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2007 HSR&D National Meeting Abstract

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National Meeting 2007

1010 — Augmenting FDA and Pharmaceutical Manufacturer Passive Pharmacovigilance Efforts: Potential Benefit of Collaboration with VA Pharmacovigilance Program

Bennett CL (Chicago VA, Northwestern University) , Angelotta C (Chicago VA, Northwestern University), Nebeker JR (VA Salt Lake City Health Care System), Dorr DA (Oregon Health & Science University ), Tigue CC (VA Chicago, Northwestern University), Raisch DW (VA Cooperative Studies Program, Albuquerque)

The Food and Drug Administration (FDA) and pharmaceutical suppliers are responsible for the majority of post-marketing pharmaceutical safety investigations. These efforts are based on “data-mining” analyses of large databases. Between 1998 and 2006, VA investigators associated with the Research on Adverse Drug events And Reports (RADAR) project conducted active pharmacovigilance efforts and identified several cases of novel and potentially serious adverse drug reactions (ADRs). We sought to determine if and how existing passive pharmacovigilance systems can be augmented by active pharmacovigilance.

We reviewed databases associated with serious ADRs previously reported by the RADAR project. We compared the completeness of adverse event descriptions contained in FDA versus RADAR databases and the completeness and timing of summary safety reports disseminated by pharmaceutical suppliers versus RADAR.

Between 1998 and 2006, RADAR investigators identified 11 serious ADRs associated with 15 drugs. Compared to clinical descriptions contained in FDA databases (n=2,296), adverse event reports in RADAR databases (n=472) had two-fold higher rates of inclusion of information on history and physical examination findings (91% versus 45%) and eight-fold higher rates of inclusion of basic science correlative study findings (31% versus 4%). Safety notifications were disseminated a median of two years earlier by pharmaceutical suppliers (two versus four years after FDA approval, respectively), although these reports were markedly less likely to include information on exposure-adjusted incidence (50% versus 92%), patient outcomes (9% versus 100%), suggestions for treatment or prophylaxis (17% versus 92%), and references (0% versus 77%).

Individual case descriptions were more complete in RADAR versus FDA databases. Clinical information contained in actively obtained RADAR databases was of higher quality, but lower quantity, than that contained in passively obtained FDA databases. Safety notifications from RADAR were more complete than those from pharmaceutical suppliers, but were less timely.

Active pharmacovigilance efforts can augment existing passive pharmacovigilance efforts of the FDA and pharmaceutical manufacturers and improve VA patient safety. Collaborations should be developed building on the strengths of independent organizations that conduct active pharmacovigilance efforts and passive pharmacovigilance efforts of the FDA and pharmaceutical manufacturers.

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