Thursday, November 22, 2018

NECC Pharmacist Under State Order


By Walter F. Roche Jr.

A pharmacist now on trial on racketeering and mail fraud charges has been the subject of a separate investigation by state regulators on charges stemming from his role in compounding drugs that were 100 times more potent than prescribed.
Under a six-page consent agreement Gene Svirskiy had his pharmacy license placed on probation for one year, but the probation was stayed for a year as long as Svirskiy complies with certain conditions including submitting periodic test results to the state. If he doesn't comply the stay could be lifted and he could face penalties ranging up to a license suspension.
Svirskiy is one of six former employees of the New England Compounding Center, facing the racketeering and mail fraud charges in a trial now being held in U.S. District Court in Boston, Mass.
After the six were arrested and arraigned in late 2014, Svirskiy, as a condition of his release, agreed not to engage in pharmacy compounding.
"Not to engage in compounding medications," the Order Setting Conditions for Release states.
Similar restrictions were placed on other defendants who were licensed NECC pharmacists or pharmacy technicians.
Svirskiy's lawyer Jeremy M. Sternberg, did not immediately respond to questions about the possible effect of the consent agreement, including Svirskiy's admissions, on his client's parole status.
Svirskiy and 13 others were indicted in December of 2014 following a two year federal investigation of the 2012 fungal meningitis outbreak that sickened nearly 800 patients in more than 20 states. Seventy-six of them, including 19 in Tennessee, died. NECC has been named by federal regulators as the source of fungus laden steroids that caused the deadly outbreak.
According to the consent agreement with the Massachusetts Board of Pharmacy, Svirskiy was a pharmacist employed at the Boulevard Pharmacy Compounding Center in Worcester, Mass. in 2016 when he was involved in compounding a drug used by patients with a thyroid condition.
Svirskiy, the agreement states, prepared an incorrect master formulation worksheet for liothyronine sodium and levothyroxine sodium aliquots." Another pharmacist then verified Svirsiky's incorrect calculation.
A pharmacist technician then prepared aliquots based on the incorrect worksheet resulting in aliquots that were 100 times more potent than required.
Subsequently the incorrectly compounded chemicals were used to fill prescriptions for two unnamed patients. The super-potent drugs were dispensed to the two patients, according to the agreement, in late January 2016, but were recalled after the errors were discovered by Svirskiy on Feb. 1.
The patients and prescribers were notified, the document states. It does not indicate whether the patients actually took the drugs and/or suffered any ill effects.
However, following the discovery, the pharmacy failed to notify state board officials as required. The manager in charge at the time for Boulevard Pharmacy was Joseph Rossetti, according to the agreement. Rossetti died last month.
Under the consent agreement, if Svirskiy complies with all the conditions the board "will not prosecute the complaint and the licensee shall have no history of discipline upon his records related to the complaint."
Testimony in the ongoing trial is scheduled to resume Monday before U.S. District Judge Richard G. Stearns. Svirskiy and the other five defendants now on trial were not charged with preparing the steroids blamed for the outbreak but for their roles in preparing other drugs at NECC.
Two co-defendants already have been convicted on racketeering and mail fraud charges and are serving federal prison sentences.
Svirskiy's consent agreement became effective Sept. 5 of this year, a little over a month before the current trial got underway.
Contact: wfrochejr999@gmail.com





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