Straight Talk About Compounding Pharmacies

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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!

After struggling with her own severe menopause symptoms and doing years of research, Ellen resolved to share what she learned from experts and her own trial and error. Her goal was to replace the confusion, embarrassment, and symptoms millions of women go through–before, during, and after menopause–with the medically sound solutions she discovered. Her passion to become a “sister” and confidant to all women fueled Ellen’s first book, Shmirshky: the pursuit of hormone happiness. As a result of the overwhelming response from her burgeoning audiences and followers’ requests for empowering information they could trust, Ellen’s weekly blog, Menopause MondaysTM, was born.

  • This is an excellent, informative post and it is obvious you have done your research. As a health coach/nutritionist for the last 35 years I have helped scores of women through menopause with few (sometimes none at all) symptoms. There are natural methods without the use of any type of hormone therapy or repercussions as there usually are when hormones are introduced. Given the proper nutrients, your body can manufacture what you need to be almost symptom free!

    • Ellen Dolgen

      Thanks for your comments, Carol. I am a huge proponenet in integrative medicine. Exercise and diet is key to a healthy life style. However, for some women, eating healthy is not going to be enough to ease menopausal symptoms. I try to make sure that women have the latest information on HT so that they can evaluate with their menopause specialist what is best for their individualized needs. There is no one-size-fits all solution.

  • I’ve used one, but I’ve also heard stories about some.

    • Ellen Dolgen

      That is why I thought it would be helpful to get the facts out about Compounding Pharmacies.

  • Thank you for the very educational information. I have been researching BioIdentical hormones for a short time. I have a friend who has experienced immense relief with BioIdentical hormone implants-However I am suffering through surgical menopause, do you cover this topic any in your book?

    • Ellen Dolgen

      Duffy, my book is out of print right now. I am in the process for updating all the info. The new book will be out shortly. I am not a huge fan of pellets as once they are inserted it is very difficult to tweak the dosage if it is not correct. How about email me at ellendolgen@ellendolgen.com and tell me a little more detail about what you are experiencing and the kind of surgery you had. I am happy to help support you in finding the help you need.

  • I had heard of compounding pharmacies but had no idea what they were about. Thanks for all this great information. Lots of food for thought here.

    • Ellen Dolgen

      So many women have asked me about them, I felt it was time to do a blog to help us all get the facts straight. Glad it was helpful.

  • hmmmm. some great information here. Makes me wonder if I wasn’t diligent enough with my mother’s meds when she was alive

    • Ellen Dolgen

      No point in looking back. Thankfully, we know more know about the different forms of hormone therapy today. With a good menopause specialist – no one should suffer anymore with debilitating symptoms.

  • What I love about you Ellen is your advocacy for UNDERSTANDING what this is all about, starting with DON’T BE SCARED get INFORMED! HRT is soooo different then it was for our mothers. I use a transdermal mist of estrogen (one puff per day), and a two week regiment of progesterone every 3 months taken orally- which balances out the estrogen and makes everything work beautifully. I plan on using these for as long as my female gyn will advise- and I’m sure I’ll hear all about any changes in therapy from you! Thank you!!!

    • Ellen Dolgen

      I love this, Cheryl. I wish more women would be open to understanding this. Sadly, so many suffer in silence. They are basing their healhcare choices on fear instead of facts. Thanks for sharing your journey. When we share, we help others!

  • I so appreciate your post and clarification. I know so many women who are confused about it. I am a big believer in HR. My provider was not a big believer in it and tried to talk me out of it (I don’t have any contraindications) but I prevailed and felt it was the right decision for me to deal with the “fog.”

    • Ellen Dolgen

      Good for you, Ines! You know when you don’t feel good! I am glad that you prevailed and the fog has lifted!

  • Left a comment earlier but it doesn’t seem to have turned up, so I’m trying again. Learned a lot from this post — thanks! I’d heard about compounding pharmacies but didn’t actually know what they were.

    • Ellen Dolgen

      Roz, I think many women are confused about compounding pharmacies. I am so glad that you found the blog post helpful!

  • You are the best. I pass your name around to everyone I know.

    • Ellen Dolgen

      Ahhhhhhhhhhhhhhhhhh, thanks Janie. I am so happy you find the information on my site helpful. Here’s hoping your 2015 is happy and healthy!

  • linda

    Oh Ellen, I will never forget your kind words when you called me all those months ago. And boy have I come a long way thanks to your heart felt wise words. I know longer am falling apart. And yes! I do use a compounding pharmacy… it works for me. Like you said, it’s not one size fits all, but we can absolutely learn from each other:) just want to add this very important point. Exercise, especially in the form of walking if you can, will help so much. Ive survived with a disability that brings on chronic pain for 15 years. We must get up and move through the pain, because when menapause hits–the exercise combined with a good Doctor will save you from shutting in with the covers pulled over your head. It does get better♡ thankyou Ellen, for ALL of your awsome info, and encouragement:)

    • Ellen Dolgen

      Linda, I am so excited to hear that you are feeling good! WOW- best news ever!!!!!!!!!!!!!!!! Thank you for your sweet words and for sharing your story. You did the hard work of putting yourself on top of your TO DO LIST and not giving up until you found the right doctor and the right individualized treatment that works for you. Happy happy 2015!

  • Melanie

    E! Thank you so much for this very informative blog! It is imperative that we educate ourselves on the importance of safety and quality with our compounded medications. There is absolutely NO reason for anyone to not use a PCAB Accredited pharmacy!

    • Ellen Dolgen

      Thanks for your comments….so happy the blog was informative!

  • Julia

    Hi Ellen! I have been using bio-hrt for about two years with fairly good results. My insurance doesn’t cover it so it gets pricey. I recently saw an infomercial for Profemin which sent me researching those types of products. I am concerned about transitioning and wonder if it would be more aggravation than it is worth. Any thoughts?

    • Ellen Dolgen

      Julia, I am not at all familiar with Profemin. You might find some more info about it here. I see that a couple of women complained about them automatically charging them for the product when they wanted to stop using it. So be careful about giving your credit card info or bank account etc. For me, I would stick with your bio-hrt. Check out different pharmacies and see if you can get a better price somewhere else. Reach out to La Vita Pharmacy at (858) 453-2500 and see what they would charge. They ship all over! Tell them you read about them in the blog on Compounding Pharmacies at EllenDolgen.com. Good luck and keep me posted!

  • Lisiana Carter

    I’ve been taking Profemin for 2 weeks now, and I fell so good. I used to have hot flashes and sweating every hour or so, I was so embarrassed when I was in public. Because of sweat, my makeup would be smeared. Thank God for Profemin. And it’s natural. I should say it really helps.

    • Thanks for sharing, Lisiana. It is always good to hear about products that are helping women!

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