This week I had the opportunity of speaking at the 17th Annual Meeting of the North American Menopause Society (NAMS) at Opryland in Nashville, Tennessee. They arranged a special post-graduate program entitled "Understanding the Controversy: Hormone Testing and Bioidentical Hormones." There was a special fee for this program, and it was a complete sellout with 400 persons (physicians, nurses, pharmacists, others) in attendance.

Speakers, in order of appearance on the program, included Bruce Patsner, MD, JD, of the Walter Reed Army Medical Center (formerly of the U.S. Food and Drug Administration); Loyd V. Allen, Jr., Ph.D., R.Ph. of the International Journal of Pharmaceutical Compounding; Lila E. Nachtigall, MD, of the New York University School of Medicine; Robert T. Chatterton, Jr., Ph.D., of the Northwestern University Feinberg School of Medicine; and Marcie K. Richardson, MD, of the Harvard Medical School. James A. Simon, MD, of the George Washington University School of Medicine, served as moderator. The format was a 30-minute presentation by each speaker followed by more than an hour of questions and answers.

Topics covered (in order presentation) were "Regulatory Issues of Compounding Drugs," "Compounding Practices and Controversies," Bioidentical versus Nonbioidentical Hormones," "Validation of Hormone Testing," and "Using Bioidentical Hormone Therapy in Clinical Practice" by Richardson and Vogel.

When entering the room prior to the presentation, one physician came to me with the question, "Did you wear your flak jacket this morning?" I must admit to some apprehension during preparation for the program, which included teleconferences with other speakers and correspondence during the weeks leading up to the program.

However, at the conclusion of the 4.5 hour program, I had the following summary of "messages" from the program:

1. Even though NAMS leadership and financial supporters tend to be negative towards compounding, the participants in the meeting were quite supportive and positive towards it.
2. Many participants, if not most, prescribe bioidentical hormone replacement therapy compounded preparations.
3. It is clear that compounding is a legal activity.
4. It is clear that compounding is a necessary and vital part of today's health care.
5. Much is gained by pharmacists working with physicians in bioidentical hormone replacement therapy.

The "negative comments" received were related to the following:

1. Pharmacists' advertisements in national magazines and claims on the Internet relate to safety and effectiveness.
2. Pharmacists tell patients that physicians don't know what they are talking about when discussing and writing prescriptions related to hormone replacement therapy.
3. Pharmacists [allegedly] change drugs and dosages without contacting the physician, telling the patient that they know better than the physician.

Participants suggested that pharmacists work with physicians as a team to evaluate the literature together and discuss seemingly contradictory studies.

In addition to many, many questions asked during the question and answer session, the following question was critical: "In light of the negative media and quality concerns, how do I find and evaluate a GOOD compounding pharmacy that I can use and send my patients to with confidence?"

Instead of needing a flak jacket, it seems that truth, education, enhanced quality standards, and sincere interest in the physician-patient-pharmacist triad relationship, is all that was needed to overcome the perceived negative influence of the Wyeth misinformation campaign.

The national media were present at the meeting, and it will be interesting to see what they publish about this subject over the next few weeks. But, let's not hold our breath. In summary, small, firm steps may result in long-lasting progress over time.


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

Head lice treatment was a main topic of conversation last week on the Compounders' Network List (CNL), with several pharmacists suggesting a formula that was published in The International Journal of Pharmaceutical Compounding (IJPC) a couple of years ago. The IJPC formula was considered very effective by those pharmacists that had used it themselves or had patients that tried it. The formula was also recently included in our RxTriad Newsletter, along with information on compounded therapies for keloids, warts, and cold sores. For a full listing of lice-related information from IJPC, including the Aromatic Head Lice Oil formula, see www.IJPC.com/editorial/SearchByKeyword.cfm?searchstr=lice . Review the latest issues of the RxTriad for distribution to physicians and other healthcare professionals at www.IJPC.com/RxTriad .

These CD's contain each issue of the Journal published during the respective calendar year. Each item is only $85. Enjoy a discount of $10 per CD when you purchase multiple CD items.

• Volume 9, 2005
• Volume 8, 2004
• Volume 7, 2003
• Volume 6, 2002
• Volume 5, 2001
• Volume 4, 2000
• Volume 3, 1999
• Volume 2, 1998
• Volume 1, 1997

View the index of articles for each and purchase them online at www.ijpc.com/products/index.cfm

This Regulatory Update has been provided by the International Academy of Compounding Pharmacists (IACP). For more information, www.iacprx.org.

Midland Court Ruling: Contested by the U.S. Food and Drug Administration (FDA)
The pharmacy compounding profession is buzzing with the recent ruling by a U.S. District Judge. The ruling undercuts the FDA's attempts to regulate the practice of compounding and is a huge victory for our profession. U.S. District Court Judge Robert Junell ruled in favor of the 10 plaintiff pharmacies in the case, Medical Center Pharmacy, et al. v. Gonzalez, stating that compounding is legal. Furthermore, he ruled that the FDA does not have authority to inspect a pharmacy's records if that pharmacy complies with applicable state laws and operates as a retail pharmacy. He also ruled that it is legal to compound from bulk pharmaceutical ingredients for nonfood animals.

Not surprisingly, the FDA is "thoroughly" contesting Judge Junell's decision in the Midland case. The FDA filed a motion for the Federal District Court in Texas to amend or alter his decision. Contesting a ruling is a routine matter, and it seems that the FDA is exhausting all of its options before it appeals the decision. Read the FDA's challenge in full here.

IACP Files Comments with Florida Board of Pharmacy on Proposed Sterile Compounding Regulations
The Florida Board of Pharmacy has been working to update its sterile compounding regulations. In August, IACP received a hearing notice and a request for comments on the draft regulations. IACP sent a copy of the draft regulations and a meeting notice to all IACP Florida members at that time. IACP also prepared initial comments on the draft regulations, which can be accessed here. Our initial comments addressed Florida's incorporation of an in-revision version of USP Chapter <797> into the draft regulations. IACP's comments also suggested that language consistent with IACP's labeling recommendations be incorporated into the proposed regulations. The Florida Board of Pharmacy was scheduled to consider the final draft regulations at its meeting on October 3, 2006. IACP will review the final draft regulations and file comments where appropriate.

Fifty (50) new citations on the treatment of burns (18) and scars/keloids (32) have been added to CompoundingToday.com's literature search database this week.

This database now has 3,931 citations from 936 sources from all over the world that are relevant to pharmacy practice. Here is a sampling of the latest additions:

Pathophysiology and current management of burn injury.
DeSanti L. Adv Skin Wound Care 2005; 18(6): 323-332.

Topical treatment of pediatric patients with burns: A practical guide.
Palmieri TL, Greenhalgh DG. Am J Clin Dermatol 2002; 3(8): 529-534.

Hypertrophic and keloidal scars: An approach to polytherapy.
Boutli-Kasapidou F, Tsakiri A, Anagnostou E et al. Int J Dermatol 2005; 44(4): 324-327.

Epidemiology, aetiology and management of abnormal scarring: A review of the literature.
Pellard S. J Wound Care 2006; 15(1): 44-48.

Causes of and treatment options for abnormal scar tissue.
Smith FR. J Wound Care 2005; 14(2): 49-52.

Are Your Kids Running on Empty? How Better Food Choices Can Make the Winning Difference
Ellen Briggs and Sally Byrd, ND, 2004
Many Hands Publishing, Deerfield Beach, Florida $27.95
Review by Dana Reed-Kane, Pharm.D., NFPPhC, FCP, FIACP, FACA

This book is a must read for anyone with children!
These days, kids grow up on chicken nuggets, macaroni and cheese, hot dogs, hamburgers, and French fries. Fast food has become a way of life in our busy society. As a result of our busy lifestyles and modern conveniences, our children our suffering from the food choices we are making for them. This book is an excellent resource for any parent who cares about their children's health and well being. In fact, giving your children better food choices will give parents smarter and better-behaved children. In this book, the authors explain why kids eat all day but are still hungry.

Read the complete review for this and other books on CompoundingToday.com's free book review section at http://compoundingtoday.com/Books/ReviewList.cfm

A compounding pharmacist can play a vital role in preparing topical cidofovir cream or gel to assist the prescribing physician and the patient in the treatment of resistant viral infections. See the article titled "Topical Cidofovir for Treatment of Resistant Viral Infections" about this subject on pages 324 through 328 of IJPC's September/October 2006 issue. If you are not a subscriber you can purchase and download the article at http://www.ijpc.com/backissues/ArticleDescription.cfm?ABS=2441

Sign up today at www.IJPC.com and start your journal print and electronic subscriptions. You can download what you are currently subscribed to and purchase electronic access to our complete set of back issues.

Topic Notebooks
Want to start a literature file on a topic of interest? Do a Medline/PubMed search and narrow it down to the specific topic of interest. Then, click on the titles and read the abstract. If it is of interest, print it out. Place these abstracts in a binder in the order of your choice (author, date of publication, etc.). Then, select the ones of which you would like a full text copy and order them online, visit a library, or ask your pharmacy student or technician to obtain them for you. By doing this, you can develop "topic notebooks" that are easy to access and read.