IMPACT OF FDA DRUG RISK COMMUNICATIONS ON HEALTH CARE UTILIZATION AND HEALTH BEHAVIORS: A SYSTEMATIC REVIEW

Abstract

Objective

To review literature on the impact of 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 sixteen medicines or therapeutic classes; one-third examined communications regarding antidepressants. Most used medical or pharmacy claims and 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 transient and modestly increased 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, though the magnitude of substitution within therapeutic classes varied across clinical contexts.

Conclusions

While some FDA drug risk communications had immediate, strong impacts, many had either delayed or 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.