Bioidentical Hormones for Menopausal Therapy

Cynthia K Sites

Disclosures

Women's Health. 2008;4(2):163-171. 

In This Article

Relevance of Compounded Hormones in Medicine

Compounding is defined as the mixing of a drug or device consistent with a licensed practitioner"s prescription.[6,7] A compounding pharmacist can not prescribe but is authorized only to prepare the prescription in accordance with the physician"s order. For many years, compounding was the only mechanism to make drugs available to the public. However in the 1900s, pharmaceutical companies assumed most of the duties of compounding, which reduced the need for compounding by individual pharmacists. Today, compounding fulfills a need for children and older patients for special preparations when the exact products needed are not commercially available. The expansion of compounding now includes requests for particular drugs for all age groups for reasons such as their derivation from a plant rather than an animal. The US FDA has stated that compounded prescriptions are both ethical and legal as long as they are prescribed by a physician for a particular patient in a "reasonable" quantity and are compounded by a licensed pharmacy.[7,51] The FDA has estimated that compounded products account for 1% of all prescriptions in the USA, or approximately 30 million prescriptions per year.[51] Compounding pharmacies are also popular in Europe. Clearly, this number of prescriptions translates into billions of US dollars or Euros per year for compounding pharmacies, for the laboratories associated with them that measure salivary hormone levels, and for hormone consultants who offer opinions regarding hormone dosing adjustments based on salivary hormone levels.

Despite the virtues of compounding for special groups of patients, there are unanswered questions about the practice. Compounded hormones have not been subject to reports of adverse events. Safety and efficacy of products have not been studied in large clinical trials. Owing to the need for greater scientific scrutiny of compounded hormones, The Endocrine Society published a position statement in October 2006, supporting the FDA regulation of all hormones, including compounded hormones, regardless of chemical structure or method of manufacture.[52] The position statement suggests that a registry of adverse events be established for hormone preparations and that uniform information about hormone side effects should be included in the packaging. Large, randomized, placebo-controlled trials of compounded hormones should provide much needed information with regard to efficacy and potential adverse events.

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