Over the past year, the Alberta Union of Provincial Employees (AUPE) has received 150 complaints from its members about exposure to one of the most toxic classes of chemical agents used in health care. Cytotoxic drugs, also known as antineoplastic drugs, have a toxic effect on cells within the body and are most often used in chemotherapy to treat cancer.
“It was alarming to us that we would walk into a health-care facility and hear or witness licensed, practical nurses, heath-care aids distributing cytotoxic medications or other hazardous medications without any form of personal protective equipment,” says Trevor Hansen, occupational health and safety and disability representative at AUPE, which represents more than 90,000 workers. “Generally, employers in the health-care industry here in Alberta were not properly advising their workers of the medication and the impact to the worker… They were not doing their due diligence.”
To date, the union has filed seven formal occupational health and safety complaints to the Ministry of Labour for different employers throughout the province in regards to a lack of training, education and personal protective equipment (PPE) for cytotoxic drugs. OHS officers visited each workplace and in every single case, a compliance order was issued, Hansen says.
Every year, the number of cancer cases in Canada increases. The Canadian Cancer Society says nearly one in two Canadians will be diagnosed with the disease in their lifetime and one in four will die from cancer.
With chemotherapy being one of the principal treatments for cancer, there are global increases in the development and use of antineoplastic agents worldwide, according to the International Agency for Research on Cancer. Currently, there are more than 100 different antineoplastic agents available.
These drugs not only attack cancer cells, but they are non-selective and affect normal cells, too. Acute reactions can include skin irritation, eye and mucous membrane irritation, nausea, vomiting, hair loss and rashes.
Due to the latency period of some of these medications, chronic issues can show up five, 10, 15 years later, such as damage to the liver, kidney, lung and heart, Hansen says.
Many antineoplastic drugs are carcinogenic, meaning that exposure could cause cancer. Studies have shown an increased risk for leukemia, non-Hogskin lymphoma, bladder cancer and liver cancer among exposed workers.
The drugs are also teratogenic, meaning that they can affect fetal development. There is a fair amount of literature regarding reproductive toxicities and cytotoxic drugs, such as infertility issues, miscarriages, stillbirths and birth defects. Employees who are pregnant, trying to conceive or breastfeeding should be reassigned to tasks where they won’t be exposed to cytotoxic drugs.
Hansen says reproductive issues are a concern among his union members who work with these drugs.
“Now they are trying to relate it back to things like miscarriages they have had, the inability to conceive children… It’s really hard to specify that this was the direct result of dealing with these types of drugs without being properly protected, but once that information becomes available, people’s minds start to ask that question,” he says. “And had they been properly protected, perhaps they wouldn’t have to ask.”
All workers who may come into contact with cytotoxic drugs have to be aware of all of these risks, receive relevant training and wear the necessary PPE to protect themselves. According to Carex Canada, occupations with potential exposure include: pharmacists and pharmacy assistants, nurses and licensed nurse practitioners, physicians, veterinarians and their assistants, environmental service workers (janitors and caretakers), shippers and receivers, industrial laundry workers and pharmaceutical manufacturing workers. Hansen adds that correctional officers can be at risk if offenders have been receiving cancer treatment.
Carex Canada estimates about 75,000 Canadian workers are exposed to antineoplastic agents. There is no safe level of exposure to cancer-causing agents. Detectable levels of cytotoxic drugs have been reported in the urine of pharmacists, pharmacy technicians, nurses and workers in drug manufacturing plants. The largest occupational group exposed is pharmacy staff (pharmacists, technicians and assistants), with 42,900 workers exposed.
ROUTES TO EXPOSURE
Cytotoxic drugs come in liquid form, which can be administered through IV or injection, as well as pill form, which sometimes needs to be split in half or crushed so the patient can swallow it easier. Along with being used to treat cancer, the drugs can also be used for rheumatoid arthritis, psoriasis, multiple sclerosis and some viral diseases, such as HIV.
Workers can be exposed through skin absorption (direct contact with the drug or indirect contact with contaminated surfaces or handling patient excreta); inhalation (breathing in drug vapours or dust); accidental injection (needles or other sharps that puncture the skin); and ingestion (not washing hands prior to eating or putting contaminated pencils and pens in the mouth).
In health care, workers along the entire medication circuit can be exposed to cytotoxic drugs. It starts with the staff involved in the receiving department, who rely on warning labels on the outside of the shipping and transport containers so they know what they are handling. Workers could be exposed if the vials of the drug are broken or if there are traces of it on the boxes.
“If there’s no safe handling protocols in place, then there’s that risk of touching it and being exposed to it,” says Komal Patel, educator at the de Souza Institute in Toronto, which provides continuing education to health-care professionals.
Pharmacy staff can be exposed when they are storing, mixing and preparing the drug or transporting it to the proper unit.
While they are administering the drug, nurses and their aids can be exposed. For example, the drug can be absorbed through their skin if they are not wearing gloves or if it permeates through the gloves.
Exposure can also occur when they are caring for the patient after treatment. Bodily fluids and excreta — such as saliva, sweat, urine, feces and vomit — may contain drug residue for up to one week. This means not only nurses can be exposed after the fact, but housekeeping and maintenance staff can be too.
“These dangerous drugs carry that 48-hour to seven-day window where they can still be impacting the health-care workers out there who have to go in and change linens and clean the rooms and work on the facilities and maintenance of beds and toilets and sinks and that whole system,” says Hansen.
In addition, there’s a whole range of support workers who may unknowingly face exposure at various points along the line, such as the dietary staff.
“They are delivering the lunch trays and they may put the tray down and maybe the patient has asked them to move something and the object is contaminated, then there’s that risk as well,” says Patel. “It’s not just necessarily the individuals who are around patients all the time.”
Anyone working with cytotoxic drugs or handling waste products should at least be wearing two pairs of chemotherapy gloves and a non-permeable chemo gown. They may also need goggles or a face shield if there is a risk of splashing and a respirator if there is an airborne risk, says Hansen.
When it comes to pharmacy staff, they have to wear two pairs of chemotherapy gloves, a chemotherapy gown, hair cover, a beard cover (if applicable), a respirator, shoe covers and safety goggles with side shields if there is a potential for splashing, says Lynne Nakashima, provincial pharmacy director at BC Cancer, which operates six cancer treatment centres across British Columbia. They are not allowed to wear any jewelry, rings or makeup, and they cannot wear contacts.
A 2014 survey by the National Institute for Occupational Safety and Health (NIOSH) in Atlanta found 80 per cent of oncology nurses and other health-care personnel were not always wearing two pairs of chemotherapy gloves and 15 per cent did not wear even a single pair. Forty-two per cent of the 2,100 survey respondents failed to always wear a non-absorbent gown with closed front and tight-fitting cuffs.
One reason why health-care professionals may not be wearing their PPE is because they are so patient-focused.
“A lot of the times the health-care staff themselves get lost in safety requirements for them as workers,” says Hansen.
To get ahead of the problem, BC Cancer makes sure it hires individuals who are adapt at following very strict policies and procedures, such as wearing all necessary PPE.
“We ask in the interview: ‘Are you the sort of person who is good at following very strict policies and procedures?’ Because if they’re not, this isn’t going to be a good place for them,” says Nakashima. “You have to do all of these procedures and you have to follow them rigorously because not only are you protecting your own health, but you’re protecting those around you.”
It’s also important to foster a safety culture where not wearing PPE is simply regarded as unacceptable among staff.
“If someone were to walk in with the wrong thing, everybody would turn around and say, ‘Go back out,’” says Nakashima. “They do kind of self-monitor in that way.”
The PPE needs to be easily accessible and workers need to be trained on how to properly don and doff the equipment as well.
When it comes to cytotoxic drugs, there needs to be strict policies and procedures in place. Aside from the national and provincial standards it has to follow, BC Cancer has created its own standard for the pharmacy staff who work with these agents. The standard covers everything from the time the drug is received on site through the mixing and dispensing of the medication, counselling of the patient and cleaning procedures, to the time it is given to the patient or it leaves the premises, says Nakashima.
One of the most important engineering controls at BC Cancer is the biological safety cabinet. It is a ventilated containment cabinet that is exhausted to the outside atmosphere to prevent re-circulation into the preparation room. For chemotherapy drugs, the exhaust and ventilation systems should operate continuously to ensure that no contaminants escape from the cabinet into the workplace, according to WorkSafeBC.
To ensure pharmacy staff are in fact following the many policies and procedures, BC Cancer requires them to complete an annual oncology certification. Every year they complete a written test and they are also observed in their day-to-day work. Evaluators have a checklist with specific criteria the workers have to meet. If they don’t score at least 85 per cent, they need to go through a re-training process, says Nakashima.
“And there’s certain aspects within those that we would consider an automatic fail if you don’t do certain things,” she says. “So some of them are smaller processes and we want you to do them and some are critical to the process.”
Closed system drug transfer devices have shown to be effective in controlling exposure to chemotherapy drugs. The devices are designed to minimize potential exposure of hazardous drugs and their vapour concentrations when transferring the drugs between containers or pieces of equipment.
BC Cancer implemented this type of system about five years ago for both its nurses and pharmacists. Nakashima says the agency has been pleased with the reduction in surface contamination.
“We take a swab and swab usual work spaces and the before and after’s are quite striking,” she says. “And once you implement, you maintain that low level of surface contamination. It’s another way the staff know they are not being exposed.”
Good communication about the types of hazards workers may be exposed to is very important. One method of doing this is door signage, which is especially useful for the support workers who do not have access to patient records, says Hansen.
“It is as simple as putting up a type of symbol on the doorway to allow those workers — the environment staff, the maintenance staff, the dietary staff — to know what they are walking into,” he says.
Posters can be another means of communication. Employers may want to have posters for restricted access zones (such as the areas where the chemotherapy drugs are mixed), appropriate use of equipment, proper handwashing, hazardous drugs and the location of spill kits.
Emergency procedures need to be clearly outlined for cytotoxic drugs in case of accidental exposure. According to the NIOSH survey, 12 per cent of respondents reported an antineoplastic drug spilled or leaked during administration.
Workers need to be trained in all of the emergency response procedures for the different scenarios that could occur.
“If it was to go into my eyes what do I do? What are the steps? If I were to ingest it somehow, what would I do? If it was absorbed into my skin, what would it do? Where do I get this information?” says Patel. “If you’re not educated then you’re not going to know what to do.”
Spill kits must be readily available in areas where drugs are stored, transported, handled and administered. A spill kit includes all necessary equipment and PPE to clean up a spill as well as step-by-step instructions. It also explains escalation processes if it’s not safe for the worker to clean the spill himself, says Nakashima. For example, if the spill is quite large, the area would need to be quarantined and the hazmat team called in to clean it up.
An accessible eyewash station that meets the criteria of ANSI/ISEA Z358.1-2014 must also be available.
It’s very important to properly dispose of hazardous drug waste, including material used to clean the spill, used gloves, paper liners, gowns, unused pills, powder residues and containers, gauze, IV bags or drug vials that contain more than trace amounts of hazardous drugs and needles and syringes. The items must be put in a sealed container or bag that is labelled as cytotoxic waste and then set aside in a safe area before it is picked up by a third-party waste disposal company. The ministry responsible for the environment regulates biomedical wastes, which includes cytotoxic waste, so employers need to make sure they are meeting the relevant legislative requirements in their jurisdiction.
“It’s not just a matter of ‘Throw it into the green garbage bin in the back of the parking lot.’ This is material that needs to be properly disposed, that needs to be properly identified and dealt with in a correct fashion,” says Hansen.
Worker training on chemotherapy drugs has to start from the very beginning with a comprehensive orientation and it has to include everybody, from front-line workers to managers, says Patel.
“It can be regulated staff, unregulated staff, you’re a manager or leader, whether you’re in a hospital setting, a community setting, it doesn’t matter where, if you are working with individuals receiving hazardous drugs or cytotoxic drugs, you should be aware of this,” she says.
Supervisors may need additional training so they understand their responsibilities in monitoring workers and ensuring they are doing what they are required to do under occupational health and safety law, says Hansen.
“These front-line supervisors have to have more knowledge than the front-line workers. These are people who your nurses, your environmental services, your maintenance individuals are going to to ask questions,” he says. “They are the point of resource.”
As a best practice, the training should be offered in various ways to meet individual learning needs.
“Some people like to read, some people like to listen, some people like to do, so make all three of those opportunities available so (workers) can learn in the way that they best learn,” says Patel.
The training should offer a practice component so workers can have the chance to test out what they have learned and make mistakes. At BC Cancer, new pharmacists practice just with water first, rather than the actual drugs, until their one-on-one trainer deems them ready to try real drug mixing.
Throughout the training process, it’s important for employers to be forthcoming with their workers so they understand the severity of the risks and take safety protocols seriously, says Hansen.
“A lot of employers don’t want to use the direct words that ‘These drugs can cause you cancer.’ They are trying to downplay it,” he says. “But wouldn’t that grab the attention of the worker a little bit more to ensure that on a day-to-day basis once I provide them the training, education, the proper PPE, that they are going to wear it?”
Health and safety professionals should make sure to evaluate the success of their cytotoxic drug risk prevention plan. Start by observing workers completing tasks (see sidebar) and asking them questions about the medications and safe handling procedures. An anonymous survey can also be deployed to the workforce.
“If everything is in place, they should be able to explain that program to you as a health and safety professional. They should be able to educate you on the program — it shouldn’t be the other way around,” says Hansen. “That’s the ideal world here.”
In order for the cytotoxic drug risk prevention program to be successful, upper management needs to be involved. Not only do they need to approve any additional costs for PPE, spill kits and training, they also set the tone for the rest of the organization.
“That’s where it starts,” says Nakashima. “If I don’t commit to the same standards of care and if I don’t support them, then nobody else is going to either. From my perspective, the buck stops here. If I am going into an area, I can’t be an exception; I have to follow the exact same policies and procedures as the rest of the staff.”
While it elicits some negative reactions, Hansen compares chemotherapy drug exposure to that of asbestos, saying the dangers of the drugs have not been properly explained to workers and the adverse health issues may be yet to come. He is urging employers to take action and put policies and procedures in place before their workers suffer any consequences.
“If the information is there and as an employer you’re either A) blind to it or B) you’re ignoring it, not only are you in violation of your required due diligence as an employer, I am going to start using the word neglect — and you don’t want that.”
This article originally appeared in the June/July 2018 issue of COS.
When conducting a review of your policies and procedures for cytotoxic chemicals, walk around the work site and note your observations. Ask yourself the following questions when determining if your workplace is properly protecting its workers:
• Are cytotoxic waste receptacles replaced when they are three-quarters full?
• Is there a designated bathroom/commode (if applicable) for any client on treatment?
• Are antineoplastic drugs properly stored in a designated secured storage area?
• Is there controlled access to medication by staff?
• If the drug needs to be refrigerated, is a dedicated fridge used?
• Are cytotoxic drugs labelled with the cytotoxic hazard symbol?
• Do staff eat, drink, smoke, apply makeup or store food/drink in the drug administration, handling or storage areas?
• Have arrangements been made with the pharmacy to provide the drugs in a ready-to-administer form to avoid crushing/cutting oral medication?
• Is the cleaning staff following procedures to minimize drug contamination throughout the workplace? For example, are dedicated mops, buckets and cloths used to clean treatment areas only?
• Are clothes, bedding, any slings, etc. of clients receiving antineoplastic drugs washed separately and immediately?
Source: Public Services Health & Safety Association