# 5104
Imagine you purchase a bottle of liquid medicine and the instructions on the box tell you to take 2 tablespoons (30mL) every 4 hours and give your 6 year-old child 1 tablespoon (15mL) every four hours.
The handy measuring device provided by the manufacturer looks like this:
Nowhere on this measuring cup are there Tablespoon markings. . . only teaspoons, and mL.
And the largest measurement – 4tsp - isn’t even a recommended dose. It is too much for a child, and not enough for an adult.
Of course, you may consider yourself lucky. Some medicines don’t even provide a measuring device.
Welcome to the confusing world of inconsistent OTC (Over-the-Counter) drug dosing instructions.
And while you might consider yourself capable of doing the mental conversion gymnastics in your head, not everyone is equally medically astute.
Besides . . any bleary-eyed, stressed out, and sleep deprived parent ladling out medicine to a sick child in the middle of the night can be subject to confusion - particularly when the instructions are less than perfectly clear.
In the fall of 2009, the FDA and the Consumer Health Products Association (CHPA) each released similar new voluntary guidelines for the packaging and dosing instructions of liquid medications, particularly those intended for use by children.
The FDA’s recommendations were pretty simple, with the main ones being:
- Measuring devices should be included for all over-the-counter liquid medications.
- Devices should be marked with calibrated units of measure that are the same as those specified in the labeled dosage directions.
- Abbreviations used on devices should be the same as those used in directions.
- Devices should not bear extraneous or unnecessary markings.
- Devices should not be significantly larger than the largest dose described.
- Abbreviations should conform to international or national standards.
- Abbreviations should be defined on devices and/or label directions.
- Decimals and fractions should be used with care and conform to recommendations
While most of these recommendations may seem fairly obvious, apparently they weren’t to the manufacturers.
According to this study, nearly all (well, 98.6%) of oral OTC medications examined prior to these guidelines being released contained dosing directions and measuring devices that were `highly variable or inconsistent’.
Ambiguities and inconsistencies that could easily lead to the under-dosing or over-dosing of a child with the medication.
JAMA has two free articles available on the subject.
A study study that takes an eye-opening look at the poorly conceived OTC dosing instructions on 200 popular pediatric oral liquid medications surveyed in 2009, and an editorial on the study.
First, a look at the study. I’ve only posted a snippet from the abstract. You’ll want to read the whole thing.
H. Shonna Yin, MD, MS; Michael S. Wolf, PhD, MPH, MA; Benard P. Dreyer, MD; Lee M. Sanders, MD, MPH; Ruth M. Parker, MD
JAMA. Published online November 30, 2010. doi:10.1001/jama.2010.1797
Abstract (Excerpts reformatted)
Results Measuring devices were packaged with 148 of 200 products (74.0%).
Within this subset of 148 products, inconsistencies between the medication's dosing directions and markings on the device were found in 146 cases (98.6%).
These included missing markings (n = 36, 24.3%) and superfluous markings (n = 120, 81.1%).
Across all products, 11 (5.5%) used atypical units of measurement (eg, drams, cc) for doses listed.
Milliliter, teaspoon, and tablespoon units were used for doses in 143 (71.5%), 155 (77.5%), and 37 (18.5%) products, respectively.
A nonstandard abbreviation for milliliter (not mL) was used by 97 products. Of the products that included an abbreviation, 163 did not define at least 1 abbreviation.
Conclusion At the time the FDA released its new guidance, top-selling pediatric OTC liquid medications contained highly variable and inconsistent dosing directions and measuring devices.
You’ll also want to read the accompanying editorial.
Ensuring Safe and Effective Use of Medication and Health Care
Perfecting the Dismount
CHPA, which is a trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplements, released a statement yesterday in response to the publication of these two articles in JAMA.
You can read it at the link below.
CHPA Statement Outlining Measuring and Dosing Improvements Already Made for Liquid OTC Medicines for Children
For now, the guidelines issued by CHPA and the FDA are strictly voluntary.
It will likely require another study some time in the future to determine how much progress has been made in the adoption of these recommendations.
