Personalised Medicine: A Case Study

When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the

A regulation exists to protect a patient’s safety – on its own it doesn’t mean that there is scientific evidence that a treatment is effective.

Patients Like Me (PLM) is a patient generated research network that strives to improve lives and a research platform in real-time that wishes to advance medicine. On this network, individuals can connect with other who has a common illness or condition, and they can monitor and share their own experiences. In PLM, the information progression data is generated about diseases that can help researchers, medical companies, pharmaceutical companies, and nonprofits, and helps create a more effective care, products, and services. Patient experience with treatments and medication are gathered, which allows treatment efficiency and any side effects to be measured and recorded. If People Like Me were to grow without a General Platform, then the network must continue to add on other niche communities as the group has done in previous

The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing. The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations. Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships.

First, the medical assistant should convert the doctor’s prescription into layman’s terms for Doris. Medication A is two teaspoons by mouth every four hours. Medication B is 2.5 milliliters by mouth three times daily (Fulcher, Fulcher, & Soto, 2012, p. 1b). Doris should be cautious of confusing her medication dosages as that could lead to possible overdose. If Doris is afraid of mixing her medications, the medical assistant should convert to the unit that Doris is more comfortable with. For example, if Doris prefers milliliters, she should take around 9.8 milliliters of medication A. Alternatively, medication B could be taken at .5 teaspoons (Fulcher, Fulcher, & Soto, 2012, p. 131). Patients taking multiple medications should have a medication

Personalized medicine can lead to the development of great discoveries that could revolutionize the world. The research of personalized medicine is new and costly but that is not the only setback this new science must face. Personalized medicine has also presented issues of race and gender that cannot be silenced until further research is conducted. It is clear that personalized medicine could provide great benefits for fighting illness, but it can lead to issues of underrepresentation of race and concerns of gender in terms of drug safety and with the little that is known right now the cost outweigh the benefits.

A review of the records reveals the member to be an adult female with a birth date of 03/14/1983. The member has a diagnosis of Generalized Anxiety Disorder. The member’s treating provider, Vickki-Ann Samuel, MD recommended the member continue treatment using the prescription medication Pexeva 30 mg.

For patients that have previously misused medication or are predisposed to addiction, opioids are not always an option for pain management. In this case, doctors use MATs, Medication Assisted Treatment, which offers a plan in order to treat addiction and offer pain relief at the same time. By offering sufficient amounts of dosage for an acceptable duration, MATs increase the length of abstinence in these patients. It has also been proven that, “MAT interventions also suppress withdrawal symptoms, extinguishing cravings, and block the reinforcing effects of the abused opioid agents” (Leahy). Buprenorphine is prescribed to women that are pregnant and is often the most popular of MATs, for it does not react with other drugs, allowing doctors

According to Madicaid.gov (2016), “Managed Care is a health care delivery system organized to manage cost, utilization, and quality. Medicaid managed care provides for the delivery of Medicaid health benefits and additional services through contracted arrangements between state Medicaid agencies and managed care organizations (MCOs) that accept a set per member per month (capitation) payment for these services.”

There are many methods in which providers are reimbursed for services. Some of these methods are:

Firstly, our current pharmacare system does not provide access to individuals who need prescription drugs and are unable to afford it (Morgan, Daw and Law 2014). Prescription drugs are inputs into the broader health care system. As such, if prescription drugs are taken on time, this allows the healthcare system to meet patient health needs (Morgan, Daw and Law 2014). Secondly, our current pharmacare system does not ensure that the financial costs associated with necessary medicine are equally distributed (Morgan, Daw and Law 2014). Unequal distribution of the costs of necessary medicine can further drive income inequality (Morgan, Daw and Law 2014). Also, employers are under no obligation to continue providing private insurance for their employees

With the use of our ever-growing genetic understanding, we are rapidly moving towards personalised cancer treatment. The availability and affordability of technologies allowing us to gain a comprehensive molecular characterisation of tumours and one’s own genetic make-up, brings personalised medicine right into the forefront of cancer treatment. Personalised medicine promises to be a potentially revolutionary new form of cancer treatment, with the use of indicators such as discrete genes and proteins to differentiate one cancer type form another and enable the use of targeted therapies. Throughout this project I explore exactly what personalised medicine is and investigate the opportunities and challenges that accompany its potential to be next new form of cancer treatment.

The U.S. Food and Drug Administration (FDA) is responsible for protecting and promoting public health through regulating pharmaceutical drugs, biologics and medical devices in the context of granting approvals for marketing authorization, surveillance of the clinical trial study of the drug, and post-marketing surveillance of the medical product. Pharmaceutical companies seek FDA approval for a new drug to be marketed which entails a long process. This process starts with submitting an application known as an investigational new drug application (IND) to start clinical trials to enroll a group of patients believed to benefit from the investigational product, and to approve that the drug is safe and effective.

The book The Personalized Medicine Revolution: How Diagnosing and Treating Disease are About to Change Forever is an interesting journey through the evolution of our scientific knowledge and subsequent technologies followed by a final foray into the most current accomplishments in personalized medicine and where it’s going.

The information put forth in this TED talk was regarding the manner treatment of disease was approached. But to discuss the future of medicine, he begins with addressing the past. The prior and current model has a downward motion and is “so profoundly simple is can be summarized in 6 words: Have disease -> Take pill -> Kill something” (TED 2015). This method has been dominant since the 1950’s because of the antibiotic revolution stemming from the introduction of antibiotics into the United States which took place over 100 years ago. The mechanism under which antibiotics function is likened to a lock and key and the specificity of the lock and key mechanism was so exquisite that fatal or lethal diseases, such as tuberculosis or pneumonia,