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.

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.

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.

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.

Compliance with Recommended Practices for Management of Controlled Substances in a Health Care Facility and Corrective Actions.

BACKGROUND: Pharmacists are required to maintain a secure inventory of medications and to ensure proper, safe, and diversion-free dispensing practices. OBJECTIVES: The primary objectives of this study were to determine compliance with recommended practices for the management of controlled substances in a mother-child teaching hospital and to identify actions to improve compliance. The secondary objective was to identify steps in the drug pathway for controlled substances and associated failure modes in the study hospital. METHODS: This descriptive cross-sectional study used a framework developed by the California Hospital Association (CHA) to assess compliance with recommended practices for the management of controlled substances in hospitals. For each criterion, a research assistant observed practices within the pharmacy, on patient care units, at outpatient care clinics, and in operating and delivery rooms. The level of compliance was recorded as compliant, partially compliant, or noncompliant. An Ishikawa diagram was developed to illustrate steps in the drug pathway and associated failure modes related to the use of controlled substances in the study hospital. RESULTS: The pathway for controlled substances at the study hospital was compliant for 56 (49.6%) of the 113 CHA criteria, partially compliant for 27 (23.9%) of the criteria, and noncompliant for 24 (21.2%) of the criteria; the remaining 6 (5.3%) criteria were not applicable. This practice evaluation highlighted 22 corrective actions, 12 (55%) that could be implemented in the short term, 8 (36%) suitable for implementation in the medium term, and 2 (9%) suitable for both the short and medium term. A total of 57 potential failure modes related to the use of controlled substances were identified. CONCLUSIONS: The pathway for controlled substances at the study hospital was compliant with almost half of the CHA criteria, and 22 corrective actions were identified. Pharmacists, physicians, and nurses should be mobilized to optimize the use of controlled substances throughout the drug-use process.

CONTEXTE: Les pharmaciens sont responsables de maintenir à jour les réserves de médicaments et doivent faire en sorte que les pratiques de distribution soient adéquates, sûres et exemptes de détournement. OBJECTIFS: Les objectifs principaux de la présente étude consistaient à déterminer le degré de conformité aux pratiques de gestion des substances contrôlées, recommandées dans un hôpital universitaire mère-enfant, et de trouver des mesures pour améliorer leur degré de conformité. L'objectif secondaire visait à recenser les étapes que suivent les substances contrôlées dans le circuit des médicaments et les modes de défaillance qui y sont associés dans l'hôpital à l'étude. MÉTHODES: La présente étude descriptive et transversale s'appuyait sur un cadre mis au point par la California Hospital Association (CHA), qui sert à évaluer le degré de conformité aux recommandations relatives aux pratiques de gestion des substances contrôlées dans les hôpitaux. Pour chaque critère, un assistant de recherche observait les pratiques dans le service de pharmacie, les unités de soins, les cliniques de consultation externe et les salles d'opération ou les salles d'accouchement. Il évaluait le degré de conformité à l'aide d'un des qualificatifs suivants : conforme, partiellement conforme ou non conforme. Un diagramme d'Ishikawa a été conçu pour illustrer les étapes du circuit des médicaments et les modes de défaillance associés à l'utilisation de substances contrôlées dans l'hôpital à l'étude. RÉSULTATS: Le circuit des substances contrôlées à l'hôpital où se déroulait l'étude était conforme à 56 (49,6 %) des 113 critères de la CHA, partiellement conforme à 27 (23,9 %) critères et non conforme à 24 (21,2 %) critères; les 6 (5,3 %) critères restants n'étaient pas applicables. Cette évaluation des pratiques a mis en évidence 22 actions correctives, dont 12 (55 %) pouvaient être mises en place à court terme, 8 (36 %) à moyen terme et 2 (9 %) à court ou à moyen terme. Les investigateurs ont repéré 57 modes de défaillance potentiels liés à l'utilisation de substances contrôlées. CONCLUSIONS: L'analyse du circuit des substances contrôlées à l'hôpital où se déroulait l'étude a révélé que près de la moitié des critères de la CHA étaient conformes, et 22 actions correctives ont été proposées. Les pharmaciens, médecins et infirmières devraient participer à l'optimisation de l'utilisation des substances contrôlées dans l'ensemble du processus de distribution des médicaments.

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.

The Impact of Phone Interruptions on the Quality of Simulated Medication Order Validation Using Eye Tracking: A Pilot Study.

INTRODUCTION: Order validation is an important component of pharmacy services, where pharmacists review orders with a focus on error prevention. Interruptions are frequent and may contribute to a reduction in error detection, thus potential medication errors. However, studying such errors in practice is difficult. Simulation has potential to study these events. METHODS: This was a pilot, simulation study. The primary objective was to determine the rate of medication error detection and the effect of interruptions on error detection during simulated validation. Secondary objectives included determining time to complete each prescription page. The scenario consisted of validating three handwritten medication order pages containing 12 orders and 17 errors, interrupted by three phone calls timed during one order for each page. Participants were categorized in groups: seniors and juniors (including residents). Simulation sessions were videotaped and eye tracking was used to assist in analysis. RESULTS: Eight senior and five junior pharmacists were included in the analysis. There was a significant association between interruption and error detection (odds ratio = 0.149, 95% confidence interval = 0.042-0.525, P = 0.005). This association did not vary significantly between groups (P = 0.832). Juniors took more time to validate the first page (10 minutes 56 seconds vs. 6 minutes 42 seconds) but detected more errors (95% vs. 69%). However, all major errors were detected by all participants. CONCLUSIONS: We observed an association between phone interruptions and a decrease in error detection during simulated validation. Simulation provides an opportunity to study order validation by pharmacists and may be a valuable teaching tool for pharmacists and pharmacy residents learning order validation.

Failure Mode, Effect, and Criticality Analysis of the Parenteral Nutrition Process in a Mother-Child Hospital: The AMELIORE Study.

BACKGROUND: The parenteral nutrition (PN) process is complex and involves multiple steps and substeps, especially in pediatrics and neonatology, given the particular needs of these patients. The objective of this study was to perform a critical analysis of the PN process at the Centre Hospitalier Universitaire Sainte-Justine to determine which potential pitfalls are related to this process and which should be prioritized when implementing corrective measures. METHODS: This is a Failure Mode, Effect, and Criticality Analysis (FMECA) study. A multidisciplinary team assessed each step of the PN process and identified associated failure modes. Adapted rating scales were used to determine severity, frequency, and detectability of the failure modes. Ratings were established through multidisplinary consensus, and a criticality index (CI) was calculated for each failure mode. RESULTS: A total of 265 failure modes were identified in the 5 major steps of the PN process. The failure mode with the highest CI was the inscription of an inaccurate weight at prescription, with a CI of 800. The step with the highest cumulative CIs was administration to patients, with a CI sum of 7691. Various recommendations aimed at minimizing the risks associated with the PN process were made following this FMECA. Additional interventions are expected to emanate from this project because data will be presented throughout the departments involved. CONCLUSION: This study is a successful example for other hospitals interested in carrying out the same kind of healthcare improvement initiative.

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.

Parenteral nutrition-associated liver disease: a retrospective study of ursodeoxycholic Acid use in neonates.

OBJECTIVES: To verify the effect of ursodeoxycholic acid (UDCA) on the duration of neonatal parenteral nutrition-associated liver disease. METHODS: Retrospective cohort study of neonates in intensive care between 2004 and 2007 presenting with parenteral nutrition-associated liver disease. RESULTS: Of 118 eligible infants, 64 received UDCA. Cholestasis lasted longer in the UDCA group (79 vs. 50 days, p=0.001). However, treatment was delayed for a median of 24 days after cholestasis onset. Multivariate Cox regression analysis showed no association between UDCA and cholestasis duration. The rate of decline of conjugated bilirubin was greater in treated patients (median 0.084 mg/dL/day vs. 0.60 mg/dL/day; p=0.009) and weight gain was greater (22.8 vs. 17.7 g/kg/day, p=0.010). CONCLUSIONS: UDCA therapy was not associated with the duration of parenteral nutrition-associated liver disease. A delay in treatment initiation might explain this result. UDCA therapy was associated with a faster decline of conjugated bilirubin and greater weight gain.

Short bowel syndrome in infants: the critical role of luminal nutrients in a management program.

Short bowel syndrome develops when the remnant mass of functioning enterocytes following massive resections cannot support growth or maintain fluid-electrolyte balance and requires parenteral nutrition. Resection itself stimulates the intestine's inherent ability to adapt morphologically and functionally. The capacity to change is very much related to the high turnover rate of enterocytes and is mediated by several signals; these signals are mediated in large part by enteral nutrition. Early initiation of enteral feeding, close clinical monitoring, and ongoing assessment of intestinal adaptation are key to the prevention of irreversible intestinal failure. The length of the functional small bowel remnant is the most important variable affecting outcome. The major objective of intestinal rehabilitation programs is to achieve early oral nutritional autonomy while maintaining normal growth and nutrition status and minimizing total parenteral nutrition related comorbidities such as chronic progressive liver disease. Remarkable progress has been made in terms of survivability and quality of life, especially in the context of coordinated multidisciplinary programs, but much work remains to be done.

Malnutrition in hospitalized children: prevalence, impact, and management.

PURPOSE: Malnutrition in hospitalized children has been reported since the late 1970s. The prevalence of acute and chronic malnutrition was examined in hospitalized patients in a general pediatric unit, and the impact and management of malnutrition were assessed. METHODS: The nutritional risk score (NRS) and nutritional status (NS) (weight, height, body mass index, and skinfold thickness) of children aged zero to 18 years were assessed upon hospital admission. Growth and energy intake were monitored every three days until discharge. RESULTS: A total of 173 children (median age three years, 88 girls) participated; 79.8% had a moderate to severe NRS and 13.3% were acutely and/or chronically malnourished. A high NRS was associated with a longer hospital stay in children older than three years (P<0.05), while a poor NS (weight for height percentile) was correlated with prolonged hospitalization in children aged three years or younger (P<0.05). Although weight did not change during hospitalization, a decrease in skinfolds was documented (n=43, P<0.05). Patients with a high NRS had lower energy intake than those not at risk. However, children with abnormal NS received 92.5% of recommended energy intake. CONCLUSIONS: This study suggests that all children admitted to hospital should have an evaluation of their NRS and NS, so that they can receive appropriate nutrition interventions provided by a multidisciplinary nutrition team.

Automated compounding of parenteral nutrition for pediatric patients: characterization of workload and costs.

OBJECTIVES: Parenteral nutrition (PN) compounding in large hospital centers is now largely automated using volumetric pump systems. No study has examined the pharmacy workload and costs associated with this process. This study was designed to characterize these elements at our center and to identify areas for potential improvement. METHODS: We retrospectively analyzed all PN orders compounded from May 19, 2007, to June 25, 2010. Patients were divided into groups according to the ward where PN was initiated. RESULTS: The age and weight of patients at initiation of PN were similar throughout the study, except in neonatology, where initiation now occurs earlier in life (age 1.3 ± 2.7 days in 2010 vs. 3.4 ± 9.4 in 2007; p=0.003). An average of 894 orders per month were compounded. A total of 59% of orders were for neonatal patients. The average cost of source solutions per PN order increased from Can$23.27 in 2007 to Can$37.78 in 2010. Partially used source solutions discarded at the end of the day represented between 7.7% and 9.2% of total source solution cost. Amino acids in 3-L bags were responsible for the largest waste, with Can$953 to Can$1048 wasted monthly. CONCLUSIONS: PN compounding at our center represents an important workload and increasing costs. A reduction in source solution waste, for example, by reducing the use of large source solution containers, would be beneficial.

Conformity of commercial oral single solid unit dose packages in hospital pharmacy practice.

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.

Craniotomy site influences postoperative pain following neurosurgical procedures: a retrospective study.

OBJECTIVE: This retrospective study was designed to assess the intensity of postoperative pain in relation to the location of craniotomy. METHODS: After Research Ethics Board approval, data were collected from the charts of all patients who underwent a craniotomy at our institution between January 2004 and December 2005. The severity of post-craniotomy pain was assessed by collecting scores obtained using an 11-point verbal rating scale and calculating the cumulative analgesic requirements for the first 48 hr postoperatively. Data were compared according to the craniotomy location. RESULTS: Data from 299 patients was available for analysis. On average, 76% of patients experienced moderate to severe postoperative pain. Frontal craniotomy was associated with lower pain scores than four of six craniotomy sites analyzed, with 49% of patients reporting mild pain, a significant difference (P < 0.05) compared with all other groups except for parietal craniotomies. Frontal craniotomy patients also had lower opioid analgesic requirements compared to patients who underwent posterior fossa craniotomy (P < 0.05). Logistic regression analysis showed that craniotomy location (P < 0.0001) and age (P = 0.004) were both independent predictors of the intensity of postoperative pain, with lower pain scores as age increased. Postoperative use of steroids, gender and presence of preoperative pain were not statistically linked to postoperative pain intensity. The prevalence of postoperative nausea and vomiting was 56% and it did not vary according to the location of craniotomy. CONCLUSION: This study shows that the intensity of postoperative pain in neurosurgery is affected by the site of craniotomy. Frontal craniotomy patients experienced the lowest pain scores, and required significantly less opioid than patients undergoing posterior fossa interventions.