Off-label psychopharmacologic prescribing for children: History supports close clinical monitoring

Pharmaceutical Health Services Research, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA.
Child and Adolescent Psychiatry and Mental Health 10/2008; 2(1):24. DOI: 10.1186/1753-2000-2-24
Source: PubMed


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.

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    • "Aufgrund unreifer Zielstrukturen und besonderer Stoffwechselbedingungen (Pharmakokinetik) besteht einerseits eine höhere Vulnerabilität für UAW durch erhöhte Plasmaspiegel , andererseits die Gefahr einer ineffektiven Behandlung durch unzureichende Wirkspiegel. Da in rund 10 % der pädiatrischen klinischen Studien mäßige bis schwere UAW vorkommen, die sehr ernsthafte Folgen wie Krankenhausaufenthalte oder Behinderung nach sich ziehen können (Sammons et al., 2008), ist eine systematische Nutzen-Risiko-Abwägung der Pharmakotherapie in dieser Altersgruppe besonders notwendig (Egberts, Mehler- Wex & Gerlach, 2011; Zito et al., 2008). "
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    ABSTRACT: Rational pharmacotherapy is a challenging task in child and adolescent psychiatry. Increasing prescription numbers contrast with the uncertainties of safety and efficacy issues. The lack of clinical (authorization) trials often implies a non- age-specific use of drugs. However, young patients show particular metabolic conditions and a higher vulnerability for adverse drug reactions. Thus it seems mandatory to create age-specific pharmacological data about efficacy and safety of psychotropic drug use in minors. Legislation authorities became aware of this situation and introduced European and national scientific pharmacovigilance regulations and programmes accordingly in order to continuously evaluate the benefit-risk-ratio, detect, collect, minimize, and prevent adverse effects of drugs by appropriate measures, e.g., therapeutic drug monitoring. In this paper the principles and needs of pharmacovigilance in child and adolescent psychiatry are discussed. Furthermore a large multicenter clinical trial («TDM-VIGIL»), funded by the German Federal Institute for Drugs and Medical Devices, is presented, which appeals to collect epidemiological prescription and safety data of psychotropic drugs in children and adolescents using an internet-based data infrastructure (patient registry).
    Zeitschrift für Kinder- und Jugendpsychiatrie und Psychotherapie 01/2015; 43(1):21-8. DOI:10.1024/1422-4917/a000329 · 0.99 Impact Factor
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    • "), ist eine systematische Nutzen-Risiko-Abwägung der Pharmakotherapie in dieser Altersgruppe besonders notwendig (Egberts, Mehler- Wex & Gerlach, 2011; Zito et al., 2008). Ein zusätzlich erschwerender Faktor für eine rationale Therapie mit Psychopharmaka bei Kindern und Jugendlichen ist, dass ein Teil der kinder-und jugendpsychiatrischen Patienten (z. "
    Pharmacopsychiatry 08/2014; 47(06). DOI:10.1055/s-0034-1386812 · 1.85 Impact Factor
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    • "While off-label use of medications is common in medicine, including in children, it is far from ideal. Experience with other medications has shown that because children are physiologically different from adults, medications that are generally safe and effective in adults are sometimes unsafe or ineffective in children [61-63]. "
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    ABSTRACT: This commentary grows out of an interdisciplinary workshop focused on controversies surrounding the diagnosis and treatment of bipolar disorder (BP) in children. Although debate about the occurrence and frequency of BP in children is more than 50 years old, it increased in the mid 1990s when researchers adapted the DSM account of bipolar symptoms to diagnose children. We offer a brief history of the debate from the mid 90s through the present, ending with current efforts to distinguish between a small number of children whose behaviors closely fit DSM criteria for BP, and a significantly larger number of children who have been receiving a BP diagnosis but whose behaviors do not closely fit those criteria. We agree with one emerging approach, which gives part or all of that larger number of children a new diagnosis called Severe Mood Dysregulation or Temper Dysregulation Disorder with Dysphoria. Three major concerns arose about interpreting the DSM criteria more loosely in children than in adults. If clinicians offer a treatment for disorder A, but the patient has disorder B, treatment may be compromised. Because DSM's diagnostic labels are meant to facilitate research, when they are applied inconsistently, such research is compromised. And because BP has a strong genetic component, the label can distract attention from the family or social context. Once a BP diagnosis is made, concerns remain regarding the primary, pharmacological mode of treatment: data supporting the efficacy of the often complex regimens are weak and side effects can be significant. However, more than is widely appreciated, data do support the efficacy of the psychosocial treatments that should accompany pharmacotherapy. Physicians, educators, and families should adopt a multimodal approach, which focuses as much on the child's context as on her body. If physicians are to fulfill their ethical obligation to facilitate truly informed consent, they must be forthcoming with families about the relevant uncertainties and complexities.
    Child and Adolescent Psychiatry and Mental Health 03/2010; 4(1):9. DOI:10.1186/1753-2000-4-9
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