Wednesday, Nov. 7, 2018
Emergency department physicians should exercise extreme caution when considering administration of Dsuvia, a powerful opioid newly approved by the Food and Drug Administration, said Kirk Cumpston, D.O., an associate professor in the Department of Emergency Medicine in the VCU School of Medicine.
Dsuvia is five to 10 times more powerful than fentanyl and 1,000 times more powerful than morphine, and can only be used in medically supervised settings such as emergency departments, surgical centers and hospitals. The drug is expected to be available in the U.S. in the first quarter of 2019 and was approved by the European Medicines Agency in June under the name Dzuveo.
Dsuvia is administered under the tongue and is already available as an intravenously delivered drug under the generic name sufentanil. Dsuvia may not be used for more than 72 hours and will have the same black box warnings about addiction risk and death as other opioids.
According to a statement from the FDA, the drug is “reserved for use in patients for whom alternative pain treatment options have not been tolerated, or are not expected to be tolerated, where existing treatment options have not provided adequate analgesia, or where these alternatives are not expected to provide adequate analgesia.”
In an interview with VCU News, Cumpston addresses how Dsuvia might impact care in emergency departments.
As an emergency department physician, are there any issues you foresee in administering Dsuvia?
I think this could be a problem in emergency departments because the drug may still be in effect in patients who are discharged. Patients may use other opioids or benzodiazepines after discharge, which could be a lethal combination when it stops them from breathing. Questions remain as to whether Dsuvia use could lead to opioid use disorder in an opioid naïve person or intensify the addiction in someone who already has opioid use disorder.
Before sufentanil was delivered sublingually, (under the tongue) physicians never dealt with such a potent oral opioid. So this really changes things a lot. No one has really been trained on how to use Dsuvia. It’s going to require a lot of safety precautions such as having naloxone (the opioid overdose reversal drug) on hand in case there is over sedation or respiratory depression. When a person comes into the emergency department, you don’t know what drugs they are already using or when they last used them. You’re taking their word for what the situation is and that may not be accurate.
How would you evaluate the effectiveness of pain treatment in emergency rooms since awareness of opioid abuse has increased?
The problem with a patient in pain is accurately assessing the amount of pain that they have. Since there is no way to measure that objectively, it depends on what the patient tells you. We try to quantify pain with the pain scale or other methods but we have no way to objectively measure pain, which compounds the problem in the emergency department. We often have no records on patients who have been seen at other facilities. In the case of Dsuvia, since the drug is not prescribed, it sounds as if its use would not be documented in the Prescription Monitoring Program. So we would not necessarily know if a patient received Dsuvia at another hospital.
Is Dsuvia the first opioid to be approved since the start of the opioid crisis?
The answer depends on when one would say the epidemic started. There have been approved abuse deterrent opioids. Abuse deterrent drugs are usually formulated in a way where you can’t crush them for intravenous use or they contain the reversal agent naloxone. The irony with that is they do not really prevent abuse. People figure out how to get around the deterrent and abuse the drug.