In a recent review of the international literature of the formulary decision-making process at the hospital level, Ouachi et al. concluded that there is a lack of standardized procedures or methods for decision making 
. Given this gap and the important role of the local and national formularies in promoting rational prescribing and aiding prescribers, institutions, and insurers in evaluating drugs, particularly new drugs, there is a need to explicitly and systematically pose critical questions that often fail to be asked or addressed in claims for new drugs 
The tool frames questions in such a way as to look for evidence of benefit and safety before placing drugs on the formulary, shifting the burden of proof onto those who would advocate placing a drug on the formulary, rather than the default assumption that, unless there is a reason to the contrary, all licensed drugs should be included. This assumption embodies the precepts of essential medicines as well principles of conservative and cost-effective prescribing 
. The questions based on these principles assume that, lacking evidence of superior safety, efficacy, or other comparative benefit, we ought not to be exposing patients or promoting and paying for expensive new drugs whose risks are poorly understood 
Some might object to this shifting of the burden of proof onto proponents of adding drugs, arguing that it represents a bias against newer drugs and their manufacturers. However, it seems appropriate to shift this responsibility to those who develop and market new drugs because they are ethically and legally charged with producing evidence of their product's safety and effectiveness. Pharmaceutical manufacturers increasingly recognize this responsibility to more rigorously address these questions, and thus should welcome more clearly defined and standardized approaches.
We acknowledge that underutilization of appropriate medications is also a problem 
. However, many underutilized drugs are generic drugs that have already found a place on the formulary. Further, formularies are primarily responsible for ensuring that needed drugs are made available, not necessarily that their use is promoted. Rather the tool is designed to support a critical function of the formulary—to serve as counterweight—balancing other forces that tend to promote more liberal use of drugs (e.g., advertising, patient demands, time pressure, inability of clinicians to have the time and expertise to critically review claims).
The tool has not been systematically evaluated to determine the impact of its deployment on decision-making processes, committee decisions, or clinical outcomes. While some data exist demonstrating that effective formularies can restrain costs 
, there are few high quality studies demonstrating the ways formularies actually improve clinical outcomes—studies sorely needed given how many lives and potentially adverse outcomes (either caused or prevented) are at stake. Box 2
lists key questions that such studies, particularly as they pertain to this tool, will need to address. The Academy of Managed Care Pharmacy has adopted an earlier version of our checklist as an appendix to version 3.0 of the AMCP Format for Formulary Submissions—the standard template that managed care organizations use to request information from manufacturers about products being considered by formulary committees. AMCP's adoption of the tool suggests that one influential US organization finds the tool to be potentially useful for its members, a limited but influential subset of the target audience for this tool 
Box 2. Evaluating and Sharpening the Formulary Decision-Making Tool: Questions to Further Validate and Evaluate This Tool
Are the questions clear, reliably interpreted by members?
How easily can checklist be deployed by the Committee?
Is it feasible to address these questions (versus insufficient information, time)?
Are these the high priority questions for the formulary committee (in general, for that particular committee)?
Are there important domains/questions overlooked?
Does it include unnecessary or less relevant questions?
How does the tool impact decision-making process and outcomes?
In what ways does it help guide meeting discussions?
What is its impact on committee decisions, patient outcomes, costs?
Educational value and user satisfaction
Is it serving a useful educational purpose (orientating new members, others)?
Do committee members like it and find it helpful?
Broader (more indirect and speculative) impacts
Does the tool enhance committee transparency, credibility, status/recruitment of members?
Does it promote higher quality of monographs, materials prepared/distributed?
Will it lead to more standardized drug lists across settings?
Does it promote better support for formulary processes; lead to more regional/centralized formulary committees?
Impacts on industry—does it help create clearer expectations, raise bar for stimulating better information, better studies, or even better drugs?
Is use of the tool too costly, requiring excessive staff time to prepare/address?
Does it lead to keeping drugs off formulary that are later proven highly valuable (i.e., does it make the formulary overly restrictive)?
Might its rigor and promotion of a stricter formulary antagonize clinicians, negatively impacting buy-in for formulary/decisions?
Our tool was found to be useful in two US public hospital formularies. While not representative of all settings and uses, one hospital employs a formulary that is more common in the US (overseeing only the inpatient formulary), while the other operates more on a “single payer” fixed budget and oversees both inpatient and outpatient drugs. Thus its applicability appears to be reasonably broad. Here, we offer the tool for a broader audience to use and test. We hope that it will prove useful in improving the quality of formulary decision making and stimulating debate related to critical questions that need to be asked, highlighting essential data needed to more safely prescribe drugs. As a guide to posing critical questions related to drugs being adopted, it represents a starting point, for both local formulary committees and national policymakers to use in their evaluations of new drugs for formulary inclusion as well as to further evaluate, test, and refine.