Friday, November 30, 2012

Compounding pharmacies-NECC and PCCA

By Lisa Brody
News Editor

11/29/2012 - For compounding pharmacies, it's been a bad few months. They have gone from a specialized niche retailer to a feared pariah in the mind of the public, all due to the actions of a large scale compounding pharmacy in Framingham, Massachusetts, the New England Compounding Center (NECC), which is accused of creating a massive outbreak of fungal meningitis through the contamination of medications for epidural steroid injections for back pain.

As of October 9, the Center for Disease Control estimated that as many as 14,000 patients may have been exposed to the tainted drug; to date, 148 patients in Michigan alone have fallen seriously ill with fungal meningitis, and six have died. Others are now being treated for secondary problems at the site of the injections, epidural abscesses, which can develop into meningitis, as well as joint infections, according to the Michigan Department of Community Health.

The outbreak has been a tragedy all around—for those unsuspecting patients in serious pain seeking relief from a steroid injection; for the doctors who unwittingly injected them, trusting that the medicine they used would be safe and sterile; and for compounding pharmacies, which have unfairly received a black eye on their profession for something they have had no hand in.

"My colleagues and I are outraged and sickened by the alleged malfeasance at NECC. They call themselves a compounding pharmacy, but in actuality they were apparently careless manufacturers who needlessly and shamefully endangered the lives of their customers," Mazen Baisa, PharmD, RPh, managing partner and clinical director of BioMed Pharmacy in Southfield said. "It is alleged by regulators that NECC somehow was able to skirt existing state and federal laws and operate its business by shortchanging quality. That is not what a compounding pharmacy does."

"This company (NECC) turned themselves into a large manufacturing company, in violation of every law to keep patients safe, and lost sight of what they were supposed to be doing," asserted product liability attorney Alyson Oliver of the Oliver Law Group in Rochester. "They were already on the radar because they already had had six violations, one of which was on this same drug. Local (compounding) companies shouldn't be tainted by this bad company. I've never seen problems with local pharmacies."

According to the Professional Compounding Centers of America (PCCA), pharmacy compounding is the art and science of preparing customized medications for patients, whose practice dates back to the origins of pharmacy. As a matter of fact, in the 1930s and 1940s, the majority of prescriptions written were compounded. As drug manufacturing by pharmaceutical companies began developing en masse in the 1950s and 1960s, compounding declined as the pharmacist's role as a preparer of medications metamorphosed into someone who dispensed manufactured dosage forms. But, in the process of creating a "one-size-fits-all" approach to dosage, some patients' needs failed to be met.

Continue Reading here

No comments: