The tragic meningitis cases that have been reported in six states have prompted some to question the role of compounding pharmacists in the U.S. health care system. Outside of pharmacy circles, the intricacies of compounding customized prescription medication treatments for individual patient needs may be little known and easily misunderstood. Traditional pharmacy compounding offers many benefits, including improving health outcomes and lowering medical costs for patients, and is fundamentally different from the now-suspended operation at the New England Compounding Center suspected to be the source of the meningitis outbreak.
What is compounding?
According to the International Academy of Compounding Pharmacists (IACP), “Compounding is a traditional part of pharmacy practice. It involves the preparation of medications on prescription by physicians and other authorized prescribers who meet unique patient healthcare needs that cannot be met with commercially manufactured and marketed drug products. This might include providing different strengths, preparing a drug with different non-active excipients for which a patient may have an allergy, or creating dosage forms which are more palatable for a patient.”
IACP estimates that there are 7,500 pharmacies in the United States that specialize in advanced compounding services of which approximately 3,000 provide sterile compounding. It also estimates that compounding prescriptions for individual patients accounts for one to three percent of all prescriptions dispensed in the United States.
What is NOT traditional compounding?
In short, the New England Compounding Center, the operation reportedly associated with the meningitis outbreak, is nothing close to traditional pharmacy compounding, according to IACP. IACP Executive Vice President and CEO David Miller told The Washington Post that making large amounts of a medication that’s commonly available and shipping it across the country is rare and at odds with mainstream compounders. “This does not look like traditional pharmacy compounding at all,” he told the paper.
Benefits of Compounding
As mentioned earlier, compounding pharmacy provides patients with many benefits which should not be overlooked. Two recent and high-profile experiences illustrate this clearly.
Would anyone pay $30,000 for a drug therapy when an equally effective alternative is available for $400 or less? That stark price differential illustrates how, every day, compounding pharmacists are helping countless pregnant women avoid premature births through affordable access to customized medication therapy at a tiny fraction of the cost of mass manufactured treatments. For decades compounding pharmacists have been a safe and reliable source of this medication, known as 17P. A 2012 review by the Food and Drug Administration affirmed its safety and effectiveness. KV Pharmaceuticals, a manufacturer, fought aggressively to end customized compounding of 17P and to require patients to exclusively use Makena, a manufactured version of the drug, for which it sought to charge as much as $30,000 for an entire course, according to The New York Times.
Countless children, parents brought relief by compounding pharmacists during 2009 H1N1 crisis. The nationwide H1N1 (swine flu) outbreak in 2009 led to a rush for Tamiflu in all forms and soon there wasn’t enough of the liquid version for children. Across the country and with the support of federal health officials and Tamiflu’s manufacturer, Roche, compounding pharmacists filled the void, as the Newark Star-Ledger and others reported. Drug shortages like this have only increased in recent years and compounding pharmacists are helping to alleviate them.
Any individual or company responsible for the serious and awful meningitis outbreak must be accountable for their actions. But it would be a mistake to malign or undermine the critical work of thousands of pharmacists providing traditional compounding services to patients because of the reported actions of an outlier that appears to be more of a small-scale manufacturer than a compounding pharmacist.
For more information about compounding and how the practice is regulated for safety and efficacy, visit www.iacprx.org.