Lansing— New state restrictions on compounding pharmacies are being proposed in the wake of a national outbreak of drug-induced meningitis that involved 264 patients and 19 deaths in Michigan.
State Attorney General Bill Schuette, state Sen. Joe Hune and Department of Licensing and Regulatory Affairs director Steve Arwood announced legislation Thursday to:
■Require Michigan compounding facilities to have on-site pharmacists responsible for compliance with state laws and standards.
■Mandate detailed records of all products handled by the pharmacies.
■Require criminal background checks for pharmacy owners not yet licensed in Michigan or licensed before Oct. 1, 2008.
■Mandate at least one inspection per two-year licensing cycle for each facility.
Hune, R-Whitmore Lake, said he will sponsor the legislation, which “is necessary and imperative ... to assure the safety of the citizens of the great state of Michigan.”
Schuette said Michigan is the national “epicenter” of meningitis complications and deaths traced to pain medications concocted at the New England Compounding Center in Massachusetts. Michigan’s 264 cases and 19 meningitis-related deaths lead the nation, according to the U.S. Centers for Disease Control and Prevention. The tainted pain medications were administered to patients at clinics in Grand Blanc, Warren, Traverse City and Brighton.
The crisis erupted last fall, igniting outrage and calls for increased regulations on compounding pharmacies. Those facilities modify drugs to meet the needs of specific patients. Schuette said they are regulated by states.
An investigation by Arwood’s agency found 470 such facilities operating in Michigan, Schuette said. While the proposed laws only could apply to in-state compounding pharmacies, he said there’s discussion in Congress about more national oversight for those that ship from state to state.
Hune said one of his constituents, from Howell, suffered painful meningitis abscesses, spent a month at University of Michigan Hospitals in Ann Arbor and missed nearly a year of work after receiving adulterated pain medication following surgery on both shoulders.
There is an ongoing grand jury investigation into the Michigan cases.
From The Detroit News: http://www.detroitnews.com/article/20130919/METRO06/309190092#ixzz2fRLxZD8x