Developing methodologies for monitoring long-term safety of psychotropic medications in children

Report on the NIMH Conference, September 25, 2000

Laurence L. Greenhill*, Benedetto Vitiello, Howard Abikoff, Jerome Levine, John S. March, Mark A. Riddle, Lisa Capasso, Thomas B. Cooper, Mark Davies, Prudence Fisher, Robert L. Findling, Jane Fried, Michael J. Labellarte, James T. McCracken, Don Mcmahon, James Robinson, Anne Skrobala, Lawrence Scahill, Elena Varipatis, John T. Walkup & 1 others Julie M. Zito

*Corresponding author for this work

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

Objective: To improve the methods for long-term assessment of drug-associated side effects and advance knowledge of the safety profile of psychotropic medications in children and adolescents. Method: A multidisciplinary, interactive workshop was hosted by the National Institute of Mental Health (NIMH) and the Research Units on Pediatric Psychopharmacology network. Participants were experts in child and adolescent psychiatry, psychopharmacology, pharmacoepidemiology, and statistics from academia, the pharmaceutical industry, the Food and Drug Administration (FDA), and the NIMH. Evaluation of drug safety was examined from five perspectives: research design and methods, industry, regulatory requirements, bioethics, and practice settings. For each of these areas, special emphasis was placed on identifying barriers and generating solutions. Results: A major obstacle is the lack of standardization of the methods used for collecting safety data. The limitations of both randomized clinical trials and passive postmarketing surveillance in assessing long-term safety were recognized. The need to consider alternative approaches, such as registries and trend analysis of population-based databases, was highlighted. Recommendations were proposed together with possible approaches to implementation. Conclusions: A concerted effort by academic researchers, industry, FDA, practitioners, and NIMH is needed to standardize methods and lay the foundations for systematic research on the long-term safety of psychotropic medications in children.

Original languageEnglish (US)
Pages (from-to)651-655
Number of pages5
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume42
Issue number6
DOIs
StatePublished - Jan 1 2003

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National Institute of Mental Health (U.S.)
Safety
Psychopharmacology
United States Food and Drug Administration
Industry
Pharmacoepidemiology
Adolescent Psychiatry
Child Psychiatry
Bioethics
Drug Evaluation
Drug Industry
Drug-Related Side Effects and Adverse Reactions
Research
Registries
Research Design
Randomized Controlled Trials
Research Personnel
Databases
Pediatrics
Education

Keywords

  • Adverse events
  • Children
  • Drug safety
  • Psychopharmacology
  • Treatment

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Psychiatry and Mental health

Cite this

Greenhill, Laurence L. ; Vitiello, Benedetto ; Abikoff, Howard ; Levine, Jerome ; March, John S. ; Riddle, Mark A. ; Capasso, Lisa ; Cooper, Thomas B. ; Davies, Mark ; Fisher, Prudence ; Findling, Robert L. ; Fried, Jane ; Labellarte, Michael J. ; McCracken, James T. ; Mcmahon, Don ; Robinson, James ; Skrobala, Anne ; Scahill, Lawrence ; Varipatis, Elena ; Walkup, John T. ; Zito, Julie M. / Developing methodologies for monitoring long-term safety of psychotropic medications in children : Report on the NIMH Conference, September 25, 2000. In: Journal of the American Academy of Child and Adolescent Psychiatry. 2003 ; Vol. 42, No. 6. pp. 651-655.
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author = "Greenhill, {Laurence L.} and Benedetto Vitiello and Howard Abikoff and Jerome Levine and March, {John S.} and Riddle, {Mark A.} and Lisa Capasso and Cooper, {Thomas B.} and Mark Davies and Prudence Fisher and Findling, {Robert L.} and Jane Fried and Labellarte, {Michael J.} and McCracken, {James T.} and Don Mcmahon and James Robinson and Anne Skrobala and Lawrence Scahill and Elena Varipatis and Walkup, {John T.} and Zito, {Julie M.}",
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Greenhill, LL, Vitiello, B, Abikoff, H, Levine, J, March, JS, Riddle, MA, Capasso, L, Cooper, TB, Davies, M, Fisher, P, Findling, RL, Fried, J, Labellarte, MJ, McCracken, JT, Mcmahon, D, Robinson, J, Skrobala, A, Scahill, L, Varipatis, E, Walkup, JT & Zito, JM 2003, 'Developing methodologies for monitoring long-term safety of psychotropic medications in children: Report on the NIMH Conference, September 25, 2000', Journal of the American Academy of Child and Adolescent Psychiatry, vol. 42, no. 6, pp. 651-655. https://doi.org/10.1097/01.CHI.0000046842.56865.EC

Developing methodologies for monitoring long-term safety of psychotropic medications in children : Report on the NIMH Conference, September 25, 2000. / Greenhill, Laurence L.; Vitiello, Benedetto; Abikoff, Howard; Levine, Jerome; March, John S.; Riddle, Mark A.; Capasso, Lisa; Cooper, Thomas B.; Davies, Mark; Fisher, Prudence; Findling, Robert L.; Fried, Jane; Labellarte, Michael J.; McCracken, James T.; Mcmahon, Don; Robinson, James; Skrobala, Anne; Scahill, Lawrence; Varipatis, Elena; Walkup, John T.; Zito, Julie M.

In: Journal of the American Academy of Child and Adolescent Psychiatry, Vol. 42, No. 6, 01.01.2003, p. 651-655.

Research output: Contribution to journalArticle

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T2 - Report on the NIMH Conference, September 25, 2000

AU - Greenhill, Laurence L.

AU - Vitiello, Benedetto

AU - Abikoff, Howard

AU - Levine, Jerome

AU - March, John S.

AU - Riddle, Mark A.

AU - Capasso, Lisa

AU - Cooper, Thomas B.

AU - Davies, Mark

AU - Fisher, Prudence

AU - Findling, Robert L.

AU - Fried, Jane

AU - Labellarte, Michael J.

AU - McCracken, James T.

AU - Mcmahon, Don

AU - Robinson, James

AU - Skrobala, Anne

AU - Scahill, Lawrence

AU - Varipatis, Elena

AU - Walkup, John T.

AU - Zito, Julie M.

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N2 - Objective: To improve the methods for long-term assessment of drug-associated side effects and advance knowledge of the safety profile of psychotropic medications in children and adolescents. Method: A multidisciplinary, interactive workshop was hosted by the National Institute of Mental Health (NIMH) and the Research Units on Pediatric Psychopharmacology network. Participants were experts in child and adolescent psychiatry, psychopharmacology, pharmacoepidemiology, and statistics from academia, the pharmaceutical industry, the Food and Drug Administration (FDA), and the NIMH. Evaluation of drug safety was examined from five perspectives: research design and methods, industry, regulatory requirements, bioethics, and practice settings. For each of these areas, special emphasis was placed on identifying barriers and generating solutions. Results: A major obstacle is the lack of standardization of the methods used for collecting safety data. The limitations of both randomized clinical trials and passive postmarketing surveillance in assessing long-term safety were recognized. The need to consider alternative approaches, such as registries and trend analysis of population-based databases, was highlighted. Recommendations were proposed together with possible approaches to implementation. Conclusions: A concerted effort by academic researchers, industry, FDA, practitioners, and NIMH is needed to standardize methods and lay the foundations for systematic research on the long-term safety of psychotropic medications in children.

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