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Are Compounding Pharmacies Safe?

Posted Oct 29 2012 1:00am
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Thanks to the recent outbreak of fungal meningitis in the United States, which is now responsible for 25 deaths across the country, compounding pharmacies are now in the cross-hairs of federal regulators, and questions are being raised about their safety.

The New England Compounding Center, (NECC), located in Massachusetts, shipped thousands of vials of a contaminated steroid injection medication used to treat back pain, to 23 states and 76 medical facilities across the country, exposing over 14,000 people to the potentially fatal disease.

As a woman who has suffered with serious back pain her entire adult life, and who has used steroid injections to manage the pain, this story definitely caught my attention. It also caught my attention because it is a compounding pharmacy at the center of the scandal.

Millions of patients use compounding pharmacies every day for their prescription medications. Many of those patients are women in perimenopause and menopause who use compounding pharmacies to provide bioidentical hormones to help them treat and manage their symptoms. Unfortunately, it is also a decision these women (and their physicians) often have to defend as well.

More often than not, regulations tend to be enforced retroactively, after an event has occurred

There has been a longstanding divide and disagreement among physicians over the safety and effectiveness of bioidentical hormones for decades now. A disagreement which pharmaceutical companies, who would rather that we all use the medications they manufacture and market to women, is happy to support, defend, and finance.

If calling into question the safety of compounding pharmacies or claiming that they are a threat to public health because they do not fall under the federal regulatory oversight of the FDA will bolster their position, you can be certain they will. All is fair in asymmetrical warfare, especially when billions of dollars of profit are at stake.

Since the outbreak, the New England Compounding Center has suspended all of its operations and recalled all of their products. However, none of this has stopped the federal government from getting involved. As anticipated, members of congress are now calling for federal regulations of compounding pharmacies.

On its face, calling for regulation of compounding pharmacies to insure the safety of public health is not unreasonable; and I am certainly not suggesting that NECC’s negligence is not a cause for serious concern – it is, and it should be.

What bothers me is the suggestion that because the FDA does not have regulatory oversight of compounding pharmacies, that they are not regulated or subject to any oversight whatsoever, because this is just not the case. Compounding pharmacies, along with all pharmacies have been regulated for decades by state regulatory boards, and are also subject to local regulation and oversight as well.

According to Dr. Paul Savage, MD¹, the problems occur because  ”more often than not, the regulations tend to be enforced retroactively. That is, after an event such as the contamination of the steroid medication in the NECC case has occurred.  Pro-active policing of the regulations do not occur with enough regularity”

In fact, that has been exactly the problem in the NECC case.  More information has recently surfaced about the failure of regulators to adequately investigate known safety violations with the NECC as far back as 1999.   So clearly, the problem is not that there is a lack of regulation of compounding pharmacies which makes them unsafe.  The problem is the negligence of the employees to adhere to already established safety policies and procedures, and the failure of regulators to enforce known violations.

If you use compounding pharmacies or are interested in using them, it is important to seek the advice of a healthcare provider that you know and trust. ”A quality health care provider” says Dr. Savage¹, “should have recommendations for compounding pharmacies, and be able to provide you with answers regarding the safety and quality required.”

It’s also important that you ask your practitioner if you are receiving any compounding products.  If you are, it is important to determine the quality and safety of the compounder.  This is especially important if you are using IV therapy, injections, or implanted medications.

Remember ladies, while it’s always a good idea to remain vigilant, it’s also a good idea to not allow mass hysteria to negatively affect or cloud your judgment!  If you have been using compounding pharmacies for your bioidentical hormone prescriptions safely up until now, there is no reason to believe that you can’t continue to do so!


¹Dr. Paul Savage MD FACEP, is the CEO of Ageology physicians group in Chicago, Illinois.  Dr. Savage is an acknowledged expert in the field of bioidentical hormones, anti-aging and regenerative medicine and metabolic medicine and is nationally known and recognized as a leader in this field.

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