Introduction: Psychoactive drug prescription for preschoolers has increased over the past decade and has been a controversial topic for those who prescribe, regulate, and research the use of psychotropics in this population. Children and adolescents are deemed vulnerable populations, at risk of being harmed by unethical or suboptimal practice and research and are in need of special protection. Historically, preschoolers have been therapeutic and research "orphans," excluded from pharmacological studies so that the evidence base for their treatment has to be extrapolated from other ages. Within the past few decades, several ethical principles guiding pediatric psychopharmacological research have been developed. The same principles could effectively guide the treatment of these patients.
Conclusion: Further studies are needed to elucidate the safety and effectiveness of psychotropics, and sound ethical guidelines for their involvement in psychiatric research are needed. This article reviews some challenges facing mental health care providers involved in prescribing or researching the use of psychoactive drugs in preschoolers. Some of these challenges are general to medical treatment and research with children, and others are particular to child psychopharmacological treatment and research.
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