FDA Unveils Safe Use Initiative that Targets Preventable Harm from Medication Use
The Food and Drug Administration today announced the Safe Use Initiative, a
program aimed at reducing the likelihood of preventable harm from medication use.
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.
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 (CMI),
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
NCPIE encourages healthcare professionals and community groups to foster patient–professional communication about medicines. However, NCPIE does not supervise or endorse the activities of any group or professional. Discussion and action concerning medicines are solely the responsibility of the patient and their healthcare professionals, and not NCPIE.
Please consult a licensed health care professional with questions or concerns about your medication and/or condition.