Friday, August 1, 2014

This chat board will make you feel real confident about sterile compounding--NOT!

Thought you were gonna link this story. A compounding pharmacy is responsible for at least 5 deaths due to contaminated intratheical methylpred
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Sterile compounding is sooooo high risk. Scary. We are getting a clean room put in. We dont know the first thing about sterile compounding. Gonna hire an experienced compounding pharmacist.
 
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Very Interesting: MUST READ!! What Compounding Pharmacies Want From Greg Abbott: Compounding pharmacies' interests run far deeper than secrecy over the lethal injection drug supply--Richie's Specialty Pharmacy--one of his specialties is a pain cream

What Compounding Pharmacies Want From Greg Abbott

 
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And then there’s the money.
A week before Abbott’s ruling, the Austin-based watchdog Texans for Public Justice released a report on Abbott’s fourth-most-generous donor in the last year, Conroe compounding pharmacist Richie Ray. As TPJ notes, Ray catapulted into the top tier of Abbott-backers with a $250,000 donation in January—a few months after the mess in The Woodlands, and days after the first of this year’s wave of botched executions.
Because Ray’s pharmacy isn’t certified as a “sterile” facility that can produce drugs for injection, his pharmacy couldn’t be Texas’ latest source. And, in a statement provided to the Observer, Ray is unequivocal that his business has nothing to do with lethal injections: “Richie’s Specialty Pharmacy has never compounded drugs that were used for executions, and we never will. Furthermore, in my 17 years as a licensed pharmacist, I have never compounded drugs that were used for executions, and I never will.”
But as a national leader in pharmacy trade groups, and a major donor to pharmacists’ political allies, he’s taken an active role on behalf of the entire industry. So was Ray hoping to buy Texas’ secrecy, and protect a fellow compounder?
Mother Jones suggested as much in a piece that ran May 28, one day before Abbott’s office ruled to keep Texas’ drug source anonymous. And sure, any time a compounding pharmacy is outed as a source for death row, it’s bad press for the whole industry—but Ray’s political agenda is surely bigger and more complex than the death penalty drugs.
Compounding pharmacies are already locked in a bigger fight—one that more directly affects their bottom line—over how they’ll be regulated by the FDA. That fight involves lawmakers and lobbyists at the state and federal levels, and Ray and his staff have been instrumental in bankrolling compounders’ interests.
Until now, the FDA had oversight of big drug manufacturers, but compounding pharmacies—which had long been little mom-and-pop shops that made drugs for pets or lollipop medications for kids—were left to state regulation. As compounders have grown, so have horror stories about tainted drug batches shipped from compounders to customers nationwide. In its report TPJ recalled the case of Dallas-based ApotheCure, whose drugs killed three patients in Oregon in 2007. Cedar Park-based Specialty Compounding was linked to infections last year in more than a dozen patients. And most notoriously, tainted drugs from the New England Compounding Center killed at least 64 people and infected more than 700 more with meningitis.
That outbreak prompted a quick response from Congress: for the first time, large-scale compounding pharmacies are set for federal regulation, with standards similar to drug manufacturers. But which businesses will fall under federal watch as “outsourcing pharmacies,” and how much that’ll cost them, is all up to rule makers at the FDA.
“That’s kind of the issue that is still unresolved,” says Robert Floyd, an Austin lobbyist for the Alliance of Independent Pharmacists. “At what level does a compound pharmacist have to make a decision to be an outsourcing facility and meet federal licensing, pay federal fees … where is that line going to be drawn?”
That may explain why so many on Ray’s pharmacy staff bet so generously on support from U.S. Sen. John Barrasso of Wyoming in 2012, or why Ray has employed top lobbyists like Craig Chick, a former adviser to House Speaker Joe Straus, and David Marwitz, who also lobbies for the Texas Pharmacy Association. In his statement to the Observer, Ray said he’s worked for years to educate the public, and lawmakers, “about what appropriate quality evidence-based compounding services should look like and how they can best serve the public safely.”
Richie’s Specialty Pharmacy, isn’t a high-volume producer likely to be caught up in the outsourcing regulation—one of its specialties is a pain cream—but it’d be important to Ray to spread a message about compounding that’s less about meningitis outbreaks or lethal injections.
Floyd provided the Observer with a statement he says “reflects the position of most compounding pharmacies” on execution drugs. In brief, this is one fight the industry wants to be left out of:
While we have no formal position on compounding pharmacies’ preparation of drugs used in executions, the pharmacy profession recognizes an individual practitioner’s right to refuse to dispense a medication based upon his or her personal, ethical and religious beliefs. In a very few cases, compounding pharmacies have been asked by a state government to prepare drugs used in executions because pharmaceutical manufacturers have unilaterally restricted distribution. We believe state corrections agencies should work first with the pharmacy services providers—the companies that provide medications to prisoners within their systems—to source or compound drugs for executions before soliciting a traditional compounding pharmacy.
Before the twin controversies over some compounding pharmacies’ dangerous products—whether accidentally or intentionally lethal—the industry got little attention and light federal regulation. What the industry likely wants, most of all, is to keep it that way.