Can You Trust Compounding Pharmacies?
Fifteen people are dead from an outbreak of fungal meningitis resulting from the negligent actions of a compounding pharmacy located in Massachusetts. The New England Compounding Center, (NECC), shipped thousands of vials of a contaminated steroid medication to twenty-three states, and seventy-six medical facilities across the country.
In addition to the deaths, there have been over two hundred documented outbreaks of fungal meningitis, and according to health officials, over 14,000 people have been put at risk of contracting the infection. Since the outbreak and deaths which began in August 2012, NECC has suspended all operations and has recalled all of their products.
Not surprisingly, the lawsuits have already begun, and the safety of compounding pharmacies is now being questioned. You can be certain there will be plenty of blame shifting and finger pointing by those involved in the health scandal in an effort to avoid lawsuits and financial ruin.
You can also be certain that the FDA and other federal regulatory bodies will flex their governmental muscles as well, since members of congress are now calling for federal regulations of compounding pharmacies.
While these questions and concerns will have an impact on all of us as healthcare patients, I believe that women in perimenopause and menopause who rely on compounding pharmacies for bioidentical hormones will become particularly vulnerable.
Are Compounding Pharmacies Regulated?
What concerns me is the suggestion that because compounding pharmacies are not regulated by the FDA, they are not subject to any regulation and oversight, because this is simply not true. Compounding pharmacies, along with all pharmacies have been regulated since the 19th century by state regulatory boards. Compounding pharmacies are also subject to local regulation and oversight as well.
The contamination of the steroid medication was not the result of a lack of oversight or federal regulation. It was the result of workers in the compounding pharmacy failing to adhere to sterile procedures and manufacturing practices.
So, while I certainly understand the need to protect the safety of public health, I don’t want to see compounding pharmacies become the sacrificial lamb in a self-righteous campaign by the FDA and congress, which have a vested personal and financial interest in this controversy.
Like so much in our capitalistic society, there is big money at stake in the healthcare industry, and you can put women’s hormone health at the top of the list. I hate to be so cynical, but the truth is, there has been a longstanding running gun battle between the pharmaceutical companies which produce synthetic hormones, and physicians who believe bioidentical hormones (most of which are compounded by compounding pharmacies) are a safer alternative.
If the drug industry can better position itself in this battle by pouring money and political influence into the equation, you can be certain they will. What this will ultimately mean for women’s hormone health, however, will still remain to be seen.
I just want it to be said, in case you may have wondered, that compounding pharmacies are regulated, and they are subject to safety procedures and policies designed to protect public health. But, if employees fail to follow those procedures and adhere to the safety standards, neither the FDA, nor congress, nor any other regulatory board can protect any of us from that.
Magnolia Miller is a certified healthcare consumer advocate in women’s health and a women’s freelance health writer and blogger at The Perimenopause Blog.