Systems and methods for dispensing statin medication over the counter

Abstract

To provide systems and methods for over the counter statin delivery to a subject.SOLUTION: In the methods, survey results from the subject are run through a first plurality of filters; when a filter in the first plurality of filters is triggered, the subject is deemed not qualified. The survey results are also run through a second plurality of filters; and, when a respective filter in the second plurality is triggered, the subject is provided with a corresponding warning. The methods proceed to a fulfillment process when no filter in the first plurality is triggered and the subject has acknowledged each warning associated with each triggered filter in the second plurality. The fulfillment stores the composition order, communicates a drug facts label for the statin to the subject, and authorizes, upon subject confirmation that the label has been read, provision of the statin to the subject, the authorization including a destination associated with the subject.SELECTED DRAWING: Figure 4C

Description

Technical Field

[0001] The present disclosure generally relates to systems and methods for identifying human subjects for the distribution of a statin pharmaceutical composition without a prescription for treating or preventing atherosclerotic cardiovascular disease, for example, by reducing cholesterol.

Background Art

[0002] Cardiovascular disease remains the leading cause of death worldwide, killing more people than all forms of cancer combined. The number of cardiovascular deaths is expected to increase to approximately 24 million per year by 2030. The direct and indirect annual costs total over $3.16 trillion, exceeding the entire GDP of the world excluding the top 30 countries.

[0003] Statins have been the cornerstone therapy for fighting heart disease for nearly 30 years. The total number of evidence for reducing cardiovascular disease events is the largest among pharmaceuticals. Statins are still the most prescribed class of pharmaceuticals.

[0004] Despite the fact that many statins will become generally available due to patent expiration in the United States and other markets by 2017, the prevalence of cardiovascular disease is expected to continue. That is, the heart disease will not disappear. The next generation shows clear signs that they will develop cardiovascular disease at high morbidity levels and will need assistance. New therapies are emerging to address cardiovascular disease, but such new therapies are expected to be combined with statins rather than replace them. Therefore, statins are expected to remain the cornerstone therapy for cardiovascular disease in the near future.

[0005] Unfortunately, as a long-term trend, many people are shown to avoid prescription medications containing statins. One approach to making statins more accessible is then to make them available over the counter (「OTC」), for example, without a prescription. However, since statins can have serious and harmful effects on certain patients, the population receiving the drug should be carefully selected and monitored. Ramkumar S.et al.,Acta Cardiol.Sin.,32(6):631-39 (2016). This is the reason why statin distribution has traditionally been regulated through exclusive prescription access. To ensure the safety of OTC distribution of statins, prospective patients must effectively self-select themselves for the drug. However, recent studies have shown that many prospective patients do not pay consistent attention to the guidelines printed on the packaging of OTC drugs 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”,Oct.15 (2015) (citing McNeil Consumer Healthcare research). According to these studies, 40% of prospective patients regard the instructions as mere guidelines, and 80% of patients do not reread the labels of previously used OTC drugs. Even more troublesome, only 58% of the men surveyed felt that it was very important to pay attention to the restrictions on OTC labels.

[0006] Previous attempts to improve self-selection and safe use of statins by OTC have been lost It ended in failure. For example, Pfizer announced in 2011 its intention to switch Lipitor from prescription-only to over-the-counter (OTC) status. Sett OTC bulletin, 16 November 2011, page 7. Pfizer aborted its attempt to move Lipitor from prescription to OTC (over-the-counter) status in the United States in 2014. Specifically, the Phase 3 "actual use" trial, which aimed to simulate the OTC use of 10 mg of Lipitor (atorvastatin calcium) completed in December 2014, was unable to achieve its basic objective based on the insufficient compliance of patients with the instruction to check their low-density lipoprotein cholesterol (LDL-C) levels and take appropriate measures based on their test results after checking their LDL-C levels.

[0007] Similarly, Merck made at least three applications for the sale of marketable lovastatin, which were rejected by the FDA in 2000, 2005, and 2007. In 2005, their proposal to permit the sale of marketable lovastatin was rejected by the FDA's Expert Advisory Committee. The committee was concerned about a market survey conducted to support the proposal that approximately one-third of the 3,316 customers to whom the marketable drug was offered decided to purchase the drug. After examining the data, the committee concluded that 45% of the purchases were inappropriate for various reasons, including the age of the subjects, the subjects' lack of knowledge about their condition, and the contraindications associated with their condition. Dyer O., BMJ, 330(7484):164 (2005). In fact, to date, statins have never been permitted OTC status in the United States, and more than 15 years have passed since Bristol-Myers Squibb and Merck & Co. first failed in their attempts to switch pravacol and lovastatin to OTC, respectively.

[0008] More than one-third of American adults are recognized as taking or already taking cholesterol-lowering drugs under current guidelines. However, according to a report by CDC researchers in the 2015 Morbidity and Mortality Weekly Report (MMWR), almost half of this group is not. By 2017, managing high levels of LDL cholesterol in 65 percent of this group of Americans is one of the main goals of the U.S. Department of Health and Human Services' Million Hearts initiative to prevent 1 million heart attacks and strokes.

[0009] Thus, the data show that there has been no significant improvement in the treatment rate from 2011 to today. In fact, as statins go off-patent and generic brands gain market share, the situation is expected to worsen. With this loss of market share, it cannot be expected that brand-name pharmaceutical companies will be able to maintain the level of support for hyperlipidemia provided over the past 30 years from a scientific, educational, and promotional perspective. Support for statins through education, science, etc. will not be received from generic manufacturers. Therefore, at present, it is unclear how the goals of the U.S. Department of Health and Human Services' Million Hearts initiative will be achieved.

[0010] Considering the above background, what is needed in the art is, for example, a system and method for identifying human subjects for the distribution of a commercially available statin pharmaceutical composition for treating or preventing atherosclerotic cardiovascular disease by lowering cholesterol. SUMMARY OF THE INVENTION

[0011] The present disclosure addresses a need in the art for systems and methods for qualifying human subjects for the distribution of commercially available statin pharmaceutical compositions for treating or preventing atherosclerotic cardiovascular disease, for example, by reducing cholesterol. The present disclosure provides systems and methods for the distribution of commercially available statins to subjects. The survey results from the subjects are applied to a first plurality of filters. When one of the first plurality of filters is activated, the subject is considered not qualified. The survey results are also applied to a second plurality of filters. When each of the second plurality of filters is activated, a corresponding warning is provided to the subject. The method proceeds to the fulfillment process if none of the filters in the first plurality are activated and the subject acknowledges each warning associated with each activated filter in the second plurality. Fulfillment stores an order for the composition, communicates the drug information label for the statin to the subject, approves the provision of the statin to the subject upon confirmation by the subject that the label has been read, and the approval includes the destination associated with the subject.

[0012] Accordingly, one aspect of the present disclosure provides a computer system for qualifying human subjects for the distribution of commercially available statin pharmaceutical compositions that reduce 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, implement a method. The method includes conducting a first survey of a subject, thereby obtaining a first plurality of survey results.

[0013] In some embodiments, the first plurality of survey results include the gender of the subject, whether the subject is female and one of (i) pregnant, (ii) lactating, or (iii) planning to become pregnant, whether the subject has or has had liver disease, the age of the subject, the total cholesterol level of the subject, the HDL cholesterol count of the subject, the systolic blood pressure of the subject, the race of the subject, whether the subject is taking a hypertensive agent, whether the subject is taking one or more agents that interact with the statin pharmaceutical composition, where the one or more agents include cyclosporine, the smoking status of the subject, the diabetes status of the subject, the alcohol intake status of the subject, whether the subject has had an adverse reaction to a cholesterol-lowering agent, and whether the subject has had an atherosclerotic cardiovascular event or has had heart surgery.

[0014] All or part of the first plurality of survey results are applied to a first plurality of filters of a first category class. When each filter within the first plurality of filters is activated, the subject is considered not eligible for distribution of the statin pharmaceutical composition and the method ends without distribution of the statin pharmaceutical composition to the subject. In some embodiments, the first plurality of filters include a pregnancy filter, a cyclosporine filter, and a liver disease filter.

[0015] The method continues by applying all or part of the first plurality of survey results to a second plurality of filters of a second category class. When each filter within the second plurality of filters is activated, a warning corresponding to each filter is provided to the subject. In some embodiments, the second plurality of filters include a total cholesterol level filter, a pooled cohort equation filter, an age filter, a drug interaction filter, an alcohol intake filter, an adverse reaction filter, and an atherosclerotic cardiovascular event filter.

[0016] In some embodiments, the pooled cohort equation filter incorporates the subject's gender, the subject's race, the subject's age, the subject's total cholesterol level, the subject's HDL cholesterol count, the subject's systolic blood pressure, whether the subject is taking a drug that interacts with statins, the subject's smoking status, and the subject's diabetes status to derive the risk of atherosclerotic cardiovascular disease. If the risk meets a first threshold range or a first threshold, the pooled cohort equation filter is considered activated.

[0017] The method continues by obtaining confirmation from the subject regarding a warning issued to the subject by any filter within a second plurality of filters.

[0018] The method continues by proceeding to a fulfillment process if (i) no filter within the first plurality of filters is activated and (ii) the subject has confirmed each warning associated with each filter within the activated second plurality of filters.

[0019] In some embodiments, the fulfillment process includes storing an indicator of a first order of a statin pharmaceutical composition in a subject profile associated with the subject, transmitting a commercial drug information label of the statin pharmaceutical composition to the subject, and upon receiving confirmation from the subject that the commercial drug information label has been received and read, approving the provision of the statin pharmaceutical composition to the subject, the approval including a destination associated with the subject (e.g., a location or store where the statin pharmaceutical composition or the statin pharmaceutical composition is to be shipped for pickup by the subject).

[0020] Another aspect of the present disclosure provides a method for qualifying a human for the distribution of a commercially available statin pharmaceutical composition for cholesterol reduction. The method includes obtaining a first information set from a human, the first information set including the human's gender, whether the human is female, and whether the human is (i) pregnant, (ii) lactating, or (iii) planning to become pregnant, whether the human has or has had a liver condition, the human's age, the human's total cholesterol level, the human's HDL cholesterol count, the human's systolic blood pressure, the human's race, whether the human is receiving hypertension treatment, whether the human is taking one or more compositions that interact with the statin pharmaceutical composition, where the one or more compositions include cyclosporine, whether the human is a smoker, the human's diabetes status, the human's alcohol intake status, whether the human has had an adverse reaction to a cholesterol-lowering composition, and whether the human has had an atherosclerotic cardiovascular event or has had heart surgery, including one or more of the foregoing. In some embodiments, the first information set includes each of the characteristics listed above.

[0021] The method also includes applying all or a portion of the information set to a first plurality of filters of a first categorical class, where when each filter within the first plurality of filters is activated, the human is considered not to be qualified for the distribution of the statin pharmaceutical composition and the method ends without distributing the statin pharmaceutical composition to the human. In some embodiments, the first plurality of filters includes one or more of a pregnancy filter, a cyclosporine filter, and a liver condition or allergic reaction to the statin pharmaceutical composition filter. In some embodiments, the first plurality of filters includes all of the filters listed above.

[0022] The method also includes applying all or part of the first information set to a second plurality of filters of a second category class, and when each filter of the second plurality of filters is activated, a human is provided with a warning corresponding to each filter. In some embodiments, the second plurality of filters incorporate one or more of total cholesterol level filter, human gender, human race, human age, human total cholesterol level, human high density lipoprotein cholesterol number, human systolic blood pressure, whether the human is taking a composition that interacts with statin, human smoking status, and human diabetes status to derive the likelihood of atherosclerotic cardiovascular condition, and when the likelihood meets a first threshold range or a first threshold, the pooled cohort equation filter is considered to be activated, a pooled cohort equation filter, an age filter, a drug interaction filter, an alcohol intake filter, a harmful reaction filter, and an atherosclerotic cardiovascular event filter, among others. In some embodiments, the second plurality of filters include all of the filters listed above.

[0023] The method continues by obtaining confirmation from the human regarding a warning issued to the human by any filter within the second plurality of filters.

[0024] The method continues by proceeding to a full fulfillment process when (i) no filter within the first plurality of filters is activated and (ii) the human has confirmed each warning associated with each filter within the activated second plurality of filters.

[0025] In some embodiments, the full fulfillment process includes storing an indicator of the first order of the statin pharmaceutical composition in the human profile, communicating the over-the-counter drug label of the statin pharmaceutical composition to the human, and approving the provision of the statin pharmaceutical composition to the human when confirmation is obtained from the human that the over-the-counter drug label has been received and read, and the approval includes the destination associated with the human.

[0026] In some embodiments, the first plurality of survey results also include whether the subject has a family history of juvenile heart attack or stroke, such as a history of previous heart attack or stroke at, for example, 45 years old, 50 years old, 55 years old, 60 years old, etc.

[0027] In some embodiments, the first plurality of survey results include the subject's hsCRP level.

[0028] 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 of the second category class include a kidney disease filter.

[0029] In some embodiments, the second plurality of filters of the second category class include an Asian filter. In some embodiments, the Asian filter is activated when the first plurality of survey results indicate that the subject is Asian.

[0030] In some embodiments, 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, thoracic aortic aneurysm, etc.).

[0031] In some embodiments, the risk of atherosclerotic cardiovascular disease is a lifetime risk, a 3-year risk, a 5-year risk, a 10-year risk, or a 15-year risk.

[0032] In some embodiments, the pooled cohort equation is implemented as a multivariable Cox proportional hazards regression.

[0033] In some embodiments, the statin pharmaceutical composition comprises lovastatin, fluvastatin, atorvastatin, rosuvastatin, simvastatin, pravastatin, or pitavastatin. For example, in some embodiments, the pharmaceutical composition is lovastatin at a daily dosage of 15 mg to 25 mg. In some embodiments, the pharmaceutical composition is fluvastatin at a daily dosage of 20 mg to 40 mg. In some embodiments, the pharmaceutical composition is atorvastatin at a daily dosage of 20 mg to 80 mg. In some embodiments, the pharmaceutical composition is rosuvastatin at a daily dosage of 2.5 mg to 15 mg. In some embodiments, the pharmaceutical composition is simvastatin at a daily dosage of 10 mg to 40 mg. In some embodiments, the pharmaceutical composition is pravastatin at a daily dosage of 10 mg to 80 mg. In some embodiments, the pharmaceutical composition is fluvastatin at a daily dosage of 70 mg to 90 mg. In some embodiments, the pharmaceutical composition is pitavastatin at a daily dosage of 1 mg to 4 mg.

[0034] In some embodiments, the commercial drug information label specifies that the statin pharmaceutical composition contains rosuvastatin and that it should be taken by the subject at a predetermined daily dosage of 4 mg to 15 mg per day.

[0035] In some embodiments, the commercial drug information label specifies that the statin pharmaceutical composition contains rosuvastatin and that it should be taken by the subject at a predetermined daily dosage of 4 mg to 11 mg per day.

[0036] In some embodiments, the commercial drug information label specifies that the statin pharmaceutical composition contains atorvastatin or simvastatin and that it should be taken by the subject at a predetermined daily dosage of 10 mg to 25 mg per day.

[0037] In some embodiments, providing a statin pharmaceutical composition to a subject includes shipping the statin pharmaceutical composition to a physical address associated with the subject. In other embodiments, providing a statin pharmaceutical composition to a subject includes shipping the statin pharmaceutical composition to a pharmacy associated with the subject.

[0038] In some embodiments, a first pregnancy filter is activated when a first plurality of survey results indicate that the subject is pregnant.

[0039] In some embodiments, an age filter is activated when a first plurality of survey results indicate that the subject is a female under 49 years old or over 76 years old.

[0040] In some embodiments, an age filter is activated when a first plurality of survey results indicate that the subject is a male under 39 years old or over 66 years old.

[0041] In some embodiments, a liver disease or allergic reaction filter for a statin pharmaceutical composition is activated when a first plurality of survey results indicate that the subject has had a liver disease or an allergic reaction to the statin pharmaceutical composition.

[0042] In some embodiments, a total cholesterol level filter is activated when a first plurality of survey results indicate that the subject has a total cholesterol of less than 130 mg / dl or more than 275 mg / dl. In some embodiments, a total cholesterol level filter is activated when a first plurality of survey results indicate that the subject has a total cholesterol of less than 160 mg / dl or more than 260 mg / dl.

[0043] In some embodiments, the risk of atherosclerotic cardiovascular disease is a 10-year risk, and the first threshold of the pooled cohort equation filter is 7.5 percent. In some embodiments, the risk of atherosclerotic cardiovascular disease is a 10-year risk, and the first threshold of the pooled cohort equation filter is 7.5 percent.

[0044] In some embodiments, the Asian filter is activated when the first plurality of findings indicate that the subject is Asian. In some embodiments, the Asian filter is not used.

[0045] In some embodiments, the drug interaction filter is activated when the first plurality of findings 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.

[0046] In some embodiments, the alcohol filter is activated when the first plurality of findings indicate that the subject consumes an average of more than 3 drinks per day. In some embodiments, the alcohol filter is activated when the first plurality of findings indicate that the subject consumes an average of more than 2 drinks per day. In some embodiments, the alcohol filter is activated when the first plurality of findings indicate that the subject consumes an average of more than 1 drink per day. In some embodiments, the alcohol filter is activated when the first plurality of findings indicate that the subject consumes an average of more than 4 drinks per day. In some embodiments, the alcohol filter is activated when the first plurality of findings indicate that the subject consumes an average of more than 5 drinks per day. In some embodiments, the alcohol filter is not used.

[0047] In some embodiments, providing a statin pharmaceutical composition to a subject in a fulfillment process comprises providing the statin pharmaceutical composition at a first predetermined daily dosage when the risk derived by a pooled cohort equation filter is within a first threshold range, and providing the statin pharmaceutical composition at a second predetermined daily dosage when the risk derived by the pooled cohort equation filter is within a second threshold range. By way of example, in some embodiments, the statin pharmaceutical composition comprises rosuvastatin, the risk of atherosclerotic cardiovascular disease is a 10-year risk, the first threshold range is 5 percent to 7.5 percent, the first predetermined daily dosage is 4 mg to 8 mg, the second threshold range is 7.5 percent to 10 percent, and the second predetermined daily dosage is 8 mg to 11 mg.

[0048] In some embodiments, the method further comprises performing a procedure that includes conducting a second survey of the subject in response to receiving a refill request from the subject for the statin pharmaceutical composition, thereby obtaining a second plurality of survey results. The second plurality of survey results includes whether the subject has experienced muscle irregularities since taking the statin pharmaceutical composition, whether the subject is pregnant, whether the subject is taking a drug that interacts with the statin pharmaceutical composition, and whether the subject has had an atherosclerotic cardiovascular event (e.g., a heart attack or stroke) or heart surgery since last ordering the statin pharmaceutical composition. The procedure further includes applying all or a portion of the second plurality of survey results to a third plurality of filters, wherein when each filter in the third plurality of filters is activated, an action corresponding to each filter is induced, and the third plurality of filters includes a pregnancy filter, a muscle irregularity filter, a second drug interaction filter, and an atherosclerotic cardiovascular event filter. The refill process further includes obtaining confirmation from the subject regarding any warnings issued to the subject by any of the filters in the third plurality of filters.

[0049] The refill process further proceeds when (i) the refill process has not yet been completed by the activation of the filters in the third plurality of filters and (ii) the subject has associated with each filter in the third plurality of filters that are activated and associated with a warning, and has confirmed each warning associated therewith.

[0050] The refill process further includes storing an indicator of a refill of the statin pharmaceutical composition in the subject profile, transmitting the over-the-counter drug information label of the statin pharmaceutical composition to the subject, and upon confirmation from the subject that the over-the-counter drug information label has been received and read, approving the offer of a refill of the statin pharmaceutical composition to the subject, the approval including the destination of the subject.

[0051] In some embodiments, the muscle irregularity filter is activated when the second plurality of findings indicate that the subject has experienced unexplained muscle cramps or weakness since taking the statin pharmaceutical composition, the pregnancy filter is activated when the second plurality of findings indicate that the subject is pregnant, resulting in the end of the refill procedure, and 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, an HIV / AIDS drug, or a cholesterol-lowering drug.

[0052] Another aspect of the present disclosure provides a method for qualifying human subjects for the distribution of a commercially available statin pharmaceutical composition for lowering cholesterol. The method includes conducting a first survey of a subject, thereby obtaining a first plurality of survey results. The first plurality of survey results includes (i) the subject's gender and whether the subject is female and one of (a) pregnant, (b) lactating, 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 race, (ix) whether the subject is taking a hypertensive agent, (x) whether the subject is taking one or more agents that interact with the statin pharmaceutical composition, where one or more of the agents includes cyclosporine, (xi) the subject's smoking status, (xii) the subject's diabetes status, (xiii) the subject's alcohol intake status, (xiv) whether the subject has had an adverse reaction to a cholesterol-lowering agent, (xv) whether the subject has had an atherosclerotic cardiovascular event or has had heart surgery. All or a portion of the first plurality of survey results is applied to a first plurality of filters of a first categorical class. When each filter within the first plurality of filters is activated, the subject is deemed not qualified for the distribution of the statin pharmaceutical composition, and the method ends without distributing the statin pharmaceutical composition to the subject. The first plurality of filters includes a pregnancy filter, a cyclosporine filter, and a liver disease filter. All or a portion of the first plurality of survey results is also applied to a second plurality of filters of a second categorical class. When each filter within the second plurality of filters is activated, a warning corresponding to each filter is provided to the subject.The second plurality of filters includes a total cholesterol level filter and a pooled cohort equation filter that incorporates the subject's gender, race, age, total cholesterol level, HDL cholesterol count, systolic blood pressure, whether the subject is taking a drug that interacts with a statin, the subject's smoking status, and the subject's diabetes status to derive the risk of atherosclerotic cardiovascular disease. When the risk meets the first threshold range or the first threshold, the pooled cohort equation filter is considered to be activated. The second plurality of filters further includes an age filter, a drug interaction filter, an alcohol intake filter, a harmful reaction filter, and an atherosclerotic cardiovascular event filter. For any warning issued to the subject by a filter within the second plurality of filters, confirmation is obtained from the subject. The method proceeds to the fulfillment process when (i) none of the filters within the first plurality of filters are activated and (ii) the subject has confirmed each warning associated with each filter within the activated second plurality of filters. The fulfillment process... The process includes storing an indicator of the first order of the statin pharmaceutical composition in the subject profile, communicating the over-the-counter drug information label of the statin pharmaceutical composition to the subject, and approving the provision of the statin pharmaceutical composition to the subject upon confirmation from the subject that the over-the-counter drug information label has been received and read. The approval includes the destination associated with the subject.

[0053] Another aspect of the present disclosure provides a non-transitory computer-readable storage medium that stores instructions that, when executed by a computer system, cause the computer system to perform any of the methods for identifying a human subject for the distribution of a commercially available statin pharmaceutical composition that reduces cholesterol as disclosed herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0054]

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[0055] Throughout several views of the drawings, like reference numerals refer to corresponding parts.

DETAILED DESCRIPTION OF THE INVENTION

[0056] In one aspect, the present disclosure conducts an investigation of a subject to obtain investigation results in order to determine whether the subject is eligible for a commercially available (OTC) statin pharmaceutical composition for the treatment or prevention of atherosclerotic cardiovascular disease. The investigation results are used as a basis for applying to a first category class of filters. If any triggering condition of the first category class of filters is activated, the subject is not eligible for the OTC statin pharmaceutical composition. The investigation results are also used as a basis for applying to a second category class of filters. If any triggering condition of the second category class of filters is activated, a warning message associated with each activated filter of the second category class is provided to the subject. If none of the filters within the first category class are activated and the subject successfully addresses the warning messages associated with each activated filter of the second category class, the Fullfilment process for OTC distribution of the statin pharmaceutical composition to the subject is initiated.

[0057] FIG. 1 shows an example of an integrated system 48 for conducting a subject survey to identify subjects for the OTC distribution of a statin pharmaceutical composition and for the distribution of the statin pharmaceutical composition to a destination associated with an identified subject. The integrated system 48 includes one or more connected user devices 102 for inputting survey data and generating a request for a statin pharmaceutical composition, one or more dispensing destination devices 104 for receiving instructions to provide the statin pharmaceutical composition to an identified subject, an over-the-counter (OTC) statin pharmaceutical composition dispensing device 250, and one or more data collection devices 200 for collecting subject data. Throughout the present disclosure, the data collection device 200 and the OTC statin pharmaceutical composition dispensing device 250 will be referred to as separate devices for purposes of clarity. That is, the disclosed functions of the data collection device 200 and the disclosed functions of the OTC statin pharmaceutical composition dispensing device 250 are included in separate devices as shown in FIG. 1. However, in practice, it will be understood that in some embodiments, the disclosed functions of the data collection device 200 and the disclosed functions of the OTC statin pharmaceutical composition dispensing device 250 may be included in a single device.

[0058] For the integrated system 48, the survey results from the subjects are applied to a first plurality of filters. When the filters within the first plurality of filters are each activated for a respective subject, that respective subject is considered not to be certified. The survey results are also applied to a second plurality of filters. When each filter within the second plurality is activated for a respective subject, that respective subject is provided with a warning associated with that respective filter. A method enabled by the integrated system 48 is that if none of the filters within the first plurality are activated and the subject acknowledges each warning associated with each activated filter within the second plurality or otherwise successfully copes, then the process proceeds to the fulfillment process. As part of the fulfillment process, an order for the composition is stored (e.g., in the user profile associated with the subject to receive the drug), drug information labels for the statin are communicated to the certified subject, and approval to dispense the statin to the subject is permitted at a specific destination associated with the subject upon confirmation that the subject has read the label.

[0059] Referring now to the embodiments in detail, examples thereof are illustrated in the accompanying drawings. In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present disclosure. It will be apparent to one of ordinary skill in the art, however, that the present disclosure may be practiced without these specific details. In other instances, well-known methods, procedures, components, circuits, and networks are not described in detail so as not to unnecessarily obscure aspects of the embodiments.

[0060] Also, terms such as first, second, etc. may be used herein to describe various elements, but it will be understood that these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, without departing from the scope of the present disclosure, a first subject can be referred to as a second subject, and similarly, a second subject can be referred to as a first subject. The first subject and the second subject are both the same subject, but not the same subject. Further, the terms "subject", "user", and "patient" are used interchangeably herein. The term insulin pen means an injection device suitable for applying individual doses of insulin, and the injection device is adapted to record and transmit dose-related data.

[0061] The terms used in the present disclosure are for the sole purpose of describing particular embodiments and are not intended to limit the invention. In the description of the invention and the claims When used, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. Also, as used herein, the term "and / or" refers to any and all possible combinations of one or more of the listed related items and is understood to be inclusive. Further, as used herein, the terms "comprises" and / or "comprising" specify the presence of the stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0062] As used herein, the term "if" may be interpreted to mean "when" or "upon" or "in response to determining" or "in response to detecting", depending on the context. Similarly, the phrases "if it is determined" or "if (a stated condition or event) is detected" may be interpreted to mean "upon determining" or "in response to determining" or "upon detecting" or "in response to detecting" (a stated condition or event), depending on the context.

[0063] As used herein, the term "over the counter" means provided by retail purchase, subject to the restrictions disclosed herein, without a prescription or authorization from a physician or practitioner.

[0064] As used herein, the term "contraindication" refers to a condition, for example, where treatment with an over-the-counter statin drug is not recommended. Contraindications include the physical characteristics of the subject, such as pregnancy or liver disease, and the use of concurrent medications, such as the use of cyclosporine. In this context, the identification of contraindications operates a first category class of filters that prevent the approval of the provision of a statin pharmaceutical composition according to some implementations of the methods, systems, and software disclosed herein.

[0065] As used herein, the term "risk factor" refers to a condition for which treatment, for example, with the use of a commercially available statin medication, is likely inadvisable. Risk factors include a subject's physical characteristics, such as cholesterol levels, and contemporaneous drug use, such as the use of blood thinners. In this context, the identification of a risk factor, according to some implementations of the methods, systems, and software disclosed herein, activates a second category class filter that prevents approval of provision of a statin pharmaceutical composition without verifying that the subject has discussed the risk factors with a healthcare professional.

[0066] In the context of the present disclosure, the classification of a condition as either a contraindication or a risk factor is specific to the particular identity and dosage of a statin pharmaceutical composition approved for commercial use. The classification of a particular condition, e.g., concurrent use of cyclosporine, may vary between different statin pharmaceutical compositions (e.g., it may be classified as a contraindication for a first statin, a risk factor for a second statin, and / or neither for a third statin). Similarly, a particular condition may be classified as a contraindication for the use of a particular statin at a first commercial dosage, a risk factor for a particular statin at a second (e.g., lower) commercial dosage, and / or a risk factor for a particular statin at a commercial dosage. amount) versus one-third (e.g., lowest) of the same specific statin).

[0067] Referring to FIG. 1, an OTC dispensing device 250 for a statin pharmaceutical composition certifies human subjects for the distribution of a commercially available statin pharmaceutical composition that reduces cholesterol. To do this, a data collection device 200 that communicates electrically with the OTC dispensing device 250 for the statin pharmaceutical composition 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 wirelessly receives this data via a radio frequency signal. In some embodiments, such signals comply with 802.11 (WiFi), Bluetooth®, or the ZigBee standard. In some embodiments, the data collection device 200 receives such data directly, analyzes the data, and passes the analyzed data to the OTC dispensing device 250 for the statin pharmaceutical composition.

[0068] In some embodiments, the data collection device 200 and / or the OTC dispensing device 250 for the statin pharmaceutical composition are not in proximity to the subject 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 may be used to survey questions from the OTC dispensing device 250 for the statin pharmaceutical composition to the user device 102, and responses to such survey questions from the user device 102 to the data collection device 200 and / or the OTC dispensing device 250 for the statin pharmaceutical composition. Further, in some embodiments, the communication network 106 is used to transmit approval for dispensing a statin survey question from the OTC dispensing device 250 for the statin pharmaceutical composition to the dispensing destination device 104.

[0069] Examples of network 106 include, but are not limited to, the World Wide Web (WWW), intranets, and / or wireless networks such as cellular phone networks, wireless local area networks (LANs), and / or metropolitan area networks (MANs), as well as other devices using wireless communication. Wireless communication optionally uses any of a plurality of communication standards, protocols, and technologies, including Global System for Mobile Communications (GSM®), Enhanced Data GSM® Environment (EDGE), High-Speed Downlink Packet Access (HSDPA), High-Speed Uplink Packet Access (HSUPA), Evolution-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®, Wireless Fidelity (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), WiMAX, protocols for email (e.g., Internet Message 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 Event Package (SIMPLE), Instant Messaging and Presence Service (IMPS)), and / or Short Message Service (SMS), or any other suitable communication protocol including communication protocols not yet developed as of the filing date of the present disclosure, but not limited thereto.

[0070] Of course, other topologies of system 48 are possible. For example, communication network Rather than relying on the work 106, one or more user devices 102 and one or more dispensing destination devices 104 may communicate directly with the data collection device 200 and / or the statin pharmaceutical composition OTC dispensing device 250. Further, the data collection device 200 and / or the statin pharmaceutical composition OTC dispensing device 250 may comprise a portable electronic device, a server computer, or actually several computers that are either linked together within a network or are virtual machines in the context of cloud computing. Thus, the exemplary topology shown in FIG. 1 serves only to illustrate the features of embodiments of the present disclosure and will be readily understood by those skilled in the art.

[0071] Referring to FIG. 2, in an exemplary embodiment, the statin pharmaceutical composition OTC dispensing device 250 includes one or more computers. For the purposes shown in FIG. 2, the statin pharmaceutical composition OTC dispensing device 250 is represented as a single computer that includes all of the functionality for qualifying human subjects for the distribution of commercially available statin pharmaceutical compositions that lower cholesterol. However, the present disclosure is not so limited. In some embodiments, the functionality for qualifying human subjects for the distribution of commercially available statin pharmaceutical compositions that lower cholesterol is distributed across any number of network computers and / or exists on each of a plurality of network computers and / or is hosted on one or more virtual machines located at a remote location accessible via the communication network 106. Those skilled in the art will understand that any of a wide variety of different computer topologies may be used in the present application and that all such topologies are within the scope of the present disclosure.

[0072] Returning to FIG. 2 with the foregoing in mind, an exemplary statin pharmaceutical composition OTC dispensing device 250 for optimizing the timing of short-acting insulin drug administration 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 magnetic disk memories and / or persistent devices 290 optionally accessed by one or more controllers 288, one or more communication buses 213 for interconnecting the foregoing components, a user interface 278 including a display 282 and an input section 280 (e.g., keyboard, keypad, touch screen), and a power supply 276 for powering the foregoing components. In some embodiments, data in the memory 192 is seamlessly shared with the non-volatile memory 290 using known computing techniques such as caching. In some embodiments, the memory 192 and / or the memory 290 includes a mass storage device located remotely from the central processing unit(s) 274. In other words, some of the data stored in the memory 192 and / or the memory 290 is actually external to the statin pharmaceutical composition OTC dispensing device 250 but may be hosted on a computer that can be electronically accessed by the statin pharmaceutical composition OTC dispensing device 250 via the Internet, an intranet, or other form of network, or an electronic cable (illustrated as element 106 in FIG. 2) using the network interface 284.

[0073] In some embodiments, the memory 192 of the statin pharmaceutical composition OTC dispensing device 250 for optimizing the timing of short-acting insulin drug administration in a prescribed insulin regimen for a subject includes ● an operating system 202 including procedures for handling various basic system services, and ● an investigation module 204, and ● For example, for the initiation of a commercially available statin pharmaceutical composition for treating or preventing atherosclerotic cardiovascular disease by reducing cholesterol, a first survey 206 for qualifying subjects, the first survey 206 including a first plurality of survey questions 208, the first survey 206, and ● A second survey 210 for qualifying subjects for reordering a statin pharmaceutical composition, the second survey 210 including a second plurality of survey questions 212, the second survey 210, and ● A first plurality of filters 214 of a first category class, each respective filter 216 within the first plurality of filters including one or more filter triggering conditions 218, the first plurality of filters 214, and ● A second plurality of filters 220 of a second category class, each respective filter 222 within the second plurality of filters including one or more filter triggering conditions 224 and one or more related filter warnings 226, the second plurality of filters 220, and ● A fulfillment module 228 for performing a fulfillment process when (i) none of the filters 216 within the first plurality of filters 214 have been activated for a subject and (ii) each warning associated with each filter 224 within the second plurality of filters 220 that has been activated as a result of a subject's response to the first survey 206 or the second survey 208 has been confirmed by the subject, the fulfillment process including communicating a commercially available drug information label 230 of the statin pharmaceutical composition to the subject and receiving confirmation from the subject that the commercially available drug information label has been received and read, the fulfillment module 228, and ● A subject profile data storage unit 232 including user profiles 234 for each of a plurality of subjects, each respective user profile 234 including information regarding the corresponding subject among the plurality of subjects, including the first order date and destination 236 and any reorder date and destination 238 of the statin pharmaceutical composition made by the corresponding subject using a statin pharmaceutical composition OTC dispensing device 250, the subject profile data storage unit 232, and storing them.

[0074] In some embodiments, the survey module 204 is accessible within any browser (phone, tablet, laptop / desktop). In some embodiments, the survey 204 is available for download to a user device 102 that runs on the native device framework and executes an operating system 102 such as Android or iOS.

[0075] In some implementations, for the distribution of a commercially available statin pharmaceutical composition that reduces cholesterol, one or more of the above data elements or modules of the statin pharmaceutical composition OTC dispensing device 250 for identifying human subjects are stored in one or more of the aforementioned memory devices and correspond to a set of instructions for performing the above functions. The above data, modules, or programs (e.g., sets of instructions) need not be implemented as separate software programs, procedures, or modules, and thus various subsets of these modules may be combined or otherwise reconfigured in various implementations. In some implementations, the memory 192 and / or 290 optionally stores a subset of the above modules and data structures. Further, in some embodiments, the memory 192 and / or 290 stores additional modules and data structures not described above.

[0076] In some embodiments, the statin pharmaceutical composition OTC dispensing device 250 for identifying human subjects for the distribution of a commercially available statin pharmaceutical composition that reduces cholesterol is a smartphone (e.g., iPhone), laptop, tablet computer, desktop computer, or other form of electronic device (e.g., gaming console). In some embodiments, the statin pharmaceutical composition OTC dispensing device 250 is not portable. In some embodiments, the statin pharmaceutical composition OTC dispensing device 250 is portable.

[0077] In some embodiments, the over-the-counter (OTC) dispensing device 250 for statin pharmaceutical compositions is not a smart phone, but a tablet computer, a desktop computer, a computer for emergency vehicles, or other forms, or a wired or wireless network device. For the sake of brevity and clarity, and to emphasize the additional software modules installed on the OTC dispensing device 250 for statin pharmaceutical compositions, only a few of the possible components of the OTC dispensing device 250 for statin pharmaceutical compositions are shown in FIG. 2.

[0078] FIG. 3 provides an illustration of a user device 102 that can be used in conjunction with the present disclosure. The user device 102 shown in FIG. 3 includes one or more processing units (CPUs) 274, a peripheral 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 including a display 282 and an input portion 280 (e.g., keyboard, keypad, touch screen), an optional accelerometer 317, an optional GPS 319, an optional audio circuit 372, an optional speaker 360, an optional microphone 362, one or more optional intensity sensors 364 for detecting the intensity of contact on a surface of the user device 102 (e.g., a touch-sensitive surface such as the touch-sensitive display system 282 of 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 foregoing components, and a power source 276 for powering the foregoing components.

[0079] In some embodiments, the input portion 280 is a touch-sensitive display such as a touch-sensitive surface. In some embodiments, the user interface 278 includes one or more embodiments of a soft keyboard. Embodiments of the soft keyboard may include symbols in standard (QWERTY) and / or non-standard configurations on the displayed icons.

[0080] The user device 102 shown in FIG. 3 optionally includes, in addition to the accelerometer(s) 317, a magnetometer (not shown) and a GPS 319 (or GLONASS or other global navigation system) receiver for obtaining information regarding the position and orientation of the user device 102 (e.g., portrait or landscape) and / or for determining the physical momentum by the subject.

[0081] The user device 102 shown in FIG. 3 is merely an example of a multifunctional device that can be used to conduct an investigation to certify the distribution of a commercially available statin pharmaceutical composition for reducing cholesterol. It should be understood that the user device 102 optionally has more or fewer components than those shown, optionally combines two or more components, or optionally has different configurations or arrangements of components. The various components shown in FIG. 3 are implemented in hardware, software, firmware, or a combination thereof, including one or more signal processing and / or application-specific integrated circuits.

[0082] The memory 192 of the user device 102 shown in FIG. 3 optionally includes high-speed random access memory and also optionally includes non-volatile memory such as one or more magnetic 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 pharmaceutical composition OTC dispensing device 250, such as the CPU(s) 274, is optionally controlled by a memory controller 368.

[0083] In some embodiments, the memory 192 of the user device 102 shown in FIG. 3 optionally includes the above-described investigation module 204 together with the statin pharmaceutical composition OTC dispensing device 250 3, the first plurality of filters 214 includes a pregnancy filter 216-1, a cyclosporine filter 216-2, and a liver disease or allergic reaction to a statin pharmaceutical composition filter 216-3. Also, in some embodiments, as further shown in FIG. 3, the second plurality of filters 220 includes a total cholesterol level filter 222-1, a pooled cohort equation filter 222-2, an age filter 222-3, a drug interaction filter 222-4, an alcohol intake filter 222-5, an adverse reaction filter 222-6, and an atherosclerotic cardiovascular event filter 222-7.

[0084] In some embodiments, the optional accelerometer 317, optional GPS 319, and / or magnetometer (not shown) of the user device 102, or such components, are used to recommend to the subject that they identify one or more preferred destinations for distribution of the over-the-counter statin pharmaceutical composition.

[0085] A peripheral interface 370 may be used to couple input and output peripherals of the device to the CPU(s) 274 and memory 192. The one or more processors 274 execute or execute various software programs and / or instruction sets stored in the memory 192, such as the survey module 204, to perform various functions of the user device 102 and process data.

[0086] In some embodiments, the peripherals interface 370, the CPU(s) 274, and the memory controller 368 are optionally implemented on a single chip. In some other embodiments, they are implemented on separate chips.

[0087] The RF (radio frequency) circuit of network interface 284 receives and transmits RF signals, also referred to as electromagnetic signals. In some embodiments, the survey module 204, survey questions 208 / 212, responses to the survey questions 208 / 212, and / or over-the-counter (OTC) drug information labels 230 are transmitted using this RF circuit. In some embodiments, RF circuit 108 converts electrical signals to / from electromagnetic signals and communicates via the electromagnetic signals with a communication network and other communication devices and / or data collection devices 200 and / or a statin pharmaceutical composition OTC dispensing device 250. RF circuit 284 optionally includes, but is not limited to, an antenna system, an RF transceiver, one or more amplifiers, a tuner, one or more oscillators, a digital signal processor, a codec chipset, a subscriber identity module (SIM) card, memory, and other well-known circuits for performing these functions. RF circuit 284 optionally communicates with communication network 106. In some embodiments, circuit 284 does not include an RF circuit and is actually connected to network 106 via one or more hardwires (e.g., an optical cable, a coaxial cable, etc.).

[0088] In some embodiments, an audio circuit 372, an optional speaker 360, and an optional microphone 362 provide an audio interface between the subject and user device 102. Audio circuit 372 receives audio data from peripheral interface 370, converts the audio data to an electrical signal, and transmits the electrical signal to speaker 360. Speaker 360 converts the electrical signal to an audible sound wave. Audio circuit 372 also receives the electrical signal converted from the sound wave by microphone 362. Audio circuit 372 converts the electrical signal to audio data and transmits the audio data to peripheral interface 370 for processing. The audio data is optionally retrieved from and / or transmitted to memory 192 and / or RF circuit 284 by peripheral interface 370.

[0089] In some embodiments, the power supply 276 optionally includes a power management system, one or more power sources (e.g., a battery, alternating current (AC)), a recharge system, a power outage 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 a portable device.

[0090] In some embodiments, the user device 102 also optionally includes one or more optical sensors 373. The optical sensor(s) 373 optionally include a charge-coupled device (CCD) or a complementary metal-oxide semiconductor (CMOS) phototransistor. The optical sensor(s) 373 receive light from the environment projected through one or more lenses and convert the light into data representing an image. The optical sensor(s) 373 optionally capture still images and / or video. In some embodiments, the optical sensor is disposed on the back of the user device 102 opposite the display 282 on the front of the user device 102, such that the input portion 280 can be used as a viewfinder for still and / or video image acquisition. In some embodiments, another optical sensor 373 is disposed on the front of the user device 102, such that an image of a subject is acquired (e.g., to verify the health, condition, or identification information of the subject as part of certifying the subject for the distribution of a commercially available statin pharmaceutical composition for lowering cholesterol, to assist in remotely diagnosing the condition of the subject, or to acquire visual physiological measurements of the subject, etc.).

[0091] As shown in FIG. 3, user device 102 preferably includes an operating system 202 that includes procedures for handling various basic system services. The operating system 202 (e.g., an embedded operating system such as iOS, DARWIN, RTXC, LINUX, UNIX®, OS X, WINDOWS®, or 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 various hardware and software components.

[0092] In some embodiments, user device 102 is a smartphone. In other embodiments, user device 102 is not a smartphone, but rather a tablet computer, a desktop computer, an emergency vehicle computer, or other form, or a wired or wireless network device. For the sake of brevity and clarity, and to emphasize additional software modules installed on user device 102, only a few of the possible components of user device 102 are shown in FIG. 3.

[0093] The system 48 disclosed in FIG. 1 can operate independently, but in some embodiments, it can also be linked to electronic medical records and exchange information in any way.

[0094] Details of system 48 for qualifying human subjects for the distribution of commercially available statin pharmaceutical compositions for reducing cholesterol have been disclosed, and details regarding the processes and features of the system according to embodiments of the present disclosure are disclosed with reference to FIGS. 4A - 4E. In some embodiments, the processes and features of such a system are performed by the survey module 204 shown in FIGS. 2 and 3 and / or the fulfillment module 228 shown in FIG. 3. In some embodiments, fulfillment module 228 and survey module 204 are a single software module.

[0095] Blocks 402 to 406. Referring to block 402 in FIG. 4A, the object of the present disclosure is to identify subjects for the distribution of a commercially available statin pharmaceutical composition that reduces cholesterol using a computer system such as the statin pharmaceutical composition OTC dispensing device 250. As shown in FIG. 2, the statin pharmaceutical composition OTC dispensing device 250 includes one or more processors 274 and a memory 192 / 290. The memory stores non-transitory instructions that implement the method when executed by one or more processors.

[0096] In some embodiments, the pharmaceutical composition of the statin includes atorvastatin (LIPITOR®), fluvastatin, LESCOL®, LESCOL XL®, rosuvastatin (ALTOPREV®), pitavastatin (LIVALO®), pravastatin (PRAVACHOL®), rosuvastatin (CRESTOR®), or simvastatin (ZOCOR®) (404). These statin pharmaceutical compositions are described in 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. American Journal of Cardiology 66:p.44B-55B, Serruys et al., 2002, “Fluvastatin for Prevention of Cardiac Events Following Successful First Percutaneous Coronary Intervention: A Randomized Controlled Trial.,” JAMA 287:p.3215-3222, Sacks et al. 1996, “The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators,” New England Journal of Medicine, 1996.335(14):p.001-9, Anonymous, 2002 “Heart Protection Study Collaborative Group, MRC / BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial,” Lancet 360:p.7-22, Jones et al., 2003, “Comparison of the efficacy and The safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial), as described in "Am J Cardiol. 92(2):152 - 60", each of which is incorporated herein by reference. In some embodiments, the statin pharmaceutical composition comprises a statin and another lipid - lowering drug such as atorvastatin / ezetimibe (LIPTRUZET®), lovastatin + niacin (ADVICOR®), simvastatin / ezetimibe (VYTORIN®), or simvastatin / niacin - ER (SIMCOR®). , and the like.

[0097] In some embodiments, the statin pharmaceutical composition comprises any compound described by any of claims 1 - 117 of U.S. Patent No. 5,969,156C1 entitled "CRYSTALLiNE [R-(R*,R*)]-2-(4-DFLUOROPHENYL)-β,δ-DiHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL ]-lH-PYRROLE-1-HEPTANOIC ACID HEMI CALCIUM SALT (ATORVASTATIN)", which is incorporated herein by reference. In some embodiments, the statin pharmaceutical composition comprises any compound disclosed in U.S. Patent No. 5,969,156 C1 entitled "CRYSTALLINE [R-(R*,R*)]-2-(4-DFLUOROPHENYL)-β,δ-DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-lH-PYRROLE-1-HEPTANOIC ACID HEMI CALCIUM SALT (ATORVASTATIN)", which is incorporated herein by reference.

[0098] In some embodiments, the statin pharmaceutical composition comprises any compound described in any of claims 1-20 of U.S. Patent No. 6,242,003 B1, entitled "Organic Compounds", which is incorporated herein by reference. In some embodiments, the statin pharmaceutical composition comprises any compound disclosed in U.S. Patent No. 6,242,003 B1, entitled "Organic Compounds", which is incorporated herein by reference.

[0099] In some embodiments, the statin pharmaceutical composition comprises 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.

[0100] In some embodiments, the statin pharmaceutical composition comprises 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.

[0101] It will be appreciated that the filters applied to the survey questions and survey responses may vary depending on the statin pharmaceutical composition being dispensed. This is due to, for example, differences in the contraindication profiles of various statins resulting from different drug-drug interactions of different statins, routes of drug clearance, etc. For example, co-administration of 500 mg of tipranavir / 200 mg BID causes a 9.4-fold increase in atorvastatin (LIPITOR®) AUC and an 8.6-fold increase in Cmax, while causing only a 1.4-fold and 2.2-fold increase in rosuvastatin (CRESTOR®) AUC and Cmax, respectively. Thus, in some embodiments, a survey to qualify subjects for OTC use of atorvastatin may ask whether the subject is currently taking tipranavir and BID, while a survey to qualify subjects for OTC use of rosuvastatin may not need to ask.

[0102] A comparison of some of the contraindications to the prescription use of some statin pharmaceuticals is shown in FIG. 8. The list of contraindications in FIG. 8 is not exhaustive. One of ordinary skill in the art may know of other contraindications for a particular statin pharmaceutical and / or may treat risk factors as contraindications depending on the intended use of the statin pharmaceutical.

[0103] For example, co-administration of a cyclosporine pharmaceutical is not a contraindication to the prescription use of rosuvastatin (e.g., CRESTOR), but there is a known drug-drug interaction. This may be because healthcare providers prescribing rosuvastatin can evaluate the risk and / or severity of drug-drug interactions in a particular patient at the prescribed dosage. However, in some embodiments, co-administration of a cyclosporine pharmaceutical is treated as a contraindication to OTC use of rosuvastatin (e.g., a subject's response to whether they are currently taking a cyclosporine pharmaceutical is applied to a type 1 filter that, if activated, prevents approval of an OTC rosuvastatin dispensing).

[0104] Similarly, in some embodiments, contraindications to the use of prescription-strength pharmaceuticals are treated only as risk factors or not at all when qualifying subjects for OTC use of low-dose statin pharmaceuticals. For example, in some embodiments where the OTC dosage of lovastatin pharmaceuticals (e.g., MEVACOR) is low enough to offset a severe drug-drug interaction with a potent CYP3A4 inhibitor, co-use of CYP3A4 pharmaceuticals is treated only as a risk factor (e.g., the subject's response as to whether they are currently taking a potent CYP3A4 inhibitor is applied to a type 2 filter and, when actuated, prompts the physician to consult with the subject about potential drug interactions before permitting approval to dispense OTC lovastatin and requires confirmation that the subject has consulted with the physician).

[0105] Referring to block 406, in some embodiments, atherosclerotic cardiovascular disease is coronary heart disease such as myocardial infarction, angina, 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 thoracic aortic aneurysm.

[0106] Blocks 408-410. Referring to block 408 of FIG. 4A, in the method, a first survey 206 of the subject is performed, thereby obtaining a first plurality of survey results for surveying questions. In some embodiments, the first survey 206 of the subject is initiated with a message such as that shown in FIG. 5A. Referring to block 410, in some embodiments, the first plurality of survey results include the subject's gender (e.g., answering a survey question 208 such as that shown in FIG. 5G), whether the subject is female, and whether (i) pregnant, (ii) lactating, or (iii) planning to become pregnant (e.g., answering a survey question 208 such as that shown in FIG. 5B), whether the subject has or has had a liver disease (e.g., answering a survey question 208 such as that shown in FIG. 5C and the attached information in FIG. 5D), the subject's age (e.g., answering a survey question 208 such as that shown in FIG. 5H), the subject's total cholesterol level (e.g., answering a survey question 208 such as that shown in FIG. 5J), the subject's high-density lipoprotein (HDL) count (e.g., answering a survey question 208 such as that shown in FIG. 5K), the subject's systolic blood pressure (e.g., answering a survey question 208 such as that shown in FIG. 5L), the subject's race (e.g., answering a survey question 208 such as that shown in FIG. 5I), whether the subject is taking a hypertension drug (e.g., answering a survey question 208 such as that shown in FIG. 5M and the attached information in FIG. 5N), whether the subject is taking one or more drugs that interact with a statin pharmaceutical composition, where the one or more drugs include cyclosporine (e.g., answering a survey question 208 such as that shown in FIG. 5E and the attached information in FIG. 5F and / or answering a survey question 208 such as that shown in FIG. 5T along with the attached information in FIG. 5U), the subject's smoking status (e.g., answering a survey question 208 such as that shown in FIG. 5P), the subject's diabetes status (e.g., answering a survey question 208 such as that shown in FIG. 5O (such as answering survey question 208 as shown), the alcohol intake status of the subject (e.g., answering survey question 208 as shown in FIG. 5R), whether the subject has ever had an adverse reaction to a cholesterol-lowering agent (e.g., answering survey question 208 as shown in FIG. 5S), and whether the subject has ever had an atherosclerotic cardiovascular event or has ever had heart surgery (e.g., answering survey question 208 as shown in FIG. 5V).

[0107] In some embodiments, the first plurality of survey results include some or all of the characteristics listed in Table 1. For example, 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 of the characteristics listed in Table 1.

[0108] Similarly, in some embodiments, the first survey includes questions that elicit answers providing some or all of the characteristics listed in Table 1. In some embodiments, the survey includes questions corresponding to each of the survey results required for the methods described herein. In other embodiments, the survey includes questions corresponding to only a subset of the survey results required for the methods described herein. In such embodiments, the other survey results required for the methods described herein are obtained through other means, e.g., from a healthcare provider, from a previous survey, from a database associated with a pharmacy, etc., at the time of registration / subscription to a service associated with identifying the subject for a marketed agent. For example, in some embodiments, the subject provides personal medical identification information associated with an insurance company, hospital, or other healthcare provider, and information about the subject required for the methods described herein, and, e.g., one or more of the survey results are obtained from an existing database associated with the personal medical identification information (e.g., the most recent cholesterol or blood pressure measurements determined for the subject).

[0109]

Table 1

[0110] In one embodiment, the first survey results include at least survey results 1 to 15, as provided in Table 1. In another embodiment, the first survey results include at least survey results 1 to 16, as provided in Table 1. In another embodiment, the first survey results include at least survey results 1 to 15 and 17, as provided in Table 1. In another embodiment, the first survey results include at least survey results 1 to 15 and 18, as provided in Table 1. In another embodiment, the first survey results include at least survey results 1 to 17, as provided in Table 1. In another embodiment, the first survey results include at least survey results 1 to 16 and 18, as provided in Table 1. In another embodiment, the first survey results include at least survey results 1 to 18, as provided in Table 1.

[0111] In some embodiments, it is contemplated that any one or more of the survey results provided in Table would not be included in the first survey results. For example, in some embodiments, the characteristics associated with a particular survey result may be beneficial when identifying subjects for one particular statin but not for another. For example, One of ordinary skill in the art will recognize that different statins have different risk and drug interaction profiles. Thus, for access to one statin with known harmful drug interactions, the survey information necessary to identify a subject may not be necessary to identify the same subject for access to a second statin. For information on clinically important statin drug interactions, see, for example, PHARMACIST’S LETTER / PRESCRIBER’S LETTER, PL Detail-Document #280405, Therapeutic Research Center, April 2012, the contents of which are hereby incorporated by reference in their entirety for all purposes.

[0112] Accordingly, the first set of survey results is intended to include any subset of the survey results provided in Table 1. For the sake of brevity, all possible combinations of the survey results provided in Table 1 are not specifically described herein. However, one of ordinary skill in the art will be able to readily envision any particular subset of the survey results provided in Table 1. Similarly, one of ordinary skill in the art may know other survey results not provided in Table 1 and may combine them with any subset of the survey results provided in Table 1 to form the first set of survey results used in the methods described herein.

[0113] Blocks 412-416. Referring to block 412 in FIG. 4A, when a first survey 206 is completed by a subject who is a candidate, thereby obtaining a first plurality of survey results, all or some of the first plurality of survey results are applied to a first plurality of filters 214 of a first category class. When each filter 216 within the first plurality of filters 214 is activated, the subject is considered not to be eligible for distribution of a statin pharmaceutical composition, and the method ends without distribution of a statin pharmaceutical composition to the subject. Blocks 414 and 416 show specific filters within the first plurality of filters and their exemplary triggering conditions for activating them.

[0114] In some embodiments, the first plurality of filters 214 of the first category class 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 of the filters listed in Table 2.

[0115] [Table 2]

[0116] In one embodiment, the first plurality of filters includes at least filters 1a to 4a, as provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 1a, 2a, and 3a, as provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 1a, 2a, and 4a, as provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 1a, 3a, and 4a, as provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 2a, 3a, and 4a, as provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 1a and 2a. In another embodiment, the first plurality of filters includes at least filters 1a and 3a, as provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 1a and 4a, as provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 2a and 3a, as provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 2a and 4a, as provided in Table 2. In another embodiment, the first plurality of filters includes at least filters 3a and 4a, as provided in Table 2.

[0117] In some embodiments, it is contemplated that any one or more of the filters provided in Table 2 will not be included in the first plurality of filters. For example, in some embodiments, a characteristic associated with certain survey results may be beneficial when it identifies subjects for one particular statin but not for another. Thus, the first plurality of filters is contemplated to include any subset of the filters provided in Table 2. Similarly, one of ordinary skill in the art may be aware of other filters not provided in Table 2 and may combine them with any subset of the filters provided in Table 2 to form the results of the first plurality of filters used in the methods described herein.

[0118] Referring to block 414, in some embodiments, the first plurality of filters 214 includes a pregnancy filter. Referring to block 416, the pregnancy filter is activated when the first plurality of survey results indicate that the subject is pregnant. In some embodiments, the pregnancy filter is activated when the first plurality of survey results indicate that the subject is pregnant, thinks they are pregnant, is breastfeeding, or plans to become pregnant, along the survey question 208 shown in FIG. 5B. When the pregnancy filter is activated, the subject is not permitted to obtain an over-the-counter statin pharmaceutical composition.

[0119] In some embodiments, the first plurality of filters 214 includes a cyclosporine filter. In some embodiments, the cyclosporine filter is activated when the first plurality of survey results indicate that the subject is taking cyclosporine, along the survey question 208 shown in FIG. 5E and the attached information in FIG. 5F. When the cyclosporine filter is activated, the subject is not permitted to obtain an over-the-counter statin pharmaceutical composition.

[0120] In some embodiments, the first plurality of filters 214 includes a liver disease or allergy reaction filter to the statin pharmaceutical composition. In some embodiments, the liver disease or allergy reaction filter to the statin pharmaceutical composition is activated when the first plurality of survey results indicate that the subject has had an allergic reaction to a liver disease or any cholesterol-lowering agent, along the survey question 208 shown in FIGS. 5C and 5S with due care. In some embodiments, the liver disease and allergy reaction filters are separate filters.

[0121] Blocks 418-438. Referring to block 418 in FIG. 4B, if none of the first plurality of filters is activated, the method continues by applying all or some of the first plurality of survey results to a second plurality of filters 220 of a second categorical class. When each filter 222 within the second plurality of filters is activated, a warning 226 corresponding to each filter is provided to the subject.

[0122] In some embodiments, the second plurality of filters 220 of the second category class include some or all of the filters listed in Table 3. For example, in some embodiments, the first plurality of survey results include 2, 3, 4, 5, 6, 7, 8, or all 9 filters listed in Table 2.

[0123]

Table 3

[0124] In some embodiments, any one or more of the filters provided in Table 3 are considered not to be included in the second plurality of filters. For example, in some embodiments, a characteristic associated with a particular survey result may be beneficial when it identifies subjects for one particular statin but not for another. Thus, the second plurality of filters are considered to include any subset of the filters provided in Table 3. Similarly, one of ordinary skill in the art may be aware of other filters not provided in Table 3 and may combine them with any subset of the filters provided in Table 3 to form the second plurality of filter results used in the methods described herein.

[0125] For example, referring to block 420 and FIG. 3, in some embodiments, the second plurality of filters 220 include a total cholesterol level filter 222-1, an age filter 222-3, a drug interaction filter 222-4, an alcohol intake filter 222-5, an adverse reaction filter 222-6, an atherosclerotic cardiovascular event filter 222-7, and / or a pooled cohort equation filter 222-2.

[0126] In one embodiment, the Pooled Cohort Equation Filter incorporates the subject's gender, race, age, total cholesterol level, HDL cholesterol count, systolic blood pressure, whether the subject is taking a drug that interacts with a statin, the subject's smoking status, and the subject's diabetes status to derive the risk of atherosclerotic cardiovascular disease. In some embodiments, the Pooled Cohort Equation also incorporates a family history of premature heart attack or stroke (e.g., a history of heart attack or stroke at age 45, 50, 55, before 60, etc.). In some embodiments, the Pooled Cohort Equation incorporates the subject's hsCRP level.

[0127] Referring to block 422, if the risk meets the first threshold range or the first threshold, the Pooled Cohort Equation Filter 222-2 is considered activated. Referring to block 424, in some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the Pooled Cohort Equation is a lifetime risk, a 5-year risk, or a 10-year risk. Referring to block 426, in some embodiments, the Pooled Cohort Equation is implemented as a multivariable Cox proportional hazards regression. Referring to block 428, in some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the Pooled Cohort Equation is a 10-year risk and the first threshold is 7.5 percent.

[0128] The Pooled Cohort Equation estimates the probability of a hard atherosclerotic cardiovascular disease (ASCVD) event or fatal cardiovascular disease occurring within a given time period such as the next 5 years, the next 10 years, etc., or over the subject's lifetime. In some embodiments, the Pooled Cohort Equation of the Pooled Cohort Equation Filter 222-2 is incorporated by reference, Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady Calculated using the guidelines described in S, D‘Agostino RB Sr, Gibbons R, Greenland P, Lackland DT, Levy D, O’Donnell CJ, Robinson J, Schwartz JS, Smith SC Jr, 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. Following Goff Id., the calculation of the 10-year risk estimate of hard ASCVD events using the pooled cohort equations is done in a series of steps. First, the natural logarithm of the subject's age, total cholesterol, HDL-C, and systolic blood pressure are calculated, with the systolic blood pressure being either a treated or untreated value. For example, the calculation of the pooled cohort equations estimates the probability of a 55-year-old white male subject who has a total cholesterol of 213 mg / dL, an HDL-C of 50 mg / dL, an untreated systolic BP of 120 mmHg, is not a smoker, and has no diabetes, and starting by first 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), determines the probability of a hard ASCVD event in the next 10 years. These values are then multiplied by the coefficients from the equations for the individual's specific race-sex group (the "Coefficients" column in Table A of Goff Id.) to obtain the "Coefficient x Value". That is, Multiply the natural logarithm of the subject's age (4.01) by the coefficient 12.344 to obtain a "Coefficient X Value" of 49.47, Multiply the natural logarithm of the subject's total cholesterol (5.36) by the coefficient 11.853 to obtain a "Coefficient X Value" of 63.55, Multiply the natural logarithm of the subject's HDL-C (3.91) by the coefficient -7.990 to obtain a "coefficient x value" of -31.26, Multiply the natural logarithm of the subject's systolic blood pressure (4.79) by the coefficient 1.764 to obtain a "coefficient x value" of 8.45.

[0129] Appropriate interaction conditions are also calculated. Following Goff Id., for a 55-year-old white male subject, the interaction conditions are as follows: Multiply Log Age (4.01) X Log total Cholesterol (5.36) by the coefficient -2.664 to obtain a "coefficient x value" of -57.24, Multiply Log Age (4.01) X Log HDL-C (3.91) by the coefficient 1.769 to obtain a "coefficient x value" of 27.73.

[0130] Next, sum these "coefficient x values" for that individual (49.47 + 63.55 - 31.26 + 8.45 - 57.24 + 27.73 = 60.69). The estimated 10-year risk of the first hard ASCVD event is formally calculated as 1 minus the 10-year baseline survival rate for the gender / race (white male in this example) at age 10, exponentiated by the sum of the "coefficient x values" calculated above minus the sum of the overall average "coefficient x values" specific to the race (white) and gender (male), or in equation form, 1 - 0.914e(60.69 - 61.18), and Here, the number 0.9144 is the 10-year baseline survival rate for white males from Goff Id., the number 60.69 is the "coefficient x value" calculated for the specific subject as detailed above, and the number 61.18 means the overall average "coefficient x value" from Goff Id. specific to the race (white) and gender (male). This is equal to a 5.3% probability of the first hard ASCVD event within 10 years.

[0131] In some embodiments, the pooled cohort equation used to calculate the risk of fatal cardiovascular disease for the pooled cohort equation filter 222-2 is the pooled cohort equation incorporated herein by reference, Perk J. et al., European Guidelines on cardiovascular disease prevention in clinical practice, European Heart Journal 33:1635-1701 (2012). In some embodiments, the pooled cohort equation filter follows a low CVD risk SCORE chart that incorporates the subject's gender, the subject's age, the subject's total cholesterol level, the subject's systolic blood pressure, and the subject's smoking status, as described in the above Perk J. et al. In some embodiments, the pooled cohort equation filter follows a high CVD risk SCORE chart that incorporates the subject's gender, the subject's age, the subject's total cholesterol level, the subject's systolic blood pressure, and the subject's smoking status, as described in the above Perk J. et al. In some embodiments, as described in Catapano AL et al., 2016 ESC / EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J. 2016 Oct 14;37(39):2999-3058, incorporated herein by reference, conversion factors are used to convert the risk of fatal cardiovascular disease to the risk of fatal and non-fatal hard cardiovascular disease events.

[0132] Referring to block 428, in some embodiments, using the SCORE guidelines, the risk of fatal cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and a first threshold, e.g., a threshold of 3% risk if it is determined that the subject's risk is less than to activate the filter. Some embodiments. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the first threshold is a 5% risk. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and a second threshold, e.g., a threshold of 4% risk if it is determined that the subject's risk is greater than to activate the filter. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the second threshold is a 9% risk. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the second threshold is a 14% risk. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and a threshold range, e.g., a threshold range of 2 - 14% risk if it is determined that the subject has a risk above or below the range in which the filter is activated. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the threshold range is a 3 - 14% risk. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the threshold range is a 5 - 14% risk. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the threshold range is a 10 - 14% risk. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the threshold range is a 2 - 9% risk.In some embodiments, the risk of fatal cardiovascular disease used in calculating the pooled cohort equation is a 10-year risk, and the threshold range is a risk of 3-9%. In some embodiments, the pooled cohort equation. The risk of fatal cardiovascular disease used in calculating the formula is a 10-year risk, and the threshold range is a risk of 5-9%. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pooled cohort equation is a 10-year risk, and the threshold range is a risk of 2-4%. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pooled cohort equation is a 10-year risk, and the threshold range is a risk of 3-4%. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pooled cohort equation is a 10-year risk, and the threshold range is a risk of 2-3%. In some embodiments, if a subject is determined to have a 10-year risk of less than 5% of fatal cardiovascular disease, lipid-lowering therapy is not indicated, for example, a second class type of filter is activated.

[0133] In some embodiments, the pooled cohort equation used to calculate the risk of cardiovascular disease-related death for the pooled cohort equation filter 222-2 is incorporated herein by reference, Teramoto et al., Japan Atherosclerosis Society. Executive summary of the It is calculated using the guidelines described in 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. In some embodiments, the pooled cohort equation filter follows the NIPPON DATA80 absolute risk assessment chart, incorporating the subject's gender, the subject's age, the subject's total cholesterol level, the subject's systolic blood pressure, and the subject's smoking status, as described in Teramoto et al. above. In some embodiments, the pooled cohort equation also incorporates the subject's glucose level.

[0134] Referring to block 428, in some embodiments, using the NIPPON DATA80 guidance, the risk of coronary death used in calculating the pool cohort equation is the 10-year risk and a first threshold, for example, a threshold of 0.5% risk if it is determined that the subject's risk is less than activating the filter. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pool cohort equation is the 10-year risk and the first threshold is a risk of 1%. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pool cohort equation is the 10-year risk and the first threshold is a risk of 2%. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pool cohort equation is the 10-year risk and a second threshold, for example, a threshold of 1% risk if it is determined that the subject's risk is greater than activating the filter. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pool cohort equation is the 10-year risk and the second threshold is a risk of 2%. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pool cohort equation is the 10-year risk and the second threshold is a risk of 5%. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pool cohort equation is the 10-year risk and the second threshold is a risk of 10%. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pool cohort equation is the 10-year risk and a threshold range, for example, a threshold range of 0.5 - 10% risk if it is determined that the subject has a risk above or below the range of activating the filter. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pool cohort equation is the 10-year risk and the threshold range is a risk of 1 - 10%. In some embodiments, the risk of fatal cardiovascular disease used in calculating the pool cohort equation is the 10-year risk and the threshold range is a risk of 2 - 10%. In some embodiments, the pool cohort equation The fatal cardiovascular disease risk used when calculating is the 10-year risk, and the threshold range is a risk of 5-10%. In some embodiments, the fatal cardiovascular disease risk used when calculating the pooled cohort equation is the 10-year risk, and the threshold range is a risk of 0.5-5%. In some embodiments, the fatal cardiovascular disease risk used when calculating the pooled cohort equation is the 10-year risk, and the threshold range is a risk of 1-5%. In some embodiments, the fatal cardiovascular disease risk used when calculating the pooled cohort equation is the 10-year risk, and the threshold range is a risk of 2-5%. In some embodiments, the fatal cardiovascular disease risk used when calculating the pooled cohort equation is the 10-year risk, and the threshold range is a risk of 0.5-2%. In some embodiments, the fatal cardiovascular disease risk used when calculating the pooled cohort equation is the 10-year risk, and the threshold range is a risk of 1-2%. In some embodiments, the fatal cardiovascular disease risk used when calculating the pooled cohort equation is the 10-year risk, and the threshold range is a risk of 0.5-1%.

[0135] In some embodiments, the pooled cohort equation filter 222-2 uses the pooled cohort equation used to calculate the risk of atherosclerotic cardiovascular disease, which is calculated using the guidelines described in 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 pooled cohort equation filter follows the China-PAR sex-specific equation described in Yang X. et al. and the supplementary information, which incorporates the sex of the subject (e.g., to determine which equation to use), the age of the subject, the systolic blood pressure of the subject, the blood pressure treatment status of the subject, the total cholesterol level of the subject, the smoking status of the subject, the diabetes status of the subject, the waist circumference of the subject, the geographical residence area of the subject (e.g., for only Chinese residents in either northern or southern China), the urbanized residence area of the subject (e.g., for only Chinese men living in either urban or rural areas), and the family history of atherosclerotic cardiovascular disease (e.g., for men only). In some embodiments, the pooled cohort equation also incorporates the HDL cholesterol level of the subject and / or the cholesterol treatment status of the subject.

[0136] Referring to block 428, in some embodiments, when using the China-PAR guidelines, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the first threshold, for example, is a threshold of 5% risk when it is determined that the risk of the subject is less than that which activates the filter. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the first threshold is a risk of 7.5%. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the second threshold, for example, is a threshold of 7.5% risk when it is determined that the risk of the subject is greater than that which activates the filter. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the second threshold is a risk of 10%. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the threshold range, for example, is a threshold range of 5-10% risk when it is determined that the subject has a risk above or below the range in which the filter is activated. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the threshold range is a risk of 7.5-10%. In some embodiments, the risk of atherosclerotic cardiovascular disease used to calculate the pooled cohort equation is the 10-year risk, and the threshold range is a risk of 5-7.5%.

[0137] In some embodiments, the pooled cohort equation used to calculate the risk of atherosclerotic cardiovascular disease for the pooled cohort equation filter 222-2 is the Guidelines for the management of absolute cardiovascular disease risk, 2012, published by the National Vascular Disease Prevention Alliance, which is incorporated herein by reference. In some embodiments, the pooled cohort equation filter is calculated using the guidelines described in Absolute cardiovascular disease risk management: Quick reference guide for health professionals, 2012, National Stroke Foundation, which follows the Australian Cardiovascular Risk Chart, incorporating the subject's gender, the subject's age, the subject's systolic blood pressure, the ratio of total cholesterol to the subject's HDL level, and the subject's smoking status. In some embodiments, the pooled cohort equation also incorporates the subject's ethnicity (e.g., only within Australia, Aboriginal, Torres Strait Islander, or other groups).

[0138] Referring to block 428, in some embodiments, using the Australian Cardiovascular Risk Chart, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 5-year risk, and a first threshold, e.g., a threshold of 5% risk if it is determined that the subject's risk is less than that which activates the filter. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 5-year risk, and the first threshold is a 10% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 5-year risk, and the first threshold is a 16% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 5-year risk, and the first threshold is a 20% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 5-year risk, and the first threshold is a 25% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 5-year risk, and a second threshold, e.g., a threshold of 30% risk if it is determined that the subject's risk is greater than that which activates the filter. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 5-year risk, and the second threshold is a 25% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 5-year risk, and the second threshold is a 20% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 5-year risk, and the second threshold is a 16% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 5-year risk, and the second threshold is a 10% risk.In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating 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 in calculating the pooled cohort equation is a 5-year risk, and a threshold range, for example, a threshold range of 5-30% risk if it is determined that the subject has a risk above or below the range in which the filter operates. Yes. In some embodiments, the risk of atherosclerotic cardiovascular disease used when calculating the pooled cohort equation is a 5-year risk, and the threshold range is a risk of 10-30%. In some embodiments, the risk of atherosclerotic cardiovascular disease used when calculating the pooled cohort equation is a 5-year risk, and the threshold range is a risk of 16-30%. In some embodiments, the risk of atherosclerotic cardiovascular disease used when calculating the pooled cohort equation is a 5-year risk, and the threshold range is a risk of 20-30%. In some embodiments, the risk of atherosclerotic cardiovascular disease used when calculating the pooled cohort equation is a 5-year risk, and the threshold range is a risk of 25-30%. In some embodiments, the risk of atherosclerotic cardiovascular disease used when calculating the pooled cohort equation is a 5-year risk, and the threshold range is a risk of 5-25%. In some embodiments, the risk of atherosclerotic cardiovascular disease used when calculating the pooled cohort equation is a 5-year risk, and the threshold range is a risk of 10-25%. In some embodiments, the risk of atherosclerotic cardiovascular disease used when calculating the pooled cohort equation is a 5-year risk, and the threshold range is a risk of 16-25%. In some embodiments, the risk of atherosclerotic cardiovascular disease used when calculating the pooled cohort equation is a 5-year risk, and the threshold range is a risk of 20-25%. In some embodiments, the risk of atherosclerotic cardiovascular disease used when calculating the pooled cohort equation is a 5-year risk, and the threshold range is a risk of 5-20%. In some embodiments, the risk of atherosclerotic cardiovascular disease used when calculating the pooled cohort equation is a 5-year risk, and the threshold range is a risk of 10-20%. In some embodiments, the risk of atherosclerotic cardiovascular disease used when calculating the pooled cohort equation is a 5-year risk, and the threshold range is a risk of 16-20%.In some embodiments, the risk of atherosclerotic cardiovascular disease used when calculating the pool cohort equation is a 5-year risk, and the threshold range is a risk of 5-16%. In some embodiments, the risk of atherosclerotic cardiovascular disease used when calculating the pool cohort equation is a 5-year risk, and the threshold range is a risk of 10-16%. In some embodiments, the risk of atherosclerotic cardiovascular disease used when calculating the pool cohort equation is a 5-year risk, and the threshold range is a risk of 5-10%.

[0139] In some embodiments, the pooled cohort equation used to calculate the risk of atherosclerotic cardiovascular disease for the pooled cohort equation filter 222-2 is calculated using the guidelines described in Anderson TJ et al., 2016 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult, Can J Cardiol. 2016 Nov;32(11):1263-1282, which is incorporated herein by reference. In some embodiments, the pooled cohort equation filter follows the Framingham Heart Study Risk Score equation (FRS), which incorporates the subject's gender, the subject's age, the subject's systolic blood pressure, the subject's blood pressure treatment status, the subject's total cholesterol level, and the subject's HDL cholesterol level, the subject's smoking status, the subject's diabetes status, and the subject's CVD event symptom status, as described in D‘Agostino RB Sr et al., General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53, which is incorporated herein by reference. In some embodiments, the pooled cohort equation filter follows the modified Framingham Heart Study Risk Score equation (FRS) , as described in Anderson TJ et al. above, incorporates the subject's gender, subject's age, subject's systolic blood pressure, subject's blood pressure treatment status, subject's total cholesterol level, and subject's HDL cholesterol level, subject's smoking status, subject's diabetes status, and subject's CVD event symptom status, and family history of juvenile cardiovascular disease. In some embodiments, the pooled cohort equation filter is the Cardiovascular Life Expectancy Model (CLEM), as set forth in Grover SA et al., Estimating the benefits of modifying risk factors of cardiovascular disease: a comparison of primary vs secondary prevention. Arch Intern Med. 1998 Mar 23;158(6):655-62, and follows the Cardiovascular Life Expectancy Model (CLEM).

[0140] Referring to block 428, in some embodiments, using the Canadian Cardiovascular Society guidelines, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and a first threshold, for example, a threshold of 5% risk if it is determined that the subject's risk is less than that which would activate the filter. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the first threshold is a 10% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and a second threshold, for example, a threshold of 20% risk if it is determined that the subject's risk is greater than that which would activate the filter. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the second threshold is a 10% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and a threshold range, for example, a threshold range of 5-20% risk if it is determined that the subject has a risk above or below the range in which the filter would be activated. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the threshold range is a 10-20% risk. In some embodiments, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the threshold range is a 5-10% risk.

[0141] In some embodiments, for example as calculated above, the probability of an ASCVD event or fatal cardiovascular disease occurring within a given time period (e.g., within the next 10 years) is modified by considering one or both of the subject's family history of juvenile heart attack or stroke and the subject's hsCRP level, for example, to reduce the likelihood of over-predicting adverse events in subjects having no family history of adverse events and / or having a healthy hsCRP level.

[0142] Referring to block 430 of FIG. 5B, in some embodiments, the risk of atherosclerotic cardiovascular disease is a 10-year risk and the first threshold of the pooled cohort equation filter is 7.5 percent. In such embodiments, the pooled cohort equation (e.g., the equation and table described in Goff Id.) is activated when the pooled cohort equation filter 222-2 indicates that there is a greater than 7.5 percent probability of a first hard ASCVD event within 10 years. When the pooled cohort equation filter 222-2 is activated, a filter warning 226 associated with the pooled cohort equation filter 222-2 is distributed to the subject. Such a warning is shown in FIG. 6. If the subject has discussed with his or her physician and the physician has said that it is okay for the subject to take a statin pharmaceutical composition, the process control will proceed to the fulfillment process described below with respect to blocks 442-458, provided that the requirements of any other activated filter are met by the subject.

[0143] In some embodiments, the risk of atherosclerotic cardiovascular disease is a 5-year risk, a 10-year risk, or a lifetime risk, and the first threshold of the pooled cohort equation filter is 4.0 percent, 4.5 percent, 5.0 percent, 5.5 percent, 6.0 percent, 6.5 percent, 7.0 percent, 7.5 percent, 8.0 percent, 8.5 percent, 9.0 percent, 9.5 percent, or 10.0 percent. In such embodiments, if the pooled cohort equation (e.g., the equation and table described in Goff Id.) indicates that there is a greater than first threshold likelihood of a first hard ASCVD event within a specified time, the pooled cohort equation filter 222-2 is activated. When the pooled cohort equation filter 222-2 is activated, a filter warning 226 associated with the pooled cohort equation filter 222-2 is distributed to the subject. Such a warning is shown in FIG. 6. If the subject has discussed with his or her physician and the physician has said that it is okay for the subject to take a statin pharmaceutical composition, process control will proceed to the fulfillment process described below with respect to blocks 442-458, provided that the requirements of any other activated filter are met by the subject.

[0144] In some embodiments, the total cholesterol level filter 222-1 is activated when a first plurality of findings indicate that the subject has a total cholesterol of 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 distributed to the subject. If the subject has discussed with his or her physician and the physician has said that it is okay for the subject to take a statin pharmaceutical composition, process control will proceed to the fulfillment process described below with respect to blocks 442-458, provided that the requirements of any other activated filter are met by the subject.

[0145] In some embodiments, the total cholesterol level filter 222-1 is activated when the first plurality of survey results indicate that the subject has a total cholesterol of 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 distributed to the subject. If the subject has discussed with their physician and the physician has said that it is okay for the subject to take a statin pharmaceutical composition, the process control will proceed to the fulfillment process described below for blocks 442-458, provided that the requirements of any other activated filter are met by the subject.

[0146] In some embodiments, the age filter 222-3 is activated when the first plurality of survey results indicate that the subject is a female 49 years of age or younger or 76 years of age or older, and the age filter is activated when the first plurality of survey results indicate that the subject is a male 39 years of age or younger or 66 years of age or older. When the age filter 222-3 is activated, a filter warning 226 associated with the age filter 222-3 is distributed to the subject. If the subject has discussed with their physician and the physician has said that it is okay for the subject to take a statin pharmaceutical composition, the process control will proceed to the fulfillment process described below for blocks 442-458, provided that the requirements of any other activated filter are met by the subject.

[0147] In some embodiments, the age filter 222-3 is activated when the first plurality of survey results indicate that the subject is a female who is 44 years old or younger, 45 years old or younger, 46 years old or younger, 47 years old or younger, 48 years old or younger, or 49 years old or younger, or 70 years old or older, 71 years old or older, 72 years old or older, 73 years old or older, 74 years old or older, 75 years old or older, or 76 years old or older. The age filter is activated when the first plurality of survey results indicate that the subject is a male who is 35 years old or younger, 36 years old or younger, 37 years old or younger, 38 years old or younger, or 39 years old or younger, or 61 years old or older, 62 years old or older, 63 years old or older, 64 years old or older, 65 years old or older, 66 years old or older, 67 years old or older, 68 years old or older, 69 years old or older, 70 years old or older, 71 years old or older, or 72 years old or older. In such embodiments, when the age filter 222-3 is activated, a filter warning 226 associated with the age filter 222-3 is distributed to the subject. If the subject has consulted with their physician and the physician has stated that it is okay for the subject to take the statin pharmaceutical composition, the process control will proceed to the fulfillment process described below with respect to blocks 442-458, provided that the requirements of any other activated filter are met by the subject.

[0148] Referring to block 432 of FIG. 4B, in some embodiments, the drug interaction filter 222-4 is activated when the first plurality of survey results indicate that the subject is currently taking a blood thinner, warfarin, an HIV / AIDS drug, colchicine, a hepatitis drug, a cholesterol-lowering drug, itraconazole, ketoconazole, or fluconazole. When the drug interaction filter 222-4 is activated, a filter warning 226 associated with the drug interaction filter 222-4 is distributed to the subject. If the subject has consulted with their physician and the physician has stated that it is okay for the subject to take the statin pharmaceutical composition, the process control will proceed to the fulfillment process described below with respect to blocks 442-458, provided that the requirements of any other activated filter are met by the subject.

[0149] Including drugs within the drug interaction filter 222-4 varies depending on the type and / or dosage of the statin pharmaceutical composition approved for commercial use. In some implementations, drugs that interact with the statin pharmaceutical composition are included within a filter in the first plurality of filters 214 rather than within the drug interaction filter 222-4 of the second plurality of filters 220. For example, according to some implementations, a particular drug (e.g., generally itraconazole or a strong CYP3A4 inhibitor) is included in the drug interaction filter 222-4 (e.g., as a risk factor) for a first statin pharmaceutical composition (e.g., rosuvastatin), but is included in a filter within the first plurality of filters 214 (e.g., as a contraindication) for a second statin pharmaceutical composition (e.g., simvastatin).

[0150] FIG. 8 includes a table of contraindications including some drug interactions between contraindicated prescription statin compositions. However, one skilled in the art will know whether to include a particular drug within the drug interaction filter 222-4 or as a separate filter within the first plurality of filters 214 based on the severity and risk of drug interactions with a particular identity, as well as the dosage of the statin approved for commercial use.

[0151] In some embodiments, the alcohol intake filter 222-5 filter is activated when the first plurality of survey results indicate that the subject is consuming an average of more than three drinks per day. When the alcohol intake filter 222-5 filter is activated, a filter warning 226 associated with the alcohol intake filter 222-5 is distributed to the subject. If the subject has discussed with their physician and the physician has said that it is okay to take the statin pharmaceutical composition, the process control will proceed to the fulfillment process described below for blocks 442-458, provided that the requirements of any other activated filters are met by the subject.

[0152] In some embodiments, the alcohol intake filter 222-5 filter is activated when the first plurality of survey results indicate that the subject consumes alcohol an average of more than 4 times a week, an average of more than 5 times a week, an average of more than 6 times a week, an average of more than 1 cup of alcohol per day, an average of more than 2 cups of alcohol per day, an average of more than 3 cups of alcohol per day, or an average of more than 4 cups of alcohol per day, or an average of more than 5 cups of alcohol per day. In such embodiments, when the alcohol intake filter 222-5 filter is activated, a filter warning 226 associated with the alcohol intake filter 222-5 filter is distributed to the subject. If the subject has consulted with their physician and the physician has stated that it is okay for the subject to take the statin pharmaceutical composition, process control will proceed to the fulfillment process described below with respect to blocks 442-458, provided that the requirements of any other activated filter are met by the subject.

[0153] In some embodiments, the adverse reaction filter 222-6 is activated when the first plurality of survey results indicate that the subject has experienced an adverse reaction to a cholesterol-lowering agent in the past. In some embodiments, the adverse reaction filter 222-6 is activated when the first plurality of survey results indicate that the subject has experienced an adverse reaction to any statin pharmaceutical in the past. In such embodiments, when the adverse reaction filter 222-6 filter is activated, a filter warning 226 associated with the adverse reaction filter 222-6 filter is distributed to the subject. If the subject has consulted with their physician and the physician has stated that it is okay for the subject to take the statin pharmaceutical composition, process control will proceed to the fulfillment process described below with respect to blocks 442-458, provided that the requirements of any other activated filter are met by the subject.

[0154] In some embodiments, the atherosclerotic cardiovascular event filter 222-7 is activated when a 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 222-7 is activated when a first plurality of survey results indicate that the subject has experienced a heart attack, stroke, or has had surgery or treatment performed on their heart. In such embodiments, when the atherosclerotic cardiovascular event filter 222-7 filter is activated, a filter warning 226 associated with the atherosclerotic cardiovascular event filter 222-7 is distributed to the subject. If the subject has discussed the matter with their physician and the physician has stated that it is okay for the subject to take a statin pharmaceutical composition, process control will proceed to the fulfillment process described below with respect to blocks 442-458, provided that the requirements of any other activated filter are met by the subject.

[0155] Referring to block 434, in some embodiments, the first plurality of survey results includes whether the subject has ever had kidney disease (e.g., answering survey question 208 such as that shown in FIG. 5Q), and the second plurality of filters includes a kidney disease filter (block 434). In such embodiments, when the kidney disease filter is activated, a filter warning 226 associated with the kidney disease filter is distributed to the subject. If the subject has discussed the matter with their physician and the physician has stated that it is okay for the subject to take a statin pharmaceutical composition, process control will proceed to the fulfillment process described below with respect to blocks 442-458, provided that the requirements of any other activated filter are met by the subject.

[0156] Referring to block 436 of FIG. 4C, in some embodiments, the second plurality of filters includes an Asian filter. In such embodiments, the Asian filter is activated when a first plurality of survey results indicates that the subject is Asian (block 438).

[0157] Referring to block 440 of FIG. 4C, the process control continues by obtaining confirmation from the subject regarding any warning issued to the subject by any of the filters within the second plurality of filters 220. If one of the filters of the first plurality of filters 214 is activated, the subject is denied access to the over-the-counter statin pharmaceutical composition.

[0158] Blocks 442-458. Referring to block 442 of FIG. 4C, as described above, the process control proceeds to the fulfillment process if (i) none of the filters within the first plurality of filters 214 are activated and (ii) the subject has confirmed each warning associated with each filter within the activated second plurality of filters.

[0159] Referring to block 444 of FIG. 4C, in some embodiments, the fulfillment process includes storing an indication of the first order of the statin pharmaceutical composition in the subject profile 234.

[0160] The fullfillment process further includes communicating to the subject the prescription drug information label 230 of the statin pharmaceutical composition. In some embodiments, the prescription drug information label specifies the use of the statin pharmaceutical composition and any risks associated with taking the statin pharmaceutical composition. For example, in some embodiments, the prescription drug information label 230 specifies that the statin pharmaceutical composition includes rosuvastatin and that it should be taken by the subject at a predetermined dosage of 2.5 mg to 15 mg per day (block 446). In another example of an embodiment, the prescription drug information label 230 specifies that the statin pharmaceutical composition includes rosuvastatin and that it should be taken by the subject at a predetermined dosage of 4 mg to 11 mg per day (block 448). In yet another example of an embodiment, the prescription drug information label 230 specifies that the statin pharmaceutical composition includes atorvastatin or simvastatin and that it should be taken by the subject at a predetermined dosage of 10 mg to 25 mg per day (block 450).

[0161] Referring again to block 444 of FIG. 4C, the fulfillment process further includes approving the provision of the statin pharmaceutical composition to the subject upon confirmation from the subject that the over-the-counter drug information label 230 has been received and read by the subject. This approval includes the destination associated with the subject. In some embodiments, the provision of the statin pharmaceutical composition to the subject includes shipping the statin pharmaceutical composition to the physical address associated with the subject (block 452). In some embodiments, the provision of the statin pharmaceutical composition to the subject includes shipping the statin pharmaceutical composition to a pharmacy associated with the subject (block 454). In some embodiments, the provision of the statin pharmaceutical composition to the subject in the fulfillment process provides the statin pharmaceutical composition at a first predetermined dosage per day when the risk derived by the pooled cohort equation filter 222-2 is within a first threshold range. The provision of the statin pharmaceutical composition to the subject in the fulfillment process provides the statin pharmaceutical composition at a second predetermined dosage per day when the risk derived by the pooled cohort equation filter 222-2 is within a second threshold range (block 456). Block 458 of FIG. 4D shows an example of such an embodiment. According to the example shown by block 458, the statin pharmaceutical composition includes rosuvastatin and the risk of atherosclerotic cardiovascular disease is a 10-year risk. Thus Moreover, what is evaluated by the pooled cohort equation filter 222-2 is the risk of the first hard ASCVD event occurring in the next 10 years. In the example shown by block 458, the first threshold range is 5 percent to 7.5 percent. 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 5 percent to 7.5 percent, the first predetermined dose per day is approved for the subject (for example, 4 mg to 8 mg in the example of block 458). Further, the second threshold range is 7.5 percent to 10 percent. 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 7.5 percent to 10 percent, the second predetermined dose per day is approved for the subject (for example, 8 mg to 11 mg in the example of block 458).

[0162] Blocks 460-462 (refill). Referring to block 460 of FIG. 4E, a procedure is implemented in response to receiving a refill request for a statin pharmaceutical composition from a subject. This procedure includes (i) performing a second examination of the subject, thereby obtaining a second plurality of examination results. The second plurality of examination results includes inquiring whether the subject has experienced muscle irregularities since taking the statin pharmaceutical composition, inquiring whether the subject is pregnant, inquiring whether the subject is taking a drug that interacts with the statin pharmaceutical composition, and inquiring whether the subject has had an atherosclerotic cardiovascular event or heart surgery since last ordering the statin pharmaceutical composition. The refill procedure further includes applying all or part of the second plurality of examination results to a third plurality of filters of a second categorical class. When each filter within the third plurality of filters is activated, the subject is provided with a warning corresponding to each filter.

[0163] In some embodiments, the third plurality of filters includes the pregnancy filter 216-1 described above with respect to blocks 412 and 414. Similar to the case of blocks 412 and 414 in the first investigation, if a second plurality of investigation results indicate that the subject is pregnant, the pregnancy filter is activated, resulting in the end of the refill process.

[0164] 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 investigation results indicate that the subject has experienced unexplained muscle cramps or weakness since taking the statin pharmaceutical composition. When the muscle irregularity filter is activated, the subject is issued a warning regarding muscle irregularities and is required to consult a physician.

[0165] 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 a second plurality of investigation results indicate that the subject is currently taking cyclosporine, a blood thinner, warfarin, an HIV / AIDS drug, or a cholesterol-lowering drug. When the muscle irregularity filter is activated, the subject is issued a warning regarding a harmful drug interaction with the statin pharmaceutical composition and is required to consult a physician.

[0166] In some embodiments, the third plurality of filters includes the atherosclerotic cardiovascular event filter 227-7 as described above with respect to block 420. When the atherosclerotic cardiovascular event filter 227-7 is activated, the subject is issued a warning regarding atherosclerotic cardiovascular events and is required to consult a physician.

[0167] The procedure is to perform the refill process again if the refill process has not been completed. For each warning issued to a subject by any filter within the third plurality of filters, excluding the pregnancy filter that causes the process to end, further include obtaining confirmation from the subject. This procedure further includes proceeding to the refill process when (i) the refill process has not yet been ended by the activation of one of the filters within the third plurality of filters (e.g., the pregnancy filter), and (ii) the subject has confirmed each warning associated with each filter within the third plurality of filters that has been activated and is associated with the warning (e.g., the muscle irregularity filter, the second drug interaction filter, and / or the muscle irregularity filter, etc.).

[0168] The refill process further includes storing an indicator of a reorder 238 of the statin pharmaceutical composition in the subject profile 234. The refill process further includes communicating the over-the-counter drug information label 230 of the statin pharmaceutical composition to the subject. The refill process further includes approving the offer of a reorder of the statin pharmaceutical composition to the subject when confirmation is obtained from the subject that the over-the-counter drug information label 230 has been received and read. The offer of this reorder includes the destination of the subject. Specific embodiments In one aspect, the present disclosure provides a method, software, and computer system for qualifying human subjects for the distribution of a commercially available statin medication for treating or preventing atherosclerotic cardiovascular disease. The computer system (e.g., computer system 250 of FIG. 2) includes instructions for conducting a subject survey (e.g., survey module 204 of FIG. 2) to obtain information about the subject necessary to apply the subject's information through at least two sets of filters (e.g., first plurality (set) of filters 214 of FIG. 2 and second plurality (set) of filters 220 of FIG. 2). The filters within the first set of filters prevent approval for the distribution of OTC statins if the subject survey results identify contraindications to OTC statins. The filters within the second set of filters generate a warning if the subject survey results identify risk factors for OTC statins. In some embodiments, the warning includes a prompt that requests the user to confirm that they have discussed the risk factors with a physician in order to proceed with the qualification for OTC statins.

[0169] The computer system then proceeds to the fulfillment process only if (i) none of the first set of filters are activated and (ii) the subject has confirmed that they have discussed each warning issued in relation to the activated second set of filters. The computer system also communicates the commercial drug information label of the statin pharmaceutical composition to the subject. When the subject receives and confirms that they have read the commercial drug information label, the computer system approves the provision of the OTC statin pharmaceutical composition to the subject.

[0170] In some embodiments, the first set of filters (e.g., first plurality (set) of filters 214 of FIG. 2) includes a pregnancy filter and one or more drug contraindication interaction filters, and the second set of filters (e.g., second plurality (set) of filters 220 of FIG. 2) includes a total cholesterol filter, a pooled cohort equation filter, an age filter, one or more personal history filters, and one or more drug risk interaction filters.

[0171] Regarding the first series of filters, the pregnancy filter is activated when the first plurality of survey results indicate that the subject is pregnant, may be pregnant, is breastfeeding, and / or plans to become pregnant. In some embodiments, the drug contraindication interaction filter includes an allergy reaction filter for a statin pharmaceutical composition, which is activated when the first plurality of survey results indicate that the subject has a liver disease (e.g., cirrhosis or hepatitis).

[0172] In some embodiments, one or more drug contraindication interaction filters include a cyclosporine filter that is activated when the first plurality of survey results indicate that the subject is taking cyclosporine, and an allergy reaction filter for a statin pharmaceutical composition that is activated when the first plurality of survey results indicate that the subject has a liver disease (e.g., cirrhosis or hepatitis). In some embodiments, the statin pharmaceutical composition filter is also activated when the first plurality of survey results indicate that the subject has an allergy reaction to any cholesterol-lowering agent (e.g., to the statin for which the patient is approved or to any statin the patient has taken in the past). In some embodiments, separate filters are implemented for liver disease and previous allergy reactions to statin pharmaceutical compositions.

[0173] Regarding the second series of filters, the total cholesterol filter is activated when the first plurality of survey results indicate that the subject has total cholesterol below a first cholesterol level threshold, where the first cholesterol level threshold is not high enough to warrant treatment with a statin or is associated with a cholesterol level above a second cholesterol level threshold, and the second cholesterol level threshold is associated with a cholesterol level that warrants treatment with a higher dosage of a statin that is commercially available. The pooled cohort equation filter is activated when the first plurality of survey results indicate that the subject is at risk of atherosclerotic cardiovascular disease meeting a first threshold range or a first threshold. The age filter is activated when the first plurality of survey results indicate that the subject is at an age where administration of a statin pharmaceutical product may be inappropriate. The personal history filter is activated when the first plurality of survey results indicate that administration of a statin pharmaceutical product may be inappropriate 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 drug that may result in a harmful interaction with a statin.

[0174] In some embodiments, the total cholesterol filter is activated when the first plurality of survey results indicate that the subject has total cholesterol 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.

[0175] In some embodiments, the pooled cohort equation filter incorporates some or all of the characteristics listed in Table 4, as determined, for example, from a set of survey results, to derive the risk of atherosclerotic cardiovascular disease in a subject. For example, in some embodiments, the first plurality of survey results includes two, three, four, five, six, seven, eight, nine, ten, or all eleven of the characteristics listed in Table 4. The pooled cohort equation filter is activated when the risk of a subject for atherosclerotic cardiovascular disease exceeds a threshold level of risk.

[0176]

Table 4

[0177] In one embodiment, the pooled cohort equation filter incorporates at least Survey Results 1-9, as provided in Table 4. In another embodiment, the first survey result includes at least Survey Results 1-10, as provided in Table 4. In another embodiment, the first survey result includes at least Survey Results 1-9 and 11, as provided in Table 4. In another embodiment, the first survey result includes at least Survey Results 1-11, as provided in Table 4.

[0178] In some embodiments, the pooled cohort equation filter calculates the probability that a subject will experience an atherosclerotic cardiovascular disease (ASCVD) event in a given time period, such as in the next 5 years, the next 10 years, etc., or over the subject's lifetime. In some embodiments, the pooled cohort equation used in the pooled cohort equation filter is the Goff DC Jr. et al. 2013 ACC / AHA guideline on the assessment of cardiovascular risk: a report of the American, which is incorporated herein by reference. Calculated using the guidelines described in College of Cardiology / American Heart Association Task Force on Practice Guidelines. Circulation. 2013;00:000-000.

[0179] In some embodiments, the pooled cohort equation filter calculates the probability of fatal cardiovascular disease over a given time period such as the next 5 years, the next 10 years, or over the lifetime of the subject. In some embodiments, the pooled cohort equation used for the pooled cohort filter is calculated using the guidelines described in 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 chart that incorporates the subject's gender, the subject's age, the subject's total cholesterol level, the subject's systolic blood pressure, and the subject's smoking status, as described in Perk J. et al. above. In some embodiments, the pooled cohort equation filter follows a high CVD risk SCORE chart that incorporates the subject's gender, the subject's age, the subject's total cholesterol level, the subject's systolic blood pressure, and the subject's smoking status, as described in Perk J. et al. above.

[0180] In some embodiments, the risk of atherosclerotic cardiovascular disease is a 10-year risk, and the first threshold of the pooled cohort equation filter is 7.5 percent. In such embodiments, the pooled cohort equation (e.g., the equation and table described in Goff Id.) is activated when it indicates that there is a greater than 7.5 percent probability of the first ASCVD event within 10 years. In some embodiments, the risk of atherosclerotic cardiovascular disease is a 5-year risk, a 10-year risk, or a lifetime risk, and the first threshold of the pooled cohort equation filter is 4.0 percent, 4.5 percent, 5.0 percent, 5.5 percent, 6.0 percent, 6.5 percent, 7.0 percent, 7.5 percent, 8.0 percent, 8.5 percent, 9.0 percent, 9.5 percent, or 10.0 percent. In such embodiments, the pooled cohort equation (e.g., the equation and table described in Goff Id.) is activated when it indicates that there is a greater than the first threshold probability of the first ASCVD event within the specified time.

[0181] In some embodiments, the age filter is activated when the first plurality of findings indicate that the subject is a female under 49 years old or 76 years old or older, and the age filter is activated when the first plurality of findings indicate that the subject is a male under 39 years old or 66 years old or older. In some embodiments, the age filter is activated when the first plurality of findings indicate that the subject is a female under 44 years old, 45 years old, 46 years old, 47 years old, 48 years old, or 49 years old, or 70 years old or older, 71 years old or older, 72 years old or older, 73 years old or older, 74 years old or older, 75 years old or older, or 76 years old or older, and the age filter is activated when the first plurality of findings indicate that the subject is a male under 35 years old, 36 years old, 37 years old, 38 years old, or 39 years old, or 61 years old or older, 62 years old or older, 63 years old or older, 64 years old or older, 65 years old or older, 66 years old or older, 67 years old or older, 68 years old or older, 69 years old or older, 70 years old or older, 71 years old or older, or 72 years old or older.

[0182] In some embodiments, one or more personal history filters include one or more alcohol intake filters, adverse reaction filters, atherosclerotic cardiovascular event filters, kidney disease filters, and Asian ethnicity filters. The alcohol intake filter is activated when a first plurality of survey results indicate that the subject routinely consumes alcohol at a level that may cause adverse side effects associated with statin administration. The adverse reaction filter is activated when a first plurality of survey results indicate that the subject has experienced an adverse reaction to a cholesterol-lowering agent in the past. The atherosclerotic cardiovascular event filter is activated when a first plurality of survey results indicate that the subject has experienced an atherosclerotic cardiovascular event in the past. The kidney disease filter is activated when a first plurality of survey results indicate that the subject has kidney disease. The Asian ethnicity filter is activated when a first plurality of survey results indicate that the subject is of Asian ethnicity.

[0183] In some embodiments, the alcohol intake filter is activated when a first plurality of survey results indicate that the subject consumes an average of more than 3 drinks per day. In some embodiments, the alcohol intake filter is activated when a first plurality of survey results indicate that the subject consumes an average of 4 or more drinks per week, 5 or more drinks per week, 6 or more drinks per week, 1 or more drinks per day, 2 or more drinks per day, 3 or more drinks per day, 4 or more drinks per day, or 5 or more drinks per day.

[0184] In some embodiments, the adverse reaction filter is activated when a first plurality of survey results indicate that the subject has had a past It is activated when it is shown that the subject has experienced an adverse reaction to a cholesterol-lowering agent. In some embodiments, the adverse reaction filter is activated when a first plurality of survey results indicate that the subject has experienced an adverse reaction to any statin drug in the past. In some embodiments, the adverse reaction filter is activated when a first plurality of survey results indicate that the subject has experienced an adverse reaction to a statin drug that is approved for over-the-counter receipt by the subject.

[0185] In some embodiments, the atherosclerotic cardiovascular event filter is activated when a 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 a first plurality of survey results indicate that the subject has experienced a heart attack, stroke, or surgery or treatment performed on their own heart.

[0186] In one aspect, the present disclosure provides a computer system for qualifying human subjects for the distribution of a commercially available statin pharmaceutical composition that reduces cholesterol. The computer system includes one or more processors and a memory, the memory including non-transitory instructions that, when executed by the one or more processors, implement a method for qualifying human subjects for the distribution of a commercially available statin pharmaceutical composition. The method includes performing a first survey of a subject, thereby obtaining a first plurality of survey results necessary to apply the first plurality of filters of a first category class and the second plurality of filters of a second category class. The method then includes applying all or a portion of the first plurality of survey results to the first plurality of filters of the first category class, where when each filter within the first plurality of filters is activated, the subject is deemed not qualified for the distribution of the statin pharmaceutical composition and the method ends without distribution of the statin pharmaceutical composition to the subject. The method then also includes applying all or a portion of the first survey results to the second plurality of filters of the second category class, where when each filter within the second plurality of filters is activated, a warning corresponding to each filter is provided to the subject. The method also includes obtaining confirmation from the subject regarding a warning issued to the subject by any filter within the second plurality of filters. The method also includes proceeding to a fulfillment process if (i) none of the filters within the first plurality of filters are activated and (ii) the subject has confirmed each warning associated with each filter within the second plurality of filters that was activated. The fulfillment process includes storing an indicator of an initial order of the statin pharmaceutical composition in a subject profile, communicating a commercially available drug information label of the statin pharmaceutical composition to the subject, and, upon obtaining confirmation from the subject that the commercially available drug information label has been received and read, approving the provision of the statin pharmaceutical composition to the subject. In some embodiments, the approval includes a destination associated with the subject.

[0187] In some embodiments, the first plurality of survey results includes a plurality of survey results selected from the survey results listed in Table 1. In one embodiment, the first plurality of survey results includes the gender of the subject, whether the subject is female and (i) pregnant, (ii) lactating, or (iii) planning to become pregnant, whether the subject has or has had liver disease, the age of the subject, the total cholesterol level of the subject, the HDL cholesterol count of the subject, the systolic blood pressure of the subject, the race of the subject, whether the subject is taking a hypertensive agent, whether the subject is taking one or more agents that interact with a statin pharmaceutical composition, where the one or more agents include cyclosporine, the smoking status of the subject, the diabetes status of the subject, the alcohol intake status of the subject, whether the subject has had an adverse reaction to a cholesterol-lowering agent, and whether the subject has had an atherosclerotic cardiovascular event or has had heart surgery.

[0188] In some embodiments, the first plurality of filters includes a plurality of filters selected from the filters listed in Table 2. In one embodiment, the first plurality of filters includes a pregnancy filter and a liver disease filter. In one embodiment, the first plurality of filters includes a pregnancy filter, a cyclosporine filter, and a liver disease filter.

[0189] In some embodiments, the second plurality of filters includes a plurality of filters selected from the filters listed in Table 3. In one embodiment, the second plurality of filters includes a total cholesterol filter, a pooled 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 pooled cohort equation filter, an age filter, a drug interaction filter, an alcohol intake filter, an adverse reaction filter, and an atherosclerotic cardiovascular event filter.

[0190] In one embodiment, the plurality of first and second filters include filters selected from the filters listed in Table 5. In some embodiments, the plurality of first filters of the first category class include a plurality of first lower filters listed in Table 5, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, or 14 filters listed in Table 5, and the plurality of second filters of the first category class include a plurality of second lower filters listed in Table 5 that are different from the plurality of first lower filters, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, or 14 filters listed in Table 5. In some embodiments, each of the filters within the plurality of first lower filters is different from each of the filters within the plurality of second lower filters (e.g., none of the filters listed in Table 5 are included in both the plurality of first lower and the plurality of second lower filters). In some embodiments, for the distribution of commercially available statin pharmaceuticals, a system for identifying subjects includes instructions for applying only one plurality of filters, e.g., filters of a single category class. In some embodiments where a method, system, or software applies a single plurality of filters, the plurality of filters include a plurality of filters selected from the filters listed in Table 5, e.g., 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 the filters listed in Table 5 correspond to the filters listed in Table 2 or Table 3, as detailed above, the threshold level sufficient to activate the corresponding filters listed in Table 2 or Table 3 is sufficient to activate the filters listed in Table 5. In some embodiments, the plurality of first filters of the first category class include some or all of the filters listed in Table 5. In some embodiments, the plurality of second filters of the second category class include some or all of the filters listed in Table 5.

[0191] In one embodiment, a pooled cohort equation filter (e.g., filter 13c) follows a low CVD risk score chart, as detailed above. In one embodiment, the pooled cohort equation filter follows a low CVD risk score chart, as detailed above. In one embodiment using the SCORE guidelines, the risk of fatal cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk, and the threshold range, e.g., the threshold range with a risk of 1-5% when it is determined that the subject has a risk above or below the range in which the filter operates.

[0192] In one embodiment, the present disclosure provides a computer system for identifying human subjects for the distribution of a commercially available statin pharmaceutical composition that reduces cholesterol. The computer system includes one or more processors and a memory, and when the memory is executed by the one or more processors, a commercially available statin pharmaceutical composition that reduces cholesterol Includes non - transient instructions for implementing a method for qualifying human subjects for the distribution of a statin pharmaceutical composition. The method includes conducting a first survey of a subject, thereby obtaining a first plurality of survey results, where the first plurality of survey results includes a plurality of survey results sufficient to be applied to each of a first plurality of filters of a first category class and a second plurality of filters of a second category class, as shown in Table 5. The method also includes applying all or part of the first plurality of survey results to a first plurality of filters of the first category class, where when each filter within the first plurality of filters is activated, the subject is considered not to be qualified for the distribution of the statin pharmaceutical composition, and the method ends without distributing the statin pharmaceutical composition to the subject, and the first plurality of filters includes a plurality of filters selected from the filters of the first category class listed in Table 5. The method also includes applying all or part of the first plurality of survey results to a second plurality of filters of the second category class, where when each filter within the second plurality of filters is activated, a warning corresponding to each filter is provided to the subject, and the second plurality of filters includes a plurality of filters selected from the filters of the second category class listed in Table 5. Then, the method includes obtaining confirmation from the subject regarding a warning issued to the subject by any filter within the second plurality of filters. Then, the method includes proceeding to a fulfillment process if (i) none of the filters within the first plurality of filters are activated and (ii) the subject has confirmed each warning associated with each filter within the activated second plurality of filters, where the fulfillment process includes storing an indicator of an initial order of the statin pharmaceutical composition in the subject profile, communicating the over - the - counter drug information label of the statin pharmaceutical composition to the subject, and upon obtaining confirmation from the subject that the over - the - counter drug information label has been received and read, approving the provision of the statin pharmaceutical composition to the subject, where the approval includes the destination associated with the subject.

[0193]

Table 5

[0194] In one embodiment, the first and second plurality of filters include filters selected from the filters listed in Table 6. In some embodiments, the first plurality of filters of the first category class include a first plurality of lower filters listed in Table 6, e.g., 2, 3, 4, 5, 6, 7, 8, or 9 filters listed in Table 6, and the second plurality of filters of the first category class include a second plurality of lower filters listed in Table 6 that are different from the first plurality of lower filters, e.g., 2, 3, 4, 5, 6, 7, 8, 9 filters listed in Table 6. In some embodiments, each of the filters within the first plurality of lower filters is different from each of the filters within the second plurality of lower filters (e.g., none of the filters listed in Table 6 are included in both the first plurality of lower and the second plurality of lower filters). In some embodiments, for the distribution of commercially available statin medications, a system for identifying subjects includes instructions for applying only one plurality of filters, e.g., filters of a single category class. In some embodiments where a method, system, or software applies a single plurality of filters, the plurality of filters include a plurality of filters selected from the filters listed in Table 6, e.g., at least 2, 3, 4, 5, 6, 7, 8, 9, or all 10 filters listed in Table 6. In some embodiments, when the filters listed in Table 6 correspond to the filters listed in Table 2 or Table 3, as detailed above, the threshold level sufficient to activate the corresponding filters listed in Table 2 or Table 3 is sufficient to activate the filters listed in Table 6. In some embodiments, the first plurality of filters of the first category class include some or all of the filters listed in Table 6. In some embodiments, the second plurality of filters of the second category class include some or all of the filters listed in Table 6.

[0195] ​In one embodiment, the pooled cohort equation filter (e.g., filter 10d) follows the NIPPON DATA80 absolute risk assessment chart as detailed above. In one embodiment using the NIPPON DATA80 guidelines, the absolute risk of death related to coronary artery disease used when calculating the pooled cohort equation is a 10-year risk and a threshold range, e.g., a threshold range of 0.5 to 2% risk if it is determined that the subject has a risk of exceeding or falling below the range in which the filter operates. In some embodiments using the NIPPON DATA80 guidelines, the dose of the statin (e.g., rosuvastatin) at which the subject is approved is 2.5 mg.

[0196] In one embodiment, the present disclosure provides a computer system for qualifying human subjects for the distribution of a commercially available statin pharmaceutical composition that reduces cholesterol. The computer system includes one or more processors and a memory, and the memory includes non-transitory instructions that, when executed by the one or more processors, implement a method for qualifying human subjects for the distribution of a commercially available statin pharmaceutical composition that reduces cholesterol. The method includes conducting a first survey of a subject, thereby obtaining a first plurality of survey results, the first plurality of survey results including a plurality of survey results sufficient to be applied to each of a first plurality of filters of a first category class and a second plurality of filters of a second category class as shown in Table 6. The method also includes applying all or part of the first plurality of survey results to a first plurality of filters of the first category class, and when each filter within the first plurality of filters is activated, the subject is considered not to be qualified for the distribution of the statin pharmaceutical composition, and the method ends without distribution of the statin pharmaceutical composition to the subject, and the first plurality of filters includes a plurality of filters selected from the filters of the first category class listed in Table 6. The method also includes applying all or part of the first plurality of survey results to a second plurality of filters of the second category class, and when each filter within the second plurality of filters is activated, a warning corresponding to each filter is provided to the subject, and the second plurality of filters includes a plurality of filters selected from the filters of the second category class listed in Table 6. The method then includes obtaining confirmation from the subject regarding a warning issued to the subject by any filter within the second plurality of filters. The method then includes (i) none of the filters within the first plurality of filters being activated and (ii) the subject for each filter within the second plurality of filters that has been activated When each warning associated with the filter is confirmed, it includes proceeding to the full fulfillment process, where the full fulfillment process involves storing an indicator of the first order of the statin pharmaceutical composition in the subject profile, communicating the over-the-counter drug information label of the statin pharmaceutical composition to the subject, and upon confirmation from the subject that the over-the-counter drug information label has been received and read, approving the provision of the statin pharmaceutical composition to the subject, and the approval includes the destination associated with the subject.

[0197]

Table 6

[0198] In one embodiment, the first and second plurality of filters include filters selected from the filters listed in Table 7. In some embodiments, the first plurality of filters of the first category class include a first plurality of lower 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 class include a second plurality of lower filters listed in Table 7 that are different from the first plurality of lower 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 of the filters within the first plurality of lower filters is different from each of the filters within the second plurality of lower filters (for example, none of the filters listed in Table 7 are included in both the first plurality of lower and the second plurality of lower filters). In some embodiments, a system for identifying subjects for the distribution of commercially available statin pharmaceuticals includes instructions for applying only one plurality of filters, for example, filters of a single category class. In some embodiments where a method, system, or software applies a single plurality of filters, the plurality of filters include a plurality of filters selected from the 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, if the filters listed in Table 7 correspond to the filters listed in Table 2 or Table 3, as detailed above, the threshold level sufficient to activate the corresponding filters listed in Table 2 or Table 3 is sufficient to activate the filters listed in Table 7. In some embodiments, the first plurality of filters of the first category class include some or all of the filters listed in Table 7. In some embodiments, the second plurality of filters of the second category class include some or all of the filters listed in Table 7.

[0199] In one embodiment, the pool cohort equation filter (e.g., filter 13e) follows the China-PAR equation as detailed above. In one embodiment using the China-PAR guidelines, the risk of atherosclerotic cardiovascular disease used in calculating the pool cohort equation is the 10-year risk, and a threshold range, e.g., a threshold range of 5-10% risk if it is determined that the subject has a risk above or below the range in which the filter operates.

[0200] ​In one embodiment, the present disclosure provides a computer system for qualifying human subjects for the distribution of a commercially available statin pharmaceutical composition that reduces cholesterol. The computer system includes one or more processors and a memory, and when the memory is executed by the one or more processors, it includes non-transitory instructions for implementing a method for qualifying human subjects for the distribution of a commercially available statin pharmaceutical composition that reduces cholesterol. The method includes conducting a first survey of a subject, thereby obtaining a first plurality of survey results, the first plurality of survey results including a plurality of survey results sufficient to be applied to each of a first plurality of filters of a first category class and a second plurality of filters of a second category class as shown in Table 7. The method also includes applying all or part of the first plurality of survey results to a first plurality of filters of a first category class, and when each filter in the first plurality of filters is activated, the subject is considered not to be qualified for the distribution of the statin pharmaceutical composition, and the method ends without distributing the statin pharmaceutical composition to the subject, and the first plurality of filters includes a plurality of filters selected from the filters of the first category class listed in Table 7. The method also includes applying all or part of the first plurality of survey results to a second plurality of filters of a second category class, and when each filter in the second plurality of filters is activated, a warning corresponding to each filter is provided to the subject, and the second plurality of filters includes a plurality of filters selected from the filters of the second category class listed in Table 7. Then, the method includes obtaining confirmation from the subject regarding a warning issued to the subject by any filter in the second plurality of filters.Next, the method includes proceeding to a full fulfillment process if (i) none of the filters in the first plurality of filters are activated and (ii) the subject has acknowledged each warning associated with each filter in the activated second plurality of filters, the full fulfillment process including storing an indication of the first order of the statin pharmaceutical composition in the subject profile, communicating the over-the-counter drug information label of the statin pharmaceutical composition to the subject, and upon confirmation from the subject that the over-the-counter drug information label has been received and read, approving the provision of the statin pharmaceutical composition to the subject, the approval including the destination associated with the subject.

[0201]

Table 7

[0202] In one embodiment, the first and second plurality of filters include filters selected from the filters listed in Table 8. In some embodiments, the first plurality of filters of the first category class include a first plurality of lower 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 class include a second plurality of lower filters listed in Table 8 that are different from the first plurality of lower filters, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 filters listed in Table 8. In some embodiments, each of the filters within the first plurality of lower filters is different from each of the filters within the second plurality of lower filters (e.g., none of the filters listed in Table 8 are included in both the first plurality of lower and the second plurality of lower filters). In some embodiments, for the distribution of commercially available statin medications, a system for identifying subjects includes instructions for applying only one plurality of filters, such as filters of a single category class. In some embodiments where a method, system, or software applies a single plurality of filters, the plurality of filters include a plurality of filters selected from the filters 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 the filters listed in Table 8 correspond to the filters listed in Table 2 or Table 3, as detailed above, the threshold level sufficient to activate the corresponding filters listed in Table 2 or Table 3 is sufficient to activate the filters listed in Table 8. In some embodiments, the first plurality of filters of the first category class include some or all of the filters listed in Table 8. In some embodiments, the second plurality of filters of the second category class include some or all of the filters listed in Table 8.

[0203] In one embodiment, the pool cohort equation filter (e.g., filter 11f) follows the Australian Absolute Cardiovascular Risk Calculator, as detailed above. Australian Absolut In one embodiment that uses the Australian Cardiovascular Risk Calculator, the risk of cardiovascular disease used in calculating the pool cohort equation is the 5-year risk, and a threshold range, e.g., a threshold range of 10-15% risk if it is determined that the subject has a risk above or below the range in which the filter operates.

[0204] In one embodiment, the present disclosure provides a computer system for qualifying human subjects for the distribution of a commercially available statin pharmaceutical composition that lowers cholesterol. The computer system includes one or more processors and a memory that, when executed by the one or more processors, includes non-transitory instructions for implementing a method for qualifying human subjects for the distribution of a commercially available statin pharmaceutical composition that lowers cholesterol. The method includes conducting a first examination of a subject, thereby obtaining a first plurality of examination results, where the first plurality of examination results includes a plurality of examination results sufficient to apply to each of a first plurality of filters of a first category class and a second plurality of filters of a second category class as shown in Table 8. The method also includes applying all or a portion of the first plurality of examination results to the first plurality of filters of the first category class, where when each filter within the first plurality of filters is activated, the subject is deemed not qualified for the distribution of the statin pharmaceutical composition and the method ends without distribution of the statin pharmaceutical composition to the subject, and the first plurality of filters includes a plurality of filters selected from the filters of the first category class listed in Table 8. The method also includes applying all or a portion of the first plurality of examination results to the second plurality of filters of the second category class, where when each filter within the second plurality of filters is activated, a warning corresponding to each filter is provided to the subject, and the second plurality of filters includes a plurality of filters selected from the filters of the second category class listed in Table 8. The method then includes obtaining confirmation from the subject regarding any warning issued to the subject by any filter within the second plurality of filters.Next, the method includes proceeding to a full fulfillment process if (i) none of the first plurality of filters are activated and (ii) the subject has confirmed each warning associated with each filter in the activated second plurality of filters, the full fulfillment process including storing an indicator of the first order of the statin pharmaceutical composition in the subject profile, communicating the over-the-counter drug information label of the statin pharmaceutical composition to the subject, and upon confirmation from the subject that the over-the-counter drug information label has been received and read, approving the provision of the statin pharmaceutical composition to the subject, the approval including the destination associated with the subject.

[0205]

Table 8

[0206] In some embodiments, the genetic polymorphism filter (e.g., filter 13f) is activated when the first plurality of findings indicate that the subject has a polymorphism selected from the SLCO1B1 (OATP1B1) and / or ABCG2 (BCRP) gene polymorphisms (e.g., SLCO1B1, c.521C>C, and / or ABCG2, c.421A>A). In some embodiments, the filter is not activated when the first plurality of findings indicate that the subject does not know whether they have one or a particular polymorphism.

[0207] In one embodiment, the first and second plurality of filters include filters selected from the filters listed in Table 9. In some embodiments, the first plurality of filters of the first category class include a first plurality of sub-filters listed in Table 9, e.g., 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 class include a second plurality of sub-filters listed in Table 9 that are different from the first plurality of sub-filters, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or 13 filters listed in Table 9. In some embodiments, each of the filters within the first plurality of sub-filters is different from each of the filters within the second plurality of sub-filters (e.g., none of the filters listed in Table 9 are included in both the first plurality and the second plurality of sub-filters). In some embodiments, for the distribution of commercially available statin medications, a system for identifying subjects includes instructions for applying only one plurality of filters, e.g., filters of a single category class. In some embodiments where a method, system, or software applies a single plurality of filters, the plurality of filters include a plurality of filters selected from the filters listed in Table 9, e.g., 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 the filters listed in Table 9 correspond to the filters listed in Table 2 or Table 3, as detailed above, the threshold level sufficient to activate the corresponding filters listed in Table 2 or Table 3 is sufficient to activate the filters listed in Table 9. In some embodiments, the first plurality of filters of the first category class include some or all of the filters listed in Table 9. In some embodiments, the second plurality of filters of the second category class The second plurality of filters include some or all of the filters listed in Table 9.

[0208] In one embodiment, the pooled cohort equation filter (e.g., filter 12g) follows the Framingham Heart Study Risk Score equation (FRS), the modified Framingham Heart Study Risk Score equation (mFRS), or the Cardiovascular Life Expectancy Model (CLEM), as detailed above. In one embodiment using the FRS, mFRS, or CLEM model, the risk of atherosclerotic cardiovascular disease used in calculating the pooled cohort equation is the 10-year risk and a threshold range, e.g., a threshold range of 10-19% risk if it is determined that the subject has a risk above or below the range in which the filter operates.

[0209] In one embodiment, the present disclosure provides a computer system for qualifying human subjects for the distribution of a commercially available statin pharmaceutical composition that reduces cholesterol. The computer system includes one or more processors and a memory that, when executed by the one or more processors, includes non-transitory instructions for implementing a method for qualifying human subjects for the distribution of a commercially available statin pharmaceutical composition that reduces cholesterol. The method includes conducting a first survey of a subject and thereby obtaining a first plurality of survey results, the first plurality of survey results including a first plurality of survey results sufficient to be applied to each of a first plurality of filters of a first category class and a second plurality of filters of a second category class as shown in Table 9. The method also includes applying all or a portion of the first plurality of survey results to a first plurality of filters of the first category class, where when each filter within the first plurality of filters is activated, the subject is deemed not to be qualified for the distribution of the statin pharmaceutical composition and the method ends without distributing the statin pharmaceutical composition to the subject, and the first plurality of filters includes a plurality of filters selected from the filters of the first category class listed in Table 9. The method also includes applying all or a portion of the first plurality of survey results to a second plurality of filters of the second category class, where when each filter within the second plurality of filters is activated, a warning corresponding to each filter is provided to the subject, and the second plurality of filters includes a plurality of filters selected from the filters of the second category class listed in Table 9. The method then includes obtaining confirmation from the subject regarding any warning issued to the subject by any filter within the second plurality of filters.Next, the method includes proceeding to a full fulfillment process if (i) none of the first plurality of filters are activated and (ii) the subject has confirmed each warning associated with each filter in the activated second plurality of filters, the full fulfillment process including storing an indicator of the first order of the statin pharmaceutical composition in the subject profile, communicating the over-the-counter drug information label of the statin pharmaceutical composition to the subject, and upon confirmation from the subject that the over-the-counter drug information label has been received and read, approving the provision of the statin pharmaceutical composition to the subject, the approval including the destination associated with the subject.

[0210]

Table 9

[0211] In some embodiments, the genetic polymorphism filter (e.g., filter 14g) is activated when the first plurality of findings indicate that the subject has a polymorphism selected from the SLCO1B1 (OATP1B1) and / or ABCG2 (BCRP) gene polymorphisms (e.g., SLCO1B1, c.521C>C, and / or ABCG2, c.421A>A). In some embodiments, the filter is not activated when the first plurality of findings indicate that the subject does not know whether they have one or a particular polymorphism.

Example

[0212] Example 1: A computer system is prepared to qualify human subjects for the distribution of a commercially available rosuvastatin pharmaceutical composition (e.g., low-dose CRESTOR) for treating or preventing atherosclerotic cardiovascular disease (e.g., by reducing cholesterol). The computer system includes an order to conduct an investigation of a subject to obtain one or more of the subject's gender, whether the subject is female and one of (i) pregnant, (ii) lactating, 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 race, whether the subject is taking a hypertension medication, whether the subject is taking one or more medications that interact with a statin pharmaceutical composition, where one or more of the medications include cyclosporine, the subject's smoking status, the subject's diabetes status, the subject's alcohol intake status, whether the subject has had an adverse reaction to a cholesterol-lowering medication, and whether the subject has had an atherosclerotic cardiovascular event or has had heart surgery.

[0213] The computer system applies the survey results to a first series of filters that each prevent approval of the distribution of OTC statins if the survey results of the subject identify a contraindication to OTC statins. In some embodiments, the first series of filters includes one or more of a pregnancy filter, a liver disease or allergic reaction to statin pharmaceutical composition filter, and an optional cyclosporine filter.

[0214] When the survey results of a subject identify risk factors for OTC statins, the computer system runs the survey results against a second set of filters that each generate a warning. In some embodiments, the first set of filters includes a total cholesterol level filter, the subject's gender, the subject's race, the subject's age, the subject's total cholesterol level, the subject's HDL cholesterol count, the subject's systolic blood pressure, whether the subject is taking a drug that interacts with statins, the subject's smoking status, and the subject's diabetes status, and incorporates a pooled cohort equation filter that derives the risk of atherosclerotic cardiovascular disease, where the pooled 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 intake filter, a harmful reaction filter, an atherosclerotic cardiovascular event filter, and one or more of an optional cyclosporine filter (e.g., if not included in the first set of filters).

[0215] The computer system then prompts the subject to confirm or deny that it has discussed these warnings with a healthcare provider (e.g., the subject's physician). The computer system then proceeds to the fulfillment process only if (i) none of the first set of filters are activated and (ii) the subject confirms that it has discussed each warning issued in connection with the activated second set of filters.

[0216] The computer system stores an indicator of the first order of OTC statins in the subject profile and transmits the over-the-counter drug information label of the statin pharmaceutical composition to the subject. When the computer system receives confirmation from the subject that it has received and read the over-the-counter drug information label, the computer system approves the offer of the OTC statin pharmaceutical composition to the subject.

[0217] Example 2: Prepare a computer system for identifying human subjects for the distribution of a commercially available atorvastatin pharmaceutical composition (e.g., low-dose LIPITOR) for treating or preventing atherosclerotic cardiovascular disease (e.g., by reducing cholesterol). The computer system includes the subject's gender, whether the subject is female and (i) pregnant, (ii) lactating, 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 race, whether the subject is taking a hypertension drug, whether the subject is taking one or more drugs that interact with the statin pharmaceutical composition, where one or more drugs include cyclosporine, the subject's smoking status, the subject's diabetes status, the subject's alcohol intake status, whether the subject has had an adverse reaction to a cholesterol-lowering drug, and whether the subject has had an atherosclerotic cardiovascular event or has had heart surgery, and includes instructions for conducting an investigation of the subject to obtain one or more of the foregoing.

[0218] The computer system applies the survey results to a first series of filters that each prevent approval of the distribution of OTC statins when the survey results of the subject identify contraindications to OTC statins. In some embodiments, the first series of filters includes one or more of a pregnancy filter, a liver disease or allergic reaction to statin pharmaceutical composition filter, and an optional cyclosporine filter.

[0219] The computer system runs the survey results against a second series of filters that each generate a warning when the survey results of the subject identify risk factors for OTC statins. In some embodiments, the first series of filters includes a total cholesterol level filter, the subject's gender, the subject's race, the subject's age, the subject's total cholesterol level, the subject's HD A pooled cohort equation filter that incorporates the L cholesterol count, the systolic blood pressure of the subject, whether the subject is taking a drug that interacts with statin, the smoking status of the subject, and the diabetes status of the subject, and that is considered activated when the risk meets a first threshold range or a first threshold, the pooled cohort equation filter, an age filter, a drug interaction filter, an alcohol intake filter, an adverse reaction filter, an atherosclerotic cardiovascular event filter, and one or more of an optional cyclosporine filter (e.g., if not included in a first set of filters).

[0220] The computer system then prompts the subject to confirm or deny that these warnings have been discussed with a healthcare provider (e.g., the subject's physician). The computer system then proceeds to the fulfillment process only if (i) none of the first set of filters are activated and (ii) the subject has confirmed that they have discussed each warning issued in relation to the activated second set of filters.

[0221] The computer system stores an indication of the first order of the OTC statin in the subject profile and communicates the over-the-counter drug information label of the statin pharmaceutical composition to the subject. Upon receiving and confirming from the subject that they have read the over-the-counter drug information label, the computer system approves the provision of the OTC statin pharmaceutical composition to the subject.

[0222] Example 3: Prepare a computer system for qualifying human subjects for the distribution of a commercially available simvastatin pharmaceutical composition (e.g., low-dose Zocor) for treating or preventing atherosclerotic cardiovascular disease (e.g., by reducing cholesterol). The computer system includes information about the subject's gender, whether the subject is female and one of (i) pregnant, (ii) lactating, 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 race, whether the subject is taking a hypertension medication, whether the subject is taking one or more medications that interact with the statin pharmaceutical composition, where the one or more medications include cyclosporine, gemfibrozil, danazol, and / or a strong CYP3A4 inhibitor, the subject's smoking status, the subject's diabetes status, the subject's alcohol intake status, whether the subject has had an adverse reaction to a cholesterol-lowering medication, and whether the subject has had an atherosclerotic cardiovascular event or has had heart surgery, and includes instructions for conducting an investigation of the subject to obtain one or more of the foregoing.

[0223] The computer system applies the survey results to a first series of filters that each prevent approval of the distribution of OTC statins if the subject's survey results identify a contraindication to OTC statins. In some embodiments, the first series of filters includes one or more of a pregnancy filter, a liver disease or allergic reaction to the statin pharmaceutical composition filter, and an optional cyclosporine, gemfibrozil, danazol, and / or strong CYP3A4 inhibitor filter.

[0224] When the survey results of a subject identify risk factors for OTC statins, the computer system runs the survey results against a second set of filters that each generate a warning. In some embodiments, the first set of filters includes a total cholesterol level filter, the subject's gender, the subject's race, the subject's age, the subject's total cholesterol level, the subject's HDL cholesterol count, the subject's systolic blood pressure, whether the subject is taking a drug that interacts with statins, the subject's smoking status, and the subject's diabetes status, and incorporates a pooled cohort equation filter that derives the risk of atherosclerotic cardiovascular disease, where a pooled cohort equation filter that is considered activated when the risk meets a first threshold range or a first threshold, an age filter, a drug interaction filter, an alcohol intake filter, a harmful reaction filter, an atherosclerotic cardiovascular event filter, and one or more of an optional cyclosporine, gemfibrozil, danazol, and / or potent CYP3A4 inhibitor filter (e.g., if not included in the first set of filters).

[0225] The computer system then prompts the subject to confirm or deny that these warnings have been discussed with a healthcare provider (e.g., the subject's physician). The computer system then proceeds to the fulfillment process only if (i) none of the first set of filters are activated and (ii) the subject confirms that they have discussed each warning issued in relation to the activated second set of filters.

[0226] The computer system stores an indication of the first order of OTC statins in the subject profile and transmits the over-the-counter drug information label of the statin pharmaceutical composition to the subject. When the computer system receives confirmation from the subject that they have received and read the over-the-counter drug information label, the computer system approves the provision of the OTC statin pharmaceutical composition to the subject.

[0227] Example 4: Prepare a computer system for identifying human subjects for the distribution of a commercially available pravastatin pharmaceutical composition (e.g., low-dose PRAVACHOL) for treating or preventing atherosclerotic cardiovascular disease (e.g., by reducing cholesterol). The computer system includes information about the subject's gender, whether the subject is female and whether the subject is (i) pregnant, (ii) lactating, 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 race, whether the subject is taking hypertension medication, whether the subject is taking one or more medications that interact with the statin pharmaceutical composition, where the one or more medications include cyclosporine, the subject's smoking status, the subject's diabetes status, the subject's alcohol intake status, whether the subject has had an adverse reaction to a cholesterol-lowering agent, and whether the subject has had an atherosclerotic cardiovascular event or has had heart surgery, and includes instructions for conducting an investigation of the subject to obtain one or more of the above.

[0228] The computer system applies the survey results to a first series of filters that each prevent approval of the distribution of OTC statins if the subject's survey results identify a contraindication to OTC statins. In some embodiments, the first series of filters includes one or more of a pregnancy filter, a liver disease or allergic reaction to statin pharmaceutical composition filter, and an optional cyclosporine filter.

[0229] When the test results of a subject identify risk factors for OTC statins, the computer system runs the test results against a second set of filters that each generate a warning. In some embodiments, the first set of filters includes a total cholesterol level filter, the subject's gender, the subject's race, the subject's age, the subject's total cholesterol level, the subject's HDL cholesterol count, the subject's systolic blood pressure, whether the subject is taking a drug that interacts with statins, the subject's smoking status, and the subject's diabetes status, and incorporates a pooled cohort equation filter that derives the risk of atherosclerotic cardiovascular conditions, where if the risk meets a first threshold range or a first threshold, the pooled cohort equation filter is considered activated, an age filter, a drug interaction filter, an alcohol intake filter, a harmful reaction filter, an atherosclerotic cardiovascular event filter, and optionally a cyclosporine filter (e.g., if not included in the first set of filters) among one or more of them.

[0230] The computer system then prompts the subject to confirm or deny that it has discussed these warnings with a healthcare provider (e.g., the subject's physician). The computer system then proceeds to the fulfillment process only if (i) none of the first set of filters are activated and (ii) the subject has confirmed that it has discussed each warning issued in relation to the activated second set of filters.

[0231] The computer system stores an indication of the first order of OTC statins in the subject profile and transmits the over-the-counter drug information label of the statin pharmaceutical composition to the subject. When the computer system receives confirmation from the subject that it has received and read the over-the-counter drug information label, the computer system approves the provision of the OTC statin pharmaceutical composition to the subject.

[0232] Example 5: Prepare a computer system for qualifying human subjects for the distribution of a commercially available fluvastatin pharmaceutical composition (e.g., low-dose LESCOL XL) for treating or preventing atherosclerotic cardiovascular disease (e.g., by reducing cholesterol). The computer system includes information about the subject's gender, whether the subject is female and whether the subject is (i) pregnant, (ii) lactating, 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 race, whether the subject is taking a hypertension medication, whether the subject is taking one or more drugs that interact with the statin pharmaceutical composition, where the one or more drugs include cyclosporine, the subject's smoking status, the subject's diabetes status, the subject's alcohol intake status, whether the subject has had an adverse reaction to a cholesterol-lowering agent, and whether the subject has had an atherosclerotic cardiovascular event or has had heart surgery, and includes instructions for conducting an investigation of the subject to obtain one or more of the foregoing.

[0233] The computer system applies the survey results to a first series of filters that each prevent approval of the distribution of an OTC statin if the subject's survey results identify a contraindication to the OTC statin. In some embodiments, the first series of filters includes one or more of a pregnancy filter, a liver disease or allergy reaction to the statin pharmaceutical composition filter, and an optional cyclosporine filter.

[0234] When the survey results of a subject identify risk factors for OTC statins, the computer system runs the survey results against a second set of filters that each generate a warning. In some embodiments, the first set of filters includes a total cholesterol level filter, the subject's gender, the subject's race, the subject's age, the subject's total cholesterol level, the subject's HDL cholesterol count, the subject's systolic blood pressure, whether the subject is taking a drug that interacts with statins, the subject's smoking status, and the subject's diabetes status, and incorporates a pooled cohort equation filter that derives the risk of atherosclerotic cardiovascular disease, and when the risk meets a first threshold range or a first threshold, the pooled cohort equation filter is considered to be activated, an age filter, a drug interaction filter, an alcohol intake filter, a harmful reaction filter, an atherosclerotic cardiovascular event filter, and one or more of an optional cyclosporine filter (e.g., if not included in the first set of filters).

[0235] The computer system then prompts the subject to confirm or deny that these warnings have been discussed with a healthcare provider (e.g., the subject's physician). The computer system then proceeds to the fulfillment process only if (i) none of the first set of filters have been activated and (ii) the subject has confirmed having discussed each warning issued in connection with the activated second set of filters. When the subject has received and confirmed reading the over-the-counter (OTC) statin pharmaceutical composition's commercial drug information label, the computer system approves the offer of the OTC statin pharmaceutical composition to the subject.

[0236] The computer system stores an indicator of the first order of OTC statins in the subject profile and transmits the commercial drug information label of the statin pharmaceutical composition to the subject. When the subject has received and confirmed reading the over-the-counter (OTC) statin pharmaceutical composition's commercial drug information label, the computer system approves the offer of the OTC statin pharmaceutical composition to the subject.

[0237] Example 6: Prepare a computer system for qualifying human subjects for the distribution of a commercially available pitavastatin pharmaceutical composition (e.g., low-dose LIVALO) for treating or preventing atherosclerotic cardiovascular disease (e.g., by reducing cholesterol). The computer system includes instructions for conducting an examination of a subject to obtain one or more of the subject's gender, whether the subject is female and whether the subject is (i) pregnant, (ii) lactating, 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 race, whether the subject is taking a hypertension drug, whether the subject is taking one or more drugs that interact with a statin pharmaceutical composition, where the one or more drugs include cyclosporine, the subject's smoking status, the subject's diabetes status, the subject's alcohol intake status, whether the subject has had an adverse reaction to a cholesterol-lowering drug, and whether the subject has had an atherosclerotic cardiovascular event or has had heart surgery.

[0238] The computer system applies the examination results to a first series of filters that each prevent approval of the distribution of an OTC statin if the examination results of the subject identify a contraindication to the OTC statin. In some embodiments, the first series of filters includes one or more of a pregnancy filter, a liver disease or allergy reaction to a statin pharmaceutical composition filter, and an optional cyclosporine filter.

[0239] When the survey results of a subject identify risk factors for OTC statins, the computer system runs the survey results against a second set of filters that each generate a warning. In some embodiments, the first set of filters includes a total cholesterol level filter, the subject's gender, the subject's race, the subject's age, the subject's total cholesterol level, the subject's HDL cholesterol count, the subject's systolic blood pressure, whether the subject is taking a drug that interacts with statins, the subject's smoking status, and the subject's diabetes status, and incorporates a pooled cohort equation filter that derives the risk of atherosclerotic cardiovascular disease, where if the risk meets a first threshold range or a first threshold, the pooled cohort equation filter is considered to be activated, an age filter, a drug interaction filter, an alcohol intake filter, a harmful reaction filter, an atherosclerotic cardiovascular event filter, and one or more of an optional cyclosporine filter (e.g., if not included in the first set of filters).

[0240] The computer system then prompts the subject to confirm or deny that it has discussed these warnings with a healthcare provider (e.g., the subject's physician). The computer system then proceeds to the fulfillment process only if (i) none of the first set of filters have been activated and (ii) the subject has confirmed that it has discussed each warning issued in relation to the activated second set of filters.

[0241] The computer system stores an indicator of the first order of OTC statins in the subject profile and transmits the over-the-counter drug information label of the statin pharmaceutical composition to the subject. When the computer system receives the over-the-counter drug information label and confirms from the subject that it has read it, the computer system approves the provision of the OTC statin pharmaceutical composition to the subject. When the computer system receives the over-the-counter drug information label and confirms from the subject that it has read it, the computer system approves the provision of the OTC statin pharmaceutical composition to the subject.

[0242] Example 7: Prepare a computer system for qualifying human subjects for the distribution of a commercially available lovastatin pharmaceutical composition (e.g., low-dose MEVACOR) for treating or preventing atherosclerotic cardiovascular disease (e.g., by reducing cholesterol). The computer system includes information about the subject's gender, whether the subject is female and one of (i) pregnant, (ii) lactating, 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 race, whether the subject is taking a hypertension drug, whether the subject is taking one or more drugs that interact with the statin pharmaceutical composition, where the one or more drugs include cyclosporine and a potent CYP3A4 inhibitor, the subject's smoking status, the subject's diabetes status, the subject's alcohol intake status, whether the subject has had an adverse reaction to a cholesterol-lowering drug, and whether the subject has had an atherosclerotic cardiovascular event or has had heart surgery, and includes instructions for conducting an investigation of the subject to obtain one or more of the above.

[0243] The computer system applies the survey results to a first series of filters that each prevent approval of the distribution of OTC statins if the subject's survey results identify a contraindication to OTC statins. In some embodiments, the first series of filters includes one or more of a pregnancy filter, a liver disease or allergic reaction to the statin pharmaceutical composition filter, and an optional cyclosporine and / or potent CYP3A4 inhibitor filter.

[0244] The computer system executes the survey results against a second set of filters that each generate a warning when the survey results of the subject identify risk factors for OTC statins. In some embodiments, the first set of filters includes a total cholesterol level filter, the subject's gender, the subject's race, the subject's age, the subject's total cholesterol level, the subject's HDL cholesterol count, the subject's systolic blood pressure, whether the subject is taking a drug that interacts with statins, the subject's smoking status, and the subject's diabetes status, and incorporates a pooled cohort equation filter that derives the risk of atherosclerotic cardiovascular disease, and when the risk meets a first threshold range or a first threshold, the pooled cohort equation filter is considered to be activated, an age filter, a drug interaction filter, an alcohol intake filter, a harmful reaction filter, an atherosclerotic cardiovascular event filter, and one or more of an optional cyclosporine and / or a potent CYP3A4 inhibitor filter (e.g., if not included in the first set of filters).

[0245] The computer system then prompts the subject to confirm or deny that it has discussed these warnings with a healthcare provider (e.g., the subject's physician). The computer system then proceeds to the fulfillment process only if (i) none of the first set of filters are activated and (ii) the subject confirms that it has discussed each warning issued in connection with the activated second set of filters.

[0246] The computer system stores an indicator of the first order of OTC statins in the subject profile and transmits the over-the-counter drug information label of the statin pharmaceutical composition to the subject. Upon receiving and confirming from the subject that it has read the over-the-counter drug information label, the computer system approves the offer of the OTC statin pharmaceutical composition to the subject. Cited and alternative embodiments All references cited in this specification are hereby incorporated by reference in their entirety for all purposes as if each individual publication or patent or patent application were specifically and individually indicated to be incorporated by reference in its entirety for all purposes.

[0247] The present invention can be implemented as a computer program product including a computer program mechanism embedded in a non-transitory computer-readable storage medium. For example, the computer program product can include program modules shown in any combination of FIGS. 1, 2, and 3 and / or described in FIG. 4 or 5. These program modules can be stored on a CD-ROM, DVD, magnetic disk storage product, USB key, or any other non-transitory computer-readable data or program storage product.

[0248] As will be apparent to those skilled in the art, many modifications and variations of this application can be made without departing from the spirit and scope of the application. The specific embodiments described herein are provided by way of example only. The embodiments were selected and described in order to best explain the principles of the invention and its practical use, thereby enabling those skilled in the art to best utilize the invention and various embodiments with various modifications suitable for the particular applications contemplated. The invention should be limited only by the terms of the appended claims together with the full scope of equivalents to which such claims are entitled.

Claims

1. A computer system for qualifying human subjects for the distribution of a commercially available statin pharmaceutical composition for lowering cholesterol, the computer system comprising one or more processors and a memory, the non-transitory instructions provided in the memory being performed when executed by the one or more processors, the method comprising: a) performing a first survey of the subject, thereby obtaining a first plurality of survey results, the first plurality of survey results including a plurality of survey results selected from those listed in Table 1; b) applying all or a portion of the first plurality of survey results to a first plurality of filters of a first category class, wherein when each filter within the first plurality of filters is activated, the subject is deemed not qualified for the distribution of the statin pharmaceutical composition and the method ends without distributing the statin pharmaceutical composition to the subject, the first plurality of filters including a plurality of filters selected from those listed in Table 2; c) applying all or a portion of the first plurality of survey results to a second plurality of filters of a second category class, wherein when each filter within the second plurality of filters is activated, a warning corresponding to each filter is provided to the subject, the second plurality of filters including a plurality of filters selected from those listed in Table 3; d) obtaining confirmation from the subject regarding the warning issued to the subject by any filter within the second plurality of filters; e) proceeding to a full fulfillment process if (i) none of the filters within the first plurality of filters are activated and (ii) the subject has confirmed each warning associated with each filter within the activated second plurality of filters, the full fulfillment process comprising: storing an indicator of a first order of the statin pharmaceutical composition in a subject profile; communicating the over-the-counter drug information label of the statin pharmaceutical composition to the subject; and Upon confirming from the subject that the commercially available drug information label has been received and read, approving the provision of the statin pharmaceutical composition to the subject, the approval including approving including the destination associated with the subject, and proceeding, including a non - transient instruction including implementing a method.

2. A computer system for identifying human subjects for the distribution of a commercially available statin pharmaceutical composition for reducing cholesterol, the computer system comprising one or more processors and a memory, and a non - transient instruction provided in the memory, which is a method performed when executed by the one or more processors, a) Conducting a first survey of the subject, thereby obtaining a first plurality of survey results, the first plurality of survey results including a first plurality of survey results, the first plurality of survey results being sufficient to be applied to a first plurality of filters of a first category class and a second plurality of filters of a second category class, obtaining; b) Applying all or part of the first plurality of survey results to a first plurality of filters of a first category class, when each filter in the first plurality of filters is activated, the subject is considered not to be eligible for the distribution of the statin pharmaceutical composition, and the method ends without distributing the statin pharmaceutical composition to the subject, the first plurality of filters including a first plurality of lower - level filters selected from the filters listed in a first reference table, the first reference table being any one of Table 5, Table 6, Table 7, Table 8, or Table 9, applying; c) Applying all or part of the first plurality of survey results to a second plurality of filters of a second category class, when each filter in the second plurality of filters is activated, a warning corresponding to each filter is provided to the subject, the second plurality of filters including a second plurality of lower - level filters selected from the filters listed in the first reference table, applying; d) Obtaining confirmation from the subject regarding the warning issued to the subject by any filter in the second plurality of filters; e) (i) None of the first plurality of filters are activated, and (ii) if the subject has confirmed each warning associated with each filter within the activated second plurality of filters, proceed to the full fulfillment process, where the full fulfillment process stores an indicator of the first order of the statin pharmaceutical composition in the subject profile, communicates the over-the-counter drug information label of the statin pharmaceutical composition to the subject, and upon confirmation from the subject that the over-the-counter drug information label has been received and read, approves the provision of the statin pharmaceutical composition to the subject, the approval including approving, including the destination associated with the subject, a computer system including non-transitory instructions for implementing a method including proceeding, including.

3. The first plurality of filters includes a pregnancy filter and a liver disease filter, The second plurality of filters includes a total cholesterol filter, a pooled cohort equation filter, an age filter, one or more personal history filters, and one or more drug risk interaction filters, the computer system according to claim 1 or 2.

4. The first plurality of survey results the gender of the subject, whether the subject is female and (i) pregnant, (ii) lactating, or (iii) one of those planning to become pregnant, whether the subject has or has had liver disease, the age of the subject, the total cholesterol level of the subject, the HDL cholesterol count of the subject, the systolic blood pressure of the subject, the race of the subject, whether the subject is taking a hypertensive drug, whether the subject is taking one or more drugs that interact with the statin pharmaceutical composition, the one or more drugs including cyclosporine, the smoking status of the subject, the diabetes status of the subject, the alcohol intake status of the subject, whether the subject has ever had an adverse reaction to a cholesterol-lowering drug, whether the subject has ever had an atherosclerotic cardiovascular event or has ever had heart surgery, including, The first plurality of filters a pregnancy filter, a cyclosporine filter, a liver disease or an allergy reaction filter for the statin pharmaceutical composition, wherein the second plurality of filters include a total cholesterol level filter, a pooled cohort equation filter that incorporates the characteristics of the subject to derive the risk of atherosclerotic cardiovascular disease or death, and when the risk meets a first threshold range or a first threshold, the pooled cohort equation filter is considered to be activated, an age filter, a drug interaction filter, an alcohol intake filter, an adverse reaction filter, and an atherosclerotic cardiovascular disease event filter, the computer system according to claim 1.

5. The computer system according to any one of claims 2 to 4, wherein the pooled cohort equation filter incorporates the gender of the subject, the race of the subject, the age of the subject, the total cholesterol level of the subject, the HDL cholesterol count of the subject, the systolic blood pressure of the subject, whether the subject is taking a drug that interacts with statin, the smoking status of the subject, and the diabetes status of the subject to derive the risk of atherosclerotic cardiovascular disease, and when the risk meets a first threshold range or a first threshold, the pooled cohort equation filter is considered to be activated.

6. The computer system according to any one of claims 2 to 4, wherein the pooled cohort equation filter incorporates the gender of the subject, the age of the subject, the total cholesterol level of the subject, the systolic blood pressure of the subject, and the smoking status of the subject to derive the risk of fatal cardiovascular disease, and when the risk meets a first threshold range or a first threshold, the pooled cohort equation filter is considered to be activated.

7. The computer system according to claim 6, wherein the pooled cohort equation filter further incorporates the glucose level of the subject.

8. The pool cohort equation filter incorporates the gender of the subject, the age of the subject, the systolic blood pressure of the subject, the blood pressure treatment status of the subject, the total cholesterol level of the subject, the smoking status of the subject, the diabetes status of the subject, the waist circumference of the subject, the geographical residence area of the subject, the urbanized residence area of the subject, and the family history of atherosclerotic cardiovascular disease to derive the risk of atherosclerotic cardiovascular disease. When the risk meets a first threshold range or a first threshold, the pool cohort equation filter is considered to be activated. The computer system according to any one of claims 2 to 4.

9. The pool cohort equation filter incorporates the gender of the subject, the age of the subject, the systolic blood pressure of the subject, the ratio of the total cholesterol of the subject to the HDL level, and the smoking status of the subject to derive the risk of atherosclerotic cardiovascular disease. When the risk meets a first threshold range or a first threshold, the pool cohort equation filter is considered to be activated. The computer system according to any one of claims 2 to 4.

10. The pool cohort equation filter incorporates the gender of the subject, the age of the subject, the systolic blood pressure of the subject, the blood pressure treatment status of the subject, the total cholesterol level of the subject, the HDL cholesterol level of the subject, the smoking status of the subject, the diabetes status of the subject, and the CVD event symptom status of the subject to derive the risk of atherosclerotic cardiovascular disease. When the risk meets a first threshold range or a first threshold, the pool cohort equation filter is considered to be activated. The computer system according to any one of claims 2 to 4.

11. The pool cohort equation filter of claim 10 further incorporates the status of the family history of juvenile cardiovascular disease. The computer system according to claim 10.

12. The first plurality of survey results further include whether the subject has ever had kidney disease. The second plurality of filters include a kidney disease filter. The computer system according to any one of claims 1 to 11.

13. The computer system according to any one of claims 1 to 12, wherein the plurality of second filters include Asian filters.

14. The computer system according to claim 13, wherein the Asian filter is activated when the plurality of first investigation results indicate that the subject is Asian.

15. The computer system according to any one of claims 1 to 14, wherein the cholesterol reduction is for treating or preventing coronary heart disease, cerebrovascular disease, peripheral arterial disease, or aortic atherosclerotic arteriosclerosis.

16. The computer system according to any one of claims 1 to 15, wherein the risk of atherosclerotic cardiovascular disease is a lifetime risk, a 5-year risk, or a 10-year risk.

17. The computer system according to any one of claims 1 to 16, wherein the pool cohort equation is implemented as a multivariable Cox proportional hazards regression.

18. The computer system according to any one of claims 1 to 17, wherein the statin pharmaceutical composition includes lovastatin, fluvastatin, atorvastatin, rosuvastatin, simvastatin, pravastatin, or pitavastatin.

19. The computer system according to any one of claims 1 to 18, wherein the over-the-counter drug information label specifies that the statin pharmaceutical composition includes rosuvastatin and that it should be taken by the subject at a predetermined daily dose of 2.5 mg to 15 mg per day.

20. The over-the-counter drug information label specifies that the statin pharmaceutical composition includes rosuvastatin and that it should be taken by the subject at a predetermined daily dose of 4 mg to 11 mg per day, or The computer system according to any one of claims 1 to 19, wherein the over-the-counter drug information label specifies that the statin pharmaceutical composition includes atorvastatin or simvastatin and that it should be taken by the subject at a predetermined daily dose of 10 mg to 25 mg per day.

21. The provision of the statin pharmaceutical composition to the subject includes shipping the statin pharmaceutical composition to a physical address associated with the subject, or The computer system according to any one of claims 1 to 20, wherein the provision of the statin pharmaceutical composition to the subject includes shipping the statin pharmaceutical composition to a pharmacy associated with the subject.

22. The pregnancy filter is activated when the first plurality of survey results indicate that the subject is pregnant. The liver disease or allergy reaction filter for the statin pharmaceutical composition is activated when the first plurality of survey results indicate that the subject has liver disease or has had an allergic reaction to the statin pharmaceutical composition. The risk of the atherosclerotic cardiovascular disease is a 10-year risk, and the first threshold of the pooled cohort equation filter is 7.5 percent. The total cholesterol level filter is activated when the first plurality of survey results indicate that the subject has a total cholesterol of less than 130 mg / dl or more than 275 mg / dl. The age filter is activated when the first plurality of survey results indicate that the subject is a woman 49 years of age or younger or 76 years of age or older. The computer system according to any one of claims 2 to 21, wherein the age filter is activated when the first plurality of survey results indicate that the subject is a man 39 years of age or younger or 66 years of age or older.

23. The risk of the atherosclerotic cardiovascular disease is a 10-year risk. The computer system according to any one of claims 2 to 21, wherein the first threshold of the pooled cohort equation filter is 7.5 percent.

24. The drug interaction filter is activated when the first plurality of survey results indicate that the subject is currently taking a blood thinner, warfarin, an HIV / AIDS drug, colchicine, a hepatitis drug, a cholesterol-lowering drug, itraconazole, ketoconazole, or fluconazole. The computer system according to any one of claims 3 to 23, wherein the alcohol intake filter is activated when the first plurality of survey results indicate that the subject consumes an average of more than 3 cups of alcohol per day.

25. When the provision of the statin pharmaceutical composition to the subject in the fullfillment process provides the statin pharmaceutical composition at a first predetermined dosage per day, and the risk derived by the pooled cohort equation filter is within a first threshold range, The computer system according to any one of claims 3 to 24, wherein when the provision of the statin pharmaceutical composition to the subject in the fullfillment process provides the statin pharmaceutical composition at a second predetermined dosage per day, the risk derived by the pooled cohort equation filter is within a second threshold range. **Claim 26** The statin pharmaceutical composition contains rosuvastatin, The risk of the atherosclerotic cardiovascular disease is a 10-year risk, The first threshold range is 5 percent to 7.5 percent, The first predetermined dosage per day is 4 mg to 8 mg, The second threshold range is 7.5 percent to 10 percent, The computer system according to claim 25, wherein the second predetermined dosage per day is 8 mg to 11 mg. **Claim 27** The method is f) In response to receiving a refill request for the statin pharmaceutical composition from the subject, (i) Conducting a second survey of the subject to thereby obtain a second plurality of survey results, wherein the second plurality of survey results include Whether the subject has experienced muscle irregularities since taking the statin pharmaceutical composition, Whether the subject is pregnant, Whether the subject is taking a drug that interacts with the statin pharmaceutical composition, and Whether the subject has had an atherosclerotic cardiovascular event or heart surgery since last ordering the statin pharmaceutical composition, and obtaining a second plurality of survey results including these. (ii) Applying all or part of the second plurality of survey results to a third plurality of filters, wherein when each filter in the third plurality of filters is activated, a warning corresponding to each filter is provided to the subject, and the third plurality of filters include The pregnancy filter, The muscle irregularity filter, The second drug interaction filter, and The atherosclerotic cardiovascular event filter, and applying them. (iii) If the refill process has not been completed, for each warning issued to the subject by any of the third plurality of filters, obtaining confirmation from the subject; (iv) (i) The refill process has not yet been completed by the operation of the filters in the third plurality of filters, and (ii) the subject has confirmed each warning associated with each filter in the third plurality of filters that has been activated and is associated with a warning, proceeding to the refill process, wherein the refill process storing an indicator of reordering of the statin pharmaceutical composition in a subject profile; communicating a commercial drug information label of the statin pharmaceutical composition to the subject; and upon obtaining confirmation from the subject that the commercial drug information label has been received and read, approving the offer of a reorder of the statin pharmaceutical composition to the subject, the offer of the reorder including approving the destination of the subject, further including proceeding, further including performing a procedure comprising the steps of any one of claims 1 to 26. The computer system according to any one of claims 1 to 26. [

28. ] The muscle irregularity filter is activated when the second plurality of survey results indicate that the subject has experienced unexplained muscle cramps or weakness since taking the statin pharmaceutical composition; The pregnancy filter is activated when the second plurality of survey results indicate that the subject is pregnant, resulting in the end of the refill procedure; The second drug interaction filter is activated when the second plurality of survey results indicate that the subject is currently taking cyclosporine, a blood thinner, warfarin, an HIV / AIDS drug, or a cholesterol-lowering drug. The computer system according to claim 27. [

29. ] A method for identifying a human subject for the distribution of a commercially available statin pharmaceutical composition for lowering cholesterol, the method comprising: a) performing a first survey of the subject, thereby obtaining a first plurality of survey results, the first plurality of survey results including a plurality of survey results selected from those listed in Table 1; obtaining; b) Applying all or part of the first plurality of survey results to a first plurality of filters of a first category class, wherein when each filter within the first plurality of filters is activated, the subject is considered not to be eligible for distribution of the statin pharmaceutical composition, and the method ends without distributing the statin pharmaceutical composition to the subject, and the first plurality of filters includes a plurality of filters selected from those listed in Table 2; applying; c) Applying all or part of the first plurality of survey results to a second plurality of filters of a second category class, wherein when each filter within the second plurality of filters is activated, a warning corresponding to each filter is provided to the subject, and the second plurality of filters includes a plurality of filters selected from those listed in Table 3; applying; d) Obtaining confirmation from the subject regarding the warning issued to the subject by any filter within the second plurality of filters; e) (i) If none of the filters within the first plurality of filters are activated and (ii) the subject confirms each warning associated with each activated filter within the second plurality of filters, proceeding to a fulfillment process, the fulfillment process including: storing an indicator of a first order of the statin pharmaceutical composition in a subject profile; transmitting a commercial drug information label of the statin pharmaceutical composition to the subject; and upon obtaining confirmation from the subject that the commercial drug information label has been received and read, approving the provision of the statin pharmaceutical composition to the subject, the approval including a destination associated with the subject; including, proceeding; including, a method.

30. A method for qualifying a human subject for distribution of a commercial statin pharmaceutical composition for reducing cholesterol, the method comprising: a) Conducting a first survey of the subject to thereby obtain a first plurality of survey results, the first plurality of survey results including a first plurality of survey results, the first plurality of survey results being sufficient to be applied to a first plurality of filters of a first category class and a second plurality of filters of a second category class; obtaining; ​ b) applying all or part of the first plurality of survey results to a first plurality of filters of a first category class, wherein when each filter in the first plurality of filters is activated, the subject is considered not to be eligible for distribution of the statin pharmaceutical composition, and the method ends without distributing the statin pharmaceutical composition to the subject, and the first plurality of filters includes a first plurality of sub-filters selected from the filters listed in a first reference table, and the first reference table is any one of Table 5, Table 6, Table 7, Table 8, or Table 9; c) applying all or part of the first plurality of survey results to a second plurality of filters of a second category class, wherein when each filter in the second plurality of filters is activated, a warning corresponding to each filter is provided to the subject, and the second plurality of filters includes a second plurality of sub-filters selected from the filters listed in the first reference table; d) obtaining confirmation from the subject regarding the warning issued to the subject by any filter in the second plurality of filters; e) (i) if none of the filters in the first plurality of filters are activated and (ii) the subject confirms each warning associated with each activated filter in the second plurality of filters, proceeding to a fulfillment process, the fulfillment process including: storing an indicator of a first order of the statin pharmaceutical composition in a subject profile; transmitting a commercial drug information label of the statin pharmaceutical composition to the subject; and upon receiving confirmation from the subject that the commercial drug information label has been received and read, approving the provision of the statin pharmaceutical composition to the subject, the approval including a destination associated with the subject; Claim 31 The first plurality of filters includes a pregnancy filter and a liver disease filter; The method according to claim 29 or 30, wherein the second plurality of filters includes a total cholesterol filter, a pooled cohort equation filter, an age filter, one or more personal history filters, and one or more drug risk interaction filters. Claim 32 A non-transitory computer-readable storage medium storing instructions that, when executed by a computer system, cause the computer system to perform a method for qualifying human subjects for distribution of a commercially available statin pharmaceutical composition for lowering cholesterol, the method comprising: a) conducting a first survey of the subject to obtain a first plurality of survey results, the first plurality of survey results including a plurality of survey results selected from those listed in Table 1; b) applying all or a portion of the first plurality of survey results to a first plurality of filters of a first category class, wherein when each filter in the first plurality of filters is activated, the subject is deemed not qualified for distribution of the statin pharmaceutical composition and the method ends without distribution of the statin pharmaceutical composition to the subject, the first plurality of filters including a plurality of filters selected from those listed in Table 2; c) applying all or a portion of the first plurality of survey results to a second plurality of filters of a second category class, wherein when each filter in the second plurality of filters is activated, a warning corresponding to each filter is provided to the subject, the second plurality of filters including a plurality of filters selected from those listed in Table 3; d) obtaining confirmation from the subject regarding the warning issued to the subject by any filter in the second plurality of filters; e) proceeding to a fulfillment process if (i) none of the filters in the first plurality of filters are activated and (ii) the subject has confirmed each warning associated with each activated filter in the second plurality of filters, the fulfillment process comprising: storing an indicator of a first order of the statin pharmaceutical composition in a subject profile; communicating the over-the-counter drug information label of the statin pharmaceutical composition to the subject; and When it is confirmed from the subject that the commercially available drug information label has been received and read, approving the provision of the statin pharmaceutical composition to the subject, the approval including approving including the destination associated with the subject, proceeding, and a non-transitory computer-readable storage medium.

33. A non-transitory computer-readable storage medium, which, when executed by a computer system, causes the computer system to implement a method for identifying a human subject for the distribution of a commercially available statin pharmaceutical composition for reducing cholesterol, the method comprising: a) Conducting a first survey of the subject, thereby obtaining a first plurality of survey results, the first plurality of survey results including the first plurality of survey results, the first plurality of survey results being sufficient to be applied to a first plurality of filters of a first category class and a second plurality of filters of a second category class; b) Applying all or part of the first plurality of survey results to a first plurality of filters of a first category class, wherein when each filter in the first plurality of filters is activated, the subject is considered not to be eligible for the distribution of the statin pharmaceutical composition and the method ends without distributing the statin pharmaceutical composition to the subject, the first plurality of filters including a first plurality of sub-filters selected from the filters listed in a first reference table, the first reference table being any one of Table 5, Table 6, Table 7, Table 8, or Table 9; c) Applying all or part of the first plurality of survey results to a second plurality of filters of a second category class, wherein when each filter in the second plurality of filters is activated, a warning corresponding to each filter is provided to the subject, the second plurality of filters including a second plurality of sub-filters selected from the filters listed in the first reference table; d) Obtaining confirmation from the subject regarding the warning issued to the subject by any filter in the second plurality of filters. e)(i) None of the filters in the first plurality of filters are activated, and (ii) if the subject has confirmed each warning associated with each filter in the activated second plurality of filters, proceed to the full fulfillment process, where the full fulfillment process store an indicator of the first order of the statin pharmaceutical composition in the subject profile; transmit the over-the-counter drug information label of the statin pharmaceutical composition to the subject; and upon confirmation from the subject that the over-the-counter drug information label has been received and read, approve the provision of the statin pharmaceutical composition to the subject, the approval including approving to include the destination associated with the subject, a non-transitory computer-readable storage medium including proceeding.

34. wherein the first plurality of filters includes a pregnancy filter and a liver disease filter; the second plurality of filters includes a total cholesterol filter, a pooled cohort equation filter, an age filter, one or more personal history filters, and one or more drug risk interaction filters, the non-transitory computer-readable storage medium according to claim 32 or 33.

35. A computer system for qualifying a human subject for the distribution of an over-the-counter statin pharmaceutical composition that reduces cholesterol, the computer system comprising one or more processors and a memory, the non-transitory instructions provided in the memory, a method performed when executed by the one or more processors, a) performing a first survey of the subject to thereby obtain a first plurality of survey results, the first plurality of survey results including the first plurality of survey results, the first plurality of survey results being sufficient to be applied to a first plurality of filters; b) applying all or part of the first plurality of survey results to a first plurality of filters, wherein when each filter in the first plurality of filters is activated, an event that restricts the distribution of the statin pharmaceutical composition occurs, the first plurality of filters including a plurality of filters selected from the filters listed in a first reference table, the first reference table being any one of Table 5, Table 6, Table 7, Table 8, or Table 9; c) (i) If none of the filters in the first plurality of filters are activated, or (ii) if all events restricting the distribution of the statin pharmaceutical composition are resolved, proceed to the full-fillment process, where the full-fillment process stores an indicator of the first order of the statin pharmaceutical composition in the subject profile, transmits the over-the-counter drug information label of the statin pharmaceutical composition to the subject, and when it is confirmed from the subject that the over-the-counter drug information label has been received and read, approves the provision of the statin pharmaceutical composition to the subject, the approval including the destination associated with the subject, and proceed, including, a non-transitory instruction including a method for implementing, a computer system.

36. Each filter in the first plurality of filters is of a first category class, and when each filter in the first plurality of filters is activated, the subject is considered not to be eligible for the distribution of the statin pharmaceutical composition, and the method ends without distributing the statin pharmaceutical composition to the subject. The computer system according to claim 35.

37. Each filter in the first plurality of filters is of a second category class, and when each filter in the first plurality of filters is activated, a warning corresponding to each filter is provided to the subject, before proceeding to the full-fillment process, the method implemented when the instruction is executed by the one or more processors obtaining confirmation from the subject about the warning issued to the subject by any filter in the first plurality of filters, and (i) if none of the filters in the first plurality of filters are activated, or (ii) if the subject has confirmed each warning associated with each activated filter in the first plurality of filters, proceeding to the full-fillment process. The computer system according to claim 35, further comprising.

38. The computer system according to any one of claims 35 to 37, wherein the first plurality of filters includes a pregnancy filter, a liver disease filter, a total cholesterol filter, a pooled cohort equation filter, an age filter, one or more personal history filters, and one or more drug risk interaction filters.

39. The first reference table is Table 5, The computer system according to any one of claims 35 to 38, wherein the first plurality of filters includes a pooled cohort equation filter that incorporates the gender of the subject, the race of the subject, the age of the subject, the total cholesterol level of the subject, the HDL cholesterol count of the subject, the systolic blood pressure of the subject, whether the subject is taking a drug that interacts with a statin, the smoking status of the subject, and the diabetes status of the subject to derive the risk of atherosclerotic cardiovascular disease. When the risk meets a first threshold range or a first threshold, the pooled cohort equation filter is considered to be activated.

40. The first reference table is Table 6, The computer system according to any one of claims 35 to 38, wherein the first plurality of filters includes a pooled cohort equation filter that incorporates the gender of the subject, the age of the subject, the total cholesterol level of the subject, the systolic blood pressure of the subject, and the smoking status of the subject to derive the risk of fatal cardiovascular disease. When the risk meets a first threshold range or a first threshold, the pooled cohort equation filter is considered to be activated.

41. The computer system according to claim 40, wherein the pooled cohort equation filter further incorporates the glucose level of the subject.

42. The first reference table is Table 7, The plurality of first filters includes a pooled cohort equation filter that incorporates the gender of the subject, the age of the subject, the systolic blood pressure of the subject, the blood pressure treatment state of the subject, the total cholesterol level of the subject, the smoking state of the subject, the diabetes state of the subject, the waist circumference of the subject, the geographical residence area of the subject, the urbanized residence area of the subject, and the family history of atherosclerotic cardiovascular disease, and derives the risk of atherosclerotic cardiovascular disease. When the risk satisfies a first threshold range or a first threshold, the pooled cohort equation filter is regarded as being activated. The computer system according to any one of claims 35 to 38.

43. The first reference table is Table 8, The plurality of first filters includes a pooled cohort equation filter that incorporates the gender of the subject, the age of the subject, the systolic blood pressure of the subject, the ratio of the total cholesterol of the subject to the HDL level, and the smoking state of the subject, and derives the risk of atherosclerotic cardiovascular disease. When the risk satisfies a first threshold range or a first threshold, the pooled cohort equation filter is regarded as being activated. The computer system according to any one of claims 35 to 38.

44. The first reference table is Table 9, The plurality of first filters includes a pooled cohort equation filter that incorporates the gender of the subject, the age of the subject, the systolic blood pressure of the subject, the blood pressure treatment state of the subject, the total cholesterol level of the subject, the HDL cholesterol level of the subject, the smoking state of the subject, the diabetes state of the subject, and the symptomatic state of CVD events, and derives the risk of atherosclerotic cardiovascular disease. When the risk satisfies a first threshold range or a first threshold, the pooled cohort equation filter is regarded as being activated. The computer system according to any one of claims 35 to 38.

45. The computer system according to claim 44, wherein the pooled cohort equation filter also incorporates the status of the family history of juvenile cardiovascular disease.

46. The computer system according to any one of claims 35 to 45, wherein the cholesterol reduction is for treating or preventing coronary heart disease, cerebrovascular disease, peripheral arterial disease, or aortic atherosclerotic disease.

47. The computer system according to any one of claims 35 to 46, wherein the risk of atherosclerotic cardiovascular disease is a lifetime risk, a 5-year risk, or a 10-year risk.

48. The computer system according to any one of claims 35 to 47, wherein the pooled cohort equation is implemented as a multivariable Cox proportional hazards regression.

49. The computer system according to any one of claims 35 to 48, wherein the statin pharmaceutical composition comprises rosuvastatin, fluvastatin, atorvastatin, rosuvastatin, simvastatin, pravastatin, or pitavastatin.

50. The computer system according to any one of claims 35 to 49, wherein the over-the-counter drug information label specifies that the statin pharmaceutical composition comprises rosuvastatin and should be taken by the subject at a predetermined daily dose of 2.5 mg to 15 mg per day.

51. The over-the-counter drug information label specifies that the statin pharmaceutical composition comprises rosuvastatin and should be taken by the subject at a predetermined daily dose of 4 mg to 11 mg per day, or The over-the-counter drug information label specifies that the statin pharmaceutical composition comprises atorvastatin or simvastatin and should be taken by the subject at a predetermined daily dose of 10 mg to 25 mg per day. The computer system according to any one of claims 35 to 50.

52. The provision of the statin pharmaceutical composition to the subject includes shipping the statin pharmaceutical composition to a physical address associated with the subject, or The provision of the statin pharmaceutical composition to the subject includes shipping the statin pharmaceutical composition to a pharmacy associated with the subject. The computer system according to any one of claims 35 to 51.

53. The first plurality of filters includes a pooled cohort equation filter, When the provision of the statin pharmaceutical composition to the subject in the full-fillment process provides the statin pharmaceutical composition at a first predetermined dosage per day, and when the risk derived by the pooled cohort equation filter is within a first threshold range, The computer system according to any one of claims 35 to 52, wherein when the provision of the statin pharmaceutical composition to the subject in the full-fillment process provides the statin pharmaceutical composition at a second predetermined dosage per day, the risk derived by the pooled cohort equation filter is within a second threshold range.

54. The method is d) in response to receiving a refill request for the statin pharmaceutical composition from the subject, (i) performing a second investigation of the subject, thereby obtaining a second plurality of investigation results, wherein the second plurality of investigation results include whether the subject has experienced muscle irregularities since taking the statin pharmaceutical composition, whether the subject is pregnant, whether the subject is taking a drug that interacts with the statin pharmaceutical composition, and whether the subject has had an atherosclerotic cardiovascular event or heart surgery since last ordering the statin pharmaceutical composition, obtaining a second plurality of investigation results including; (ii) applying all or part of the second plurality of investigation results to a second plurality of filters, wherein when each filter in the second plurality of filters is activated, a warning corresponding to the respective filter is provided to the subject, and the second plurality of filters include a pregnancy filter, a muscle irregularity filter, a second drug interaction filter, and an atherosclerotic cardiovascular event filter, applying; (iii) when the re-full-fillment process has not been completed, obtaining confirmation from the subject for each warning issued to the subject by any filter in the second plurality of filters; (iv) (i) the re-full-fillment process has not yet been completed by the activation of the filters in the second plurality of filters, and (ii) the subject is associated with each filter in the second plurality of filters that has been activated and is associated with a warning When each of the warnings is confirmed, proceed to the refill process, where the refill process includes storing an indicator of reordering the statin pharmaceutical composition in the subject profile, communicating the over-the-counter drug information label of the statin pharmaceutical composition to the subject, and upon confirmation from the subject that the over-the-counter drug information label has been received and read, approving the offer of a reorder of the statin pharmaceutical composition to the subject, the offer of the reorder including approving the destination of the subject, further including proceeding, including performing a procedure including proceeding, the computer system according to any one of claims 35 to 53.

55. The muscle irregularity filter is activated when the second plurality of survey results indicate that the subject has experienced unexplained muscle spasms or weakness since taking the statin pharmaceutical composition, The pregnancy filter is activated when the second plurality of survey results indicate that the subject is pregnant, resulting in the end of the refill procedure, The second drug interaction filter is activated when the second plurality of survey results indicate that the subject is currently taking cyclosporine, a blood thinner, warfarin, an HIV / AIDS drug, or a cholesterol-lowering drug, the computer system according to claim 45.

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