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Pharmacokinetic assessment in patients receiving continuous RRT: perspectives from the Kidney Health Initiative.
Nolin TD, Aronoff GR, Fissell WH, Jain L, Madabushi R, Reynolds K, Zhang L, Huang SM, Mehrotra R, Flessner MF, Leypoldt JK, Witcher JW, Zineh I, Archdeacon P, Roy-Chaudhury P, Goldstein SL, Kidney Health Initiative
(2015) Clin J Am Soc Nephrol 10: 159-64
MeSH Terms: Acute Kidney Injury, Critical Illness, Drug Dosage Calculations, Humans, Nephrology, Pharmaceutical Preparations, Pharmacokinetics, Renal Replacement Therapy
Show Abstract · Added October 28, 2014
The effect of AKI and modern continuous RRT (CRRT) methods on drug disposition (pharmacokinetics) and response has been poorly studied. Pharmaceutical manufacturers have little incentive to perform pharmacokinetic studies in patients undergoing CRRT because such studies are neither recommended in existing US Food and Drug Administration (FDA) guidance documents nor required for new drug approval. Action is urgently needed to address the knowledge deficit. The Kidney Health Initiative has assembled a work group composed of clinicians and scientists representing academia, the FDA, and the pharmaceutical and dialysis industries with expertise related to pharmacokinetics, AKI, and/or CRRT. The work group critically evaluated key considerations in the assessment of pharmacokinetics and drug dosing in CRRT, practical constraints related to conducting pharmacokinetic studies in critically ill patients, and the generalizability of observations made in the context of specific CRRT prescriptions and specific patient populations in order to identify efficient study designs capable of addressing the knowledge deficit without impeding drug development. Considerations for the standardized assessment of pharmacokinetics and development of corresponding drug dosing recommendations in critically ill patients with AKI receiving CRRT are proposed.
Copyright © 2015 by the American Society of Nephrology.
0 Communities
1 Members
0 Resources
8 MeSH Terms
Pharmacokinetics and pharmacodynamics of imipenem and meropenem in critically ill patients treated with continuous venovenous hemodialysis.
Afshartous D, Bauer SR, Connor MJ, Aduroja OA, Amde M, Salem C, Groszek JJ, Fissell WH
(2014) Am J Kidney Dis 63: 170-1
MeSH Terms: Anti-Bacterial Agents, Critical Illness, Drug Dosage Calculations, Female, Gram-Negative Bacterial Infections, Humans, Imipenem, Male, Medication Errors, Meropenem, Metabolic Clearance Rate, Middle Aged, Renal Dialysis, Thienamycins
Added February 25, 2014
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1 Members
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14 MeSH Terms
Adverse drug events during AKI and its recovery.
Cox ZL, McCoy AB, Matheny ME, Bhave G, Peterson NB, Siew ED, Lewis J, Danciu I, Bian A, Shintani A, Ikizler TA, Neal EB, Peterson JF
(2013) Clin J Am Soc Nephrol 8: 1070-8
MeSH Terms: Acute Kidney Injury, Adult, Aged, Biomarkers, Creatinine, Drug Dosage Calculations, Drug-Related Side Effects and Adverse Reactions, Female, Glomerular Filtration Rate, Hospitalization, Humans, Hypotension, Inappropriate Prescribing, Kidney, Linear Models, Logistic Models, Male, Medication Errors, Middle Aged, Multivariate Analysis, Risk Factors, Tennessee, Time Factors, Treatment Failure
Show Abstract · Added August 21, 2013
BACKGROUND AND OBJECTIVES - The impact of AKI on adverse drug events and therapeutic failures and the medication errors leading to these events have not been well described.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS - A single-center observational study of 396 hospitalized patients with a minimum 0.5 mg/dl change in serum creatinine who were prescribed a nephrotoxic or renally eliminated medication was conducted. The population was stratified into two groups by the direction of their initial serum creatinine change: AKI and AKI recovery. Adverse drug events, potential adverse drug events, therapeutic failures, and potential therapeutic failures for 148 drugs and 46 outcomes were retrospectively measured. Events were classified for preventability and severity by expert adjudication. Multivariable analysis identified medication classes predisposing AKI patients to adverse drug events.
RESULTS - Forty-three percent of patients experienced a potential adverse drug event, adverse drug event, therapeutic failure, or potential therapeutic failure; 66% of study events were preventable. Failure to adjust for kidney function (63%) and use of nephrotoxic medications during AKI (28%) were the most common potential adverse drug events. Worsening AKI and hypotension were the most common preventable adverse drug events. Most adverse drug events were considered serious (63%) or life-threatening (31%), with one fatal adverse drug event. Among AKI patients, administration of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, antibiotics, and antithrombotics was most strongly associated with the development of an adverse drug event or potential adverse drug event.
CONCLUSIONS - Adverse drug events and potential therapeutic failures are common and frequently severe in patients with AKI exposed to nephrotoxic or renally eliminated medications.
1 Communities
5 Members
0 Resources
24 MeSH Terms
Antimicrobial dosing in acute renal replacement.
Fissell WH
(2013) Adv Chronic Kidney Dis 20: 85-93
MeSH Terms: Acute Kidney Injury, Anti-Bacterial Agents, Antifungal Agents, Biological Availability, Critical Care, Critical Illness, Drug Administration Schedule, Drug Dosage Calculations, Humans, Inactivation, Metabolic, Metabolic Clearance Rate, Piperacillin, Practice Guidelines as Topic, Renal Replacement Therapy, Tissue Distribution
Show Abstract · Added August 21, 2013
Acute kidney injury (AKI) is a common problem in hospitalized patients and is associated with significant morbidity and mortality. Two large trials showed no benefit from increased doses of renal replacement therapy (RRT) despite previous clinical data suggesting that increased clearance from RRT has beneficial effects. Since infection is the leading cause of death in AKI, my group and others hypothesized that increased RRT antibiotic clearance might create a competing morbidity. The data from my group, as well as those of other groups, show that many patients are underdosed when routine "1 size fits all" antibiotic dosing is used in patients with AKI receiving continuous RRT (CRRT). Here, concepts of drug distribution and clearance in AKI are briefly discussed and then 1 antibiotic (piperacillin) is discussed in depth to illustrate the challenges in applying the medical literature to clinical practice. The fact that published data on drug dosing in AKI and dialysis reflect the evolution of practice patterns and often do not apply to present prescribing habits is also discussed. A more general approach to drug dosing facilitates situation-specific prescribing by the nephrologist and critical care specialist.
Copyright © 2013 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.
0 Communities
1 Members
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15 MeSH Terms
Cardiovascular pharmacogenomics.
Roden DM, Johnson JA, Kimmel SE, Krauss RM, Medina MW, Shuldiner A, Wilke RA
(2011) Circ Res 109: 807-20
MeSH Terms: Biological Transport, Biotransformation, Cardiovascular Agents, Cardiovascular Diseases, Drug Dosage Calculations, Genetic Variation, Humans, Patient Selection, Pharmacogenetics, Precision Medicine, Risk Assessment, Treatment Outcome
Show Abstract · Added June 26, 2014
Patients vary in their responses to drug therapy, and some of that variability is genetically determined. This review outlines general approaches used to identify genetic variation that influences drug response. Examples from specific therapeutic areas are presented, such as cholesterol management, arrhythmias, heart failure, hypertension, warfarin anticoagulation, and antiplatelet agents. A brief view of potential pathways to implementation is presented.
0 Communities
1 Members
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12 MeSH Terms
Facilitating pharmacogenetic studies using electronic health records and natural-language processing: a case study of warfarin.
Xu H, Jiang M, Oetjens M, Bowton EA, Ramirez AH, Jeff JM, Basford MA, Pulley JM, Cowan JD, Wang X, Ritchie MD, Masys DR, Roden DM, Crawford DC, Denny JC
(2011) J Am Med Inform Assoc 18: 387-91
MeSH Terms: Algorithms, Anticoagulants, Aryl Hydrocarbon Hydroxylases, Cytochrome P-450 CYP2C9, Data Mining, Databases, Nucleic Acid, Drug Dosage Calculations, Electronic Health Records, Genome-Wide Association Study, Humans, Linear Models, Mixed Function Oxygenases, Natural Language Processing, Pharmacogenetics, Precision Medicine, United States, Vitamin K Epoxide Reductases, Warfarin
Show Abstract · Added December 10, 2013
OBJECTIVE - DNA biobanks linked to comprehensive electronic health records systems are potentially powerful resources for pharmacogenetic studies. This study sought to develop natural-language-processing algorithms to extract drug-dose information from clinical text, and to assess the capabilities of such tools to automate the data-extraction process for pharmacogenetic studies.
MATERIALS AND METHODS - A manually validated warfarin pharmacogenetic study identified a cohort of 1125 patients with a stable warfarin dose, in which 776 patients were managed by Coumadin Clinic physicians, and the remaining 349 patients were managed by their providers. The authors developed two algorithms to extract weekly warfarin doses from both data sets: a regular expression-based program for semistructured Coumadin Clinic notes; and an advanced weekly dose calculator based on an existing medication information extraction system (MedEx) for narrative providers' notes. The authors then conducted an association analysis between an automatically extracted stable weekly dose of warfarin and four genetic variants of VKORC1 and CYP2C9 genes. The performance of the weekly dose-extraction program was evaluated by comparing it with a gold standard containing manually curated weekly doses. Precision, recall, F-measure, and overall accuracy were reported. Associations between known variants in VKORC1 and CYP2C9 and warfarin stable weekly dose were performed with linear regression adjusted for age, gender, and body mass index.
RESULTS - The authors' evaluation showed that the MedEx-based system could determine patients' warfarin weekly doses with 99.7% recall, 90.8% precision, and 93.8% accuracy. Using the automatically extracted weekly doses of warfarin, the authors successfully replicated the previous known associations between warfarin stable dose and genetic variants in VKORC1 and CYP2C9.
0 Communities
3 Members
0 Resources
18 MeSH Terms
Characteristics and effects of nurse dosing over-rides on computer-based intensive insulin therapy protocol performance.
Campion TR, May AK, Waitman LR, Ozdas A, Lorenzi NM, Gadd CS
(2011) J Am Med Inform Assoc 18: 251-8
MeSH Terms: Adult, Attitude to Computers, Decision Support Systems, Clinical, Drug Dosage Calculations, Drug Therapy, Computer-Assisted, Female, Guideline Adherence, Humans, Hypoglycemia, Insulin, Intensive Care Units, Male, Middle Aged, Practice Patterns, Nurses', Retrospective Studies, Tennessee
Show Abstract · Added January 20, 2015
OBJECTIVE - To determine characteristics and effects of nurse dosing over-rides of a clinical decision support system (CDSS) for intensive insulin therapy (IIT) in critical care units.
DESIGN - Retrospective analysis of patient database records and ethnographic study of nurses using IIT CDSS.
MEASUREMENTS - The authors determined the frequency, direction-greater than recommended (GTR) and less than recommended (LTR)- and magnitude of over-rides, and then compared recommended and over-ride doses' blood glucose (BG) variability and insulin resistance, two measures of IIT CDSS associated with mortality. The authors hypothesized that rates of hypoglycemia and hyperglycemia would be greater for recommended than over-ride doses. Finally, the authors observed and interviewed nurse users.
RESULTS - 5.1% (9075) of 179,452 IIT CDSS doses were over-rides. 83.4% of over-ride doses were LTR, and 45.5% of these were ≥ 50% lower than recommended. In contrast, 78.9% of GTR doses were ≤ 25% higher than recommended. When recommended doses were administered, the rate of hypoglycemia was higher than the rate for GTR (p = 0.257) and LTR (p = 0.033) doses. When recommended doses were administered, the rate of hyperglycemia was lower than the rate for GTR (p = 0.003) and LTR (p < 0.001) doses. Estimates of patients' insulin requirements were higher for LTR doses than recommended and GTR doses. Nurses reported trusting IIT CDSS overall but appeared concerned about recommendations when administering LTR doses.
CONCLUSION - When over-riding IIT CDSS recommendations, nurses overwhelmingly administered LTR doses, which emphasized prevention of hypoglycemia but interfered with hyperglycemia control, especially when BG was >150 mg/dl. Nurses appeared to consider the amount of a recommended insulin dose, not a patient's trend of insulin resistance, when administering LTR doses overall. Over-rides affected IIT CDSS protocol performance.
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16 MeSH Terms