Kelly Nichole Weidenbach, BSc¹, Daniel S. Budnitz, MD, MPH¹, Aaron B Mendelsohn, PhD, MPH², Joseph L. Annest, PhD³, and Thomas J Schroeder, MS⁴. (1) National Center for Injury Prevention and Control, Division of Injury and Disability Outcomes and Programs, CDC, 4770 Buford Highway, NE MS-F41, Atlanta, GA 30341, (770) 488-4230, kyw8@cdc.gov, (2) Office of Drug Safety, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20817, (3) National Center for Injury Prevention and Control, Office of Statisitcs and Programming, CDC, 4770 Buford Highway, NE MS-K59, Atlanta, GA 30341, (4) United States Consumer Product Safety Comission, 4330 East West Highway, Bethesda, MD 20814

Adverse drug events (ADEs) occur when therapeutic drugs (medications, vaccines, and nutritional supplements) have injurious rather than salutary effects. Up to 106,000 deaths occur each year due to ADEs, making it the fifth leading cause of death in the United States. While much national attention has focused on ADEs that occur in hospitalized patients, little attention has been paid to the more common problem of ADEs that occur in non-hospitalized persons. A nationally representative surveillance system for ADEs that occur outside of the in-patient hospital setting is needed to quantify the burden of injury from these outpatient ADEs and guide intervention and prevention efforts. The CDC, CPSC, and FDA collaborated to create National Electronic Injury Surveillance System – Cooperative Adverse Drug Event Surveillance (NEISS-CADES). NEISS-CADES is based upon the National Electronic Injury Surveillance System–All Injury Program (NEISS-AIP), an ongoing, active, population-based surveillance system for all injuries, including ADEs, treated in hospital emergency departments (EDs). To increase the detail of ADE reporting in NEISS-AIP, we incorporated key elements of the FDA’s MedWatch 3500/3500A form into data collection in NEISS-AIP. We will describe the operation of NEISS-CADES and present an assessment of the system based upon principles of the 2001 CDC guidelines for evaluating public health surveillance systems. Initial results from the first year of data collection will also be presented.NEISS-CADES demonstrates three public health agencies sharing public health expertise and leveraging existing resources to develop the first active, population-based surveillance system for outpatient ADEs in the United States.

Learning Objectives:

• 1)Recognize the significance of establishing an active, on-going surveillance system to monitor ADEs
• 2)Describe the burden of out-of-hospital ADEs
• 3)Understand the strengths and limitations NEISS-CADES for ADE surveillance

Keywords: Drug Safety, Injury Control

Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.