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Punishments Rare for Pharmacy Malpractice

courthouse-blue-skySince 1990, the U.S. Food and Drug Administration (FDA) has logged more than 200 adverse events associated with compounded medications produced by pharmacies across the country. USA Today reports that despite increasing incidents of pharmacy malpractice – from contaminated drugs to improper sterilization techniques – punishments are few and far between for such negligent acts that often resulted in tragedy for patients.

After pouring over state and federal court records that documented countless incidents of negligence among compounding pharmacies, researchers found that it wasn’t regulatory punishments that shut down offenders – it was litigation in the form of personal injury lawsuits and large court-ordered awards that did the job.

Compounding pharmacies subject to lighter federal regulations

In the United States, massive outbreaks of meningitis have been attributed to transgressions from compounding pharmacies, which blend specialty raw ingredients to make compound medications. Some 16 states have reported 300 cases of meningitis and the illness has been traced to a Framingham, Massachusetts-based compounding pharmacy that purportedly distributed injectable steroids that had been contaminated with fungus. Now, the New England Compounding Center is named as defendant in at least three personal injury lawsuits. The compounding pharmacy had its license permanently revoked by the Massachusetts Board of Registration in Pharmacy after the agency found sterilization and quality control compliance violations in the facility.

However, since compounding pharmacies are largely free of strict FDA regulations, the punishment for any wrongdoing is typically limited to state-imposed license revocations, but even these are rare. Even more alarming, reports USA Today, cases of pharmacy malpractice seldom result in criminal penalties, as legislation makes it difficult to hold pharmacists criminally liable for medications that they produce or sell.

The recent meningitis outbreak is the second one in the U.S. An earlier 2002 outbreak was also blamed on a compounding pharmacy, Urgent Care Pharmacy in South Carolina, whose inadequate sterilization practices resulted in drug contamination with the same fungus. After state investigations and actions to improve quality control practices, Urgent Care was issued a $10,000 fine and its head pharmacist had his license suspended. But such measures are wholly ineffective, it seems, as that same pharmacist was allowed to continue working on a probationary basis, in good professional standing, no less.

It was litigation from more than a dozen injured patients that finally caught up with Urgent Care, which declared bankruptcy in the face of multiple lawsuits. “The regulatory system failed,” says a North Carolina lawyer who secured $1 million in damages for the family of a woman who lost her life in the 2002 meningitis outbreak. “I think the regulatory system is not working, because the conditions in that plant were absolutely abysmal…If these people aren’t stopped through litigation,” the attorney added, “they’re not going to be stopped.”

Pharmacy malpractice and illegal drugs

Controversy surrounding compounding pharmacies extends to more than just contaminated medications – the facilities have also been tied to the distribution of illegal and counterfeit drugs. So-called “pill mills” that dispense narcotic painkillers such as oxycodone without valid justification have been found to rely on certain pharmacies to fill those prescriptions. In one such case, the U.S. Drug Enforcement Agency seized thousands of dollars in assets from a compounding pharmacy in Georgia, alleging it was part of an illegal network of drug distributers.

Yet the DEA admits it struggles to adequately monitor and police compounding pharmacies since they have permissions to handle controlled drugs. DEA spokeswoman Barbara Carreno explains that state pharmacy boards maintain authority to regulate compounders, but these state boards lack the resources necessary to ensure pharmacists are dispensing drugs in accordance with the law. Similar to the FDA, states have limited resources when it comes to reviewing sterilization and quality control compliance, and as a consequence, compounding pharmacies can produce “a lot of bad drugs” between inspections.