How DeKalb Medical Fixed Drug Safety Problems After Fatal Error

By Steven Porter

A nursing home patient with dementia who was admitted last October to DeKalb Medical in Decatur, Georgia, died after the hospital gave her 10 times the maximum daily dose of a calcium channel blocker.

The overdose death resulted in a finding of immediate jeopardy by the Centers for Medicare & Medicaid Services and spurred a series of patient safety reforms, many of which seek to reduce overreliance on technology.

“Our staff, physicians, pharmacists, nurses, other healthcare team members—and I don’t think this is unique to our hospital system—have become very task-oriented in their actions as it relates to working with an electronic medical record,” said Sharon Mawby, MSN, RN, NEA-BC, vice president of patient care services and chief nursing officer for DeKalb.

“Many hospitals, in an effort to decrease keystrokes for a practitioner, have developed order sets and systems which allow our practitioners to simply check boxes or choose from dropdown screens,” she said.

That efficiency, without proper safeguards, can make it easier for healthcare workers to carry out unsafe orders methodically, without a second thought, Mawby said.

“Why aren’t we asking questions?” she added. “Why aren’t we stopping to listen to our gut when something doesn’t feel right?”

What went wrong

The doctor who ordered 100 mg of amlodipine besylate tablets failed to second-guess an existing error made by another physician in the patient’s file. A pharmacist tasked with reviewing the order missed the error as well, even though DeKalb’s medication management system alerted the pharmacist to the unsafe dosage.

Pharmacists may mistakenly override a medication safety alert because they are inundated with false alarms, DeKalb’s pharmacy director told inspectors after the fatal incident, according to an inspection report CMS released to HealthLeaders Media in response to a public records request.

The rate of adverse drug events originating during an inpatient stay at U.S. hospitals declined 23.8% from 2010 to 2014, falling most dramatically among patients ages 65 and older, according to a study released in January by the Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project.

But the quality concerns over “alert fatigue,” which can make it more difficult to catch medication errors before they harm patients, continue to plague hospitals and health systems nationwide.

Research conducted by Adrian Wong, PharmD, MPH, BCPS, BCCCP, an outcomes research and pharmacy informatics fellow at Brigham and Women’s Hospital in Boston, found that nearly three-quarters of medication safety alerts were overridden over a three-year period at a large teaching institution he studied. About 40% of the overrides were deemed inappropriate.

Despite the numbing effects of alert fatigue, a second DeKalb pharmacist caught the doctor’s error last October, notified the first pharmacist of the problem, and kept the unsafe order from being processed, according to the CMS documents.

But the pharmacists failed to contact the doctor to modify the mistaken order.

When the patient was transferred from the Express Admission Unit to a medical wing, a registered nurse followed the unmodified order. The nurse scanned the patient’s wristband and the medication packaging to verify the proper dose, then the nurse helped the patient take all 10 amlodipine tablets.

The patient’s blood pressure dropped sharply, and she was transferred to the ICU, where she was placed on a ventilator until her death two days later.

Mawby said individual workers were held responsible for the actions they took with “reckless disregard” for safe medication administration procedures. She declined to say whether anyone was fired.

Seeking systemic solutions

When serious medication mistakes occur, it may be tempting to place blame squarely on the shoulders of the doctors, pharmacists, and nurses who erred. But beyond holding individuals responsible for their actions, DeKalb’s leadership team also identified several systemic problems it could solve.

Below are five key steps DeKalb took to shore up patient safety at its organization:

(1) Medication safety team restructured

The three-hospital system already had a standing team tasked with addressing medication safety concerns. But the fatal error last October prompted DeKalb to restructure, revamp, and revitalize the initiative, Mawby said.

“The problem with the previous team was that it was not robustly overseen, so even though they reported directly to the pharmacy and therapeutics committee, there was no link to the board for information,” she said. “There was really no direct link to me for patient care to help them solve issues.”

The restructured team—which rewrote its charter—now reports to the board quality committee, linking it directly to C-suite leadership for more consistent communication.

(2) Data points identified, tracked

To quantify DeKalb’s problems and progress, the medication safety team identified key data points it will track in an effort to trend all medication safety errors and adverse drug events that rise above a defined level of severity.

The team will keep an especially close eye on one metric, Mawby said: the number of overridden medication safety alerts.

After months of planning and technical EMR adjustments, the team began formally tracking these overridden alerts in February. At the beginning of the month, there were 433 alerts overridden in a single day. By the end of the month, DeKalb slashed that number by 60%, to 175 alerts overridden in a single day.

“It’s a definite improvement, but the fix is going to take a long time,” Mawby said.

For starters, the EMR and related systems require that every medication be mapped individually to identify its safe dosage parameters. If the parameters are too strict, then healthcare workers will be bogged down with unneeded alerts; if they’re too lax, then those who prescribe and administer medication will be driving without guardrails.

“You can’t just turn the button on and say, ‘OK, we’ve got these dose quantity alerts on for
everything,’ ” Mawby said. “It just doesn’t work that way.”

The goal should not be to reach zero overridden alerts, Mawby noted. The goal should be to track and verify that the alerts are being overridden for the right reasons.

(3) Changes to EMR systems implemented

As the medication safety team has begun to track overridden alerts more closely, the DeKalb team has pinpointed which medications and providers need the attention of a fine-toothed comb.

“We’ve been able to go in and readjust order sets so they’re not alerting inappropriately,” Mawby said. “We’ve been able to go in and teach physicians and pharmacists and show them what they’re doing wrong.”

Arguably the most significant systemic problem that contributed to last October’s incident was rooted in DeKalb’s EMR setup. Although the pharmacists who were tasked with reviewing and filling the unsafe medication order received an automated safety alert from the system, the physician did not.

That setup has since been changed. DeKalb turned on medication safety alerts for prescribing physicians as well, offering immediate feedback when an order appears to contradict safe practices.

“The only way that a physician, or person ordering the medication, can get past the alert now is by choosing the appropriate override comment as to why the order is given outside of the normal parameters,” Mawby said.

“When the medication order gets to the pharmacist, they will be able to see why the medication was overridden. They will be the second line of defense to make sure that that’s an appropriate reason as well to override an alert.”

(4) Policies and training updated

In addition to targeted training for physicians, pharmacists, and others involved in medication administration, DeKalb implemented more general safety training and information-sharing initiatives on a regular basis.

These initiatives include daily safety briefings.

“Those are led by our senior leaders, which is somebody from the C-suite,” Mawby said. “And at these daily safety briefings, we report out on safety events that may have occurred in the past 24 hours or issues that we are concerned might be an event in the next 24 hours.”

Attendees include hospital leaders from across the DeKalb system, including representatives from facilities services, sanitation, and other teams not directly involved in patient care.

(5) Transparency practiced

In the immediate aftermath of the medication safety error, DeKalb hosted town halls that were mandatory for all patient care services staff and optional for the rest of the system’s employees.

“One of the best things that we did as an organization was be completely transparent about the event that occurred,” Mawby said, noting that nearly 800 people attended.

Leaders stood in front of DeKalb staff, outlined what went wrong, and identified eight missed opportunities that could have stopped the error from harming the patient.

“It brought a lot of caregivers to tears,” Mawby said.

This transparency in the wake of a tragedy that stemmed from individual and systemic blunders alike is necessary to foster a culture of safety.

“You’ve got to have a culture of safety in the hospital that is supportive of asking questions and bringing concerns forward,” Mawby said.

“This horrible event actually has changed us in so many ways that we’ve expanded our focus beyond medication administration to include other items around patient safety,” she added. “It has to become an overriding theme for us.”