Invented by James Blasetto, Judy Firor, David Guiga, William Mongan, Robert Prybolsky, Richard L. Skelly, AstraZeneca UK Ltd
The market for over-the-counter statins is driven by several factors. First, there is a growing awareness of the health risks associated with high cholesterol levels. High cholesterol levels can lead to heart disease, stroke, and other serious health problems. As a result, many people are looking for ways to lower their cholesterol levels without having to visit a doctor.
Second, there is a growing demand for convenience. Many people lead busy lives and do not have the time or inclination to visit a doctor for a prescription. Over-the-counter statins offer a convenient option for people who want to manage their cholesterol levels on their own.
Finally, there is a growing trend towards self-care and self-management of health. People are increasingly taking responsibility for their own health and are looking for ways to manage their health without relying on doctors or other healthcare professionals.
The market for systems and methods to dispense a statin over-the-counter includes a range of products and services. These include:
1. Automated dispensing machines: These machines are designed to dispense statins and other medications without the need for a prescription. They are typically located in pharmacies and other retail locations.
2. Online pharmacies: Many online pharmacies offer over-the-counter statins that can be ordered online and delivered to your doorstep.
3. Health apps: There are a growing number of health apps that offer advice and guidance on managing cholesterol levels. Some of these apps also offer over-the-counter statins that can be ordered through the app.
4. Health clinics: Some health clinics offer over-the-counter statins as part of their services. These clinics may also offer advice and guidance on managing cholesterol levels.
The market for systems and methods to dispense a statin over-the-counter is expected to continue to grow in the coming years. As more people become aware of the health risks associated with high cholesterol levels, and as more people seek out convenient and self-managed healthcare options, the demand for over-the-counter statins is likely to increase.
However, it is important to note that over-the-counter statins are not suitable for everyone. People with certain medical conditions or who are taking other medications may not be able to take statins. It is important to consult with a healthcare professional before starting any new medication, including over-the-counter statins.
In conclusion, the market for systems and methods to dispense a statin over-the-counter is a growing and important market. As more people seek out convenient and self-managed healthcare options, the demand for over-the-counter statins is likely to continue to increase. However, it is important to use these products responsibly and to consult with a healthcare professional before starting any new medication.
The AstraZeneca UK Ltd invention works as follows
A method for treating atherosclerotic cardiomyopathy in a subject who is eligible for over-the counter access to statin pharmaceutical composition is provided. The statin pharmaceutical composition may include atorvastatin or fluvastatin.
Background for Systems and methods to dispense a statin over-the-counter
Cardiovascular diseases remain the leading cause of death worldwide, killing more people than all other types of cancer combined. By 2030, the number of cardiovascular deaths will rise to 24 million per year. More than $316 billion in annual direct and indirect costs are incurred annually. This is more than the total gross domestic product (GDP), of all countries in the world, except for the top 30.
Statins have been a cornerstone treatment for heart disease since nearly three decades. There is no other evidence that cardiovascular disease can be reduced than statins. Statins remain the most commonly prescribed class of medicine.
Despite the fact many statins being generically available in the United States without a patent, it is still expected that cardiovascular disease will persist. This means that heart disease will not disappear. There are clear signs that the next generation will develop high-prevalence cardiovascular disease and will need assistance. While there are many novel treatments for cardiovascular disease, they will likely be used in combination with statins. Statins will continue to be the cornerstone treatment for cardiovascular disease in the future.
Unfortunately, long-term trends show that many people avoid prescription drugs, including statins. Statins can be made more accessible by being available over-the-counter (?OTC?) without the need for a prescription. Statins can cause severe adverse effects in some patients so it is important to carefully select and monitor the people who are receiving statins. Ramkumar S. et al., Acta Cardiol. Sin., 32(6):631-39 (2016). Statin distribution was traditionally controlled by prescription access. Prospective patients must self-select the medication in order to ensure safety. Recent research has shown that prospective patients are not paying enough attention to the guidelines on OTC drug packaging to ensure responsible and safe use. PR Newswire Association, “Americans Should Pay More Attention To Over-the-Counter Medicine Labels According to New Survey?”, Oct. 15, 2015 (citing McNeil Consumer Healthcare research). These studies show that 40% of potential patients view the directions only as guidelines, and that 80% of patients don’t re-read OTC medication labels they have already used. Worse, 58% of the men surveyed did not consider it important to read OTC labels.
There are currently two legal pathways that allow for the legal marketing of OTC drugs in the United States. The first pathway involves marketing in compliance with an OTC Drug Monograph. This sets the regulatory standards for nonprescription drugs not covered by human drug application. The FDA conducts a three-phase OTC drug review to create an OTC monograph. Phase I of the review is where an advisory panel decides whether the OTC composition proposed could be considered safe and effective for self-treatment. The second pathway involves marketing under an approved product-specific, new drug application (NDA) or an abbreviated, new drug application. A consumer research study is necessary to determine whether a label can be used to promote an over-the counter label for a drug that is subject to regulatory approval through an NDA. This is done based on the proposed labeling of the drug. Oliver, A., Regulatory Rapporteur. 10(3):4-9, 2013. This is incorporated herein by reference.
But, efforts to switch distribution of cardiovascular drugs that could have far-reaching benefits to society’s health from prescription-only to OTC models have failed repeatedly due to concerns about patient selection and medication. Statins that are used to lower cholesterol may be the most well-documented case.
The Background section contains information that is intended to enhance understanding of the invention’s general background. It should not be construed as acknowledging or suggesting that the information constitutes prior art known to someone skilled in the art.
Given the background, systems are required to qualify a human subject for delivery over-the-counter of statin pharmaceutical compositions to lower cholesterol.
The present disclosure addresses a need in the art to provide systems and methods for qualifying a subject for over-the-counter administration of a statin composition (e.g. a rosuvastatin prescription composition such as rosuvastatin Calcium) in order treat or prevent heart disease. The present disclosure provides systems and methods for the over-the-counter delivery of a statin composition to a subject. The subject is given an information set and the algorithm uses it. The algorithm compares the information set to a first plurality. The subject is not eligible for statin treatment if a filter is fired in the first plurality. The algorithm also compares the information against a second plurality. The subject receives a warning when a filter in the second plurality fires. When no filter from the first plurality has been fired, the method moves to a fulfillment step. The subject has acknowledged each warning associated each filter fired in the second plurality. The fulfillment process stores the composition, transmits to the subject a drug facts label for statin pharmaceutical composition, and authorizes the subject to receive the statin pharmaceutical composition upon confirmation from the subject that it has been read.
Accordingly, one of the aspects of the present disclosure provides a way to qualify a subject for over-the-counter delivery of a statin-based pharmaceutical composition. In order to determine a first set of information, the method involves completing an assessment survey. The first information set may include the following: the subject’s gender, age, and breastfeeding status.
The method also involves applying an algorithm to the initial information set. The algorithm compares all or part of the first set to a first plurality assessment filters. The subject is not eligible for statin treatment if a filter from the first plurality is fired. The procedure is terminated without authorizing the provision of the statin pharmaceutical composition. The first plurality may include a pregnancy filter or a severe drug interaction filter. In some embodiments, this includes one or more of the following: an age filter; a pregnancy filter; a total cholesterol filter; a HDL cholesterol and LDL cholesterol filters; a blood pressure filter; an atherosclerotic heart disease (ASCVD); risk pooled cohort equation filter; and a liver condition filter.
The algorithm also runs all of the information against a second plurality assessment filters. The subject receives a warning when a filter from the second plurality is fired. The second plurality includes one or more of an alcohol intake filter, a first adverse response filter, and a moderate drug interactions filter. In some embodiments, this filter also includes a moderate drug interaction filter. The second plurality, however, is not like the first plurality, which does not allow for the provision of the statin drug composition to the subject.
The process continues by obtaining acknowledgement from the subject for any warning issued by any filter in the second plurality. According to some embodiments, acknowledgment can be a written acknowledgment, a verbal acknowledgement or an electronic acknowledgment like an electronic signature.
The method continues by continuing with a fulfillment process until no filter in the first plurality has been fired, and the subject has acknowledged every warning associated with the filter in the second plurality that was fired.
In some embodiments, fulfillment includes the storage of an indication in a subject profil of an initial order statin pharmaceutical mixture, communicating an over the-counter drug tag for the statin pharmacy composition and authorizing, after confirmation from the subject that they have received and read the label, the provision of the statin prescription composition to the subject.
In some embodiments, the statin drug composition contains a active ingredient of Rosuvastatin (or a pharmaceutically acceptable sodium thereof) Some embodiments include rosuvastatin, a calcium active ingredient in the statin pharmaceutical composition. Some embodiments include an active ingredient from the group of atorvastatin (lovastatin), fluvastatins, pitavastatins, pravastatin and simvastatin.
The present disclosure, in one aspect, provides a method of re-qualifying subjects for over-the-counter provisions (e.g., subject previously qualified to receive a statin pharmaceutical component) of the statin medicinal composition. This optionally occurs with a method of qualifying the subject for an original order of the statin pharmacy composition. In order to get a second set of information, the method involves a subject re-assessment survey. The second information set may include the following: whether the subject experienced a documented heart attack since they last received the statin prescription composition; whether they are pregnant or nursing; whether or not the subject takes any compositions that interact the statin pharmacy composition; whether or not the subject has suffered from liver problems since their last statin pharmaceutical formulation provision; whether or not the subject has experienced muscle irregularities since receiving the statin composition pharmaceutical composition; and the subject’s alcohol intake.
The method also involves applying an algorithm to the second set. The algorithm compares the second information set to a first plurality re-assessment filter. The subject is not eligible for statin treatment if a filter from the first plurality is fired. The method is therefore terminated without authorizing the re-provisioning of the statin pharmaceutical composition. Some embodiments include one or more of the following: a heart event filter, cholesterol status filter, a pregnancy filter, severe drug interaction filter and a liver condition filter.
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