Hospital Pharmacies Step Up Compounding Efforts In Wake Of Meningitis Outbreak

By Fred Bever November 28, 2012 Updated Nov 28, 9:11 am

BOSTON — Physicians and hospitals are scrambling for the specialty compounds produced by the New England Compounding Center in Framingham and a related company, Ameridose. Both companies closed following the national meningitis outbreak caused by contaminated steroids made by NECC that killed 36 people and sickened 510.

Some hospitals in Massachusetts are responding in ways that could be better for patients.

MGH Pharmacy Goes 24/7

Patients at Massachusetts General Hospital take some 400,000 doses of medication every month — 4.8 million a year. And until two months ago, close to a million of them were compounded by third-party vendors, such as NECC and, even more, Ameridose. Now, most of that work has been brought in house to MGH’s central pharmacy.

It’s a clinical beehive where technicians in varying surgical outfits fill IV bags and sort syringes. Behind air-locked doors, more workers sit under high-tech bays — or “hoods” — compounding sterile medications.

Just outside this “clean room,” lead technician Meghan Federico sorts test tubes.

“It’s what we put our samples in, specimen samples, to test for sterility,” Federico said.

No doubt this was a busy place before Ameridose was closed. But now, this lab is really humming.

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Malpractice bills spawn rift over meningitis settlement

Nov. 27, 2012  

An attorney for meningitis victims worries that lame-duck Michigan legislators will enact a series of medical malpractice bills that would make it harder for clients to recover damages.

Supporters of the legislation say the bills won't impact meningitis cases.

The bills would expand immunity for medical professionals and place limits on damages plaintiffs could receive.

"Any changes to malpractice standards will make it more difficult for steroid patients to bring a case," said Marc Lipton, who is representing Howell meningitis victim Brenda Bansale.

The bills have awaited action by the Senate Insurance Committee for several months.

State Sen. Joe Hune, the committee chairman, said the bills "wouldn't involve the meningitis cases."

"We've been meeting with trial lawyers and members of the medical profession," said Hune, R-Hamburg Township. "Hopefully, we'll be coming to some kind of consensus."

At least two of four bills could be released as soon as today with floor debate and a potential vote coming as soon as Thursday, Hune said.

A spokeswoman for Senate Majority Leader Randy Richardville, R-Monroe, said it was hoped they would all come to the floor before the Senate adjourns for the year.

"There is a desire to see it happen," Richardville spokeswoman Amber McCann said. "There's a laundry list of items awaiting action, and medical malpractice is on that list."

Of the four bills, S.B. 1116 would exempt medical professionals from liability if they acted with "reasonable good faith" based on medical practices and patients' best interest.

While this is considered the centerpiece of malpractice reform, Hune said the bill "probably wouldn't be released" from committee today.

Another bill, S.B. 1115, would place limits on damages issued for the loss of household services. That bill caused a particular concern for Lipton.

"My client has been disabled for three months. That means she doesn't do things that she normally does like cooking, cleaning and balancing the checkbook. There's an economic value to that," Lipton said.

Among the other bills, S.B. 1117, tightens requirements for expert witnesses in malpractice cases while S.B. 1118 limits the time frame for interest on damages.

A fifth bill, dealing with emergency room cases, has yet to be debated by the committee.

Bansale is among those seeking damages from New England Compounding Pharmacy Inc. Health officials believe the contaminated steroids were mixed at the now-closed Massachusetts facility. Congress is debating whether to expand the U.S. Food and Drug Administration's ability to regulate similar facilities.

Michigan law restricts victims of defective FDA-approved drugs from suing drug manufacturers, though legal professionals believe the compounding facility can be sued because its products are exempt from FDA review.

Hune earlier joined Gov. Rick Snyder and Attorney General Bill Schuette in calling for the Bureau of Health Professionals to suspend the compounding pharmacy's license, which would prevent it from marketing any more products in Michigan.

The Michigan Department of Community Health has linked four deaths in Livingston County to the meningitis outbreak. In all, the department says 178 cases, including 10 deaths, have been connected to the outbreak in Michigan.

Contact Daily Press & Argus reporter Wayne Peal at (517) 548-7081 or at wpeal@gannett.com.

Source found here

Case Count as of November 26, 2012: 510* States: 19* Deaths: 36*