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Labels, dosing devices on kids' meds called confusing
November 30th, 2010
04:42 PM ET

Labels, dosing devices on kids' meds called confusing

Confusing label instructions can make it difficult for parents to give a sick child the right dose of liquid over-the-counter medicines,  according to a new study published Tuesday in the Journal of the American Medical Association. Researchers found that about half of adults make mistakes when giving children medications, and complicated labeling may be contributing to the problem.

Researchers looked at 200 top-selling liquid pediatric over-the-counter medications sold in the United States including pain relievers, cough and cold products, and allergy and gastrointestinal medicines. About a quarter of the products did not include a measuring device such as a cup, dropper or oral syringe, and of those that did, 99 percent had some sort of mismatch between the written dosing directions on the bottle or label and the dosing markings on the measuring device, according to the study.

In some cases the directions used terms such as teaspoon or tablespoon while the cup or dropper listed doses only in milliliters. Rarely were there instructions to convert from one form of measurement to another, according to the study. Cups or other devices often had doses marked that did not match the doses indicated on the bottle. One medicine called for a dosage of 1 tablespoon but the cup provided had markings for tsp, or teaspoons, according to the study.

"It's very confusing and it makes it hard for parents to correctly dose the medicine for their children," says study author Dr. H. Shonna Yin, assistant professor of pediatrics at NYU School of Medicine in New York. "We think this is really an issue of patient safety and needs to be urgently addressed."

In 2009 the Food and Drug Administration set voluntary guidelines to address some of these issues after reports of accidental overdosing in children. Researchers conducted this study to gather baseline data to make it easier to track if and when companies make changes to comply with the new guidelines. The FDA recommends that all OTC liquid products include a measuring device and that the same units of measurement and abbreviations appear on the device and in the written label instructions.  It also recommends limited  marking on the dosing cups or devices – only those needed to get the right dose.  The FDA also recommends standardizing abbreviations. Decimals and fractions should be used sparingly and studies need to be done to determine how well consumers can follow the directions.

Last year, the Consumer Health Products Association, an organization that represents companies that make OTC liquid products, issued  guidelines similar to those of the FDA.

In a statement issued in response to the study, the CHPA said, "The OTC medicine industry takes very seriously its responsibility to help parents and caregivers safely and correctly administer OTC pediatric oral medicines to children. It is our goal that all OTC medicines will fully follow the [CHPA] guidelines by the end of 2011."

Yin is concerned, however, that the voluntary guidelines that the FDA and industry have put forth will not solve the problem. "The FDA should be taking steps, setting standards, and regulating the products so that all OTC medications for kids comply with the standards," she says.

Yin plans to do a follow-up study on compliance in about a year. In the mean time experts suggest that caregivers call their doctor or pharmacist if they are confused about dosing. The CDC offers additional advice for parents online.


soundoff (18 Responses)
  1. Jennifer

    We need dosing based on weight and height, not age, and we do need everything in milliliters. My daughter is 6.5 years old and only weighs 37 pounds. I don't dose her at levels for six to twelve year olds because she isn't even on the growth chart.
    Jennifer
    http://www.babyminding.com

    November 30, 2010 at 18:49 | Report abuse | Reply
    • Erin

      Jennifer, I agree. My son who is 14 months has always been much taller and bigger than other children his age. He's 34 inches tall and weighs 26lbs.
      On INFANT drops it says do not give to children under two with out asking a doctor how much you should give them.... but yet they are infant drops not CHILDRENS drops.
      I think the directions and labeling should change.

      December 1, 2010 at 11:18 | Report abuse |
    • Yo mama!

      Do Yew feed yo baby?!?!?

      December 1, 2010 at 12:14 | Report abuse |
    • KDW

      I moved to Canada soon after my son's birth so labeling may be different up here. All the medication we have bought him here has dosing by age and weight. We were told it is better to use the weight of the child to dose than the age. I've also never seen any issues with no droppers or with non-matching dose info and the droppers. Everything here is given in ml and all droppers are split into the appropriate ml dosage markings. I do remember that the tylenol I bought him in the US had no dosage info for children under 2 y/o and I had to ask the doctor. Seemed weird that it was like that.

      December 1, 2010 at 14:03 | Report abuse |
    • laurab68

      Jennifer I know how you feel. My daughter is 7 and only weighs 34 lbs. Believe me it's not from lack of trying to get her to put weight on. It's genetic. I was 36lbs @ 8 years old, my niece is a double 00 and my mother was also a stick growing up. I ate 2 french fries as a kid and I was full. So don't worry about it.
      Maybe you should get your meds from here in Canada. As the previous poster said, all meds here in Canada have either droppers or proper dosing labels by weight. I can't explain why the US doesn't follow what Canada does in this regard.

      December 3, 2010 at 11:50 | Report abuse |
  2. Marilyn

    Some pharmacies refuse to provide measuring devices even for prescription meds, claiming doing so is merely "optional". And not all OTC meds provide measuring devices, either. So for both OTC and Prescription doses, it becomes guesswork using whatever is available at home. As for asking the pharmacists or pharmacy techs for dosing advice, be wary and double check. On several occasions when a measuring device was provided, it was the wrong one! In the most frightening example of this, the pharmacy error would have meant a dangerous overdose to our infant, as she had mistaken the metric conversion.

    November 30, 2010 at 19:49 | Report abuse | Reply
  3. CJ

    What the...I've never run into this problem with my daughter's medications. Everything I've bought had a dosing device, and they always matched the instructions on the bottle. I've always double-checked to be on the safe side. I'm actually very curious what specific products had these problems. I've bought name brands and generics of ibuprofen, acetaminophen, and cold medicines, so it's not like I always just use one or two brands.

    December 1, 2010 at 00:41 | Report abuse | Reply
    • Melanie

      Same here! My oldest is 15 and I've rarely run into dosing problems, even 15 years ago. Occasionally I might find something, but 99%? No way. I would also be interested in knowing what products they looked at.

      December 1, 2010 at 10:21 | Report abuse |
    • las730

      Me too. I don't know what is wrong with parents these days. I never had a problem, never over medicated my kids, etc.,

      December 3, 2010 at 11:52 | Report abuse |
  4. RM

    with the information available to people these days there is zero excuse for not figuring out any unit conversion by yourself in 5 min. people need to start using their brains once in a while, companies/governments should NOT do all the work for you so that you never have to think... it is your responsibility as a parent to figure it out, nobody's responsibility but yours

    December 1, 2010 at 09:44 | Report abuse | Reply
    • Bonnie

      Don't you think that companies have some responsibility to put out clear information regarding their products? Or, do you think they can be as sloppy as they want? Have you ever tried calculating dosages while converting units in the middle of the night, with a feverish baby screaming in your ears?

      December 2, 2010 at 11:19 | Report abuse |
  5. Tracy

    Dosage by age is ridiculous. My daughter is 9 years old but is 4ft 10in and weighs 92 pounds. If I used that scale she would never get the correct amount she needed to feel better!

    December 1, 2010 at 11:38 | Report abuse | Reply
  6. michelle

    Bravo! RM my theought as well. Why are people who can't do simple math conversions reproducing anyway.

    December 1, 2010 at 11:40 | Report abuse | Reply
  7. Sam

    Amen RM and Michelle, the conversion process just isn't that complicated. Don't rely on others to do the work that you should be able to complete as a parent.

    December 1, 2010 at 12:28 | Report abuse | Reply
  8. Valerie

    RM, Michelle and Sam, not all parents have access to the internet or can just pop on over to the library when their child is sick. And with the current state of our education system, I doubt any of us can convert in our heads based on what we didn't learn in school.

    December 1, 2010 at 13:29 | Report abuse | Reply
  9. Ashleen

    My son is 12 months old, 35 inches tall and 25 pounds. Obviously, he's as big as some 2.5 year olds! Dosing by age sets up for error. Weight/height doses are more accurate.

    It isn't hard to convert measurements, but doing it while running on 3 hours of sleep for 3 days with a sick screaming baby isn't always an option. The companies should have the same measurements on their dosers as their boxes/bottles.
    If you went into a restaurant and they gave you soup on a plate with a fork to eat it, you'd be irritated, wouldn't you? It's their "job" to give you the "right" items. The drug companies have the same job, but the wrong dosage of acetaminophen is deadly while trying to eat soup with a fork is not.

    December 2, 2010 at 16:17 | Report abuse | Reply
  10. terri berkley

    Check with your pediatrician or insurance company for after hours nursing lines. It seems like the question arises after doctor offices are closed. If you are not certain of the dose call them. I would rather pay a copay charge if necessary than give an incorrect dose of medicine. By the way, my daughter has a g-button that was surgically placed when she was 6 weeks old. She is almost 2 and has never taken 8 ounces at one feeding. She is in the 37 percentile for height and weight. Being too small is just as unhealthy as being over weight. If you child struggles with food contact a nutritionist. They have great ideas on how to increase calories for children who eat very little.

    December 3, 2010 at 15:35 | Report abuse | Reply
  11. razzlea

    http://razzlea.blogspot.com/

    December 31, 2010 at 10:07 | Report abuse | Reply

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