OTC industry moves toward ml-only dosing for children's liquid formulations
WASHINGTON — The Consumer Healthcare Products Association board of directors on Wednesday announced changes to CHPA’s voluntary guidelines addressing dosing of liquid pediatric over-the-counter medicines.
Key changes to the voluntary guidelines include:
Deleting “spoon” labeling (i.e., teaspoon, tablespoon) on dosing directions and dosing devices;
Specifying use of “mL” only in dosing directions and on devices; and
Deleting the provision in dosing directions of a definition of any volumetric unit of measure (i.e., mL = milliliter).
The updated guidelines replace the previous version of this document approved in November 2009 that specifies mL as the preferred unit of measure.
“The makers of OTC medicines fully support using mL as the standard unit of measurement on all liquid orally ingested OTC medicines for children, as we believe this uniformity will make proper dosing easier for parents,” said CHPA resident and CEO Scott Melville. “We know from recent a study released in Pediatrics that parents who used milliliter-only units made fewer dosing errors than those who used teaspoon or tablespoon units. We hope this change combined with the ongoing educational efforts of the CHPA Educational Foundation will contribute to a significant decline in medication errors.”
The changes are supported by the Centers for Disease Control and Prevention PROTECT (Preventing Overdoses and Treatment Errors in Children Taskforce) Initiative, who partners with the CHPA Educational Foundation on the UpandAway.org safe medicine storage campaign.
In addition, the National Council on Prescription Drug Programs has also recommended a move to “mL only” labeling (for prescription liquid medicines), and a recent FDA draft guidance document addressing issues aimed at enhancing safe use of OTC pediatric liquid acetaminophen products also specifies that dosing directions should be provided in mL only.