Study Objective
Acute kidney injury (AKI) is a common condition associated with both short‐term and long‐term consequences including dialysis, chronic kidney disease, and mortality. Although the ...United States Food and Drug Administration Adverse Event Reporting System (FAERS) database is a powerful tool to examine drug‐associated events, to our knowledge, no study has analyzed this database to identify the most common drugs reported with AKI. The objective of this study was to analyze AKI reports and associated medications in the FAERS database.
Design
Retrospective pharmacovigilance disproportionality analysis.
Data Source
Food and Drug Administration Adverse Event Reporting System database.
Measurements and Main Results
We queried the FAERS database for reports of AKI from 2004 quarter 1 through 2015 quarter 3. Extracted drugs were assessed using published references and categorized as known, possible, or new potential nephrotoxins. The reporting odds ratio (ROR), a measure of reporting disproportionality, was calculated for the 20 most frequently reported drugs in each category. We retrieved 7,241,385 adverse event reports, of which 193,996 (2.7%) included a report of AKI. Of the AKI reports, 16.5% were known nephrotoxins, 18.6% were possible nephrotoxins, and 64.8% were new potential nephrotoxins. Among the most commonly reported drugs, those with the highest AKI ROR were aprotinin (7614 reports; ROR 115.70, 95% confidence interval CI 110.63–121.01), sodium phosphate (1687 reports; ROR 55.81, 95% CI 51.78–60.17), furosemide (1743 reports; ROR 12.61, 95% CI 11.94–13.32), vancomycin (1270 reports, ROR 12.19, 95% CI 11.45–12.99), and metformin (4701 reports; ROR 10.65, 95% CI 10.31–11.00). The combined RORs for the 20 most frequently reported drugs with each nephrotoxin classification were 3.71 (95% CI 3.66–3.76) for known nephrotoxins, 2.09 (95% CI 2.06–2.12) for possible nephrotoxins, and 1.55 (95% CI 1.53–1.57) for new potential nephrotoxins.
Conclusion
Acute kidney injury was a common reason for adverse event reporting in the FAERS. Most AKI reports were generated for medications not recognized as nephrotoxic according to our classification system. This report provides data on medications needing further research to determine the risk of AKI with these new potential nephrotoxins.
IMPORTANCE:Recent reports identify that among hospitalized coronavirus disease 2019 patients, 30% require ICU care. Understanding ICU resource needs remains an essential component of meeting current ...and projected needs of critically ill coronavirus disease 2019 patients.
OBJECTIVES:This study queried U.S. ICU clinician perspectives on challenging aspects of care in managing coronavirus disease 2019 patients, current and anticipated resource demands, and personal stress.
DESIGN, SETTING, AND PARTICIPANTS:Using a descriptive survey methodology, an anonymous web-based survey was administered from April 7, 2020, to April 22, 2020 (email and newsletter) to query members of U.S. national critical care organizations.
MEASUREMENTS AND MAIN RESULTS:Through a 16-item descriptive questionnaire, ICU clinician perceptions were assessed regarding current and emerging critical ICU needs in managing the severe acute respiratory syndrome coronavirus 2 infected patients, resource levels, concerns about being exposed to severe acute respiratory syndrome coronavirus 2, and perceived level of personal stress. A total of 9,120 ICU clinicians responded to the survey, representing all 50 U.S. states, with 4,106 (56.9%) working in states with 20,000 or more coronavirus disease 2019 cases. The 7,317 respondents who indicated their profession included ICU nurses (n = 6,731, 91.3%), advanced practice providers (nurse practitioners and physician assistants; n = 334, 4.5%), physicians (n = 212, 2.9%), respiratory therapists (n = 31, 0.4%), and pharmacists (n = 30, 0.4%). A majority (n = 6,510, 88%) reported having cared for a patient with presumed or confirmed coronavirus disease 2019. The most critical ICU needs identified were personal protective equipment, specifically N95 respirator availability, and ICU staffing. Minimizing healthcare worker virus exposure during care was believed to be the most challenging aspect of coronavirus disease 2019 patient care (n = 2,323, 30.9%). Nurses report a high level of concern about exposing family members to severe acute respiratory syndrome coronavirus 2 (median score of 10 on 0–10 scale). Similarly, the level of concern reached the maximum score of 10 in ICU clinicians who had provided care to coronavirus disease 2019 patients.
CONCLUSIONS:This national ICU clinician survey identifies continued concerns regarding personal protective equipment supplies with the chief issue being N95 respirator availability. As the pandemic continues, ICU clinicians anticipate a number of limited resources that may impact ICU care including personnel, capacity, and surge potential, as well as staff and subsequent family members exposure to severe acute respiratory syndrome coronavirus 2. These persistent concerns greatly magnify personal stress, offering a therapeutic target for professional organization and facility intervention efforts.
Consensus definitions have been reached for both acute kidney injury (AKI) and chronic kidney disease (CKD) and these definitions are now routinely used in research and clinical practice. The KDIGO ...guideline defines AKI as an abrupt decrease in kidney function occurring over 7 days or less, whereas CKD is defined by the persistence of kidney disease for a period of >90 days. AKI and CKD are increasingly recognized as related entities and in some instances probably represent a continuum of the disease process. For patients in whom pathophysiologic processes are ongoing, the term acute kidney disease (AKD) has been proposed to define the course of disease after AKI; however, definitions of AKD and strategies for the management of patients with AKD are not currently available. In this consensus statement, the Acute Disease Quality Initiative (ADQI) proposes definitions, staging criteria for AKD, and strategies for the management of affected patients. We also make recommendations for areas of future research, which aim to improve understanding of the underlying processes and improve outcomes for patients with AKD.
Utilization of telemedicine allows pharmacists to extend the reach of clinical interventions, connecting them with patients and providers, but the overall impact of these services is under-studied.
...Identify the impact of clinical pharmacist telemedicine interventions on clinical outcomes, subsequently defined as clinical disease management, patient self-management, and adherence, in outpatient or ambulatory settings.
A literature search was conducted from database inception through May 2016 in Medline, SCOPUS, and EMBASE. Broad terms “telemedicine”, “telehealth”, and “telephone” were used in combination with “pharmacist” or “pharmacy” and “telepharmacy”. The search and extraction process followed PRISMA guidelines. Results were screened for pharmacist interventions and reviewed to identify studies in outpatient our ambulatory settings. Studies of non-clinical outcomes (i.e. dispensing or product preparation) and with no comparator were excluded. The final studies were categorized by types of outcomes reported: clinical disease management, patient self-management, and adherence.
Only 34 studies measured clinical outcomes against a comparator, consistent with the research question. The majority utilized scheduled models of care (n = 29). Telephone was the most common communication method (n = 25). The most utilized interventions were pharmacist-led telephonic clinics (n = 10). Most studies focused on chronic disease management in adults including hypertension, diabetes, anticoagulation, depression, hyperlipidemia, asthma, heart failure, HIV, PTSD, CKD, stroke, COPD and smoking cessation. Twenty-three studies had a positive impact with one reporting negative results. Higher positive impact rate was observed for scheduled (72.4%, 21/29) and continuous (100%, 2/2) models compared to responsive/reactive (25%, 1/4).
Clinical pharmacy telemedicine interventions in the outpatient or ambulatory setting, primarily via phone, have an overall positive impact on outcomes related to clinical disease management, patient self-management, and adherence in the management of chronic diseases. Commonalities among studies with positive impact included utilization of continuous or scheduled models via telephone, with frequent monitoring and interventions. Studies identified did not evaluate benefits of video capability over telephone or cost-effectiveness, both of which are useful directions for future study.
As more specialized care gets centralized in centers of excellence, patients admitted to rural hospitals may be at a disadvantage at the time of accessing expertise or receiving advanced care. In ...this setting, telemedicine models provide a justification to equalize care across different levels. The diversity in telemedicine services is vast and is expanding. Even with all the subsets of telemedicine, including telepharmacy, telestroke, teledialysis, and tele-emergency medicine, the reasons for providing services and associated limitations are similar. However, there is a lack of empirical research including best practices and resultant outcomes for these subsets of telemedicine models.
Over the last decade, the discovery of novel renal biomarkers and research on their use to improve medication effectiveness and safety has expanded considerably. Pharmacists are uniquely positioned ...to leverage this new technology for renal assessment to improve medication dosing and monitoring. Serum cystatin C is a relatively new, inexpensive, functional renal biomarker that responds more quickly to changing renal function than creatinine and is not meaningfully affected by age, sex, skeletal muscle mass, dietary intake, or deconditioning. Cystatin C has been proposed as an adjunct or alternative to creatinine for glomerular filtration rate assessment and estimation of drug clearance. Tissue inhibitor of metalloproteinase‐2·insulin‐like growth factor‐binding protein 7 (TIMP‐2·IGFBP7) is a composite of two damage biomarkers released into the urine at a checkpoint in mitosis when renal cells undergo stress or sense a future risk of damage. Concentrations of TIMP‐2·IGFBP7 increase before a rise in serum creatinine is evident, thus providing insightful information for evaluation in the context of other patient data to predict the risk for impending kidney injury. This article provides a brief overview of novel renal biomarkers being used as a mechanism to improve medication safety including a discussion of cystatin C, as part of drug‐dosing algorithms and specifically for vancomycin dosing, and the use of TIMP‐2·IGFBP7 for risk prediction in acute kidney injury and drug‐induced kidney disease. Select cases of clinical experience with novel renal biomarkers are outlined, and lessons learned and future applications are described.
Shock syndromes are associated with unacceptably high rates of mortality in critically ill patients despite advances in therapeutic options. Vasodilatory shock is the most common type encountered in ...the intensive care unit. It is manifested by cardiovascular failure, peripheral vasodilatation, and arterial hypotension leading to tissue hypoperfusion and organ failure. Hemodynamic support is typically initiated with fluid resuscitation strategies and administration of adrenergic vasopressor agents in nonresponsive patients to restore arterial pressure with subsequent adequate organ reperfusion. Unfortunately, high catecholamine dosing requirements may be necessary to achieve targeted hemodynamic goals that may increase the risk of vasopressor‐induced adverse events. The purpose of this article is to review the clinical efficacy and safety data and potential role in therapy for catecholamine‐sparing agents in vasodilatory shock. Adjunctive therapeutic options to reduce vasoactive support requirements without compromising arterial pressure include arginine vasopressin and analogs, corticosteroids, midodrine, methylene blue, and angiotensin II. Although concomitant vasopressin and corticosteroids have a more defined role in evidence‐based guidelines for managing shock, clinicians may consider other potential catecholamine‐sparing agents.
Sepsis-associated acute kidney injury (SA-AKI) is common in critically ill patients and is strongly associated with adverse outcomes, including an increased risk of chronic kidney disease, ...cardiovascular events and death. The pathophysiology of SA-AKI remains elusive, although microcirculatory dysfunction, cellular metabolic reprogramming and dysregulated inflammatory responses have been implicated in preclinical studies. SA-AKI is best defined as the occurrence of AKI within 7 days of sepsis onset (diagnosed according to Kidney Disease Improving Global Outcome criteria and Sepsis 3 criteria, respectively). Improving outcomes in SA-AKI is challenging, as patients can present with either clinical or subclinical AKI. Early identification of patients at risk of AKI, or at risk of progressing to severe and/or persistent AKI, is crucial to the timely initiation of adequate supportive measures, including limiting further insults to the kidney. Accordingly, the discovery of biomarkers associated with AKI that can aid in early diagnosis is an area of intensive investigation. Additionally, high-quality evidence on best-practice care of patients with AKI, sepsis and SA-AKI has continued to accrue. Although specific therapeutic options are limited, several clinical trials have evaluated the use of care bundles and extracorporeal techniques as potential therapeutic approaches. Here we provide graded recommendations for managing SA-AKI and highlight priorities for future research.
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