In November 2012, I wrote a blog about an outbreak of fungal meningitis that resulted from poor quality control procedures at a Massachusetts compounding pharmacy. It was first reported in September of that year, but evolved into national news because of the alleged horrendous breech in the pharmacy’s compounding practices. The news headlines continued for months as a few isolated illnesses exploded into 419 cases and more than 30 deaths.
Recently, more compounding pharmacies have been in the news for poor quality control issues. A Georgia compounding pharmacy recalled all of its sterile products after the Food and Drug Administration (FDA) documented concerns about the safety of the products shipped from there. The alarm focused on sterile eye drops prepared at the facility. Cases of endophthalmitis, a serious eye infection that can lead to blindness, were traced to the eye drops prepared in and shipped from this pharmacy.
That was the second specialty pharmacy in a week to recall products based on public safety concerns. Earlier, a New Jersey compounding pharmacy recalled all of its products after mold was discovered in bags of magnesium sulfate used to make their sterile preparations.
Compounding pharmacies are specialty practices that create drug formulations based on individual patient needs. Such products historically are prepared on a “made-to-order basis”, usually because available commercial products are not appropriate for the patient. A number of reasons could trigger a special patient need from a compounding pharmacy.
A patient may be allergic to a preservative in a commercially available eye drop and therefore the physician might order a compounding pharmacy to prepare a sterile formulation without any preservative. Or a patient might require a dose concentration that isn’t available in a ready-made product (such as, a much lower or higher concentration than available from a drug manufacturer).
Essentially, compounding pharmacies are the modern version of ancient chemists who created medicines from plants leaves and roots. The coal tar compounds of the 19th century and the primitive sulfa antibiotics of the early 20th century are examples of such compounding practices.
There are many fine, reputable compounding pharmacies all across the United States. Unfortunately, it only takes a few “bad apples” to spoil the reputation of the entire professional category.
The pharmacies that seem to make the news are those compounding facilities that expand well beyond their traditional roles of preparing individual prescriptions for individual patients. When a compounding pharmacy distributes hundreds and thousands of drug doses to multiple clinics outside of its local geographic community, they begin to function as drug manufacturers—but without the scrutiny of the FDA.
Compounding pharmacies are licensed and regulated by each state’s Board of Pharmacy. The FDA regulates only drug manufacturing facilities, not pharmacies. When a compounding pharmacy prepares drug doses in massive quantities for widespread distribution, that entity is operating outside of the laws of pharmacy practice and begins to function as a drug manufacturer, albeit without FDA approval for drug manufacturing.
A recent article by Liz Szabo in USA Today quoted Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. Ms. Woodcock stated, “Health care professionals should ensure that any medicines they administer to patients are obtained from appropriate, reliable sources and are properly administered.”
I could not have said it better myself! Physicians and clinics that don’t use local businesses for drug compounding invite potential disaster. Compounding pharmacies are not drug manufacturers. When such pharmacies choose to function as drug manufacturers and operate without proper regulatory approval, they do so at their own peril, as well as the patients they serve.
Compounding pharmacies are a highly valued specialty in pharmacy practice and provide a much needed service. But, when they operate outside of their legal parameters, it’s a Prescription For Murder.
Thoughts? Comments? I’d love to hear them!