Bioidentical Hormones - U.S. Senate Special Committee on Aging
Bioidentical Hormones - U.S. Senate Special Committee on Aging Bioidentical Hormones - U.S. Senate Special Committee on Aging
145 human-ho'rmones that occur naturally in the body or -to the natural source from which they are derived. Question. How safe is "bioidentical" hormone therapy from a pharmacist's viewpoint? . As a pharmacist, many things that occur naturally in the body are used therapeutically, including water, electrolytes (sodium, potassium, etc.), thyroid, pancreatic enzymes and insulin. We~.are simply replacing what the body has lost.
146 WHITE PAPER #1 DID YOU KNOW THAT WITHOUT PHARMACY COMPOUNDING: * children would not have available to them syrups, elixirs, suspensions and emulsions for most drugs that would make it easier to take medications a i * elders would not have access to new dosage forms to make it-easier to take their medications * patients, while hospitalized, would receive numerous different drugs individually - instead of combined in a single intravenous admixture * cancer drugs, if they could be given, would have to be given individually, rather than combined, which would result in longer administration times * physicians would not have most nuclear pharmaceuticals available to diagnose or treat illnesses * adults would be limited to very few strengths of drugs, unless they were willing to break the tablets apart to obtain the dose needed * therapy of many types would not be available to patients, to include bioidentical hormone replacement therapy (BHRT) * patients would need to take drugs orally or by injection instead of by the newer methods of delivery into the body, to include transdermal gels, etc. * drugs that are discontinued due to "economic reasons" by a pharmaceutical manufacturer would no longer be available to patients * drugs that are in short supply would not be available and this would interrupt a patient's therapy that took so long to stabilize * orphan drugs would be available to limited patients only * patients would not have the option of new therapeutic approaches that physicians would like to use * patients who are allergic to a preservative, dye, flavor, or other ingredient in a commercial product would have no options * individuals maintained on "intravenous feeding" would require several different individual components administered separately instead of a single, compounded mixture
- Page 97 and 98: 94 the only compelling reason to ta
- Page 99 and 100: 96 identical hormones synthesized f
- Page 101 and 102: 98 The world as we know it, from ba
- Page 103 and 104: 100 thereby experienced long period
- Page 105 and 106: 102 Bio-identical progesterone repl
- Page 107 and 108: 104 had reached optimum theoretical
- Page 109 and 110: 106 and the patient can be can reas
- Page 111 and 112: 108 Estradiol and Analytical Resear
- Page 113 and 114: 110 A controlled systematic pilot c
- Page 115 and 116: 112 of set doses. The Wiley Protoco
- Page 117 and 118: 114 I'd advocate for either Accredi
- Page 119 and 120: 116 D.C., and established a goal to
- Page 121 and 122: 118 If this legislation passes, fed
- Page 123 and 124: first and second finger on the barr
- Page 125 and 126: 122 These products that have been s
- Page 127 and 128: 124 Bcl-2, survivin and variant CD4
- Page 129 and 130: 126 These are experiments by other
- Page 131 and 132: 128 cerebro-cellular inflammation c
- Page 133 and 134: 130 Years # women *1>0.5 8 *1+ 9 *2
- Page 135 and 136: *Breast cancer 132 -57 y.o. recurre
- Page 137 and 138: 134 *Labor intense for patient and
- Page 139 and 140: 136 Senator SMITH. Thank you very m
- Page 141 and 142: 138 makes these hormones uniquely s
- Page 143 and 144: 140 tomize the Wiley Protocol by ra
- Page 145 and 146: 142 "natural," because all lead to
- Page 147: 144 maceutical commerce, often with
- Page 151 and 152: 148 WHITE PAPER #2 Pharmacy Compoun
- Page 153 and 154: 150 bleeding of the bowel, locate t
- Page 155 and 156: 152 compounding standards can be en
- Page 157 and 158: 154 I. The FDA's definition of a "N
- Page 159 and 160: 156 ORIIGINAL CONTrMIBTION JANMA-EX
- Page 161 and 162: Initially, the design allowed women
- Page 163 and 164: ards analyses," stratified by clini
- Page 165 and 166: year). These 'drop-in" rates were a
- Page 167 and 168: years of prior use, 11 vs 2; HR, 4.
- Page 169 and 170: trogen plus progestin exposure. Clo
- Page 171 and 172: 168 RISKS AND BENEFITS OF ESTROGEN
- Page 173 and 174: EFFECTS OF POSTMENOPAUSAL ESTIROGEN
- Page 175 and 176: EFFECTS OF POSTMENOPAUSAL ESTROGEN
- Page 177 and 178: EFFECTS OF POSTMENOPAUSAL ESTROGEN
- Page 179 and 180: pEyECTS OF POSTMENOPAUSAL ESTROGEN
- Page 181 and 182: EFFECTS OF POSTMENOPAUSAL ESTROGEN
- Page 183 and 184: EFFECTS OF POSTMENOPAUSAL ESTROGEN
- Page 185 and 186: 10000 isoor i I ea '° a wan 20-24
- Page 187 and 188: ~SDt~rpa g~2~Q ~ !~fm~. b~e ~ ng jh
- Page 189 and 190: Is associated with an Increased ris
- Page 191 and 192: 188 Postmenopausal hormone therapy
- Page 193 and 194: group (P= 04001), and In this subgr
- Page 195 and 196: Treatmnent recommendations Based on
- Page 197 and 198: 21.Grodsteln F. Manson JE, Colditz
145<br />
human-ho'rm<strong>on</strong>es that occur naturally in the body or -to the natural source from<br />
which they are derived.<br />
Questi<strong>on</strong>. How safe is "bioidentical" horm<strong>on</strong>e therapy from a pharmacist's viewpoint?<br />
.<br />
As a pharmacist, many things that occur naturally in the body are used therapeutically,<br />
including water, electrolytes (sodium, potassium, etc.), thyroid, pancreatic<br />
enzymes and insulin. We~.are simply replacing what the body has lost.<br />
<str<strong>on</strong>g>Bioidentical</str<strong>on</strong>g> horm<strong>on</strong>es ] are: available in commercially manufactured '(e.g.,<br />
Prometriuim, Estragel, Androgel) and compounded forms. These have been* recognized<br />
as safe and 'effective by the Food and Drug Administrati<strong>on</strong>. Since these horm<strong>on</strong>es<br />
are the same as what the body has been producing for years, they should<br />
be safe, effective and without adverse problems provided the dosing is d<strong>on</strong>e properly,<br />
which is worked out between the physician, patient and the pharmacist. So<br />
yes, in my opini<strong>on</strong> they are safe and effective when properly used.<br />
Questi<strong>on</strong>. We have discussed how you believe that the states are in the best positi<strong>on</strong><br />
to regulate the practice of pharmacy compounding. I am told <strong>on</strong>e of the challenges<br />
facing state boards of pharmacy is the lack of sufficient staffing (and funding)<br />
to do the type of inspecti<strong>on</strong>s and investigati<strong>on</strong>s that could provide a higher level of<br />
oversight.How many additi<strong>on</strong>al staff members would each state need to start making<br />
a greater enforcement impact, and how much would it potentially cost to provide<br />
the pers<strong>on</strong>nel and training that they need?<br />
. Answer. The practice of pharmacy should be regulated by the state boards of<br />
pharmacy. As pharmacy practice changes, the state boards adapt to these changes.<br />
The standards of the USP related to pharmacy compounding are being implemented<br />
by the states, either directly or by rewriting them <strong>on</strong> a state-by-state basis. Enclosed<br />
please find a document prepared about three years ago, entitled "Reas<strong>on</strong>s the FDA<br />
Should Not Be Involved In Pharmacy Compounding."<br />
The individual state boards of pharmacy may need some supplemental funding for<br />
additi<strong>on</strong>al inspectors, depending up<strong>on</strong> the needs of the individual states. This may<br />
range from 1 to 5 additi<strong>on</strong>al inspectors per state with an overall average estimate<br />
of 2 per state, or 100 new inspectors. At salary plus benefits of about $100,000 per<br />
year per positi<strong>on</strong> this amounts to $10 milli<strong>on</strong> dollars. This could be provided initially<br />
ini the form of grants for the first few years; si iiar to other programs provided.by<br />
the Federal Government, as the states eventually assume funding for these<br />
and the fede'ral funds are decreased and eventually eliminated as the program becomes<br />
totally supported at the state level.