# US 12,002,558 B2 · Systems and methods for dispensing a statin medication over the counter > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,002,558 B2 - Document ID: US12002558B2 - Status: Granted - Kind: B2 - Application number: 17/898,115 - Filed: 2022-08-29 - Published: 2023-01-05 - Granted: 2024-06-04 - Earliest claimed: 2016-12-20 - Assignees: AstraZeneca UK Limited - Applicants: Astrazeneca UK Limited - Inventors: James Blasetto; Judy Firor; David Guiga; William Mongan; Robert Prybolsky; Richard L. Skelly - Web page: https://patentgrep.com/patent/US12002558B2 ## CPC - G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients - A61K 31/505: Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim - G16H 10/20: for electronic clinical trials or questionnaires - G16H 50/30: for calculating health indices; for individual health risk assessment - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract A method is provided for treatment of atherosclerotic cardiovascular disease in a subject in need thereof by administering a statin pharmaceutical composition to the subject when the subject is qualified for over-the-counter access to the statin pharmaceutical composition. In some embodiments, the statin pharmaceutical composition includes atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin as an active ingredient. ## Claims ### Claim 1 A method of managing cholesterol in a subject, the method comprising: at a computer system comprising one or more processors and a memory, the memory comprising non-transitory instructions which, when executed by the one or more processor, perform an algorithm comprising: a) receiving a request for a statin pharmaceutical composition; b) obtaining information, about the subject, comprising: an age of the subject, a gender of the subject, when the subject is female, whether the subject is pregnant or breastfeeding, a race with which the subject identifies, whether the subject is taking one or more medications that interact with the statin pharmaceutical composition, whether the subject has had an atherosclerotic cardiovascular event; data required by a pooled cohort equation that calculates a risk of the subject developing an atherosclerotic disease; whether the subject has liver disease, an alcohol consumption status of the subject, and whether the subject has had an adverse reaction to a cholesterol lowering medication; c) comparing all or a portion of the information about the subject against a plurality of filters, wherein the plurality of filters comprises a filter of a first type and a filter of a second type and, when a respective filter in the plurality of filters is fired by the comparing, the subject is deemed unqualified for delivery of the statin pharmaceutical composition when the respective filter is of the first type or the subject is provided with a warning corresponding to the respective filter when the respective filter is of the second type, and wherein the plurality of filters comprises: an age filter, a pregnancy filter, a drug interaction filter, an atherosclerotic cardiovascular event filter; a pooled cohort equation filter, a liver disease filter, an alcohol consumption filter, and an adverse reaction filter; and d) when each filter in the plurality of filters that is configured to deem the subject unqualified for delivery of the statin pharmaceutical composition when fired has not been fired: obtaining a corresponding acknowledgement from the subject for each respective warning associated with each filter in the plurality of filters that was fired in the comparing c) that is not configured to deem the subject unqualified for delivery of the statin pharmaceutical composition when fired, wherein the corresponding acknowledgment is confirmation that the subject has discussed the respective warning with a medical practitioner, and authorizing a provision of the statin pharmaceutical composition; the method further comprising: administering the statin pharmaceutical composition to the subject, upon authorization of the provision, to manage cholesterol in the subject. ### Claim 2 (depends on 1) The method of claim 1, wherein the information further comprises whether the subject, when female, is planning to become pregnant. ### Claim 3 (depends on 1) The method of claim 1, wherein the information further comprises whether the one or more medications that interact with the statin pharmaceutical composition includes cyclosporine. ### Claim 4 (depends on 1) The method of claim 1, wherein the information further comprises whether the atherosclerotic cardiovascular event includes having a heart procedure. ### Claim 5 (depends on 1) The method of claim 1, wherein the data required by the pooled cohort equation comprises: a total cholesterol level of the subject, an HDL cholesterol count of the subject, a systolic blood pressure of the subject, whether the subject is taking a high blood pressure medication, a diabetes status of the subject, and a smoking status of the subject. ### Claim 6 (depends on 1) The method of claim 1, wherein the plurality of filters further comprises a total cholesterol level filter. ### Claim 7 (depends on 1) The method of claim 1, wherein the algorithm further comprises communicating an over-the-counter facts label for the statin pharmaceutical composition to the subject before the authorization of the provision. ### Claim 8 (depends on 7) The method of claim 7, wherein the algorithm further comprises receiving confirmation from the subject that the over-the-counter facts label for the statin pharmaceutical composition has been received and read by the subject before the authorization of the provision. ### Claim 9 (depends on 1) The method of claim 1, wherein the authorizing d) further comprises storing an indication in a subject profile of the order for the statin pharmaceutical composition. ### Claim 10 (depends on 1) The method of claim 1, wherein the subject has a coronary heart disease, a cerebrovascular disease, a peripheral artery disease, or an aortic atherosclerotic disease. ### Claim 11 (depends on 1) The method of claim 1, wherein the age filter is fired when the information indicates that the subject is over the age of 75. ### Claim 12 (depends on 1) The method of claim 1 wherein, when the age filter is fired, the subject is provided with a warning. ### Claim 13 (depends on 1) The method of claim 1, wherein the pregnancy filter is fired when the information indicates that the subject is (i) pregnant, (ii) breastfeeding, or (iii) planning to become pregnant. ### Claim 14 (depends on 13) The method of claim 13, wherein when the pregnancy filter is fired the pregnancy filter deems the subject unqualified for delivery of the statin pharmaceutical composition. ### Claim 15 (depends on 1) The method of claim 1, wherein the drug interaction filter is fired when the information indicates that the subject is taking an HIV/AIDS medication, colchicine, or a hepatitis medication. ### Claim 16 (depends on 1) The method of claim 1 wherein, when the drug interaction filter is fired, the subject is provided with a warning. ### Claim 17 (depends on 1) The method of claim 1, wherein the atherosclerotic cardiovascular event filter is fired when the information indicates the subject has had a heart attack, a stroke, or a heart procedure, and when the atherosclerotic cardiovascular event filter is fired, the subject is provided with a warning. ### Claim 18 (depends on 1) The method of claim 1, wherein the pooled cohort equation filter is fired when the information indicates that the subject has a 10-year risk of atherosclerotic cardiovascular disease of less than five percent, and when the pooled cohort equation filter is fired the subject is provided with a warning. ### Claim 19 (depends on 1) The method of claim 1, wherein the pooled cohort equation filter incorporates the sex 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 medication that interacts with a statin, the smoking status of the subject, and the diabetes status of the subject to derive a risk for the atherosclerotic cardiovascular disease, and when the pooled cohort equation filter is fired, the subject is provided with a warning. ### Claim 20 (depends on 1) The method of claim 1, wherein: the liver disease filter is fired when the information indicates that subject has liver disease, and when the liver disease filter is fired the liver disease filter deems the subject unqualified for delivery of the statin pharmaceutical composition. ### Claim 21 (depends on 1) The method of claim 1, wherein the alcohol consumption filter is fired when the information indicates the subject consumes an average of three or more servings of alcohol per day and, when the alcohol consumption filter is fired, the subject is provided with a warning. ### Claim 22 (depends on 1) The method of claim 1, wherein the adverse reaction filter is fired when the information indicates that the subject has had an adverse reaction to a cholesterol lowering medication and when the adverse reaction filter is fired, the subject is provided with a warning. ### Claim 23 (depends on 1) The method of claim 1 wherein, the information further comprises whether the subject has a kidney disease, and the plurality of filters includes a kidney disease filter that is fired when the information indicates that the subject has kidney disease. ### Claim 24 (depends on 1) The method of claim 1, wherein the plurality of filters includes an Asian descent filter that is fired when the information indicates that the subject identifies with Asian descent. ### Claim 25 (depends on 1) The method of claim 1, wherein the statin pharmaceutical composition comprises lovastatin, fluvastatin, atorvastatin, rosuvastatin, simvastatin, pravastatin, or pitavastatin. ### Claim 26 (depends on 1) The method of claim 1, wherein the statin pharmaceutical composition comprises rosuvastatin and the subject is administered a daily dosage of from 4 mg to 11 mg, the statin pharmaceutical composition comprises atorvastatin and the subject is administered a daily dosage of 10 mg, the statin pharmaceutical composition comprises lovastatin and the subject is administered a daily dosage of from 15 mg to 25 mg, the statin pharmaceutical composition comprises simvastatin and the subject is administered a daily dosage of from 10 mg to 25 mg, the statin pharmaceutical composition comprises pravastatin and the subject is administered a daily dosage of from 10 mg to 80 mg, the statin pharmaceutical composition comprises fluvastatin and the subject is administered a daily dosage of from 20 mg to 40 mg, or the statin pharmaceutical composition comprises pitavastatin and the subject is administered a daily dosage of from 1 mg to 4 mg. ### Claim 27 (depends on 1) The method of claim 1, wherein, at least two of the filters in the plurality of filters deem the subject unqualified for delivery of the statin pharmaceutical composition when fired, and at least two of the filters in the plurality of filters provide the subject with a warning when fired.