History of Hazardous Drugs

Nitrogen mustard, which was first used as a chemical weapon in World War I, caused bone marrow and lymph tissue regression in exposed service men. For this reason, the potent chemical was suggested as a treatment for lymphoid malignancies. This is often considered the beginning of the modern age of cancer chemotherapy (Brown et al., 2001).
Surgery and radiation therapy were the primary treatments for cancer in the 1950s. The National Chemotherapy Program, a federal program funded in 1955, supported the development of new chemotherapy agents. Due to advances in science, chemotherapy is now commonly administered for the treatment of cancer in patients with both solid tumors and hematologic malignancies. The United States Food and Drug Administration (FDA) approved 85 drugs used in the treatment of cancer between the years of 1949 and 1992, 85 drugs in the next eight years (1993-2000), and 34 drugs during the three-year period from 2001 to 2004 (FDA, 2004).
In the 1970s, several chemotherapy agents were linked to secondary leukemia and other cancers in treated patients. This information was accompanied by the notion that health risks might extend to persons occupationally exposed to the drugs (Donner, 1978; Ng, 1970). Lancet published the first convincing evidence in a letter to the editor by Falck, et al in 1979. In a small, but controlled study, mutagenic activity (as measured by the Ames test) was found in the urine of patients who received chemotherapy as well as nurses who administered chemotherapy. The Ames test measures genetic mutations in bacteria after exposure to compounds. Ninety percent of known carcinogens test positive on this test. The test is reliable during drug excretion in the urine, which is usually within 48 hours of exposure. It has neither high sensitivity nor specificity (Polovich, 2003). Several other studies followed that demonstrated risks from occupational exposure to chemotherapy.

OSHA published guidelines for the safe handling of [chemotherapy]agents...[that] described the equipment, garments, and work practices aimed at protecting pharmacists and nurses...

The Occupational Safety and Health Administration (OSHA), whose mission is to protect the health and safety of workers, became interested in the occupational risk of handling chemotherapy agents in the early 1980s. During a visit to a northern California hospital, California OSHA became aware of the facility’s chemotherapy preparation practices. The subsequent investigation resulted in the facility being cited for failure to provide protection for the pharmacists (Power, 1983). The safe handling program that was implemented was described in the American Journal of Hospital Pharmacy (Stolar, Power, & Veile, 1983) and became the basis for the first American Society of Hospital Pharmacists (ASHP) Technical Assistance Bulletin on Handling Cytotoxic Drugs (ASHP, 1990).
After several years of published data suggesting harm from occupational exposure to chemotherapy drugs, OSHA published guidelines for the safe handling of those agents (1986). The guidelines described the equipment, garments, and work practices aimed at protecting pharmacists and nurses from exposure. While the guidelines are not considered as standards, enforceable by law, the guidelines are responsible for hospitals and other health care organizations’ implementation of safe handling precautions.
In the 1970s and 1980s it was common practice for nurses to perform drug preparation activities in medication rooms on nursing units (Stolar, 1988). The main route of exposure to hazardous drugs (Table 2) was thought to be inhalation of drug aerosols generated during preparation. To reduce this risk, OSHA guidelines state that cytotoxic drug preparation must be performed in a biological safety cabinet (BSC) in a designated area, usually a pharmacy. A BSC has vertical airflow that moves away from the worker, as opposed to horizontal airflow that moves away from the product toward the worker. Vertical airflow protects the worker, while horizontal airflow is designed to protect the sterile product from contamination. Air leaving a BSC is filtered through a HEPA (high efficiency particulate air) filter.


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