Therapeutic drug monitoring as a measure of proactive pharmacovigilance in child and adolescent psychiatry.

INTRODUCTION: Off-label or unlicensed use of psychotropic drugs is common rather than the exception in child and adolescent psychiatry. This use exposes patients to an unknown additional risk of ineffective or even harmful treatment. In addition, treatment with psychotropic drugs during a period of life when the patient undergoes marked developmental hormonal and neurobiological changes often requires different dosing regimes in later life and may result in adverse drug reactions, which are either not seen in adults at all or not in the same frequency. Areas covered: Given these critical safety issues, efficient pharmacovigilance methods as part of routine practice are essential for the improvement of patient care. The purpose of this article is to introduce methods to increase the safety of psychotropic drug use in youngsters. In particular, therapeutic drug monitoring (TDM) as a routine measure of proactive pharmacovigilance is discussed. Expert opinion: Given the special features of psychopharmacological therapy in children and adolescents in day-to-day clinical practise, proactive surveillance by using a close standardized 'patient monitoring' and long-term follow-up with TDM is very important. This approach could minimize the risk of exposing paediatric patients to ineffective treatments of uncertain or unknown risks.