Straight Talk About Compounding Pharmacies
When menopausal symptoms plague your every waking hour during the day…and night…it’s likely time to investigate whether hormone therapy (HT – formerly referred to as HRT) is the right decision for you. However, there are so many options not only in what kind of hormones you should take, but also which type of pharmacy—traditional or compounding—you want to frequent to get those meds that keep you feeling like your new and improved self.
Maybe you’ve already gone to your regular doctor to ask about how to keep your hot flashes, flashpoint temper, and insomnia at bay, but you might still be confused about the different forms of HT– bioidentical vs. non bioidentical options.
Conversely, you might be wondering if you should just ‘go it alone’ and use a combination of what you know makes you feel better, such as diet and meditation. No wonder you’re confused about what to do!
Whether it’s a patch, gel, drops or pills, hormones are available in all varieties and forms. In addition to the manufactured meds that maybe your mom took, bio-identical hormones are popular because women want something to mimic the hormones made in their own bodies, such as estradiol that naturally decreases as you go through menopause.
Now throw the idea of a compounding pharmacy in the mix vs. the conventional corner drug store and you might wonder if you should go back to ‘eeny, meeny, miny moe’ game to make the final decision.
What Is A Compounding Pharmacy?
Christine Givant, RPH and Deb Hubers from the La Vita Compounding Pharmacy in San Diego offer this explanation: compounding pharmacies prepare medications by mixing raw ingredients to custom formulate a medication that results in an exact dosage and strength for each individual patient. These medications are compounded based on a doctor’s prescription.
The two add that no pharmacy, conventional or compounding is regulated by the FDA, but rather by individual state board of pharmacies and each state has different requirements. However, they point out that reputable compounding pharmacies use ingredients sourced from an FDA-approved chemical house. That’s why it’s critical to select a compounding pharmacy that is approved by the Pharmacy Compounding Accreditation Board or PCAB. Pharmacies accredited by the PCAB not only comply with quality standards, but have also demonstrated that they’ve undergone strict evaluations by inspectors.
Because there have been instances of problems with compounding pharmacies, the US Congress recently reviewed additional methods of oversight. That resulted in the legislative body passing a law for increased oversight of drug compounding and President Obama signing the Drug Quality and Security Act into law just last fall.
So, Is A Compounding Pharmacy for You?
Well, first and most importantly, choose your doctor with care and discuss with them whether you want to go the compounding route. Each doctor will likely have a different view.
There are a growing number of specialists solely dedicated to helping menopausal women. If you’re not certain if one practices in your area, the North American Menopause Society can help you locate one near you.
A new study at Case Western Reserve University states that many women, leery of taking conventional hormones and tired of their regular doctors not taking them seriously are even seeking anti-aging physicians for hormonal therapy routes. Sometimes hormonal therapy will utilize bio-identical hormones and that’s the subject of another study showing some women prefer using an anti-aging specialist to distinguish between manufactured and bio-identical hormones, as it relates to their individual health.
Additionally, you might want to consider an Institute for Functional Medicine (IFM) certified practitioner. This means that they are experienced in functional medicine, which utilizes each patient’s environment, lifestyle and genetic information to address health issues including chronic disease. This approach, recommended by Deb Hubers of La Vita Compounding Pharmacy, takes into account your diet, how you live your life, what diseases you suffered from in early childhood and current stressors in your life. Based on that information, the practitioner orders tests that might uncover things you hadn’t considered, such as leaky gut syndrome or sensitivities to certain foods. The IFM certified practitioner then pulls all of this ‘new’ information together, along with any genetic mutations and how they affect your metabolic pathways, especially during menopause, to determine a very specific course of treatment. Researchers now understand that those pathways provide critical information as to what is going on in your body at the cellular level and that is instrumental in treating disease, fighting obesity and even determining what nutrition your body requires, so that you remain healthy throughout menopause.
If you’d like to locate an IFM certified practitioner in your area, click here and then key in your zip code first; then, check the box indicating that you want your search to show only ‘IFM certified practitioners.’ You can limit your search to the distance you’re willing to drive to visit one.
It’s critical for you to do your homework and investigate which type of menopause specialist will work the best for you, as you consider undergoing hormone therapy.
So, after finding the right specialist, should you go manufactured or compounded bio-identical hormones? First and foremost, educate yourself, but also pay attention to which entity is publishing the research, as in this recommendation against bio-identical compounding. A different study gives an entirely different view, based on a study of women with an average age of 52 taking bio-identical compounded hormones and who actually realized a significant decrease in irritability and emotional liability.
There is a fierce competition for your dollars, especially now as thousands of baby boomers seek relief from menopausal symptoms.
Lab Tests are Critical
Lab testing provides baseline markers, according to Deb, and leads to the best treatment protocols for each patient. Then, ongoing testing helps the doctor evaluate if the treatment is working.
“The laboratory tests are actually used as a precautionary or safety measure for many patients’ treatment plan. This standard testing often does not evaluate many of the markers doctors that specialize in hormone therapy utilize to evaluate a patient, such as thyroid tests,” says Deb.
“For example, to totally evaluate a patients’ thyroid function, you need more than just a TSH level. Hormones are only one part of the biochemistry pathway and true functional medicine providers need to evaluate genomics like MTHF mutations and micronutrient levels of a patient in addition to hormone levels. Modifying hormone levels of a patient should be taken seriously and understanding the endocrine pathways is a sophisticated science. Laboratory testing is a critically important tool in treating patients and assuring the patient’s treatment is properly monitored.”
“Compounding pharmacies formulate medications based on a physician’s prescription for an individual patient and are not in the business of making medical claims that any formulations are safer than commercial alternatives. Therefore, a physician and patient MUST be allowed to have the invaluable option of choice in their medical care,” finished Deb.
In other words, pay attention, ask questions, get your lab work done when the doctor requests it and stay on top of the results to determine if the HT course you’ve decided upon with you physician is working—for you.
D.o. and Insurance
On January 1, 2012, a new policy called D.o. went into effect that changes the way compounded medications are reimbursed, forcing pharmacies to reject some insurance claims. Now, there is new reason to read the fine print very carefully, when it comes to your insurance carrier covering medications from compounding pharmacies.
In fact, it was announced recently that three compounding pharmacies have joined forces to file a lawsuit against Express Scripts, the country’s largest pharmacy benefit manager. That’s because Express Scripts said, ‘No,’ to covering more than 1,000 active ingredients used by compounding pharmacies to produce creams, ointments and other medications, essentially meaning that if it’s not covered by insurance, then you’ll end up paying more.
In the fog of menopause, it’s difficult to wade through all of the information associated with HT and the pharmacies that dispense the meds. But—you’ll be glad you did, because if given just the right medication and dosage, the difference between how you feel now and you will feel is…well, the difference between night and day. So, research and discover what the best options are for you and soon you’ll be smiling during the day and sleeping like a baby at night; just like you used to!