The mutagenic effect of cytostatic was first demonstrated in nurses administering antimitotic more than 40 years ago, in the journal The Lancet [1].
The urine samples showing urinary concentrations of cytostatic.
Today, more than a hundred studies highlight the risks for healthcare workers administering chemotherapy to develop adverse effects due to their exposure to cytotoxic drugs.
These undesirable effects can be moderate, acute or even severe, sometimes inducing genetic modifications [2].. Scientific studies reporting additional risks of developing cancer or the occurrence of spontaneous miscarriages in nurses exposed to anti-cancer drugs, have also been widely published in the past 20 years [3].
In Europe, it is reported that occupational exposure to dangerous agents produces 17,185 miscarriages and more than 10,108 malformations each year [4].
Also in Europe, more than 7 million nurses are exposed each year to dangerous carcinogenic, mutagenic and reprotoxic drugs.
The European Commission has estimated that in 2012, up to 107,000 cancer deaths were attributed to occupational exposure to carcinogens, making cancer the leading cause of work-related deaths in the European Union (EU) [4].
According to EU-OSHA (Occupational Safety and Health Administration), these substances present the most dangerous chemical risk factors in healthcare.
It is estimated that in Europe each year, occupational exposure to dangerous drugs alone produces 2,220 new cases of leukemia, leading to an additional 1,467 deaths of healthcare professionals [4]..
It has been shown that among nurses working in daycare departments, and handling a large amount of medication during the chemotherapy administration process, the amount of genetic damages was greater than in the rest of the nurse’ population.
Since cancer often takes decades to develop, a case of leukemia diagnosed today could be the product of exposures dating from the 1970s or 1980s…
Recently, a study on health workers holding different responsibilities, all handling dangerous drugs, reported that nurses working in oncology units were more often exposed to cytotoxic drugs than staff working in preparation and reconstitution of antimitotic. Positive cytotoxic samples were found in the urine of 55% of the 104 nurses participating in the study [5].
Despite the widespread use in pharmacies of personal protective equipment, isolators, laminar flow hoods, or automated compounding robots, but also the use of closed systems (CSTD) aiming at reducing the risks of inhalation, ingestion or skin contact for pharmacy-technicians, the use of CSTD is very rarely seen, if not at all, in day care or hospitalization services, even though recognized bodies such as NIOSH [6], USP 800 [7], ASCO [8] or the European Parliament [9] have published official texts, recommending the use of these safety systems to reduce the risk of exposure during administration of dangerous drugs.
In the United States, the entry into force of “USP 800” on December 1, 2019, makes the use of CSTD mandatory during administration of chemotherapy, whereas this remains “only a recommendation” when it comes of the preparation of these treatments.
A recent update to the EU Directive [10] also recommends (among other protective measures) the use of closed systems in order to reduce the exposure of healthcare workers to a level “As Low As Reasonably Acceptable” (ALARA).
However, it must be noted that these recommendations are still only rarely applied, or even little adopted, in many countries with regard to CSTDs [11].
A multicenter study by the Boston Cancer Institute [12], however concluded that during simulated administrations, the rate of contamination by cytotoxic was considerably reduced using CSTD, when compared to administration carried out without using a closed system.
A survey conducted by AFIC and Vygon on 129 French cancer nurses, between January and April 2020, established that a large majority of nurses think they are at risk when handling cytotoxic drugs, that there is a lack of scientific training and information on the risks and consequences of repeated exposure to cytostatic drugs.
Mostly the nurses interviewed confirmed that they wear PPE during the administration of chemotherapy, and respect good practices, but are still sometimes numerous not protecting themselves sufficiently or still very rarely use CSTDs to protect themselves from chemical risks, while everyone is aware that at each stage of treatment, there is a potential risk of contamination by inhalation, ingestion or skin contact.
The well-established practice of priming the infusion line at the end of the treatment, shows that the rinsing protocols are generally applied, however the flushing volumes, in the absence of any relevant scientific study, are quite heterogeneous and vary according to the establishments and / or operators, and do not guarantee the total elimination of cytotoxic molecules in the tubing, once it has been primed, as demonstrated by a recent work from Oncopole (Pharmacy Dept) in Toulouse [13]..
Influencing practice change, by making risk information easily accessible and explaining that use of appropriate PPE is an effective bulwark against contamination, and finally generalize the use of CSTDs as a mechanical barrier to chemical and bacteriological contamination, represents the essential stages allowing to create the essential conditions for safety, so that the personnel handling chemotherapies in Daycare Departments, or in homecare, can work in a well-deserved protected environment.
In this perspective, a group of international experts on exposure risks, collaborating in a group named “CytoPrevent”, led by Paul Sessink[14], will work on proposing concrete actions, aiming to accelerate both the awareness of local actors, but also at European level to strengthen the regulations on healthcare personal protection, following the United States, far ahead of the rest of the world on adopting very concrete measures to create a safe environment when handling cytotoxic drugs.
Results – Cancerology nurses survey AFIC-VYGON (january – april 2020)
Number of participants: 129
1 Falck et al, The Lancet, June 9, 1979, Mutagenicity in urine of nurses handling cytostatic drugs.
2 Undeger et al, Mutation Research 439 (1999), Assessment of DNA damage in nurses handling antineoplastic drugs by the alkaline COMET assay.
3 Sessink et al, Drug Safety 1999 Apr; 20 (4), Drugs Hazardous to Healthcare Workers. Ratner et al. BMC Nursing 2010, 9:15 Cancer incidence and adverse pregnancy outcome in registered nurses potentially exposed to antineoplastic drugs. Lawson et al, American Journal of Obstetrics, April 2012, Occupational exposures among nurses and risk of spontaneous abortion.
5 Ndaw, Références en Santé au Travail, juin 2018, Exposition professionnelle des personnels de santé hospitaliers aux médicaments cytotoxiques.
6 National Institute for Occupational Safety and Health. NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. http://www.cdc.gov/niosh/docs/2004-165/. (accessed 2018 Feb 28).
7 https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare. General chapter
<797> pharmaceutical compounding – sterile preparations. http://www.usp.org/compounding/general-chapter-797.
Bruce E. Beans, USP <800> Adds Significant Safety Standards, Facility Upgrades Needed to Protect Employees from Hazardous Drugs, P T. 2017 May; 42(5): 336–339,disponible sur: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5398627/ & https://www.pccarx.com/Blog/recommendations-for-navigating-usp-800
8 American Society of Clinical Oncology (ASCO), Standards for Safe Handling of Hazardous Drugs, 2019.
9Preventing occupational exposure to cytotoxic and other hazardous drugs, European Policy Recommendations, 2016.
10 Directive (EU) 2019/130 of the European Parliament and of the Council of 16 January 2019 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work.
11 Official Regulations and Recommendations Guide on the Protection of Healthcare Personnel exposed to Cytotoxics (Vygon document- May 2020)
12 Bartel et al, AJHP, February 2018, Multicenter evaluation of a new closed system drug-transfer device in reducing surface contamination by antineoplastic hazardous drugs.
13 « Evaluation de l’efficacité du rinçage post perfusion »P.Claraz et al, GERPAC 2019, Pharmacie et Service de gestion des risques professionnels- Oncopole Toulouse.
14 Paul Sessink : Docteur en Chimie et en Sciences Médicales (1996), il est l’auteur d’une thèse sur “ le monitoring de l’exposition aux agents antinéoplasiques », et le fondateur d’une société qui réalise des études et analyses de contamination par les cytotoxiques, pour les établissements hospitaliers ou pour l’industrie pharmaceutique. Il est le co-auteur de plus d’une quarantaine d’articles scientifiques sur les risques environnementaux et biologiques liés à l’exposition aux agents cytotoxiques. Il a contribué à la rédaction des nouvelles recommandations publiées en 2016, par le Parlement Européen sur les moyens de réduire les risques d’exposition aux cytotoxiques.
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