by Peter Eisler, USA TODA
WASHINGTON -- The legal landscape is littered with charges of negligence and misconduct by compounding pharmacies such as the one implicated in the nation's ongoing meningitis outbreak, but they rarely result in tough punishments, an examination of legal records shows.
In some cases, there's almost no penalty for pharmacies that break the rules, and the people who run them simply continue with business as usual, sometimes with tragic results.
Compounding pharmacies, which mix specialized and hard-to-get medications from raw ingredients, have been tied repeatedly to illness outbreaks -- the Food and Drug Administration has recorded about 200 "adverse events" linked to 71 compounded products since 1990. Some of those cases were eerily similar to the current meningitis episode, which has killed 28 so far.
USA TODAY reviewed state and federal court records, investigative reports and regulatory actions on dozens of cases in which compounding pharmacies produced contaminated or adulterated medication, mismeasured dosages, or manufactured and distributed drugs that were counterfeit or illegal. In many cases, it wasn't regulatory action that shut down those operations; it was damage awards they couldn't afford to pay.
Continue reading here
No comments:
Post a Comment