First-in-nation rule targets hazardous drugs

Washington relies on 'tiered approach'

Washington became the first state to issue a rule to protect health care workers who handle hazardous drugs — a move that proponents hope will prompt other states to take similar action.

It is a watershed moment for the protection of health care workers from substances that pose cancer and reproductive risks, says Melissa A. McDiarmid, MD, MPH, DABT, director of the Occupational Health Program at the University of Maryland School of Medicine in Baltimore. "These drugs are some of the most hazardous families of chemicals in health care," she says. "It's a long time in coming."

The dangers of working with toxic pharmaceuticals were brought to life in a series by InvestigateWest, a group of independent investigative journalists who publish online. They told the stories of pharmacists, a nurse and a veterinarian who developed cancer from working with chemotherapeutic agents. The articles prompted the Washington legislature to pass a law requiring a rule on hazardous drugs.

Although safety practices have evolved since those health care workers were mixing and administering drugs with virtually no protection, workers are still being exposed, says McDiarmid. In a study1 of 109 health care workers, McDiarmid and colleagues in North Carolina and Texas found a 20% increase in chromosomal abnormalities in workers with a moderate level of drug handling (100 or more chemotherapeutic drug-handling events in a six-week period). Those with the highest level of exposure (500 drug-handling events) had a 2.5-fold increase in chromosomal abnormalities.

The "signature" chromosomal abnormalities found in oncology workers were the same as those observed in patients treated with these drugs, McDiarmid notes. Smokers and workers with previous treatment with chemotherapy, radiation, or genotoxic drugs were excluded from the study.

"There aren't many industries that are allowed to have human carcinogens as a regular part of their mission," McDiarmid says. "Our mission is important and these drugs are lifesaving to our patients. But we have to figure out a way [to provide the chemotherapy] and not mortgage the health of our workers in the process."

States may eventually lead the way to national protections, she says.

Not all hazards are equal

The Washington rule, which was issued in January and will become effective beginning in 2014, is based on a 2004 alert and 2010 update from the National Institute for Occupational Safety and Health (NIOSH). NIOSH has identified 157 hazardous drugs and outlined measures that should be taken to prevent exposure (http://1.usa.gov/AuX1NS)

The Washington Department of Labor & Industries (L&I) uses the NIOSH framework but allows health care facilities to take a "tiered approach," with different levels of precautions based on a hazard assessment. Retail pharmacies had argued that if all drugs on the list were treated in the same manner, they couldn't even dispense pre-packaged oral contraceptives without special safety equipment.

"We recognize and acknowledge that all the drugs on the NIOSH list are not equally hazardous," says Michael Silverstein, MD, MPH, assistant director of the Department of Labor & Industries. "There is relative toxicity that differs from drug to drug and the exposure circumstance is different. [This is] a tiered program that matches the precautions to the nature of the exposure and the risk."

L&I is setting up an advisory committee with employer and employee representatives to help guide the implementation. The agency also is setting up model programs. "If [employers] have a tiered program that is consistent with the model programs, they're going to be in compliance with the rule," Silverstein says.

The rule requires hazard assessment and training of employees. Echoing the successful Bloodborne Pathogens Standard, it requires an exposure control plan that must be updated annually with input from frontline employees. It requires the mixing, compounding or crushing of hazardous drugs to occur within a ventilated cabinet, double-gloving in higher risk activities, and other safe handling practices. Employers must have written spill response procedures and appropriate personal protective equipment.

One important element has been deferred. Because NIOSH is updating guidance on medical surveillance related to hazardous drugs, L&I decided to hold off on that issue and consider adding a new provision at a later date.

NIOSH will periodically update its list of hazardous drugs, which now totals 157. There also may be new methods of exposure control. Silverstein says the Washington rule was designed to allow flexibility. "We think we've written a rule that is going to be durable, at least in the foreseeable future," he says. "It's written in such a way that it could be adapted [to changes]."

[Editor's note: The Hazardous Drugs rule is available at http://1.usa.gov/xhEUrh.]

Reference

1. McDiarmid MA, Oliver MS, Roth TS et al. Chromosome 5 and 7 abnormalities in oncology personnel handling anticancer drugs. J Occup Environ Med 2010; 52:1028-1034.