'Engineering overkill': A potent new opioid painkiller is trying to solve a problem that doesn't exist, doctors say

• The government's leading food and drug authority recently approved a potent new opioid called Dsuvia that dissolves under the tongue and can be taken without an IV.
• Several experts strongly opposed the approval, which came amidst an epidemic of opioid overdose deaths and addiction.
• The CEO of the company behind the drug said she created it to keep people from being "one step away from being killed by a tired nurse or a doctor who ordered the wrong drug."
• But it's unclear how big of a problem deaths from medication mistakes involving opioids actually are.
• More importantly, an easier solution to that problem would involve simple labeling changes, doctors said.

Throughout Pamela Palmer's career as chief medical officer of a specialty hospital for pain management, she repeatedly served as an expert witness in wrongful death lawsuits involving opioids. In many of those suits, she said, people died because of a simple and avoidable medication error, where a clinician had accidentally given a patient the wrong liquid opioid.

"The problem is, morphine looks like fentanyl looks like dilaudid," Palmer told Business Insider. "They all look the same."

An anesthesiologist by training, Palmer created a new formulation of an opioid, called Dsuvia, explicitly to avoid these kinds of accidental deaths.

The drug was approved by by the Food and Drug Administration on November 2. It's a tiny blue tablet, packaged in a special single-use applicator, that dissolves under the tongue and begins working to relieve pain in under an hour.

"It dawned on me - what if we could design an oral form of these drugs that worked as quickly as the liquid, but basically you weren't one step away from being killed by a tired nurse or a doctor who ordered the wrong drug," Palmer said. "You could have almost a fool-proof way of treating someone."

In addition, Palmer said the new drug would help patients whose pain can't be treated efficiently with an IV or an injection, such as soldiers on the battlefield or patients whose veins are difficult to find.

In a statement announcing the new drug's approval, FDA commissioner Scott Gottlieb echoed this reasoning. He also said the Pentagon had "worked closely" with Palmer's company to develop the drug for use on the battlefield, where it would fill what he called a "specific and important, but limited, unmet medical need."

Many emergency room doctors appear to disagree with the need for yet another opioid, however.

While some of them aren't necessarily opposed to the approval of a new opioid (thousands of patients need them, even as thousands more are dying from addiction), many of them say Dsuvia aims to solve a set of problems that doesn't exist - at least not at the magnitude in which Palmer presented it.

More importantly, the experts said, there are easier and simpler ways to prevent mistakes and help make sure that doctors are giving patients the right dose of pain relievers.

Dsuvia is 'not a game-changer'

One of the critics is Raeford Brown, an anesthesiologist at the University of Kentucky and the chair of the FDA advisory committee that voted in favor of the drug while he was absent. Brown, who also leads a consumer advocacy group called Public Citizen, told NPR that he was not present for the vote because of a scheduling conflict.

"We have worked very diligently over the last three or four years to try to improve the public health, to reduce the number of potent opioids on the street," Brown told NPR. "I don't think this is going to help us in any way."

Dsuvia is a different formulation of an already available drug called sufentanil, which is used as an anesthetic for surgeries and other invasive medical procedures. While sufentanil must be injected or delivered via an IV, Dsuvia can be taken orally.

"We've taken a wonderful old drug and delivered it in a way that's user-friendly. An ER doctor could never have used it before," Palmer said.

Yet because so many other opioids already exist, Dsuvia is unnecessary, several physicians said. The benefits of a single-use package, and of a new way of giving the painkiller, aren't particularly significant, they said.

"I agree that patients need to be treated for pain, but I don't think this solves that problem except maybe in a very incremental way," Jeremy Samuel Faust, an attending physician in the department of emergency medicine at Brigham and Women's Hospital in Boston and an instructor at Harvard Medical School, told Business Insider.

"It's not a game-changer," he added.

'Like engineering overkill'

Because of the wide range of available opioids and the frequency with which they are given, medical dosing errors do happen. Dosing errors include situations where the wrong type or dose of medication is given to a patient and they're either under-treated for their pain or given too much medication, potentially injuring or killing them.

Good data on just how frequent these errors are and how often they harm or even kill patients is lacking. A 2012 report authored by the nonprofit healthcare accreditation organization the Joint Commission suggested that while the errors were common, they could not determine how frequently they were fatal.

"Of the opioid-related adverse drug events - including deaths - that occurred in hospitals and were reported to The Joint Commission's Sentinel Event database (2004-2011), 47% were wrong dose medication errors," the report read.

If the main problem with current opioids is that they are easily mixed up, physicians say there are much simpler solutions than introducing a more potent oral opioid.

"If the real concern is the wrong bottle, why not color-code the bottles?" asked Ernest Rasyidi, a psychiatrist in the emergency clinician decision unit at St. Joseph Hospital in Orange, California.

"There are plenty of low-cost solutions out there if this is a systems problem," Rasyidi said. "But this would be a very complicated and round-about way of solving that issue. It's like engineering overkill."

Faust agreed.

"Medication errors are a problem but I wouldn't say that the solution is adding another medication that's packaged differently. Why not better labeling?"

But Palmer believes Dsuvia solves a problem that isn't currently being addressed.

"The future is Dsuvia. It's not starting an IV and giving a liquid that even has the remotest possibility of being confused for another drug," she said.

She compared the need for new and better opioids to the car industry.

"They're dangerous but they're necessary," Palmer said.

"When you have something dangerous but necessary, you have to innovate."

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