FDA Dumps Bar Code Experiment With Compounder
February 8th, 2013 // 6:22 pm @ jmpickett
In the wake of the fungal meningitis outbreak that was linked to a compounding pharmacy and has so far caused as many as 45 deaths, the FDA has nixed an experiment proposed several years ago by a different compounding pharmacy that hoped to use bar codes after its medicines were shipped as a way of identifying patient use. The idea, of course, is not the same as compounding specific drugs for individual patients with prescriptions ahead of time.
The proposal, which was made by PharMEDium Services, actually dates to 2005. But in a recent letter to the compounder, the FDA cites two reasons for changing its mind. The first, of course, is the scandal over meningitis, which was traced to the New England Compounding Center. The pharmacy, which recently went bankrupt and is being sued by some patients, had all sorts of cleanliness problems, according to a subsequent FDA inspection (see this and this).
Although the FDA was willing to consider the pilot study, the meningitis outbreak (see this) caused the agency to “re-examine its exercise of enforcement discretion with regard to the need for valid, patient-specific prescriptions,†according to a February 5 letter to the PharMEDium. The FDA adds that it is “particularly concerned about the large-scale distribution of compounded sterile drugs to healthcare facilities nationwide when appropriate compliance standards may not have been met…†(here is the letter).
And this speaks to the other reason the FDA is walking away from the experiment. PharMEDium failed to follow through on maintaining the circumstances under which the bar code proposal could be considered. For instance, in 2007, PharMEDium told FDA inspectors it was the responsibility of hospitals receiving its drugs to link them to patients and there was no surveillance to ensure this was done. The FDA issued a warning letter (here it is).
A few months later, the FDA could not establish patient linkage when following up eight cases of a bacterial infection in hospitals in Maryland and California that may have been linked to one of its drugs, but neither hospital was able to do so. And a 2010 inspection found that PharMEDium was still failing to provide maintain specific information that would link patients to its drug.
On its face, the bar code experiment may have seemed reasonable, although the notion does seem to contradict the previously stated agency concerns about compounding pharmacies that engage in large-scale distribution to far-flung customers. Moreover, the agency did issue a rather stern warning letter in 2007 and, three years later, found PharMEDium was still unable to make good on its own initiative.
Consequently, the FDA should have put the kibosh on this program right then and there. Although PharMEDium may have found a clever way to broaden its market, the compounder was apparently unwilling or unable to take the necessary steps to convince the agency this was a sound approach. Unfortunately, it took the recent meningitis outbreak to make the FDA move faster. We asked PharMEDium for comment and will update you accordingly.
