Under the former NJ Governor Christie administration, a 2017 law was passed to begin the process of identifying stakeholders who may be able to construct legislation to protect healthcare workers who are exposed to hazardous drugs in oncology. Some work practices place pharmacists, animal handlers, veterinarians, oncologists and nurses at risk of contact with these toxic drugs. Many of these drugs cause terratogenic and mutagenic effects in both men, women, and offspring. The National Institute for Occupational Safety and Health (NIOSH) identified 204 hazardous drugs, which may be toxic to exposed workers. In addition, both the State of Washington and California have enacted legislation to protect all workers from exposure, which includes training, biological monitoring and medical surveillance. This is a very important issue that needs further review and consideration.

1. NJ HAZARDOUS
DRUG SAFE
HANDLING ACT
Presented by:
Bernard L. Fontaine, Jr., CIH, CSP, FAIHA
The Windsor Consulting Group, Inc.

2. HAZARDOUS DRUG SAFETY OVERVIEW
OSHA and NIOSH identified worker exposure to hazardous drugs as a problem
of increasing health concern. Preparation, administration, manufacturing, and
disposal of hazardous medications may expose hundreds of thousands of
workers, principally in healthcare facilities and the pharmaceutical industry, to
potentially significant workplace levels of these chemicals.

3. Animal or
Veterinary
Facilities
Internal and
External
Compound
Facilities
Hospitals
and
Healthcare
Facilities
NJ STATUTE
Workers Affected by
Hazardous Drug Safety Act

4. HEALTHCARE WORKERS AT-RISK
About 8 million U.S. healthcare workers are potentially exposed to
hazardous drugs, including pharmacy and nursing personnel, nurse
practitioners, physicians and physician’s assistants, operating room
personnel, environmental services workers, workers in research labs,
veterinary care workers, and shipping and receiving personnel.

5. HEALTHCARE WORKERS AT-RISK
Various acute toxic effects of antineoplastic agents are well documented
in patients treated with high doses of these agents. These include such
effects as nausea, rashes, hair loss, liver and kidney damage, hearing
loss, cardiac and hematopoietic toxicities.
Chronic health effects related to occupational exposure to antineoplastic
agents include liver and kidney damage, damage to the bone marrow,
damage to the lungs and heart, infertility (temporary and permanent),
effects on reproduction and the developing fetus in pregnant women,
hearing impairment, and cancer.

6. WHEN WE WORK SMART
Antineoplastic cytotoxic medications, anesthetic agents, anti-
viral agents, and others, have been identified as hazardous.
These hazardous medications are capable of causing serious
effects including cancer, organ toxicity, fertility problems, genetic
damage, and birth defects.
Workers can be protected from exposures to hazardous
drugs through prescriptive engineering and administrative
controls, medical surveillance and protective equipment.

7. OBJECTIVES OF NJ STATUTE
 Evaluate workplace to assess all health and safety hazards and risk,
 Environmental wipe sampling is a relatively new approach used to
determine the level of workplace contamination by antineoplastic agents,
 Regularly review the inventory of hazardous drugs, equipment, and work
practices,
 Conduct regular training reviews with all potentially exposed workers,
 Implement a program for safely handling hazardous drugs at work and
review program annually,

8. OBJECTIVES OF NJ STATUTE
 Establish procedures and provide training for handling hazardous drugs
safely, cleaning up spills, and using respirators and PPE properly,
 Establish work practices related to both drug manipulation techniques
and to general hygiene practices - not permitting eating or drinking in
areas where drugs are handled (the pharmacy or clinic),
 Develop workplace procedures for using and maintaining all equipment
that functions to reduce exposure - ventilated cabinets, closed system
drug-transfer devices, needleless systems, and PPE.

9. APPLICABLE OSHA STANDARDS
OSHA addresses exposure to hazardous drugs in specific OSHA
standards for general industry such as the Occupational
Exposure to Hazardous Chemicals in Laboratories (29 CFR
1910.1450) and the (globally harmonized) Hazard
Communication (HAZCOM) standard (29 CFR 1910.1200).

10. NIOSH LIST OF ANTINEOPLASTIC AND OTHER HAZARDOUS
DRUGS IN HEALTHCARE SETTINGS
 The NIOSH Alert: Preventing Occupational
Exposures to Antineoplastic and Other Hazardous
Drugs in Health Care Settings (2004) identified a list
of major hazardous drugs.
 The list was compiled by four institutions and a list
from the Pharmaceutical Research and Manufacturers
of America (PhRMA).
 Current update (2016) adds 34 drugs and includes a
review of the 2004 list.

11. (1) Written, site-specific hazardous drug control programs to
avoid occupational exposure to hazardous drugs via transport,
compounding, administering, disposing, or handling of the drugs;
(2) Hazard assessments to determine precautions necessary to
protect health care personnel from exposure to hazardous drugs;
(3) Engineering controls to eliminate or minimize exposure;
(4) Personal protective equipment (PPE) and the
circumstances under which PPE shall be used by health care
personnel;
(5) Safe handling practices to receive, store, prepare,
administer, handle wastes, cleaning up spills, housekeeping,
container labeling, signage, and maintenance procedures;

12. (6) Spill control and response procedures;
(7) Training standards and training programs;
(8) Recordkeeping, including records related to training
sessions, qualifications, incident reports, and other information; and
(9) Medical surveillance, which shall include provisions
requiring, at a minimum, a medical evaluation for health care
personnel who directly handle hazardous drugs, at no cost to the at-
risk personnel, at the time of hiring, upon exposure to hazardous
drugs, and upon request when such request is related to reproductive
concerns.

13. Medical Surveillance: Several biological endpoints can be used to
monitor healthcare workers’ exposure to antineoplastic agents. Most
endpoints measure various types of genotoxic damage.
 Urinary mutagenicity
 Chromosomal aberrations
 Sister chromatid exchanges
 Micronuclei induction
 DNA damage
 HPRT mutations
 Thioether excretion
 Occupational monitoring: analytical studies
 Urinary excretion of antineoplastic agents