Off-Label Prescription for Paediatric In- And Out_Patients at a Tertiary Hospital in Lagos, Nigeria

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Oreagba, I.A.
Omotoso, K.S.
Joda, A.E.
Sonibare, T
Oshikoya, K.A.
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West African Journal of Pharmacology and Drug Research
The licensing process of medicines aims at ensuring their safety, efficacy and quality. Although many medicines are not licenced for paediatric use, they are nevertheless prescribed for children outside the terms of their product license (off-label). Our main objective was to assess off-label prescribing and to document the level of this practice in paediatric patients attending a tertiary hospital in Lagos, Nigeria. Prescriptions received by children aged 16 years or less during a 24-month period (January 2010 to December 2011) were obtained from the case notes of randomly selected patients from a list of patients who had previously attended the Lagos University Teaching Hospital (LUTH). Data collected include demographic information, medicines prescribed and the nature of off-label medicine. A total of 1207 prescriptions were analysed from the case notes of 430 patients. Prevalence of Off-label prescription was 6.6% and commoner in males (62.5%) than females (37.5%). Young children, aged 1-5 years, (40.0%) and Infants, aged 1-12 months, (36.3%) were the two groups most commonly prescribed off-label medicines. Off-label prescription due to inappropriate dosage (38.7%) and unapproved age use (25%) were the two commonest categories observed in this study. Anti-infective (46.3%) and cardiovascular (38.7%) medicines were the two classes of off-label medicines most frequently prescribed. Off-label prescribing in paediatric patients is still prevalent however the magnitude is considerably lower than previously reported. Off-label prescribing should be evidence based and further studies should address the need for adequate dosing guidelines for such prescribed medicines.
Staff publications
Off-label , Unlicensed , Medicine , Children , Paediatrics , Hospital , Prescription , Lagos State , Research Subject Categories::PHARMACY
Oreagba, I.A., Omotoso, K.S, Joda, A.E., Sonibare, T. and Oshikoya, K.A. (2015). Off-Label Prescription for Paediatric In- And Out_Patients at a Tertiary Hospital in Lagos, Nigeria. West Afr. J. Pharmacol. Drug Res., 30:18-27