Mandatory guidelines for labelling of OTC liquid medication for children should be issued, said researchers who found major inconsistencies in labels and dosage measuring devices.
Researchers at the NYU School of Medicine reviewed the warning labels and dosing devises of 200 paediatric oral liquid over-the-counter (OTC) medications with dosing instructions for children under twelve-years-old.
According to lead author Dr. H. Shonna Yin the team tested top-selling drugs produced by different manufacturers, identifying “an unacceptable level of inconsistency in labels and measuring devices of OTC liquid medications for children.”
“We found that 25 per cent of the products we looked at did not include a dosing device, like a cup or a dropper for giving the medicine,” said Yin. “Of the products that included a measuring device, almost 99 per cent had directions on the bottle’s label and dose markings that did not match.”
Moreover, the researchers explained that over half of the reviewed products lacked standard abbreviations for commonly used terms such as teaspoon or milliliter, instead using the abbreviated terms “cc” and “drams,” which they claim can confuse parents and “increase the likelihood of misdosing.”
Yin told in-PharmaTechnologist the problems with inconsistencies were found across product types categorised as analgesic, cough and cold, allergy and gastrointestinal medicines and were made by both large and small drug manufacturers.
The study was implemented after the US Food and Drug Administration (FDA) issued a set of voluntary guidelines last year, advocating greater consistency in dosing instructions and accompanying measuring devices following several reports of accidental overdosing in children as a result of the problem.
Prior to release of the guidelines, there were no official regulations and standards about issues related to inconsistent dosing directions and devices, said Yin.
She hopes that now, by acknowledging there is an issue, the FDA and the Consumer Healthcare Products Association (CHPA) will help drug manufacturers address the problem of inconsistencies between measuring devices and warning labels.