References: 
1. Oates M. Facilitating informed medical treatment through production and disclosure of research into off-label uses of pharmaceuticals. NYU Law Rev. 2005;80:1272-1308.
2. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166:1021-1026.
3. Kramer SI, McCall WV. Off-label prescribing: 7 steps for safer, more effective treatment. Curr Psychiatry. 2006;5:15-16, 21-22, 26-28.
4. Fountoulakis KN, Nimatoudis I, Iacovides A, Kapri­nis G. Off-label indications for atypical anti­psychotics: a systematic review. Ann Gen Hosp Psychiatry. 2004; 3:4.
5. Zito JM, Derivan AT, Kratochvil CJ, et al. Off-label psychopharmacologic prescribing for children: history supports close clinical monitoring. Child Adolesc Psychiatry Ment Health. 2008;2:24.
6. Dell ML, Vaughan BS, Kratochvil CJ. Ethics and the prescription pad. Child Adolesc Psychiatric Clin N Am. 2008;17:93-111, ix.
7. Zito JM, Safer DJ, dosReis S, et al. Psychotropic practice patterns for youth: a 10-year perspective. Arch Pediatr Adolesc Med. 2003;157:17-25.
8. Olfson M, Marcus SC,Weissman MM, Jensen PS.National trends in the use of psychotropic medications by children. J Am Acad Child Adolesc Psychiatry. 2002;41:514-521. 9. Nemeroff CB, Kalali A, Keller MB, et al. Impact of publicity concerning pediatric suicidality data on physician practice patterns in the United States. Arch Gen Psychiatry. 2007;64:466-472. 10. Dresser R. At law: the curious case of off-label use. Hastings Cent Rep. 2007;37:9-11. 11. Bright JL. Positive outcomes through the appropriate use of off-label prescribing. Arch Intern Med. 2006;166:2554-2555. 12. Psaty BM, Ray W. FDA guidance on off-label promotion and state of the literature from sponsors. JAMA. 2008;299:1949-1951. 13. Stafford RS. Regulating off-label use: rethinking not been FDA-approved for the specific use requires a higher standard of informed consent. A recent poll of over 2000 adults revealed that most patients are not aware that physicians are permitted to prescribe medications for indications that are not approved by the FDA.15 Clinicians should have an interactive discussion with the patient (or the person authorized to make medical decisions on the patient’s behalf) regarding the nature of off-label use, the reasons for choosing a non–FDA-approved medicine, and the risks specifically associated with the proposed use. This discussion, along with any written materials provided to the patient, should be included in the patient’s chart. If the medication the clinician is recommending also has a black box warning about its use, the clinician must conduct an informed consent discussion that takes into account the regulatory requirements and monitoring schedules set forth by the FDA for these uses. (Dell and colleagues6 provide an excellent discussion regarding informed consent when prescribing psychotropics for children.) Conclusion As with other sources of liability for prescribing, the best defense against malpractice liability for prescribing off-label is to provide high-quality care when selecting, prescribing, and monitoring medications, and to engage in meaningful informed consent discussions with your patients. Dr Edersheim is senior consultant in the Law and Psychiatry Service at Massachusetts General Hospital in Boston and a clinical instructor in psychiatry at Harvard Medical School. She reports no conflicts of interest concerning the subject matter of this article. References 1. Oates M. Facilitating informed medical treatment through production and disclosure of research into off-label uses of pharmaceuticals. NYU Law Rev. 2005;80:1272-1308. 2. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166:1021-1026. 3. Kramer SI, McCall WV. Off-label prescribing: 7 steps for safer, more effective treatment. Curr Psychiatry. 2006;5:15-16, 21-22, 26-28. 4. Fountoulakis KN, Nimatoudis I, Iacovides A, Kaprinis G. Off-label indications for atypical antipsychotics: a systematic review. Ann Gen Hosp Psychiatry. 2004; 3:4. 5. Zito JM, Derivan AT, Kratochvil CJ, et al. Off-label psychopharmacologic prescribing for children: history supports close clinical monitoring. Child Adolesc Psychiatry Ment Health. 2008;2:24. 6. Dell ML, Vaughan BS, Kratochvil CJ. Ethics and the prescription pad. Child Adolesc Psychiatric Clin N Am. 2008;17:93-111, ix. 7. Zito JM, Safer DJ, dosReis S, et al. Psychotropic practice patterns for youth: a 10-year perspective. Arch Pediatr Adolesc Med. 2003;157:17-25.
8. Olfson M, Marcus SC,Weissman MM, Jensen PS. the role of the FDA. N Engl J Med. 2008;358:1427- 1429.
9. Nemeroff CB, Kalali A, Keller MB, et al. Impact of publicity concerning pediatric suicidality data on physician practice patterns in the United States. Arch Gen Psychiatry. 2007;64:466-472.
10. Dresser R. At law: the curious case of off-label use. Hastings Cent Rep. 2007;37:9-11.
11. Bright JL. Positive outcomes through the appropriate use of off-label prescribing. Arch Intern Med.2006;166:2554-2555.
12. Psaty BM, Ray W. FDA guidance on off-label promotion and state of the literature from sponsors. JAMA. 2008;299:1949-1951.
13. Stafford RS. Regulating off-label use: rethinking the role of the FDA. N Engl J Med. 2008;358:1427- 1429.
14. Beck JM, Azari ED. FDA, off-label use, and informed consent: debunking myths and misconceptions. Food Drug Law J. 1998;53:71-104.
15. Frank B, Gupta S, McGlynn DJ. Psychotropic medications and informed consent: a review. Ann Clin Psychiatry. 2008;20:87-95.
16. Krautkamer CJ. Neurontin and off-label marketing. Virtual Mentor: AMA J Ethics. 2006;8(6):397-402.
17. American Psychiatric Association. Position statement. Patient Access to Treatments Prescribed by Their Physicians. July 2007. http://www.psych.org/MainMenu/EducationCareerDevelopment/Library/ PositionStatements.aspx. Accessed December 8, 2008.
18. Buckman Company v Plantiffs’ Legal Committee. 531 US 341, 121 SCt 1012 (2001).
19. Simon RI, Gold LH. Textbook of Forensic Psychiatry. Arlington,VA:American Psychiatric Publishing, Inc; 2004:187-188.
20. Appelbaum PS, Gutheil TG. Clinical Handbook of Psychiatry and the Law. 4th ed. Philadelphia:Wolters Kluwer/Lippincott Williams & Wilkins; 2007:126-127.
Evidence-Based References
Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166:1021-1026.
Zito JM, Safer DJ, dosReis S, et al. Psychotropic practice patterns for youth:a 10-year perspective.Arch Pediatr Adolesc Med. 2003;157:17-25.