Understanding the Assessment of Psychotropic Drug Harms in Clinical Trials to Improve Social Workers' Role in Medication Monitoring

For the past generation, drug therapy has become a primary form of helping mental health clients, many of whom derive substantial benefits from it. The responsible use of modern medications for all of the helping professions, however, requires ongoing education that includes not only the intended effects of psychotropic medications, but also any unintended, harmful effects. Based on a largely unmet need in the social work literature, the purpose of this integrative review is to facilitate social work practitioners' understanding of current practices in clinical trial research for assessing psychotropic drugs' harm. This could lead to more significant involvement of practitioners in detecting psychotropic drug harms in their clients, thereby contributing to improved practices in mental health. We performed a comprehensive review of interdisciplinary sources on the policies, procedures, and practices of assessing harms in clinical drug testing, including U.S. Food and Drug Administration (FDA) guidelines for safety analyses, biomedical and statistical reviews of trial design limitations and possibilities for assessing harms, and descriptions of actual practices in assessing and reporting harms of psychotropic drugs. This integrative review is presented in the spirit of advancing evidence-based practice, in which highlighting what we do not know is as important in informing clients as is sharing what we do know, both desirable and undesirable (Gambrill, 2006). The review concludes with recommendations for social work practice, research, and policy. Extensive pharmaceutical industry involvement in producing prescription drug knowledge and disseminating it to professionals, policymakers, and the public has resulted in well-documented publication biases and considerable uncertainty about drug efficacy and safety (Medawar, Hardon, & Herxheimer, 2004; Melander, Ahlqvist-Rastad, Meijer, & Beermann, 2003; Perlis et al., 2005; Turner, Matthews, Linardatos, Tell, & Rosenthal, 2008; Wazana, 2000). There have been publicized concerns about the association of suicidal thinking and behavior with antidepressant, stimulant, and anticonvulsant drugs (Alonso-Zaldivar, 2006; Healy & Whitaker, 2003; Mundy, 2008), and discoveries during litigation against drug companies about hidden or minimized adverse events (AEs) (Avorn, 2006; Kesselheim & Avorn, 2007; Kondro & Sibbald, 2004; State of Connecticut v. Eli Lilly and Company, 2008). As a result, professionals and the public are alert to the fact that some drug effects, especially of a behavioral or psychological nature, remain unrecognized at the time of drug approval and are too tardily recognized after a drug has reached the market. Such uncertainty as to the nature and intensity of drug effects poses a serious problem for making informed decisions about the drug treatment of distress and disorder. As a preliminary to this review, we sought to assess social work's involvement in evaluating drug safety issues by searching Social Work Abstracts, Social Services Abstracts, and Sociological Abstracts (for the previous 15 years) for the key words side effects, adverse effects, harm, safety, and psychopharmacology along with medication or psychotropic. We retrieved 38, 175, and 120 citations, respectively. Reviewing this literature, we concluded that current textbooks (Bentley & Walsh, 2006; Dziegelewski & Leon, 2001) and review articles (Bentley, 2003; Farmer, Bentley, & Walsh, 2006; Walsh, 1999) on psychopharmacology and social work largely aim to educate social workers on types of medication, indications, known side effects, concerns for special populations, and ethical issues with regard to professional values. Few reports, however, scrutinize clinical trials. Otis and King (2006) advised counselors on various unanticipated effects and discontinuation reactions that remain unaccounted for in clinical trials. Cohen (2002) and Cohen and Jacobs (2007) outlined methodological and conceptual limitations of randomized controlled drug trials, raising doubts about the scientific evidence supporting widespread drug use. …