EMINENCE, Ky. (WDRB) -- At least three children were hospitalized after taking prescription medication from a pharmacy in Eminence, according to the Kentucky Board of Pharmacy.
The board is now investigating.
"The allegation is specifically that there was a medication error regarding a compounded version of clonidine oral solution, or a liquid medication, that was made at the pharmacy. And the allegation is that there was an error made that resulted in three pediatric patient hospitalizations," said Christopher Harlow, executive director of the Kentucky Board of Pharmacy.
Over the weekend, Henry County EMS to post a message on Facebook with this warning: "If your child has been prescribed clonidine oral suspension and it was filled at Med Save in Eminence, DO NOT administer it to your child. We have reason to believe that there is something wrong with their shipment. DO NOT USE."
According to the National Institutes for Health website, clonidine is "an antihypertensive drug that lowers blood pressure and heart rate by relaxing the arteries and increasing the blood supply to the heart; it has other FDA-approved indications such as treatment of attention deficit hyperactivity disorder (ADHD) in children; management of tics commonly found with Tourette syndrome; and adjunct therapy for severing cancer-related pain."
WDRB News went to Henry County Monday, but no one from Med Save pharmacy in Eminence would agree to an interview. In a phone call to the pharmacy Tuesday, a man who identified himself as the owner said he was not commenting.
Harlow said the Kentucky Board of Pharmacy learned about the local health alert from EMS on Monday, and also received several phone calls.
"We immediately deployed our inspection staff to investigate the situation," he said.
Beth and Ian Burkett said their 21-month-old son, Henry, is back home after being in the hospital in Louisville all weekend.
Ian Burkett said after giving Henry his typical dose of liquid clonidine Friday night, Henry quickly became so drowsy he couldn't respond to questions or sit up on his own.
"It seemed like he was having a reaction to his medicine because it was a brand new bottle that he had just started," Ian Burkett said. "This was the first dose out of it. And it wasn't affecting him like it normally does."
Henry was taken by ambulance to Norton Children's in downtown Louisville. His parents said he was discharged from the hospital Monday afternoon, but still has a "long road" ahead.
"It was definitely an overdose because he received Narcan on the way to the hospital," Ian Burkett said. "And then he actually received the maximum amount of Narcan in the ER that he was allowed to have."
He said Henry was then sedated, intubated and put on a ventilator.
Ian Burkett said Henry has been taking clonidine for months and has never had a reaction like this before. He said they picked up the medication from Med Save pharmacy in Eminence.
"It's a compounded medicine and there's not many pharmacies in the area that do compounding," he said. "I mean, we have two or three pharmacies in Eminence that are available to us and Med Save is the only one that can fulfill that prescription."
He's now talking to Henry's doctor about other medications that could work for their son.
"... Because we're definitely not ever going to trust another pharmacy to do a compound medicine, especially for him," Ian Burkett said.
Tabitha Drew said a similar situation happened with her 5-year-old daughter, who was also hospitalized in downtown Louisville.
Drew said over the weekend, she gave her daughter clonidine she had picked up from the same pharmacy.
"Her eyes rolled to the back of her head," Drew said. "She would not talk to me. I kept tapping her leg, you know, 'please talk to me, open your eyes, do anything.' She wouldn't answer me."
The Kentucky Board of Pharmacy said there are still several questions that need answers.
"It's our job to find out what happened and to really ensure the safety of people of Kentucky," said Harlow.
Harlow said the board believes the situation was isolated to Med Save pharmacy in Eminence, related to a specific compounded medication.
"We have no reason to believe that parents should be concerned if they're getting compounded medications from other pharmacies. We have no other reports of quality concerns out of other compounding pharmacies at this time," he said.
He said a typical investigation would include reviewing records and conducting interviews. He said everyone has been very cooperative with the investigation.
"What we're going to do is find the root cause," Harlow said. "And if there was an error made, we will work with the pharmacy and take appropriate action whether it's related to corrective action, whether it's related to development of quality assurance, whether it's training. Let us do our job and find the root cause and the hope is that this doesn't happen to anyone else."
Harlow said the board is working to answer several questions:
"Was it related to the ingredients? Was it related to the compounding? The dispensing? The dosing? So, really we're looking at all facets of where the error occurred and then we will take appropriate action, if needed," he said.
Henry's parents said this has been traumatic for them and their son.
"We want answers, we want people to be held accountable," Ian Burkett said. "So this doesn't happen again."
The Kentucky Board of Pharmacy said there's no timeline on the investigation but it's working quickly.
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