[January 06, 2014] |
|
CDC study strongly underscores progress made by industry voluntary labeling guidelines
WASHINGTON --(Business Wire)--
The Consumer Healthcare Products Association (CHPA) says the makers of
over-the-counter (OTC) pediatric liquid medications have made
significant progress in carrying out voluntary efforts to promote safe
use through standardized dosing directions and dosing devices, as
underscored by the results of a Centers for Disease Control and
Prevention (CDC) study released today in "Pediatrics."
In 2009, CHPA members approved voluntary labeling guidelines for all
pediatric liquid medications in an effort to reduce the potential for
dosing errors. Following reports of unintentional overdoses in 2011, the
U.S. Food and Drug Administration (FDA) finalized similar
recommendations for standardizing labeling and dosing devices included
with OTC liquid medications.
Today's "Pediatrics" article, "Adherence to Label and Device
Recommendations for Over-the-Counter Pediatric Liquid Medications,"
discusses the results of a study conducted by the Centers for Disease
Control and Prevention (CDC) to assess recommendation adherence for
national brand name orally ingested OTC liquid pediatric
analgesics/antipyretics and cough, cold, and allergy medications
available after the FDA guidance was finalized. The report found high
levels of adherence to most recommendations provided in the final DA
Guidance as well as the CHPA guideline.
"This report shows that our industry is making great progress, and it
demonstrates our commitment to proactively working to empower consumers
to safely use our products in order to reduce treatment errors in
children," said Barbara Kochanowski, CHPA's vice president, Regulatory &
Scientific Affairs. "Hand in hand with our efforts to improve labeling
is our commitment to educating parents about the importance of safe
medicine storage. Accidental, unsupervised medicine ingestions are the
leading cause of emergency department visits related to medication
exposure, and reminding parents to store all medicines out of the reach
and sight of young children is a top CHPA priority."
Top-tier recommendations from the 2011 FDA Voluntary Guidance and 2009
CHPA Voluntary Guidance include the following:
-
Dosing devices should be included with all products
-
Atypical units should not be used (eg, drams, dropperfuls)
-
Teaspoon and tablespoon units should not be used together
-
Trailing zeros should not be used (to avoid 10-fold dosing errors)
-
Leading zeros should be used before decimal doses <1 (to avoid 10-fold
dosing errors)
-
Small font should be used with numerals in fractions (to avoid
interpreting "1/2" as "1 or 2")
-
Dosing devices should not bear extraneous or unnecessary volumetric
units
-
Dosing devices should not be significantly larger than the largest
doses in the directions
-
Dosing devices should provide markings that can readily measure doses
in the directions
The Consumer Healthcare Products Association (CHPA) is the
133-year-old trade association representing the leading manufacturers
and marketers of over-the-counter (OTC) medicines and dietary
supplements. Every dollar spent by consumers on OTC medicines saves the
U.S. healthcare system $6-$7, contributing a total of $102 billion in
savings each year. CHPA is committed to promoting the increasingly vital
role of over-the-counter medicines and dietary supplements in America's
healthcare system through science, education, and advocacy.
chpa.org
[ Back To TMCnet.com's Homepage ]
|