The NIOSH Hazardous Drug Alert:

How Does It Affect Your Organization?

Submitted by Charlotte A. Smith, R.Ph., M.S., HEM, is president of PharmEcology® Associates, LLC (www.pharmecology.com)

ON MARCH 25, 2004, THE NATIONAL INSTITUTE FOR OCCUPATIONAL Safety and Health (NIOSH) issued a pre-publication version of a guidance document formally titled: Preventing Occupational Exposures to ntineoplastic and other Hazardous Drugs in Healthcare Settings.   More commonly known as the Hazardous Drug Alert, the document was approximately three years in the making, and involved professionals from various disciplines, along with government and industry representatives.   It provides enhanced and updated information to supplement the OSHA Technical Manual.

The Alert can be accessed on the Internet ( www.cdc.gov/niosh/docs/2004-HazDrugAlert ). The five-page summary at the beginning of the document should be printed out, posted, and distributed to employees.   The remainder of the 93 pages provides greater details, case studies, and references.   One of the most important aspects of the Alert is an updated sample list of drugs considered hazardous, included in Appendix A (pp. 77 to 82).

Expanding the Definition of a Hazardous Drug

An important feature of the Alert is a revision of the 1990 American Society of Health-System Pharmacists (ASHP) definition of hazardous drugs. The original four characteristics of genotoxicity, carcinogenicity, teratogenicity, and evidence of serious organ impairment at low doses were expanded to six characteristics:

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, which mimic existing drugs as determined hazardous by the above criteria

Pay special attention to the sixth characteristic, as health care organizations will need to evaluate new drugs entering their facilities against this criterion. Due to the increased awareness of employee exposure to reproductive toxins, reproductive hormones such as estrogens, progesterone, testosterone and related drugs are now listed as hazardous drugs.

Review Engineering Controls and Personal Protective Equipment Recommendations

Perhaps the most relevant recommendations for the departments of pharmacy, nursing, materials management and purchasing include the guidance involving engineering controls and personal protective equipment (PPE).

Review this short checklist to see where your organization may need to consider changes or purchases in equipment to improve engineering controls or PPE:

Engineering Controls:

• Biological safety cabinets or containment isolators, exhausted through HEPA-filters and, whenever feasible, exhausted to the outdoors, away from air intake locations.

• Syringes and intravenous (IV) sets with Luer-Lok™ fittings for preparing and administering hazardous drugs.

• Closed-system, drug-transfer device and needle-less systems (such as the PhaSeal closed transfer system) to protect pharmacy and nursing personnel during preparation and administration.

• Transfer of hazardous drugs within a sealed plastic bag or other sealable container. (Note: Bags should be labeled as “hazardous drugs,” “chemotherapy,” or other appropriate label, and not labeled as “biohazardous,” as this term refers to infectious waste.)

• Decontamination of work surfaces with an appropriate deactivation and cleaning agent before and after each activity and at the end of each shift. An example of a double towelette deactivation system is SuperGen's Surface Safe.

• Segregation of bulk chemotherapy and other hazardous drugs into hazardous waste containers, such as those available from Hospitec, Inc., rather than yellow or white trace chemotherapy containers, and disposal by a hazardous waste disposal firm (not a regulated medical waste disposer).

Personal Protective Equipment:

• Use of two pairs of powder-free, disposable chemotherapy gloves with the outer one covering the gown cuff whenever there is risk of exposure to hazardous drugs.
• Change of gloves every 30 minutes or when torn, punctured or contaminated; discarded immediately in a yellow chemotherapy waste container.
• Use of chemotherapy gloves, protective clothing, and eye protection by workers unpacking hazardous drugs, to protect against spills from breakage and possible contamination of vials during the manufacturing process.
• Use of disposable gowns made of low-lint and low permeability fabric, with closed front, long sleeves, and elastic or knit closed cuff; gowns should NOT be reused when removed.
• Use of face shields to avoid splash incidents involving eyes, nose, or mouth when adequate engineering controls are not available (such as emptying of bed pans from patients taking chemotherapy drugs).

The preceding checklist outlines areas where products are needed by your organization to assure employee safety when handling hazardous drugs. Additional administrative controls, including developing and maintaining a hazardous drug list, providing relevant Material Safety Data Sheets (MSDSs), and reviewing all relevant policies and procedures are essential to ensuring a safe work environment. Encourage relevant managers and Safety Committee members to review the Hazardous Drug Alert in its entirety to provide maximum employee, patient and visitor safety.

For the relevant sections of the OSHA Technical Manual, see Section VI Chapter 2: Controlling Occupation Exposure to Hazardous Drugs accessed at: www.osha-slc.gov/dts/osta/otm/otm_vi/otm_vi_2.html

Hazardous Waste Disposal Service Providers Include:

Clean Harbors . . . . . . . . . . . . . . . . . . . . . . . .www.cleanharbors.com

Heritage Environmental Services . . . . . .www.heritage-enviro.com

Onyx Environmental Services . . . . . . . . .www.onyxes.com

Teris, LLC . . . . . . . . . . . . . . . . . . . . . . . . . . . . .www.terisna.com

Where to find it:

PhaSeal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .www.phaseal.com

Surface Safe . . . . . . . . . . . . . . . . . . . . . . . . . .www.supergen.com

Hazardous Waste Containers . . . . . . . . . .www.hospitecinc.com

ChemoBlock T Nitrile Plus Gloves . . . . . .www.tycohealthcare.com

Disposable Face Shields . . . . . . . . . . . . . . .www.hcl-intl.com

Charlotte A. Smith, R.Ph., M.S., HEM, is president of PharmEcology® Associates, LLC, an information management and consulting company specializing in the cost-effective, compliant management of hazardous pharmaceutical waste. Ms. Smith can be contacted at csmith@pharmecology.com, 262-814-2635, or through www.pharmecology.com .