Drug utilization study of off-label drug use in outpatient department of psychiatry: a prospective study at a tertiary care teaching hospital

Abstract

Background: In the absence of standard psychiatric prescribing information, physician often use drugs in an off-label way. Many studies have been published across the globe reporting different rates of off-label use. There is currently no study based on Indian Drug Formulary.Methods: After taking permission from Institutional Ethics Committee (IEC), a prospective study was conducted among 285 patients attending Psychiatry outpatient department for the period of 4 months. Data related to demographic parameters, diagnosis of psychiatry conditions and drugs details were collected directly from the patient's medical records and entered in Case Record Form (CRF).The off-label drugs were categorized as per National Formulary of India. Multivariate binary logistic regression model was used to determine the predictors of off- label drug prescribing. The data were statistically analyzed using SPSS version 19 and chi-square test.Results: A total of 285 patients (169 males, 116 females) were included in the study with mean age of 36.54±13.91 years. Most of the patients (n=65, 22.8%) were diagnosed as schizophrenic. Out of 285 patients, 133(46.6%) received at least one off-label drug. A total 841 drugs were prescribed out of which 167(19.85%) were off-label. The drug most frequently prescribed as off-label were trihexiphenidyl HCL 29 (10.2%), clozapine 23 (8.1%) and clonazepam 13 (4.6%).Conclusions: Off label drugs used among psychiatry patients was 19.85%. The most frequently used off-label drugs was trihexiphenidyl HCL. The use of off-label drugs in psychiatric patients has been reportedly increasing which warrant national drug regulatory authorities to review and revise safe administration such drugs.

Off-label Drug Prescribing: Deciphering the Ambiguity

“…Majority of patients attending the psychiatric OPD were prescribed the off label drugs (39.5%) and the most frequently used drugs in off-label manner were clonazepam (12.4%), lorazepam 30 (12%), and trihexyphenidyl HCL (10%). 5 A higher incidence of Insomnia in most psychiatric patients warranted the higher overall use of Benzodiazepines. Drugs such as clonazepam, lorazepam are used in depression, mania, bipolar disorder, obsessive compulsive disorder in off label manner as these drugs provide a calming effect to the patients and prevent acute manic episodes.…”