Pharmacoeconomics: an emerging discipline.

The economic pressures of cost containment, pricing competition, and managed care have bootstrapped the application of health economic evaluation into the specialized area of pharmacoeconomics. The rapid development of the field has lead to criticism within the discipline and skepticism from consumers of pharmacoeconomic studies. The need for consensus upon standards of design and analysis will result in guidelines and more stringent peer review. The relative merits of current approaches are reviewed with respect to the limitations and generalizability of each type of study and common pitfalls in the design, analysis, and promotion of pharmacoeconomic studies. Future trends and regulatory issues are discussed. Finally, the role of pharmacoeconomics in drug development and marketing is evaluated.