Saturday, May 3, 2014

Tougher pharmacy rules eyed

Bills requiring out-of-state medical compounders to have one accountable pharmacist could have prevented a fungal meningitis outbreak that claimed eight Livingston County lives, state Sen. Joe Hune, R-Hamburg Township, said.
On Thursday, Hune’s legislation placing new regulations on compounding pharmacies in Michigan and those doing business in Michigan was approved in the Senate Health Policy Committee.
The bills were in response to the 2012 fungal meningitis outbreak linked to tainted steroids from the New England Compounding Center, or NECC, in Massachusetts. The tainted pain injections were administered at multiple Michigan clinics, including Michigan Pain Specialists in Genoa Township.
The resulting meningitis outbreak claimed 19 Michigan lives, including those of eight county residents. Three additional Michigan deaths are counted as Indiana cases because treatment occurred in that state.
Hune’s legislation requires both in- and out-of-state compounding pharmacies, which combine two or more medicines, to have one accountable pharmacist licensed in Michigan.
The rules, had they been in place and enforced in 2012, could have halted NECC’s tainted products from entering Michigan, Hune said.
“There is an ability for enforcement action against that boss of that facility, so that is a huge step forward,” he said.
The proposed “pharmacist in charge” rule is one of several that, if violated, would result in a maximum 15-year prison sentence in cases of patient death.
Senate Bill 704 also would allow emergency license suspension if an immediate public health risk were identified.
It would require pharmacy license applicants who intend to compound medicines to be accredited through a national organization.
Pharmacists also would be required to maintain records of compounded medicines and be subject to at least one state inspection every two years.
Background checks would be required for pharmacy owners who are not yet licensed, and for those licensed prior to Oct. 1, 2008.
Hune said the proposed rules would have applied more directly to last year’s case of tainted dextrose solution distributed from a South Lyon compounding pharmacy.
Fungi were discovered in vials of the Specialty Medicine Compounding Pharmacy product at Henry Ford Hospital in Detroit.
No cases of illness were reported, but the South Lyon pharmacy last month was ordered closed and fined a total $100,000.
The local case centered around owner and pharmacist Kenny Walkup Jr. allegedly acting as a drug manufacturer by distributing large volumes of compounded medicines to Michigan clinics and hospitals.
The pharmacy was only licensed to provide the combined drugs to individuals.
Walkup had applied for a manufacturer’s license, but a decision on his application was pending when the tainted solution was discovered in Detroit.
Hune, who sits on the Senate Health Committee, said he pushed for the bills to receive hearings during the hectic state budget season.
The main bill was introduced in December and didn’t get its first committee hearing until April. Hune said the legislation has received little, if any pushback outside of initial concerns from the pharmaceutical industry.
“We want to get this stuff done. It’s the right thing for our people,” Hune said.
Michigan Attorney General Bill Schuette said the advancing legislation would keep Michiganders safe from tainted compounded medicines.
“This legislation will hold every compounding pharmacy operating in the state of Michigan responsible for the drugs they distribute and ensure pharmacists put patient safety first,” Schuette said.
The U.S. Drug Quality and Security Act, also introduced in reaction to the NECC outbreak, gives compounding pharmacies the option to be regulated by the U.S. Food and Drug Administration.
The law, signed in November, requires the pharmacies to pay a fee for the regulation.
Proponents of the law claim pharmacies will seek the regulation in order to have FDA-approved products on the market.
Critics argue compounding pharmacies will not voluntarily seek regulation or want to pay for it.

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