Pharmacy Compounding Redux

Now that the dust has begun to settle, it is becoming apparent that compounding pharmacies are not unregulated, just relatively lightly regulated, for all of the reasons offered by the Food and Drug Administration in its December 4, 2006 "Warning Letter" to New England Compounding Center (the "FDA has long recognized the important public health function served by traditional pharmacy compounding" as a matter of enforcement discretion). 

The compounding pharmacy itself apparently tested very little, though touted its limited results as a safety selling point (http://online.wsj.com/article/SB10001424052970204076204578076891268537914.html?mod=googlenews_wsj).

We could look to Missouri as a place that does require sampled testing of compounding pharmacies . We could also look to Kansas as a state that co-sponsored the failed Safe Compounding Act of 2007, attempting to federalize inspection authority over compounding authorities, something traditionally left to the states by the FDA and by the courts.

What does Kansas know that the rest of us don't?  That state resources to police compounding pharmacies are stretched thin.  That safety concerns in compounding pharmacies can go undiscovered by state watch dogs for long periods of time.  Missouri, after all, got interested in compounding pharmacy testing after its own compounding pharmacy tragedy. A compounding pharmacist in Kansas City, Mo., admitted diluting drugs –
including chemotherapy medications – for more than 4,200 patients
between 1990 and 2001. 

Today, the New York Times reports that potency and accuracy problems in tested compounded medications were found to be rife in Missouri and elsewhere, involving as much as a quarter of all compounded medications in those places. 

The conventional thinking is that food and drug purity outrage is cyclical, predictable, and contained. Hard questions remain unasked about the purity of out-sourced components for FDA approved drugs.

Pharmacy Compounding – Everything Old is New Again

To quote Monty Python, I have had that funny feeling of deja vu all over again this past week while watching news of the unfolding meningitis outbreak traceable to fungal meningitis from pharmacy compounding.  This is because we talk about pharmacy compounding rarely, typically when prompted by an outbreak of illness traced to compounded products.  Sadly, for the lives lost (and I fear there will be more), we do not focus on the roll of pharmacy compounding and its relationship to  prescription drug impurities the rest of the time.

In June of 2002, the unevenly regulated nature of pharmacy compounding was all over the press in northern California because of the death of George Stahl from bacterial meningitis traceable to to a cortisone shot using pharmacy-compounded medical supplies.  Mass prescription drug manufacturing is heavily regulated by the Food and Drug Administration.  Compounding pharmacies, allowed to operate in the interstitial regulatory world between the FDA and state pharmacy boards — are much more lightly regulated.

In an increasingly standardized world, compouding pharmacists were allowed to continue to compound because they were believed to serve the non-standard patients.  Compounding a prescription drug without a common preservative might be the only way to make that medication available to a patient allergic to the preservative, for example. 

But there's also a reimbursement story here. FDA-approved drugs cost more.  Regulation is not free. Compounding may be an attempt to circumvent expensive regulation.  It certainly raises more questions when the compounding pharmacy is  producing a significant volume of a lower priced drug to be sold to the health care providers of the standard patients.  The conduit of the compounded medication is the health care provider paid a set fee for the medication and its administration — someone seeking a higher profit margin by sourcing a product at a better non-regulated or lightly regulated price.

What is interesting about this is that there is nothing new about this.  In health care, everything old is new again. Just as pharmacist compounding is as old as the profession itself, our cyclical panic over this practice is a perennial.

In particular, the FDA's Pharmacy Compounding Committee of the 1990's tried to promote a stautory ban on sterile products (like cortisone shots) that for safety reasons should be determined to be demonstrably difficult to compound safely.  And that bill attempted to constrain the mass marketing of these dangerous-to compound-safely drugs. 

But the statute failed at the Supreme Court on First Amendment grounds.  You can read Thompson v. Western States Medical Center here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM155167.pdf

Maybe it is time to rethink the premise of a ruling that pharmacists do not make enough profit out of compounded prescriptions to justify regulating them for safety under the FDA.  Justice O'Connor may have had  the truth of it  precisely inverted.  The truth is that larger scale compounding is quite lucrative, for compounding pharmacies and their health care provider purchasers alike.