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Purpose: Training represents a considerable portion of research activities and is vastly different for each clinical trial. This variation is partially explained by the lack of detailed regulations surrounding training procedures, which hinders the ability of investigational drug service (IDS) staff to plan their workload. The aim of this study was to quantify the workload associated with trial-specific training of IDS staff. The secondary aim was to identify the factors associated with training complexity., Methods: A retrospective study was carried out in the IDS of a mother and child university hospital. Trial-specific documents on which the pharmacy staff was trained were analyzed. Workload was calculated by measuring reading time. The readability of each document was determined by the Flesch Reading Ease score. The complexity of the trials was established using the scoring method of Calvin-Lamas et al. The influence of the following factors on training was assessed by analysis of variance: sponsor type, research phase, and research focus by medical specialty., Results: A total of 93 clinical trials and 433 documents were included. Investigator's brochures were the longest (a mean [SD] of 107 [46] pages; P < 0.0001) and most difficult documents to read (mean [SD] readability score, 25.5 [4.4]; P < 0.0001). Trials with industry sponsors required a significantly longer overall reading time (mean [SD], 12.26 [6.72] hours; P < 0.0001). On average, a mean (SD) of 9.42 (7.16) hours of reading were necessary to train one employee for a clinical trial., Conclusion: This study is the first to document reading time necessary for training of IDS staff. The training workload varied by sponsor type, while the research phase and medical specialty had little impact. IDS units would benefit from a tool that could identify complex trials., (© American Society of Health-System Pharmacists 2023. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

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., (© The Author(s) 2021. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objective: To describe the problems faced by young patients and their parents when obtaining and using compounded drugs., Methods: This prospective observational descriptive study included patients 0 to 21 years of age who were discharged from a mother-child tertiary hospital with a prescription containing at least one compounded drug between February 2016 and July 2016. Families were called 7 to 10 business days after discharge to complete a telephone follow-up questionnaire. Retail pharmacies were contacted to obtain additional information in order to compare the dispensed compounded drug with the prescription and published master formulas., Results: The parents of 71 patients with a median age of 6.9 months were surveyed regarding 99 compounded drugs corresponding to 34 different oral formulations. Out of 314 issues identified, 252 were considered as problems: 9 involved major and 243 minor problems with real or potential consequences., Conclusion: This study identified a significant number of compounding-related problems. It suggests that current practice standards are insufficient and action should be taken to improve the use and the dispensation of compounded drugs to ensure patients' safety.

Objectives: To describe practice and perceptions of hospital pharmacy technicians (HPTs) in France and in Quebec, Canada. The secondary objective was to compare both work settings to identify differences., Methods: Cross-sectional online survey in December 2016 and February 2017. The survey was comprised of four sections: demographic, factors contributing to career choice and satisfaction, perceptions regarding training, skills and recognition and interest in new opportunities. The proportion of responses from respondents in France and Quebec was compared with a chi-squared test., Key Findings: There were 101 respondents from France and 224 from Quebec. In comparison with Quebec respondents, French respondents came from large hospitals (France: 87%, 84/97 versus Quebec: 50%, 112/223, P < 0.001). Few HPTs supported pharmacists' clinical activities (France: 4%, 4/97 versus Quebec: 29%, 65/222, P < 0.001). A majority of HPTs indicated that working in the healthcare field contributed to their job satisfaction (France: 94%, 87/93 versus Quebec: 90%, 188/209). Respondents found their training sufficient (France: 54%, 49/90 versus Quebec: 78%, 159/205, P < 0.001). However, few identified having access to sufficient continuing education (France: 40%, 36/90 versus Quebec: 29%, 59/205). Not many thought that their job was well recognized in their centre (France: 13%, 12/90 versus Quebec: 13%, 26/203). However, they felt it had a direct impact on the quality of care, especially in Quebec (France: 86%, 77/90 versus Quebec: 98%, 199/203, P < 0.001). The majority was interested in supporting the pharmacists' clinical activities (France: 91%, 78/86 versus Quebec: 82%, 163/199)., Conclusions: Overall, HTP from France and Quebec shared a satisfaction about their profession. They showed an interest in increased recognition and responsibilities (e.g. training, pharmacist support)., (© 2018 Royal Pharmaceutical Society.)

Objective: To assess unlicensed and off-label drug use in a tertiary care paediatric hospital in Canada on a single day., Methods: A cross-sectional study in a tertiary care paediatric hospital was conducted on one randomly selected day. Active prescriptions for children <18 years of age were analyzed. Unlicensed drug use was defined as the use of nonmarketed drugs in Canada or marketed drugs with pharmacy compounding. Off-label drug use was defined as the use of marketed drugs in Canada for an unapproved age group, indication, dosing, frequency and/or route of administration. Off-label drug uses associated with strong scientific support were analyzed using the Pediatric Dosage Handbook, 14th edition and Micromedex(®) Solutions. Number and proportion of unlicensed and off-label drug uses, and off-label drug uses associated with strong scientific support were measured., Results: A total of 2145 drug prescriptions were extracted on March 5, 2014, for inclusion in the present study. The unlicensed drug use rate was 8.3% (57 unlicensed drug products; 75 nonmarketed drug prescriptions and 103 pharmacy compounding prescriptions) and the off-label drug use rate was 38.2% (161 substances; 819 prescriptions). Reasons for off-label drug use included unapproved age group (n=436 [53.2%]), dosing (n=226 [27.6%]), frequency (n=206 [25.2%]), indication (n=45 [5.5%]) and administration route (n=46 [5.6%]). Of the off-label drug prescriptions, 39.3% (n=322) were associated with strong scientific support., Conclusions: On a randomly selected day, 8.3% of prescriptions were unlicensed and 38.2% were off-label for children hospitalized at the authors' institution. Of off-label prescriptions, only 39.3% were associated with strong scientific support.

Objectives: The primary objective was to rank barriers to change in pharmacy practice. Our secondary objective was to create a simulation game to stimulate reflection and discussion on the topic of change management., Methods: The game was created by the authors and used during a symposium attended by 43 hospital pharmacy leaders from all regions of Canada (Millcroft Conference, Alton, Ontario, June 2013). The main theme of the conference was 'managing change'., Key Findings: The simulation game, the rating of 35 barriers to change and the discussion that followed provided an opportunity for hospital pharmacy leaders to reflect on potential barriers to change, and how change might be facilitated through the use of an organized approach to change, such as that described in Kotter's eight-step model., Conclusions: This simulation game, and the associated rating of barriers to change, provided an opportunity for a group of hospital pharmacy leaders in Canada to reflect on the challenges associated with managing change in the healthcare setting. This simulation game can be modified and used by pharmacy practitioners in other countries to help identify and rank barriers to change in their particular pharmacy practice setting., (© 2015 Royal Pharmaceutical Society.)

Objectives: 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., Methods: This was a cross-sectional descriptive study. All paediatric hospitals from Canada and the main hospitals from France were contacted. A survey was conducted from May-September 2012. Descriptive statistics were performed., Key Findings: Results from 11 paediatric hospitals in Canada (11/12, 92%) and 11 (11/18, 61%) in France were obtained. There was a similar number of ongoing paediatric clinical trials per hospital in France versus Canada (38 (10-81) versus 20 (4-178)). A lower number of pharmacists per hospital was observed in France (17 (11.5-35) versus 45 (18.9-76.8)), but a similar number of pharmacists were assigned to clinical trials (1.5 (1-3) versus 1.9 (0.2-17.4)). Institutional protocols represented the majority of paediatric clinical trials in France (61% (14-100) versus 25% (0-100)). Similar pharmacy support services were offered, but the majority of French respondents also offered help for institutional protocol development (91 versus 50% P = 0.063). The main issues associated with paediatric clinical research were absence of financial interest from the pharmaceutical industry, prohibitive cost versus profit ratio, small patient cohorts and the non-availability of the appropriate drug formulations., Conclusions: Difficulties related to pharmaceutical compounding were identified as the main hindrance to paediatric clinical research; particular attention should be paid to these details when setting up a paediatric trial., (© 2014 Royal Pharmaceutical Society.)

Objectives: To establish a consensual and coherent ranking of healthcare programmes that involve the presence of ward-based and clinic-based clinical pharmacists, based on health outcome, health costs and safe delivery of care., Methods: This descriptive study was derived from a structured dialogue (Delphi technique) among directors of pharmacy department. We established a quantitative profile of healthcare programmes at five sites that involved the provision of ward-based and clinic-based pharmaceutical care. A summary table of evidence established a unique quality rating per inpatient (clinic-based) or outpatient (ward-based) healthcare programme. Each director rated the perceived impact of pharmaceutical care per inpatient or outpatient healthcare programme on three fields: health outcome, health costs and safe delivery of care. They agreed by consensus on the final ranking of healthcare programmes., Key Findings: A ranking was assigned for each of the 18 healthcare programmes for outpatient care and the 17 healthcare programmes for inpatient care involving the presence of pharmacists, based on health outcome, health costs and safe delivery of care. There was a good correlation between ranking based on data from a 2007-2008 Canadian report on hospital pharmacy practice and the ranking proposed by directors of pharmacy department., Conclusions: Given the often limited human and financial resources, managers should consider the best evidence available on a profession's impact to plan healthcare services within an organization. Data are few on ranking healthcare programmes in order to prioritize which healthcare programme would mostly benefit from the delivery of pharmaceutical care by ward-based and clinic-based pharmacists., (© 2012 The Authors. IJPP © 2012 Royal Pharmaceutical Society.)

Objectives: To evaluate the impact of a debate on pharmacy students' perceptions, using online pharmacy practice as the debate topic., Methods: This is a quasi-experimental interrupted time-series study. A 60 min debate was organized as a lunchtime meeting. A four-category Likert scale questionnaire (fully agree, partially agree, partially disagree, fully disagree) measured the debate participants' level of agreement with 25 statements (main issues associated with online pharmacy) in the pre-phase (before the debate), post-phase 1 (after the debate) and post-phase 2 (6 months after the debate). One hundred and seventy-seven students were recruited (response rate of 100% in the pre-phase and post-phase 1, 31% in post-phase 2). Four questions measured the perceptions of the students on this pedagogical technique., Key Findings: The overall proportion of respondents in favour of online pharmacy practice showed little variation among the three phases. However, on average (mean ± SD) 43 ± 8% of the respondents changed their opinion, 21 ± 7% reversed their opinion, 22 ± 4% nuanced their opinion and 1 ± 1% radically changed their opinion. Respectively 98% (post-phase 1) and 96% (post-phase 2) of the respondents were of the opinion that debate was a very useful teaching formula in their pharmacist training and 79 and 66% thought debate significantly changed their opinion of the issue., Conclusions: Few data have been collected on the use of debates as part of healthcare professional training. The impact of a debate on how pharmacy students feel about online pharmacy practice is described., (© 2012 The Authors. IJPP © 2012 Royal Pharmaceutical Society.)

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.

Background: There are limited published data on the labelling of single unit dose packages in hospitals., Setting and Participants: The study was conducted in three large hospitals (two adult and one paediatric) in the metropolitan Montreal area, Quebec, Canada., Objective: The objective is to evaluate the labelling of commercial oral single solid unit dose packages available in Canadian urban hospital pharmacy practice., Method: The study endpoint was the labelling conformity of each unit dose package for each criterion and overall for each manufacturer. Complete labelling of unit dose packages should include the following information: (1) brand name, (2) international non-proprietary name or generic name, (3) dosage, (4) pharmaceutical form, (5) manufacturer's name, (6) expiry date, (7) batch number and (8) drug identification number. We also evaluated the ease with which a single unit dose package is detached from a multiple unit dose package for quick, easy and safe use by pharmacy staff. Conformity levels were compared between brand-name and generic packages., Results: A total of 124 different unit dose packages were evaluated. The level of conformity of each criterion varied between 19 and 50%. Only 43% of unit dose packages provided an easy-to-detach system for single doses. Among the 14 manufacturers with three or more unit dose packages evaluated, eight (57%) had a conformity level less than 50%., Conclusion: This study describes the conformity of commercial oral single solid unit dose packages in hospital pharmacy practice in Quebec. A large proportion of unit dose packages do not conform to a set of nine criteria set out in the guidelines of the American Society of Health-System Pharmacists and the Canadian Society of Hospital Pharmacists.

Purpose: The results of contamination monitoring during a one-year pilot period are described., Summary: A hematology-oncology satellite pharmacy conducted contamination monitoring for one year, using methotrexate as the index marker. From January 12, 2005, to December 21, 2005, 40 sampling sessions occurred during which 238 wipe samples (excluding positive controls) were collected. Each week, seven wipe samples were prepared by pharmacy technicians. Samples were obtained from the blank reference (site 0), the external metallic window frame of the main biological safety cabinet (BSC) (site 1), the back of the phone receiver (site 2), the external surface of an i.v. solution bag that was inside the BSC the previous hour (site 3), a working surface used for the final packaging and labeling (site 4), and the floor of the preparation room (site 5). The sixth sample was a positive methotrexate control. The methotrexate was detected by a high-performance liquid chromatograph with a fluorometric detector. Five samples tested positive for methotrexate-two from site 1, one from site 2, one from site 4, and one from site 0 (the blank); the last finding was thought to have most likely been the result of an error or sample mix-up during the wipe-sampling procedures. Despite differences in the sampling methods used, the type of wetting solution used, and the volume of desorption solution, the results were consistent with the literature in terms of few positive results., Conclusion: A program was developed to monitor surface contamination by methotrexate in a hematology-oncology satellite pharmacy.