Psychotropic medications and informed consent: a review.
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.
Department of Psychiatry, University of Buffalo School of Medicine and Biomedical Sciences, Buffalo, New York, USA. bfrank@thefrankgroup.com
Bradford
B
Frank
Sanjay
S
Gupta
Daniel J
DJ
McGlynn
D000328:Adult; D000075202:Contraindications; D011307:Drug Prescriptions; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008318:Malpractice / Q000145:classification; D016743:Mental Competency; D011247:Pregnancy; D011619:Psychotropic Drugs / Q000009:adverse effects* / Q000627:therapeutic use
D011619:Psychotropic Drugs