Assignment: For this assignment, you will synthesize scientific research with relevant health policy, and write a professional editorial piece for public

Instructions
As a healthcare professional, effective communication is an essential skill for you to have. For this assignment, you will synthesize scientific research with relevant health policy, and write a professional editorial piece for public consumption.

Your role: Content contributor for The American Journal of Nursing

Audience: Healthcare professionals, nursing and administrative.

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Format: 3-page paper, editorial style. Plus, a cover and reference page. A minimum of three scholarly sources should be included. In-text citations are required. APA style should be followed throughout.

Refer to the article Engaging policy in science writing: Patterns and strategies within Unit 3 Topic 2 for additional guidance on using the “push” style of writing.
Structure:

Choose any scientific research topic, with relevant and reliable scholarly sources available for you to review. If your background is clinical, your focus may be heavy on the science or clinical elements. If your background is more administrative, you may choose research which is more closely related to a social issue (such as emergency contraceptives, vaping use, etc.)
Choose a policy or proposed policy that directly relates to your area of scientific research.
Write an editorial article, approximately 3 pages in length, summarizing the scientific research on your chosen topic, and aligning it with relevant health policy. Explain the need for increased awareness around the topic:
Who needs to do something about it,
When action is needed,
What that action could look like, and
Why such action will positively influence the future of healthcare.
Submit
Word document

Assignment Resource(s)
The American Journal of Nursing website: https://journals.lww.com/ajnonline/pages/default.aspx

Ruhl, J. B., Posner, S. M., & Ricketts, T. H. (2019). Engaging policy in science writing: Patterns and strategies. PLoS One, 14(8) http://dx.doi.org/10.1371/journal.pone.0220497

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Assignment Paper

Over the past few years, there has been controversial news pertaining prescription drug area after the Food and Drug Administration (FDA) linked with a series of controversial drug approval, an instance that has evoked the need for drug pricing reforms. When reflecting on the criteria that FDA applies when approving medication, it poses different questions concerning the drug manufacturer’s and user’s plight. For instance, over the years, there has been an issue in approving Alzheimer’s medication. However, in June 2021, the FDA approved Aduhelm, a medication essential in treating Alzheimer’s illness (Karlawish & Grill, 2021). The surprising part concerns how FDA’s advisory committee backlashed the ineffectiveness of the FDA in approving the drug since it had earlier on experienced different controversies. There has been a fallout among committee members from such a misunderstanding, considering that some FDA advisory committee quit their jobs after learning that the agency approved the drug.

In the medical field, evidence-based research is essential since it helps the stakeholders assess the effectiveness of a process to ensure that it is safe for all target patient populations. Hence, some of the advisory board reacted because they felt belittled by the agency approving the medication without following the due process. The fallout of the FDA and its advisory committee after approving Aduhelm has triggered internal conflicts since FDA also experiences opposition from other key players in the industry(Karlawish & Grill, 2021). Some of these players include the hospital systems, where most have shown no faith in the new approved Alzheimer’s treatment; thus, they do not even administer or prescribe Aduhelm. There is also a decline in funding from key insurers since they do not feel comfortable funding an approved drug without clinical evidence proving that the drug will not harm the patients. All these are summed up by the ongoing case concerning a patient that succumbed while undergoing Aduhelm in its trial. Initially, Aduhelm has had many controversies since its price was set at £56000 despite its uncertainty about clinical efficacy. Such pricing has also triggered the Alzheimer association, which greatly criticized the drug pricing immediately after its approval

Medical experts also presented their concerns, indicating that if Aduhelm is accepted in prescription, it will cause other cost-related implications for its beneficiaries and medicare. Due to such backlash, Biogen decided to cut the price of the drug but half from its initial price after they experienced weak sales, though, despite the drug price, it was still way above average(Karlawish & Grill, 2021). The FDA’s move to approve a drug whose evidence-based research does not have enough evidence can contribute to a lack of trust, thus affecting the patient’s overall well-being. That means the FDA will continue having serious problems while implementing health policy. That is because, when FDA was approving the rejected drug, there were existing policies that the agency overlooked. However, there is a need for all stakeholders that work with FDA to ensure that reforms are made in the agency. FDA reforms will be essential to ensure that the agency starts to resonate with other stakeholders and regain its initial trust and transparency. All stakeholders will need to be addressed when evaluating the possible policy reforms. These stakeholders include the patients, nurses, physicians, and FDA serving members. The reason why the involvement of these stakeholders matters is to prevent instances where the FDA will ever approve any medication that is below standard to avoid harming the patients

The main issues that influence reform processes regard the slow legislative process. That is because there are various pending bills concerning drug pricing, which is an issue that influences not only the patient but also some federal bodies that cater to the well-being of the patients like medicare. However, by the looks of things, President Joe Biden’s administration has taken the issue seriously and commissioned a comprehensive plan to address high drug costs. (Collington & Lazonick, 2022). In most cases, these issues of overpricing drugs concern the issue of monopoly where drug manufacturers and distributors fail to have competition, thus taking advantage of such situations, not knowing that by the end of the day, it is the patients that will suffer more since most cannot afford high rate drugs. Hence, just like the President has enrolled the plan on drug pricing, there is also a need to formulate effective policies to regulate the functionality of the FDA, which should prohibit the agency from approving any drug that is below the expected quality. Also, the medical team should emphasize the need for evidence-based research that will enable the agency to only deal with important data when making decisions (Portney, 2020). Above all, the prescription drug policy is still viable since the pharmaceutical regulators and other nurse representatives will advocate for the reduction of drug pricing. However, the FDA’s decision to approve Aduhelm without sufficient evidence is an issue that will continue causing complications especially for federal agencies since they can no longer be trusted with patients’ health since there is already evidence of the FDA’s ignorance. The controversy will also influence the pharmaceutical industry since they must engage in proper evidence-based research to prevent manufacturing a drug that will have lower or no profit to the company.

References

Collington, R., & Lazonick, W. (2022). Pricing for Medicine Innovation: A Regulatory Approach to Support Drug Development and Patient Access. Institute for New Economic Thinking Working Paper Series, (176). https://ssrn.com/abstract=4057643

Karlawish, J., & Grill, J. D. (2021). The approval of Aduhelm risks eroding public trust in Alzheimer research and the FDA. Nature Reviews Neurology, 17(9), 523-524. https://doi.org/10.1038/s41582-021-00540-6

Portney, L. G. (2020). Foundations of clinical research: applications to evidence-based practice. FA Davis.