Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS)

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Grant Final Report Grant ID: R18 HS 017045 Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS) Inclusive dates: 12/01/07 - 09/30/10 Principal Investigator: Lazarus, Ross, MBBS, MPH, MMed, GDCompSci Team members: Michael Klompas, MD, MPH Performing Organization: Harvard Pilgrim Health Care, Inc. Project Officer: Steve Bernstein Submitted to: The Agency for Healthcare Research and Quality (AHRQ) U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov 2 Key Words: electronic health records, vaccinations, adverse event reporting The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services of a particular drug, device, test, treatment, or other clinical service. 3 Final Report Purpose This research project was funded to improve the quality of vaccination programs by improving the quality of physician adverse vaccine event detection and reporting to the national Vaccine Adverse Event Reporting System (VAERS), via the following aims:

Aim 1. Identify required data elements, and develop systems to monitor ambulatory care electronic medical records for adverse events following vaccine administration.

Aim 2. Prepare, and securely submit clinician approved, electronic reports to the national Vaccine Adverse Event Reporting System (VAERS).

Aim 3. Comprehensively evaluate ESP:VAERS performance in a randomized trial, and in comparison to existing VAERS and Vaccine Safety Datalink data.

Aim 4. Distribute documentation and application software developed and refined in Aims 1 and 2 that are portable to other ambulatory care settings and to other EMR systems. 

Preliminary data were collected from June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these doses, 35,570 possible reactions (2.6 percent of vaccinations) were identified. This is an average of 890 possible events, an average of 1.3 events per clinician, per month. These data were presented at the 2009 AMIA conference. In addition, ESP:VAERS investigators participated on a panel to explore the perspective of clinicians, electronic health record (EHR) vendors, the pharmaceutical industry, and the FDA towards systems that use proactive, automated adverse event reporting. Adverse events from drugs and vaccines are common, but underreported. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA). Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed. Barriers to reporting include a lack of clinician awareness, uncertainty about when and what to report, as well as the burdens of reporting: reporting is not part of clinicians’ usual workflow, takes time, and is duplicative. Proactive, spontaneous, automated adverse event reporting imbedded within EHRs and other information systems has the potential to speed the identification of problems with new drugs and more careful quantification of the risks of older drugs. Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation.