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Wiping Out Hazardous Drug Contamination

On February 20, 2008, William Zamboni, PharmD, PhD, had been at the UNC Eshelman School of Pharmacy for barely a week. He didn’t have a lab or even a computer yet, but he already had an opportunity knocking on his office door.

In came Stephen Eckel, PharmD, MHA, the assistant director of pharmacy at UNC Hospitals and an adjunct assistant professor at the School. Eckel pitched an idea for a collaboration: creating a reference lab to measure the level of chemotherapy contamination on surfaces in places that worked with anticancer drugs, such as hospitals, pharmacies, clinics, and labs.

Zamboni was confident that they could develop a way to detect the contamination, but he had some doubts about what they would find.

“Initially, I wasn’t a believer,” says Zamboni, an associate professor at the School. “I didn’t think the level of chemotherapy contamination was a problem. I knew we could measure it, but I didn’t know if the level would be detectable or, even if we detected exposure, if the level would be relevant.”

Nonetheless, Eckel’s proposal piqued Zamboni’s interest and they embarked on a partnership that, in the four years since their initial meeting, has made a true believer out of Zamboni and spawned a successful spinoff company, ChemoGLO LLC, which offers products and services to detect and clean up surface contamination of anticancer agents and other hazardous drugs.

“It was almost like the perfect storm,” Zamboni says. “I had the expertise. Stephen had the idea, the vision, and the connections. And UNC, because of the way they think about creating companies, really fostered the collaboration and development and helped us do this.”

A Better Alternative

Eckel, a leading expert on the issue of chemotherapy contamination in the workplace, says studies have found that people who prepare and administer chemotherapy drugs are at risk of developing complications from exposure to those drugs. Despite the harmful effects, however, he says the issue has only started to receive more attention in recent years.

“I’ve given talks all over the world on cancer-drug contamination and the risks associated with it for employees, and every time when I walk away, somebody would come up to me and say, ‘I never knew that was a concern,’ ” Eckel says.

“So part of the problem is just the need for education, and part of the solution is to keep people aware of the problem. It’s ok to prepare chemotherapy—obviously people need it—but we need to make sure that people are doing it in a safe environment that minimizes risks to both patients and employees.”

Part of the safeguards involves conducting periodic surface wipe tests to measure the level of contamination in the workplace. At UNC Hospitals, Eckel and his colleagues had been sending their test samples to a company overseas for analysis, which required shipping with dry ice and waiting three to four months to get the results. That cumbersome process got Eckel thinking about creating a better alternative.

“Around the same time, the UNC Eshelman School of Pharmacy was hiring faculty, and oncology was a big focus, so I started wondering, ‘Why can’t we do this?’ ” Eckel says.

He took the idea to Howard McLeod, PharmD, the director of the School’s Institute for Pharmacogenomics and Individualized Therapy, and McLeod introduced him to Zamboni, who had just joined the School and the institute.

Using a grant from Carmel Pharma Inc., Eckel and Zamboni set up a reference lab and a series of research projects within Zamboni’s lab. By April 2010, they had developed ChemoGLO, an easy-to-use kit and analytical reference lab for measuring surface contamination of five anticancer drugs.

Eckel and Zamboni say ChemoGLO offers several advantages over other surface wipe tests. A single kit can be used to measure multiple types of anticancer agents. Clients can ship their samples to the reference lab at room temperature, which means they are not constrained by the limited lifespan of dry ice and thus can ship from anywhere in the world. Also, the reference lab can deliver a report in two to three weeks, a considerably faster turnaround. In addition, clients receive an enhanced analysis that shows how their levels compare with all other sites that have used the kit, along with suggestions on how to reduce contamination.

Converting Skeptics

Over the past three years, ChemoGLO has been used in more than one thousand studies at more than three hundred hospitals around the United States. In addition, the kit has been used in three hospitals in Japan, and the lab has been contacted by sites in the United Kingdom and Asia.

Eckel and Zamboni say that eighty to ninety percent of the sites they’ve tested showed detectable levels of contamination. The results of early tests wiped away Zamboni’s doubts as the samples from many sites showed contamination levels that were ten to a hundred times higher than the concentration needed to kill cancer cells in vitro.

“I never thought the levels of exposure would be this high,” Zamboni says. “It’s in many different places at high levels. It’s in the hood. It’s on the floor. It’s on tables. It’s on door knobs. It’s on computers. It’s in the transfer trays. It’s even outside of where they are mixing the chemotherapy.”

Many of the clients were similarly surprised by the high levels at their sites and followed up with Eckel and Zamboni on how to reduce the contamination. However, the ChemoGLO team also had to win over some skeptics. Occasionally clients would send them blank samples without telling them so as to test the validity of their kit. Zamboni and Eckel say that ChemoGLO has been up to the challenge and that these occasions have even offered opportunities to educate clients about chemotherapy contamination.

“Someone at one notable site actually decided to collect a blank sample from his desktop in his office, which was not near where the chemotherapy was prepared,” Eckel says. “The sample came back positive, so he challenged us and said, ‘I’m not sure this is really good science.’ We talked to him about how you can actually transfer contamination from the preparation area to other areas from your lab coat. Since his experience with ChemoGLO, he has become a believer based on this education.

“As people have seen the data and recognized that there is a lot that goes into trying to minimize contamination, they have become more reliant on our routine monitoring.”

Branching Out

By 2012, the ChemoGLO operation had outgrown its original setup in Zamboni’s lab, but Eckel and Zamboni were prepared. In February of that year, they licensed the technology from UNC and turned ChemoGLO into a private spinoff company. Less than a year after its creation, ChemoGLO LLC is already turning a profit.

The company has also developed a new product to help wipe out contamination. Test results from ChemoGLO’s repeat clients showed that while implementing best practices after the initial test reduced detectable contamination, it did not completely eliminate it. So the ChemoGLO team started working on a way to get rid of the remnant.

“This contamination is very difficult to clean up because these drugs have very different solubilities,” Zamboni says. “If you use just alcohol or just water, or even a mixture of the two, you can’t clean up the drugs.”

The solution the team came up with was Hazardous Drug Clean (HDClean), a packet of two towlettes, each containing a novel mixture. When used in sequence, the towlettes can remove all detectable surface chemotherapy contamination. Zamboni says the form factor was inspired in part by his brother-in-law, who owns a company that makes towlettes for cleaning industrial respirators.

ChemoGLO has signed a licensing agreement with UNC-Chapel Hill for the technology behind HDClean and will begin offering the product in February 2013.

“The idea for HDClean is that it would clean up, at the end of the day or the shift, any remnant that wasn’t mitigated through best practices,” Eckel says. “HDClean should not be used in place of best practices, but it provides one more solution to minimize the contact an individual has with hazardous drugs.”

Hospitals had previously used a cleaning product that was not specifically designed for chemotherapy contamination. The company that makes that product, Zamboni says, has never published data demonstrating that it removes drugs from surfaces. Furthermore, the product had a foul odor and left oily residues.

“We worked through a bunch of different mixtures and ingredients to come up with towlettes that can clean a wide variety of drugs,” Zamboni says. “We wanted to be able to clean up many different types of drugs, and we didn’t want any strong odor or oily residue. HDClean achieves all of those goals.

“Since we had the surface-contamination reference lab, we could also prove that our towlettes worked.”

Positioned to Grow

Having the reference lab also positions the company to explore other opportunities, Zamboni says. For instance, the reference lab has the capacity to test for anticancer drugs other than the five currently detected by ChemoGLO, as well as antibiotics and immunosuppressants. Also, aside from regular monitoring services, the lab can be used for research and development, such as helping companies test new products or methods for eliminating contamination.

The opportunities aren’t limited to the business side. On the research front, the ChemoGLO team has participated in studies of surface contamination in the US and Japan. Also, the researchers are planning to investigate the effect of ingesting chemotherapy contamination.

“I feel quite lucky that this came about,” Zamboni says of the collaboration that gave birth to ChemoGLO. “It’s a prime example of the things that make UNC such a great place to work. One is the collaborative nature of the people that work here. A second thing is the support: We couldn’t have done this without the research infrastructure from the School, the UNC Lineberger Comprehensive Cancer Center, and Carolina Kickstart; the mentoring and advising from people at the School, the hospital, and the University; and the support from the Office of Technology Development.

“I can tell you, none of this would’ve happened at many other places because they don’t have that entrepreneurial spirit and mentality, and they certainly don’t have the same level of expertise, infrastructure, and mentoring that UNC has.”