Guidelines needed for inconsistent OTC medication dosing warnings, urge researchers

By Alexandria Pešić

- Last updated on GMT

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.

“The CHPA guidance that was issued demonstrates that manufacturers of OTC products are interested in making a change,”​ said Yin, who explained that the Centres for Disease Control and Prevention (CDC) is planning to perform another assessment of children’s OTC products in the next year through its PROTECT initiative, to ensure drugmakers have made improvements to warning labels and measuring devices.

Drug giants compliant with guidelines

in-PharmaTechnologist spoke with UK drug major, GlaxoSmithKline (GSK), about the CHPA guidelines issued in 2009 to standardize dosing directions and dosing devices in OTC paediatric drug products.

While GSK says it has very few drugs targeted towards children in the US, and it is unknown whether its medicines were reviewed in the study, the firm said it makes every effort to ensure its products comply with regulatory guidelines.

“GSK takes the safety of all of its medicines seriously and is committed to ensuring that all of its medicines contain clear and comprehensive labelling that explains the benefits and risks of the medicine helping to ensure appropriate use in compliance with local regulatory requirements​,” said a spokesperson.

Despite such efforts, Ruth Parker, co-leader of the study, believes guidelines aren’t enough to combat problems with inconsistent dosage warnings. “Given how many products are affected, it seems unlikely that the voluntary guidelines alone set by the FDA and industry will fix this problem,” ​she said.

Instead, she added, “Standards and regulatory oversight will likely be needed to ensure that all products contain label information and dosing device markings that match and are understandable and useful.”

Related topics: Drug Delivery, Regulations, QA/QC

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