Current pattern of off-label drug use among hospitalized pediatric patients: a cross-sectional study

Pharmacy Practice

  • Mehreen Aslam1Faculty of Pharmaceutical Sciences, Department of Pharmacy Practice, Government College University Faisalabad, Faisalabad, Pakistan.
  • Shahid Shah1Faculty of Pharmaceutical Sciences, Department of Pharmacy Practice, Government College University Faisalabad, Faisalabad, Pakistan.
  • Ghulam Abbas2Faculty of Pharmaceutical Sciences, Department of Pharmaceutics, Government College University Faisalabad, Faisalabad, Pakistan.
  • Haris Khurram3Department of Mathematics and Computer Science, Faculty of Science and Technology, Prince of Songkla University, Pattani Campus, Pattani, Thailand., 4Department of Science and Humanities, National University of Computer and Emerging Science, Chiniot-Faisalabad Campus, Chiniot, Pakistan.
  • Abdullah Assiri5Department of Clinical Pharmacy, College of Pharmacy, King Khalid University, Abha, Saudi Arabia.

Volume 23 Issue 3 Pages 1-9

DOI: 10.18549/PharmPract.2025.3.3211

Abstract

Background: Many hospitalized pediatrics receive off-label drugs that are not tested prior to being put on the market. Objective: To assess the prescribing pattern of off-label drug use among hospitalized pediatric patients in Punjab, Pakistan. Method: A cross-sectional study was conducted from October 2023 to February 2024 from 3 governments and 3 private hospitals of 5 most populated cities (Faisalabad, Lahore, Gujranwala, Multan, Islamabad) of Punjab, Pakistan. Stratified random sampling was applied to select samples from pediatric wards of hospitals. All the drugs were classified as off-label or on-label on the basis of package insert and BNF. Off-label drug use was categorized on the basis of route of administration, indication, frequency, formulation, dose and age. Frequency distribution is used to explore the data. Chi-square test was used to explore the association between on-label and off-label categories against various variables. Finally, Multiple logistic regression models were used to find the determinants of off-label drugs. Results: Of 2100 prescriptions, a total of 472 (22%) patients received off-label drugs. Most off-label drugs were found in Faisalabad (55.2%). In all age groups, children were more prone to off-label use (30.60%). The presence of chronic illness was significantly associated with off-label drug use (p<0.05). Off-label drug use in children general ward was 2 times more than the other wards. A statistically significant correlation (p<0.001) was found between the on-label and off-label drug use within the diagnostic category. In all prescribed drug categories, anti-infective for systemic use accounts highest off-label use followed by systemic hormonal preparation (13.5%) and the most common off-label drug category was off-label by indication. Conclusion: High level of off-label drug prescriptions was found in children as compared to neonates. Off-label drugs showed poor results in patients with chronic illness. The number of drugs prescribed by an MBBS physician increases the chances of off-label prescriptions.

Keywords

  • Hospitalized pediatrics
  • Off-label use
  • Prescribing pattern
  • Pediatric patients
Pharmacy Practice

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