Top-selling pediatric OTC analgesic, cough and cold, allergy, and gastrointestinal liquid medications in the United States are plagued with highly variable and inconsistent dosing directions and measuring devices, according to a study published ahead-of-print on the Journal of the American Medical Association's website.
Top-selling pediatric over-the-counter (OTC) analgesic, cough and cold, allergy, and gastrointestinal liquid medications in the United States are plagued with highly variable and inconsistent dosing directions and measuring devices, according to a study published ahead-of-print on the Journal of the American Medical Association's (JAMA) website.
The US Department of Education estimates that 1 in 3 American adults and at least 1 in 4 American parents have limited health literacy. "Decoding medication labels and understanding how to use measuring devices correctly are health literacy tasks that many find difficult," stressed H. Shonna Yin, MD, lead author on this JAMA paper. "Several Institute of Medicine [IOM] reports have identified variable and poor-quality drug labeling as a leading root cause of consumer confusion with a high potential to lead to unintentional misuse of products."
In recognition of this, both FDA and the Consumer Health Products Association (CHPA) in late 2009 released voluntary guidelines to industry groups responsible for manufacturing, marketing, or distributing OTC liquid medications. Some notable recommendations made by these groups regarding OTC liquid medications included supplying a measuring device of the correct size and bearing only necessary markings, and assuring the device and directions use standard and matching abbreviations and units.
The authors found that of the top 200 liquids, only 148 (74%) were accompanied by a measuring device as recommended by guidance. Of these 148 liquids, inconsistencies between dosing directions and markings on the accompanying device were found in nearly all (~99%) cases, including unneeded (81%) or missing markings (24%). Variable units of measurements [milliliters (72%), teaspoons (78%), tablespoons (19%), and less commonly, cubic centimeters and drams (6%)] were also found across evaluated liquids. Abbreviations were commonly used by these product, some of which were nonstandard (49%) and often undefined (84% had ≥1 undefined abbreviation).
"The FDA guidelines released in 2009 are another step toward the goal of providing clear, consistent, and actionable medication information to consumers," noted the authors. However, they suggested, "Given the high prevalence of baseline inconsistencies, regulatory oversight may be helpful in accelerating adoption of the guidance recommendations."
Yin HS, Wolf MS, Dreyer BP, Sanders LM, Parker RM. Evaluation of consistency in dosing directions and measuring devices for pediatric nonprescription liquid medications. JAMA. 2010, Nov 30. [Epub ahead of print]. Available at: http://jama.ama-assn.org/content/early/2010/11/30/jama.2010.1797.long. Accessed December 9, 2010.
US Department of Health and Human Services and FDA Center for Drug Evaluation and Research. Guidance for industry: dosage delivery devices for OTC liquid drug products. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM188992.pdf. Accessed December 9, 2010.