Medicines for children: safety as an afterthought

Abstract

On Sept 21, WHO released a long overdue and thorough report, Safety of medicines for children, that highlights the unacceptable state of monitoring medicine-related problems in children worldwide. Many issues make safety of paediatric medicines an extremely difficult area to study. Medicines are often used in an off-label or unlicensed way—ie, they have not been tested in a particular age group or are given using adult formulations. Tablets that are too big are crushed, and liquids that are too concentrated are diluted. There is very little information on how such reformulation affects bioavailability and there is an increased risk of overdosing. New medicines that are licensed for children do not have evidence of long-term benefit, let alone risk. Especially in chronic conditions, medicines will have to be given over much longer periods than in adults and side-effects may only appear later in life or affect particular developmental stages, such as puberty, in a way that cannot be predicted. Young children might not be able to express sensations or complaints, and less serious adverse events could go unnoticed. In developing countries, medicines for children are often not available at all, or substandard drugs are sold illegally. Shortages of health-care workers make errors more common, and children often have serious comorbidities and malnutrition that exacerbate toxicity. The measures recommended by the report should be country specific, with a commissioner for medicines safety in children's hospitals or paediatric departments; regional pharmocovigilance centres providing easy access to information, support for reporting, and feedback; and a national pharmacovigilance programme that includes education of health-care workers and academic credit for research in this area. There is much to do to even start putting these measures into place and many reasons can be found why difficulties cannot be overcome. Safety of medicines in children as an afterthought is an unacceptable state of affairs. Children have a right to safe and effective medicines and nations' health systems should be judged on how they treat their children.