When I was interviewed by Vox News for a podcast last month, I mentioned a recent recall involving confused unit dosing. I’d like to explore that issue in more depth this month.
August 2018 recall of children’s liquid medicine
A news release issued by the Pfizer Inc. on August 27, 2018, began with the following sentence:
Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).
Let’s take a closer look that. What that means is that if someone was paying attention to the number of units and not the units themselves (teaspoons vs. milliliters) — and why wouldn’t everyone expect consistency between the two? —that person could have given their child a significant overdose all the while thinking that they were following the directions.
As the Food and Drug Administration noted:
That is putting it mildly. Since there are roughly 5 mL in a teaspoon, giving the smallest dose in teaspoons could result in administering a whopping 20 mL more than prescribed. For a 72-95 pound 11-year-old child, the error compounds to an overdose of 60 mL when only a 15 mL dose was intended!
While not necessarily deadly, the recalls note that “The most common symptoms associated with ibuprofen overdose include nausea, vomiting, headache, drowsiness, blurred vision and dizziness.”
I’m not a doctor, but I image the reactions could be worse for a small child whose health was compromised before the overdose was innocently administered by a caregiver.
We’re just not moving quickly enough to remove such errors from our medical system. As noted by the Institute for Safe Medication Practices in 2015:
While progress is being made in hospitals in regards to prescribing liquids in mL, many hospitals still use dosing devices that have household measures (e.g., teaspoonful, dessertspoonful, tablespoonful) and, as above, even drams and ounces. This sets healthcare professionals up to fail because the dosage scales on embossed cups are difficult to read, have dangerous abbreviations that are easily confused (e.g., TBS and TSP), and measures that are no longer used (e.g., drams). .
It’s easy enough to make mistakes moving between U.S. customary and metric units without having organizations responsible for our over-the-counter medicines layering on their own errors that might be difficult to immediately perceive.
But changing to the metric system will cost money, I hear some cry
One of the pushbacks I’ve gotten over the years is that it would cost money to switch to the metric system. Let’s take a second and consider the cost of a recall such as the one cited here.
According to Investopedia:
Though insurance may cover a minimal amount to replace defective products, a majority of product recalls result in lawsuits. Between lost sales, replacement costs, government sanctions, and lawsuits, a significant recall can become a multi-billion dollar ordeal. For multi-billion dollar companies, an expensive short-term loss can be easily overcome, but when shareholders and customers lose confidence, there may be greater long-term effects such as plummeting stock prices.
The bottom line: This recall of children’s medicine could have been completely avoided if we weren’t constantly juggling multiple measurement systems in this country.
I’m not saying that using one set of units would solve all problems. After all, it’s still possible a company could put out dosing instruction that contained a typo (or a host of other problems), but let’s do what we can to try to remove easily avoidable errors from the system.
Cost of a recall?
Based on some research I did, it sounds like an average recall cost is over $10 million dollars in direct costs (pulling product off the shelves, etc), while indirect costs (lawsuits, fines, and customer avoidance, stock price, harm to reputation) can mount for years after the recall.
That’s something to highlight when talking about using consistent measures and the cost to implement them.
Thanks for getting this far!
Some resources on the cost of recalls: