Inadvertent exposures to pharmaceutical drugs: overview

Details

• Personal Author:
  Weston A
• Description:
  Inadvertent exposure to pharmaceutical drugs can occur through multiple routes (drug development and manufacturing worker exposure/pharmacist exposure/healthcare worker exposure/patient exposure), several of which will be explored during this symposium. The first presentation will address research/development and manufacturing worker exposures, where risk assessment may be based on chemical structure, and comparisons made with known, structurally similar drugs. Also relevant to this is the use of equipment in the context of synthesis of a previous drug, where residual materials may contaminate a subsequent preparation. Therefore Risk-based Manufacture of Pharmaceutical Products is an important consideration. The second presentation will consider patient safety in the context of such residual contamination of pharmaceutical products. Specifically, the acceptable level for genotoxic impurities occurring during drug synthesis, the threshold for toxicological concern, and acceptable daily exposure will be explored. the third presentation will consider exposures to healthcare workers, especially in the context of antineoplastic drugs. The presence of antineoplastic drugs and their metabolites in the urine of nurses and other healthcare professionals confirms exposure. in each of these three exposure scenarios, pharmaceutical agents can cause genotoxic and/or mutagenic damage. Studies of workers and patients inadvertently exposed to pharmaceutical agents have included testing of surrogate tissues (peripheral white blood cells and buccal cells) for DNA damage; in vitro mutagenicity testing of urine has also been used as a marker of exposure. These and other testing measures have been employed to assess the efficacy of engineering controls and personal protective equipment to prevent inadvertent exposures. [Description provided by NIOSH]
• Subjects:
  Antineoplastic Agents Biopharmaceutics Blood Chemistry Delivery Of Health Care DNA Drug Therapy Environmental Exposure Environmental Monitoring Hazardous Substances Health Personnel Manufacturing And Industrial Facilities Mutagens Neoplasms Occupational Exposure Occupational Health Risk Assessment Safety Toxicology

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• Keywords:
  Antineoplastic-agents Blood-cells Chemical-analysis Chemical-factory-workers Chemical-industry-workers Chemical-manufacturing-industry Chemical-properties Chemical-reactions Chemical-structure Chemical-synthesis Chemotherapy DNA-damage Drug-therapy Drugs Employee-exposure Exposure-assessment Genotoxic-effects Genotoxicity Health-care Health-care-personnel Health-hazards Industrial-exposures Medical-care Medical-personnel Medical-treatment Mutagenicity Pharmaceuticals Risk-analysis Toxic-materials

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• ISSN:
  0893-6692
• Document Type:
  Text
• Genre:
  Abstract or Summary
• Place as Subject:
  OSHA Region 3 ; West Virginia
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Division:
  DRDS - Division of Respiratory Disease Studies
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Volume:
  52
• NIOSHTIC Number:
  nn:20040093
• Citation:
  Environ Mol Mutagen 2011 Oct; 52(S1):S27
• Federal Fiscal Year:
  2012
• Peer Reviewed:
  False
• Source Full Name:
  Environmental and Molecular Mutagenesis
• Supplement:
  S1
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:1d8bff8d606f9d576143ae2aa2d76bc9e0cc611e3e1a2ac95bfa6092d1a9036ee196364041d5ae876dc0eb1367543ba0cf152275cde1da8c50fe48e6f5114bdc
• Download URL:
  https://stacks.cdc.gov/view/cdc/193070/cdc_193070_DS1.pdf
• File Type:
  [PDF - 893.17 KB ]