Friday, May 17, 2013

Compound pharmacies helping patients, but what are the risks? By Todd McDermott, Anchor Published On: May 17 2013 04:23:34 PM EDT Updated On: May 17 2013 05:33:51 PM EDT

The shocking deaths of 21 polo ponies in Wellington in 2009 first put a microscope on compound pharmacies. 
Then came the tainted steroid last year from a Massachusetts compound pharmacy that caused a deadly national meningitis outbreak.
Now, the FDA is inspecting these operations that mix and manufacture drugs.
For all the controversy, compound pharmacies also are still helping many patients. But there are warnings you need to know about.
Just last month, The Food and Drug Administration began what amounts to a crackdown on compound pharmacies, inspecting, for the first time, nearly three dozen of these operations around the country that mix one or more prescription drugs together to create unique formulas not found in standard pharmacies.
The focus wasn't small "boutique" operations like Premier Compounding in Palm Beach Gardens, but on larger facilities that have become nearly factory-sized operations.
Local compound pharmacist Eric Larson told
"The reason they got in trouble is that they were doing things they shouldn't have been doing from the beginning," local compound pharmacist Eric Larson told WPBF 25 News.
The result is what the FDA calls  "devastating repercussions." Last fall, a fungal meningitis outbreak linked to a tainted steroid from a Massachusetts compound pharmacy killed 51 people ... and counting. The latest death was in Florida in March.
In August 2011, 12 people suffered eye infections from the drug Avastin, which was re-packaged by a compound pharmacy. Some of those infections resulted in blindness. 
A few months later, drugs for eye surgeries that were made in an Ocala compound pharmacy caused partial to severe vision loss in almost three dozen patients. Each state's Board of Pharmacy has regulations that should have protected those patients. But enforcement may have been a problem.
"These laws have been in place for years," Larson said. "The problem was people were trying to go around those laws to cut corners to make more profits."
But there are more than just profits at stake. Compound pharmacies fill a growing need for grateful patients.
"Compounded formulations when done properly are a Godsend," hormone specialist Dr. Gloria Hakkarainen.
She frequently uses medications for off-label purposes in formulations she's created with compound pharmacists. Based on the needs of the patient, the best method of delivery might be a cream to be rubbed on or a liquid to be ingested or a hormone best delivered when mixed with other hormones, or, even a dosage or drug combination the big drug companies don't even make.
"Usually what I tell patients is what I'm making for you is something that is not easily available by standard medications in a routine pharmacy," Hakkarainen said. "I'm going to get the pharmacist to make a formulation that delivers the medicine where we want it , when we want it and in the proper dose."
But the FDA says some large compound pharmacies are making and distributing drugs outside the bounds of traditional compounding in a way that's of "great concern," Hakkarainen said.
In a recent article titled "The Special Risks of Pharmacy Compounding," the FDA warns you should ask your doctor if there's an FDA-approved drug you can take. If not, check to see whether your pharmacist is trained in compounding the medication you've been prescribed and get the right information about using and storing the medications.
Also, be sure to ask your pharmacist if your doctor requested a compound drug. Finally, if you experience any problems, call your doctor and pharmacist right away.
Larson goes further and warns that patients should look for the caps, gowns, gloves, and protective equipment that mark a safe, sterile, compounding operation.
The compounding pharmacy industry isn't going away. Premier Compounding owner and pharmacist Tracy Christian stresses that her company uses only FDA-approved, active pharmaceutical ingredients. She said she believes that while the large operations shipping drugs out of state may change, her business will flourish.
"The pharmacies that are specializing in compounding and doing it the right ways are going to rise to the top," Christian said.
And Hakkarainen said she believes making the right choice in compounding is really up to you and your doctor.
"Make sure the pharmacy is reputable, make sure the doctor is well-versed with the pharmacist and make sure the doctor is making the formulation, not your pharmacist," she said.

1 comment:

Kenneth Woliner, MD said...

I practice in Florida, specifically Palm Beach County where this report was published. Florida simply doesn't collect enough $$$ in licensure fees from pharmacies (including compounding pharmacies such as Franck's Compounding Lab that killed those polo ponies and blinded those patients), to hire enough trained inspectors to ensure compounding pharmacies are not "manufacturing" or "wholesale distributing" drugs without a license. What is worse, there is so little $$$ available to the Bureau of Enforcement that valid, legally sufficient complaints, get put on a shelf due to "lack of manpower".

At a recent Board of Pharmacy committee meeting, one (honorable) compounding pharmacist said to me "I'd gladly pay an extra $1,000 per year to the state as a licensure fee (multiply that times 8,864 currently licensed pharmacies in Florida = $8,86 million dollars) to ensure the state had enough inspectors and enforcement power to identify, prosecute, and discipline rogue pharmacies who are endangering patient safety."

A future "Question of the day" could be, "Should state legislatures pass laws to raise pharmacy licensure fees by $500 - $1,000 extra per year, to have enough resources to properly inspect pharmacies and discipline those that are acting outside of scope by (unsafely) doing manufacturing and/or wholesale distributing without a license?"

(BTW, pharmacies generate between $1 million and $40 million each, in "gross revenue" per year. A $500 surcharge to allow inspections won't break anybody, nor cause pharmacies to go out of business en mass.)

Kenneth Woliner, MD