) phototransistors. The one or more optical sensors 373 receive light from the environment projected through one or more lenses and convert the light into data representing an image. The one or more optical sensors 373 optionally capture still images and / or video. In some embodiments, the optical sensors are located on the back of the user device 102, opposite to the display 282 on the front of the user device 102, such that input 280 can be used as a viewfinder for acquiring still and / or video images. In some embodiments, another optical sensor 373 is located on the front of the user device 102, such that an image of the subject is acquired (e.g., to verify the subject's health, condition, or identity as part of qualifying the subject for over-the-counter delivery of a statin drug composition for lowering cholesterol, to aid in remote diagnosis of the subject's condition, or to acquire the subject's visual physiological measurements, etc.).

[0107] like Figure 3 As shown, user device 102 preferably includes an operating system 202, which contains programs for handling various basic system services. The operating system 202 (e.g., iOS, DARWIN, RTXC, LINUX, UNIX, OS X, WINDOWS, or an embedded operating system such as VxWorks) includes various software components and / or drivers for controlling and managing general system tasks (e.g., memory management, storage device control, power management, etc.) and facilitates communication between the various hardware and software components.

[0108] In some embodiments, user device 102 is a smartphone. In other embodiments, user device 102 is not a smartphone, but a tablet computer, desktop computer, emergency vehicle computer, or other form of wired or wireless networked device. For the sake of brevity and clarity, Figure 3 Only a few of the possible components of user device 102 are shown in order to better highlight the additional software modules installed on user device 102.

[0109] Although Figure 1 The disclosed system 48 can operate independently, but in some embodiments, it can also be linked to electronic medical records to exchange information in any way.

[0110] Since details of the system 48 for the over-the-counter delivery of statin drug compositions for lowering cholesterol to qualify human subjects have already been disclosed, please refer to [reference needed]. Figures 4A to 4EDetailed flowcharts relating to processes and features of a system according to embodiments of the present disclosure are disclosed. In some embodiments, such processes and features of the system are provided by… Figure 2 and 3 The survey module 204 and / or shown Figure 3 The execution module 228 shown is used for execution. In some embodiments, the execution module 228 and the investigation module 204 are a single software module.

[0111] Boxes 402-406: Reference Figure 4A Box 402, the objective of this disclosure is to enable subjects to receive over-the-counter delivery of statin drug compositions for lowering cholesterol using a computer system such as the statin composition OTC dispensing device 250. Figure 2 As shown, the statin drug composition OTC dispensing device 250 includes one or more processors 274 and a memory 192 / 290. The memory stores non-transitory instructions that, when executed by the one or more processors, perform the method.

[0112] In some embodiments, the statin composition includes atorvastatin. Fluvastatin LESCOL lovastatin pitavastatin Pravastatin rosuvastatin or simvastatin (404). These statin combinations are described in the following literature: Lee et al., 2007, “Comparison of Efficacy and Tolerability of Pitavastatin and Atorvastatin: an 8-Week, Multicenter, Randomized, Open-Label, Dose-Titration Study in Korean Patients with Hypercholesterolemia”, Clin Ther, 2007; 29:2365-73; Bradford et al., 1990, “Expanded clinical evaluation of lovastatin (EXCEL) study design and patient characteristics of a double-blind, placebo-controlled study in patients with moderate hypercholesterolemia”. "hypercholesterolemia," *American Journal of Cardiology* 66: pp. 44B-55B; Serruys et al., 2002, "Fluvastatin for Prevention of Cardiac Events Following Successful First Percutaneous Coronary Intervention: A Randomized Controlled Trial," *JAMA* 287: pp. 3215-3222; Sacks et al., 1996, "Effects of Pravastatin on Coronary Events Following Myocardial Infarction in Patients with Average Cholesterol Levels.""The effect of pravastatin oncoronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators" New England Journal of Medicine, 1996 335(14): 001-9; Anonymous, 2002 "Heart Protection Study Collaborative Group, MRC / BHF Heart Protection Study of cholesterol lowering with simvastatin 20,536 high-risk individuals: a randomized placebo-controlled trial" (trial)" Lancet 360: 7-22; Jones et al., 2003, "Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial)," American Journal of Cardiology 92(2):152–60, each of the above references is incorporated herein by reference. In some embodiments, the statin composition comprises a statin and another lipid-lowering agent, such as atorvastatin / ezetimibe. Lovastatin + Niacin Simvastatin / Ezetimibe Simvastatin / Niacin Extended-Release Tablets

[0113] In some embodiments, the statin composition comprises any compound of any one of claims 1-117 of U.S. Patent No. 5,969,156C1 entitled “Crystalline [R-(R*,R*)]-2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemicalcium salt (atorvastatin)”, which is incorporated herein by reference. In some embodiments, the statin composition includes any compound disclosed in U.S. Patent No. 5,969,156C1 entitled “Crystal [R-(R*,R*)]-2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemicalcium salt (atorvastatin)”, which is incorporated herein by reference.

[0114] In some embodiments, the statin composition comprises any compound of any one of claims 1-20 of U.S. Patent No. 6,242,003B1 entitled "Organic Compounds," which is incorporated herein by reference.

[0115] In some embodiments, the statin composition includes any compound disclosed in U.S. Patent Nos. 5,854,259, 5,586,336, 6,465,477, 7,022,713, and / or 8,557,993, each of which is incorporated herein by reference.

[0116] In some embodiments, the statin composition includes any compound disclosed in U.S. Patent Nos. 6,316,460, 6,858,618, 7,030,152, 7,964,614, and / or RE37314, each of which is incorporated herein by reference.

[0117] It should be understood that the survey questions and filters used in the survey responses can vary depending on the assigned statin combination. This is due to the differences in the contraindications of various statins, such as different drug-drug interactions, drug clearance pathways, etc. For example, co-administration of 500 mg telanavir / 200 mg BID may lead to adverse reactions with atorvastatin. AUC increased 9.4-fold and led to an 8.6-fold increase in Cmax, but rosuvastatin... AUC and Cmax increased only 1.4-fold and 2.2-fold, respectively. Therefore, in some embodiments, a survey qualifying a subject for OTC use of atorvastatin may ask the subject whether they are currently taking telanavir and BID, while a survey qualifying a subject for OTC use of rosuvastatin may not ask the aforementioned question.

[0118] Figure 8 This paper presents a comparison of some contraindications for the prescribing use of several statin drugs. Figure 8 The list of contraindications in this study is not exhaustive. Those skilled in the art can recognize other contraindications for specific statins and / or consider risk factors as contraindications based on the intended use of the statin.

[0119] For example, while drug-drug interactions are known, concomitant use of cyclosporine agents is not a contraindication to the prescribing use of rosuvastatin (e.g., CRESTOR). This is likely because a medical professional prescribing rosuvastatin can assess the risk and / or severity of drug-drug interactions in a particular patient at the prescribed dosage. However, in some embodiments, concomitant use of cyclosporine agents is considered a contraindication to the over-the-counter (OTC) use of rosuvastatin (e.g., applying a subject's answer regarding whether they are currently taking cyclosporine agents to a type 1 filter, which, when activated, prevents authorized dispensing of OTC rosuvastatin).

[0120] Similarly, in some embodiments, when qualifying a subject for access to lower-dose OTC use of a statin, contraindications to the use of a prescription-strength agent are considered as risk factors only, or not at all. For example, in some embodiments where the OTC dose of a lovastatin agent (e.g., MEVACOR) is low enough to offset serious drug-drug interactions with strong CYP3A4 inhibitors, the use of a CYP3A4 inhibitor is considered as a risk factor only (e.g., the subject's answer regarding whether they are currently taking a strong CYP3A4 inhibitor is applied to a type 2 filter, which, when activated, prompts the subject to consult their physician about possible drug-drug interactions and requires confirmation that the subject has consulted their physician before authorizing the dispensing of OTC lovastatin).

[0121] Reference box 406, in some embodiments, atherosclerotic cardiovascular disease is coronary artery disease, such as myocardial infarction, angina pectoris, or coronary artery stenosis. In some embodiments, atherosclerotic cardiovascular disease is cerebrovascular disease, such as transient ischemic attack, ischemic stroke, or carotid artery stenosis. In some embodiments, atherosclerotic cardiovascular disease is peripheral artery disease, such as claudication. In some embodiments, atherosclerotic cardiovascular disease is aortic atherosclerotic disease, such as abdominal aortic aneurysm or descending thoracic artery aneurysm.

[0122] Boxes 408-410: Reference Figure 4A In box 408, in the method, a first survey 206 is conducted on the subject, thereby obtaining a first plurality of survey results for the survey questions. In some embodiments, using, for example... Figure 5A The message shown is used to initiate the first survey 206 of the subject. Referring to block 410, in some embodiments, the first plurality of survey results include: the subject's gender (e.g., in response to...). Figure 5G The survey questions shown include: 208, etc.; whether the subject is female and whether they are in one of the following states: (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant (e.g., in response to...). Figure 5B The survey questions shown in Figure 208, etc.); whether the subject has or has had liver disease (e.g., in response to such survey questions). Figure 5C The survey questions shown include 208 and other survey questions. Figure 5D (included information); the age of the subject (e.g., in response to, such as...) Figure 5H The survey questions shown in Figure 208, etc.); the total cholesterol level of the subjects (e.g., in response to, such as Figure 5J The survey questions shown in Figure 208, etc.); the subject's high-density lipoprotein (HDL) cholesterol count (e.g., in response to, as shown in Figure 208, etc.). Figure 5K The survey questions shown in Figure 208, etc.); the subject's systolic blood pressure (e.g., in response to, such as Figure 5L The survey questions shown in Figure 208, etc.; the race of the respondents (e.g., in response to such survey questions). Figure 5I The survey question shown is 208, etc.; whether the subject is taking high blood pressure medication (e.g., in response to such...). Figure 5M The survey questions shown include 208 and other survey questions. Figure 5N (Incidental information); whether the subject is taking one or more drugs that interact with a statin combination, wherein the one or more drugs contain cyclosporine (e.g., in response to such...). Figure 5E The survey questions shown include 208 and other survey questions. Figure 5F Additional information, and / or in response to such Figure 5TThe survey questions shown include 208 and other survey questions. Figure 5U (included information); the subject's smoking status (e.g., in response to...) Figure 5P The survey questions shown in Figure 208, etc.); the subject's diabetes status (e.g., in response to, as shown in Figure 208, etc.). Figure 5O The survey questions shown include 208 and other survey questions; the subjects' drinking status (e.g., in response to, for example) Figure 5R The survey questions shown include: 208, etc.; whether the subject has ever had an adverse reaction to cholesterol-lowering drugs (e.g., in response to...). Figure 5S The survey questions shown include 208, etc.; and whether the subject has had an atherosclerotic cardiovascular event or undergone heart surgery (e.g., in response to such...). Figure 5V The survey questions shown include 208 and other survey questions.

[0123] In some embodiments, the first plurality of survey results include some or all of the features listed in Table 1. In some embodiments, the first plurality of survey results include 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, or all 24 features listed in Table 1.

[0124] Similarly, in some embodiments, the first survey includes questions that elicit responses providing some or all of the features listed in Table 1. In some embodiments, the survey includes questions corresponding to each of the survey results required by the method described herein. In other embodiments, the survey includes questions corresponding only to a subset of the survey results required by the method described herein. In such embodiments, other survey results required by the method described herein are obtained in other ways, such as from healthcare providers, from previous surveys, from data associated with pharmacies, etc., when registering for / subscribing to services associated with qualifying a subject for over-the-counter medications. For example, in some embodiments, the subject provides a personal medical assessment associated with an insurance company, hospital, or other healthcare provider, and information about the subject required by the method described herein, such as one or more survey results, is obtained from a pre-existing database associated with the personal medical assessment (e.g., the subject's last cholesterol or blood pressure measurement).

[0125] Table 1. Exemplary Survey Results

[0126]

[0127]

[0128] In one embodiment, the first survey result includes at least survey results 1-15 provided in Table 1. In another embodiment, the first survey result includes at least survey results 1-16 provided in Table 1. In another embodiment, the first survey result includes at least survey results 1-15 and 17 provided in Table 1. In another embodiment, the first survey result includes at least survey results 1-15 and 18 provided in Table 1. In another embodiment, the first survey result includes at least survey results 1-17 provided in Table 1. In another embodiment, the first survey result includes at least survey results 1-16 and 18 provided in Table 1. In another embodiment, the first survey result includes at least survey results 1-18 provided in Table 1.

[0129] It is envisioned that, in some embodiments, any one or more of the findings provided in Table 1 will not be included in the first findings. For example, in some embodiments, the features associated with a particular findings will be informative when qualifying a subject for one particular statin rather than another. For example, a technician will recognize that different statins have different risks and drug interaction profiles. Therefore, the information required to qualify a subject for one statin with known adverse drug interactions may not be necessary to qualify the same subject for a second statin. For information on clinically significant statin interactions, see, for example, PHARMACIST'S LETTER / PRESCRIBER'S LETTER, PL Detail-Document #280405, Therapeutic Research Center, April 2012, the contents of which are incorporated herein by reference in their entirety for all purposes.

[0130] Therefore, it is envisioned that the first survey result comprises any subset of the survey results provided in Table 1. For the sake of brevity, not all possible combinations of the survey results provided in Table 1 are specifically described herein. However, those skilled in the art will be able to readily envision any particular subset of the survey results provided in Table 1. Similarly, those skilled in the art can understand other survey results not provided in Table 1 that can be combined with any subset of the survey results provided in Table 1 to form the first survey result used in the method described herein.

[0131] Boxes 412-416: Reference Figure 4AIn box 412, once the first survey 206 has been completed by a potential subject, thereby obtaining the first plurality of survey results, all or some of the survey results from the first plurality of survey results are run against the first plurality of filters 214 for the first category. When a corresponding filter 216 in the first plurality of filters 214 is activated, the subject is deemed ineligible for delivery of the statin drug composition, and the method terminates without delivery of the statin drug composition to the subject. Boxes 414 and 416 illustrate specific filters in the first plurality of filters and exemplary triggering conditions for activating said filters.

[0132] In some embodiments, the first plurality of filters 214 of the first category includes some or all of the filters listed in Table 2. For example, in some embodiments, the first plurality of survey results includes two, three, or all four filters listed in Table 2.

[0133] Table 2. Exemplary filters for Category 1

[0134] 1a Pregnancy filter 2a First drug interaction filter (e.g., cyclosporine filter) 3a Liver disease filter 4a Allergy Filter

[0135] In one embodiment, the first plurality of filters includes at least filters 1a-4a provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 1a, 2a, and 3a provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 1a, 2a, and 4a provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 1a, 3a, and 4a provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 2a, 3a, and 4a provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 1a and 2a provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 1a and 3a provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 1a and 4a provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 2a and 3a provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 2a and 4a provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 3a and 4a provided in Table 2.

[0136] It is envisioned that, in some embodiments, any one or more filters provided in Table 2 will not be included in the first plurality of filters. For example, in some embodiments, the features associated with a particular survey outcome will be informative when qualifying a subject for one particular statin drug instead of another. Therefore, it is envisioned that the first plurality of filters include any subset of the filters provided in Table 2. Similarly, those skilled in the art can recognize other filters not provided in Table 2 that can be combined with any subset of the filters provided in Table 2 to form the first plurality of filters used in the methods described herein.

[0137] Reference block 414, in some embodiments, the first plurality of filters 214 includes a pregnancy filter. Reference block 416, the pregnancy filter is activated when the first plurality of survey results indicate that the subject is pregnant. In some embodiments, when according to Figure 5B As shown in survey question 208, the pregnancy filter is activated when the first plurality of survey results indicate that the subject is pregnant, considering pregnancy, breastfeeding, or planning pregnancy. If the pregnancy filter is activated, the subject is not permitted to obtain the statin drug composition over-the-counter.

[0138] In some embodiments, the first plurality of filters 214 include cyclosporine filters. In some embodiments, when according to Figure 5E The survey questions shown are 208 and Figure 5F The accompanying information states that the first plurality of survey results indicate that the cyclosporine filter was activated while the subject was taking cyclosporine. If the cyclosporine filter is activated, the subject is not permitted to obtain statin compositions over-the-counter.

[0139] In some embodiments, the first plurality of filters 214 include filters for liver disease or allergic reactions to statin drug compositions. In some embodiments, when respectively according to Figure 5C and 5S As shown in survey question 208, when the first plurality of survey results indicate that the subject has liver disease or an allergic reaction to any cholesterol-lowering drug, the liver disease or allergy reaction filter for the statin drug composition is activated. In some embodiments, the liver disease and allergy reaction filters are separate filters.

[0140] Boxes 418-438: Reference Figure 4BIn box 418, if no filter among the first plurality of filters is activated, the method continues to run all or part of the survey results from the first plurality of survey results for the second plurality of filters 220 of the second category. When a corresponding filter 222 in the second plurality of filters is activated, a warning 226 corresponding to the corresponding filter is provided to the subject.

[0141] In some embodiments, the second plurality of filters 220 of the second category includes some or all of the filters listed in Table 3. For example, in some embodiments, the first plurality of survey results includes 2, 3, 4, 5, 6, 7, 8, or all 9 filters listed in Table 2.

[0142] Table 3. Exemplary filters in the second category

[0143] 1a Total cholesterol level filter 2a Summary Queue Equation Filter 3a Age Filter 4a Drug Interaction Filter 5b Drinking filters 6b Adverse reaction filter 7b Atherosclerotic cardiovascular event filter 8b Kidney disease filter 9b Asian bloodline filter

[0144] It is envisioned that, in some embodiments, any one or more filters provided in Table 3 will not be included in the second plurality of filters. For example, in some embodiments, the features associated with a particular survey outcome will be informative when qualifying a subject for one particular statin drug instead of another. Therefore, it is envisioned that the second plurality of filters include any subset of the filters provided in Table 3. Similarly, those skilled in the art can recognize other filters not provided in Table 3 that can be combined with any subset of the filters provided in Table 3 to form the second plurality of filters used in the methods described herein.

[0145] For example, reference box 420 and Figure 3 In some embodiments, the second plurality of filters 220 includes a total cholesterol level filter 222-1, an age filter 222-3, a drug interaction filter 222-4, an alcohol consumption filter 222-5, an adverse reaction filter 222-6, an atherosclerotic cardiovascular event filter 222-7, and / or a summary cohort equation filter 222-2.

[0146] In one embodiment, the pooled cohort equation filter incorporates the subject's sex, ethnicity, age, total cholesterol level, HDL cholesterol count, systolic blood pressure, whether the subject is taking medications that interact with statins, smoking status, and diabetes status to extrapolate the risk of atherosclerotic cardiovascular disease. In some embodiments, the pooled cohort equation also incorporates a family history of early-onset heart attack or stroke (e.g., a history of heart attack or stroke before age 45, 50, 55, 60, etc.). In some embodiments, the pooled cohort equation incorporates the subject's hsCRP level.

[0147] Reference box 422: When the risk meets a first threshold range or a first threshold, the filter of the summary cohort equation 222-2 is considered to be activated. Reference box 424: In some embodiments, the atherosclerotic cardiovascular disease risk used to calculate the summary cohort equation is a lifetime risk, a 5-year risk, or a 10-year risk. Reference box 426: In some embodiments, the summary cohort equation is implemented in the form of a multivariate Cox proportional hazards regression. Reference box 428: In some embodiments, the atherosclerotic cardiovascular disease risk used to calculate the summary cohort equation is a 10-year risk, and the first threshold is 7.5%.

[0148] The pooled cohort equation estimates the probability of hard atherosclerotic cardiovascular disease (ASCVD) events or fatal cardiovascular events occurring within a given time period (such as the next 5 years, the next 10 years, or the lifetime of the subject). In some embodiments, the summary cohort equations for the summary cohort equation filter 222-2 are calculated using the guidelines set forth in the following literature: Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB Sr, Gibbons R, Greenland P, Lackland DT, Levy D, O'Donnell CJ, Robinson J, Schwartz JS, Smith SCJr, Sorlie P, Shero ST, Stone NJ, Wilson PW. "2013 ACC / AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology / American Heart Association Task Force on Practice Guidelines," Circulation 2013; 00:000–000, which is incorporated herein by reference. Following Goff's method, calculating the 10-year risk estimate of hard ASCVD events using the pooled cohort equation is accomplished through a series of steps. First, the natural logarithm of the subject's age, total cholesterol, HDL-C, and systolic blood pressure is calculated, with systolic blood pressure being a treated or untreated value. For example, the calculation of the pooled cohort equation, using Goff's method, estimates the probability of a 55-year-old white male subject with a total cholesterol of 213 mg / dL, HDL-C of 50 mg / dL, and untreated systolic blood pressure of 120 mm Hg, who is non-smoking and has no diabetes, having a hard ASCVD event within the next 10 years. This calculation begins by taking the natural logarithm of the subject's age (4.01), the natural logarithm of the subject's total cholesterol (5.36), the natural logarithm of the subject's HDL-C (3.91), and the natural logarithm of the subject's systolic blood pressure (4.79). These values ​​are then multiplied by the coefficients in the equation (coefficients column of Table A, Goff's method) from the individual's specific race-sex group to obtain a "coefficient × value". That is:

[0149] Multiplying the natural logarithm of the subject's age (4.01) by a coefficient of 12.344 yields a coefficient × value of 49.47.

[0150] The natural logarithm of the subjects' total cholesterol (5.36) was multiplied by a coefficient of 11.853 to obtain a coefficient × value of 63.55.

[0151] Multiplying the natural logarithm of the subject's HDL-C (3.91) by a coefficient of -7.990 yields a coefficient × value of -31.26.

[0152] Multiply the natural logarithm of the subject's systolic blood pressure (4.79) by a factor of 1.764 to obtain a "factor × value" of 8.45.

[0153] Also calculate any appropriate interaction terms. According to Goff, in the case of a 55-year-old white male subject, the interaction terms are:

[0154] The logarithm of age (4.01) x the logarithm of total cholesterol (5.36) multiplied by a coefficient of -2.664 yields a coefficient x value of -57.24.

[0155] The logarithm of age (4.01) x the logarithm of HDL-C (3.91) multiplied by the coefficient 1.769 gives the coefficient x value of 27.73.

[0156] Then the sum of these "coefficients × values" for each individual is calculated (49.47 + 63.55 - 31.26 + 8.45 - 57.24 + 27.73 = 60.69). The 10-year risk estimate for the first hard ASCVD event is formally calculated as 1 minus the baseline survival rate at year 10 for sex / race (in this case, white male), raised to the power of the exponent obtained by subtracting the population-specific average "coefficients × values" for race (white) and sex (male) from the sum of the "coefficients × values" calculated above; or, in the form of an equation:

[0157] 1-0.9144° (00.08-01.18)

[0158] The figure 0.9144 represents the baseline survival rate at 10 years for white males from Goff et al., the figure 60.69 is the coefficient-value calculated for the specific subjects mentioned above, and the figure 61.18 is the overall average coefficient-value for race (white) and sex (male) from Goff et al. This corresponds to a 5.3% probability of experiencing a first hard ASCVD event within 10 years.

[0159] In some embodiments, the pooled cohort equation for calculating the risk of fatal cardiovascular disease using the pooled cohort equation filter 222-2 is calculated using the guidelines set forth in the following literature: Perk J. et al., European Guidelines on cardiovascular disease prevention in clinical practice, European Heart Journal 33:1635–1701 (2012), which is incorporated herein by reference. In some embodiments, the pooled cohort equation filter follows a low CVD risk score (SCORE) table that incorporates the subject's sex, age, total cholesterol level, systolic blood pressure, and smoking status, as set forth in the preceding literature by Perk J. et al. In some embodiments, the pooled cohort equation filter follows a high CVD risk score (SCORE) table that incorporates the subject's sex, age, total cholesterol level, systolic blood pressure, and smoking status, as set forth in the preceding literature by Perk J. et al. In some embodiments, a conversion factor is used to convert the risk of fatal cardiovascular disease into the risk of fatal plus non-fatal hard cardiovascular events, as illustrated in the following literature: Catapano AL et al., 2016 ESC / EAS Guidelines for the Management of Dyslipidaemias, European Journal of Cardiology, 14 October 2016; 37(39):2999-3058, which is incorporated herein by reference.

[0160] Referring to reference box 428, in some embodiments, a scoring (SCORE) guideline is used to calculate the risk of fatal cardiovascular disease in the aggregate cohort equation as a 10-year risk, and a first threshold, such as a threshold for the trigger filter when a subject's risk is determined to be less than it, is a 3% risk. In some embodiments, the risk of fatal cardiovascular disease in the aggregate cohort equation is a 10-year risk, and the first threshold is a 5% risk. In some embodiments, the risk of fatal cardiovascular disease in the aggregate cohort equation is a 10-year risk, and a second threshold, such as a threshold for the trigger filter when a subject's risk is determined to be greater than it, is a 4% risk. In some embodiments, the risk of fatal cardiovascular disease in the aggregate cohort equation is a 10-year risk, and the second threshold is a 9% risk. In some embodiments, the risk of fatal cardiovascular disease in the aggregate cohort equation is a 10-year risk, and the second threshold is a 14% risk. In some embodiments, the risk of fatal cardiovascular disease in the aggregate cohort equation is a 10-year risk, and a threshold range, such as a threshold range for the trigger filter when a subject's risk is determined to be higher or lower than it, is a 2-14% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 3-14% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 5-14% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 10-14% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 2-9% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 3-9% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 5-9% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 2-4% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 3-4% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 2-3% risk. In some embodiments, lipid-lowering therapy is not indicated; for example, a second-category filter is activated when a subject is determined to have a 10-year risk of fatal cardiovascular disease of less than 5%.

[0161] In some embodiments, the pooled cohort equation for calculating the risk of cardiovascular disease-related death is calculated using the guidelines set forth in the following literature: Teramoto et al., Executive summary of the Japan Atherosclerosis Society (JAS) guidelines for the diagnosis and prevention of atherosclerotic cardiovascular diseases in Japan-2012 version, J Atheroscler Thromb, 2013; 20(6):517-23, which is incorporated herein by reference. In some embodiments, the pooled cohort equation filter follows the NIPPON DATA80 absolute risk assessment table, which incorporates the subject's sex, age, total cholesterol level, systolic blood pressure, and smoking status, as set forth in the preceding literature by Teramoto et al. In some embodiments, the summative cohort equation also incorporates the subject’s glucose level.

[0162] Referring to reference box 428, in some embodiments, using NIPPON DATA80 guidance, the risk of coronary artery death for calculating the aggregate cohort equation is a 10-year risk, and a first threshold, such as a threshold for the trigger filter when the subject's risk is determined to be less than it, is a 0.5% risk. In some embodiments, the risk of fatal cardiovascular disease for calculating the aggregate cohort equation is a 10-year risk, and the first threshold is a 1% risk. In some embodiments, the risk of fatal cardiovascular disease for calculating the aggregate cohort equation is a 10-year risk, and the first threshold is a 2% risk. In some embodiments, the risk of fatal cardiovascular disease for calculating the aggregate cohort equation is a 10-year risk, and a second threshold, such as a threshold for the trigger filter when the subject's risk is determined to be greater than it, is a 1% risk. In some embodiments, the risk of fatal cardiovascular disease for calculating the aggregate cohort equation is a 10-year risk, and the second threshold is a 2% risk. In some embodiments, the risk of fatal cardiovascular disease for calculating the aggregate cohort equation is a 10-year risk, and the second threshold is a 5% risk. In some embodiments, the risk of fatal cardiovascular disease for calculating the aggregate cohort equation is a 10-year risk, and the second threshold is a 10% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range, such as the threshold range of the trigger filter when a subject's risk is determined to be higher or lower, is 0.5-10% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 1-10% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 2-10% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 5-10% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 0.5-5% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 1-5% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 2-5% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 0.5-2% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 1-2% risk. In some embodiments, the risk of fatal cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 0.5-1% risk.

[0163] In some embodiments, the summary cohort equation for calculating the risk of atherosclerotic cardiovascular disease is calculated using the guidelines set forth in the following literature: Yang X. et al., Predicting the 10-Year Risks of Atherosclerotic Cardiovascular Disease in Chinese Population: The China-PAR Project (Prediction for ASCVD Risk in China) Circulation 2016 Nov 8; 134(19):1430-1440, which is incorporated herein by reference. In some embodiments, the aggregated cohort equation filter follows a China PAR sex-specific equation that incorporates the subject's sex (e.g., to determine which equation to use), age, systolic blood pressure, blood pressure treatment status, total cholesterol level, smoking status, diabetes status, waist circumference, geographic residence (e.g., for Chinese residents only, whether northern or southern China), urban residence (e.g., for Chinese male residents only, whether urban or rural), and family history of atherosclerotic cardiovascular disease (e.g., for males only), as described in Yang X. et al., as previously described in the literature and supplementary information. In some embodiments, the aggregated cohort equation also incorporates the subject's HDL cholesterol level and / or cholesterol treatment status.

[0164] Referring to reference box 428, in some embodiments, using Chinese PAR guidelines, the risk of atherosclerotic cardiovascular disease used to calculate the aggregate cohort equation is a 10-year risk, and a first threshold, such as a threshold for the trigger filter when a subject's risk is determined to be less than it, is a 5% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the aggregate cohort equation is a 10-year risk, and the first threshold is a 7.5% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the aggregate cohort equation is a 10-year risk, and a second threshold, such as a threshold for the trigger filter when a subject's risk is determined to be greater than it, is a 7.5% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the aggregate cohort equation is a 10-year risk, and the second threshold is a 10% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the aggregate cohort equation is a 10-year risk, and a threshold range, such as a threshold range for the trigger filter when a subject's risk is determined to be higher or lower than it, is a 5-10% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 7.5-10% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 5-7.5% risk.

[0165] In some embodiments, the pooled cohort equation for calculating the risk of atherosclerotic cardiovascular disease is calculated using the guidelines set forth in the following literature: National Vascular Disease Prevention Alliance, Guidelines for the management of absolute cardiovascular disease risk, 2012, which is incorporated herein by reference. In some embodiments, the pooled cohort equation filter follows the Australian cardiovascular risk table, which incorporates the subject's sex, age, systolic blood pressure, ratio of total cholesterol to HDL, and smoking status, as set forth in the following literature: Absolute cardiovascular disease risk management: Quick reference guide for health professionals, 2012, National Stroke Foundation. In some embodiments, the pooled cohort equation also incorporates the subject's ancestry (e.g., only in Australia, for Indigenous, Torres Strait Islander, or other groups).

[0166] Referring to reference box 428, in some embodiments, the Australian Cardiovascular Risk Table is used, and the risk of atherosclerotic cardiovascular disease in the aggregate cohort equation is a 5-year risk, and a first threshold, such as a threshold for the trigger filter when the subject's risk is determined to be less than it, is a 5% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease in the aggregate cohort equation is a 5-year risk, and the first threshold is a 10% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease in the aggregate cohort equation is a 5-year risk, and the first threshold is a 16% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease in the aggregate cohort equation is a 5-year risk, and the first threshold is a 20% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease in the aggregate cohort equation is a 5-year risk, and the first threshold is a 25% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease in the aggregate cohort equation is a 5-year risk, and a second threshold, such as a threshold for the trigger filter when the subject's risk is determined to be greater than it, is a 30% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the second threshold is a 25% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the second threshold is a 20% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the second threshold is a 16% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the second threshold is a 10% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the second threshold is a 5% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the threshold range, such as the threshold range of the trigger filter when a subject's risk is determined to be higher or lower, is 5-30% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the threshold range is 10-30% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the threshold range is 16-30% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the threshold range is 20-30% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the threshold range is 25-30% risk.In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the threshold range is 5-25% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the threshold range is 10-25% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the threshold range is 16-25% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the threshold range is 20-25% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the threshold range is 5-20% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the threshold range is 10-20% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the threshold range is 16-20% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the threshold range is 5-16% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the threshold range is 10-16% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 5-year risk, and the threshold range is 5-10% risk.

[0167] In some embodiments, the pooled cohort equation for calculating the risk of atherosclerotic cardiovascular disease is calculated using the guidelines set forth in the following literature: Anderson TJ et al., 2016, Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult, Canadian Journal of Cardiology, November 2016; 32(11):1263-1282, which is incorporated herein by reference. In some embodiments, the summary cohort equation filter follows the Framingham Heart Study Risk Scoreequation (FRS), which incorporates subject sex, age, systolic blood pressure, blood pressure treatment status, total cholesterol level, HDL cholesterol level, smoking status, diabetes status, and CVD event history, as described in the following reference: D'Agostino RB Sr et al., General cardiovascular risk profile for use in primary care: the Framingham Heart Study, Circulation, 12 February 2008; 117(6):743-53, which is incorporated herein by reference. In some embodiments, the aggregated cohort equation filter follows the modified Framingham Heart Study Risk Rating Equation (FRS), which incorporates factors such as subject sex, age, systolic blood pressure, blood pressure treatment status, total cholesterol level, HDL cholesterol level, smoking status, diabetes status, CVD event history, and family history of premature cardiovascular disease, as described by Anderson TJ et al., as previously described.In some embodiments, the summary cohort equation filter follows the Cardiovascular Life Expectancy Model (CLEM), as described in the following reference: Grover SA et al., "Estimating the benefits of modifying risk factors of cardiovascular disease: a comparison of primary vs. secondary prevention," Archives of Internal Medicine, March 23, 1998; 158(6):655-62, which is incorporated herein by reference.

[0168] Referring to reference box 428, in some embodiments, using guidance from the Canadian Cardiovascular Society, the risk of atherosclerotic cardiovascular disease (ACD) used to calculate the pooled cohort equation is a 10-year risk, and a first threshold, such as a threshold for the trigger filter when a subject's risk is determined to be less than it, is a 5% risk. In some embodiments, the risk of ACD used to calculate the pooled cohort equation is a 10-year risk, and the first threshold is a 10% risk. In some embodiments, the risk of ACD used to calculate the pooled cohort equation is a 10-year risk, and a second threshold, such as a threshold for the trigger filter when a subject's risk is determined to be greater than it, is a 20% risk. In some embodiments, the risk of ACD used to calculate the pooled cohort equation is a 10-year risk, and the second threshold is a 10% risk. In some embodiments, the risk of ACD used to calculate the pooled cohort equation is a 10-year risk, and a threshold range, such as a threshold range for the trigger filter when a subject's risk is determined to be higher or lower than it, is a 5-20% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 10-20% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is a 10-year risk, and the threshold range is 5-10% risk.

[0169] In some embodiments, the probability of an ASCVD event or fatal cardiovascular event occurring within a given time period (e.g., within the next 10 years) is modified (e.g., as calculated above) by considering one or both of the subject's family history of early-onset heart attack or stroke and the subject's hsCRP level to reduce the likelihood of over-predicting adverse events, such as the likelihood in subjects without a family history of adverse events and / or with healthy hsCRP levels.

[0170] refer to Figure 5B In box 430, in some embodiments, the risk of atherosclerotic cardiovascular disease is a 10-year risk, and the first threshold of the summary cohort equation filter is 7.5%. In such embodiments, the summary cohort equation filter 222-2 is activated if the summary cohort equation (e.g., Goff, as illustrated above) indicates a probability greater than 7.5% of the occurrence of the first hard ASCVD event within 10 years. When the summary cohort equation filter 222-2 is activated, a filter warning 226 associated with the summary cohort equation filter 222-2 is delivered to the subject. Figure 6 Such warnings are shown in the document. If the subject indicates that they have spoken with their doctor and the doctor has said that it is okay to take the statin combination, then process control will continue with the fulfillment of the procedures discussed below with respect to boxes 442-458, provided that the subject meets any other requirements of the activated filter.

[0171] In some embodiments, the risk of atherosclerotic cardiovascular disease is a 5-year risk, a 10-year risk, a lifetime risk, and a first threshold for the summary cohort equation filter is 4.0%, 4.5%, 5.0%, 5.5%, 6.0%, 6.5%, 7.0%, 7.5%, 8.0%, 8.5%, 9.0%, 9.5%, or 10.0%. In such embodiments, the summary cohort equation filter 222-2 is activated if the summary cohort equation (e.g., Goff, as the equations and tables described above) indicates a probability of the first hard ASCVD event occurring within a specified time period greater than the first threshold. When the summary cohort equation filter 222-2 is activated, a filter warning 226 associated with the summary cohort equation filter 222-2 is delivered to the subject. Figure 6 Such warnings are shown in the document. If the subject indicates that they have spoken with their doctor and the doctor has said that it is okay to take the statin combination, then process control will continue with the fulfillment of the procedures discussed below with respect to boxes 442-458, provided that the subject meets any other requirements of the activated filter.

[0172] In some embodiments, the total cholesterol level filter 222-1 is activated when the first plurality of survey results indicate that the subject's total cholesterol is less than 130 mg / dL or greater than 275 mg / dL. When the total cholesterol level filter 222-1 is activated, a filter warning 226 associated with the total cholesterol level filter 222-1 is delivered to the subject. If the subject indicates that they have spoken with their doctor and the doctor has said that the statin composition is safe to take, then process control continues the fulfillment process discussed below with respect to boxes 442-458, provided that the subject meets the requirements of any other activated filters.

[0173] In some embodiments, the total cholesterol level filter 222-1 is activated when the first plurality of survey results indicate that the subject's total cholesterol is less than 100 mg / dL, less than 110 mg / dL, less than 115 mg / dL, less than 120 mg / dL, less than 125 mg / dL, less than 130 mg / dL, less than 135 mg / dL, or greater than 250 mg / dL, greater than 255 mg / dL, greater than 260 mg / dL, greater than 265 mg / dL, greater than 270 mg / dL, greater than 275 mg / dL, greater than 280 mg / dL, greater than 285 mg / dL, greater than 290 mg / dL, greater than 295 mg / dL, or greater than 300 mg / dL. When the total cholesterol level filter 222-1 is activated, a filter warning 226 associated with the total cholesterol level filter 222-1 is delivered to the subject. If the subject indicates that they have spoken with their doctor and the doctor said it is okay to take the statin combination, then process control will continue with the fulfillment of the process discussed below with respect to boxes 442-458, provided that the subject meets any other requirements of the activated filter.

[0174] In some embodiments, age filters 222-3 are activated when the first plurality of survey results indicate that the subject is a woman aged 49 years or younger or 76 years or older, and age filters are activated when the first plurality of survey results indicate that the subject is a man aged 39 years or younger or 66 years or older. When age filter 222-3 is activated, a filter warning 226 associated with age filter 222-3 is delivered to the subject. If the subject indicates that they have spoken with their doctor and the doctor said that the statin composition is suitable, then process control continues with the fulfillment process discussed below with respect to boxes 442-458, provided that the subject meets the requirements of any other activated filters.

[0175] In some embodiments, the age filter 222-3 is activated when the first plurality of survey results indicate that the subject is a woman aged 44 or younger, 45 or younger, 46 or younger, 47 or younger, 48 or younger, 49 or younger, or aged 70 or older, 71 or older, 72 or older, 73 or older, 74 or older, 75 or older, or 76 or older; and the age filter is activated when the first plurality of survey results indicate that the subject is a man aged 35 or younger, 36 or younger, 37 or younger, 38 or younger, or 39 or younger, or aged 61 or older, 62 or older, 63 or older, 64 or older, 65 or older, 66 or older, 67 or older, 68 or older, 69 or older, 70 or older, 71 or older, or 72 or older. In this embodiment, when age filter 222-3 is activated, a filter warning 226 associated with age filter 222-3 is delivered to the subject. If the subject indicates that they have spoken with their doctor and the doctor says it is okay to take the statin composition, then process control continues with the fulfillment process discussed below with respect to boxes 442-458, provided that the subject meets the requirements of any other activated filters.

[0176] refer to Figure 4B In some embodiments, at box 432, when the first plurality of survey results indicate that the subject is currently taking a blood thinner, warfarin, HIV / AIDS medication, colchicine, hepatitis medication, cholesterol-lowering medication, itraconazole, ketoconazole, or fluconazole, drug interaction filter 222-4 is activated. When drug interaction filter 222-4 is activated, a filter warning 226 associated with drug interaction filter 222-4 is delivered to the subject. If the subject indicates that they have spoken with their doctor and the doctor has said it is okay to take the statin combination, then process control continues with the fulfillment of the procedures discussed below with respect to boxes 442-458, provided that the subject meets the requirements of any other activated filters.

[0177] The inclusion of a drug within drug interaction filters 222-4 depends on the identity and / or dosage of the statin composition authorized for over-the-counter use. In some embodiments, a drug that interacts with the statin composition is included in the filters of the first plurality of filters 214, rather than in the drug interaction filters 222-4 of the second plurality of filters 220. For example, according to some embodiments, a specific drug (e.g., typically itraconazole or a strong CYP3A4 inhibitor) is included in the drug interaction filter 222-4 for the first statin composition (e.g., rosuvastatin) (e.g., as a risk factor), but is included in the filter of the first plurality of filters 214 for the second statin composition (e.g., simvastatin) (e.g., as a contraindication).

[0178] Figure 8 A contraindication table containing several prescription statin compositions includes several contraindicated drug-drug interactions. However, based on the severity and risk of drug interactions with statins authorized for over-the-counter use at specific doses, those skilled in the art will know whether to include a certain drug within drug interaction filters 222-4 or as a separate filter among the first plurality of filters 214.

[0179] In some embodiments, alcohol filters 222-5 are activated when the first plurality of survey results indicate that the subject consumed an average of three or more servings of alcohol per day. When alcohol filters 222-5 are activated, a filter warning 226 associated with alcohol filters 222-5 is delivered to the subject. If the subject indicates that they have spoken with their doctor and the doctor has said that it is appropriate to take the statin combination, then process control continues with the fulfillment procedures discussed below with respect to boxes 442-458, provided that the subject meets the requirements of any other activated filters.

[0180] In some embodiments, the alcohol filter 222-5 is activated when the first plurality of survey results indicate that the subject consumes an average of four or more drinks per week, an average of five or more drinks per week, an average of six or more drinks per week, an average of one or more drinks per day, an average of two or more drinks per day, an average of three or more drinks per day, or an average of four or more drinks per day, or an average of five or more drinks per day. In such embodiments, when the alcohol filter 222-5 is activated, a filter warning 226 associated with the alcohol filter 222-5 is delivered to the subject. If the subject indicates that they have spoken with their doctor and the doctor has said that it is okay to take the statin drug composition, then process control continues with the fulfillment process discussed below with respect to boxes 442-458, provided that the subject meets the requirements of any other activated filters.

[0181] In some embodiments, adverse reaction filter 222-6 is activated when the first plurality of survey results indicate that the subject has a past adverse reaction to a cholesterol-lowering drug. In some embodiments, adverse reaction filter 222-6 is activated when the first plurality of survey results indicate that the subject has a past adverse reaction to any statin agent. In such embodiments, when adverse reaction filter 222-6 is activated, a filter warning 226 associated with adverse reaction filter 222-6 is delivered to the subject. If the subject indicates that they have spoken with their doctor and the doctor said it is okay to take the statin drug composition, then process control continues the fulfillment process discussed below with respect to boxes 442-458, provided that the subject meets the requirements of any other activated filters.

[0182] In some embodiments, the atherosclerotic cardiovascular event filter 222-7 is activated when the first plurality of survey results indicate that the subject has experienced a past atherosclerotic cardiovascular event. In some embodiments, the atherosclerotic cardiovascular event filter 222-7 is activated when the first plurality of survey results indicate that the subject has experienced a heart attack, stroke, or cardiac operation / procedure. In such embodiments, when the atherosclerotic cardiovascular event filter 222-7 is activated, a filter warning 226 associated with the atherosclerotic cardiovascular event filter 222-7 is delivered to the subject. If the subject indicates that they have spoken with their doctor and the doctor said that it is okay to take the statin composition, then process control continues with the fulfillment process discussed below with respect to boxes 442-458, provided that the subject meets the requirements of any other activated filters.

[0183] Reference box 434, in some embodiments, the first plurality of survey results include whether the subject has kidney disease (e.g., in response to such...). Figure 5Q The survey question 208 shown is an example of a survey question, and the second plurality of filters includes a kidney disease filter (box 434). In such embodiments, when the kidney disease filter is activated, a filter warning 226 associated with the kidney disease filter is delivered to the subject. If the subject indicates that they have spoken to their doctor and the doctor says it is okay to take the statin composition, then process control continues with the fulfillment process discussed below with respect to boxes 442-458, provided that the subject meets the requirements of any other activated filters.

[0184] refer to Figure 4C In some embodiments, the second plurality of filters includes an Asian ancestry filter (box 436). In such embodiments, the Asian ancestry filter is activated when the first plurality of survey results indicate that the subject is Asian (box 438).

[0185] refer to Figure 4C In box 440, process control continues by obtaining confirmation from the subject of any warnings issued to the subject by any of the filters in the second plurality of filters 220. If a filter in the first plurality of filters 214 is activated, the subject is denied access to the over-the-counter statin composition.

[0186] Boxes 442-458: Reference Figure 4C In box 442, as discussed above, process control continues to the performance process when (i) no filter in the first plurality of filters 214 is activated and (ii) the subject has confirmed each warning associated with each activated filter in the second plurality of filters.

[0187] refer to Figure 4C In some embodiments, the fulfillment process includes storing instructions for the initial ordering of a statin drug composition in a subject profile 234.

[0188] The process further includes delivering an over-the-counter (OTC) drug fact label 230 to the subject of the statin composition. In some embodiments, the OTC drug fact label specifies the use of the statin composition and any risks associated with taking the statin composition. For example, in some embodiments, the OTC drug fact label 230 specifies that the statin composition comprises rosuvastatin and that the subject takes the statin composition at a predetermined daily dose between 2.5 mg and 15 mg (box 446). In another example embodiment, the OTC drug fact label 230 specifies that the statin composition comprises rosuvastatin and that the subject takes the statin composition at a predetermined daily dose between 4 mg and 11 mg (box 448). In another example embodiment, the OTC drug fact label 230 specifies that the statin composition comprises atorvastatin or simvastatin and that the subject takes the statin composition at a predetermined daily dose between 10 mg and 25 mg (box 450).

[0189] Refer again Figure 4CBox 444, the fulfillment process further includes: authorizing the delivery of a statin composition to the subject upon the subject's confirmation that they have received and read the over-the-counter drug fact label 230. The authorization includes a destination associated with the subject. In some embodiments, delivering the statin composition to the subject includes shipping the statin composition to a physical address associated with the subject (box 452). In some embodiments, delivering the statin composition to the subject includes shipping the statin composition to a pharmacy associated with the subject (box 454). In some embodiments, when the risk derived through the summary cohort equation filter 222-2 is within a first threshold range, the statin composition is delivered to the subject during the fulfillment process at a first predetermined daily dose. When the risk derived through the summary cohort equation filter 222-2 is within a second threshold range, the statin composition is delivered to the subject during the fulfillment process at a second predetermined daily dose (box 456). Figure 4D Box 458 illustrates an example of such an embodiment. According to the example shown in box 458, the statin composition includes rosuvastatin, and the risk of atherosclerotic cardiovascular disease is a 10-year risk. Therefore, the risk of the first hard ASCVD event occurring within the next 10 years is assessed by the pooled cohort equation filter 222-2. In the example shown in box 458, the first threshold ranges between 5% and 7.5%. This means that if the pooled cohort equation filter 222-2 determines that the risk of the first hard ASCVD event occurring within the next 10 years is between 5% and 7.5%, then a first predetermined daily dose (e.g., between 4 mg and 8 mg in the example of box 458) is authorized to the subject. Further, the second threshold ranges between 7.5% and 10%. This means that if the summary cohort equation filter 222-2 determines that the risk of the first hard ASCVD event occurring within the next 10 years is between 7.5% and 10%, then a second predetermined daily dose (e.g., between 8 mg and 11 mg in the example of box 458) is authorized to the subject.

[0190] Frame 460-462 (reorder): Reference Figure 4EBox 460, in response to receiving a reorder request for a statin composition from a subject, executes a procedure. The procedure includes: (i) conducting a second survey on the subject, thereby obtaining a second plurality of survey results. The second plurality of survey results include: asking the subject whether they have experienced muscle irregularities since taking the statin composition; asking the subject whether they are pregnant; asking the subject whether they are currently taking any medication that interacts with the statin composition; and asking the subject whether they have had an atherosclerotic cardiovascular event (or undergone heart surgery) since their last order of the statin composition. The reorder procedure further includes: running all or part of the survey results from the second plurality of surveys against a third plurality of filters of a second category. When a corresponding filter in the third plurality of filters is activated, the subject is provided with a warning corresponding to that filter.

[0191] In some embodiments, the third plurality of filters includes the pregnancy filter 216-1 described above with respect to boxes 412 and 414. Similar to the cases in boxes 412 and 414 during the initial survey, the pregnancy filter is activated and causes termination of the re-performance procedure when the second plurality of survey results indicate that the subject is pregnant.

[0192] In some embodiments, the third plurality of filters includes a muscle irregularity filter. Referring to block 462, in some embodiments, the muscle irregularity filter is activated when a second plurality of survey results indicate that the subject has experienced unexplained muscle spasms or weakness since taking the statin composition. When the muscle irregularity filter is activated, the subject is warned about the muscle irregularity and advised to consult a physician.

[0193] In some embodiments, the third plurality of filters includes a second drug interaction filter. In some embodiments, the second drug interaction filter is activated when the second plurality of findings indicate that the subject is currently taking cyclosporine, a blood thinner, warfarin, HIV / AIDS medication, or a cholesterol-lowering drug. When the muscle irregularity filter is activated, the subject is warned of adverse drug interactions with the statin combination and is advised to consult a physician.

[0194] In some embodiments, the third plurality of filters includes the atherosclerotic cardiovascular event filter 227-7 described above with respect to 420. When the atherosclerotic cardiovascular event filter 227-7 is activated, it issues a warning to the subject about atherosclerotic cardiovascular events and requests the subject to consult a physician.

[0195] The procedure further includes obtaining confirmation from the subject of each warning issued to the subject by any of the third plurality of filters, except for the pregnancy filter that caused the termination of the re-performance process, while the re-performance process has not been terminated. The procedure further includes continuing the re-performance process when (i) activation of a filter in the third plurality of filters (e.g., the pregnancy filter) has not terminated the re-performance process and (ii) the subject has confirmed each warning associated with each activated filter in the third plurality of filters (e.g., the muscle irregularity filter, the second drug interaction filter, and / or the muscle irregularity filter, etc.).

[0196] The re-fulfillment process further includes storing an instruction for reordering the statin composition 238 in the subject profile 234. The re-fulfillment process further includes delivering an over-the-counter drug fact label 230 of the statin composition to the subject. The re-fulfillment process further includes authorizing a reorder of the statin composition to the subject upon the subject confirming that they have received and read the over-the-counter drug fact label 230. This reorder provides the subject with their destination. Specific Implementation

[0198] On one hand, this disclosure provides methods, software, and computer systems for qualifying human subjects for over-the-counter delivery of statin drugs used to treat or prevent atherosclerotic cardiovascular disease. The computer system (e.g., Figure 2 The computer system 250 in the system includes tools for conducting surveys on subjects (e.g., Figure 2 The survey module 204) in the middle) obtains filters for at least two series (e.g., Figure 2 The first multiple (group) filters 214 and Figure 2 The second set of multiple filters (220) provides instructions on the necessary information about the subject. Filters in the first set of filters block authorized delivery of OTC statins, where the subject's findings identify contraindications to OTC statins. Filters in the second set of filters generate warnings, where the subject's findings identify risk factors for OTC statins. In some embodiments, the warning includes a prompt requiring the user to confirm that they have discussed the risk factors with their doctor in order to continue eligibility for OTC statins.

[0199] Then, the computer system continues the process only if (i) no filters in the first series of filters are activated, and (ii) the subject has confirmed that they have discussed each warning issued by the activated second series of filters. The computer system also transmits an over-the-counter (OTC) drug fact label to the subject for the statin composition. Once the subject confirms that they have received and read the OTC drug fact label, the computer system authorizes the delivery of the OTC statin composition to the subject.

[0200] In some embodiments, the first series of filters (e.g., Figure 2 The first set of multiple (groups) filters 214 includes a pregnancy filter and one or more drug contraindication-interaction filters, and the second series of filters (e.g., ...) Figure 2 The second multiple (group) filters 220) in the ) include a total cholesterol filter, a summary cohort equation filter, an age filter, one or more personal history filters, and one or more drug risk-interaction filters.

[0201] Regarding the first series of filters, the pregnancy filter is activated when the first plurality of survey results indicate that the subject is pregnant, believes they may be pregnant, is breastfeeding, and / or plans to become pregnant. In some embodiments, the drug contraindication-interaction filter includes an allergy filter for the statin drug composition, which is activated when the first plurality of survey results indicate that the subject has liver disease (e.g., cirrhosis or hepatitis).

[0202] In some embodiments, the one or more drug contraindication-interaction filters comprise: a cyclosporine filter, activated when the first plurality of survey results indicate that the subject is taking cyclosporine; and an allergy filter for statin compositions, activated when the first plurality of survey results indicate that the subject has liver disease (e.g., cirrhosis or hepatitis). In some embodiments, a statin composition filter is activated when the first plurality of survey results indicate that the subject has had an allergic reaction to any cholesterol-lowering drug (e.g., to a statin that the patient is eligible for, or to any statin that the subject has previously taken). In some embodiments, separate filters are implemented for liver disease and previous allergic reactions to statin compositions.

[0203] Regarding the second series of filters, the total cholesterol filter is activated when the first plurality of survey results indicate that the subject's total cholesterol is below a first cholesterol level threshold or above a second cholesterol level threshold, wherein the first cholesterol level threshold is associated with a cholesterol level that is not high enough to warrant treatment with statins, and wherein the second cholesterol level threshold is associated with a cholesterol level that warrants treatment with a higher dose of statins than that available over-the-counter. The pooled cohort equation filter is activated when the first plurality of survey results indicate that the subject's risk of atherosclerotic cardiovascular disease meets a first threshold range or the first threshold. The age filter is activated when the first plurality of survey results indicate that the subject's age may be unsuitable for statin product administration. The personal history filter is activated when the first plurality of survey results indicate that statin product administration may be unsuitable due to risks associated with the subject's personal history. The drug risk-interaction filter is activated when the first plurality of survey results indicate that the subject is taking a medication that may cause adverse interactions with statins.

[0204] In some embodiments, the total cholesterol level filter is activated when the first plurality of survey results indicate that the subject's total cholesterol is less than 100 mg / dl, less than 110 mg / dl, less than 115 mg / dl, less than 120 mg / dl, less than 125 mg / dl, less than 130 mg / dl, less than 135 mg / dl, or greater than 250 mg / dl, greater than 255 mg / dl, greater than 260 mg / dl, greater than 265 mg / dl, greater than 270 mg / dl, greater than 275 mg / dl, greater than 280 mg / dl, greater than 285 mg / dl, greater than 290 mg / dl, greater than 295 mg / dl, or greater than 300 mg / dl.

[0205] In some embodiments, the summary cohort equation filter combines some or all of the features listed in Table 4, such as those determined based on a set of survey results, to determine a subject's risk of atherosclerotic cardiovascular disease. For example, in some embodiments, the first plurality of survey results include 2, 3, 4, 5, 6, 7, 8, 9, 10, or all 11 features listed in Table 4. The summary cohort equation filter is activated when a subject's risk of atherosclerotic cardiovascular disease exceeds a threshold risk level.

[0206] Table 4. Exemplary features for summarizing queue equation filters

[0207]

[0208] In one embodiment, the summary cohort equation filter incorporates at least survey results 1-9 provided in Table 4. In another embodiment, the first survey results include at least survey results 1-10 provided in Table 4. In yet another embodiment, the first survey results include at least survey results 1-9 and 11 provided in Table 4. In yet another embodiment, the first survey results include at least survey results 1-11 provided in Table 4.

[0209] In some embodiments, the pooled cohort equation filter calculates the probability that a subject will experience a hard atherosclerotic cardiovascular disease (ASCVD) event within a given time period, such as the next 5 years, the next 10 years, or in the subject's lifetime. In some embodiments, the pooled cohort equation used for the pooled cohort equation filter is calculated using guidelines set forth in the following literature: Goff DC Jr. et al., 2013 ACC / AHA Guidelines for Cardiovascular Risk Assessment: Report of the American College of Cardiology / American Heart Association Practice Guidelines Working Group, Circulation 2013; 00:000-000, which is incorporated herein by reference.

[0210] In some embodiments, the pooled cohort equation filter calculates the probability of a fatal cardiovascular disease occurring within a given time period, such as the next five years, the next ten years, or in the lifetime of the subject. In some embodiments, the pooled cohort equation used for the pooled cohort filter is calculated using guidelines set forth in the following literature: Perk J. et al., Guidelines for the Prevention of Cardiovascular Disease in European Clinical Practice, European Journal of Cardiology 33:1635–1701 (2012), which is incorporated herein by reference. In some embodiments, the pooled cohort equation filter follows a low CVD risk score (SCORE) table that incorporates the subject's sex, age, total cholesterol level, systolic blood pressure, and smoking status, as set forth in the preceding literature by Perk J. et al. In some embodiments, the pooled cohort equation filter follows a high CVD risk score (SCORE) table that incorporates the subject's sex, age, total cholesterol level, systolic blood pressure, and smoking status, as set forth in the preceding literature by Perk J. et al.

[0211] In some embodiments, the risk of atherosclerotic cardiovascular disease is a 10-year risk, and the first threshold of the aggregated cohort equation filter is 7.5%. In such embodiments, the aggregated cohort equation filter is activated if the aggregated cohort equation (e.g., Goff, as illustrated above) indicates a probability of the first ASCVD event occurring within 10 years greater than 7.5%. In some embodiments, the risk of atherosclerotic cardiovascular disease is a 5-year risk, a 10-year risk, a lifetime risk, and the first threshold of the aggregated cohort equation filter is 4.0%, 4.5%, 5.0%, 5.5%, 6.0%, 6.5%, 7.0%, 7.5%, 8.0%, 8.5%, 9.0%, 9.5%, or 10.0%. In such embodiments, the aggregated cohort equation filter is activated if the aggregated cohort equation (e.g., Goff, as illustrated above) indicates a probability of the first hard ASCVD event occurring within a specified time period greater than the first threshold.

[0212] In some embodiments, the age filter is activated when the first plurality of survey results indicate that the subject is a woman aged 49 or younger or 76 or older, and the age filter is activated when the first plurality of survey results indicate that the subject is a man aged 39 or younger or 66 or older. In some embodiments, the age filter is activated when the first plurality of survey results indicate that the subject is a woman aged 44 or younger, 45 or younger, 46 or younger, 47 or younger, 48 or younger, 49 or younger, or aged 70 or older, 71 or older, 72 or older, 73 or older, 74 or older, 75 or older, or 76 or older; and when the first plurality of survey results indicate that the subject is a man aged 35 or younger, 36 or younger, 37 or younger, 38 or younger, or 39 or younger, or aged 61 or older, 62 or older, 63 or older, 64 or older, 65 or older, 66 or older, 67 or older, 68 or older, 69 or older, 70 or older, 71 or older, or 72 or older.

[0213] In some embodiments, the one or more personal history filters include one or more filters selected from an alcohol consumption filter, an adverse reaction filter, an atherosclerotic cardiovascular event filter, a kidney disease filter, and an Asian ancestry filter. The alcohol consumption filter is activated when the first plurality of survey results indicate that the subject routinely consumes alcohol at levels that could cause adverse side effects due to statin administration. The adverse reaction filter is activated when the first plurality of survey results indicate that the subject has a history of adverse reactions to cholesterol-lowering drugs. The atherosclerotic cardiovascular event filter is activated when the first plurality of survey results indicate that the subject has a history of atherosclerotic cardiovascular events. The kidney disease filter is activated when the first plurality of survey results indicate that the subject has kidney disease. The Asian ancestry filter is activated when the first plurality of survey results indicate that the subject is of Asian ancestry.

[0214] In some embodiments, the drinking filter is activated when the first plurality of survey results indicate that the subject consumes an average of three or more drinks per day. In some embodiments, the drinking filter is activated when the first plurality of survey results indicate that the subject consumes an average of four or more drinks per week, an average of five or more drinks per week, an average of six or more drinks per week, an average of one or more drinks per day, an average of two or more drinks per day, an average of three or more drinks per day, or an average of four or more drinks per day, or an average of five or more drinks per day.

[0215] In some embodiments, the adverse reaction filter is activated when the first plurality of survey results indicate that the subject has experienced an adverse reaction to a cholesterol-lowering drug in the past. In some embodiments, the adverse reaction filter is activated when the first plurality of survey results indicate that the subject has experienced an adverse reaction to any statin agent in the past. In some embodiments, the adverse reaction filter is activated when the first plurality of survey results indicate that the subject has experienced an adverse reaction to a statin agent that the subject is eligible to receive over-the-counter.

[0216] In some embodiments, the atherosclerotic cardiovascular event filter is activated when the first plurality of survey results indicate that the subject has experienced an atherosclerotic cardiovascular event in the past. In some embodiments, the atherosclerotic cardiovascular event filter is activated when the first plurality of survey results indicate that the subject has experienced a heart attack, stroke, or cardiac surgery.

[0217] On one hand, this disclosure provides a computer system for qualifying a human subject for over-the-counter delivery of a statin drug composition for lowering cholesterol. The computer system includes one or more processors and a memory including non-transitory instructions that, when executed by the one or more processors, perform a method for qualifying a human subject for over-the-counter delivery of a statin drug composition. The method includes: conducting a first survey on the subject, thereby obtaining first plurality of survey results required for running a first plurality of filters for a first category and a second plurality of filters for a second category. The method then includes: running all or some of the survey results from the first plurality of filters for the first category, wherein when a corresponding filter in the first plurality of filters is activated, the subject is deemed ineligible for delivery of the statin drug composition, and the method terminates without delivery of the statin drug composition to the subject. The method then includes: running all or some of the survey results from the second plurality of filters for the second category, wherein when a corresponding filter in the second plurality of filters is activated, a warning corresponding to the corresponding filter is provided to the subject. The method further includes: obtaining confirmation from the subject of any warning issued to the subject by any filter in the second plurality of filters. The method further includes: continuing the performance process when (i) no filter in the first plurality of filters is activated and (ii) the subject has acknowledged each warning associated with each activated filter in the second plurality of filters. The performance process includes: storing an instruction for an initial order of the statin composition in a subject profile; transmitting an over-the-counter (OTC) drug fact label of the statin composition to the subject; and authorizing the delivery of the statin composition to the subject upon the subject's acknowledgment that they have received and read the OTC drug fact label. In some embodiments, the authorization includes a destination associated with the subject.

[0218] In some embodiments, the first plurality of survey results comprise a plurality of survey results selected from those listed in Table 1. In some embodiments, the first plurality of survey results comprise: the subject's sex; whether the subject is female and whether the subject is in one of the following states: (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant; whether the subject has or has had liver disease; the subject's age; the subject's total cholesterol level; the subject's HDL cholesterol count; the subject's systolic blood pressure; the subject's ethnicity; whether the subject is taking antihypertensive medication; whether the subject is taking one or more medications that interact with the statin drug composition, wherein the one or more medications contain cyclosporine; the subject's smoking status; the subject's diabetes status; the subject's alcohol consumption status; whether the subject has had an adverse reaction to cholesterol-lowering medications; and whether the subject has had an atherosclerotic cardiovascular event or undergone heart surgery.

[0219] In some embodiments, the first plurality of filters comprises a plurality of filters selected from the filters listed in Table 2. In one embodiment, the first plurality of filters comprises a pregnancy filter and a liver disease filter. In another embodiment, the first plurality of filters comprises a pregnancy filter, a cyclosporine filter, and a liver disease filter.

[0220] In some embodiments, the second plurality of filters includes a plurality of filters selected from those listed in Table 3. In one embodiment, the second plurality of filters includes a total cholesterol filter, a summary cohort equation filter, an age filter, one or more personal history filters, and one or more drug risk-interaction filters. In one embodiment, the second plurality of filters includes a total cholesterol level filter, a summary cohort equation filter, an age filter, a drug interaction filter, an alcohol consumption filter, an adverse reaction filter, and an atherosclerotic cardiovascular event filter.

[0221] In one embodiment, the first plurality of filters and the second plurality of filters comprise filters selected from those listed in Table 5. In some embodiments, the first plurality of filters of a first category comprise a first plurality of filters listed in Table 5, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, or 14 filters listed in Table 5, and the second plurality of filters of the first category comprise a second plurality of filters listed in Table 5, which are different from the first plurality of filters, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, or 14 filters listed in Table 5. In some embodiments, each filter in the first plurality of filters is different from each filter in the second plurality of filters (e.g., no filter listed in Table 5 is included in both the first and second plurality of filters). In some embodiments, a system for qualifying a subject for over-the-counter delivery of a statin includes instructions to apply only one or more filters, such as filters from only a single category. In some embodiments, when the method, system, or software applies one or more filters, the multiple filters include a selection of filters listed in Table 5, for example, at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or all 15 filters listed in Table 5. In some embodiments, when a filter listed in Table 5 corresponds to a filter listed in Table 2 or Table 3, a threshold level sufficient to activate the corresponding filter listed in Table 2 or Table 3, as described in detail above, is sufficient to activate the filter listed in Table 5. In some embodiments, the first multiple filters of a first category include some or all of the filters listed in Table 5. In some embodiments, the second multiple filters of a second category include some or all of the filters listed in Table 5.

[0222] In one embodiment, the aggregated cohort equation filter (e.g., filter 13c) follows a low CVD risk scoring table, as described in detail above. In one embodiment, the aggregated cohort equation filter follows a low CVD risk scoring table, as described in detail above. In one embodiment, a scoring (SCORE) guideline is used to calculate the risk of fatal cardiovascular disease in the aggregated cohort equation as a 10-year risk, and a threshold range, such as the threshold range for triggering the filter when a subject's risk is determined to be higher or lower than it, is a 1-5% risk.

[0223] In one embodiment, this disclosure provides a computer system for qualifying a human subject for over-the-counter delivery of a statin drug composition for lowering cholesterol. The computer system includes one or more processors and a memory including non-transitory instructions that, when executed by the one or more processors, perform a method for qualifying a human subject for over-the-counter delivery of a statin drug composition for lowering cholesterol. The method includes: conducting a first survey on a subject to obtain a first plurality of survey results, wherein the first plurality of survey results include a plurality of survey results sufficient to be run against a first plurality of filters of a first category and a second plurality of filters of a second category, as indicated in Table 5. The method further includes: running all or some of the survey results of the first plurality of survey results against the first plurality of filters of the first category, wherein when a corresponding filter among the first plurality of filters is activated, the subject is deemed ineligible for delivery of the statin drug composition, and the method terminates without delivery of the statin drug composition to the subject, wherein the first plurality of filters include a plurality of filters selected from the first category filters listed in Table 5. The method further includes: running all or part of the survey results from the first plurality of survey results for the second plurality of filters of the second category, wherein when a corresponding filter in the second plurality of filters is activated, a warning corresponding to the corresponding filter is provided to the subject, and wherein the second plurality of filters comprises a plurality of filters selected from the second category filters listed in Table 5. The method then includes: obtaining from the subject confirmation of any warning issued to the subject for any filter in the second plurality of filters. The method then includes: continuing the performance process when (i) no filter in the first plurality of filters is activated and (ii) the subject has confirmed each warning associated with each activated filter in the second plurality of filters, wherein the performance process includes: storing an instruction for an initial order of the statin composition in the subject profile; transmitting an over-the-counter drug fact label of the statin composition to the subject; and authorizing the delivery of the statin composition to the subject when the subject confirms that they have received and read the over-the-counter drug fact label, wherein the authorization includes a destination associated with the subject.

[0224] Table 5. Exemplary Filters

[0225] 1c Allergy filters for statins 2c Liver disease filter 3c Kidney damage filter 4c Myopathy Filter 5c Cyclosporine filter 6c Pregnancy or breastfeeding filter 7c Hypothyroidism filter 8c Personal or family history filter for muscle disorders 9c Adverse reaction filter 10c Drinking filters 11c Asian bloodline filter 12c Drug Interaction Filter 13c Summary Queue Equation Filter 14c Lactose intolerance filter 15c Age Filter

[0226] In one embodiment, the first plurality of filters and the second plurality of filters comprise filters selected from those listed in Table 6. In some embodiments, the first plurality of filters of a first category comprise a first sub-plurality of filters listed in Table 6, for example, 2, 3, 4, 5, 6, 7, 8, or 9 filters listed in Table 6, and the second plurality of filters of the first category comprise a second sub-plurality of filters listed in Table 6, which are distinct from the first sub-plurality of filters, for example, 2, 3, 4, 5, 6, 7, 8, or 9 filters listed in Table 6. In some embodiments, each filter in the first sub-plurality of filters is distinct from each filter in the second sub-plurality of filters (e.g., no filter listed in Table 6 is included in both the first and second sub-plurality of filters). In some embodiments, a system for qualifying a subject for over-the-counter delivery of a statin includes instructions to apply only one plurality of filters, such as only filters from a single category. In some embodiments, when the method, system, or software applies a single plurality of filters, the plurality of filters comprises a plurality of filters selected from the filters listed in Table 6, for example, at least 2, 3, 4, 5, 6, 7, 8, 9, or all 10 filters listed in Table 6. In some embodiments, when a filter listed in Table 6 corresponds to a filter listed in Table 2 or Table 3, a threshold level sufficient to activate the corresponding filter listed in Table 2 or Table 3 is sufficient to activate the filter listed in Table 6, as described in detail above. In some embodiments, the first plurality of filters of the first category comprises some or all of the filters listed in Table 6. In some embodiments, the second plurality of filters of the second category comprises some or all of the filters listed in Table 6.

[0227] In one embodiment, the aggregated cohort equation filter (e.g., filter 10d) follows the NIPPON DATA80 absolute risk assessment table, as described in detail above. In one embodiment, using the NIPPON DATA80 guidelines, the risk of coronary disease-related death for the aggregated cohort equation is calculated as a 10-year risk and a threshold range, such as the threshold range for triggering the filter when a subject's risk is determined to be higher or lower than it, is 0.5-2% risk. In some embodiments, using the NIPPON DATA80 guidelines, the subject is eligible for a dose of 2.5 mg of a statin (rosuvastatin).

[0228] In one embodiment, this disclosure provides a computer system for qualifying a human subject for over-the-counter delivery of a statin drug composition for lowering cholesterol. The computer system includes one or more processors and a memory including non-transitory instructions that, when executed by the one or more processors, perform a method for qualifying a human subject for over-the-counter delivery of a statin drug composition for lowering cholesterol. The method includes: conducting a first survey on a subject to obtain a first plurality of survey results, wherein the first plurality of survey results include a plurality of survey results sufficient to be run against a first plurality of filters of a first category and a second plurality of filters of a second category, as indicated in Table 6. The method further includes: running all or some of the survey results of the first plurality of survey results against the first plurality of filters of the first category, wherein when a corresponding filter among the first plurality of filters is activated, the subject is deemed ineligible for delivery of the statin drug composition, and the method terminates without delivery of the statin drug composition to the subject, wherein the first plurality of filters include a plurality of filters selected from the first category filters listed in Table 6. The method further comprises: running all or part of the survey results from the first plurality of survey results for the second plurality of filters of the second category, wherein when a corresponding filter in the second plurality of filters is activated, a warning corresponding to the corresponding filter is provided to the subject, and wherein the second plurality of filters comprises a plurality of filters selected from the second category filters listed in Table 6. The method then comprises: obtaining from the subject confirmation of any warning issued to the subject for any filter in the second plurality of filters. The method then comprises: continuing the performance process when (i) no filter in the first plurality of filters is activated and (ii) the subject has confirmed each warning associated with each activated filter in the second plurality of filters, wherein the performance process comprises: storing an instruction for an initial order of the statin composition in the subject profile; transmitting an over-the-counter drug fact label of the statin composition to the subject; and authorizing the delivery of the statin composition to the subject when the subject confirms that they have received and read the over-the-counter drug fact label, wherein the authorization includes a destination associated with the subject.

[0229] Table 6. Exemplary Filters

[0230] 1d Allergy filters for statins 2d Liver disease filter 3d Pregnancy or breastfeeding filter 4d Cyclosporine filter 5d Kidney damage filter 6d Drinking filters 7d Hypothyroidism filter 8d Age Filter 9d Drug Interaction Filter 10d Summary Queue Equation Filter

[0231] In one embodiment, the first plurality of filters and the second plurality of filters comprise filters selected from those listed in Table 7. In some embodiments, the first plurality of filters of a first category comprise a first plurality of filters listed in Table 7, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, or 14 filters listed in Table 7, and the second plurality of filters of the first category comprise a second plurality of filters listed in Table 7, which are different from the first plurality of filters, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, or 14 filters listed in Table 7. In some embodiments, each filter in the first plurality of filters is different from each filter in the second plurality of filters (e.g., no filter listed in Table 7 is included in both the first and second plurality of filters). In some embodiments, a system for qualifying a subject for over-the-counter delivery of a statin includes instructions to apply only one or more filters, such as filters from only a single category. In some embodiments, when the method, system, or software applies one or more filters, the multiple filters include a selection of filters listed in Table 7, for example, at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or all 15 filters listed in Table 7. In some embodiments, when a filter listed in Table 7 corresponds to a filter listed in Table 2 or Table 3, a threshold level sufficient to activate the corresponding filter listed in Table 2 or Table 3 is sufficient to activate the filter listed in Table 7, as described in detail above. In some embodiments, the first multiple filters of a first category include some or all of the filters listed in Table 7. In some embodiments, the second multiple filters of a second category include some or all of the filters listed in Table 7.

[0232] In one embodiment, the aggregated cohort equation filter (e.g., filter 13e) follows the Chinese PAR equation, as described in detail above. In one embodiment, using the China-PAR guidelines, the risk of atherosclerotic cardiovascular disease for calculating the aggregated cohort equation is a 10-year risk, and a threshold range, such as the threshold range for triggering the filter when a subject's risk is determined to be higher or lower than it, is a 5-10% risk.

[0233] In one embodiment, this disclosure provides a computer system for qualifying a human subject for over-the-counter delivery of a statin drug composition for lowering cholesterol. The computer system includes one or more processors and a memory including non-transitory instructions that, when executed by the one or more processors, perform a method for qualifying a human subject for over-the-counter delivery of a statin drug composition for lowering cholesterol. The method includes: conducting a first survey on a subject to obtain a first plurality of survey results, wherein the first plurality of survey results include a plurality of survey results sufficient to be run against a first plurality of filters of a first category and a second plurality of filters of a second category, as indicated in Table 7. The method further includes: running all or some of the survey results of the first plurality of survey results against the first plurality of filters of the first category, wherein when a corresponding filter among the first plurality of filters is activated, the subject is deemed ineligible for delivery of the statin drug composition, and the method terminates without delivery of the statin drug composition to the subject, wherein the first plurality of filters include a plurality of filters selected from the first category filters listed in Table 7. The method further includes: running all or part of the survey results from the first plurality of survey results for the second plurality of filters of the second category, wherein when a corresponding filter in the second plurality of filters is activated, a warning corresponding to the corresponding filter is provided to the subject, and wherein the second plurality of filters comprises a plurality of filters selected from the second category filters listed in Table 7. The method then includes: obtaining from the subject confirmation of any warning issued to the subject for any filter in the second plurality of filters. The method then includes: continuing the performance process when (i) no filter in the first plurality of filters is activated and (ii) the subject has confirmed each warning associated with each activated filter in the second plurality of filters, wherein the performance process includes: storing an instruction for an initial order of the statin composition in the subject profile; transmitting an over-the-counter drug fact label of the statin composition to the subject; and authorizing the delivery of the statin composition to the subject when the subject confirms that they have received and read the over-the-counter drug fact label, wherein the authorization includes a destination associated with the subject.

[0234] Table 7. Exemplary Filters

[0235]

[0236]

[0237] In one embodiment, the first plurality of filters and the second plurality of filters comprise filters selected from those listed in Table 8. In some embodiments, the first plurality of filters of a first category comprise a first sub-plurality of filters listed in Table 8, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 filters listed in Table 8, and the second plurality of filters of the first category comprise a second sub-plurality of filters listed in Table 8, which are different from the first sub-plurality of filters, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 filters listed in Table 8. In some embodiments, each filter in the first sub-plurality of filters is different from each filter in the second sub-plurality of filters (e.g., no filter listed in Table 8 is included in both the first and second sub-plurality of filters). In some embodiments, a system for qualifying a subject for over-the-counter delivery of a statin includes instructions to apply only one plurality of filters, such as only filters from a single category. In some embodiments, when the method, system, or software applies a single plurality of filters, the plurality of filters may comprise a plurality of filters selected from those listed in Table 8, for example, at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or all 13 filters listed in Table 8. In some embodiments, when a filter listed in Table 8 corresponds to a filter listed in Table 2 or Table 3, the threshold level of the corresponding filter listed in Table 2 or Table 3 is sufficient to activate, as described in detail above, the threshold level of the filter listed in Table 8. In some embodiments, the first plurality of filters of the first category comprises some or all of the filters listed in Table 8. In some embodiments, the second plurality of filters of the second category comprises some or all of the filters listed in Table 8.

[0238] In one embodiment, the aggregated cohort equation filter (e.g., filter 11f) follows the Australian absolute cardiovascular risk calculator, as described in detail above. In one embodiment, the Australian absolute cardiovascular risk calculator is used to calculate the cardiovascular disease risk of the aggregated cohort equation as a 5-year risk, and a threshold range, such as the threshold range for triggering the filter when a subject's risk is determined to be higher or lower than it, is 10-15% risk.

[0239] In one embodiment, this disclosure provides a computer system for qualifying a human subject for over-the-counter delivery of a statin drug composition for lowering cholesterol. The computer system includes one or more processors and a memory including non-transitory instructions that, when executed by the one or more processors, perform a method for qualifying a human subject for over-the-counter delivery of a statin drug composition for lowering cholesterol. The method includes: conducting a first survey on a subject to obtain a first plurality of survey results, wherein the first plurality of survey results include a plurality of survey results sufficient to be run against a first plurality of filters of a first category and a second plurality of filters of a second category, as indicated in Table 8. The method further includes: running all or some of the survey results of the first plurality of survey results against the first plurality of filters of the first category, wherein when a corresponding filter among the first plurality of filters is activated, the subject is deemed ineligible for delivery of the statin drug composition, and the method terminates without delivery of the statin drug composition to the subject, wherein the first plurality of filters include a plurality of filters selected from the first category filters listed in Table 8. The method further comprises: running all or part of the survey results from the first plurality of survey results for the second plurality of filters of the second category, wherein when a corresponding filter in the second plurality of filters is activated, a warning corresponding to the corresponding filter is provided to the subject, and wherein the second plurality of filters comprises a plurality of filters selected from the second category filters listed in Table 8. The method then comprises: obtaining from the subject confirmation of any warning issued to the subject for any filter in the second plurality of filters. The method then comprises: continuing the performance process when (i) no filter in the first plurality of filters is activated and (ii) the subject has confirmed each warning associated with each activated filter in the second plurality of filters, wherein the performance process comprises: storing an instruction for an initial order of the statin composition in the subject profile; transmitting an over-the-counter drug fact label of the statin composition to the subject; and authorizing the delivery of the statin composition to the subject when the subject confirms that they have received and read the over-the-counter drug fact label, wherein the authorization includes a destination associated with the subject.

[0240] Table 8. Exemplary Filters

[0241] 1f Allergy filters for statins 2f Liver disease filter 3f Kidney damage filter 4f Myopathy Filter 5f Pregnancy or breastfeeding filter 6f Hypothyroidism filter 7f Personal or family history filter for muscle disorders 8f Drinking filters 9f Asian bloodline filter 10f Drug Interaction Filter 11f Summary Queue Equation Filter 12f Age Filter 13f Genetic polymorphism filter

[0242] In some embodiments, a genetic polymorphism filter (e.g., filter 13f) is activated when the first plurality of survey results indicate that the subject has a polymorphism selected from SLCO1B1 (OATP1B1) and / or ABCG2 (BCRP) (e.g., SLCO1B1, c.521CC and / or ABCG2, c.421AA). In some embodiments, the filter is activated when the first plurality of survey results indicate that the subject is unaware of whether they possess one or a specific polymorphism.

[0243] In one embodiment, the first plurality of filters and the second plurality of filters comprise filters selected from those listed in Table 9. In some embodiments, the first plurality of filters of a first category comprise a first sub-plurality of filters listed in Table 9, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or 13 filters listed in Table 9, and the second plurality of filters of the first category comprise a second sub-plurality of filters listed in Table 9, which are distinct from the first sub-plurality of filters, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or 13 filters listed in Table 9. In some embodiments, each filter in the first sub-plurality of filters is distinct from each filter in the second sub-plurality of filters (e.g., no filter listed in Table 9 is included in both the first and second sub-plurality of filters). In some embodiments, a system for qualifying a subject for over-the-counter delivery of a statin includes instructions to apply only one plurality of filters, such as only filters from a single category. In some embodiments, when the method, system, or software applies a single plurality of filters, the plurality of filters comprises a plurality of filters selected from the filters listed in Table 9, for example, at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, or all 14 filters listed in Table 9. In some embodiments, when a filter listed in Table 9 corresponds to a filter listed in Table 2 or Table 3, a threshold level sufficient to activate the corresponding filter listed in Table 2 or Table 3 is sufficient to activate the filter listed in Table 9, as described in detail above. In some embodiments, the first plurality of filters of the first category comprises some or all of the filters listed in Table 9. In some embodiments, the second plurality of filters of the second category comprises some or all of the filters listed in Table 9.

[0244] In one embodiment, the pooled cohort equation filter (e.g., filter 12g) follows the Framingham Heart Study Risk Rating Equation (FRS), the modified Framingham Heart Study Risk Rating Equation (mFRS), or the Cardiovascular Life Expectancy Model (CLEM), as described in detail above. In one embodiment, the risk of cardiovascular disease used to calculate the pooled cohort equation, whether using FRS, mFRS, or CLEM, is a 10-year risk, and a threshold range, such as the threshold range for triggering the filter when a subject's risk is determined to be higher or lower than it, is 10-19% risk.

[0245] In one embodiment, this disclosure provides a computer system for qualifying a human subject for over-the-counter delivery of a statin drug composition for lowering cholesterol. The computer system includes one or more processors and a memory including non-transitory instructions that, when executed by the one or more processors, perform a method for qualifying a human subject for over-the-counter delivery of a statin drug composition for lowering cholesterol. The method includes: conducting a first survey on a subject to obtain a first plurality of survey results, wherein the first plurality of survey results include a plurality of survey results sufficient to be run against a first plurality of filters of a first category and a second plurality of filters of a second category, as indicated in Table 9. The method further includes: running all or some of the survey results of the first plurality of survey results against the first plurality of filters of the first category, wherein when a corresponding filter among the first plurality of filters is activated, the subject is deemed ineligible for delivery of the statin drug composition, and the method terminates without delivery of the statin drug composition to the subject, wherein the first plurality of filters include a plurality of filters selected from the first category filters listed in Table 9. The method further includes: running all or part of the survey results from the first plurality of survey results for the second plurality of filters of the second category, wherein when a corresponding filter in the second plurality of filters is activated, a warning corresponding to the corresponding filter is provided to the subject, and wherein the second plurality of filters comprises a plurality of filters selected from the second category filters listed in Table 9. The method then includes: obtaining from the subject confirmation of any warning issued to the subject for any filter in the second plurality of filters. The method then includes: continuing the performance process when (i) no filter in the first plurality of filters is activated and (ii) the subject has confirmed each warning associated with each activated filter in the second plurality of filters, wherein the performance process includes: storing an instruction for an initial order of the statin composition in the subject profile; transmitting an over-the-counter drug fact label of the statin composition to the subject; and authorizing the delivery of the statin composition to the subject when the subject confirms that they have received and read the over-the-counter drug fact label, wherein the authorization includes a destination associated with the subject.

[0246] Table 9. Exemplary Filters

[0247] 1g Allergy filters for statins 2g Liver disease filter 3g Kidney damage filter 4g Myopathy Filter 5g Pregnancy or breastfeeding filter 6g Cyclosporine filter 7g Hypothyroidism filter 8g Personal or family history filter for muscle disorders 9g Drinking filters 10g Asian bloodline filter 11g Drug Interaction Filter 12g Summary Queue Equation Filter 13g Age Filter 14g Genetic polymorphism filter

[0248] In some embodiments, a genetic polymorphism filter (e.g., filter 14g) is activated when the first plurality of survey results indicate that the subject has a polymorphism selected from SLCO1B1 (OATP1B1) and / or ABCG2 (BCRP) (e.g., SLCO1B1, c.521CC and / or ABCG2, c.421AA). In some embodiments, the filter is activated when the first plurality of survey results indicate that the subject is unaware of whether they possess one or a specific polymorphism.

[0249] Example

[0250] Example 1: A computer system for qualifying human subjects for over-the-counter delivery of a rosuvastatin drug composition (e.g., low-dose CRESTOR) for the treatment or prevention of atherosclerotic cardiovascular disease (e.g., by lowering cholesterol). The computer system includes instructions for surveying the subject to obtain one or more of the following: the subject's sex; whether the subject is female and whether the subject is in one of the following states: (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant; whether the subject has or has had liver disease; the subject's age; the subject's total cholesterol level; the subject's HDL cholesterol count; the subject's systolic blood pressure; the subject's ethnicity; whether the subject is taking antihypertensive medication; whether the subject is taking one or more drugs that interact with the statin drug composition, wherein the one or more drugs contain cyclosporine; the subject's smoking status; the subject's diabetes status; the subject's alcohol consumption status; whether the subject has had an adverse reaction to cholesterol-lowering drugs; and whether the subject has had an atherosclerotic cardiovascular event or undergone heart surgery.

[0251] The computer system runs survey results against a first series of filters, each blocking authorized delivery of OTC statins, where the survey results of the subjects identify contraindications to the OTC statins. In some embodiments, the first series of filters includes one or more of the following: a pregnancy filter, a liver disease filter, or an allergy filter to the statin composition, and optionally a cyclosporine filter.

[0252] The computer system runs survey results against a second series of filters that generate warnings, wherein the subjects' survey results identify risk factors for OTC statins. In some embodiments, the first series of filters includes one or more of the following: a total cholesterol level filter; a summary cohort equation filter that combines the subject's sex, race, age, total cholesterol level, HDL cholesterol count, systolic blood pressure, whether the subject is taking a statin-interacting drug, smoking status, and diabetes status to deduce the risk of atherosclerotic cardiovascular disease, wherein the summary cohort equation filter is considered activated when the risk meets a first threshold range or a first threshold; an age filter; a drug interaction filter; an alcohol consumption filter; an adverse reaction filter; an atherosclerotic cardiovascular event filter; and an optional cyclosporine filter (e.g., when not included in the first series of filters).

[0253] The computer system then prompts the subject to confirm or deny that they have discussed these warnings with a medical professional (e.g., their doctor). The computer system then continues the process only if (i) no filters in the first series are activated, and (ii) the subject has confirmed that they have discussed each warning issued by the activated second series of filters.

[0254] The computer system stores the initial order instructions for the OTC statin drug in the subject's profile and sends the subject an over-the-counter drug fact label for the statin drug composition. Once the subject confirms that they have received and read the over-the-counter drug fact label, the computer system authorizes the delivery of the OTC statin drug composition to the subject.

[0255] Example 2: A computer system for qualifying human subjects for over-the-counter delivery of an atorvastatin drug composition (e.g., low-dose LIPITOR) for the treatment or prevention of atherosclerotic cardiovascular disease (e.g., by lowering cholesterol). The computer system includes instructions for surveying the subject to obtain one or more of the following: the subject's sex; whether the subject is female and whether the subject is in one of the following states: (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant; whether the subject has or has had liver disease; the subject's age; the subject's total cholesterol level; the subject's HDL cholesterol count; the subject's systolic blood pressure; the subject's ethnicity; whether the subject is taking antihypertensive medication; whether the subject is taking one or more drugs that interact with the statin drug composition, wherein the one or more drugs contain cyclosporine; the subject's smoking status; the subject's diabetes status; the subject's alcohol consumption status; whether the subject has had an adverse reaction to cholesterol-lowering drugs; and whether the subject has had an atherosclerotic cardiovascular event or undergone heart surgery.

[0256] The computer system runs survey results against a first series of filters, each blocking authorized delivery of OTC statins, where the survey results of the subjects identify contraindications to the OTC statins. In some embodiments, the first series of filters includes one or more of the following: a pregnancy filter, a liver disease filter, or an allergy filter to the statin composition, and optionally a cyclosporine filter.

[0257] The computer system runs survey results against a second series of filters that generate warnings, wherein the subjects' survey results identify risk factors for OTC statins. In some embodiments, the first series of filters includes one or more of the following: a total cholesterol level filter; a summary cohort equation filter that combines the subject's sex, race, age, total cholesterol level, HDL cholesterol count, systolic blood pressure, whether the subject is taking a statin-interacting drug, smoking status, and diabetes status to deduce the risk of atherosclerotic cardiovascular disease, wherein the summary cohort equation filter is considered activated when the risk meets a first threshold range or a first threshold; an age filter; a drug interaction filter; an alcohol consumption filter; an adverse reaction filter; an atherosclerotic cardiovascular event filter; and an optional cyclosporine filter (e.g., when not included in the first series of filters).

[0258] The computer system then prompts the subject to confirm or deny that they have discussed these warnings with a medical professional (e.g., their doctor). The computer system then continues the process only if (i) no filters in the first series are activated, and (ii) the subject has confirmed that they have discussed each warning issued by the activated second series of filters.

[0259] The computer system stores the initial order instructions for the OTC statin drug in the subject's profile and sends the subject an over-the-counter drug fact label for the statin drug composition. Once the subject confirms that they have received and read the over-the-counter drug fact label, the computer system authorizes the delivery of the OTC statin drug composition to the subject.

[0260] Example 3: Preparation of a computer system for qualifying human subjects for over-the-counter delivery of a simvastatin drug composition (e.g., low-dose Zocor) for the treatment or prevention of atherosclerotic cardiovascular disease (e.g., by lowering cholesterol). The computer system includes instructions for surveying the subject to obtain one or more of the following: the subject's sex; whether the subject is female and whether the subject is in one of the following states: (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant; whether the subject has or has had liver disease; the subject's age; the subject's total cholesterol level; the subject's HDL cholesterol count; the subject's systolic blood pressure; the subject's ethnicity; whether the subject is taking antihypertensive medication; whether the subject is taking one or more drugs that interact with the statin drug composition, wherein the one or more drugs comprise cyclosporine, gemfibrozil, danazol, and / or a strong CYP3A4 inhibitor; the subject's smoking status; the subject's diabetes status; the subject's alcohol consumption status; whether the subject has had an adverse reaction to cholesterol-lowering drugs; and whether the subject has had an atherosclerotic cardiovascular event or undergone heart surgery.

[0261] The computer system runs survey results against a first series of filters, each blocking authorized delivery of OTC statins, wherein the survey results of the subjects identify contraindications to the OTC statins. In some embodiments, the first series of filters includes one or more of the following: a pregnancy filter, a liver disease filter, or an allergy filter to the statin composition, and optionally filters for cyclosporine, gemfibrozil, danazol, and / or strong CYP3A4 inhibitors.

[0262] The computer system runs survey results against a second series of filters that generate warnings, wherein the subjects' survey results identify risk factors for OTC statins. In some embodiments, the first series of filters includes one or more of the following: a total cholesterol level filter; a summary cohort equation filter that combines the subject's sex, race, age, total cholesterol level, HDL cholesterol count, systolic blood pressure, whether the subject is taking medications that interact with statins, smoking status, and diabetes status to deduce the risk of atherosclerotic cardiovascular disease, wherein the summary cohort equation filter is considered activated when the risk meets a first threshold range or a first threshold; an age filter; a drug interaction filter; an alcohol consumption filter; an adverse reaction filter; an atherosclerotic cardiovascular event filter; and optionally, filters for cyclosporine, gemfibrozil, danazol, and / or strong CYP3A4 inhibitors (e.g., when not included in the first series of filters).

[0263] The computer system then prompts the subject to confirm or deny that they have discussed these warnings with a medical professional (e.g., their doctor). The computer system then continues the process only if (i) no filters in the first series are activated, and (ii) the subject has confirmed that they have discussed each warning issued by the activated second series of filters.

[0264] The computer system stores the initial order instructions for the OTC statin drug in the subject's profile and sends the subject an over-the-counter drug fact label for the statin drug composition. Once the subject confirms that they have received and read the over-the-counter drug fact label, the computer system authorizes the delivery of the OTC statin drug composition to the subject.

[0265] Example 4: A computer system for qualifying human subjects for over-the-counter delivery of a pravastatin drug composition (e.g., low-dose PRAVACHOL) for the treatment or prevention of atherosclerotic cardiovascular disease, e.g., by lowering cholesterol. The computer system includes instructions for surveying the subject to obtain one or more of the following: the subject's sex; whether the subject is female and whether the subject is in one of the following states: (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant; whether the subject has or has had liver disease; the subject's age; the subject's total cholesterol level; the subject's HDL cholesterol count; the subject's systolic blood pressure; the subject's ethnicity; whether the subject is taking antihypertensive medication; whether the subject is taking one or more drugs that interact with the statin drug composition, wherein the one or more drugs contain cyclosporine; the subject's smoking status; the subject's diabetes status; the subject's alcohol consumption status; whether the subject has had an adverse reaction to cholesterol-lowering drugs; and whether the subject has had an atherosclerotic cardiovascular event or undergone heart surgery.

[0266] The computer system runs survey results against a first series of filters, each blocking authorized delivery of OTC statins, where the survey results of the subjects identify contraindications to the OTC statins. In some embodiments, the first series of filters includes one or more of the following: a pregnancy filter, a liver disease filter, or an allergy filter to the statin composition, and optionally a cyclosporine filter.

[0267] The computer system runs survey results against a second series of filters that generate warnings, wherein the subjects' survey results identify risk factors for OTC statins. In some embodiments, the first series of filters includes one or more of the following: a total cholesterol level filter; a summary cohort equation filter that combines the subject's sex, race, age, total cholesterol level, HDL cholesterol count, systolic blood pressure, whether the subject is taking a statin-interacting drug, smoking status, and diabetes status to deduce the risk of atherosclerotic cardiovascular disease, wherein the summary cohort equation filter is considered activated when the risk meets a first threshold range or a first threshold; an age filter; a drug interaction filter; an alcohol consumption filter; an adverse reaction filter; an atherosclerotic cardiovascular event filter; and an optional cyclosporine filter (e.g., when not included in the first series of filters).

[0268] The computer system then prompts the subject to confirm or deny that they have discussed these warnings with a medical professional (e.g., their doctor). The computer system then continues the process only if (i) no filters in the first series are activated, and (ii) the subject has confirmed that they have discussed each warning issued by the activated second series of filters.

[0269] The computer system stores the initial order instructions for the OTC statin drug in the subject's profile and sends the subject an over-the-counter drug fact label for the statin drug composition. Once the subject confirms that they have received and read the over-the-counter drug fact label, the computer system authorizes the delivery of the OTC statin drug composition to the subject.

[0270] Example 5: A computer system for qualifying human subjects for over-the-counter delivery of a fluvastatin drug composition (e.g., low-dose LESCOL XL) for the treatment or prevention of atherosclerotic cardiovascular disease, e.g., by lowering cholesterol. The computer system includes instructions for surveying the subject to obtain one or more of the following: the subject's sex; whether the subject is female and whether the subject is in one of the following states: (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant; whether the subject has or has had liver disease; the subject's age; the subject's total cholesterol level; the subject's HDL cholesterol count; the subject's systolic blood pressure; the subject's ethnicity; whether the subject is taking antihypertensive medication; whether the subject is taking one or more drugs that interact with the statin drug composition, wherein the one or more drugs contain cyclosporine; the subject's smoking status; the subject's diabetes status; the subject's alcohol consumption status; whether the subject has had an adverse reaction to cholesterol-lowering drugs; and whether the subject has had an atherosclerotic cardiovascular event or undergone heart surgery.

[0271] The computer system runs survey results against a first series of filters, each blocking authorized delivery of OTC statins, where the survey results of the subjects identify contraindications to the OTC statins. In some embodiments, the first series of filters includes one or more of the following: a pregnancy filter, a liver disease filter, or an allergy filter to the statin composition, and optionally a cyclosporine filter.

[0272] The computer system runs survey results against a second series of filters that generate warnings, wherein the subjects' survey results identify risk factors for OTC statins. In some embodiments, the first series of filters includes one or more of the following: a total cholesterol level filter; a summary cohort equation filter that combines the subject's sex, race, age, total cholesterol level, HDL cholesterol count, systolic blood pressure, whether the subject is taking a statin-interacting drug, smoking status, and diabetes status to deduce the risk of atherosclerotic cardiovascular disease, wherein the summary cohort equation filter is considered activated when the risk meets a first threshold range or a first threshold; an age filter; a drug interaction filter; an alcohol consumption filter; an adverse reaction filter; an atherosclerotic cardiovascular event filter; and an optional cyclosporine filter (e.g., when not included in the first series of filters).

[0273] The computer system then prompts the subject to confirm or deny that they have discussed these warnings with a medical professional (e.g., their doctor). The computer system then continues the process only if (i) no filters in the first series are activated, and (ii) the subject has confirmed that they have discussed each warning issued by the activated second series of filters.

[0274] The computer system stores the initial order instructions for the OTC statin drug in the subject's profile and sends the subject an over-the-counter drug fact label for the statin drug composition. Once the subject confirms that they have received and read the over-the-counter drug fact label, the computer system authorizes the delivery of the OTC statin drug composition to the subject.

[0275] Example 6: Preparation of a computer system for qualifying human subjects for over-the-counter delivery of a pitavastatin drug composition (e.g., low-dose LIVALO) for the treatment or prevention of atherosclerotic cardiovascular disease (e.g., by lowering cholesterol). The computer system includes instructions for surveying the subject to obtain one or more of the following: the subject's sex; whether the subject is female and whether the subject is in one of the following states: (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant; whether the subject has or has had liver disease; the subject's age; the subject's total cholesterol level; the subject's HDL cholesterol count; the subject's systolic blood pressure; the subject's ethnicity; whether the subject is taking antihypertensive medication; whether the subject is taking one or more drugs that interact with the statin drug composition, wherein the one or more drugs contain cyclosporine; the subject's smoking status; the subject's diabetes status; the subject's alcohol consumption status; whether the subject has had an adverse reaction to cholesterol-lowering drugs; and whether the subject has had an atherosclerotic cardiovascular event or undergone heart surgery.

[0276] The computer system runs survey results against a first series of filters, each blocking authorized delivery of OTC statins, where the survey results of the subjects identify contraindications to the OTC statins. In some embodiments, the first series of filters includes one or more of the following: a pregnancy filter, a liver disease filter, or an allergy filter to the statin composition, and optionally a cyclosporine filter.

[0277] The computer system runs survey results against a second series of filters that generate warnings, wherein the subjects' survey results identify risk factors for OTC statins. In some embodiments, the first series of filters includes one or more of the following: a total cholesterol level filter; a summary cohort equation filter that combines the subject's sex, race, age, total cholesterol level, HDL cholesterol count, systolic blood pressure, whether the subject is taking a statin-interacting drug, smoking status, and diabetes status to deduce the risk of atherosclerotic cardiovascular disease, wherein the summary cohort equation filter is considered activated when the risk meets a first threshold range or a first threshold; an age filter; a drug interaction filter; an alcohol consumption filter; an adverse reaction filter; an atherosclerotic cardiovascular event filter; and an optional cyclosporine filter (e.g., when not included in the first series of filters).

[0278] The computer system then prompts the subject to confirm or deny that they have discussed these warnings with a medical professional (e.g., their doctor). The computer system then continues the process only if (i) no filters in the first series are activated, and (ii) the subject has confirmed that they have discussed each warning issued by the activated second series of filters.

[0279] The computer system stores the initial order instructions for the OTC statin drug in the subject's profile and sends the subject an over-the-counter drug fact label for the statin drug composition. Once the subject confirms that they have received and read the over-the-counter drug fact label, the computer system authorizes the delivery of the OTC statin drug composition to the subject.

[0280] Example 7: Preparation of a computer system for qualifying human subjects for over-the-counter delivery of a lovastatin drug composition (e.g., low-dose MEVACOR) for the treatment or prevention of atherosclerotic cardiovascular disease (e.g., by lowering cholesterol). The computer system includes instructions for surveying the subject to obtain one or more of the following: the subject's sex; whether the subject is female and whether the subject is in one of the following states: (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant; whether the subject has or has had liver disease; the subject's age; the subject's total cholesterol level; the subject's HDL cholesterol count; the subject's systolic blood pressure; the subject's ethnicity; whether the subject is taking antihypertensive medication; whether the subject is taking one or more drugs that interact with the statin drug composition, wherein the one or more drugs comprise cyclosporine and a strong CYP3A4 inhibitor; the subject's smoking status; the subject's diabetes status; the subject's alcohol consumption status; whether the subject has had an adverse reaction to cholesterol-lowering drugs; and whether the subject has had an atherosclerotic cardiovascular event or undergone heart surgery.

[0281] The computer system runs survey results against a first series of filters, each blocking authorized delivery of OTC statins, where the survey results of the subjects identify contraindications to the OTC statins. In some embodiments, the first series of filters includes one or more of the following: a pregnancy filter, a liver disease filter, or an allergy filter to the statin composition, and optionally a cyclosporine and / or strong CYP3A4 inhibitor filter.

[0282] The computer system runs survey results against a second series of filters that generate warnings, wherein the subjects' survey results identify risk factors for OTC statins. In some embodiments, the first series of filters includes one or more of the following: a total cholesterol level filter; a summary cohort equation filter that combines the subject's sex, race, age, total cholesterol level, HDL cholesterol count, systolic blood pressure, whether the subject is taking medications that interact with statins, smoking status, and diabetes status to deduce the risk of atherosclerotic cardiovascular disease, wherein the summary cohort equation filter is considered activated when the risk meets a first threshold range or a first threshold; an age filter; a drug interaction filter; an alcohol consumption filter; an adverse reaction filter; an atherosclerotic cardiovascular event filter; and optionally, a cyclosporine and / or strong CYP3A4 inhibitor filter (e.g., when not included in the first series of filters).

[0283] The computer system then prompts the subject to confirm or deny that they have discussed these warnings with a medical professional (e.g., their doctor). The computer system then continues the process only if (i) no filters in the first series are activated, and (ii) the subject has confirmed that they have discussed each warning issued by the activated second series of filters.

[0284] The computer system stores the initial order instructions for the OTC statin drug in the subject's profile and sends the subject an over-the-counter drug fact label for the statin drug composition. Once the subject confirms that they have received and read the over-the-counter drug fact label, the computer system authorizes the delivery of the OTC statin drug composition to the subject.

[0285] References and Alternative Examples

[0286] All references cited in this article are incorporated herein by reference in their entirety and for all purposes as if each individual publication, patent, or patent application were specifically or individually indicated to be incorporated herein by reference in their entirety for all purposes.

[0287] This invention can be embodied in the form of a computer program product, which includes a computer program mechanism embedded in a non-transitory computer-readable storage medium. For example, the computer program product may include... Figure 1 , 2The program modules shown in any combination of 3 and / or described in Figures 4 or 5. These program modules may be stored on a CD-ROM, DVD, disk storage product, USB key, or any other non-transitory computer-readable data or program storage product.

[0288] Many modifications and variations can be made to this invention without departing from its spirit and scope, as will be apparent to those skilled in the art. Specific embodiments described herein are given by way of example only. These embodiments were chosen and described to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to best utilize the invention and its various embodiments with modifications suitable for the contemplated particular uses. This invention is defined only by the full scope of the appended claims together with their equivalents.

Claims

1. A non-transitory computer-readable storage medium storing one or more programs, said one or more programs including instructions that, when executed by a computer system, cause the computer system to perform a method, said method comprising: a) Receiving requests from human subjects for statin drug compositions; b) Provide a survey for obtaining multiple survey results from the subjects, wherein the multiple survey results include: The age of the subjects, The gender of the subject, If the subject is female, whether the subject is (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant, The race of the subjects Whether the subject is taking one or more medications that interact with a statin combination, including cyclosporine. Whether the subject has ever experienced an atherosclerotic cardiovascular event or undergone heart surgery, The subjects' total cholesterol levels, The subjects' high-density lipoprotein cholesterol count, The subject's systolic blood pressure Whether the subject is taking high blood pressure medication, The subjects' diabetes status, The smoking status of the subjects, Whether the subject has liver disease, The subjects' alcohol consumption status, Whether the subjects experienced adverse reactions to cholesterol-lowering drugs, and c) Receiving multiple survey results; and d) Applying an algorithm to multiple survey results, using the algorithm: i) Running all or part of the survey results for multiple filters, wherein when a corresponding filter among the multiple filters is activated, the process is terminated or a warning corresponding to the corresponding filter is provided to the subject, and wherein the multiple filters include: Age filter Pregnancy filter, Drug interaction filters Atherosclerotic cardiovascular event filter; Total cholesterol level filter, Summary queue equation filter, Liver disease filter, Drinking filters, and Adverse reaction filter, ii) While the process is not terminated, obtain the subject's confirmation of each warning issued to the subject by any of the multiple filters, and iii) The process continues if: (1) the process has not been terminated by the activation of a filter among the plurality of filters, and (2) the subject has identified each warning associated with each activated filter among the plurality of filters and associated with a warning, wherein the process further includes: Instructions for reordering statin drug compositions are stored in the subject's file. Send the over-the-counter drug label of the statin combination to the subjects, and After the subject confirms that they have received and read the label of the over-the-counter drug, the statin drug composition is authorized to be provided to the subject.

2. The non-transitory computer-readable storage medium of claim 1, wherein the subject suffers from coronary heart disease, cerebrovascular disease, peripheral artery disease, or aortic atherosclerosis.

3. The non-transitory computer-readable storage medium of claim 1, wherein an age filter is activated when multiple survey results indicate that the subject is over 75 years of age.

4. The non-transitory computer-readable storage medium of claim 1, wherein the subject receives a warning when the age filter is activated.

5. The non-transitory computer-readable storage medium of claim 1, wherein a pregnancy filter is activated when multiple survey results indicate that the subject is (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant.

6. The non-transitory computer-readable storage medium of claim 1, wherein the process is terminated when the pregnancy filter is activated.

7. The non-transitory computer-readable storage medium of claim 1, wherein a drug interaction filter is activated when multiple survey results indicate that a subject is taking HIV / AIDS drugs, colchicine, or hepatitis drugs.

8. The non-transitory computer-readable storage medium of claim 1, wherein the subject receives a warning when the drug interaction filter is activated.

9. The non-transitory computer-readable storage medium of claim 1, wherein the atherosclerotic cardiovascular event filter is activated when multiple survey results indicate that the subject has had a heart attack, stroke, or heart surgery.

10. The non-transitory computer-readable storage medium of claim 1, wherein the subject receives a warning when the atherosclerotic cardiovascular event filter is activated.

11. The non-transitory computer-readable storage medium of claim 1, wherein the total cholesterol filter is activated when multiple survey results indicate that the subject's total cholesterol is below 130 mg / dl.

12. The non-transitory computer-readable storage medium of claim 1, wherein the subject receives a warning when the total cholesterol filter is activated.

13. The non-transitory computer-readable storage medium of claim 1, wherein the aggregated cohort equation filter is activated when multiple survey results indicate that the subject has a 10-year risk of atherosclerotic cardiovascular disease of less than 5%.

14. The non-transitory computer-readable storage medium of claim 1, wherein the summary cohort equation filter includes the subject's sex, age, systolic blood pressure, blood pressure treatment status, total cholesterol level, smoking status, diabetes status, waist circumference, geographic residence, urban residence, and family history of atherosclerotic cardiovascular disease, thereby determining the risk of having atherosclerotic cardiovascular disease.

15. The non-transitory computer-readable storage medium of claim 1, wherein the summary queue equation is implemented in the form of a multivariate Cox proportional hazards regression.

16. The non-transitory computer-readable storage medium of claim 1, wherein the subject receives a warning when the summary queue equation filter is activated.

17. The non-transitory computer-readable storage medium according to claim 1, wherein... The liver disease filter is activated when multiple survey results indicate that a subject has liver disease, and The process is terminated when the liver disease filter is activated.

18. The non-transitory computer-readable storage medium of claim 1, wherein the drinking filter is activated when multiple survey results indicate that the subjects drink an average of three or more servings of alcohol per day.

19. The non-transitory computer-readable storage medium of claim 1, wherein the subject receives a warning when the alcohol filter is activated.

20. The non-transitory computer-readable storage medium of claim 1, wherein an adverse reaction filter is activated when multiple survey results indicate that a subject has an adverse reaction to any cholesterol-lowering drug.

21. The non-transitory computer-readable storage medium of claim 1, wherein the subject receives a warning when the adverse reaction filter is activated.

22. The non-transitory computer-readable storage medium according to claim 1, wherein... Further findings included whether the participants had kidney disease, and Multiple filters include a nephropathy filter, which is activated when multiple survey results indicate that a subject has kidney disease.

23. The non-transitory computer-readable storage medium according to claim 1, wherein... Multiple filters include an Asian ancestry filter, which is activated when multiple survey results indicate that the subject is of Asian ancestry.

24. The non-transitory computer-readable storage medium of claim 1, wherein the statin drug composition comprises lovastatin, fluvastatin, atorvastatin, rosuvastatin, simvastatin, pravastatin, or pitavastatin.

25. The non-transitory computer-readable storage medium of claim 1, wherein the statin composition comprises rovastatin, and the daily dose for the subject is 4 mg to 11 mg.

26. The non-transitory computer-readable storage medium of claim 1, wherein the statin composition comprises atorvastatin, and the daily dose for the subject is 10 mg.

27. The non-transitory computer-readable storage medium of claim 1, wherein the statin composition comprises lovastatin, and the daily dose for the subject is 15 mg to 25 mg.

28. The non-transitory computer-readable storage medium of claim 1, wherein the statin composition comprises simvastatin, and the daily dose for the subject is 10 mg to 25 mg.

29. The non-transitory computer-readable storage medium of claim 1, wherein the statin composition comprises pravastatin, and the daily dose for the subject is 10 mg to 80 mg.

30. The non-transitory computer-readable storage medium of claim 1, wherein the statin composition comprises fluvastatin, and the daily dose for the subject is 20 mg to 40 mg.

31. The non-transitory computer-readable storage medium of claim 1, wherein the statin composition comprises pitavastatin, and the daily dose for the subject is 1 mg to 4 mg.

32. The non-transitory computer-readable storage medium of claim 1, wherein for each warning issued to the subject by any of the plurality of filters, the confirmation received from the subject is proof that the subject has discussed the respective warning with the physician.

33. The non-transitory computer-readable storage medium according to claim 1, wherein... At least two of the multiple filters terminate the process upon activation; and The subject is alerted when at least two of the multiple filters are activated.

34. A computer system for qualifying human subjects for over-the-counter delivery of a statin drug composition for lowering cholesterol, said computer system comprising one or more processors and a memory, said memory including non-transitory instructions that, when executed by said one or more processors, perform a method comprising: a) Conduct a first survey to obtain first plurality of survey results from the subjects, wherein the first plurality of survey results include: The gender of the subject, If the subject is female, whether the subject is (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant, Whether the subject has or has had liver disease, The age of the subjects, The subjects' total cholesterol levels, The subjects' high-density lipoprotein cholesterol count, The subject's systolic blood pressure The race of the subjects Whether the subject is taking high blood pressure medication, Whether the subject is taking one or more medications that interact with a statin combination, including cyclosporine. The smoking status of the subjects, The subjects' diabetes status, The subjects' alcohol consumption status, Whether the subjects experienced adverse reactions to cholesterol-lowering drugs, and Whether the subject has ever experienced an atherosclerotic cardiovascular event or undergone heart surgery; b) Perform the following procedure on the first plurality of survey results, wherein the procedure: i) Running all or part of the first plurality of survey results for multiple filters, wherein when a corresponding filter among the plurality of filters is activated, the process is terminated or a warning corresponding to the filter is provided to the subject, wherein the plurality of filters includes: Pregnancy filter, Cyclosporine filter, Filters for liver disease or allergies to statin combinations. Total cholesterol level filter, The summary cohort equation filter includes the subject's gender, age, systolic blood pressure, blood pressure treatment status, total cholesterol level, smoking status, diabetes status, waist circumference, geographic residence, urban residence, and family history of atherosclerotic cardiovascular disease to determine the risk of atherosclerotic cardiovascular disease. The summary cohort equation filter is considered activated when the risk meets or exceeds a first threshold. An age filter is also included. Drug interaction filters Drinking filters, Adverse reaction filters, and Atherosclerotic cardiovascular event filter; ii) While the process is not terminated, obtain the subject's confirmation of each warning, which is issued to the subject by any of the multiple filters; and iii) The process continues if: 1) the process has not been terminated by the activation of a filter among the plurality of filters; or 2) the subject has identified each warning associated with each activated filter among the plurality of filters and associated with a warning, wherein the process further includes: Instructions for the initial order of statin drug compositions are stored in the subject's file. Send the subjects the over-the-counter drug label of the statin combination, and After the subject confirms that they have received and read the over-the-counter drug label, authorization is granted to provide the subject with a statin composition, wherein the authorization includes a subject-related destination, thereby enabling the subject to obtain the statin composition for lowering cholesterol upon authorization.

35. The computer system according to claim 34, wherein The first set of findings further included whether the participants had kidney disease, and Multiple filters include a kidney filter.

36. The computer system of claim 34, wherein Multiple filters include Asian ancestry filters.

37. The computer system of claim 36, wherein an Asian ancestry filter is triggered when a first plurality of survey results indicate that the subject is Asian.

38. The computer system of claim 34, wherein the use of an over-the-counter statin composition to lower cholesterol is for the treatment or prevention of coronary heart disease, cerebrovascular disease, peripheral artery disease, or aortic atherosclerosis.

39. The computer system of claim 34, wherein the risk of atherosclerotic cardiovascular disease is a lifetime risk, a 5-year risk, or a 10-year risk.

40. The computer system of claim 34, wherein the summary queue equation of the summary queue equation filter is implemented in the form of multivariate Cox proportional hazards regression.

41. The computer system of claim 34, wherein the statin drug composition comprises lovastatin, fluvastatin, atorvastatin, rosuvastatin, simvastatin, pravastatin, or pitavastatin.

42. The computer system of claim 34, wherein the label of the over-the-counter drug product specifies that the statin composition includes rovastatin, and the predetermined dose taken by the subject daily is between 2.5 mg and 15 mg.

43. The computer system according to claim 42, wherein The label of the over-the-counter drug indicates that the statin composition includes rovastatin, and the prescribed daily dose is 4 mg to 11 mg, or The label of the over-the-counter drug indicates that the statin drug composition includes atorvastatin or simvastatin, and the predetermined dose for the subject is 10 mg to 25 mg per day.

44. The computer system according to claim 34, wherein Providing a subject with a statin composition includes shipping the statin composition to a physical address associated with the subject, or Providing a subject with a statin composition includes shipping the statin composition to a pharmacy associated with the subject.

45. The computer system according to claim 34, wherein The pregnancy filter is activated when the first multiple survey results indicate that the subject is pregnant. When multiple survey results indicate that a subject has liver disease or an allergic reaction to a statin composition, the liver disease or allergic reaction to a statin composition filter is activated. The risk of atherosclerotic cardiovascular disease is a 10-year risk, with a first threshold of 7.5% for the pooled cohort equation filter. The total cholesterol level filter was activated when the first multiple survey results indicated that the subject's total cholesterol was below 130 mg / dl or above 275 mg / dl, and An age screener is activated when the first multiple survey results indicate that the participant is a woman aged 49 or under or 76 or over. The age filter was activated when the first multiple survey results showed that the subjects were men aged 39 or under or 66 or over.

46. ​​The computer system of claim 34, wherein The risk of atherosclerotic cardiovascular disease is a 10-year risk, and The first threshold for the summary queue equation filter is 7.5%.

47. The computer system of claim 34, wherein When multiple findings indicate that a subject is currently taking blood thinners, warfarin, HIV / AIDS medication, colchicine, hepatitis medication, cholesterol-lowering medication, itraconazole, ketoconazole, or fluconazole, the drug interaction filter is activated, and The alcohol filter is activated when multiple survey results indicate that subjects consume an average of three or more servings of alcohol per day.

48. The computer system according to claim 34, wherein When the risk obtained through the aggregated cohort equation filter is within a first threshold range, the subject is given the statin composition at the first predetermined daily dose, and When the risk obtained by the summary cohort equation filter is within the second threshold range, the subject is given a second predetermined daily dose of the statin composition.

49. The computer system according to claim 48, wherein Statin drug compositions include rovastatin. The risk of atherosclerotic cardiovascular disease is a 10-year risk. The first threshold range is between 5% and 7.5%. The first threshold range is between 5% and 7.5%; the first predetermined daily dose is between 4 mg and 8 mg. The second threshold ranges between 7.5% and 10%, and The second daily prescribed dose is between 8 mg and 11 mg.

50. The computer system of claim 34, wherein the method further comprises: c) In response to a received reorder request for a statin composition from a subject, perform the following procedure, which includes: (i) Conducting a second survey to obtain a second plurality of survey results from the respondents, wherein the second plurality of survey results include: Whether the subjects experienced muscle irregularities after taking the statin combination drug. Whether the subject is pregnant, Whether the subject is taking any medication that interacts with the statin combination, and Has the subject experienced any atherosclerotic cardiovascular events or undergone heart surgery since the last order of the statin combination? (ii) Running all or part of the results from the second plurality of surveys for a third plurality of filters, wherein when a corresponding filter in the third plurality of filters is triggered, the subject provides a warning corresponding to the corresponding filter, wherein the third plurality of filters include: Pregnancy filter, Muscle irregularity filter, The second drug interaction filter, and Atherosclerotic cardiovascular event filter; (iii) While the reordering process is not terminated, obtain the subject's confirmation of each warning issued to the subject by any of the third or more filters, and (iv) The re-performance process continues while (i) the re-performance process has not yet terminated due to the activation of a filter in the third plurality of filters, and (ii) the subject has identified each warning associated with each activated filter in the third plurality of filters and associated with the warning, wherein the re-performance process further includes: Instructions for reordering statin drug compositions are stored in the subject's file. Send the subjects the over-the-counter drug label of the statin combination, and After the subject confirms that they have received and read the over-the-counter drug label, authorization is granted to re-deliver the statin drug composition to the subject, wherein the re-delivered statin drug composition includes the subject's destination.

51. The computer system according to claim 50, wherein When a second set of multiple findings indicated that subjects experienced unexplained muscle cramps or weakness after taking a statin combination, the muscle irregular filter was activated. When a second set of findings indicates that a subject is pregnant and leads to termination of the process, the pregnancy filter is activated, and The second drug interaction filter is activated when multiple findings indicate that the subject is currently taking cyclosporine, blood thinners, warfarin, HIV / AIDS medication, or cholesterol-lowering drugs.

52. A computer system comprising a memory and one or more processors, wherein the one or more processors perform a method comprising: a) Conducting a first survey to obtain first plurality of survey results from the subjects, wherein the first plurality of survey results include: The gender of the subject, When the subject is female, whether the subject is (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant, Whether the subject has or has had liver disease, The age of the subjects, The subjects' total cholesterol levels, The high-density lipoprotein cholesterol levels of the subjects, The subject's systolic blood pressure The race of the subjects Whether the subject is taking high blood pressure medication, Whether the subject is taking one or more medications that interact with a statin combination, including cyclosporine. The smoking status of the subjects, The subjects' diabetes status, The subjects' alcohol consumption status, Did the subjects experience any adverse reactions to cholesterol-lowering drugs, and Whether the subject has experienced an atherosclerotic cardiovascular event or undergone heart surgery; b) Applying a process to the first plurality of survey results, wherein the process: i) Running all or part of the first plurality of survey results for multiple filters, wherein the process is terminated or a warning corresponding to the corresponding filter is provided to the subject when a corresponding filter in the first plurality of filters is activated, wherein the plurality of filters includes: Pregnancy filter, Cyclosporine filter, Filters for liver disease or statin allergies Total cholesterol level filter, The summary cohort equation filter includes the subject's gender, age, systolic blood pressure, blood pressure treatment status, total cholesterol level, smoking status, diabetes status, waist circumference, geographic residential area, urban residential area, and family history of atherosclerotic cardiovascular disease, thereby determining the risk of atherosclerotic cardiovascular disease. The summary cohort equation filter is considered activated when the risk meets or exceeds a first threshold range. Age filter Drug interaction filters Drinking filters, Adverse reaction filters, and Atherosclerotic cardiovascular event filter; ii) While the process is not terminated, obtain the subject's confirmation of each warning issued to the subject by any of the multiple filters; and iii) The process continues if: 1) the process has not been terminated by the activation of a filter among the plurality of filters; or 2) the subject has identified each warning associated with each activated filter among the plurality of filters and associated with a warning, wherein the process further includes: Instructions for the initial order of statin drug compositions are stored in the subject's file. Send the subjects the over-the-counter drug label of the statin combination, and After the subject confirms that they have received and read the over-the-counter drug label, authorization is granted to provide the subject with a statin drug composition, wherein the authorization includes a subject-related destination, thereby enabling the subject to obtain the statin drug composition for lowering cholesterol upon authorization.

Images