Just a few comments on the AMA resolution passed this week. The comments are divided into 4 parts as per the resolution:

AMA will call on the FDA:

(1) to conduct clinical surveys for purity and dosage accuracy of compounded bioidentical hormones;

The AMA is apparently unaware of the current standards for compounding according to USP Chapters <795> and <797>. The source of the active pharmaceutical ingredient (API) is USP-grade chemicals, many from the same producer and same batches as those used in the pharmaceutical industry. Also, I'm not sure what is meant by a "clinical surveys for purity and dosage accuracy"? I would think this should be "chemical analysis for purity and dosage accuracy" of compounded bioidentical hormones. Chemical analysis is rapidly becoming routine in compounding pharmacies, so this has already been and is currently being addressed. Also, compendial requirements for compounded preparations are just as strict as for manufactured medications (generally �10%).

(2) to require compounding pharmacies to report adverse events and to create a registry of those events;

This has already been addressed with the USP MedMarx reporting system. It has been in operation for many years and compounders can report adverse events through this system.

(3) to require "uniform patient information" such as warnings and precautions on compounded bioidentical hormone products; and

Patient information can be drug and drug product specific and is not simple to put together. With all the dosage forms and combinations used in BHRT, it may be a challenge to come up with suitable information that is a one-size fits all. However, some pharmacists already do this and it is something that can be addressed at a national level, rather than having every pharmacy developing their own. This may be a suitable project for a national organization.

(4) to restrict pharmacies from using the term "bioidentical" to describe compounded hormone treatment.

The term "bioidentical" is perfectly proper. It simply means "life-identical" or hormones that are identical to those already in the body. Premarin cannot be advertised as a "bioidentical" hormone because it isn't one. However, some commercially available progesterone, testosterone, estradiol, etc. products can properly use the term in their products as they are "bioidentical." Does this mean that manufacturers could start using the term "bioidentical" but compounders could not?

The AMA is apparently unaware, or chooses to ignore, the tremendous advances in quality compounding and compounding standards that have occurred over the past 10-15 years. True, there may be a few (very few) errors made but then one must look at the "acetaminophen" recall of millions of commercial dosage units just last week as well as the drugs removed from the market after being FDA approved and taken by millions of patients. What are the priorities here? Something that affects relatively few patients or something that affects millions of patients? Quite possibility the AMA should be addressing their concerns to all the drug product recalls and requirements for Black Box warnings and "483s" related to poor manufacturing practices (of which Wyeth is a recipient).

The AMA also ignores the fact that pharmacy and medicine are professions established by the statutes of each state, or more simply stated-the profession of pharmacy and medicine are established by the states, and the laws and regulations are developed at the state level. If a federal agency (e.g., FDA) attempts to impact the practice of state-regulated pharmacy, they may also attempt to impact the practice of state-regulated medicine. According to some interpretations, physicians "break the law" every time they prescribe an "off-label" medication, which may impact over half of the prescriptions written. What will happen when a federal agency attempts to regulate states' physicians by telling them they can no longer prescribe for off-label uses unless they want to have possible charges brought against them by the FDA?

Just a few thoughts to ponder...


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

Veterinary compounding is extremely important and necessary for veterinarians responsible for the care of animals, large and small, as well as for pet owners. Just as it is with human patients, all veterinary patients are not the same, and some may require the expertise of a compounding pharmacist to prepare specialized medications. The focus of IJPC's November/December 2006 issue is on veterinary compounding, and the issue contains some valuable articles, case reports, and formulations related to that topic. Readers will also find articles related to topics other than veterinary medicine in the issue. If you are not a subscriber you can purchase and download a specific article at www.ijpc.com/editorial/SearchByIssue.cfm?PID=2469

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

In response to the AMA resolution, P2C2 will engage patients and prescribers, and we have created a landing page for this campaign at www.SaveMyMedicine.org/. We encourage you to direct your patients who take BHRT and especially their prescribers with whom you work to this page. Getting patients to write letters is helpful, but prescribers carry extra authority, particularly with the AMA. The more prescribers we can get to write letters, the better.

Our goal is to convey to AMA that there is a large and passionate constituency of patients and prescribers who support access to bioidentical hormones and who oppose unilateral FDA intervention, and that if the AMA considers future action on matters related to compounding, it should consult with IACP.

In addition, IACP has been conducting some limited media outreach, and we are working with our allies to generate a letter to the AMA from the profession expressing disappointment. To view our press release, click here.

If you would like to use talking points to guide your conversations with your patients and prescribers, we have developed a fact sheet that is available on IACP's members-only website. Please click here to view the fact sheet.

Again, please keep in mind that this neither requires nor empowers FDA to take these actions. In fact, we do not believe the FDA has the authority to implement these suggestions. However, it does give the agency and pharmaceutical manufacturers like Wyeth more ammunition to justify their agenda.

If you have any questions regarding this email, please contact IACP's Regulatory Affairs Director, Jennifer Goodrum at jennifer@iacprx.org or 281.782.9424.

The cover artwork of the International Journal of Pharmaceutical Compounding's premiere issue is an electronically generated representation of the evolution of compounding pharmacy and the history of individualized patient care.

IJPC had a drawing at a Professional Compounding Centers of America meeting for a framed copy of this poster and the winner is: Ron Hale, VP of Pharmacy Operations, Geneva Woods Health Care Services, Anchorage, AK 99508

You can purchase an un-framed copy of this poster where the best of both worlds of pharmacy's past & future are together at www.ijpc.com/Products/ProductDescription.cfm?PID=11

Karsten Duncan was the winner of a drawing for an iPOD at the National Community Pharmacists Meeting in Las Vegas, NV.

Visit us at booth #2365 at the American Society of Health-System Pharmacists meeting, December 3-8, 2007 in Anaheim, CA.

Even in winter we need to be careful about the amount of UV rays that are absorbed by our skin and inspect our skin for unusual lesions. This week we have added 43 citations on the subject of cancer and precancerous lesions of the skin to CompoundingToday.com's literature search database. Here is a sampling:

Chemoprevention of photocarcinogenesis by selected dietary botanicals.
Baliga MS, Katiyar SK. Photochem Photobiol Sci 2006; 5(2): 243-253.

Immunological strategies to fight skin cancer.
Berman B, Perez OA, Zell D. Skin Therapy Lett 2006; 11(5): 1-7.

Current modalities and new advances in the treatment of basal cell carcinoma.
Ceilley RI, Del Rosso JQ. Int J Dermatol 2006; 45(5): 489-498.

Current treatments of actinic keratosis.
Gold MH, Nestor MS. J Drugs Dermatol 2006; 5(2 Suppl): 17-25.

Escharotic and other botanical agents for the treatment of skin cancer: A review.
Jellinek N, Maloney ME. J Am Acad Dermatol 2005; 53(3): 487-495.

Be Thankful!
Thanksgiving is next week and we need to remember the purpose for which it is intended. Professionally, I am thankful that I am a pharmacist and have many challenges and opportunities to address every day to make a difference in patients' lives and pharmacy practice.