Bioidentical Hormones - U.S. Senate Special Committee on Aging

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237 APhA Statement to tie <strong>Senate</strong> <strong>Special</strong> <strong>Committee</strong> on Aging April 19, 2007 These groups saw the value of voluntary programs to improve compounding activity. The initial work of PCAB included the development of compounding principles that must be followed by pharmacies that choose to be PCAB accredited. The PCAB principles are as follows: * Compounding is the preparation of components into a drug product either as the result of a practitioner's prescription drug order based on a valid practitioner/patient/pharmacist relationship in the course of professional practice, or for the purpose of, or as an incident to, research, teaching, or chemical analysis that are not for sale or dispensing. Compounding is a part of the practice of pharmacy subject to regulation and oversight from the state boards of pharmacy. Compounded medication may be dispensed to prescribers for office use, where applicable state law permits. Office use does not include prescribers reselling compounded medications. * Compounding may be conducted in anticipation of receiving prescription orders when based on routine, regularly observed prescribing patterns. Anticipatory compounding is limited to reasonable quantities, based on such patterns. * Compounding does not include the preparation of copies of commercially available drug products. Compounded preparations that produce, for the patient, a significant difference between the compounded drug and the comparable commercially available drug product or are determined, by the prescriber, as necessary for the medical best interest of the patient are not copies of commercially available products. "Significant" differences may include, for example, the removal of a dye for a medical reason (such as an allergic reaction), changes in strength, and changes in dosage form or delivery mechanism. Price differences are not a "significant" difference to justify compounding. * Both the prescriber (via the prescription) and the patient (via the label) should be aware that a compounded preparation is dispensed. * The pharmacy may advertise or otherwise promote that it provides prescription drug compounding services. Such advertising should include only those claims, assertions, or inference of professional superiority in the compounding of drug products that can be independently and scientifically substantiated. United States Pharmacopeia In addition to the collective effort represented by PCAB, individual organizations have pursued improvements in pharmacy compounding practice. The United States Pharmaceopeia (USP), the official drug standard setting body for our country, has a long history of addressing pharmacy compounding. The USP establishes standards for compounding medications. Recently, the USP has strengthened its USP Chapter Nonsterile Compounding and USP Chapter Sterile Compounding standards. Conclusion Through compounding, pharmacists fulfill a legitimate and essential need -providing patients with medications tailored to their needs. The professional education and training of pharmacists provides the unique knowledge and skills necessary to fulfill this health care need. By working together, prescribers and pharmacists help patients access otherwise unavailable therapies such as cream for breast cancer patients' radiation bums, or anticonvulsants in a suppository form when patients' veins are not accessible for injection. Without compounding, many physicians, pharmacists and patients would lose access to valuable treatments.
238 APhA Statement to the <strong>Senate</strong> <strong>Special</strong> <strong>Committee</strong> on Aging April 19, 2007 APhA supports the <strong>Committee</strong>'s efforts to discuss this important issue and appreciates the opportunity to share the perspective of pharmacists on this issue. While pharmacist compounding improves patients' lives every day, we must continually improve our practices to provide the best patient care. Improving our efforts to provide quality compounded products will reqiire collaborative efforts of consumers, the profession, State Boards of Pharmacy, and the FDA. Each stakeholder has an expertise that is essential in assuring the continued availability of this practice with the quality patients deserve. Consumers must play a role in all of these efforts, as we are pursuing this work for them. The profession must take the lead in guiding the regulatory agencies in how to draw the line between compounding and manufacturing, and in developing guidelines and voluntary accreditation or certification processes to demonstrate compliance with those guidelines. The State Boards of Pharmacy, responsible for regulating the profession, should maintain their primary regulatory role of pharmacy practice, including compounding. The FDA has a role in regulating manufacturers, as well as defining some broad guidance, such as the identification of substances that should not be used in manufacturing or compounding because the substances have been withdrawn from the market for safety and efficacy concerns. All of these efforts require collaboration, coordination, and ongoing communication. To that end, pharmacists are ready to partner with stakeholders to develop effective strategies to improving the quality of compounding practices. Thank you for the opportunity to present the views of the nation's pharmacists. APhA looks forward to working with the <strong>Committee</strong> to ensure that patients are receiving quality compounded products.
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S. HRG. 110-129 Bioidentica
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CONTENTS Page Opening Statement of
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2 The sale of bioidentical hormone
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4 ever, as Dr. Wartofsky points out
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6 with every stage of the disease:
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8 I am pleased to appear before thi
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10 When the trials began, many rese
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Women who began treatment more than
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14 One small trial using oral estra
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16 FDA is aware that a growing numb
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18 DEPARTMENT OF HEALTH & HUMAN SER
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20 safety and efficacy. However, as
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22 adulteration and misbranding pro
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24 The 2002 CPG reflects FDA's curr
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26 Equally concerning are claims by
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28 concerned about the use and mark
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30 Part I: Materials and Partnershi
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32 drugs, when the compounding of t
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34 Our staff identified 34 Web site
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1. Introduction 36 Chairman Kohl, R
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diet and fitness products. 5 For ex
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include "natural" progesterone crea
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42 unique to the computer age, such
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computer users to spam(ftuce.0ov -
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46 accuracy of advertising for heal
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48 Now, you have identified in your
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50 claim." Therefore, since the ter
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52 Such quality control problems ha
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54 Statement Before the U.S. <stron
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in the U.S., whereas WHI participan
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58 between science and hearsay and
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60 How can we determine whether bio
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62 doctors-are not getting the obje
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64 27. Writing Group for the PEPI T
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66 Dr. MANSON. Well, I think that m
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68 Statement of Leonard Wartofsky,
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70 in the WHI. In fact, no study as
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In summary, the Endocrine Society i
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74 The FDA also regulates aspects o
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Statement of Loyd V. Allen, Jr., Ph
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82 Senator SMITH. Dr. Allen, as I h
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84 Now, when you are talking about
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86 The only thing the WHI proved wa
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88 Testimony Of T.S. Wiley before t
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Confusion and Media Hype 90 Instead
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92 see a doctor tell a diabetic nea
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94 the only compelling reason to ta
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96 identical hormones synthesized f
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98 The world as we know it, from ba
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100 thereby experienced long period
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102 Bio-identical progesterone repl
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104 had reached optimum theoretical
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106 and the patient can be can reas
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108 Estradiol and Analytical Resear
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110 A controlled systematic pilot c
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112 of set doses. The Wiley Protoco
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114 I'd advocate for either Accredi
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116 D.C., and established a goal to
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118 If this legislation passes, fed
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first and second finger on the barr
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122 These products that have been s
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124 Bcl-2, survivin and variant CD4
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126 These are experiments by other
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128 cerebro-cellular inflammation c
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130 Years # women *1>0.5 8 *1+ 9 *2
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*Breast cancer 132 -57 y.o. recurre
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134 *Labor intense for patient and
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136 Senator SMITH. Thank you very m
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138 makes these hormones uniquely s
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140 tomize the Wiley Protocol by ra
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142 "natural," because all lead to
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144 maceutical commerce, often with
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146 WHITE PAPER #1 DID YOU KNOW THA
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148 WHITE PAPER #2 Pharmacy Compoun
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150 bleeding of the bowel, locate t
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152 compounding standards can be en
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154 I. The FDA's definition of a "N
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156 ORIIGINAL CONTrMIBTION JANMA-EX
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Initially, the design allowed women
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ards analyses," stratified by clini
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year). These 'drop-in" rates were a
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years of prior use, 11 vs 2; HR, 4.
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trogen plus progestin exposure. Clo
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168 RISKS AND BENEFITS OF ESTROGEN
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EFFECTS OF POSTMENOPAUSAL ESTIROGEN
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EFFECTS OF POSTMENOPAUSAL ESTROGEN
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pEyECTS OF POSTMENOPAUSAL ESTROGEN
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10000 isoor i I ea '° a wan 20-24
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~SDt~rpa g~2~Q ~ !~fm~. b~e ~ ng jh
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Page 199 and 200: _ ORWIGNAL CONTIuBUTION 196 Postmen
Page 201 and 202: showed no striking differences in H
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Page 205 and 206: 202 HORMONE THERAPY USE AND RISK OF
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Page 213 and 214: 210 ,lmcCII na: CLI I tr: tarty ver
Page 215 and 216: 212 ,mucmai rimi &ronos farty bstro
Page 217 and 218: 214 LntIucwu miau: rronos nary estr
Page 219 and 220: XVI. PNharmacy Licensure Requiremen
Page 221 and 222: XVI. Pharmacy Licensure Requirement
Page 223 and 224: 220 Roster of Board of Pharmacy Ece
Page 225 and 226: 050. 0l7404405400 Al-h. PeVbU 03283
Page 227 and 228: Conclusions * Age is a powerful ris
Page 229 and 230: Women's Health Initiative Trials of
Page 231 and 232: Hormone Therapy after WHI * Change
Page 233 and 234: Statement of the American Pharmacis
Page 235 and 236: 232 APhA Statement to the S
Page 237 and 238: 234 APhA Statement to the S
Page 239: 236 APhA Statement to the S
Page 243 and 244: 240 Written Testimony of Steven F.
Page 245 and 246: 242 STATEMENT OF DAVID G. ADAMS On
Page 247 and 248: 244 Report on State Laws and Regula
Page 249 and 250: 246 Only one state, Utah, requires
Page 251: 248 5. Compounding Copies of FDA-Ap
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Bioidentical Hormones - U.S. Senate Special Committee on Aging

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