Digital Health Records’ Risks Emerge as Deaths Blamed on Systems
When Scot Silverstein’s 84-year-old mother, Betty, starting mixing up her words, he worried she was having a stroke. So he rushed her to Abington Memorial Hospital in Pennsylvania.
After she was admitted, Silverstein, who is a doctor, looked at his mother’s electronic health records, which are designed to make medical care safer by providing more information on patients than paper files do. He saw that Sotalol, which controls rapid heartbeats, was correctly listed as one of her medications.
- Special Report: Medical Technology: Electronic Health Records
Days later, when her heart condition flared up, he re-examined her records and was stunned to see that the drug was no longer listed, he said. His mom later suffered clotting, hemorrhaged and required emergency brain surgery. She died in 2011. Silverstein blames her death on problems with the hospital’s electronic medical records.
“I had the indignity of watching them put her in a body bag and put her in a hearse in my driveway,” said Silverstein, who has filed a wrongful-death lawsuit. “If paper records had been in place, unless someone had been using disappearing ink, this would not have happened.”
Abington Memorial is vigorously fighting the allegations and doesn’t comment on pending cases, said Linda Millevoi, a spokeswoman for the hospital.
Electronic health records are supposed to improve medical care by providing physicians quick and easy access to a patient’s history, prescriptions, lab results and other vital data. While the new computerized systems have decreased some kinds of errors, such as those caused by doctors’ illegible prescriptions, the shift away from paper has also created new problems, with sometimes dire consequences.
Dangerous doses of drugs have been given because of confusing drop-down menus; patients have undergone unnecessary surgeries because their electronic records displayed incorrect information; and computer-network delays in sending medical images have resulted in serious injury or death, according to a study published in 2011 based on reports submitted to the U.S. Food and Drug Administration.
According to a study published in December by the Pennsylvania Patient Safety Authority, the number of reports about medical errors associated with electronic records is growing. Of 3,099 incidents reported over an eight-year period, 1,142 were filed in 2011, more than double the number in 2010.
Digital medical records, a cornerstone of U.S. President Barack Obama’s push to modernize the nation’s health-care system, are increasingly common at the doctor’s office. About 69 percent of U.S. physicians said they used these electronic records in 2012, according to the journal Health Affairs. That number is likely to grow as the government dangles bonuses for early adopters and imposes penalties starting in 2015 for those who don’t upgrade.
$24 Billion Market
The electronic-medical-records market generated an estimated $24.2 billion in revenue globally last year and will grow an average of almost 10 percent a year through 2015, according to Accenture Research. The biggest providers of these systems are Epic Systems Corp., McKesson Corp., Cerner Corp., Allscripts Healthcare Solutions Inc. and Siemens AG.
Digital records have dramatically reduced some common medical errors. More than 17 million medication mistakes are now avoided in the U.S. each year because of hospitals’ use of computerized prescription-ordering systems, according to a study published in February in the Journal of the American Medical Informatics Association. In such systems, sloppy handwriting is irrelevant, and doctors get pop-up alerts when attempting to prescribe dangerous drug combinations.
“I would never go back to paper charts -- clearly electronic records are better,” said Leora Horwitz, a doctor and assistant professor of medicine at Yale University School of Medicine. “But while they’re good, they’re so far from great it’s astonishing.”
Last month, nurses at Marin General Hospital in California complained about an electronic medical-record system made by McKesson that they said was causing medications to be ordered for the wrong patients.
Jamie Maites, a spokeswoman at Marin General, said the hospital has made “significant progress” in dealing with the issues. The rollout has been “challenging,” yet “has resulted in a safer hospital for our patients,” she wrote in an e-mail. Kris Fortner, a spokesman for McKesson, said the company is working with Marin General to address the concerns.
"Aside from some initial issues related to changes in nursing workflow, feedback from Marin’s leadership to McKesson about the implementation has been positive," Fortner wrote in an e-mail.
Epic Systems was the target of criticism last year by nurses working in Contra Costa County, near San Francisco. They complained that glitches in the county’s $45 million system, such as medications disappearing from electronic files, were endangering patients’ lives.
In one month, 129 complaints were filed by nurses at county detention facilities, where the problems were most acute, according to Jerry Fillingim, labor representative at National Nurses United.
Some problems in Contra Costa arose because of human error -- medications were entered incorrectly into the Epic system when it went live, said Rajiv Pramanik, chief medical information officer for the county. There has been “dramatic improvement” among staff members in using the technology and the system’s “strengths are tremendous,” he said.
Barb Hernandez, a spokeswoman for Epic, declined to comment.
Unlike U.S. medical-device makers, which must report all malfunctions, serious injuries and deaths involving their products to the FDA, software companies that make electronic medical records are under no such requirement.
As a result, little is known about the risks of their systems, since there is no central database of error reports and makers of electronic records often prohibit customers from discussing unsafe processes. That practice creates “unacceptable risks to safety,” according to a 2011 report from the Institute of Medicine of the National Academies.
One of the most comprehensive studies on the topic examined adverse-event reports submitted to the FDA from January 2008 to July 2010. Of 899,768 reports, 436 unique events involved health information technology, including electronic records, and 46 were associated with patient harm, including four deaths, according to the study, entitled “Patient Safety Problems Associated With Healthcare Information Technology.”
“People are still in fantasy mode that just by putting technology into health care it will make it better -- and that’s not real,” said Enrico Coiera, professor at the University of New South Wales in Sydney and co-author of the study.
Much of what is known is through voluntary reports.
“The emphasis on doctors self-reporting errors is ludicrous,” said Ross Koppel, adjunct professor of sociology at the University of Pennsylvania and co-author of a 2005 study that found a widely used electronic prescription-ordering system contributed to 22 types of medication errors.
“When a locomotive crashes into two apartment buildings, we know about it,” he said. “When a patient gets the wrong med, we seldom know about it.”
Cerner, one of the industry’s big players, voluntarily reports problems with its technologies to the FDA even for unregulated products such as electronic records, said Megan Moriarty, a spokeswoman at the Kansas City, Missouri-based company. Customers are permitted to disclose safety issues to “appropriate entities” or in “professionally appropriate venues,” she wrote in an e-mail.
Siemens, based in Munich, submits required adverse-event information to the FDA and doesn’t prohibit customers from disclosing problems, Matthias Kraemer, a spokesman, wrote in an e-mail. The company is assessing how to appropriately submit voluntary reports to the FDA and already has a "mature" system in place for customers to report problems with its regulated and unregulated technologies, Kraemer said.
Claire Weingarden, a spokeswoman for Allscripts, declined to comment on the voluntary reporting system, as did McKesson and Epic.
While the FDA doesn’t regulate the electronic records, the Office of the National Coordinator for Health Information Technology, part of the U.S. Department of Health and Human Services, is overseeing the rollout of the systems and sets the safety standards.
“So far, the evidence we have doesn’t suggest that health information technology is a significant factor in safety events,” said Jodi Daniel, director of ONC’s office of policy and planning. “That said, we’re very interested in understanding where there may be a correlation and how to mitigate risks that do occur.”
When it comes to electronic records, the most dangerous time for patients appears to be immediately after a facility installs the new technology.
At Children’s Hospital of Pittsburgh, mortality rates increased after the implementation of an electronic records system from Cerner in 2002, according to a study published in 2005 in the journal Pediatrics.
During the 18 months examined, the mortality rate increased to 6.6 percent in the five months after the system was installed, from 2.8 percent in the 13 months before, according to the study.
Delays in treating patients may have contributed to the deaths, the researchers said. Those delays were caused by several issues, including the number of clicks required to submit prescription orders and by restrictions imposed by the software on when doctors could order medications for incoming patients.
The study examined only a small sample of patients over a short period of time and was “fundamentally flawed,” said Wendy Zellner, spokeswoman for the University of Pittsburgh Medical Center, which owns the hospital. Since the system was implemented, the severity-adjusted mortality rate has decreased by 35 percent, she said.
The hospital, one of the most automated in the country, has since corrected issues such as delays in getting medications for incoming patients, she said. In response to a request for comment, Moriarty, Cerner’s spokeswoman, referred to the hospital’s statement.
“Any time you computerize a process, it can create new problems, and it typically does,” said David Bates, a doctor and chief quality officer at Boston’s Brigham and Women’s Hospital, who has studied errors associated with electronic records.
Betty Silverstein’s case came to light because her son Scot, who is also a health-care informatics professor at Drexel University, has for more than a decade been one of the loudest voices urging caution in the adoption of electronic records.
He said he is suing the hospital in part to find out how his mother’s heart drug disappeared from her file. The omission of the vital medicine led the hospital to give her corrective medications and perform emergency surgery, which ultimately led to her death, he said.
Still, he said his goal isn’t to stop the spread of these systems.
“My mom would be around right now, bopping around, if they had simply not forgotten to give her $2 of medicine,” he said. “I want to fix the technology. The technology can help. But it has to be done right.”