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Exploratory Findings of Prescribing Unlicensed and Off-Label Medicines Among Children and Neonates

Authors Shakeel S, Iffat W, Nesar S, Zaidi H, Jamshed S

Received 15 September 2019

Accepted for publication 28 November 2019

Published 5 February 2020 Volume 2020:9 Pages 33—39

DOI https://doi.org/10.2147/IPRP.S231134

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Professor Jonathan Ling


Sadia Shakeel,1,2 Wajiha Iffat,2 Shagufta Nesar,3 Hina Zaidi,3 Shazia Jamshed4,5

1Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, University Sains Malaysia, Penang, Malaysia; 2Faculty of Pharmaceutical Sciences, Dow University of Health Sciences, Karachi, Pakistan; 3Faculty of Pharmacy, Hamdard University, Karachi, Pakistan; 4Department of Pharmacy Practice, Kulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan, Pahang, Malaysia; 5Qualitative Research-Methodological Applications in Health Sciences Research Group, Kulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan, Pahang, Malaysia

Correspondence: Shazia Jamshed
Pharmacy Practice, Kulliyyah of Pharmacy, Indera Mahkota Campus, Kuantan 25200, Pahang, Malaysia
Email shazia_jamshed@iium.edu.my

Objective: A cross-sectional study was carried out to evaluate the practice of unlicensed and off-label drug prescribing/dispensing in children and neonates by physicians and clinical pharmacists in the metropolitan city of Karachi.
Methods: The study was conducted for the duration of 5 months – November 2018 to March 2019 – in different clinics and tertiary care hospitals of Karachi, Pakistan. Respondents were interviewed by our researchers using 30 items questionnaire. Descriptive statistics were used to evaluate the answers of respondents to survey items. Pearson correlation and independent sample t-test were employed to recognize the association between the responses of participants and independent variables. P values less than 0.05 were considered statistically significant.
Results: A total of 421 questionnaires were completed by physicians and clinical pharmacists. The mean age of the study participants was 49.5 years. Around 98% of pharmacists and 93.5% of physicians were well conversant with the definition of unlicensed and off-label drugs. Around 68% of physicians and 77% of pharmacists reported that they were more concerned about the efficacy of such drugs as compared to that of licensed medicines in children. The most frequent off-label categories observed in the study were dose (65.21%) and indication (17.52%). A vast majority (> 80%) thought that approving new drugs by regulatory authorities will drop the occurrence of medication errors due to incorrect dosing. The British National Formulary (BNF) for children was used as the best reliable source of information among respondents.
Conclusion: The present study highlighted the common practice of unlicensed and off-label drug prescribing in pediatrics; however, respondents showed their concern towards decreasing such practice and are likely to welcome initiatives intended to assure medication safety in children.

Keywords: unlicensed drug and off-label prescribing, physicians, clinical pharmacists, Pakistan


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