Prescription Pattern of Unlicensed and Off-Label Medicines for Children Aged 0-5 Years in a Tertiary Hospital and a Primary Health Care Centre in Nigeria (Report‪)‬

The prescription and use of unlicensed and off-label medicines for children present deep ethical and moral challenges. Children often receive several prescription, non-prescription (over-the-counter) and/or herbal medicines when they become ill. Most of these medicines have not been properly tested in controlled clinical trials for their age group. (1) Younger children have been shown to receive more medicines than older children and adolescents. (2,3) Following the sulphanilamide and thalidomide tragedies of the 1930s and 1960s, respectively, there has been growing global concern about the safety of medicines administered to children. (4,5) Parents, caregivers and policy makers have a legal and moral responsibility to protect children from problems caused by medicines, particularly adverse reactions. (6) Children are not just small adults. They are the most precious resource of any nation, and their health is vital for the future success of any society. Their vital organs, especially the liver, kidney and brain, are not fully developed. Their metabolism and excretion of medicines may differ from those in adults, predisposing them to harmful effects. For example, it has been demonstrated that for some medicines hepatic glucoronidation is lower in children aged 13-24 months than in adults. (7) Some researchers have shown that children, especially younger ones, are particularly vulnerable to adverse effects of medicines. (8,9) Furthermore, young children are unable to describe what they experience. Crying may be the only sign of distress they may show when affected by adverse medication events. There is therefore considerable cause for concern about use of medicines in children.