Schuette, Hune Commend Unanimous House Passage of Bills Prioritizing Patient Safety, Reducing Risk of NECC-Style Tragedy in Michigan
by Juanski
LANSING – Attorney
General Bill Schuette and Senator Joe Hune today praised the Michigan House
for unanimously passing vital consumer protection legislation that
strengthens oversight of compounding pharmacies. Senate Bills 704 and 904,
sponsored by Senator Joe Hune (R-Brighton), were passed out of the House
with a 110-0 vote, were returned to the Senate who unanimously concurred the
vote, and are now on their way to Governor Snyder for his signature.
“This tragedy
inflicted upon hundreds of Michigan citizens, causing some to lose their
lives, could have been prevented with stricter standards for compounding
pharmacies,” said Schuette. “We owe it to these victims to ensure a disaster
of this magnitude does not strike twice. This legislation will hold
responsible, every compounding pharmacy operating in the state, for the
drugs they distribute and require pharmacists to put patient safety first.”
“While we can’t
bring back the lives lost in the NECC tragedy, we can put tougher measures
in place for compounding pharmacies, which will protect Michigan citizens in
the future,” said Senator Hune. “My colleagues in the legislature
understand that this legislation will protect patient safety, and I’m proud
that we’ve stood together in order to accomplish this goal.”
The legislation, introduced last December, followed a
comprehensive review of existing state regulations and statutes in the wake
of the meningitis outbreak linked to
New England Compounding
Center (NECC). This now-defunct Massachusetts company, allegedly
distributed tainted steroid injections to patients at clinics in four
Michigan counties: Genesee, Livingston, Macomb and Grand Traverse. Michigan
patients were hit hardest by the multi-state outbreak, with 264 infections
and 22 deaths according to the most recent official tallies recorded by the
Centers for Disease Control and Prevention and the Michigan Department of
Community Health.
Senate Bills 704 and 904
Senator Hune, who represents Livingston County, one of the four
Michigan counties hardest hit by the meningitis outbreak, worked with
Attorney General Schuette to introduce SB 704. The legislation will add the
following four safeguards, among others, to Michigan law governing
pharmacies, and compounding pharmacies in particular:
Senate Bill 904 amends the Pharmacy Practice and Drug Control section of the
Public Health Code and is tie-barred to SB 704.
Immediate
Action Following the Meningitis Outbreak
On October 12,
2012, following verified reports that NECC was responsible for the
meningitis outbreak, Schuette acted to suspend the company’s pharmacy
license in the state of Michigan. In a formal Complaint and Order of
Summary Suspension filed with the Department of Licensing and Regulatory
Affairs, Schuette alleged that NECC acted as a “drug manufacturer” – not a
compounding facility – by distributing large amounts of medication to
various hospitals and clinics in Michigan. The company had only been
licensed to fill individual prescriptions for Michigan patients as a
compounding facility. NECC’s license was suspended and the company was
forced to cease operations in Michigan.
On December 12,
2012, the Michigan Board of Pharmacy Disciplinary Subcommittee formally
agreed to the license surrender, and NECC voluntarily surrendered their
Michigan pharmacy and controlled substance licenses. As a result, NECC can
no longer do business in the state of Michigan, and its surrender was
reported as a disciplinary surrender to other states. Because the order
provides that the surrender is based on a breach of Michigan’s Public Health
Code, the State of Michigan can deny licensure to any individual who had a
financial interest in NECC and applies for a new pharmacy license in the
future.
General Bill Schuette and Senator Joe Hune today praised the Michigan House
for unanimously passing vital consumer protection legislation that
strengthens oversight of compounding pharmacies. Senate Bills 704 and 904,
sponsored by Senator Joe Hune (R-Brighton), were passed out of the House
with a 110-0 vote, were returned to the Senate who unanimously concurred the
vote, and are now on their way to Governor Snyder for his signature.
“This tragedy
inflicted upon hundreds of Michigan citizens, causing some to lose their
lives, could have been prevented with stricter standards for compounding
pharmacies,” said Schuette. “We owe it to these victims to ensure a disaster
of this magnitude does not strike twice. This legislation will hold
responsible, every compounding pharmacy operating in the state, for the
drugs they distribute and require pharmacists to put patient safety first.”
“While we can’t
bring back the lives lost in the NECC tragedy, we can put tougher measures
in place for compounding pharmacies, which will protect Michigan citizens in
the future,” said Senator Hune. “My colleagues in the legislature
understand that this legislation will protect patient safety, and I’m proud
that we’ve stood together in order to accomplish this goal.”
The legislation, introduced last December, followed a
comprehensive review of existing state regulations and statutes in the wake
of the meningitis outbreak linked to
New England Compounding
Center (NECC). This now-defunct Massachusetts company, allegedly
distributed tainted steroid injections to patients at clinics in four
Michigan counties: Genesee, Livingston, Macomb and Grand Traverse. Michigan
patients were hit hardest by the multi-state outbreak, with 264 infections
and 22 deaths according to the most recent official tallies recorded by the
Centers for Disease Control and Prevention and the Michigan Department of
Community Health.
Senate Bills 704 and 904
Senator Hune, who represents Livingston County, one of the four
Michigan counties hardest hit by the meningitis outbreak, worked with
Attorney General Schuette to introduce SB 704. The legislation will add the
following four safeguards, among others, to Michigan law governing
pharmacies, and compounding pharmacies in particular:
Accountability
at the Top: All pharmacies must have a “Pharmacist-in-Charge”
who is licensed and responsible for ensuring the pharmacy follows
state laws and regulations.
Record-Keeping: Compounding pharmacists must maintain a record
for all sterile compounded drug products detailing the product’s
name, strength quantity and dosage, formula to compound, date of
preparation, identifying prescription number, manufacturer and lot
number of each ingredient, name of the person who prepared the
compound, and the name of the pharmacist who approved the compound.
Checks: Criminal background checks will be required for
pharmacy owners who are not yet licensed, and for those licensed
prior to October 1, 2008.
Robust Oversight: Pharmacies, manufacturers and wholesalers
engaged in compounding will submit to regular inspections by state
authorities at least once during each two-year licensing cycle.
Senate Bill 904 amends the Pharmacy Practice and Drug Control section of the
Public Health Code and is tie-barred to SB 704.
Immediate
Action Following the Meningitis Outbreak
On October 12,
2012, following verified reports that NECC was responsible for the
meningitis outbreak, Schuette acted to suspend the company’s pharmacy
license in the state of Michigan. In a formal Complaint and Order of
Summary Suspension filed with the Department of Licensing and Regulatory
Affairs, Schuette alleged that NECC acted as a “drug manufacturer” – not a
compounding facility – by distributing large amounts of medication to
various hospitals and clinics in Michigan. The company had only been
licensed to fill individual prescriptions for Michigan patients as a
compounding facility. NECC’s license was suspended and the company was
forced to cease operations in Michigan.
On December 12,
2012, the Michigan Board of Pharmacy Disciplinary Subcommittee formally
agreed to the license surrender, and NECC voluntarily surrendered their
Michigan pharmacy and controlled substance licenses. As a result, NECC can
no longer do business in the state of Michigan, and its surrender was
reported as a disciplinary surrender to other states. Because the order
provides that the surrender is based on a breach of Michigan’s Public Health
Code, the State of Michigan can deny licensure to any individual who had a
financial interest in NECC and applies for a new pharmacy license in the
future.
continue to read here
No comments:
Post a Comment