The Use Of Off-Label Drug Use In Pediatrics

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

Due to these incidents and many severe cases of drug side effects that had happened in the past including deaths, the current way drugs are developed and approved are unethical. Therefore, reform in FDA’s management as well as the guidelines is necessary to strengthen safety standards and eliminate problems regarding drug development and regulation.

Compliance how do we prescribe better tasting medication without the child really loving the taste. depending on the age of the child, we do not want them to love it,We want them to tolerate it. Safety and completely understanding the challenge of the pediatric community starts with the one who prescribes the medication . I agree with you we must also look at care givers, So much must be taken into consideration before writing that

All staff at Gap know that this should be strictly adhered to as the aim of the policy is to protect us and the children against medication errors. The dose and frequency of a child’s medication should be very clearly stated and must always be followed exactly, this is because there is considerable risk of harming a child if they are given medication that has not been prescribed to them or if the medication they do need is given to them at the wrong time or in the wrong amount. If a member of staff were to issue a child with incorrect medicine then they could well face losing their job or end up entering a lawsuit, especially if a child becomes seriously ill.

The dangers and possible harmful effects that these medications hold for a young child will not help the parents feel too convinced about the usage of medication. As stated in Time this month, “We know that kids are not just little adults, they metabolize medications differently” (Kluger, et al). Parents might feel scared or reluctant to administer medication after hearing assertions about the dangers. Parents worry enough about their kids everyday without the use of a strong medication. The tendency to assume that doctors fear the usage of medication in children is overwhelming. It is more than clear to see why parents, or anyone affected by this disorder

Risk assessment is a powerful means by which individual children can be encouraged to manage their own medication. Through agreeing a number of risks of a child administering their own medication such as giving themselves an incorrect dose, procedures can be put into place

Improve the safety of using medications. The findings were that often medication error were made because medications and other solutions were removed from their original

In states where school nurses are allowed to delegate some of their functions, nurses should only delegate administration of medications when it is safe for the students. School nurses should never delegate medication administration in cases of an unreasonable risk or harm to the student. Doing so, the nurse could be considered for disciplinary action, even if the state law provides immunity from civil liability (Schwab & Gelfman, 2005). Although state laws may allow for the delegation of the administration of oral medications, delegating other forms of medicines, including injectable, intravenous, or rectal medications is often prohibited. In fact, delegation of injectable medications may be limited to life-saving situations (Department of Health,

Medication errors are focused on: terms and definitions; incidence of and harm; risk factors; avoidance; disclosure, legalities & consequences (Wittich, Burkle & Lanier, 2014). Medication errors categories have been developed by the American Society of Health-System Pharmacists (ASHP). Examples of these categories are based on prescribing, omitting drugs not administered, timing, unauthorized drug, wrong dosage, wrong preparation, expired drug, not using laboratory data to monitor toxicity (Wittich, Burkle & Lanier, 2014). Additionally, this article examines in depth common causes leading to medication errors, drug nomenclature, similar sounding drugs, unapproved abbreviations and handwriting, medical staff shortages and manufacturer medication shortages. Even though this article provides an informative overview for physicians, other allied health personnel may benefit too. This is valuable knowledge for the health care professional not just physicians in order to provide safe care for their

Many Americans continue to believe that if a medication has been approved by the FDA it is safe for us to use, but the facts are many times they are not. You only have to look at all the medications that have been pulled from the market after many people lost their lives or had their health decay from these medications to know that nothing could be further from the truth. It helps to find a physician who will tell you to change your lifestyle rather than prescribe a pill that might have harmful side effects.

The court found in favor of the manufacturer stating “federal law still preempted injured patients from bringing lawsuits in state courts, because the state laws in question require a safer label, not communicating with the FDA about the possibility of creating a safer label,” (Glantz & Annas, 2011, p. 682). Despite this regulatory standing, a controversial issue may entail for the FDA in the allowance of medications to be “interchanged” to promote an additional avenue for savings in prescription medications. Much foresight needs to be included to protect the safety and well-being of patients.

The next level of concern arises with what exactly is being given out. While many pharmaceutical companies swear by their products, it is easy to forget that at the end of the day they are

Moreover, patients often have less knowledge than the prescriber does about the appropriateness of the drug, where it can be very misinforming for the consumer. Lastly, drug efficacy is a problem in all contexts. Since stakeholders are likely, less informed than manufacturers it causes both the consumer and prescriber to depend on the manufacturer for information of the effectiveness of the drug (Bennett, Quick, Velasquez, 2016).

One of the multiple dangers of giving a child over the counter cough and cold medication is mixing two or more different medications. “There were additional 26 cases of ADR’s to OTC medications that involved more than one product and were excluded from consideration” (Vassilev 316). Due to the fact that there was not only a dozen but more than two dozen people that overdosed their children on over the counter medication because they gave them more than one medication that lead to an overdose is to many Cough and cold medication is any medication that includes more than one antihistamine, decongestant, expectorant, or antitussive taken by mouth. The common ingredients in cough medications are diphenhydramine, doxylamine, phenylephrine, and pseudoephedrine which is linked to the most deaths. The side effects for the types of medications are cardiac arrhythmias for decongestants, hallucinations for antihistamines, and an altered level of consciousness for antitussives. Around 7000 children are treated for secondary side effects each year in emergency departments due to cough medications. The three biggest reasons that people overdose on these medications is because they receive the medicine to often, they are receiving to big of a dose, or they are receiving multiple cough medications containing the same ingredient (Lazarus 534). With all the information about cough and cold medication that they have out there and the warnings on the medication bottle labels, it does not seem

In the United States, a drug can only be advertised legally after being approved by the Food and Drug Administration (FDA). Once attaining at least one FDA-approved use, physicians can prescribe a drug for other unapproved uses, based on their clinical judgment; this is referred to as “off-label use” (McCambridge, 2008). In general, marketing drugs for off-label uses is illegal; however, pharmaceutical companies have gone to various lengths within their legal rights to accomplish exactly that.