Almost 950 Florida-licensed pharmacies engage in “sterile compounding,” the type of high-risk drug-making that led to a deadly fungal meningitis epidemic last year, according to a Department of Health survey released last week.
Sterile compounders are now given priority for state inspections, but it’s going to be a daunting task to check them all, judging from the survey report and interviews with pharmacists and health department officials. There are two reasons:
--One-third of the 950 are based out of state, like the New England Compounding Center, the source of contaminated drugs that caused the epidemic. Florida law doesn’t give health officials any authority over out-of-state licensees.
--While the state has 18 inspectors for pharmacies, the health department said, only five of them are licensed pharmacists. And even the pharmacists need extra training to inspect the high-risk sterile compounders, officials said.
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Next week, the Board of Pharmacy will meet in St. Augustine to hear recommendations on what to do from its Compounding Rule Making Committee. Chairwoman Michele Weizer, a Doctor of Pharmacy from Boca Raton, said her group will suggest that sterile compounders be required to get a special permit – a request that would require legislative action.
The way Florida law stands now, all pharmacies licensed by the state board could, if they wished, start compounding. Half of them, about 4,500, engage in compounding to some extent, the survey showed. But most confine it to lower-risk capsules or lotions.
Florida law allows compounding not only for its original rationale -- mixing a drug that is tailor-made for an individual patient -- but also for "office use" by physicians who administer the drugs to patients as part of their practice.
DeAnn Mullins, a Panhandle pharmacist who serves on the Pharmacy Board's compounding committee, said she thinks some compounding pharmacies are "hiding behind the 'office use'" provision to justify high-volume production and distribution. Some doctors or health-care facilities may be ordering from these compounders to save money, she said.
Prescription compounding has been going on for centuries, but in the last few years some practitioners have strayed from its original intent of helping a patient who cannot take or obtain a commercially produced product.
In some cases, hospital executives say, they have to order from bulk compounders because pharmaceutical manufacturers have cut back or stopped production of low-demand, low-profit drugs that some patients simply must have.
To the Food and Drug Administration, said Emeritus Professor Paul Doering at the University of Florida College of Pharmacy, the bulk-compounding business model “looks and sounds and smells a lot like manufacturing.”
The FDA regulates drug manufacturers, at least in theory. But whenever FDA has tried to regulate big compounders, Doering said, the courts have blocked it, saying pharmacies are regulated by the states.
State health departments that could license and inspect traditional compounders often weren’t equipped to take on the high-volume, high-tech sterile compounders – especially the ones located out of state.
Since the New England Compounding Center “debacle,” Doering said, “every state in this union has gone behind closed doors in tense meetings saying, “Oh my gosh, what are we going to do?’ We’d better step it up.’”
Sterile compounds must remain free of any dust or organisms because they will come into direct contact with the bloodstream, the spine, the eyes, or some other vulnerable body part, Doering said.
“There is no margin for error,” he said, “and there’s always the potential for things to go wrong. Let’s face it, we’re not baking bread here. We’re not making plastic soldiers for little kids to play with. We’re making medicine.”
One of those who makes both traditional and sterile compounds is Dan Fucarino, owner of Carrollwood Pharmacy and a former member of the state Board of Pharmacy.
"My reaction when I first heard about the (New England Compounding Center) was of course extreme worry for the families of those people who had received it. My second reaction was, ‘Oh boy, this is really going to hurt compounding.’”
He is pursuing accreditation so that he can reassure doctors and patients that Carrollwood Pharmacy meets the highest standards for purity and quality.
Asked to review the Health Department survey results, Fucarino said he was disturbed to see how many out-of-state sterile compounders were shipping drugs to doctors and hospitals in Florida.
"How does the Board of Pharmacy know that an out-of-state pharmacy is living up to the standards that Florida has? Right now, and until things change, we really don't.”
In a phone-call meeting Jan. 16 (a recording is available at the Board of Pharmacy web site), the compounding committee discussed several ideas for getting more control over sterile compounders from out-of-state. However, a suggestion that they be required to gain accreditation from an organization that meets the approval of the Pharmacy Board drew protests over the expense from some compounders’ attorneys. Such a requirement would require legislative approval.
Executive Director Mark Whitten said he had heard that the National Association of Pharmacy Boards is trying to come up with a solution for out-of-state monitoring, since all the member states are looking for one.
At the Jan. 16 meeting, the compounding committee used a list of recommendations from The Board of Pharmacy in Massachusetts as a good model.
Among the suggestions on the list:
--The frequency and fee schedules for inspections should be structured according to risk, so that sterile compounders would be inspected most frequently and be charged the highest fees to support the extra cost.
--The state board should be given statutory authority to regulate compounding pharmacies that are based in other states but distribute medications within Massachusetts. A model for how that might be done is due by Dec. 31, 2013.
--All inspectors and investigators must be pharmacists with at least five years of experience, as well as training in investigative techniques. Those who inspect sterile compounders should have specific training, and at least one of the inspectors should have at least five years of experience in sterile compounding.
--The law should establish whistleblower protections and rewards for those employed in pharmacies, and fines against organizations that violate state law.
The epidemic, which came to light in September, is now on the wane. In its Jan. 28 report, the Centers for Disease Control lists a total of 693 cases and 45 deaths in 19 states that resulted from contaminated vials of methylprednisolone acetate shipped from New England Compounding Center.
While about 250 patients had solely meningitis, even more than that had a spinal infection instead. Many had both.
Most of the patients had received epidural injections in the spine for pain relief, while some had shots in the knee or other joints.
The case count in Florida stands at 25, with three deaths.
