meningitis

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Budget Victim: Inspections For Compounding Pharmacies. Really?

Remember all that outrage last year when we learned that a Framingham compounding pharmacy, the New England Compounding Center, was at the heart of national meningitis outbreak? And remember what followed: a flurry of new government oversight measures, tough public health safeguards, pledges of “Never again.”

So what happened?

Kevin Outterson, a professor at the Boston University School of Law and co-director of the Health Law Program, reports today that additional money that was supposed to be used to inspect compounding pharmacies around the state was cut to zero. At least for now.

(WBUR)

(WBUR)

Blogging for The Incidental Economist, he reminds us why the inspections are important: “fungal meningitis from improperly compounded products killed 55 people and infected more that 600.” But apparently, in the latest state budget proposal, money for inspections has been cut, Outterson writes:

All of these products originated in Massachusetts, but all of the injuries occurred in other states. But Massachusetts felt some responsibility for the failures at NECC, as acknowledged by both Gov. Patrick and the Interim Commissioner of Public Health. The DPH enacted emergency regulations on Nov. 1, 2012 and the Governor’s special commission delivered a comprehensive set of recommendations. Both efforts informed the Governor’s proposed legislation in January 2013 and several bills pending in the Massachusetts House and Senate. Continue reading

Advocates: Public Health Slashed Too Far, Risk ‘Not Acceptable’

Accused former state chemist Annie Dookhan

Accused former state chemist Annie Dookhan (Josh Reynolds/AP)

Normally, just the words “public health infrastructure” are enough to make people’s eyes glaze over and roll upwards. But not this year in Massachusetts. Not when the state has seen a huge scandal in the state crime lab that called into questions thousands of convictions. And then a horrifying national outbreak of meningitis that killed three dozen people and raised serious questions about oversight of the local compounding pharmacy where the tainted steroids were made.

Dr. Alan Meyers connected the dots of the two scandals in a guest post here, pointing out the dangers of cutting public health funding too far. Now the latest state emergency budget cuts have been proposed. Rachel reported last week here that health care in its various forms takes the hardest hit of all. And today, the Massachusetts Public Health Association is sending over a letter to the Patrick administration imploring it to stop cutting the basic public health measures that keep us all safer.

We are writing with an urgent message that funding for basic elements of our public health infrastructure – protections that we all rely on every day – is not sufficient to meet basic needs, and we implore you to reverse the trend of disinvestment from these essential services.

That infrastructure includes food inspections, licensing of medical machines like X-rays, emergency preparedness, monitoring of the system to report on infectious diseases, and more. “This type of infrastructure is not sexy and it is not free,” the letter says. “It does not have a constituency that will hold rallies on the State House steps. But we all benefit from it each and every day – and mostly, we take it for granted.”

Read on for the association’s warning that the level of public health risk is not acceptable, and a sweeping summing-up of the drastic cuts to the state’s public health structure over the last few years.

We understand that all areas of government have needed to tighten their belts during these difficult economic times. We do not fault your Administration or the Legislature for looking for budget savings from all state agencies in order to meet your responsibility to pass a balanced budget.

However, if we accept that the pre-recession resources are no longer available to fund our public health infrastructure, we must be prepared to accept a lower level of services, oversight, and monitoring. We at the Massachusetts Public Health Association do not find this increased level of risk to be acceptable. Continue reading

Steroid Debacle Prompts Hospital Pharmacies To Ramp Up In-House Compounding

The “clean room” at Massachusetts General Hospital’s central pharmacy. (Fred Bever/WBUR)

It would be going a little far to call this a silver lining of the national outbreak of meningitis from tainted steroids that has now killed 36 people and sickened over 500. But it is perhaps heartening that the drug shortage that has arisen because the steroids’ makers closed down may lead to some long-term improvements in how hospital pharmacies operate.

In case you missed it, WBUR ran an extremely excellent story by reporter Fred Bever this morning that featured the scene at Massachusetts General Hospital’s central pharmacy:

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.

That means a far heavier in-house workload:

“We’ve increased our hours. We have three hoods that are full on all three shifts, that we didn’t have before,” [lead technician Meghan] Federico said. “We were Monday through Friday 7:30 to 4:00 operation, and now we’re 24/7.”

Check out the full story on WBUR.org here. It concludes that Partners Healthcare, the state’s biggest health care provider, “is mulling the idea of creating its own compounding pharmacy that would serve all the hospitals in its system.”

You want something done right, do it yourself…

 

Bigby: Pharmacy, Lower-Level Staffers To Blame For Public Health Debacles

Dr. JudyAnn Bigby, Mass. secretary of health and human services

As hearings on the meningitis outbreak get under way today on both Beacon Hill and Capitol Hill, WBUR’s Deborah Becker aired an incisive interview on Morning Edition today with Dr. JudyAnn Bigby, the Massachusetts Health and Human Services Secretary.

The full sound file is here, but let me highlight one of the sharper moments. Toward the end, Deborah Becker asked the same essential question in several ways: Who, really, is responsible for these two major recent public health debacles in Massachusetts, the state crime drug lab scandal and the meningitis outbreak that emanated from a Framingham pharmacy that fell so incredibly through the state regulatory cracks?

What Deborah didn’t ask explicitly, but that I hear some people wondering sotto voce, is: Are you responsible, Secretary Bigby? If the widely respected public health commissioner, John Auerbach, had to resign over the state crime lab scandal, at what point does the buck stop with you?

In the interview, Dr. Bigby notes that the state board of pharmacy was the only entity that was truly responsible for overseeing the Framingham compounding pharmacy that produced the tainted drugs, and she says efforts are under way to improve the board and its inspections.

“Right now, we are in the field doing unannounced inspections of pharmacies, and we believe that in the future, that this is a necessary step to make sure that there is further oversight of the pharmacies.”

DB: And what would you say to the folks who say, ‘Yes, now you’re doing inspections but did it take 32 deaths and several complaints against this compounding pharmacy?’

JB: I think that is a very appropriate question. This travesty is one of the worst disasters in health care that I can remember that was preventable, and I do believe the NECC operated under conditions where they not only violated state and federal laws but they also violated their own practices. and we need to make sure that this never happens again.

DB: So if you’re looking at this, who’s responsible for the failure here? Is it a systemic failure? Continue reading

Mass Layoff By Ameridose, Company Linked To Troubled Compounding Pharmacy

WBUR’s Martha Bebinger reports:

The sister company of the Framingham pharmacy linked to the nationwide meningitis outbreak is temporarily laying off 790 employees.

Ameridose and its marketing company, Medical Sales Management share owners with New England Compounding Center, the pharmacy tied to steroids tainted with a deadly fungus. Ameridose has been under investigation and closed for more than a month even though inspectors have not found problems with any Ameridose products. Sources say the closure is costing Ameridose more than a million dollars a week. In a letter to employees, Human Resources director Geri Weinstein says Ameridose hopes the layoffs are temporary and that employees will be brought back to work. But Weinstein says that while the company expects to reopen, it will likely be at a reduced level.

Even with the layoffs, some employees will remain, according to a company spokesperson, who said: “Enough staff has been kept on to both manage the recall that is underway and to implement the recommendations that are expected from the FDA.”

Here’s a copy of the letter to employees:

Responding to reports of the layoffs, the Massachusetts Hospital Association put out this statement:

“While not commenting directly on Ameridose’s actions regarding its employees, the company’s cessation of production of important medications aggravates an increasingly serious problem of drug shortages for hospitals. MHA and its hospital members will continue to work with DPH in an effort to address this issue and seek alternative sources of needed medications.”

Lab Scandal, Meningitis Outbreak: Signs Of Risky Public Health Cuts

Accused former state chemist Annie Dookhan

Accused former state chemist Annie Dookhan (Josh Reynolds/AP)

By Dr. Alan Meyers
Guest Contributor

If you’ve been following the news for the last few weeks, you’re aware of two public health disasters here in Massachusetts: The state drug-testing laboratory scandal and the contaminated products from a Framingham compounding pharmacy that have now killed 28 patients.

Sad to say, I am not at all surprised. I take these two debacles as signs of the very dangerous times that we’re living in. Our political discourse seems to be in the grip of the simplistic and misleading notion that government spending is bad, and taxing anyone to raise the funds for government spending is also bad. This idea is based in ideology. Remember Grover Norquist’s famous admonition that government should be so small that he can drag it into the bathroom and drown it in the bathtub?

Dr. Alan Meyers

Dr. Alan Meyers

Yet it’s emblematic of our public schizophrenia that at the same time, if there is any role of government that everyone agrees on, it’s to keep the population safe. (When a super-storm hits, for example.)

That sentiment leads to widespread support for military spending, but consider: What do you think the chances are that you’ll be injured in a military or terrorist attack, the kind of thing that could be protected against with warships and missiles? Not very high, right? Now, what do you think is the probability that you’ll be injured by a preventable event that was not prevented because of a lax public health infrastructure? An uninspected drug, a food-borne illness, a disease spread by unvaccinated neighbors?

The current state public health budget is not adequate to protect us from certain known hazards. Continue reading

FDA: 'Greenish Black' Matter In Steroid Vials, Mold In NECC 'Clean Rooms'

(multimediaimpre/flickr)


Federal inspectors found “greenish black” matter in 83 vials returned to the Framingham pharmacy linked to the nationwide meningitis outbreak — vials from the same batch of steroids that have now killed 25 people in 18 states.

The FDA’s observations build on findings from state inspectors released Tuesday. The raw materials used to mix steroids were not sterile and inspectors say New England Compounding Center had no required proof that its sterilizing procedures were effective.

In addition, the FDA found mold and bacteria on surfaces and in air samples of two so-called “clean rooms” where NECC pharmacists produced numerous drugs.

The FDA’s report (PDF) mentions that NECC turned off its air conditioning overnight and that the rooftop units of that system are about 100 feet from a recycling facility that produces a lot of dust.

But the report does not reach any conclusion about the source of fungus in tainted steroids that continues to make patients sick.

Troubled Compounding Pharmacy ‘Clean’ Room Not Clean, Inspectors Say

WBUR’s Martha Bebinger reports:

(WBUR)

State investigators have found numerous health and safety problems at the Framingham pharmacy allegedly tied to 23 meningitis deaths, but still don’t know how fungus got into steroid vials.

Inspectors with the Department of Public Health say they found black particles in vials of steroid returned to New England Compounding Center…the steroid that has caused 23 deaths and made 304 patients in 16 states sick.

The “clean room” where the steroids were produced did not meet basic standards including untested sterilizing equipment, dirty floor entrance mats and protective hoods that weren’t cleaned.

Governor Deval Patrick, speaking at a news conference today, extended condolences to all those affected by this outbreak. He says the state will begin unannounced visits of the other 25 pharmacies that mix drugs in Massachusetts and require more specific reporting.

The state’s preliminary report is here. Continue reading

Mass. Hospital Association: Errors In FDA List Of Who Got NECC Products

(multimediaimpre/flickr)

This just in from the Massachusetts Hospital Association:

“As the Massachusetts Department of Public Health and federal Food and Drug Administration (FDA) investigations into New England Compounding Center continue, today the FDA issued two lists of hospitals and other care providers that reportedly received products that were shipped from New England Compounding Center (NECC) on or after May 21, 2012.

The Massachusetts Hospital Association (MHA) has been in touch with several hospitals across the state that have reviewed the FDA list and determined that it was inaccurate. In some instances, hospitals on the list report that they have received no products from NECC. Hospitals in other states are also reporting extensive errors on the list. We understand the FDA list was derived from NECC records and were not confirmed with hospitals on the list. We have contacted FDA to inform them that the list has inaccuracies and to request that corrective action be taken.”

The FDA notice that the association refers to, including the list of NECC customers, is here.

The First Meningitis Patient, And The Medical Mystery Of The Black Mold

Exserohilum rostratum

Exserohilum rostratum (Wikimedia Commons)

 

The medical detective story of how Vanderbilt doctors figured out the link between tainted steroid injections and life-threatening meningitis came out almost three weeks ago — but now you can read the full (and frightening) clinical details of that “index case” in The New England Journal of Medicine here. 

The authoritative account includes the disturbing details of a man in his fifties who suddenly went into rapid decline a month after he had a spinal steroid injection. He comes in with “nausea, malaise, fatigue, chills, and decreased appetite.” Despite antibiotics, his pain worsens and he becomes “agitated, with incomprehensible speech.” He’s treated with more drugs, but by his sixth day in the hospital, he’s having “intermittent staring spells, and a transient right facial droop.” The next day, the lab identifies the fungus Aspergillus and he is treated for it, but to little avail.

On hospital day 11, the patient abruptly became unresponsive, with rhythmic shaking of the head that was consistent with seizure activity. He was intubated and mechanical ventilation was initiated. A head CT scan showed intraventricular hemorrhage involving the lateral ventricles, subarachnoid hemorrhage in the perimesencephalic cistern, and worsening hydrocephalus.

The man died on his 22nd day in the hospital.

‘It remains a mystery as to why the index case is the sole case in which A. fumigatus was detected.’

The New England Journal also features an informative update on the meningitis outbreak, which points up an oddity of the findings thus far: That first, index case reported finding Aspergillus fumigatus in the patient, but that fungus “has not been detected in any of the subsequent 200-plus cases. The major culprit appears to be Exserohilum rostratum, a plant pathogen that rarely causes human disease. This mold has been cultured or identified by means of a polymerase-chain-reaction (PCR) assay from cerebrospinal fluid in at least 25 patients and has been detected in at least one unopened vial from the implicated lot of methylprednisolone.”

The theory that E. Rostratum, a black mold, is the villain here fits with past cases: Continue reading