Attitudes, knowledge and views on off-label prescribing in children among healthcare professionals in Malaysia

  • Shamala BalanEmail author
  • Mohamed Azmi Ahmad Hassali
  • Vivienne S. L. Mak
Research Article


Background Off-label prescribing in children is associated with several prerequisites such as ensuring sound and scientific evidence and obtaining written consent prior to use of off-label drugs to ensure that protection is provided to patients and healthcare professionals. Adherence to the pre-requisites depends on the attitude, views and knowledge of the pharmacists and doctors involved in this practice. Objective To explore the attitudes, knowledge and views on off-label prescribing in children among hospital—based pharmacists and paediatric doctors. Setting The study was conducted in a 620-bedded general hospital located in the urban area of central Peninsular Malaysia. Method Face to face, semi-structured interviews with 12 pharmacists and 12 paediatric doctors. Interviews were audio-recorded, transcribed and analysed using constant comparison method. Main outcome measure Themes surrounding hospital—based pharmacists’ and paediatric doctors’ attitude, knowledge and views on off-label prescribing in children. Results Four themes were derived: knowledge on off-label prescribing in children, views on off-label prescribing in children, attitude towards off-label prescribing in children and guidance on off-label prescribing in children. Conclusion There is a need to increase the knowledge of hospital—based pharmacists and paediatric doctors and address several concerns on off-label prescribing in children. The decision to prescribe or dispense off-label drugs involved collective decision-making mechanisms and guidance is required with regards to offlabel prescribing in children.


Attitude Children Knowledge Malaysia Off-label prescribing Paediatricians Pharmacists 



The authors would like to thank the Director-General of Health Malaysia for permission to publish this paper. The authors would also like to thank the pharmacists and paediatric doctors who took part in this study.


There is no funding received from any bodies for the conduct of the research.

Conflicts of interest

All authors declare that they have no conflict of interest.


  1. 1.
    Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr. 2005;164(9):552–8.Google Scholar
  2. 2.
    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.Google Scholar
  3. 3.
    Lee JL, Redzuan AM, Shah NM. Unlicensed and off-label use of medicines in children admitted to the intensive care units of a hospital in Malaysia. IntJClinPharm. 2013;35(6):1025–9.Google Scholar
  4. 4.
    Mohamad NF, Ali AM, Shah NM. Respiratory drugs prescribed off-label among children in the outpatient clinics of a hospital in Malaysia. Int J Clin Pharm. 2015;37(1):127–32.Google Scholar
  5. 5.
    Tan RW, Shah NM. Antihistamines prescribed off-label among paediatric patients at a tertiary care hospital setting in Malaysia. Int J Clin Pharm. 2016;38(5):1277–85.Google Scholar
  6. 6.
    Henry V. Off-label prescribing: legal implications. J Leg Med. 1999;20(3):365–83.Google Scholar
  7. 7.
    Sharma AN, Arango C, Coghill D, Gringras P, Nutt DJ, Pratt P, et al. BAP position statement: off-label prescribing of psychotropic medication to children and adolescents. J Psychopharmacol. 2016;30(5):416–21. Scholar
  8. 8.
    Director General of Health M. [The Use of Consent Form for Treatment Using Unregistered Medicine or Indication (Off-label)]. Official Portal of Pharmaceutical Services Division, Ministry of Health, Malaysia 2016, p 2.Google Scholar
  9. 9.
    Ekins-Daukes S, Helms PJ, Taylor MW, McLay JS. Off-label prescribing to children: attitudes and experience of general practitioners. Br J Clin Pharmacol. 2005;60(2):145–9.Google Scholar
  10. 10.
    McLay JS, Tanaka M, Ekins-Daukes S, Helms PJ. A prospective questionnaire assessment of attitudes and experiences of off label prescribing among hospital based paediatricians. Arch Dis Child. 2006;91(7):584–7.Google Scholar
  11. 11.
    Stewart D, Rouf A, Snaith A, Elliott K, Helms PJ, McLay JS. Attitudes and experiences of community pharmacists towards paediatric off-label prescribing: a prospective survey. Br J Clin Pharmacol. 2007;64(1):90–5.Google Scholar
  12. 12.
    Mukattash T, Hawwa AF, Trew K, McElnay JC. Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials. Eur J Clin Pharmacol. 2011;67(5):449–61.Google Scholar
  13. 13.
    Saullo F, Saullo E, Caloiero M, Menniti M, Carbone C, Chimirri S, et al. A questionnaire-based study in Calabria on the knowledge of off-label drugs in pediatrics. J Pharmacol Pharmacother. 2013;4(Suppl1):S51–4.Google Scholar
  14. 14.
    Balan S, Hassali M, Mak V. Awareness, knowledge and views of off-label prescribing in children: a systematic review. Br J Clin Pharmacol. 2015;80(6):1269–80.Google Scholar
  15. 15.
    Mukattash TL, Wazaify M, Khuri-Boulos N, Jarab A, Hawwa AF, McElnay JC. Perceptions and attitudes of Jordanian paediatricians towards off-label paediatric prescribing. Int J Clin Pharm. 2011;33(6):964–73.Google Scholar
  16. 16.
    Piñeiro PR, Ruiz AM, Avendaño SC, Román RE, Cabrera GL, Cilleruelo OM et al., editors. [Results from the 2012-2013 paediatric national survey on off-label drug use in children in Spain (OL-PED study)]. Anales de Pediatria (Barcelona, Spain: 2003); 2014.Google Scholar
  17. 17.
    Mukattash T, Millership J, Collier P, McElnay J. Public awareness and views on unlicensed use of medicines in children. Br J Clin Pharmacol. 2008;66(6):838–45.Google Scholar
  18. 18.
    Lenk C, Koch P, Zappel H, Wiesemann C. Off-label, off-limits? Parental awareness and attitudes towards off-label use in paediatrics. Eur J Pediatr. 2009;168(12):1473–8.Google Scholar
  19. 19.
    Bang V, Mallad A, Kannan S, Bavdekar S, Gogtay N, Thatte U. Awareness about and views of parents on the off-label drug use in children. Int J Risk Saf Med. 2014;26(2):61–70.Google Scholar
  20. 20.
    Dye JF, Schatz IM, Rosenberg BA, Coleman ST. Constant comparison method: a kaleidoscope of data. Qualitative Rep. 2000;4(1):1–10.Google Scholar
  21. 21.
    Morse JM, Barrett M, Mayan M, Olson K, Spiers J. Verification strategies for establishing reliability and validity in qualitative research. Int J Qual Methods. 2002;1(2):13–22.Google Scholar
  22. 22.
    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):218–22.Google Scholar
  23. 23.
    Oguz SS, Kanmaz HG, Dilmen U. Off-label and unlicensed drug use in neonatal intensive care units in Turkey: the old-inn study. Int J Clin Pharm. 2012;34(1):136–41.Google Scholar
  24. 24.
    Ellul IC, Grech V. Off-label and unlicensed paediatric prescribing in a community setting: a prospective longitudinal cohort study in Malta. Paediatr Int Child Health. 2014;34(1):12–8.Google Scholar
  25. 25.
    Schweigertova J, Durisova A, Dolnikova D, Ondriasova E, Balazova M, Slezakova V, et al. Off-label and unlicensed use of medicinal products in the neonatal setting in the Slovak Republic. Pediatr Int. 2016;58(2):126–31.Google Scholar
  26. 26.
    Silverstein FS, Ferriero DM. Off-label use of antiepileptic drugs for the treatment of neonatal seizures. Pediatr Neurol. 2008;39(2):77–9. Scholar
  27. 27.
    Fukada C, Kohler JC, Boon H, Austin Z, Krahn M. Prescribing gabapentin off-label: perspectives from psychiatry, pain and neurology specialists. Can Pharm J. 2012;145(6):280–284.e1.Google Scholar
  28. 28.
    DeMonaco HJ, Ali A, Hippel E. The major role of clinicians in the discovery of off-label drug therapies. Pharmacother. 2006;26(3):323–32.Google Scholar
  29. 29.
    Balan S, Hassali M, Mak V. Non-regulatory related factors leading to off-label prescribing in children: a concept map. Res Social Adm Pharm. 2017;13(6):1219–21.Google Scholar
  30. 30.
    Kos M, Wertheimer AI, Mrhar A. Satisfaction with pharmacotherapy for approved and off-label indications-a Delphi study. Ann Pharmacother. 2005;39(4):649–54.Google Scholar
  31. 31.
    Marchetti F, Bua J, Ventura A, Notarangelo LD, Di Maio S, Migliore G, et al. The awareness among paediatricians of off-label prescribing in children: a survey of Italian hospitals. Eur J Clin Pharmacol. 2007;63(1):81–5.Google Scholar
  32. 32.
    Uppal NK, Dupuis LL, Parshuram CS. Documentation of pediatric drug safety in manufacturers’ product monographs. Paediatr Drugs. 2008;10(3):193–7. Scholar
  33. 33.
    d’Aloja E, Paribello F, Demontis R, Müller M. Off-label drugs prescription in neonatology: a physician’s duty or a medical hazardous attitude? J Matern Fetal Neonatal Med. 2011;24(sup1):99–100.Google Scholar
  34. 34.
    Chisholm A. Exploring UK attitudes towards unlicensed medicines use: a questionnaire-based study of members of the general public and physicians. Int J Gen Med. 2012;5:27–40. Scholar
  35. 35.
    Ellul I, Grech V, Attard-Montalto S. Maltese prescribers use of off-label and unlicensed medicines in children: perceptions and attitudes. Int J Clin Pharm. 2016;38(4):788–92. Scholar
  36. 36.
    Alderson P. Competent children? Minors’ consent to health care treatment and research. Soc Sci Med. 2007;65(11):2272–83.Google Scholar
  37. 37.
    Coyne I. Research with children and young people: the issue of parental (proxy) consent. Child Soc. 2010;24(3):227–37.Google Scholar
  38. 38.
    Largent EA, Miller FG, Pearson SD. Going off-label without venturing off-course: evidence and ethical off-label prescribing. Arch Intern Med. 2009;169(19):1745–7.Google Scholar
  39. 39.
    Hughes CM, McCann S. Perceived interprofessional barriers between community pharmacists and general practitioners: a qualitative assessment. Br J Gen Pract. 2003;53(493):600–6.Google Scholar
  40. 40.
    Al-Quteimat OM, Amer AM. Evidence-based pharmaceutical care: the next chapter in pharmacy practice. Saudi Pharm J. 2016;24(4):447–51.Google Scholar
  41. 41.
    Charani E, Castro-Sanchez E, Sevdalis N, Kyratsis Y, Drumright L, Shah N, et al. Understanding the determinants of antimicrobial prescribing within hospitals: the role of “prescribing etiquette”. Clin Infect Dis. 2013;57(2):188–96.Google Scholar
  42. 42.
    Mattick K, Kelly N, Rees C. A window into the lives of junior doctors: narrative interviews exploring antimicrobial prescribing experiences. J Antimicrob Chemother. 2014;69(8):2274–83. Scholar
  43. 43.
    Barrett JS, Narayan M, Patel D, Zuppa AF, Adamson PC. Prescribing habits and caregiver satisfaction with resources for dosing children: rationale for more informative dosing guidance. BMC Pediatr. 2011;11(1):25–34. Scholar
  44. 44.
    Philip NS, Mello K, Carpenter LL, Tyrka AR, Price LH. Patterns of quetiapine use in psychiatric inpatients: an examination of off-label use. Ann Clin Psychiatry. 2008;20(1):15–20.Google Scholar
  45. 45.
    Halverstam CP, Lebwohl M. Nonstandard and off-label therapies for psoriasis. Clin Dermatol. 2008;26(5):546–53.Google Scholar
  46. 46.
    Browner W, Baron R, Solkowitz S, Adler L, Gullion D. Physician management of hypercholesterolemia. A randomized trial of continuing medical education. West J Med. 1994;161(6):572–8.Google Scholar
  47. 47.
    Bordage G, Carlin B, Mazmanian PE. Continuing medical education effect on physician knowledge: effectiveness of continuing medical education: American college of chest physicians evidence-based educational guidelines. Chest. 2009;135(3_suppl):29S–36S.Google Scholar
  48. 48.
    Mansouri M, Lockyer J. A meta-analysis of continuing medical education effectiveness. J Contin Educ Health Prof. 2007;27(1):6–15.Google Scholar
  49. 49.
    Norman GR, Shannon SI, Marrin ML. The need for needs assessment in continuing medical education. BMJ. 2004;328(7446):999–1001.Google Scholar
  50. 50.
    Balan S, Hassali MA, Mak VS. Two decades of off-label prescribing in children: a literature review. World J Pediatr. 2018;14:1–3.Google Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.School of Pharmaceutical SciencesUniversiti Sains MalaysiaPenangMalaysia
  2. 2.Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical SciencesMonash UniversityMelbourneAustralia

Personalised recommendations