FDA Draft National Adverse Event Plan

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Adverse drug events (ADEs) have been defined as an injury resulting from medical intervention related to a drug. ADEs can occur in any health care setting, including inpatient (for example, acute care hospitals), outpatient, and long-term care settings (for example, nursing homes).

Given the U.S. population’s large and ever-increasing magnitude of medication exposure, the potential for harms from ADEs constitutes a critical patient safety and public health challenge. 

  • Inpatient settings: ADEs comprise an estimated one-third of all hospital adverse events, affect approximately two million hospital stays annually, and prolong hospital length of stay by approximately 1.7 to 4.6 days. 
  • Outpatient settings: ADEs account for over 3.5 million physician office visits, an estimated one million emergency department visits, and approximately 125,000 hospital admissions each year.

As a result of increased attention to reduce and prevent the dangers associated with adverse drug events, the U.S. Department of Health & Human Services (HHS), in partnership with the U.S. Department of Defense, U.S. Department of Veterans Affairs, and the U.S. Bureau of Prisons has developed the National Action Plan for Adverse Drug Event Prevention.

The draft National Action Plan for Adverse Drug Event (ADE) Prevention seeks to engage all stakeholders in coordinated, aligned, multisector, and health literate effort to reduce ADEs that are the most common, clinically significant, preventable, and measurable. The draft National Action Plan for ADE Prevention has two key objectives: 

  • Identify common, clinically significant, preventable, and measurable ADEs. 
  • Align the efforts of federal health agencies to reduce patient harms from these specific ADEs nationally. 

Based on national ADE data from inpatient and outpatient settings, three types of ADEs were considered to be common, clinically significant, preventable, and measureable, and therefore selected as the high-priority targets of this Action Plan: anticoagulants, diabetes agents, and opioids

The draft Action Plan suggests a four-pronged approach to reduce patient harms from these three ADEs:

  1. Surveillance,
  2. Prevention,
  3. Incentives and Oversight, and
  4. Research.

The draft Action Plan identifies the federal government’s highest priority strategies and opportunities for advancement that will have the greatest impact on reducing ADEs. The implementation of these strategies is expected to result in safer and higher quality health care services, reduced health care costs, informed and engaged consumers, and, ultimately, improved health outcomes. 

The draft Action Plan provides federal agencies and external stakeholders with a framework to identify strategies and select specific actions to take. The intended endusers of the draft Action Plan are policymakers, health care professionals, public and private sector organizations, and communities who can organize and take action towards preventing highpriority ADEs.

The draft Action Plan should serve as a catalyst to promote leaders at the federal, state, and local levels to implement evidence-based guidelines and engage in strategies that will help to advance the goals of the draft Action Plan. 

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