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We read with great interest the leading article ‘Lest we forget…’.1 The authors give a compelling account, against a historical background, of the importance of ethical review of research trials, and the tension between improving the health of the paediatric population versus the rights of the individual child.
Although there is a lot of truth in the ‘therapeutic orphan’ status of paediatric patients (given the historical dearth of pharmacological research in paediatrics), there is an opportunity for any clinician involved in the care of children to improve the health of the entire paediatric population without encountering ethical dilemmas: reporting paediatric adverse drug reactions (ADRs) through the UK's yellow card scheme. Much drug data, used in children, on efficacy and safety has been extrapolated from adult trials. This has led to the use of off-label and unlicensed medications in children, a practice associated with a higher risk of ADRs.2 3 Children may also suffer different ADRs from adults (eg, growth suppression).It is estimated that at least 30,000 people need to be treated with a drug to ensure that you do not miss at least one patient with an ADR which has an incidence of 1 in 10 000 exposed individuals,4 more than would normally be tested during drug development. Thus phase I, II and III trials, carried out before a drug has been granted a licence, may not uncover rare but serious ADRs. Improvements in the healthcare of children through appropriate use of pharmaceutical agents are therefore dependent on post marketing surveillance — phase IV clinical trials — such as the UK's ‘Yellow Card scheme’, a spontaneous reporting scheme run by the Medicines and Healthcare Products Regulatory Agency (MHRA). The information received through this scheme from doctors, nurses, pharmacists, patients, and carers is analysed nationally and shared with the Uppsala Monitoring Centre (UMS) in Sweden. The UMS receives reports of suspected adverse drug reactions from the member countries in the WHO Programme, so that weak “signals” in drug safety might be amplified and regulatory authorities of member countries alerted. The literature suggests up to 95% of ADRs may not be reported;5 6 we wish to highlight that the protection of paediatric patients lies not only with the research ethics community, but, ‘lest we forget’, also with clinicians prescribing medications in paediatric patients.
Competing interests Both authors are members of the MHRA Trainee Doctors Advisory Board.
Provenance and peer review Not commissioned; internally peer reviewed.