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Adverse Events from Insulin Prescribing 'An Epidemic'

 |  By cclark@healthleadersmedia.com  
   March 13, 2014

The results of a CDC study on insulin use errors suggest the need for a more individualized examination of which patients are prescribed insulin, with special attention to their life expectancy, level of frailty, and other diseases or conditions.

When clinicians look for ways to reduce healthcare-associated harm, how patients with diabetes are prescribed insulin is probably not at the top of their list.

Used by more than 5.3 million Americans with diabetes in a given year, the drug saves lives, preventing serious complications from diabetes such as amputations, kidney disease, and blindness.

But research this week from the Centers for Disease Control and Prevention shows the unexpected frequency with which insulin use errors—and often insulin overprescribing — cause blood sugar levels to drop too low, prompting a surprisingly high number of patients to rush to the emergency department. Almost a third of those patients require an inpatient admission.

The report should prompt a national re-examination of how doctors prescribe this important drug, how manufacturers package it, and how well patients and families are educated in the proper way to use it.

"We knew from previous work that insulin, which is a complex medication to manage, causes quite a few emergency room visits for adverse events," says Andrew Geller, MD, lead author of the paper published this week in JAMA Internal Medicine.

But what they didn't understand before the study was the high number of ED visits provoked by hypoglycemic episodes—about 100,000 a year, or 500,000 over the span of the five-year study that ended in 2011. That alone, Geller says, amounts to $600 million a year in ED treatment costs, much of it preventable.

And they didn't have any idea that nearly 30% of those patients' hypoglycemic conditions were serious enough to require hospitalization.

"We really didn't appreciate is the full severity of these insulin-related emergency visits," he told me in a telephone interview. "Almost two thirds of these visits involved hypoglycemia with either loss of consciousness, seizure, confusion or brain injury, injuries from falls, and altered mental status," Geller says.

Octogenarians Most Vulnerable
The study should, the authors suggest, provoke a much more individualized examination of which patients are prescribed insulin, with special attention to their life expectancy and level of frailty, and what other diseases or conditions they have.

It's essential to note that those most at risk were people over the age of 80.

Octogenarians were more than twice as likely to have taken an insulin-related trip to the ED than younger insulin users, and nearly five times as likely to be admitted, prompting questions about whether people at that age should be taking insulin in the first place.

"We need to go back to old fashioned doctoring, back to the basics," where each patient's diabetes treatment is tailored to their specific needs, Geller says.

What's particularly interesting, Geller says, is that the precipitating factor resulting in the insulin hypoglycemic event (IHE) was documented in 21% of the patients, and when that was sorted out, meal-related misadventures were the number one cause.

Patients who ended up in the hospital with an IHE neglected to eat shortly after taking a rapid-acting insulin or didn't adjust their insulin dosage when they ended up eating less. More than 22% of ED visits prompted by the IHE involved the patient taking the wrong product—for example the patient mixed up long-acting versus short-acting insulin because the packaging looks the same, Geller says.

While manufacturers have made some changes to the packaging to differentiate products, the boxes and pens with different dosages and strengths still look too much alike, and that is easily fixed, he says.

And 12% involved taking the wrong dose or the patient confusing dosage units.

Sei Lee, MD, of the Division of Geriatrics at the University of California San Francisco, who specializes in adverse drug events in frail elderly, says the Geller paper highlights an insulin overtreatment "epidemic," adding that "the vast majority of hypoglycemia episodes are caused by the health care system."

"I believe we are probably treating diabetes too aggressively on average in the U.S.," says Lee, who authored an invited commentary in the same issue of JAMA IM. "This is a major contributor to this epidemic of hypoglycemia. We have 100,000 ED visits a year because of it, and that's way too many."

A Call for More Precise Glucose Targets
Lee and Geller are both critical of the way the healthcare system now treats people with diabetes on several levels. A major problem is that while research in the last few years has highlighted problems when blood sugar gets too low, "lower is not better," and industry guidelines and quality measures don't spell that out.

"What I suggest we do first is, we shouldn't have a diabetes target of A1c of 'less than,' says Lee. "It should be a range, 6.5 to 7 or between 6.5 to 7.5." But this has not yet been incorporated in national guidelines set by the National Committee for Quality Assurance, nor is it yet a measure endorsed by the National Quality Forum.

Of special concern is the question the report raises about whether insulin should be prescribed at all for patients over age 80, especially those who take other medications that could cross react, and especially if their cognitive abilities make them unable to take the right dose in the right way all the time. While Geller says his research doesn't have the data to say yes or no to that question, Lee has a different view.

"Insulin should be avoided in most non-hospitalized adults older than 80 years," he wrote. "Most in this age group have significant comorbid conditions, functional limitations, and limited life expectancy." All it does for people at that age, he says, is expose them to "the immediate hypoglycemia risks with little chance of benefit. Although some persons in their 80s are unusually healthy and may benefit from insulin, most are likely to be harmed."

In recent months, the American Geriatrics Society has added this recommendation to its list of five in the "Choosing Wisely" campaign: "Avoid using medications to achieve hemoglobin A1c <7.5% in most adults age 65 and older; moderate control is generally better."

Lee says many organizations that establish quality benchmarks might want to see more research that expands results of a 2008 study, the ACCORD Trial. But that's been tough to finance, and most of the studies were supported by the pharmaceutical companies that make insulin, he says.

"It's not surprising to me that a for-profit company that is making medications is going to focus on the positive aspects of their products. And we can't expect anything else. That would be like asking Ford to tell us the worst thing about their cars. No, they're going to advertise the best things about their cars. That's just natural activity for a for-profit company."

The data about adverse consequences of some products comes out long after the initial trial. "In this case, after these medications have been in use awhile is when we get a much fuller sense of what the potential harms are. That's a weakness in our current system, but it's pretty clear that benefits are being reported much more assiduously than the evidence of harm," Lee says.

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