Part Two: FDA-MIT Database Project Should Improve Drug-safety Monitoring
In our first part to this series, we took a look at the extent of serious adverse drug reactions (ADRs) in the U.S. In this next part, we will consider how some of these serious ADRs might be prevented.
In a prepublication copy of a report announced by the National Academy of Sciences' Institute of Medicine (IOM) in July 2006, "Preventing Medication Errors", it was estimated that at least 1.5 million adverse drug reactions annually in the United States are preventable events.
Since so many serious adverse drug reactions are preventable, we are able to reduce the number of ADR events if we make improvements in various aspects of our drug-safety system. Most experts agree that this can be accomplished by strategies on two fronts, one targeting the prescribing stage and the other aimed at monitoring stage. In this article we look at an example of change and improvement as regards monitoring, specifically how emerging drug-safety issues might be better detected.
In August 2006 it was announced that the FDA and the Massachusetts Institute of Technology (MIT) will jointly develop a new automated system that would regularly search federal government databases as well as some private health care sector databases in real time for unusual and emerging patterns that could indicate potential safety concerns with prescription drugs.
To appreciate the significance of this improvement, one must understand that the current drug monitoring system used by the FDA is primarily based on manual assessment of voluntary reports submitted to the FDA's MedWatch program, sometimes months or years after an adverse drug reaction event has occurred. Moreover, it is widely acknowledged that, for numerous reasons, with the current MedWatch monitoring system the true incidence of serious adverse drug reactions is underreported. In fact, it is often suggested that due to this underreporting the FDA may learn of fewer than 1 in 10 ADR events in the U.S. By these standards, the MedWatch system can be criticized as both incomplete and slow when it comes to drug side effects monitoring.
In comparison, a more automated system capable of searching multiple databases -- including those compiled by major health insurance providers and federal agencies like the Veterans Administration -- in real time should be far better at recognizing patterns of unanticipated side effects that may be indicative of emerging drug-safety issues.
According to an August 17, 2006 Associated Press article about this FDA-MIT collaboration, in addition to this new automated monitoring system, the FDA has another idea about how to develop more current drug-safety information.
The FDA also plans to begin publishing reports for doctors that would alert them to potential problems with drugs and devices, Gottlieb said. That could prompt doctors to watch for similar problems and report them when found to the FDA. The reports would resemble the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report, which regularly alerts doctors to outbreaks of disease.
In the next part of this ADRs in US series, we will look at how the number of adverse drug reactions might be reduced at the drug prescribing stage, with our focus on medication errors.
(Posted by: Tom Lamb)