Cynthia Tanguay

Multicenter study of environmental contamination with cyclophosphamide, ifosfamide, and methotrexate in 48 Canadian hospitals:

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.

Pilot study of biological monitoring of four antineoplastic drugs among Canadian healthcare workers.

Purpose There are health risks to workers occupationally exposed to antineoplastic drugs. We hypothesized that implementing a biological monitoring program would be feasible. The goal was to present the results of our pilot cross-sectional study of biological monitoring of four antineoplastic drugs. Methods We recruited workers from the hematology–oncology department and control workers in a mother–child university health center. This study was preceded by an information period during which we aimed at enhancing the workers’ awareness and knowledge of the risks of occupational exposure. Participants filled out a journal containing activities performed and personal protective equipment worn. One urine sample was collected at the end of their shift. Samples were analyzed by UPLC/MS-MS for the presence of cyclophosphamide, ifosfamide, methotrexate, and alpha-fluoro-beta-alanine (5-fluorouracile’s main urinary metabolite). Results The participation rate was 85.7% (102/119). No urine sample had detectable concentrations of any of the four drugs evaluated (0/101; 0/74 nurses, 0/11 pharmacists, 0/9 pharmacy technicians, and 0/7 doctors). In the 5 days before sampling, 67/92 (72.8%) hematology–oncology participants performed at least one activity with antineoplastic drugs. Nurses wore all of the recommended protection for technical activities (86.2%), but rarely for non-technical activities (14.9%). Pharmacists and pharmacy technicians wore all of the recommended protection for all activities (100.0%). Conclusions This pilot study had a good participation rate. The absence of positive samples was a good indication that the measures in place ensured workers’ safety, even though we found areas where the worker protection can be enhanced.

Prioritizing Pharmaceutical Activities A Simulation by Pharmacy Residents

Objectives: The primary objective was to examine the consistency of prioritization decisions made by pharmacy residents in a simulated environment where the available resources are constrained. Secondary objectives were to rank the factors that influenced their prioritization and to compare the residents’ results with those of Canadian pharmacy leaders. Methods: We have developed a prioritization exercise that aims at evaluating how pharmaceutical activities are prioritized. The simulation was conducted with hospital pharmacy residents in 2 Quebec universities in 2011. Results: Residents covered a similar number of activities in the prioritization simulation (mean 27 of 32). Teams tended to favor a broad range of services delivered less comprehensively. Participants ranked “perception of the favorable impact of the activity on health outcomes” higher than “conclusive evidence available to support the decisions.” The relative weight attributed per domain was similar between pharmacy residents and pharmacy leaders, but their ranking of factors that influenced their decisions was different. Conclusions: Pharmacy residents opted to provide a wide range of services, but at a low level of comprehensiveness. The high variation between each team’s coverage per activity in this simulation supports the observation that pharmacy residents do not agree on a core set of pharmaceutical activities that should be prioritized.

Recensement et analyse des preuves sur le rôle et sur les retombées de l’activité pharmaceutique : développement d’un outil sur Internet

BACKGROUND Considering the increase in healthcare expenses, stakeholders need to make choices, including healthcare program funding, and professional activities to prioritise. PURPOSE The main objective was to list evidences about the role and impact of pharmacists. METHODS Themes were chosen according to three dimensions of the pharmacist profession: (1) activities, (2) healthcare programs and (3) disorders. A literature search was conducted for each theme. A bibliographic data sheet was completed for each article. An analytic data sheet, consisting of descriptive and impact outcomes, was also completed for the most relevant articles. For each theme, a synthesis was elaborated. The website Impact Pharmacie (http://impactpharmacie.org) was developed. RESULTS A total of 70 synthesis were written. A total of 1442 articles were included with a bibliographic data sheet, and 914 with an analytic data sheet. Six hundred and fifty articles had positive outcomes on the role of the pharmacist, representing 803 different positive outcome markers. Pharmacists had positive outcomes on morbidity (n=212), adherence (n=92), costs (n=36), adverse effects (n=26), drug errors (n=31) and mortality (n=13). CONCLUSION This descriptive study presents the review of the evidence on the role and the impact of pharmacists activities, which led to the Impact Pharmacie website. This francophone website can contribute to support clinical pharmacy development, and to a better use of pharmacists in healthcare.

Environmental contamination with methotrexate in Canadian community pharmacies

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 drugs 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.

Closed‐system drug‐transfer devices in addition to safe handling of hazardous drugs versus safe handling alone for reducing healthcare staff exposure to infusional hazardous drugs

and obtaining full texts for references considered relevant based on the full text. Besides, these studies (which do not mention CSTD in the title or abstract) are likely to show no evidence of benefit of CSTD (the probable reason for not mentioning about CSTD in the title or abstract); therefore, the systematic review authors’ conclusions are unlikely to change. The intra-cluster correlation coefficient was not reported in any of the studies. Therefore, the systematic review authors used the intra-cluster correlation coefficient of 0.10 decided a priori based on studies about implementation research. The results were robust in a sensitivity analysis of using 0.05 for intra-cluster correlation coefficient (i.e. half the correlation noted in similar studies) for most analyses; therefore, the systematic review authors’ conclusions are unlikely to change if the studies had reported the intra-cluster correlation. However, the systematic review authors recommend the study authors to report intra-cluster correlation in future to enable accurate estimation of the results. This is the first systematic review on the topic. The systematic review authors disagree with the study authors who concluded that routine CSTD use is beneficial 26, 60-63, 65-68, . Ignoring the design effect by not adjusting the effect estimates for intra-cluster correlation can lead to an underestimation of random errors; therefore, this could lead to erroneous conclusions. Ignoring the design effect by the study authors, the risk of bias in the studies, and the excessive importance given to unvalidated surrogate outcomes by the study authors are the major differences in the conclusions between this systematic review and the primary research studies. The systematic review authors also disagreed with any guidelines or recommendations that CSTD should be used routinely whenever possible 27, . The possible reasons for our disagreement with those guidelines or recommendations that CSTD should be used routinely are the same as the reasons why we disagree with the study authors who concluded that routine CSTD use is beneficial.

Paediatric clinical research from the perspective of hospital pharmacists from France and Canada

To compare pharmacy support for paediatric research services in France and Canada and to describe the perception of pharmacists and rank the paediatric clinical research issues.

OHP-060 Paediatric Clinical Research: Current Situation and Pharmaceutical Constraints in France and Canada

Background Paediatric clinical research represents a challenge and faces particular pharmaceutical constraints. Purpose The main objective was to describe the current pharmaceutical situation in paediatric clinical research in France and Canada. The secondary objective was to identify factors that discourage paediatric clinical research. Materials and Methods Cross-sectional survey of 12 pharmacy departments from France and 12 from Canada with an online 50-question survey (June–September 2012). The median [minimum-maximum] was calculated for each country and compared using the Mann-Whitney or Fisher’s exact test. Respondents were asked to rank, in order of importance from 1–10 (1 being the most important), factors that discourage paediatric clinical research. Results There was a similar number of ongoing paediatric clinical trials in France and Canada (38 [10–81] vs. 20 [4–178], p = 0.205). A lower number of pharmacists per hospital was observed in France (17 [11.5–35] vs. 45 [18.9–76.8], p = 0.009), but a similar number of pharmacists were assigned to clinical trials (1.5 [1–3] vs. 1.9 [0.2–17.4], p = 0.921). Institutional protocols represented the majority of paediatric clinical trials in France (61% [14–100] vs. 25% [0–100]). Similar services were offered, but the majority of French respondents offered help with institutional protocol development (91% vs. 50%, p = 0.063). The majority of respondents reported that the payment provided by the investigators was insufficient to cover pharmaceutical support costs and that formulations were not easily obtained from manufacturers. Respondents from both countries ranked more highly the same factors that discourage paediatric clinical research, such as absence of financial interest from the pharmaceutical industry (median rank 2 [1–6] vs. 4 [1–10]), prohibitive cost versus profit ratio (2 [1–3] vs. 3 [2–9]), small patient cohorts per hospital (2 [1–7] vs. 4.5 [1–10] and the non-availability of appropriate drug formulations (3 [1–9] vs. 5 [1–10]). Conclusions Similar constraints were identified in France and Canada. Further studies are required to identify relevant incentives to better support pharmacists’ role in paediatric clinical research. No conflict of interest.