R J L Heron1, F C Pickering. 1. Safety, Health & Risk Management, AstraZeneca, Alderley House, Alderley Park, Cheshire SK10 4TF, UK. richard.heron@astrazeneca.com
Abstract
BACKGROUND: Workers involved in the manufacture of pharmaceutical products are exposed in the course of their work to the active pharmaceutical ingredient (API) in the products. Such APIs are designed to produce biological change in the human body, which is an unacceptable outcome in the pharmaceutical worker. AIM: To review the evidence for the presence of the health effects of APIs in the pharmaceutical industry. METHOD: The study employed a literature review based on a systematic search of the MEDLINE database. RESULTS: Studies have shown that such biological effects can be produced, particularly in personnel working with potent compounds such as steroids, compounds with capacity to cause cumulative damage such as cytotoxic anti-cancer drugs and antibiotics, unless careful risk assessment and appropriate control measures are implemented. CONCLUSION: There is limited epidemiological evidence for increased mortality and morbidity in this population, but adverse effects on health from exposure to potent agents, such as corticosteroids, sex hormones and antibiotics, can occur. The protection of workers from the potential harmful effects of APIs poses a significant challenge for the pharmaceutical industry.
BACKGROUND: Workers involved in the manufacture of pharmaceutical products are exposed in the course of their work to the active pharmaceutical ingredient (API) in the products. Such APIs are designed to produce biological change in the human body, which is an unacceptable outcome in the pharmaceutical worker. AIM: To review the evidence for the presence of the health effects of APIs in the pharmaceutical industry. METHOD: The study employed a literature review based on a systematic search of the MEDLINE database. RESULTS: Studies have shown that such biological effects can be produced, particularly in personnel working with potent compounds such as steroids, compounds with capacity to cause cumulative damage such as cytotoxic anti-cancer drugs and antibiotics, unless careful risk assessment and appropriate control measures are implemented. CONCLUSION: There is limited epidemiological evidence for increased mortality and morbidity in this population, but adverse effects on health from exposure to potent agents, such as corticosteroids, sex hormones and antibiotics, can occur. The protection of workers from the potential harmful effects of APIs poses a significant challenge for the pharmaceutical industry.
Authors: Alistair B A Boxall; Murray A Rudd; Bryan W Brooks; Daniel J Caldwell; Kyungho Choi; Silke Hickmann; Elizabeth Innes; Kim Ostapyk; Jane P Staveley; Tim Verslycke; Gerald T Ankley; Karen F Beazley; Scott E Belanger; Jason P Berninger; Pedro Carriquiriborde; Anja Coors; Paul C Deleo; Scott D Dyer; Jon F Ericson; François Gagné; John P Giesy; Todd Gouin; Lars Hallstrom; Maja V Karlsson; D G Joakim Larsson; James M Lazorchak; Frank Mastrocco; Alison McLaughlin; Mark E McMaster; Roger D Meyerhoff; Roberta Moore; Joanne L Parrott; Jason R Snape; Richard Murray-Smith; Mark R Servos; Paul K Sibley; Jürg Oliver Straub; Nora D Szabo; Edward Topp; Gerald R Tetreault; Vance L Trudeau; Glen Van Der Kraak Journal: Environ Health Perspect Date: 2012-05-30 Impact factor: 9.031