Today, tens of millions of people in the United States depend on prescription and over‐the‐counter (OTC) medications to sustain their health—as many as 3 billion prescriptions are written annually. Too many people, however, suffer unnecessary injuries, even death, as a result of preventable medication errors or misuse.
The approaches used today for managing medication risks in the United States were put in place over the last century, often in a piecemeal fashion and usually in response to various crises and specific needs. Although FDA and many other stakeholders have been working to improve how the healthcare system manages medication risks in the United States, it is widely recognized that more needs to be done to protect the public from preventable harm from medication use. All participants in the healthcare community at large—patients, consumers, caretakers, healthcare practitioners, pharmacists, healthcare systems, health insurers, drug manufacturers, FDA, and other Federal agencies—have a role to play in managing medication risks and reducing preventable harm from medication. We believe that much preventable harm from medications results from problems that can be addressed best in a more coordinated, systematic manner, with interventions across all sectors of the medication distribution and use system.Medicine safety
FDA’s Safe Use Initiative contained in the report (Click on the link at the end for a PDF version on the report). Through this initiative, FDA seeks to partner and collaborate with relevant stakeholders to measurably reduce preventable harm from medications, thereby improving patient health. FDA proposes to identify, using a transparent and collaborative process, specific candidate cases (e.g., drugs, drug classes, and/or therapeutic situations) that are associated with significant amounts of preventable harm. Cases will be carefully analyzed for their potential for coordinated FDA/stakeholder actions to better manage related risks and reduce harm. If the analysis suggests a potential benefit from an intervention, FDA and its interested partners will develop appropriate activities and evaluation metrics. In the months ahead, FDA intends to:
• Develop a general list of candidate cases for collaborative analysis and intervention. The list will be developed through extensive consultation with all interested public and private stakeholders and may include one or more of the existing opportunities listed in the Proposal section of this report.Through a coordinated effort, involving all interested stakeholders, we can work to minimize the risks associated with using medications and reduce preventable harm.
• Collaborate with Federal partners to develop population‐based national estimates of preventable harm from medications, categorized by drug, drug classes, and therapeutic situations.
• Open a public docket to receive suggestions and comments related to this report, risk management issues, and proposed candidate cases.
• Hold a series of meetings to gather broad public feedback as the candidate list is being developed.
• Based on the public contribution just outlined and the best available population‐based data, work with interested partners to select specific candidate cases for analysis, intervention proposals, and evaluation metrics.
• During the Initiative’s first 12 months, implement a small number of interventions. Each intervention will have an explicit plan for measuring impact. Interventions may involve FDA regulatory actions in concert with actions by other stakeholders.
FDA's (Food and Drug Administration) Safe Use Initiative