Off-label prescription of psychotropic medications in a sample of Italian psychiatrists working in private practice: a cross sectional study

Caterina Bonamici 1, Alessia Guicciardi 1, Alex Curti 1, Anna Rita Atti 2, Jessica Balducci 1, Giorgio Mattei 1,3, Letizia Valle 1, Gian Maria Galeazzi 1,4, Silvia Ferrari 1,4

1 Section of Clinical Neurosciences, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy; 2 Department of Biomedical and NeuroMotor Sciences, University of Bologna, Italy; 3 Department of Economics and Marco Biagi Foundation, University of Modena and Reggio Emilia, Modena, Italy; 4 Department of Mental Health and Drug Abuse, AUSL Modena, Italy

DOI 10.36148/2284-0249-383


Off-label prescription refers to the use of a drug outside the terms of its Marketing Authorization. According to the literature, this practice is particularly common in clinical psychiatry.


To describe patterns of off-label prescription in a sample of Italian psychiatrists working in private practice.


An ad hoc questionnaire was developed and sent by e-mail to a sample of Italian psychiatrists working in private practice in the Region Emilia-Romagna. The questionnaire assessed frequency of off-label prescription, reasons associated with it, diagnostic categories more often associated with such practice, main sources of information used to support off-label prescription, and psychotropic agents most commonly prescribed off-label, as well as medical-legal implications. Data were analysed by means of univariate and multivariate ordered logistic regressions. 


Fifty psychiatrists (female: 44%) out of 129 who received the e-mail invitation responded (response rate: 39%). Off-label prescription was found to be inversely proportional to clinicians’ age (OR = 10.53 [95% CI 2.13-52.13]). Most commonly, second-generation antipsychotics (SGAs) were prescribed to patients diagnosed with personality disorders (PDs) (OR = 0.08 [95% CI 0.02-0.36]). A higher rate of off-label prescription was also associated to relying more on pharmaceutical sales representatives (OR = 0.58 [95%CI 0.01-0.30]) or personal professionals’ clinical experience (OR = 0.05 [95% CI 0.01-0.36]) and less on other colleagues’ experience (OR = 11.80 [95% CI 4.16-33.50]) as source of information. 


Off-label prescription is common, especially among young psychiatrists, who frequently rely on previous personal clinical experience, especially when prescribing SGAs for treating patients with PDs. Respondents pointed to the need for further research and training on the topic addressed by the present study. 

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