Current pattern of off-label drug use among hospitalized pediatric patients: a short-term longitudinal study
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Keywords
Hospitalized pediatrics, Off-label use, Prescribing pattern, Pediatric patients
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 longitudinal 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.
References
the European Academy of Paediatrics and the European society for Developmental Perinatal and Pediatric Pharmacology.
European journal of pediatrics, 2020. 179: p. 839-847.
2. Meyers, R.S., et al., K ey potentially I nappropriate D rugs in pediatrics: the KIDs list. The Journal of Pediatric Pharmacology and
Therapeutics, 2020. 25(3): p. 175-191.
3. van der Zanden, T.M., et al., Off‐label, but on‐evidence? A review of the level of evidence for pediatric pharmacotherapy.
Clinical Pharmacology & Therapeutics, 2022. 112(6): p. 1243-1253.
4. Shah, S.S., et al., Off-label drug use in hospitalized children. Archives of pediatrics & adolescent medicine, 2007. 161(3): p.
282-290.
5. Roberts, R., et al., Pediatric drug labeling: improving the safety and efficacy of pediatric therapies. Jama, 2003. 290(7): p. 905-
11.
6. Palčevski, G., N. Skočibušić, and V. Vlahović-Palčevski, Unlicensed and off-label drug use in hospitalized children in Croatia: a
cross-sectional survey. European journal of clinical pharmacology, 2012. 68: p. 1073-1077.
7. Rothgeb, A. and R.D. Beckett, Off-label use information in electronic drug information resources. 2022. 110(4): p. 471-477.
8. Wick, J.Y., Enigmatic, but understandable: empiric therapy. The Consultant pharmacist: the journal of the American Society of
Consultant Pharmacists, 2007. 22(8): p. 691-694.
9. Dharmapalan, D., J. Bielicki, and M. Sharland, Harmonization of Amoxicillin Dose, Duration, and Formulation for Acute
Childhood Respiratory Infections. Antibiotics (Basel), 2023. 12(7). 10. Maheshwari, A. and M.R. Sood, Drugs acting on the gut: prokinetics, antispasmodics, laxatives, in Pediatric Neurogastroenterology:
Gastrointestinal Motility Disorders and Disorders of Gut Brain Interaction in Children. 2023, Springer. p. 555-571.
11. Meng, M., et al., Off-label use of drugs in pediatrics: a scoping review. European Journal of Pediatrics, 2022. 181(9): p. 3259-
3269.
12. Petkova, V., et al., Off-Label Prescribing in Pediatric Population—Literature Review for 2012–2022. Pharmaceutics, 2023.
15(12): p. 2652.
13. Shakeel, S., et al., Patterns and predictors of off-label drug prescribing in psychiatric practice: a qualitative study. Pharmacy,
2021. 9(4): p. 203.
14. Ishizaki, T., et al., Drug prescription patterns and factors associated with polypharmacy in> 1 million older adults in Tokyo.
Geriatrics & Gerontology International, 2020. 20(4): p. 304-311.
15. Porta, A., et al., Off-label antibiotic use in children in three European countries. European journal of clinical pharmacology,
2010. 66: p. 919-927.
16. Oshikoya, K.A., et al., Off-label prescribing for children with chronic diseases in Nigeria; findings and implications. Expert
opinion on drug safety, 2017. 16(9): p. 981-988.
17. Eguale, T., et al., Association of off-label drug use and adverse drug events in an adult population. JAMA internal medicine,
2016. 176(1): p. 55-63.
18. Shrestha, R. and S. Prajapati, Assessment of prescription pattern and prescription error in outpatient Department at Tertiary
Care District Hospital, Central Nepal. Journal of pharmaceutical policy and practice, 2019. 12: p. 1-9.
19. Kouti, L., et al., Pattern and extent of off-label and unlicensed drug use in neonatal intensive care units in Iran. BMC pediatrics,
2019. 19: p. 1-7.
20. Lass, J., et al., Off label use of prescription medicines in children in outpatient setting in Estonia is common. Pharmacoepidemiol
Drug Saf, 2011. 20(5): p. 474-81.
21. Laforgia, N., et al., Off‐label and unlicensed drug use among neonatal intensive care units in S outhern I taly. Pediatrics
International, 2014. 56(1): p. 57-59.
22. Shah, S.S., et al., Off-label drug use in hospitalized children. Arch Pediatr Adolesc Med, 2007. 161(3): p. 282-90.
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