Are kids at risk from additives in ‘off-label’ medication?


Children may be exposed to harmful levels of preservatives and additives due to ‘off label’ prescription of adult formulations, a compounding pharmacist has warned

Queensland-based compounding pharmacist Matthew Bellgrove says he wants to increase awareness of the risks amongst Australia’s medical community after a number of papers on the issue were published in the UK.

In a recent article published in The Pharmaceutical Journal, Sara Arthur and Anna Burgess from the Welsh Medicines Information Centre said that most preservatives, fillers and dyes (called excipients) were not harmful to adults, however they had the “potential to lead to adverse effects” in children.

“Oral liquid formulations, such as solutions and suspensions, are commonly given to young children because they are easy to swallow,” said the authors.

“However, many liquid formulations have not been studied extensively, or authorised for paediatric use. This has resulted in the widespread routine clinical use of unlicensed medicines, and the use of adult medicines outside of their licence, usually referred to as ‘off-label’ use, in children.”

Mr Bellgrove who operates National Custom Compounding on the Gold Coast, agreed with Ms Arthur and Ms Burgess’ article, saying great consideration should be taken concerning excipients when prescribing adult medicines for children.

“A child’s hepatic and renal systems are under-developed, meaning they can’t metabolise and eliminate excipients as well as an adult,” Mr Bellgrove said.

“The cases of children being harmed from an overdose of a certain excipient would be uncommon, however the risk is still there.”

Mr Bellgrove said there were many alternatives to ‘off label’ prescribing for children including compounded medication.

“By law pharmaceutical manufacturers must provide details on all excipients used in their products, and their volumes, and there are readily available guidelines on safe limits of all expedients for children. You simply have to do the math.

“However you can by-pass all of this by getting rid of the excipients altogether. A compounding pharmacist can make up medications without using any preservatives, fillers and additives. That way you remove all uncertainty.

“There are compounding pharmacies across the country that can safely make up medications, from scratch, free from any of the excipients. The excipients are added by drug manufacturers primarily to ensure the medication remains stable when being shipped long distances. They’re also added to prolong shelf-life, or improve the taste or look of the product.

“But they’re not necessary to make the medication work.”

Mr Bellgrove said anyone concerned about the excipients in their child’s medication should talk it over with their doctor.

“Your child’s doctor is the professional best placed to provide you with information on the excipients in your child’s medication and if they pose any risk at all to your children. In the vast majority of cases the answer will be no, but if you’re worried, speak to your doctor about your concerns.”

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