Did you know that about 30% of drugs prescribed children medications have never even been tested on children? Or, did you know that up to 95% of drugs given to babies in intensive care – have never been tested on them either?
According to a new report, these statistics are true, and children are being prescribed unlicensed medicines that could be causing harm. This begs the question, are prescription children medications safe?
And, the new government study is demanding an urgent investigation into the “unacceptable” fact that almost a third of drugs given to sick children are officially approved for only adult use.
It warns of “a high number of drug errors” in which children may be wrongly prescribed too much of a medicine because the doses are meant for adults.
In the past, pharmaceutical companies have not had an obligation to test medicines on children. The law changed in 2007 and new drugs coming to market must now be tested on children before they can be used on them.
But, that still leaves the older drugs untested that were approved before 2007, which includes common antibiotics, painkillers, asthma inhalers and cancer medicines.
According to the Daily Mail, the UK Department of Health commissioned the study and the resulting report was written by “leading child health experts,” This was called the “Children and Young People’s Health Outcomes Forum”.
The lack of formal testing is alarming to the Health Outcomes forum because no one knows how many children may have had problems that were never reported or properly acknowledged. This could be placing an unknown burden on the UK health system. The Medicines and Healthcare products Regulatory Agency would be the appropriate agency to conduct such an in-depth investigation.
Lack Of Guidelines For Children Medicines
The reasoning is that the Department of Health does not give guidelines for prescribing unlicensed drugs to children and therefore the potential for drug errors is much higher.
The report, from the Children and Young People’s Health Outcomes Forum, says: “New medicines account for a relatively small percentage of those used by children, and those introduced before [the 2007] legislation largely remain unregulated and, critically, therefore possibly untested formally in children.
“This contributes to the high number of drug errors and leads to wider implications – including the fact that the National Institute for Health and Clinical Excellence will not give advice on unlicensed medicines and this limits the guidance that they can offer on care for children.”
It goes on to caution: “The Forum believes that the situation with regard to the absence of licensing for the majority of children and young people’s medicines in this country is unacceptable.”
One roadblock to testing new drugs on children is the ethical concern about testing drugs on children. Regulators have made it difficult for drug companies to get approval for such testing. Lack of any regulatory requirement is another issue. Once a drug is approved for adults, there is no requirement that drug companies test the drugs on children. This helps the drug companies finances but may indicate some lobbying or influence peddling with government.
Some believe that a lack of formal testing on children is not as much of a problem as the investigators say it is. And that it would be more of a hassle and financial burden in order to test medications that have been used on the market for decades.