A Case Study on the Vigilance Project

Americans have access to and benefit from one of the most technologically advanced pharmaceutical systems in the world. However, this system is also very strict and tedious. The system this paper will evaluate is the United States Food and Drug Administration (FDA), more specifically, the FDA’s Center for Drug Evaluation and Research (CDER). Although, having access to this system can be frustrating to those that are in the pharmaceutical development industry or those that have illnesses and need the best drugs available in order to cope with their symptoms.

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.

When it comes to medication errors several things may occur such as adverse drug event, unexpected deterioration, and even death in severe cases. AHRQ (2015) states, “an adverse drug event (ADE) is defined as harm experienced by a patient as a result of exposure to a medication, and ADEs account for nearly 700,000 emergency department visits 100,000 hospitalizations each year.” There are many ways that errors may occur such as dispensary errors, prescription errors

2. Medication Error Reports. (2009). Food and Drug Administration. Retrieved May 19, 2013, from www. Fda.gov/Drug Safety/Medication Errors

Due to the large number of consumers being prescribed multiple medications, and the complexity of managing those medications, it is of a major safety concern that systems are in place for clinicians to reconcile patients medications to resolve any discrepancies in what the patient is using, or should be using, and newly added ones.

Throughout the readings communication was identified as a vital component for establishing and maintaining relationships. Porter-O Grady sanctioned for leaders to establish firm rules of engagement to help support a positive group dynamic (2013). While Kelly & Tazbir explained that friction and conflict were a normal part of group development and were representative of the Storming stage of group process (2014). Moreover, they explained that with assistance from the team leader the team can overcome these obstacles, strengthen inter-professional relationships, and enter into the Norming stage (Kelly & Tazbir, 2014). Here the team is able to participate in the effective exchange of communication and begin making progress toward goals. This represents progression into the Performing stage of group process (Kelly & Tazbir, 2014). When the team has met its intended target they are ready to anylze the outcomes of their work and enter the final stage of group process—Adjourning (Kelly & Tazbir,

Encourage the use of computer-generated or electronic medication administration records. Plan for the implementation of computerized prescriber order entry systems. Consider the use of machine-readable code (i.e., bar coding) in the medication administration process. Use computerized drug profiling in the pharmacy. Be a demanding customer of pharmacy system software; encourage vendors to incorporate and assist in implementing an adequate standardized set of checks into computerized hospital pharmacy systems (e.g., screening for duplicate drug therapies, patient allergies, potential drug interactions, drug/lab interactions, dose ranges, etc.)”. (Association,

Medication errors in the hospital setting have significant potential to result in serious injury and even death, thus effecting patients, families, health care professionals, and hospitals. Approximately 400,000 adverse drug effects (ADE) occur each year (Institute of Medicine, 2006). Considering that not all medication errors are discovered and reported, this number is likely to be underestimated. These errors not only contribute to patient morbidity and mortality, but also cause increased length of stay and hospital expenses. It is estimated by the Institute of Medicine (IOM) that $3.5 billion is spent annually as a result of ADEs (IOM, 2006).

research. (Grounder, 2013) Today pharmaceutical companies are held to a very high safety standard when it comes to marketing

Adverse drug events are the sixth leading cause of death in the United States and represent a significant financial burden to healthcare institutes at an estimated cost of $5.6 million per hospital per year (Meguerditchian N, Krotneva, Reidel, Huang, & Tamblyn, 2013). According to The Joint Commission (2006), medication reconciliation is the process of comparing a patient’s medication orders to all of the medications the patient has been taking. This reconciliation is done to identify and resolve medication discrepancies, which are unintended or unexplained

Drug mishaps initially happen to be of critics and detractors of all patients. Pharmaceutical errors and mistakes are preventable episodes that happen because of a blunder during the time spent endorsing, administering, and administrating. Extreme cases frequently prompt negligence claims. The danger variables for drug blunders is talked around and also proposed systems to control them. In the coming of innovation, the medicine organization environment is

Corporations and business organizations have to face lawsuits due to breach of different laws i.e., consumers laws, copyright laws, compensation laws, security laws, antitrust, employment or environmental laws. For violating any of these laws companies have to pay fines and even go bankrupt. Current paper is a report on one such lawsuit that caused GlaxoSmithKline loss of billions of dollars. The author selected "Avandia Lawsuit" to focus in this report. Avandia is a drug used to treat type 2 diabetes and was prepared by GlaxoSmithKline which was approved by U.S Government in 1998 and became best selling drug. Company generated profit through its sale but soon complains arose due to increasing incidences of heart disease and stroke as side effect of the drug.

They design the drug therapy protocol and indicate the appropriate dosage to use so that patients get the optimal outcome of the medication. Clinical assessments are vital to test the efficiency and the safety of an existing medication specifically through therapeutic drug monitoring. This practice is known to provide effective pharmacologic therapy though producing the maximum benefit of a drug which can remain longer period of time within the patients and have almost no toxicity that could cause harm to patients. This is why therapeutic drug monitoring in the field of pharmacy is essential enough to figure out an effective medication against a disease without any dangerous toxic actions involved to improve patients’ quality of life and hopefully find exceptional cures which is one of the pharmacists’

Pharm Universe is a global pharmaceutical organization that was established nine years ago. The company currently operates with 1,500 representatives across the globe and is headquartered in Boston, Massachusetts, USA. The company was founded after the success of work of a senior scientist in the line of business developing an alternative cure medicine for reducing the lung and other blood clusters. The new alternative medicine incredibly lessened the probability of clot occurrences.

PharMed International is one of the world’s largest pharmaceutical companies. It was established two years ago when ValMed and PharmCO merged. PharMed is obligated to keep detailed records of how its drugs perform by relying on sophisticated database such as the Vigilance which will be used by division employees around the globe. The core team responsible for designing and implementing Vigilance has three members in the United States: Frank Lanigan, Carol Reynolds, and Mike Powell; and four members based in France:Didier Amrani, Karine Bareaut, Merline Bucquet and Fabrice Lemaire. In addition to the core team, five subteams were formed. Overall, half of