The impact of an electronic hospital system on therapeutic drug monitoring

2021 ◽  
Author(s):  
Paul Firman ◽  
Karen Whitfield ◽  
Ken‐Soon Tan ◽  
Alexandra Clavarino ◽  
Karen Hay
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Therapeutic Drug ◽  
Hospital System ◽  
The Impact ◽  
Electronic Hospital

scholarly journals Preanalytical considerations in therapeutic drug monitoring of immunosuppressants with dried blood spots

Diagnosis ◽  
2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Adrian Klak ◽  
Steven Pauwels ◽  
Pieter Vermeersch
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Current Knowledge ◽  
Dried Blood Spots ◽  
Therapeutic Drug ◽  
Drying Time ◽  
Blood Spots ◽  
Home Based ◽  
The Impact ◽  
Blood Spot

Abstract Background Dried blood spots (DBSs) could allow patients to prepare their own samples at home and send them to the laboratory for therapeutic drug monitoring (TDM) of immunosuppressants. The purpose of this review is to provide an overview of the current knowledge about the impact of DBS-related preanalytical factors on TDM of tacrolimus, sirolimus and everolimus. Content Blood spot volume, blood spot inhomogeneity, stability of analytes in DBS and hematocrit (Hct) effects are considered important DBS-related preanalytical factors. In addition, the influence of drying time has recently been identified as a noteworthy preanalytical factor. Tacrolimus is not significantly influenced by these factors. Sirolimus and everolimus are more prone to heat degradation and exhibited variations in recovery which were dependent on Hct and drying time. Summary and outlook DBS-related preanalytical factors can have a significant impact on TDM for immunosuppressants. Tacrolimus is not significantly influenced by the studied preanalytical factors and is a viable candidate for DBS sampling. For sirolimus and everolimus more validation of preanalytical factors is needed. In particular, drying conditions need to be examined further, as current protocols may mask Hct-dependent effects on recovery. Further validation is also necessary for home-based self-sampling of immunosuppressants as the sampling quality is variable.

scholarly journals 1737. Impact of Therapeutic Drug Monitoring (TDM) of Azole Prophylaxis in Lung Transplant Recipients on the Development of Positive Fungal Events

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S636-S636
Author(s):  
Anooj Shah ◽  
Carly D’Agostino ◽  
Kathleen Cunningham ◽  
Clare Kane ◽  
Michael G Ison ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Lung Transplant ◽  
Study Groups ◽  
Fungal Species ◽  
Therapeutic Drug ◽  
Transplant Recipients ◽  
Lung Transplant Recipients ◽  
Index Value ◽  
The Impact

Abstract Background The utility and clinical impact of therapeutic drug monitoring (TDM) of prophylactic azole antifungals in lung transplant recipients is not well described. The objective of this study was to investigate the impact of TDM of azole prophylaxis in lung transplant recipients on the development of positive fungal events. Methods A retrospective analysis was performed on 47 lung transplant recipients between 2013 and 2018 at Northwestern Memorial Hospital. A positive fungal event was defined as fungal species on BAL culture and/or positive BAL Aspergillus galactomannan (GM) with an index value ≥1.0. Study groups were defined based on attainment of therapeutic trough levels after initiation of oral therapy (therapeutic if posaconazole level ≥0.7 μg/mL or voriconazole ≥1–5.5 μg/mL, subtherapeutic if ≥2 consecutive levels of posaconazole <0.7 μg/mL or voriconazole <1 μg/mL after initial dose increase). Results There were no differences in baseline characteristics (Figure 1). There were a total of 11 fungal events with 3 (12.0%) occurring in the therapeutic cohort and 8 (36.4%) in those subtherapeutic (P = 0.08). In the 5 patients with a positive GM, the mean index was 2.02 ± 0.95. 7/30 (23.3%) of patients on posaconazole had a fungal event, with 2/7 (28.6%) requiring treatment at the time of event. For patients on voriconazole, 4/17 (23.5%) had a fungal event, with 1/4 (25.0%) requiring treatment. Mean time to fungal event was 164.5 ± 8.9 days vs. 135.9 ± 13.7 days in the therapeutic and subtherapeutic group, respectively (P = 0.05). All patients on posaconazole suspension who experienced a fungal event were subtherapeutic (3/3, 100%) compared with the majority of patients on posaconazole delayed release (DR) tablets who achieved therapeutic levels (17/22, 77.3%). Mean posaconazole trough level observed in the patients receiving DR tablet was 2.15 ± 0.95 μg/mL. Conclusion There was an association between two consecutive subtherapeutic azole prophylaxis levels and positive fungal events indicating a role for TDM in lung transplant recipients. Time to fungal event post-transplant was shorter in subtherapeutic patients. As anticipated, the use of posaconazole suspension resulted in subtherapeutic levels. This study presents an opportunity for further research of the impact of TDM on clinical outcomes to optimize patient care. Disclosures All authors: No reported disclosures.

scholarly journals Combining Therapeutic Drug Monitoring and Pharmacokinetic Modelling Deconvolutes Physiological and Environmental Sources of Variability in Clozapine Exposure

Pharmaceutics ◽  
2021 ◽  
Vol 14 (1) ◽  
pp. 47
Author(s):  
Kenneth H. Wills ◽  
Stephen J. Behan ◽  
Michael J. Nance ◽  
Jessica L. Dawson ◽  
Thomas M. Polasek ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Smoking Status ◽  
Therapeutic Drug ◽  
Population Pharmacokinetic ◽  
Pharmacokinetic Modelling ◽  
Environmental Covariates ◽  
Poppk Model ◽  
Post Hoc ◽  
The Impact

Background: Clozapine is a key antipsychotic drug for treatment-resistant schizophrenia but exhibits highly variable pharmacokinetics and a propensity for serious adverse effects. Currently, these challenges are addressed using therapeutic drug monitoring (TDM). This study primarily sought to (i) verify the importance of covariates identified in a prior clozapine population pharmacokinetic (popPK) model in the absence of environmental covariates using physiologically based pharmacokinetic (PBPK) modelling, and then to (ii) evaluate the performance of the popPK model as an adjunct or alternative to TDM-guided dosing in an active TDM population. Methods: A popPK model incorporating age, metabolic activity, sex, smoking status and weight was applied to predict clozapine trough concentrations (Cmin) in a PBPK-simulated population and an active TDM population comprising 142 patients dosed to steady state at Flinders Medical Centre in Adelaide, South Australia. Post hoc analyses were performed to deconvolute the impact of physiological and environmental covariates in the TDM population. Results: Analysis of PBPK simulations confirmed age, cytochrome P450 1A2 activity, sex and weight as physiological covariates associated with variability in clozapine Cmin (R2 = 0.7698; p = 0.0002). Prediction of clozapine Cmin using a popPK model based on these covariates accounted for <5% of inter-individual variability in the TDM population. Post hoc analyses confirmed that environmental covariates accounted for a greater proportion of the variability in clozapine Cmin in the TDM population. Conclusions: Variability in clozapine exposure was primarily driven by environmental covariates in an active TDM population. Pharmacokinetic modelling can be used as an adjunct to TDM to deconvolute sources of variability in clozapine exposure.

scholarly journals Impact of Triazole Therapeutic Drug Monitoring Availability and Timing

2019 ◽  
Vol 63 (10) ◽  
Author(s):  
Erin K. McCreary ◽  
Meg Bayless ◽  
Ahn P. Van ◽  
Alexander J. Lepak ◽  
Donald A. Wiebe ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Clinical Outcomes ◽  
Antifungal Therapy ◽  
Drug Concentration ◽  
Drug Monitoring ◽  
Therapeutic Drug ◽  
Reference Laboratory ◽  
Serum Concentrations ◽  
Concentration Result ◽  
The Impact

ABSTRACT Therapeutic drug monitoring (TDM) is an established strategy to optimize antifungal therapy with certain triazoles. While established relationships exist between concentration and safety or efficacy, the impact of TDM timing on outcomes is unknown. We report clinical outcomes, including antifungal exposure and mortality, in patients receiving institutional versus reference laboratory TDM. The availability of in-house triazole assays reduced the time to drug concentration result (12 versus 68 h; P < 0.001) and time to achieve therapeutic serum concentrations (10 versus 31 days; P < 0.001). Subtherapeutic concentrations were associated with higher patient mortality (32% versus 13.3%; P = 0.036).

scholarly journals Prospective evaluation of improving fluoroquinolone exposure using centralised therapeutic drug monitoring (TDM) in patients with tuberculosis (PERFECT): a study protocol of a prospective multicentre cohort study

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e035350
Author(s):  
Simone HJ van den Elsen ◽  
Marieke GG Sturkenboom ◽  
Onno Akkerman ◽  
Linda Barkane ◽  
Judith Bruchfeld ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Therapeutic Drug ◽  
Sputum Smear ◽  
Conversion Rates ◽  
Number Of Patients ◽  
Study Results ◽  
Mdr Tb ◽  
The Impact ◽  
Historical Controls

IntroductionGlobal multidrug-resistant tuberculosis (MDR-TB) treatment success rates remain suboptimal. Highly active WHO group A drugs moxifloxacin and levofloxacin show intraindividual and interindividual pharmacokinetic variability which can cause low drug exposure. Therefore, therapeutic drug monitoring (TDM) of fluoroquinolones is recommended to personalise the drug dosage, aiming to prevent the development of drug resistance and optimise treatment. However, TDM is considered laborious and expensive, and the clinical benefit in MDR-TB has not been extensively studied. This observational multicentre study aims to determine the feasibility of centralised TDM and to investigate the impact of fluoroquinolone TDM on sputum conversion rates in patients with MDR-TB compared with historical controls.Methods and analysisPatients aged 18 years or older with sputum smear and culture-positive pulmonary MDR-TB will be eligible for inclusion. Patients receiving TDM using a limited sampling strategy (t=0 and t=5 hours) will be matched to historical controls without TDM in a 1:2 ratio. Sample analysis and dosing advice will be performed in a centralised laboratory. Centralised TDM will be considered feasible if >80% of the dosing recommendations are returned within 7 days after sampling and 100% within 14 days. The number of patients who are sputum smear and culture-negative after 2 months of treatment will be determined in the prospective TDM group and will be compared with the control group without TDM to determine the impact of TDM.Ethics and disseminationEthical clearance was obtained by the ethical review committees of the 10 participating hospitals according to local procedures or is pending (online supplementary file 1). Patients will be included after obtaining written informed consent. We aim to publish the study results in a peer-reviewed journal.Trial registration numberClinicalTrials.gov Registry (NCT03409315).

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