ipl-logo

Off-Regulatory Bodies: A Case Study

303 Words2 Pages

The principal objective of the drug regulatory bodies is to make sure that medicines are marketed only after appropriately scrutinized for their efficacy, safety and quality. Once the approval is granted, however, FDA (Food and Drug Administration) has a minimal role in determining whether drugs are prescribed for their approved uses as indicated on the product labels. Off-label drug use refers to the prescription of licensed drugs for clinical indications or in a manner different from that approved by the drug regulatory body. Off-label drug use takes many forms like use of drugs for an unapproved indication, in a patient population, through a route of administration, or with a dose not specified in the approved labelling (22).
Off-label

Show More
Related

  • Summary Of Stephanie Saul's Drug Makers Pay For Lunch

    469 Words  | 2 Pages

    A doctor should always take into consideration what is best for their patients without being influenced by anyone. In Stephanie Saul’s article “Drug Makers Pay for Lunch as they Pitch” she discusses how pharmaceutical companies use free lunches as an incentive to influence Doctors to prescribe their brand drugs. Many see this situation of pharmaceutical companies purchasing meals for a Doctor’s entire office as not having any effect on the doctor’s decision to prescribe their brand. The reality is that these free lunches do influence a doctor to prescribe a certain brand drug when writing a patient’s prescription. A doctor should consider what is the best option for a patient something that is affordable and if the case is that a name brand drug is the best option it should not be influenced by the pharmaceutical company in any way.

    Read More

  • Clostridium Difficile In Hospitals

    1149 Words  | 5 Pages

    Healthcare professionals must talk to their patients about possible side-effects of drugs they are taking and make sure they understand what can happen. In doing so, patients may start to understand why something is happening to them and it is a normal side-effect, which can not only lead to trust from the patients to providers, but can lead to the passing of knowledge from one to another which may prevent future

    Read More

  • Regulatory Compromise Chapter 3 Summary

    504 Words  | 3 Pages

    The Regulatory Compromise (Chapter three) starts off with discussing the influence that philanthropy had on politics around the time of the World Wars and depression of the early 20th century. One of the problems that existed at the time was the urge to influence laws with the power of philanthropy. An example of this is the court ruling against the validity of a gift for women’s rights because it was aimed to “directly and exclusively change the laws”. During this time, being philanthropic in order to gain political power, or change laws, was not accepted. There were certain rules against whether or not a charitable gift was even considered “charitable” depending on the purpose it was meant to serve.

    Read More

  • Meat Labeling Industry In Upton Sinclair's The Jungle

    1028 Words  | 5 Pages

    They are also supposed to inspect the factories at which these drugs are made to make sure that they are safe and clean factories. Yet last year there was only enough inspectors to inspect “13 of the 713 Chinese factories that produce medicine for U.S consumers”, despite the rising concern about Chinese drugs and their safety. So there is no way to know how safe and clean the working conditions are of these other seven hundred Chinese factories that these drugs were made in. But with only $2 billion there is no way to employee enough employees to conduct these inspections and investigate every drug thoroughly. Some believe that it is not a lack of funding that prevents the FDA from doing their job, it is

    Read More

  • How Did The Demise Of The Regulators

    849 Words  | 4 Pages

    The Regulators, like the Sons of Liberty fought the corruption of the government during the years that lead up to the American Revolution. However, unlike the Sons of Liberty, the Regulators did not use violence to get their points across. They resorted to removing corrupt government officials and electing their own leaders into office. From the very beginning, the Piedmont backcountry farmers from North Carolina suffered enormous opposition from the wealthy elites, as well as the Governor of North Carolina himself. It seemed that Governor William Tryon made it his goal in life to disband the Regulators, and in the end he was successful.

    Read More

  • The Regulator Movement

    528 Words  | 3 Pages

    The village of Paxton was located in eastern Pennsylvania. Paxton became a place of political and racial unrest during Pontiac’s Rebellion. Paxton was still part of the frontier until the 1760’s and was populated by Scots-Irish. They requested soldiers and weapons because of their vulnerability to attack. Their request was ignored because of the legislators who were Quakers.

    Read More

  • Government Regulatory Considerations

    795 Words  | 4 Pages

    I would advise to accept the promotion. Even though taking this promotion would bump him up to the next tax bracket, I would reassure my friend that because our tax code is marginalized, “you’ll never take home less than you earn” (Video Engager, 2016). A marginalized tax code guarantees that you only pay income tax on the amount of money that you make above the tax bracket that you are in. this assures that you will not take home less income because of a higher tax bracket.

    Read More

  • Adderall Argumentative Essay

    849 Words  | 4 Pages

    There 's plenty of drugs the world may think is fine to use only because it 's given to you by a doctor. All prescribed drugs are made to help someone in some kind of way; some drugs are being issued without having the focus on how it can affect the patient in a harmful way. In most cases, these drugs are free based on the patient health insurance, which may cause some to take advantage of the treatments. In that case, both the doctor and patient should be aware of the uses, abuses and side effects of these drugs such as Adderall. Adderall is a commonly prescribed drug that is known for treating mostly kids.

    Read More

  • Off Label Drugs Essay

    596 Words  | 3 Pages

    Off-label Drugs Use in Pediatrics Off-label is the use of drugs that are not officially approved by the FDA; however, for children, this is common because for years there are no studies on medical products that are approved for children with therapeutic needs (Haslund-Krog et al. 2014). When children are sick, parents and caregivers are frustrated and want drugs for the diagnose, this leaves the healthcare professional to find proper medications that will treat the problem. According to Magalhães et al. (2015), drugs go through a clinical trial that is approved for safety before being marketed; this is usually under a selected population. Unfortunately, the pediatric population has been left out without a proper clinical trial.

    Read More

  • Generic Medication Pros And Cons

    1714 Words  | 7 Pages

    The brand name must either update their labeling or the generic manufacturer can ask the FDA to initiate a label change. If the FDA agrees with the label change proposed by the generic manufacturer, the manufacturer can ask and pressure the brand-name manufacturer to change its label, ultimately triggering a change in the generics label. One way that generic manufacturers can change part of its label on its own is through the FDA’s “changes being effected” (CBE) regulation. The CBE regulation allows “certain preapprov[ed] labeling changes that add or strengthen a warning to improve drug safety.” Another way generic manufacturers can warn the medical community about warnings pertaining to its medication, which are not present on its label is by sending “Dear Doctor” letters.

    Read More

  • Regulatory Bodies In Schools

    835 Words  | 4 Pages

    Legislations affect how schools work by ensuring that pupils, staff, parents, and visitors are safe in the school setting. The legislation in schools allows pupils and staff to be aware of their rights within the school setting. The legislations are put in place to ensure that children are in a safe environment to learn and continue learning. The legislation allows the school setting to run smoothly as the legislations are being adhered to by staff and pupils which helps keep the school setting calm. 4.3 Explain the roles of regulatory bodies relevant to the education sector which exist to monitor and enforce the legislative framework including: .

    Read More

  • Clinical Audit Assignment

    2077 Words  | 9 Pages

    Drug Kardexes were gathered and audited under certain criteria in order to identify potential risk areas in drug prescribing and administration, and also to provide ways in which these risks can be reduced or eliminated and reinforce drug management policies’ and guidelines. NICE (2002) audit cycle will be applied to this assignment to provide an acceptable framework (Appendix 1). Step 1: Preparing for Audit. The first step in the audit process is to identify which type of audit is to be carried out.

    Read More

  • Their Structure And Powers, Part I: Administrative Agencies

    268 Words  | 2 Pages

    Part I: Administrative Agencies: Their Structure and Powers Congress authorizes these agencies to make rules to deal with problems they don't want to deal with. Congress ultimately doesn't want to make hard decisions because the negative effects opposition to these decisions cause; and these agencies may develop and implement the most intrusive or controversial policies. Regulations are put in place to create protection for people and for the world that we live in. These regulations regulate “virtually every aspect of modern business life, including the natural environment, corporate finance, transportation, telecommunications, energy, labor relations, and trade practices.” This will protect us from things like monopolies; and will allow

    Read More

  • The Pros And Cons Of Government Regulations

    207 Words  | 1 Pages

    In conclusion, there is proof to support both sides of the argument that can be backed statistically and with other evidence. Some may choose sides and say that jobs are killed completely as more and more regulations are put forth by the government and be completely against them or others may believe that government regulations are a good thing and that they may cause some jobs to be lost but that in the long run, regulations are best for the good of the world around them. In my opinion, after researching both sides, I feel that government regulations are not as big of threat to jobs as some may think. Often times it seems that other reasons for jobs being killed are blamed on the government regulations when it is more than likely a result

    Read More

  • Regulation Vs Deregulation

    973 Words  | 4 Pages

    Regulation vs. Deregulation The question of whether transportation should be regulated or deregulated is a critically important one. Regulation in the context of transportation may fall into different categories including the regulation of the quality of product such as safety, etc. (Savage, 2006). More importantly, regulation in the context of transportation pertains to the economic forms of regulation such as regulation pertaining to “prices, output, entry and exit” (Savage, 2006).

    Read More

More about Off-Regulatory Bodies: A Case Study

Open Document