High tidal volumes in patients with acute respiratory distress syndrome and acute lung injury lead to ventilator-induced lung injury and increased mortality. We evaluated the impact of tidal volumes ...on cardiac surgery outcomes.
We examined prospectively recorded data from 3,434 consecutive adult patients who underwent cardiac surgery. Three groups of patients were defined based on the tidal volume delivered on arrival at the intensive care unit: (1) low: below 10, (2) traditional: 10-12, and (3) high: more than 12 ml/kg of predicted body weight. We assessed risk factors for three types of organ failure (prolonged mechanical ventilation, hemodynamic instability, and renal failure) and a prolonged stay in the intensive care unit.
The mean tidal volume/actual weight was 9.2 ml/kg, and the tidal volume/predicted body weight was 11.5 ml/kg. Low, traditional, and high tidal volumes were used in 724 (21.1%), 1567 (45.6%), and 1,143 patients (33.3%), respectively. Independent risks factors for high tidal volumes were body mass index of 30 or more (odds ratio OR 6.25; CI: 5.26-7.42; P < 0.001) and female sex (OR 4.33; CI: 3.64-5.15; P < 0.001). In the multivariate analysis, high and traditional tidal volumes were independent risk factors for organ failure, multiple organ failure, and prolonged stay in the intensive care unit. Organ failures were associated with increased intensive care unit stay, hospital mortality, and long-term mortality.
Tidal volumes of more than 10 ml/kg are risk factors for organ failure and prolonged intensive care unit stay after cardiac surgery. Women and obese patients are particularly at risk of being ventilated with injurious tidal volumes.
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 cm
2
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/cm
2
; irinotecan, 3.6 ng/cm
2
), a perfusion pump (cyclophosphamide, 19.6 ng/cm
2
) and on a cytotoxic waste bin cover (gemcitabine, 4.97 ng/cm
2
). Floors in patient rooms had highest levels of cytarabine (0.12 ng/cm
2
) and methotrexate (6.38 ng/cm
2
). 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.
Background
Occupational exposure to hazardous drugs can decrease fertility and result in miscarriages, stillbirths, and cancers in healthcare staff. Several recommended practices aim to reduce this ...exposure, including protective clothing, gloves, and biological safety cabinets ('safe handling'). There is significant uncertainty as to whether using closed‐system drug‐transfer devices (CSTD) in addition to safe handling decreases the contamination and risk of staff exposure to infusional hazardous drugs compared to safe handling alone.
Objectives
To assess the effects of closed‐system drug‐transfer of infusional hazardous drugs plus safe handling versus safe handling alone for reducing staff exposure to infusional hazardous drugs and risk of staff contamination, and to determine if the better reuse of multi‐dose vials leads to cost savings.
Search methods
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, OSH‐UPDATE, CINAHL, Science Citation Index Expanded, economic evaluation databases, the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov to October 2017.
Selection criteria
We included comparative studies of any study design (irrespective of language, blinding, or publication status) that compared CSTD plus safe handling versus safe handling alone for infusional hazardous drugs.
Data collection and analysis
Two review authors independently identified trials and extracted data. We calculated the risk ratio (RR) and mean difference (MD) with 95% confidence intervals (CI) using both fixed‐effect and random‐effects models. We assessed risk of bias according to the risk of bias in non‐randomised studies of interventions (ROBINS‐I) tool, used an intracluster correlation coefficient of 0.10, and we assessed the quality of the evidence using GRADE.
Main results
We included 24 observational cluster studies (359 hospitals) in this review. We did not find any randomised controlled trials or formal economic evaluations. In 22 studies, the people who used the intervention (CSTD plus safe handling) and control (safe handling alone) were pharmacists or pharmacy technicians; in the other two studies, the people who used the intervention and control were nurses, pharmacists, or pharmacy technicians. Therefore, the evidence is mainly applicable to pharmacists or pharmacy technicians. The CSTD used in the studies were PhaSeal (13 studies), Tevadaptor (2 studies), SpikeSwan (1 study), PhaSeal and Tevadaptor (1 study), varied (5 studies), and not stated (2 studies). Therefore, the evidence is mainly applicable for PhaSeal. The studies' descriptions of the control groups were varied. Twenty‐two studies provide data on one or more outcomes for this systematic review. All the studies are at serious risk of bias. The quality of evidence is very low for all the outcomes.
Very low certainty evidence from small studies is insufficient to determine whether there is any important difference between CSTD and control groups in the proportion of people with positive urine tests for exposure between the CSTD and control groups for any of the drugs: cyclophosphamide alone (RR 0.83, 95% CI 0.46 to 1.52; I² = 12%; 2 studies; 2 hospitals; 20 participants; CSTD: 76.1% versus control: 91.7%); cyclophosphamide or ifosfamide (RR 0.09, 95% CI 0.00 to 2.79; 1 study; 1 hospital; 14 participants; CSTD: 6.4% versus control: 71.4%); and cyclophosphamide, ifosfamide, or gemcitabine (RR not estimable; 1 study; 1 hospital; 36 participants; 0% in both groups).
Very low certainty evidence from small studies is insufficient to determine whether there is any important difference between CSTD and control groups in the proportion of surfaces contaminated or the quantity of contamination. Overall, out of 24 comparisons in pharmacy areas or patient‐care areas, there was a reduction in the proportion of surfaces contaminated in only one comparison and out of 15 comparisons in pharmacy areas or patient‐care areas, there was a reduction in the quantity of contamination in only two comparisons.
None of the studies report on atmospheric contamination, blood tests, or other measures of exposure to infusional hazardous drugs such as urine mutagenicity, chromosomal aberrations, sister chromatid exchanges, or micronuclei induction.
None of the studies report short‐term health outcomes such as reduction in skin rashes, medium‐term reproductive health outcomes such as fertility and parity, or long‐term health outcomes related to the development of any type of cancer or adverse events.
Five studies (six hospitals) report the potential cost savings through the use of CSTD. The studies used different methods of calculating the costs, and the results were not reported in a format that could be pooled via meta‐analysis. There is significant variability between the studies in terms of whether CSTD resulted in cost savings (the point estimates of the average potential cost savings ranged from (2017) USD −642,656 to (2017) USD 221,818).
The healthcare professionals in the studies that provide data were mostly pharmacists or pharmacy technicians. Therefore, the evidence is mainly applicable to pharmacists and pharmacy technicians. Most of the studies that provide information for this review evaluated the use of PhaSeal; therefore the findings are mostly applicable to PhaSeal.
Authors' conclusions
Currently, no firm conclusions can be drawn on the effect of CSTD combined with safe handling versus safe handling alone due to very low certainty evidence available for the main outcomes.
Multicentre randomised controlled trials may be feasible depending upon the proportion of people with exposure. The next best study design is interrupted time‐series. Future studies should evaluate exposure to a relevant selection of hazardous drugs used in the hospital, and they should measure direct short‐term health outcomes.
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.
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.
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.
To ensure compliance with the legal and normative framework, the professional orders, which supervise the practice of pharmacy have established a professional inspection process. In addition to this ...process, other external organizations also require an accreditation, authorization, certification or validation process for professional practices.
The main objective is to identify and compare the methods of evaluating pharmaceutical practice in hospitals in France and Quebec.
In order to identify and compare the methods of evaluating pharmaceutical practice in hospitals in France and Quebec, our approach allowed us to identify more organizations in France (i.e., High Authority of Health, Regional Health Agencies, the National Order of Pharmacists, the Nuclear Safety Agency, the Biomedicine Agency and the National Agency for the Safety of Medicines and Health Products) than in Quebec (i.e., Accreditation Canada, Ordre des pharmaciens du Québec and Health Canada). The study highlights the legal framework and applicable standards, the surveyors, the evaluation methods and the particularities for the evaluation of the hospital, the pharmacy department and the members of the department.
This study highlights the evaluation processes of pharmaceutical practice in hospitals. In France, as in Quebec, we recognize the importance of the drug circuit in the hospital, the development and operation of a pharmacy department and the practice of pharmacy. While there are more similarities for the assessment of the drug circuit in hospitals and pharmacy department, important differences are observed for the assessment of individuals. We believe that the publication of a comparative analysis can contribute to discussions and exchanges to benefit from the best practices of each country.
Abstract
Objectives
The study sought to assess the clinical performance of a machine learning model aiming to identify unusual medication orders.
Materials and Methods
This prospective study was ...conducted at CHU Sainte-Justine, Canada, from April to August 2020. An unsupervised machine learning model based on GANomaly and 2 baselines were trained to learn medication order patterns from 10 years of data. Clinical pharmacists dichotomously (typical or atypical) labeled orders and pharmacological profiles (patients’ medication lists). Confusion matrices, areas under the precision-recall curve (AUPRs), and F1 scores were calculated.
Results
A total of 12 471 medication orders and 1356 profiles were labeled by 25 pharmacists. Medication order predictions showed a precision of 35%, recall (sensitivity) of 26%, and specificity of 97% as compared with pharmacist labels, with an AUPR of 0.25 and an F1 score of 0.30. Profile predictions showed a precision of 49%, recall of 75%, and specificity of 82%, with an AUPR of 0.60, and an F1 score of 0.59. The model performed better than the baselines. According to the pharmacists, the model was a useful screening tool, and 9 of 15 participants preferred predictions by medication, rather than by profile.
Discussion
Predictions for profiles had higher F1 scores and recall compared with medication order predictions. Although the performance was much better for profile predictions, pharmacists generally preferred medication order predictions.
Conclusions
Based on the AUPR, this model showed better performance for the identification of atypical pharmacological profiles than for medication orders. Pharmacists considered the model a useful screening tool. Improving these predictions should be prioritized in future research to maximize clinical impact.
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To assess the effectiveness of closed‐system drug‐transfer of infusional hazardous drugs in addition to safe ...handling versus safe handling alone for reducing the exposure and risk of staff contamination to infusional hazardous drugs.
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