Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Use of off-label and unlicensed drugs in pediatric patients: A longitudinal prevalence survey from Lahore, Pakistan

Muhammad Hafeez¹, Nadeem Irfan Bukhari¹, Nasir Abbas¹, Khalid Hussain¹, Amjad Hussain¹, Zikria Saleem¹

¹University College of Pharmacy, University of the Punjab, Lahore, Pakistan; ²School of Pharmaceutical Sciences, Universiti Sains Malaysia, Malaysia.

For correspondence:- Zikria Saleem Email: nadeem_irfan@hotmail.com Tel:+923004259738

Accepted: 21 September 2019 Published: 31 October 2019

Citation: Hafeez M, Bukhari NI, Abbas N, Hussain K, Hussain A, Saleem Z. Use of off-label and unlicensed drugs in pediatric patients: A longitudinal prevalence survey from Lahore, Pakistan. Trop J Pharm Res 2019; 18(10):2197-2201 doi: 10.4314/tjpr.v18i10.28

© 2019 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

Purpose: To assess the extent of use of unlicensed/off-label drug in the children hospitalized in The Children’s Hospital and Institute of Child Health, Lahore, Pakistan.

Methods: A prospective prevalence study was carried out in the selected hospital. A total of 1946 pediatric patients were hospitalized during study period. The patients’ demographic data and unlicensed/off-label drug use were noted by the researcher using a structured questionnaire and then analyzed.

Results: During the survey period, 102 (5.24 %) pediatric patients received at least one off-label drug/unlicensed drug. The unlicensed drug was administered to 65 patients (63.7 %) while off-label drug was administered to 37 patients (36.3%). Milrinone (23.5%) was the most frequently prescribed unlicensed drug.

Conclusion: The administration of unlicensed/off-label drug to treat different diseases in pediatric population is widespread in the health facility studied. These findings will provide guidance to new researchers in clinical trials, especially on cardiovascular drugs, opioid analgesic, antiemetic and anticancer drugs.

Keywords: Pediatric, Off-label drugs, Unlicensed drugs