Browsing by Subject "nephrology"

Now showing 1 - 4 of 4
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    The aftermath of coronavirus disease of 2019: devastation or a new dawn for nephrology?
    (Oxford, 2020) Agarwal, Rajiv; Medicine, School of Medicine
    The acute crisis with the coronavirus disease of 2019 (COVID-19) caused by the novel coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) is the largest biomedical catastrophe of our lifetimes. Like so many other disasters in the past, such as war, famine, social unrest and economic calamities, this too shall pass, but it will undoubtedly leave the world changed. Some of the changes are already evident, but some are inevitable once we get over this pandemic. In this perspective, I provide examples of how the virus is already inducing change in the practice of medicine at large and for nephrology in particular. As is true for many changes, some persist after the emergency is over, so I speculate on how nephrology may change once we surmount this predicament (Figure 1).
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    Big data in nephrology-a time to rethink
    (Oxford, 2018) Agarwal, Rajiv; Sinha, Arjun D.; Medicine, School of Medicine
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    Biosimilars—Emerging Role in Nephrology
    (American Society of Nephrology, 2019-09-01) Wish, Jay B.; Medicine, School of Medicine
    The Food and Drug Administration (FDA) defines a “biosimilar” agent as a biologic that is highly similar to the reference or originator biologic product notwithstanding minor differences in clinically inactive components with no clinically meaningful differences in terms of the safety, purity, and potency. The advantage of biosimilars is that they are usually about 15%–30% less expensive than the reference product, which results in system-wide cost savings and increased patient access. Because biologic drugs are produced by living organisms, they are by nature heterogeneous and identical copies cannot be made, unlike generic versions of small-molecule drugs. Proposed biosimilars must undergo a rigorous evaluation process to demonstrate a high degree of structural and functional similarity with the reference biologic. Once that is confirmed, a stepwise process of comparison with the reference agent with regard to animal trials, pharmacokinetics/pharmacodynamics, immunogenicity, and human efficacy/safety is conducted. The experience with biosimilars in other highly regulated markets where patent protection for originator biologics is not as robust as in the United States has been favorable in terms of safety, efficacy, and cost savings. An FDA approval pathway was created in 2009 to expedite the approval of biosimilars; as of early 2018 nine agents had been approved through that pathway, none in nephrology. The first United States biosimilar epoetin was approved on May 15, 2018, but does not have an interchangeability designation, meaning that prescribers must specifically write for the biosimilar product for patients to receive it. Given the unfamiliarity of biosimilars within the nephrology community it is recommended that educational programs be developed to address this unmet need and for research to be conducted addressing the perceptual, clinical, and economic effect of biosimilars on our patients.
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    Evidence-based development of a nephrotoxic medication list to screen for acute kidney injury risk in hospitalized children
    (Oxford, 2019-10-30) Goswami, Elizabeth; Ogden, Richard K.; Bennett, William E, Jr.; Goldstein, Stuart L; Hackbarth, Richard; Somers, Michael J G; Yonekawa, Karyn; Misurac, Jason; Pediatrics, School of Medicine
    Purpose Medications are commonly associated with acute kidney injury (AKI). However, in both clinical practice and research, consideration of specific medications as nephrotoxic varies widely. The Nephrotoxic Injury Negated by Just-in-time Action quality improvement collaborative was formed to focus on prevention or reduction of nephrotoxic medication-associated AKI in noncritically ill hospitalized children. However, there were discrepancies among institutions as to which medications should be considered nephrotoxic. The collaborative convened a Nephrotoxic Medication (NTMx) Subcommittee to develop a consensus for the classification of nephrotoxic medications. Summary The NTMx Subcommittee initially included pediatric nephrologists, a pharmacist, and a pediatric intensivist. The committee reviewed NTMx lists from the collaborative and identified changes from the initial NTMx list. The NTMx Subcommittee conducted a literature review of the disputed medications and assigned an evidence grade based on the reported association with nephrotoxicity and the quality of the data. The association between medication exposure and AKI was also determined using administrative data from the Pediatric Health Information Systems database. The NTMx Subcommittee then came to a majority consensus regarding which medications should be included on the list. The subcommittee’s recommendations were presented to the larger collaborative for approval, and consensus was achieved. The list continues to be reviewed and updated annually. Conclusion Formation of a multicenter quality-improvement initiative exposed current limitations as to which medications are considered nephrotoxic in clinical and research settings and presented an opportunity to approach this problem using an evidence-based process. A consensus definition of nephrotoxic-medication exposure was achieved.