Editorial: Compounding the problem

If chemical weapons killed 64 people on U.S. soil, the nation would be in a frenzy trying to determine what measures could be taken to prevent it from happening again.

Yet Americans largely reacted with a shrug when 64 people died, including four here in Ocala, and thousands more were sickened last year due to tainted steroid injections.

Sure, the incident led to national media coverage of problems at the Massachusetts compounding pharmacy where the steroid was produced and others like it. But the state and federal response has been mostly voluntary regulations that inspire little confidence that compounding pharmacies are receiving adequate oversight and that the public's safety is being protected.

For the past nine months, Star-Banner staff writer Fred Hiers has investigated the thousands of compounding pharmacies in Florida and beyond that are becoming significant players in the nation's drug market. His eye-opening series published last week, “Compound Fractures,” shows that the public remains at risk from unsafe drugs made at those pharmacies.

Last year's 64 deaths made for the most deadly compounding calamity in U.S. history. But they weren't the first deaths connected to compounding pharmacies. Drugs made in compounding pharmacies in Alabama, Maryland, South Carolina and Texas were previously linked to deaths due to problems such as drug contamination, improper sterilization practices and potency levels far higher than drug labels indicated.

Compounding pharmacies have taken advantage of outdated laws letting them make risky drugs in ever-increasing quantities and complexities while only drawing the same kind of regulation as a neighborhood pharmacy. They are making sterile compounds on a larger scale than ever intended, yet lack the equipment, testing and quality control of major drug manufacturers.

And our state and federal lawmakers refusal to impose real regulations on these operations is merely compounding the problem.

Congress did recently pass a law that encourages compounders to adopt stringent industry guidelines, but the legislation doesn't make them do so. Florida and other states are also operating under largely voluntary rules and lack the regulatory infrastructure, manpower and experience to regulate compounding pharmacies.

The U.S. Food and Drug Administration, which has consistently pressed for more regulatory authority over the compounding labs to no avail, this year inspected three Florida pharmacies and found each failed to ensure their compounded drugs met sterility and potency tests. One was an Ocala pharmacy, formerly known as Franck's Compounding Lab, which made drugs that killed 21 polo horses and damaged 31 people's eyesight.

Despite such incidents, experts such as University of Florida College of Pharmacy professor emeritus Paul Doering warn that regulations for compounding pharmacies remain inadequate.

It's hard to understand why scores of deaths and injuries haven't been enough to force real regulation.

Let's hope that Hiers' series opens the eyes of lawmakers and regulators to the serious problems remaining at compounding pharmacies before another tragedy happens.

http://www.ocala.com/article/20140102/OPINION01/131239929?p=1&tc=pg#gsc.tab=0