Thursday, November 7, 2013

Treatment of pharmacy defended

About two weeks before Specialty Medicine Compounding Pharmacy was forced to close its doors, state Sen. Joe Hune said the business followed “a very rigorous standard” through its professional accreditation.

The state last week suspended the South Lyon pharmacy’s operating license because fungi were discovered in one of its sterile injected products last month at Henry Ford Hospital in Detroit.
As a result, the professional accreditation Hune, R-Hamburg Township, earlier mentioned has been suspended pending outcome of the state’s investigation.

The pharmacy immediately made the contamination public and recalled its other sterile products, none of which were believed to be contaminated. No cases of illness have been reported at the Detroit hospital, and it’s unknown if the contaminated product was given to patients.

Still, Hune — and the South Lyon pharmacy — said state Attorney General Bill Schuette didn’t overreact or act prematurely last week when he announced the pharmacy’s license suspension.
Hune earlier cited the pharmacy — and its pharmacist, Kenny Walkup Jr. — as examples of responsible compounding as Hune crafted legislation that would create stricter state oversight of compounding pharmacies, which combine elements of two or more medicines to treat individual needs.

“He reached out to us and said, ‘Will you come out and visit? This is what a world-class facility does,’ ” Hune recalled this week.

“It seemed like a good facility, and maybe just an error occurred. I don’t know,” he added.
Schuette’s office, citing the ongoing investigation, would not comment when asked if Schuette may have acted prematurely in obtaining the license suspension.

“Due to the ongoing state investigation, we have no additional comment at this time,” his spokeswoman, Joy Yearout, said.

The South Lyon pharmacy’s contamination quickly drew the state’s attention in the wake of last year’s fungal meningitis outbreak linked to tainted steroids produced at the New England Compounding Center in Massachusetts.

The NECC-related outbreak has been tied to 264 cases of illness and 19 deaths in Michigan.

Facing the music

The state Department of Licensing and Regulatory Affairs has confiscated all controlled substances at the South Lyon facility and forced the business to cease operations.

Schuette’s Oct. 29 complaint alleges the South Lyon pharmacy acted as a drug manufacturer by distributing large amounts of medication to multiple Michigan facilities, including Henry Ford Hospital, without a license to do so. He said Walkup had applied for a license to manufacture drugs but was rejected because the pharmacy had not met U.S. Food and Drug Administration registration requirements.

That means Walkup was only licensed to fill individual prescriptions for Michigan patients, Schuette said.

In the process, Schuette obtained a suspension of the pharmacy’s license, as well as the suspension of Walkup’s pharmacist and controlled-substance licenses. A formal hearing before an administrative law judge will be required to dissolve the suspension. The state Pharmacy Disciplinary Subcommittee will determine potential sanctions against the facility.

The South Lyon business is not being treated unfairly by the state, however, business spokesman David Ball said. Ball said the pharmacy maintains it took all necessary steps both to prevent product contamination and to take action once contamination was discovered, however.

“Patient safety always comes first, even when business is disrupted. Owner Kenny Walkup is saddened that he cannot currently serve the pharmacy’s patients but remains committed to the concept of patient safety first,” Ball said.

“We are sure the state is trying to do the right thing. We want the state and the public to know that Specialty Medicine Compounding Pharmacy has always operated with patient safety top of mind,” he added. “It has served its patients well by delivering high-quality medications and by providing patient education.”

Ball noted the pharmacy was accredited by the Pharmacy Compounding Accreditation Board, or PCAB, before the licenses were pulled. He said the board is considered the nation’s leading agency for compounding pharmacy accreditation.

The PCAB suspended the pharmacy’s accreditation pending the outcome of the state investigation. The board, under its rules, immediately suspends accreditation when licenses have been suspended, PCAB Executive Director Joe Cabaleiro said.

Cabaleiro said the South Lyon pharmacy has taken all the right steps in preventing patient harm, however. He said a fraction of 1 percent of compounded medications is contaminated in some fashion.

He said the NECC tragedy has made license suspensions in cases of compounded drug contamination par for the course, however. In many cases, compounding pharmacy suspensions are removed if pharmacies work to address problems, Cabaleiro added, but the public image damage to an extent is already done at that point.

He said similar contamination of regulated manufactured drugs has not resulted in pharmaceutical companies being shut down.

“There is a little bit of a difference in the way that things are being handled,” Cabaleiro said.
The South Lyon business in October dispensed a dextrose-based intravenous solution called D50 to Henry Ford Hospital in Detroit, two vials of which were found contaminated by a pharmacy technician. Tests showed one vial had penicillium fungus and another contained aspergillus fungus.
Penicillium, which in some cases produces the antibiotic penicillin, rarely causes illness. The identity of the penicillium species in D50 has not been identified, Henry Ford officials said.

Aspergillus is known to occasionally cause illness, especially in those with weakened immune systems.

Henry Ford Health Sys­tem has removed D50 and all other medications produced by Specialty Medicine Compounding Pharmacy from its facilities.

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