Safe Use of Drugs Requires Reports From Clinicians

Karen Weiss, MD, MPH

February 17, 2011

Editorial Collaboration

Medscape &

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Hello. I am Dr. Karen Weiss, Program Director for the US Food and Drug Administration's (FDA's) Safe Use Initiative in the Center for Drug Evaluation and Research. I am pleased to be here today as part of the FDA's Expert Commentary Series on Medscape to talk about the Safe Use Initiative. Our program's mission is to collaborate with others in healthcare to reduce preventable harm from medications, which is a significant public health problem.

Although precise figures are difficult to determine, studies suggest up to 50% of the harm from medications is preventable, which translates into about 1.5 million preventable adverse drug events each year.

The Safe Use Initiative complements FDA's more traditional regulatory activities, which include drug approval, postmarket surveillance, and those recently authorized by Congress to require drug manufacturers to develop Risk Evaluation and Mitigation Strategies (REMS) to enhance safety.

Drugs have to be used correctly. If not, there is the potential for causing harm. The goal of the Safe Use Initiative is to reduce this preventable harm.

Since launching the Safe Use Initiative, FDA has met with healthcare providers and other stakeholders to discuss safety issues. These meetings have been very fruitful, but we need to hear more about safety issues from all parts of healthcare. We want to know what safety issues you encounter, to determine how the Safe Use program can help. We have opened a docket to receive suggestions on potential Safe Use topics. Information about how to access the docket is on our Website at We invite your comments and suggestions, so that we can learn more about how harm occurs and what interventions will help.

While we continue to gather input, the Safe Use team has already started work on specific projects, which are described on our Website. For instance, earlier this year, FDA asked manufacturers to reduce the amount of acetaminophen in combination prescription pain medications to 325 mg per tablet or capsule. This is intended to reduce the incidence of acetaminophen-induced liver injury. There is a related issue. When a patient picks up his or her prescription acetaminophen medicine from the pharmacy, the label attached to the bottle often abbreviates acetaminophen as "APAP." If a patient does not know "APAP" and "acetaminophen" are the same, they could take a prescription and over-the-counter acetaminophen product at the same time and unintentionally overdose. The Safe Use staff is working with pharmacy, processing software, and compendium organizations to bring about the changes necessary to replace "APAP" with "acetaminophen" on these prescription products.

In conclusion, through a coordinated effort involving all interested stakeholders, we can work to minimize risks associated with using medications and reduce preventable harm. We need your assistance in this effort, and we encourage you to participate by providing input on our Website. Thank you.


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