Anwendung von Medikamenten außerhalb oder ohne Zulassung im stationären Bereich
Loading...
Files
Date
Authors
Publisher
Philipps-Universität Marburg
Supervisors
Abstract
Prior to registration drugs must undergo extensive assessments that include studies to investigate dose finding, pharmacokinetics, pharmacodynamics, safety, efficacy and quality .The results of these assessments are expressed in the product license.
Internationally, especially in the United States of America and Great Britain, there is great interest in the problem of missing or inadequate licensing of drugs for children, which is associated with doubts regarding the efficacy and safety of paediatric pharmacotherapy. In Germany, however, there were no current information on the extent of off-label or unlicensed drug use in children in the inpatient and outpatient care. The importance of this issue for Germany had been demonstrated as early as 1981 by data obtained on an pediatric intensive care unit.
In order to obtain current information on the extent and nature of the use of medications in children of different age groups during their hospitalization at university hospitals, this study was conducted as part of a European multicenter study investigating drug use in paediatrics.
During the survey period a total of 140 children were treated with 234 different drugs, which were prescribed a total of 1146 times.
333 (29%) of the prescriptions were in line with the regulatory labels, 687 (60%) of the prescriptions were categorised as off-label and 126 (11%) of the prescriptions were categorised as unlicensed drug use. This resulted in a total of 813 (71%) prescriptions being either off-label or unlicensed.
There were clear differences between the three observed wards. About half (51%) of the prescriptions on the infectious disease ward were off-label or unlicensed. The majority of prescriptions on the oncology/renal ward and the intensive care unit with a Neonatology focus were off-label or unlicensed (72% and 79%, respectively). Overall only 17 of the 140 paediatric patients were exclusively treated with medications according to their labels.
Children have a right to receive safe and effective drug therapy and should no longer remain "therapeutic orphans".
In order to address this dilemma and to provide age-appropriate dosing guidelines and pharmaceutical formulations, multicenter clinical studies involving paediatric patients are urgently needed. These studies have to take into account the distinct pharmacological, legal, ethical and psychological characteristics of children.
Review
Metadata
Contributors
Supervisor:
Dates
Created: 2011Issued: 2011-08-08Updated: 2011-08-08
Faculty
Medizin
Publisher
Philipps-Universität Marburg
Language
ger
Data types
DoctoralThesis
Keywords
paediatricOff -labeldrug therapyArzneimitteltherapieZulassungsstatusArzneimittelsicherheitKinderunlicensedchildrenlizenziert
DFG-subjects
lizenziertZulassungsstatusKinderArzneimittelsicherheitArzneimitteltherapie
DDC-Numbers
610
show more
Knöppel, Carmen: Anwendung von Medikamenten außerhalb oder ohne Zulassung im stationären Bereich. : Philipps-Universität Marburg 2011-08-08. DOI: https://doi.org/10.17192/z2011.0449.
License
This item has been published with the following license: In Copyright