What All The News Reports Are Missing in the New England Compounding Center Meningitis Outbreak

This new article, 47 patients linked to meningitis infections, from CNN notes that nearly 10% of drugs administered in the United States come from compound pharmacies, according to a 2003 Government Accountability Office report.  However, there are a number of things that the reporters fail to point out.    Some articles cite the tragic Franck's case involving the 21 dead horses.  The Food and Drug Administration attempted to stop Franck in that case but a district court judge in Florida said it did not have any jurisdiction over veterinary compounding.  The FDA appeal to the 11th Circuit Federal Court of Appeal.  The case will be argued next month.  In the mean time Franck was at it again, causing eye infections from human drug compounds.  No one can fault the FDA in that case because the FDA had tried to stop Franck.  The state board of pharmacy imposed a fine for the dead horses.  The insurance companies are now suing Franck to get back their money.

Other articles fail to cite the end result of the Apothecure and Gary D. Osborn case, where human compounded drugs resulted in deaths.  In that case the federal government prosecuted Apothecure and Gary D. Osborn after all the civil lawsuits.  Apothecure and Gary D. Osborn pled guilty but were recently sentenced to no jail time and a $100,000 fine was imposed on both-- not much for the harm caused.  But again the FDA and the United States Attorney's Office in the Northern District of Texas did take action.  They did try to stop the bad compounders.

But as my previous post noted, we must have compounded drugs. No one seems to be pointing out that a lot higher percentage of compounded drugs are used on animals. That is so evident in the veterinary world where most of the drugs used for animals are either human drugs or most likely compounded drugs made special for a specific animal.    What must continue to be stressed is that there is a place for compounded drugs and that there are good compounding pharmacies and pharmacists out there who do everything within their powers to follow all the rules and regulations, who have compliant sterile rooms, who spend the money to test to make sure the compound is what it is suppose to be.  Tragic as the New England Compounding Center meningitis outbreak is hopefully the world of compounded drugs for both humans and animals will become a better, safer environment, not one that no longer exists.

Update:  News articles are now reporting on the Apothecure and Gary D. Osborn case.  Still not much coverage on why we must have compounded drugs in the United States.  See previous post for a list of reasons compounded medications for animals and humans are essential.

Article from Boston Globe Notes That New England Compounding Center is under Investigation by State and Federal Authorities After Meningitis Outbreak

Compounding pharmacy oversight is questioned after meningitis outbreak

By Liz Kowalczyk and Kay Lazar

| Globe Staff October 06, 2012

Compounding pharmacies started as small mom-and-pop stores that mixed hard-to-find medications for local doctors and their patients who had allergies, difficulty swallowing, or otherwise could not take mass-produced drugs.
But amid growing drug shortages in the pharmaceutical industry, some large compounders such as the New England Compounding Center stepped in and ­expanded their business far beyond the industry’s homespun roots.
The Framingham company, whose products are implicated in a nationwide outbreak of fungal meningitis that sickened more people Friday, listed dozens of products online and apparently took thousands of orders from doctors, clinics, and hospitals in at least 23 states, a transformation that regulators have not kept pace with, critics and even some industry executives said.
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47 people: 7 states now linked to infection

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NORTH CAROLINA BOARD OF PHARMACY SUMMARILY SUSPENDS NEW ENGLAND COMPOUNDING CENTER’S PHARMACY PERMIT

WEDNESDAY, OCTOBER 3, 2012

NORTH CAROLINA BOARD OF PHARMACY SUMMARILY SUSPENDS NEW ENGLAND COMPOUNDING CENTER’S PHARMACY PERMIT NUMBER 08439.  The Board of Pharmacy today summarily suspended out-of-state pharmacy permit number 08439 held by the New England Compounding Center, 697 Waverly Street, Framingham, Massachusetts 07102.  Board staff strongly advises any pharmacy or other health care facility in North Carolina that has any sterile product compounded by New England Compounding Center to take immediate, appropriate action.  The Board’s summary suspension order may be found here (click here).

North Carolina clinicians are advised to be alert for communications from North Carolina Public Health concerning this matter.

More information concerning the circumstances leading to the Board’s action may be found here: 

http://www.newschannel5.com/story/19710698/meningitis-investigators-eye-link-to-compounding-pharmacy

http://www.nytimes.com/2012/10/03/health/meningitis-cases-are-linked-to-steroid-injections.html?hpw&_r=1&

List of 23 States that Received Compounded Injection from New England Compounding Center

Twenty-three states have received medication from NECC among the three recalled lots: California, Connecticut,  Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas and West Virginia.

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Hundreds at risk in meningitis outbreak Health officials are now trying to track down people in 23 states who got epidural steroid injections. NBC’s Robert Bazell reports.

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Rare meningitis cases at 26 in 5 states, 4 deaths

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More on the New England Compounding Center

The Wall Street Journal has an article regarding the New England Compounding Center entitled, Meningitis Tied to Pharmacy: Authorities Investigate Maker of Steroid Injections Linked to Deadly Outbreak.  To read the article click here.