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Dangers Of Off-Label Advertising
"Off–Label" Marketing
Introduction
Pharmaceutical companies are receiving negative allegations due to the "off–label" advertising of drugs. The Federal and Drug Administration require
strict regulations for the use of "off–label" drugs in the pharmaceutical industry. "Off–label" practice of drugs are not prohibited, however, promoting
the drugs are illegal. The concern of effective treatment is weighing the benefits and risks of "off–label" drugs for the best interest of the patient. In
addition, companies who fail to comply with the FDA regulations, face consequences such as costly fines as well as criminal issues. Pharmaceutical
companies often settle with the government, due to lack of proper procedures, complying with public health agencies. Modifying the policies of
pharmaceutical companies with a different approach will limit the misuse of "off–label" drugs (Ghillyer, 2014). ... Show more content on
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"Off–label" drug promotion "Off–Label" drug prescribing is a common practice throughout the medical field. "Off–label" drugs are FDA approved
drugs for unapproved uses on the label. The "off–label" drug prescribing is based on the physicians' judgement of the "off–label" drug that will benefit
the patient and not harm them. Conversely, "off–label" drug promotion is prohibited by the FDA, in regards, to lack of scientific study on efficacy and
safety. Additionally, pharmaceutical manufacturers can only discuss the information on the label of the drug and anything other than that is considered
"off–label" promotion (Samolla,
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The Paradox of Choice
It all comes down to one question. Is it better when you have more choices or when you have fewer choices? Most people would answer more
choices as they would feel less limited because it is common to associate having more choices with having more freedom and having more freedom
with having more welfare. In fact, this is not always correct as you may not have enough knowledge to know which may be the most beneficial to you
in the long run. This is turn relates to what is best known as the paradox of choice because we may think we have more but in reality we have less and
find ourselves in a far more complex situation. The paradox of choice explains in depth how certain individuals and societies are affected when the
matter of choice comes ... Show more content on Helpwriting.net ...
Medical centres are now much more helpful than before by offering many solutions to individuals (Gillespie). This is actually seen as an advantage
to patients because they will have more awareness in terms of how serious their illness is and doctors are now able to list many more treatment
options to patients than before giving patients the freedom to choose the treatment they want to undergo. In turn, most people don't know what is
best for them and they can end up choosing a certain type of treatment which can end up causing another sickness that can be fatal due to side
effects (Iyengar). The advertisement of prescription medicines is also a great contribution to such a situation because individuals look at how good
the advertisements look and assume that taking the certain prescription medicine being advertised will be the solution to their problem. This then
causes doctors to be persuaded into writing prescriptions for their patients to have their desired medicines. Yet again this is another example of
freedom of choice which is what people want because they will feel even better by being able to choose what medicine to take. As a result, some
individuals can actually be lucky and successfully treat themselves but many end up aggravating their health by trying medicines that can cause a
negative response on their bodies. In the modern world, people now have the flexibility to work whenever they want and in almost any location
(Salecl). This is a big
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Off Label Research Essay
The United States Food and Drug Administration (FDA) drug approval process requires clinical trials that demonstrate efficacy for a specific
indication prior to market availability. Once approval for an indication is given, however, the FDA has a minimal role in determining whether drugs
are prescribed for their approved uses or for other "off–label" indications not part of the FDA–approved product labeling. Prior studies of off–label
prescribing have typically been conducted in narrowly defined clinical contexts, including psychiatric disorders,1,2 bacterial infections,3 in children2,4
as well as in "orphan" clinical conditions not well served by FDA approved drugs.5,6 These studies have demonstrated that off–label use is frequent in
these clinical areas, that such uses arise from diverse circumstances, and that there is substantial variation in the available evidence supporting
particular off–label uses. Notably, while raising some concerns about off–label use, the studies also... Show more content on Helpwriting.net ...
Although several drug classes, including anticonvulsants, antipsychotics, and antibiotics, were associated with a higher frequency of off–label use,
other drug characteristics such as manufacturer, and annual sales levels did not predict the likelihood of off–label prescribing. While this study
highlighted the magnitude of off–label drug use in the absence of evidence regarding efficacy, it made no attempt to define the level of concern
associated with specific drugs. We sought to build upon these studies to develop a systematic process for prioritizing future federally sponsored
research and policy initiatives regarding off–label drug use based on the concept of value of
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Off-Label Lawsuits In A Pharmaceutical Company
Ghillyer (2014), explains that how organizations are operated and controlled as corporate governance. Pharmaceutical companies have been the focus
of questionable conduct in regards to corporate governance for years. Unlawful promotions and marketing of drugs as well as failure to properly and
accurately report safety date led to several off–label lawsuits (Ghillyer, 2014). According to Ghillyer (2014), medications and drugs have many uses
that are often not approved by the Federal Drug Administration. In 2012 Abbott Laboratories were involved in a lawsuit related to illegal marketing.
The company promoted a medication to control and treat agitation, aggression, and schizophrenia. The medication had only been approved for
treatment of seizures, migraines, and bipolar mania. GlaxoKline–Smith was also involved in a settlement regarding off–label promotions for marketing
Wellbutrin for weight loss, sexual dysfunction, substance addiction, and behavioral... Show more content on Helpwriting.net ...
It is a benefit versus risk gamble that these companies take. An example: marijuana is a plant that is medically proven to reduce nausea. Long–term use
has not been evaluated, and it is illegal in most states. However, people continue to utilize it for its alleviating benefits despite the risk of not being
approved by the Federal Drug Administration. The Federal Drug Administration struggles to have control over the legalization of marijuana. The battle
of getting marijuana legalized for medical purposes is a struggle that some states will continue to fight against the Federal Drug Administration. The
argument that has been made is that one may benefit from marijuana for medical uses. Some patients have had beneficial results from marijuana, and
they prefer to use the drug instead of over the counter medication or treatment (Berg,
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Sample Case Conceptualization And Nursing Case Study Patricia
Patricia is an 84–year–old female who is diagnosed with metastatic colon cancer (C18.9). She also suffers from anemia. Patricia underwent a right
hemicolectomy and a partial omentectomy, with noted bulky adenopathy at the base of the mesentery again, this proved to be moderately differentiated
adenocarcinoma with mucinous features with venous, lymphatic and perineural invasion present. 22/32 lymph nodes were involved with cancer,
margins were negative, pathologically this was a T3 N2b cancer. Patricia was treated with 5–FU and leucovorin but still experienced disease
progression, with adverse side effects and found to have metastasis to the liver and bone which is KRAS and NRAS wild type. Patricia is currently on
Erbitux weekly. She is malaise,
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A Social Learning Approach For Prescription Drug Misuse...
A Social Learning Approach to Prescription Drug Misuse Among College Students takes a socio–theoretical approach to prescription drug misuse
(PDM) among college students in the US by examining the issue through Aker's social learning theory (Watkins 2016). Watkins emphasizes the
legitimacy of the problem by citing relevant statics that illustrate how prescription drug misuse has shifted from a minor trend to a growing public health
issue (ibid). As well, there is evidence that obtaining prescription drugs from peers correlated with a higher frequency of alcohol consumption and
substance use (ibid). It is necessary to examine this issue through a socio–theoretical lens, as the paper makes case for how the social relations behind
PDM give insight into patterns behind their use (ibid). For example, Watkins notes a study that determined that drugs purchased illicitly (unfamiliar
source) are more likely to be misused compared to prescription drugs obtained for free from a relative or peer (ibid).
Watkins examines PDM through Aker's 'Social Learning Theory', a theory that examines how deviant behaviours are created through social feedback
from ones environment (Deutschmann 2007;Watkins 2016). He justifies this as an apt theoretical approach for examining PDM among college
students, as the college lifestyle tends to replace one's family as the primary influencers of one's behaviour (Watkins 2016). Overall, Watkins offers a
comprehensive explanation of Aker's socio–theoretical
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Natural Label Remover Research Paper
Common Examples of a Natural Label Remover Tool Natural things are great. It is a wonderful alternative we can have as we live our daily lives.
It became a way we could reminisce how our ancestors managed to live their day to day encounter only with natural stuffs. These days, their ways
seemed to be extinct. However, there are some natural things used these days. But, it takes you to discover them even more because they are
somehow modernized. A label remover tool is one of them. It has a lot of options you can choose from in doing so. There are little known tricks in
using common items in removing labels. Find out more in the following. Washing it with water with dish soap. You could use this in two ways.
Preparing water with dish soap... Show more content on Helpwriting.net ...
Due to the appearance of oils, it has become a wonderful alternative in peeling off the label you see on your product. It is important that you
determine which kind of oil you have easier access with. Knowing this would narrow down the choices you have to choose from. However, the
most common is the use of baby oil and cooking oil. Alcohol. You may see a lot of types of this in varying percentages. Whatever kind you would
like to choose, it always does the same superb job in removing what you wanted to come off so badly. It could serve as a solution you could use in
solving the dilemma you have in making the label come off from the thing it sticks on. Vinegar. This also has some kinds. However, it is important
for you to understand that all of its types are good in helping you out getting rid of the stubborn sticky side which usually was caused by the price
sticker placed by most stores. Using vinegar, especially the one called, the apple cider vinegar, it does a great miracle in taking that stubborn paper
off. Therefore, these are only a few of the common examples you can use as tool for the removal of that annoying sticky label. With the knowledge of
these things, you shall be able to effectively take off the unwanted with ease. So, dont delay. Try it now. Get ready to be
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Medication Off Label Is A Patient Right
Medications off label is a patient right. The Brazilian pharmaceutical market is the ninth largest in the world and the second among the BRIC
countries (First is China, with Russia and India occupying third and fourth), annually handling about R $ 28 billion, a growth trend. Among the
six largest pharmaceutical companies in the world, four are Brazilian. Currently there are about 540 pharmaceutical companies registered in
Brazil. The growth of this sector, in general, has been remarkable and very favorable to patients. The high investment in research and development
of new drugs allowed disease very recently (from a historical point of view) taken by incurable or high mortality rate may gradually being
controlled by the use of drugs and. In some cases, this evolution walks to the discovery of a cure. AIDS may be cited as notorious example,
emerged in Brazil in the early 80s, with a high rate of mortality and suffering, and "only" 16 years later, it became a disease that through the drugs
allow the infected person lead a normal life, "in a chronic and controllable way". However, according to economic data released by the Association
of Pharmaceutical Research (Interfarma) in Brazil they invested just over $ 139 million in research, while in the world they invested $ 40 billion.
Brazil 's participation in clinical trials worldwide is 1.2%, and the time taken for approval of a clinical trial in Brazil is between 10 and 14 months.
Between 2005 and 2009 the international patent
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The Legal And Ethical Implications Associated With...
I aim to explain the drug development process, to explore the legal and ethical implications associated with wrongful off–label prescribing, and provide
my recommendations for reform of the pharmaceutical industry. I will consistently refer to the GlaxoSmithKline case to display the maleficent inner
workings of the multinational pharmaceutical company. Glaxo was involved in the biggest health care fraud settlement in U.S. history for introducing
and encouraging physicians to off–label prescribe their patients six misbranded drugs, Paxil, Wellbutrin, Advair, Lamictal, Avandia and Zofran.
Kickbacks were paid to physicians that prescribed those drugs but also for the drugs Imitrex, Flovent, Lotronex, and Valtrex. Glaxo also failed to
report safety data to the Food and Drug Administration (FDA) for Avandia, a diabetes drug. I find this issue to be so important because I hope to
pursue a career in health law. My health policy major and relevant coursework ignited my interest in the legal issues strewn throughout our health care
system. The United States Pharmacopoeia (USP) was established to set the standards for the manufacture, nomenclature, indications, and chemical
characteristics of drugs and continues to do so today. In 1938, the Pure Food and Drug Act created the FDA, to ensure the, "safety, efficacy, and
appropriate labeling and advertising of pharmaceutical products before approving them for sale" (Blum, 2002). Prescription drugs are developed and
both pre–clinical and
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The Controversy Of Animal Welfare
"Hormone–free", "organic", "grass–fed", and "natural" are labels that animal and plant producers use to inform consumers of what they are eating.
These claims are misleading and usually increase the prices of those products. By increasing the price and sticking a label that reads "natural" makes
consumers think that this product is better for them. Animal Welfare Approved gives an example of an egg carton boasting the statement that its eggs
are "natural." This statement can legally come from an industrial farm where the hens do not forage the way a chicken does "naturally." According to
the USDA, farms have to get organic certifications and accreditations in order to sell, label, and represent their products as organic. It is difficult to
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Business Ethics
Business Research Ethics
"Ethics are norms or standards of behavior that guide moral and choices about our behavior and our relationship with others" (Cooper & Schindler,
2011, p.). When a business conducts a research, the business uses ethics to guarantee that no individual will be hurt or suffers from the consequences
from the research. When a business is planning a research, some of the ethics a business must consider are to: protect the rights of the individual,
follow the ethical standards, and to ensure that the information that is acquire is ethical. The purpose of the research is not to allow any type of
physical harm, discomfort, pain, embarrassment, and the loss of privacy (Cooper & Schindler, 2011). According to "Copper... Show more content on
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Without requiring drug companies to publish all of their safety data, these companies can submit information that only provides only what seems to be
positive data and hide the negative data. "Pharmaceutical companies can manipulate their own trial data to manufacture good results" (Benson, 2010).
In a legal case against Neurontin, Pfizer and Parke–Davis used some strategies to cover up some unfavorable findings from their research. When their
strategies were uncovered in 2008, Pfizer and Parke–Davis detained reports where it proved that there was no evidence of the drug's efficacy, their
negative data was reinterpreted, and the grouping of negative and positive studies to counterbalance the results. According to "Ramirez de Arellano"
(2009), "In some cases, legitimate researchers saw their findings rewritten and recast to, in the words of one of company's medical writer, to make
[the overall picture] sound better than it looks on the graphs." Pfizer and Parke–Davis were skewing information on off–label uses of Neurontin. They
manipulated their data to support their findings, and failed to report any negative outcome from their findings. When pharmaceutical companies skew
or manipulate their findings on a drug, people who take Neurontin for off–label uses are endangering their lives. The FDA does not approve Neurontin
for off–label uses because Pfizer and Parke–Davis cannot prove the
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Off Label Drugs Use
Off–Label Drugs Use is using a medication to treat a disease condition other than what it's approved for by drug regulatory agencies. Abdulah et al.
(2015) documented that "Pharmacotherapy is usually based on drugs that are approved for a specific indications, dosages, and routes of administration
or population. However, this does not preclude the use of the medicine outside of those terms" (pg.470). Although, the use of unapproved medications
are common and legal without controversies (Mayhew, 2009). However, adequate precautions should be taken not to administer overdose due to
immaturity or weakness of the excretory organ. Also the off–label drugs can be use only if approved medication has been used without any therapeutic
relief or an adverse... Show more content on Helpwriting.net ...
2015). So many strategical methods can be applied to achieve a safety use of the off label medications, such as collaboration of the regulatory
agencies, the provider/prescribers and the pharmaceutical companies in determining a common and safe guideline. Also, using the patient's height and
weight to calculate appropriate dosage needed. In addition, a small starting dose should be prescribed and increased dosage gradually as tolerated as
long as the liver and kidney functions are within normal range. Finally, parents should be instructed to stop the medication and report to the health care
provider once an adverse reactions are
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Neuroenhancing Drugs Analysis
In a society where quantity of work overpowers quality of work, there is no wonder why "neuroenhancing" drugs such as Adderall and Ritalin are on
the rise of consumption. As more people adopt the idea that these drugs are cognitively beneficial; the more they secretly use them for non–medical
reasons. Margaret Talbot, a writer for The New Yorker, looks more into this problem in her article, "From Brain Gain: The Underground World of
"Neuroenhancing" Drugs". Throughout this article Talbot focuses on a new trend of drug use, such as Adderall and Ritalin, for non–medical intentions.
She focuses mainly on the increase of drug use by scholars and public intellectuals throughout her article. Talbot successfully proves to her audience
that non–medical... Show more content on Helpwriting.net ...
Through the use of logos Talbot first makes clear the concerns she has for the purposes for using these drugs. In paragraph 7 she lists all the symptoms
that drugs like Adderall could cause; some of which include nervousness, headaches, sleeplessness, and the even have a high potential for abuse. Talbot
warns the readers that using drugs in this type of manner could ultimately harm them in the long run. She stresses that the way society focuses more on
taking these drugs to help complete work rather than . To help with this she also uses anecdotal evidence throughout her summaries of each of her
interviews. She picks what kind of things to put in the essay and only uses the part of the interviews that make her argument
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Persuasive Essay On Off Label Drugs
Greg a 14–year–old boy living with his parents in the basement. He has to take these off label prescription drug. An off label prescription drug is a
drug that isn't prescription by a doctor or pro. Greg could find these drugs on the streets or even with his family members. Be sure to take your drugs
to a doctor and get them copied and your drugs. Greg is taking these drugs to feel better but he doesn't know if they should be off labeled by a pro or
just somebody else. When off label drugs were in the 1980's it is different than today. It's different because the drugs used back then were, just for
pain. But today we use drugs to get better with an illness or disease. Off label drugs has been used since the 1980's, supporters and no supporters argue
if off label drugs are a good thing or not. This is what the doctors did in the 1980's, there was one problem; the drugs had been tested on and approved
for people with severe arrhythmias ("off label"). It took a long time for people to stop prescribing these drugs because they just couldn't believe it and
killed over 50,000 people in ... Show more content on Helpwriting.net ...
The first reason is Many people with cancer have to take these if they want to survive or get better ("Off Label Drugs"). Every other kid gets to live
by a single drop of this prescribe drug. 85% of kids survive these conditions (Gulfo 4). That companies have the right to market their products to doctors.
FDA announced that there were important public policy reasons for allowing manufactures to disseminate truthful and non–misleading medical journal
articles ("Off Label Drugs"). Some doctors who support off label drugs prescribe say that it actually helps when companies that do the work and not
doctors ("off label"). The doctors should be the people that save people's life and makes kids great and healthy again, not the people that put drugs on
markets that people can
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The Techniques Of A Good Design
A good design makes the document attractive and easier to read. This chapter describes some of the techniques of document design that will make
writing more appealing. Some of these techniques are the choice of paper and print, the use of white space and the ways of formatting headings, lists
and graphs. First, one should use 81/2– x 11– inch, 24–pound, white or off–white paper for printout. Also, using a good printer will give a professional
appearance. In any case, it is important to select appropriate size and font style for a document. Usually one should use 12 size fonts with Times New
Roman for business documents. In addition, one should use white spaces including margins and the space between sections to give visual appeal. As a
general guideline, a paper should have 1–inch margin for all four sides except for first page, which should have a 2–inch margin. Moreover, for any
document that is single–spaced, it is better to use double space between paragraphs. Finally, sloppiness in a document is unprofessional. Hence, one
should always read a final hard copy, as it is possible for printing error to appear on printed page but not on a computer screen. Next, formatting
makes paper attractive and easier to read. For a document longer than half page, it is good to use headings. Heading makes paper less intimidating
and provides readers a chance to pause and reflect on what they have read. It also allows readers to preview the contents of a document by reading the
headings
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Adderall: A Growing Trend Among College Students Essay
Adderall: A Growing Trend Among College Students
Brian,* a 20–year–old Northeastern University student, carefully lays out his "stash" of blue pills on a table one Sunday evening. As he organizes
them into groups according to size and dosage, he mentally runs through his class work and assignments for the week.
"A physics quiz on Tuesday," he says, eyes still fixed on thedozen or so blue pills on the table. "A calc test on Friday and a lab due on Thursday."
Brian sinks back into his chair with a sigh of defeated enthusiasm. A weekend full of late night socialization and early afternoon wake up calls has
finally given way to the harsh realization of an intense week of school work. As Brian prepares for Monday morning to rear its ... Show more content on
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Research has indicated that 3–5% of the general population is afflicted with ADHD, with at least one diagnosis in every classroom in America.
Adderall has emerged as the leading prescription medication to treat ADHD. Approved by the FDA in 1996, Adderall prescriptions have grown in
leaps and bounds, overtaking the once popular medication Ritalin as the leader in treating ADHD. The number of prescriptions given for the drug
has skyrocketed in recent years, going from 200,000 in 2001, to 4.3 million in 2002, to 6.4 million in 2003. The profit margins for Shire have
reflected such growth. According to manufacturers, Adderall brought in sales of $475.5 million in 2003, a 49% increase from its 2002 earning and a
number that looks to continue to rise. The success of Adderall motivated Shire to extend their patent on its production until the year 2018. It also
produced the birth of a new, more improved form of Adderall. Adderall XR has the same desired effects of its early counterpart, but is unique in that it
contains two types of drug beads designed to give double–pulsed delivery of amphetamines, intensifying the effect and sustaining it over longer
periods. While more and more doctors and parents are turning to Adderall and Adderall XR as an effective treatment for ADHD, the drug has found a
comfortable niche among the college subculture.
The National Institute of Health
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The Rossafella Records Label (RRL)
The Rossafella Records Label (RRL) is an independent, multifaceted entertainment company that aims to supply profitable; audio and visual
entertainment, to a diverse, international consumer group. Located in Bondi, Sydney RRL will capitalise on the growing entertainment market across
the country through the production and promotion of high quality entertainment. Most services related to the mixing, engineering, and recording of
music will be kept in house, which allows the business to have maximum efficiency of its capital, also promoting the idea of a familiar aesthetic
associated with the label. To achieve these goals, The Record Label will engage in a expansive; traditional and online marketing campaign to promote
album sales, online sales... Show more content on Helpwriting.net ...
This campaign will include the use of traditional print and media advertising as well as the Internet. Direct advertising campaigns will be of
significant importance to the Company as the RRL is offering our programs a wide variety of musicians and sound artists. The CEO of RRL will act
as the initial artist and repertoire manager for the initial years of the business. In regards to promoting artists' materials and music productions, the
RRL will use many forms of promotion and distribution to generate an audience for its independent genres. The business will produce tracks and music
videos simultaneously so that the business can generate as much exposure as possible for each artist. The true goal of the business is to develop an
ongoing distribution with a major record label so that the business can shift its distribution capital risk to a third party. While this will decrease the
revenues in the business in the long run, Management feels that shifting the capital risk from distribution to a third party outweighs the potential profit
benefits in the future. In order to accomplish this, the business must continually develop its track record for the next two to four
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Essay on Adderall Addiction
Finals week remains a stressful time for college students. A student may have three to five tests in a matter of four days. However, these tests, unlike
most, can be worth up to twenty percent of a semester grade. That is a great amount of pressure on a student. With about six hours of sleep a night,
eighteen hours of study never seems like enough. Then again, there may be a solution that allows the student to focus on the study so eighteen hours is
enough. Better yet, maybe sleep is unnecessary. This is a reality for the 6.4 percent of college students that use unprescribed Adderall. College students
all over the country take Adderall everyday to improve performance in school. College can be a challenge with endless papers, tests, and ... Show more
content on Helpwriting.net ...
When a person that at the normal level takes the pill, extreme focus is achieved. However, consequences that may include lack of creativity and
health effects are added. Other symptoms of drug use include loss of appetite, trouble with sleep, and overall illness (McLaughlin). More serious
side effects include high blood pressure (Jaffe). Adderall can also be harmful to the cardiovascular system, which can lead to heart disease
(Green).The use of this drug can affect the body in serious ways for a person without a prescription. Despite the lethal side effects, Adderall is so
widely abused that there is a shortage of the drug.
According to a 2009 study, white students, Greek organization participation, students with low grade point averages and students who attend
competitive schools are the most likely to abuse Adderall (Rabiner). In the same study at Duke University, about eighteen percent of students had taken
Adderall at least ten times within six months (Rabiner). In general, these are students that procrastinate or have too much activity worked into their
schedule. In a different study from the New Yorker, results showed that users of Adderall were ten times more likely to have smoked marijuana and
twenty times more likely to use cocaine (Gillen). The students that take Adderall want to improve poor grades or allow more time to study. A student
can obtain Adderall easy. An anonymous Quinnipiac student had said, "Saying Adderall is easy to get
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Illegal Off Label Promotion Is Personal Choice Of Actions
CLAIM THREE
Illegal off–label promotion is personal choice of actions.
Thinking about the responsibility for illegal off–label promotion, question of the chain of command pops out. Who initiates that type of campaigns and
actions? Sometimes it's company's established strategy; sometimes it's sales force's desire to reach the quota. What happens when company's ideas
confront with common sense and legal responsibilities of the employees? Do they really have a choice?
Lynn A. Morrison was medical sales representative at pharmaceutical company B. Braun for almost 10 years when suddenly she was fired on April 2,
2007. Morrison was promoting pain control medication in Michigan's hospitals. In her decade practice she repeatedly was prompted by the company to
promote off–labeled usage of the products. She reported several times to her supervisor that she wouldn't follow their lead and get involved into
unlawful marketing campaigns. The first time she acknowledged her discomfort with off–label promotion to her supervisor in January 2000. Later on,
in November 2000 she got a warning for her objections on the training by the regional manager. In the next six years, Morrison occasionally faced the
off–label promotion motivations but wasn't overwhelmed by them. Until the situation in the early 2006 when Morrison refused to adjust the pricing for
one of the clients and reported situation to Compliance Department. After that incident, Morrison got few complaints from the customers about
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Gunnar Monical. Professor Greg Murray. Egl 101-13. 17 March
Gunnar Monical
Professor Greg Murray
EGL 101–13
17 March 2017
Pills aren't Thrills
In the hectic pill–popping world we live in today, around 6.5 million people in the U.S. currently abuse prescription medication and out of those 6.5
million, 4.5 of those people abuse pain relievers according to Nova Science Publishers (Greer). Codeine, oxycodone, Adderall, and Xanax just to
name a few of the favorites among abusers (Fahey and Miller). These medications can end up on the streets and in the hands of party–goers looking for
a "good time". Dangerous pills such as those listed above can be quite useful by people with authentic medical conditions such as anxiety and ADHD,
but also have the power to be abused by teenage party goers that crave a ... Show more content on Helpwriting.net ...
This was a vicious cycle then and still is a vicious cycle now. With doctors handing out prescriptions, such as opiates nonchalantly to patients that have
minor conditions such as a pulled muscle, it is more than likely fueling drug abuse like gasoline to a fire. Although, if someone has ever had to receive
medication that requires more effort than grabbing it off of the convenience store shelf, realize that pharmacists now cannot legally distribute
prescription medication without one 's' personal prescription. The Encyclopedia of Alcohol andDrugs in North America also notes that Vicodin and
Xanax earn the title as two of the most commonly prescribed drugs distributed by doctors and also reside as the most commonly abused prescription
drugs in United States.
Deemed as socially acceptable when used for non–medical reasons, prescription drugs such as amphetamines commonly infiltrate college campuses. As
a college student, it isn't uncommon to be overwhelmed with the piles of homework and tests to study for. It also isn't uncommon to hear about
students using non prescribed amphetamines such as Adderall and Ritalin to aide in the process of studying for big exams and finals. Although studies
show that Ritalin and Adderall could be beneficial in small doses to treat children with attention deficit disorder, students that use large amounts of these
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E-Prescribing is an Incentive by the Centre for Medicare &...
E–Prescribing is an incentive by the Centre for Medicare & Medicaid Services (CMS). It allows the electronic transmission of prescriptions between
qualified medical practitioners and physicians. The aim of the program is to improve the drug prescription system by avoiding errors resulting from
handwritten prescriptions. The E–prescribing program runs on various standards. These standards are spelt out and added in Part D of the Medicare
Prescription Drug, Improvement, and Modernization Act 2003 (CMS, 2013).
The standards outline clearly the eligibility criteria for prescribing physicians and participating pharmacies. The standards also inform participants on
best practice in issues regarding refill prescriptions, cancellation of prescriptions and changes in prescription among other things. Moreover, the
standards cover administrative guidelines regarding the operation of the system. The standards also cover the drugs covered by the benefits program of
the E–Prescribing system. There is a standard on medical history that allows prescribers access information on drugs currently available to the patient
so as to guide them in the prescription service. Fill Status Notification is a standard that allows prescribers follow up on the prescriptions status such
as it's been picked up or not (CMS, 2013). This standard serves to allow prescribers follow their patients' adherence to prescriptions.
The E–Prescribing Program was developed on a timeline. In November, 2005, the initial
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The Ethical Implications Of Doctor Prescribing
The process of identification involves the awareness that a decision needs to be made but also the recognition of the ethical implications of that
decision (Manias 2013). The central ethical issue surrounds the doctor prescribing her medication for something other than its purpose. There is a
moral and ethical reason for the patient to take the medication as prescribed. It is a matter of trust between the patient and doctor. According to
Web–MD, "Off–label" means the medication is being used in a manner not specified in the FDA 's approved packaging label, or insert. Every
prescription drug marketed in the U.S. carries an individual, FDA–approved label. This label is a written report that provides detailed instructions
regarding the ... Show more content on Helpwriting.net ...
The common prototype for this objection is taking drugs to perform well on test. Taking drugs such as Ritalin, Adderall, Provigil and other drugs
designed to keep them awake and focused provides the dishonest student with the advantage over his or her peers. Such an unfair advantage is a clear
ethical issue. Merriam–Webster's dictionary defines cheating as "to use dishonest methods to achieve a goal".
Ethical decisions are informed decisions; critical thinking about human problems requires knowledge (Manias 2013). Prescription medication is so
controlling that a doctor must determine if it is in the best interest of the patient to take the medication. There are side effects and possible harmful
effects with every prescription that is written. Legally, patients are not permitted to sell or share prescription medications with others. This matter is
much more than just a legal implication. Morally and ethically, patients should beware that even though it may be well intentioned, they should at no
time share or sell prescription medication. What is useful for one could possibly be fatal to another.
StakeholdersTaking medication for the reason other than labeledWays to cope with stressful situationsConsequences
SaraAddiction/codependent on medication to complete future assignmentsFocus, Go over any material from practice tests, Budget your time, Eat
before a test, make sure you have sufficient time
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Writing Like A White Guy, By Jaswinder Bolina And George...
Authors often use literary devices and writing techniques in their works. During the past block, we studied texts that exemplify the power of discourse.
Each text uses the literary device and writing technique of labels. Authors utilize labels to influence their readers' understanding and to construct reality.
Jaswinder Bolina and George Orwell adopt the technique of labels in their stories "Writing like a White Guy," and "Politics and the English
Language", respectively. Both authors incorporate and discuss this device and its roles in literature and a reader's perception. Bolina, in his piece,
addresses how often times the writing style of an author is wrongly associated with the race of the author, as readers associate incorrect labels about
him and his writing. He elaborates on how language, race, and poetry relate to each other in regards to an author and his writing style. Bolina is an
English writer who moved to the United States in 2002. A major influence for Bolina was his father. His father originally immigrated to the United
Kingdom from India in 1965, more specifically Bolina Doaba, Punjab. His dream was to become a writer and a poet; however, his father warned him
that he would not be welcomed into the literary world with the name that he has. On the other hand, Orwell argues that writers take advantage of their
audiences and use writing styles to deceive and sway opinions. Orwell highlights the ability of language to impact politics and political beliefs to be
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Loss of the Creature Outside Analysis Essay
People in society today have influences throughout their life that help structure and dictate their thoughts. Choices are made based on these influences,
and when these influences begin to take shape as different labels, no real choices are made. People begin to compromise their right to think on their
own and instead turn to the most convenient choice. This is how a great deal of society has acts today, choosing the easiest path just so that person can
get a given task out of the way and continue on with their life. These influences are frequently seen in politics today. People become so wrapped up in
political parties that they become more interested in who is running in which party, instead of which candidate, at any level of ... Show more content on
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"He too could use an instructor and a book and a technique, but he would use them as subordinates, just as he would the jackknife" (Percy 489).
Percy conveys to the reader that the experts must not be used to form and manipulate any experiences or ideas, but instead used as tools to help
guide a person as that person has a genuine experience or forms an idea of their own. Voters who do not take the time to research candidate's specific
views tend to assume that because they belong to a particular party the candidate's views will align with the voter's view. If voters aren't paying
attention to specifically who they are voting for and instead voting out of convenience, they aren't making their vote count and the candidate that the
majority of the people share the most views with might not be elected. Similarly to Walker Percy, John Berger stresses the importance of making
your own decisions not based on what others endorse; to do so will bring the power back to the people. This comes with the implications that the
people are not in complete control, and John Berger uses mystification to show that the art critics are in control of the art world because they are
making art less accessible (Berger 103). According to the Campaign Finance Institute, out of a random sample of 100 candidates that were elected to
the House of Representatives, 20% of their
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Medicine And Control Of Drugs
Medicine and Control "100 people die from drug overdoses every day in the United States."(Centers for Disease Control and Prevention, December
12, 2011) this statistic is decently high, as it means that for every one hundred thousand people in the United States, about twelve die per day due to
high doses of prescription painkillers. The method for controlling these substances varies from extreme control to very lenient, allowing them to be
misused, stolen, and in a rare case prescribed unnecessarily. Usually, the system in place can protect people with good sensibilities, by making the
prescriptions require a refill as given by their doctor. However this does not stop all possibilities, and can be a problem if the medications are stolen or
lost, causing the patient to lack the drugs in an emergency. The system can be improved upon, with more regular doctor visits, and policy changes to
how prescriptions are handled in general. The method by which a prescription medication is acquired currently, is via a doctor request. A patient will
visit a medical professional, who will then review the patient's history and prescribe a medication depending on the ailment, whether it is pain, nausea,
or perhaps a lack of ability to focus on the subject at hand. After the initial visit it is up to the patient to request a follow up with the doctor, unless
their condition is more serious or requires a stricter schedule.
While there are many different prescription drugs abused, the most
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The Character Tommy In Kazuo Ishiguro's Never Let Me Go
When we were born, the only thing we had was the genes that our father and mother had inherited us. Our life cannot be determined only by the
genes that have been inherited by mom and dad. The genes that we have inherited are only like a "starter pack" of our life. All of our genes are
made up of 23 pairs of chromosomes and are used to build our fundamental. However, these genes that we inherited cannot fully determine who we
all are fully. One ordinary little tiny seeds itself cannot grow into a big strong tree all on its own. The seed is just the beginning of everything. As
time goes on, we will gradually become stronger and more powerful from our experiences. The experiences that we gained will keep us steady from
all the obstacles that we face in life. Our achievements will gradually transform us into becoming who we are now. With time, we will experience many
different kinds of things, people, decision–making, situation, and etc.... These things will benefit us to becoming our better selves. In this paper, we are
going to analyze the character Tommy in Kazuo Ishiguro's Never Let Me Go unfolding what makes us who we are through time tearing off our "labels"
and showing our true self.
In Kazuo Ishiguro's Never Let Me Go, the novel starts with our narrator Kathy sitting before the end of her life looking back at her childhood as a
child in Hailsham, narrating her memories to us. The novel surrounds the life of three characters: Kathy, Tommy, and Ruth, who are all clones.
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Medical Fraud
MEDICAL FRAUD
In this abstract, I will explain the specifics of my research and a detailed outline of my paper.
Understanding the topic of medical fraud and off labeling is important, especially for consumers who participate in the use of prescription drugs. It
is imperative to understand what your doctor is prescribing and knowing the specific uses of said drug. Off labeling may occur and recognizing this
fact will only benefit a wise consumer and make them aware of the risks of using a drug that was prescribed for a uses not on the label. This topic is
especially important during the time of new Healthcare reform. Although it seems like we should be able to trust our doctors and believe what they tell
us and the drugs they approve ... Show more content on Helpwriting.net ...
While it would seem to be illegal to keep medical information from a patient, doctors are not required to tell a patient that a drug is being used off
label. (Findlaw, 2009)
A big example of what off labeling would be Aspirin, though not as seemingly harmful as other drugs could be. While aspirin has been a common
pain reliever for more than 100 years, in 1988 doctors began recommending its use in preventing heart attacks. Many drugs are found to remedy
ailments other than those they were originally intended to treat, and as prescription drug use has soared, patients are increasingly taking them for off
label purposes. (Findlaw, 2009)
With all of the off label drug use comes a lot of controversy as well. While it's understood that prescribing a drug for off label use is not considered
illegal, the debate lies within whether the benefits outweigh the risk.
So what can be risky about off labeling? Doctors emphasize that off label prescribing has its place in medical practice, but they also admit that using
a drug off label can raise the risk of lawsuits should a patient have unwanted or bad side effects. In The Journal of Law,Medicine & Ethics, Joel Frader,
MD states that "Off–label prescribing can expose patients to risky and ineffective treatments"(Vucci, 2009). In his further opinion, Frader emphasizes
that although some off–label therapies can be beneficial and even lifesaving for some patients, in most cases, there is
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Does The Form Ask All To Determine What The Client's...
Does the form ask all of the necessary questions to determine what the client's presenting problem is? The form has a question that asks what the
problem(s) are that the person is seeking help for and includes 3 numbered lines for the response. However, this is not adequate to determine what the
client's presenting problems are. This format assumes that the client is fully aware of the problems presented and that the client can articulate the
problems easily and in a limited space. There is not enough room to adequately describe the presenting problem or problems and not enough prompting
questions to uncover the problems if the client has a difficult time articulating them.
Are there too many or too few questions? The form has too many ... Show more content on Helpwriting.net ...
The population in the area the organization serves is overwhelmingly English speaking and there is no indication on the organization's website that
there is any bilingual staff available. It does not appear that the organization intends to serve anyone that is not English speaking. For this reason, a
form that is available solely in English seems appropriate. If there are individuals in the area that are monolingual in a language other than English,
interpretation services would be needed.
Is there enough space to write in what is needed in each answer space? There is not enough space to write in what is needed to provide an adequate
response in each answer space. The font is small and there are no spaces between questions in many areas of the form. The length of blank lines
provided for answers is determined by how close the last word of the question is to the end of the page and does not appear to be based on the amount
of space needed to adequately answer the question.
Should the intake form be reformatted so it is easier to read? The intake form should be reformatted so it is easier to read. The font is small and
there are no spaces between questions in most areas. This makes the form look overwhelming at first glance. If someone was vision impaired, it
would be difficult to see the questions. In some areas the layout of the form makes it easy to lose your place when answering questions. This is
especially apparent in the areas requesting
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The Politics and Economics of FDA Drug Approval Essay
The Politics and Economics of FDA Drug Approval
The United Sates Food and Drug Administration has been protecting American consumers for around 70 years. The FDA assures the safety drugs,
medical devices, chemicals, cosmetics, foods and additives by evaluating products for approval. Controversy has recently been surrounding the FDA's
drug approval process, due to a general trend to get pharmaceuticals on the market more quickly. The FDA has been under pressure from congress and
the public to speed approval, but pharmaceutical companies, who benefit more than anyone form accelerated drug approval, have also been applying
pressure to the FDA through congress. The speeding of the approval process helps patients with incurable illnesses ... Show more content on
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The Radiation Control for Health and Safety Act guarantees consumers protection from excess radiation in certain devices. Lastly, The Public Health
Service Act expanded the FDA's authority to cover serums and vaccines and also justified the inspections of restaurants (Food and Drug Administration
[Britannica]). The FDA is adjusting to a switch in leader ship since Jane Heney, previously the FDA's deputy commissioner of operations, was
nominated in June 1998. Heney, the first woman to head the FDA, has a packed resume that includes a vice presidency of the University of New
Mexico and a specialization in cancer research. Her strategy for the future of the FDA includes the enforcement of new federal laws to modernize
the FDA and addressing concerns about drug safety and approval speed, as well as controlling food contamination (Davis 5D). The FDA requires
pharmaceutical companies to conduct years of research on their drugs before they begin the actual process approval. Drug companies submit test
results to the FDA to be reviewed by their scientists; the FDA actually does no preliminary research on the drugs. In order to be approved, the
companies must prove to the FDA that each drug is safe and effective and that the benefits of the drug must outweigh its side effects. The FDA has
800 to 900 employees involved in reviewing drugs before they get to the market. After a drug is approved, the FDA researches by collecting and
analyzing thousands of reports each
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Quit Smoking Headline
Headline: Prescription drugs to help you quit smoking – Off–label drugs
Reference:
Prescription Drugs to Help You Quit Smoking https://www.cancer.org/healthy/stay
–away–from–tobacco/guide–quitting–smoking
/prescription–drugs–to–help–you–quit–smoking.html Accessed February 6, 2017
Off–label Drug Use
What is off–label drug use? https://www.cancer.org/treatment/treatments–and–side–effects/treatment–types/chemotherapy/off–label–drug–use.html
Accessed February 6, 2017
Drugs Can Help You QuitSmoking http://www.health.com/health/condition–article/0,,20210994,00.html Accessed February 6, 2017
Written by: Hai Anh Nguyen Ngoc
Reviewed by:
Body text starts here:
Opening: For people who want to quit smoking, there are various methods and approaches ... Show more content on Helpwriting.net ...
Adiitionally, the dose should be lowered slowly, as a sudden stop during using this drug may bring about a range of severe effects.
Clonidine
Clonidine is another older drug that helps people quit smoking. It has been approved by the FDA to treat high blood pressure.
If you want to use Clonodine, consult a doctor first. Most common side effects of Clonodine include dizziness, dry mouth, weakness, constipation,
drowsiness, unusual tiredness. More severe ones are allergic reactions, a slow heart rate, and very high or very low blood pressure. The drugs can
also affect the ability to drive or operate a machinery.
Clonidine can be used 3 days before you quit, or the same day you stop smoking. It can be given a the form of a pill (cartillage) or a skin–patch. It
should not be stopped suddenly, as unless the doses are lowered over 2 to 4 days, your blood pressure, agitation, confusion, or tremors will increase
significantly.
Closing: This method can only be used if you have a prescription from the doctors. Thus, consult with your health care provider carefully to find out
what would suit
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Evergreen Management Essay
Problem Statement:
The main problem facing Evergreen management is how to make the promotion decision when the best candidate, Charlie Pace, is taking the
medication off–label Adderall to enhance his working performance. Albert, a senior partner at Evergreen Investments, finds it difficult to make his
final personnel decision which is fair for both Charlie Pace and Daniel Faraday as well as benefit the company in long term.
Objective and Goal:
The objective is to find the best candidate for the position of managing vice president of the company. A fair personnel decision will help all
employees to believe that they have equal opportunities in working and rising to higher positions. Long term, the new manager will be able to
contribute and ... Show more content on Helpwriting.net ...
In fact, using Adderall and other cognitive– enhancing drugs in the workplace is a controversial issue for many companies. Similar to taking off–label
medicines in football games, many people consider taking drugs in the workplace as an unethical action. If the management promote employees who
use Adderall to boost their working performance, it will be unfair for others who only work by their natural abilities. In contrast, if the promotion is
based on medicines usages, this will violate employees' privacy. Besides the ethical issues, the management should also consider the strategy issues in
order to make a wise personnel decision. This means that the management should be able to predict how the decision affects the company in the future.
For example, although Adderall and other cognitive–enhancing drugs can help people to feel stronger, more energetic and exciting, their benefits will
dissipate after a period of time. If the employees stop taking Adderall, they might not maintain their working performance. As a result, their
productivity might be decreased, and the profit of the company will be negatively affected. Some people believe Adderall may help them to improve
their brainpower and concentration; however, others argue that they are unhealthy and cause a lot of serious side effects. Users have to suffer
unexpected negative effects of this medicine and may
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Off Label Promotion : Profitable Health Jeopardizing Act...
Off–label promotion: profitable health jeopardizing act of defiance or costly freedom of speech?
INTRODUCTION
Over the years there is the discussion on the nature of off–label promotion. Promotion for an unapproved by the Food and Drug Administration usage
of a drug, medical device or biologic is prohibited by the 1938 Food, Drug and Cosmetics Act, and subjects the product to the misbranding provisions.
On the other hand, off–label promotion is deemed to be a constitutional right protected by the First Amendment. Numerous debates, lawsuits and court
rulings still don't clear up the dilemma of off–label promotion.
HISTORY OF OFF–LABEL PROMOTION REGULATIONS
Off–label use of drugs and medical devices is common practice in the United States. ... Show more content on Helpwriting.net ...
Another law that imposes liability on healthcare manufacturers is the False Claim Act also known as Lincoln Law. Initially, the law was applied to
people who defraud federal programs but in the late 90s the Act commenced to be applied to frauds associated with the promotions of the healthcare
goods. The first recognition of off–label promotion was made in 1996 when Franklin v. Parke–Davis lawsuit was filed. Dr. David Franklin filed the
False Claim Act case based on his concerns on his former employer's, pharmaceutical company Parker–Davis, off–label promotion of anti–epileptic
drug Neurontin. The proposed claim that off–label promotion complies with the False Claim Act was new and controversial. It took 8 years of legal
disputes to attain equally beneficial settlement of $430 million in fines and penalties. The Franklin v. Parker–Davis case set a precedent for numerous
off–label promotion cases, which still remain urgent matter for both lawsuits and public debates.
CLAIM ONE
Off–label promotion is law–prohibited action, which is used to increase sales profits.
The numerous cases were filled against the giant multinational corporations with allegation in fraud, kickbacks, noncompliance with established laws
and regulations. Companies tend to commit the same mistakes year after year despite the existing precedents. What motivates manufacturers to take
illegal actions? Why
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The Drug Of Prescription Drugs
As the NFL grows in infamy from their many concussion scandals, the misusing of prescription drugs is overshadowed, but still remains as a major
issue in the NFL. A huge problem facing the NFL today is the ill advised use of painkillers as it affects former players and current players alike. If
nothing is done to stop this dilemma, players will continue to be affected by the accoutrements of painkillers. Only through DEA investigations,
increased restrictions on prescription drugs, and increased monitoring of player's mental health, will we end the epidemic of the misuse of painkillers
in the NFL. Background of the Problem As NFL players continue their careers, they become household names that people start to look up to as role
models.... Show more content on Helpwriting.net ...
With injuries plaguing the NFL, team doctors are able to use drugs such as prescription painkillers to allow players to play through pain. NFL
team doctors are able to to receive and distribute illegal painkillers with ease. In a Vice Sports article about the suppliers of the NFL's painkiller
addiction, Aaron Gordon states, "SportPharm,...from at least June of 2009 to June of 2010, illegally provided prescription drugs to 81 team doctors
across American college and professional sports" (Gordon, 2014, para. 2). Many NFL team doctors claim that they did not know about the illegal
drugs and that they only use these companies for their systems of business. Gordon expresses that in a U–T San Diego report written by Michael
Lipman, NFL teams are not only using SportPharm, an unlicensed California Pharmacy, for their convenient tracking system, but for the buying of
massive quantities of painkillers. These painkillers end up in the hands of the players who have the potential of misusing them from their intended
use which can destroy their lives. One cause of professional football player's painkiller addictions is that Doctors feel pushed to have the players
continue playing. Some doctors believe that if they do not load up their players with heavy drugs to be able to play, they will be let go from their
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The Use Of Off-Label Drug Use In Pediatrics
Off–Label Drug Use in Pediatrics
Off–label means the medication is being used in a manner not specified in the FDA's approved packaging label, or insert. Off–label prescribing occurs
when a child receives a medication that has not received FDA approval for the child's age or diagnosis, it occurs when the patients have exhausted all
other approved options, as may be the case with rare diseases or cancer. (WebMD, n.d) Off–label prescription lack information on the medication
safety, efficacy, and proper use in children such as dosing and interactions and this has been associated with adverse drug events (Bazzano,
Mangione–Smith, Schonlau, Suttorp, & Brook, 2009)
The best clinical practice is still to use drugs with FDA indications when ... Show more content on Helpwriting.net ...
Prescribing a drug off–label may be necessary when no FDA–approved drug is available due to lack of research. (Mayhew, 2009)
A lack of suitable formulations exacerbates these problems. Many medicines have a bitter taste, which children may then refuse to take. Parents can
worry about the health consequences of adding a spoonful of sugar or including other additives to improve palatability. In other cases, prescribers
might need to measure a small fraction of an adult formulation and few package inserts offer adequate information to guide dosing, which further
increase the risk of error (Tomlin & Morris, 2009)
Strategies Use in Off–Label Medication Strategies to improve the off–label use and dosage of drugs for infants to adolescences are to make providers
aware of how dangerous prescribing these medications can be. Ideally, children should receive drugs licensed for that age group. However, relatively
few medications have undergone clinical trials in children and prescribing unlicensed medications is inevitable in many indications. Labeling
medications properly with correct dosages as well as labeling them for whom they should be used or may help as well. When an unlicensed medicine is
appropriate, health professionals should identify whether specials or imports are available.
Off–label medicines may be appropriate if the patient requires urgent treatment, but are usually subjected to limited quality assurance.
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Wilbur Unisex Research Paper
In a small, sleepy town in upstate New York, a devastating crime has been committed. Dr. Andreas Poppy was known to be a bit of a lazy doctor
when making house calls. He would leave a "pill and a bill" and leave the rest up to fate. This earned him a few enemies along the way, but no one
thought that he would ever be kidnapped and used for his access to prescription drugs. When Wilbur Unisex came upon the scene he was able to
deduce that four men had been waiting to kidnap Dr. Poppy, take him, his drugs, and his prescription pad, and make a break for the Canadian border.
The evidence in the room that Wilbur Unisex came upon points to four men as the culprits. First, the shelves along the wall held items that would
indicate four people had been using the cabin. There were four sets of dishes and cups stacked on the shelves and there were large containers of food,
which would indicate that more than one person was using the cabin. Another piece of evidence that suggest that four people were present was the
arrangement of the room itself. There is evidence that there were three men playing cards at the table. There were three hands set up around the table....
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One can conclude that the men were from Canada from the coins they were using to gamble with. They left behind several Canadian coins on the
table, which is a clear indication that they men were not from upstate New York. Another clue was left behind to tell police where they were
planning on taking Dr. Poppy. A small map with an "X" marking a spot in Canada was lying carelessly on the floor by the door. There is also
evidence that Dr. Poppy was taken, and not killed. Next to the map is what appears to be tape and rope. This would suggest that the men bound the
doctor and took him with them on their trip back up to Canada. In Canada, the men hope to use Dr. Poppy to secure more prescription
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Drug Use Attention Deficit Hyperactive Disorder Essay
Introduction Studies indicate as many as 34% of students at institutions of higher education in the United States of America have used Attention Deficit
Hyperactive Disorder (ADHD) stimulants illegally (Desantis and Hane par. 5). This alarmingly high number begs the questions: Are these drugs
dangerous? Do people think that it is acceptable to use neuroenhancers? More interestingly, though, could these drugs potentially academically benefit
their consumers in an academic environment? Adderall is a drug used to increase the focus and concentration of someone with a mental disorder such
as ADHD. Although illegal, these drugs are often used without a prescription by students. At one American university, 6.9% of students had admitted
to using Adderall at least once in college (Desantis and Hane par. 4). This same study found that 81% of participants think that illegal use of Adderall
is "'not dangerous at all' or only 'slightly dangerous'" and 0 of the 175 participants admitted to the knowledge that stimulants posed a significant health
risk (Desantis and Hane par. 6) There is evidence from one study that these drugs can increase cognitive abilities, but there have been no conclusive
studies that examined the negative side–effects of these drugs when used for non–medical reasons (Lucke, Bell, Partridge, and Hall par. 10). This
suggests that neuroenhancing drugs could be used for the betterment of society. If effective, these drugs have the potential to increase efficiency in
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Argument For Coolmini
CONSENT FOR ZELTIQ COOLMINIВ®
CoolMiniВ® is a cryolipolytic process used in adults to treat visible fat and affect the appearance of lax tissue under the chin (submental area).
CoolMiniВ® procedure uses a non–invasive vacuum applicator to draw in tissue and deliver controlled cooling at the surface of the skin to target and
kill fat cells. Then, the body eliminates dead cells over a period of weeks. This improves appearance by helping you lose unwanted fat in your face
and neck. Desired results may take more than one treatment. The results are long–term but vary by individual. Submental fat bulges and laxity are
cosmetic issues that some people choose to treat; they do not require treatment. There are also many other treatment options ... Show more content on
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The procedure, as well as potential risks, benefits, have been fully explained. Common risks have been discussed, but not all potential risks are
covered, and there may be other risks that are possible or unknown.
Any factor that impairs healing may increase the risk of complications or a poor outcome. Examples of important risks include smoking, diabetes,
immunocompromised conditions (e.g. steroid use), and collagen vascular disease (e.g. lupus, scleroderma). I understand that I may be at increased risk
of complications if I have any risk factor that impairs healing.
I understand that this procedure is purely elective. I can decide not to allow it at any time. I also understand that the results are not guaranteed, that
outcomes are different with each individual, and that multiple treatments may be necessary. I also understand that I will be responsible for any future
costs for treatments undertaken to improve, complete, or rectify the current
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A Brief Note On The Ethics Of Placebo
1.The Ethics of Placebo.
In medical field, it is quite interesting considering how the brain works and the power of mind perception that can affect the overall body. In this
case, placebos are examples that justify this. Placebos are mainly given to a patient to ease the pain and to satisfy their desire of wanting to receive a
medical care or treatments or plainly just the desire of the doctor to help. Regarding to whether patient should be informed or not, I think that informing
a patient is not obligatory when prescribing a placebo. Scientifically, it is proven that the use of placebo in treating some diseases seems to work
effectively with or without deception. Kaptchuk et al. (2010) reported that nearly 60% of patients with irritable bowel syndrome felt better after
knowingly consuming placebos (in the form of sugar pills) comparing to 35% of patients without such medication. But if we take an insight look at the
research, even though the patients know about the placebo, the researchers however, also added that it has shown to promote or generate a self–healing
processes related to mind–body connection. This implicates that it might not be the placebo itself that cause such placebo effects but how it is given in
terms of addressing the message to the patients. In other words, they implanted a suggestion to the patients that even though it is just a sugar pill but it
is proven to be useful that made patients became more convinced that it has the same effect as the actual
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Prescription Drug Promotion Essay
The Office of Prescription Drug Promotion (OPDP) of the U.S Food and Drug Administration (FDA) has reviewed a print advertisement for the
approved product LATISSEВ® (Bimatoprost Opthalmic Solution 0.03%) in various pharmaceutical journals and magazines. This print advertisement
was found to have inadequate balance of benefit and risk information. As a result, LATISSEВ® print advertisement was found to violate PhRMA
Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines. It specifically violates the guideline principle # 2, 10,11, 13,
14, 16. This print advertisement is concerning from a public health perspective because it creates a misleading and misinformed impression about the
safety and approved indication for LATISSEВ® .
Background
Below are the indication and summary of the most serious and most common risks associated with the use of LATISSEВ®.
According to its FDA–approved product labeling :
LATISSEВ® is aprostaglandin analog, indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and
darkness.
Important limitations of Use:
Use in pediatric patients below the age of 16 years is ... Show more content on Helpwriting.net ...
LATISSEВ® solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be
exacerbated is required to be mentioned in the print advertisement. Also, the direction that it is important to apply LATISSEВ® only to theskin of the
upper eyelid margin at the base of the eyelashes using the accompanying sterile applicators should have been mentioned to inform the patients about the
proper usage of the product. Such statements raise considerable public health concerns and are particularly alarming when not informed in the
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Dangers of Off-Label Drug Promotion

  • 1. Dangers Of Off-Label Advertising "Off–Label" Marketing Introduction Pharmaceutical companies are receiving negative allegations due to the "off–label" advertising of drugs. The Federal and Drug Administration require strict regulations for the use of "off–label" drugs in the pharmaceutical industry. "Off–label" practice of drugs are not prohibited, however, promoting the drugs are illegal. The concern of effective treatment is weighing the benefits and risks of "off–label" drugs for the best interest of the patient. In addition, companies who fail to comply with the FDA regulations, face consequences such as costly fines as well as criminal issues. Pharmaceutical companies often settle with the government, due to lack of proper procedures, complying with public health agencies. Modifying the policies of pharmaceutical companies with a different approach will limit the misuse of "off–label" drugs (Ghillyer, 2014). ... Show more content on Helpwriting.net ... "Off–label" drug promotion "Off–Label" drug prescribing is a common practice throughout the medical field. "Off–label" drugs are FDA approved drugs for unapproved uses on the label. The "off–label" drug prescribing is based on the physicians' judgement of the "off–label" drug that will benefit the patient and not harm them. Conversely, "off–label" drug promotion is prohibited by the FDA, in regards, to lack of scientific study on efficacy and safety. Additionally, pharmaceutical manufacturers can only discuss the information on the label of the drug and anything other than that is considered "off–label" promotion (Samolla, ... Get more on HelpWriting.net ...
  • 2. The Paradox of Choice It all comes down to one question. Is it better when you have more choices or when you have fewer choices? Most people would answer more choices as they would feel less limited because it is common to associate having more choices with having more freedom and having more freedom with having more welfare. In fact, this is not always correct as you may not have enough knowledge to know which may be the most beneficial to you in the long run. This is turn relates to what is best known as the paradox of choice because we may think we have more but in reality we have less and find ourselves in a far more complex situation. The paradox of choice explains in depth how certain individuals and societies are affected when the matter of choice comes ... Show more content on Helpwriting.net ... Medical centres are now much more helpful than before by offering many solutions to individuals (Gillespie). This is actually seen as an advantage to patients because they will have more awareness in terms of how serious their illness is and doctors are now able to list many more treatment options to patients than before giving patients the freedom to choose the treatment they want to undergo. In turn, most people don't know what is best for them and they can end up choosing a certain type of treatment which can end up causing another sickness that can be fatal due to side effects (Iyengar). The advertisement of prescription medicines is also a great contribution to such a situation because individuals look at how good the advertisements look and assume that taking the certain prescription medicine being advertised will be the solution to their problem. This then causes doctors to be persuaded into writing prescriptions for their patients to have their desired medicines. Yet again this is another example of freedom of choice which is what people want because they will feel even better by being able to choose what medicine to take. As a result, some individuals can actually be lucky and successfully treat themselves but many end up aggravating their health by trying medicines that can cause a negative response on their bodies. In the modern world, people now have the flexibility to work whenever they want and in almost any location (Salecl). This is a big ... Get more on HelpWriting.net ...
  • 3. Off Label Research Essay The United States Food and Drug Administration (FDA) drug approval process requires clinical trials that demonstrate efficacy for a specific indication prior to market availability. Once approval for an indication is given, however, the FDA has a minimal role in determining whether drugs are prescribed for their approved uses or for other "off–label" indications not part of the FDA–approved product labeling. Prior studies of off–label prescribing have typically been conducted in narrowly defined clinical contexts, including psychiatric disorders,1,2 bacterial infections,3 in children2,4 as well as in "orphan" clinical conditions not well served by FDA approved drugs.5,6 These studies have demonstrated that off–label use is frequent in these clinical areas, that such uses arise from diverse circumstances, and that there is substantial variation in the available evidence supporting particular off–label uses. Notably, while raising some concerns about off–label use, the studies also... Show more content on Helpwriting.net ... Although several drug classes, including anticonvulsants, antipsychotics, and antibiotics, were associated with a higher frequency of off–label use, other drug characteristics such as manufacturer, and annual sales levels did not predict the likelihood of off–label prescribing. While this study highlighted the magnitude of off–label drug use in the absence of evidence regarding efficacy, it made no attempt to define the level of concern associated with specific drugs. We sought to build upon these studies to develop a systematic process for prioritizing future federally sponsored research and policy initiatives regarding off–label drug use based on the concept of value of ... Get more on HelpWriting.net ...
  • 4. Off-Label Lawsuits In A Pharmaceutical Company Ghillyer (2014), explains that how organizations are operated and controlled as corporate governance. Pharmaceutical companies have been the focus of questionable conduct in regards to corporate governance for years. Unlawful promotions and marketing of drugs as well as failure to properly and accurately report safety date led to several off–label lawsuits (Ghillyer, 2014). According to Ghillyer (2014), medications and drugs have many uses that are often not approved by the Federal Drug Administration. In 2012 Abbott Laboratories were involved in a lawsuit related to illegal marketing. The company promoted a medication to control and treat agitation, aggression, and schizophrenia. The medication had only been approved for treatment of seizures, migraines, and bipolar mania. GlaxoKline–Smith was also involved in a settlement regarding off–label promotions for marketing Wellbutrin for weight loss, sexual dysfunction, substance addiction, and behavioral... Show more content on Helpwriting.net ... It is a benefit versus risk gamble that these companies take. An example: marijuana is a plant that is medically proven to reduce nausea. Long–term use has not been evaluated, and it is illegal in most states. However, people continue to utilize it for its alleviating benefits despite the risk of not being approved by the Federal Drug Administration. The Federal Drug Administration struggles to have control over the legalization of marijuana. The battle of getting marijuana legalized for medical purposes is a struggle that some states will continue to fight against the Federal Drug Administration. The argument that has been made is that one may benefit from marijuana for medical uses. Some patients have had beneficial results from marijuana, and they prefer to use the drug instead of over the counter medication or treatment (Berg, ... Get more on HelpWriting.net ...
  • 5. Sample Case Conceptualization And Nursing Case Study Patricia Patricia is an 84–year–old female who is diagnosed with metastatic colon cancer (C18.9). She also suffers from anemia. Patricia underwent a right hemicolectomy and a partial omentectomy, with noted bulky adenopathy at the base of the mesentery again, this proved to be moderately differentiated adenocarcinoma with mucinous features with venous, lymphatic and perineural invasion present. 22/32 lymph nodes were involved with cancer, margins were negative, pathologically this was a T3 N2b cancer. Patricia was treated with 5–FU and leucovorin but still experienced disease progression, with adverse side effects and found to have metastasis to the liver and bone which is KRAS and NRAS wild type. Patricia is currently on Erbitux weekly. She is malaise, ... Get more on HelpWriting.net ...
  • 6. A Social Learning Approach For Prescription Drug Misuse... A Social Learning Approach to Prescription Drug Misuse Among College Students takes a socio–theoretical approach to prescription drug misuse (PDM) among college students in the US by examining the issue through Aker's social learning theory (Watkins 2016). Watkins emphasizes the legitimacy of the problem by citing relevant statics that illustrate how prescription drug misuse has shifted from a minor trend to a growing public health issue (ibid). As well, there is evidence that obtaining prescription drugs from peers correlated with a higher frequency of alcohol consumption and substance use (ibid). It is necessary to examine this issue through a socio–theoretical lens, as the paper makes case for how the social relations behind PDM give insight into patterns behind their use (ibid). For example, Watkins notes a study that determined that drugs purchased illicitly (unfamiliar source) are more likely to be misused compared to prescription drugs obtained for free from a relative or peer (ibid). Watkins examines PDM through Aker's 'Social Learning Theory', a theory that examines how deviant behaviours are created through social feedback from ones environment (Deutschmann 2007;Watkins 2016). He justifies this as an apt theoretical approach for examining PDM among college students, as the college lifestyle tends to replace one's family as the primary influencers of one's behaviour (Watkins 2016). Overall, Watkins offers a comprehensive explanation of Aker's socio–theoretical ... Get more on HelpWriting.net ...
  • 7. Natural Label Remover Research Paper Common Examples of a Natural Label Remover Tool Natural things are great. It is a wonderful alternative we can have as we live our daily lives. It became a way we could reminisce how our ancestors managed to live their day to day encounter only with natural stuffs. These days, their ways seemed to be extinct. However, there are some natural things used these days. But, it takes you to discover them even more because they are somehow modernized. A label remover tool is one of them. It has a lot of options you can choose from in doing so. There are little known tricks in using common items in removing labels. Find out more in the following. Washing it with water with dish soap. You could use this in two ways. Preparing water with dish soap... Show more content on Helpwriting.net ... Due to the appearance of oils, it has become a wonderful alternative in peeling off the label you see on your product. It is important that you determine which kind of oil you have easier access with. Knowing this would narrow down the choices you have to choose from. However, the most common is the use of baby oil and cooking oil. Alcohol. You may see a lot of types of this in varying percentages. Whatever kind you would like to choose, it always does the same superb job in removing what you wanted to come off so badly. It could serve as a solution you could use in solving the dilemma you have in making the label come off from the thing it sticks on. Vinegar. This also has some kinds. However, it is important for you to understand that all of its types are good in helping you out getting rid of the stubborn sticky side which usually was caused by the price sticker placed by most stores. Using vinegar, especially the one called, the apple cider vinegar, it does a great miracle in taking that stubborn paper off. Therefore, these are only a few of the common examples you can use as tool for the removal of that annoying sticky label. With the knowledge of these things, you shall be able to effectively take off the unwanted with ease. So, dont delay. Try it now. Get ready to be ... Get more on HelpWriting.net ...
  • 8. Medication Off Label Is A Patient Right Medications off label is a patient right. The Brazilian pharmaceutical market is the ninth largest in the world and the second among the BRIC countries (First is China, with Russia and India occupying third and fourth), annually handling about R $ 28 billion, a growth trend. Among the six largest pharmaceutical companies in the world, four are Brazilian. Currently there are about 540 pharmaceutical companies registered in Brazil. The growth of this sector, in general, has been remarkable and very favorable to patients. The high investment in research and development of new drugs allowed disease very recently (from a historical point of view) taken by incurable or high mortality rate may gradually being controlled by the use of drugs and. In some cases, this evolution walks to the discovery of a cure. AIDS may be cited as notorious example, emerged in Brazil in the early 80s, with a high rate of mortality and suffering, and "only" 16 years later, it became a disease that through the drugs allow the infected person lead a normal life, "in a chronic and controllable way". However, according to economic data released by the Association of Pharmaceutical Research (Interfarma) in Brazil they invested just over $ 139 million in research, while in the world they invested $ 40 billion. Brazil 's participation in clinical trials worldwide is 1.2%, and the time taken for approval of a clinical trial in Brazil is between 10 and 14 months. Between 2005 and 2009 the international patent ... Get more on HelpWriting.net ...
  • 9. The Legal And Ethical Implications Associated With... I aim to explain the drug development process, to explore the legal and ethical implications associated with wrongful off–label prescribing, and provide my recommendations for reform of the pharmaceutical industry. I will consistently refer to the GlaxoSmithKline case to display the maleficent inner workings of the multinational pharmaceutical company. Glaxo was involved in the biggest health care fraud settlement in U.S. history for introducing and encouraging physicians to off–label prescribe their patients six misbranded drugs, Paxil, Wellbutrin, Advair, Lamictal, Avandia and Zofran. Kickbacks were paid to physicians that prescribed those drugs but also for the drugs Imitrex, Flovent, Lotronex, and Valtrex. Glaxo also failed to report safety data to the Food and Drug Administration (FDA) for Avandia, a diabetes drug. I find this issue to be so important because I hope to pursue a career in health law. My health policy major and relevant coursework ignited my interest in the legal issues strewn throughout our health care system. The United States Pharmacopoeia (USP) was established to set the standards for the manufacture, nomenclature, indications, and chemical characteristics of drugs and continues to do so today. In 1938, the Pure Food and Drug Act created the FDA, to ensure the, "safety, efficacy, and appropriate labeling and advertising of pharmaceutical products before approving them for sale" (Blum, 2002). Prescription drugs are developed and both pre–clinical and ... Get more on HelpWriting.net ...
  • 10. The Controversy Of Animal Welfare "Hormone–free", "organic", "grass–fed", and "natural" are labels that animal and plant producers use to inform consumers of what they are eating. These claims are misleading and usually increase the prices of those products. By increasing the price and sticking a label that reads "natural" makes consumers think that this product is better for them. Animal Welfare Approved gives an example of an egg carton boasting the statement that its eggs are "natural." This statement can legally come from an industrial farm where the hens do not forage the way a chicken does "naturally." According to the USDA, farms have to get organic certifications and accreditations in order to sell, label, and represent their products as organic. It is difficult to ... Get more on HelpWriting.net ...
  • 11. Business Ethics Business Research Ethics "Ethics are norms or standards of behavior that guide moral and choices about our behavior and our relationship with others" (Cooper & Schindler, 2011, p.). When a business conducts a research, the business uses ethics to guarantee that no individual will be hurt or suffers from the consequences from the research. When a business is planning a research, some of the ethics a business must consider are to: protect the rights of the individual, follow the ethical standards, and to ensure that the information that is acquire is ethical. The purpose of the research is not to allow any type of physical harm, discomfort, pain, embarrassment, and the loss of privacy (Cooper & Schindler, 2011). According to "Copper... Show more content on Helpwriting.net ... Without requiring drug companies to publish all of their safety data, these companies can submit information that only provides only what seems to be positive data and hide the negative data. "Pharmaceutical companies can manipulate their own trial data to manufacture good results" (Benson, 2010). In a legal case against Neurontin, Pfizer and Parke–Davis used some strategies to cover up some unfavorable findings from their research. When their strategies were uncovered in 2008, Pfizer and Parke–Davis detained reports where it proved that there was no evidence of the drug's efficacy, their negative data was reinterpreted, and the grouping of negative and positive studies to counterbalance the results. According to "Ramirez de Arellano" (2009), "In some cases, legitimate researchers saw their findings rewritten and recast to, in the words of one of company's medical writer, to make [the overall picture] sound better than it looks on the graphs." Pfizer and Parke–Davis were skewing information on off–label uses of Neurontin. They manipulated their data to support their findings, and failed to report any negative outcome from their findings. When pharmaceutical companies skew or manipulate their findings on a drug, people who take Neurontin for off–label uses are endangering their lives. The FDA does not approve Neurontin for off–label uses because Pfizer and Parke–Davis cannot prove the ... Get more on HelpWriting.net ...
  • 12. Off Label Drugs Use Off–Label Drugs Use is using a medication to treat a disease condition other than what it's approved for by drug regulatory agencies. Abdulah et al. (2015) documented that "Pharmacotherapy is usually based on drugs that are approved for a specific indications, dosages, and routes of administration or population. However, this does not preclude the use of the medicine outside of those terms" (pg.470). Although, the use of unapproved medications are common and legal without controversies (Mayhew, 2009). However, adequate precautions should be taken not to administer overdose due to immaturity or weakness of the excretory organ. Also the off–label drugs can be use only if approved medication has been used without any therapeutic relief or an adverse... Show more content on Helpwriting.net ... 2015). So many strategical methods can be applied to achieve a safety use of the off label medications, such as collaboration of the regulatory agencies, the provider/prescribers and the pharmaceutical companies in determining a common and safe guideline. Also, using the patient's height and weight to calculate appropriate dosage needed. In addition, a small starting dose should be prescribed and increased dosage gradually as tolerated as long as the liver and kidney functions are within normal range. Finally, parents should be instructed to stop the medication and report to the health care provider once an adverse reactions are ... Get more on HelpWriting.net ...
  • 13. Neuroenhancing Drugs Analysis In a society where quantity of work overpowers quality of work, there is no wonder why "neuroenhancing" drugs such as Adderall and Ritalin are on the rise of consumption. As more people adopt the idea that these drugs are cognitively beneficial; the more they secretly use them for non–medical reasons. Margaret Talbot, a writer for The New Yorker, looks more into this problem in her article, "From Brain Gain: The Underground World of "Neuroenhancing" Drugs". Throughout this article Talbot focuses on a new trend of drug use, such as Adderall and Ritalin, for non–medical intentions. She focuses mainly on the increase of drug use by scholars and public intellectuals throughout her article. Talbot successfully proves to her audience that non–medical... Show more content on Helpwriting.net ... Through the use of logos Talbot first makes clear the concerns she has for the purposes for using these drugs. In paragraph 7 she lists all the symptoms that drugs like Adderall could cause; some of which include nervousness, headaches, sleeplessness, and the even have a high potential for abuse. Talbot warns the readers that using drugs in this type of manner could ultimately harm them in the long run. She stresses that the way society focuses more on taking these drugs to help complete work rather than . To help with this she also uses anecdotal evidence throughout her summaries of each of her interviews. She picks what kind of things to put in the essay and only uses the part of the interviews that make her argument ... Get more on HelpWriting.net ...
  • 14. Persuasive Essay On Off Label Drugs Greg a 14–year–old boy living with his parents in the basement. He has to take these off label prescription drug. An off label prescription drug is a drug that isn't prescription by a doctor or pro. Greg could find these drugs on the streets or even with his family members. Be sure to take your drugs to a doctor and get them copied and your drugs. Greg is taking these drugs to feel better but he doesn't know if they should be off labeled by a pro or just somebody else. When off label drugs were in the 1980's it is different than today. It's different because the drugs used back then were, just for pain. But today we use drugs to get better with an illness or disease. Off label drugs has been used since the 1980's, supporters and no supporters argue if off label drugs are a good thing or not. This is what the doctors did in the 1980's, there was one problem; the drugs had been tested on and approved for people with severe arrhythmias ("off label"). It took a long time for people to stop prescribing these drugs because they just couldn't believe it and killed over 50,000 people in ... Show more content on Helpwriting.net ... The first reason is Many people with cancer have to take these if they want to survive or get better ("Off Label Drugs"). Every other kid gets to live by a single drop of this prescribe drug. 85% of kids survive these conditions (Gulfo 4). That companies have the right to market their products to doctors. FDA announced that there were important public policy reasons for allowing manufactures to disseminate truthful and non–misleading medical journal articles ("Off Label Drugs"). Some doctors who support off label drugs prescribe say that it actually helps when companies that do the work and not doctors ("off label"). The doctors should be the people that save people's life and makes kids great and healthy again, not the people that put drugs on markets that people can ... Get more on HelpWriting.net ...
  • 15. The Techniques Of A Good Design A good design makes the document attractive and easier to read. This chapter describes some of the techniques of document design that will make writing more appealing. Some of these techniques are the choice of paper and print, the use of white space and the ways of formatting headings, lists and graphs. First, one should use 81/2– x 11– inch, 24–pound, white or off–white paper for printout. Also, using a good printer will give a professional appearance. In any case, it is important to select appropriate size and font style for a document. Usually one should use 12 size fonts with Times New Roman for business documents. In addition, one should use white spaces including margins and the space between sections to give visual appeal. As a general guideline, a paper should have 1–inch margin for all four sides except for first page, which should have a 2–inch margin. Moreover, for any document that is single–spaced, it is better to use double space between paragraphs. Finally, sloppiness in a document is unprofessional. Hence, one should always read a final hard copy, as it is possible for printing error to appear on printed page but not on a computer screen. Next, formatting makes paper attractive and easier to read. For a document longer than half page, it is good to use headings. Heading makes paper less intimidating and provides readers a chance to pause and reflect on what they have read. It also allows readers to preview the contents of a document by reading the headings ... Get more on HelpWriting.net ...
  • 16. Adderall: A Growing Trend Among College Students Essay Adderall: A Growing Trend Among College Students Brian,* a 20–year–old Northeastern University student, carefully lays out his "stash" of blue pills on a table one Sunday evening. As he organizes them into groups according to size and dosage, he mentally runs through his class work and assignments for the week. "A physics quiz on Tuesday," he says, eyes still fixed on thedozen or so blue pills on the table. "A calc test on Friday and a lab due on Thursday." Brian sinks back into his chair with a sigh of defeated enthusiasm. A weekend full of late night socialization and early afternoon wake up calls has finally given way to the harsh realization of an intense week of school work. As Brian prepares for Monday morning to rear its ... Show more content on Helpwriting.net ... Research has indicated that 3–5% of the general population is afflicted with ADHD, with at least one diagnosis in every classroom in America. Adderall has emerged as the leading prescription medication to treat ADHD. Approved by the FDA in 1996, Adderall prescriptions have grown in leaps and bounds, overtaking the once popular medication Ritalin as the leader in treating ADHD. The number of prescriptions given for the drug has skyrocketed in recent years, going from 200,000 in 2001, to 4.3 million in 2002, to 6.4 million in 2003. The profit margins for Shire have reflected such growth. According to manufacturers, Adderall brought in sales of $475.5 million in 2003, a 49% increase from its 2002 earning and a number that looks to continue to rise. The success of Adderall motivated Shire to extend their patent on its production until the year 2018. It also produced the birth of a new, more improved form of Adderall. Adderall XR has the same desired effects of its early counterpart, but is unique in that it contains two types of drug beads designed to give double–pulsed delivery of amphetamines, intensifying the effect and sustaining it over longer periods. While more and more doctors and parents are turning to Adderall and Adderall XR as an effective treatment for ADHD, the drug has found a comfortable niche among the college subculture. The National Institute of Health ... Get more on HelpWriting.net ...
  • 17. The Rossafella Records Label (RRL) The Rossafella Records Label (RRL) is an independent, multifaceted entertainment company that aims to supply profitable; audio and visual entertainment, to a diverse, international consumer group. Located in Bondi, Sydney RRL will capitalise on the growing entertainment market across the country through the production and promotion of high quality entertainment. Most services related to the mixing, engineering, and recording of music will be kept in house, which allows the business to have maximum efficiency of its capital, also promoting the idea of a familiar aesthetic associated with the label. To achieve these goals, The Record Label will engage in a expansive; traditional and online marketing campaign to promote album sales, online sales... Show more content on Helpwriting.net ... This campaign will include the use of traditional print and media advertising as well as the Internet. Direct advertising campaigns will be of significant importance to the Company as the RRL is offering our programs a wide variety of musicians and sound artists. The CEO of RRL will act as the initial artist and repertoire manager for the initial years of the business. In regards to promoting artists' materials and music productions, the RRL will use many forms of promotion and distribution to generate an audience for its independent genres. The business will produce tracks and music videos simultaneously so that the business can generate as much exposure as possible for each artist. The true goal of the business is to develop an ongoing distribution with a major record label so that the business can shift its distribution capital risk to a third party. While this will decrease the revenues in the business in the long run, Management feels that shifting the capital risk from distribution to a third party outweighs the potential profit benefits in the future. In order to accomplish this, the business must continually develop its track record for the next two to four ... Get more on HelpWriting.net ...
  • 18. Essay on Adderall Addiction Finals week remains a stressful time for college students. A student may have three to five tests in a matter of four days. However, these tests, unlike most, can be worth up to twenty percent of a semester grade. That is a great amount of pressure on a student. With about six hours of sleep a night, eighteen hours of study never seems like enough. Then again, there may be a solution that allows the student to focus on the study so eighteen hours is enough. Better yet, maybe sleep is unnecessary. This is a reality for the 6.4 percent of college students that use unprescribed Adderall. College students all over the country take Adderall everyday to improve performance in school. College can be a challenge with endless papers, tests, and ... Show more content on Helpwriting.net ... When a person that at the normal level takes the pill, extreme focus is achieved. However, consequences that may include lack of creativity and health effects are added. Other symptoms of drug use include loss of appetite, trouble with sleep, and overall illness (McLaughlin). More serious side effects include high blood pressure (Jaffe). Adderall can also be harmful to the cardiovascular system, which can lead to heart disease (Green).The use of this drug can affect the body in serious ways for a person without a prescription. Despite the lethal side effects, Adderall is so widely abused that there is a shortage of the drug. According to a 2009 study, white students, Greek organization participation, students with low grade point averages and students who attend competitive schools are the most likely to abuse Adderall (Rabiner). In the same study at Duke University, about eighteen percent of students had taken Adderall at least ten times within six months (Rabiner). In general, these are students that procrastinate or have too much activity worked into their schedule. In a different study from the New Yorker, results showed that users of Adderall were ten times more likely to have smoked marijuana and twenty times more likely to use cocaine (Gillen). The students that take Adderall want to improve poor grades or allow more time to study. A student can obtain Adderall easy. An anonymous Quinnipiac student had said, "Saying Adderall is easy to get ... Get more on HelpWriting.net ...
  • 19. Illegal Off Label Promotion Is Personal Choice Of Actions CLAIM THREE Illegal off–label promotion is personal choice of actions. Thinking about the responsibility for illegal off–label promotion, question of the chain of command pops out. Who initiates that type of campaigns and actions? Sometimes it's company's established strategy; sometimes it's sales force's desire to reach the quota. What happens when company's ideas confront with common sense and legal responsibilities of the employees? Do they really have a choice? Lynn A. Morrison was medical sales representative at pharmaceutical company B. Braun for almost 10 years when suddenly she was fired on April 2, 2007. Morrison was promoting pain control medication in Michigan's hospitals. In her decade practice she repeatedly was prompted by the company to promote off–labeled usage of the products. She reported several times to her supervisor that she wouldn't follow their lead and get involved into unlawful marketing campaigns. The first time she acknowledged her discomfort with off–label promotion to her supervisor in January 2000. Later on, in November 2000 she got a warning for her objections on the training by the regional manager. In the next six years, Morrison occasionally faced the off–label promotion motivations but wasn't overwhelmed by them. Until the situation in the early 2006 when Morrison refused to adjust the pricing for one of the clients and reported situation to Compliance Department. After that incident, Morrison got few complaints from the customers about ... Get more on HelpWriting.net ...
  • 20. Gunnar Monical. Professor Greg Murray. Egl 101-13. 17 March Gunnar Monical Professor Greg Murray EGL 101–13 17 March 2017 Pills aren't Thrills In the hectic pill–popping world we live in today, around 6.5 million people in the U.S. currently abuse prescription medication and out of those 6.5 million, 4.5 of those people abuse pain relievers according to Nova Science Publishers (Greer). Codeine, oxycodone, Adderall, and Xanax just to name a few of the favorites among abusers (Fahey and Miller). These medications can end up on the streets and in the hands of party–goers looking for a "good time". Dangerous pills such as those listed above can be quite useful by people with authentic medical conditions such as anxiety and ADHD, but also have the power to be abused by teenage party goers that crave a ... Show more content on Helpwriting.net ... This was a vicious cycle then and still is a vicious cycle now. With doctors handing out prescriptions, such as opiates nonchalantly to patients that have minor conditions such as a pulled muscle, it is more than likely fueling drug abuse like gasoline to a fire. Although, if someone has ever had to receive medication that requires more effort than grabbing it off of the convenience store shelf, realize that pharmacists now cannot legally distribute prescription medication without one 's' personal prescription. The Encyclopedia of Alcohol andDrugs in North America also notes that Vicodin and Xanax earn the title as two of the most commonly prescribed drugs distributed by doctors and also reside as the most commonly abused prescription drugs in United States. Deemed as socially acceptable when used for non–medical reasons, prescription drugs such as amphetamines commonly infiltrate college campuses. As a college student, it isn't uncommon to be overwhelmed with the piles of homework and tests to study for. It also isn't uncommon to hear about students using non prescribed amphetamines such as Adderall and Ritalin to aide in the process of studying for big exams and finals. Although studies show that Ritalin and Adderall could be beneficial in small doses to treat children with attention deficit disorder, students that use large amounts of these ... Get more on HelpWriting.net ...
  • 21. E-Prescribing is an Incentive by the Centre for Medicare &... E–Prescribing is an incentive by the Centre for Medicare & Medicaid Services (CMS). It allows the electronic transmission of prescriptions between qualified medical practitioners and physicians. The aim of the program is to improve the drug prescription system by avoiding errors resulting from handwritten prescriptions. The E–prescribing program runs on various standards. These standards are spelt out and added in Part D of the Medicare Prescription Drug, Improvement, and Modernization Act 2003 (CMS, 2013). The standards outline clearly the eligibility criteria for prescribing physicians and participating pharmacies. The standards also inform participants on best practice in issues regarding refill prescriptions, cancellation of prescriptions and changes in prescription among other things. Moreover, the standards cover administrative guidelines regarding the operation of the system. The standards also cover the drugs covered by the benefits program of the E–Prescribing system. There is a standard on medical history that allows prescribers access information on drugs currently available to the patient so as to guide them in the prescription service. Fill Status Notification is a standard that allows prescribers follow up on the prescriptions status such as it's been picked up or not (CMS, 2013). This standard serves to allow prescribers follow their patients' adherence to prescriptions. The E–Prescribing Program was developed on a timeline. In November, 2005, the initial ... Get more on HelpWriting.net ...
  • 22. The Ethical Implications Of Doctor Prescribing The process of identification involves the awareness that a decision needs to be made but also the recognition of the ethical implications of that decision (Manias 2013). The central ethical issue surrounds the doctor prescribing her medication for something other than its purpose. There is a moral and ethical reason for the patient to take the medication as prescribed. It is a matter of trust between the patient and doctor. According to Web–MD, "Off–label" means the medication is being used in a manner not specified in the FDA 's approved packaging label, or insert. Every prescription drug marketed in the U.S. carries an individual, FDA–approved label. This label is a written report that provides detailed instructions regarding the ... Show more content on Helpwriting.net ... The common prototype for this objection is taking drugs to perform well on test. Taking drugs such as Ritalin, Adderall, Provigil and other drugs designed to keep them awake and focused provides the dishonest student with the advantage over his or her peers. Such an unfair advantage is a clear ethical issue. Merriam–Webster's dictionary defines cheating as "to use dishonest methods to achieve a goal". Ethical decisions are informed decisions; critical thinking about human problems requires knowledge (Manias 2013). Prescription medication is so controlling that a doctor must determine if it is in the best interest of the patient to take the medication. There are side effects and possible harmful effects with every prescription that is written. Legally, patients are not permitted to sell or share prescription medications with others. This matter is much more than just a legal implication. Morally and ethically, patients should beware that even though it may be well intentioned, they should at no time share or sell prescription medication. What is useful for one could possibly be fatal to another. StakeholdersTaking medication for the reason other than labeledWays to cope with stressful situationsConsequences SaraAddiction/codependent on medication to complete future assignmentsFocus, Go over any material from practice tests, Budget your time, Eat before a test, make sure you have sufficient time ... Get more on HelpWriting.net ...
  • 23. Writing Like A White Guy, By Jaswinder Bolina And George... Authors often use literary devices and writing techniques in their works. During the past block, we studied texts that exemplify the power of discourse. Each text uses the literary device and writing technique of labels. Authors utilize labels to influence their readers' understanding and to construct reality. Jaswinder Bolina and George Orwell adopt the technique of labels in their stories "Writing like a White Guy," and "Politics and the English Language", respectively. Both authors incorporate and discuss this device and its roles in literature and a reader's perception. Bolina, in his piece, addresses how often times the writing style of an author is wrongly associated with the race of the author, as readers associate incorrect labels about him and his writing. He elaborates on how language, race, and poetry relate to each other in regards to an author and his writing style. Bolina is an English writer who moved to the United States in 2002. A major influence for Bolina was his father. His father originally immigrated to the United Kingdom from India in 1965, more specifically Bolina Doaba, Punjab. His dream was to become a writer and a poet; however, his father warned him that he would not be welcomed into the literary world with the name that he has. On the other hand, Orwell argues that writers take advantage of their audiences and use writing styles to deceive and sway opinions. Orwell highlights the ability of language to impact politics and political beliefs to be ... Get more on HelpWriting.net ...
  • 24. Loss of the Creature Outside Analysis Essay People in society today have influences throughout their life that help structure and dictate their thoughts. Choices are made based on these influences, and when these influences begin to take shape as different labels, no real choices are made. People begin to compromise their right to think on their own and instead turn to the most convenient choice. This is how a great deal of society has acts today, choosing the easiest path just so that person can get a given task out of the way and continue on with their life. These influences are frequently seen in politics today. People become so wrapped up in political parties that they become more interested in who is running in which party, instead of which candidate, at any level of ... Show more content on Helpwriting.net ... "He too could use an instructor and a book and a technique, but he would use them as subordinates, just as he would the jackknife" (Percy 489). Percy conveys to the reader that the experts must not be used to form and manipulate any experiences or ideas, but instead used as tools to help guide a person as that person has a genuine experience or forms an idea of their own. Voters who do not take the time to research candidate's specific views tend to assume that because they belong to a particular party the candidate's views will align with the voter's view. If voters aren't paying attention to specifically who they are voting for and instead voting out of convenience, they aren't making their vote count and the candidate that the majority of the people share the most views with might not be elected. Similarly to Walker Percy, John Berger stresses the importance of making your own decisions not based on what others endorse; to do so will bring the power back to the people. This comes with the implications that the people are not in complete control, and John Berger uses mystification to show that the art critics are in control of the art world because they are making art less accessible (Berger 103). According to the Campaign Finance Institute, out of a random sample of 100 candidates that were elected to the House of Representatives, 20% of their ... Get more on HelpWriting.net ...
  • 25. Medicine And Control Of Drugs Medicine and Control "100 people die from drug overdoses every day in the United States."(Centers for Disease Control and Prevention, December 12, 2011) this statistic is decently high, as it means that for every one hundred thousand people in the United States, about twelve die per day due to high doses of prescription painkillers. The method for controlling these substances varies from extreme control to very lenient, allowing them to be misused, stolen, and in a rare case prescribed unnecessarily. Usually, the system in place can protect people with good sensibilities, by making the prescriptions require a refill as given by their doctor. However this does not stop all possibilities, and can be a problem if the medications are stolen or lost, causing the patient to lack the drugs in an emergency. The system can be improved upon, with more regular doctor visits, and policy changes to how prescriptions are handled in general. The method by which a prescription medication is acquired currently, is via a doctor request. A patient will visit a medical professional, who will then review the patient's history and prescribe a medication depending on the ailment, whether it is pain, nausea, or perhaps a lack of ability to focus on the subject at hand. After the initial visit it is up to the patient to request a follow up with the doctor, unless their condition is more serious or requires a stricter schedule. While there are many different prescription drugs abused, the most ... Get more on HelpWriting.net ...
  • 26. The Character Tommy In Kazuo Ishiguro's Never Let Me Go When we were born, the only thing we had was the genes that our father and mother had inherited us. Our life cannot be determined only by the genes that have been inherited by mom and dad. The genes that we have inherited are only like a "starter pack" of our life. All of our genes are made up of 23 pairs of chromosomes and are used to build our fundamental. However, these genes that we inherited cannot fully determine who we all are fully. One ordinary little tiny seeds itself cannot grow into a big strong tree all on its own. The seed is just the beginning of everything. As time goes on, we will gradually become stronger and more powerful from our experiences. The experiences that we gained will keep us steady from all the obstacles that we face in life. Our achievements will gradually transform us into becoming who we are now. With time, we will experience many different kinds of things, people, decision–making, situation, and etc.... These things will benefit us to becoming our better selves. In this paper, we are going to analyze the character Tommy in Kazuo Ishiguro's Never Let Me Go unfolding what makes us who we are through time tearing off our "labels" and showing our true self. In Kazuo Ishiguro's Never Let Me Go, the novel starts with our narrator Kathy sitting before the end of her life looking back at her childhood as a child in Hailsham, narrating her memories to us. The novel surrounds the life of three characters: Kathy, Tommy, and Ruth, who are all clones. ... Get more on HelpWriting.net ...
  • 27. Medical Fraud MEDICAL FRAUD In this abstract, I will explain the specifics of my research and a detailed outline of my paper. Understanding the topic of medical fraud and off labeling is important, especially for consumers who participate in the use of prescription drugs. It is imperative to understand what your doctor is prescribing and knowing the specific uses of said drug. Off labeling may occur and recognizing this fact will only benefit a wise consumer and make them aware of the risks of using a drug that was prescribed for a uses not on the label. This topic is especially important during the time of new Healthcare reform. Although it seems like we should be able to trust our doctors and believe what they tell us and the drugs they approve ... Show more content on Helpwriting.net ... While it would seem to be illegal to keep medical information from a patient, doctors are not required to tell a patient that a drug is being used off label. (Findlaw, 2009) A big example of what off labeling would be Aspirin, though not as seemingly harmful as other drugs could be. While aspirin has been a common pain reliever for more than 100 years, in 1988 doctors began recommending its use in preventing heart attacks. Many drugs are found to remedy ailments other than those they were originally intended to treat, and as prescription drug use has soared, patients are increasingly taking them for off label purposes. (Findlaw, 2009) With all of the off label drug use comes a lot of controversy as well. While it's understood that prescribing a drug for off label use is not considered illegal, the debate lies within whether the benefits outweigh the risk. So what can be risky about off labeling? Doctors emphasize that off label prescribing has its place in medical practice, but they also admit that using a drug off label can raise the risk of lawsuits should a patient have unwanted or bad side effects. In The Journal of Law,Medicine & Ethics, Joel Frader, MD states that "Off–label prescribing can expose patients to risky and ineffective treatments"(Vucci, 2009). In his further opinion, Frader emphasizes that although some off–label therapies can be beneficial and even lifesaving for some patients, in most cases, there is ... Get more on HelpWriting.net ...
  • 28. Does The Form Ask All To Determine What The Client's... Does the form ask all of the necessary questions to determine what the client's presenting problem is? The form has a question that asks what the problem(s) are that the person is seeking help for and includes 3 numbered lines for the response. However, this is not adequate to determine what the client's presenting problems are. This format assumes that the client is fully aware of the problems presented and that the client can articulate the problems easily and in a limited space. There is not enough room to adequately describe the presenting problem or problems and not enough prompting questions to uncover the problems if the client has a difficult time articulating them. Are there too many or too few questions? The form has too many ... Show more content on Helpwriting.net ... The population in the area the organization serves is overwhelmingly English speaking and there is no indication on the organization's website that there is any bilingual staff available. It does not appear that the organization intends to serve anyone that is not English speaking. For this reason, a form that is available solely in English seems appropriate. If there are individuals in the area that are monolingual in a language other than English, interpretation services would be needed. Is there enough space to write in what is needed in each answer space? There is not enough space to write in what is needed to provide an adequate response in each answer space. The font is small and there are no spaces between questions in many areas of the form. The length of blank lines provided for answers is determined by how close the last word of the question is to the end of the page and does not appear to be based on the amount of space needed to adequately answer the question. Should the intake form be reformatted so it is easier to read? The intake form should be reformatted so it is easier to read. The font is small and there are no spaces between questions in most areas. This makes the form look overwhelming at first glance. If someone was vision impaired, it would be difficult to see the questions. In some areas the layout of the form makes it easy to lose your place when answering questions. This is especially apparent in the areas requesting ... Get more on HelpWriting.net ...
  • 29. The Politics and Economics of FDA Drug Approval Essay The Politics and Economics of FDA Drug Approval The United Sates Food and Drug Administration has been protecting American consumers for around 70 years. The FDA assures the safety drugs, medical devices, chemicals, cosmetics, foods and additives by evaluating products for approval. Controversy has recently been surrounding the FDA's drug approval process, due to a general trend to get pharmaceuticals on the market more quickly. The FDA has been under pressure from congress and the public to speed approval, but pharmaceutical companies, who benefit more than anyone form accelerated drug approval, have also been applying pressure to the FDA through congress. The speeding of the approval process helps patients with incurable illnesses ... Show more content on Helpwriting.net ... The Radiation Control for Health and Safety Act guarantees consumers protection from excess radiation in certain devices. Lastly, The Public Health Service Act expanded the FDA's authority to cover serums and vaccines and also justified the inspections of restaurants (Food and Drug Administration [Britannica]). The FDA is adjusting to a switch in leader ship since Jane Heney, previously the FDA's deputy commissioner of operations, was nominated in June 1998. Heney, the first woman to head the FDA, has a packed resume that includes a vice presidency of the University of New Mexico and a specialization in cancer research. Her strategy for the future of the FDA includes the enforcement of new federal laws to modernize the FDA and addressing concerns about drug safety and approval speed, as well as controlling food contamination (Davis 5D). The FDA requires pharmaceutical companies to conduct years of research on their drugs before they begin the actual process approval. Drug companies submit test results to the FDA to be reviewed by their scientists; the FDA actually does no preliminary research on the drugs. In order to be approved, the companies must prove to the FDA that each drug is safe and effective and that the benefits of the drug must outweigh its side effects. The FDA has 800 to 900 employees involved in reviewing drugs before they get to the market. After a drug is approved, the FDA researches by collecting and analyzing thousands of reports each ... Get more on HelpWriting.net ...
  • 30. Quit Smoking Headline Headline: Prescription drugs to help you quit smoking – Off–label drugs Reference: Prescription Drugs to Help You Quit Smoking https://www.cancer.org/healthy/stay –away–from–tobacco/guide–quitting–smoking /prescription–drugs–to–help–you–quit–smoking.html Accessed February 6, 2017 Off–label Drug Use What is off–label drug use? https://www.cancer.org/treatment/treatments–and–side–effects/treatment–types/chemotherapy/off–label–drug–use.html Accessed February 6, 2017 Drugs Can Help You QuitSmoking http://www.health.com/health/condition–article/0,,20210994,00.html Accessed February 6, 2017 Written by: Hai Anh Nguyen Ngoc Reviewed by: Body text starts here: Opening: For people who want to quit smoking, there are various methods and approaches ... Show more content on Helpwriting.net ... Adiitionally, the dose should be lowered slowly, as a sudden stop during using this drug may bring about a range of severe effects. Clonidine Clonidine is another older drug that helps people quit smoking. It has been approved by the FDA to treat high blood pressure. If you want to use Clonodine, consult a doctor first. Most common side effects of Clonodine include dizziness, dry mouth, weakness, constipation, drowsiness, unusual tiredness. More severe ones are allergic reactions, a slow heart rate, and very high or very low blood pressure. The drugs can also affect the ability to drive or operate a machinery. Clonidine can be used 3 days before you quit, or the same day you stop smoking. It can be given a the form of a pill (cartillage) or a skin–patch. It should not be stopped suddenly, as unless the doses are lowered over 2 to 4 days, your blood pressure, agitation, confusion, or tremors will increase significantly. Closing: This method can only be used if you have a prescription from the doctors. Thus, consult with your health care provider carefully to find out what would suit
  • 31. ... Get more on HelpWriting.net ...
  • 32. Evergreen Management Essay Problem Statement: The main problem facing Evergreen management is how to make the promotion decision when the best candidate, Charlie Pace, is taking the medication off–label Adderall to enhance his working performance. Albert, a senior partner at Evergreen Investments, finds it difficult to make his final personnel decision which is fair for both Charlie Pace and Daniel Faraday as well as benefit the company in long term. Objective and Goal: The objective is to find the best candidate for the position of managing vice president of the company. A fair personnel decision will help all employees to believe that they have equal opportunities in working and rising to higher positions. Long term, the new manager will be able to contribute and ... Show more content on Helpwriting.net ... In fact, using Adderall and other cognitive– enhancing drugs in the workplace is a controversial issue for many companies. Similar to taking off–label medicines in football games, many people consider taking drugs in the workplace as an unethical action. If the management promote employees who use Adderall to boost their working performance, it will be unfair for others who only work by their natural abilities. In contrast, if the promotion is based on medicines usages, this will violate employees' privacy. Besides the ethical issues, the management should also consider the strategy issues in order to make a wise personnel decision. This means that the management should be able to predict how the decision affects the company in the future. For example, although Adderall and other cognitive–enhancing drugs can help people to feel stronger, more energetic and exciting, their benefits will dissipate after a period of time. If the employees stop taking Adderall, they might not maintain their working performance. As a result, their productivity might be decreased, and the profit of the company will be negatively affected. Some people believe Adderall may help them to improve their brainpower and concentration; however, others argue that they are unhealthy and cause a lot of serious side effects. Users have to suffer unexpected negative effects of this medicine and may ... Get more on HelpWriting.net ...
  • 33. Off Label Promotion : Profitable Health Jeopardizing Act... Off–label promotion: profitable health jeopardizing act of defiance or costly freedom of speech? INTRODUCTION Over the years there is the discussion on the nature of off–label promotion. Promotion for an unapproved by the Food and Drug Administration usage of a drug, medical device or biologic is prohibited by the 1938 Food, Drug and Cosmetics Act, and subjects the product to the misbranding provisions. On the other hand, off–label promotion is deemed to be a constitutional right protected by the First Amendment. Numerous debates, lawsuits and court rulings still don't clear up the dilemma of off–label promotion. HISTORY OF OFF–LABEL PROMOTION REGULATIONS Off–label use of drugs and medical devices is common practice in the United States. ... Show more content on Helpwriting.net ... Another law that imposes liability on healthcare manufacturers is the False Claim Act also known as Lincoln Law. Initially, the law was applied to people who defraud federal programs but in the late 90s the Act commenced to be applied to frauds associated with the promotions of the healthcare goods. The first recognition of off–label promotion was made in 1996 when Franklin v. Parke–Davis lawsuit was filed. Dr. David Franklin filed the False Claim Act case based on his concerns on his former employer's, pharmaceutical company Parker–Davis, off–label promotion of anti–epileptic drug Neurontin. The proposed claim that off–label promotion complies with the False Claim Act was new and controversial. It took 8 years of legal disputes to attain equally beneficial settlement of $430 million in fines and penalties. The Franklin v. Parker–Davis case set a precedent for numerous off–label promotion cases, which still remain urgent matter for both lawsuits and public debates. CLAIM ONE Off–label promotion is law–prohibited action, which is used to increase sales profits. The numerous cases were filled against the giant multinational corporations with allegation in fraud, kickbacks, noncompliance with established laws and regulations. Companies tend to commit the same mistakes year after year despite the existing precedents. What motivates manufacturers to take illegal actions? Why ... Get more on HelpWriting.net ...
  • 34. The Drug Of Prescription Drugs As the NFL grows in infamy from their many concussion scandals, the misusing of prescription drugs is overshadowed, but still remains as a major issue in the NFL. A huge problem facing the NFL today is the ill advised use of painkillers as it affects former players and current players alike. If nothing is done to stop this dilemma, players will continue to be affected by the accoutrements of painkillers. Only through DEA investigations, increased restrictions on prescription drugs, and increased monitoring of player's mental health, will we end the epidemic of the misuse of painkillers in the NFL. Background of the Problem As NFL players continue their careers, they become household names that people start to look up to as role models.... Show more content on Helpwriting.net ... With injuries plaguing the NFL, team doctors are able to use drugs such as prescription painkillers to allow players to play through pain. NFL team doctors are able to to receive and distribute illegal painkillers with ease. In a Vice Sports article about the suppliers of the NFL's painkiller addiction, Aaron Gordon states, "SportPharm,...from at least June of 2009 to June of 2010, illegally provided prescription drugs to 81 team doctors across American college and professional sports" (Gordon, 2014, para. 2). Many NFL team doctors claim that they did not know about the illegal drugs and that they only use these companies for their systems of business. Gordon expresses that in a U–T San Diego report written by Michael Lipman, NFL teams are not only using SportPharm, an unlicensed California Pharmacy, for their convenient tracking system, but for the buying of massive quantities of painkillers. These painkillers end up in the hands of the players who have the potential of misusing them from their intended use which can destroy their lives. One cause of professional football player's painkiller addictions is that Doctors feel pushed to have the players continue playing. Some doctors believe that if they do not load up their players with heavy drugs to be able to play, they will be let go from their ... Get more on HelpWriting.net ...
  • 35. The Use Of Off-Label Drug Use In Pediatrics Off–Label Drug Use in Pediatrics Off–label means the medication is being used in a manner not specified in the FDA's approved packaging label, or insert. Off–label prescribing occurs when a child receives a medication that has not received FDA approval for the child's age or diagnosis, it occurs when the patients have exhausted all other approved options, as may be the case with rare diseases or cancer. (WebMD, n.d) Off–label prescription lack information on the medication safety, efficacy, and proper use in children such as dosing and interactions and this has been associated with adverse drug events (Bazzano, Mangione–Smith, Schonlau, Suttorp, & Brook, 2009) The best clinical practice is still to use drugs with FDA indications when ... Show more content on Helpwriting.net ... Prescribing a drug off–label may be necessary when no FDA–approved drug is available due to lack of research. (Mayhew, 2009) A lack of suitable formulations exacerbates these problems. Many medicines have a bitter taste, which children may then refuse to take. Parents can worry about the health consequences of adding a spoonful of sugar or including other additives to improve palatability. In other cases, prescribers might need to measure a small fraction of an adult formulation and few package inserts offer adequate information to guide dosing, which further increase the risk of error (Tomlin & Morris, 2009) Strategies Use in Off–Label Medication Strategies to improve the off–label use and dosage of drugs for infants to adolescences are to make providers aware of how dangerous prescribing these medications can be. Ideally, children should receive drugs licensed for that age group. However, relatively few medications have undergone clinical trials in children and prescribing unlicensed medications is inevitable in many indications. Labeling medications properly with correct dosages as well as labeling them for whom they should be used or may help as well. When an unlicensed medicine is appropriate, health professionals should identify whether specials or imports are available. Off–label medicines may be appropriate if the patient requires urgent treatment, but are usually subjected to limited quality assurance. ... Get more on HelpWriting.net ...
  • 36. Wilbur Unisex Research Paper In a small, sleepy town in upstate New York, a devastating crime has been committed. Dr. Andreas Poppy was known to be a bit of a lazy doctor when making house calls. He would leave a "pill and a bill" and leave the rest up to fate. This earned him a few enemies along the way, but no one thought that he would ever be kidnapped and used for his access to prescription drugs. When Wilbur Unisex came upon the scene he was able to deduce that four men had been waiting to kidnap Dr. Poppy, take him, his drugs, and his prescription pad, and make a break for the Canadian border. The evidence in the room that Wilbur Unisex came upon points to four men as the culprits. First, the shelves along the wall held items that would indicate four people had been using the cabin. There were four sets of dishes and cups stacked on the shelves and there were large containers of food, which would indicate that more than one person was using the cabin. Another piece of evidence that suggest that four people were present was the arrangement of the room itself. There is evidence that there were three men playing cards at the table. There were three hands set up around the table.... Show more content on Helpwriting.net ... One can conclude that the men were from Canada from the coins they were using to gamble with. They left behind several Canadian coins on the table, which is a clear indication that they men were not from upstate New York. Another clue was left behind to tell police where they were planning on taking Dr. Poppy. A small map with an "X" marking a spot in Canada was lying carelessly on the floor by the door. There is also evidence that Dr. Poppy was taken, and not killed. Next to the map is what appears to be tape and rope. This would suggest that the men bound the doctor and took him with them on their trip back up to Canada. In Canada, the men hope to use Dr. Poppy to secure more prescription ... Get more on HelpWriting.net ...
  • 37. Drug Use Attention Deficit Hyperactive Disorder Essay Introduction Studies indicate as many as 34% of students at institutions of higher education in the United States of America have used Attention Deficit Hyperactive Disorder (ADHD) stimulants illegally (Desantis and Hane par. 5). This alarmingly high number begs the questions: Are these drugs dangerous? Do people think that it is acceptable to use neuroenhancers? More interestingly, though, could these drugs potentially academically benefit their consumers in an academic environment? Adderall is a drug used to increase the focus and concentration of someone with a mental disorder such as ADHD. Although illegal, these drugs are often used without a prescription by students. At one American university, 6.9% of students had admitted to using Adderall at least once in college (Desantis and Hane par. 4). This same study found that 81% of participants think that illegal use of Adderall is "'not dangerous at all' or only 'slightly dangerous'" and 0 of the 175 participants admitted to the knowledge that stimulants posed a significant health risk (Desantis and Hane par. 6) There is evidence from one study that these drugs can increase cognitive abilities, but there have been no conclusive studies that examined the negative side–effects of these drugs when used for non–medical reasons (Lucke, Bell, Partridge, and Hall par. 10). This suggests that neuroenhancing drugs could be used for the betterment of society. If effective, these drugs have the potential to increase efficiency in ... Get more on HelpWriting.net ...
  • 38. Argument For Coolmini CONSENT FOR ZELTIQ COOLMINIВ® CoolMiniВ® is a cryolipolytic process used in adults to treat visible fat and affect the appearance of lax tissue under the chin (submental area). CoolMiniВ® procedure uses a non–invasive vacuum applicator to draw in tissue and deliver controlled cooling at the surface of the skin to target and kill fat cells. Then, the body eliminates dead cells over a period of weeks. This improves appearance by helping you lose unwanted fat in your face and neck. Desired results may take more than one treatment. The results are long–term but vary by individual. Submental fat bulges and laxity are cosmetic issues that some people choose to treat; they do not require treatment. There are also many other treatment options ... Show more content on Helpwriting.net ... The procedure, as well as potential risks, benefits, have been fully explained. Common risks have been discussed, but not all potential risks are covered, and there may be other risks that are possible or unknown. Any factor that impairs healing may increase the risk of complications or a poor outcome. Examples of important risks include smoking, diabetes, immunocompromised conditions (e.g. steroid use), and collagen vascular disease (e.g. lupus, scleroderma). I understand that I may be at increased risk of complications if I have any risk factor that impairs healing. I understand that this procedure is purely elective. I can decide not to allow it at any time. I also understand that the results are not guaranteed, that outcomes are different with each individual, and that multiple treatments may be necessary. I also understand that I will be responsible for any future costs for treatments undertaken to improve, complete, or rectify the current ... Get more on HelpWriting.net ...
  • 39. A Brief Note On The Ethics Of Placebo 1.The Ethics of Placebo. In medical field, it is quite interesting considering how the brain works and the power of mind perception that can affect the overall body. In this case, placebos are examples that justify this. Placebos are mainly given to a patient to ease the pain and to satisfy their desire of wanting to receive a medical care or treatments or plainly just the desire of the doctor to help. Regarding to whether patient should be informed or not, I think that informing a patient is not obligatory when prescribing a placebo. Scientifically, it is proven that the use of placebo in treating some diseases seems to work effectively with or without deception. Kaptchuk et al. (2010) reported that nearly 60% of patients with irritable bowel syndrome felt better after knowingly consuming placebos (in the form of sugar pills) comparing to 35% of patients without such medication. But if we take an insight look at the research, even though the patients know about the placebo, the researchers however, also added that it has shown to promote or generate a self–healing processes related to mind–body connection. This implicates that it might not be the placebo itself that cause such placebo effects but how it is given in terms of addressing the message to the patients. In other words, they implanted a suggestion to the patients that even though it is just a sugar pill but it is proven to be useful that made patients became more convinced that it has the same effect as the actual ... Get more on HelpWriting.net ...
  • 40. Prescription Drug Promotion Essay The Office of Prescription Drug Promotion (OPDP) of the U.S Food and Drug Administration (FDA) has reviewed a print advertisement for the approved product LATISSEВ® (Bimatoprost Opthalmic Solution 0.03%) in various pharmaceutical journals and magazines. This print advertisement was found to have inadequate balance of benefit and risk information. As a result, LATISSEВ® print advertisement was found to violate PhRMA Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines. It specifically violates the guideline principle # 2, 10,11, 13, 14, 16. This print advertisement is concerning from a public health perspective because it creates a misleading and misinformed impression about the safety and approved indication for LATISSEВ® . Background Below are the indication and summary of the most serious and most common risks associated with the use of LATISSEВ®. According to its FDA–approved product labeling : LATISSEВ® is aprostaglandin analog, indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. Important limitations of Use: Use in pediatric patients below the age of 16 years is ... Show more content on Helpwriting.net ... LATISSEВ® solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated is required to be mentioned in the print advertisement. Also, the direction that it is important to apply LATISSEВ® only to theskin of the upper eyelid margin at the base of the eyelashes using the accompanying sterile applicators should have been mentioned to inform the patients about the proper usage of the product. Such statements raise considerable public health concerns and are particularly alarming when not informed in the ... Get more on HelpWriting.net ...