By Walter F. Roche, The Tennessean
Tennessee officials say that the owners of the Massachusetts drug compounding firm blamed in the death of 13 Tennessee patients failed to report a formal disciplinary action in another state more than a year before the current fungal meningitis outbreak.
Woody McMillin, spokesman for the Tennessee Department of Health, said Friday that officials of New England Compounding failed to report to the state Pharmacy Board that the firm had been the subject of an April 15, 2011, cease-and-desist order by Colorado regulators.
"The way the cease-and-desist order is written, our staff believes this formal discipline should have been reported to us," McMillin said.
If it had been reported, the spokesman said, the agency would have opened a complaint against the company and presented a recommendation for disciplinary action to the state Pharmacy Board.
Under board rules, the failure to report the discipline could have triggered a wide array of penalties ranging from a reprimand to a fine or a cease-and-desist order, similar to that issued in Colorado.
McMillin said the staff would then have followed up to implement whatever penalty, if any, the board chose to impose.
In Colorado, New England Compounding was ordered to cease and desist from sending compounded drugs into the state without a patient specific prescription as required under state and federal law.
The order was issued after a Colorado inspector discovered that New England had shipped drugs to a Denver-area hospital without a prescription.
According to the federal Centers for Disease Control and Prevention, there have been no cases of fungal meningitis reported in that state during the current outbreak.
1 more sick in TN
Regulators in Massachusetts have said that New England Compounding sent thousands of doses of methylprednisolone acetate to Tennessee and other states without patient-specific prescriptions.
The disclosure of New England Compounding's failure to report the Colorado action to Tennessee regulators came as the CDC disclosed that one more Tennessee patient has been stricken with fungal meningitis. That brings to 82 the total number of patients who have contracted the disease as a result of the tainted spinal steroid.
The CDC report shows the number of deaths in Tennessee from the outbreak remains at 13. The last report was on Wednesday.
Nationwide the number of meningitis infections rose from 461 to 480, while the number of deaths increased by one to 33.
The largest number of cases continues to be in Michigan, where the number of patients infected jumped from 148 to 158. Michigan has had eight deaths, second only to Tennessee.
Other states reporting new infections include Indiana, New Jersey and Ohio. Indiana also reported one new death, pushing its total to five, third highest in the country.