Early Vancomycin Concentrations and the Applications of a Pharmacokinetic Extrapolation Method to Recognize Sub-Therapeutic Outcomes

Santalo, Oscar; Baig, Umima; Poulakos, Mara N.; Brown, Daniel L.

doi:10.3390/pharmacy4040037

Cited by 6 publications

(3 citation statements)

References 16 publications

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“…Samples drawn several hours before or immediately after an administration of vancomycin lead to inaccurate interpretation of vancomycin trough concentrations. Situations like this may lead to incorrect adaption of vancomycin therapy [ 12 , 24 , 28 ].…”

Section: Discussionmentioning

confidence: 99%

Experience of Vancomycin Therapeutic Drug Monitoring in Two Multidisciplinary Hospitals in Latvia

et al. 2022

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Background and Objectives: Management of infectious diseases is a huge burden to every healthcare system worldwide. Antimicrobial resistance, including antibacterial resistance, is an increasing problem worldwide; therefore, more new antibiotics are necessary to be discovered. Meanwhile, “old” antibacterial agents are still administered to fight infectious diseases caused by resistant bacteria. One of these antibacterial agents is vancomycin, which is effective in treating serious systemic infections caused by gram-positive bacteria. Thus, it is necessary to perform vancomycin concentration measurements in plasma due to its narrow therapeutic index. Various approaches are implemented for more precise therapy, including therapeutic drug monitoring (TDM) of vancomycin and with a supervision of a clinical pharmacist. The purpose of the study was to investigate if the TDM practice is improved with a local vancomycin TDM protocol applied in a hospital. The results of TDM in two multidisciplinary hospitals, one with a local TDM protocol implemented and applied and the other with no local TDM protocol implemented and applied, were compared. Materials and Methods: A retrospective study was performed in two multidisciplinary hospitals in Latvia. The data were collected for a time period of 4 years (2016–2020) in a hospital without a local TDM protocol and for a time period of 2 years (2018–2020) in a hospital with a local TDM protocol, starting with a period of time when the vancomycin TDM protocol was developed. The data about the patients included in the study were analyzed based on gender, age, body weight, and renal function. Vancomycin therapy was analyzed based on dosing schemes (vancomycin dose and dosing interval), data about loading and maintenance doses, vancomycin concentration, and details about vancomycin concentration (sampling time and concentration level). Results: Differences between the hospitals were found in terms of the initiation of vancomycin administration and concentration sampling. In the hospital with a TDM protocol compared with the hospital without a TDM protocol, more accurate initiation was found, alongside adaption of therapy (97.22% vs. 18.95%, p < 0.001), better performance of administration of a loading dose (22.73% vs. 1.29%, p < 0.01), and reaching of target concentration (55.56% vs. 35.29%, p < 0.01). Concentration sampling in the correct timeframe before the vancomycin dose and vancomycin administration did not show statistically better results in either of the hospitals (4.60% vs. 6.29%, p = 0.786). Conclusions: Better results of adequate adjustments of vancomycin therapy were achieved in the hospital with a TDM protocol. In the long term, sustainable results and regular medical professionals’ training is necessary.

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Section: Discussionmentioning

confidence: 99%

Experience of Vancomycin Therapeutic Drug Monitoring in Two Multidisciplinary Hospitals in Latvia

et al. 2022

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“…Studies using trough concentrations of drugs with a short half-life for PK modeling provide a good example of blood drawn at times different than scheduled times. Santalo et al 15 reported vancomycin trough concentrations are often measured early, producing results that do not reflect actual troughs and may subsequently lead to inappropriate dosing. Similarly, as discussed in the next paragraph, dose times that are incorrectly recorded result in an overall shift of the PK curve.…”

Section: Sampling Time Errorsmentioning

confidence: 99%

Approaches to handling missing or “problematic” pharmacology data: Pharmacokinetics

Irby

Ibrahim

Dauki

et al. 2021

CPT Pharmacom & Syst Pharma

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Missing or erroneous information is a common problem in the analysis of pharmacokinetic (PK) data. This may present as missing or inaccurate dose level or dose time, drug concentrations below the analytical limit of quantification, missing sample times, or missing or incorrect covariate information. Several methods to handle problematic data have been evaluated, though no single, broad set of recommendations for commonly occurring errors has been published. In this tutorial, we review the existing literature and present the results of our simulation studies that evaluated common methods to handle known data errors to bridge the remaining gaps and expand upon the existing knowledge. This tutorial is intended for any scientist analyzing a PK dataset with missing or apparently erroneous data. The approaches described herein may also be useful for the analysis of nonclinical PK data. Overview Data from clinical trials is frequently incomplete, particularly datasets collected during large, late phase trials, during routine clinical patient care or follow-up visits. Portions of data may be missing or inaccurate due to factors such as study site noncompliance, patient noncompliance, inappropriate sample handling, data entry errors, and analytical problems. How "problematic" data are handled can impact its interpretation, especially when data used for population pharmacokinetic (PPK) modeling contains missing or erroneous data. Prior to beginning an analysis, pharmacometricians often spend a large portion of time dealing with problematic data. During data cleaning (data quality assurance), the first step is to identify missing or problematic data. Concentration-time data and dosing records are often the primary concern, but other issues, such as missing or questionable covariate data, must also be considered. Once issues/discrepancies are identified, the next challenge is to evaluate frequency of occurrence of each type of problem and the associated reason to establish appropriate methods for handling these erroneous data. Prior studies have addressed handling of specific types of problematic data, though no set of broad recommendations spanning the various types of problematic data have been previously presented. Accepted Article This article is protected by copyright. All rights reserved Through review of published methods, simulation of data sets with known errors, and evaluation using different methods for handling these errors, this tutorial aims to provide guidance for dealing with problematic clinical (and some non-clinical) concentration vs. time, dosing, and covariate data. This tutorial is intended to be utilized by scientists analyzing pharmacokinetic data with either missing data or where apparently questionable or erroneous data is present. Although data quality assurance (QA) and control (QC) are essential to successful modeling, this tutorial assumes the dataset has already undergone appropriate QC or was assembled from locked, clean data. Basic assessments include exploratory data analysis by plotting and...

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“…They play a significant role in the treatment of diseases caused by Gram-positive bacteria by blocking the substrate that is necessary for enzymes to take part in cell wall synthesis [73]. Vancomycyn, an exemplary glycopeptide drug, can be applied in the treatment of pneumonia, endocarditis, or meningitis [74].…”

Section: Antibiotics and Their General Characteristicsmentioning

confidence: 99%

Electrochemical Immunosensors for Antibiotic Detection

2019

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Antibiotics are an important class of drugs destined for treatment of bacterial diseases. Misuses and overuses of antibiotics observed over the last decade have led to global problems of bacterial resistance against antibiotics (ABR). One of the crucial actions taken towards limiting the spread of antibiotics and controlling this dangerous phenomenon is the sensitive and accurate determination of antibiotics residues in body fluids, food products, and animals, as well as monitoring their presence in the environment. Immunosensors, a group of biosensors, can be considered an attractive tool because of their simplicity, rapid action, low-cost analysis, and especially, the unique selectivity arising from harnessing the antigen–antibody interaction that is the basis of immunosensor functioning. Herein, we present the recent achievements in the field of electrochemical immunosensors designed to determination of antibiotics.

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Early Vancomycin Concentrations and the Applications of a Pharmacokinetic Extrapolation Method to Recognize Sub-Therapeutic Outcomes

Cited by 6 publications

References 16 publications

Experience of Vancomycin Therapeutic Drug Monitoring in Two Multidisciplinary Hospitals in Latvia

Experience of Vancomycin Therapeutic Drug Monitoring in Two Multidisciplinary Hospitals in Latvia

Approaches to handling missing or “problematic” pharmacology data: Pharmacokinetics

Electrochemical Immunosensors for Antibiotic Detection

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