A Retrospective and Commentary on FDA’s Bar Code Rule

Abstract

Food and Drug Administration (FDA) published a final regulation in 2004 that requires pharmaceutical manufacturers to place linear bar codes on certain human drug and biological products. The intent was that bar codes would be part of a system where healthcare professionals would use bar code scanning equipment and software to electronically verify against a patient’s medication regimen that the correct medication is being given to the patient before it is administered, which could ultimately reduce medication errors. In the 2004 prospective regulatory impact analysis, FDA anticipated that the rule would stimulate widespread adoption of bar code medication administration technology among hospitals and other facilities, thereby generating public health benefits in the form of averted medication errors. FDA estimated that annualized net benefits would be $5.3 billion. In this retrospective analysis, we reassess the costs and benefits of the bar code rule and our original model and assumptions. Employing the most recent data available on actual adoption rates of bar code medication administration technology since 2004 and other key determinants of the costs and benefits, we examine the impacts of the bar code rule since its implementation and identify approaches to improve the accuracy of future analyses. In this retrospective study, we use alternative models of health information technology diffusion to create counterfactual scenarios against which we compare the benefits and costs of the bar code rule. The magnitudes of the costs and benefits of the 2004 rule are sensitive to assumptions about the counterfactual technology adoption rate, with the upper-bound range of calculated annualized net benefits between $2.7 billion and $6.6 billion depending on the baseline scenario considered.

Disclaimer: The findings, interpretations, and conclusions expressed in this article are those of the authors in their private capacities, and they do not represent the views of the Food and Drug Administration.