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