Formulary decisions: then and now.

An institution's formulary is a constantly evolving entity with a myriad of considerations that must be taken into account when any agent or chemical entity is being evaluated for formulary inclusion or is under review to continue as a therapeutic option. Originally a simple list of available agents, the formulary has developed into a required part of the hospital's administrative structure and an authoritative source for cost-effective management of drug use within the institution. In recent years, closer evaluations of internal processes surrounding drugs with black-box warnings, safety protocols, and the development of programs such as the risk evaluation and mitigation strategies (REMS) have added to the costs of using some therapeutic agents. Whether it is regulatory agencies levying fines for inappropriate use of a drug, the cost of compliance with various therapeutic protocols within an institution, or the costs of adhering to the requirements of REMS, formulary choices have a much greater impact on an institution's budget now than they did in the recent past. In the future, one may also see reduced or denied payments under increasingly recognized "never events," should they be applied specifically to a given drug or class of drugs. Forward-looking pharmacists must accept the challenge of making thoughtful formulary decisions within this complex milieu that extends well beyond assessment of cost-effectiveness focused on therapeutic efficacy and acquisition costs.