FDA Launches Investigation Into Compounding Pharmacies In The Wake Of Deadly Fungal Meningitis Outbreak
A recent press release from the Food and Drug Administration left many consumers worried about the safety of their medications. The FDA revealed that over the course of the last few months, an investigation has uncovered possibly life-threatening safety issues at more than 30 compounding pharmacies across the country. The issues were discovered after the deadly fungal meningitis outbreak prompted closer scrutiny of the nation’s specialized pharmacies.
An especially scary example of the problems present in the nation’s
compounding pharmacies was found in Florida where the FDA said it discovered
medicine with floating black particles. At a different pharmacy, inspectors
with the FDA discovered rust and mold in supposed “clean rooms.”
Dozens of facilities had problems with their sterilization procedures,
including allowing workers into rooms with medicine despite having tears
in their gloves. All these violations are serious and could be responsible
for yet another deadly outbreak like the one started in Massachusetts.
The series of inspections took place across the country over the last two or three months, the result of a major enforcement effort by the FDA that targeted compounding pharmacies in the wake of the deadly fungal meningitis outbreak. That horrible incident was caused by unsterile conditions at the New England Compounding Center and led to more than 50 deaths and serious injuries to some 700 patients.
Not only do compounding pharmacies have sterilization issues, but the FDA revealed that many are also aggressive and uncooperative with investigators. The press release indicated that several facilities refused to grant the FDA access to their records or their operations and only after the FDA received court orders did the pharmacies comply.
The series of inspections have led to a corresponding rash of drug recalls. A few weeks ago a pharmacy in New Jersey recalled all of its products after a nurse at a hospital saw specks of what turned out to be mold floating in bags of medicine. A few days later a Georgia company recalled 60 products after patients reported suffering eye infections due to unsterile medications. Earlier this week, a Nevada company with operations in Tennessee recalled all its sterile products after an FDA inspection uncovered sanitary problems.
Though the recent enforcement push by the FDA is welcome news, it is not cause for celebration. The problems uncovered are likely the tip of the iceberg in terms of safety issues that have gone unnoticed for years. Strict regulation and more stringent penalties need to be implemented to bring these compounding pharmacies under more careful scrutiny and to ensure the safety of millions of Americans who rely on the medications they produce every day.
Those who have suffered injuries at the hand of their doctor should be aware that legal remedies might be available to them. If you would like to speak with a Mississippi medical malpractice attorney about a potential medical malpractice claim, call Mississippi medical malpractice lawyers at Kobs & Philley today at (601) 863-8170.
Source: “FDA finds widespread safety issues at compounding pharmacies,” by Lena Sun, published at WashingtonPost.com.
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