Irene M Gathuru, Jeanine M Buchanich, Gary M Marsh, David G Dolan
Extensive research is conducted to evaluate the safety and efficacy of candidate drugs prior to marketing and distribution, but few epidemiological studies have examined the occupational health of production workers who manufacture these drugs. This paper reviewed the occupational health research published during 1973-2014 regarding adverse health outcomes in pharmaceutical manufacturing workers. Most investigations were prompted by suspected disease clusters. Workers generally had a better mortality experience than their referent populations, but they experienced adverse health outcomes including cancer, endocrine dysfunction, cancer, and liver disease. However, most studies lacked detailed occupational exposure data, and they failed to identify the chemicals used in drug manufacture, including the active pharmaceutical ingredients (APIs). Integrated occupational health research is needed to evaluate exposures and long-term health outcomes among these workers. Since manufacturing operations are frequently outsourced to plants in Asia, this research could inform mitigation measures to protect production workers in this global industry.
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Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report
