Lifesaving drugs may be killing health workers

Nurses, pharmacists and others who handle chemo drugs have been getting sick. Despite multiple studies that indicate the drugs actually may cause cancers, the federal government doesn’t require safeguards on the job.

By Carol Smith

 

 for full story see  http://seattletimes.nwsource.com/html/localnews/2012327665_chemo11.html

Sue Crump braced as the chemo drugs dripped into her body. She knew treatment would be rough. She had seen its signature countless times in the ravaged bodies and hopeful faces of cancer patients in hospitals where she had spent 23 years mixing chemo as a pharmacist.

At the same time, though, she wondered whether those same drugs ”” experienced as a form of “secondhand chemo” while she mixed the drugs as a pharmacist at Swedish Medical Center and elsewhere ”” may have caused her cancer to begin with.

Chemo is poison, by design. It’s descended from deadly mustard gas first used against soldiers in World War I.

Crump knew she had her own war on her hands. She wanted to live long enough to see her 21-year-old daughter, Chelsea, graduate college.

And she wanted something else: She wanted young pharmacists and nurses to pay attention to her story.

Crump, who died of pancreatic cancer in September at age 55, was one of thousands of health-care workers who on the job was chronically exposed to chemotherapy agents for years before there were even voluntary safety guidelines in place.

Now some of those workers are being diagnosed with cancers that occupational-health specialists say could be linked to exposure to those same powerful drugs that have saved hundreds of thousands of patient lives.

An InvestigateWest investigation has found that the federal Occupational Safety and Health Administration (OSHA) does not regulate exposure to these toxins in the workplace, despite multiple studies documenting ongoing contamination and exposures.

Studies as far back as the 1970s have linked increased rates of certain cancers to nurses and physicians. Occupational-health experts believe that’s because when nurses, pharmacists, technicians and, increasingly, even veterinarians mix and deliver the drugs, accidental spills, sprays and punctures put them in close, frequent contact with hazardous drugs.

A just-completed study from the U.S. Centers for Disease Control (CDC) ”” 10 years in the making and the largest to date ”” confirms that chemo continues to contaminate the work spaces where it’s used and in some cases is still being found in the urine of those who handle it, despite knowledge of safety precautions.

Chemo agents have been classified as hazardous by OSHA since the mid-1980s. Hazardous drugs are those known or suspected to cause cancer, miscarriages, birth defects or other serious health consequences.

Jordan Barab, deputy assistant secretary of labor for OSHA, said in written response to questions from InvestigateWest that the agency doesn’t have the resources to regulate workplace-drug exposures, although it is concerned about the issue.

OSHA has no regulatory authority to enforce safety practices with fines or sanctions, other than under its “General Duty” clause ”” a catchall regulation that allows OSHA inspectors to warn an employer if they see something that concerns them.

According to documents obtained by InvestigateWest through the Freedom of Information Act, OSHA has used the General Duty clause only once in 10 years to cite any health-care institution, including hospitals, clinics and dental and veterinary offices, for their handling of hazardous drugs.

“There is no other occupation population (that handles) so many known human carcinogens,” said Thomas Connor, a research biologist with National Institute for Occupational Safety and Health (NIOSH). Connor has spent 40 years studying the effect of chemo agents on workers and is one of the lead authors on the latest study.

Tracing an individual’s cancer to a particular exposure is difficult. It’s one of the main reasons safety advocates have been thwarted in their efforts to get stricter regulations.

But the ranks of those who have became symbols for increased safety include pharmacists Bruce Harrison, of St. Louis, and Karen Lewis, of Baltimore; veterinarian Brett Cordes, of Scottsdale, Ariz.; and nurse Sally Giles, of Vancouver, B.C.

Like Crump, all of them eventually got cancer, or in Lewis’ case, a precancerous condition. Cordes was diagnosed four years ago at age 35. Giles was in her 40s, and Lewis and Harrison were in their 50s when diagnosed. All but Lewis and Cordes are now dead.

Early exposure

On an afternoon in May of 2009, Crump sat in a coffee shop near her Redmond home and perused a list of chemo drugs now deemed hazardous for health-care workers to handle. She runs her fingers down the page. It’s a long list: cyclophosphamide, doxorubicin, fluorouracil, methotrexate. And the list went on.

“Yeah, I worked with all of them,” she said. Crump started at Swedish Medical Center in the early 1980s, before pharmacists used special protective “hoods” over countertops to contain spray and chemo contamination. They didn’t use gowns or gloves.

They had no reason to think they should. Occasionally, drugs would spill on the countertops.

“We would wipe it off and throw (the towels) in the garbage,” she said.

Most of the chemo came in vials and would be transferred into plastic IV bags. Sometimes there would be spray when they punctured the vials. Other drugs came in ampuls, glass vessels sized for a single infusion. “I’d file the neck of it, then snap real fast,” she said. “A lot of times, I got cuts.”

“But the feeling at the time was ”” whatever little vapors or splash ”” it was such a low exposure through the skin, it was insignificant.”

That was a common attitude then ”” and now, said Dr. Melissa McDiarmid, director of occupational health at University of Maryland.

“So many people think: It’s just a ‘little bit.’ They don’t understand it’s a little bit of something designed to be toxic and to be highly absorbed biologically.”

A silent threat

Danish epidemiologists used cancer-registry data from the 1940s through the late 1980s to first report a significantly increased risk of leukemia among oncology nurses and, later, physicians. Last year, another Danish study of more than 92,000 nurses found an elevated risk for breast, thyroid, nervous-system and brain cancers.

“It’s been a silent threat for a long time, with very little attention by the government,” said Bill Borwegen, occupational health and safety director for Service Employees International Union (SEIU), the labor union that represents nurses nationally.

“We are concerned how they are handled. There’s such a dearth of info on how to sample these agents. People don’t know how to clean surfaces.”

Chemotherapy agents, when dispersed in the air or onto surfaces, are invisible, difficult to clean, long-lasting, easily spread and capable of causing genetic damage. They’ve been found on the outsides of the drug vials shipped from manufacturers, on floors and countertops, on keyboards, and garbage cans and doorknobs.

Seth Eisenberg, an oncology nurse who works at Seattle Cancer Care Alliance and speaks nationally to nurses about safety issues, calls contamination of workplaces a “double whammy.”

“It’s difficult to detect,” he said. “And difficult to get rid of.”

Researchers at NIOSH, a division of the CDC, were so concerned, they issued an extensive alert about handling high-risk drugs.

The guidelines, published in 2004, urge strict precautions, including use of impervious chemo gowns, double-gloving, use of sophisticated “closed-system” devices and specialized ventilation hoods, face shields and respirators, “clean rooms” and other precautions.

But the NIOSH guidelines outlined in the alert are voluntary.

That’s wrong, said McDiarmid. “We can no longer have these be optional … We’re talking human carcinogens here.”

Change in procedure

Ten years into Crump’s career, reports of health effects related to chemo exposure began to surface in Europe, and health-care workers started adopting rudimentary safety procedures.

Her pharmacy manager at Swedish took the warnings seriously and installed special ventilated hoods in the work spaces ”” considered state-of-the-art at the time.

The trouble was, the hoods were designed to keep chemicals sterile by blowing contaminants away from them and back out of the hood. That meant the worker standing outside the hood was still getting exposed, Crump said.

Lanny Turay worked in the same pharmacy as Crump and recalled many of the same experiences. He now manages pharmacy operations at Swedish Cancer Institute.

Safety practices have evolved over the years. Swedish now has a special dedicated area for mixing chemo and uses a different type of hood that no longer blows air back at the workers. Workers wear special gowns, gloves and sleeves, and they take other precautions to keep chemo from spreading around, he said.

Still, Crump wondered whether those early, ongoing exposures had contributed to the cancers she and her peers have gotten. She first recalled getting alarmed after a pharmacy tech ”” someone with whom she mixed a lot of chemo ”” died at age 29 of a brain tumor. Around the same time, several colleagues experienced miscarriages.

Since that time, a number of studies have shown an association between exposure to chemo agents and adverse reproductive effects including miscarriage, birth defects and low birth weights.

A 2005 survey of 7,500 nurses, reported in the journal Oncology Nursing Society, found significant associations with infertility and miscarriage in nurses who handled chemo before the age of 25.

Nurses, who occasionally spill the chemo drugs on their clothing or splash it on their skin, had a greater chance of premature labor if they administered nine or more doses of chemo per day. The survey also found that nurses who didn’t use gloves as often while preparing chemo were more likely to have children with learning disabilities.

“Now all these people about my age are getting cancer ”” cervical, ovarian, prostate, endometrial, brain,” Crump said. “All of us, at one time or another, worked with chemo ”” we wondered, well, is there a connection?”

Boosting safety

Swedish, Crump’s former employer, has taken some advanced measures to protect its workers, said Turay, manager of oncology pharmacy operations.

“Sue Crump would be pleased to see what she would see today,” said Turay. “She would also, I think, mimic what I’m saying … that we’ve made great strides to be a better provider of care and a safer provider of care.”

Some larger academic cancer-treatment centers, including Seattle Cancer Care Alliance, M.D. Anderson Cancer Center in Texas, and Huntsman Cancer Institute in Utah, also have taken safety precautions that include use of closed-system technology devices (CSTDs) to protect workers from exposures.

The devices, which add up to about $15 per chemo dose to the cost of care, are not required by law and not yet widely used in all settings where these drugs are used. Safety experts said using them is like adding air bags to a car ”” they add a layer of safety.

“Generally speaking, it’s the larger academic institutions who have been adopters of CSTDs,” said Eisenberg, the Seattle Cancer Care Alliance nurse who consults nationally on safety issues. “Unfortunately, the smaller community-based facilities (and physician offices) have largely ignored their use.”

There are more than 5.5 million workers involved in nursing, pharmacy, transport and cleanup of chemo waste. Of those, experts estimate, about 2 million actually mix or dispense chemo. It can be a messy job. McDiarmid, the occupational-health expert, got interested after she saw a nurse spill the contents of a bottle of chemo drugs on herself and become violently ill.

Those numbers will grow; the ranks of cancer patients are projected to climb by 50 percent in the next decade as the population ages. More people will be required to prepare and deliver their treatment. And more of those people likely will be in nonhospital settings such as outpatient clinics or private homes.

In addition, chemo drugs have found wider application in the treatment of arthritis, multiple sclerosis and other diseases. For example, methotrexate is used to treat autoimmune diseases such as arthritis, and azathioprine and mitoxantrone are used to treat multiple sclerosis.

And veterinarians are increasingly using these drugs to treat animals, putting those who work in vets’ offices in contact with chemo.

Generic drugs have made the treatment more affordable for pet owners, said Cordes, who became a safety consultant after he was diagnosed with thyroid cancer.

Cordes said he, like many veterinarians he’s spoken with, handled chemo without understanding its dangers. More safety information is made available to practitioners of human medicine, he said.

“We slip through the cracks.”

Beating the odds

On a sunny day in June 2009, Sue Crump has a list of things to do. She needs to teach her daughter, Chelsea, about mortgages and schedule an appointment with a financial planner. They are going through boxes of old photographs.

“I’m a practical thinker,” she said. “And I’m practical about this.”

By this, she means pancreatic cancer. Pancreatic cancer carries a grim prognosis. By the time it’s diagnosed, it’s typically too late to cure.

Crump already has outlived various prognoses ”” three to six months, then six months to a year. It’s been more than a year now. Crump attributes it to sheer orneriness. “I’m Scotch and Irish,” she said. “My Dad always said I’m two kinds of stubborn.”

But cancer is a leveler, and her tumor markers are on the march. They’ve quadrupled in a few months.

By last fall, the cancer was on its final assault.

Chelsea Crump took a semester off from school to take care of her mom.

Sue Crump was stubborn to the end, cheating her expected death several times. She spent her last days in the Redmond home she had built, on land she had cleared by herself. She finally succumbed, surrounded by her family and her beloved dogs, in her living room on Sept. 13.

Shortly before she died, she said she hoped talking about her experiences would make new health-care workers pay a little more attention.

“Safety needs to be revisited,” she said. “People don’t take this seriously enough.”

And she extracted a promise from her daughter.

Just before her mother died, Chelsea Crump promised she would go back to school and finish the degree in journalism she had started.

She also promised she would share her mother’s story.

Carol Smith, a co-founder of InvestigateWest and former Seattle Post-Intelligencer medical reporter, can be reached at csmith@invw.org