Investigation ongoing into 'alleged medication error' at Med Save Pharmacy in Eminence

EMINENCE, Ky. (WDRB) -- The investigation to an "alleged medication error" continues in Henry County.

In an emergency called meeting on Aug. 28, the Kentucky Board of Pharmacy ordered Med Save Pharmacy in Eminence to "cease all compounding and dispensing of compounded medications." The order was signed by the pharmacy that day and is in effect.

This comes after the state board of pharmacy said: "The alleged medication error led to the hospitalization of three children who were dispensed a compounded clonidine oral suspension."

The incident appears isolated to Med Save Pharmacy in Eminence, investigators believe, and only affected those three kids.

An inspection done by the state board Aug. 26 came back with "significant findings" that weren't in compliance with state and federal law, the board said Thursday. Those include:

Lack of documented training of pharmacy personnel
Lack of appropriate pharmacist oversight, including the verification by a pharmacist of compounding procedures and final compounded preparations
Missing or inappropriate documentation for compounding records and pharmaceutical ingredient storage condition

"The lack of documentation was specific to the training of the pharmacy personnel involved in compounding as well as storage conditions of the ingredients used in compounding," Christopher Harlow, executive director of the Kentucky Board of Pharmacy, said on Friday. "... There was what appeared to be inaccurate or missing information on their formula records. We also ... had concerns of whether or not there was appropriate pharmacist oversight of the compounding practices and the checking and verification of the final products."

According to the FDA, compounding "is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient."

Information provided by the Kentucky Board of Pharmacy shows only one other pharmacy in Eminence — the CVS on North Main Street — is able to do non-sterile compounding.

Med Save Pharmacy in Eminence, Kentucky. *(WDRB photo from Friday, Aug. 30. 2024)*

Harlow said there's no timeline for Med Save in Eminence to begin compounding again.

"If Med Save in Eminence wants to compound again, they will need to prove to the board that they are in compliance with state and federal law," Harlow said Friday. "And then they would have to come before the board, and the board would then make a decision whether to release them from that order."

Despite multiple requests for an interview earlier in the week and again on Friday, Med Save in Eminence has continued to decline to comment. Harlow said the pharmacy is still open, but no longer compounding.

One woman said she learned about the investigation from a friend and said she's praying for the kids who were hospitalized.

"I just feel bad for them," said Maria Berry, who lives in Henry County. "Hopefully, they can find out what happened."

Last weekend, the Henry County EMS posted 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."

The Kentucky Board of Pharmacy said it soon began the investigation.

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."

Friday, Harlow said the investigation is still ongoing.

"We are still collecting and gathering all the information needed to fully find the root cause of the alleged medication error," he said.

He said the pharmacy is cooperating with the investigation.

'Definitely an overdose'

Beth and Ian Burkett said Tuesday that their 21-month-old son, Henry, was back home after being in the hospital in Louisville over the weekend. Ian Burkett said after giving Henry his typical dose of liquid clonidine on Aug. 23, 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 Burkett *(photo provided by family on Aug. 27, 2024)*

Ian Burkett said Henry has been taking liquid 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.

Henry was taken by ambulance to Norton Children's in downtown Louisville. His parents said despite being discharged, he 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.

Aug. 30, Henry's parents said he's steadily working through is recovery and improving daily.

Another parent, Tabitha Drew said an ambulance rushed her 5-year-old daughter Rayven Winters from Henry County to Norton Children's Hospital in downtown Louisville on Sunday night.

She said she picked up a prescription for clonidine at Med Save in Eminence and gave it to her daughter, who soon became unresponsive.

"Within 10 minutes of her having it, she looked at me and said, 'Mommy, I'm very sleepy,' then she rubbed her eyes and passed out," Drew said.

Drew said Rayven has been in the hospital since last Sunday, but the child is expected to return home on Saturday.

"If anyone has received a compounded medication from Med Save in Eminence, you know, we would advise that they contact their doctor and find an alternative pharmacy," Harlow said Friday.

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