Current and Future Considerations for the Safe Handling of Hazardous Drugs

Occupational exposure to oncology medications and other hazardous drugs has been a mounting public health concern for several decades.1,2 According to the National Institute for Occupational Safety and Health (NIOSH), more than 5.5 million workers may be exposed to hazardous drugs in the United States.3 Other estimates suggest that about 8 million US health care workers may be exposed to hazardous drugs every year.4 These estimates include shipping and receiving personnel, pharmacists, and health care workers.3 Hazardous drugs are defined as chemicals that exhibit 1 or more of the following characteristics: carcinogenicity, genotoxicity, teratogenicity, reproductive toxicity, or organ toxicity.5 Many antineoplastic drugs, antiviral agents, bioengineered drugs, and antibiotics interrupt cell growth or DNA synthesis, causing adverse reproductive effects in patients and medical professionals.6 Health care workers may be exposed to hazardous drugs while preparing, administering, or disposing of drugs or while handling bodily fluids of treated patients.5 Often, needlestick injuries or contaminated or broken vials/ampoules are sources of hazardous drug exposure.7 Results from several studies have detected metabolites of chemotherapy drugs in the urine of health care workers, confirming that hazardous drug exposure is a widespread problem.7

Exposure to hazardous drugs may cause acute and chronic health effects. Acute effects include skin irritation, hair loss, nausea, liver and kidney damage, hearing loss, cardiac toxicities, and decreases in blood cell counts.8 Adverse skin effects are common.7 For example, a health care worker developed a rash after emptying containers of urine from oncology patients treated with vincristine and doxorubicin.9 Both drugs are associated with localized and systemic allergic reactions in patients and health care workers handling the medications.9

There are fewer studies of chronic health effects associated with hazardous drug exposure in health care workers, but the chronic effects in patients treated with these are better known.8 It was the observation of secondary cancers in treated patients that triggered concerns about health care workers involved in handling anticancer drugs.2 According to National Cancer Institute data from 1973 to 2000, cancer survivors have a 14% greater risk of developing a new malignancy compared with the general population.10 Many individuals who develop a new cancer do so in a separate organ system than the first cancer. This suggests that cancer treatments are potentially carcinogenic.10 Other chronic health effects include those affecting reproductive and fertility outcomes in men and women. Most of the medications on the NIOSH list of hazardous drugs negatively affect the reproductive system, and many can be passed through breast milk. Because many antitumor drugs prevent cell division, the danger to a rapidly growing fetus can be considerable.2 For women, exposure to antineoplastic drugs may cause damage to ovarian follicles, decreased ovarian volume, and ovarian fibrosis, which may lead to amenorrhea and menopausal symptoms.11 Pregnant women should be especially careful to avoid exposure to hazardous drugs. One study demonstrated an increased risk of spontaneous abortion in nurses who reported occupational exposure to antineoplastic drugs compared with nurses who did not report such exposure.12 Men may experience primary or secondary hormonal changes and can pass hazardous drugs to a female or a developing fetus via contamination on clothing or skin or during sexual intercourse.11

Current guidelines suggest that a comprehensive safety program is necessary to reduce hazardous drug exposure in the workplace. A successful safety program should integrate personal protective equipment (PPE) with administrative, engineering, and work practice controls.13 Recent updates to the United States Pharmacopeia (USP) Chapter <800> will require implementation of additional safety standards for hazardous drug handling. These updates aim to improve safety for all health care workers.13 However, safety practice gaps are problematic. A recent online NIOSH survey investigated current practices used to reduce chemical exposures.13 Overall, survey results showed deficiencies in training and in awareness regarding procedures and national guidelines. Survey results also indicated that health care workers do not always adhere to hazardous drug safety guidelines.13

Handling of Hazardous Drugs

Hazardous drugs pose exposure and health risks to health care workers involved in drug preparation and administration. Millions of medications are compounded each year in the United States. Compounding is often necessary to obtain tailored dosages of a drug or for the treatment of rare diseases.14 By providing access to individualized medicine, pharmacy compounding plays an important role in treating patients with unique medical needs.15 Thus, guidelines to protect pharmacy workers involved in the compounding of nonsterile and sterile preparations containing antineoplastic drugs were put into standard pharmacy practice in 2007.16 In general, the guidelines recommend the use of engineering controls, administrative controls, work practice controls, and PPE to reduce occupational exposure to hazardous drugs.16

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