Mass. governor proposes new compounding pharmacy legislation
BOSTON — Massachusetts Gov. Deval Patrick has introduced legislation that would give the state government broader power over compounding pharmacies, the governor’s office announced.
Patrick’s legislation would reform the board of pharmacy by requiring special licensing for sterile compounding; authorizing the pharmacy board to assess fines against pharmacies that violate policies while creating whistleblower protections for pharmacists and other staff; requiring licensing for pharmacies out of state that deliver and dispense medications within Massachusetts; and establishing a clear process to restructure and reorganize the board’s membership to include four pharmacists, as well as several non-pharmacists, including one nurse, one physician, one pharmacy technician, one quality-improvement expert and three public members.
The legislation is based on recommendations from the state Commission on Pharmacy Compounding, which Patrick established in October 2012 amid a nationwide outbreak of fungal meningitis traced to contaminated injectable steroids prepared at the Framingham, Mass.-based New England Compounding Center. That epidemic has sickened 656 people and killed 39 in 19 states as of Monday, according to the Centers for Disease Control and Prevention.
"There is no action that we in government can take to prevent all abuses in all industries, but we must do what we can," Patrick said. "This legislation makes patient safety paramount and will help fill the gaps in compounding pharmacy monitoring that allowed NECC to operate in the shadows. Together, these changes can ensure that the tragic events of last fall never happen again."
In addition, Patrick will direct the Department of Public Health to increase inspection staff at the Board of Pharmacy and require that all inspectors be pharmacists with at least five years’ clinical experience, as well as additional training for inspectors working in sterile compounding. Another rule will require sterile compounding pharmacies to report volume and distribution, alerting the Board of Pharmacy when a pharmacy is acting like a manufacturer, which requires a Food and Drug Administration license.
Athenahealth to acquire mobile health app provider
WATERTOWN, Mass. — A company that provides cloud-based electronic health record, practice management and care-coordination services is buying a developer of point-of-care mobile health applications for physicians.
Athenahealth announced Monday that it would buy Epocrates for about $293 million, or $11.75 per share. The deal for Epocrates, used by more than 330,000 physicians, is expected to close in second quarter 2013, pending approval from Epocrates’ shareholders and other conditions.
"I have been an admirer of Epocrates since it first emerged and have watched the company grow consistently, one app download at a time, as it has cemented itself in to the consciousness of America’s physicians," Athenahealth president, chairman and CEO Jonathan Bush said. "No other company has been able to replicate the brand awareness, familiarity and trust that Epocrates has across the clinical mobile user base."
Prasco launches authorized generic version of Lysteda
CINCINNATI, Ohio — Drug maker Prasco Labs has launched an authorized generic version of a drug used to treat heavy menstrual bleeding, the company said Monday.
Prasco announced the launch of tranexamic acid tablets in the 650 mg strength, an authorized generic version of Ferring Pharmaceuticals’ Lysteda. Authorized generics are branded drugs marketed under their generic names at a discount, usually through third-party companies, to compete with Food and Drug Administration-approved generics.
"We are pleased to welcome Ferring Pharmaceuticals into Prasco’s family of brand partners with the introduction of the authorized generic of Lysteda tablets," Prasco CEO Chris Arington said. "With the choice of tranexamic acid tablets, customers benefit from the same consistent supply and quality of the brand they are accustomed to."