OFF-LABEL USE OF ANTIPSYCHOTICS AND ANTIDEPRESSANTS- A DOUBLE EDGED
SWORD -- OBLIGES A CLOSE MONITORING
Abstract
Nowadays the prescription of off-label in psychiatric practice is very
common, exclusively in the pregnant women, pediatric and geriatric
groups due to the lack of available standards and alternatives, that
elevate the safety issue in the vulnerable groups. This observational
study performed in a Tertiary Care Teaching Hospital for six months
prospectively and retrospectively. It involved 549 patients with a mean
age of 37.13 ± 12.62 years (range 9–81 years) and male: female ratio
was 1:1.3, showing a higher incidence of the female population as
compared to previous Indian studies which reported a higher population
of males. We found approximately 1550 drugs prescriptions in which the
44% were antipsychotic and antidepressants. The indication of drugs was
found to be 560 in numbers, in which 31.5% of drugs prescription not
found any distinguish indication. Amitriptyline 19.51% was the most
commonly prescribed drug followed by the Escitalopram 17.0%, Clonazepam
12.1%, Fluoxetine 11.2%, Sertraline 6.5%, etc. Also the various
adverse effect association recorded with this prescribing pattern. The
off-label prescription was ascertaining with the application of drug
package insert (US-FDA) and National formulary of India 2011 and 2016
was used as a reference basis to ascertain the off-label prescribing.
Wide variability was noticed in prescribing practices among clinicians,
however it is not limited to psychiatric only. The conclusion of the
study underlined a prerequisite accountability of healthcare
professional on the way to safe medication practices through a lot of
scientific evidence for the risks and benefits profiling of off-label
medication