Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, December 4, 2012
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.
Monday, December 3, 2012
IACP’s Recommended Changes to the State Practice Acts & an Update on the FDA’s Response to Meningitis Situation
IACP will be formally announcing a robust list of state practice act change recommendations on Thursday, December 6, 2012 during a national town hall teleconference exclusively for IACP members, state pharmacy associations and state Boards of Pharmacy.
For more information on the teleconference, send an email to iacpinfo@iacprx.org.
IACP members, if you are unable to participate, the teleconference will be recorded and posted to the Member Center of the IACP website at www.iacprx.org.
Source IACP website
Meningitis Outbreak Sweeps Across America…But Where Did It Come From?
Submitted by Dr Marc Macera on Mon, 12/03/2012 - 15:40
In late September and early October, cases of fungal meningitis began to spring up, seemingly out of nowhere, across America. States such as New Hampshire, New York, New Jersey, Ohio, Michigan, Maryland and Tennessee reported case after case of fungal meningitis. Experts were baffled as to what was causing the outbreak…especially because the predominant fungus identified in patients was Exserohilum rostratum, which is a rare cause of fungal meningitis. As more states began to report cases of meningitis a pattern began to develop. All patients suffering from the identified fungal meningitis received an injection of preservative-free methylprednisolone, a steroid injection mainly used to control back pain. Once the steroid injections were implicated as the potential cause of the outbreak they were traced back to the New England Compounding Center pharmacy in Framingham, Massachusetts, where they were prepared. After government officials carried out an investigation, they concluded the steroid injections in question were contaminated during preparation and ultimately lead to the outbreak. As the findings of the report were made public one question began to surface…how could this have happened? The short answer is the New England Compounding Center prepared the steroid injections under conditions that were NOT sterile. The long answer is one riddled with controversy and implications towards pharmacy companies putting profit before patient safety. A compounding pharmacy typically prepares custom medications for individuals based on doctors’ prescriptions. In other words, a compounding pharmacy makes medication preparations for individuals that are different from the available mass-manufactured products on a case by case basis. Compounding pharmacies are not supposed to mass-produce medications and ship them out for resale. However, that is exactly what the New England Compounding Center did. They mass-produced a steroid injection and shipped more than 17,000 vials to pain clinics in 23 states. In essence, the New England Compounding Center turned a compounding pharmacy into a manufacturing company ignoring existing laws, sterility protocols and patient safety all for the speculated goal of profit. As of November 26, 2012, a total of 510 cases of fungal meningitis, including 36 deaths, have been reported in 19 states across America from the implicated New England Compounding Center’s steroid injection. Although the steroid injection has been recalled and the New England Compounding Center has been shut down the infection rate and death toll continue to rise. With that unsettling news in mind, many are wondering what will be done to prevent future tragedies like this meningitis outbreak from occurring again. Some individuals are calling for stronger state compounding laws while others are lobbying for more government led pharmacy inspections. Although the public is split on what they ultimately want done they do agree on one point…if the new laws and protocols do not address pharmacy companies placing profit before patient safety it will only be a matter of time before another health care crisis sweeps across America.
Source found here
In late September and early October, cases of fungal meningitis began to spring up, seemingly out of nowhere, across America. States such as New Hampshire, New York, New Jersey, Ohio, Michigan, Maryland and Tennessee reported case after case of fungal meningitis. Experts were baffled as to what was causing the outbreak…especially because the predominant fungus identified in patients was Exserohilum rostratum, which is a rare cause of fungal meningitis. As more states began to report cases of meningitis a pattern began to develop. All patients suffering from the identified fungal meningitis received an injection of preservative-free methylprednisolone, a steroid injection mainly used to control back pain. Once the steroid injections were implicated as the potential cause of the outbreak they were traced back to the New England Compounding Center pharmacy in Framingham, Massachusetts, where they were prepared. After government officials carried out an investigation, they concluded the steroid injections in question were contaminated during preparation and ultimately lead to the outbreak. As the findings of the report were made public one question began to surface…how could this have happened? The short answer is the New England Compounding Center prepared the steroid injections under conditions that were NOT sterile. The long answer is one riddled with controversy and implications towards pharmacy companies putting profit before patient safety. A compounding pharmacy typically prepares custom medications for individuals based on doctors’ prescriptions. In other words, a compounding pharmacy makes medication preparations for individuals that are different from the available mass-manufactured products on a case by case basis. Compounding pharmacies are not supposed to mass-produce medications and ship them out for resale. However, that is exactly what the New England Compounding Center did. They mass-produced a steroid injection and shipped more than 17,000 vials to pain clinics in 23 states. In essence, the New England Compounding Center turned a compounding pharmacy into a manufacturing company ignoring existing laws, sterility protocols and patient safety all for the speculated goal of profit. As of November 26, 2012, a total of 510 cases of fungal meningitis, including 36 deaths, have been reported in 19 states across America from the implicated New England Compounding Center’s steroid injection. Although the steroid injection has been recalled and the New England Compounding Center has been shut down the infection rate and death toll continue to rise. With that unsettling news in mind, many are wondering what will be done to prevent future tragedies like this meningitis outbreak from occurring again. Some individuals are calling for stronger state compounding laws while others are lobbying for more government led pharmacy inspections. Although the public is split on what they ultimately want done they do agree on one point…if the new laws and protocols do not address pharmacy companies placing profit before patient safety it will only be a matter of time before another health care crisis sweeps across America.
Source found here
Sunday, December 2, 2012
Basic Veterinary Compounding Course
ACA National Training Laboratory (map)
Basic Veterinary Compounding Course Basic Veterinary
Compounding is a 15 hour course The overall goal of this practice based course
is to introduce the pharmacist and pharmacy technician to veterinary pharmacy
compounding.This program provides the fundamental techniques for compounding
medications for animals, as well as establishing and marketing a veterinary
pharmacy practice. For Additional Information and to REGISTER ONLINE - Click
Here $1095 (Non Member price) * $995 (Membe...
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