NIOSH List of Antineoplastic and Other Hazardous Drugs in

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

National Institute for Occupational Safety and Health

NIOSH List of Antineoplastic

and Other Hazardous Drugs

in Healthcare Settings 2010

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

National Institute for Occupational Safety and Health

NIOSH List of Antineoplastic and Other

Hazardous Drugs in Healthcare Settings 2010

This document is in the public domain and may be freely copied or reprinted.

Disclaimer

Mention of any company or product does not constitute endorsement by the National Institute for

Occupational Safety and Health (NIOSH). In addition, citations to Web sites external to NIOSH do

not constitute NIOSH endorsement of the sponsoring organizations or their programs or products.

Furthermore, NIOSH is not responsible for the content of these Web sites.

OrDering infOrmatiOn

To receive documents or other information about occupational safety and health topics, contact

NIOSH at

Telephone: 1–800–CDC–INFO (1–800–232–4636)

TTY:1–888–232–6348

E-mail: [email protected]ov

or visit the NIOSH Web site at www.cdc.gov/niosh

For a monthly update on news at NIOSH, subscribe to NIOSH eNews by visiting

www.cdc.gov/niosh/eNews.

DHHS (NIOSH) Publication Number 2010−167

September 2010

Preamble: e National Institute for Occupational Safety and Health (NIOSH) Alert: Preventing

Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings was

published in September 2004 (http://www.cdc.gov/niosh/docs/2004-165/). In Appendix A of the

Alert, NIOSH identied a sample list of major hazardous drugs. e list was compiled from infor-

mation provided by four institutions that have generated lists of hazardous drugs for their respec-

tive facilities and by the Pharmaceutical Research and Manufacturers of America (PhRMA) from

the American Hospital Formulary Service Drug Information (AHFS DI) monographs [ASHP/

AHFS DI 2003]. is update adds 21 drugs to the original list in the 2004 Alert. ese additions are

new drugs or existing drugs that had new warnings from 2004 to 2007. e review process for the

addition of the new listings is described in the Federal Register: http://www.cdc.gov/niosh/docket/archive/

pdfs/NIOSH-105-A/0105-A-042909-FR_Notice.pdf

Appendix A • drugs Considered HAzArdous

ASHP Deﬁnition of Hazardous

Drugs

In this Alert, NIOSH presents a standard pre-

cautions or universal precautions approach

to handling hazardous drugs safely: that is,

NIOSH recommends that all hazardous drugs

be handled as outlined in this Alert. erefore,

no attempt has been made to perform drug

risk assessments or propose exposure limits.

e area of new drug development is rapidly

evolving as unique approaches are being taken

to treat cancer and other serious diseases.

General Approach to Handling

Hazardous Drugs

Hazardous drugs include those used for can-

cer

otherapy, antiviral drugs, hormones,

some bioengineered drugs, and other miscella-

neous drugs. e denition of hazardous drugs

used in this Alert is based on an ASHP de-

nition that was originally developed in 1990

[ASHP 1990]. us the denition may not ac-

curately reect the toxicity criteria associated

with the newer generation of pharmaceuticals

entering the health care setting. For example,

bioengineered drugs target specic sites in the

;

d 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 gath-

ering data on the potential toxicity and health

eects related to highly potent drugs and bio-

engineered drugs. erefore, 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.

Deﬁning Hazardous Drugs

e ASHP denes hazardous drugs in their

1990 revision of Technical Assistance Bulletin on

Handling Hazardous Drugs [ASHP 1990]. e

bulletin gives criteria for identifying poten-

tially hazardous drugs that should be handled

in accordance with an established safety pro-

gram [McDiarmid et al. 1991; Arrington and

McDiarmid 1993]. e criteria are prioritized

to reect the hierarchy of potential toxicity de-

scribed below. Since the hazardous drugs cov-

ered by this Alert were designed as therapeu-

tic agents for humans, human toxicity proles

should be considered superior to any data from

animal models or in vitro systems. Additional

guidance for dening hazardous drugs is avail-

able in the following citations: carcinogenicity

[61 Fed. Reg. 17960–18011 (1996b); IARC 2010],

teratogenicity [56 Fed. Reg. 63798–63826

(1991)], developmental toxicity [56 Fed. Reg.

63798–63826 (1991)], and reproductive toxic-

ity [61 Fed. Reg. 56274–56322 (1996a)]. Physi-

cal 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

e 1990 ASHP denition of hazardous drugs

was revised by the NIOSH Working Group on

Hazardous Drugs for this Alert. Drugs consid-

ered hazardous include those that exhibit one

or more of the following six characteristics in

humans or animals:

1. Carcinogenicity

2. Teratogenicity or other developmental tox-

icity

†

ASHP [1990] denition of hazardous drugs:

1. Carcinogenicity

2. Teratogenicity or other developmental toxicity

3. Reproductive toxicity

4. Organ toxicity at low doses

5. Genotoxicity

6. Structure and toxicity proles of new drugs that

mimic existing drugs determined hazardous by

the above criteria.

†

All drugs have toxic side eects, but some exhibit toxic-

ity at low doses. e level of toxicity reects a contin-

uum from relatively nontoxic to production of toxic

eects 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 tox-

icity, developmental toxicity, or reproductive toxic-

ity has been used by the pharmaceutical industry to

develop occupational exposure limits (OELs) of less

than 10 µg/m

aer applying appropriate uncertainty

3. Reproductive toxicity

†

4. Organ toxicity at low doses

†

5. Genotoxicity

‡

Structure and toxicity proles of new drugs

that mimic existing drugs determined hazard-

ous by the above criteria

Determining Whether a Drug is

Hazardous

Many hazardous drugs used to treat cancer

bind to or damage DNA (for example, alkylat-

ing agents). Other antineoplastic drugs, some

antivirals, antibiotics, and bioengineered drugs

interfere with cell growth or proliferation, or

with DNA synthesis. In some cases, the non-

selective actions of these drugs disrupt the

growth and function of both healthy and dis-

eased cells, resulting in toxic side eects for

treated patients. ese nonselective actions

can also cause adverse eects in health care

workers who are inadvertently exposed to haz-

ardous drugs.

Early concerns about occupational exposure to

antineoplastic drugs rst 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 physiologi-

cal eect) or cause irreversible eects. As the

use and number of these potent drugs increase,

factors [Sargent and Kirk 1988; Naumann and Sar-

gent 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.

‡

In evaluating mutagenicity for potentially hazardous

drugs, responses from multiple test systems are need-

ed before precautions can be required for handling

such agents. e EPA evaluations include the type of

cells aected and in vitro versus in vivo testing [51

Fed. Reg. 34006–34012 (1986)].

so do opportunities for hazardous exposures

among health care workers. For example, an-

tineoplastic drugs such as cyclophosphamide

have immunosuppressant eects that proved

benecial for treating nonmalignant diseas-

es such as rheumatoid arthritis and multiple

sclerosis [Baker et al. 1987; Moody et al. 1987;

Chabner et al. 1996; Abel 2000].

is document 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

the Alert should be applied when handling that

drug. Also included is a list of drugs that should

be handled as hazardous. is list is based on

a compilation of lists from four health care fa-

cilities, one drug manufacturers’ organization,

and NIOSH.

In addition to using the list of hazardous drugs

presented here, each organization should cre-

ate its own list of drugs considered to be haz-

ardous. is document presents guidance for

making such a facility-specic list (see section

entitled How to Generate your own List of Haz-

ardous 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 haz-

ardous drugs in this document (current only

to the printing date of this document) will

help employers and workers to determine

when precautions are needed. However, re-

liance 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 infor-

mation becomes available. To fill this knowl-

edge gap, NIOSH will update an internet list

periodically, adding new drugs considered

to be hazardous and removing those that re-

quire 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 identifi-

cation 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. In-

stitutions 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) ap-

proval, and the OSHA hazard communication

standard does not mandate evaluation of every

marketed drug. Instead, compliance requires

practice-specic assessments for drugs used at

any one time by a facility. However, hazardous

drug evaluation is a continual process. Local

hazard communication programs should pro-

vide for assessment of new drugs as they enter

the marketplace, and when appropriate, reas-

sessment of their presence on hazardous drug

lists as toxicological data become available to

support recategorization. Toxicological data

are oen incomplete or unavailable for inves-

tigational drugs. However, if the mechanism of

action suggests that there may be a concern, it

is prudent to handle them as hazardous drugs

until adequate information becomes available

to exclude them.

Some drugs dened as hazardous may not pose

a signicant risk of direct occupational exposure

because of their dosage formulation (for ex-

ample, 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-specic lists of hazardous drugs (usu-

ally developed by pharmacy or nursing depart-

ments) 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 evalu-

ate 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 man-

ufacturers, 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 den-

ing hazardous drugs

Examples of Hazardous Drugs

e following list contains a sampling of major

hazardous drugs. e 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 Informa-

tion (AHFS DI) monographs [ASHP/AHFS

DI 2003], and (3) a NIOSH review of new drug

approvals and new drug warning from 2004 to

2007. is review resulted in the addition of 21

new entries to the list. e OSHA hazard com-

munication standard requires hazardous drugs

to be handled using special precautions. e

mandate applies not only to health care profes-

sionals who provide direct patient care but also

to others who support patient care by partici-

pating in product acquisition, storage, trans-

portation, housekeeping, and waste disposal.

Institutions may want to adopt this list or com-

pare theirs with the list on the NIOSH Web site.

Caution: Drugs purchased and used by a facil-

ity may have entered the marketplace aer the

list below was assembled. erefore, 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, tera-

togenicity, or reproductive or developmental

toxicity, use the precautions stipulated in this

Alert. If a drug meets one or more of the cri-

teria for hazardous drugs listed in this Alert,

handle it as hazardous.

e listing below will be updated periodically

on this website.

e attached list of hazardous drugs super-

sedes the 2004 list: http://www.cdc.gov/niosh/

docs/2004-165/

Sample List of Drugs that Should be Handled as Hazardous*

Drug Source

AHFS Pharmalocologic-therapeutic

classiﬁcation

Aldesleukin 4,5 10:00 Antineoplastic agents

Alefacept 6 84:92 Miscellaneous skin and mucous

membrane 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 10:00 Antineoplastic agents

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 10:00 Antineoplastic agents

Azathioprine 2,3,5 92:44 Unclassied therapeutic agents

(immunosuppressant)

Bacillus Calmette-Guerin

(BCG)

†

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

Bortezomib 6 10:00 Antineoplastic agents

Bosentan 6 24:12.92 Vasodilating 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 92:40 Unclassied therapeutic agents

(GnRH antagonist)

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

Chloramphenicol 1,5 8:12.08 Antibacterials

Choriogonadotropin alfa 5 68:18 Gonadotropins

Cidofovir 3,5 8:18.32 Antiviral nucleoside

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

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

Clofarabine 6 10:00 Antineoplastic agents

(Continued)

Sample List of Drugs that Should be Handled as Hazardous (Continued)

Drug Source

AHFS Pharmalocologic-therapeutic

classiﬁcation

Colchicine 5 92:16 Unclassied therapeutic agents

(antigout agents)

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

Cyclosporin 1 92:00 Immunosuppressive agents

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

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

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

Dasatinib 6 10:00 Antineoplastic agents

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

Decitabine 6 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 92:08 Unclassied therapeutic agents

(5-alpha reductase inhibitor)

Entecavir 6 8:18.32 Antiviral nucleoside

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

Estrogen-progestin

combinations

5 68:12 Contraceptives

Estrogens, conjugated 5 68:16.04 Estrogens

Estrogens, esteried 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 92:08 Unclassied therapeutic agents

(5-alpha reductase inhibitor)

(Continued)

Sample List of Drugs that Should be Handled as Hazardous (Continued)

Drug Source

AHFS Pharmalocologic-therapeutic

classiﬁcation

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

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 8:18.32 Antiviral nucleoside

Ganirelix acetate 5 92:40 Unclassied 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 10:00 Antineoplastic agents

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

Leunomide 3,5 92:36 Unclassied therapeutic agents

(antineoplastic agent)

Lenalidomide 6 92:20 Unclassied therapeutic agents

(biologic response modiers)

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

Medroxyprogesterone

acetate

6 68:32 Progestins

Megestrol 1,5 10:00 Antineoplastic agents

(Continued)

Sample List of Drugs that Should be Handled as Hazardous (Continued)

Drug Source

AHFS Pharmalocologic-therapeutic

classiﬁcation

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

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 92:44 Unclassied therapeutic agents

(immunosuppressive agents)

Nafarelin 5 68:18 Gonadotropins

Nelarabine 6 10:00 Antineoplastic agents

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

Palifermin 6 84:16 Cell stimulants

Paroxetine HCl 6 28:16.04.20 Selective seretonin uptake

inhibitors

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

Pemetrexed 6 10:00 Antineoplastic agents

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

Pentetate calcium trisodium 6 Not in AHFS

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)

Podolox 5 84:92 Miscellaneous skin and mucous

membrane agents (mitotic

inhibitor)

Podophyllum resin 5 84:92 Miscellaneous skin and

mucousmembrane agents (mitotic

inhibitor)

(Continued)

Sample List of Drugs that Should be Handled as Hazardous (Continued)

Drug Source

AHFS Pharmalocologic-therapeutic

classiﬁcation

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

Raloxifene 5 68:16.12 Estrogen agonists-antagonists

Raltitrexed 5 Not in AHFS (antineoplastic agent)

Rasagiline mesylate 6 28:36 Antiparkinsonian agents

Ribavirin 1,2,5 8:18.32 Antiviral nucleoside

Risperidone 6 28:16.08.04 Atypical antipsychotics

Sirolimus 6 92:00 Immunosuppressive agents

Sorafenib 6 10:00 Antineoplastic agents

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

Sunitinib malate 6 10:00 Antineoplastic agents

Tacrolimus 1,5 92:44 Unclassied 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 92:20 Unclassied therapeutic agents

(biologic response modier)

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 10:00 Antineoplastic agents

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

(retinoid)

Triuridine 1,2,5 52:04.06 Antivirals

Trimetrexate glucuronate 5 8:30.92 Miscellaneous antiprotozoals

Triptorelin 5 10:00 Antineoplastic agents

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

Valganciclovir 1,3,5 8:18.32 Antiviral nucleoside

(Continued)

Sample List of Drugs that Should be Handled as Hazardous (Continued)

Drug Source

AHFS Pharmalocologic-therapeutic

classiﬁcation

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

Vidarabine 1,2,5 Not in AHFS

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

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

Vorinostat 6 10:00 Antineoplastic agents

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

Zonisamide 6 28:12.92 Anticonvulsant

*ese lists of hazardous drugs were used with the permission of the institutions that provided them and were

adapted for use by NIOSH. e sample lists are intended to guide health care providers in diverse practice set-

tings and should not be construed as complete representations of all of the hazardous drugs used at the referenced

institutions. Some drugs dened as hazardous may not pose a signicant 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 formu-

lations are altered outside a ventilated cabinet (for example, if tablets are crushed or dissolved, or if capsules are

pierced or opened).

†

BCG preparation should be done using aseptic techniques. To avoid cross-contamination, parenteral drugs should

not be prepared in areas where BCG has been prepared. A separate area for the preparation of BCG suspension is

recommended. All equipment, supplies, and receptacles in contact with BCG should be handled and disposed of

as biohazardous. If preparation cannot be performed in a containment device, then respiratory protection, gloves

and a gown should be worn to avoid inhalation or contact with BCG organisms.

1. e NIH Clinical Center, Bethesda, MD (Revised 8/2002). e NIH Health Clinical Center Hazardous Drug

(HD) List is part of the NIH Clinical Center’s hazard communication program. It was developed in compli-

ance with the OSHA hazard communication standard [29 CFR 1910.1200] as it applies to hazardous drugs

used in the workplace. e list is continually revised and represents the diversity of medical practice at the

NIH Clinical Center; however, its content does not reect an exhaustive review of all FDA-approved medica-

tions that may be considered hazardous, and it is not intended for use outside the NIH.

2. e Johns Hopkins Hospital, Baltimore, MD (Revised 9/2002).

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

4. e University of Michigan Hospitals and Health Centers, Ann Arbor, MI (Revised 2/2003)

5. is 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

Pharmacologic-erapeutic Classication categories [ASHP/AHFS DI 2003] and applying the denition

for hazardous drugs. e list also includes drugs from other sources that satisfy the denition for hazard-

ous drugs [PDR 2004; Sweetman 2002; Shepard 2001; Schardein 2000; REPROTOX 2003]. Newly approved

drugs that have structures or toxicological proles that mimic the drugs on this list should also be included.

is list was revised in June 2004.

6. NIOSH addition 2010 updated using ASHP/AHFS DI 2010.

references

Abel EA [2000]. Immunosuppressant and cyto-

toxic drugs: unapproved uses or indications. Clin

Dermatol 18:95–101.

Arrington DM, McDiarmid MA [1993]. Compre-

hensive program for handling hazardous drugs.

Am J Hosp Pharm 50:1170–1174.

ASHP (American Society of Hospital Pharma-

cists) [1990]. ASHP technical assistance bulletin

on handling cytotoxic and hazardous drugs. Am J

Hosp Pharm 47:1033–1049.

ASHP/AHFS DI (American Hospital Formulary

Service Drug Information) [2003]. AHFS drug in-

formation online updates [www.ahfsdruginforma-

tion.com].

ASHP/AHFS DI (American Hospital Formulary

Service Drug Information) [2010]. AHFS drug in-

formation online updates [www.ahfsdruginforma-

tion.com].

Baker GL, Kahl LE, Zee BC, Stolzer BL, Agarwal

AK, Medsger TA Jr [1987]. Malignancy following

treatment of rheumatoid arthritis with cyclophos-

phamide. Long-term case-control follow-up study.

Am J Med 83(1):1–9.

CFR. Code of Federal regulations. Washington,

DC: U.S. Government Printing Oce, Oce of

the Federal Register.

Chabner BA, Allegra CJ, Curt GA, Calabresi P

[1996]. Antineoplastic agents. In: Hardman JG,

Lim-

bird LE, eds. Goodman and Gilman’s the pharma-

cological basis of therapeutics. 9th ed. New York:

McGraw-Hill, pp. 1233–1287.

IARC [2010]. IARC monographs on the evaluation

of the carcinogenic risk of chemicals to humans.

Lyons, France: World Health Organization, Inter-

national Agency for Research on Cancer. [www.

iarc.fr]. Date accessed: March 2010.

McDiarmid MA, Gurley HT, Arrington D [1991].

Pharmaceuticals as hospital hazards: managing

the risks. J Occup Med 33(2):155–158.

Moody DJ, Kagan J, Liao D, Ellison GW, Myers

LW [1987]. Administration of monthly-pulse cy-

clophosphamide in multiple sclerosis patients.

Effects of long-term treatment on immunologic

parameters. J Neuroimmunol 14(2):161–173.

Naumann BD, Sargent EV [1997]. Setting occupa-

tional exposure limits for pharmaceuticals. Occup

Med: State of the Art Rev 12(1):67–80.

NIOSH [2004]. NIOSH alert: preventing occu-

pational exposure to antineoplastic and other

hazardous drugs in health care settings. U.S. De-

partment of Health and Human Services, Public

Health Service, Centers for Disease Control and

Prevention, National Institute for Occupational

Safety and Health, DHHS (NIOSH) Publication

No. 2004–165.

PDR [2004]. Physician’s desk reference for drug

interactions. Montvale, NJ: omson Healthcare

[www.pdr.net/]. Date accessed: March 2004.

REPROTOX [2003]. An information system on

environmental hazards to human reproduction

and

development. Washington, DC: Columbia

Hospital

for Women Medical Center, Reproductive Toxicol-

ogy Center [http://reprotox.org]. Date accessed:

February 2004.

Sargent EV, Kirk GD [1988]. Establishing airborne

exposure control limits in the pharmaceutical in-

dustry. Am Ind Hyg Assoc J 49(6):309–313.

Sargent EV, Naumann BD, Dolan DG, Faria EC,

Schulman L [2002]. e importance of human

data in the establishment of occupational expo-

sure limits. Hum Ecol Risk Assess 8(4):805–822.

Schardein, JL [2000]. Chemically induced birth

defects. 3rd ed., rev. New York: Marcel Deckker,

Inc.

Shepard TH [2001]. Catalog of teratogenic agents.

10th ed. Baltimore, MD: Johns Hopkins Univer-

sity Press [www.depts.washington.edu/~terisweb].

Date accessed: Feb. 2004.

Sweetman SC [2003]. Martindale: the complete

drug reference. 33rd ed. London: Pharmaceutical

Press.

To receive NIOSH documents or more information about

occupational safety and health topics, contact NIOSH at

1–800–CDC–INFO (1–800–232–4636)

TTY: 1–888–232–6348

E-mail: cdcinfo@cdc.gov

or visit the NIOSH Web site at www.cdc.gov/niosh.

For a monthly update on news at NIOSH, subscribe to

NIOSH eNews by visiting www.cdc.gov/niosh/eNews.

DHHS (NIOSH) Publication No. 2010–167

safer • healthier • people

Delivering on the Nation’s promise:

safety and health at work for all people

through research and prevention

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

National Institute for Occupational Safety and Health

4676 Columbia Parkway

Cincinnati, Ohio 45226–1998

Oﬃ cial Business

Penalty for Private Use $300