The government and Wyeth are counting on the fact that no single compounder can bear the economic burden of donation. Wiley's way means that no one pharmacist has to.
Santa Barbara, CA (PRWEB) August 8, 2007
As many as two million women in the U.S. use customized hormones for menopause symptoms. T.S. Wiley is the developer of the Wiley Protocol® (http://www.thewileyprotocol.com), a patent pending delivery system consisting of bio-identical estradiol and progesterone in topical cream preparations. Wiley has pioneered the standardization of the formulation using a unique compounding procedure and color coded packaging all available to physicians and women at a recommended retail price. In order to fill a physician's prescription for the Wiley Protocol, pharmacists must be registered by Wiley Systems™, Inc. in a licensing agreement.
Wiley testified in April before the Senate Sub-Committee on Aging and the United States Senate in Washington D.C., presenting her expertise in endocrinology and experience with bio-identical hormone replacement therapy. Her opinion was solicited by the Senate on the Safe Compounding Drug Act of 2007. She testified that it would severely restrict access to commonly compounded medications that many patients rely on, especially bio-identical hormones for women.
Registration for pharmacists means, in essence, a trade for the right to use the name Wiley Protocol for the product produced when a physician calls in a prescription for the Wiley Protocol, in exchange for a contract that specifies the methods, materials, packaging and recommended pricing of the Wiley Protocol at their individual pharmacies. These requirements of good compounding (manufacturing) practices apply only to the production and compounding of the Wiley Protocol.
"With more women and medical practitioners laware of the Wiley Protocol we need pharmacies to accommodate the prescriptions and it is our goal that any woman in any city or town can pick up her prescription for the Wiley Protocol and it will be exactly the same as every other woman's, everywhere else," said T.S. Wiley, founder of the Wiley Protocol and Wiley Systems, Inc.
In order for a pharmacist to become registered to compound and dispense the Wiley Protocol, Wiley Systems provides a training course taught by Dana Nelson, BS, MS, FASCP. Nelson is the pharmacist in charge of training the registered pharmacies for standardization and use of the Wiley Protocol methods and materials preparation. He and his training staff provide hands-on training either in San Luis Obispo, California or on-site at individual pharmacies nationwide. A training DVD and a Pharmacy Methods and Materials Preparation Manual of intellectual property is available only to registered pharmacies.
Wiley has created the registered pharmacy system to circumvent the current lack of legitimacy and availability of bio-identical hormones for testing and study. By standardizing the compounds in the Wiley Protocol and registering enough pharmacies, the Wiley Protocol can then be donated (a minuscule percent of total sales volume contractually per pharmacy) and studied by the IRB at University of Texas in a standard acceptable to the National Institute of Health (NIH), which dictates that a study substance must be donated.
Wiley concludes, "The government and Wyeth are counting on the fact that no single compounder can bear the economic burden of donation. Wiley's way means that no one pharmacist has to."
Upon registration, Wiley Systems will contact the pharmacist with training information and how to obtain the pharmacy version of the Clinical Practice Guidelines Manual shared by physicians everywhere. It is T.S Wiley's goal that pharmacists and physicians be "on the same page" when answering the questions and adjusting the dosages of customers on the Wiley Protocol.
In addition, the anecdotal clinical evidence of the effectiveness of certain maneuvers to individualize the rhythmic tempo to each woman's needs has been codified for easy access and practice in a leather bound, cardboard-covered, tabbed by symptom "Clinical Practice Guidelines." An invaluable reference guide, it contains knowledge learned from the group diagnostics with doctors and more than 1,000 women on the Protocol for three or more years.
Any pharmacist calling upon his peers to join the Wiley Protocol project will, when a friend or colleague registers, receive an incremental per recruit referral discount on the packaging, making the production of The Wiley Protocol even more profitable.
For more information about the schedule visit the Wiley Protocol Physicians Training and Certification. To inquire about availability and accommodations contact Caren Abdela at 805.565.7508.
About Wiley Systems™
Wiley Systems, Inc. was founded in 2005 in Santa Barbara, California. T.S. Wiley is the developer of The Wiley Protocol®, a trademarked patent pending delivery system consisting of bio-identical estradiol and progesterone in topical cream preparations dosed in a rhythmic natural cycle. The hormone levels in serum blood work mimic those produced by a twenty year-old woman. The Wiley Protocol is the only bio-identical hormone replacement therapy (BHRT) that has used bio-identical hormones in a bio-mimetic way or that has ever been developed under the scrutiny of a practicing oncologist.
The authentic Wiley Protocol is only available at compounding pharmacies that have agreed to the standardized methods, materials, packaging and recommended pricing. In exchange, Wiley Systems provides intellectual property and sells pre-stamped 28WP logo-bearing packaging consisting of bags, labels and syringes in the branded colors of purple and green. The Wiley Protocol name assures customers that they are receiving the authentic Wiley Protocol.
Kristin Gabriel, Director of Marketing Communications
O: 323.650.2838; C: 213.840.6978