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 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.
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).
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 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.
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.
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.
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
both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling
Medication is crushed and given with applesauce, (for those that cant sallow whole pills) while others are given the medication with water. Some won’t take the medication at all. Other patients refuse to bathe themselves. Resident #8, a white older man who was a very good attorney when he was younger had a stroke and now barely talks, but he will smile occasionally. Due to the stroke, he now has a lazy eye, and stares a lot. When nurse asked him “isn’t she beautiful,” (talking about me) he just smiled at me. Another Resident, #9, an older black women had a conversation with me; I asked her if she wanted to take a walk and she said “you can take a walk” – came off a bit strong at first and actually frightened me to continue talking to her as
When people go to their doctors, they trust that these medical professionals have the knowledge necessary to prescribe a medication that will have no harmful interactions with any current medications or have any dangerous side effects that will cause more harm than help. People don’t pick up drugs that they find sitting on the side of the street and just start taking them without knowing exactly what they are putting into their bodies; however it is a frightening reality that people are unknowingly ingesting unknown pharmaceuticals in their drinking water. Nearly seventy percent of Americans are on at least one prescription drug, and more than half take two, according to Mayo Clinic and Olmsted Medical Center researchers (Nearly 7 in 10 Americans).
Prescription drugs are killing more and more Americans every day by the thousands.Study shows that the number of deaths is rising dramatically because, of confusion, misuse,and abusing the prescription drugs.So due to all of the deaths caused by overdosing on prescription drugs, are they really helping in the medical field? And if so, why are doctors still prescribing these drugs if they know so many people overdose on them?
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
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