Meningitis: Bug Infecting More Than 400 an Unlikely Culprit

By Michael Smith, North American Correspondent, MedPage Today

Published: November 05, 2012

The mold linked to the fungal meningitis outbreak is an unlikely pathogen that has left clinicians scrambling to diagnose and treat affected patients and wondering what to expect next.
Exserohilum rostratum is one of a class of black molds, so-called because they have melanin in their cell walls, that only rarely cause human illness and even more rarely cause invasive disease, experts told MedPage Today.
"They really prefer to infect plants," according to Carol Kauffman, MD, of the University of Michigan in Ann Arbor.
As of Monday, according to the CDC, the outbreak has claimed 30 lives and made 429 people sick in 19 states.
E. rostratum is found pretty much everywhere in soil and decaying matter, but its most common clinical manifestation is allergic sinusitis, with occasional cases of keratitis if the mold gets into a scratch on the cornea, Kauffman said.
In rare cases, a splinter can carry the mold deep into tissue, leading to a localized infection.
That, in a sense, is what has happened in the meningitis outbreak. "Unfortunately," Kauffman said, "it happens to be a localized infection in the central nervous system."
The outbreak has been linked to injections of a steroid, preservative-free methylprednisolone acetate, that was contaminated with E. rostratum.
The majority of cases have involved some sort of central nervous system infection, mainly meningitis, although several patients have presented with classic stroke symptoms thought to be caused by the fungal infection.
The outbreak, which came to light in late September with a single case in Tennessee, is the largest outbreak ever of fungal meningitis, a CDC spokesman told MedPage Today.
Read Full article here

Compounding pharmacies face the music November 5, 2012 By zintro

The rare fungal meningitis outbreak in 11 states tied to a compounding pharmacy in Massachusetts is spurring calls for tighter federal regulations for the 3,000 outfits in the US. We asked Zintro experts to explain how the outbreak will affect this industry.

Patrick Stone, an expert in biotechnology regulatory compliance, says that compound pharmacies nationwide have enjoyed the protection of their states’ pharmacy board or have not engaged in interstate distribution. Stone explains: “This means that compound pharmacies do not have to operate under good manufacturing procedures to compound their drug products. The FDA routinely inspects compound pharmacies for verification that compounded drug products are for a specific patient prescription and not a bulk manufacturing process,” he says. “Many times, FDA auditors find that the inspected compounding pharmacy is manufacturing bulk drug products, sometimes even sterile drug products, without sterility controls in place.”

The New England Compounding Center in Framingham, Mass.has been tied to more than 20 deaths and over 300 patients have been affected following injections of steroids that the company manufactured. “Between May 21 and September 24, 2012, patients in up to 17 US states have possibly received injections of products from this company. This is going beyond compounding pharmacy practice and into national distribution of a drug product,” Stone cautions. “The FDA should have regulated this company under strict drug manufacturing laws with the systems approach method of inspection. Congress is now going to have to decide whether or not to provide FDA with proper regulatory oversight of this type of drug manufacturing operation. Only time will tell if FDA has to keep its hands tied or if public safety measures will be put in place to keep this type of outbreak from happening again.”

Dana Hadfield, an expert in pharmacy management, says that it is important look at the motivations of the compounding pharmacy in question. “It’s possible that this situation was started by a pharmaceutical company that did not want to make products with little profit because they are off patent,” says Hadfield. “We now experience many drug shortages because of this type of behavior. Unfortunately, this was a perfect storm type of situation. The drug in question has unique chemical attributes as a suspension, to be given intrathecally (into the spinal cord with no preservatives), and a terrible error occurred somewhere in processing.”

By Maureen Aylward

Source found here

2nd North Texan Contacts Meningitis From Tainted Steroid Shots « CBS Dallas / Fort Worth

2nd North Texan Contacts Meningitis From Tainted Steroid Shots « CBS Dallas / Fort Worth

Minutes detail NECC’s history with regulators

Minutes detail NECC’s history with regulators

Meningitis survivor: 'We're killing our own people'

Chesapeake, Va. — Ginny Rauch thought she was going to die. The pain in her legs and back was so excruciating that she could hardly breathe at times. A steroid shot that was supposed to ease her back pain had instead left her with a near-fatal case of fungal meningitis.
That was 2002. Now, 10 years later, Rauch has flashbacks to her ordeal and says she is angry that a new meningitis outbreak has killed 29 people and sickened 377 across the U.S., including in North Carolina.
“When I heard what happened to all these people, I could just not believe that this had happened, because it’s cleanliness,” Rauch said. “If they had done what they said they were going to do, this would’ve never happened.”

Rauch was one of the lucky ones 10 years ago. She survived, while two other North Carolinians died. The 71-year-old former Raeford music teacher, who now lives in Virginia, says she is on a mission to hold the Food and Drug Administration accountable for the tainted medicine, even if that means speaking before Congress.
“I just don’t feel that we should ever have to have this conversation again. To me, it’s ridiculous. It’s absolutely ridiculous,” Rauch said. “We’re killing our own people in the United States from filth.”
A Spartanburg, S.C., pharmacy manufactured the tainted medicine that sickened Rauch and killed two others. The current meningitis cases stem from a specialty pharmacy in Framingham, Mass.
In both cases, the shots came from compounding pharmacies. Compounding, which involves making a special order for an existing drug, is something all pharmacies do. Pharmacy experts say special orders aren’t the problem. The problem is when pharmacies start mass producing those special orders for the public, instead of just for one patient.
“It’s hard not to attribute this to greed, simple greed,” said Jay Campbell, executive director of the North Carolina Board of Pharmacy, which inspects pharmacies. “The issue is where is the line between legitimate compounding pharmacies and full-blown manufacturing?”
Campbell says big compounding companies can sell drugs for less. They need FDA inspection but often operate in a gray area and avoid the type of oversight Campbell thinks they need.
The FDA released a statement to WRAL Investigates, saying that its "regulatory authority over compounding pharmacies is more limited by statute than it is for typical drug manufacturers."
"Compounding pharmacies and pharmacists are responsible for the quality and safety of the drugs they produce for patients. The FDA will continue to act within its existing authorities to protect public health and help ensure the safety of medical products," the FDA's statement continued.
"Once the immediate crisis is contained, the FDA is committed to working with Congress, compounders, the states, and all other stakeholders to strengthen the system to prevent tragedies like this from happening again."

Inspectors struggle to visit clinics regularly

In North Carolina, eight state inspectors cover 1,600 pharmacies across the state, 40 to 50 of which specialize in compounding. At that rate, it takes two to three years to do routine visits for each.
Compounding pharmacies are regulated by state boards of pharmacy and are exempt from FDA regulations. The FDA regulates only the ingredients.
No meningitis outbreaks have been tied to North Carolina pharmacies, but in 2005, large drug orders from Triangle Compounding Pharmacy were called into question after a woman died using the company's numbing gel for hair removal. The company was issued an Order of Reprimand, which is a form of public discipline that goes to the National Practitioner Data Bank. No problems have been reported since.
The WRAL Investigates team examined two years of state inspections for all North Carolina pharmacies and found no major problems. However, inspectors noted several times that compounding areas needed to be cleaned better to avoid cross contamination of drugs. Inspectors also found a lot of expired drugs still on shelves.
FDA inspectors struggle with resources for routine inspections as well.
In 2008, pre-filled syringes of saline from an Angier company – under FDA inspection – were linked to a bacterial infection outbreak that killed five people and infected at least 288. Two managers of the company, AM2PAT, pleaded guilty to fraud and allowing tainted drugs into the marketplace and were serving four-year sentences in federal prison.
Federal authorities are still searching for Dushyant Patel, the company’s former president and chief executive, who was indicted on 10 federal charges, including fraud and selling adulterated medical devices. Authorities said in 2010 that he might have fled to his native India.
After a 2005 warning letter to AM2PAT, inspectors found no major safety violations in annual visits.
Read entire article here

Indiana Board of Pharmacy today voted to indefinitely suspend the license of NECC

Start Date: 11/5/2012 All Day End Date: 11/5/2012

inShare0 Entry Description INDIANAPOLIS – The Indiana Board of Pharmacy today voted to indefinitely suspend the license of the Massachusetts pharmacy connected to the meningitis outbreak. Indiana Attorney General Greg Zoeller’s office recently filed an emergency petition asking the Indiana Board of Pharmacy to suspend the license of the New England Compounding Center (NECC) which is based in Framingham, Mass. The company responded last week and agreed to the suspension. The board voted 7-0 today on the agreement for indefinite summary suspension during its scheduled meeting in Indianapolis. “The Attorney General’s Office will now move forward with filing a formal complaint with the Indiana Board of Pharmacy,” Zoeller said. “The board can then consider the case and determine the most appropriate discipline.” On Monday, the Indiana State Department of Health (ISDH) confirmed 51 cases of fungal meningitis and four deaths in the state stemming from a tainted steroid injection produced by NECC. As a licensed non-resident pharmacy whose products are distributed and sold in Indiana, NECC is legally responsible for the “proper and safe storage and distribution of drugs and devices.” According to ISDH, there are now 1,502 people in Indiana who have been exposed to the contaminated medication through an epidural or joint injection. Patients exposed in Indiana have been contacted by their healthcare provider. In September, the U.S. Centers for Disease Control and Prevention (CDC) in coordination with the Food and Drug Administration identified the NECC as the compounding pharmacy that produced the epidural steroid injections that caused the onset of meningitis in certain patients. Shortly after, NECC ceased production and initiated a recall of the drugs. As of Nov. 5, the CDC had indentified 404 cases of fungal meningitis and 29 deaths across 19 states stemming from NECC’s tainted steroid injections. The cause of contamination of the steroid injections is still under investigation. -30-

Contact Information: Name: Erin Reece Phone: 317.232.0168 Email: Erin.Reece@atg.in.gov

Congressional panels to hold hearings on meningitis outbreak | Reuters

Congressional panels to hold hearings on meningitis outbreak | Reuters

The Doctor’s World Chasing Clues to Detect Outbreak By LAWRENCE K. ALTMAN, M.D. Published: November 5, 2012

The e-mail Dr. Marion A. Kainer received on Sept. 18 suggested an investigation of a case of fungal meningitis and stroke in a man whose immune system was normal and whose only risk for the infection was a spinal injection of a steroid.

  “Alarm bells went off” because of its rarity, Dr. Kainer, an epidemiologist at the Tennessee health department, said in an interview.

She immediately began what became a national investigation that has now identified 409 cases, including 30 deaths, from a fungus so unusual that it is not in medical textbooks. The fungus was transmitted through injections of a contaminated steroid drug prepared by the New England Compounding Center in Framingham, Mass.

Dr. Kainer’s investigation led Tennessee to take extraordinary measures to track down 1,009 people at risk of the fungal infection. The state is credited as the driving force in discovering one of the most shocking outbreaks in the annals of American medicine.

Continue reading here 

FDA chief will testify at first meningitis hearing - 21 News Now, More Local News for Youngstown, Ohio -

FDA chief will testify at first meningitis hearing - 21 News Now, More Local News for Youngstown, Ohio -

Fungal meningitis cases soar to 112 in Michigan with 8 dead - News - Source Newspapers

Fungal meningitis cases soar to 112 in Michigan with 8 dead - News - Source Newspapers

Reflections on the Recent Compounding Tragedy

Reflections on the Recent Compounding Tragedy

30 deaths; 419 sick latest from cdc

Ed Silverman at Pharmalot Blog Ask What the FDA Will Look Like After the Election

Here is what Ed has to say:

Four more years or a few more weeks? Those are the choices in the upcoming election, but how might this affect the FDA? Apart from an occasional reference, the agency is not part of the campaign dialogue, notes Steve Grossman of the Alliance For A Stronger FDA non profit. And in his view, this is a good thing, since “any intelligent discussion requires a long-term perspective and a mastery of detail and nuance, both of which are in short supply during sound bite-oriented politicking. But of course, the FDA will be afftected, one way or the other.

“First, is the potential for 8.2 percent federal budget cuts in January. Sequester, as the process is known, will leave FDA with about $320 million less to spend in Fiscal Year 13 than it did in Fiscal Year 12. This includes cuts to taxpayer-funded FDA appropriations, about a $2.5 billion base, and user fee revenue, nearly a $1.4 billion base). If cuts were applied entirely to FDA personnel, the agency would have to cut or furlough about 1,000 people.

“We know that the sequester of FDA funding has consequences: food will be less safe; drug and device approvals will be slower; problems with imports and globalization will become more numerous; and FDA modernization will be severely slowed. Note that this is the opposite of what everyone – critics included – wants. The precise impact is hard to quantify because FDA will try to prioritize its remaining manpower to avoid immediate disasters and avoid any visible failure to approve life-saving therapies.

“Congress does not want to reduce the federal deficit through a sequester. This view is supported by President Obama and his opponent, Governor Romney. Despite this seeming unanimity, an alternative deficit reduction package would need to deal with entitlement programs and taxes. So, politically, deficit reduction is a mess and sequester may happen,” writes Grossman, who is executive director of the non profit, which includes patient advocacy groups, drugmakers, former goverment officials, law firms, trade groups and consultants (see here).

And what about the commish? Will Margaret Hamburg remain if Obama is re-elected? Will Romney do what former president George W. Bush did and let the agency drift with temporary leadership for months on end? “Historically,” Grossman offers, “change at FDA is affected by the interest level of the President (most Presidents aren’t interested in FDA); a growing or shrinking agency budget; an acting versus a confirmed commish,” and Congress.

Not surprisngly, he offers several scenarios. If Obama remains in the White House, Hamburg is likely to remain as well, at least for the first year, especially if there is no sequester. You can read more about the varying possibilities here, although Grossman notes that “it is only a slight exaggeration to suggest the agency would be set adrift and some panic might set in” if there is a sequester and a long-term acting commish.

“If Governor Romney is elected, then the main drivers of change are likely to be his interest level, how quickly he nominates a new commissioner, how controversial his nominee is, and the federal budget situation,” he writes, adding that his attention is likely to be drawn in many other directions. “The best situation would be a well-known, well-respected, candidate who could win easy confirmation. That person would have the opportunity to make a lot of changes, although there would be notable differences if a new commissioner faces budget cuts.”

Of course, ‘well respected’ means different things to different people. The notion, meanwhile, that the FDA would largely continue on its current path with an Obama re-election is not hard to imagine, at least for the short run. With Romney in the White House, however, the agency is likely to look and feel quite differently – and have a commish who is willing to ‘swing the pendulum’ away from an emphasis on safety and take any number of steps to speed approvals, regardless of budget cuts. In fact, a Romney commish is likely to boast about a goal of approving more drugs with fewer resources. 

Ed's blog is found here

Veterinary Drugs Stakeholder Forum Meeting #1 for 2010-2015 Friday, November 9, 2012 USP Headquarters, Rockville, Maryland Sanja Modric, DVM, Ph.D., FDA Center for Veterinary Medicine (CVM), Chair Draft Agenda

2:30 p.m. 6. Compounding: Background and USP’s Role (15 min each)
a. Regulatory Perspective TBD
b. AVMA Perspective Butch KuKanich
c. Industry Perspective Rob Hunter
d. USP Perspective Gigi Davidson
e. Discussion


Source found here

The Op-Ed: Compounding & Laissez Faire Rules // Pharmalot

The Op-Ed: Compounding & Laissez Faire Rules // Pharmalot

Meningitis outbreak offers lawmakers a chance for rare bipartisanship

Fungal meningitis doesn’t care whether its victims are Democrats or Republicans.
That’s why Tennessee’s congressional delegation should join together, party with party, and sign on to a proposed new law that would give the U.S. Food and Drug Administration clear guidelines to enforce safety at compounding pharmacies.
U.S. Rep. Edward Markey, a Democrat, represents the Framingham, Mass., community where the meningitis culprit, New England Compounding Center, is located. His proposed bill recognizes a giant hole in regulation of pharmacies that compound their own drugs: No one has taken ownership of enforcing the laws they ignored.
The truth is the FDA had the tools all along to stop this. But it wasn’t vigilant, dumping responsibility on state pharmacy boards. As we know by now, they didn’t get the job done.
Drug compounding has been used traditionally by doctors and pharmacists to make medication that wasn’t commercially available for a patient. But some companies, like the one in question, twisted that to set up widespread manufacturing of drugs to compete with more expensive ones already on the market. In this case, inspectors found massive amounts of what looked like mold in the plant.

The tainted steroid injections have made 78 Tennesseans sick, and 12 of them have died. Nationwide, 387 people have contracted fungal meningitis and 29 have died.
Attorney Peter Barton Hutt, chief counsel at the FDA in the 1970s, told Tennessean reporter Josh Brown that a 1938 law gave the FDA the power to stop this entire fiasco from happening. That law said companies cannot stockpile drugs, and if there is an approved drug already on the market, they cannot compound a competing drug. This firm apparently violated both of those rules. The FDA sent them a letter in 2006 warning them they were not supposed to be manufacturing commercially available drugs, and that they were illegally making medication without a prescription.
But the FDA, citing a lack of resources and two court cases, chose to leave it up to state pharmacy boards to do the enforcing. And that has not happened.

No commitments

Markey’s bill would make enforcement of the law much easier. It would require pharmacies that sell drugs across state lines to register with the FDA and comply with minimum safety standards. It would also require patients to be warned if they are given a drug not approved by the FDA.
When he announced his plans, two Tennessee lawmakers weighed in.
U.S. Rep. Marsha Blackburn, R-Brentwood, said the FDA “plays a critical role in ensuring the safety of our nation’s pharmaceuticals.”
Sen. Lamar Alexander was similarly cautious: We need to “do our best to make sure this never happens again,” he said.
Neither said whether they will support Markey’s bill; nor has U.S. Rep. Jim Cooper, D-Nashville, or any other from Tennessee’s delegation.
But they need to. Patients should have confidence when they go to a doctor for relief from back pain, not fear. And that confidence can only come if the agency responsible for enforcement is written in stone.
It won’t heal the ill people being treated or bring back those who died. But clear enforcement rules could stop this from ever happening again.

Gail Kerr’s column runs on Sundays, Mondays and Wednesdays. She can be reached at 615-259-8085 or gkerr@tennessean.com.

Ameridose halts Florida shipments amid meningitis issues with related company South Florida Business Journal Date: Monday, November 5, 2012, 10:17am EST

The Florida Department of Business and Professional Regulation has reached an agreement with Ameridose LLC to temporarily halt all shipments to facilities in Florida.

Ameridose’s management is associated with the New England Compounding Center, which is the compounding pharmacy linked to the ongoing outbreak of fungal meningitis from contaminated medications.
On Oct. 31, Ameridose issued a voluntary recall of its unexpired products in circulation. Health care professionals should cease using any products from Ameridose at this time and should return the products to the company.
Facilities with Ameridose products, which may include hospitals, clinics and other establishments, should contact the company at 888-820-0622 for instructions on how to return the products. A complete list of recalled products subject to this recall is available on the company's website.

Continue reading here

Meningitis outbreak: TN health workers sensed danger

By Tom Wilemon | The Tennessean
It was just an email about a single case of illness, but a gut instinct developed through years of disease detective work made Dr. Marion Kainer sense a bigger danger.



Kainer, the director of health care associated infections for the Tennessee Department of Health, started investigating the day she got that email and hasn't stopped since. She camped out in her office for three weeks, leading a team of state workers as they traced the source of what would become a national outbreak of fungal meningitis.
Within the first three days, they had enough evidence to alert federal officials of the burgeoning crisis. They had pain clinics removing suspect medicine from shelves before other states had even determined who had it in stock. Those actions kept the outbreak from affecting more Tennesseans.
The outbreak that they identified, linked to contaminated epidural steroid injections from a specialty pharmacy in Massachusetts, has sickened 404 people nationwide, killing 29 of them. The toll would be higher -- with a high potential for public panic -- had it not been for Tennessee, said Dr. Paul Jarris, executive director of the Association of State and Territorial Health Officials.
"By the time we learned this was a problem around the country, the information from Tennessee had already narrowed it down to what the problem was," Jarris said. "Imagine how frightening it would have been if 23 states had a meningitis outbreak and we didn't know what caused it."
He called the actions of the Tennessee Department of Health "a textbook case of how to do it right."
Tenn. acted early.

Continue reading here

Doctors unsure of recovery time for meningitis patients

November 5, 2012

As increased numbers of meningitis patients leave hospital care, health officials remain uncertain how long it will take for the patients' health to be fully restored.

"The clinical course for each patient differs, and it is too early to say what their long-term function and care issues will be," said Dr. Lakshmi Halasyamani, chief medical officer at Saint Joseph Mercy Hospital in Washtenaw County, where at least 75 patients have been treated for meningitis-related symptoms since late September. Of those, 45 are recovering at home.

After-care issues came into sharper focus with the recent hospitalization and release of George Cary, whose wife, Lillian, was among seven Michigan residents to have died of fungal meningitis.

Continue reading here

FDA spokesperson discusses ongoing anti-counterfeiting efforts In an exclusive interview with Healthcare Packaging, FDA spokesperson Sarah Clark-Lynn addresses the role of supply chain shareholders and packaging in anti-counterfeiting efforts. By Jim Butschli, Editor-in-chief

In October, the U.S. Food and Drug Administration, in partnership with international regulatory regulatory and law enforcement agencies, took action against more than 4,100 Internet pharmacies that illegally sold potentially dangerous, unapproved drugs to consumers.

Here’s what FDA spokesperson Sarah Clark-Lynn had to say about counterfeiting and the role of packaging in anti-counterfeiting efforts:
HCP: How significant is this action with regard to pharmaceutical counterfeiting? Is this the first time such a broad-based global effort has resulted in such action? Could this beginning of further global actions?

Continue reading here

Docket Sheet in Evanston v. FP Pharmaceuticals, Inc, Franck's Homecare, LLC,Franck's Infusion Pharmacy, Franck's Lab, Inc., Franck's Pharmacy, Inc..

Date Filed	#	Docket Text
10/26/2012	1	COMPLAINT against All Defendants with Jury Demand filed by Evanston Insurance Company. Filing fee paid: Receipt #OCA2912, $350.00. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Civil Cover Sheet)(MJT) Modified on 10/26/2012 (MJT). (Entered: 10/26/2012)
10/26/2012		Summons issued as to FP Pharmaceuticals, Inc., Franck's Homecare, LLC, Franck's Infusion Pharmacy, Franck's Lab, Inc., Franck's Pharmacy, Inc.. (MJT) (Entered: 10/26/2012)
10/26/2012	2	AMENDED STANDING ORDER: Filing of documents that exceed twenty-five pages. Signed by All Jacksonville Judges on 05/25/05. (MJT) (Entered: 10/26/2012)
10/30/2012	3	NOTICE of designation under Local Rule 3.05 - track 2. Signed by Deputy Clerk on 10/30/2012. (Attachments: # 1 Case Management Report Form, # 2 Consent Letter and Form)(EAM) (Entered: 10/30/2012)
10/31/2012	4	ORDERED: Plaintiff Evanston Insurance Company is DIRECTED to file an amended complaint disclosing the name of the omitted member of Franck's Homecare, LLC, on or before November 6, 2012. See Order for details. Signed by Judge Marcia Morales Howard on 10/31/2012. (LPB) (Entered: 10/31/2012)
11/01/2012		Set/reset deadlines/hearings: Amended complaint due by 11/6/2012. (LMF) (Entered: 11/01/2012)
11/02/2012	5	AMENDED COMPLAINT For Declaratory Judgment against Evanston Insurance Company with Jury Demand filed by Evanston Insurance Company. Related document: 1 Complaint filed by Evanston Insurance Company.(Curtis, Lauren) (Entered: 11/02/2012)

If readers want any particular documents posted, just let me know and I will try to get them posted.

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Updated Docket Sheet in Insurance Litigation Involving Franck's

09/20/2012	7	ANSWER and affirmative defenses to 1 Complaint with Jury Demand, COUNTERCLAIM against The Cincinnati Insurance Company by Franck's Pharmacy, Inc., Franck's Lab, Inc..(Gudaitis, Christine) (Entered: 09/20/2012)
09/20/2012	8	CERTIFICATE of interested persons and corporate disclosure statement by Franck's Lab, Inc., Franck's Pharmacy, Inc. identifying Corporate Parent Franck's Lab, Inc. for Franck's Lab, Inc.; Corporate Parent Franck's Pharmacy, Inc. for Franck's Pharmacy, Inc... (Gudaitis, Christine) (Entered: 09/20/2012)
09/21/2012	9	NOTICE. (LMF) No PDF attached. Entered in error. Modified on 9/21/2012 (LMF). (Entered: 09/21/2012)
09/21/2012	10	NOTICE by Quorum Management Corp. of Acceptance of Service of Process (Mejer, Alvaro) (Entered: 09/21/2012)
09/21/2012	11	ANSWER and affirmative defenses to 1 Complaint by Quorum Management Corp..(Mejer, Alvaro) (Entered: 09/21/2012)
09/26/2012	12	CERTIFICATE of interested persons and corporate disclosure statement by The Cincinnati Insurance Company identifying Corporate Parent CINCINNATI FINANCIAL CORPORATION for The Cincinnati Insurance Company.. (Glenny, David) (Entered: 09/26/2012)
09/27/2012	13	ANSWER and affirmative defenses to 1 Complaint by Guillermo Caset, Nicholas Espain, Juan Martin Nero.(Shapiro, Craig) (Entered: 09/27/2012)
10/03/2012	14	ANSWER and affirmative defenses to 1 Complaint by Diamond State Insurance Company.(Goodman, Joshua) (Entered: 10/03/2012)
10/05/2012	15	AMENDED COMPLAINT for declaratory judgment and further relief filed by The Cincinnati Insurance Company. Related document: 1 Complaint filed by The Cincinnati Insurance Company.(Glenny, David) Modified on 10/9/2012 (LMF). (Entered: 10/05/2012)
10/15/2012	16	Agreed MOTION to stay Fee and Cost Claims Post-Judgment by Franck's Pharmacy, Inc.(Gudaitis, Christine) Modified on 10/16/2012 (LMF). (Entered: 10/15/2012)
10/22/2012	17	ORDER granting 16 Motion to stay fee and cost claims post-judgment for Defendant Franck's Lab, Inc.. Signed by Senior Judge Wm. Terrell Hodges on 10/22/2012. (LRH) (Entered: 10/22/2012)
10/22/2012	18	ANSWER and affirmative defenses with Jury Demand to 15 Amended complaint, Amended COUNTERCLAIM against The Cincinnati Insurance Company by Franck's Lab, Inc..(Gudaitis, Christine) (Entered: 10/22/2012)
10/24/2012	19	ANSWER and affirmative defenses to 15 Amended complaint by Quorum Management Corp..(Mejer, Alvaro) (Entered: 10/24/2012)
10/25/2012	20	Agreed MOTION to amend/correct 17 Order on motion to stay by Franck's Lab, Inc.. (Gudaitis, Christine) Modified on 10/26/2012 (MJT). (Entered: 10/25/2012)
10/25/2012	21	ANSWER and affirmative defenses to 15 Amended complaint by Guillermo Caset, Nicholas Espain, Juan Martin Nero.(Shapiro, Craig) Modified on 10/26/2012 (MJT). (Entered: 10/25/2012)
10/29/2012	22	ORDER granting 20 motion to amend/correct. See Order for details. Signed by Senior Judge Wm. Terrell Hodges on 10/29/2012. Copies mailed/emailed. (MAM) (Entered: 10/29/2012)
10/30/2012	23	REPLY to 18 Amended COUNTERCLAIM by The Cincinnati Insurance Company. Related document: 18 Answer to 15 Amended Complaint, Amended Counterclaim.(Glenny, David) Modified on 10/31/2012 (MJT). (Entered: 10/30/2012)
10/30/2012	24	Agreed MOTION for extension of time to file answer or otherwise plead re 15 Amended complaint by Anthony J. Campbell. (Gudaitis, Christine) Modified on 10/31/2012 (MJT). (Entered: 10/30/2012)
10/31/2012	25	ENDORSED ORDER granting 24 Defendant-Campbell's Agreed Motion for Extension of Time: on or before November 5, 2012, Defendant-Campbell shall file his response to Plaintiff's Amended Complaint. Signed by Magistrate Judge Philip R. Lammens on 10/31/2012. (JLS) (Entered: 10/31/2012)
10/31/2012		Set deadline for Anthony J. Campbell: Answer due by 11/5/2012. (MJT) (Entered: 10/31/2012)

State of Illinois and K-V have reached settlement agreement: K-V files Notice of Voluntary Dismissal

 10/09/2012 32 MINUTE entry before Honorable Susan E. Cox: Counsel contacted the Court. They have reached a settlement and will need additional time to finalize settlement documents. Settlement conference set for 10/11/12 at 1:00 p.m. is stricken. Parties to move for dismissal before the district judge. All matters relating to the referral of this action having been resolved, this case is returned to the assigned judge. Case no longer referred to the Honorable Susan E. Cox. Mailed notice (vkd, ) (Entered: 10/09/2012) 10/25/2012 33 NOTICE of Voluntary Dismissal by K-V Pharmaceutical Company (Libowsky, Stephen) (Entered: 10/25/2012)

Meningitis scandal shows how regulators failed to keep up with compounding industry

November 04, 2012The fallout from the meningitis scandal seems to worsen every day. Tainted vials of steroids from New England Compounding Center, a Framingham specialty pharmacy, have led to more than 300 illnesses, at least 28 deaths, and now, a voluntary recall of products from the company’s sister pharmacy, which could have ripple effects in hospitals nationwide. State officials, once cautious, have now stepped up their rhetoric, but their newfound fury calls into relief a larger problem: How state regulators somehow failed to notice, over the past decade, the dramatic growth and apparent production shortcuts that occurred in a compounding pharmacy industry that has come to play a critical role in medical treatment.
Compounding pharmacies operate under a legal structure that treated them as mom-and-pop operations, which create small quantities of carefully prepared medicine for patients with particular needs. But New England Compounding Center and its sister company, Westborough-based Ameridose, had much larger ambitions than the typical neighborhood drugstore. Apparently capitalizing on a culture of lax oversight, they wound up doing what amounts to mass production, potentially in violation of a state law that forbade them to dispense drugs without individual prescriptions.
Major pharmaceutical companies are subject to strict federal oversight. But the task of regulating compounding pharmacies fell to a once-obscure entity called the Massachusetts Board of Registration in Pharmacy. The 11 members of this board are appointed by the governor and work under the purview of the Department of Public Health’s Bureau of Health Care Safety and Quality. Board members are responsible for licensing pharmacists, ensuring high standards of professional conduct, and protecting the public welfare. By law, the bulk of the members are themselves pharmacists, presumably because people who know an industry intimately may be well equipped to police it. (Boards that oversee individual doctors and nurses operate in a similar way.)
Yet compared with its counterparts in other states, the Massachusetts pharmacy board has suffered from a lack of transparency and efficiency. It does not produce an annual report, and until the current crisis struck, did not conduct regular unnanounced investigations of specialty pharmacies.
Continue reading here 

Meningitis outbreak puts spotlight on pharmacies that make medicines from scratch

By James T. Mulder, The Post-Standard The Post-Standard
on November 04, 2012 at 9:00 AM, updated November 04, 2012 at 9:44 AM

Syracuse, N.Y. -- In the pharmacy at the back of Vernak Farms Country Store in Skaneateles, a technician wearing a hairnet, gloves, mask and lab coat uses a machine to blend a creamy ointment that looks like icing for a cake. Patients will rub the mixture into their skin to relieve pain.

Another technician nearby uses a glass mortar and pestle to mix white powder and other ingredients to make “rectal rockets,” special suppositories for hemorrhoid sufferers.
Those items and some other medicines produced at the pharmacy can take hours to make from scratch.
“It’s kind of like an art form,” says Charlene Vernak, the pharmacist in charge, who co-owns the store near the hamlet of Borodino with her husband, Christopher Vernak, who runs the non-pharmacy part of the store.

Charlene Vernak operates a compounding pharmacy, a type of specialty drugstore relatively unknown until a deadly national outbreak of meningitis was recently linked to drugs made by a compounding pharmacy in Massachusetts. Compounding pharmacies make customized medicine for patients with unique health needs that cannot be treated with the mass-produced drugs that regular pharmacies offer.

She and other compounding pharmacists say their small pharmacies have nothing in common with the operation in Massachusetts that was preparing drugs for national distribution and functioning more like a big manufacturer than a pharmacy.

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Steroid company’s political ties surface as meningitis outbreak worsens

Victims of the meningitis outbreak blamed for 29 deaths across 19 states are now reporting spinal infections, The New York Times reported Thursday.
Most of the reports of the infection, known as an epidural abscess, have originated in Michigan, site of 112 meningitis cases during the outbreak.
“This is a significant shift in the presentation of this fungal infection, and quite concerning,” said Dr. Lakshmi K. Halasyamani, chief medical officer at St. Joseph Mercy Hospital in Ann Arbor, Michigan. “An epidural abscess is very serious. It’s not something we expected.”Nationally, 404 people have been diagnosed with meningitis since late September, after using a contaminated steroid issued by the New England Compounding Center (NECC). The Food and Drug Administration confirmed the company’s link to the outbreak last month when it matched the contaminant involved in the outbreak, Exserohilum rostratum, to a steroid batch the company made in August.

Salon reported on Tuesday that while NECC has been reprimanded several times over the past decade, the company was spared from more serious sanctions by entering into a consent agreement with a state agency, the Massachusetts Board of Registration in Pharmacy.
The company’s president and co-owner, Greg Coniglario, was also revealed to have hosted a fundraiser for Massachusetts Republican Sen. Scott Brown (R-MA), one of 10 senators to sign a letter asking the FDA to loosen regulations on the drug compounding industry.
Coniglario has allegedly contributed thousands of dollars to both Brown’s campaign and former Massachusetts Governor Mitt Romney’s presidential campaign.
About 14,000 people were injected with the steroid, methylprednisolone acetate, after it was initially shipped to hospitals. The drug is mostly used to treat neck and back pain, but some patients reported infections after being injected for arthritic joint pain.
Both NECC and a sister company, Ameridose — also owned by NECC’s owners, Coniglario and Barry Cadden — have been shuttered during the investigation, and their products have been recalled.

Raw Story (http://s.tt/1rS8s)

K-V Litigation Before International Trade Commission

International Trade Commission has directed respondents and interest parties to answer.  To view the notice filed by the Internal Trade Commission click here

Hologic challenges KV over Makena - Medical Marketing and Media

Hologic challenges KV over Makena - Medical Marketing and Media

Hospital in Missouri Has Reported that It Received Products from NECC

7:16 PM, Nov 2, 2012
Festus, MO (KSDK) - A hospital in Jefferson County received a product manufactured by a northeastern medical company that has since been recalled due to its ties to a meningitis outbreak.
Jefferson Memorial Hospital reported to the Missouri Department of Health it received the unnamed product from a hospital located outside the state.
The product was made by New England Compounding Center, the same facility where drugs related to the nationwide meningitis outbreak. The product itself has not been linked to the meningitis outbreak, but was nonetheless recalled.
Jefferson Memorial Hospital told the Department of Health and Senior Services that the product may have been given to a patient. The hospital has started contacting any patients who may have received the product.
No illnesses connected to the products distributed by the New England Compounding Center have been reported in Missouri.
KSDK

Source found here

State board to vote on pharmacy’s license Monday

By: Angelle Barbazon
abarbazon@etruth.com 

INDIANAPOLIS — The Indiana Board of Pharmacy is expected to vote Monday whether to suspend the license of a pharmaceutical company connected to a multistate fungal meningitis outbreak.

The board will meet at 8:30 a.m. Monday in Indianapolis to discuss the future of the New England Compounding Center’s presence in the state. Indiana Attorney General Greg Zoeller filed an emergency petition at the end of October asking the board to remove the Massachusetts company’s license to do business in Indiana.

Cases of fungal meningitis have been confirmed in 19 states after tainted steroid medications were distributed to clinics across the country, according to the U.S. Centers for Disease Control and Prevention. There have been 404 infections reported nationwide, including 50 in Indiana. Thirty-three of the cases in Indiana are linked to Elkhart County. Infections related to the contaminated drugs have killed 29 people nationwide, three of whom died after receiving injections at OSMC Outpatient Surgery Center in Elkhart. The clinic contacted close to 400 patients after the medications were recalled in September.

The New England Compounding Center has agreed to have its pharmacy license suspended in Indiana, according to the attorney general’s office. If the pharmacy board votes to accept the center’s agreement Monday, the company will no longer be allowed to operate in Indiana. After the vote, the attorney general plans to file a formal complaint with the pharmacy board, which will then decide on disciplinary action against the company.

Seven lawsuits have been filed in Elkhart County by OSMC patients against the pharmaceutical company and its affiliates. OSMC has not been named in any of the lawsuits.

Source found here

Erkan v. New England Compounding Pharmacy, Inc. et al

Erkan v. New England Compounding Pharmacy, Inc. et al

Meningitis outbreak: Quick dose of drugs slows rate of deaths

4:00 AM, Nov 3, 2012

Twelve of the 78 people sickened with fungal meningitis in Tennessee have died — a 15 percent mortality rate, but one that state epidemiologist Dr. Tim F. Jones says is deceiving.

• Discuss the fungal meningitis outbreak on Facebook
• Continuing coverage of the fungal meningitis outbreak

Patients who are diagnosed early and who receive prompt treatment with antifungal medications have much better survival prospects. Thirty-five of these patients have been discharged from hospitals — 15 of them on Friday, according to the Tennessee Department of Health
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Compounding pharmacies fill important medical niche

By Carolyn Y. Johnson

| Globe Staff November 03, 2012

Among the many surprises that have emerged since a Framingham pharmacy was implicated in a national fungal meningitis outbreak is this one: Hundreds of US hospitals, includ­ing most of those in Massachusetts, bought medications from the lightly regulated New England Compounding Center.
Unlike major drug manufacturers, the specialty pharmacy was not regularly inspected or monitored by the Food and Drug Administration, yet prestigious hospitals from Massachusetts General to Yale-New Haven were among its customers, according to a list posted online by the FDA.
Hospitals and pharmacists say companies such as New England Compounding play a critical role in supplying scarce drugs, specialized medications, and individually packaged doses. But over the years, some companies have grown so large that they quietly crossed a line, acting more like drug manufacturers than pharmacies that prepare drugs for individual ­patients.
“We do think we need to clarify some of the regulations and who is doing the regulation,” said Dr. Elizabeth Mort, interim senior vice president of quality and safety at Massachusetts General Hospital. “We want to be part of that conversation, because we’re at the ­delivery end. We want to make sure we have continuous, ­uninterrupted, high-quality drugs delivered to our patients.”

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Meningitis Outbreak: Tests reveal fungi, but cause is mystery

9:48 PM, Nov 3, 2012

One is a common black mold that likes to feast on bread. Another is pigmented yeast that can live in the air, soil and water. A third is a fungus, usually found in soil and on plants, that thrives in warm and humid climates.

All seemingly different, yet they share one thing in common: They were in supposedly sterile medications prepared by the specialty pharmacy linked to a nationwide fungal meningitis outbreak that has sickened 404 and killed 29, including 12 in Tennessee.

So far, lab tests have found three types of fungus and 10 bacterial strains in unopened medicines that New England Compounding Center produced in its Framingham, Mass., facility. And more contaminants likely will be discovered as the impacts of the facility’s unsterile conditions become clearer, experts said.

“Those findings are not surprising, given how appalling the conditions were when those drugs were being made,” said Dr. Michael Carome of Public Citizen, a nonprofit advocacy group. “It would be surprising if they don’t find more contaminants.”

However, scientists may never be able to unravel exactly how the drugs became contaminated.

Three fungi confirmed

Federal health officials believe three NECC-produced lots of preservative-free methylprednisolone acetate (MPA), a corticosteroid that’s often injected to relieve pain, are responsible for the outbreak. All of the victims received shots in their backs or joints from those lots.

Those lots, as well as every NECC-made product on the market, have been recalled and now are being spot-tested for sterility.

The U.S. Centers for Disease Control and Prevention and the Federal Drug Administration say their labs have found three kinds of fungus in unopened MPA vials from two of those suspect lots:

• Exserohilum rostratum, which likes soils and plants in warm, damp conditions.

• Rhizopus stolonifer, a common black bread mold.

• Rhodotorula laryngis, a yeast that can be found just about anywhere in the environment.

Test results from the third lot have not been made public, but the CDC said the other results “strengthen the link between preservative-free MPA vials and the outbreak.”

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Bad medicine: Local drug compounder says more regulation isn’t the answer - PhotoGallery - Courier News

Bad medicine: Local drug compounder says more regulation isn’t the answer - PhotoGallery - Courier News

IACP's Legislative and Regulatory Update for Compounders: What You Don’t Know Can Hurt You

IACP's Regional Education Meeting in Foley, Alabama

Public Event · By IACP

• • Thursday, December 13, 2012
  • 7:00pm until 9:30pm in CST

• mediStat - 110 East Azalea Ave., Foley, AL 36535

• Legislative and Regulatory Update for Compounders: What You Don’t Know Can Hurt You As a part of the International Academy of Compounding Pharmacist’s 20th Anniversary, IACP launched a traveling LIVE pharmacy law CE course. After a successful 2011, we’re continuing the series of live regional educational programs that give pharmacists and technicians 2.0 contact hours (.20 CEUs) of LIVE pharmacy law continuing education credit and a chance to learn and network with their local colleagues. At this seminar, ... you will hear from IACP’s Executive Vice President & CEO David G. Miller, RPh as he presents an in-depth presentation on legislative and regulatory issues that affect you and your practice. Whether you’re a veteran compounder or just thinking about implementing this critical health service for your community, we hope you’ll join us for an evening of education and fellowship. This seminar is a knowledge based activity designed for any pharmacist, technician or pharmacy student currently involved in or interested in building their understanding about compounding pharmacy. This program is accredited for LIVE pharmacy law for pharmacists and technicians. At the conclusion of this seminar, the attendee will be able to: - Compare two ongoing actions by the FDA as they pertain to veterinary and human compounding. - Explain the statutory meaning of “FDA approved drug product.” - Describe how CMS definitions of “covered drug products” affect reimbursement and access to API-based compound preparations. - Describe federal agency initiatives to restrict and limit the use of APIs for veterinary compounding. - Define “constructive transfer” and the difference between judicial and agency interpretations of its legality. - List three different issues which are being addressed by state agencies and how they affect compounding. _____________________________________ Thursday, December 13, 2012 mediStat 110 East Azalea Ave., Foley, AL 36535 7:00 – 7:30 p.m. Check-in 7:30 – 9:30 p.m. Educational Session _____________________________________ IACP Members: FREE Non-Members: FREE Student Pharmacists: FREE This program is made possible through an unrestricted educational grant-in-aid from mediStat. Because space is limited, pre-registration is strongly encouraged. Please RSVP by November 29, 2012 Visit: www.iacprx.org/RegionalEducationMeetings to register online. Questions: Call the IACP office at (281) 933-8400 See More

Statement by a Compounding Pharmacist

I Am a Compounding Pharmacist

Added by No Author on November 3, 2012.
Saved under Columnists, Health
Tags: compounding, pharmacist

Three months ago, most Americans would have shrugged at that statement.
Today, those same Americans would have a different reaction, and quite possibly a negative one.
Compounding pharmacies are on the front pages because of the ongoing tragedy that is attributable to the actions of the New England Compounding Center (NECC), based in Massachusetts.
I have just returned from an International Compounding Symposium. The symposium was intended to discuss the latest and greatest in the realm of Pharmaceutical Compounding. The tone of the meetings was overshadowed by this incident. My colleagues and I, to a man, are outraged and sickened by the alleged malfeasance at NECC. They called themselves a compounding pharmacy, but in actuality they were apparently careless manufacturers who needlessly and shamefully endangered the lives of their customers.
It is alleged by regulators that NECC somehow was able to skirt existing state and federal laws and operate its business by shortchanging quality. That is not what a compounding pharmacist does.
What is a compounding pharmacist?
We make drugs for people who can’t take conventional medications that are manufactured by big companies. We customize medications; we compound specialized drugs for children; we make intravenous solutions; we make sterile eye drops as well as medications for pets. We also can compound medications when a conventional medication is unavailable, when a patient cannot use the conventional medications due to allergies to binders fillers and or dyes, something that is happening more often as of late.
We are your local pharmacist, and we make some of the drugs that many of you take to make your lives better or easier.
In short, compounding pharmacists fill the needs of patients who have unique health needs that can’t be met by off-the-shelf, manufactured medications. These personalized medications, prescribed by licensed practitioners and prepared under strictly controlled conditions by specially trained compounding pharmacists, are the only way to better health for these individuals.
What we don’t do is manufacture big batches of drugs and then send them off at cut-rate prices across the country, which is what NECC is alleged to have done. We don’t know all the details about what NECC was up to and why they weren’t stopped before this tragedy happened, but we do know some facts.
We do know that NECC had been cited by the FDA and by Massachusetts State regulators.
We also know that neither the FDA nor Massachusetts state regulators followed up effectively on their warnings, because the misbehavior continued. We know that the NECC was careless with the safety of its patients. And we have now been told by officials that much of what they did was illegal.
What we need to do now is find out all the facts and find out what exactly happened with the NECC and with its regulators. We need a thorough and complete assessment of state and federal laws governing the practice of pharmacy. We also must be sure that laws and regulations are enforced.
Our profession is determined to work with regulators, government officials, boards, and others to ensure that the bodies charged with enforcement (FDA, DEA, state boards of pharmacy) are able to do their jobs.
There have been calls for the federal Food and Drug Administration to take over regulation of pharmacies, but the FDA has always had the authority to visit and inspect any pharmacy at any time, on its own or in response to complaints. Regulators at the state level might be better positioned to enforce rules and inspect facilities than this federal agency and its very broad scope.
There are a couple of steps that can be taken immediately.
Professional standards issued by the United States Pharmacopeial Convention, a nonprofit organization that sets rules to identify the strength, quality and purity of medications, have not been adopted by every state. Every state should immediately adopt these USP standards.
The meningitis outbreak is a national tragedy. My heart goes out to all the people and their families that have been affected. Our profession stands ready to work with leaders from government to make sure that what happened at NECC never happens again.
Jack Nie RPh. is owner of Nie’s Pharmacy & Wellness Center located in Independence
Source found here

As pharmacies face scrutiny, state of Texas’ oversight drops

Posted: 8:00 p.m. Saturday, Nov. 3, 2012

By Eric Dexheimer

American-Statesman Staff

In 2008, the Texas State Board of Pharmacy warned that there needed to be more testing of compounded drugs — prescription medications mixed and prepared by individual pharmacies, typically with much less oversight than government regulators demand of drug manufacturers.
A year earlier Texas legislators had for the first time given the agency $50,000 a year to pay for random testing, which it had begun. But “we believe that the agency should be conducting more tests,” the board’s administrators wrote in the request for their 2010-2011 budget. “Any problem with these products could have dramatic and potentially life-threatening effects on the patient.”
Instead, thanks to budget cuts, over the past three years the number of pharmacies whose products the state tests for contamination, sterility and potency to ensure patient safety has plummeted.
In 2010, the agency conducted tests on medications compounded at 65 Texas pharmacies. The following year, the number dropped to 30. By the end of fiscal year 2012, in August, the number had plunged to only 21 — less than a third from only two years earlier.
Money the agency spent on the testing program slid 72 percent over that time.
Testing fewer than two dozen pharmacies is “absolutely not” sufficient to protect patients, said state Sen. Leticia Van de Putte (D-San Antonio), a licensed pharmacist who sponsored the bill authorizing state regulators to test mixed drug samples. “You just hope to God nothing goes wrong.”
The pharmaceutical compounding industry has come under sudden scrutiny after federal investigators linked an injectable steroid medicine prepared by the New England Compounding Center to 29 meningitis deaths and 377 cases of sickness across 19 states. While U.S. Food and Drug Administration records show the company sent the drug — injected in the spine to relieve back pain — to medical facilities in Texas, the state has reported only a single case of illness tied to it.
The U.S. Centers for Disease Control identified a fungus found in vials of the drug as the likely culprit. Subsequent inspections found unsanitary conditions at the Framingham, Mass., pharmacy and regulators ordered the facility shuttered. Last week state regulators closed a second pharmacy and promised more rigorous oversight.
Texas’s compound testing program has whithered during a time when the number of state pharmacies has grown steadily, to about 6,300; and despite the fact that in a given year state regulators found up to a third of the samples tested did not contain the potencies identified on their labels. Pharmaceutical standards permit variations of 10 percent in either direction, so the compounds identified by the state’s testing were too weak or too strong by at least 11 percent, said Gay Dodson, the pharmacy board’s executive director.
Some medicines were off by more, she said. But, Dodson added, she could not identify the facilities or the drugs: A 2009 Texas law prohibits release of the information unless the pharmacy is disciplined, or the board determines the public’s health is at risk — a situation that has not arisen.
Pharmacists compound medicine when specific patients need special doses or combinations of drugs not available from manufacturers. The process can range from combining two ointments, to mixing several powerful drugs under sterile conditions.
The FDA closely regulates manufacturers, requiring regular product testing and inspections. But the oversight of compounding pharmacies has largely fallen to the states. Most perform comparatively less regulation even as the industry has expanded.
Instead of requiring a patient prescription to make a custom medicine, for example, newer state laws permit compounding pharmacies to produce large batches of mixed drugs for hospitals and clinics in anticipation of patients’ needs. New England Compounding sent as many as 500 doses at a time of its specially produced steroid to individual Texas hospitals, FDA records show, prompting some to question if the company was more manufacturer than pharmacy.
Not all pharmacies compound medicine. Yet like most states Texas does not require a separate registration for those that do, so officials here concede they don’t know how many of the facilities mix drugs. The Missouri City, Texas-based International Academy of Compounding Pharmacists estimates that about half of the country’s 56,000 pharmacies do basic medicine mixing, with about 3,000 nationwide performing sophisticated sterile compounding.
Van de Putte said she would introduce a bill in the next legislative session mandating a better tracking system in Texas.
Unlike nearly every other state, Texas has an existing compounding pharmacy testing program. Passed into law in 2005, it was not funded until 2007. Industry representatives stress that druggists have been compounding medicines on their own for hundreds of years, and that errors are rare. “They’re extremely uncommon,” confirmed Paul Holder, assistant director of enforcement for the Texas Board of Pharmacy.
Yet medication compounded at Texas pharmacies also has caused serious harm. A year before the state implemented its testing program, three people — two in Oregon and one in Washington — died after being injected with drugs mixed at a Dallas pharmacy.
Subsequent tests of the medicine prepared by ApotheCure revealed it was “super-potent, containing 640 percent of the level of colchicine declared on the label,” according to federal records. A gout medicine, colchicine has been used off-label to treat back pain.
Prosecution of the case has dragged. When state and federal regulators first asked to review the company’s records, ApotheCure refused, and the Texas pharmacy board filed a lawsuit forcing the company to comply. In November 2010, ApotheCure, while denying wrong-doing, agreed to pay a $125,000 fine to the state pharmacy board and install better quality control procedures.
This past April — four years after the deaths — ApotheCure pharmacist Gary Osborn pleaded guilty to misdemeanor violations of federal laws for shipping misbranded medicine. A separate lawsuit brought by the state of Texas alleging violations of the state’s Food, Drug and Cosmetic Act is scheduled to go to trial later this month, said a spokesman for Greg Abbott, the Texas attorney general. Meanwhile, ApotheCure has remained in business.
Another Texas pharmacy narrowly averted tragedy due to a compounding error. In 2008, 17 babies at Corpus Christi’s Christus Spohn Hospital received intravenous doses of heparin, an anti-coagulant drug, that were 100 times stronger than recommended. The mistake, discovered by nurses who quickly administered a drug to counter the heparin’s effects, was traced to the hospital pharmacy, which had incorrectly mixed the medicine. “At least five patients may have experienced bleeding,” according to state records.
Three months later, the hospital paid a $1,200 fine to the pharmacy board and agreed to institute new quality-control policies in its pharmacy.
The decline in the scope of the Texas’s compounding pharmacy testing program parallels an overall contraction of the state’s oversight of pharmacies and pharmacists exacerbated by the state’s budget crisis.
Over the past decade, the number of pharmacies across the state has grown by about 1,200. During the same period, the number of the Texas State Board of Pharmacy inspectors charged with ensuring the facilities meet state quality standards has remained at six. (The agency has had a seventh inspector, but the position currently is unfilled.) The Austin-based inspector’s territory alone ranges southeast to Galveston and west to Junction.
Holder said the agency’s goal is to inspect every pharmacy once every two years; each inspector is expected to evaluate 400 facilities a year — an average of about two per day. But even if they meet that goal, the agency still falls short of its goal by more than 1,000 pharmacies each year.
“If you do the math, it doesn’t work,” Holder acknowledged.
Budget cuts of 5 and 2.5 percent in 2010-11, and 10 percent in 2012-13, “have had a dramatic impact on TSBP’s ability to properly do our job of protecting the public,” Dodson wrote two months ago in the agency’s 2014-15 Legislative Appropriations Request.
Van de Putte added that state lawmakers’ concern last session over proliferating pill mills — clinics that overprescribe narcotic pain medications — also diverted scarce resources. “The Legislature was very clear on where the agency needed to concentrate its efforts,” she said.
Yet even when accounting for the short-staffing, the state’s method of overseeing compound pharmacies is spotty. If the Texas pharmacy board receives a complaint about a specific pharmacy, inspectors can — but don’t always — demand a test of a compound. They also can — but don’t always — require the facility to submit compound samples for testing if a pharmacy fails one of several check-offs during a regular inspection.
Even then, inspectors generally only test compounds if the facility happens to have a sample of the mixed drug handy. “If a pharmacy doesn’t already have something prepared, we don’t want to ask them to make it because we know they’ll be careful” while inspectors watch, Holder said.
“It’s really kind of hit and miss,” he added.
Dodson vowed her agency will be more aggressive conducting compounded drug tests this year: “I think every state now is saying, ‘We don’t want to be the next Massachusetts.’”

---

Watchdog coverage
This story continues ongoing scrutiny of state regulatory agencies by Eric Dexheimer, a Statesman investigative reporter since 2006. His previous work has included in-depth articles on state oversight of the lottery, bingo, occupational standards and economic development trust funds.

Herson v. New England Compounding Pharmacy, Inc., et al

Herson v. New England Compounding Pharmacy, Inc., et al

Many hospital pharmacies, including those in Maine, are being forced to compound their own medications or use other drugs to treat patients.

By Michael R. Cohen, R.Ph.
In response to the national outbreak of fungal meningitis, it makes sense for healthcare providers to seriously consider whether they have an ethical and legal obligation to inform end users when they dispense high risk sterile products prepared by a compounding pharmacy. To do that, doctors who inject these products need to be informed of the source.
While some physicians order compounded preparations directly from external compounding pharmacies, others simply prescribe the compounded medication and leave it up to the pharmacy or office staff to secure it from a reputable source. Thus, they may not know that a drug has been compounded from non-sterile ingredients or by an external pharmacy.

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