KUMJ | VOL. 18 | NO. 4 | ISSUE 72 | OCT.-DEC. 2020
Prescription Pattern Monitoring and Off-label Use of Medicines in the Pediatric Department at Tertiary Care Teaching Hospital
Pandey S, Yadav CK, Ghimire P, Shrestha AC
Abstract: Background
Off-label use means the use, concerning dosage, indication, route of administration,
or age, of pharmaceutical products which are beyond the terms of the product
license. For regulatory bodies and physicians, the global challenge is to achieve
optimum pediatric drug therapy.
Objective
This prospective observational work was carried out in the paediatric department
to evaluate the prescribing pattern of medicines and to identify the use of off-label
drugs.
Method
A cross-sectional study was carried in 200 paediatric patients of ages between 0 and
12 years at the paediatric outpatient department of Universal College of Medical
Sciences, Bhairahawa. Data were collected by reviewing the prescription paper and
the required information was recorded using a structured data collection sheet
prepared for study. The prescribing pattern was assessed by using the World Health
Organization (WHO) Prescription Indicators and off-label use was assessed using the
WHO Children Formulary 2010.
Result
Among 413 total prescriptions, only 5.56% of drugs were found to be prescribed
by generic name, 16.7% of prescriptions were found to be antibiotic and 57.62% of
prescribed drugs were from essential drug list. Out of 413 prescribed drugs, 16.46%
of drugs were found to be off-label. The maximum extent of off-label prescribing was
51.47% in the child, followed by infants (42.6%) and neonates (5.8%). Fexofenadine;
antihistaminic (23.56%), Amoxicillin+clavulanic acid; antibiotic (22.06%) had higher
off-label use. Off-label dose (71.8%) was the most common cause of off-label
prescribing.
Conclusion
Off-label prescribing among pediatric patients is common.More eminence data
on the safety and efficacy of off-label medicines must be generated to rationalize
paediatric pharmacotherapy.
Keyword : Child, Neonates, Off-label drug use, Pediatric, Prescription pattern monitoring studies (PPMS)
