Meningitis-linked firm sold drugs without prescriptions: emails

October 13, 2012|Toni Clarke and Aaron Pressman | Reuters

Its "pharmacy license did not allow it to ship large quantities for general use," Michigan Attorney General Bill Schuette said on Friday as the state suspended the company's license and opened an investigation. If found guilty of violating the Michigan public health code, officials of NECC, which produced the tainted steroid linked to the scandal, could face a prison sentence, the attorney general's complaint said.

Several other states including Indiana, Minnesota and Ohio are investigating the company. Still others, including New Hampshire and the hardest hit state of Tennessee, have scheduled administrative hearings on possible violations.

Massachusetts prohibits pharmacies such as NECC, which create drugs that are unavailable from pharmaceutical companies, from selling medications without being in receipt of a prescription. It is not illegal, however, for healthcare providers to buy in bulk from licensed pharmacies, of which NECC was one.

Emails between NewSouth NeuroSpine and NECC show NECC solicited bulk orders with the promise of lower costs in return for higher ordering volume - sometimes offering competitive price quotes for drugs that had not been ordered by the physician.

In July, Barron offered in an email to supply NewSouth NeuroSpine with 50 vials per month of a steroid at a cost of $20 per vial.

"If you are using approximately 50 per month your total yearly savings, if sourced through NECC, would be $4,500," Barron said in an email.

Frank York, the chief executive of NewSouth, told Reuters the center did not order or purchase the steroid from NECC. The products it ordered, he said, included items such as a contrast agent used in X-rays that the center could not get elsewhere in the dosages it needed and were provided without prescriptions.

And while the physicians were asked by NECC to fill out a "Prescription Order Form," the form acted more as a bulk ordering form than a standard physician's prescription, York said.

In one email, Barron asked the clinic to provide NECC with a list of patients scheduled for upcoming procedures "to correspond with the medication."

"If you are ordering 75 units we will need a representation of patients that you plan to use the medication on," Barron said in the email. "If one day's schedule has close to 75 patients that will be acceptable to fulfill the order. If it is easier for you to provide a simple list of names that would be OK too."

The clinic did not provide its schedule to NECC for patient privacy reasons, according to York, who added that the clinic did not receive any of the tainted steroid implicated in the meningitis outbreak.

Even without the names or individual prescriptions, however, NECC continued to supply NewSouth, York said.

Massachusetts health officials said at a press briefing on Thursday that NECC appears to have been operating in violation of the state's compounding pharmacy licensing requirements, though they did not go into detail.

"This organization chose to apparently violate the licensing requirements under which they were allowed to operate," Madeleine Biondolillo, director of the Bureau of Health Care and Safety at the Massachusetts Department of Public Health, said on a call with reporters on Thursday.

State and federal regulators in the briefing declined to say whether they previously knew about NECC's bulk sales to entities including the U.S. Department of Veterans Affairs. They said investigations were ongoing.

Regulators were not immediately available to comment on NECC's interactions with Ameridose.

While Massachusetts conducts periodic inspections of compounding pharmacies, the state does not track the volume of medications prepared and distributed at its licensed pharmacies, Biondolillo said.