Monday, May 13, 2013

Compounding Pharmacies: The saga continues. JPosted by Jim LewisMay 13, 2013 8:49 AM

The Legal Examiner contains an excellent post by Jim Lewis, an attorney. The post is very direct and to the point about compounding pharmacies.  His post is quoted below:

As we learned during last year's fungal meningitis outbreak, some compounding pharmacies are mass-producing drugs rather than tailoring the ingredients of one drug to meet a patient's particular needs due to, for instance, allergies. So instead of potentially harming one person, New England Compounding Center's manufacturing practices put more than 14,000 people at risk of developing fungal meningitis when three lots of epidural steroid were contaminated with "greenish black foreign matter," per the FDA's eight-page investigation report.
You'd think compounding pharmacies following in NECC's footsteps would have cleaned up their act after 700 people contracted fungal meningitis and more than 50 people died. Unfortunately, you'd be mistaken. Between February and April 2013, the FDA found dozens of safety issues, including black particulate and mold, as it investigated 30 compounding pharmacies. "These priority inspections were focused on firms that produce high-risk sterile products, a key segment of the multibillion-dollar industry that has fallen between the regulatory cracks," The Washington Post reported. "FDA officials say the inspections show compounders, in many cases, are failing to ensure the safety of their products, despite months of stepped-up scrutiny from state and federal regulators, as well as consumer groups." Not only that, they just don't seem to care. Rather than spend money to fix whatever is causing rust to form in clean rooms or to buy gloves that don't tear while handling medications, they invested man hours in trying to block the FDA inspections. "Five of the pharmacies ... initially denied investigators access to their facilities or to their records, or refused to let them make copies of records," according to the Post. "The agency prevailed — but in one case not until after it had a court-ordered inspection warrant."
What can the consumer do? Research your pharmacy and see if there have been any reports, complaints or FDA sanctions imposed. Talk to the pharmacist to understand his or her quality control procedures. Some of the problems may never be discovered by the end-user of the product, but inquiring about the substances you ingest is never a bad thing.

Quoted from the Legal Examiner found here 

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