Critics charge that drug-compounding pharmacies require government oversight

Juli Leonard/THE NEWS & OBSERVER - Sara Berg is comforted by her husband, Ron Tzur, in 2005, during an interview about their daughter, Shiri Berg, who died in January 2005.

Shiri Berg was a 22-year-college student when she went to a spa in Raleigh, N.C., in late 2004 for laser hair removal. Soon, she was dead, killed by a powerful pain-numbing cream, called Lasergel, that she bought from the spa, applied over a “substantial portion of her body” and covered with plastic wrap, according to state regulators.

The spa’s two doctors were disciplined — one had his license suspended and the other was reprimanded — by the state medical board for dispensing the medication without a prescription. The pharmacy that made the anesthetic cream, Triangle Compounding Pharmacy, was reprimanded by the state board of pharmacy and later warned by the Food and Drug Administration that Lasergel “may be toxic at high doses.”

(N/A/VIA THE NEWS & OBSERVER) - Undated family photo of Shiri Berg, who died in January 2005.

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Hospitals and doctors increasingly depend on the growing number of drug compounding facilities.

Today, Joe Cabaleiro, who was a part-owner of Triangle at the time of Berg’s death and also was reprimanded by the state pharmacy board, is executive director of a national organization dedicated to improving the safety and quality of compounding pharmacies. The group, the Pharmacy Compounding Accreditation Board, conducts on-site inspections and offers voluntary accreditation to the thousands of compounders nationwide.

Cabaleiro said Berg’s death was one of the reasons he went to work for the board. “Those unfortunate events highlighted the problem, and strengthened my desire to ensure that there’s a standard of quality,” the Cary, N.C., resident said.

Whether his organization is achieving its stated goals is in dispute. Only 162 compounding pharmacies, or about 2 percent of the 7,500 total, have been accredited. New England Compounding Center, which made the tainted steroid injections linked to the recent fungal meningitis outbreak was not accredited. The death toll from that outbreak rose Thursday to 20.

Hospitals and doctors who buy compounded drugs often don’t require accreditation; many don’t even seem to know about it. “Right now, you have the option to get accredited or walk away, and there really aren’t huge consequences either way,” Cabaleiro said.

Industry officials have touted the board as a reason why compounding pharmacies don’t need increased federal regulation. “We do not need legislation to set standards, nor do we need to test our quality procedures and techniques against those standards,” wrote Kenneth Baker, a lawyer and former executive director of the accrediting board, in a May 15 op-ed in the trade publication Drug Topics. Accreditation ensures that “tough standards have been used” in preparing the compounded medications, he wrote.

Industry critics reject that idea. The board is “an industry fig leaf,” said Sarah Sellers, a former FDA official who worked on compliance issues involving compounding.

Michael Carome, deputy director of the health research group at consumer advocacy organization Public Citizen, said accreditation “is certainly not an appropriate substitute for FDA oversight and ensuring good manufacturing practices. Those are what make a drug safe.”

Cabaleiro acknowledged that the accrediting requirements are less extensive than those set by the FDA for commercial drugmakers. But pharmacists are covered by a “different set of practices,” he said. When pharmacists follow best practices, he said, “it should result in a sterile product that is appropriate and safe for the patient.”

Accrediting organizations play an important role in the nation’s health-care system. Hospitals regularly submit to inspections by an independent group to ensure eligibility for Medicare payments. Ambulatory-care facilities undergo similar inspections, as do doctors who perform even minor surgeries in their offices.

The Pharmacy Compounding Accreditation Board was formed by eight pharmacy organizations in 2004 — around the time, Sellers said, when the FDA’s authority to regulate compounding pharmacies was being limited by legal challenges. She said the industry wanted to set a higher standard for quality, as well as deflect calls for stepped-up regulation and protect itself against liability.

The board accredits pharmacies that have met industry standards on several measures, including sterility, proper procedure and patient education. The process costs as much as $5,000. Yearly fees are based on the number of prescriptions made daily. Pharmacies often spend six months preparing records and getting facilities ready for the inspection, Cabaleiro said.

Pharmacies that have been accredited say the process can pinpoint problems, enhance their credibility and be useful for marketing to patients and doctors.

Some pharmacies have turned to accreditation after a tragedy.

Lisa Strucko, a co-owner of the Compounding Center in Leesburg, said her pharmacy sought accreditation after a 5-year-old child died after taking improperly compounded medicine used to control bed-wetting. The pharmacy trained personnel and built a new facility to “validate our processes and standards,” she said.

For other pharmacies, the time and money involved are too big a burden. “The fact that so few of these pharmacies actually have the accreditation seems to reflect the fact that customers don’t really ask for it,” said Linda Bentley, chair of the law firm Mintz Levin’s FDA practice group.

Triangle Compounding sought accreditation after the Berg case. Five months after the state board reprimanded the pharmacy and its owners, Triangle became North Carolina’s first accredited facility.

Berg had gone to Premier Body Laser Services seeking hair-removal services. The spa shut down shortly after her death in January 2005. Berg’s family filed a lawsuit against the Raleigh spa, the spa’s two medical directors and Triangle. The case was settled out of court, and the details of the settlement are not public. Officials at Triangle didn’t respond to several requests for comment.

The Berg family’s court complaint alleged that the spa instructed Berg to apply Lasergel prior to her appointment and cover the areas targeted for hair removal in plastic wrap. The medication caused seizures as Berg was driving on a freeway before her scheduled appointment. She fell into a coma and died eight days later. An autopsy revealed a toxic level of lidocaine in the cream that caused Berg’s death.

In written answers to the complaint, both the spa and Triangle denied liability.

The pharmacy halted production of the medication “immediately” after Berg’s death and prior to a warning letter from the FDA about the dangers of topical anesthetic creams, Cabaleiro said.

In reprimanding Triangle and it owners, the North Carolina Board of Pharmacy said the actions of the pharmacy and its owners constituted “negligence in the practice of pharmacy.” It found that Triangle had packaged the cream with instructions initially intended for a different drug, making “minor edits” to make it apply to the new product.

The state board also faulted Triangle for producing a medication that doctors later resold, which violates pharmacy state regulations. It said the pharmacy should have taken steps to determine whether the cream was being resold.

“With the ability to compound medications for patients comes a tremendous responsibility to ensure that these products are safe and used appropriately,” the state board said.

Alice Crites contributed to this report.

 
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