Risk Benefit Analysis : A Review

This report is submitted in partial fulfillment of requirement for MASTERS OF SCIENCE IN DRUG REGULATORY AFFAIRS RISK BENEFIT ANALYSIS- A REVIEW SUBMITTED TO Dr Jun-Yen-Yeh Subject: PHA653- Seminar in Social and Administrative Sciences Drug Regulatory Affairs Division of Pharmaceutical Sciences Spring 2015 Word count for Abstract: 149 Main text: 2763 Student name: Dewangi A. Kothari Student Id: 100493156 Date of submission: 23 Apr 2015 RISK BENEFIT ANALYSIS - A REVIEW Abstract: In order to ensure safe and effective use of human and veterinary drugs, biological products and medical devices around the world, health authorities all over the world perform an essential assessment- Risk benefit analysis (RBA). Risk benefit analysis is therefore a basis of regulatory decisions in the premarket and post market review process, thereby involving both qualitative and quantitative analysis with acknowledgments, arguments, claims, evidences, reasons and warrants supporting them. RBA framework basically involves essential elements that both regulatory authorities and pharmaceutical companies must consider throughout the development, review and pre and post marketing phase of medicines in order to have balanced approach during risk and benefit analysis. The aim of this article to understand what is basically the concept of risk benefit analysis and type of methods for analyzing risk and benefit of pharmaceutical product. This article also explains how important risk benefit

Introduction The twenty-first century has seen pharmaceutical companies grow in unprecedented size and strength. Due to the unprecedented growth the larger pharmaceutical companies have gained leverage and power in the prescription drug industry, but they lack innovation to market and they seek ways to help the business continue to increase its profits. The pharmaceutical industry was once ethically sound and was a valuable player in the development of human health. However, overtime with the lack of innovation pharmaceutical companies are becoming an unethical market that exploits patients, doctors and anyone else it can to increase its profitability. With eyes only on profitability this can create a hazard for patients because there

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References Byerly, W. (2009). Working with the institutional review board. American Journal of Health-System Pharmacy: AJHP: Official Journal Of The American Society Of Health System Pharmacists, 66(2), 176-184. Retrieved from http://library.kaplan.edu/content.php?pid=150035

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Following the guidelines by policymakers and the CDC to limit prescription of opioid medications, there have been numerous instances that highlight the pharmaceutical industry’s role in propagating initiatives that are contrary to these guidelines hence thwarting the fight against opioid abuse (Bement et al., 2014). The opioid pharmaceutical market is worth about $ 10 billion in sales annually which explains why the pharmaceutical industry would be reluctant in joining the fight against opioid abuse. The pharmaceutical industry perceives the fight against opioid use as a setback. As a result, the industry is constantly looking for measures to earn more profits by aggressively expanding the market for more drugs that are related to opioid use such that the answer to opioid addiction is to use more pills. The pharmaceutical industry is aggressively manufacturing alternative drugs to treat the side-effects of opioid use like constipation. Historically, the pharmaceutical industry has been accused of providing misleading information concerning the addictive features of some opioid medications which further frustrates the initiatives to stop opioid abuse since the addiction levels will be high for

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Opioid analgesics are the widely prescribed medications for both non-cancer and cancer-related pain. Opioid dugs provide significant benefit for patients, when they used for their approved indications. However, opioids are also carries the risk of abuse, misuse and death. In 2009, more than 15,500 people died in the United States due to overdose of narcotic pain relievers. In order to combat the opioid misuse, abuse, and addiction, FDA has taken many steps to address this problem over the last few decades. The task force’s multi- pronged approach targets, drug development, opioid labeling, prescriber education, patient education, exploring innovative packaging and storage to prevent abuse, encouraging the development of products that treat abuse and overdose and role of other agencies.

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FDA Drug Approval Process Tricia Garbuzovas COM/172 October 5, 2011 Cassandra Baker FDA Drug Approval Process Americans must wait up to 19 years after a discovered treatment before they can participate in benefits of a new medication (Philipson & Sun, 2008). The regulatory process drug manufacturers need to endure before releasing potentially life-saving medication is an extremely expensive, time-consuming process. The Center for Drug Evaluation and Research (CDER) is the main department of the Food and Drug Administration (FDA) responsible for the safety of drugs (both prescription and over-the-counter) sold in the United States (Food and Drug Administration, 2011). This department scrutinizes the testing of new drugs and

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* What are the risks involved? Technical risk, a large portion of all development costs are spent on drugs that never reach the market.

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Introduction: Since 2001, compounded drugs have caused more than 1,000 illnesses, and 87 deaths in the United States (cite 1). All of these unfortunate incidents were caused by errors during the manufacturing of compounded drugs, and in most cases, because of contamination. On the 25th of September 2013, the Drug Quality and Security Act, also known as H.R. 3204, was introduced, and three days later, was passed by the House of Representatives. On the 18th of November, this Act cleared the Senate. On the 27th of September, 2013, President Barack Obama signed the Drug Quality and Security Act into law (cite 2).

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Historically speaking, according to Narconon (2015), the issue of prescription drug abuse began in the 1800’s when consumers could self-prescribe medications such as cocaine and morphine. In the 1900’s, the Pure Food and Drug and Harrison Narcotic Tax acts were put into place as measures to control the sale and distribution of these substances (Narconon International, 2015). Today, the prescription drug problem continues to be a growing issue that has many consequences in our society.

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Subject: Identify one drug which has a controversial risk/benefit profile. Explain one aspect which makes this drug controversial.

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The scope of the drug development process is defined to prepare the audience to understand the role of regulatory affairs professionals. Responsibilities and roles of regulatory affair’s professional are explained and described in the presentation. However, the functional role of a regulatory affair professional in cross-functional area has not been included. Addressing the Importance of communication skills and experience can provide added incentive to the reader for personality or characteristic of the profession. The presentation is direct to the point and delivers basic understanding of the role to the audience. However, it can be expanded to include additional details such as educational prerequisite and job characters to describe the professional

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Prescription drug abuse and misuse is becoming a major public health issue in the United

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Approval and Regulation To better understand the issues associated with the prescription drug industry, it would first be best to understand their development and approval process. For a new drug to enter the market, it must first undergo a lengthy and often expensive research and development. Once a company submits an application for a new drug, it is their responsibility to provide the evidence showing its safety and effectiveness. Until they have undergone these criteria of guidelines and standards set in place, they will not receive FDA approval.

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Medical Ethics in Drug Trials Thousands of people voluntarily enroll in clinical drug trials every year. They are putting their health and safety at risk by participating in a drug trial. One would think they would be doing this to promote medical advancement, but in all actuality, it is for the

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