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International Journal of Clinical Pharmacy

, Volume 39, Issue 4, pp 860–866 | Cite as

Unlicensed and off-label use of drugs in pediatric surgical units at tertiary care hospitals of Pakistan

  • Muhammad Aamir
  • Jamshaid Ali KhanEmail author
  • Faisal Shakeel
  • Syed Muhammad Asim
Research Article
  • 193 Downloads

Abstract

Background Unlicensed and off-label prescribing practice is global dilemma around the world. This pioneering study was designed to determine unlicensed and off-label use of drug in surgical wards of tertiary care hospitals of Pakistan. Objective To assess unlicensed and off-label use of drugs in pediatric surgical unit at three tertiary care hospitals in Peshawar, Pakistan. Setting Two government and one private tertiary care hospitals in Pakistan. Method Drug profiles of 895 patients from three different clinical settings were evaluated for unlicensed and off-label use of drugs using Micromedex DRUGDEX. Main outcome measure Characteristics of the unlicensed and off-label drug prescriptions. Result Total of 3168 prescribed drugs were analyzed in this study. Indication (38.7%) and dose (34.8%) were the most frequent off-label categories. In comparison with the corresponding reference categories, infants and children, male patients and having less than five prescribed drugs were significant predictors of unlicensed prescriptions. In comparison with the corresponding reference categories, significant predictors of off-label drug prescribing were children younger than two year, children between 2–12 years, patient staying at hospital less than 5 days and patients having less than five prescribed drugs. Conclusion The prevalence of unlicensed and off-label drug prescriptions are high at pediatric surgical ward of tertiary care hospitals. More awareness of the efficacy and safety of drugs are required in pediatrics. In addition, new formulations with advanced dosing for children are also required to minimize the risk of adverse outcomes.

Keywords

Off-label medicine use Pakistan Pediatrics Unlicensed medicines 

Notes

Acknowledgements

Special thanks to the Directorate of Science and Technology, Khyber Pakhtunkhwa, for their support through the provision of Micromedex DRUGDEX database.

Funding

None.

Conflicts of interest

The authors declare that they have no conflict of interest.

References

  1. 1.
    Wilson JT. An update on the therapeutic orphan. Pediatrics. 1999;104(Supplement 3):585–90.PubMedGoogle Scholar
  2. 2.
    Wettermark B, Hammar N, MichaelFored C, Leimanis A, Otterblad Olausson P, Bergman U, et al. The new Swedish Prescribed Drug Register—opportunities for pharmacoepidemiological research and experience from the first six months. Pharmacoepidemiol Drug Saf. 2007;16(7):726–35.CrossRefPubMedGoogle Scholar
  3. 3.
    Schneeweiss S, Avorn J. A review of uses of health care utilization databases for epidemiologic research on therapeutics. J Clin Epidemiol. 2005;58(4):323–37.CrossRefPubMedGoogle Scholar
  4. 4.
    Bellis JR, Kirkham JJ, Thiesen S, Conroy EJ, Bracken LE, Mannix HL, et al. Adverse drug reactions and off-label and unlicensed medicines in children: a nested case? Control study of inpatients in a pediatric hospital. BMC Med. 2013;11(1):1.CrossRefGoogle Scholar
  5. 5.
    Jain SS, Bavdekar S, Gogtay NJ, Sadawarte PA. Off-label drug use in children. Indian J Pediatr. 2008;75(11):1133–6.CrossRefPubMedGoogle Scholar
  6. 6.
    Di Paolo ER, Stoetter H, Cotting J, Frey P, Gehri M, Beck-Popovic M, et al. Unlicensed and off-label drug use in a Swiss paediatric university hospital. Swiss Med Wkly. 2006;136(13/14):218.PubMedGoogle Scholar
  7. 7.
    Lindell-Osuagwu L, Korhonen M, Saano S, Helin-Tanninen M, Naaranlahti T, Kokki H, et al. Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature. J Clin Pharm Ther. 2009;34(3):277–87.CrossRefPubMedGoogle Scholar
  8. 8.
    Cuzzolin L, Atzei A, Fanos V. Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety. Expert Opin Drug Saf. 2006;5(5):703–18.CrossRefPubMedGoogle Scholar
  9. 9.
    Williams JR. The Declaration of Helsinki and public health. Bull World Health Organ. 2008;86(8):650–2.CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Kimland E, Odlind V. Off-label drug use in pediatric patients. Clin Pharmacol Ther. 2012;91(5):796–801.CrossRefPubMedGoogle Scholar
  11. 11.
    Czaja AS, Valuck R. Off-label antidepressant use in children and adolescents compared with young adults: extent and level of evidence. Pharmacoepidemiol Drug Saf. 2012;21(9):997–1004.CrossRefPubMedGoogle Scholar
  12. 12.
    Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ. 2000;320(7227):79–82.CrossRefPubMedPubMedCentralGoogle Scholar
  13. 13.
    Saiyed MM, Lalwani T, Rana D. Off-label medicine use in pediatric inpatients: a prospective observational study at a tertiary care hospital in India. Int J Pediatr. 2014. doi: 10.1155/2014/415815
  14. 14.
    Cuzzolin L, Zaccaron A, Fanos V. Unlicensed and off-label uses of drugs in paediatrics: a review of the literature. Fundam Clin Pharmacol. 2003;17(1):125–31.CrossRefPubMedGoogle Scholar
  15. 15.
    Al Khaja KA, Al Ansari TM, Damanhori AH, Sequeira RP. Evaluation of drug utilization and prescribing errors in infants: a primary care prescription-based study. Health Policy. 2007;81(2):350–7.CrossRefPubMedGoogle Scholar
  16. 16.
    Dos Santos L, Heineck I. Drug utilization study in pediatric prescriptions of a university hospital in southern Brazil: off-label, unlicensed and high-alert medications. Farm Hosp. 2012;36(4):180–6.CrossRefPubMedGoogle Scholar
  17. 17.
    Langerová P, Vrtal J, Urbánek K. Incidence of unlicensed and off-label prescription in children. Ital J Pediatr. 2014;40(1):1.CrossRefGoogle Scholar
  18. 18.
    Corny J, Lebel D, Bailey B, Bussières J-F. Unlicensed and off-label drug use in children before and after pediatric governmental initiatives. J Pediatr Pharmacol Ther. 2015;20(4):316–28.PubMedPubMedCentralGoogle Scholar
  19. 19.
    Czarniak P, Bint L, Favié L, Parsons R, Hughes J, Sunderland B, et al. Clinical setting influences off-label and unlicensed prescribing in a paediatric teaching hospital. PLoS ONE. 2015;10(3):e0120630.CrossRefPubMedPubMedCentralGoogle Scholar
  20. 20.
    Magalhães J, Rodrigues AT, Roque F, Figueiras A, Falcão A, Herdeiro MT, et al. Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review. Eur J Clin Pharmacol. 2015;71(1):1–13.CrossRefPubMedGoogle Scholar
  21. 21.
    Hsien L, Breddemann A, Frobel A-K, Heusch A, Schmidt KG, Läer S, et al. Off-label drug use among hospitalised children: identifying areas with the highest need for research. Pharm World Sci. 2008;30(5):497–502.CrossRefPubMedGoogle Scholar
  22. 22.
    Teigen A, Wang S, Truong BT, Bjerknes K. Off‐label and unlicensed medicines to hospitalised children in Norway. J Pharm Pharmacol. 2017;69(4):432–8.Google Scholar
  23. 23.
    Lindell-Osuagwu L, Hakkarainen M, Sepponen K, Vainio K, Naaranlahti T, Kokki H, et al. Prescribing for off-label use and unauthorized medicines in three paediatric wards in Finland, the status before and after the European Union Paediatric Regulation. J Clin Pharm Ther. 2014;39(2):144–53.CrossRefPubMedGoogle Scholar
  24. 24.
    Turner S, Longworth A, Nunn AJ, Choonara I. Unlicensed and off label drug use in paediatric wards: prospective study. BMJ. 1998;316(7128):343–5.CrossRefPubMedPubMedCentralGoogle Scholar
  25. 25.
    Turner S, Nunn A, Fielding K, Choonara I. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study. Acta Paediatr. 1999;88(9):965–8.CrossRefPubMedGoogle Scholar
  26. 26.
    Khdour MR, Hallak HO, Alayasa KSAA, AlShahed QN, Hawwa AF, McElnay JC, et al. Extent and nature of unlicensed and off-label medicine use in hospitalised children in Palestine. Int J Clin Pharm. 2011;33(4):650–5.CrossRefPubMedGoogle Scholar
  27. 27.
    Sammons H, Choonara I. Clinical trials of medication in children, 1996–2002. Eur J Clin Pharmacol. 2005;61(2):165–7.CrossRefPubMedGoogle Scholar
  28. 28.
    Food and Drug Administration. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Fed Regist. 1998;63(231):66631–72.Google Scholar
  29. 29.
    Pandolfini C, Bonati M, Sammons H, Choonara I, Jacqz-Aigrain E, Danes I, et al. A European clinical trials registry for children. Paediatr Perinat Dr Ther. 2003;5:98–100.CrossRefGoogle Scholar

Copyright information

© Springer International Publishing 2017

Authors and Affiliations

  1. 1.Department of PharmacyUniversity of PeshawarPeshawarPakistan
  2. 2.Department of PharmacySarhad University of Science and Information TechnologyPeshawarPakistan
  3. 3.Department of StatisticsUniversity of PeshawarPeshawarPakistan

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