A Kentucky doctor's medical license was placed on probation for five years after his wife improperly handled flu vaccines and wrote prescriptions under his name, according to Kentucky's medical licensing board.
The state Board of Medical Licensure ordered Dr. Paul McLaughlin's medical license to be placed on probation after multiple patients reported nodules appearing after receiving a flu shot in October and November 2018.
The patients were given the shots at the Location Vaccination clinic in Mount Sterling, about 35 miles east of Lexington, which is owned and operated by McLaughlin's wife, according to the order.
After the clinic received calls reporting adverse reactions from at least 16 patients, McLaughlin's wife, Fairshinda McLaughlin, began prescribing short-term antibiotics to treat the reactions, the order said. The antibiotics were prescribed under Dr. Paul McLaughlin's name and without the patients being physically assessed, according to the order.
Paul McLaughlin was fined $5,000 and must reimburse the board $1,793.75, the order said. He also must pass a course addressing medical ethics and misconduct, complete five hours of continuing medical education on vaccine administration and create a written policy for storage and administration of vaccines and protocols should adverse reactions occur, according to the order.
The board issued the order after hearing a report from the Kentucky Department of Public Health, which said the outbreak of adverse reactions was "likely due to the preparation, storage and/or handling practices" at the clinic. KDPH also said that the clinic's operator and those who handled and administered the vaccines were all unlicensed medical professionals.
Paul McLaughlin appeared before a medical licensing board panel on June 20, 2019, and said he and his wife became aware of the outbreak of adverse reactions during Thanksgiving week of 2018. But the board noted that many of the prescriptions were written before Thanksgiving.
The board also said in its order that records from the Centers for Disease Control and Prevention showed the clinic contacted the CDC on November 5, 2018, and reported that 16 patients had abscess nodules nearly a month after receiving the flu shot.
The board order says the caller was told to contact the Kentucky Immunization Program in the Vaccine Adverse Event Reporting System, or VAERS, to submit a report but a report was never submitted.
CDC records showed that a clinic staffer called the CDC on November 13 and asked if the CDC could test the needles to see if there were any issues with the equipment used to administer the vaccines.
The CDC told the caller that syringes could be submitted to local, county or state health department for testing but nothing was submitted for testing.
By December, at least three patients were treated by the Clark County Health Department for reactions from the vaccinations they received at Location Vaccination. The department reported the reactions to the Montgomery County Health Department, which contacted the medical office and confirmed there was an outbreak of adverse reactions, but no information had been reported to VAERS.
KDPH then interviewed Paul McLaughlin about the reactions. He confirmed that he was aware of the reactions and that he had received a vaccination and suffered a reaction that resolved with antibiotic treatment. He also said the CDC was contacted but it "wasn't really interested."
In December 2018, KDPH sent a letter about the outbreak of reactions to patients who may have been injected with the vaccine. The department then began receiving calls from patients saying the doctor's wife was contacting them directly and calling in prescriptions for antibiotics and steroids without any physical assessment or testing.
If antibiotics are prescribed inappropriately, there could be serious consequences, the order said.
According to KDPH, it was unclear whether Paul McLaughlin knew that his wife was calling in prescriptions, but the prescriptions were submitted under his name and license.
The medical licensing board said McLaughlin had delegated his medical responsibilities to an unlicensed medical professional and his failure to address the outbreak of adverse reactions had contributed to a public health crisis.
According to the order, Paul McLaughlin denied that he had delegated his medical responsibilities or reacted inappropriately to the vaccination reactions. In a statement, an attorney for McLaughlin denied any wrongdoing on the doctor's part and suggested the adverse reactions could have been a result of "well recognized side-effects associated with most vaccines."
The attorney's statement also said the board has not restricted the doctor's license but sets out the "unproven accusation of others."
According to the order, if the board determines that Paul McLaughlin has violated any terms of the order, he may face additional punishment, including having his license revoked.