Health effects of exposure to active pharmaceutical ingredients (APIs)

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.

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

The study employed a literature review based on a systematic search of the MEDLINE database.

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.

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.