CUMBERLAND — Without knowing, up until a few days ago, Cumberland police and countless local residents might have been using faulty devices that deliver naloxone, an opioid overdose antidote. The devices were recalled nearly six months ago due to a risk of serious injury or death. Frostburg police on Sunday said they were unaware of the recall.
The manufacturer of the devices, Teleflex Medical Inc., on Oct. 27 sent an “urgent” recall notification to its distributors of the products.
The failure of the devices to properly deliver medication “can lead to serious injury or death in certain emergency situations,” the notification stated and noted that the company had received complaints about the atomizers malfunctioning.
On Nov. 18, the Maryland Department of Health and Mental Hygiene notified all county health departments of the recall.
"Although naloxone still will act to reverse an opioid overdose, defective devices may cause a risk of under-dosing of naloxone during nasal administration," the DHMH's website states.
The notification stated there were 32 defective atomizers and urged health departments to check stock and replace equipment.
That includes the Allegany County Health Department, which supplies naloxone kits that include atomizers to local law enforcement, as well as the public via an annual grant.
“All of the local health departments are authorized as Overdose Response Programs to conduct training and distribute naloxone,” Christopher Garrett, director of DHMH’s office of communications, said via email. “When we learned of the recall, we issued a press release … and sent an email notification to all our authorized programs. We frequently sent updates by email to all programs on the status of the recall and response.”
This week, nearly half a year after the DHMH notified county health departments, Cumberland police and local residents were still using defective atomizers.
As of April 12, Cumberland police had responded to 49 overdoses and administered naloxone to more than half of them.
Eleven of the 49 overdose victims died.
On Monday, just hours after the Cumberland Times-News contacted local police and the health department to ask about the recall, PharmaCare — the pharmacy used by ACHD to fill naloxone prescriptions — emailed local law enforcement, with the exception of Frostburg police, and asked them to check numbers on their atomizers to see if they’re on the recall list.
Cumberland Police Lt. Chuck Ternent said that was the first time his department had heard of the recall.
"I was not aware," Ternent said. “If we find any atomizers that have been recalled, the officer is to go to the pharmacy immediately and switch it for a new one.”
Cumberland Police Lt. James Burt said on Tuesday, “We are exchanging them as we speak.”
Atomizer's are used to administer naloxone through the nose. The drug can also be given intravenously. However, local law enforcement must rely on the atomizer.
"Our police officers do not have advanced medical training like the fire department paramedics,” Ternent said.
“In order to do (an invasive) medical procedure like needle drug delivery on another person, the administrator is required to have advanced medical training, which we do not have," Ternent, said.
Nearly three months after the recall, local resident John Apple in February attended an ACHD naloxone training event where he was given a kit with an atomizer.
"People should have been informed that the nasal injector does not work,” Apple said after he recently learned of the recall.
“You … go to this class to get certified to save someone’s life and you're given the materials to do so but they don't work properly,” Apple said. “(That’s) a big mess up.”
As of April 25, Apple had not received official notification of the faulty device or how to replace it.
On Monday, when asked by CTN via email if the Allegany Health Department was aware of the recall, Becky Meyers, ACHD’s director of outpatient addictions, replied, “I’m looking into this.”
On Tuesday, Meyers said the defective devices have been isolated.
"There were multiple lot numbers involved in this recall," Meyers said. "Some lots we provided were affected, some were not. Our supplier has quarantined the affected lot numbers, returned the affected lots to Teleflex and has received a new batch of atomizers that are not affected by the recall."
She also emailed, “Obviously, with the amount of training and supply we have completed and distributed, we have had and will have trainees with affected lot numbers.”
PharmaCare will replace defective atomizers, Meyers said and urged the public to contact the pharmacy in the hospital at Willowbrook Road to return the faulty devices.
“In the interest of public and patient safety, we suggest and encourage to still give the Narcan even if unsure about your atomizer,” Meyers said via email. “It’s better to receive some medication than none at all.”
Sgt. Irvin Buskirk at the Frostburg Police Department, for now, plans to follow that suggestion.
On Sunday, he said he had not heard of the recall and was not aware that any of his fellow officers had either.
Buskirk said he talked to officers on all shifts and none mentioned the email notification of the recall from PharmaCare.
Frostburg police get their atomizers from ACHD.
"As far as I know, no one here knows about (the recall),” Buskirk said. "By the time this stuff dwindles down to the working ant it takes a while … (The system) is flawed."
He said until replacements can be secured, he will use the atomizers he has.
"If I get a call for an (overdose) right now, I’m using it,” he said.
Frostburg Police Chief Royce Douty on Sunday said no email regarding the recall was sent to his department.
Thom Duddy is executive director of communications for Adapt Pharma — maker of NARCAN Nasal Spray, which is the first and only nasal form of naloxone approved by the Food and Drug Administration for the emergency treatment of a known or suspected opioid overdose.
The NARCAN nasal device does not require assembly, which is important for individuals without medical experience including police officers and the members of the public, Duddy said.
"We designed it for anyone to use,” he said.
However, more problems plague the overdose epidemic, Duddy said.
"We don't just have heroin today, we have fentanyl," he said.
According to the Centers for Disease Control and Prevention, more naloxone is required to help people who overdose on synthetic opioids such as fentanyl, Duddy said.
Fentanyl, according to the National Institute on Drug Abuse, is similar to morphine but 50 to 100 times more potent.
Additionally, DHMH recently issued a statement to inform the public that at least three recent Maryland opioid-related overdoses were due to a potent synthetic opioid known as carfentanil, an elephant tranquilizer that’s 10,000 times stronger than morphine.
According to the statement, one death occurred in Frederick and the other two Anne Arundel counties.
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• Teresa McMinn, Cumberland Times-News Digital Editor, email@example.com, 301-707-9673 (mobile)