Child and adolescent psychopharmacology in the new millennium: a workshop for academia, industry, and government.
ABSTRACT To give academic researchers, government officials, and industry scientists an opportunity to assess the state of pediatric psychopharmacology and identify challenges facing professionals in the field.
Increased federal spending and the introduction of pediatric exclusivity led to large increases in pediatric psychopharmacology research in the 1990s. Despite the increase in research, concerns exist about methods and incentives for making new medications available for use in pediatric psychiatric disorders. In recognition of these concerns, the Duke Clinical Research Institute held a roundtable in September 2004. Participants from the National Institutes of Health, regulatory agencies, academia, and the pharmaceutical industry spoke about the effects of government regulations such as the U.S. Food and Drug Administration Modernization Act and the Pediatric Research Equity Act on pediatric research from academic, clinical, and industry perspectives, and bioethical considerations of such research.
To ensure development of new drugs for treating psychiatric disorders in children and adolescents, we must address the challenges posed by the regulatory environment governing pediatric psychopharmacology research. Strategies were identified for improving the evidence base for psychopharmacologic interventions in youth before widespread use and for more effectively defining a research agenda for the future.
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ABSTRACT: The purpose of licensing system is to ensure that the medicines are examined for safety, efficacy and quality. Nevertheless, off-label or unlicensed drug usages in pediatric practice is widespread in Korea and worldwide. Psychotropics are one of the most commonly used off-label or unlicensed drugs. The most valid approach to face this dilemma will be to have more evidences from pediatric pharmacological studies. Clinicians, in addition, need to monitor closely their off-label or unlicensed drug prescriptions to minimize the trial and error in practice. Researchers should publish their experiences and provide guidelines. Pharmaceutical companies, regulatory authorities, and consumer organizations should endeavor altogether for the children's right to get safe and efficacious drugs as adults do. Here, the definition as well as the current status of off-label and unlicensed drug prescriptions will be introduced. Critical issues regarding the off label drugs are discussed. In addition, I will describe the present condition as to the off-label and unlicensed drugs in child and adolescent psychiatry and the authorization process of off-label drug prescription in Korea. Lastly, direction we should like to take in this field will be mentioned.06/2011; 22(2). DOI:10.5765/JKACAP.2011.22.2.067
Journal of Pediatric Health Care 02/2013; DOI:10.1016/j.pedhc.2013.01.005 · 1.97 Impact Factor
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ABSTRACT: In this study, I investigated patterns and predictors of service utilization for children with mood disorders. The Behavioral Model for Health Care Utilization was used as an organizing framework for identifying predictors of the number and quality of services utilized. Hierarchical regression was used in secondary data analyses of the Multi-Family Psychoeducational Psychotherapy study (MF-PEP), a randomized controlled trial of 165 children aged 8–12 with mood disorders. The children were using an average of two services, with pharmacotherapy and school services as most frequent. Children with bipolar disorders used significantly more and higher quality services than children with depressive disorders. Parent knowledge of mood disorders, area of residence, and perceived need for treatment were all related to the number of services families were utilizing. Parent knowledge of mood disorders and treatment, child’s age, and mood symptom severity were all predictors of the quality of services being utilized. Findings highlight the impact of non-need factors on service utilization and the potential to decrease disparities caused by these factors. For example, increasing efforts to educate both the general public and individual families coming in for treatment about children’s mental health may improve service utilization patterns in this population.Journal of Child and Family Studies 08/2012; 21(4). DOI:10.1007/s10826-011-9512-x · 1.42 Impact Factor