Mandatory Reporting for Medical Mishaps:
Is There Middle Ground?

Health care is an increasingly complex enterprise, and complexity introduces danger. For example, while new drug treatments have the potential to cure disease and greatly improve quality of life, they also carry significant risks.

Drugs must be tested before they are marketed, but side effects are not always detected in clinical trials. As patients take more and more drugs, drug interactions require greater attention. Mistakes are possible at many points in the process from the writing of a prescription to drug administration. One study, widely cited in news reports, estimated that 100,000 people die each year from adverse drug reactions. Although other estimates are lower, there is agreement that the number affected is significant.

Experts believe that better information is key to progress on patient safety. Without accurate reporting of adverse events and "near misses," it is difficult to identify patterns that point to serious safety problems and impossible to establish a baseline against which to gauge the success or failure of safety initiatives. A recent report from the Institute of Medicine suggests that only a small percentage of adverse drug events and other mishaps are reported through internal hospital channels. A number of states require hospitals to report certain categories of adverse events to state agencies, but underreporting is believed to be significant at this level as well. Voluntary systems face similar problems; a report just released by the inspector general of the Department of Health and Human Services recommends that a voluntary reporting system established by the Food and Drug Administration (FDA) be replaced by a mandatory one.

An effective system will have to address barriers to reporting. Factors frequently cited include fears concerning damage to reputation, disciplinary action, liability for damages in a civil lawsuit, and in rare cases, criminal liability. There is also the "hassle factor" associated with filing reports, especially if this work is perceived as a burden with no benefit. In addition, in a voluntary system, or a mandatory system without effective enforcement, those who consistently report adverse events and errors may appear less safe than non-reporting colleagues and competitors. These factors affect both individuals and institutions. Privileges that keep reports out of litigation and confidentiality protections are often proposed as solutions to the problem of underreporting, but such measures may undermine public trust and create concerns about accountability.

The Institute of Medicine report concludes that in cases of serious injury or death a mandatory reporting system with some degree of public access, and potential for sanctions, is necessary for purposes of policing deficient practice and ensuring accountability. Separate sanction-free voluntary reporting systems are necessary for purposes of prevention. These would cover the remainder of cases, picking up the "near misses" that would be exceedingly difficult to capture through a mandatory system. In both systems, reporting could be increased through standardization of forms to lessen the paperwork burden and investment of resources in data analysis and feedback channels to health care providers. The inspector general's report recommends that the Health Care Financing Administration require hospitals participating in Medicare and Medicaid to report serious, unexpected drug reactions to the FDA. While seeking to encourage more broad-based reporting, the FDA would also like to create a voluntary network of "sentinel hospitals" that would engage in more comprehensive monitoring of side effects and other adverse drug events and serve as sites for development and testing of preventive measures.

The advance copy of the Institute of Medicine report, To Err Is Human, is available on-line.

The views expressed in the articles in Health Law Perspectives are those of their respective authors. The articles do not necessarily reflect the views of the University of Houston or the Health Law and Policy Institute.

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©2006 Texas Medical Center

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