Pharmacovigilance is defined as study and surveillance of post marketed drugs. The importance of pharmacovigilance is to ensure the safety of drugs consumed by patients. So, why U.S. Food and Administration (FDA) still surveillance post marketed drug even though, these drugs go through such vigorous review, follow strict procedures and standards that are in compliance with GMP established by FDA during clinical trials and also goes through CDER. The Center of Drug Evaluation and Research (CDER) is a part of FDA that is responsible for the safety and effectiveness of all drugs ranging from prescription drugs to over-the-counter, which includes; shampoo, deodorant, sunscreens, vitamins etc. The way the research and investigation at CDER works is that, there are different departments for types of products. For example; generic drug, clinical review, biotechnology products or therapeutics products. Not only, CDER is responsible for safety and effectiveness of the drugs but they also provide information on how to use the drugs safely and effectively for both healthcare professional and co...
The FDA was given the authority to approve pharmaceutical products for marketing in the U.S. as a result of the Federal Food, Drug, and Cosmetic Act, passed in 1938 (FDA par 2). In 1960’s, the agency issued final regulations for prescription drug advertising, which stipulated that these ads must not be false or misleading, present a “fair balance” of information describing both the risks and benefits of a drug, include facts that are “material” to the product’s advertised uses, and include a “brief summary” that mentions every risk described in the product’s ...
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
A blockbuster drug is the one which generates more than $1 billion of revenue for the pharmaceutical company that sells it each year."In the pharmaceutical industry, a blockbuster drug is termed as the one that achieves acceptance by prescribing physicians as a therapeutic standard for, most commonly, a highly prevalent chronic (rather than acute) condition. 'Blockbuster’ drugs play a key role in the pharmaceutical industry. However, discovery and development alone are not enough to create a blockbuster; the firms must be able to market the drug aggressively to achieve the potential gains from their innovation. A report from URCH Publishing estimated that one third of the pharma market is accounted for by blockbuster drugs by value. Between 2000 and 2005 drugs with more than $1billion in sales accounted for 28 to 36% of global sales changes in the sales of these drugs can cause large changed in a firms profitability .There are arguments that while many firms are capable of discovering and developing new drugs, only a handful of firms are capable of successfully commercializing a breakthrough innovation. This commercialization capability is what creates a blockbuster: without this capability, even a major innovation would not reach blockbuster status For example: Cimetidine was the first drug to reach a $1 billion target thus making it a blockbuster drug.
both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling
This assignment will discuss the professional, legal and ethical issues related to the self-use of medication by nurses. It will also explore the importance of reporting this misconduct by both professionals in the scenario and how they might do so. The self-use of medication by nurses is not allowed or justifiable according to the guidance provided to nurses by An Bord Altranais (ABA 2007). It will also be evident throughout this assignment the need for Jack to report Linda’s self-use of the medication or urge Linda to do so regardless of the consequences it may present to both him and Linda as according to Nurses and Midwifery Board of Ireland (NMBI 2013), nurses can now be held responsible for not taking action. This is because delivering the greatest level of care to a patient is an essential role of a nurse and the main focus of the nurse’s work should be on caring for that patient (ABA 2010). There is also an ethical duty upon both nurses to report the misconduct according to the four ethical principles; Beneficence, non-maleficence, justice and autonomy (Edwards 2009).
I pleased to apply to the PharmD program as the program is one area that corresponds to my career dreams. Being part of this program gives one the opportunity to gain an excellent experience in working and collaborating with various health care providers in the ward. But more importantly, it facilitates a practical environment in dealing more closely with patients. Hence, it helps to provide the ultimate health care services to patients. Also, it permits me to carry on gaining different knowledge, skills, and values in addition to those I have already developed during my undergraduate studies. My interest in being a clinical pharmacist was first aroused during my SPEP rotation in the hospital setting where I was really impressed with the role of clinical pharmacists who provide a consistent process of patient care with healthcare teams to maintain the appropriateness, effectiveness and safety of the medication use. Unlike a pharmacist, a clinical pharmacist has a more diversified responsibilities and closeness to direct patient care. Moreover, provides
The geriatric population is rapidly growing as individuals continue to benefit from medical advances and pharmaceutical treatments. A large number of this population will need to take some form of medication to maintain a functional lifestyle. Multiple medications can affect the elderly population differently than younger generations. This paper will discuss how polypharmacy impacts geriatrics and the will focus specifically on analgesics and antihistamines. It will also examine demographic factors, changes within the aging body, prescription and nonprescriptive medications, and the role of the nurse practitioner when caring for these patients.
Pharmacokinetics provides a basis to assess the course of drugs and their effects on the body (Dhillon & Kostrzewski, 2006). The processes of pharmacokinetics can be broken down into the absorption, distribution, biotransformation, and excretion in, through, and out of the body. These are major concepts that guide medication use and dosage selection (Association of Surgical Technologists, 2017).
The FDA most definitely has the important task to assure U.S. citizens the availability of safe food and drugs. This importance was realized by the men that worked toward moving it into legislation. The resultant agency continued to enforce its policies consistently into the modern century without a loss of momentum. However if the FDA is impaired by means of a governmental shutdown then it is of great importance to continue the consistency in food and drug standards that it holds. Standards that hold great importance today like the standards of the FDA’s initiation.
The rise in cost of prescription drugs affects all sectors of the health care industry, including private insurers, public programs, and patients. Spending on prescription drugs continues to be an important health care concern, particularly in light of rising pharmaceutical costs and the aging population. Prescription drugs have grown to become an essential component of health care. For millions of Americans, prescription drugs are necessary to their health and ability to function in society. While prescriptions are a relatively small portion of overall health spending, they are a main reason for certain health spending trends, growing almost twice as fast all other health services in recent years. Prescription costs can be the costliest expense in your budget, especially if you are on a fixed income. The wealthy can easily afford their medications, but for an increasing population such as the elderly, choosing among purchasing medication, paying bills, or buying food is a real concern.
For a drug to get to market it must go through several stages of research and development (Abbott and Vernon). Starting with discovery research, preclinical testing on animals, three phases of clinical trials on humans, and finally FDA (Food and Drug Administration) approval (Abbott and Vernon). Out of several thousands of drugs only a few will make it to the FDA approval stage (Abbott and Vernon). Testing is a highly regulated, time consuming, and expensive process. From beginning to end the process can take fifteen years and less than one of five compounds will make it to market where it is still not guaranteed to succeed (Abbott and
Prescription drug abuse has become a major epidemic across the globe, shattering and affecting many lives of young teenagers. Many people think that prescription drugs are safer and less addictive than “street drugs.” After all, these are drugs that moms, dads, and even kids brothers and sisters use. The dangers are not easily seen, but the future of our youth will soon be in severe danger if the problem is not addressed,it will continue to get worse if action is not taken soon. Prescription drugs are only supposed to be consumed by patients who have been examined and have a medical report by a professional, more and more teens are turning to the family’s medicine cabinet to “get high” but what they are actually doing is severely harming themselves, kids today are turning away from the street drugs and abusing the “prescribed” drugs that are that are at their very own home.
Prescription drugs do not always cause addiction, but a specific group of prescription narcotics can increase dependency on the medication and cause a severe addiction. For many people that become addicted to prescribed medicines, it changes their life forever. Prescription drugs are equally as dangerous as street drugs, if not more so. High powered pain relievers are safe if taken properly, but some people pop multiples a day which can cause coma and even death.
Do you know what FDA is? Do you know how effective it is? Do you know what it stands for? Do you know how it's useful in our community? Well keep reading and you'll find out. A simple definition of FDA is the responsibility of protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has to review, approve and monitor the safety in a timely manner. FDA sees that the public has access to truthful and non-misleading products.
Pharmacists play a key role in patient care and well-being. Not only do quality pharmacists dispense prescriptions to their patient’s, but they also consul them on how to get superior results. By maintain a thoughtful relationship and open communication with patients, pharmacists are able to best access their patient’s needs. As a pharmacist, it would be my goal to have that strong relationship with my patients. My dad personally struggled with taking his prescriptions, as most individuals diagnosed with severe clinical depression do. Clearly it is not his pharmacist’s fault my dad didn’t take his medication before it was too late. His pharmacist simply did his job. However, as a pharmacist, I would go above and beyond, the extra mile, to access