Med Save under investigation by Kentucky authorities after allegations of ‘non-compliance’

The Kentucky Board of Pharmacy is investigating Med Save in “several areas of non-compliance” after the hospitalization of three children in Henry County.

An investigation into the pharmacy’s practices began Monday, with cooperation, after the board received notification of an alleged compounded medication error.

According to a news release from the board, violations of state and federal law were found, including the lack of documented training for employees, lack of appropriate pharmacy oversight and lack of verification or sufficient documents for compounding preparations, procedures, records and storage.

The Board of Pharmacy follows United States Pharmacopeia standards for pharmaceutical compounding, the FDA standard, and an emergency meeting was called by the case review panel Wednesday. Med Save then signed an order to stop the compounding and dispensing of medications like clonidine.

According to the FDA website, pharmaceutical compounding is done when “a patient who cannot be treated with an FDA-approved medication, such as a patient who has an allergy to a certain dye and needs a medication to be made without it, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form.” 

The ongoing investigation follows the hospitalization of three children who were prescribed compounded clonidine oral suspension at the Eminence, Kentucky, pharmacy. The board believes the incident is isolated to the Med Save location and only the three patients were impacted.

“The Kentucky Board of Pharmacy assures the public that we hold the pharmacy accountable for practicing outside the standard of practice for a compounding pharmacy,” the board stated.

The board asks anyone similarly impacted to report it immediately.

Med Save was not available for immediate comment.

Kentucky Kentucky authorities investigate incident hospitalizing 3 children