Disciplinary Action in Nevada Against Pathway Specialty Compounds

The Nevada State Board of Pharmacy recently filed a disciplinary action against:

Michelle Badten, R.Ph (11-092A-RPH-S)
Kenton Crowley, R.Ph (11-092B-RPH-S)
Timothy Brown, R.Ph (11-092C-RPH-S)
Pathway Specialty Compounds (11-092-PH-S)

In 2011, Pathway Specialty Compounds compounded calcium gluconate The calcium gluconate was contaminated and made several individuals sick.  The complaint also contains additional allegations. To view that complaint, click here

The following news article about Pathway appears here.

Pharmacy accused of sickening nine patients

By Darcy Spears

CREATED Jan. 6, 2012

Nevada Board of Pharmacy filing

Las Vegas, NV (KTNV) -- A pharmacist whose name surfaced in the Michael Jackson death investigation is once again under scrutiny.
This time, after nine people became dangerously ill.
Contact 13 Chief Investigator Darcy Spears has the exclusive story.
"It just seems like the standard of practice was not followed in this case," says Dr. Paul Oesterman, Associate Professor of Pharmacy at Roseman University of Health Sciences.
Dr. Oesterman was appalled when he learned what happened at Pathway Pharmacy on Sunset Road and Eastern Avenue.
"It was an inappropriate product to use, they recognized this and labeled it themselves but then they still went ahead and used it."
Darcy: "Is that unconscionable in your mind?"
Dr. Oesterman: "In my mind, it is, yes. They should have never used it."
In a complaint recently filed by the State Board of Pharmacy, Pathway is accused of multiple violations of state laws involving a substance called calcium gluconate.
It's a specially-prepared compound used to treat calcium deficiencies due to hormone imbalance, some skin conditions, even to relieve muscle cramps from black widow spider bites.
The complaint says the calcium gluconate from Pathway caused nine cases of sepsis -- a dangerous bacterial blood infection that resulted in people being hospitalized.
All nine people who got sick were patients of Dr. Fuller Royal, who runs the Nevada clinic.
He's the one who originally diagnosed them with sepsis and reported those cases to the Southern Nevada Health District, who passed the complaint on to the Nevada Board of Pharmacy.
We've called Dr. Royal multiple times for comment, but he hasn't returned any of those calls.
We wanted to ask him why he used a single-use vial to inject multiple patients.
"It was not appropriate to be dispensed to multiple patients," says Tim Brown, one of three pharmacists named in the state Complaint, and the only one who would talk to us.
He explained that the calcium gluconate was labeled for oral use only, but because of a shortage of the injectable formula, his colleagues devised a workaround.
As he told the State Board in answer to their accusations, he blames the whole thing on "the reckless behavior of an individual, basically a rogue pharmacist."
He identifies that pharmacist as Dr. Kenton Lance Crowley who we found posing, seemingly shirtless, in his Facebook profile picture.
His name made national news in 2009 when the pharmacy where he had worked was raided in connection with the Michael Jackson death investigation. It's unclear when Crowley left Applied Pharmacy and he was never charged in that case.
In 2008, he permanently lost his on-again off-again license to practice in California after the state board there determined he was a threat to public safety.
Board records show he's got a history of DUI convictions, drug abuse including a near-fatal overdose, dispensing the wrong medication, working while under the influence, sending dangerous drugs out of state without a prescription and providing drugs to an addict.
He did significant jail and prison time on multiple convictions.
Despite all that, he got licensed here in Nevada on a probationary basis.
"I am concerned that this person did get a license," says Dr. Oesterman, who hopes this case will force the Nevada Pharmacy Board to look more closely at applicants from out of state.
No one from the board would talk to us because of the pending complaint, which also names Michelle Badten -- another pharmacist with a history of prescription drug abuse.
The state accuses her, Tim Brown and Pathway with failing to provide the checks and balances that should have prevented Crowley from delivering the tainted calcium gluconate to Dr. Royal.
"We're in business for the public, to help the public, for the public good, for health, not anything like this. This is not a situation where we would ever want to find ourselves in and want to be in any way responsible for," Brown says.
He blames Crowley for coercing other Pathway staff members into behaving recklessly by threatening their jobs.
"And in this market, that's a valid threat. So does it justify what happened? No," Brown says. " We terminated him upon this last incident and so from our standpoint, problem solved."
We tried to track down Kenton Crowley but colleagues say he disappeared after he was fired.
He did not respond to any of our calls or emails.
The Pharmacy Board will hear this case on January 18 and we'll let you know what disciplinary action they take.  

Apothecare Compounding Solutions in Rhode Island

On May 17, 2012, the State of Rhode Island Department of Health reprimanded Apothecare Compounding Solutions in Rhode Island for various violations, one of which includes permitting drugs to be compounded in a manner inconsistent to the USP 795 standards.  Apothecare Compounding Solutions has admitted these allegations.  To view the consent order, click here

Royal Palm Compounding Pharmacy Disciplined by North Carolina Board of Pharmacy

THE NORTH CAROLINA BOARD OF PHARMACY recently entered a consent order of discipline against
Royal Palm Compounding Pharmacy.  To view the consent order, click here.

Urgent: Franck's Compounded Prescription Recall

Urgent: Compounded Prescription Recall

Contact
Consumer:
352-690-6773

Media:
352-622-2913

FOR IMMEDIATE RELEASE - May 25, 2012 - This is to inform you of a product recall involving:

All Sterile Human and Veterinary Prescriptions Distributed by Franck’s Pharmacy From November 21, 2011 to May 21, 2012.

This recall is being initiated after the U.S. Food and Drug Administration ("FDA") notified us that environmental sampling of our clean room revealed the presence of microorganisms and fungal growth. In light of the FDA’s findings and the resulting possible risk of infection, we have decided that it is imperative that we recall all human and veterinary sterile preparations that have left our control. Accordingly, we are extending the recall to all sterile preparations we have provided to you since November 21, 2011.
If any of these sterile preparations remains under your control, it is essential that you do not use them and that employing appropriate practices, you destroy all such sterile preparations and all remaining portions of such sterile preparations.
This recall should be carried out to the User/Physician level. Your assistance is appreciated and necessary to prevent patient illness. Physicians should be advised to review and evaluate their patient records to determine if any adverse events may have resulted from use of the recalled products. Please report any adverse events to Franck’s Compounding Pharmacy and FDA’s MedWatch program.
FDA will expect us to be able to account for all of the sterile preparations subject to this recall. As a result, it is critically important that you read, complete, and return the enclosed response form as soon as possible.
We will update you with any relevant details as they become available to us. If you have any questions please call us at 352-690-6773, Monday through Friday from 9AM to 5 PM, EST.
This recall is being made with the knowledge of the Food and Drug Administration.