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Tuesday, December 4, 2012
Reform is Coming: The Purpose of This Blog Has Been Accomplished
When I began this blog in March 2012, I was stunned at the lack of education and knowledge about compounding in the veterinary and medical world. I have learned so much since beginning this blog. I hope you have to. In the beginning of this blog, I could foresee a tragic event such as the NECC meningitis outbreak happening. I hoped it wouldn't. I hoped the worst of tragedies had already been seen in cases such as Franck's, and Apothecure and similar cases, but I knew the odds were great that something bad would happen based on the way things were done or not done in the compounding world and when it did happen it would be big. The one good thing that can possibly come out of that big bad thing is reform of the compounding world--better knowledge, better education, better procedures, better practices, better communication, better enforcement, better everything. It is not enough for organizations to point their finger at the federal government. All share in the blame. All must take responsibility and all must work together to improve the situation to make sure nothing like the NECC meningitis outbreak happens again. Whether the federal government passes some sort of legislation and takes over most of the jurisdiction of compounding or the states keep the jurisdiction and strengthen the teeth of the rules and regulations they have, reform is needed and I have no doubt reform is headed our way. There is much left for many to do. There is much knowledge to be gained. There is much education that still must be accomplish.
Fungal Meningitis From Injections: Not Even Close To Over
There’s been an extraordinary outbreak going on over the past few months here in the United States: cases of fungal meningitis, a rare illness, primarily caused by Exserohilum rostratum, a plant pathogen that is equally rare as a cause of human infections. Since the beginning of October, 541 people have been made ill by the infection, in 19 states, and 36 have died. The cause has been traced to contamination in steroid injections for pain relief, made by a compounding pharmacy in Massachusetts which — according to federal investigative reports — was operating outside the lines of what compounding pharmacies are allowed to do. More than 14,000 people are believed to have received the shots.
I haven’t been covering the outbreak because I’ve been following other stories, and also because friends in the mainstream media, particularly the excellent health-science team at the Boston Globe, have been covering it well. (Here’s an archive from their paid site and one from their free site.) But last night I happened to get a close and moderately exclusive look at this complex story, so I thought I’d share.
The back-story: I am on the board of the Association of Health Care Journalists. One of the many things AHCJ does is to offer grant-funded training programs and fellowships for writers. This week, our 2012-13 Regional Fellows (who are funded by the Leona M. and Harry B. Helmsley Charitable Trust and this year come from Tennessee, Mississippi, Alabama, Florida, Georgia and South Carolina) are getting an inside look at the operations of the Centers for Disease Control and Prevention here in Atlanta. Last night, the group got a personal briefing on the meningitis outbreak from Dr. John Jernigan, who is the CDC’s director of the Office of Health Associated Infections Prevention Research and Evaluation, and the clinical lead in the meningitis investigation.
When we follow disease investigations in the media, we tend to focus on the detective story: who got sick, how many of them there are, and how the cause was found. Once those questions are answered, for many reporters, the story is over. But what struck me, in Jernigan’s description of this outbreak, is that this story will continue long after most of the reporters covering it have moved on to other issues. These patients, it turns out, are facing unusually lengthy, high-dose, toxic and expensive treatment, with uncertain odds of success. Months after the injections were delivered, he said, it isn’t possible to say that any of these patents are cured; in fact, at this point, no one can say just how “cure” will be defined.
I live-tweeted Jernigan’s chat as it was delivered to our small group, and made a Storify of it afterward to share. Here you go.
Source found here
Malpractice Bills May Impact Meningitis Outbreak Victims
4 Dec, 2012 17:00 CET
In Michigan, a new set of medical malpractice bills before the state legislature may make recovery of damages difficult for victims and increase immunity for healthcare professionals.
The Daily Press and Argus reports that the bills may even limit the damages sought by the victims of the nationwide meningitis outbreak that has sickened 510 people and resulted in 36 deaths. Supporters of the bill deny any such impact on meningitis suits. Michigan has been one of the state’s hardest hit by the outbreak.
The bills have been awaiting approval by the state’s Senate Insurance Committee for several months.
Contaminated steroid shots mixed at the Massachusetts-based New England Compounding Center (NECC) have been linked to the recent meningitis outbreak by federal health officials.
Michigan law provides immunity to pharmaceutical companies from being sued if the product in question is an FDA-approved. But NECC can likely be sued because compounding pharmacies and their products do not come under the FDA’s oversight.
Source found here
Monday, the CDC announced it found microbial contamination in three more medicines distributed by New England Compounding Center
The number of Tennessee cases of infections from tainted spinal steroids has jumped by four to a total of 88 cases, according to data compiled by the state Health Department.
- Discuss the fungal meningitis outbreak on Facebook
- Continuing coverage of the fungal meningitis outbreak
Health Department spokesman Woody McMillin said Monday that the number of deaths from the fungal meningitis outbreak remains at 13. He said the number of infections climbed from 84 to 86 on Nov. 28 and jumped to 88 over the weekend.
The CDC reported Monday that the number of infections nationwide jumped from 510 early last week to 541 and the number of deaths remained at 36.
Also Monday, the CDC announced it found microbial contamination in three more medicines distributed by New England Compounding Center of Framingham, Mass., the pharmacy blamed for the outbreak. They were the anti-inflammatory steroids triamcinolone and betamethasone, and cardioplegia, which paralyzes the heart for surgery. In a media release, the CDC said it was unclear how the tainted medicines would affect patients.
All New England Compounding Center medicines have been recalled.
Michigan continues to show the most cases at 198, a 20 case increase over a week ago. That state has reported 10 deaths. Other states reporting increases include New Jersey, which jumped from 34 to 38 and Indiana, which went from 57 to 59 cases. Ohio increased by one, going to 19 cases.
The outbreak has been blamed by state and federal health officials on fungus-tainted methylprednislone acetate injected into the spines of patients with severe back and neck pain.
Meanwhile three new lawsuits have been filed against New England Compounding in Davidson Circuit Court by victims and their families. Now 17 have been filed there, though five have been transferred to U.S. District Court. Nationwide, some 80 cases have been filed in federal court alone.
Source found here
Case Count and State Chart: 541* States: 19* Deaths: 36*
State | Total Case Counts | Meningitis (with or without other infection)* | Stroke without Lumbar Puncture only | Paraspinal/Spinal Infection only | Peripheral Joint Infection only | Deaths |
---|---|---|---|---|---|---|
TOTALS | 541 | 363 | 8 | 153 | 17 | 36 |
Florida (FL) | 24 | 19 | 3 | 2 | 0 | 3 |
Georgia (GA) | 1 | 1 | 0 | 0 | 0 | 0 |
Idaho (ID) | 1 | 1 | 0 | 0 | 0 | 0 |
Illinois (IL) | 2 | 2 | 0 | 0 | 0 | 0 |
Indiana (IN) | 59 | 50 | 1 | 8 | 0 | 6 |
Maryland (MD) | 23 | 22 | 0 | 1 | 0 | 1 |
Michigan (MI) | 198 | 64 | 1 | 120 | 13 | 10 |
Minnesota (MN) | 13 | 11 | 0 | 2 | 0 | 0 |
North Carolina (NC) | 3 | 3 | 0 | 0 | 0 | 1 |
New Hampshire (NH) | 13 | 9 | 0 | 0 | 4 | 0 |
New Jersey (NJ) | 38 | 36 | 0 | 2 | 0 | 0 |
New York (NY) | 1 | 0 | 0 | 1 | 0 | 0 |
Ohio (OH) | 19 | 16 | 0 | 3 | 0 | 0 |
Pennsylvania (PA) | 1 | 1 | 0 | 0 | 0 | 0 |
Rhode Island (RI) | 3 | 2 | 0 | 1 | 0 | 0 |
South Carolina (SC) | 1 | 1 | 0 | 0 | 0 | 0 |
Tennessee (TN) | 88 | 74 | 3 | 11 | 0 | 13 |
Texas (TX) | 2 | 2 | 0 | 0 | 0 | 0 |
Virginia (VA) | 51 | 49 | 0 | 2 | 0 | 2 |
* Some patients with meningitis had other infections diagnosed in addition; the majority of these other
Why Do We Need Two Classes of Compounding Margaret?
Margaret Hamburg in testimony before Congress tells them that there should be two classes of compounders. The first is traditional compounding for individual patients on an as needed basis. Non-traditional compounding, the kind practiced by NECC and others, poses a higher risk according to Hamburg and should require federal (i.e. FDA) oversight.
Hamburg suggests non-traditional compounders would be distinguished by characteristics or activities like -- sterile compounding, the amount of product made, production prior to prescriptions received for a patient, shipping drugs interstate, shipping drugs to sellers or distributors other than the patient (or their physician). etc.
Hamburg says these compounders should have to adhere to GMPs and be under more oversight. Addtionally, compounders should not make copies of drugs approved by FDA (i.e. Makena) except under extremem shortage situations, should not make complex dosage forms -- extended release, transdermal patches, liposomal products, etc -- or make biologics.
Why? I say if compounders want to act like small drug manufacturers they shouldn't be called compounders and should be required to adhere to the existing drug manufacturing regulations and be overseen as such. Then the FDA would have clear oversight without any more legislative needs for "clarity".
Why make it so complicated?
Posted by Bruce Lehr Nov 14th 2012.
Source found here
University of New England pharmacy students blend custom meds for animal patients
9 hours ago — Bangor Daily News
PORTLAND, Maine - Pharmacy students at the University of New England are learning how to formulate custom medications not only for their future customers, but also for those customers pets. Doctoral students are studying how to safely compound veterinary drug prescriptions, mixing up batches of the same medications humans take ... [...]
Source found here
Court: off-label promotion protected
Published on Monday, December 3, 2012
The U.S. Court of Appeals for the Second Circuit said in a 2-1 ruling in United States v. Caronia on Monday that the "government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug and Cosmetic Act (FDCA)] for speech promoting the lawful, off-label use of an FDA-approved drug." In the ruling, Judge Denny Chin wrote that so long as the off-label use of the FDA-approved drug is legal, the government's interpretation of FDCA's misbranding provisions to prohibit and criminalize the promotion of off-label use "unconstitutionally restrict[s] speech." FDCA prohibits misbranding, but does not expressly prohibit the promotion or marketing of drugs for off-label use. Chin noted that off-label promotion that is false or misleading is not protected by the First Amendment. In a dissenting opinion, Judge Debra Ann Livingston said the ruling "calls into question the very foundations of our century-old system of drug regulation," adding that if drug companies "were allowed to promote FDA-approved drugs for nonapproved uses, they would have little incentive to seek FDA approval for those uses."
The case concerns Alfred Caronia, a former specialty sales consultant at Orphan Medical, which was acquired by Jazz Pharmaceuticals plc (NASDAQ:JAZZ). He was convicted in 2008 of conspiracy to introduce a misbranded drug into interstate commerce based on audio recordings in which he promoted the off-label use of narcolepsy drug Xyrem sodium oxybate. Caronia, who was sentenced to one-year probation and 100 hours of community service, appealed, arguing that his conviction was based solely on his speech and therefore violated his First Amendment rights. The appeals court vacated and remanded to the lower court the decision convicting Caronia.
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