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  1. News & Events for Human Drugs

CDER Conversation: Safe Use of Medicine Relies on Strong Research

CDER Conversation
Scott Winiecki, MD, Director of FDA’s Safe Use Initiative, Office of Center Director, CDER

Tens of millions of people in the United States depend on prescription and over-the-counter (OTC) medications to feel better and improve or maintain their health. In the U.S., outpatient pharmacies fill more than four billion prescriptions annually. However, the use of medications, including OTC medications, typically involves some risk. FDA’s Safe Use Initiative works to reduce the serious harms that can result from medication use.  For example, some medications to treat patients with diabetes can result in low blood sugar and certain pain medications can lead to misuse and abuse. FDA believes that, in many instances, these risks can be significantly reduced if people committed to the safe use of medications work together.

What is the Safe Use Initiative?

The mission of FDA’s Safe Use Initiative is to create and facilitate collaborations in the public and private sectors of the health care community. The goal of the Safe Use Initiative is to reduce preventable harm by identifying specific medication risks and developing, implementing and evaluating cross-sector interventions with partners who want to improve safe medication use. A big part of our mission is to support research that helps advance the safe use of medicine and reduce preventable harm.

What do you mean by preventable harm?

Preventable harm includes any side effect of a medication that could be reduced or prevented if all available knowledge is considered.  Most people think about dosing errors and drug interactions, but it also includes addressing over-prescribing (for example of pain medication or antibiotics) and identifying situations where safety can be improved through standardization (using checklists to ensure the quality of care). Prescription drug misuse and abuse as well as accidental ingestion in children are also preventable harms. The Safe Use Initiative focuses on this particular aspect of drug safety.

How does research contribute to the safe use of medicine?

As part of the Safe Use Initiative, FDA is committed to reducing preventable harm from drugs by soliciting and funding projects that develop innovative methods to mitigate or reduce risks related to medication use. The studies we fund help us understand, for example, which patients are at the greatest risk of serious side effects and how medicine can be packaged to reduce accidental poisoning in children.  Other research has examined how providing physicians with information about their prescribing compared to their peers can help reduce the use of certain antibiotics when there are more appropriate medicines available. The studies we support can often be put to use in an office or hospital setting, making health care safer for everyone.

Who conducts this kind of safety research?

Safety does not fall under any single profession, medical specialty, age group, or drug class. That is why FDA wants to raise awareness of the Safe Use Initiative to help make sure we don’t miss valuable research to support. Proposals for funding can come from different parts of the health care community, including academia; other government agencies; healthcare professionals; hospitals and pharmacies; patients and consumer organizations; and for-profit companies.

What are some examples of FDA funded research in this area?

The FDA has funded a lot of important research through its Safe Use Initiative.  One project identified best practices in the use of anticoagulants (blood thinners).  These medicines are a frequent cause of emergency room visits, especially for elderly patients.  Experts worked to identify the best ways to care for patients taking these drugs and compiled a “how to” manual.  By using this manual, a clinic can ensure that it is doing everything to provide the highest quality of care for patients taking these medications.

Another research project identified diabetics who are at the greatest risk of falls due to low blood sugar.  By identifying this group (about 1% of diabetic patients), health care providers can work with patients to decrease their risk of falls and reduce the serious and sometimes deadly effects of low blood sugar.

One current project is looking at prescribing pain medications after surgery. Studies show that many patients are prescribed more pills for pain than they actually take.  By understanding how many pills most patients need, the treatment can be standardized. In this way, patients will receive the medicine they need but we can reduce the amount “leftover” that might be misused or accidentally taken by a child. 

More examples of FDA-funded research can be found here: Safe Use Initiative.

Where can researchers get more information to apply for funding?

The FDA has an open announcement under the FDA’s Broad Agency Announcements (FDABAA-19-00123) for the Advanced Research and Development of Regulatory Science. This is a competitive announcement in which research proposals are being solicited from a range of individuals/organizations (e.g., schools of public health/pharmacy students and faculty, other academic researchers, nonprofits, professional associations, etc.) to reduce preventable harm from drugs. 

If you have a research project that you think would be a good fit, we are happy to arrange a call and discuss that idea. Conversations must take place before you submit an official White Paper, which is the first step in your application.

Please contact us at CDERSafeUseInitiative@fda.hhs.gov with questions or for more information.