NASHVILLE, Tenn. (AP) — The Tennessee Board of Pharmacy says it has adopted new regulations for compounding pharmacies licensed by the state following recent outbreaks of illnesses associated with tainted medicines created at these specialty pharmacies.
The Pharmacy Board said in a news release that the new rules will improve safeguards for public health while also ensuring that drugs in short supply will be available. Compounding pharmacies mix custom formulations of drugs based on doctors’ specifications.
The board said the changes include expedited suspension of sterile compounding by a pharmacy or manufacturer after a serious problem is discovered and adding sterile compounding registration to licenses issued by the state.
News release from TennCare:
NASHVILLE – The Bureau of TennCare has selected Magellan Health Services as the new Pharmacy Benefits Manager (PBM) for the state Medicaid program. The three-year, $35 million contract was awarded in December 2012, signaling the start of six months of extensive preparation and readiness reviews. The transition from Catamaran, TennCare’s current PBM, to Magellan will take effect June 1, 2013.
The TennCare PBM administers the pharmacy claims system which is an online system that processes all pharmacy transactions, administers TennCare’s Preferred Drug List and negotiates rebates and discounts with drug manufacturers.
“We have been able to control pharmacy spending in the TennCare program through effective management of our pharmacy benefit,” said Health Care Finance and Administration Deputy Commissioner Darin Gordon. “We look forward to working with Magellan to continue providing excellent service to our members as well as appropriately managing pharmacy costs.”
Magellan Health Services was selected through a competitive bid process in which bidders were evaluated on a combination of technical expertise and cost.
“We are very confident in the new partnership with Magellan Health Services,” said TennCare Pharmacy Director Bryan Leibowitz. “We are working to ensure a smooth transition for our providers and members.”
The contract with Magellan is a three-year contract with two one-year extension options. In addition to TennCare, Magellan serves 40 health plans, several pharmaceutical manufacturers and other state Medicaid programs in their pharmaceutical segment of business.
TennCare is the state’s Medicaid program that provides health care for 1.2 million Tennesseans.
A state panel is chomping at the bit to punish the compounding pharmacy responsible for an outbreak of fungal meningitis that has killed nine Tennesseans, reports WPLN. But the Board of Pharmacy was barred from assessing penalties at a special-called meeting Tuesday.
Barry Cadden – co-founder of the New England Compounding Center – voluntarily surrendered his state license in a negotiated agreement. The deal does permit the state to fine Cadden, but the board of pharmacy’s attorney says that will have to wait. For one, they still don’t know exactly how many tainted vials were shipped to Tennessee.
Board member Joyce McDaniel – the one non-pharmacist on the panel – wanted to go forward anyway.
“I would have thought by now we would have a number of vials because we can do $1,000 per vial and know how many of those vials actually had prescriptions with them. I mean, I’m ready to do the fines today.”
According to the state Department of Health, more than 2,500 injectable steroid doses were shipped to Tennessee, though not all were used. More compounded drugs are also now in question after investigation by federal authorities.
The Tennessee Board of Pharmacy’s attorney says there will eventually be fines and – in his words – they will be “significant.”