Safe Use Initiative: Opportunities for Collaboration

A sampling of drugs, drug classes or therapeutic areas that could benefit from stakeholder collaboration

 

Long-acting beta agonists (LABA)
Some patients who take long-acting beta agonists (LABAs) for asthma experience exacerbations of asthma symptoms, which can result in hospitalizations and death. On June 2, 2010, FDA announced revisions to the prescribing information for LABA labels to improve their safety. Under the Safe Use Initiative, FDA is interested in developing partnerships within healthcare delivery systems to explore ways to identify and improve suboptimal LABA prescribing and use practices.

 

Pain medications for patients over 65
Pain is a very prevalent condition in older adults. Without proper management, patients may be undertreated or they may use pain medications inappropriately. FDA’s Safe Use Initiative will address barriers to the safe use of pain medications and strategies for potential interventions. We will bring together experts in geriatric care, pain management, and medication safety and representatives of healthcare delivery systems—public and private—to discuss these issues.

 

Extended release/Long-acting (ER/LA) opioids
Extended release/long-acting opioids are widely prescribed analgesics for specific types of pain. Despite previous efforts to mitigate the risks, their misuse and serious adverse outcomes continue to increase. FDA will require manufacturers of ER/LA opioids to develop Risk Evaluation and Mitigation Strategies (REMS) as one way to mitigate the risks associated with these drugs. FDA is exploring additional voluntary, partnership activities as part of the Safe Use Initiative that can extend beyond the REMS.

 

Acetaminophen toxicity
Acetaminophen, used for treating pain and fever, is an active ingredient in over 600 prescription and over-the-counter medications. Daily dosing in excess of the recommended maximum labeled dose has been associated with serious liver injury and death. Despite efforts (since the early 1990s) to reduce acetaminophen-related liver injury, acetaminophen overdose remains the most common cause of drug-induced liver injury leading to liver transplant in the United States. FDA held an advisory committee meeting in June 2009 to seek input on mitigating the risks of acetaminophen overdose. Since that meeting, FDA has an ongoing public education campaign, is participating in education coalitions and is considering new regulatory actions. Additional collaborations with healthcare stakeholder groups as part of the Safe Use Initiative can strengthen and amplify communication and education and be the springboard for alternate strategies to help decrease unintentional overdose.

 

Alcohol-based surgical preps and operating room fires
An estimated 100 to 600 fires occur per year in surgical settings.¹Ã‚ Although this number is small, a surgical fire can have serious consequences, as it may result in serious burns and even death. FDA-regulated products are implicated in surgical fires, including alcohol-based preps, electrocautery devices, and supplemental oxygen. Surgical fires are entirely preventable if operating suite personnel and the surgical team develop and follow certain procedures. As part of Safe Use, collaborations with relevant stakeholders — from oversight groups to direct patient care staff — can identify and implement activities to further reduce the occurrence of surgical fires.