Sen. Lamar Alexander to participate in hearing regarding fungal meningitis outbreak

By James Harrison

Published Friday, November 9th 2012

 Sen. Lamar Alexander announced Thursday he will continue seeking answers regarding a national outbreak of fungal meningitis at a Senate hearing next week.

Alexander, who will likely be the ranking Republican member of the Senate Health, Education, Labor and Pensions Committee next year, issued a statement saying he hoped senators would be able to get to the bottom of the cause of the outbreak and recommend ways to make certain it would never happen again.
The outbreak, traced to a compounding center in Boston, has been linked to 425 sicknesses and 31 deaths across the country—with 13 of those deaths occurring in Tennessee.
The death toll in Tennessee is the highest of any state in the country.
"This hearing is an important step to learning as much as we can about this tragic outbreak so that we can ensure that it never happens again," Alexander said. "Tennessee officials identified the outbreak and responded quickly to the cases in our state, and I'm asking for their insights to help legislators in our next step."
Alexander asked that representatives from the Tennessee Department of Health, the Tennessee Board of Pharmacy, the Tennessee Pharmacists Association, the Tennessee Medical Association, the Tennessee Hospital Association and the Tennessee Board of Medical Examiners to submit testimony regarding the issue.
The hearing is Nov. 15.
It has been 42 days since the outbreak of fungal meningitis was first reported. According to the National Centers for Disease Control and Prevention, three lots of contaminated, preservative-free methylprednisolone acetate—a product used in steroid injections—were distributed to 23 states, exposing 14,000 patients.
The drugs were recalled Sept. 26, leading the CDC to estimate that the period for the highest risk of infections will come to a close in early November. Tennessee recently established a health hotline for people concerned about the outbreak.
The number is 1-855-CRISIS-1 or 1-855-274-7471.
Meningitis is an inflammation of the protective membranes covering the brain and spinal cord. Fungal meningitis is a form of meningitis that is caused by fungal infection.

Source found here

Fungal meningitis risk decreases; Alexander asks for comments

Fungal meningitis risk decreases; Alexander asks for comments

Why did patients get meningitis from contaminated steroids? The doses weren't sterile, and they sat too long on the shelf.

Elizabeth Weise, USA TODAYShare

 7:43PM EST November 8. 2012 - The longer the steroids that killed 31 people sat, the more dangerous they became, a study by health officials in Tennessee has found.

Of nearly 150 Tennessee patients who were exposed to possibly contaminated steroid injections, those who received them from vials more than 50 days old were five times more likely to develop meningitis than those whose medicine came from vials less than 50 days old. The rate of infection for those who got the older medicine was 19%, dramatically higher than the 3% for those who received fresher medication.
"The longer something sits, the longer that culture medium has to grow and nurture a really lethal batch of the infectious agent," said Albert Wu, director of the Center for Health Services and Outcomes Research at Johns Hopkins University in Baltimore.
The steroid was produced by New England Compounding Center (NECC) in Framingham, Mass. It is blamed in a nationwide outbreak of fungal meningitis that has sickened 424 people and killed 31. It was injected as a relief for spine and joint pain.
STORY: 150 patients got old drugs in meningitis outbreak
Two things went wrong. First, drugs from a compounding pharmacy typically wouldn't have sat for 50 days before being used. The pharmacist would make up the drug when it was prescribed and hand it to the patient or "send it over to the doctor, where it would be used the next day," said Michael Posey, editor of Pharmacy Today.
Second, and more important, the drugs from NECC were supposed to be sterile but weren't. The company claimed to have performed sterility tests on its products, but the Massachusetts Board of Pharmacy says the testing was inadequate and shipments were made before the safety of the medicines had been verified. The company could not be reached for comment.
If the drug had been sterile, as the medical centers that bought it believed, a longer shelf life would not have been a problem, said Timothy Jones, Tennessee state epidemiologist and senior author on the study, published in this week's edition of the New England Journal of Medicine. "If there's nothing in there, then there's nothing to grow."
Unbeknownst to the physicians administering the shots, the drug was contaminated with fungus. Jones said the doctors who administered the injections were not at fault. "There's just nothing they could have done," he said. "Really, it honestly was not anything they could have known."
So far, no other states have reported higher infection rates for patients receiving older batches of the medicine, but that's probably because Tennessee's health department first identified and began tracking the meningitis outbreak.
"We were a couple of weeks ahead in terms of collecting our data," Jones said. "My expectation is that as other states catch up and learn more about their cases, there will be growing evidence for this."
Contributing: Liz Szabo; Tom Wilemon and Walter F. Roche Jr. of The Tennessean
Source found here

Local drug firms to cut 790 jobs as a result of deadly meningitis outbreak

Source:   Boston Business Journal by Craig Douglas, Managing editor/online vertical products and research

Date: Friday, November 9, 2012, 6:43am EST - Last Modified: Friday, November 9, 2012, 11:16am EST

Craig Douglas

Ameridose LLC, an affiliate of the drug-compounding pharmacy at the center of a deadly fungal meningitis outbreak in the United States, is cutting 650 positions as it grapples with an indefinite closure following regulatory scrutiny of its sterilization practices.

According to the Boston Globe, Ameridose employees have been notified of their pending termination from the company, effective Friday.

“While we continue to expect to resume operations, we have now determined that because of the continued inspection by state and federal authorities it may be necessary to resume operations at a reduced level,” read a letter, cited by the Globe, to affected workers from Ameridose’s director of human resources, Geri Weinstein.
In addition to the 650 workers at Ameridose, which is based in Westborough and is a major supplier of injectible drugs to medical care providers nationally, another 140 workers at another affiliate, Medical Sales Management in Framingham, also will lose their jobs as a result of the investigations and related closures. Both companies share owners with the New England Compounding Center, the Framingham-based drug maker at the root of the fungal meningitis outbreak that has already killed 31 people and infected hundreds more.
“It was the Company’s expectation that the suspension of operations would be temporary in nature and that we would be able to fully resume operations in a short time period,” Weinstein's letter continued, according to the Globe.
Ameridose voluntarily closed Oct. 10 following the meningitis outbreak to ensure that its practices were in line with state and federal regulations specific to the drug-compounding industry. According to an Ameridose employee at the time, the move was intended to strengthen the companies operations and enable it to become a “best in class” producer and distributor of products within this specialized niche in the drug-development industry

More on IACP's Position: KEY Points Re: States

November 7, 2012

IACP Participating in U.S. Senate HELP Committee Hearing on November 15, 2012, at 10 am EST.

The International Academy of Compounding Pharmacists’ (IACP) David G. Miller, RPh, Executive Vice President & CEO, has been invited to testify before a U.S. Senate HELP Committee hearing, “Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak” on November 15, 2012 at 10 am EST, in 106 Dirksen Senate Office Building in Washington, D.C.

Please click here for more information on the Hearing and its panel participants.

“IACP appreciates the opportunity to provide input as the U.S. Senate HELP Committee seeks to better understand current federal and state oversight of pharmacy compounding and explore the possibilities for a legislative solution to the tragedy surrounding New England Compounding Center (NECC) business practices,” said IACP Vice President of Government Affairs Sarah Dodge. “We believe we share similar goals: an understanding of how this tragedy happened, what can be done to prevent it from ever happening again, and ultimately how do we assure that compounding pharmacists are able to practice their professional expertise without overly burdensome regulations which inhibit quality patient care."

The state and federal regulatory scheme for pharmacy compounding is complex – IACP members have valuable experience and technical understanding of the laws that govern our industry. IACP stands ready to help legislators and regulators to assist in conducting a thorough and complete assessment of state and federal laws governing the practice of pharmacy. We believe this assessment should also examine how regulators exercise their jurisdiction and discretion in enforcement. IACP strongly believes that, in Massachusetts and other states, many laws and regulations exist that – if they had been followed and compliance had been enforced - would have severely mitigated the potential for the tragic meningitis infections that have occurred.

The apparent and tragic results of NECC’s alleged behavior undermine the fundamentals of pharmacy, which include doing no harm. We are determined to help find the problem and solve it. Our profession stands ready to work with leaders from across the federal and state governments to make sure that what happened at NECC never happens again.

Not only does Massachusetts have state sterility requirements and United States Pharmacopeia (USP) Standard compliance requirements, but it retains the right to pull a pharmacy’s license, if that pharmacy is practicing outside the scope of its licensing requirements.

By all current indications, the operations of NECC were clearly outside of the scope of the state’s licensure requirements and their license should have been pulled long ago. The state and the FDA should have worked together to force the pharmacy to register as a manufacturer, but also to comply with Current Good Manufacturing Practice Guidelines (CGMP). Unfortunately, NECC showed a blatant disregard for existing rules and regulations (no matter what the law was, their behavior indicates that they would not have followed it). Additionally, and still to be answered by both regulatory agencies, was the fundamental question: if both the state and the FDA knew of problems at NECC – and did based on publicly disclosed documents – why did they fail to follow-up or take action? New regulations or new laws are meaningless if the regulatory agencies charged with upholding them simply fail to do their job.

IACP would support the following state actions to help mitigate further problems with sterility and other potential patient hazards:

• All Boards of Pharmacy must be adequately funded by state legislatures in a manner sufficient to hire trained/educated pharmacists to conduct regular inspections of all pharmacies. Too many Boards have been "de-funded" by legislatures that have funneled revenue from the Boards into the states' general funds leaving administrative gaps;
• Board inspectors conducting compounding pharmacy inspections in both community and institution settings must receive training in both the state regulations pertaining to compounding as well as the practice itself;
• All states must adopt mandatory compliance with USP 795/797 standards. Only 17 currently have that on their books;
• State Boards must "police" themselves and provide the necessary assurances to other state Boards which depend upon them for conducting inspections for non-resident pharmacies in a regular and consistent manner. Massachusetts’s Board obviously failed to execute its responsibilities both to its citizens as well as patients in other states in which NECC was licensed by not conducting regular inspections.

IACP looks forward to the opportunity to testify before the Senate HELP Committee on November 15th to further address these critical issues.

In addition to the U.S. Senate Hearing, the House Energy & Commerce Committee will hold its own hearing on November 14, 2012. Click here for more information.

The Academy will update the IACP Membership on both of these hearings in future communications

COPASS v. NEW ENGLAND COMPOUNDING PHARMACY INC. et al

COPASS v. NEW ENGLAND COMPOUNDING PHARMACY INC. et al

The big pharmacy failure

The big pharmacy failure

Maryland looks to Tighten Compounding Regulations

Friday, November 09, 2012

Pharmacy board looks to tighten regulations

Out of state centers scrutinized following meningOut of state centers scrutinized following meningitis outbreak

by Holly Nunn Staff writer

In response to an outbreak of meningitis linked to tainted drugs, the Maryland Board of Pharmacy is looking to strengthen its regulations on out-of-state facilities permitted to do business in the state.
The recent outbreak originated in such a facility in Massachusetts.
At a hearing Wednesday before the House Health and Government Operations Committee, board executive director LaVerne Naesea said she is weighing options to prevent future outbreaks in Maryland.
“These problems are going to occur,” said Naesea, noting that 660 pharmacies that operate outside the state hold Maryland permits. “Our job is to prevent them, to protect patients in Maryland.”
As of Nov. 5, 23 cases in Maryland had been linked to contaminated steroid injections, including one fatality. Nationwide, 30 have died and more than 400 in 19 states have been infected, according to the U.S. Centers for Disease Control and Prevention.
Meningitis is an inflammation of the tissue surrounding the spinal cord. The source of the outbreak has been tracked to contaminated steroid injections from a compounding pharmacy in Massachusetts, called the New England Compounding Center. A compounding pharmacy alters pharmaceutical products to fit patient needs.
As it concerns compounding by facilities inside the state, the board has a comprehensive set of regulations, said Anna Jeffers, legislation and regulations manager for the pharmacy board.
“Since 2008, [when regulations were implemented], we have not had any major issues as those that you read in the newspaper like this outbreak we’re dealing with now,” Naesea said. “The gap that has to be filled is making sure that we have oversight of out of state [compounding facilities.]”
Currently, the Board of Pharmacy does not inspect facilities outside the state, but is looking at ways to do that.
One way would be to send inspectors out to those compounding facilities that hold Maryland permits on a routine basis, Naesea said. Another would be to make stricter reporting requirements of problems in those facilities.
The board also may recommend that the General Assembly tie compounding centers into a law that was passed in the 2012 legislative session that strengthened requirements for out-of-state pharmacies, but did not include compounding centers.
The board will review its options at a Nov. 28 meeting and then make recommendations to the committee about strengthening regulations.
Seven Maryland medical facilities have been identified as having received contaminated products from the New England Compounding Center, and the Maryland Department of Health and Mental Hygiene estimates that as many as 1,100 patients may have been injected with contaminated steroids.
Since becoming aware of the outbreak in September, the facilities and DHMH have notified about 1,700 patients.
A major source of the problem is a lack of regulation from state and federal agencies, according to a report by Maryland Department of Health and Mental Hygiene doctors. Of the 7,500 compounding facilities in the U.S., only 2 percent participate in voluntary accreditation programs.
The department plans to advocate for stronger regulation of compounding pharmacies from the U.S. Food and Drug Administration. FDA officials did not return calls for comment.

“There have been some concerns about what authority the FDA has and does not have, and that will hopefully be clarified quickly,” said David Blythe, an epidemiologist with DHMH.

Source found here

150 patients got old drugs in meningitis outbreak

Tom Wilemon and Walter F. Roche Jr., The (Nashville) TennesseanShare

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Almost 1 in 5 of those patients developed fungal infection, a rate higher than for those treated with fresher medicine.

7:48PM EST November 8. 2012 - NASHVILLE — Nearly 150 patients exposed to potentially contaminated steroid injections in Tennessee received medicine more than 7 weeks old, even though industry guidelines say its shelf life should have been no longer than 24 hours.
Almost 1 in 5 of those patients developed a fungal infection — a rate dramatically higher than for those treated with fresher medicine, according to the Tennessee Department of Health.
The methylprenisolone acetate produced by Massachusetts-based New England Compounding Center is blamed in a nationwide outbreak of fungal meningitis that has sickened 424 people and killed 31 in 19 states.

USA Today found here

Regulating Compounding Pharmacies after NECC — NEJM

Regulating Compounding Pharmacies after NECC — NEJM