When children – many of them just born – need to be given medicine, how can its safe and effective use be guaranteed?
That is the question at the heart of a research programme being headed by James McElnay, Professor of Pharmacy Practice at the School of Pharmacy at Queen’s, where he is also Pro-Vice-Chancellor for Research and Postgraduates.
His main professional interest is in the area of clinical pharmacy – where the pharmacist becomes much more involved in clinical decision-making around the use of medicines in patients. This was just becoming an important new aspect of pharmacy when he was completing his PhD at Queen’s in 1979. As a postdoctoral researcher at the University of Iowa, he further explored the new developments, then began to pursue them in a research programme at Queen’s when he joined as a lecturer.
He says, ‘The reason I have become interested in children in particular is because the whole use of medicine in children, especially premature infants and babies, is often without an evidence base. Medicines are often not tested or licensed for use in children. The reasons for that are obvious – there can be significant ethical issues around children participating in dose ranging clinical trials – so many of the medicines are used in an unlicensed fashion, with no labelled instructions as to what dose would be appropriate.
‘This creates a dilemma for doctors. They know a medicine may help, but dosing becomes a bit of a guestimate.’
But now more evidence is being gathered and Professor McElnay and his group are a key part of that process. ‘We started looking at children who were already prescribed medicines of interest. We’ve developed techniques to measure medicines in a single drop of blood applied to filter"I maintain that children should have access to evidence-based medicine." paper when a sample is being taken for another clinical purpose. By measuring the amount of medicine in the ‘blood spot’ we can begin to build up a pattern. Working collaboratively with neonatologists and paediatricians, we receive samples from a range of different children at our lab and we’re able mathematically to construct the kind of profile you would normally obtain from a traditional clinical trial.’
The research programme has been running for ten years. Other aspects include adherence of children to medicine – are parents giving medicine to a child in the way it has been prescribed? A complimentary stream of the work also involves the excipients which are used in medicines.
‘It’s common for drug companies to use excipients, for example a preservative, when they’re manufacturing a medicine but there’s increasing evidence that these agents can have adverse effects, particularly in premature babies.’
Now Professor McElnay is carrying out a study in partnership with the Universities of Liverpool and Leicester, and with groups in France and Estonia looking at how newborn infants are able to handle excipients. ‘With a premature baby there is premature liver and kidney development so you can imagine that if a child like that is being given medicine every day and the body isn’t able to get rid of the excipient, then there is the risk of toxicity.’
Funding for the research programme over the years has come from Action Medical Research, The Health and Social Care Research and Development Office, the British Council, Arthritis Research UK, Atlantic Philanthropies and the Medical Research Council.
‘I also have had a stream of international PhD students who are funded by their own governments or universities. They want to come and have experience in our lab with the kind of clinical pharmacy work I’m doing.’
Professor McElnay says, ‘This is a long-term project with significant scope for influential publications. We have evidence that our publications are having an impact on how paediatric medicine is practised. We are providing evidence that can be incorporated into the British National Formulary for Children, a publication that didn’t exist when we started this work.
‘The project is linked into the Improving Children’s Lives initiative at Queen’s. The latter is a fantastic initiative which involves a number of Schools across the University, partially funded by the Atlantic Philanthropies and the Health and Social Care Research and Development Office. It focuses on children’s rights. I maintain that children should have access to evidence-based medicine in the same way you or I have. That’s a basic human right of a child.’
Click here to download a the PDF version of this article.
