scholarly journals Is Computer-Assisted Aminoglycoside Dosing Managed by a Pharmacist a Safety Tool of Pharmacotherapy?

2019 ◽  
pp. S87-S96
Author(s):  
E. DVOŘÁČKOVÁ ◽  
P. PÁVEK ◽  
B. KOVÁČOVÁ ◽  
J. RYCHLÍČKOVÁ ◽  
O. SUCHOPÁR ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Therapy Monitoring ◽  
Therapeutic Drug ◽  
Control Group ◽  
Computer Assisted ◽  
Clear Trend ◽  
Cost Avoidance ◽  
Aminoglycoside Therapy ◽  
Group 1

This pilot prospective study verified the hypothesis that use of computer-assisted therapeutic drug monitoring of aminoglycosides by pharmacists leads to better safety therapeutic outcomes and cost avoidance than only concentration measurement and dose adjustments based on a physician’s experience. Two groups of patients were enrolled according to the technique of monitoring. Patients (Group 1, n=52) underwent monitoring by a pharmacist using pharmacokinetic software. In a control group (Group 2, n=11), plasma levels were measured but not interpreted by the pharmacist, only by physicians. No statistically significant differences were found between the groups in factors influenced by therapy. However, the results are not statistically significant but a comparison of the groups showed a clear trend towards safety and cost avoidance, thus supporting therapeutic drug monitoring. Safety limits were achieved in 76 % and 63 % of cases in Groups 1 and 2, respectively. More patients achieved both concentrations (peak and trough) with falling eGFR in Group 1. In present pilot study, the pharmacist improved the care of patients on aminoglycoside therapy. A larger study is needed to demonstrate statistically significantly improved safety and cost avoidance of aminoglycoside therapy monitoring by the pharmacist using pharmacokinetic software.

scholarly journals ß-endorphins as Possible Markers for Therapeutic Drug Monitoring

2007 ◽  
Vol 7 (1) ◽  
pp. 11-15 ◽  
Author(s):  
Radivoj Jadrić ◽  
Emina Kiseljaković ◽  
Sabaheta Hasić ◽  
Mira Winterhalter-Jadrić
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Therapy Monitoring ◽  
Patient Treatment ◽  
Therapeutic Drug ◽  
Control Group ◽  
Psychoactive Drugs ◽  
Antidepressive Drugs ◽  
Beta Endorphins

This study was performed in order to investigate possible role of brain beta-endorphins as markers of antidepressive drugs therapy monitoring. Experiment was done using amitriptyline and trazodone as antidepressants. For quantification of brain beta-endorphins we used RIA technique. Our results showed significant decrease of brain beta-endorphins concentration in drug-pretreated animals, vs. those in of control group treated with 0,95% NaCl. The lower values were obtained in trazodone pre-treated animals. This study shows that use of psychoactive drugs have influence on brain beta-endorphins concentration. beta-endorphins could be of great importance, used as markers for evaluation of patient treatment.

scholarly journals Therapeutic Drug Monitoring by Pharmacists: Does It Reduce Costs?

2020 ◽  
Vol 3 (2) ◽  
pp. 69-71
Author(s):  
Pedro Cardoso ◽  
C. Santos ◽  
Francisco Rocha-Gonçalves
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Medical Center ◽  
Tertiary Hospital ◽  
Therapeutic Drug ◽  
Economic Dimension ◽  
Total Cost ◽  
Cost Avoidance ◽  
Implementation Costs ◽  
Pharmaceutical Interventions

ABSTRACT Therapeutic drug monitoring (TDM) has as its main objective to ensure that the plasma drug concentration remains within the appropriate range. Regarding the economic dimension of TDM, it is known that there are gains in health outcomes; however, there is still little evidence for the benefit of this procedure performed by pharmacists within the hospital context. With this project, we aimed to create a matrix of cost avoidance associated with TDM performed by pharmacists and to quantify the total avoided costs in 1 year, by implementing a TDM process in a tertiary hospital. For the studied period, we collected 362 pharmaceutical interventions related to TDM of antibiotics performed in adults. As a result, considering these data, the total cost avoidance in 1 year was 371,018 ($416,584.58) at one medical center. We conclude that TDM is highly cost-avoidant and that the implementation costs by pharmaceutical services is clearly lower than the benefit achieved.

scholarly journals TRICYCLIC ANTIDEPRESSANTS;

2012 ◽  
Vol 19 (02) ◽  
pp. 197-201
Author(s):  
Shah KHALID ◽  
MOWADAT HUSSAIN RANA ◽  
NAJAM AKHTAR
Keyword(s):  
Side Effects ◽  
Therapeutic Drug Monitoring ◽  
Study Design ◽  
Drug Monitoring ◽  
Lower Incidence ◽  
Tricyclic Antidepressant ◽  
Military Hospital ◽  
Therapeutic Drug ◽  
Control Group ◽  
Treatment Of Depression

Introduction: Despite advancements in the treatment of depression and availability of newer compounds, TCAs likeamitriptyline remain to be the cornerstone of antidepressive therapy for more than three decades, however significantly more patients receivinga tricyclic withdraw from treatment mainly because of side effects. Higher response, lower incidence of side effects and improved compliancecan be enhanced by the optimal use of Therapeutic Drug Monitoring (TDM). No research data is currently available on the therapeutic drugmonitoring of TCAs in Pakistan. Objectives: To compare the relative efficacy of Tricyclic antidepressant in the treatment of depression, with andwithout Therapeutic Drug Monitoring Main Outcome Measures: Changes in HAMD scores in patients on TCAs. Study Design: A Quasiexperimental study design was used. Setting: The study was conducted at Department of Psychiatry, Military Hospital Rawalpindi. Subjects:34 patients completed the study in the monitored group (with TDM) and 33 in control group (without TDM). Methods: Serum TCA levels andHAMD scores at baseline and subsequently at sixth, eighth and tenth week of treatment were collected. In all the subjects, all the blood sampleswere drawn as a fasting sample in early morning. Results: The mean age of the monitored group was 31.97 years (SD=10.432) while that of thecontrol group was 33.52 years (SD=9.385). in the monitored group 20 (58.82 %) of the patients were males while 14 (41.17%) were females, inthe control group 22 (66.66%) were males and 11(33.33%) were female patients. A significant reduction in HAMD scores was noted at 8 weeksof treatment. The groups did not differ in terms of efficacy of TCAs, however the monitored group had fewer dropouts than the control group.Conclusions: Lower incidence of side effects and improved compliance can be enhanced by the optimal use of Therapeutic Drug Monitoring(TDM) of TCAs.

scholarly journals Assessment of Anti-Hypertensive Drug Adherence by Serial Aldosterone-To-Renin Ratio Measurement

2021 ◽  
Vol 12 ◽  
Author(s):  
Fabrizio Buffolo ◽  
Elisa Sconfienza ◽  
Jacopo Burrello ◽  
Isabel Losano ◽  
Giulio Mengozzi ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Practice ◽  
Therapeutic Drug Monitoring ◽  
Arterial Hypertension ◽  
Drug Monitoring ◽  
Therapeutic Drug ◽  
Control Group ◽  
Ratio Measurement ◽  
Adherence Assessment ◽  
Raas Inhibitors

Reduced or absent compliance to anti-hypertensive treatment is a major obstacle to the achievement of blood pressure target in patients with arterial hypertension. Current available methods for therapeutic adherence assessment display low accuracy, limited applicability in clinical practice and/or high costs. We designed a prospective study to evaluate the accuracy of serial measurement of ARR to assess the therapeutic compliance to RAAS inhibitors. We prospectively enrolled 80 subjects: 40 patients with arterial hypertension and 40 normotensive controls. The ARR was evaluated at baseline and 2 and 8 week after initiation of a RAAS inhibitor in patients with hypertension, and at baseline and 2 weeks for the control group. Adherence to the prescribed therapy was confirmed by therapeutic drug monitoring. We observed a significant increase of renin levels and reduction of aldosterone levels after RAAS inhibitors initiation, with consequent reduction of ARR. Delta ARR (ΔARR), defined as relative change in ARR before and after treatment initiation, provided high accuracy for determination of therapeutic compliance, with an AUC of 0.900 at 2 weeks and 0.886 at 8 weeks. A cut-off of −48% of ΔARR provided 90% sensitivity and 75% specificity, at 2 and 8 weeks. In conclusion, the measurement of ΔARR is a powerful test, cheap and widely available to accurately identify the non-adherence to RAAS inhibitors treatment. Herein we propose the implementation of ΔARR in clinical practice through a multi-step flow-chart for the management of patients with uncontrolled blood pressure, with identification of those suspected of non-adherence, reserving therapeutic drug monitoring for non-adherence confirmation.

scholarly journals Therapeutic drug monitoring of infliximab compared to standard clinical treatment with infliximab: study protocol for a randomised, controlled, open, parallel-group, phase IV study (The NOR-DRUM study)

2019 ◽  
Author(s):  
Silje Watterdal Syversen ◽  
Guro Løvik Goll ◽  
Kristin Kaasen Jørgensen ◽  
Inge Christoffer Olsen ◽  
Øystein Sandanger ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Treatment Strategy ◽  
Inflammatory Diseases ◽  
Therapeutic Drug ◽  
Control Group ◽  
Drug Concentrations ◽  
Immune Mediated ◽  
Parallel Group ◽  
Phase Iv

Abstract Background Infliximab (INX) and other TNF-inhibitors (TNFi) have revolutionised the treatment of several immune mediated inflammatory diseases. Still, many patients do not respond sufficiently to therapy or loose efficacy over time. The large individual variation in serum drug concentrations on standard doses and the development of anti-drug antibodies are thought to be major reasons for treatment failures. Therapeutic drug monitoring (TDM), an individualised treatment strategy based on systematic assessments of serum drug concentrations, has been proposed as a clinical tool to optimise efficacy of INX treatment. TDM seems reasonable both from a clinical and an economical point of view, but the effectiveness of this treatment strategy has not yet been demonstrated in randomised clinical trials. The NORwegian DRUg Monitoring study (NOR-DRUM) aims to assess the effectiveness of TDM, both with regard to achieve remission in patients starting INX treatment (part A) as well as to maintain disease control in patients on INX treatment (part B). Methods The NOR-DRUM study is a randomised, open, controlled, parallel-group, comparative, multi-centre, national, superiority, phase IV study with two separate parts, NOR-DRUM A and NOR-DRUM B. Patients with rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, ulcerative colitis, Crohn’s disease and psoriasis are included. In both study parts participants are randomised 1:1 to either TDM of infliximab (intervention group) or to standard treatment with infliximab without knowledge of drug levels or ADAb status (control group). 400 patients starting INX therapy will be included in NOR-DRUM A. The primary outcome is remission at 30 weeks. In NOR-DRUM B, 450 patients on maintenance treatment with INX will be included. The primary endpoint is occurrence of disease worsening during the 52 weeks study period. Discussion As the first trial to assess the effectiveness, safety and cost-effectiveness of TDM in patients receiving TNFi for a range of immune mediated inflammatory diseases, we hope that the NOR-DRUM study can contribute to the advancement of evidence based personalised treatment with biological medicines.

Body mass index as a determinant of clozapine plasma concentrations: A pharmacokinetic-based hypothesis

2021 ◽  
Vol 35 (3) ◽  
pp. 273-278
Author(s):  
Maxim Kuzin ◽  
Ekkehard Haen ◽  
Christoph Hiemke ◽  
Benjamin Bochon ◽  
Karolina Bochon ◽  
...  
Keyword(s):  
Body Mass Index ◽  
Therapeutic Drug Monitoring ◽  
Body Mass ◽  
Drug Monitoring ◽  
Plasma Concentrations ◽  
High Body Mass Index ◽  
Therapeutic Drug ◽  
Control Group ◽  
D Values ◽  
The Impact

Background: Knowledge regarding the impact of body composition measures on pharmacokinetics of antipsychotics is limited. Aims: Our aim was to investigate the impact of body weight and body mass index on clozapine pharmacokinetics using a therapeutic drug monitoring database. Methods: A large therapeutic drug monitoring dataset of clozapine plasma concentrations considering three patient subgroups was analysed: a control group (CLZ0, 20–30 kg/m2, n=266), a group with high body mass index (CLZhigh, body mass index ⩾30 kg/m2, n=162) and with low body mass index values (CLZlow, body mass index <20 kg/m2, n=27). Comparisons of plasma and dose-adjusted plasma concentrations (C/D) of clozapine were based on the Spearman’s correlation ( rs), Kruskal Wallis and Mann-Whitney-U tests. For percentages we used the Pearson chi-square test (χ2). To assess effects of confounders we used bootstrapping analysis of covariates. Results/outcomes: Regarding demographic characteristics, groups differed only for sex percentage with more females than males in CLZlow and CLZhigh compared to CLZ0 ( p=0.001 for χ2 test). Plasma and C/D values were positively associated with body mass index ( rs=0.108, p=0.022 and rs=0.156, p=0.001 respectively). Intergroup differences were observed for plasma and dose-adjusted concentrations of clozapine ( p=0.031 and p=0.029 for Kruskal Wallis respectively): post-hoc pairwise comparisons showed higher plasma concentrations and C/D of clozapine in CLZhigh compared to CLZ0 ( p=0.014 and p=0.007 respectively for Mann-Whitney U-test), by mean 21 and 18%, respectively. Differences for C/D values remained after accounting for sex ( p=0.02). Conclusions/interpretation: In obese patients, bioavailability, distribution or elimination of clozapine may be altered due to increased clozapine deposits in fat tissue and hepatic enzyme activity changes.

scholarly journals Possibilities of the efficiency and safety control of rivaroxaban application in patients with atrial fibrillation

2021 ◽  
Vol 23 (2) ◽  
pp. 9-16
Author(s):  
Evgeny V. Kryukov ◽  
Alexey B. Prokofiev ◽  
Andrey A. Danko ◽  
Artyom I. Dmitriev ◽  
Evgeny S. Melnikov ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Therapeutic Drug Monitoring ◽  
Blood Serum ◽  
Drug Monitoring ◽  
Therapeutic Drug ◽  
Control Group ◽  
Safety Control ◽  
Average Maximum ◽  
Hemorrhagic Complications ◽  
Anticoagulant Drug

The results of a study of the concentration of rivaroxaban in the peripheral blood in patients with atrial fibrillation, receiving different doses of rivaroxaban, as well as in the case of developing hemorrhagic complications, are presented. 65 patients admitted for treatment for atrial fibrillation were examined. As an anticoagulant drug, rivaroxaban was prescribed at a dose of 15 or 20 mg once a day, depending on the state of renal function. The patients were divided into 3 groups depending on the prescribed dose of rivaroxaban and the presence or absence of hemorrhagic complications. At the same time, each patient underwent therapeutic drug monitoring of the drug. It was found that in patients, who received rivaroxaban at a dose of 15 mg, in 35% of cases its concentration in the blood was below the average minimum values. In patients, who received the drug at a dose of 20 mg, in 16% of cases its concentration in the blood serum exceeded the average maximum values. Patients treated with 15 mg of rivaroxaban lacked any hemorrhagic complications. In the group of patients with advanced hemorrhagic complications who received rivaroxaban at a dose of 20 mg, its serum concentration at all stages of therapeutic drug monitoring was significantly higher than the average maximum values and more than 4 times higher than in the control group (without hemorrhagic complications). The results of the study indicate the advisability of conducting therapeutic drug monitoring with the determination of rivaroxaban concentrations in the blood serum of patients receiving the drug, especially when they develop hemorrhagic complications.

scholarly journals Therapeutic drug monitoring of infliximab compared to standard clinical treatment with infliximab: study protocol for a randomised, controlled, open, parallel-group, phase IV study (The NOR-DRUM study)

2019 ◽  
Author(s):  
Silje Watterdal Syversen ◽  
Guro Løvik Goll ◽  
Kristin Kaasen Jørgensen ◽  
Inge Christoffer Olsen ◽  
Øystein Sandanger ◽  
...  
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Treatment Strategy ◽  
Inflammatory Diseases ◽  
Therapeutic Drug ◽  
Control Group ◽  
Drug Concentrations ◽  
Immune Mediated ◽  
Parallel Group ◽  
Phase Iv

Abstract Background: Infliximab (INX) and other TNF-inhibitors (TNFi) have revolutionised the treatment of several immune mediated inflammatory diseases. Still, many patients do not respond sufficiently to therapy or loose efficacy over time. The large individual variation in serum drug concentrations on standard doses and the development of anti-drug antibodies are thought to be major reasons for treatment failures. Therapeutic drug monitoring (TDM), an individualised treatment strategy based on systematic assessments of serum drug concentrations, has been proposed as a clinical tool to optimise efficacy of INX treatment. TDM seems reasonable both from a clinical and an economical point of view, but the effectiveness of this treatment strategy has not yet been demonstrated in randomised clinical trials. The NORwegian DRUg Monitoring study (NOR-DRUM) aims to assess the effectiveness of TDM, both with regard to the achievement of remission in patients starting INX treatment (part A) as well as to maintain disease control in patients on INX treatment (part B). Methods: The NOR-DRUM study is a randomised, open, controlled, parallel-group, comparative, multi-centre, national, superiority, phase IV study with two separate parts, NOR-DRUM A and NOR-DRUM B. Patients with rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, ulcerative colitis, Crohn’s disease and psoriasis are included. In both study parts participants are randomised 1:1 to either TDM of infliximab (intervention group) or to standard treatment with infliximab without knowledge of drug levels or ADAb status (control group). NOR-DRUM A will include 400 patients starting INX therapy. The primary outcome is remission at 30 weeks. In NOR-DRUM B, 450 patients on maintenance treatment with INX will be included. The primary endpoint is occurrence of disease worsening during the 52 weeks study period. Discussion: As the first trial to assess the effectiveness, safety and cost-effectiveness of TDM in patients receiving TNFi for a range of immune mediated inflammatory diseases, we hope that the NOR-DRUM study will contribute to the advancement of evidence based personalised treatment with biological medicines.

Diagnose und Monitoring bei chronisch-entzündlicher Darmerkrankung

2018 ◽  
Vol 75 (5) ◽  
pp. 316-328
Author(s):  
Christian Ansprenger ◽  
Emanuel Burri
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Morbus Crohn ◽  
Therapeutic Drug ◽  
Körperliche Untersuchung

Zusammenfassung. Die Diagnose und auch die Überwachung von chronisch entzündlichen Darmerkrankungen ruht auf mehreren Säulen: Anamnese, körperliche Untersuchung, Laborwerte (im Blut und Stuhl), Endoskopie, Histologie und Bildgebung. Die Diagnose kann nicht anhand eines einzelnen Befundes gestellt werden. In den letzten Jahren hat sich das Therapieziel weg von klinischen Endpunkten hin zu endoskopischen und sogar histologischen Endpunkten entwickelt. Für einige dieser neuen Therapieziele existiert allerdings noch keine allgemein gültige Definition. Regelmässige Endoskopien werden von Patienten schlecht toleriert, weshalb Surrogat-Marker wie Calprotectin untersucht wurden und eine gute Korrelation mit der mukosalen Entzündungsaktivität nachgewiesen werden konnte. Entsprechend zeigte sich bei Morbus Crohn eine Algorithmus-basierte Therapiesteuerung – unter anderem basierend auf Calprotectin – einer konventionellen Therapiesteuerung überlegen. Die Überwachung der medikamentösen Therapie («Therapeutic Drug Monitoring» [TDM]) ist ein zweites Standbein des Monitoring von chronisch entzündlichen Darmerkrankungen. Mit zunehmendem Einsatz vor allem der Biologika-Therapien wurden sowohl reaktives TDM (in Patienten mit klinischem Rezidiv) als auch proaktives TDM (in Patienten in Remission / stabiler Erkrankung) untersucht und haben (teilweise) Eingang in aktuelle Richtlinien gefunden. Zukünftige Studien werden die vorgeschlagenen Therapieziele besser definieren und den Nutzen der medikamentösen Therapieüberwachung auf den Krankheitsverlauf weiter untersuchen müssen.

Sign in / Sign up

Export Citation Format

Share Document