The formulary process from a risk management perspective.

During their evolution over the past 6 decades, hospital formularies have become more than a list of drugs that an institution keeps in stock. Today, an agent under formulary consideration must be examined not only in light of its relative efficacy, safety, and acquisition cost, but consideration must also be given to the potential indirect costs that accompany its use. Federal regulations have, for some drugs, added layers of administrative actions that must be followed to ensure their appropriate use. Examples of this are risk evaluation and mitigation strategies (REMS) and duties that may be implied or expressly addressed in the black-box warnings associated with some classes of agents and, in isolated instances, specific drugs within a given class. Regulatory interpretation of these programs and warnings has often led to the expectation that the institution providing the agent will implement effective protocols and procedures to minimize the risk of adverse events to a patient in addition to or in accordance with required programs such as REMS. The consequences for failing to meet this expectation can lead to regulatory sanctions; the potential also exists for liability exposure. Risk management principles apply to all levels of the decision-making process for evaluating a new agent for formulary inclusion or when reevaluating an agent's formulary status. Pharmacists play an important role in mitigating these risks by carefully evaluating every agent from a broader perspective.