The Top 3 Myths about Compounding Pharmacies
My very first menopausal symptom was brain fog! I would lose my train of thought, mid-sentence. My husband, David, began finishing my sentences for me during business meetings and even socially. Next to go was my sleep! I was not sleepless in Seattle with Tom Hanks…I was sleepless – every night -with David!
Then came Ms. Flash. I remember my first hot flash like it was yesterday. It was a beautiful spring day, so I couldn’t blame the weather. I was wearing a lightweight pantsuit for work, so I was not overdressed. David and I were in a business meeting and suddenly I felt a flush of heat radiate throughout my body. My whole body seemed to be blushing and then glistening. When I rose from my chair, I noticed that something wet was dripping down the inner seam of my pant leg. For a minute, I thought I had wet my pants! But oh no…I was perspiring!
Luckily, I always carry a big purse (I think it makes my hips look smaller). With my purse planted firmly in front of my body and my husband tightly behind me, I made a quick exit to our car after the meeting. I know I had come from a business meeting, but I looked like I had just finished a Bikram yoga class or I had run a 10K.
So what’s a gal to do?? First and foremost, you need a fabulous menopause specialist. If you don’t have one, I have some great tips in my free eBook, MENOPAUSE MONDAYS The Girlfriends Guide to Surviving and Thriving During Perimenopause and Menopause!
After I found a good menopause specialist, I took a personal inventory of things that I can control. I eat healthy, exercise every day, and lead a what I call a very healthy lifestyle. Ok, so I do admit, my cocktail hour is sacred! My martini is 7 points on Weight Watchers. It is built into my points every day – period – end of discussion!
I tried incorporating acupuncture into my routine, but, sadly it did not alleviate my brain fog, hot flashes, insomnia or sudden emotional highs and lows. I would have even been happy with a placebo effect! But, sadly acupuncture did not help me.
On a scale of 1-10, my quality of life was around a 2. There was no way I was going to live like this! I was not functioning at work nor at home. I soon found out that I was in a big club! Many women have very difficult, often life changing menopausal symptoms that are only elevated by hormone therapy (HT).
You can learn more about the different kinds of hormones in Chapter 15 and 16 in my free eBook. For the sake of this blog, suffice to say that you can get your hormones from FDA approved pharmacies or from non-FDA approved compounding pharmacies.
Compounding pharmacies prepare medications by mixing raw ingredients to 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 reason they are not FDA-approved is that these hormones are compounded specifically for your personal needs. Pharma cannot get a patent on them. Each prescription is slightly different. Many women do better on the FDA-approved hormones others do better on compounded hormones.
According to Science Daily, close to 36 million prescriptions per year are written for FDA-approved hormone therapy. The number of prescriptions for compounded hormone therapy for women at menopause has reached an estimated 26 to 33 million a year.
To learn more about Compounding Pharmacies, I reached out to Christine Givant, RPH and Deb Hubers Co-Founders of La Vita Compounding Pharmacy (PCAB® Accredited).
I asked La Vita to give us the top 3 myths about Compounding Pharmacies:
1. Myth: Compounding pharmacies are a relatively “new concept” and only sell hormones.
Fact: A patient may be allergic to or even intolerant to an ingredient found in the commercially manufactured form of the medication. A compounding pharmacist can make the medication without the allergy-inducing ingredient such as lactose, preservatives, dyes, gluten and sugar.
Drug shortages can adversely affect drug therapy, compromise or delay medical procedures. Compounding pharmacists can provide access to discontinued medications and drugs in the short supply by compounding the specific drug, based on a physician’s prescription, using pharmaceutical base ingredients to provide patients the care they need.
2. Myth: Compounding Pharmacies are not regulated.
Fact: Compounding Pharmacies are rigorously regulated by the State’s Board of Pharmacy and the FDA.
Physically inspected once a year, requiring compounding pharmacies follow these procedures:
- Quality chemicals purchased from FDA approved chemical houses.
- Testing all formulas for “beyond use dating” to establish proven formula stability.
- All sterile batches are tested for endotoxins, microbial, and fungus by an independent outside lab. All batches are quarantined until sterility is passed prior to release.
- Clean room is certified twice yearly.
- All equipment is maintained and calibrated daily and recorded in a log.
- All temperatures and humidity readings are monitored and recorded daily in the general lab, sterile room, storage room, and refrigerators.
- All Certificates of Analysis for each lot # are signed off by a pharmacist verifying potency and stored in a retrievable file.
- Compounding staff team is formally trained twice yearly, including hands-on compounding, and written tests
3. Myth: All compounding pharmacies are the same and offer equivalent products.
Fact: Compounding pharmacies are not all created equally. Their products are always custom made for the patient so knowing how to find high quality and safety is imperative.
- Look for the PCAB® Accreditation seal. Only 1% of all US pharmacies are accredited for sterile and non-sterile compounding.
- PCAB® requires executing an extensive formal Quality Assurance program which involves deeper scrutiny and follow-up.
- PCAB® requires continual reporting and monitoring of prescription errors, discrepancies, patient complaints, infectious disease programs, and audits of critical processes.
I asked Chris to comment on the recent NAMS (North American Menopause) Survey which states, “the possibility of higher rates of endometrial side effects related to compounded products”.
Chris replied, “At the end of its own survey this article states, ‘This study is too small to make a definitive statement about side effects’ …yet makes a statement nonetheless. They then cite two articles as reference. The first article references a few in-clinic cases and goes on about compounded pharmacy not being under FDA scrutiny etc. Although, the FDA can walk into any compounding pharmacy on any day and inspect. And believe me, they do it. This is an opportunity to state that not all compounding pharmacies are created equal and encourage patients to seek out an accredited pharmacy. (See Myth #3 above.)
The second article cited after stating ‘the study is too small to make a definitive statement about side effects’ a study with only three patients and it mostly suggests that the issue isn’t with compounded progesterone per se but rather there might be a possible issue with topical use of progesterone, in particular, being protective enough vs other dosage routes. This is a different topic of conversation all the way around.”
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!
Suffering in silence is OUT! Reaching out is IN!
Click here to download my free eBook, MENOPAUSE MONDAYS The Girlfriend’s Guide to Surviving and Thriving During Perimenopause and Menopause.