By Maureen Lafrenière
Antineoplastic agents—a large family of drugs used in chemotherapy—kill fast-growing cancer cells by disrupting cell function, affecting cell DNA, or preventing cell growth. The same mechanisms also disturb healthy cells, presenting serious side-effects for chemotherapy patients and a potential risk to others that come into contact with these drugs.
While their therapeutic value in treating cancer is widely accepted, many cytotoxic drugs used in chemotherapy are known or are probable human carcinogens, mutagens (causing genetic mutations), genotoxins (damaging to DNA), and teratogens (causing malformations in embryos); they are all classified as hazardous drugs.
Adverse health effects from occupational exposures to these drugs have been observed and documented since the 1970s, leading public health agencies and professional associations to develop guidelines for their safe handling. Adopting such standards has helped to reduce worker exposure in healthcare facilities, but studies from the ‘80s and 90s continued to detect the presence of hazardous drugs both in workplaces and in the blood and urine samples of workers.
Acknowledging the evidence of ongoing exposures to hazardous drugs as well as the absence of any scientific evidence related to safe exposure levels—there is no established safe level—the U.S. National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), published an official Alertin 2004 titled, “NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings.” It opens with the following text:
Warning! Working with or near hazardous drugs in health care settings may cause skin rashes, infertility, miscarriage, birth defects, and possibly leukemia or other cancers.
As an authoritative reference, the publication aimed to raise awareness among healthcare workers and their employers, and also to recommend procedures and equipment that would prevent “second-hand chemo.” The Alert deals with all stages of the complex handling chain of antineoplastic agents in hospitals and clinics, from delivery and storage to mixing, labeling, administering to patients, and disposal. Concerns include spill prevention, contamination of surfaces, furniture, equipment, clothing and bedding, and the disposal of contaminated protective clothing and equipment. This document does not include possible occupational exposures in the manufacturing and shipping environments, which have been studied separately.
Studies carried out in American and Canadian hospitals have suggested that workplace contamination may be more widespread than originally thought, affecting workers who do not handle hazardous drugs; a 2011 study in several Vancouver hospitals measured traces of antineoplastic drugs at every stage of handling and on different surfaces. Carex Canada (CARcinogen EXposure), a research project on carcinogen surveillance, points to hospital workers in housekeeping, laundry, shipping, receiving and transport as being vulnerable to exposures to hazardous drugs—in addition to the estimated 63,000 nurses, pharmacists and pharmacy assistants, veterinarians and veterinary assistants, and physicians who handle these drugs across Canada. Of particular concern to many researchers is the daily contact with hazardous drugs that many workers are exposed to, and which can continue over several years. Some researchers suggest that nurses and other health workers who handle drugs have a greater cancer risk than the patients who receive them. Long-term, low exposures have been linked to infertility, miscarriage, birth defects and several cancers.
Quebec guidelines for handling antineoplastic drugs
The Association paritaire pour la santé et la sécurité du travail du secteur affaires sociales (ASSTSAS), a partnership of union and employer associations,was getting ready to review its 1995 guidelines on handling antineoplastic drugs in hospitals when the NIOSH Alert appeared, late in 2004. Instead, it set up a task force of professionals from its member associations to study the Alert and review the related scientific literature. The very comprehensive Guide de prévention : Manipulation sécuritaire des médicaments dangereux, publishedby the ASSTSAS in 2008, has become an important reference guide and standard-setter in Quebec.
Several other associations offer excellent publications for their members, which are available to healthcare workers in Quebec, including:
The Association des pharmaciens des établissements de santé du Québec published a set of technical guidelines for pharmaceutical oncologists, in 1996 (revised in 2003), with exacting standards for the handling and preparation of antineoplastic agents as well as the minimum requirements for workplace equipment and protective gear, training standards, incident reporting, and medical surveillance of personnel.
The Ordre des pharmaciens du Québec published a special bulletin in 2010 on the handling of dangerous drugs that presents rules and guidelines as well as pertinent research on equipment and procedures related to workplace safety.
The Fédération de la santé et des services sociaux (FSSS), a union representing nearly 130,000 members working in private and public health care, social services and daycares in Québec (affiliated with the Confédération des syndicats nationaux [CSN]), published a bulletin in 2014 on preventing exposures to antineoplastic drugs, with special emphasis on dealing with the particular variables encountered in ambulatory care.
La vitesse blesse(“speed causes harm”), published by the Fédération interprofessionnelle de la santé du Québec, an alliance of healthcare professionals representing nearly 65,000 workers, powerfully presents (poster-style) a summary of preventive measures for handling hazardous drugs, as well as a list of other occupational risks for nurses and physicians, and the danger of moving too quickly.
The Canadian Union of Public Employees (CUPE) offers a health and safety fact sheet on cytotoxic drugs with background information, instructions and guidelines, and the union’s position on what protections should be provided by the employer.
Reducing occupational exposure
Carex Canada concludes that the best approach to controlling workplace exposures to antineoplastics is a combination of three strategies:
• Devices or designs that physically isolate workers from the source of exposure: engineering controls, e.g. ventilated biological safety cabinets and closed-system drug transfer devices;
• Procedures and practices that minimize worker exposure: administrative controls, e.g. wiping all vials before opening them, receiving adequate training to use equipment such as CSTDs (see below);
• Barriers: the use of personal protective equipment (PPE), especially gowns and gloves.
In addition, a 2013 editorial in Oncology Nursing News reported observations from a number of studies about other factors affecting exposure risk:
- Workload pressure: the use of safety precautions tends to decrease as the number of patients increases, as workers felt obliged to find shortcuts; busier and more congested clinics also experienced more drug spills and other accidents;
- Availability of equipment: where gowns and other protection gear are most easily available, workers will understand their importance and will use them;
- A culture of safety: good management oversight concerning procedures, equipment, and workload as well as subsequent follow-ups tell workers that safety is important to the institution and encourage the confidence necessary for reporting spills and other contamination (frequently under-reported);
- Government support for surface testing and equipment: although shown to be effective in reducing exposures, these are often beyond the means of small hospitals and clinics.
Closed-system drug transfer devices (CSTDs), a relatively recent technology, allows the mixing of drugs within an airtight chamber that prevents liquid and vapours from escaping. Despite NIOSH recommendations to adopt CSTDs, many institutions have been slow to acquire the technology partly because of the high cost and also due to the lack of independent scientific studies comparing various designs.
An expanding industry
The use of antineoplastic drugs is expected to expand due to several factors:
• a projected increase in cancer incidence worldwide (IARC, 2013);
• an increase in cancer cases in the growing population segment over 65;
• the increased use of antineoplastic agents for non-malignant diseases such as multiple sclerosis and rheumatoid arthritis;
• new and more potent combinations of hazardous drugs;
• an increase in the use of chemotherapy in veterinary medicine.
No legal framework
Good preventive guidelines may be firmly in place and followed, but as in the U.S.,no legal framework exists to oblige health institutions in Quebec to conform to the recommendations of the ASSTSAS. Workers are best able to ensure their safety and that of their co-workers by becoming familiar with handling guidelines, by requesting training and confirming that the right equipment is available in the workplace, and by getting support, if needed, from professional associations, unions and health agencies.
Bill 10 and concerns about worker safety
In a November statement, the FSSS-CSN’s committee on occupational health and safety publicly expressed concerns about upcoming provincial legislation to reform Quebec’s healthcare system.
Pointing to the years of work needed to overcome a “paralysis in risk-prevention activities” following the major healthcare system reform in 2004, it is convinced that the issue will be once again be placed on the back burner, to the detriment of health and social service workers. Citing wide support for its position and viable alternative solutions put forth to the parliamentary commission, the committee is asking for the withdrawal of Bill 10 based on the risks it presents to workers.
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