Hostname: page-component-78c5997874-xbtfd Total loading time: 0 Render date: 2024-11-18T18:55:20.017Z Has data issue: false hasContentIssue false

Handling Worker and Third-Party Exposures to Nanotherapeutics During Clinical Trials

Published online by Cambridge University Press:  01 January 2021

Extract

Nanomedicine is a rapidly growing field in the academic as well as commercial arena. While some had predicted nanomedicine sales to reach $20.1 billion in 2011, the actual growth was much more rapid, with the global nanomedicine market being valued at $53 billion in 2009, and forecast to increase at an annual growth rate of 13.5% to reach more than $100 billion in 2014. In 2006, more than 130 nanotechnology-based drugs and delivery systems had entered preclinical, clinical, or commercial development. The European Medicines Agency (EMA) reviewed 18 marketing authorization applications for nanomedicines in 2010. In 2011, 22 drugs that had been approved by the FDA, and 87 Phase I and Phase II clinical trials were listed in the U.S. National Institutes of Health (NIH) data base, www.clinicaltrials.gov. Although the fastest growing areas of nanomedicine are applications in medical imaging and diagnosis using contrast-enhancing agents, most nanomedicine research and commercialization is in the area of cancer drug therapy, including nano gold shells.

Type
Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Thassu, D. Deleers, M., and Pathak, Y., Nanoparticulate Drug Delivery Systems (Informa Healthcare: New York, London, 2007).CrossRefGoogle Scholar
Boisseau, P. and Loubaton, B. “Nanomedicine, Nanotechnology in Medicine,” Comptes Rendus Physique 12, no. 7, (2011): 620636.CrossRefGoogle Scholar
Moran, A. N., “Nanomedicine Lacks Recognition In Europe,” Nature Biotechnology 24, no. 2 (2006): 121.CrossRefGoogle Scholar
See Boisseau, and Loubaton, , supra note 2.Google Scholar
See Thassu, et al., supra note 1; Boisseau, and Loubaton, , supra note 2; Murashov, V., “Occupational Exposure to Nanomedical Applications,” Nanomedicine and Nanobiotechnology 1, no. 2 (2009): 203213.Google Scholar
Singh, R. Pantarotto, D. Lacerda, L. Pastorin, G. Klumpp, C. Prato, M. Bianco, A., and Kostarelos, K., “Tissue Biodistribution and Blood Clearance Rates of Intravenously Administered Carbon Nanotube Radiotracers,” Proceedings of the National Academy of Sciences 103, no. 9 (2006): 33573362.CrossRefGoogle Scholar
National Science and Technology Council Committee on Technology Subcommittee on Nanoscale Science, and Technology (NSET), National Nanotechnology Initiative: Strategic Plan, Washington, D.C., 2011, available at <http://www.nano.gov/node/581> (last visited November 28, 2012).+(last+visited+November+28,+2012).>Google Scholar
Roco, M. Renn, O., and Jäger, A., “Nanotechnology Risk Governance,” in Roco, M. Renn, O. Jäger, A., eds., Global Risk Governance (The Netherlands: Springer, 2008): 301–27, available at <http://www.springerlink.com/content/j102352637435844/> (last visited November 28, 2012).CrossRefGoogle Scholar
Auffan, M. Rose, J. Bottero, J.Y. Lowry, G. V. Jolivet, J. P., and Wiesner, M. R., “Towards a Definition of Inorganic Nanoparticles from an Environmental, Health and Safety Perspective,” Nature Nanotechnology 4, no. 10 (2009): 634641.CrossRefGoogle Scholar
Ferrari, M., “Cancer Nanotechnology: Opportunities and Challenges,” Nature Reviews Cancer 5, no. 3 (2005): 161171, abstract available at <http://www.ncbi.nlm.nih.gov/pubmed/15738981> (last visited November 28, 2012).CrossRefGoogle Scholar
Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Science, Reporting Format for Nanotechnology-Related Information in CMC Review, June 2010, available at <www.fda.gov/downloads/AboutFDA/CentersOffices/…/UCM214304.pdf> (last visited November 28, 2012).+(last+visited+November+28,+2012).>Google Scholar
Occupational Safety and Health Administration (OSHA), “Safety and Health Tips: Nanotechnology,” available at <http://www.osha.gov/dsg/nanotechnology/nanotechnology.html> (last visited November 28, 2012).+(last+visited+November+28,+2012).>Google Scholar
National Institute for Occupational Safety and Health (NIOSH), Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials (2009), available at <www.cdc.gov/niosh/docs/2009-125/pdfs/2009-125.pdf> (last visited November 28, 2012).+(last+visited+November+28,+2012).>Google Scholar
Maynard, A. D., “Don't Define Nanomaterials,” Nature 475, no. 7354 (2011): 31, available at <http://www.nature.com/nature/journal/v475/n7354/full/475031a.html> (last visited November 28, 2012).CrossRefGoogle Scholar
Maynard, A. D. and Kuempel, E. D., “Airborne Nanostructured Particles and Occupational Health,” Journal of Nanoparticle Research 7, no. 6 (2005): 587614.CrossRefGoogle Scholar
See NIOSH, supra note 16; ISO, ISO TR 27628 Workplace Atmospheres—Ultrafine, Nanoparticles and Nanostructured Aerosols—Inhalation Exposure Characterization and Assessment, 2006; Johnson, D. R. Methner, M. M. Kennedy, A. J., and Steevens, J. A., “Potential for Occupational Exposure to Engineered Carbon-Based Nanomaterials in Environmental Laboratory Studies,” Environmental Health Perspectives 118, no. 1 (2010): 4954; Ramachandran, G. Ostraat, M. Evans, D. E. Methner, M. M. O'shaughnessy, P. D'Arcy, J. Geraci, C. L. Stevenson, E. Maynard, A. D., and Rickabaugh, K., “A Strategy for Assessing Workplace Exposures to Nanomaterials,” Journal of Occupational and Environmental Hygiene 8, no. 11 (2011): 673–685.CrossRefGoogle Scholar
Food and Drug Administration (FDA), “Investigational New Drug Application Process,” 2011, available at <http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm> (last visited November 28, 2012).+(last+visited+November+28,+2012).>Google Scholar
National Institutes of Health (NIH), “Understanding Clinical Trials,” 2007 <http://clinicaltrials.gov/ct2/info/understand#Q19> (last visited November 28, 2012); see FDA, supra note 23.+(last+visited+November+28,+2012);+see+FDA,+supra+note+23.>Google Scholar
Kandlikar, M. Ramachandran, G. Maynard, A. Murdock, B., and Toscano, W., “Health Risk Assessment for Nanoparticles: A Case for Using Expert Judgment,” Journal of Nanoparticle Research 9, no. 1 (2007): 137156.CrossRefGoogle Scholar
de Jong, W. H. and Borm, P. J. A., “Drug Delivery and Nanoparticles: Applications and Hazards,” International Journal of Nanomedicine 3, no. 2 (2008): 133149.CrossRefGoogle Scholar
Hoet, P. H. M. Brüske-Hohlfeld, I., and Salata, O. V., “Nanoparticles – Known and Unknown Health Risks,” Journal of Nanobiotechnology 2, no. 12 (2004): 15 pages, available at <http://www.jnanobiotechnology.com/content/pdf/1477-3155-2-12.pdf> (last visited November 28, 2012); Geiser, M. Rothen-Rutishauser, B. Kapp, N. Schürch, S. Kreyling, W., and Schulz, H., “Ultrafine Particles Cross Cellular Membranes by Nonphagocytic Mechanisms in Lungs and in Cultured Cells,” Environmental Health Perspectives 113 (2005): 1555–1560, available at <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1310918/> (last visited November 28, 2012); Oberdorster, G. Oberdorster, E., and Oberdorster, J., “Nanotoxicology: An Emerging Discipline Evolving for Studies of Ultrafine Particles,” Environmental Health Perspectives 113, no. 7 (2005): 823–839; Dobrovolskaia, M. A. and McNeil, S. E., “Immunological Properties of Engineered Nanomaterials,” Nature Nanotechnology 2, no. 8 (2007): 469–478, available at <http://dx.doi.org/10.1038/nnano.2007.223> (last visited November 28, 2012); Resnik, D. B. and Tinkle, S. S., “Ethical Issues in Clinical Trials Involving Nanomedicine,” Contemporary Clinical Trials 28, no. 4 (2007): 433–441; Oberdürster, G. Elder, A., and Rinderknecht, A., “Nanoparticles and the Brain: Cause for Concern?” Journal of Nanoscience and Nanotechnology 9, no. 8 (2009): 4996–5007.CrossRefGoogle Scholar
Sayes, C. M. Marchione, A. A. Reed, K. L., and Warheit, B.D., “Comparative Pulmonary Toxicity Assessments of C60 Water Suspensions in Rats: Few Differences in Fullerene Toxicity in vivo in Contrast to in vitro Profiles,” Nano Letters 7 (2007): 23992406; Donaldson, K. Borm, P. J. Oberdorster, G. Pinkerton, K. E. Stone, V., and Tran, C. L., “Concordance Between in vitro and in vivo Dosimetry in the Proinflammatory Effects of Low Toxicity, Low Solubility Particles: The Key Role of the Proximal Alveolar Region,” Inhalation Toxicology 20 (2008): 53–62.CrossRefGoogle Scholar
Kroll, A. Pillukat, M. H. Hahn, D. Schnekenburger, J., “Current in vitro Methods in Nanoparticle Risk Assessment: Limitations and Challenges,” European Journal of Pharmaceutics and Biopharmaceutics 72 (2009): 370377.CrossRefGoogle Scholar
Kuempel, E. Geraci, C., and Schulte, P., “Risk Assessment Approaches and Research Needs for Nanomaterials: An Examination of Data and Information from Current Studies,” Nanotechnology: Toxicological Issues and Environmental Safety and Environmental Safety (2007): 119145.CrossRefGoogle Scholar
Fischer, H. C. and Chan, W. C. W., “Nanotoxicity: The Growing Need For in vivo Study,” Current Opinions in Biotechnology 18 (2007): 565571; McAuliffe, M. E. and Perry, M. J., “Are Nanoparticles Potential Male Reproductive Toxicants? A Literature Review,” Nanotoxicology 1, no. 3 (2007): 204–210; Wiwanitkit, V. Sereemaspun, A., and Rojanathanes, R., “Effect of Gold Nanoparticles on Spermatozoa: The First World Report,” Fertility and Sterility 91, no. 1 (2009): E7-e8, available at <http://www.sciencedirect.com/science/article/B6T6K-4RB5BNR-2/2/33a12feb54d3316276cbabaa2d9492b0> (last visited November 28, 2012); Shvedova, A. A. and Kagan, V. E., “The Role of Nanotoxicology in Realizing the ‘Helping without Harm’ Paradigm of Nanomedicine: Lessons from Studies of Pulmonary Effects of Single-Walled Carbon Nanotubes,” Journal of Internal Medicine 267, no. 1 (2010): 106–18, available at <http://dx.doi.org/10.1111/j.1365-2796.2009.02188.x> (last visited November 28, 2012).CrossRefGoogle Scholar
See Resnik, and Tinkle, , supra note 32.Google Scholar
Kocher, R. and Sahni, N. R., “Rethinking Health Care Labor,” New England Journal of Medicine 365 (2012): 13701372.CrossRefGoogle Scholar
U.S. Dept. of Labor (US DOL), Career Guide to Industries, “Health Care,” Bureau of Labor Statistics, 2006–2007 edition), at pp 231, <http://www.bls.gov/oco/cg/cgs035.htm> (last visited November 28, 2012)+(last+visited+November+28,+2012)>Google Scholar
Lipscomb, J. and Borwegen, B., “Health Care Workers,” in Levy, B. S. and Wegman, D. H., eds., Occupational Health: Recognizing and Preventing Work-Related Disease and Injury, 4th ed. (Philadelphia: Lipppincott Williams & Wilkins, 2000): At 767–778; Centers for Disease Control (CDC), “Overview: Risks and Prevention of Sharps Injuries in Healthcare Personnel,” in Workbook for Designing, Implementing, and Evaluating a Sharps Injury Prevention Program,” available at <http://www.cdc.gov/sharpssafety/> (last visited November 28, 2012).Google Scholar
Centers for Disease Control and Prevention & National Institutes of Health (CDC/NIH), Biosafety in Microbiological and Biomedical Laboratories: Centers for Disease Control and Prevention, 5th ed., 2009, National Institutes of Health, available at <www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf> (last visited November 28, 2012).+(last+visited+November+28,+2012).>Google Scholar
See NIOSH, supra note 16.Google Scholar
National Institute for Occupational Safety and Health (NIOSH), Preventing Occupational Exposure to Antineoplastic and other Hazardous Drugs in Health Care Settings, 2004, available at <http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165sum.pdf> (last visited November 28, 2012).+(last+visited+November+28,+2012).>Google Scholar
See NIOSH, supra note 16; National Institute for Occupational Safety and Health (NIOSH), Workplace Solutions: Medical Surveillance for Health Care Workers Exposed to Hazardous Drugs, DHHS (NIOSH) Publication Number 2007–117 (2007); National Institute for Occupational Safety and Health (NIOSH), Workplace Solutions: Personal Protective Equipment for Health Care Workers Who Work with Hazardous Drugs, DHHS (NIOSH) Publication No. 2009-106 (2009); National Institute for Occupational Safety and Health (NIOSH), NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, DHHS (NIOSH) Publication Number 2010–167 (2010).Google Scholar
See Murashov, , supra note 8.Google Scholar
Naumann, B. D. Sargent, E. V. Starkman, B. S. Fraser, W. J. Becker, G. T., and Kirk, G. D., “Performance-Based Exposure Control Limits for Pharmaceutically Active Ingredients,” American Industrial Hygiene Association Journal 57 (1996): 3342; World Health Organization (WHO), Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials, vol. 2 (including updates), Good Manufacturing Practices and Inspection, updated ed., Geneva, WHO, 2004, available at <http://whqlibdoc.who.int/publications/2004/9241546190.pdf> (last visited November 28, 2012).CrossRefGoogle Scholar
See NIOSH, supra note 50.Google Scholar
See Murashov, , supra note 8.Google Scholar
Amass, L. Ling, W. Freese, T. E. Reiber, C. Annon, J. J. Cohen, A. J. McCarty, D. Reid, M. S. Brown, L. S. Clark, C. Ziedonis, D. M. Krejci, J. Stine, S. Winhusen, T. Brigham, G. Babcock, D. Muir, J. A. Buchan, B. J., and Horton, T., “Bringing Buprenorphine-Naloxone Detoxification to Community Treatment Providers: The NIDA Clinical Trials Network Field Experience,” American Journal on Addictions 13 (2004): S42S66; Wood, F. Prout, H. Acharjya, A. Nuttall, J. Hood, K., and Butler, C., “Exploring the Ethical and Practical Challenges of Conducting Clinical Trials in Care Home Settings,” Trials 12, Supp. 1 (2011): A38; Abernethy, P. Schwartzberg, L. S. Li, D. Scott, D., and Hensley, M., “Feasibility of Conducting Home-based Clinical Trials in Patients with Advanced Pancreatic Cancer,” Journal of Clinical Oncology 28, no. 15 (2010): May 20 Supplement, Abstract e14647; Sackley, C. M. Atkinson, C. J., and Walker, M. F., “Occupational Therapy in Nursing and Residential Care Settings: A Description of a Randomised Controlled Trial Intervention,” British Journal of Occupational Therapy 67, no. 3 (2004): 104–110; Lucas, G. M. Flexner, C. W., and Moore, R. D., “Directly Administered Antiretroviral Therapy in the Treatment of HIV Infection: Benefit or Burden?” AIDS Patient Care and STDs 16, no. 11 (2002): 527–535; Eisch, J. S. Colling, J. Ouslander, J. Hadley, B. J., and Campbell, E., “Issues in Implementing Clinical Research in Nursing Home Settings,” Journal of the New York State Nurses Association 22, no. 3 (1991): 18–22.CrossRefGoogle Scholar
See US DOL, supra note 45.Google Scholar
Henriksen, K. Joseph, A. Zayas-Cabán, T., “The Human Factors of Home Health Care: A Conceptual Model for Examining Safety and Quality Concerns,” Journal of Patient Safety 5, no.4 (2009): 229236.CrossRefGoogle Scholar
Myers, A. Jensen, R. C. Nestor, D., and Rattiner, J., “Low Back Injuries among Home Health Aides Compared with Hospital Nursing Aides,” Home Health Care Service Quarterly 14 (1993): 149155.CrossRefGoogle Scholar
Gershon, R. Pogorzelska, M. Qureshi, K., and Sherman, M., “Home Health Care Registered Nurses and the Risk of Percutaneous Injuries: A Pilot Study,” American Journal of Infection Control 36 (2008): 165172; Danzig, L. E. Short, L. J. Collins, K. Mahoney, M. Sepe, S. Bland, L., and Jarvis, W. R. “Bloodstream Infection Associated with Needleless Intravenous Infusion System in Patients Receiving Home Infusion Therapy,” Journal of the American Medical Association 273 (1995): 1862–1864; Do, A. N. Ray, B. J. Banerjee, S. Ilian, A. F. Barnett, B. J. Pham, M. H. Hendricks, K. A., and Jarvis, W. R., “Bloodstream Infection Associated with Needleless Device Use and the Importance of Infection-Control Practices in the Home Health Care Setting,” Journal of Infectious Diseases 179 (1999): 442–448.CrossRefGoogle Scholar
See Gershon, , supra note 69.Google Scholar
See NIOSH, supra note 54.Google Scholar
See Gershon, , supra note 69.Google Scholar