Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Pharmacoepidemiological assessment of off-label drug use in pediatric ambulatory departments at four tertiary care hospitals in Pakistan

Rabeea Sharif¹, Muhammad Aamir², Faisal Shakeel³, Shah Faisal⁴, Jamshaid Ali Khan¹

¹Department of Pharmacy, University of Peshawar; ²Department of Pharmacy, Sarhad University of Science and Information Technology, Peshawar, Pakistan; ³College of Clinical Pharmacy, University of Michigan, USA; ⁴Department of Pharmacy, University of Malakand, Chakdara, Pakistan.

For correspondence:- Jamshaid Khan Email: jamshaidkhan@uop.edu.pk

Accepted: 15 September 2020 Published: 30 October 2020

Citation: Sharif R, Aamir M, Shakeel F, Faisal S, Khan JA. Pharmacoepidemiological assessment of off-label drug use in pediatric ambulatory departments at four tertiary care hospitals in Pakistan. Trop J Pharm Res 2020; 19(10):2219-2225 doi: 10.4314/tjpr.v19i10.28

© 2020 The authors.
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Abstract

Purpose: To assess the frequency and possible predictors of off-label drug use in ambulatory pediatric units of four tertiary healthcare institutions in a Pakistani city.

Methods: A prospective study was conducted at the pediatric ambulatory department of four tertiary care hospitals of Peshawar, Pakistan. A total 1589 patients were included in the study which to evaluate their prescriptions for off-label drug use with the aid of Thomson Healthcare Micromedex DRUGDEX database.

Results: A total of 79 different drugs were prescribed 5668 times to pediatric patients. A high rate of off-label drug use (71.8 %) was observed in this study. Compared to corresponding reference categories, infants (OR 4.134, 95 % CI 2.076-8.235) and children (OR 1.857, 95 % CI 0.967-3.568) were more likely to receive off-label prescriptions. However, pediatric patients receiving less than four drugs (OR 0.414, 95 % CI 0.312-0.548) were less likely to receive off-label prescriptions.

Conclusion: A high incidence of off-label drug use has been observed in the ambulatory pediatric population studied, especially in infants. More research is needed to identify and evaluate the contributory factors to off-label use of drugs in ambulatory pediatric population in developing countries to achieve optimal drug therapy for pediatrics.

Keywords: Pediatric population, Ambulatory, Off-label drug use