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Purpose: The main objective was to determine the efficacy of various types of cleaning equipment and products after deliberate contamination with cyclophosphamide. The secondary objective was to test various cleaning scenarios using these equipment and products., Methods: The study had two phases: testing of cleaning equipment (wipe : woven microfibers - Hygen®, two layers of non-woven microfibres and an inner layer of highly absorbent viscose fibres - MicronSolo®, two layers of non-woven microfibres and an inner layer of highly absorbent viscose fibres - MicroMix®, simili-tissu (low filament production) - Tork® and, mop : woven microfibers - Hygen®, microfibre and viscose - MicroOne®) and products (disinfectant : quaternary ammonium - DR100®, chlorine 0.1% - Zochlor® - Brutab® - PCS® NPH, sodium hypochlorite 2%, cleaner : detergent - Nu- Action 3®, cleaner and disinfectant: sodium hypochlorite 0.6% + detergent - Aliflex® and water) in phase 1 and testing of various cleaning procedures in phase 2. Specific areas of a room with a laminar flow hood (class II/type B2) were contaminated with 10 mcg of cyclophosphamide. Different types of surfaces were cleaned with various scenarios and the remaining cyclophosphamide was measured by the Institut national de santé publique du Québec. All tests were performed in triplicate., Results: A total of 189 samples were obtained: 42 negative controls and positive controls, 54 during phase 1 and 93 during phase 2. All products were more than 96.5% effective. The 0.1% chlorines were the most effective products. Cleaning procedures with two or three products had average cleaning efficacies of 99.94-99.99%. Efficacy increased with the number of successive cleanings. When two products were used, the average cleaning efficacy varied between 99.78% and 99.98%, depending on the surface., Conclusion: All cleaning products tested reduced cyclophosphamide contamination by more than 96.58%. Cleaning efficacy increased with successive cleaning. No scenario was effective in removing 100% of traces. Additional studies with larger samples should be conducted to confirm these results.

Purpose: No occupational exposure limit exists for antineoplastic drugs. The main objective of this study was to describe environmental contamination with cyclophosphamide, ifosfamide and methotrexate in pharmacy and patient care areas of Canadian hospitals in 2012. The secondary objective was to compare the 2012 environmental monitoring results with the 2008-2010 results., Methods: Six standardized sites in the pharmacy and six sites on patient care areas were sampled in each participating center. Samples were analyzed for the presence of cyclophosphamide, ifosfamide and methotrexate by UPLC-MS-MS. The limit of detection (LOD) was 1.8 pg/cm² for cyclophosphamide, 2.2 pg/cm² for ifosfamide and 8.0 pg/cm² for methotrexate. The comparison of surface contamination between the 2008-2010 and 2012 studies was made with the 75th percentile of cyclophosphamide concentration., Results: A total of 33 hospitals participated in the study and 363 samples were collected. Overall, 40 % (147/363) of the samples were positive for cyclophosphamide, 18 % (68/363) were positive for ifosfamide and 5 % (17/363) were positive for methotrexate. In 2012, the 75th percentile value of cyclophosphamide surface concentration was of 9.4 pg/cm², which is four times lower than the 2008-2010 75th percentile of 40 pg/cm². In both studies, the 75th percentile for ifosfamide and methotrexate concentration was lower than the LOD., Conclusions: Surface contamination by cyclophosphamide, ifosfamide and methotrexate in Canadian hospitals is improving both in terms of the proportions of positive samples and in terms of the surface concentration of antineoplastic drugs. A local 75th percentile value should be use to assess local contamination and interpret local results.

Objective: Compare the efficacy of the cleaning technique usually employed in our healthcare facility to eliminate environmental contamination with cyclophosphamide with that of the Surface Safe commercial kit., Methods: This is a three-step evaluative and comparative study involving: (i) the voluntary contamination of the surface of a hood with a pre-established quantity of cyclophosphamide (20,000,000 ng), (ii) the cleaning of the work surface of the hood using a cleaning technique usually employed in our healthcare facility or that of the product Surface Safe, and (iii) the quantification of cyclophosphamide detected on the work surface. The usual cleaning technique involves the use of a mixture of 0.05% chlorhexidine and 70% ethyl alcohol to clean surfaces, whereas the product Surface Safe involves a combined two-step sodium hypochlorite and sodium thiosulfate wash., Results: The median concentrations of cyclophosphamide detected after the use of the usual technique and the product Surface Safe came to 165 ng cm(-2) (40-570) and 65 ng cm(-2) (57-110), respectively. The results obtained showed an average 99.5% efficacy in reducing the quantity of cyclophosphamide (ng) detected on the work surface for each of the two techniques that were evaluated., Conclusion: The study demonstrates that reducing the residual concentration of cyclophosphamide on work surfaces to levels lower than 1 ng cm(-2) remains difficult despite the use of cleaning techniques with a high percentage of efficacy. It stressed the importance of combining two successive cleaning techniques to maximally restrict the residual concentration of hazardous drugs and suggests the use of a combination of sodium hypochlorite and sodium thiosulfate to best reduce environmental contamination levels.

Objective: Evaluate contamination on the external surfaces of cyclophosphamide vials available on the Canadian market during storage in pharmacy departments and the efficacy of decontaminating the external surfaces of vials using various cleaning techniques., Methods: The study consisted of three phases: the quantification of cyclophosphamide on the external surfaces of 10 vials of Procytox and 10 vials of Cytoxan available on the Canadian market with or without prewashing (Phases I and II) and the quantification of cyclophosphamide on the surfaces of 30 deliberately contaminated empty sterile vials cleaned using three different washing techniques (Phase III). The quantification of cyclophosphamide was conducted using ultra performance liquid chromatography with tandem mass spectrometry., Results: In Phase I, we observed that 9 of 10 vials of Procytox and 4 of 10 vials of Cytoxan had traces of cyclophosphamide. The average concentration of cyclophosphamide measured on the vials was higher for Procytox than it was for Cytoxan. In Phase II, we observed that simply by washing vials with water we could effectively eliminate the presence of contamination on 6 of 10 Procytox vials and on 10 of 10 Cytoxan vials. Phase III demonstrated the efficacy of using a cloth soaked in soapy water to clean the contaminated vials., Conclusion: This pilot study demonstrates the presence of contamination on the external surfaces of cyclophosphamide vials from two manufacturers on the Canadian market. It suggests that cleaning vials from manufacturers and wholesalers may help to reduce the risk of occupational exposure. There is a need for a pilot study to establish guidelines on decontamination agents and cleaning process to eliminate the presence of contamination on vial surfaces.

To evaluate the efficacy of two decontamination protocols on cyclophosphamide surface contamination and to explore its lasting effect 30 days later.

Introduction: Occupational exposure to antineoplastic drugs can lead to long-term adverse effects on workers' health. A reproducible Canadian surface monitoring program was established in 2010. The objective was to describe contamination with 11 antineoplastic drugs measured on 12 surfaces among hospitals participating in this annual monitoring program. Methods: Each hospital sampled six standardized sites in oncology pharmacies and six in outpatient clinics. Ultra-performance liquid chromatography coupled with tandem mass spectrometry was used for cyclophosphamide, docetaxel, doxorubicin, etoposide, 5-fluorouracil, gemcitabine, irinotecan, methotrexate, paclitaxel, and vinorelbine. Platinum-based drugs were analyzed by inductively coupled plasma mass spectrometry; this excludes inorganic platinum from the environment. Hospitals filled out an online questionnaire about their practices; a Kolmogorov–Smirnov test was used for some practices. Results: One hundred and twenty-four Canadian hospitals participated. Cyclophosphamide (405/1445, 28%), gemcitabine (347/1445, 24%), and platinum (71/756, 9%) were the most frequent. The 90th percentile of surface concentration was 0.01 ng/cm² for cyclophosphamide and 0.003 ng/cm² for gemcitabine. Centers that prepared 5000 or more antineoplastic per year had higher concentrations of cyclophosphamide and gemcitabine on their surfaces (p = 0.0001). Almost half maintained a hazardous drugs committee (46/119, 39%), but this did not influence the cyclophosphamide contamination (p = 0.051). Hazardous drugs training was more frequent for oncology pharmacy and nursing staff than for hygiene and sanitation staff. Conclusions: This monitoring program allowed centers to benchmark their contamination with pragmatic contamination thresholds derived from the Canadian 90th percentiles. Regular participation and local hazardous drug committee involvement provide an opportunity to review practices, identify risk areas, and refresh training. [ABSTRACT FROM AUTHOR]

Hazardous drugs (HD) traces are measured in most hospitals that perform environmental surveillance. Uncertainties exist regarding the cleaning agents and procedures needed to completely remove HD contamination The objective was to evaluate the efficacy of four cleaning solutions and two types of mops in reducing contamination on a floor contaminated with a predetermined amount of cyclophosphamide (CP).

Introduction: Occupational exposure to antineoplastic drugs can lead to long-term adverse effects on workers' health. Environmental monitoring is conducted once a year, as part of a Canadian monitoring program. The objective was to describe contamination with 11 antineoplastic drugs measured on surfaces. Methods: Six standardized sites in oncology pharmacy and six in outpatient clinic were sampled in each hospital. Samples were analyzed by ultra-performance liquid chromatography coupled with tandem mass spectrometry (non-platinum drugs) and by inductively coupled plasma mass spectrometry (platinum-based drugs). The limits of detection (in ng/cm2) were: 0.0006 for cyclophosphamide; 0.001 for docetaxel; 0.04 for 5-fluorouracil; 0.0004 for gemcitabine; 0.0007 for irinotecan; 0.0009 for methotrexate; 0.004 for paclitaxel, 0.009 for vinorelbine, 0.02 for doxorubicine, 0.0037 for etoposide and 0.004 for the platinum. Sub-analyses were done with a Kolmogorov-Smirnov test Results: 122 Canadian hospitals participated. Cyclophosphamide (451/1412, 32% of positive samples, 90th percentile of concentration 0.0160 ng/cm2) and gemcitabine (320/1412, 23%, 0.0036 ng/cm2) were most frequently measured on surfaces. The surfaces most frequently contaminated with at least one drug were the front grille inside the biological safety cabinet (97/121, 80%) and the armrest of patient treatment chair (92/118, 78%).The distribution of cyclophosphamide concentration was higher for centers that prepared ≥ 5000 antineoplastic drug preparations/year (p < 0.0001). Conclusions: This monitoring program allowed centers to benchmark their contamination with pragmatic contamination thresholds derived from the Canadian 90th percentiles. Problematic areas need corrective measures such as decontamination. The program helps to increase the workers' awareness. [ABSTRACT FROM AUTHOR]

Introduction: Healthcare workers exposure to antineoplastic drugs can lead to adverse health effects. Guidelines promote the safe handling of antineoplastic drugs, but no safe exposure limit was determined. Regular surface sampling contributes to ensuring workers safety. Methods: A cross-sectional monitoring is conducted once a year with voluntary Canadian centers, since 2010. Twelve standardized sampling sites were sampled. Samples were analyzed by high performance mass coupled liquid chromatography. The limits of detection (in ng/cm2) were: 0.001 for cyclophosphamide and gemcitabine; 0.3 for docetaxel and ifosfamide; 0.04 for 5-fluorouracil and paclitaxel; 0.003 for irinotecan; 0.002 for methotrexate; 0.01 for vinorelbine. Results: The surfaces from 109 centers were sampled between 01/01/2020–18/06/2020. Twenty-six centers delayed their participation because of the COVID-19 pandemic. 1217 samples were analyzed. Surfaces were frequently contaminated with cyclophosphamide (34% positive, 75th percentile 0.00165 ng/cm2) and gemcitabine (16% and <0.001 ng/cm2). The armrest of patient treatment chairs (84% to at least one drug), the front grille inside the biological safety cabinet (BSC) (73%) and the floor in front of the BSC (55%) were frequently contaminated. Centers that prepared ≥5000 antineoplastic drugs annually had higher concentration of cyclophosphamide on their surfaces (p < 0.0001). Contamination measured on the surfaces was reduced from 2010 to 2020. Conclusions: This large-scale study showed reproducible long term follow up of the contamination of standardized sites of Canadian centers and a reduction in surface contamination from 2010 to 2020. Periodic surface sampling help centers meet their continuous improvements goals to reduce exposure as much as possible. The COVID-19 pandemic had a limited impact on the program. [ABSTRACT FROM AUTHOR]

Objective: Occupational exposure to antineoplastic drugs (ANPs) occurs mainly through dermal contact. Our study was set up to assess the potential exposure of hospital sanitation (HS) personnel, for whom almost no data are available, through contamination of surfaces they regularly touch. Methods: In the oncology departments of two hospitals around Montreal, surface wipe samples of 120–2000 cm2 were taken at 10 sites cleaned by the HS personnel and five other sites frequently touched by nursing and pharmacy personnel. A few hand wipe samples were collected to explore skin contamination. Wipes were analyzed by ultra-performance liquid chromatography tandem–mass spectrometry for 10 ANPs. Results: Overall, 60.9% of 212 surface samples presented at least one ANP above the limits of detection (LOD). Cyclophosphamide and gemcitabine were most often detected (52% and 31% of samples respectively), followed by 5–fluorouracil and irinotecan (15% each). Highest concentrations of five ANPs were found in outpatient clinics on toilet floors (5–fluorouracil, 49 ng/cm2; irinotecan, 3.6 ng/cm2), a perfusion pump (cyclophosphamide, 19.6 ng/cm2) and on a cytotoxic waste bin cover (gemcitabine, 4.97 ng/cm2). Floors in patient rooms had highest levels of cytarabine (0.12 ng/cm2) and methotrexate (6.38 ng/cm2). Hand wipes were positive for two of 12 samples taken on HS personnel, seven of 18 samples on nurses, and two of 14 samples on pharmacy personnel. Conclusions: A notable proportion of surfaces showed measurable levels of ANPs, with highest concentrations found on surfaces cleaned by HS personnel, who would benefit from appropriate preventive training. As potential sources of worker exposure, several hospital surfaces need to be regularly monitored to evaluate environmental contamination and efficacy of cleaning. [ABSTRACT FROM AUTHOR]

Introduction: The primary objective was to describe environmental contamination with National Institute for Occupational Safety and Health Group 1 hazardous drugs in oncology pharmacies and outpatient clinics in Canada in 2019, as part of an annual surveillance project. Methods: In each participating center, 12 standardized sites (6 in the oncology pharmacy and 6 in outpatient clinic) were sampled. Each sample was prepared to allow quantification of six antineoplastic drugs (cyclophosphamide, ifosfamide, methotrexate, gemcitabine, 5-fluorouracil, and irinotecan) by ultra-performance liquid chromatography-tandem mass spectrometry. Samples were also tested for three additional antineoplastic drugs (docetaxel, paclitaxel, and vinorelbine) without quantification. The impact of certain characteristics of the sampling sites was evaluated with a Kolmogorov–Smirnov test for independent samples. Results: Ninety-three Canadian centers participated in 2019, with a total of 1045 surfaces sampled. Cyclophosphamide was the drug most often found in the surface samples (32.4% of samples with positive result), followed by gemcitabine (20.3%). The front grille inside the biological safety cabinet (81.5% of samples positive for at least one antineoplastic drug) and the armrest of a treatment chair (75.8%) were the most frequently contaminated surfaces. Centers with more oncology inpatient and outpatient beds, those that prepared more antineoplastic drugs each year, and those that used more cyclophosphamide each year had higher concentrations of cyclophosphamide contamination on the surfaces tested (p < 0.0001). Conclusion: Traces of dangerous drugs were found in oncology pharmacies and oncology outpatient clinics in 93 Canadian hospitals in 2019. However, the quantities measured were very small. Every healthcare worker should consider these work areas to be contaminated and should wear appropriate protective equipment. [ABSTRACT FROM AUTHOR]

Context Oncology workers are occupationally exposed to antineoplastic drugs. This exposure can induce adverse health effects. In order to reduce their exposure, contamination on surfaces should be kept as low as possible. Objectives To monitor environmental contamination with cyclophosphamide, ifosfamide, and methotrexate in oncology pharmacy and patient care areas in Canadian hospitals. To describe the impact of some factors that may limit contamination. Methods This is a descriptive study. Twelve standardized sites were sampled in each participating center (six in the pharmacy and six in patient care areas). Samples were analyzed for the presence of cyclophosphamide, ifosfamide, and methotrexate by ultra-performance liquid chromatography tandem mass spectrometry technology. Descriptive statistical analyses were done and results were compared with a Kolmogorov–Smirnov test for independent samples. Results In 2015, 48 hospitals participated in this study (48/202, 24%). Overall, 34% (181/525) of the samples were positive for cyclophosphamide, 8% (41/525) for ifosfamide, and 6% (31/525) for methotrexate. The 75th percentile value of cyclophosphamide surface concentration was 6.9 pg/cm2. For ifosfamide and methotrexate, they were lower than the limit of detection. Centers who prepared more antineoplastic drugs per year and centers who used more cyclophosphamide per year showed significantly higher surface contamination (p < 0.0001). Over the years, we observed a reduction in surface contamination. Conclusion In comparison with other multicenter studies that were conducted in Canada, the concentration of antineoplastic drugs measured on surfaces is decreasing. Regular environmental monitoring is a good practice in order to maintain contamination as low as reasonably achievable. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate environmental contamination with methotrexate, cyclophosphamide, and ifosfamide in Quebec, Canada, community pharmacies and to describe hazardous drug handling practices in these pharmacies. Methods: Three standardized sites were sampled in each participating community pharmacy. Samples were analyzed for the presence of cyclophosphamide, ifosfamide, and methotrexate by high-performance liquid chromatography tandem mass spectrometry. The limits of detection were 0.10, 0.12, and 0.41 ng/mL for cyclophosphamide, ifosfamide, and methotrexate, respectively. Nine working practices were assessed. Results: 20 community pharmacies participated in the study, and 60 samples were analyzed. No traces of cyclophosphamide or ifosfamide were detected. Traces of methotrexate were found in 12 of 20 pharmacies (60%) Of the 20 pharmacies, 8 (40%) had a storage space reserved for hazardous drugs and none had a preparation area reserved for handling methotrexate tablets. All of the participating community pharmacies had a tablet counter reserved for the handling of hazardous drugs, and all pharmacies cleaned their tablet counter reserved for handling hazardous drugs after use. None of the pharmacies cut or crushed methotrexate tablets. Conclusion: The growing number of hazardous drug represents a challenge for community pharmacies. Community pharmacists must be made aware of their presence and the need to comply with personal protection measures to reduce staff occupational exposure to hazardous drugs. [ABSTRACT FROM AUTHOR]

Objective. To describe environmental contamination with hazardous drugs in a hospital pharmacy setting before and after reorganizing a hematology-oncology satellite pharmacy. Methods. This is a descriptive study of surface contamination with cyclophosphamide, ifosfamide, and methotrexate in two hematology-oncology satellite pharmacies. In order to measure surface contamination with hazardous drugs, samples from four distinct measurement sites within the pharmacy were taken in each of the two phases (pre- and postphases) using a sampling procedure and an analytical method modified from Larson et al. Results. A total of 133 samples from four measurement sites were taken and analyzed over the course of the study (specifically 60 prephase samples and 73 postphase samples). The study showed a significant increase in the number of positive samples (from 66.7% to 90.4%, p<0.001) from the pre- to the postphase. The increase, however, is only significant in terms of the location where completed preparations were placed after they had come out from under the hood (from 0/15 to 21/28, p<0.001) and the work surface (from 8/15 to 15/15, p = 0.006) and only in terms of ifosfamide. Furthermore, for the other sites studied, the number of positive samples remained unchanged between the pre- and postphase. A statistically significant difference between the pre- and postphase was observed in terms of ifosfamide for three of the four measurement sites studied and methotrexate for one of the four sites. Average concentrations were higher in the post phase in three of the four cases. Conclusion. This study describes environmental contamination with hazardous drugs in a hospital pharmacy setting before and after reorganizing a hematology-oncology satellite pharmacy. The study showed that a refitting of the hemato-oncology pharmacy is not a sufficient strategy to reduce the environmental contamination by ifosfamide because a significant increase in the number of positive samples from the pre- to the postphase have been observed. Many factors can contribute to influence the contamination of hazardous drugs such as the workflow and the training of the personal. Continuous environmental surveillance of hazardous drugs is required to document traces and help reduce risks. [ABSTRACT FROM AUTHOR]