September 19, 2013
LANSING - Attorney General Bill Schuette, Steve Arwood, Director, Department of Licensing and Regulatory Affairs (LARA), and Senator Joe Hune (R-Hamburg) today proposed new legislation to strengthen oversight of compounding pharmacies.
The announcement follows a comprehensive review of existing state regulations and statutes in the wake of the meningitis outbreak linked to New England Compounding Center (NECC), a now-defunct Massachusetts company, which 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 19 deaths according to the most recent official tallies recorded by the Centers for Disease Control and Prevention and the Michigan Department of Community Health.
"This was a horrific tragedy where Michigan citizens seeking pain relief left clinics with devastating meningitis infections, or even worse, lost their lives," said Schuette. "We owe it to the victims and their families to find answers, and to do all we can to ensure a tragedy of this magnitude never happens again. This legislation will hold accountable every compounding pharmacy operating in Michigan and ensure these companies put patient safety before their bottom line."
"This incident was tragic," said Arwood. "Our department prioritizes new regulations based on the immediate threat posed to the health and safety of Michigan citizens. Clearly, this is an area that requires immediate attention to reduce the risk of this ever happening again."
Immediately following the meningitis outbreak, Schuette and the Snyder Administration worked together to conduct a thorough and complete review of the existing regulatory and legal framework addressing compounding pharmacies operating in Michigan. Following the review by experts from the Department of Licensing and Regulatory Affairs, the Michigan Board of Pharmacy, and the Department of Attorney General, it was determined that new legislation was needed to strengthen oversight of compounding pharmacies and ensure patient safety.
Senator Joe Hune (R-Hamburg), who represents Livingston County, one of the four Michigan counties hardest hit by the meningitis outbreak, plans to work with Schuette and Arwood to introduce the legislation. The legislation is anticipated to 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.
Accurate 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.
Background Checks: Criminal background checks will be required for pharmacy owners who are not yet licensed, and for those licensed prior to October 1, 2008.
Regular and 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.
"I want to thank Attorney General Schuette for his work to find justice for the victims of fungal meningitis in Michigan. The NECC was reckless in their actions, and I find that pursuing legislation to strengthen oversight over compounding pharmacies is the least we can do to provide safeguards from this foolishness from happening in our state again," said Hune. "It is a necessary and imperative action to assure the safety of the citizens of the great state of Michigan. Our citizens cannot afford to fall victim to such ridiculous imprudence."
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.
As of September 16, 2013, the Michigan Department of Community Health (MDCH) reports Michigan citizens have been hardest hit, with 264 infections and 19 deaths. Three additional deaths of Michigan residents who received treatment at an Indiana clinic are listed in Indiana patient counts, due to the location where they received the tainted treatments. The latest CDC reports can be viewed online.
On October 6, 2012, NECC issued a recall of all its products currently in circulation that were produced and distributed from its facility in Framingham, Massachusetts. More information about the recall, including a list of affected medications can be found online.
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