Paediatric prescribing | Action Medical Research

Touching Lives - December 2002

Paediatric prescribing

Did you know that before a new medicine is launched, the extensive set of trials — to determine if it is safe to use and the dosages are set at correct levels — are carried out on adults? And that in general, pharmaceutical companies do not test drugs specifically for use with children?

“The lack of properly tested drugs for use in children, I would argue, is a violation of their basic human rights,” says Professor James McElnay, who adds: “In this 21st Century, when there is a growing need for clinical excellence, the time has come for doctors to be armed with the confidence of evidence-based guidelines. Children are not merely little adults.”

Professor McElnay, is an Action Medical Researcher who has led a groundbreaking study into the effect of medicines in youngsters.

The study, which received Action Medical Research funding of £214,000 over the past three and a half years, has recently come to a close. Some of the important findings from the research are detailed here.

Paediatric Prescribing Dossier

  • Children and babies differ from adults in the way they absorb and handle drugs because their liver and kidneys are less developed. This can have potentially hazardous consequences, for example, through over-dosing.

  • Yet figures estimate that as many as 90 per cent of babies, and 66 per cent of children being treated in hospital are prescribed drugs that are unlicensed, or approved only for use in adults (British Medical Journal: 321 4 November 2000 p 1093).

  • The aim of the Action Medical Research study was to gain a better understanding of medicines which are commonly prescribed to hospitalised children, but which haven’t been specifically tested and licensed for these young patients.

  • It was spearheaded at Belfast’s Queen’s University and Royal Hospital for Sick Children, in collaboration with Liverpool’s Alder Hey Children’s Hospital.

  • More than 1,000 blood samples were collected from almost 500 infants and children as part of their routine clinical management, and the effect of the medicines analysed. Medicines included drugs used for post-operative pain, heart conditions and oral sedatives.

  • Although Professor McElnay stressed that the doses selected by doctors in the study were on the whole appropriate and safe, full control of symptoms was not always achieved, especially regarding the control of pain.

  • According to the findings, 42.1% of young patients were still suffering moderate pain after being given Diclofenac as a post-operative painkiller. And in a small percentage of patients (1.3%) the pain was recorded as severe. This could mean doctors are erring on the side of caution, a finding which the researchers would like to investigate further.

  • The main success of the study, however, has been establishing the sophisticated methods for performing the research, which is now ripe for expansion. The plan is to continue the work, and the team is actively seeking collaboration with other children’s hospitals in order to research more medicines.

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