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.

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.

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).

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.

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.

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.

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.

Pharmacists' perceptions of a machine learning model for the identification of atypical medication orders.

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.

Implementation of a Computerized Provider Order Entry System in a Pediatric Hospital in Canada.

The Centre Hospitalier Universitaire Sainte-Justine (Montreal, Canada) is a pediatric academic tertiary hospital that has begun the implementation of a commercial computerized provider order entry system (CPOE) in October 2019. The objectives of this paper are 1) to estimate the impact of the CPOE system on medication errors, and 2) to identify vulnerability issues related to the configuration of the CPOE system's design. Using a pre-post implementation methodology measuring medication errors captured by clinical pharmacists revealed that the implementation of a CPOE has eliminated all prescription conformity (e.g., missing fields) and legibility errors. Pharmacists have continued to detect medication errors, especially inappropriate dosing instructions, and to intervene in similar clinical situations (medication reconciliation, deprescribing, adjusting orders). Additionally, the vulnerability analysis, based on typical clinical order test cases in an inpatient pediatric setting, highlighted the need to configure a clinical decision support system that can identify inappropriate dosing instructions for pediatric patients.

A randomized double-blind trial comparing the effect on pain of an oral sucrose solution versus placebo in children 1-3 months old needing bladder catheterization.

OBJECTIVE: The efficacy of oral sweet solutions to decrease pain in infants during painful procedures remains uncertain. This study aimed to compare the efficacy of an oral sucrose solution versus placebo in reducing pain during bladder catheterization in infants in the Emergency Department (ED). METHODS: A randomized, double-blind clinical trial was conducted in a pediatric university-affiliated hospital ED. Infants 1-3 months old were recruited and randomly allocated to receive 2 ml of sucrose or placebo, 2 min before bladder catheterization. The primary outcome measure was the difference in pain scores as assessed by the Face, Legs, Activity, Cry and Consolability (FLACC) Pain Scale during procedure. Secondary outcome measures were the difference in pain scores using the Neonatal Infant Pain Scale (NIPS), crying time, variations in heart rate and adverse events. RESULTS: Eighty-three participants were recruited and completed the study, 41 and 42 in the sucrose and placebo groups, respectively. The mean difference in FLACC scores compared to baseline was 5.3 in the sucrose group vs. 6.4 in the placebo group during catheterization. There were no differences in FLACC scores or NIPS scores measured at 1, 3 and 5 min post procedure. Mean crying times were similar: 97 vs. 110 s. No significant difference was found in participants' heart rate variations. No adverse events were reported. CONCLUSIONS: In infants undergoing bladder catheterization in the ED, administration of an oral sweet solution was not associated with lower pain as measured by the FLACC and NIPS scales. Participants' heart rate variations and crying times did not change when sucrose was provided.

RéSUMé: OBJECTIF: L'efficacité des solutions sucrées orales pour diminuer la douleur chez les nourrissons pendant les procédures douloureuses reste incertaine. Cette étude visait à comparer l'efficacité d'une solution de saccharose orale par rapport à un placebo pour réduire la douleur pendant le cathétérisme vésical chez les nourrissons dans le service d'urgence. MéTHODES: Un essai clinique randomisé en double aveugle a été mené dans les urgences d'un hôpital universitaire pédiatrique. Des nourrissons âgés de 1 à 3 mois ont été recrutés et répartis au hasard pour recevoir 2 ml de sucrose ou de placebo, 2 minutes avant le cathétérisme vésical. La principale mesure des résultats était la différence dans les scores de douleur évalués par l'échelle de douleur FLACC (Face, Legs, Activity, Cry and Consolability) pendant la procédure. Les mesures de résultats secondaires étaient la différence des scores de douleur en utilisant l'échelle de douleur du nourrisson néonatal (NIPS), la durée des pleurs, les variations de la fréquence cardiaque et les événements indésirables. RéSULTATS: Quatre-vingt-trois participants ont été recrutés et ont terminé l'étude, 41 et 42 dans les groupes sucrose et placebo, respectivement. La différence moyenne des scores FLACC par rapport à la ligne de base était de 5,3 dans le groupe sucrose contre 6,4 dans le groupe placebo pendant le cathétérisme. Il n'y avait aucune différence dans les scores FLACC ou NIPS mesurés à 1, 3 et 5 minutes après la procédure. La durée moyenne des pleurs était similaire : 97 contre 110 secondes. Aucune différence significative n'a été constatée dans les variations de la fréquence cardiaque des participants. Aucun événement indésirable n'a été signalé. CONCLUSIONS: Chez les nourrissons soumis à un cathétérisme vésical aux urgences, l'administration d'une solution sucrée orale n'était pas associée à une douleur moindre, telle que mesurée par les échelles FLACC et NIPS. Les variations de la fréquence cardiaque et les temps de pleurs des participants ne changeaient pas lorsque du saccharose était administré.

Soins plus ­ mise en place d'une intervention à trois volets visant à accroître la visibilité et la disponibilité du pharmacien dans un hôpital pédiatrique : une étude randomisée contrôlée.

BACKGROUND: The pharmacist's role within the multidisciplinary team is often poorly understood. Various interventions can be put into place to promote the role of the pharmacist in the hospital setting with families, patients, and other health care professionals. Few studies have described the feasibility and assessed the impact of such interventions, particularly in pediatrics. OBJECTIVES: To describe the implementation of a 3-part intervention aimed at increasing the visibility of pharmacists and their role on the treatment team, with the goal of optimizing the pharmaceutical care of hospitalized patients in the general pediatric units of CHU Sainte-Justine, in Montréal, Quebec, and to compare the perceptions and satisfaction of patients' parents and of health care professionals with exposure to either usual pharmaceutical care or to pharmaceutical care incorporating the intervention. METHODS: This single-blind, randomized, controlled experimental study involved patients admitted to general pediatric units between March 5 and August 8, 2019. In addition to usual care, the intervention included delivery of an information brochure about pharmaceutical services and care, access to a telephone line (which allowed families and patients to contact a pharmacy resident during their stay in hospital and up to 1 month after discharge), and completion of a standardized discharge form by the pharmacist responsible for the patient. The participants and health professionals concerned were surveyed to determine their perceptions and level of satisfaction. RESULTS: A total of 641 participants were included in the study, 321 in the intervention group and 320 in the control group. The brochure was given to all parents in the intervention group. Twelve phone calls were made through the dedicated telephone line. The standardized discharge form was completed for 46.7% (150/321) of the participants in the intervention group. Most of the parents and patients who responded to the survey, in either group (81.2%, 298/367), reported satisfaction with the pharmaceutical services and care received. Of participants in the intervention group, 83.9% were satisfied with the pharmaceutical care and services received, compared with 78.5% of those in the control group (p = 0.18). In addition, 60.3% (111/184) of participants in the intervention group said that the information about medications that was provided during the hospital stay gave them new knowledge, compared with 48.1% (87/181) of those in the control group (p = 0.019). The results of the survey showed that care providers were in agreement with the intervention. CONCLUSIONS: The 3 components of the intervention were implemented in the pediatric units over a period of 5 months. The intervention was perceived as positive by the parents and care providers concerned, and the respondents were mostly satisfied with the services and pharmaceutical care offered.

Utilisation de l'intelligence artificielle en pharmacie : une revue narrative.

BACKGROUND: Artificial intelligence (AI) can be described as an advanced technology in which machines display a certain form of intelligence. OBJECTIVES: The primary objective was to perform a narrative review of studies evaluating the feasibility and impact of AI in pharmacy. The secondary objective was to create a mind map of AI in health care. DATA SOURCES: Four databases were consulted: PubMed, Medline, Embase, and CINAHL. STUDY SELECTION AND DATA EXTRACTION: Four search strategies were developed. Initial selection of articles was based on their titles and abstracts; the full texts were then evaluated by a research assistant, with review by a pharmacist. Articles were included if they described or evaluated the feasibility or impact of AI in pharmacy. DATA SYNTHESIS: A total of 362 articles were identified by the literature review, of which 18 met the inclusion criteria. The studies were mainly conducted in the United States (72%, 13/18). The article topics were, in decreasing order, prediction of response to treatments and adverse effects (33%, 6/18), patient prioritization (28%, 5/18), treatment adherence (22%, 4/18), validation of prescriptions and electronic prescription (17%, 3/18), and other themes (e.g., diagnosis, costs, insurance, and verification of syringe volume). CONCLUSIONS: This narrative review highlighted 18 studies evaluating the feasibility and impact of AI in pharmacy. The studies used various methodologies in different settings, both retail pharmacies and hospital pharmacies. It is still too soon to predict the implications of AI for pharmacy, but these studies emphasize the importance of attention in this area.

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.

Profile of Antimicrobial Use in the Pediatric Population of a University Hospital Centre, 2015/16 to 2018/19.

BACKGROUND: Antimicrobial stewardship is a standard practice in health facilities to reduce both the misuse of antimicrobials and the risk of resistance. OBJECTIVE: To determine the profile of antimicrobial use in the pediatric population of a university hospital centre from 2015/16 to 2018/19. METHODS: In this retrospective, descriptive, cross-sectional study, the pharmacy information system was used to determine the number of days of therapy (DOTs) and the defined daily dose (DDD) per 1000 patient-days (PDs) for each antimicrobial and for specified care units in each year of the study period. For each measure, the ratio of 2018/19 to 2015/16 values was also calculated (and expressed as a proportion); where the value of this proportion was ≤ 0.8 or ≥ 1.2 (indicating a substantial change over the study period), an explanatory rating was assigned by consensus. RESULTS: Over the study period, 94 antimicrobial agents were available at the study hospital: 70 antibiotics (including antiparasitics and antituberculosis drugs), 14 antivirals, and 10 antifungals. The total number of DOTs per 1000 PDs declined from 904 in 2015/16 to 867 in 2018/19. The 5 most commonly used antimicrobials over the years, expressed as minimum/maximum DOTs per 1000 PDs, were piperacillin-tazobactam (78/105), trimethoprim-sulfamethoxazole (74/84), ampicillin (51/69), vancomycin (53/68), and cefotaxime (55/58). In the same period, the care units with the most antimicrobial use (expressed as minimum/maximum DOTs per 1000 PDs) were hematology-oncology (2529/2723), pediatrics (1006/1408), and pediatric intensive care (1328/1717). CONCLUSIONS: This study showed generally stable consumption of antimicrobials from 2015/16 to 2018/19 in a Canadian mother-and-child university hospital centre. Although consumption was also stable within drug groups (antibiotics, antivirals, and antifungals), there were important changes over time for some individual drugs. Several factors may explain these variations, including disruptions in supply, changes in practice, and changes in the prevalence of infections. Surveillance of antimicrobial use is an essential component of an antimicrobial stewardship program.

CONTEXTE: La gestion des antimicrobiens est une pratique courante dans les centres hospitaliers afin de réduire l'utilisation inappropriée des antimicrobiens et le risque de résistance. OBJECTIF: Décrire l'évolution de l'utilisation des antimicrobiens dans un centre hospitalier universitaire de 2015­16 à 2018­19. MÉTHODES: Dans cette étude rétrospective, descriptive et transversale, les dossiers pharmacologiques ont servi à déterminer le nombre de jours de traitement (NJT) et la dose définie journalière (DDD) par 1000 jours-présence (JP) pour chaque antimicrobien et pour chaque unité de soins par année de l'étude. Pour chaque mesure, on a également comparé le ratio de 2018­19 à celui de 2015­16, qui est exprimé en proportion; lorsque la valeur de cette proportion était ≤ 0,8 ou ≥ 1,2, ce qui indiquait un changement important durant la période de l'étude, une note explicative a été attribuée par consensus. RÉSULTATS: Durant la période à l'étude, 94 antimicrobiens ont été disponibles dans notre centre : 70 antibiotiques (dont les antiparasitaires et les antituberculeux), 14 antiviraux et 10 antifongiques. Le nombre total de NJT par 1000 JP a diminué de 904 en 2015­16 à 867 en 2018­19. Les cinq antimicrobiens utilisés le plus fréquemment et présentés en minimum / maximum de NJT par 1000 JP étaient les suivants : piperacilline-tazobactam (78/105), trimethoprim-sulfamethoxazole (74/84), ampicilline (51/69), vancomycine (53/68) et cefotaxime (55/58). Pendant la même période, les unités de soins qui faisaient la plus grande utilisation d'antimirobiens (exprimée en minimum / maximum de NJT par 1000 JP) étaient hématologie-oncologie (2529/2723), pédiatrie (1006/1408) et soins intensifs pédiatriques (1328/1717). CONCLUSIONS: Cette étude démontre une consommation stable d'antimicrobiens entre 2015­16 et 2018­19 dans un centre hospitalier universitaire mère-enfant canadien. Malgré le fait que la consommation entre les groupes d'antimicrobiens (antibiotiques, antiviraux, antifongiques) était stable, on a constaté d'importantes variations concernant certains médicaments individuels. Plusieurs facteurs peuvent expliquer cette variation, notamment des ruptures d'approvisionnement, des changements de pratique et des changements dans la prévalence d'infections. La surveillance de la consommation des antimicrobiens est une partie essentielle de tout programme d'antibiogouvernance.

Providing Suitable Pediatric Formulations for Canadian Children: A Call for Action.

BACKGROUND: Many medications given to children have no commercially available, age-appropriate formulations. This leads to manipulation of dosage forms designed for adults (compounding), which can result in an increased risk of dosing errors and adverse events, lack of medication adherence because of taste issues, and suboptimal dosing with therapeutic failure. OBJECTIVES: To determine which drugs required compounding for oral administration to children in a Canadian hospital and, for each compounded drug, to determine whether it was available as licensed oral pediatric formulations in the United States or the European Union. METHODS: Drugs requiring compounded liquid formulations for oral administration, dispensed from January 1 to December 31, 2015, at a Canadian university-affiliated tertiary pediatric hospital, and prepared in a quantity exceeding 0.5 L per year, were retrospectively identified. The online drug databases of Health Canada, the US Food and Drug Administration, the European Medicines Agency (EMA), and the UK Medicines and Healthcare Products Regulatory Agency were searched to determine the availability of child-friendly oral formulations for these drugs. The regulatory status in each jurisdiction was also compared. For licensed formulations with potential concerns about excipient safety, EMA guidelines for sorbitol, propylene glycol, ethanol, and sodium benzoate were used to determine pediatric suitability. RESULTS: Of the 56 compounded drugs investigated, 27 (48%) had a suitable commercialized child-friendly formulation available outside Canada. Overall, these drugs had been on the Canadian market for a median of 35 years, and almost half (27 [48%]) had a pediatric indication in Canada. CONCLUSIONS: Canada is lagging behind the United States and the European Union in ensuring availability of and access to suitable pediatric formulations. Potential explanations for this gap include small market size, regulatory uncertainties, and reimbursement shortcomings. Steps must be taken to implement pediatric-sensitive regulations and incentives, as well as reimbursement policies, to address these unmet needs.

CONTEXTE: Plusieurs médicaments administrés aux enfants ne sont pas disponibles commercialement sous une forme pharmaceutique adaptée à leur âge. Ceci entraîne une manipulation des formes destinées aux adultes (préparation magistrale) et peut conduire à une augmentation du risque d'erreurs de dosage et d'effets indésirables, un manque d'observance médicamenteuse secondairement à des problèmes de goût, et un dosage sous-optimal associé à des échecs thérapeutiques. OBJECTIFS: Définir les médicaments qui exigent une préparation magistrale pour être administrés par voie orale aux enfants dans un hôpital canadien et, pour chaque médicament faisant l'objet d'une préparation magistrale, déterminer s'il est disponible sous une forme pharmaceutique orale autorisée pour les enfants aux États-Unis ou dans l'Union européene. MÉTHODES: Les médicaments nécessitant des préparations magistrales liquides pour administration orale, distribués entre le 1er janvier et le 31 décembre 2015 dans un hôpital de soins pédiatriques tertiaires affilié à une université canadienne et dont la quantité préparée était supérieure à 0.5 L par an, ont été déterminés rétrospectivement. Les bases de données en ligne de médicaments de Santé Canada, de la Food and Drug Administration américaine, de l'Agence européenne des médicaments (AEM) et de la Medicines and Healthcare Products Regulatory Agency (Royaume-Uni) ont été interrogées pour déterminer la disponibilité de formes pharmaceutiques orales adaptées aux enfants pour ces médicaments. Le statut réglementaire de chaque pays a également fait l'objet d'une comparaison. Pour les formes pharmaceutiques autorisées présentant des problèmes potentiels d'innocuité des excipients, les directives de l'AEM concernant le sorbitol, le propylène glycol, l'éthanol et le benzoate de sodium ont servi à déterminer si un usage pédiatrique était acceptable. RÉSULTATS: Des 56 médicaments étudiés faisant l'objet d'une préparation magistrale, 27 (48 %) avaient une forme pharmaceutique commercialisée adaptée aux enfants en dehors du Canada. Au total, ces médicaments sont sur le marché canadien depuis une médiane de 35 ans et près de la moitié (27 [48 %]) ont une indication pédiatrique au Canada. CONCLUSIONS: Le Canada accuse un retard par rapport aux États-Unis et à l'Union européenne quant à la disponibilité et à l'accès à des formes pharmaceutiques adéquates pour les enfants. La petite taille du marché, les incertitudes en matière réglementaire et les lacunes concernant le remboursement pourraient notamment expliquer cet écart. Il est nécessaire de prendre des mesures pour mettre en place des réglementations et des incitatifs ainsi que des politiques de remboursement axés sur les enfants pour répondre à ces besoins criants.

Detection of serious adverse drug reactions using diagnostic codes in the International Statistical Classification of Diseases and Related Health Problems.

Canadian hospitals are legally required to report serious adverse drug reactions (ADRs). This study aimed to assess the ability to detect serious ADRs from diagnostic codes and the potential benefit of adding stand-alone diagnostic codes to the regular process for detecting serious ADRs. In this descriptive study, clinical pharmacists and a reference work on drug-induced diseases allowed to identify diagnostic codes in the International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Canada (ICD-10-CA), reflecting clinical manifestations related to an ADR. Records for admissions to a large urban mother-child hospital in the fiscal year 2018-2019, as coded by medical archivists, were analysed. Of 69 ICD-10-CA diagnostic codes reflecting an ADR identified, 38 were included in the detailed analysis of patient records and 18 (which appeared in 130 admissions) deemed to indicate a serious ADR. Among the 130 admissions analysed, 70 serious ADRs were identified, of which 52 were previously detected by the regular process and 18 were not, increasing the detection of serious ADRs by 34.6% (18/52). These 18 serious ADRs were newly identified from 11 of the 18 codes reflecting clinical manifestation of a serious ADR. Adding ICD-10-CA diagnostic codes not associated with external cause codes can increase the capacity to detect serious ADRs in hospitals. Over a 12-month period, the use of 11 such diagnostic codes increased the detection capacity for serious ADRs by 34.6%.

Surveillance des substances contrôlées en établissements de santé : une contribution à la gestion de la crise des opioïdes au Canada.

BACKGROUND: The use of controlled substances, especially opioids, is a public health concern. Canada is the country with the second greatest opioid use in the world. The use of these substances is associated with problems of misuse, as evidenced by North America's opioid crisis. OBJECTIVES: To describe and analyze usage patterns for controlled substances in a health care facility from 2003/04 to 2017/18, and to propose a tool for monitoring the use of controlled substances in this setting. METHOD: In this retrospective descriptive study, usage data for all controlled substances were extracted from the institution's supply management software for the period April 1, 2003, to March 31, 2018. The data are presented according to the Anatomical Therapeutic Chemical classification in terms of number of Defined Daily Doses (DDD) per 1000 inpatient-days, using the DDD values proposed by the World Health Organization. Only descriptive statistics were determined. RESULTS: During the last 15 years, use of controlled substances at the study facility dropped by 43% (min. 739 and max. 1292 DDD/1000 inpatient-days per year). From 2003/04 to 2017/18, the main therapeutic classes consumed (in decreasing order) were opioids, hypnotics and sedatives, anxiolytics, and general anesthetics. The main opioid molecules consumed in 2017/18 were hydromorphone and injectable morphine. CONCLUSIONS: This retrospective descriptive study showed a decrease in the consumption of controlled substances in the study facility from 2003/04 to 2017/18. It also demonstrated the feasibility of developing a tool for monitoring the use of controlled substances in a health care facility. This approach could be implemented at a larger scale to foster comparisons between facilities.