Off-label prescription for paediatric in-and outpatients at a tertiary hospital in Lagos, Nigeria

Abstract

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. Keywords : off-label, unlicensed, medicine, children, hospital, Lagos Resume Le processus d'autorisation des medicaments vise a assurer leur securite, l'efficacite et la qualite. Bien que de nombreux medicaments ne sont pas autorises pour un usage pediatrique, ils sont cependant prescrits pour les enfants en dehors des conditions de leur licence de produit (hors AMM). Notre principal objectif etait d'evaluer la prescription hors AMM et de documenter le niveau de cette pratique chez les enfants frequentant un hopital tertiaire a Lagos, au Nigeria. Prescriptions recues par les enfants âges de 16 ans ou moins au cours d'une periode de 24 mois (Janvier de 2010 a Decembre 2011) ont ete obtenus a partir des notes de cas de patients choisis au hasard parmi une liste de patients qui avaient deja participe a l'hopital universitaire de Lagos (LUTH). Les donnees recueillies comprennent des renseignements demographiques, les medicaments prescrits et la nature de la medecine off-label. Un total de 1207 prescriptions ont ete analysees a partir des notes de cas de 430 patients. Prevalence de Off-label prescription a ete de 6,6% et plus frequent chez les hommes (62,5%) que les femmes (37,5%). Les jeunes enfants, âges de 1-5 ans, (40,0%) et les nourrissons âges de 1-12 mois, (36,3%) sont les deux groupes les plus couramment prescrits des medicaments hors AMM. Off-label prescription due a une posologie inadequate (38,7%) et l'utilisation de l'âge non approuve (25%) ont ete les deux categories les plus courantes observees dans cette etude. Anti-infectieux (46,3%) et cardiovasculaires (38,7%) des medicaments sont les deux classes de medicaments hors AMM les plus frequemment prescrits. Off-label prescrire chez les patients pediatriques est encore repandu mais l'ampleur est considerablement plus faible que precedemment rapporte. Off-label prescription devrait etre une preuve fondee et d'autres etudes devrait repondre au besoin de directives de dosage adequates pour ces medicaments prescrits.