By James Limbach
ConsumerAffairs.com
November 5, 2009
The Food and Drug Administration (FDA) is promoting a program aimed at reducing the likelihood that you'll be harmed by the medicines you take.
"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 by taking the wrong medicine or too much of the medicine they're supposed to take. 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."
As outlined a report, titled, "FDA's Safe Use Initiative -- Collaborating to Reduce Preventable Harm from Medicines," the agency 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 (Tylenol), implementing safeguards against surgery fires caused by alcohol-based surgical preps, and avoiding contamination of multiple use medication vials.
FDA has also made public its new 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.
Accidental overdoses can be caused by 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."
