Using a compounding pharmacy might seem foreign to some, but a necessity to many. Unlike Walgreens or CVS, a compounding pharmacy makes special medications for doctors, not just some doctors- all doctors, including NBC’s chief medical editor, Dr. Nancy Snyderman. Compounding Pharmacies make small batches of tailored medications ranging from specialized cancer treatments to bioidentical hormone therapy.
Without a doubt, tragedy has struck due to a contaminated injectible medication produced by a compounding pharmacy (New England Compounding Center in Massachusetts (NECC).
As you may be aware, the Center for Disease Control (CDC) has announced an outbreak of fungal meningitis due to contaminated injections of corticosteroids for patients with back and joint pain. The current CDC count of causes has reached 198 with 15 confirmed deaths. Fungal meningitis is not contagious, but can be fatal, especially if left untreated.
Americans, the medical establishment, the media and the United States government are all rightfully calling for a review of the policies that led up to this event.
However, great caution should be taken not to throw the baby out with the bathwater.
Why are Compounding Pharmacies Important?
Compounding pharmacies are an important component to the medical healthcare system. Compounding pharmacies assist physicians by giving us the ability to order medications that are not otherwise available through traditional commercial pharmacies. This includes taking commonly prescribed medications which may contain an additive which is unwanted and making the medication without the additive. Compounding pharmacies can also take “bad tasting” medications and make them taste better, for the use with our patients who are children or patients who wish to have their daily medications easier to tolerate.
Many patients rely on compounding pharmacies to prepare medications like natural (bioidentical) hormones in the treatment for menopause and low male testosterone. I am aware that many compounding pharmacies may not be up to snuff; however this does not apply to the compounding pharmacies that closely follow and adhere to national and state regulations.
Many compounding pharmacies such as Diplomat National Compounding Pharmacy, Medaus Pharmacy and University Compounding Pharmacy, to mention a few, compound medication in accordance with United States Pharmacopeia (USP) guidelines 797 and 795. These compounding pharmacies have compounding policies and procedures which have been validated and approved under our Accreditation Commission for Healthcare (ACHC) and Community Health Accreditation Program (CHAPS) accreditations.
In the view of either “tightening” federal regulations on compounding pharmacies, or at the very least reviewing the policies (and possible lack of regulation and/or enforcement) which did not catch this tragedy before it struck, let us ask ourselves, to which balance is best. Certainly, a review of how this tragedy occurred and a knowledgeable plan to implement to lower the risk of this occurring again should be explored.
On the flip side, banning compounding of medications would be a tragedy for the hundreds of thousands of Americans who rely on compounding pharmacies for their health and well-being.
FAQ’s on Compounding Pharmacies
What is pharmacy compounding?
Pharmacy compounding is the customized preparation for a medicine that may not otherwise be available. These medications are prescribed by a physician, veterinarian, or other prescribing practitioner, and compounded by a state-licensed pharmacist. A growing number of people and animals have unique health needs that off-the-shelf, one-size-fits-all prescription medicines cannot meet. For them, customized medications are the only way to better health.
What’s the difference between a compounding pharmacy and a drug manufacturer?
A compounding pharmacy makes customized prescription medications as prescribed by a physician, veterinarian or other prescribing practitioner. A drug manufacturer makes FDA-approved prescription drugs for mass markets in predetermined set strengths and dosage forms.
Why isn’t compounding regulated by the FDA? How is compounding regulated?
All pharmacies and pharmacists are licensed and strictly regulated at the state level. Compounding is a core component of pharmacy and has always been regulated by state boards, which are constantly updating their standards and regulations. In addition, standards set by the USP are integrated into the practice of pharmacy compounding. There are also several accrediting bodies that have developed national standards to accredit pharmacies. Diplomat has obtained two such accreditations and is in the final stages of seeking two others.