Background: There is increasing concern about the safety of various psychotropic medications within the scientific community, as evidenced by the number of black-box warnings issued by the Food and Drug Administration (FDA), and "Dear Doctor" letters sent by pharmaceutical companies. Health-care providers need to be mindful of the increasing ethical, legal, and financial risks associated with prescribing these medications.
Methods: The English language literature was searched using Medline and the Internet using relevant terms such as "black-box warning," "malpractice," "off-label prescribing," "informed consent," "medications and pregnancy," and with specific medication names, and appropriate articles and information were selected.
Results: Essential elements of obtaining informed consent when prescribing psychotropic medications to patients who are presumed to have capacity to make decisions regarding their health care are reviewed. In addition, specific concerns vis-a-vis use of psychotropics during pregnancy, off-lable use, and combining medications are discussed. Finally, ten essentials of informed consent are noted, with a focus on practicing good medicine and avoiding malpractice law suits.
Conclusions: There are an ever increasing number of special interest groups and legal firms lining up against psychiatry and psychiatrists, especially when it comes to prescribing "powerful, potentially dangerous, mind-altering, psychotropic medications." Obtaining informed consent has always been important, but never more so than now.
Haw C, Stubbs J. Haw C, et al. J Intellect Disabil Res. 2005 Nov;49(Pt 11):858-64. doi: 10.1111/j.1365-2788.2005.00723.x. J Intellect Disabil Res. 2005. PMID: 16207284
Dell ML, Vaughan BS, Kratochvil CJ. Dell ML, et al. Child Adolesc Psychiatr Clin N Am. 2008 Jan;17(1):93-111, ix. doi: 10.1016/j.chc.2007.08.003. Child Adolesc Psychiatr Clin N Am. 2008. PMID: 18036481 Review.
Mills MJ, Eth S. Mills MJ, et al. J Clin Psychiatry. 1987 Sep;48 Suppl:28-33. J Clin Psychiatry. 1987. PMID: 3624218
Rendina N, Brodaty H, Draper B, Peisah C, Brugue E. Rendina N, et al. Int J Geriatr Psychiatry. 2009 Mar;24(3):226-31. doi: 10.1002/gps.2094. Int J Geriatr Psychiatry. 2009. PMID: 18666309
Muramatsu RS, Litzinger MH, Fisher E, Takeshita J. Muramatsu RS, et al. Am J Geriatr Pharmacother. 2010 Apr;8(2):98-114. doi: 10.1016/j.amjopharm.2010.03.003. Am J Geriatr Pharmacother. 2010. PMID: 20439060 Review.
Blasdel G, Everhart A, St Amand C, Gaddis M, Grimstad F. Blasdel G, et al. Transgend Health. 2023 Dec 13;8(6):526-533. doi: 10.1089/trgh.2021.0208. eCollection 2023 Dec. Transgend Health. 2023. PMID: 38130984
Edersheim JG, Stern TA. Edersheim JG, et al. Prim Care Companion J Clin Psychiatry. 2009;11(3):115-9. doi: 10.4088/pcc.08r00717. Prim Care Companion J Clin Psychiatry. 2009. PMID: 19617944 Free PMC article. No abstract available.