Thursday, September 19, 2013

Meningitis outbreak prompts legislation to tighten pharmacy regulations

Regulations and oversight of pharmacies would be strengthened under legislation proposed today by Michigan Attorney General Bill Schuette and state Rep. Joe Hune, R-Hamburg Township.

The announcement came a year after Michigan was hit hard by a fungal meningitis outbreak caused by a contaminated steroid used to ease backpain. The public health crisis was linked to tainted steroids prepared by the New England Compounding Center, a compounding pharmacy in Massachusetts. Hundreds of people were sickened by tainted shots, and more than 60 have died. Michigan recorded 264 infections and 19 deaths from the toxic shots.

The bills would require pharmacies to have a “pharmacist-in-charge,” who is responsible for ensuring full compliance with state laws and regulations; maintain records for all sterile compounded drug products and the name of the person who prepared the compound, submit to criminal background checks for pharmacy owners, and submit to regular inspections by state authorities at least once every two years.

“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,” Hune said.

Schuette called the incident a horrific tragedy for people who were merely seeking pain relief.

“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,” he said. “This legislation will hold accountable every compounding pharmacy operating in Michigan and ensure these companies put patient safety before their bottom line."

■ Related: Pharmacy fight looms in wake of meningitis outbreak

Beginning in May 2012, the New England Compounding Center, which has since closed, shipped 17,000 vials of contaminated preservative-free methylprednisolone acetate to facilities in 23 states, leading to the deadly outbreak. Steroid shots are a relatively common treatment for back pain.

According to the Centers for Disease Control and Prevention, there have been 750 cases of illness and 64 deaths linked to the outbreak. In Michigan, 264 people fell ill. Nineteen people have died, not including three Michigan residents whose deaths are included in Indiana’s case count because they received their shots there.

■ Special report Day 1: National fungal meningitis outbreak hits Michigan the hardest; 259 infected, 14 killed

■ Special report Day 2: Meningitis outbreak sparks investigations, lawsuits, fears

■ Time line: Meningitis outbreak time line: From first contaminated steroid injections to latest Michigan death

The state Court of Appeals also granted Schuette’s request to empanel a grand jury to investigate the tainted drugs. That investigation continues under the seal of grand jury secrecy.

The crisis sparked outrage nationwide and prompted calls for greater oversight of compounding pharmacies. At such pharmacies, pharmacists mix and modify drugs to suit the needs of an individual patient.

The Food and Drug Administration licenses drug manufacturers but not compounding pharmacies, leaving it primarily up to states to monitor them. Compounded drugs are not approved by the FDA, but the agency does have some authority over them when it receives a report of contamination or other problems.

Earlier this year, Larry Wagenknecht, CEO of the Michigan Pharmacists Association, told the Free Press that the Michigan Public Health Code says all pharmacists are responsible for the strength, quality and purity of drugs dispensed with a prescription. But because there have been no state licenses or mandates that apply specifically to compounding pharmacies or sterile compounding, the practice has been difficult to track.

A U.S. House bill seeks to clarify federal authority over certain pharmaceutical providers.

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