One week ago, a study came out in the Journal of the American Medical Association indicating that approximately half of all adults who give medicine to their children end up giving them the wrong dosage. This often happens either because of confusing instructions on the medicine box or bottle, because the devices provided to measure the medicine have markings in units which do not match the units in the instructions, or because no measuring devices are provided at all. As reported in Dr. Sanjay Gupta’s blog on cnn.com, about 25% of medicines do not come with a measuring device, and of the 75% that do, a whopping 99% have inconsistencies between the dosing instructions on the label and the dosing markings on the measuring device.
In response to reports last year of children overdosing because their parents provided them with the wrong doses of medicine, the FDA issued a series of voluntary guidelines to drug companies suggesting steps by which they might decrease the risk posed by this fundamental flaw in their products. The steps they suggested are quite obvious: “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.”
Surely it didn’t take a genius to figure those ones out. Putting aside the fact that it was wrong for drug companies to even think of releasing drugs with inconsistent units of measurement, the most glaring atrocity in this whole situation is that the FDA has not made their guidelines mandatory. The FDA has a duty to ensure that all drugs which are released on the market, and especially ones that are OTC and not regulated by a doctor, are safe to be used. Safe means not only that taking the recommended dosage will not do undue harm, but also that the packaging and measuring devices are designed in such a way as to ensure that it is very easy for the average person, and even those of subpar intelligence, to take the correct dose.
Going back to the CNN blog post, the author writes, “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.” While this would technically be enough information to calculate the correct dosage, even providing conversion factors is still, I think, not good enough. Health is a universal right, and the ability to multiply should not be a prerequisite. I suspect that drug companies like the lack of regulation because it allows them to manufacture a generic measuring cup for all the different products which they produce, and the fact that the FDA has allowed them to get away with this for so long (and is still allowing them to do so) is a fundamental failure on the part of the government to protect its people.
1 comment:
Dosing mistakes for young children are more dangerous because a small absolute difference in the amount of medication is a bigger change in the amount of medicine per pound of body weight. Incorrect labeling is a problem, because it makes it much harder to get the correct dose. The other problem is that we don’t know all that much about how well most drugs work in very young children, or if the doses are best calculated by age, or by body weight. I have to agree with Alex, the recommendations from the FDA for labeling should be made mandatory. Right now, it is far too easy to make a mistake measuring out the medicine. Tablespoon and teaspoon are too easy to get mixed up when they are abbreviated, and there is a big potential for mistakes there. Still, I also think we need to do more to find out what safe doses of these medicines for children really are, since many are not recommended for use in small children.
http://jama.ama-assn.org/content/304/23/2595.full
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