Prescription Safety: Compound Medical 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 in the North Central Florida city of Ocala, and thousands more were sickened last year because of tainted steroid injections.

Compounding pharmacies make — compound — medicine from scratch, as opposed to simply selling pills, liquids and the like made by pharmaceutical companies. Traditionally, this was done for special needs. However, in recent years, some large compounding pharmacies have become factories essentially — not specialists.

The incident led to national media coverage of problems at a Massachusetts compounding pharmacy where the tainted steroid was produced, as well as a focus on similar large compounding pharmacies. However, the state and federal responses have been mostly voluntary regulations that inspire little confidence that compounding pharmacies are receiving adequate oversight and that the public's safety is being protected.

A report in the Ocala Star-Banner in December investigated the thousands of compounding pharmacies in Florida and beyond that are becoming significant players in the nation's drug market. It showed 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 because of problems such as drug contamination, improper sterilization practices and potency levels far higher than drug labels indicated.

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Compounding pharmacies have taken advantage of outdated laws letting them make risky drugs in ever-increasing quantities and complexities while only drawing the same kind of regulation as a neighborhood pharmacy.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.

Congress recently passed 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 its 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.

Lawmakers and regulators should recognize and resolve the serious problems remaining at compounding pharmacies to prevent another tragedy.

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