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Editorial: Commercially Manufactured Bioidentical Hormones

It is very disappointing that Wyeth Laboratories has filed a complaint with the U.S. Food and Drug Administration (FDA). The complaint contains some inaccurate information and appears to be written by someone that is not totally aware of the history and intricacies of bioidentical hormone therapy (BHRT), commercial products that have been and are currently available, and pharmaceutical compounding that is initiated by physicians and patients. It appears to be aimed at discrediting physicians and pharmacists that are dedicated to working together to individualize patient care through pharmaceutical compounding. In this short space, there is not room to address all the issues, but I have addressed just a few.

1. The active ingredients that naturally occur in the body, are FDA-approved ingredients and many are commercially available but not necessarily in the dosage forms, strengths, or specific combinations needed by patients.
2. These hormones have been studied extensively in clinical trials.
3. These hormones are natural to the human body and are identical to what the body has been, and still is, producing (but not in sufficient quantities as one ages).
4. The hormones all have individual official USP monographs in the current U.S. Pharmacopeia (Estradiol USP; Estriol USP; Estrone USP; Progesterone USP; Testosterone USP).

The vast majority of compounding for BHRT involves estradiol, estriol, estrone, progesterone, and testosterone. All these have been in commercially available, manufactured products over the years, still are available, and, as such, undergo clinical trials prior to approval. (Estrone may not be commercially available now but has been in the past.)

USP monographs for estradiol, in addition to the bulk substance, include Estradiol Vaginal Cream USP, Estradiol Pellets USP, Estradiol Injectable Suspension USP, and Estradiol Tablets USP. USP monographs for estrone, in addition to the bulk substance, include Estrone Injection USP and Estrone Injectable Suspension USP. USP monographs for progesterone, in addition to the bulk substance, include Progesterone Injection USP, Progesterone Intrauterine Contraceptive System USP, Progesterone Injectable Suspension USP, and Progesterone Vaginal Suppositories USP. USP monographs for testosterone, in addition to the bulk substance, include Testosterone Injectable Suspension USP. These lists do not include any of the ester forms of the hormones.

Let's look at some of the COMMERCIAL products that contain the same ingredients as compounded preparations that the Wyeth letter says are dangerous, unapproved, and should not be compounded.

Sad to say, it is apparent that Wyeth is again trying to protect its financial interests following the situation involving its conjugated estrogens product and the Women's Health Initiative trials. It is very hard to respect a company that is intent on doing harm to pharmacies that have served for years in distributing and supporting Wyeth's products. It is also hard to respect a company that does not want patients to receive the best treatment possible�one-size does not fit all patients. But, then again, it may be a sign of the times when so many entities misrepresent and falsify public disclosures and documents for their own gain. But that still does not make it right!

Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief

Want to know what's going on in compounding? Look no further than IJPC's free network. More than 1000 pharmacists are talking. This week postings reached a record number. There were more than 40 postings on Thursday. Discussions included:

• Supplier of quinidine sulfate
• A formula for ketamine and bupivicaine topical spray
• Ways to treat "gout" besides indomethacin
• A formula for glycopyrrolate solution
• Treating E Coli vaginal infection
• Medicare Part D

Process Changes at Lucile Packard Children's Hospital Result in Safer and More Efficient Nutrition Compounding
The introduction of the Baxa automated compounder and Monterey Medical Software allows a leading children's hospital to minimize med errors, reduce man hours and improve clinical efficacy. See full article at PR Web

Shortage
Scopolamine Transdermal
Strength: 1.5 mg
Comment: Scopolamine transdermal systems are on nationwide back order. Novartis Consumer Health Division is releasing Transderm Scop to wholesalers as it becomes available but has no estimated release date for routine supplies. Baxter Anesthesia and Critical Care also supplies Transderm Scop but currently has no product available or an estimated release date for routine supplies. (10/26/05, University of Utah, Drug Information Service)

• 12.011 - Inventory-Veterinary Supplies
• 6.013.13 - ACCULAB LA-60 Analytical Balance-Use and Maintenance
• 6.013.39 - ACCULAB LA-60 Analytical Balance-Calibration
• 6.013.14 - ACCULAB LA-110 Analytical Balance-Use and Maintenance
• 6.013.40 - ACCULAB LA-110 Analytical Balance-Calibration
• 6.013.15 - ACCULAB LA-200 Analytical Balance-Use and Maintenance
• 6.013.41 - ACCULAB LA-200 Analytical Balance-Calibration
• 6.013.7 - ACCULAB LT-120 Analytical Balance-Use and Maintenance
• 6.013.42 - ACCULAB LT-120 Analytical Balance-Calibration
• 6.013.43 - ACCULAB LT-320 Analytical Balance-Use and Maintenance
• 6.013.44 - ACCULAB LT-320 Analytical Balance-Calibration
• 6.013.45 - ACCULAB LT-620 Analytical Balance-Use and Maintenance
• 6.013.46 - ACCULAB LT-620 Analytical Balance-Calibration
• 6.013.47 - ACCULAB LT-3200 Analytical Balance-Use and Maintenance
• 6.013.48 - ACCULAB LT-3200 Analytical Balance-Calibration
• 6.013.49 - ACCULAB LT-4200 Analytical Balance-Use and Maintenance
• 6.013.50 - ACCULAB LT-4200 Analytical Balance-Calibration
• 6.013.51 - ACCULAB LT-7200 Analytical Balance-Use and Maintenance
• 6.013.52 - ACCULAB LT-7200 Analytical Balance-Calibration
• 6.026 - Dry-Heat Sterilizing Oven-Use
• 6.028 - Dry-Heat Sterilizing Oven-Calibration

Measuring Small Quantities of Liquids
Need to routinely measure out very small quantities of liquids for compounding? Why not purchase a "variable micropipettor?" Although expensive, they can pay for themselves in time saved and accuracy achieved. Generally three different sizes are available for measuring different volumes and may include 200 �L to 1000 �L (0.2 to 1 mL), 20 �L to 200 �L and 2 �L to 20 �L. Several other sizes are available but the sizes listed here are more common. Select the size that meets your needs. The tips are disposable so there is no "carryover" from one measurement to the next. Think of the time saved by not having to prepare dilutions to obtain very small quantities!