@article{037ded84e8844909a586b5f39ac43866,
title = "Off-label psychopharmacologic prescribing for children: History supports close clinical monitoring",
abstract = "The review presents pediatric adverse drug events from a historical perspective and focuses on selected safety issues associated with off-label use of medications for the psychiatric treatment of youth. Clinical monitoring procedures for major psychotropic drug classes are reviewed. Prior studies suggest that systematic treatment monitoring is warranted so as to both minimize risk of unexpected adverse events and exposures to ineffective treatments. Clinical trials to establish the efficacy and safety of drugs currently being used off-label in the pediatric population are needed. In the meantime, clinicians should consider the existing evidence-base for these drugs and institute close clinical monitoring.",
author = "Zito, {Julie M.} and Derivan, {Albert T.} and Kratochvil, {Christopher J.} and Safer, {Daniel J.} and Fegert, {Joerg M.} and Greenhill, {Laurence L.}",
note = "Funding Information: At the country level, in German adult psychiatry a therapeutic drug monitoring network (TDM) was established [52-54]. Supported by a research grant after preparatory work by the commission on developmental psychopharmacology from the German professional societies in child and adolescent psychiatry in 2008, a child psychiatric TDM network was founded [55]. This therapeutic drug monitoring network comprises the measurement of plasma or serum levels and the documentation of clinical effectiveness and unwanted side effects. Therapeutic drug monitoring thus is aiming at defining therapeutic ranges of plasma or serum levels in order to maximize clinical effects while minimizing the risk of side effects or toxicity, particularly in high risk populations e.g., the developing child. Pilot work showing the high variation of plasma levels of atypical neuroleptics in children has been published [56]. The general need for this network was described by Gerlach et al. in 2006 [57], and has been accepted by the boards of the three professional societies in Germany.",
year = "2008",
month = sep,
day = "15",
doi = "10.1186/1753-2000-2-24",
language = "English (US)",
volume = "2",
journal = "Child and Adolescent Psychiatry and Mental Health",
issn = "1753-2000",
publisher = "BioMed Central",
}