FDA's Safe Use Initiative to address preventable harm due to medication misuse, errors, and other related problems

Towards the end of 2009, FDA launched a new medication safety initiative.

Key Points

Towards the end of 2009, FDA launched a new medication safety initiative. This initiative, now referred to as the 'FDA's Safe Use Initiative - Collaboration to Reduce Preventable Harm from Medications' aims to create and facilitate public and private collaborations within the healthcare system to reduce preventable harm associated with medication misuse, errors, and other medication-related problems.

Through this initiative, FDA hopes to improve upon many of the approaches currently used to manage medication risks in the United States, many of which were put in place over the last century as reactionary measures to specific needs or emergencies.

"Too many people suffer unnecessary injuries from avoidable medication misuse, errors and other problems," said FDA Commissioner Margaret A. Hamburg, MD.


Specifically, the initiative plans to unite federal agencies such as FDA, Agency for Health Care Research and Quality (AHRQ), the Centers for Disease Control (CDC), and the Drug Enforcement Agency (DEA), together with healthcare professionals and professional societies, pharmacies, hospitals, and other healthcare entities, drug developers, manufacturers and distributors, as well as, patients, caregivers, consumers, and their representative organizations in order to manage medication risk in the United States.

"Only through coordinated interventions across all sectors of the healthcare system can we substantially reduce preventable injuries from using medications. All participants in the healthcare community have a role to play in reducing the risks and preventing injuries from medication use." said Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research.

At present, many millions of Americans require prescription and/or OTC medications to improve or preserve their health; with as many as 3 billion prescriptions written yearly. As a result of this vast use of medications, it is estimated that at least one and one-half million preventable adverse drug events occur within the healthcare system annually; resulting in hundreds of thousands of injuries and deaths.

Adverse events from medication use have been linked to more than 4 million visits to emergency departments, healthcare provider's offices, or other outpatient settings annually and greater than 100,000 hospitalizations each year.

According to FDA officials, "Many injuries associated with medication use could be prevented with currently available knowledge."

In fact, current estimates suggest anywhere from 11% to 50% of injuries, depending on the population or setting studied and terminology used, may be preventable.


During the initiative's first year, FDA said it plans to implement a small number of medication safety programs.

Some key interventions highlighted by FDA include, evaluating consumer medication information, communicating about the risk of inadvertent overexposure to acetaminophen, implementing safeguards against fires during surgical procedures caused by alcohol-based surgical preperations, and avoiding contamination of multiple use medication vials.

Furthermore, FDA officials said that the agency intends to collaborate with all members of the healthcare system by holding a series of public meetings to gather feedback as they continue to try and identify the most serious medication-related safety issues and strategies to prevent them.


FDA's Safe Use Initiative – Collaboration to Reduce Preventable Harm from Medicines. Available at: http://books.nap.edu/openbook.php?record_id=11623&page=R1. Accessed November 12, 2009.

Institute of Medicine of the National Academies, Preventing Medication Errors', National Academies Press, 2007. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188961.pdf. Accessed November 12, 2009.