Recently, a horrendous outbreak of fungal meningitis was reported in the news. I watched in awe as the story evolved from a few isolated illnesses to 419 cases in 19 states that resulted in 30 deaths, at last count.
I write novels of murder and mayhem and, since I practiced clinical pharmacy long before becoming a writer, the plots in my stories usually involve a medicinal component. Murder, Mayhem and Medicine are components of my (fictional) world these days, and these headlines have all the makings of my most sinister plots; but this horror is unfolding in real time and putting an ominous spotlight on compounding pharmacies.
News reports suggest negligence on the part of the compounding pharmacy involved and inspections by both the Massachusetts State Board of Pharmacy and the FDA resulted in shutting down the business.
First off, what are compounding pharmacies? They are specialty pharmacies that create pharmaceutical products that fit the unique needs of a specific patient.
These special needs include: 1) changing the dosing form of a commercial medication (like crushing a pill into a liquid suspension or dissolving a drug powder into an IV solution); 2) developing a drug dose similar to a commercial product but without inert ingredients that a patient may be allergic to; 3) formulating the exact dose needed (such as making a higher concentration than a commercially available drug); or 4) adding flavor to a medication (often used with children who require therapies with adult dose medications).
Compounding pharmacies are the modern version of where ancient chemists created medicines from plants and roots. The coal tar compounds of the 19th century and the primitive sulfa antibiotic formulas of the early 20th century are the results of such compounding practices.
While there are only a few such compounding pharmacies in any large community (and maybe none in smaller communities), these specialty pharmacies provide a much-needed service to patients and their physicians when a required therapy is not commercially available. But the traditional triangular relationship of physician-pharmacy-patient still remains: orders occur for a specific patient for a specific need from a specific physician.
When a compounding pharmacy goes beyond those parameters and distributes hundreds and thousands of drug doses to multiple clinics outside of a local geographic community, then that pharmacy operates outside of the laws of pharmacy practice and functions as a drug manufacturer.
A drug manufacturer makes FDA-approved prescription drugs for mass distribution in predetermined strengths and dosage forms. The FDA also requires drug manufacturers to follow Current Good Manufacturing Practices (CGMP). Specific state boards of pharmacy do not require or enforce such regulations since pharmacies don’t mass market their products.
When a pharmacy moves its business model away from the traditional physician-pharmacy-patient relationship, it no longer acts as a pharmacy. When the business model includes providing specific dosing to multitudes of clinics in multiple states, then that business has transitioned into a drug manufacturer, and the governing agencies and the regulations change.
In such a case, the state’s board of pharmacy would no longer be the agency governing the business. The FDA would become responsible for regulating the safe operation of that business and may well require the product distributed to go through a new drug approval process.
The pharmacy in the news recently was shut down for several reasons. It appears that they were functioning as a manufacturer, but not licensed as one, and distributing large quantities of sterile injections across state lines to multiple clinics. Such injections, called epidural injections, are accepted medical practices and the clinics practiced within acceptable guidelines because they trusted that the product they were injecting was manufactured according to Current Good Manufacturing Practices. But the FDA was not regulating the business since it was licensed as a pharmacy.
This fact has the FDA, the Massachusetts State Board of Pharmacy, the governor of Massachusetts and the Energy and Commerce Committee of the House of Representatives scrambling to come up with tougher laws and regulations to track the volume and distribution of compounded drugs.
Presently, there’s a “legal gray area” between state and federal agencies in this regard and a “regulatory black hole” for this type of pharmacy. Legitimate compounding pharmacies play an important role in today’s healthcare industry, but definite rules must be enforced when a pharmacy transitions from providing specifically compounded prescriptions and crosses that line into mass production and distribution of drug products.
Thoughts? Comments? I’d love to hear them!