The pharmaceutical analogy for simulation: a policy perspective.

David M. Gaba, MD In this issue of Simulation in Healthcare, Dr. Matt Weinger provides a provocative conceptual piece that analyses simulation as if it were a drug. The principles of pharmacokinetics (what the body does to the drug) and pharmacodynamics (what the drug does to the body) are used as analogies to consider how to think about the impact that different kinds of simulation activities have on individual learners and learner populations. This thoughtful piece provides much food for thought. It is complemented by an editorial by Dr. David Cook that provides a cogent examination of the implications of this analogy for the practice of simulation and research concerning simulation techniques and their affects on learners. Dr. Weinger’s inventive article and Dr. Cook’s editorial are collectively a significant advance in our conceptualization of simulation as an intervention. I like to expand a little bit on the thread of thought that they have initiated. Over the last few years, I have been speaking about issues at the level of public policy for which the comparison of the simulation endeavor to the pharmaceutical endeavor has been important. This analysis is quite complementary to the outstanding points raised by Drs. Weinger and Cook. In general, at the policy level in the United States, the handling of drugs as interventions is quite different from the handling of simulation as interventions. First, there is a national organization [the Food and Drug Administration (FDA)] that is charged by law with regulating the approval of pharmaceuticals (and devices) for use in patient care. For the most part, no “drug” can be sold to patients in the United States unless it has been approved by the FDA as safe and effective (this neglects a small minority of situations where patients obtain non-FDA-approved drugs from other countries). Testing for safety and efficacy is the responsibility of the manufacturer, whose compiled data (from their own studies and those published by others) are presented for scrutiny by the agency. There is of course no comparable regulation or regulatory agency for simulation as an intervention. Its relative safety has not been seriously challenged, although we all recognize that it is a powerful tool that can trigger unpleasant reactions, and possibly long-term side effects, in a handful of participants. The efficacy of simulation has been left to the marketplace of ideas, curricula, programs, and products to decide. Those of us who have been pioneers of simulation might consider ourselves lucky that we did not encounter regulatory barriers that might have stifled innovation in the development of simulation devices and techniques over the last 20 years. However, the regulatory structure for “Big Pharma” (as it is often called) has created structural requirements and incentives for them to fund and conduct serious and costly research on the efficacy of the pharmaceutical interventions. Surely, drug makers would like nothing better than to forego such expensive studies. The only things that drive them to invest millions of dollars in studies, often lasting years, are that (i) they stand to make millions, or billions of dollars selling their (patented) molecules as drugs, and (ii) there is a regulatory gateway that they must prove efficacy before sales can begin. Neither incentive currently applies to simulation as an intervention. I believe that the current status of research on the impact and efficacy of simulation as an intervention to improve patient care processes, patient quality and safety, and (ultimately) improved patient outcome is rather weak. If, along the lines of the approach of Weinger and of Cook, we use the pharmaceutical analogy, here is what we have typically done to date. From the Stanford University School of Medicine, Center for Immersive and Simulation-based Learning, Palo Alto, CA.