[nursebedlam]

Children at risk over prescription practice

The World Today - Friday, 30 July , 2004 12:27:49
Reporter: Nick McKenzie
ELEANOR HALL: When doctors prescribe medicines for children, most parents don't pause to consider that the drugs might actually be harmful.

But a new study has found that the common practice of prescribing to children, medicine that has only been tested on adults increases the risk of the child having an adverse reaction.

And as Nick McKenzie reports, some experts say pharmaceutical companies are avoiding doing research in the area of medicine prescription for children, because their market is dominated by adults.

NICK MCKENZIE: Kate is the mother of two young children. Just last week she says her youngest child was prescribed medicine that is usually only taken by adults. For her child, it triggered a temporary rash and breathing problems. For her, it meant a rethink of how doctors prescribe medicine to children.

KATE: It horrifies me in a way. The doctor said to me, 'look you know, about how much does she way?' And I told her, but it seemed to me a slightly dangerous way of prescribing medicines because the antibiotic was a medicine which would usually be prescribed to adults. So I think it's really concerning for parents.

NICK MCKENZIE: It's an issue addressed in a new study being presented today at the National Medicines Symposium in Brisbane.

The Royal Melbourne Children's Hospital's Dr Sean Beggs is the author of the study.

SEAN BEGGS: A lot of drugs that are used in children haven't been studied in children. It's because most of the studies are initially done in adults. So we know that the majority of drugs on the market – about 80 per cent of them – have only been studied and licensed for use in adults.

We don't have for starters to know the appropriate dose when giving to children. So we might be giving them inappropriate dose, because the dosing is extrapolated down from the adult studies. There's a potential for unknown side effects or toxicity. The drugs don't get… the reactions and the safety of the drugs don't get surveyed in the same sort of post-marketing surveillance way that they are done for the adults if that's what the drug is licensed to use.

NICK MCKENZIE: Dr Beggs' study compared the adverse reactions suffered by two groups of children. One group had only been prescribed medicine that's effect on children was well known. The other group was prescribed a new class of drug which had not been thoroughly tested on children.

SEAN BEGGS: Over the same period of time, there was five reactions reported to the new class of drug, indicating that on a usage base the rate of adverse drug reaction or bad side effects to the drug was a lot higher.

NICK MCKENZIE: Dr Beggs says much more work needs to be done to determine what drugs can be safely used by children. But he says pharmaceutical companies are not stepping up to fill that knowledge void.

SEAN BEGGS: The drugs won't be used very much as compared to how often they'll be used in adults. So therefore the impetus isn't there as much to do the study.

NICK MCKENZIE: It's a view shared by the Chairman of the National Prescribing Service, Dr Stephen Phillips. He also says the administering of drugs in tablet form to children – meaning parents often have to cut tablets in half so their child gets the right dose – exacerbates the problem.

STEPHEN PHILLIPS: Potentially it contributes a significant amount, but once again, all we have is the information that's available from these sorts of small studies. We don't have large-scale information involved in the clinical trials to effectively assess the adverse event rates in children or to effectively assess in fact, the effectiveness of these drugs in some indications in children. So we need to teach the community how to be wary of their medicines and how to use them wisely.

NICK MCKENZIE: Given the lack of in-depth knowledge about the whole issue, how alarmed then should parents be as a result of this study?

STEPHEN PHILLIPS: I don't think alarm is the right word. I think what people need to be is cautious and appropriate in how they approach taking medicines. And if we can teach people how to approach using medicines wisely, then clearly they'll be less chance of adverse events even in the face of this lack of information. But at a system-wide level, we need to have governments and the pharmaceutical industry pulling together to try and ensure that we actually plug this gap.

ELEANOR HALL: Dr Stephen Philips, the Chairman of The National Prescribing Service, ending that report by Nick McKenzie.

http://www.abc.net.au/worldtoday/con...4/s1165576.htm