BY MICHAEL MILLENSON

In the mid-1990s, researching a book about the quality of medical care, I discovered how the profession had for years been ignoring evidence about the appalling death toll from preventable medical error. Though I’d never myself experienced an error, I became an activist.

Recently, however, a relative was a victim, and the frustrating persistence of error became personally painful.

Thanks to my relative being acutely aware of the need to be alert (and a bit of luck), no harm was caused by what could have been a serious medication mistake. That was the good news. The bad news is that even Famous Name Hospitals, like the one where my relative was treated, are rarely doing everything possible to forestall the impact of inevitable human fallibility.

September 17 was World Patient Safety Day, and the theme for the next 12 months is “Medication Without Harm.” That makes this an opportune time to examine more closely what the profession euphemistically calls a “medication misadventure.”

My relative’s care began how you’d expect from a renowned academic medical center. From the time she was admitted, there was top-notch treatment for a complex set of conditions. Then, one day, a nurse came into the room to infuse a solution of magnesium, an essential electrolyte. And here is where patient alertness paid off.

Two hours into an expected three-hour infusion, with an IV in one arm, my relative used her other arm and an iPad to access the hospital’s patient portal, which, thanks to a Congressional mandate, discloses patient test results. In the portal my relative saw that her magnesium levels were actually normal. By chance, a doctor came by on a regular rounding, and my relative showed her the results. The doctor checked the electronic health record (EHR), spoke to the nurse and then quickly stopped the infusion. The doctor and nurse assured my relative that no harm had been done.

Unmentioned by the clinicians was the avoided threat of magnesium toxicity, which the National Library of Medicine says can cause “fatal complications such as hypotension, respiratory paralysis, and cardiac arrest.”

More than 200,000 Americans lose their lives to preventable medical error every year, according to an estimate by the Department of Health and Human Services (HHS). Medication errors are the most common “adverse event,” occurring as often as one out of every 13 hospital admissions, according to the HHS Office of the Inspector General (OIG). My relative was lucky her infusion wasn’t a more toxic drug.

Overall patient harm is startlingly common. An OIG report in May found that a little over one quarter of hospitalized Medicare patients experience some sort of harm, whether permanent or temporary. Unfortunately, there’s no national reporting system, although there is a growing effort to get Congress to establish a National Patient Safety Board. The current hodgepodge of reporting too often leaves all but the worst mistakes invisible. At first, that’s what happened here.

After my relative contacted me, I tried via a respectful email to get Famous Name Hospital’s patient safety director to launch what’s called a root cause analysis. She replied that my relative might have misunderstood “normal level” and should talk to her doctor. (The reply ignored that the doctor had immediately stopped the infusion.) Alas, denial, even with no lawsuit threat, remains an all-too-common response. A serious investigation commenced only when I utilized my professional contacts to get attention further up the chain of command, and my relative filed a formal grievance.

Famous Name Hospital prides itself on a “safety culture.” However, the veteran nurse on my relative’s floor had not filed an incident report about this “near miss.” Invisibility means no opportunity to learn. When an investigation was undertaken, it found that the infusion order in the Epic EHR, the platform used by many of the nation’s leading hospitals, was entered when my relative was admitted two weeks before. When she was transferred to a different floor, Epic required the doctor to uncheck the box for each test ordered; someone had missed a box.

It was also a holiday weekend in July, when a new group of medical residents takes over. Moreover, my relative’s veteran nurse was distracted, dealing with questions from other nurses while trying to double-check the EHR. As a result, she didn’t see the normal magnesium level.

As thorough as the investigators were in some respects, one omission stood out. The World Health Organization (WHO), the sponsor of World Safety Day, lists six principles in its global patient safety action plan. The very first is “engage patients and families as partners in safe care.” At Famous Name Hospital, clinicians interviewed other clinicians but not my relative, even after I prodded them to do so.

Lacking patient input, the report stated that the medication error was discovered by two doctors. And though a 100-cc bag of fluid was in my relative’s arm for two hours, the investigators reported that only a quarter of the liquid had been infused; my relative’s estimate was half to two-thirds.

In sum, the hospital’s version of events was that they found the error and did so at an early enough point that no harm could have been done. They did apologize, however, and assured my relative they were implementing changes to prevent a recurrence – which was why we insisted on an investigation.

Along with invisibility, provider inertia is another enemy of improvement. It’s typically not malevolent, just the heavy weight of “we’re busy” and “this is how we do things here.” Famous Name Hospital said their procedure was to have Patient Relations interview patients, a rational policy for complaints about food or noise, but a wholly inadequate response to a situation demanding clinical expertise.

Earlier this year, a group of senior government physicians wrote in a blunt commentary in the New England Journal of Medicine that “health care safety has declined” during the Covid pandemic, illustrating lack of “a sufficiently resilient safety culture and infrastructure.” Allowing patients to report medical errors as “partners in safe care,” in the WHO’s words, could help restore that resilience. This idea was actually considered by the Obama administration in 2012, but quickly shot down by providers.

We can do better. Again, to their credit, Famous Name Hospital recognized the medication error represented a system flaw, not a “bad” doctor or nurse problem. However, since the book that I wrote was entitled Demanding Medical Excellence: Doctors and Accountability in the Information Age, I was interested to see what role information technology might play.

A 2020 article in the Joint Commission Journal concluded that 68 percent of the alerts about medication issues issued by a machine learning system from a company called MedAware spotted problems not discovered by conventional tools. So I reached out to MedAware’s CEO, Dr. Gidi Stein, about my relative’s situation. He replied that if the EHR showed that the blood level of an electrolyte was within normal range before or during the infusion, the clinical team would have received an alert.

Which brings us to the third factor mitigating against a “zero harm” environment: “income.” I don’t know the cost of MedAware or similar products, but I’m certain it’s less than the cost of revenue-generating medical devices hospitals are routinely eager to purchase. Unfortunately, even at institutions prone to boasting about high-quality care, physicians and nurses advocating for systems and staff to make care safer are constantly asked to make “the business case for patient safety.”

As I’ve written about beginning in 2010 and repeatedly since, the ugly truth is that medical error can be profitable for hospitals. For instance, in a Journal of Healthcare Management article entitled “Does Patient Safety Pay?”, researchers advised hospital executives that “targeted” improvement in patient safety performance could improve financial performance.

My relative asked the Patient Relations department to make sure to remove the infusion charge from the bill.

In his recent book Making Healthcare Safe: The Story of the Patient Safety Movement, patient safety pioneer Dr. Lucian Leape scathingly concluded that “most health-care organizations fall woefully short of achieving a culture of safety,” including “most highly regarded academic medical centers.” Despite decades of effort, wrote Leape, a pediatric surgeon and adjunct professor at Harvard’s T.H. Chan School of Public Health, “there is no sense of commitment, no goal of zero harm.”

We can do better. And some hospitals quietly are. For a doctoral thesis exploring how to reduce the cost of medication errors, Walden University’s Janice Chobanuk conducted semi-structured interviews with 10 high-reliability U.S. hospitals and reviewed documents related to medication management. A high-reliability approach, she found, depended upon leadership support, open communication with feedback loops, sustaining a culture focused on error prevention and patient partnerships. That last factor affected all the others.

“The active engagement of patients…in error prevention and safety in hospitals can prevent errors, improve patient satisfaction, reduce litigations and reduce costs associated with medication mistakes,” Chobanuk wrote.

If Famous Name Hospital clinicians had interviewed my relative, they might have reached the same conclusion. No matter how skilled, dedicated or well-intentioned the care provider, errors will occur. It’s crucial to have an alert and informed patient as a partner in order to help prevent harm.

Medical error is a painful experience for patients and families even without physical harm ­– as my relative and I experienced – and yes, also for the providers involved. To prevent harm, everyone involved in care must constantly use all the information available to them to demand medical excellence.

Michael Millenson is a consultant specializing in quality of care, patient empowerment, and web-based health.