When your kid spikes a fever in the middle of the night, have you ever found yourself, bleary-eyed, puzzling over the correct dosage of liquid meds?
Maybe the bottle tells you to administer a teaspoon, but the measuring device included with the medicine is delineated in milliliters. Assuming you even know the correlation (1 tsp = 5 mL), doing the math in the midnight hours is probably not the safest thing for your child.
Now the Journal of the American Medical Association (JAMA) is weighing in, with a new study published online today of 200 of the top-selling cough/cold, allergy, analgesic and gastrointestinal over-the-counter liquid medications for children that finds disturbing levels of inconsistency in medication labeling and measuring devices. (More on Time.com: Who’s Afraid of the Flu? Not Moms)
Despite new voluntary guidelines released in Nov. 2009 by the U.S. Food and Drug Administration (FDA) for drug companies that make liquid medications — especially for children — the confusion persists.
The study, conducted by H. Shonna Yin of the New York University School of Medicine and Bellevue Hospital Center, New York, found that although a standardized measuring device — you know, that little plastic cup — was included with 74% of the medicines, nearly all contained at least one inconsistency between the labeled directions and the little cup in terms of doses marked on the device or the unit of measurement.
While a quarter of the products were missing necessary markings, 81% of the measuring cups included superfluous markings, which can confuse parents even further. In 89% of products, the text used to indicate units of measurement differed between the product’s label and the enclosed measuring device — “teaspoon” on the label, perhaps, and “tsp” on the measuring cup. (More on Time.com:Who’s Linked In? 7% of Babies Boast their Own Email Address)
Unaccustomed to measuring Motrin in cubic centimeters or drams? To further stymie mom and dad, 11 products relied on nonstandard units such as those.
What about developing a standardized measuring device to be included with all medication? It’s not so easy, says Darren DeWalt, an associate professor of medicine at the University of North Carolina at Chapel Hill who penned an accompanying editorial in JAMA calling for an end to the confusion.
“The problem is not all people are well-educated and giving them a universal syringe or spoon with all these markings will actually be confusing,” says DeWalt. Instead, enclosed measuring cups should contain only the relevant dosings, say the study authors and the FDA. (More on Time.com: Parents, Stop Using Infant Sleep Positioners; They’re Linked to 12 Deaths)
Kids are misdosed frequently, says DeWalt, either under- or overdosed. “It’s very common for these mistakes to get made, but we don’t have adequate surveillance for under- or overdosages because most of the time, this is happening at home,” he says.
How often does this actually harm a child? In most cases, overdosing probably goes unnoticed. But if, for example, children get two or three times the correct dose of Tylenol, four or five times a day for four or five days during an illness, they could suffer liver damage. Considering that more than half of U.S. children take at least one medication a week — mostly non-prescription drugs — it might be time for the FDA to toughen its voluntary guidelines.
To address the problems, the researchers call for change in three areas:
- a standardized measuring device should be included with all over-the-counter liquid medicines
- dosing directions on the label should align with markings on the associated measuring device
- measurement units, abbreviations and numeric formats should be standardized for all products
While the average cost to bring a new drug to market is $800 million, it appears drug companies spend very little money ensuring their instructions are understandable, says DeWalt, who advocates in the accompanying JAMA editorial for the use of milliliters in lieu of teaspoons. A milliliter is a milliliter (mL), but a teaspoon is not a teaspoon; the average kitchen teaspoon holds more than 5 mL (the one DeWalt pulled from his drawer contained 8 mL).
“The most elegant and efficient medical therapies will fail if patients or caregivers cannot adequately and accurately administer the therapy,” he wrote in the editorial.
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