Compounding pharmacies have received quite a bit of airtime lately–but they are nothing new. Before the modern mass production of drugs, individual pharmacists, chemists, or even herbalists compounded all medicines. The term, compounded, simply refers to drugs mixed by compounding pharmacists to create a unique medication. While numerous valid reasons exist for the compounding of certain drugs, the practice remains controversial, especially when discussing the compounding of menopausal hormone replacement therapy medications.
Why are some drugs compounded?
- To change the form of a drug–for ex: from a pill to a liquid
- To extract an ingredient to which a patient has a known allergy
- To change (increase or decrease) the dosage for patients whose needs differ from the dosages commercially available
When judiciously compounded, and in close collaboration with a prescribing physician, compounding pharmacists can produce safe and useful custom medications. While an ideal scenario, sometimes the compounding results in an inert, dangerous, or deadly medicinal product. Pharmacy standards, practice and oversight can vary from state to state. Individual states issue pharmacy licensing through their individual state pharmacy boards. With no uniform standard in place, the quality and compounding expertise at various pharamacies can differ greatly. Some pharmacies create a misleading impression that patients should purchase all menopausal hormone therapy as compounded products from them. They imply that their particular compounding processes render these products safe and effective. Many leading gynecologists want their patients to know about the possible dangers associated with off-label, compounded hormone mixtures. And the American College of Obstetricians (ACOG) and The North American Menopause Society (NAMS) agree that these products could pose a serious health risk.
Since the FDA does not regulate the medications compounded at pharmacies, including those for hormone therapy, patients use them at their own peril. Compounded products do not undergo the same rigorous approval process as other prescription drugs. Because no federal standards exist to ensure the quality of the products, most ingredients used to make these compounds do not have FDA approval; many are not “natural”, despite some pharmacy claims. They may contain synthetic ingredients that can cause stress on the body when ingested or processed. To complicate matters further, compounded mixtures do issue the same safety warnings seen and required on FDA-approved hormone therapies.
The FDA has given a stamp of approval to many widely produced, commercially available, hormone therapy medications. Patients should always consult closely with a physician when choosing any course of treatment. Physicians and patients should work together to find the right therapy for each individual’s body and lifestyle.
Medical Translation by Amy E. Shoultz, PhD. in concert with Dr. Maryann Prewitt, MD, FACOG
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