TY  - JOUR
A1  - Just, Katja S.
A1  - Scholl, Catharina
A1  - Boehme, Miriam
A1  - Kastenmüller, Kathrin
A1  - Just, Johannes M.
A1  - Bleckwenn, Markus
A1  - Holdenrieder, Stefan
A1  - Meier, Florian
A1  - Weckbecker, Klaus
A1  - Stingl, Julia C.
T1  - Individualized versus standardized risk assessment in patients at high risk for adverse drug reactions (the IDrug randomized controlled trial) – never change a running system?
JF  - Pharmaceuticals
N2  - The aim of this study was to compare effects of an individualized with a standardized risk assessment for adverse drug reactions to improve drug treatment with antithrombotic drugs in older adults. A randomized controlled trial was conducted in general practitioner (GP) offices. Patients aged 60 years and older, multi-morbid, taking antithrombotic drugs and at least one additional drug continuously were randomized to individualized and standardized risk assessment groups. Patients were followed up for nine months. A composite endpoint defined as at least one bleeding, thromboembolic event or death reported via a trigger list was used. Odds ratios (OR) and 95% confidence intervals (CI) were calculated. In total, N = 340 patients were enrolled from 43 GP offices. Patients in the individualized risk assessment group met the composite endpoint more often than in the standardized group (OR 1.63 [95%CI 1.02–2.63]) with multiple adjustments. The OR was higher in patients on phenprocoumon treatment (OR 1.99 [95%CI 1.05–3.76]), and not significant on DOAC treatment (OR 1.52 [95%CI 0.63–3.69]). Pharmacogenenetic variants of CYP2C9, 2C19 and VKORC1 were not observed to be associated with the composite endpoint. The results of this study may indicate that the time point for implementing individualized risk assessments is of importance.
KW  - adverse drug reactions
KW  - pharmacogenetics
KW  - pharmacogenomics
KW  - personalized medicine
KW  - phenprocoumon
KW  - DOACs
KW  - older adults
KW  - bleeding
KW  - thromboembolism
Y1  - 2021
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-248557
SN  - 1424-8247
VL  - 14
IS  - 10
ER  - 
TY  - JOUR
A1  - Egberts, Karin
A1  - Fekete, Stefanie
A1  - Häge, Alexander
A1  - Hiemke, Christoph
A1  - Scherf-Clavel, Maike
A1  - Taurines, Regina
A1  - Unterecker, Stefan
A1  - Gerlach, Manfred
A1  - Romanos, Marcel
T1  - Therapeutisches Drug Monitoring zur Optimierung der Psychopharmakotherapie von Kindern und Jugendlichen: Update und Leitfaden für die Praxis
JF  - Zeitschrift für Kinder- und Jugendpsychiatrie und Psychotherapie
N2  - Trotz verbesserter Evidenzbasis bestehen in der kinder- und jugendpsychiatrischen Pharmakotherapie viele Unsicherheiten über die Wirkung und Verträglichkeit der häufig off-label oder in Kombinationstherapie verordneten Medikamente. Gerade auch vor dem Hintergrund der in vielen Fällen notwendigen mittel- bis langfristigen Einnahme sollen unerwünschte Arzneimittelwirkungen in dieser Altersstufe möglichst minimiert und eine auf die individuellen Charakteristika der Patientin oder des Patienten zugeschnittene, effektive Dosierung gefunden werden. Kinder und Jugendliche scheinen nicht nur besonders anfällig für bestimmte unerwünschte Arzneimittelwirkungen, sondern sind auch iatrogenen Risiken durch Dosierungs- oder Applikationsfehler ausgesetzt, die zu Unter- oder Überdosierungen führen können mit entsprechend negativen Auswirkungen auf den Therapieerfolg. Neben einer strengen Indikationsstellung sind daher eine präzise Dosisfindung sowie systematische Überwachung der Sicherheit der Psychopharmakotherapie unverzichtbar. In diesem Artikel wird Therapeutisches Drug Monitoring als hilfreiches klinisches Instrument vorgestellt und beschrieben, wie dessen richtige Anwendung sowohl die Wirksamkeit als auch die Sicherheit und Verträglichkeit einer Psychopharmakotherapie im Kindes- und Jugendalter zum unmittelbaren Nutzen für die Patientinnen und Patienten verbessern kann.
N2  - Despite the improved evidence base, many uncertainties remain in child and adolescent psychiatric pharmacotherapy about the efficacy and tolerability of drugs, which are often prescribed off-label or in combination therapy in this age group. Because medium- to long-term use is unavoidable in many cases, clinicians should minimize adverse drug reactions as far as possible and tailor an effective dosage to the individual characteristics of the patient. Not only are children and adolescents particularly vulnerable to certain adverse drug effects, they are also exposed to iatrogenic risks from dosing or application errors, which can lead to under- or overdosing with correspondingly negative effects on the success of the therapy. In addition to determining a strict indication, it is therefore essential to establish precise dosage and systematic monitoring of the safety of the psychopharmacotherapy. This article introduces therapeutic drug monitoring as a useful clinical tool and describes how its correct application in practice can improve the efficacy as well as the safety and tolerability of psychotropic therapy in children and adolescents for the immediate benefit of patients.
T2  - Therapeutic drug monitoring to optimize psychopharmacotherapy in children and adolescents - Update and guidelines for practice
KW  - Psychopharmakotherapie
KW  - unerwünschte Arzneimittelwirkungen
KW  - Pharmakovigilanz
KW  - Therapeutisches Drug Monitoring
KW  - Qualitätssicherung
KW  - psychopharmacotherapy
KW  - adverse drug reactions
KW  - pharmacovigilance
KW  - therapeutic drug monitoring
KW  - quality assurance
Y1  - 2022
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-262038
SN  - 1422-4917
SN  - 1664-2880
VL  - 50
IS  - 2
ER  -