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Safe Use Initiative: Preventing Harm from Medicines

Medicines are powerful. They can cure disease, relieve symptoms, and help you stay healthy. But they can also do a lot of damage if taken incorrectly, when not needed, or when prescribed inappropriately.

The Food and Drug Administration (FDA) believes that many medication-related risks can be prevented if everyone committed to the safe use of medicines works together. Acting on that belief, the agency launched the Safe Use Initiative in November 2009 to foster collaborations within the health care community that will help prevent medication errors, misuse, and abuse.

Studies estimate that up to 50 percent of harm from medication use could be prevented. According to the Institute of Medicine, this would translate into about 1.5 million preventable incidents each year.

The goal of the Safe Use Initiative is to

  • identify specific, preventable harm related to medication use
  • develop methods (interventions or strategies) to reduce harm
  • identify ways to measure the success of these interventions

Tens of millions of people in the U.S. take prescription or over-the-counter (non-prescription) medicines each year, says Karen Weiss, M.D., director of the Safe Use Initiative. “If we can reduce injury that occurs because people are not prescribing or taking medications optimally, we can improve their individual health and the health of the public.”

Working Together

In its regulatory role, FDA has always tried to prevent medication errors, says Weiss. “A lot of what we do at FDA to reduce medication errors is because we have the authority from Congress to regulate drugs, drug labeling, and drug manufacturing standards.”

But the Safe Use Initiative is different, says Weiss, because it involves collaborations with other parts of the health care industry and professions—besides drug manufacturers and distributors—to reduce harm in ways that do not require regulation. Potential collaborators include

  • physicians, nurses, and other health care professionals and their professional societies
  • state and federal agencies
  • pharmacies, hospitals, and other health care facilities
  • health insurers
  • patients, caregivers, consumers, and groups representing their interests


FDA continues to add opportunities for collaboration to its growing list of projects that could reduce preventable harm from medicines. Two such opportunities are

  • to support and assist in the removal of abbreviations on prescription container labels
  • to support efforts to educate patients about the misuse and abuse of prescription drugs

Although FDA regulates prescription drug labeling—the printed material that accompanies such drugs—individual states regulate the label that the pharmacist attaches to the pill bottle. FDA is working with pharmacies, medical standards organizations, and others to set standards for this bottle label, such as spelling out the full name of a prescription drug instead of using an abbreviation that consumers may not understand.

For example, the prescription form of acetaminophen is often abbreviated “APAP” on the label of the bottle the consumer is given at the pharmacy. If consumers don’t know that “APAP” and “acetaminophen” are the same and are already taking an over-the-counter acetaminophen product (such as Tylenol or another brand), they could be taking too much acetaminophen and accidentally overdose. Too much acetaminophen can cause liver damage.

The Safe Use Initiative team is also working to make consumers aware of the importance of checking drug labels in general because many have the same ingredient—like acetaminophen, which can be found in more than 600 medications.

Another Safe Use Initiative project addresses the taking of prescription drugs when not needed. “About 55 percent of people who misuse or abuse prescription drugs get them from friends and family,” says Dale Slavin, Ph.D., associate director of the Safe Use Initiative.

“We need to create opportunities for discussion between the patient and the doctor,” Slavin says. “We, through collaborative efforts, want to provide tools that the doctor can use to have frank conversations with patients, and tools that the patient can use to understand the benefits, risks, and limitations of their treatment.”

This is especially important for opioid drugs, says Slavin, “where the abuse potential is there, the dependence potential is there, and the potential for others to steal or misuse their drugs is there.”

FDA invites comments and suggestions on drug safety issues and how to prevent harm at

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Posted June 29, 2011

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