A study recently published by USA Today reveals that compounding pharmacies are rarely held accountable for producing dangerous pharmaceuticals such as the NECC back injections that caused a nationwide fungal meningitis outbreak.
Reporters looked at legal action taken by regulatory agencies against compounding centers and found that harsh punishments are very rare for these specialty pharmacies. The majority of accountability for patient harm appears to be in the form of pharmaceutical product liability lawsuits brought by injured consumers.
A product liability lawsuit can often force a negligent pharmacy out of business and provoke licensing revocations that prevent employees from obtaining work. Civil lawsuits also often draw public attention to a pharmacy’s unsanitary conditions, which means that doctors will avoid ordering drugs from the pharmacy to avoid medical malpractice liability.
USA Today reports that Food and Drug Administration has recorded over 200 adverse events from just 71 compounding products and that some of the situations are very similar to the current fungal meningitis outbreak. An investigation into the fungal meningitis outbreak has revealed that there have been multiple complaints regarding Massachusetts-based NECC but that the owners were able to avoid being publically reprimanded every time.
Some FDA compliance officials have also noted that many state regulators lack the true resources to force problem pharmacies out of business until after a mass bacteria or fungal outbreak occurs.
Source: USA Today, “Harsh punishments rare for drug compounding mistakes,” Peter Eisler, Nov. 1, 2012