To the detriment of the profession, the art of prescription compounding has taken a black eye in the last year.
Compounders of sterile products are now under the microscope of the media and the Food and Drug Administration (FDA) due to the incompetence of a couple of bad apples.
There have been two incidents linked to dangerous and fatal situations.
The first incident occurred in September 2012 at the New England Compounding Center (NECC) in Massachusetts where methylprednisolone acetate for injection was manufactured and sent to clinics in several states for use in patients with joint pain and/or inflammation. The result was that several patients became ill and even died due to the product being contaminated with fungal meningitis.
The second incident occurred in the summer of 2013 in Tennessee where Main Street Pharmacy was manufacturing a similar product. Seven patients in other states who received their product reported skin abscesses after being injected with methylprednisolone acetate. In both cases, the pharmacies in question were acting as manufacturers rather than compounders.
Compounding is when a pharmacy makes a preparation based on a prescription written by a physician to be dispensed for a specific patient. Manufacturing, as in these two examples mentioned above, is when pharmacies make a product in bulk and distribute to doctors offices and clinics without a specific or identified patient. In both the NECC and Main Street Pharmacy cases, the product was sent to clinics and doctors offices in several states.
The FDA has always had jurisdiction over the manufacturing of sterile products, but the compounding of these products has been relegated to individual state authorities. With the news of the fungal meningitis outbreak, the FDA urged Congress to increase their authority over these matters.
Sterile compounding facilities have employed their respective state boards of pharmacy to oversee the practices of compounding and have relied on USP 797 sterile compounding standards issued by the United States Pharmacopeia (USP) to enforce safe practice procedures for compounding a preparation for a specific patient.
It is not fair to compounding pharmacies that the manufacturing practices of NECC and Main Street Pharmacy were linked by the media to compounding. Patients and pharmacies will now suffer the consequences of these two incidents from here forward.
Upon inspection of these two pharmacies, various violations were identified such as spiders found in the labs, as well as expired products and even unlicensed workers. The fines and license suspensions fit the crime of placing the public at risk, but at the same time have also put a chokehold on sterile compounders everywhere who continue to practice compounding safely by following USP 797.
With the media citing dangerous pharmacy practices, patients who need individual sterile preparations are consequently scared to inject medications which were prescribed by their doctor and safely made by a certified sterile compounder.
Organizations such as the Pharmacy Compounding Accreditation Board (PCAB) can assist the state boards of pharmacy with regulating and inspecting pharmacies that prepare sterile products for individual patients.
This organization identifies facilities that have met minimum compounding standards by placing their seal of approval for the public to see, which in turn should make prescribers and patients feel more at ease and confident when choosing a compounding pharmacy.
The United States Senate has voted on Bill S.959 (Pharmaceutical Quality, Security, and Accountability Act) at some point during the 2013 legislative session. This bill was written based on the news from the NECC and Main Street Pharmacy outbreaks. The bill limits access to both sterile and non-sterile compounded medications due to a heightened oversight by the FDA.
Because the bulk chemicals that are used in compounding are not FDA approved, the FDA would categorize compounds as new drugs and would require a New Drug Application to be filed for each compound prepared. This will ultimately increase the cost for pharmacies and their patients.
Even with the changes that the FDA was seeking, this bill is not preventing further incidents from occurring that are similar to those of Main Street Pharmacy or the NECC, as the bill does not include hospitals.
Furthermore, prescription insurances such as Medicare Part D and Express Scripts, who processes claims for Tricare, have placed restrictions on which compounded products are covered under their programs. This action severely limits which medications patients are able to afford.
It is of the utmost importance that pharmacists take the time to educate the public and make them aware of these limitations by reaching out to their patients and urging them to call their respective U.S. Senators to voice their opinions about how this bill, if indeed passed, will adversely affect their livelihoods.
Chris Alvarado, PharmD