Health effects of exposure to active pharmaceutical ingredients (APIs).
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.


OBJECTIVE
To review the evidence for the presence of the health effects of APIs in the pharmaceutical industry.


METHODS
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.


CONCLUSIONS
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.
D000970:Antineoplastic Agents / Q000009:adverse effects; D009783:Dermatitis, Occupational / Q000209:etiology; D004345:Drug Industry; D064420:Drug-Related Side Effects and Adverse Reactions; D006728:Hormones / Q000009:adverse effects; D006801:Humans; D009784:Occupational Diseases / Q000139:chemically induced*; D016273:Occupational Exposure / Q000009:adverse effects*
D000970:Antineoplastic Agents; D006728:Hormones