R.I. Company Pushes Efforts to Address ‘Secondhand Chemo’

 The Environmental Protection Agency strictly regulates the disposal of unused chemotherapy substances and any container or instrument contaminated by them. However, chemo drugs excreted at home by patients two to three days later pose a concern, but there are no regulations regarding the handling of this waste. (istock)

The Environmental Protection Agency strictly regulates the disposal of unused chemotherapy substances and any container or instrument contaminated by them. However, chemo drugs excreted at home by patients two to three days later pose a concern, but there are no regulations regarding the handling of this waste. (istock)

By FRANK CARINI/ecoRI News staff

Jim Mullowney had spent much of his professional career, up until 2008 at least, working to protect people from the dangers of industrial chemicals. His life’s work changed that year when his mother was diagnosed with cancer. He quickly learned that chemotherapy drugs are much nastier, and that they are being unsuspectingly taken home.

Currently about 85 percent of chemotherapy patients receive their infusions at a hospital or health-care facility. (Home infusion therapy is on the rise and is expected to grow.) They are then sent home — typically with little warning about the dangers the chemicals that soon will be exiting their bodies can pose to family members and caregivers for the next two to three days.

Anyone who touches these contaminated fluids, say, by cleaning the toilet, helping a patient as she vomits, or with other tasks caregivers and family selflessly perform, could absorb dangerous amounts of an active cytotoxic drug.

Despite being a University of Massachusetts-educated environmental chemist and having spent nearly three decades working with industry’s most vile chemicals, it had never occurred to Mullowney that some chemicals used in medical treatments were actually more dangerous than those that are regulated in factories.

Mullowney told ecoRI News back in 2012 that “empty vials, empty IV bags, the gloves nurses wear, everything that comes into contact with these materials, even in trace amounts, is treated like it is a chemical weapon. Yet, we inject it into a patient where it passes through the body in three or four days. There’s no thought to where it ends up or the impact these powerful chemicals have on a household.”

This situation still exists today, but, thanks to efforts by Mullowney and his Middletown, R.I.-based company, among others, the problem is now being addressed.

This week Mullowney is attending the annual American Society of Health-System Pharmacists (ASHP) convention in California. The emerging issue of “secondhand chemo” will likely be among the topics discussed.

“This stuff is still going down the drain,” Mullowney told ecoRI News on Nov. 29, a few days before he left for Anaheim. “If a doctor slipped a bag of chemo into the pocket of a patient and sent him home, they’d send him to jail.”

Health-care professionals and pharmaceutical companies are well aware of the risks, according to Mullowney. He said drug producers and hospital officials understand the dangers accidental exposure to cytotoxic drugs pose to their employees. Every step, from drug production through injection into a patient, is carefully controlled to minimize health risks.

In a hospital setting, the Environmental Protection Agency (EPA) strictly regulates the disposal of unused cytotoxic substances and any container or instrument contaminated by them. It’s a crime, for instance, to dispose of containers holding even trace amounts of these drugs — the wrapper the drugs came in, and anything that came in contact with the drug — by any means other than through the chemical waste disposal industry.

Next December new federal regulations on hazardous drug handling will take effect. These regulations will force the control of hazardous drugs, including some of the drugs that are excreted by chemo patients in their urine, feces, vomit, sweat, and saliva.

The problem, according to Mullowney, is that of the billions of dollars being spent by hospitals nationwide to comply with United States Pharmacopeia 800 won’t do anything to control secondhand chemo — the human waste containing up to 90 percent of the drug that is excreted by patients at home.

Cytotoxic chemotherapeutic drugs were originally developed in the 1940s, when patients with lymphomas began receiving nitrogen mustard (mustard gas) as a therapeutic agent. Clinicians at that time wore only gloves, masks, and gowns, since there were few safety standards in place.

Mullowney founded Pharma-Cycle LLC about a decade ago to address what the company calls a “major public health and environmental issue.” The Middletown company says, “Cytotoxic drugs, used in chemotherapy treatment, are dangerous materials with roots as chemical weapons.”

“One of the first uses of a hazardous chemical for therapeutic purposes occurred after nitrogen mustard, a chemical weapon used in World War I, was observed to cause bone marrow and lymph tissue regression in exposed soldiers. Nitrogen mustard was then used as a treatment for lymphoid malignancies in what many consider to be the first instance of cancer chemotherapy,” according to The Joint Commission, a nonprofit that accredits more than 21,000 U.S. health-care organizations and programs.

Growing concerns
The use of chemotherapeutics grew significantly in the ’60s and ’70s. This increased use was followed by reports of traces of chemo agents in the urine of oncology nurses and health-care workers and produced side effects similar to those of chemotherapy patients: nausea, vomiting, hair loss, and mouth sores.

In 1985 and again in 1990, the ASHP published a technical assistance bulletin on handling chemo drugs and other hazardous compounds. This report and continued concerns for health professional safety prompted the Occupational Safety and Health Administration in 1995 to issue a new guideline on controlling occupational exposure to hazardous drugs, such as chemotherapeutics.

In 2004, the National Institute for Occupational Safety and Health issued the NIOSH Alert: “Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings.”

Genotoxic and cytotoxic compounds, most commonly found in chemo drugs, work by either mutating or killing cells. Unlike poisons, which can be safe when exposure is limited to tiny amounts, genotoxins and cytotoxins act more like “chemical germs,” Mullowney said, where even minimal exposure can cause a devastating chain reaction.

The World Health Organization (WHO) considers contact with residual amounts of chemotherapy drugs a significant risk requiring collection, containment, and proper disposal to avoid exposure “through contact with body fluids and secretions of patients undergoing chemotherapy.”

According to a 2013 WHO report, any wastes produced by these patients within 48 hours of drug administration, and in some cases for up to a week, should be considered genotoxic.

The human body can only destroy a portion of these genotoxic drugs. The rest passes out of the patient in urine, feces, vomit, and sweat. This waste can still have enough of the dangerous drug to kill developing cells and/or cause mutations in vulnerable people.

Mullowney said that despite the otherwise well-regulated and well-managed handling of dangerous medical waste, chemotherapy patients treated with any of more than two dozen different chemotherapy drugs who return home after outpatient treatment can inadvertently but easily expose others to contamination through seemingly benign occurrences such as urine splashed on a bathroom floor, clean up after an episode of vomiting, or the handling of bed sheets.

Chemo crusade
When his mother was diagnosed with breast cancer, he researched the drugs she was prescribed and looked into other cancer treatments. He found that the cornerstone chemotherapeutic drugs attack DNA and pass through cancer patients as active chemicals.

Both shocked and saddened by the lack of elaborate practices that deal with chemo drugs in the home or even warnings about the dangers they present to a patient’s family and friends. Mullowney and eventually Pharma-Cycle set out to educate the public and, surprisingly, the health-care industry itself.

It’s been a long journey, but the health-care industry, cancer patients, and their families are beginning to understand the concern. Mullowney gave a TED Talk last year in Newport about these hidden dangers of chemo drugs. He has testified at a Rhode Island Special Legislative Commission to study pharmaceutical contamination in the water supply.

Pharma-Cycle has developed a Family Safe System that is mailed to patients’ homes, and includes devices for collection and automatic sequestering of contaminated bodily wastes. The supplies — cotton gloves, disposable utensils, vomit bags, wet wipes, and disposable sheets — arrive in a 16-inch box.

Used sheets, gloves, utensils, barf bags, and collected feces and urine are placed back into the box, which includes five layers of protection. Implementing an easy-to-use matrix designed by Pharma-Cycle, liquids are turned into solids and made safe and legal to ship.

The boxes filled with chemo-tainted hazardous materials are shipped to secure chemical landfills in the United States and Canada. Other companies have designed similar programs to deal with chemo-patient waste.

Hundreds of drugs are used to fight cancer. The most powerful are cytotoxic, which kill cancer cells anywhere in the body and, unfortunately, fast-growing healthy cells anywhere in the body. The goal of chemo drugs is to poison the cancer before killing the patient.

Of the more than 200 drugs used in various chemo treatments, two to three dozen are a real problem, including doxorubicin, cyclophosphamide, fluorouracil, cyclophosphamide, and etoposide. These drugs are excreted in active form in the few days after each chemotherapy infusion.

The Occupational Safety and Health Administration in 1986 released recommendations for hospitals to use high levels of protective equipment when working with chemotherapy patients and/or their bodily wastes.

While industrial chemicals are highly regulated, pharmaceuticals are not — at least when it comes to disposal. Since the 1970s, it has been illegal, for example, to dump paint thinners and polychlorinated biphenyls (PCBs) down the drain. But the waste of chemo-treated patients is routinely flushed down the toilet.

The American Cancer Society warns that toilets being used by patients undergoing chemotherapy can be a hazard for children and pets, it recommends that chemo patients use a separate bathroom, and that men sit down when urinating.

Mullowney said society has to stop flushing these toxic chemicals into the environment. Only a quarter of what was used on a patient may leave the body, he said, but it doesn’t take a large amount of these chemicals to have an impact.

Chemotherapy chemicals are known to cause birth defects, immune dysfunction such as myelodysplastic syndrome (pre-leukemia), and miscarriages. Patients can even develop other cancers that don’t appear for several years. For example, cyclophosphamide, which is used to treat breast cancer, can cause bladder cancer.

The unborn, babies, and children have huge numbers of fast-growing cells that can be attacked by post-patient chemotherapy drugs. When chemo patients are sent home, they are unintentionally bringing DNA-mutating drugs into their homes and dumping them into the environment, according to Mullowney.

Secondhand problems
Less than three decades ago people gave little thought about how cigarette smoke could impact non-smokers. Scientific studies eventually discovered the dangers, and the EPA, in 1993, concluded that secondhand smoke was causing some 3,000 lung cancer-related deaths annually. It took another decade before a scientific and legal consensus emerged and laws banning smoking in workplaces, bars, restaurants, and many public places passed.

Mullowney noted that a similar debate is emerging about secondhand chemotherapy. He said concern is growing that chemo drugs may be having an impact on those who manufacture the drugs, the pharmacists who compound them, the nurses who administer them, and family and friends who assist cancer patients.

At the moment, however, little research has been done on the health and environmental impacts of secondhand chemo. Some medical professionals have said Mullowney and others have overstated the public health and environmental threats posed by these drugs through human waste.

Cytotoxic chemicals have been identified in waterways and the water supply in the United Kingdom, Brazil, Germany, and Switzerland, according to various studies.

In August 2017, Pharma-Cycle was approached by a large pharmacy company in Denmark to market its collection devices for human waste containing cytotoxic drugs in the United States. Earlier last year, the company had filed patents on a collection device that is so similar to Pharma-Cycle that it in fact infringes on several patents.

Mullowney said he has been talking with this company to launch a pilot program using a combination of its bag system with Pharma-Cycle’s patented program.