This article was written by Krista Shaffer, co-owner of Koshland Pharm -- my favorite compounding pharmacy -- located in San Francisco. It is reprinted here with her permission.
A recent article came out in Forbes’ online magazine entitled “Women Fooled By Untested Hormones From Compounding Pharmacies”(February 20,2015). As a co-owner of a compounding pharmacy that values patient care and therefore quality as its primary mission, I’d like to respond to the critique that this article makes of compounded medications.
The topic of the Forbes article is a recent study that was published in the online journal Menopause, The Journal of the North American Menopause Society, about women’s use of hormone replacement therapy. Even though the source of funding for this study is not mentioned in the Forbes article, this piece of information is important. The study was funded by TherapeuticsMD, which is a pharmaceutical company working to bring hormone products to market. This company certainly has the right to fund a study of hormone usage among women – but to not mention its involvement leaves out an important contextual backdrop for the study’s design.
In addition to providing the funding, TherapeuticsMD also put together the questionnaire that was used in the study, which helps explain why certain questions were asked, and why other questions might not have been asked. One of the survey’s findings is that 76% of the 800 women surveyed didn’t know if compounded hormones are FDA-approved or not. The results are written up in a way that suggest this finding is surprising and alarming.
But did the women surveyed believe that FDA approval was the most important element in assessing the quality of the medications they were taking? We don’t know because this follow-up question was not asked. How would the women surveyed have responded if they had been asked, “How do you evaluate the quality of the hormone products you are taking?”
Compounding pharmacies do not claim (and should not claim) that their medications are FDA-approved, for the FDA is not the regulatory body entrusted with monitoring their conduct– that regulatory role is played by state boards of pharmacy. Did the women surveyed know that compounding pharmacies are regulated by state boards of pharmacy, and were they aware of the quality assurance measures taken by the compounding pharmacy they use? This is important information to know.
The assumption of this Forbes article is that non-FDA-approved means “dangerous.” The FDA is put in the role as the solution to a problem.
Quality matters in compounded medications – but this can happen without expanding the role of the FDA in the field of compounding pharmacy. As the recent outbreak of a superbug in LA’s Ronald Reagan Hospital illustrates, the FDA already has a big job – such as regulating the use of medical instruments in hospitals which can prove dangerous when not cleaned properly. The compounding industry has always argued that the FDA should not take on the additional role of policing compounding pharmacies. The primary role of regulation should stay with state boards of pharmacy, which understand the industry better than the FDA does, for the FDA’s area of focus is mass-manufacturing and hospital settings.
The Forbes article ends with a caution against compounding pharmacies, stating, “Fewer than 50 compounding pharmacies have volunteered to subject themselves to the agency’s [the FDA’s] stricter oversight.” This statement represents a lack of understanding of the new federal legislation written about compounding pharmacies (the Drug Quality and Security Act of 2013), for it does not distinguish between outsourcing facilities and traditional compounding pharmacies. Outsourcing facilities, as defined by the new law, make sterile medications in large quantities without patient-specific prescriptions and ship across state lines, while traditional compounding pharmacies make patient-specific prescriptions and work within their own state. Only outsourcing facilities have been asked to voluntarily register with the FDA, since traditional compounding pharmacies are still regulated by state boards of pharmacy. To make it sound as though “fewer than 50 compounding pharmacies” have high quality standards because they have not registered as outsourcing facilities is simply wrong.
Pharmacies with good policies and procedures, top-of-the-line equipment and continual quality control can make compounded medications that rival mass-produced pharmaceuticals in both their potency and purity. However, variation does exist in individual pharmacies’ quality assurance procedures. It is important for both doctors and patients to critically evaluate the compounding pharmacies that they are using for customized medications. Here are six key questions to ask of a compounding pharmacy to evaluate its quality assurance program.
Are women fooled by hormones from compounding pharmacies, as the Forbes article states, or are they critically evaluating their options for hormone replacement therapy?
What is your experience? Do quality considerations play a role when you choose a mass-manufactured or compounded medication? How do you assess quality in customized medications made by a compounding pharmacy?
Krista Shaffer, Outreach Director at Koshland Pharm