2.1. Pharmaceutical in the Environment: An Evidence-based Review: Introduction (Ruhoy)

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By Ilene Ruhoy.

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2.1. Pharmaceutical in the Environment: An Evidence-based Review: Introduction (Ruhoy)

  1. 1. Pharmaceutical In the Environment: <br />An Evidence-based Review <br />Ilene S. Ruhoy, M.D., PhD<br />Director, Institute for Environmental Medicine<br />Touro University Nevada<br />Henderson, Nevada 89014<br />Ilene.ruhoy@tun.touro.edu<br />Source: US Environmental Protection Agency. Paul Horn, Union Tribute. Retrieved from: http://www.flickr.com/photos/cooljerk/219637528/#/<br />
  2. 2. Course Objectives<br />1<br />Review current research <br />on pharmaceutical residues found in water sampling studies.<br />2<br />Understand the various sources <br />of pharmaceuticals in the environment.<br />3<br />4 <br />Discuss the ecological impact <br />of pharmaceuticals in the environment.<br />Examine the potential <br />for human health impact from exposure to pharmaceutical residues.<br />
  3. 3. Sections <br />Pharmaceuticals as Chemicals<br />Significance of long-term exposure to multiple APIs <br />Evidence for ecotoxity<br />Environmental Impact of Disposal<br />PharmEcovigilance<br />Reducing Unused Pharmaceuticals<br />Conclusion<br />
  4. 4. Pharmaceuticals as Chemicals<br />
  5. 5. Stockpiling & <br />improper storage<br />Leftover Drugs<br />Imprudent prescribing & patient use<br />Imprudent disposal<br />Residues recycled from environment<br />Wasted healthcare resources<br />Poisonings<br />
  6. 6. The Chemical Universe<br />We live in a chemical sea of continually changing composition <br />– comprising both anthropogenic and naturally occurring chemical stressors.<br />Unlike biota, chemical pollutants have no boundaries in their global distribution – “everything is everywhere,” only the concentrations vary.<br />
  7. 7. The Chemical Universe<br />The KNOWNUniverse<br />As of Sept. 2009, over 50 million organic and inorganic substances had been assigned CAS RNs.*<br /><ul><li>35 million commercially available
  8. 8. ¼ million inventoried or regulated by numerous government bodies worldwide
  9. 9. Representing:0.7% of commercially available0.5% of the known chemicals.
  10. 10. 12,000new substances are added each day.</li></ul>* Indexed by the American Chemical Society's Chemical Abstracts Service in their CAS Registry; excluding bio-sequences such as <br />proteins and nucleotides: http://www.cas.org/expertise/cascontent/registry/regsys.html<br />
  11. 11. The Chemical Universe<br />The largest virtual chemical database yet reported comprises small drug-like molecules – a total of over 977,000,000 structures (Blum and Reymond, 2009).<br />Restricted to organic molecules containing fewer than 14 atoms of C, N, O, and S (and limited types of Cl-substituted molecules). Excluded likely substituents such as F, Br, I, P, Si, metals, and most Cl.<br />Database represents the enormously large numbers of chemicals that could possibly be synthesized just from a very limited spectrum of types of elements and numbers of atoms. <br />Source: Blum, L. C., and J.-L. Reymond. 2009. 970 Million Druglike Small Molecules for Virtual Screening in the Chemical Universe Database GDB-13. J. Am. Chem. Soc. 131 (25):8732-8733.<br />
  12. 12. The Universe of Commercial APIs<br /><ul><li>Over 21,000 formulated drug products (ingredients, strengths, and forms)
  13. 13. Over 1,460 FDA-approved small-molecule APIs(oral >80, parenteral >420, topical >270)
  14. 14. Over 3,200 experimental drugs</li></ul>Sources:<br /><ul><li>WishartDS, Knox C, Guo AC, Cheng D, Shrivastava S, Tzur D, et al. "DrugBank: a knowledgebase for drugs, drug actions and drug targets." Nucl Acids Res 2008, 36(suppl_1):D901-906; doi:10.1093/nar/gkm958.
  15. 15. DrugBankPharmaBroswe web page: http://www.drugbank.ca/pharmabrowse#mainB. </li></li></ul><li>Emerging Contaminants (EC):Humanity’s Chemical Footprints and Fingerprints<br />They enter the environment by way of diffuse, complex, and interconnected networks fed by myriad numbers of people.<br />ECs reflect:<br /><ul><li>The intimate, inseparable, and immediate connections of humans and the environment.
  16. 16. The combinedactions, behaviors, and activities of individuals.
  17. 17. The extensive interconnections and feedback loops between humans and the environment.
  18. 18. ECs serve as direct measures of the types, extent, and magnitude of these connections.</li></li></ul><li>PPCPs as Environmental Pollutants?<br />PPCPsare a diverse group of chemicals comprising<br /><ul><li>All human and veterinary drugs (available by prescription or over-the-counter, including the new genre of “biologics”)
  19. 19. Diagnostic agents(e.g., X-ray contrast media)
  20. 20. “Nutraceuticals” (bioactive food supplements such as huperzine A)
  21. 21. And other consumer chemicals, such as fragrances (e.g., musks) and sun-screen agents (e.g., 4-methylbenzylidene camphor; octocrylene)
  22. 22. Also included are “excipients” (so-called “inert” ingredients used in PPCP manufacturing and formulation; e.g., parabens)</li></li></ul><li>Beneficiaries & Stakeholders<br />The topic of drug disposal is a deceivingly complex and exasperating topic. <br />While it is but one of the many aspects of the larger issue of pharmaceuticals in the environment (PiE), drug disposal has proved to be the most visible and frustrating one to address. Recognized as a problem by the healthcare community in the 1960’s, only since roughly 2005 had any dialog and debate begun among an extraordinarily broad spectrum of communities: <br />► environmental science► healthcare (physicians, nurses, hospitals, long-term care facilities)► pharmaceutical industry (primarily via PhRMA)► pharmacy industry► insurance industry► local, state, & federal regulators and legislators(resulting in myriad proposed, rejected, and passed bills)► operators of water and wastewater treatment facilities► news media► the public► countless other stakeholders (especially numerous professional societies and trade associations).<br />The primary federal involvement has been among: the Executive Office of the President (ONDCP), Department of Justice (DEA), FDA, and EPA.<br />
  23. 23. Available: http://www.epa.gov/nerlesd1/chemistry/pharma/image/drawing.pdf<br />

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