Chemotherapy is an essential part of the treatment regimen for many patients with cancer, but it can also endanger the health of nurses and other personnel who mix and administer the drugs.
While the dangers of "second-hand exposure" are well known and have been studied, contamination is not being regularly monitored at the administration level, according to a new report released by MindMetre Research, a United Kingdom–based independent research group that regularly addresses patient and healthcare worker safety across Europe.
The authors note that the risks to staff who prepare these drugs in the pharmacy are well documented and regulated, but the risk for potentially harmful exposure among those administering the drugs, such as nurses, often seems to be overlooked
"The anecdotal evidence that harm is being sustained by chemotherapy nurses in UK NHS [National Health Service] Trusts examined by MindMetre in the report would tend to indicate that contamination levels between pharmacy and point of administration are not always regularly or thoroughly investigated," said Paul Lindsell, managing director of MindMetre Research.
"The absence of consistently collected evidence in the cytotoxic drug administration trial in a majority of hospitals, combined with persistent financial pressure on healthcare systems across Europe, may well have led to a tendency not to investigate contamination too systematically," he told Medscape Medical News. "Yet it is precisely that administration procedure that tends to lead to greatest risk of exposure, with current standard bag and spike methods opening the door to regular contaminant escape through spillage or aerosolization."
No Regulatory Framework
But to date, no European-wide legislation, guidelines, or minimum standards have precisely defined administration processes.
Lindsell pointed out extensive European and national legislation addressing occupational hazards, including European Union (EU) Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. However, the European legislation does not address hazardous chemicals in the healthcare setting in great detail.
"In the absence of adequate, detailed and specific EU regulation of the exposure of healthcare workers to cytotoxic and other hazardous drugs, the monitoring conducted at national level appears to be patchy," he explained. "Some EU Member States have implemented their own guidelines or good-practice guides, while some have guidelines provided by scientists or national associations but not adopted by governments; and others have not addressed the issue."
The problem isn't limited to Europe. As previously reported by Medscape Medical News, a study conducted several years ago in the United States found that the overall rate of exposure to the skin or eyes in the past year among nurses working in outpatient settings was 16.9%.
The study found that there was no regulatory framework for chemotherapy delivery in ambulatory oncology settings but that a favorable working environment, lower nursing workloads, and adherence to two-nurse chemotherapy verification were associated with reduced exposure.
Reports of Health Problems
In the current paper, MindMetre examined anecdotal evidence from chemotherapy nurses in UK NHS Trusts.
Three nurses working in Yorkshire reported that they had experienced significant hair loss since working in oncology as a specialty. Several nurses employed in the West Midlands reported experiencing flu-like symptoms when a particular antineoplastic drug was being administered to patients. These symptoms vanished when the course of treatment ended.
An unusually high incidence of miscarriages was reported among chemotherapy nurses working in North West, and this was paralleled by similar reports from East Anglia, Humberside, the South West, and the Midlands.
Even though these data cannot be regarded as quantitative, the authors note, the fact that harm from occupational exposure is being reported at all "would suggest that this area of healthcare worker safety merits further investigation, as well as better standards of healthcare worker protection."
MindMetre adds that several robust studies from both the United States and Europe have confirmed that exposure to these agents can harm healthcare workers.
They also point out these anecdotes may not be specific to England. Because oncology nurse occupational protection standards are fairly similar across Europe, it can be assumed that the situation is likely to be similar across the other main economies of Europe: Germany, France, Italy, and Spain.
In fact, an investigation in Spain in 2017 examined staff and union complaints about nurse exposure to (and damage from) cytotoxic drugs and imposed a mandatory increase in standards of preparation and administration of these hazardous substances
The legal process around this case is ongoing, and one staff member has been awarded compensation for damages stemming from exposure to cytotoxic drugs. Another outcome was that the facility has dramatically improved its protection of healthcare workers across the entire cytotoxic drug preparation and administration cycle.
In particular, the hospital has now implemented closed system transfer devices (CSTDs) and introduced measures in their pharmacy that reduce contamination rates to virtually zero.
Lindsell explained that the US National Institute for Occupational Safety and Health (NIOSH) defines a CSTD as "a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system."
"With regards to mandating the use of closed systems in Europe, Spain has a possible exemplary role," he said. "Official guidance published by the Spanish National Institute of Safety and Hygiene at Work specifically uses as its basis the NIOSH definition of CSTDs. Furthermore, they have also published a list of hazardous drugs commercialized in Spain, with recommendations on those that should be prepared and administered using a CSTD."
Official guidance from the Health Authorities in other European countries has not yet defined the requirements of truly closed systems quite so closely as in Spain, Lindsell noted, although some do reference the NIOSH guidelines. "However, given growing awareness of the issue, such clarification is likely to spread across Europe at the national level in the near future," he said.
Risks in the United States
Commenting on the paper, Martha Polovich, PhD, RN, an assistant professor at the Byrdine F. Lewis School of Nursing and Health Professions, Georgia State University, Atlanta, noted that CSTDs do not always completely eliminate any escape of cytotoxic drugs.
"Multiple studies indicate that they prevent or significantly reduce leakage, but not all CSTDs are equally effective, and not all have studies to support their effectiveness," said Dr Polovich, who is also an expert in occupational hazardous drug exposure of healthcare workers. "However, CSTDs represent the only engineering controls that protect nurses during hazardous drug administration."
Dr Polovich also told Medscape Medical News that environmental contamination is not regularly monitored in the United States either. "Most testing for surface contamination with hazardous drugs is done in research studies, not as routine clinical sites," she said. "The main reason is that there are few laboratories that perform the assays and there is no consensus as to what level of contamination — other than zero — is acceptable."
Pharmacists and other healthcare workers are also at risk for exposure, and Dr Polovich pointed out that a Canadian study found that those with the highest level of exposure had no direct handling activities yet worked in the areas where chemotherapy was present (Ann Occup Hyg. 2014;58:761-770).
"If increasing safety was free, no one would argue about this issue at all. Introduction of equipment that adds cost to healthcare organizations is unlikely to occur without legislation or regulation that requires it," she added.