and Prevention’s (CDC’s) PROTECT Initiative.1 Each contains recommendations, but neither discusses existing levels and types of inconsistencies. The study reported in this presentation aims to quantitatively clarify the issues.

The study sampled 200 top-selling OTC products that included oral liquid medications, analgesic, cough/cold, allergy, or gastrointestinal (GI) products with dosing directions for children under 12 years of age. More than half (59 percent) of the products were cough/cold remedies, followed by GI products (22 percent), analgesics (11 percent), and allergy medicines (8 percent).

The study found a very high rate of inconsistency and variability in labels and devices for pediatric OTC liquid medications. Problems included

  • No dosage delivery device included

  • Inconsistency between label and dosage delivery device

  • Superfluous markings on the device

  • Missing necessary markings on the device

  • Markings for units of measure that do not match what is on the label

  • Format of numeric text (decimals/fractions) does not match label text

  • Inconsistency across products

  • Nonstandard abbreviation for milliliter (not mL)

  • Nonstandard abbreviation for teaspoon (not tsp)

  • Units of measurement other than milliliter, teaspoon, and tablespoon

  • Inconsistent use of numeric text (decimals/fractions)

  • Lack of consumer guidance on appropriate use

One out of four products did not include a device for administering the medication. Almost all (99 percent) products had one or more inconsistencies between the label and dosage delivery device. For example, 81 percent had superfluous markings on the device (Table 3-1), such as ounce or milliliter measurements when the dosing called for measurements in teaspoons. Two thirds (67 percent) used a nonstandard abbreviation for milliliter. The FDA recommended standard and the U.S. Pharmacopeia (USP) standard is lowercase m and uppercase L for mL.

1

The CHPA Board of Directors adopted a voluntary program that recommends manufacturers take specific steps in labeling, packaging, and promotion of over-the-counter oral pediatric cough and cold medicines (http://www.chpa-info.org/scienceregulatory/Voluntary_Codes.aspx#PediatricCoughCold).



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement