Risk Benefit Analysis : A Review

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

Due to these incidents and many severe cases of drug side effects that had happened in the past including deaths, the current way drugs are developed and approved are unethical. Therefore, reform in FDA’s management as well as the guidelines is necessary to strengthen safety standards and eliminate problems regarding drug development and regulation.

With access to prescription drugs, people are able to treat a multitude of diseases and illnesses. These drugs help deal with pain, inability to sleep, depression, and much more. Every day we are increasingly living in a world where there is better living through chemicals. However, what most do not seem to see is the rising tide of pain, illness, and ultimately death being caused by the pills people take every day. Most keep drugs in a special place in their minds, where they see them as harmless. Sadly, this is not the case, and in some cases our prescription drugs can be just as harmful as illegal drugs (King 68).

FDA’s Center for Drug Evaluation and Research (CDER) works to ensure that the drugs release in the market are safe to be used by general public. They evaluate prescription as well as non-prescription drugs for their safety effectiveness and quality. They review the drug before being marketed to improve overall health

Consult www.phrma.org, The Pharmaceutical Research and Manufacturers of America. What steps is the branded industry taking to address the

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.

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

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.

Product liability laws allow drug users to sue the manufacture, not the FDA, for any adverse drug reactions and side effects. While the FDA oversees drug safety, they do not ensure it. To avoid the costs associated with lawsuits and the risk of a bad name, drug companies do their best to fully, sometimes overly test products before release. “When product liability law attempts to ensure safety already assured by the FDA, prices may be inefficiently high due to liability costs that do not deter manufacturers from producing unsafe products” (Philipson & Sun, 2008, p. 86).

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

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).

In the same country where someone dies from accidental prescription drug overdose every 19 minutes, one must ask what is being done by the FDA to stop this. The answer to this is quite simple. Nothing. In the past thirty years, approximately 90% of all the new drugs approved by the FDA have had little to no advantages over existing drugs on the

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

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

Due to the fact that because drug trials were poorly regulated in the early 1970’s Phase I research was conducted on prisoners. The FDA was granted authority to monitor research that involved humans in the 1978; at which time, the FDA ordered each institution to devise an Institutional Review Board (IRB). The IRB was to generate and monitor the rules of the trials on all studies done within the universality. The IRB was comprised of faculty members who volunteered to evaluate their colleagues’ studies. Unfortunately, before 2005, FDA inspectors’ primary focus was on verifying the clinical trial data, not the human subjects involved in them.