When it comes to balancing your hormones with bioidentical approaches, getting to know a reliable, compounding pharmacist in your area is an essential first step. Few traditional pharmacists better understand the biochemistry of hormones in the body, or can tailor a prescription to individual need based on hormone test results. And if you have a problem swallowing pills, a skilled compounder can solve that with sublingual troches that taste good while dissolving under the tongue, non-allergenic topical creams that can be applied anywhere on the skin, or vaginal suppositories, nasal sprays, drops, tinctures, you name it! Many of these specially designed delivery systems are so effectively absorbed by the body it takes much less hormone to achieve much greater benefit… the so-called “Goldilocks” approach to dosing hormones appropriately – not too much nor too little, but just right!
Every since the WHI (Women’s Health Initiative Study) found that synthetic hormones like those used in common HRT combinations, increased risks for stroke, heart attack, blood clots, and breast cancer, compounding pharmacists across the country have become key players in the shift to natural hormones and the Bioidentical Hormone Restoration model, a.k.a. BHRT, where patients, providers, and compounders partner to detect and correct imbalances that diminish health …not to mention energy, mood, memory, strength, libido…I could go on…and on!
As happens every now and then, the bad practices of one pharmacy can cast aspersions upon all. In one such incident last year, a pharmacy in Massachusetts used improper procedures in formulating a sterile medication which led to an outbreak of meningitis and the death of hospital patients injected with the toxin. In light of this tragic event, it seems appropriate to clarify that it is exceedingly rare and to talk about the regulation of pharmacy, and safety measures that GOOD compounders use.
For starters, all compounding pharmacies are subject to government oversight by three different regulatory agencies: 1) the State Board of Pharmacy, which ensures adherence to state laws and good pharmacy 2) the FDA, which regulates the integrity of the drugs and active ingredients compounders purchase; and 3) the DEA, which regulates how compounding businesses buy and dispense controlled substances.
Evidently, the pharmacy in Massachusetts, (the New England Compounding Center) had previously received warning letters from the FDA, ignored safety guidelines, and, had illegally shipped prescriptions to states in which they were not a licensed pharmacy. Not only was the purity of the chemicals they used questionable given the meningitis outbreak, this particular facility was known as an “outlier” in the compounding world. According to Natalie Gustafson, RPh., and owner of Pacific Compounds and Lloyd Center pharmacies, in Hillsboro, and Portland, Oregon, “these people were not even closely representative of how most pharmacies operate, which is to put the patient first and to have numerous quality control measures in place to ensure the safety of patients and employees alike.” Natalie, and her assistant, Pharm-Tech, Cory Dolan, emphasize that to find a compounder you can trust absolutely, it is essential that you talk with them and ask the following key questions:
- Have you passed inspection by your governing bodies: The State Board of Pharmacy: FDA and the DEA? Have you ever been written up by your State Board?
- Are you licensed by PCCA (Pharmaceutical Compounding Centers of America)?
- Do you use only pure USP grade chemicals?
- Do you run any outside testing of the sterility and potency of your formulations by impartial labs?
- Do you have safety measures in place like human checks of all prepared formulas in addition to computer checks?
- Do you individually label, bar-code, and record the chemicals used in your formulations?
- Do you have a clean room (with powder hood, etc.) to reduce cross-contamination?
- Do you use the latest technology your industry has to offer?
- Do you and your staff regularly obtain continuing education credits and training?
Bottom line: Your compounder is your friend, if and only if, they can answer all the questions above with resounding positives!
How to find a good compounder? Easy. Get to know who has a name in your area. Talk to your provider and find out who she/he recommends, or visit PCCA’s website: www.pcca.com or International Academy of Compounding Pharmacists: www.iacprx.org for a list of trained compounders by zipcode. Conversely, if you are looking for a provider (see my July 31, 2012 post: How to Find a Natural-Hormone Friendly Provider) your compounding pharmacist is an excellent resource since they know all the docs in town who know what they’re doing when prescribing bioidenticals. ZRT Laboratory, a top hormone testing lab in the country has a great provider resource directory that includes providers and compounders at www.zrtlab.com
Once you find someone that sounds good, stop by their pharmacy. Check out their premises, the levels of cleanliness, certificates and registrations of their technicians, available information and resources. A top level facility should ideally have a viewing window where you can observe technicians hard at work under the hood, in the clean room, attired as they should be in the appropriate sterile garb, etc.. A GOOD compounder should offer medical professionals and interested patients tours of their lab and safety procedures. These are the kinds of things to look for so that you can trust your compounder without a shadow of a doubt.
Please chime in to this conversation if you yourself happen to be a compounding pharmacist, natural friendly hormone provider or concerned health care consumer looking for hormone balance!! Tell us your experience of working with compounders and stay tuned for Kyle’s upcoming blog post from the provider perspective!