The National Institute for Occupational Safety and Health is requesting public comment on the definition of hazardous drugs and adding new drugs to the existing list of hazardous drugs in the workplace.

The 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/).  Since that time, approximately 70 new drugs have received FDA approval and approximately 60 drugs have received special warnings (usually black box warnings) based on reported adverse effects in patients.  An additional 18 drugs were included from the updated NIH Hazardous Drug List.  From this list of approximately 150 drugs, 62 drugs were determined to have one or more characteristic of a hazardous drug.

NIOSH has assessed the scientific literature and found no reason to change the definition of hazardous drugs at this time. NIOSH has also evaluated the information available for the three groups of drugs and identified a subset of 62 drugs that may be hazardous to health care workers who handle them.

This preliminary list represents drugs that fit one or more of the characteristics of a hazardous drug as defined by NIOSH.

New FDA Drug Warnings FITTING NIOSH Criteria for Hazardous Drugs 2006	Fit2006-05-07-07.pdf (14KB; 3 pgs)
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Those drugs that did not meet the NIOSH criteria are listed in below.

New FDA Drugs and Warnings NOT FITTING NIOSH Criteria for Hazardous Drugs 2006	NotFit2006-05-07-07.pdf (18KB; 5 pgs)
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NIOSH criteria for defining a hazardous drug:

1. Carcinogenicity
2. Teratogenicity or other developmental toxicity ^††
3. Reproductive toxicity ^††
4. Organ toxicity at low doses ^††
5. Genotoxicity ^{‡ ‡}
6. Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria.

^††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.

 ^‡‡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)].

References

NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings 2004. U.S. Department 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.

Naumann BD, Sargent EV [1997]. Setting occupational exposure limits for pharmaceuticals. Occup Med: State of the Art Rev 12(1):67–80.

Sargent EV, Kirk GD [1988]. Establishing airborne exposure control limits in the pharmaceutical industry. Am Ind Hyg Assoc J 49(6):309–313.

Sargent EV, Naumann BD, Dolan DG, Faria EC, Schulman L [2002]. The importance of human data in the establishment of occupational exposure limits. Hum Ecol Risk Assess 8(4):805–822.

This form should be used to send your comments to NIOSH for review and comment:

The comment period for this Docket closed at 5:00 p.m. EDT on September 20, 2007