Problems with computerized provider order entry systems have been associated with adverse medical events, according to reports submitted to FDA on electronic health record malfunctions, the Huffington Post Investigative Fund reports.
The Investigative Fund analyzed reports submitted to FDA during the past two years and identified 237 reports of adverse events associated with health IT systems. Investigators found that most of the problems involved medical ordering software or programs that provide such software with data on recommended drug doses, test results and other information.
Investigators noted that it is unclear how often CPOE problems occur because most reports are submitted to FDA voluntarily.
When asked about the investigation findings, National Coordinator for Health IT David Blumenthal said he has not seen evidence to justify a reduced commitment to CPOE systems. Blumenthal added that his office is examining the issue of health IT-related safety events (Schulte/Schwartz [1], Huffington Post Investigative Fund, 4/20).
Investigation Examines FDA Enforcement
In related news, an Investigative Fund analysis of FDA audits and data suggests that the agency lacks a systematic method to track the safety of EHR systems, the Huffington Post Investigative Fund reports.
Of the 237 health IT-related adverse events reported in the previous two years, the Investigative Fund found that approximately:
- 50% were reported to FDA after two or more months had passed;
- 20% were reported after nearly a year; and
- 10% were reported after about two years.
Investigators said they found little evidence that FDA followed up on the reports or took action against organizations that are required to file such reports but failed to do so.
However, FDA officials said they recently have improved their systems for adverse event reporting and enforcement (Schulte/Schwartz [2], Huffington Post Investigative Fund, 4/20).
New Recommendations
Today, the Health IT Policy Committee approved recommendations from its adoption and certification work group that call for increased oversight of EHR safety.
The recommendations urge the Office of the National Coordinator for Health IT to work with FDA and other organizations to determine how federal agencies can play a role in ensuring the safety of health IT systems (Goedert, Health Data Management, 4/21).