title: Understanding the assessment of psychotropic drug harms in clinical trials to improve social workers' role in medication monitoring.
abstract: The purpose of this integrative review is to facilitate social work practitioners' understanding of how psychotropic drug harms are assessed in clinical trials and to make specific suggestions for social workers' increased involvement in detecting drug harms in their clients. The authors undertook a comprehensive review of interdisciplinary sources relating to policies, procedures, and evidence of current practices in adverse event assessment in clinical trial research. Results revealed that few guidelines exist for assessing harms in clinical drug research. Current practices consist primarily of asking research trial subjects general, open-ended questions or relying on spontaneous patient reports. These methods produce inconsistent data and are inadequate to fully inform. Meta-analysis of adverse effect rates across studies has further proven difficult and inconclusive. To address some of these limitations, the authors recommend that social workers contribute to a fuller understanding of drug effects by eliciting clients' own views of treatment effects and by monitoring ongoing effects using a concise yet comprehensive treatment emergent effects checklist. Social workers should also support policy initiatives that lessen or remove control over drug testing from pharmaceutical companies.
authors.affiliation: Robert Stempel College of Public Health and Social Work, Florida International University, Miami, FL 33199, USA. shughes5@msn.com
authors.forename: Shannon
authors.initials: S
authors.lastname: Hughes
authors.forename: David
authors.initials: D
authors.lastname: Cohen
mesh_terms: D002986:Clinical Trials as Topic; D064420:Drug-Related Side Effects and Adverse Reactions; D006291:Health Policy; D006801:Humans; D024382:Professional Role; D011600:Psychopharmacology; D011619:Psychotropic Drugs / Q000009:adverse effects* / Q000592:standards; D012947:Social Work; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011619:Psychotropic Drugs