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Cincinnati, OH 45226–1998
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Telephone: 1–800–35–NIOSH (1–800–356–4674)
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or visit the NIOSH Web site at www.cdc.gov/niosh
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DHHS (NIOSH) Publication Number 2004−165
Ê

September 2004
Ê

SAFER • HEALTHIER • PEOPLETM

ii 
Foreword
Ê

The purpose of this Alert is to increase awareness among health care workers and their employers about the health risks posed by working with hazardous drugs and to provide them 

with measures for protecting their health. Health care workers who prepare or administer 

hazardous drugs or who work in areas where these drugs are used may be exposed to these 

agents in the air or on work surfaces, contaminated clothing, medical equipment, patient 

excreta, and other surfaces. Studies have associated workplace exposures to hazardous 

drugs with health effects such as skin rashes and adverse reproductive outcomes (including 

infertility, spontaneous abortions, and congenital malformations) and possibly leukemia and 

other cancers. The health risk is influenced by the extent of the exposure and the potency 

and toxicity of the hazardous drug. To provide workers with the greatest protection, employers 

should (1) implement necessary administrative and engineering controls and (2) assure that 

workers use sound procedures for handling hazardous drugs and proper protective equipment. The Alert contains a list of drugs that should be handled as hazardous drugs. 

This Alert applies to all workers who handle hazardous drugs (for example, pharmacy and 

nursing personnel, physicians, operating room personnel, environmental services workers, 

workers in research laboratories, veterinary care workers, and shipping and receiving personnel). Although not all workers in these categories handle hazardous drugs, the number of 

exposed workers exceeds 5.5 million. The Alert does not apply to workers in the drug manufacturing sector. 

The production, distribution, and application of pharmaceutical medications are part of a 

rapidly growing field of patient therapy. New areas of pharmaceutical development will bring 

fundamental changes to methods for treating and preventing diseases. Both traditional medications and bioengineered drugs can be hazardous to health care workers who must handle 

them. This NIOSH Alert will help make workers and employers more aware of these hazards 

and provide the tools for preventing exposures. 

John Howard, M.D. 

Director 

National Institute for Occupational

 Safety and Health 

Centers for Disease Control

 and Prevention 

iii 

Contents
Ê

Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
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Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 

Potential for Worker Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Ê

Conditions for Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
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Exposure Routes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
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Evidence for Worker Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
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Evidence for Health Effects in Workers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
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Mutagenicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
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Developmental and Reproductive Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
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Cancer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
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Current Standards and Recommendations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
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OSHA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
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EPA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
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Additional Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
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Case Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
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Case 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
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Case 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
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Case 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
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Case 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
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Case 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
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Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
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Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Ê

Summary of Recommended Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Ê

Detailed Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
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Receiving and Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
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Drug Preparation and Administration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
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Initial steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
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Preparing hazardous drugs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Ê

Administering hazardous drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
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Ventilated Cabinets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Ê

Use of cabinets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
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vii 
Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
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Air flow and exhaust . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
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Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Ê

Routine Cleaning, Decontaminating, Housekeeping, and Waste Disposal . . . . 16
Ê

Cleaning and decontaminating. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
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Housekeeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
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Waste disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
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Spill Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Ê

Medical Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Ê

Additional Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Ê

Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
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References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Ê

Appendices
Ê

A. Drugs Considered Hazardous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Ê

General Approach to Handling Hazardous Drugs . . . . . . . . . . . . . . . . . . . . . . 31
Ê

Defining Hazardous Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Ê

ASHP Definition of Hazardous Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Ê

NIOSH Revision of ASHP Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Ê

Determining Whether a Drug is Hazardous. . . . . . . . . . . . . . . . . . . . . . . 32
Ê

How to Generate Your Own List of Hazardous Drugs . . . . . . . . . . . . . . . . 33
Ê

Where to Find Information Related to Drug Toxicity . . . . . . . . . . . . . . . . . 34
Ê

Examples of Hazardous Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Ê

B. Abbreviations and Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Ê

C. NIOSH Hazardous Drug Safety Working Group . . . . . . . . . . . . . . . . . . . . . . . . 49
Ê

viii 
 

 

 

 

 

 

 

 

 

 

Preventing Occupational Exposures to 

Antineoplastic and Other Hazardous 

Drugs in Health Care Settings
Ê

Warning! 

Working with or near hazardous drugs in health care settings 

may cause skin rashes, infertility, miscarriage, birth defects, 

and possibly leukemia or other cancers. 

The National Institute for Occupational 

Safety and Health (NIOSH) requests assistance in preventing occupational exposures to antineoplastic drugs (drugs 

used to treat cancer) and other hazardous drugs in health care settings. Health 

care workers who work with or near hazardous drugs may suffer from skin rashes, infertility, miscarriage, birth defects, 

and possibly leukemia or other cancers. 

Workers may be exposed to hazardous 

drugs in the air or on work surfaces, 

clothing, medical equipment, and patient urine or feces. The term hazardous 

drugs, as it is used in this Alert, includes 

drugs that are known or suspected to 

cause adverse health effects from exposures in the workplace. They include 

drugs used for cancer chemotherapy, 

antiviral drugs, hormones, some bioengineered drugs, and other miscellaneous drugs. The health risk depends 

on how much exposure a worker has to 

these drugs and how toxic they are. Exposure risks can be greatly reduced by 

(1) making sure that engineering controls such as a ventilated cabinet are 

used and (2) using proper procedures 

and protective equipment for handling 

hazardous drugs. 

This Alert warns health care workers 

about the risks of working with hazardous drugs and recommends methods and equipment for protecting their 

health. The Alert addresses workers in 

health care settings, veterinary medicine, research laboratories, retail pharmacies, and home health care agencies; it does not address workers in the 

drug manufacturing sector. Included in 

the Alert are five case reports of workers who suffered adverse health effects 

after being exposed to antineoplastic 

drugs. 

NIOSH requests that employers, editors 

of trade journals, safety and health officials, and unions bring the recommendations in this Alert to the attention of 

all workers who are at risk. 

1
Ê
 

 

 

 

 

 

 

 

BACKGROUND 

Drugs have a successful history of use in 

treating illnesses and injuries, and they 

are responsible for many of our medical 

advances over the past century. However, 

virtually all drugs have side effects associated with their use by patients. Thus, both 

patients and workers who handle them are 

at risk of suffering these effects. In addition, it is known that exposures to even very 

small concentrations of certain drugs may 

be hazardous for workers who handle them 

or work near them. 

The term hazardous drugs was first used by 

the American Society of Hospital Pharmacists (ASHP) [ASHP 1990] and is currently 

used by the Occupational Safety and Health 

Administration (OSHA) [OSHA 1995, 1999]. 

Drugs are classified as hazardous if studies 

in animals or humans indicate that exposures to them have a potential for causing 

cancer, developmental or reproductive toxicity, or harm to organs. Many hazardous 

drugs are used to treat illnesses such as 

cancer or HIV infection [Galassi et al. 1996; 

McInnes and Schilsky 1996; Erlichman and 

Moore 1996]. See Appendix A for examples 

of hazardous drugs and a full discussion of 

criteria used to define and classify them as 

hazardous. 

Although the potential therapeutic benefits 

of hazardous drugs outweigh the risks of side 

effects for ill patients, exposed health care 

workers risk these same side effects with no 

therapeutic benefit. Occupational exposures 

to hazardous drugs can lead to (1) acute 

effects such as skin rashes [McDiarmid and 

Egan 1988; Valanis et al. 1993a,b; Krstev 

et al. 2003]; (2) chronic effects, including 

adverse reproductive events [Selevan et al. 

1985; Hemminki et al. 1985; Stücker et al. 

1990; Valanis et al. 1997, 1999; Peelen et 

al. 1999]; and (3) possibly cancer [Skov et 

al. 1992]. 

Guidelines have been established for handling hazardous drugs, but adherence to 

these guidelines has been reported to be 

sporadic [Valanis et al. 1991, 1992; Mahon et al. 1994; Nieweg et al. 1994]. In 

addition, measurable concentrations of 

some hazardous drugs have been documented in the urine of health care workers 

who prepared or administered them—even 

after safety precautions had been employed 

[Ensslin et al. 1994, 1997; Sessink et al. 

1992b, 1994a,b, 1997; Minoia et al. 1998; 

Wick et al. 2003]. Environmental studies of 

patient-care areas have documented measurable concentrations of drug contamination, even in facilities thought to be following 

recommended handling guidelines [Minoia 

et al. 1998; Connor et al. 1999; Pethran et 

al. 2003]. 

The numbers and types of work environments 

containing antineoplastic drugs are expanding as these agents are used increasingly for 

nonmalignant rheumatologic and immunologic diseases [Baker et al. 1987; Moody et 

al. 1987; Chabner et al. 1996; Abel 2000] 

and for chemotherapy in veterinary medicine [Rosenthal 1996; Takada 2003]. This 

Alert summarizes the health effects associated with occupational exposure to these 

agents and provides recommendations for 

safe handling. 

POTENTIAL FOR WORKER 

EXPOSURE 

Workers may be exposed to a drug throughout its life cycle—from manufacture to 

2 Hazardous Drugs in Health Care Settings 
transport and distribution, to use in health 

care or home care settings, to waste disposal. The number of workers who may be 

exposed to hazardous drugs exceeds 5.5 

million [U.S. Census Bureau 1997; BLS 

1998, 1999; NCHS 1996]. These workers 

include shipping and receiving personnel, 

pharmacists and pharmacy technicians, 

nursing personnel, physicians, operating 

room personnel, environmental services 

personnel, and workers in veterinary practices where hazardous drugs are used. This 

Alert addresses workers in health care settings, veterinary medicine, research laboratories, retail pharmacies, and home health 

care agencies; it does not address workers 

in the drug manufacturing sector. 

CONDITIONS FOR EXPOSURE 

Both clinical and nonclinical workers may be 

exposed to hazardous drugs when they create aerosols, generate dust, clean up spills, 

or touch contaminated surfaces during the 

preparation, administration, or disposal of 

hazardous drugs. The following list of activities may result in exposures through inhalation, skin contact, ingestion, or injection: 

 Reconstituting powdered or lyophilized 

drugs and further diluting either the reconstituted powder or concentrated liquid forms of hazardous drugs [Fransman 

et al. 2004] 

 Expelling air from syringes filled with hazardous drugs 

 Administering hazardous drugs by intramuscular, subcutaneous, or intravenous 

(IV) routes 

 Counting out individual, uncoated oral 

doses and tablets from multidose bottles 

 Unit-dosing uncoated tablets in a unitdose machine 

 Crushing tablets to make oral liquid 

doses [Dorr and Alberts 1992; Shahsavarani et al. 1993; Harrison and Schultz 

2000] 

 Compounding potent powders into custom-dosage capsules 

 Contacting measurable concentrations of 

drugs present on drug vial exteriors, work 

surfaces, floors, and final drug products 

(bottles, bags, cassettes, and syringes) 

[McDevitt et al. 1993; Sessink et al. 

1992a,b, 1994b; Minoia et al. 1998; 

Connor et al. 1999, 2002; Schmaus et 

al. 2002] 

 Generating aerosols during the administration of drugs, either by direct IV push 

or by IV infusion 

 Priming the IV set with a drug-containing solution at the patient bedside (this 

procedure should be done in the pharmacy) 

 Handling body fluids or body-fluid-contaminated clothing, dressings, linens, 

and other materials [Cass and Musgrave 

1992; Kromhout et al. 2000] 

 Handling contaminated wastes generated at any step of the preparation or 

administration process 

 Performing certain specialized procedures (such as intraoperative intraperitoneal chemotherapy) in the operating 

room [White et al. 1996; Stuart et al. 

2002] 

Hazardous Drugs in Health Care Settings 3 
 Handling unused hazardous drugs or 

hazardous-drug-contaminated waste 

 Decontaminating and cleaning drug 

preparation or clinical areas 

 Transporting infectious, chemical, or 

hazardous waste containers 

 Removing and disposing of personal protective equipment (PPE) after handling 

hazardous drugs or waste 

EXPOSURE ROUTES 

Exposures to hazardous drugs may occur 

through inhalation, skin contact, skin absorption, ingestion, or injection. Inhalation 

and skin contact/absorption are the most 

likely routes of exposure, but unintentional 

ingestion from hand to mouth contact and 

unintentional injection through a needlestick or sharps injury are also possible [Duvall and Baumann 1980; Dorr 1983; Black 

and Presson 1997; Schreiber et al. 2003]. 

A number of studies have attempted to 

measure airborne concentrations of antineoplastic drugs in health care settings 

[Kleinberg and Quinn 1981; Neal et al. 

1983; McDiarmid et al. 1986; Pyy et al. 

1988; McDevitt et al. 1993; Sessink et al. 

1992a; Nygren and Lundgren 1997; Stuart 

et al. 2002; Kiffmeyer et al. 2002; Larson et 

al. 2003]. In most cases, the percentage of 

air samples containing measurable airborne 

concentrations of hazardous drugs was low, 

and the actual concentrations of the drugs, 

when present, were quite low. These results 

may be attributed to the inefficiency of sampling and analytical techniques used in the 

past [Larson et al. 2003]. Both particulate 

and gaseous phases of one antineoplastic 

drug, cyclophosphamide, have been reported in two studies [Kiffmeyer et al. 2002; 

Larson et al. 2003]. 

Since the early 1990s, 14 studies have 

examined environmental contamination of 

areas where hazardous drugs are prepared 

and administered at health care facilities in 

the United States and several other countries [Sessink et al. 1992a; Sessink et al. 

1992b; McDevitt et al. 1993; Pethran et 

al. 1998; Minoia et al. 1998; Rubino et al. 

1999; Sessink and Bos 1999; Connor et al. 

1999; Micoli et al. 2001; Vandenbroucke et 

al. 2001; Connor et al. 2002; Kiffmeyer et 

al. 2002; Schmaus et al. 2002; Wick et al. 

2003]. Using wipe samples, most investigators measured detectable concentrations 

of one to five hazardous drugs in various 

locations such as biological safety cabinet 

(BSC) surfaces, floors, counter tops, storage areas, tables and chairs in patient treatment areas, and locations adjacent to drughandling areas. All of the studies reported 

some level of contamination with at least 

one drug, and several reported contamination with all the drugs for which assays were 

performed. Such widespread contamination 

of work surfaces makes the potential for 

skin contact highly probable in both pharmacy and patient areas. 

EVIDENCE FOR WORKER 

EXPOSURE 

Evidence indicates that workers are being exposed to hazardous drugs and are 

experiencing serious health effects despite 

current work practice guidelines. Protection 

from hazardous drug exposures depends on 

safety programs established by employers 

4 Hazardous Drugs in Health Care Settings 
 

 

 

 

 

 

 

 

 

 

 

 

and followed by workers. Factors that affect 

worker exposures include the following: 

 Drug handling circumstances (preparation, administration, or disposal) 

 Amount of drug prepared 

 Frequency and duration of drug handling 

 Potential for absorption 

 Use of ventilated cabinets* 

 PPE 

 Work practices 

The likelihood that a worker will experience 

adverse effects from hazardous drugs increases with the amount and frequency of exposure 

and the lack of proper work practices. 

Worker exposures have been assessed by 

studies of biological markers of exposure. 

No single biological marker has been found 

to be a good indicator of exposure to hazardous drugs or a good predictor of adverse 

health effects [Baker and Connor 1996]. 

Sessink and Bos [1999] noted that 11 of 

12 studies reported cyclophosphamide in 

the urine of health care workers tested, indicating continued exposure despite safety 

precautions. 

Harrison [2001] reported that six different drugs (cyclophosphamide, methotrexate, ifosfamide, epirubicin and cisplatin/ 

carboplatin) were detected in the urine of 

health care workers by 13 of 20 investigations. Two recent studies have documented antineoplastic drugs in the urine 

*

A ventilated cabinet is a type of engineering control designed 

to protect workers. Examples include BSCs and isolators 

designed to prevent hazardous drugs inside the cabinet 

from escaping into the work environment. See the Glossary 

in Appendix B for additional descriptions of engineering 

controls. 

of pharmacy and nursing personnel [Pethran et al. 2003; Wick et al. 2003]. Pethran 

and coworkers collected urine samples in 

14 German hospitals over a 3-year period. 

Cyclophosphamide, ifosfamide, doxorubicin, and epirubicin (but not daunorubicin or 

idarubicin) and platinum (from cisplatin or 

carboplatin) were identified in urine samples 

from many of the study participants. A U.S. 

investigation demonstrated that use of a 

closed-system device for 6 months reduced 

both the concentration of cyclophosphamide or ifosfamide in the urine of exposed 

health care workers and the percentage of 

samples containing these drugs [Wick et 

al. 2003]. Hazardous drugs have also been 

documented in the urine of health care 

workers who did not handle hazardous drugs 

but were potentially exposed through fugitive aerosols or secondary contamination of 

work surfaces, clothing, or drug containers 

[Sessink et al. 1994b; Mader et al. 1996; 

Pethran et al. 2003]. 

EVIDENCE FOR HEALTH EFFECTS 

IN WORKERS 

By the 1970s, the carcinogenicity of several 

antineoplastic drugs in animals was well 

established [Shimkin et al. 1966; Weisberger 1975; Schmahl and Habs 1978]. 

Likewise, a number of researchers during 

this period linked the therapeutic use of 

alkylating agents in humans to subsequent 

leukemias and other cancers [Harris 1975, 

1976; IARC 1979]. Many health care professionals began to question the safety of 

occupational exposure to these agents [Ng 

and Jaffe 1970; Donner 1978; Johansson 

1979]. 

Hazardous Drugs in Health Care Settings 5 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Mutagenicity 

A number of studies indicate that antineoplastic drugs may cause increased genotoxic 

effects in pharmacists and nurses exposed in 

the workplace [Falck et al. 1979; Anderson 

et al 1982; Nguyen et al. 1982; Rogers and 

Emmett 1987; Oestricher et al. 1990; Fuchs 

et al. 1995; Ündeger et al. 1999; Norppa et 

al. 1980; Nikula et al. 1984; McDiarmid et 

al. 1992; Sessink et al. 1994a; Burgaz et al. 

1988]. Several studies that have not linked 

genotoxic effects with worker exposures may 

be explained by technical confounders and 

a lack of accurate blood and urine sampling 

in exposed workers [Sorsa et al. 1985; McDiarmid et al. 1992]. When all the data are 

considered, the weight of evidence associates hazardous drug exposures at work with 

increased genotoxicity [Sorsa and Anderson 

1996; Baker and Connor 1996; Bos and 

Sessink 1997; Hewitt 1997; Sessink and 

Bos 1999; Harrison and Schulz 2001]. 

Developmental and Reproductive 

Effects 

A recent review of 14 studies described 

an association between exposure to antineoplastic drugs and adverse reproductive 

effects, and 9 studies showed some positive association [Harrison 2001]. The major 

reproductive effects found in these studies were increased fetal loss [Selevan et 

al. 1985; Stücker et al. 1990], congenital 

malformations depending on the length of 

exposure [Hemminki et al. 1985], low birth 

weight and congenital abnormalities [Peelen et al. 1999], and infertility [Valanis et al. 

1999]. 

Cancer 

Several reports have addressed the relationship of cancer occurrence to health care 

workers’ exposures to antineoplastic drugs. 

A significantly increased risk of leukemia 

has been reported among oncology nurses 

identified in the Danish cancer registry for 

the period 1943−1987 [Skov et al. 1992]. 

The same group [Skov et al. 1990] found 

an increased, but not significant, risk of leukemia in physicians employed for at least 

6 months in a department where patients 

were treated with antineoplastic drugs. 

CURRENT STANDARDS AND 

RECOMMENDATIONS 

Currently, no NIOSH recommended exposure 

limits (RELs), OSHA permissible exposure 

limits (PELs), or American Conference of 

Governmental Industrial Hygienists (ACGIH) 

threshold limit values (TLVs®) have been 

established for hazardous drugs in general. 

An OSHA PEL and an ACGIH TLV have been 

established for soluble platinum salts [29 

CFR† 1910.1000; ACGIH 2003]. However, 

these standards are based on sensitization 

and not on the potential to cause cancer. A 

PEL, an REL, and a TLV have also been established for inorganic arsenic compounds, 

which include the antineoplastic drug arsenic trioxide [29 CFR 1910.1018; NIOSH 

2004; ACGIH 2003]. A workplace environmental exposure level (WEEL) has been 

established for some antibiotics, including 

chloramphenicol (AIHA 2002). Some pharmaceutical manufacturers develop riskbased occupational exposure limits (OELs) 

to be used in their own manufacturing settings, and this information may be available 

†

Code of Federal Regulations. See CFR in references. 

6 Hazardous Drugs in Health Care Settings 
 

 

 

 

 

 

 

 

 

 

 

 

 

on material safety data sheets (MSDSs) or 

from the manufacturer [Sargent and Kirk 

1988; Naumann and Sargent 1997; Sargent et al. 2002]. 

U.S. Environmental Protection Agency (EPA) 

regulations under the Resource Conservation and Recovery Act (RCRA) [42 USC‡ 

6901−6992] apply to the management of 

hazardous wastes, which include nine antineoplastic drugs [40 CFR 260–279]. 

OSHA 

OSHA originally published guidelines for antineoplastic drugs in 1986 [OSHA 1986]. Current OSHA standards and guidelines that address hazardous drugs include the following: 

 Hazard communication standard [29 CFR 

1910.1200] 

 Occupational exposure to hazardous chemicals in laboratories standard [29 CFR 

1910.1450] 

 OSHA Technical Manual; Section VI, 

Chapter 2: Controlling Occupational Exposure to Hazardous Drugs [OSHA 1999]. 

Main elements of these 1999 OSHA 

guidelines include the following: 

— Categorization of drugs as hazardous 

— Hazardous drugs as occupational risks 

— Work area 

— Prevention of employee exposure 

— Medical surveillance 

— Hazard communication 

— Training and information dissemination 

— Recordkeeping 

‡

United States Code. See USC in references. 

EPA 

EPA/RCRA regulations require that hazardous waste be managed by following a 

strict set of regulatory requirements [40 

CFR 260–279]. The RCRA list of hazardous wastes was developed in 1976 and 

includes only about 30 pharmaceuticals, 9 

of which are antineoplastic drugs. Recent 

evidence indicates that a number of drug 

formulations exhibit hazardous waste characteristics [Smith 2002]. OSHA [1999] and 

ASHP [1990] recommend that hazardous 

drug waste be disposed of in a manner similar to that required for RCRA-listed hazardous waste. Hazardous drug waste includes 

partially filled vials, undispensed products, 

unused IVs, needles and syringes, gloves, 

gowns, underpads, contaminated materials 

from spill cleanups, and containers such as 

IV bags or drug vials that contain more than 

trace amounts of hazardous drugs and are 

not contaminated by blood or other potentially infectious waste. Published EPA guidelines are as follows: 

 U.S. Environmental Protection Agency 

(EPA). Managing Hazardous Waste: A 

Guide for Small Businesses [EPA 2001]. 

 U.S. Environmental Protection Agency 

(EPA). RCRA Hazardous Waste Regulations [40 CFR Parts 260–279]. 

Additional Guidelines 

Additional guidelines that address hazardous drugs or the equipment in which they 

are manipulated include the following: 

 Centers for Disease Control (CDC) and 

National Institutes of Health (NIH). Primary Containment for Biohazards [CDC/ 

NIH 2000]. Provides guidance on the 

selection, installation, testing, and use 

of BSCs. 

Hazardous Drugs in Health Care Settings 7 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 NIH. Recommendations for the Safe 

Handling of Cytotoxic Drugs [NIH 2002]. 

Includes recommendations for the safe 

preparation and administration of cytotoxic drugs. 

 ASHP. ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous 

Drugs [ASHP 1990]. An informed discussion of the dangers and safe handling 

procedures for hazardous drugs. 

 Oncology Nursing Society. Chemotherapy 

and Biotherapy Guidelines and Recommendations for Practice [Brown et al. 

2001]. Provides complete guidelines for 

the administration of antineoplastic drugs, 

including safe handling guidelines. 

 Oncology Nursing Society. Safe Handling 

of Hazardous Drugs [Polovich 2003]. 

Includes proper handling guidelines for 

hazardous drugs. 

 United States Pharmacopeia. Chapter 

<797> Pharmaceutical Compounding— 

Sterile Preparations [USP 2004]. Details 

the procedures and requirements for 

compounding sterile preparations and 

sets standards applicable to all settings 

in which sterile preparations are compounded. 

 National Sanitation Foundation (NSF) 

and American National Standards Institute (ANSI). NSF/ANSI 49–2002 Class II 

(Laminar Flow) Biosafety Cabinetry [NSF/ 

ANSI 2002]. Addresses classification and 

certification of Class II BSCs and provides 

a definition for Class III BSCs. 

 PDA. Technical Report No. 34: Design 

and Validation of Isolator Systems for 

the Manufacturing and Testing of Health 

Care Products [PDA 2001]. A supplemental publication to the PDA Journal 

of Pharmaceutical Science and Technology. Provides definitions, design, and operation and testing guidance for types of 

isolators used in the health care product 

manufacturing industry. 

 American Glovebox Society (AGS). 

Guidelines for Gloveboxes; 2nd edition 

[AGS 1998]. Provides guidance on the 

design, testing, use, and decommissioning of glovebox containment systems. 

CASE REPORTS 

The following cases illustrate the range of 

health effects reported after exposure to 

antineoplastic drugs: 

Case 1 

A female oncology nurse was exposed to a 

solution of carmustine when the complete 

tubing system fell out of an infusion bottle 

of carmustine, and all of the solution poured 

down her right arm and leg and onto the 

floor [McDiarmid and Egan 1988]. Although 

she wore gloves, her right forearm was unprotected, and the solution penetrated her 

clothing and stockings. Feeling no sensation 

on the affected skin areas, she immediately 

washed her arm and leg with soap and water 

but did not change her clothing. A few hours 

later, while at work, she began to experience minor abdominal distress and profuse 

belching followed by intermittent episodes of 

nonbloody diarrhea with cramping abdominal pain. Profuse vomiting occurred, after 

which she felt better. The nurse went to the 

emergency room, where her vital signs and 

physical examination were normal. No specific therapy was prescribed. She felt better 

the following day. Carmustine is known to 

8 Hazardous Drugs in Health Care Settings 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

cause gastric upset, and the investigators 

attributed her gastrointestinal distress to 

systemic absorption of carmustine. 

Case 2 

A 39-year-old pharmacist suffered two episodes of painless hematuria (blood in the 

urine) and was found to have cancer (a 

grade II papillary transitional cell carcinoma) 

[Levin et al. 1993]. Twelve years before 

her diagnosis, she had worked full time 

for 20 months in a hospital IV preparation 

area where she routinely prepared cytotoxic agents, including cyclophosphamide, 

fluorouracil, methotrexate, doxorubicin, and 

cisplatin. She used a horizontal laminar-flow 

hood that directed the airflow toward her. 

Because she was a nonsmoker and had no 

other known occupational or environmental 

risk factors, her cancer was attributed to 

her antineoplastic drug exposure at work— 

though a cause and effect relationship has 

not been established in the literature. 

Case 3 

A 41-year-old nurse who had worked on an 

oncology ward for 13 years suffered from 

nasal discharge, difficult breathing, and attacks of coughing 1 to 2 hours after beginning work [Walusiak et al. 2002]. During the 

third year of her employment on the ward, 

she developed difficult breathing while away 

from work. Her total IgE was low, and specific IgE antibodies to common agents and 

skin prick tests to common allergens (including latex) were all negative. The patient 

was subjected to a number of single-blind 

bronchial challenge tests with antineoplastic 

drugs, and she was monitored by spirometry 

and peak expiratory flow measurements. On 

the basis of clinical findings, the investigators concluded that the evidence was consistent with a diagnosis of allergic asthma. 

Case 4 

A malfunctioning BSC resulted in possible 

exposure of nursing personnel to a number 

of antineoplastic drugs that were prepared 

in the BSC [Kevekordes et al. 1998]. Blood 

samples from the nurses were analyzed 

for genotoxic biomarkers 2 and 9 months 

after replacement of the faulty BSC. At 

2 months, both sister chromatid exchanges 

(SCEs) and micronuclei were significantly 

elevated compared with those of a matched 

control group. At 9 months, the micronuclei concentrations were similar to those of 

the 2-month controls. SCEs were not determined at 9 months. The investigators concluded that the elevation in biomarkers had 

resulted from the malfunctioning of the BSC, 

which resulted in worker exposure to the antineoplastic drugs. They also concluded that 

the subsequent replacement with a new BSC 

contributed to the reduced effect seen with 

the micronucleus test at 9 months. 

Case 5 

A 41-year-old patient-care assistant working on an oncology floor developed an 

itchy rash approximately 30 minutes after 

emptying a commode of urine into a toilet 

[Kusnetz and Condon 2003]. She denied 

any direct contact with the urine, wore a 

protective gown and nitrile gloves, and followed hospital policy for the disposal of 

materials contaminated with antineoplastic 

drugs. The rash subsided after 1 to 2 days. 

Three weeks later, she had a similar reaction approximately 1 hour after performing 

the same procedure for another patient. 

Upon investigation, it was found that both 

hospital patients had recently been treated 

with vincristine and doxorubicin. The patientcare assistant had no other signs or symptoms and reported no changes in lifestyle 

Hazardous Drugs in Health Care Settings 9 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

and no history of allergies or recent infections. After treatment with diphenhydramine 

(intramuscular) and oral corticosteroids, her 

symptoms disappeared. Although the cause 

could not be definitely confirmed, both vincristine and doxorubicin have been 

RECOMMENDATIONS 

associated with allergic reactions when given to 

patients. The aerosolization of the drug present in the urine may have provided enough 

exposure for symptoms to develop. 

CONCLUSIONS 

Recent evidence summarized in this Alert 

documents that worker exposure to hazardous drugs is a persistent problem. Although 

most air-sampling studies have not demonstrated significant airborne concentrations 

of these drugs, the sampling methods used 

in the past have come into question [Larson 

et al. 2003] and may not be a good indicator of contamination in the workplace. In 

all studies involving examination of surface 

wipe samples, researchers have determined 

that surface contamination of the workplace 

is common and widespread. Also, a number 

of recent studies have documented the excretion of several indicator drugs in the urine 

of health care workers. Results from studies 

indicate that worker exposure to hazardous 

drugs in health care facilities may result in 

adverse health effects. 

Appropriately designed studies have begun 

and are continuing to characterize the extent and nature of health hazards associated 

with these ongoing exposures. NIOSH is currently conducting studies to further identify 

potential sources of exposure and methods 

to reduce or eliminate worker exposure to 

these drugs. To minimize these potentially 

acute (short-term) and chronic (long-term) 

effects of exposure to hazardous drugs at 

work, NIOSH recommends that at a minimum, employers and health care workers 

follow the recommendations presented in 

this Alert. 

Summary of Recommended 

Procedures 

1. Assess the hazards in the workplace. 

 Evaluate the workplace to identify and 

assess hazards before anyone begins 

work with hazardous drugs. As part of 

this evaluation, assess the following: 

— Total working environment 

— Equipment (i.e., ventilated cabinets, 

closed-system drug transfer devices, 

glovebags, needleless systems, and 

PPE) 

— Physical layout of work areas 

— Types of drugs being handled 

— Volume, frequency, and form of drugs 

handled (tablets, coated versus uncoated, powder versus liquid) 

— Equipment maintenance 

— Decontamination and cleaning 

— Waste handling 

— Potential exposures during work, including hazardous drugs, bloodborne 

pathogens, and chemicals used to 

deactivate hazardous drugs or clean 

drug-contaminated surfaces 

— Routine operations 

10 Hazardous Drugs in Health Care Settings 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

— Spill response 

— Waste segregation, containment, and 

disposal 

 Regularly review the current inventory 

of hazardous drugs, equipment, and 

practices, seeking input from affected workers. Have the safety and health 

staff or an internal committee perform 

this review. 

 Conduct regular training reviews with 

all potentially exposed workers in workplaces where hazardous drugs are used. 

Seek ongoing input from workers who 

handle hazardous drugs and from other 

potentially exposed workers regarding the 

quality and effectiveness of the prevention program. Use this input from workers 

to provide the safest possible equipment 

and conditions for minimizing exposures. 

This approach is the only prudent public 

health approach, since safe concentrations for occupational exposure to hazardous drugs have not been conclusively 

determined. 

2. Handle drugs safely. 

 Implement a program for safely handling hazardous drugs at work and 

review this program annually on the 

basis of the workplace evaluation. 

Establish work policies and procedures 

specific to the handling of hazardous 

drugs. These policies and procedures 

should address and define the following: 

— Presence of hazardous drugs 

— Labeling 

— Storage 

— Personnel issues (such as exposure 

of pregnant workers) 

— Spill control 

— Detailed procedures for preparing, 

administering, and disposing of hazardous drugs 

 Establish procedures and provide 

training for handling hazardous drugs 

safely, cleaning up spills, and using all equipment and PPE properly. 

Inform workers about the location and 

proper use of spill kits. Make these kits 

available near all potential sources of 

exposure. Make sure that training conforms to the requirements of the OSHA 

hazard communication standard [29 

CFR 1910.1200] and other relevant 

OSHA requirements such as the PPE 

standard [29 CFR 1910.132]. In addition, establish procedures for cleaning 

and decontaminating work areas and 

for proper waste handling and disposal 

of all contaminated materials, including 

patient waste. 

 Establish work practices related to 

both drug manipulation techniques 

and to general hygiene practices— 

such as not permitting eating or drinking in areas where drugs are handled 

(the pharmacy or clinic). 

3. Use and maintain equipment 

properly. 

 Develop workplace procedures for 

using and maintaining all equipment 

that functions to reduce exposure— 

such as ventilated cabinets, closedsystem drug-transfer devices, needleless systems, and PPE. 

Detailed Recommendations 

Receiving and Storage 

 Begin exposure control when hazardous 

drugs enter the facility. The most significant exposure risk during distribution 

Hazardous Drugs in Health Care Settings 11 
and transport is from spills resulting from 

damaged containers. 

 Prepare workers for the possibility that 

spills might occur while they are handling containers (even when packaging 

is intact during routine activities), and 

provide them with appropriate PPE. 

 Make sure that medical products have 

labeling on the outsides of containers 

that will be understood by all workers 

who will be separating hazardous from 

nonhazardous drugs. 

 Wear chemotherapy gloves [ASTM in 

press], protective clothing, and eye 

protection when opening containers 

to unpack hazardous drugs. Such PPE 

protects workers and helps prevent contamination from spreading if damaged 

containers are found. 

 Wear chemotherapy gloves to prevent 

contamination when transporting the vial 

or syringe to the work area. 

 Store hazardous drugs separately from 

other drugs, as recommended by ASHP 

[1990] and other chemical safety standards. 

 Store and transport hazardous drugs in 

closed containers that minimize the risk 

of breakage. 

 Make sure the storage area has sufficient 

general exhaust ventilation to dilute and 

remove any airborne contaminants. 

 Depending on the physical nature and 

quantity of the stored drugs, consider installing a dedicated emergency exhaust 

fan that is large enough to quickly purge 

airborne contaminants from the storage 

room in the event of a spill and prevent 

contamination in adjacent areas. 

Drug Preparation and Administration 

Initial steps 

 As part of the hazard assessment described earlier, evaluate and review the 

entire drug preparation and administration process to identify points at which 

drugs might be released into the work 

environment. Always consider the possibility of contamination on the outside of 

containers [Ros et al. 1997; Hepp and 

Gentschew 1998; Delporte et al. 1999; 

Nygren et al. 2002; Favier et al. 2003; 

Mason et al. 2003]. 

 Limit access to areas where drugs are 

prepared to protect persons not involved 

in drug preparation. 

 Coordinate tasks associated with preparing and administering hazardous drugs 

for most effective control of worker exposures. 

Preparing hazardous drugs 

 Use a ventilated cabinet designed to 

reduce worker exposures while preparing 

hazardous drugs (see following section 

entitled Ventilated Cabinets). 

 Train all staff who use ventilated cabinets 

to employ work practices established for 

their particular equipment. The safe use 

of any control depends on proper work. 

 Practice proper technique and use of 

equipment. 

 Include initial and periodic assessments 

of technique in the safety program [Harrison et al. 1996], and verify technique 

during drug administration. 

 Wear protective gloves and gowns if you 

are involved in preparation activities 

such as opening drug packaging, handling vials or finished products, labeling 

12 Hazardous Drugs in Health Care Settings 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

hazardous drug containers, or disposing 

of waste. 

 Wear PPE (including double gloves and 

protective gowns) while reconstituting 

and admixing drugs: 

— Make sure that gloves are labeled 

as chemotherapy gloves and make 

sure such information is available on 

the box [ASTM in press] or from the 

manufacturer. 

— Consider latex-sensitive workers 

[NIOSH 1997] and remember that a 

number of glove materials are suitable for protecting workers from antineoplastic drugs [Connor 1999; 

Singleton and Connor 1999; Klein et 

al. 2003]. 

— Consider using chemotherapy gloves 

for hazardous drugs that are not chemotherapy drugs or for which no information is available. 

— Use double gloving for all activities involving hazardous drugs. Make sure 

that the outer glove extends over 

the cuff of the gown [Connor 1999; 

Brown et al. 2001]. 

— Inspect gloves for physical defects 

before use. 

— Wash hands with soap and water before donning protective gloves and 

immediately after removal. 

— Change gloves every 30 minutes or 

when torn, punctured, or contaminated. Discard them immediately in a 

yellow chemotherapy waste container 

[ASHP 1990; Brown et al. 2001]. 

— Use disposable gowns made of 

polyethylene-coated polypropylene 

(which is nonlinting and nonabsorbent). These gowns offer better protection than polypropylene gowns 

against many of the antineoplastic 

drugs [Connor 1993; Harrison and 

Kloos 1999]. Make sure gowns have 

closed fronts, long sleeves, and elastic or knit closed cuffs. 

— Dispose of protective gowns after 

each use. 

— Use disposable sleeve covers to protect the wrist area and remove the 

covers after the task is complete. 

 When drug preparation is complete, seal 

the final product in a plastic bag or other 

sealable container for transport before 

taking it out of the ventilated cabinet. 

 Seal and wipe all waste containers inside 

the ventilated cabinet before removing 

them from the cabinet. 

 Remove all outer gloves and sleeve covers and bag them for disposal while you 

are inside the ventilated cabinet. 

 Wash hands with soap and water immediately after removing gloves. 

 Consider using devices such as closedsystem transfer devices, glovebags, and 

needleless systems when transferring 

hazardous drugs from primary packaging 

(such as vials) to dosing equipment (such 

as infusion bags, bottles, or pumps). 

Closed systems limit the potential for generating aerosols and exposing workers to 

sharps. Evidence documents a decrease in 

Hazardous Drugs in Health Care Settings 13 
 

 

drug contaminants inside a Class II BSC 

when a closed-system transfer device 

is used [Sessink et al. 1999; Vandenbroucke and Robays 2001; Connor et al. 

2002; Nygren et al. 2002; Spivey and 

Connor 2003; Wick et al. 2003]. 

— Remember that a closed-system 

transfer device is not an acceptable 

substitute for a ventilated cabinet 

and should be used only within a 

ventilated cabinet. 

— Use appropriate PPE and work practices even when you are using a 

closed system. 

 Have pharmacy personnel prime the IV 

tubing and syringes inside the ventilated 

cabinet, or prime them in-line with nondrug solutions—never in the patient’s 

room. 

Administering hazardous drugs 

 Administer drugs safely by using protective medical devices (such as needleless 

and closed systems) and techniques 

(such as priming of IV tubing by pharmacy personnel inside a ventilated 

cabinet or priming in-line with nondrug 

solutions). 

 Wear PPE (including double gloves, 

goggles, and protective gowns) for all activities associated with drug administration—opening the outer bag, assembling 

the delivery system, delivering the drug 

to the patient, and disposing of all equipment used to administer drugs. 

 Attach drug administration sets to the IV 

bag, and prime them before adding the 

drug to the bag. 

 Never remove tubing from an IV bag containing a hazardous drug. 

 Do not disconnect tubing at other points 

in the system until the tubing has been 

thoroughly flushed. 

 Remove the IV bag and tubing intact 

when possible. 

 Place disposable items directly in a yellow chemotherapy waste container and 

close the lid. 

 Remove outer gloves and gowns, and 

bag them for disposal in the yellow chemotherapy waste container at the site of 

drug administration. 

 Double-bag the chemotherapy waste 

before removing the inner gloves. 

 Consider double bagging all contaminated equipment. 

 Wash hands with soap and water before 

leaving the drug administration site. 

Ventilated Cabinets 

Use of cabinets 

 Mix, prepare, and otherwise manipulate, count, crush, compound powders, 

or pour liquid hazardous drugs inside a 

ventilated cabinet designed to prevent 

hazardous drugs from being released 

into the work environment. 

 Do not use supplemental engineering 

or process controls (such as needleless 

systems, glove bags, and closed-system 

drug transfer devices) as a substitution 

for ventilated cabinets, even though 

such controls may reduce the potential 

for exposure when preparing and administering hazardous drugs. 

Selection 

 Consult the following document for performance test methods and selection 

14 Hazardous Drugs in Health Care Settings 
 

 

 

 

 

 

 

 

 

 

 

 

 

criteria for BSCs: Primary Containment 

for Biohazards: Selection, Installation 

and Use of Biological Safety Cabinets, 

2nd edition [CDC/NIH 2000]. 

 Select a ventilated cabinet depending on 

the need for aseptic processing. Aseptic 

technique is important for protecting 

hazardous drugs from possible contamination. However, it is also important to 

consider worker protection and to assure that worker safety and health is 

not sacrificed. Therefore, when asepsis 

is required or recommended, use ventilated cabinets designed for both hazardous drug containment and aseptic 

processing. Aseptic requirements are 

generally regulated by individual State 

boards of pharmacy [Thompson 2003; 

USP 2004]. 

 When asepsis is not required, a Class I 

BSC or an isolator intended for containment applications (a “containment isolator”) may be sufficient. 

 When aseptic technique is required, use 

one of the following ventilated cabinets: 

— Class II BSC (Type B2 is preferred, 

but Types A2 and B1 are allowed 

under certain conditions) 

— Class III BSC 

— Isolators intended for asepsis and 

containment (aseptic containment isolators) [NSF/ANSI 2002; PDA 2001] 

Air flow and exhaust 

 Regardless of type, equip each ventilated 

cabinet with a continuous monitoring device to confirm adequate air flow before 

each use. 

 Use a high-efficiency particulate air filter 

(HEPA filter) for the exhaust from these 

controls, and where feasible, exhaust 

100% of the filtered air to the outside. 

 Install the outside exhaust so that the 

exhausted air is not pulled back into the 

building by the heating, ventilating, and 

air conditioning (HVAC) systems or by the 

windows, doors, or other points of entry. 

 Place fans downstream of the HEPA filter 

so that contaminated ducts are maintained under negative pressure. 

 Do not use a ventilated cabinet that recirculates air inside the cabinet or exhausts 

air back into the room environment unless the hazardous drug(s) in use will not 

volatilize (evaporate) while they are being handled or after they are captured by 

the HEPA filter. Information about volatilization should be supplied by the drug 

manufacturer (possibly in the MSDS) or 

by air-sampling data. 

 Seek additional information about placement of the cabinet, exhaust system, and 

stack design from NSF/ANSI 49–2002 

[NSF/ANSI 2002]. Incorporate their recommendations regardless of the type of 

ventilated cabinet selected. 

Maintenance 

 Identify a safety and health representative familiar with potential drug exposures and their hazards. Ask that person 

to review in advance all maintenance activities performed on ventilated cabinets 

and exhaust systems associated with 

hazardous drug procedures. 

 Develop a written safety plan for all routine maintenance activities performed on 

equipment that could be contaminated 

with hazardous drugs. 

Hazardous Drugs in Health Care Settings 15 
 

 

 

 

 

 

 

 

 Properly install and maintain and routinely clean any Class II BSC. 

— Field-certify its performance (1) after 

installation, relocation, maintenance 

repairs to internal components, and 

HEPA filter replacement, and (2) every 6 months thereafter [NSF/ANSI 

2002; OSHA 1999]. 

— Prominently display a current fieldcertification label on the ventilated 

cabinet [NSF/ANSI 2002]. 

 Treat other types of ventilated cabinets 

similarly with regard to care and frequency-of-performance verification 

tests. 

 Select the appropriate performance and 

test methods for isolators, depending on 

the type (containment-only or aseptic 

containment), the operating pressure 

(positive or negative and designed magnitude), and the toxicity of the hazardous 

drug: 

— At a minimum, provide isolators with 

a leak test and a containment integrity test such as those described 

in Guidelines for Gloveboxes [AGS 

1998]. 

— Perform a HEPA filter leak test (described in NSF/ANSI [2002]) for isolators that rely on HEPA filtration for 

containment. 

— Perform additional tests as required 

by local and/or national jurisdictions 

to verify aseptic conditions. 

 Make sure that workers performing maintenance are 

— familiar with applicable safety plans, 

— warned about hazards, and 

— trained in appropriate work techniques and PPE needed to minimize 

exposure. 

 Remove all hazardous drugs and chemicals, and decontaminate the ventilated 

cabinet before beginning maintenance 

activities. 

 Warn occupants in the affected areas 

immediately before the maintenance activity begins, and place warning signs on 

all equipment that may be affected. 

 Strictly follow all applicable lockout/tagout 

procedures [29 CFR 1910.147]. 

 Decontaminate and bag equipment parts 

removed for replacement or repair before 

they are taken outside the facility. 

 Seal used filtration media in plastic immediately upon removal, and tag it for 

disposal as chemotherapy waste; or dispose of it as otherwise directed by the 

environmental safety and health office or 

applicable regulation. 

Routine Cleaning, Decontaminating, 

Housekeeping, and Waste Disposal 

Cleaning and decontaminating 

 Perform cleaning and decontamination 

work in areas that are sufficiently ventilated to prevent buildup of hazardous airborne drug concentrations. Develop protocols prohibiting the use of unventilated 

areas such as storage closets for drug 

storage or any tasks involving hazardous 

drugs. 

 Clean work surfaces with an appropriate deactivation agent (if available) and 

cleaning agent before and after each activity and at the end of the work shift. 

16 Hazardous Drugs in Health Care Settings 
 

 

 

 

 

 

 

 

 

 

 

 Establish periodic cleaning routines for 

all work surfaces and equipment that 

may become contaminated, including 

administration carts and trays. 

 At a minimum, wear safety glasses with 

side shields and protective gloves for 

cleaning and decontaminating work. 

 Wear face shields if splashing is possible. 

 Wear protective double gloves for decontaminating and cleaning work. 

— Select them by referring to the MSDS, 

glove selection guidelines, or information from the glove manufacturer. 

— Make sure the gloves are chemically 

resistant to the decomtamination or 

cleaning agent used. 

Housekeeping 

 Wear two pairs of protective gloves and a 

disposable gown if you must handle linens, feces, or urine from patients who 

have received hazardous drugs within 

the last 48 hours—or in some cases, 

within the last 7 days [Cass and Musgrave 1992]. 

 Dispose of the gown after each use or 

whenever it becomes contaminated. 

 Wear face shields if splashing is possible. 

 Remove the outer gloves and the gown 

by turning them inside out and placing them into the yellow chemotherapy 

waste container. Repeat the procedure 

for the inner gloves. 

 Wash hands with soap and water after 

removing the gloves. 

Waste disposal 

 Be aware of the various types of waste 

generated by preparing and administering hazardous drugs: partially filled vials, 

undispensed products, unused IVs, needles and syringes, gloves, gowns, underpads, and contaminated materials from 

spill cleanups. 

 Place trace wastes (those that contain 

less than 3% by weight of the original 

quantity of hazardous drugs)—such 

as needles, empty vials and syringes, 

gloves, gowns, and tubing—in yellow 

chemotherapy waste containers. Assuring that drug-contaminated waste is 

properly contained will protect workers 

from respiratory exposure to volatile or 

micro-aerosolized drugs [Connor et al. 

2000; Kiffmeyer et al. 2002; Larson et 

al. 2003]. 

— Place soft trace items (those that are 

contaminated with trace amounts of 

hazardous drugs) in yellow chemotherapy bags for disposal by incineration at a regulated medical waste 

facility. 

— Place empty vials and sharps such 

as needles and syringes in chemotherapy waste containers designed 

to protect workers from injuries and 

dispose of them by incineration at a 

regulated medical waste facility. 

 Do not place hazardous drug-contaminated sharps in red sharps containers 

that are used for infectious wastes, 

since these are often autoclaved or 

microwaved [ASHP 1990; OSHA 1999; 

Smith 2002]. 

 Dispose of P-listed arsenic trioxide and 

its containers and any bulk amounts 

of U-listed drugs [40 CFR 261.33] in 

Hazardous Drugs in Health Care Settings 17 
 

 

 

 

 

 

 

 

 

 

hazardous waste containers at a RCRApermitted incinerator. Nine hazardous 

drugs in Appendix A are listed as hazardous waste§

 by EPA. 

 Consider disposing of other bulk hazardous drugs (that is, expired or unused vials, ampoules, syringes, bags, and bottles of hazardous drugs or solutions of 

any other items with more than trace 

contamination) in a manner similar to 

that required for RCRA-defined hazardous wastes as recommended by ASHP 

[1990] and OSHA [1999]. 

Spill Control 

 Manage hazardous drug spills according 

to the established, written policies and 

procedures for each workplace. 

 Be aware that the size of the spill might 

determine who is authorized to conduct 

the cleanup and decontamination and 

how the cleanup is managed. 

 Assure that the written policies and procedures address the protective equipment required for various spill sizes, the 

possible spreading of material, restricted 

access to hazardous drug spills, and 

signs to be posted. 

 Assure that cleanup of a large spill is 

handled by workers who are trained in 

handling hazardous materials [29 CFR 

1910.120]. 

 Locate spill kits and other cleanup materials in the immediate area where exposures may occur. 

§

Arsenic trioxide is a P-listed hazardous waste. Chlorambucil, 

cyclophosphamide, daunorubicin HCI, diethylstilbestrol, 

melphalan, mitomycin, streptozocin, and uracil mustard 

are U-listed hazardous wastes. See 40 CFR 261.33. 

 As required by OSHA, follow a complete 

respiratory protection program, including 

fit-testing, if you wear respirators such 

as those contained in some spill kits 

[29 CFR 1910.134]. Use NIOSH-certified respirators [42 CFR 84]. Surgical 

masks do not provide adequate protection. 

 Dispose of all spill cleanup materials in a 

hazardous chemical waste container, in 

accordance with EPA/RCRA regulations 

regarding hazardous waste—not in a 

chemotherapy waste or biohazard container. 

Medical Surveillance 

 In addition to preventing exposure to hazardous drugs and carefully monitoring the 

environment, make medical surveillance 

an important part of any safe handling 

program for hazardous drugs. 

 If you handle hazardous drugs, participate in medical surveillance programs 

provided at your workplace. 

 If you handle hazardous drugs but have 

no medical surveillance program at work, 

see your private health care provider for 

routine medical care. Be sure to inform 

him or her about your occupation and 

possible exposures to hazardous drugs. 

 Refer to the OSHA Technical Manual: 

Controlling Occupational Exposure to 

Hazardous Drugs, Section VI Chapter 2 

[OSHA 1999]. This document currently 

recommends that workers handling hazardous drugs be monitored in a medical 

surveillance program that includes the 

taking of a medical and exposure history, 

physical examination, and some laboratory tests. 

18 Hazardous Drugs in Health Care Settings 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Refer to the guidelines of professional 

organizations such as the ASHP [1990] 

and the Oncology Nursing Society [Brown 

et al. 2001], which recommend medical surveillance as the recognized standard of occupational health practice for 

hazardous drug handlers. The American 

College of Occupational and Environmental Medicine (ACOEM) also recommends surveillance for these workers in 

their Reproductive Hazard Management 

Guidelines [ACOEM 1996]. 

 Use a worker’s past exposure his

ACKNOWLEDGMENTS 

tory as 

a surrogate measure of potential exposure intensity. 

 If you are an occupational health professional who is examining a drug-exposed 

worker, ask questions that focus on the 

worker’s symptoms relating to the organ 

systems that are known targets for the 

hazardous drugs. 

— For example, after an acute exposure such as a splash or other drug 

contact with skin or mucous membranes, focus the physical examination on the exposed areas and the 

clinical signs of rash or irritation to 

those areas. 

— Include a complete blood count with 

differential and a reticulocyte count in 

the baseline and periodic laboratory 

tests. These may be helpful as an 

indicator of bone marrow reserve. 

 Monitor the urine of workers who handle 

hazardous drugs with a urine dipstick or 

a microscopic examination of the urine 

for blood [Brown et al. 2001]. Several antineoplastic agents are known to 

cause bladder damage and blood in the 

urine of treated patients. 

 Conduct environmental sampling and/or 

biological monitoring when exposure is 

suspected or symptoms have been noted. 

ADDITIONAL INFORMATION 

Additional information about exposure to 

hazardous drugs is available at 1–800–35– 

NIOSH (1–800–356–4674), fax: 1–513– 

533–8573, E-mail: pubstaft@cdc.gov, or 

Web site: www.cdc.gov/NIOSH. 

Additional information about hazardous drug 

safety is available at www.osha.gov. 

This Alert was written by G. Edward Burroughs, 

Ph.D., C.I.H.1; Thomas H. Connor, Ph.D.1; 

Melissa A. McDiarmid, M.D., M.P.H.4; Kenneth 

R. Mead, M.S., P.E.1; Luci A. Power, M.S., 

R.Ph.6; and Laurence D. Reed, M.S.1 

Major contributors to this Alert were Barbara 

J. Coyle, B.S.N., R.N. C.O.H.N.-S.2

; Duane R. 

Hammond, B.S.M.E.1

; Melissa M. Leone, R.N., 

B.S.N.3

; Marty Polovich, M.N., R.N., A.O.C.N.5; 

and Douglas D. Sharpnack, D.V.M.1 

Contributions to this Alert were also made 

by members of the NIOSH Hazardous Drug 

Safe Handling Working Group. A complete 

listing of the agencies and organizations who 

contributed to this Alert is listed in Appendix 

C. Anne C. Hamilton, Vanessa Becks, Susan 

Afanuh, Jane Weber, Andre Allen, Anne Votaw, and Teresa Lewis provided editorial and 

production services. 

1

NIOSH; 2State of Wisconsin; 3Apria Healthcare; 4University 

of Maryland; 5Oncology Nursing Society; 6University of 

California Medical Center 

Hazardous Drugs in Health Care Settings 19 
 

 

 

 

 

 

 

 

 

 

 

 

 

Support for the development of this Alert 

was provided by the National Occupational Research Agenda (NORA) Control Technology and Personal Protective Equipment 

Team and the NORA Reproductive Health 

Research Team. 

Please direct comments, questions, or requests for additional information to the following: 

Director, Division of Applied Research

 and Technology
Ê

National Institute for Occupational

 Safety and Health
Ê

4676 Columbia Parkway
Ê

Cincinnati, OH 45226–1998
Ê

Telephone: 1–513–533–8462 or
Ê

1–800–35–NIOSH
Ê

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30 Hazardous Drugs in Health Care Settings 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

APPENDIX A
Ê

DRUGS CONSIDERED HAZARDOUS
Ê

General Approach to Handling 

Hazardous Drugs 

In this Alert, NIOSH presents a standard 

precautions or universal precautions approach to handling hazardous drugs safely: 

that is, NIOSH recommends that all hazardous drugs be handled as outlined in this 

Alert. Therefore, no attempt has been made 

to perform drug risk assessments or propose exposure limits. The area of new drug 

development is rapidly evolving as unique 

approaches are being taken to treat cancer 

and other serious diseases. 

Defining Hazardous Drugs 

Hazardous drugs include those used for 

cancer chemotherapy, antiviral drugs, hormones, some bioengineered drugs, and 

other miscellaneous drugs. The definition of 

hazardous drugs used in this Alert is based 

on an ASHP definition that was originally 

developed in 1990 [ASHP 1990]. Thus the 

definition may not accurately reflect the 

toxicity criteria associated with the newer 

generation of pharmaceuticals entering the 

health care setting. For example, bioengineered drugs target specific sites in the 

body; and although they may or may not be 

toxic to the patient, some may not pose a 

risk to health care workers. 

NIOSH and other organizations are still 

gathering data on the potential toxicity and 

health effects related to highly potent drugs 

and bioengineered drugs. Therefore, when 

working with any hazardous drug, health 

care workers should follow a standard precautions approach along with any recommendations included in the manufacturer’s 

MSDSs. 

ASHP Definition of Hazardous 

Drugs 

The ASHP defines hazardous drugs in their 

1990 revision of Technical Assistance Bulletin on Handling Hazardous Drugs [ASHP 

1990]. The bulletin gives criteria for identifying potentially hazardous drugs that should 

be handled in accordance with an established 

safety program [McDiarmid et al. 1991; Arrington and McDiarmid 1993]. The criteria 

are prioritized to reflect the hierarchy of 

potential toxicity described below. Since the 

hazardous drugs covered by this Alert were 

designed as therapeutic agents for humans, 

human toxicity profiles should be considered 

superior to any data from animal models 

or in vitro systems. Additional guidance for 

defining hazardous drugs is available in the 

following citations: carcinogenicity [61 Fed. 

Reg. 17960–18011 (1996b); IARC 2004], 

teratogenicity [56 Fed. Reg. 63798–63826 

(1991)], developmental toxicity [56 Fed. 

Reg. 63798–63826 (1991)], and reproductive toxicity [61 Fed. Reg. 56274–56322 

Hazardous Drugs in Health Care Settings 31 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1996a)]. Physical characteristics of the 

agents (such as liquid versus solid, or water versus lipid solubility) also need to be 

considered in determining the potential for 

occupational exposure. 

NIOSH Revision of ASHP 

Definition 

The 1990 ASHP definition of hazardous 

drugs** was revised by the NIOSH Working 

Group on Hazardous Drugs for this Alert. 

Drugs considered hazardous include those 

that exhibit one or more of the following six 

characteristics in humans or animals: 

1. Carcinogenicity 

2. Teratogenicity or other developmental 

toxicity†† 

3. Reproductive toxicity†† 

4. Organ toxicity at low doses†† 

**ASHP [1990] definition of hazardous drugs: 

1. Genotoxicity (i.e., mutagenicity and clastogenicity in 

short-term test systems) 

2. Carcinogenicity in animal models, in the patient population, or both, as reported by the International Agency for 

Research on Cancer (IARC) 

3. Teratogenicity or fertility impairment in animal studies 

or in treated patients 

4. Evidence of serious organ or other toxicity at low doses 

in animal models or treated patients. 

††All drugs have toxic side effects, but some exhibit toxicity 

at low doses. The level of toxicity reflects a continuum 

from relatively nontoxic to production of toxic effects in 

patients at low doses (for example, a few milligrams or 

less). For example, a daily therapeutic dose of 10 mg/ 

day or a dose of 1 mg/kg per day in laboratory animals 

that produces serious organ toxicity, developmental 

toxicity, or reproductive toxicity has been used by the 

pharmaceutical industry to develop occupational 

exposure limits (OELs) of less than 10 μg/m3 after 

applying appropriate uncertainty factors [Sargent and 

Kirk 1988; Naumann and Sargent 1997; Sargent et 

al. 2002]. OELs in this range are typically established 

for potent or toxic drugs in the pharmaceutical industry. 

Under all circumstances, an evaluation of all available 

data should be conducted to protect health care 

workers. 

5. Genotoxicity‡‡ 

6. Structure and toxicity profiles of new 

drugs that mimic existing drugs determined hazardous by the above 

criteria. 

Determining Whether a Drug is 

Hazardous 

Many hazardous drugs used to treat cancer 

bind to or damage DNA (for example, alkylating agents). Other antineoplastic drugs, some 

antivirals, antibiotics, and bioengineered drugs 

interfere with cell growth or proliferation, or 

with DNA synthesis. In some cases, the 

nonselective actions of these drugs disrupt 

the growth and function of both healthy and 

diseased cells, resulting in toxic side effects 

for treated patients. These nonselective 

actions can also cause adverse effects in 

health care workers who are inadvertently 

exposed to hazardous drugs. 

Early concerns about occupational exposure to antineoplastic drugs first appeared 

in the 1970s. Although the antineoplastic 

drugs remain the principal focus of this 

Alert, other drugs may also be considered 

hazardous because they are potent (small 

quantities produce a physiological effect) or 

cause irreversible effects. As the use and 

number of these potent drugs increase, so 

do opportunities for hazardous exposures 

among health care workers. For example, 

antineoplastic drugs such as cyclophosphamide have immunosuppressant effects that 

proved beneficial for treating nonmalignant 

‡‡In evaluating mutagenicity for potentially hazardous drugs, 

responses from multiple test systems are needed before 

precautions can be required for handling such agents. 

The EPA evaluations include the type of cells affected 

and in vitro versus in vivo testing [51 Fed. Reg. 34006– 

34012 (1986)]. 

32 Hazardous Drugs in Health Care Settings 
 

 

 

diseases such as rheumatoid arthritis 

and multiple sclerosis [Baker et al. 1987; 

Moody et al. 1987; Chabner et al. 1996; 

Abel 2000]. 

This appendix presents criteria and sources 

of information for determining whether a 

drug is hazardous. When a drug has been 

judged to be hazardous, the various precautions outlined in this Alert should be applied 

when handling that drug. Also included is a 

list of drugs that should be handled as hazardous. This list is based on a compilation of 

lists from four health care facilities and one 

drug manufacturers’ organization. 

In addition to using the list of hazardous drugs 

presented here, each organization should 

create its own list of drugs considered to 

be hazardous. This appendix presents guidance for making such a facility-specific list 

(see section entitled How to Generate your 

own List of Hazardous Drugs). Once this list 

is made, newly purchased drugs should be 

evaluated against the organization’s hazardous drug criteria and added to the list if they 

are deemed hazardous. 

Some organizations may have inadequate 

resources for determining their own list of 

hazardous drugs. If so, the sample list of 

hazardous drugs in this appendix (current 

only to the printing date of this document) 

will help employers and workers to determine when precautions are needed. However, reliance on such a published list is a concern because it quickly becomes outdated 

as new drugs continually enter the market 

or listed drugs are removed when additional 

information becomes available. To fill this 

knowledge gap, NIOSH will update an internet list annually, adding new drugs considered to be hazardous and removing those 

that require reclassification. This hazardous 

drug list will be posted on the NIOSH Web 

site at www.cdc.gov/niosh. 

How to Generate Your Own List of 

Hazardous Drugs 

The OSHA hazard communication standard 

[29 CFR 1910.1200] requires employers to 

develop a hazard communication program 

appropriate for their unique workplace. An 

essential part of the program is the identification of all hazardous drugs a worker may 

encounter in the facility. Compliance with 

the OSHA hazard communication standard 

entails (1) evaluating whether these drugs 

meet one or more of the criteria for defining 

hazardous drugs and (2) posting a list of the 

hazardous drugs to ensure worker safety. 

Institutions may wish to compare their lists 

to the sample listing in this document or on 

the NIOSH Web site. 

It is not likely that every health care provider or facility will use all drugs that have 

received U.S. Food and Drug Administration (FDA) approval, and the OSHA hazard 

communication standard does not mandate 

evaluation of every marketed drug. Instead, 

compliance requires practice-specific assessments for drugs used at any one time 

by a facility. However, hazardous drug evaluation is a continual process. Local hazard 

communication programs should provide 

for assessment of new drugs as they enter the marketplace, and when appropriate, 

reassessment of their presence on hazardous drug lists as toxicological data become available to support recategorization. 

Toxicological data are often incomplete or 

unavailable for investigational drugs. However, if the mechanism of action suggests 

that there may be a concern, it is prudent 

Hazardous Drugs in Health Care Settings 33 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

to handle them as hazardous drugs until 

adequate information becomes available to 

exclude them. 

Some drugs defined as hazardous may not 

pose a significant risk of direct occupational 

exposure because of their dosage formulation (for example, coated tablets or capsules—solid, intact medications that are administered to patients without modifying the 

formulation). However, they may pose a risk 

if solid drug formulations are altered, such as 

by crushing tablets or making solutions from 

them outside a ventilated cabinet. 

Where to Find Information 

Related to Drug Toxicity 

Practice-specific lists of hazardous drugs 

(usually developed by pharmacy or nursing 

departments) should be comprehensive, including all hazardous medications routinely 

used or very likely to be used by a local practice. Some of the resources that employers 

can use to evaluate the hazard potential of 

a drug include, but are not limited to, the 

following: 

 MSDSs 

 Product labeling approved by the U.S. 

FDA (package inserts) 

 Special health warnings from drug manufacturers, FDA, and other professional 

groups and organizations 

 Reports and case studies published in 

medical and other health care profession 

journals 

 Evidence-based recommendations from 

other facilities that meet the criteria defining hazardous drugs 

Examples of Hazardous Drugs 

The following list contains a sampling of major hazardous drugs. The list was compiled 

from information provided by (1) four institutions that have generated lists of hazardous drugs for their respective facilities, (2) 

the American Hospital Formulary Service 

Drug Information (AHFS DI) monographs 

[ASHP/AHFS DI 2003], and (3) several other 

sources. The OSHA hazard communication 

standard requires hazardous drugs to be 

handled using special precautions. The mandate applies not only to health care professionals who provide direct patient care but 

also to others who support patient care by 

participating in product acquisition, storage, 

transportation, housekeeping, and waste disposal. Institutions may want to adopt this list 

or compare theirs with the list on the NIOSH 

Web site. 

Caution: Drugs purchased and used by a 

facility may have entered the marketplace 

after the list below was assembled. Therefore, this list may not be all-inclusive. 

If you use a drug that is not included in the 

list of examples, check the available literature to see whether the unlisted drug should 

be treated as hazardous. Check the MSDS 

or the proper handling section of the package insert; or check with other institutions 

that might be using the same drug. If any 

of the documents mention carcinogenicity, 

genotoxicity, teratogenicity, or reproductive or 

developmental toxicity, use the precautions 

stipulated in this Alert. If a drug meets one or 

more of the criteria for hazardous drugs listed 

in this Alert, handle it as hazardous. 

The listing below is a sample of what will be 

available on the NIOSH Web site [www.cdc.gov/ 

niosh], and this list will be updated annually. 

34 Hazardous Drugs in Health Care Settings 
Sample list of drugs that should be handled as hazardous*
Ê

AHFS Pharmacologic-Therapeutic 

Drug Source Classification 

Aldesleukin 4,5 10:00 Antineoplastic agents 

Alemtuzumab 1,3,4,5 10:00 Antineoplastic agents 

Alitretinoin 3,4,5 84:36 Miscellaneous skin and 

mucous membrane agents (Retinoid) 

Altretamine 1,2,3,4,5 Not in AHFS (Antineoplastic agent) 

Amsacrine 3,5 Not in AHFS (Antineoplastic agent) 

Anastrozole 1,5 10:00 Antineoplastic agents 

Arsenic trioxide 1,2,3,4,5 10:00 Antineoplastic agents 

Asparaginase 1,2,3,4,5 10:00 Antineoplastic agents 

Azacitidine 3,5 Not in AHFS (antineoplastic agent) 

Azathioprine 2,3,5 92:00 Unclassified therapeutic 

agents (immunosuppressant) 

Bacillus Calmette-Guerin 1,2,4 80:12 Vaccines 

Bexarotene 2,3,4,5 10:00 Antineoplastic agents 

Bicalutamide 1,5 10:00 Antineoplastic agents 

Bleomycin 1,2,3,4,5 10:00 Antineoplastic agents 

Busulfan 1,2,3,4,5 10:00 Antineoplastic agents 

Capecitabine 1,2,3,4,5 10:00 Antineoplastic agents 

Carboplatin 1,2,3,4,5 10:00 Antineoplastic agents 

Carmustine 1,2,3,4,5 10:00 Antineoplastic agents 

Cetrorelix acetate 5 92:00 Unclassified therapeutic 

agents (GnRH antagonist) 

Chlorambucil 1,2,3,4,5 10:00 Antineoplastic agents 

Chloramphenicol 1,5 8:12 Antibiotics 

Choriogonadotropin alfa 5 68:18 Gonadotropins 

Cidofovir 3,5 8:18 Antivirals 

Cisplatin 1,2,3,4,5 10:00 Antineoplastic agents 

Cladribine 1,2,3,4,5 10:00 Antineoplastic agents 

Colchicine 5 92:00 Unclassified therapeutic 

agents (mitotic inhibitor) 

(See footnotes at end of table)

Hazardous Drugs in Health Care Settings 35 
Sample list of drugs that should be handled as hazardous* (Continued)
Ê

AHFS Pharmacologic-Therapeutic 

Drug Source Classification 

Cyclophosphamide 1,2,3,4,5 10:00 Antineoplastic agents 

Cytarabine 1,2,3,4,5 10:00 Antineoplastic agents 

Cyclosporin 1 92:00 Immunosuppressive agents 

Dacarbazine 1,2,3,4,5 10:00 Antineoplastic agents 

Dactinomycin 1,2,3,4,5 10:00 Antineoplastic agents 

Daunorubicin HCl 1,2,3,4,5 10:00 Antineoplastic agents 

Denileukin 3,4,5 10:00 Antineoplastic agents 

Dienestrol 5 68:16.04 Estrogens 

Diethylstilbestrol 5 Not in AHFS (nonsteroidal synthetic 

estrogen) 

Dinoprostone 5 76:00 Oxytocics 

Docetaxel 1,2,3,4,5 10:00 Antineoplastic agents 

Doxorubicin 1,2,3,4,5 10:00 Antineoplastic agents 

Dutasteride 5 92:00 Unclassified therapeutic 

agents (5-alpha reductase inhibitor) 

Epirubicin 1,2,3,4,5 10:00 Antineoplastic agents 

Ergonovine/methylergonovine 5 76:00 Oxytocics 

Estradiol 1,5 68:16.04 Estrogens 

Estramustine phosphate 1,2,3,4,5 10:00 Antineoplastic agents 

 sodium 

Estrogen-progestin combina- 5 68:12 Contraceptives 

tions 

Estrogens, conjugated 5 68:16.04 Estrogens 

Estrogens, esterified 5 68:16.04 Estrogens 

Estrone 5 68:16.04 Estrogens 

Estropipate 5 68:16.04 Estrogens 

Etoposide 1,2,3,4,5 10:00 Antineoplastic agents 

Exemestane 1,5 10:00 Antineoplastic agents 

Finasteride 1,3,5 92:00 Unclassified therapeutic 

Agents (5-alpha reductase inhibitor) 

Floxuridine 1,2,3,4,5 10:00 Antineoplastic agents 

(See footnotes at end of table)

36 Hazardous Drugs in Health Care Settings 
Sample list of drugs that should be handled as hazardous* (Continued)
Ê

AHFS Pharmacologic-Therapeutic 

Drug Source Classification 

Fludarabine 1,2,3,4,5 10:00 Antineoplastic agents 

Fluorouracil 1,2,3,4,5 10:00 Antineoplastic agents 

Fluoxymesterone 5 68:08 Androgens 

Flutamide 1,2,5 10:00 Antineoplastic agents 

Fulvestrant 5 10:00 Antineoplastic agents 

Ganciclovir 1,2,3,4,5 8:18 Antiviral 

Ganirelix acetate 5 92:00 Unclassified therapeutic 

agents (GnRH antagonist) 

Gemcitabine 1,2,3,4,5 10:00 Antineoplastic agents 

Gemtuzumab ozogamicin 1,3,4,5 10:00 Antineoplastic agents 

Gonadotropin, chorionic 5 68:18 Gonadotropins 

Goserelin 1,2,5 10:00 Antineoplastic agents 

Hydroxyurea 1,2,3,4,5 10:00 Antineoplastic agents 

Ibritumomab tiuxetan 3 10:00 Antineoplastic agents 

Idarubicin 1,2,3,4,5 Not in AHFS (antineoplastic agent) 

Ifosfamide 1,2,3,4,5 10:00 Antineoplastic agents 

Imatinib mesylate 1,3,4,5 10:00 Antineoplastic agents 

Interferon alfa-2a 1,2,4,5 10:00 Antineoplastic agents 

Interferon alfa-2b 1,2,4,5 10:00 Antineoplastic agents 

Interferon alfa-n1 1,5 10:00 Antineoplastic agents 

Interferon alfa-n3 1,5 10:00 Antineoplastic agents 

Irinotecan HCl 1,2,3,4,5 10:00 Antineoplastic agents 

Leflunomide 3,5 92:00 Unclassified therapeutic agents 

(antineoplastic agent) 

Letrozole 1,5 10:00 Antineoplastic agents 

Leuprolide acetate 1,2,5 10:00 Antineoplastic agents 

Lomustine 1,2,3,4,5 10:00 Antineoplastic agents 

Mechlorethamine 1,2,3,4,5 10:00 Antineoplastic agents 

Megestrol 1,5 10:00 Antineoplastic agents 

Melphalan 1,2,3,4,5 10:00 Antineoplastic agents 

(See footnotes at end of table)

Hazardous Drugs in Health Care Settings 37 
Sample list of drugs that should be handled as hazardous* (Continued)
Ê

AHFS Pharmacologic-Therapeutic 

Drug Source Classification 

Menotropins 5 68:18 Gonadotropins 

Mercaptopurine 1,2,3,4,5 10:00 Antineoplastic agents 

Methotrexate 1,2,3,4,5 10:00 Antineoplastic agents 

Methyltestosterone 5 68:08 Androgens 

Mifepristone 5 76:00 Oxytocics 

Mitomycin 1,2,3,4,5 10:00 Antineoplastic agents 

Mitotane 1,4,5 10:00 Antineoplastic agents 

Mitoxantrone HCl 1,2,3,4,5 10:00 Antineoplastic agents 

Mycophenolate mofetil 1,3,5 92:00 Immunosuppressive agents 

Nafarelin 5 68:18 Gonadotropins 

Nilutamide 1,5 10:00 Antineoplastic agents 

Oxaliplatin 1,3,4,5 10:00 Antineoplastic agents 

Oxytocin 5 76:00 Oxytocics 

Paclitaxel 1,2,3,4,5 10:00 Antineoplastic agents 

Pegaspargase 1,2,3,4,5 10:00 Antineoplastic agents 

Pentamidine isethionate 1,2,3,5 8:40 Miscellaneous anti-infectives 

Pentostatin 1,2,3,4,5 10:00 Antineoplastic agents 

Perphosphamide 3,5 Not in AHFS (antineoplastic agent) 

Pipobroman 3,5 Not in AHFS (antineoplastic agent) 

Piritrexim isethionate 3,5 Not in AHFS (antineoplastic agent) 

Plicamycin 1,2,3,5 Not in AHFS (antineoplastic agent) 

Podoflilox 5 84:36 Miscellaneous skin and mucous 

membrane agents (mitotic inhibitor) 

Podophyllum resin 5 84:36 Miscellaneous skin and mucous 

membrane agents (mitotic inhibitor) 

Prednimustine 3,5 Not in AHFS (antineoplastic agent) 

Procarbazine 1,2,3,4,5 10:00 Antineoplastic agents 

Progesterone 5 68:32 Progestins 

Progestins 5 68:12 Contraceptives 

(See footnotes at end of table)

38 Hazardous Drugs in Health Care Settings 
Sample list of drugs that should be handled as hazardous* (Continued)
Ê

AHFS Pharmacologic-Therapeutic 

Drug Source Classification 

Raloxifene 5 68:16.12 Estrogen agonists-antagonists 

Raltitrexed 5 Not in AHFS (antineoplastic agent) 

Ribavirin 1,2,5 8:18 Antiviral 

Streptozocin 1,2,3,4,5 10:00 Antineoplastic agents 

Tacrolimus 1,5 92:00 Unclassified therapeutic 

agents (immunosuppressant) 

Tamoxifen 1,2,5 10:00 Antineoplastic agents 

Temozolomide 3,4,5 10:00 Antineoplastic agents 

Teniposide 1,2,3,4,5 10:00 Antineoplastic agents 

Testolactone 5 10:00 Antineoplastic agents 

Testosterone 5 68:08 Androgens 

Thalidomide 1,3,5 92:00 Unclassified therapeutic 

agents (immunomodulator) 

Thioguanine 1,2,3,4,5 10:00 Antineoplastic agents 

Thiotepa 1,2,3,4,5 10:00 Antineoplastic agents 

Topotecan 1,2,3,4,5 10:00 Antineoplastic agents 

Toremifene citrate 1,5 10:00 Antineoplastic agents 

Tositumomab 3,5 Not in AHFS (antineoplastic agent) 

Tretinoin 1,2,3,5 84:16 Cell stimulants and 

proliferants (retinoid) 

Trifluridine 1,2,5 52:04.06 antivirals 

Trimetrexate glucuronate 5 8:40 Miscellaneous anti-infectives 

(folate antagonist) 

Triptorelin 5 10:00 Antineoplastic agents 

Uracil mustard 3,5 Not in AHFS (antineoplastic agent) 

Valganciclovir 1,3,5 8:18 Antiviral 

Valrubicin 1,2,3,5 10:00 Antineoplastic agents 

Vidarabine 1,2,5 52:04.06 Antivirals 

Vinblastine sulfate 1,2,3,4,5 10:00 Antineoplastic agents 

(See footnotes at end of table)

Hazardous Drugs in Health Care Settings 39 
Sample list of drugs that should be handled as hazardous* (Continued)
Ê

AHFS Pharmacologic-Therapeutic 

Drug Source Classification 

Vincristine sulfate 1,2,3,4,5 10:00 Antineoplastic agents 

Vindesine 1,5 Not in AHFS (antineoplastic agent) 

Vinorelbine tartrate 1,2,3,4,5 10:00 Antineoplastic agents 

Zidovudine 1,2,5 8:18:08 Antiretroviral agents

*These lists of hazardous drugs were used with the permission of the institutions that provided them and were adapted for 

use by NIOSH. The sample lists are intended to guide health care providers in diverse practice settings and should not 

be construed as complete representations of all of the hazardous drugs used at the referenced institutions. Some drugs 

defined as hazardous may not pose a significant risk of direct occupational exposure because of their dosage formulation 

(for example, intact medications such as coated tablets or capsules that are administered to patients without modifying 

the formulation). However, they may pose a risk if solid drug formulations are altered outside a ventilated cabinet (for 

example, if tablets are crushed or dissolved, or if capsules are pierced or opened). 1The NIH Clinical Center, Bethesda, MD (Revised 8/2002). 

The NIH Health Clinical Center Hazardous Drug (HD) List is part of the NIH Clinical Center’s hazard communication 

program. It was developed in compliance with the OSHA hazard communication standard [29 CFR 1910.1200] as it 

applies to hazardous drugs used in the workplace. The list is continually revised and represents the diversity of medical 

practice at the NIH Clinical Center; however, its content does not reflect an exhaustive review of all FDA-approved 

medications that may be considered hazardous, and it is not intended for use outside the NIH. 2The Johns Hopkins Hospital, Baltimore, MD (Revised 9/2002). 

3The Northside Hospital, Atlanta, GA (Revised 8/2002). 

4The University of Michigan Hospitals and Health Centers, Ann Arbor, MI (Revised 2/2003). 5This sample listing of hazardous drugs was compiled by the Pharmaceutical Research and Manufacturers of America 

(PhRMA) using information from the AHFS DI monographs published by ASHP in selected AHFS PharmacologicTherapeutic Classification categories [ASHP/AHFS DI 2003] and applying the definition for hazardous drugs. The list also 

includes drugs from other sources that satisfy the definition for hazardous drugs [PDR 2004; Sweetman 2002; Shepard 

2001; Schardein 2000; REPROTOX 2003]. Newly approved drugs that have structures or toxicological profiles that mimic 

the drugs on this list should also be included. This list was revised in June 2004. 

40 Hazardous Drugs in Health Care Settings 
IV 

APPENDIX B
Ê

ABBREVIATIONS AND GLOSSARY
Ê

Abbreviations 

ACGIH American Conference of Governmental Industrial Hygienists 

ACOEM American College of Occupational and Environmental Medicine 

AHFS American Hospital Formulary Service 

AHFS DI American Hospital Formulary Service Drug Information 

AGS American Glovebox Society 

ANSI American National Standards Institute 

ASHP American Society of Health-System Pharmacists (before 1995,

 American Society of Hospital Pharmacists) 

BSC Biological safety cabinet 

CDC Centers for Disease Control and Prevention 

FDA U.S. Food and Drug Administration 

ft foot (feet) 

HEPA high-efficiency particulate air 

HIV human immunodeficiency virus 

HVAC heating, ventilating, and air conditioning 

IARC International Agency for Research on Cancer 

intravenous 

kg kilogram(s) 

LPN licensed practical nurse 

m3 cubic meter(s) 

mg milligram(s) 

min minute (s) 

MSDS material safety data sheet 

NIH National Institutes of Health 

Hazardous Drugs in Health Care Settings 41 
 

 

 

 

NIOSH National Institute for Occupational Safety and Health 

NSF National Sanitation Foundation 

OEL(s) occupational exposure limit(s) 

ONS Oncology Nursing Society 

OSHA Occupational Safety and Health Administration 

PDA PDA (formerly, the Parenteral Drug Association) 

PEL(s) permissible exposure limit(s) 

PPE personal protective equipment 

RCRA Resource Conservation and Recovery Act 

REL(s) recommended exposure limit(s) 

RN registered nurse 

SCE(s) sister chromatid exchange(s) 

TLVs® threshold limit values of the ACGIH 

μg microgram 

WEEL workplace environmental exposure limit 

Glossary 

Antineoplastic drug: A chemotherapeutic agent that controls or kills cancer cells. 

Drugs used in the treatment of cancer are 

cytotoxic but are generally more damaging 

to dividing cells than to resting cells. 

Aseptic: Free of living pathogenic organisms or infected materials. 

Barrier system: An open system that can 

exchange unfiltered air and contaminants 

with the surrounding environment. 

Barrier isolator: This term has various interpretations, especially as they pertain to 

hazard containment and aseptic processing. For this reason, it has been omitted 

from this Alert. 

Biohazard: An infectious agent or hazardous biological material that presents a risk 

to the health of humans or the environment. 

Biohazards include tissue, blood or body fluids, and materials such as needles or other 

equipment contaminated with these infectious agents or hazardous biological materials. 

Biomarker: A biological, biochemical or 

structural change that serves as an indicator of potential damage to cellular components, whole cells, tissues, or organs. 

BSC (biological safety cabinet): A BSC 

may be one of several types, as described 

here [CDC/NIH 1999; NSF/ANSI 2002]: 

Class I BSC: A BSC that protects personnel and the work environment but 

does not protect the product. It is a 

42 Hazardous Drugs in Health Care Settings 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

negative-pressure, ventilated cabinet usually operated with an open front and a 

minimum face velocity at the work opening of at least 75 ft/min. A Class I BSC is 

similar in design to chemical fume hood 

except all of the air from the cabinet is 

exhausted through a HEPA filter (either 

into the laboratory or to the outside). 

Class II BSC: A ventilated BSC that 

protects personnel, product, and the 

work environment. A Class II BSC has 

an open front with inward airflow for personnel protection, downward HEPA-filtered laminar airflow for product protection, and HEPA-filtered exhausted air for 

environmental protection. 

Type A1 (formerly, Type A): These 

Class II BSCs maintain a minimum inflow velocity of 75 ft/min, have HEPAfiltered downflow air that is a portion 

of the mixed downflow and inflow air 

from a common plenum, may exhaust 

HEPA-filtered air back into the laboratory or to the environment through an 

exhaust canopy, and may have positive-pressure contaminated ducts and 

plenums that are not surrounded by 

negative-pressure plenums. They are 

not suitable for use with volatile toxic 

chemicals and volatile radionucleotides. 

Type A2 (formerly, Type B3): These 

Class II BSCs maintain a minimum 

inflow velocity of 100 ft/min, have 

HEPA-filtered downflow air that is a 

portion of the mixed downflow and 

inflow air from a common exhaust 

plenum, may exhaust HEPA-filtered 

air back into the laboratory or to the 

environment through an exhaust 

canopy, and have all contaminated 

ducts and plenums under negativepressure or surrounded by negativepressure ducts and plenums. If these 

cabinets are used for minute quantities of volatile toxic chemicals and 

trace amounts of radionucleotides, 

they must be exhausted through 

properly functioning exhaust canopies. 

Type B1: These Class II BSCs maintain a minimum inflow velocity of 100 

ft/min, have HEPA-filtered downflow 

air composed largely of uncontaminated, recirculated inflow air, exhaust 

most of the contaminated downflow 

air through a dedicated duct exhausted to the atmosphere after passing 

it through a HEPA filter, and have all 

contaminated ducts and plenums under negative pressure or surrounded 

by negative-pressure ducts and plenums. If these cabinets are used 

for work involving minute quantities 

of volatile toxic chemicals and trace 

amounts of radionucleotides, the 

work must be done in the directly exhausted portion of the cabinet. 

Type B2 (total exhaust): These Class 

II BSCs maintain a minimum inflow velocity of 100 ft/min, have HEPA-filtered 

downflow air drawn from the laboratory 

or the outside, exhaust all inflow and 

downflow air to the atmosphere after 

filtration through a HEPA filter without recirculation inside the cabinet or 

return to the laboratory, and have all 

contaminated ducts and plenums under negative pressure or surrounded by 

directly exhausted negative-pressure 

ducts and plenums. These cabinets 

may be used with volatile toxic chemicals and radionucleotides. 

Hazardous Drugs in Health Care Settings 43 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Class III BSC: A BSC with a totally enclosed, ventilated cabinet of gas-tight 

construction in which operations are conducted through attached rubber gloves 

and observed through a nonopening view 

window. This BSC is maintained under 

negative pressure of at least 0.50 inch 

of water gauge, and air is drawn into the 

cabinet through HEPA filters. The exhaust 

air is treated by double HEPA filtration or 

single HEPA filtration/incineration. Passage of materials in and out of the cabinet is generally performed through a dunk 

tank (accessible through the cabinet floor) 

or a double-door pass-through box (such 

as an autoclave) that can be decontaminated between uses. For a more detailed 

description, refer to CDC/NIH [2000], 

Primary Containment for Biohazards: Selection, Installation and Use of Biological 

Safety Cabinets, 2nd edition. [www.cdc. 

gov/od/ohs/biosfty/bsc/bsc.htm]. 

Chemotherapy drug: A chemical agent 

used to treat diseases. The term usually 

refers to a drug used to treat cancer. 

Chemotherapy glove: A medical glove that 

has been approved by the FDA for use when 

handling antineoplastic drugs. 

Chemotherapy waste: Discarded items such 

as gowns, gloves, masks, IV tubing, empty 

bags, empty drug vials, needles and syringes, 

and other items generated while preparing 

and administering antineoplastic agents. 

Closed system: A device that does not exchange unfiltered air or contaminants with 

the adjacent environment. 

Closed system drug-transfer device: A drug 

transfer device that mechanically prohibits the 

transfer of environmental contaminants into 

the system and the escape of hazardous 

drug or vapor concentrations outside the 

system. 

Cytotoxic: A pharmacologic compound that 

is detrimental or destructive to cells within 

the body. 

Deactivation: Treating a chemical agent (such 

as a hazardous drug) with another chemical, 

heat, ultraviolet light, or other agent to create 

a less hazardous agent. 

Decontamination: Inactivation, neutralization, or removal of toxic agents, usually by 

chemical means. 

Engineering controls: Devices designed 

to eliminate or reduce worker exposures to 

chemical, biological, radiological, ergonomic, 

or physical hazards. Examples include laboratory fume hoods, glove bags, retracting syringe needles, sound-dampening materials 

to reduce noise levels, safety interlocks, and 

radiation shielding. 

Genotoxic: Capable of damaging the DNA 

and leading to mutations. 

Glove box: A controlled environment work 

enclosure providing a primary barrier from 

the work area. Operations are performed 

through sealed gloved openings to protect 

the worker, the ambient environment, and/ 

or the product. 

Glove bag: A glove box made from a flexible plastic film. Operations are performed 

through sealed gloved openings to protect 

the worker, the work environment, and/or 

the product. 

Hazardous drug: Any drug identified by at 

least one of the following six criteria: carcinogenicity, teratogenicity or developmental 

44 Hazardous Drugs in Health Care Settings 
 

 

 

 

 

 

 

 

toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, or new drugs that mimic 

existing hazardous drugs in structure or toxicity. 

Hazardous waste: Any waste that is a 

RCRA-listed hazardous waste [40 CFR 

261.30–33] or that meets a RCRA characteristic of ignitability, corrosivity, reactivity, or 

toxicity as defined in 40 CFR 261.21–24. 

Health care settings: All hospitals, medical clinics, outpatient facilities, physicians’ 

offices, retail pharmacies, and similar facilities dedicated to the care of patients. 

Health care worker: All workers who are 

involved in the care of patients. These include pharmacists, pharmacy technicians, 

nurses (registered nurses [RNs], licensed 

practical nurses [LPNs], nurses aids, etc.), 

physicians, home health care workers and 

environmental services workers (housekeeping, laundry, and waste disposal). 

HEPA filter: High-efficiency particulate air 

filter rated 99.97% efficient in capturing 

0.3-micron-diameter particles. 

Horizontal laminar flow hood (horizontal 

laminar flow clean bench): A device that 

protects the work product and the work area 

by supplying HEPA-filtered air to the rear of 

the cabinet and producing a horizontal flow 

across the work area and out toward the 

worker. 

Isolator: A device that is sealed or is supplied with air through a microbially retentive 

filtration system (HEPA minimum) and may 

be reproducibly decontaminated. When 

closed, an isolator uses only decontaminated interfaces (when necessary) or rapid 

transfer ports (RTPs) for materials transfer. 

When open, it allows for the ingress and/or 

egress of materials through defined openings that have been designed and validated 

to preclude the transfer of contaminants or 

unfiltered air to adjacent environments. An 

isolator can be used for aseptic processing, 

for containment of potent compounds, or 

for simultaneous asepsis and containment. 

Some isolator designs allow operations 

within the isolator to be conducted through 

attached rubber gloves without compromising asepsis and/or containment. 

Aseptic isolator: A ventilated isolator 

designed to exclude external contamination from entering the critical zone inside 

the isolator. 

Aseptic containment isolator: A ventilated isolator designed to meet the 

requirements of both an aseptic isolator 

and a containment isolator. 

Containment isolator: A ventilated isolator designed to prevent the toxic materials processed inside it from escaping 

to the surrounding environment. 

Lab coat: A disposable or reusable openfront coat, usually made of cloth or other 

permeable material. 

MSDS: Material safety data sheet. These 

sheets contain summaries provided by the 

manufacturer to describe the chemical properties and hazards of specific chemicals and 

ways in which workers can protect themselves from exposure to these chemicals. 

Mutagenic: Capable of increasing the spontaneous mutation rate by causing changes in 

the DNA. 

Hazardous Drugs in Health Care Settings 45 
 

 

 

OEL: Occupational exposure limit. An industry or other nongovernment exposure limit 

usually based on scientific calculations of 

airborne concentrations of a substance that 

are considered to be acceptable for healthy 

workers. 

PDA: An international trade association 

serving pharmaceutical science and technology. Formerly known as the Parenteral 

Drug Association. 

PEL: OSHA permissible exposure limit: The 

time-weighted average concentration of a 

substance to which nearly all workers may 

be exposed for up to 8 hours per day, 40 

hours per week for 30 years without adverse 

effects. A PEL may also include a skin designation. 

PPE: Personal protective equipment. Items 

such as gloves, gowns, respirators, goggles, 

face shields, and others that protect individual workers from hazardous physical or 

chemical exposures. 

REL: NIOSH recommended exposure limit: 

An occupational exposure limit recommended by NIOSH as being protective of worker 

health and safety over a working lifetime. 

The REL is frequently expressed as a timeweighted average exposure to a substance 

for up to a 10-hour workday during a 40-

hour work week. 

Respirator: A type of PPE that prevents 

harmful materials from entering the respiratory system, usually by filtering hazardous 

agents from workplace air. A surgical mask 

does not offer respiratory protection. 

Risk assessment: Characterization of potentially adverse health effects from human 

exposure to environmental or occupational 

hazards. Risk assessment can be divided 

into five major steps: hazard identification, 

dose-response assessment, exposure assessment, risk characterization, and risk 

communication. 

Sister chromatid exchange: The exchange 

of segments of DNA between sister chromatids. 

Standard precautions (formerly universal precautions): The practice in health 

care of treating all patients as if they were 

infected with HIV or other similar diseases 

by using barriers to avoid known means of 

transmitting infectious agents [CDC 1987, 

1988]. These barriers can include nonporous 

gloves, goggles, and face shields. Careful 

handling and disposal of sharps or the use 

of needleless systems are also important. 

TLVs®: Threshold limit values. These values 

are exposure limits established by the ACGIH. They refer to airborne concentrations 

of chemical substances and represent conditions under which it is believed that nearly 

all workers may be repeatedly exposed, day 

after day, over a working lifetime, without 

adverse health effects. 

Ventilated cabinet: A type of engineering 

control designed for purposes of worker protection (as used in this document). These 

devices are designed to minimize worker exposures by controlling emissions of airborne 

contaminants through the following: 

 The full or partial enclosure of a potential 

contaminant source 

 The use of airflow capture velocities to 

capture and remove airborne contaminants near their point of generation 

 The use of air pressure relationships that 

define the direction of airflow into the 

cabinet 

46 Hazardous Drugs in Health Care Settings 
Examples of ventilated cabinets include 

BSCs, containment isolators, and laboratory 

fume hoods. 

WEEL (workplace environmental exposure level): Occupational exposure limits 

developed by the American Industrial Hygiene Association as a chemical concentration to which nearly all workers may be 

repeatedly exposed for a working lifetime 

without adverse health effects. 

Hazardous Drugs in Health Care Settings 47 

 

APPENDIX C
Ê

NIOSH HAZARDOUS DRUG SAFETY WORKING GROUP
Ê

The following members of the NIOSH Hazardous Drug Safety Working Group provided 

leadership, information, and recommendations for this document: 

Tito Aldape, Microflex Corporation 

Roger W. Anderson, Dr.P.H., University of 

Texas M.D. Anderson Cancer Center 

Britton Berek, Joint Commission on 

Accreditation of Healthcare Organizations 

Stephen Brightwell, NIOSH 

G. Edward Burroughs, Ph.D., C.I.H., NIOSH 

Thomas H. Connor, Ph.D., NIOSH 

Barbara D. Coyle, B.S.N., R.N. C.O.H.N.-S., 

State of Wisconsin 

Gayle DeBord, Ph.D., NIOSH 

Robert DeChristoforo, M.S., National 

Institutes of Health 

Phillup C. Dugger, U.S. Oncology, Inc. 

Barbara A. Grajewski, Ph.D., NIOSH 

Dori Greene, U.S. Oncology, Inc. 

Duane R. Hammond, B.S.M.E., NIOSH 

Bruce R. Harrison, M.S., R.Ph., B.C.O.P., 

Department of Veterans Affairs 

Hye-Joo Kim, U.S. Food and Drug 

Administration 

L.D. King, International Academy of 

Compounding Pharmacists 

Nancy Kramer, R.N., B.S.N., Coram 

Healthcare 

R. David Lauper, Pharm.D., SuperGen, Inc. 

Melissa M. Leone, R.N., B.S.N., Apria 

Healthcare 

Chiu S. Lin, Ph.D., U.S. Food and Drug 

Administration 

Barbara A. MacKenzie, NIOSH 

Charlene Maloney, NIOSH 

Melissa A. McDiarmid, M.D., M.P.H., 

University of Maryland 

Kenneth M. Mead, M.S., P.E., NIOSH 

Martha T. O’Lone, U.S. Food and Drug 

Administration 

Jerry Phillips, U.S. Food and Drug 

Administration 

Marty Polovich, M.N., R.N., A.O.C.N., 

Oncology Nursing Society 

Luci Power, M.S., R.Ph., University of 

California Medical Center 

Angela C. Presson, M.D., M.P.H., OSHA 

Hank Rahe, Containment Technologies 

Group, Inc 

Laurence D. Reed, M.S., NIOSH 

Anita L. Schill, Ph.D., M.P.H., NIOSH 

Teresa Schnorr, Ph.D., NIOSH 

Douglas Sharpnack, D.V.M., NIOSH 

Hazardous Drugs in Health Care Settings 49 
Charlotte A. Smith, M.S., R.Ph., 

PharmEcology Associates, LLC 

Sandi Yurichuk, American Federation of 

State, County and Municipal Employees 

American Nurses Association 

American Society of Health-System 

Pharmacists 

Oncology Nursing Society 

Pharmaceutical Research and 

Manufacturers of America 

Service Employees International Union 

U.S. Environmental Protection Agency 

Baxa Corporation 

Nuaire, Inc 

The Baker Company, Inc. 

50 Hazardous Drugs in Health Care Settings