FDA Safe Use Initiative: Safe Only When Taken as Directed

FDA Safe Use Initiative: Safe Only When Taken as Directed
FDA Safe Use Initiative: Safe Only When Taken as Directed

Taking a drug incorrectly can lead to preventable harm. But the FDA and other stakeholders aim to minimize that through the Safe Use Initiative.

You would never do it on purpose, but it happens all too often. Taking a drug in the wrong amount, confusing one drug for another, or taking a drug for too long a time are caused by human error and are called “preventable harms.” The FDA has created the Safe Use Initiative to educate the public about these problems and how to avoid them.

Examples of preventable harm are cases such as Tylenol (acetaminophen) given to children leading to serious adverse events such as liver damage and even death. Why? Parents accidentally gave infants a teaspoon of a highly concentrated formulation of the drug – the dosage for a less concentrated version for older kids – rather than a much smaller amount. Or the parent gave the second dose too soon because of misreading the instructions or simple parent fatigue.

Preventable adverse events are a serious problem in the United States. The National Academy of Medicine estimates at least 1.5 million such events occur each year.

The FDA is working with researchers, doctors, consumer groups and other interested stakeholders to try to minimize these preventable events in the future. Research projects are underway to further this mission with projects such as creating a tool that helps identify who might be at risk of long-term opioid use following orthopedic surgery. Another project is to refine the best practices for the use of pediatric cough and cold medicines (examining different language in the labeling instructions, for example).

One Program is Aiming to Improve the Labeling of Prescription Medications

And speaking of acetaminophen, one program is aiming to improve the labeling of prescription medications that contain the pain medication to prevent potential overdoses. While OTC drugs have to list all of their active ingredients, the label on a prescription bottle may not clearly indicate that the medication contains acetaminophen.

On June 15, the FDA will hold a one-day public meeting at its headquarters in suburban Washington, DC, to discuss reducing preventable harms with guest speakers and stakeholders, including members of federal agencies and patient advocacy groups as well as representatives from health insurers and members. If you’re not in the Washington area, you can still view the symposium as it will be webcast.

The meeting is a step in the right direction. Here’s hoping many more ideas will come out of it so preventable harms are minimized.

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