My colleague Lena Sun and I have taken a long look at the regulation of compounding pharmacies - the type of pharmacy responsible for the deadly meningitis outbreak - and where critics see holes in the system. From today's Washington Post:
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.”
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.
Read the rest of the story here.