Compounding pharmacies are supposed to improve patients’ health by providing custom medications that are tailored to the medical needs of a specific group of patients. Unfortunately, compounding pharmacies tends to fall into a gray area of regulation, and patients are suffering as a result.
Last year, hundreds of people became ill and at least 53 people died from a meningitis outbreak caused by contaminated steroid shots that were produced by New England Compounding Pharmacy, a compounding pharmacy in Massachusetts. Most recently, two compounding pharmacies recalled certain drugs amidst safety concerns. Clinical Specialties recalled several lots of Avastin last month after receiving five reports of eye infections from doctors who used Avastin to treat macular degeneration and Med Prep Consulting recalled 83 different kinds of drugs after it found particles (that were later found to be mold) floating in five bags of compounded magnesium sulfate solution.
Concerns about the safety of compounding pharmacies are not without cause. In fact, federal inspectors report that they have found dozens of potentially dangerous safety problems at 30 specialized pharmacies. According to officials for the U.S. Food and Drug Administration (FDA), the inspections show that compounding pharmacies are failing to ensure the safety of their products in many cases.
During the inspections, FDA officials found “black particles of unknown origin” in vials of an injectable medicine, rust and mold in “clean rooms,” inadequate microbial testing, and tears in gloves worn by technicians — all of which could result in potentially fatal drug contaminations.
Currently, compounding pharmacies are not required to adhere to the same stringent standards of other drug manufacturers even though the medicines they are producing are often mass-produced and can result in serious illness and death if not produced correctly. As a result, the FDA is calling on Congress to grant the FDA increased oversight authority over compounding pharmacies that produce high-risk sterile products. Dr. Margaret A. Hamburg, the head of the FDA, recently wrote on the FDA’s blog:
“While our investigation of this deadly outbreak has been a top priority, our responsibility at FDA is also to help make sure this doesn’t happen again. We are currently deploying resources to work with states to inspect certain state-licensed pharmacies that produce sterile drug products that we believe may present the highest risk… But our authorities are limited and not the right fit for FDA to provide appropriate and efficient oversight of this growing industry. There should be legislation that establishes appropriate, minimum federal standards for firms that compound sterile drug products in advance of or without a prescription and ship them interstate. FDA must have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations.”
The Chicago unsafe pharmaceutical attorneys at Ankin Law Offices, LLC are committed to protecting the public from dangerous pharmaceuticals. If you have been injured by the meningitis outbreak or another unsafe pharmaceutical, contact the skilled Chicago unsafe pharmaceutical drug law firm of Ankin Law Offices, LLC at (312) 600-0000 to discuss a possible personal injury or product liability lawsuit.