FDA Safe Use Initiative

FDA NEWS RELEASE

For Immediate Release: Nov. 4, 2009

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

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

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.

“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

Should we eliminate combination products that contain acetaminophen?

So many combination products contain acetaminophen. You'll find them in prescription drugs (like Vicodin and Percocet) as well as in many over-the-counter (OTC) cough/cold medicines. For instance, Nyquil has an equivalent dose of 1000 mg of Tylenol (acetaminophen). If someone took Nyquil for a cold and then took some additional Tylenol for a headache, he could have a serious liver problem in a few days from a Tylenol overdose. Many people don't look at the ingredients of cold/cough medicines and they also don't realize that acetaminophen = Tylenol (just a different name).

Now, the FDA panel focused on prescription combination products that contain acetaminophen. Why? Because the data shows that acetaminophen-related overdoses occur mainly with prescription drugs. Maybe that's because some people are taking Vicodin and Percocet for drug-abuse problems and they're more prone to suicidal tendencies. Perhaps some people are "popping pain pills" to relieve intractable pain.

Regardless, I think that if we're going to change combination prescription drugs, then we should also re-evaluate combination OTC products that contain acetaminophen. Otherwise, consumers may get the wrong message. My hope is that we simply improve labeling and public health awareness but that all the products still remain available.

Government panel may pull drugs containing acetaminophen

A government panel assembled by the FDA may make some recommendations to pull some very common medications off the shelf. Acetaminophen (common brand name Tylenol) is a very safe drug that is mainly used to treat pain and fevers. However, an overdose of Tylenol can also be lethal because it can destroy the liver. We can live without our spleen, but we can't live without our liver, so that's why a Tylenol overdose can be fatal. Some people die as they wait for a liver transplant.

According to CNN (quoting the FDA), "overdoses of acetaminophen have been linked to 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths during the 1990s." Of course, we also know that millions of people safely use Tylenol without any problems. The advisory panel could vote to pull over-the-counter drugs that use acetaminophen in combination with other ingredients that treat flu and cold symptoms, allergies or sleeplessness. This includes common drugs like: NyQuil, Pamprin and Allerest. Does this just mean that consumers will learn how to use over-the-counter drugs for off-label purposes? The FDA doesn't have to follow the advisory panel recommendation, so when this is all over, it may all be meaningless.

CNN also reports that the Consumer Healthcare Products Association (CHPA) strongly opposes the elimination of OTC (over-the-counter) acetaminophen containing combination products. Interesting? Click here to read the CNN story.