Respiratory drugs prescribed off-label among children in the outpatient clinics of a hospital in Malaysia
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Background Prescribing medicines in an unlicensed and off-label manner for children is a widespread practice around the world. Objectives To determine the extent and predictors of off-label respiratory drug prescriptions for children in the outpatient clinics of a hospital in Malaysia. Setting Outpatient clinics at the Universiti Kebangsaan Malaysia Medical Centre, a tertiary teaching hospital in Malaysia. Methods The pharmacy-based computer system and medical records of the patients were utilized to collect data from 220 pediatric patients who were prescribed at least one respiratory drug from July 2011 to December 2011. Main outcome measure Characteristics of the off-label respiratory drug prescriptions were measured. Results A total of 134 children (60.9 %) received at least one respiratory drug prescribed in an off-label manner. The most common reasons for the off-label prescribing of drugs were off-label use by indication (31.5 %), followed by higher than the recommended dose (24.9 %) and lower than the recommended frequency (17.1 %). Diphenhydramine was the most common respiratory drug prescribed off-label. The number of medications prescribed was the only significant predictor of off-label prescription of respiratory drugs. Pediatric patients receiving 4–6 medications were 7.8 times more likely to receive at least one off-label respiratory drug compared to pediatric patients that received 1–3 medications (OR 7.8, 95 % CI 1.74–37.44). Conclusion There was substantial prescribing of respiratory drugs for children in an off-label manner at the outpatient clinics at the Universiti Kebangsaan Malaysia Medical Centre. This highlights the need for more research to be carried out on respiratory drugs in the pediatric population.
KeywordsChildren Malaysia Off-label Outpatient Pediatrics Respiratory drugs
Special thanks to the pharmacy staff at the UKMMC for access to the pharmacy’s computerized dispensing database. The authors would also like to thank the hospital medical records staff for their help in retrieving the medical records.
No funding was received for this research study.
Conflicts of interest
There are no conflicts of interest to declare.
- 1.Turner S, Nunn A, Choonara I. Unlicensed drug use in children in the UK. Paediatr Perinat Drug Ther. 1997;1:52–5.Google Scholar
- 2.Drug Control Authority. Terms of Reference. National Pharmaceutical Control Bureau: Ministry of Health Malaysia. 1984.Google Scholar
- 3.National Pharmaceutical Control Bureau, (NPCB) Ministry of Health Malaysia. [cited 1 Nov 2012]; Available from http://portal.bpfk.gov.my/index.cfm?&menuid=47.
- 6.European Commission. EU pharmaceutical legislation 2006. [cited 20 Oct 2014]; Available from http://ec.europa.eu/health/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf.
- 12.Drug Formulary, 5th ed. Pharmacy Department, Pusat Perubatan Universiti Kebangsaan Malaysia; 2010.Google Scholar
- 13.Master Index of Medical Specialties (MIMS) Malaysia. [cited 12 Nov 2012]; Available from http://www.mims.com.
- 14.ICH Expert Working Group. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Harmonized Tripartite Guidelines, Clinical Investigation of Medicinal Products in the Pediatric Population (E11). 2000. [cited 20 Oct 2014]; Available from http://www.ich.org.