Intranasal ketamine for procedural sedation in children: An open-label multicenter clinical trial.

INTRODUCTION: There are limited options for pain and distress management in children undergoing minor procedures, without the burden of an intravenous line insertion. Prior to this study, we conducted a dose-escalation study and identified 6 mg/kg as a potentially optimal initial dose of intranasal ketamine. OBJECTIVE: To assess the efficacy and safety of intranasal ketamine at a dose of 6 mg/kg for procedural sedation to repair lacerations with sutures in children in the emergency department. METHODS: We conducted a single-arm, open-label multicenter clinical trial for intranasal ketamine for laceration repair with sutures in children aged 1 to 12 years. A convenience sample of 30 patients received 6 mg/kg of intranasal ketamine for their procedural sedation. The primary outcome was the proportion (95% CI) of patients who achieved an effective procedural sedation. RESULTS: We recruited 30 patients from April 2018 to December 2019 in two pediatric emergency departments in Canada. Lacerations repaired were mostly facial in 21(70%) patients and longer than 2 cm in 20 (67%) patients. Sedation was effective in 18/30 (60% [95% CI 45, 80]) children and was suboptimal in 5 (17%) patients but procedure was completed in them with minimal difficulties. Sedation was poor in the remaining 7 (23%) patients, with 3 (10%) of them required additional sedative agents. No serious adverse events were reported. CONCLUSIONS: Using a single dose of 6 mg/kg of intranasal Ketamine for laceration repair led to successful sedation in 60% of patients according to our a priori definition. An additional 17% of patients were considered suboptimal, but their procedure was still completed with minimal difficulty. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT03053947).

Additive Value of Intranasal Fentanyl on Ibuprofen for Pain Management of Children With Moderate to Severe Headaches: A Randomized Controlled Trial.

BACKGROUND: Few studies have evaluated the rapid pain improvement provided by medications for children presenting to an emergency department (ED) with headaches. OBJECTIVE: Our aim was to evaluate pain reduction provided by intranasal fentanyl (INF) compared with placebo in addition to ibuprofen. METHODS: A single-center, double-blinded, randomized, placebo-controlled clinical trial was conducted in a tertiary care pediatric ED. All children aged 8-17 years presenting with a moderate to severe headache were eligible. Study participants were randomly allocated to receive INF 1.5 µg/kg (maximum dose of 100 µg) or similar placebo solution. Co-administration of oral ibuprofen 10 mg/kg (maximum dose of 600 mg) was also provided. The primary outcome was the mean pain rating reduction at 15 min. RESULTS: Among the 62 participants, the median age was 14 years (interquartile range [IQR] 12-16 years in both groups) and the median initial visual analog scale (VAS) score was 64 (IQR 55-72 in the intervention group; IQR 50-81 in the control group). There was no difference in the mean pain score reduction at 15 min between the two groups (mean difference 2 mm; 95% CI -7 to 11 mm). Mean VAS score reductions were also similar at 30 and 60 min. Adverse events were more frequent in the INF group (risk ratio 2.8; 95% CI 1.29 to 6.22), but all events were minor and transient. No significant differences were found in other outcomes. CONCLUSIONS: This study did not find a benefit from INF for providing additional pain relief in children presenting to ED with headaches.

Effect on Pain of an Oral Sucrose Solution vs. Placebo in Children 1 to 3 Months Old Needing Nasopharyngeal Aspiration: A Randomized Controlled Trial.

BACKGROUND: Oral sweet solutions have been proposed as effective pain-reducing agents for procedures. OBJECTIVES: To compare the efficacy of an oral sucrose solution vs. placebo in alleviating pain in children (1-3 months) during nasopharyngeal aspiration (NPA). METHODS: A randomized, double-blind, controlled clinical trial was conducted in a pediatric hospital emergency department. Participants (aged 1-3 months) requiring NPA were randomly allocated to receive 2 mL of 88% sucrose (SUC) or 2 mL of a placebo (PLA) 2 min prior to the procedure. The primary outcome was the mean difference in pain scores at 1 min post NPA as assessed by the Face, Legs, Activity, Cry and Consolability (FLACC) Pain Scale. RESULTS: Seventy-two participants completed the study, 37 receiving SUC and 35 PLA. The mean difference in FLACC scores compared with baseline was 3.3 (2.5-4.1) for SUC vs. 3.2 (2.3-4.1) for PLA (p = .094) at 1 min and -1.2 (-1.7-0.7) for SUC vs. -0.8 (-1.5 to -0.1) for PLA (p = 0.66) at 3 min after NPA. For the Neonatal Infant Pain Scale scores, it was 2.3 (1.6-3.0) (SUC) vs. 2.5 (1.8-3.2) (PLA) (p = .086) at 1 min and -1.2 (-1.6 to -0.8) (SUC) vs. -0.8 (-1.3 to 0.2) (PLA) (p = 0.59) 3 min after NPA. There was no difference in the mean crying time, 114 (98-130) s, SUC vs. 109 (92-126) s, PLA (p = 0.81). No significant difference was found in participants' heart rate at 1 min 174 (154-194) beats/min in SUC vs. 179 (160-198) beats/min in PLA (p = 0.32). CONCLUSIONS: In infants (1-3 months) undergoing NPA, administration of an oral sweet solution did not statistically decrease pain scores.

Estimating the Weight of Children During Simulated Emergency Situations Using the Broselow Tape: Are We Underestimating the Risks of Errors?

OBJECTIVE: The objective of this study was to evaluate whether residents can accurately estimate children's weight using the Broselow tape. METHOD: We conducted a preplanned secondary analysis from an experimental trial. Participants were residents in pediatrics, family medicine, and emergency medicine rotating in the ED. Residents were randomly assigned to 2 sets of paired scenarios during 2 sessions. They were asked to estimate the weight of a manikin using the Broselow tape at the beginning of each scenario. The first scenario from the initial session and the last scenario from the second session were used for the current study. The primary analysis was the proportion of participants who accurately estimated manikin weight within a 10% margin of error. RESULTS: Forty residents were recruited. Thirty-two (80%) reported knowledge of the Broselow tape and 13 (32.5%) reported previous use. Weight estimation was accurate in 60% (24/40; 95% confidence interval [CI], 45%-74%) during the first scenarios. Error in weight estimation differed by greater than 25% in 28% (11/40). Error in estimation was not associated with previous knowledge (odds ratio, 6.2; 95% CI, 0.68-56) or previous use (odds ratio, 0.9; 95% CI, 0.23-3.5) of the Broselow tape. In the last scenario, 88% accurately estimated manikin weight (35/40; 95% CI, 73%-95%). CONCLUSIONS: Although most residents reported knowledge of the Broselow tape, 40% made erroneous weight estimations by at least 10% with the first use in this simulation study. With repeated use, they improved significantly over time. Teaching appropriate use of the Broselow tape should be part of residency-training curricula and pediatric advanced life support course.

Determination of good pharmacovigilance reporting practices in Quebec hospital pharmacies using a modified Delphi method.

PURPOSE: Many published guidelines are available for health care providers describing the best way to manage patient's adverse drug reactions (ADRs). However, there is a lack of guidance on the best way to promote and manage ADR reporting within hospitals. The goal of this study was to develop good pharmacovigilance reporting practices (GPRPs). METHODS: This descriptive study used a modified Delphi method. The research team developed 41 statements, according to a modified Specific Measurable Attainable Realistic Timely (SMART) method and grouped them in six categories: organization (n = 12 statements), pharmacovigilance committee (n = 4), database (n = 5), training (n = 5), tools (n = 3), and quality (n = 12). The Delphi consultation (two online rounds, conducted in 2018) involved directors of pharmacy in Quebec hospitals. RESULTS: Of 30 directors of pharmacy invited to participate in the first round, 27 (90%) did so. Following this round, the wording of five statements was modified according to pre-established rules. Twenty-five (93%) of the original 27 participants responded during the second round. Of the initial 41 statements, 37 were selected (average score ≥ 7); the other four were eliminated. Of the 37 statements selected, 22 had a "must do" formulation, 12 had a "should do" formulation, and three had a "may do" formulation. CONCLUSION: Using a modified Delphi method, we established a set of GPRPs for hospital pharmacy based on 37 statements. To our knowledge, these are the first GPRPs published in the hospital pharmacy literature.

Investigational drug labeling variability.

BACKGROUND/AIMS: In comparison with commercial drugs, there are few regulations concerning the labeling of investigational drugs. This leads to variability in their content and layout. This increases the risk of errors during storage, validation, compounding, dispensing and administration. The aim of this study was to evaluate the conformity and variability of investigational drug labels. Additional exploratory aims were to evaluate the use of an automated script to describe the labels and to identify the factors associated with the ease of finding a kit number. METHODS: An 87-criterion list was developed to evaluate content, format and readability. It included eight criteria to evaluate the conformity to the Canadian Food and Drugs Regulation. A systematic cross-sectional evaluation of all investigational drug labels in our 500-bed mother-child center was performed. All active protocols during the period of 14-22 February 2018 were included. Labels from drugs that were sourced locally were excluded. Labels affixed to the outside (external) and inside (internal) containers, as well as labels from American and European sponsors, were compared with the chi-square and Student's t tests. A script was developed in Python to automatically determine key information (number of words, main colors and their proportion). A short survey was conducted with a convenience sample of pharmacists to rate the ease of finding the kit number on labels. Correlation was evaluated with different factors. RESULTS: A total of 27 protocols were included (24 internal and 34 external labels). The majority (33/34) of external labels were compliant with the Regulation. Some internal labels did not state the expiry date (9/13), the sponsor address (2/13) or storing conditions (1/13). A total of 10 criteria were different between internal and external labels, for instance, the number of languages was higher on external labels (median 3 (2-14) vs 10 (2-50); p = 0.013). Five criteria were different depending on the sponsors' location, for instance, European sponsors were more prone to use bold characters (25% vs 61%, p = 0.034). There was a mean of 146 ± 111 words and 78.3% ± 7.3% empty space per label. These were positively correlated (p < 0.001). The proportion of free space on a label was also correlated with the ease of finding the kit number (p = 0.002). CONCLUSION: We measured a high variability in the labeling of investigational drugs. Key information was missing from labels affixed to internal containers, despite the use of a high number of pages. The automation worked well and further work is needed to identify criteria that may improve readability and reduce error risk. Detailed and harmonized international guidelines are needed.

Patient access to compounded drugs in paediatrics after discharge from a tertiary centre.

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.

A Randomized Double-Blind Trial Comparing the Effect on Pain of an Oral Sucrose Solution vs. Placebo in Children 1 to 3 Months Old Undergoing Simple Venipuncture.

BACKGROUND: Few clinical trials evaluating the efficacy of oral sweet solutions for procedures in the emergency department (ED) have been published. OBJECTIVES: To compare the efficacy of an oral sucrose solution vs. a placebo in reducing pain in infants undergoing venipuncture without cannulation. METHODS: A randomized, double-blinded clinical trial was conducted in a pediatric ED. Infants 1 to 3 months old were randomly allocated to receive 2 mL of 88% sucrose or 2 mL of placebo, 2 min prior to venipuncture. The outcome measures were the difference in pain levels as assessed by the Face, Legs, Activity, Cry and Consolability Pain Scale (FLACC) and Neonatal Infant Pain Scale (NIPS) scores, crying time, and variations in heart rate. RESULTS: Eighty-two participants were recruited. Data were analyzed for 38 patients from each group (excluding protocol deviations). The mean difference in FLACC scores 1 min post venipuncture compared with baseline was 2.84 ± .64 (sucrose) vs. 2.71 ± .62 (placebo) (p = 0.98). For the NIPS score, it was 2.32 ± .47 (sucrose) vs. 1.63 ± .49 (placebo) (p = 0.60). The difference in the median crying time was not statistically significant between the two groups: 63.0 ± 3 (sucrose) vs. 48.5 ± 5 s (placebo) (p = 0.17). No significant difference was found in participants' heart rates 1 min post venipuncture compared with baseline: 33 ± 6 (sucrose) vs. 24 ± 5 beats per minute (placebo) (p = 0.44). CONCLUSIONS: In infants 1 to 3 months of age undergoing simple venipuncture, administration of an oral sweet solution did not statistically decrease pain scores, and participants' heart rate variations and crying time were not significantly changed.

Unlicensed and off-label drug use in paediatrics in a mother-child tertiary care hospital.

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.

OBJECTIF: Évaluer l'emploi des médicaments non brevetés et utilisés dans une indication non autorisée en une seule journée dans un hôpital pédiatrique de soins tertiaires du Canada. MÉTHODOLOGIE: Des chercheurs ont réalisé une étude transversale dans un hôpital pédiatrique de soins tertiaires au cours d'une journée sélectionnée au hasard. Ils ont analysé les prescriptions actives des enfants de moins de 18 ans. Les médicaments non brevetés désignaient les médicaments non commercialisés au Canada ou commercialisés, mais préparés en pharmacie. Les médicaments utilisés dans une indication non autorisée (MUINA) désignaient les médicaments commercialisés au Canada utilisés dans un groupe d'âge, une indication, une dose, une fréquence ou une voie d'administration non approuvé. Les chercheurs ont analysé les MUINA associés à un solide appui scientifique au moyen du Pediatric Dosage Handbook, 14th edition et de Micromedex® Solutions. Ils ont calculé le nombre et la proportion de médicaments non brevetés et de MUINA prescrits, ainsi que celui des MUINA liés à un solide appui scientifique. RÉSULTATS: Le 5 mars 2014, les chercheurs ont extrait 2 145 prescriptions de médicaments qu'ils ont incluses dans la présente étude. Le taux d'utilisation de médicaments non brevetés s'élevait à 8,3 % (57 produits non brevetés, 75 médicaments non commercialisés et 103 préparations pharmaceutiques) et celui de MUINA, à 38,2 % (161 substances; 819 prescriptions). Les raisons pour lesquelles les prescriptions étaient considérées comme des MUINA étaient un groupe d'âge (n=436 [53,2 %]), une dose (n=226 [27,6 %]), une fréquence (n=206 [25,2 %]), une indication (n=45 [5,5 %]) ou une voie d'administration (n=46 [5,6 %]) non approuvé. Parmi les MUINA, 39,3 % (n=322) étaient liés à un solide appui scientifique. CONCLUSIONS: Au cours d'une journée sélectionnée au hasard, 8,3 % des prescriptions n'étaient pas brevetées et 38,2 % étaient utilisées dans une indication non autorisée chez les enfants hospitalisés dans l'établissement des auteurs. Parmi les MUINA, seulement 39,3 % étaient liés à un solide appui scientifique.

Parental Report of Morphine Use at Home after Pediatric Surgery.

OBJECTIVE: To describe the use of morphine at home for acute postoperative pain in children. STUDY DESIGN: This was a prospective, descriptive study. Patients less than 12 years of age who underwent surgery and who received a discharge prescription for morphine between January and May 2014 were included. Parents were given a logbook to note their use of morphine at home. A follow-up call was performed 3 days after discharge. The primary outcome was whether or not parents administered morphine according to the discharge prescription. Prescription filling rates, storage at home, administration devices used, and disposal of remaining morphine were also evaluated. RESULTS: A total of 243 subjects were recruited; 56% (95% CI, 46%-66%) of participants with a regular basis prescription administered the medication as prescribed. This number was 85% (95% CI, 78%-92%) in subjects receiving an as-needed prescription, including those who did not administer any morphine because of an absence of pain. Although 76% (95% CI, 68%-84%) of parents filled the morphine prescription when prescribed as needed, most administered two doses or less. In a subset of 77 subjects for whom we obtained detailed prescription data, only 9.2% of prescribed doses were administered. CONCLUSION: We observed that large amounts of morphine have been prescribed and dispensed into homes without being administered. This study identified a need to re-evaluate the quantity of morphine prescribed and dispensed after pediatric surgery.

Impact and appreciation of two methods aiming at reducing hazardous drug environmental contamination: The centralization of the priming of IV tubing in the pharmacy and use of a closed-system transfer device.

OBJECTIVES: The main objective was to evaluate the impact of two methods aiming at reducing hazardous drug environmental contamination: the centralization of the priming of IV tubing in the pharmacy and the use of a closed-system transfer device. The secondary objective was to evaluate the satisfaction of pharmacy technicians using a survey. METHODS: Sites in the hematology-oncology satellite pharmacy and care unit were analyzed for the presence of cyclophosphamide, ifosfamide and methotrexate before and after the centralization of the priming of IV tubing in the pharmacy and before and after using a closed-system transfer device. The limits of detection for cyclophosphamide, ifosfamide and methotrexate were, respectively, of 0.0015 ng/cm(2), 0.0012 ng/cm(2) and 0.0060 ng/cm(2). The pharmacy technician satisfaction was evaluated using a questionnaire. RESULTS: A total of 225 samples was quantified. After the centralization of priming in the pharmacy, no significant difference was found in the proportion of positive samples for cyclophosphamide, ifosfamide and methotrexate. Traces of cyclophosphamide found on the floor in patient care areas was significantly reduced (median[min-max] 0.08[0.06-0.09]ng/cm(2) vs. 0.03[0.02-0.05], p < 0.0001). After using a closed-system transfer device, a significant difference was found for the proportion of cyclophosphamide positive samples (15/45(33%) vs. 0/45(0%), p < 0.0001), but no significant difference was found for ifosfamide (12/45(27%) vs. 5/45(11%), p = 0.059) and methotrexate (1/45(2%) vs. 2/45(4%), p = 0.557). Pharmacy technicians raised issues following the centralization of priming (e.g. workload) and the use of closed-system transfer devices (e.g. spills, particles, workload and handling difficulties). CONCLUSION: The centralization of the priming of IV tubing in the pharmacy reduced floor contamination in patient care areas without increasing surface contamination in the pharmacy. Closed-system transfer devices reduced contamination in pharmacy, but handling issues were raised by pharmacy technicians.

[Approach to upgrading pharmaceutical care: the example of immunization]. / Démarche pour la mise à niveau de soins pharmaceutiques en établissement de santé: l'exemple de l'immunisation.

AIM: This article describes an approach to upgrading pharmaceutical care in healthcare facilities. METHODS: This is a descriptive study supporting the upgrade of pharmaceutical care in the field of immunization [blinded for review], in a 500-bed mother-child university hospital. Our approach consisted of 3 steps: (1) a review of the literature, (2) a description of the profile of the sector and (3) a description of upgrading of pharmacists' practices in immunization. RESULTS: A total of 19 articles were reviewed. No specific pharmaceutical activity based on very good quality data was identified (A).However, eight pharmaceutical activities based on good quality data (B) or with an insufficient level of proof (D) related to immunization practices were identified. A review of pharmaceutical activities (2013-2014) accounted for an annual expenditure of $ CAN 4,227 for vaccines compared to $ SCAN 27,633,944 for all drugs. A total of 9,254 doses of vaccines were prescribed for 3,544 patients. The planned revision of immunization activities includes a medication reconciliation process targeting immunization requirements, systematic consultation of pharmacy dispensing records for patients hospitalized for more than one month to ensure adherence to the Quebec Immunization Protocol, systematic reporting of vaccine adverse reactions, and implementation of information reviews about new vaccines. CONCLUSION: Few data are available concerning the impact of pharmacists in immunization. This descriptive study proposes a number of steps designed to upgrade pharmaceutical practices in a university hospital.

Disponibilité de l'information médicale requise pour la déclaration d'une réaction indésirable médicamenteuse à Santé Canada: une étude exploratoire.

Background: Since 2019, health care facilities have been required to report serious adverse drug reactions (ADRs) to Health Canada. Objectives: To describe the availability of information required for reporting an ADR to Health Canada from medical records using 2 methods (systematic and in-depth reporting) and to compare the time required to find the information. Methods: This retrospective and prospective descriptive study involved serious ADRs occurring in a mother-child centre and reported between April 1, 2021, and March 31, 2023. The variables needed to complete the Health Canada reporting form were collected using 2 distinct methods. Results: Among the 270 serious ADRs reported retrospectively, 140 were sampled. The average availability of variables was 82.3% (standard deviation [SD] 11.3%), with average data collection time of 50 (SD 25) minutes. For the prospective part of the study, 15 serious ADRs were studied. The availability of variables was 82.8% (SD 6.9%) and 91.9% (SD 7.8%), for systematic and in-depth reporting, respectively, with data collection times of 44 (SD 17) and 130 (SD 33) minutes, respectively. Conclusions: The challenge of finding, in patients' medical records, all of the information needed for reporting an ADR to Health Canada required an in-depth approach. However, the in-depth method took 3 times as long as a search limited to places in the record where specific information should be found. To improve record keeping, additional training for clinicians could be considered and, potentially, development of a computerized clinical record that includes a dedicated form for documenting ADRs.

Contexte: Depuis 2019, les établissements de santé doivent déclarer les réactions indésirables graves aux médicaments (RIM graves) à Santé Canada. Objectifs: Décrire la disponibilité de l'information requise pour la déclaration d'une RIM à Santé Canada dans les dossiers médicaux par deux méthodes (soit, systématique et approfondie) et comparer le temps nécessaire pour retrouver l'information. Méthode: Étude descriptive rétrospective et prospective des RIM graves survenues en centre mère-enfant et déclarées entre le 1er avril 2021 et 31 mars 2023. Les variables nécessaires pour remplir le formulaire de déclaration de Santé Canada ont été collectées par deux méthodes distinctes. Résultats: Parmi les 270 RIM graves déclarées en rétrospectif, 140 ont été échantillonnées. La disponibilité moyenne des variables était de 82,3 % (écart-type [SD] 11,3 %), pour une durée de collecte de 50 (SD 25) minutes. Du côté prospectif, 15 RIM graves ont été étudiées, la disponibilité des variables était, pour chacune des méthodes respectivement, de 82,8 (SD 6,9 %) et 91,9 (SD 7,8 %), pour des temps de collecte respectifs de 44 (SD 17) et 130 (SD 33) minutes. Conclusions: La difficulté que représente l'identification de toutes les informations requises dans les dossiers médicaux pour la déclaration d'une RIM à Santé Canada nécessite une recherche approfondie. Toutefois, la recherche approfondie demande trois fois plus de temps qu'une recherche qui se limiterait aux endroits où l'information devrait se retrouver. Il est possible d'envisager de dispenser une formation supplémentaire aux cliniciens pour améliorer la tenue de dossiers et, éventuellement, le recours à un dossier clinique informatisé qui comprend un formulaire dédié à la documentation des RIM.

Improving medication safety in a paediatric hospital: a mixed-methods evaluation of a newly implemented computerised provider order entry system.

OBJECTIVES: Computerised provider order entry (CPOE) systems have been implemented around the world as a solution to reduce ordering and transcription errors. However, previous literature documented many challenges to attain this goal, especially in paediatric settings. The objectives of this study were to (1) analyse the impact of a paediatric CPOE system on medication safety and (2) suggest potential error prevention strategies. METHODS: A pre-post observational study was conducted at the pilot ward (n=60 beds) of a paediatric academic health centre through mixed methods. The implementation project and medication management workflows were described through active participation to the project management team, observation, discussions and analysis of related documents. Furthermore, using incident reports, the nature of each error and error rate was compared between the preperiod and postperiod. RESULTS: The global error rate was lower, but non-statistically significant, in the post implementation phase, which was mostly driven by a significant reduction in errors during order acknowledgement, transmission and transcription. Few errors occurred at the prescription step, and most errors occurred during medication administration. Furthermore, some errors could have been prevented using a CPOE in the pre-implementation period, and the CPOE led to few technology-related errors. DISCUSSION AND CONCLUSION: This study identified both intended and unintended effects of CPOE adoption through the entire medication management workflow. This study revealed the importance of simplifying the acknowledgement, transmission and transcribing steps through the implementation of a CPOE to reduce medication errors. Improving the usability of the electronic medication administration record could help further improve medication safety.

Training workload in the investigational drug service of a university hospital center.

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.

Drug Prescriptions Requiring Compounding at a Canadian University Affiliated Pediatric Hospital: A Cross-Sectional Study.

Despite ongoing international efforts, many drugs administered to children must be compounded from dosage forms designed for adults because they remain unavailable in commercial formulations that suit their needs. Even though oral drug compounding is common in pediatrics, the extent of this practice has not been well described in recent years. This cross-sectional and retrospective study was conducted at a Canadian university-affiliated, 484-bed, tertiary care pediatric hospital and its rehabilitation centre on two randomly selected days. A total of 606 hospitalized children with 5465 prescriptions were included. Overall, compounded drugs for enteral administration (CDEA) represented 13% of all prescriptions (enteral and parenteral) and 23% of prescriptions for enteral administration. Of the 390 prescribed drugs, 122 required compounding. CDEA were mostly liquids (n = 478 [67%]) and mainly included drugs of the central nervous (35%), cardiovascular (21%), and gastro-intestinal (12%) systems. Nearly half (N = 298 [49%]) of children had at least one CDEA prescribed in their medical file. Many CDEA are available as commercial products in other jurisdictions. Collaboration is needed between all stakeholders to make these drugs available to Canadian children.

Exploration de l'association possible entre la consommation d'antibiotiques et l'émergence de résistance dans un centre hospitalier universitaire mère-enfant.

Background: The emergence of antibiotic resistance has contributed to the development of multidrug-resistant bacteria, which is a major concern. Objectives: The primary objective was to explore the possible association between antibiotic use and the emergence of resistance in a mother-child university hospital. Method: This retrospective study was conducted in a university hospital centre. Antibiotic-bacteria pairs were established, taking into account the number of isolates, actual antibiotic use, and clinical relevance. For each pair, a comparison of 2 variables (antibiotic utilization and rate of resistance) was quantified with the Pearson coefficient. Three analyses were conducted: no lag between utilization and resistance, 1-year lag, and 2-year lag. Results: Thirty antibiotic-bacteria pairs were selected from hematology-oncology and 18 from neonatology. In hematology-oncology, 6 pairs had a positive correlation (Pearson coefficient > 0.7): 2 pairs involving meropenem, 2 involving ceftazidime, and 2 involving piperacillin-tazobactam. In 3 of these cases, there was no lag between consumption of antibiotics and presence of resistance. In neonatology, 3 antibiotic-bacteria pairs had a positive correlation, 1 each involving vancomycin, cloxacillin, and meropenem. Conclusions: It is possible to explore the potential association between consumption of antibiotics and emergence of resistance in a particular centre. Our exploratory approach was based on manual data processing. It would be interesting to consider a continuous systematic approach, allowing automatic generation of correlations.

Pharmacogenetic testing in pediatric neurology: a pragmatic study evaluating clinician and patient perceptions.

Aim: To evaluate clinicians' and patients' perceptions of pharmacogenetic testing in a clinical setting. Materials & methods: This is a pragmatic mixed-method prospective observational study. Hospital pharmacists and neurologists participated in focus groups regarding pharmacogenetic testing; patients who received pharmacogenetic testing and their community pharmacists completed surveys to assess their perception of these tests. Results: Most study participants had a positive view of pharmacogenetic testing. Three major themes were identified from the focus groups: receptiveness to pharmacogenetic testing, pharmacogenetic test characteristics and integrating pharmacogenetic tests into practice. Conclusion: The views reported are encouraging for the eventual implementation of pharmacogenetics in practice. Local integration of these tests is an essential step to improve patient care through personalized medicine.

Genetic tests can help predict patients' response to medication. This study aimed to evaluate clinicians' and patients' perceptions of these genetic tests. Pediatric patients, with epilepsy, were tested and completed a survey to assess their perception of these tests. A survey was also completed by their community pharmacists, and virtual discussion groups were held with hospital pharmacists and neurologists. Most participants had a positive view of these tests, with three major themes identified from the discussion groups: receptiveness to testing, test characteristics and integration of tests into practice. The views reported are encouraging for the eventual implementation of these tests in practice, an essential step to improve patient care through personalized medicine.