Safety and Health Handbook for Cytotoxic Drugs

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Lancet published the first convincing evidence in a letter to the editor by Falck, et al in 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.

Safety and Health Handbook for Cytotoxic Drugs - Samuel J. Murff - Google книги

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, Several other studies followed that demonstrated risks from occupational exposure to chemotherapy. 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 s.

The subsequent investigation resulted in the facility being cited for failure to provide protection for the pharmacists Power, After several years of published data suggesting harm from occupational exposure to chemotherapy drugs, OSHA published guidelines for the safe handling of those agents The guidelines described the equipment, garments, and work practices aimed at protecting pharmacists and nurses from exposure.

In the s and s it was common practice for nurses to perform drug preparation activities in medication rooms on nursing units Stolar, 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.

Cytotoxic drugs - the management of

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. Nurses who administer chemotherapy can be exposed to aerosols or droplets of drugs generated during administration. Body fluids of patients receiving hazardous drugs are a potential source of exposure. Gloves and gowns are recommended to protect nurses against splash contamination during drug administration and handling patient wastes.

Data indicated that health care workers who used safe handling precautions were not exposed Anderson et al. Organizations acquired BSCs, gowns, gloves, and goggles, and implemented the recommendations in pharmacies and nursing units. Health care workers felt assured that following the guidelines would protect them from the hazards of exposure.

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Following the implementation of the OSHA guidelines, there was a decrease in the number of publications related to occupational exposure to hazardous drugs. This seemed to be a reflection of the decreased concern.

What are Cytotoxic Drugs ?

In , Sessink and others published new data related to hazardous drug exposure. This was the first of 14 studies NIOSH, that found hazardous drug residue on work surfaces in pharmacies and drug administration areas. The first U. This study looked for cyclophosphamide in surface wipe samples in an oncology pharmacy and an outpatient oncology clinic of a university hospital. A total of 76 wipe samples were collected from the inside of the biological safety cabinet, floor, and countertop in the pharmacy, and from countertops, sink, and a video display terminal in the clinic.

A larger U. Results suggest that current work practices do not prevent the release of hazardous drugs, resulting in drug residue on surfaces. Drug residue on surfaces can result in exposure for health care workers through the dermal route. Due to advances in science, highly sensitive tests that were not available in the s are now able to measure the presence of hazardous drugs in the urine of health care workers.

Safety and Health Handbook for Cytotoxic Drugs

The surface contamination studies demonstrated that engineering controls and work practices do not prevent the release of hazardous drugs. Drug handling activities such as reconstitution, transfer between containers, spiking and unspiking IV containers, priming IV tubing, and connecting or disconnecting syringes from injection ports may result in leakage and surface contamination. The OSHA guidelines suggest that drugs may leak during the manipulations required to reconstitute powders and the transfer of drug from one container to another.

Since contamination has been found on the outside of biological safety cabinets and on floors around them, it is clear that such engineering controls do not always contain the hazard.

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  • Incorrect operator technique can interfere with airflow and allow the escape of drug aerosols. Accidental drug spills obviously contribute to surface contamination. A drug spilled inside a BSC can be transferred to the outside of drug containers.

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    One study measured floor contamination with fluorouracil and ifosfamide after the renovation and cleaning of a pharmacy. In another setting, a clean, but used BSC was installed in a newly constructed drug preparation room. Both reports raise the question of the efficacy of current methods for cleaning and decontamination of areas where hazardous drugs are prepared.

    IV equipment has been designed with patient safety in mind, and not health care worker protection. One study demonstrated leakage from needle-less connectors on IV equipment Kromhout, et al. The spots were not visible without the scanning devices, and the workers were not aware of the contamination. These studies indicate that leakage from conventional IV equipment is a potential source of exposure for nurses. One closed-system device is available in the United States. Several studies have demonstrated the effectiveness of the closed-system device in reducing surface contamination.

    Connor et al. The system is not in common use, however, largely due to cost. As a result of all of these findings, there is new attention focused on the risks of health care workers who handle hazardous drugs. The data suggest that:. While most hazardous drugs are used in the treatment of persons with cancer, they are also used for non-oncology indications, such as rheumatoid arthritis, lupus, nephritis, and multiple sclerosis. For example, methotrexate is used as a medical treatment for tubal ectopic pregnancy. The increasing use of such drugs outside the oncology arena increases the number of health care workers who may be potentially exposed.

    It is estimated that as many as 5. Department of Commerce, By far, health care workers at greatest risk for exposure are pharmacists who prepare hazardous drugs, and nurses who may both mix and administer the drugs. However, all other individuals involved in both direct and indirect care of persons who receive such drugs should be considered potentially exposed.

    The potential adverse health risks from occupational exposure to hazardous drugs are based on the inherent toxicities of the drugs. The same health effects that occur in patients who receive therapeutic doses of the drugs are possible if employees are exposed. Hazardous drugs are genotoxic, carcinogenic, teratogenic or cause developmental toxicity. Many result in adverse reproductive outcomes and cause organ toxicity at low doses. Health care workers who have been exposed to hazardous drugs have reported acute symptoms such as skin irritation, sore throat, cough, dizziness, headache, allergic reaction, diarrhea, nausea, and vomiting Harrison, Liver damage was reported in three consecutive head nurses on a particular oncology unit who worked with chemotherapy for several years Sotaniemi, Sutinen, Arranto, Sutinen, Sotaniemi, Harrison reviewed fourteen studies that looked at adverse reproductive outcomes of health care workers exposed to hazardous drugs.

    Nine of the studies showed adverse outcomes related to exposure. The outcomes included fetal loss, congenital malformations, and infertility. Selevan, Lindbohm, Hornung, and Hemminki reported an odds ratio of 2. An odds ratio of 1. Hemminki reported an odds ratio of 4. In a matched case-control study of nurses and pharmacists, a small but significant relationship was found between women who handled antineoplastic agents and infertility. Based on urinary excretion of cyclophosphamide in pharmacists and nurses, Bos and Sessink calculated the systemic uptake of the drug.

    Based on the level of exposure of 3. An exposure of m g per day, which has been calculated based on urinary excretion of cyclophosphamide in exposed nurses, may represent an increase in cancer risk estimated at excess cases per million Connor et al.

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    From the mids until the information about surface contamination became available, there was little interest or concern among health care workers. Information about health effects from low levels of occupational exposure is sparse in recent literature. The fact that many reports of adverse effects were published before the implementation of safe handling precautions, has contributed to the lack of concern among nurses regarding hazardous drug handling.

    Table 3 describes the personal protective equipment essential for hazardous drug handling. Mahon et al. A recent study by Martin and Larsen reported the chemotherapy-handling practices of nurses working in outpatient settings.