FDA Unveils Safe Use Initiative That Targets Preventable Harm From Medication Use

FDA Unveils Safe Use Initiative That Targets Preventable Harm From Medication
Use

Agency also releases drug dosage guidance for measuring devices included with
OTC medications

SILVER SPRING, Md., Nov. 4 /PRNewswire-USNewswire/ -- The U.S. Food and Drug
Administration today announced the Safe Use Initiative, a program aimed at
reducing the likelihood of preventable harm from medication use.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

"Too many people suffer unnecessary injuries from avoidable medication misuse,
errors and other problems. The FDA is launching the Safe Use Initiative to
develop targeted solutions for reducing these injuries," said FDA Commissioner
Margaret A. Hamburg, M.D.

Millions of people are harmed every year from inappropriate medication use.
Many injuries occur as a result of incomplete access to information about a
drug, a patient, or the patient's condition.

Other preventable sources of harm include unintentional misuse of medications,
medication abuse, and attempts at self harm. Unintended exposure to
prescription medications such as opioid drugs can cause harm, even death, in a
single dose, if taken by someone other than the patient who was prescribed the
medication.

"Only through coordinated interventions across all sectors of the health care
system can we substantially reduce preventable injuries from using
medications," said Janet Woodcock, M.D., director of the FDA's Center for Drug
Evaluation and Research. "All participants in the health care community have a
role to play in reducing the risks and preventing injuries from medication
use."

More detailed information on the new program was contained in a report,
titled, "FDA's Safe Use Initiative - Collaborating to Reduce Preventable Harm
from Medicines." The report was released by Drs. Hamburg and Woodcock at FDA's
annual Science Writers Symposium at the agency's White Oak Campus in Silver
Spring, Md.

As outlined in the report, the FDA intends to collaborate with health care
professionals and other stakeholders to identify drugs and drug classes that
are linked to preventable harm. A list of specific problems, cross-sector
interventions for reducing harm from these problems, and the metrics for
success will be developed.

The report highlights several risk-reduction projects that may benefit from
Safe Use collaborations, including evaluating consumer medication information,
communicating about the risk of inadvertent overexposure to acetaminophen,
implementing safeguards against surgery fires caused by alcohol-based surgical
preps, and avoiding contamination of multiple use medication vials.

To further advance the Safe Use Initiative, the FDA intends to hold a series
of public meetings to gather feedback as the candidate list is being developed
and will open a public docket to receive comments on the report and proposed
candidate cases.

The agency also today made public new FDA guidance for companies that
manufacture, market, or distribute over-the-counter liquid medications
packaged with dosage delivery devices such as calibrated cups, droppers,
syringes and spoons.

The guidance document, titled "Dosage Delivery Devices for OTC Liquid Drug
Products," was posted for advanced viewing in the Federal Register today.

Accidental overdoses can be caused by dosage delivery devices that are unclear
or are inconsistent with the labeled dosing instructions.

"This new drug dosage guidance document is an example of steps that can be
taken to ensure safer medication use," said Woodcock. "Many accidental
overdoses result from confusion about exactly how much of a drug to take.
Better measuring devices will help patients, parents, and other caregivers use
the right amount of these medications - the safest and most effective dose -
especially for children."

For more information: http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Karen Riley of the U.S. Food and Drug Administration, +1-301-796-4674,
karen.riley@fda.hhs.gov