Giving kids the correct dose of medicine is a little like a
guessing game. Almost all top-selling, over-the-counter liquid meds for
children contain inconsistent dosing directions and measuring devices.
Of the 200 types examined in a recent study, most had
directions that did not match what was marked on the measuring device.
"This is an issue of patient safety and needs urgent
attention," says Ruth Parker, professor of medicine at Emory University, who
co-led the study, which is reported in the December 15 issue of JAMA. "Given
how many products are affected, it seems unlikely that the voluntary guidelines
alone set by the FDA (Food and
Drug Administration) and industry will fix this problem."
Inadequate guidance
Parker says the current guidance does not contain a timeline
for compliance or specify consequences for non-compliance. "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," she adds.
A standardized measuring device was included with 148 of the
products examined. Confusing information in these products included
inconsistencies between dosing directions and markings on the measuring device
(98.6 percent); missing markings on measuring devices (24.3 percent);
superfluous markings (81.1 percent); atypical units of measurement (5.5
percent); nonstandard abbreviations; and lack of definitions for abbreviations.
One-fourth of the products did not contain a dosing device
at all, which means parents could have trouble selecting the right amount of
medicine.
The study was conducted for the 52 weeks ending October 30,
2009, and included 99 percent of the U.S. market of analgesic, cough/cold,
allergy and gastrointestinal OTC oral liquid products with dosing information
for children younger than 12.
FDA steps in
In November 2009, in response to reports of unintentional
drug overdoses among children given over-the-counter medicines, the FDA released new voluntary industry
guidelines that recommended greater consistency and clarity in dosing
directions for OTC medications and their measuring devices.
The voluntary guidelines recommended that all OTC liquid
medications include a measuring device, the product's device and directions
should use the same abbreviations and units of measurement, devices should have
only necessary markings and should not hold much more than the largest dose
described, abbreviations should be standard and defined and decimals or
fractions should be used carefully.
They also recommended more research to confirm accurate use
of this information by consumers.
