Objective: To review literature on the impact of The Food and Drug Administration (FDA) drug risk communications on medication utilization, health care services use, and health outcomes.
Data Sources: The authors searched MEDLINE and the Web of Science for manuscripts published between January 1990 and November 2010 that included terms related to drug utilization, the FDA, and advisories or warnings. We manually searched bibliographies and works citing selected articles and consulted with experts to guide study selection.
Study Selection: Studies were included if they involved an empirical analysis evaluating the impact of an FDA risk communication.
Data Extraction: We extracted the drug(s) analyzed, relevant FDA communication(s), data source, analytical method, and main outcome(s) assessed.
Results: Of the 1432 records screened, 49 studies were included. These studies covered 16 medicines or therapeutic classes; one third examined communications regarding antidepressants. Most used medical or pharmacy claims and a few rigorously examined patient-provider communication, decision making, or risk perceptions. Advisories recommending increased clinical or laboratory monitoring generally led to decreased drug use, but only modest, short-term increases in monitoring. Communications targeting specific subpopulations often spilled over to other groups. Repeated or sequential advisories tended to have larger but delayed effects and decreased incident more than prevalent use. Drug-specific warnings were associated with particularly large decreases in utilization, although the magnitude of substitution within therapeutic classes varied across clinical contexts.
Conclusions: Although some FDA drug risk communications had immediate and strong impacts, many had either delayed or had no impact on health care utilization or health behaviors. These data demonstrate the complexity of using risk communication to improve the quality and safety of prescription drug use, and suggest the importance of continued assessments of the effect of future advisories and label changes. Identifying factors that are associated with rapid and sustained responses to risk communications will be important for informing future risk communication efforts.
*Department of Health Care Policy, Harvard Medical School, Boston, MA
†Department of Medicine, University of Chicago Hospitals, Chicago, IL
‡Department of Neurology, Johns Hopkins Medicine, Baltimore, MD
§Center for Health and the Social Sciences, University of Chicago
∥Department of Pediatrics, University of Chicago Hospitals, Chicago
¶Department of Pediatrics, NorthShore University Health System, Evanston
#Department of Pharmacy Practice, University of Illinois at Chicago School of Pharmacy, Chicago, IL
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S.B.D. and A.S.H. are both co-first authors.
Supported by the Agency for Healthcare Research and Quality (RO1 HS0189960) and the University of Chicago Clinical and Translational Science Award. S.B.D. was supported by grant T32MH019733-17, E.R.D. was supported by the Robert Wood Johnson Physician Faculty Scholars Program and H.A.H. was supported by a Robert Wood Johnson Foundation Investigator Award in Health Policy Research. The funding sources had no role in the design and conduct of the study; collection, management, analysis, or interpretation of the data; and preparation, review, or approval of the manuscript for publication.
Dr Alexander has served as an ad hoc member of the FDA Drug Safety and Risk Management Advisory Committee and is a consultant for IMS Health. There are no other disclosures to report.
Reprints: G. Caleb Alexander, MD, MS, Center for Health and the Social Sciences, The University of Chicago, 5841S. Maryland, MC 2007, Chicago, IL 60637. E-mail: firstname.lastname@example.org.