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.