This story has been updated.
More than one-third of 9000 pediatric hospital reports described a drug dosing error that was usually related to too much or too little medicine due to the usability of the electronic health record (EHR), according to a study published Monday in Health Affairs
In 609 cases, the error reached the patient, said lead author Raj Ratwani, PhD, MA, director of the National Center for Human Factors in Healthcare at MedStar Health. Of those, 129 caused minor or major harm, but no fatalities were reported.
Ratwani published a similar study
last spring about the usability of EHRs negatively affecting patients.
“The high-level point is similar, which is that the usability of electronic health records is associated with impacting patient care, and can be associated with patient harm,’” said Ratwani in an interview with the The American Journal of Managed Care®.
The study shows concerns about “the ways EHRs are designed and implemented, and the impact that can have on our children,” he said.
The analysis was carried out using data between 2012 and 2017 from 3 medical facilities in 3 states – 2 children’s hospitals and 1 adult/pediatric hospital. The pattern of usability challenges and medication errors were the same across the 3 sites. Two hospitals used Epic and 1 hospital used Cerner as their EHR vendors, the study said.
The most common usability challenges were associated with system feedback and the visual display.
“What we’re seeing is that many of those system feedback issues are not functioning as they should,” Ratwani said. “Even when you have a medication that might be 5- or 10-fold higher than what a child should be receiving, and could potentially be lethal, the EHR is not flagging those medications. That’s a serious, serious concern, because that can have direct patient harm, and even result in death.
The 21st Century Cures Act of 2016 was supposed to help address this issue by setting new criteria for EHRs used in the care of children. But the 2 pieces have yet to be implemented. The law directed the Office of the National Coordinator for Health Information Technology (ONC), the federal agency that oversees EHRs, to develop voluntary criteria to certify EHRs used in the care of children. The authors urged that the ONC “prioritize safety in developing these regulations.”
Current EHR criteria does not distinguish between children and adults.
“We know that treating children is different than treating adults,” Ratwani said, explaining the importance of the issue.
The ONC is also required, under the law, “to develop a reporting program that collects improved, real world data on the functions of different EHR systems—including on their usability,” according to the study. Ratwani described it as a transparent way to describe how the EHRs actually work and said the ONC should collect information on harm associated with the use of EHRs.
The ONC recently issued a request for information on the reporting tool and the comments received are under review, a spokesman said Monday. A proposal on pediatric criteria is also being reviewed, he wrote in an email to AJMC®
The researchers said 3 key factors can undermine efforts to enhance usability and safety for patients, including children.
Some EHR developers might not be adhering to policies that promote usability, but their products are being certified by the private sector, government-authorized certification bodies as if they are. “Those certifying bodies may not know what criteria to look for. They may not have the usability expertise,” said Ratwani.
Second, test-case scenarios, which are used by EHR vendors to evaluate usability and safety, might not represent real-world clinical care scenarios.
Third, the testing itself could become irrelevant, since the EHR product will become customized during implementation at each site, and the product used is very different than what was evaluated. “We can’t simply look at these events and blame the vendor,” said Ratwani, who said some customizations could undo features built in by the vendor.
Ratwani RM, Savage E, Will A, et al. Identifying electronic health record usability and safety challenges in pediatric settings. Health Aff (Millwood).
2018;37(11):1752-1759. doi: 10.1377/hlthaff.2018.0699.