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International audience; Objective: Two tools are currently available in the literature to evaluate the usability of medication alert systems, the instrument for evaluating human factors principles in medication-related decision support alerts (I-MeDeSA) and the tool for evaluating medication alerting systems (TEMAS). This study aimed to compare their convergent validity, perceived usability, usefulness, strengths, and weaknesses, as well as users' preferences.Method: To evaluate convergent validity, two experts mapped TEMAS' items against I-MeDeSA's items with respect to the usability dimensions they target. To assess perceived usability, usefulness, strengths, and weaknesses of both tools, staff with expertise in their medication alerting system were asked to use French versions of the TEMAS and I-MeDeSA. After the use of each tool, participants were asked to complete the System Usability Scale (SUS) and answer questions about the understandability and usefulness of each tool. Finally, participants were asked to name their preferred tool. Numeric scores were statistically compared. Free-text responses were analyzed using an inductive approach.Results: Forty-five participants from 10 hospitals took part in the study. In terms of convergent validity, I-MeDeSA focuses more on the usability of the graphical user interface while TEMAS considers a wider range of usability principles. Both tools have a fair level of perceived usability (I-MeDeSA' SUS score = 61.85 and TEMAS' SUS score = 62.87), but results highlight that revisions are necessary to both tools to improve their usability. Participants found TEMAS more useful than I-MeDeSA (t = -3.63, p =.005) and had a clear preference for TEMAS to identify problems in formative evaluation (39 of 45; 0.867, p

Background The use of a ‘do not interrupt’ vest during medication administration rounds is recommended but there have been no controlled randomized studies to evaluate its impact on reducing administration errors. We aimed to evaluate the impact of wearing such a vest on reducing such errors. The secondary objectives were to evaluate the types and potential clinical impact of errors, the association between errors and several risk factors (such as interruptions), and nurses’ experiences. Methods This was a multicenter, cluster, controlled, randomized study (March–July 2017) in 29 adult units (4 hospitals). Data were collected by direct observation by trained observers. All nurses from selected units were informed. A ‘Do not interrupt’ vest was implemented in all units of the experimental group. A poster was placed at the entrance of these units to inform patients and relatives. The main outcome was the administration error rate (number of Opportunities for Error (OE), calculated as one or more errors divided by the Total Opportunities for Error (TOE) and multiplied by 100). Results We enrolled 178 nurses and 1346 patients during 383 medication rounds in 14 units in the experimental group and 15 units in the control group. During the intervention period, the administration error rates were 7.09% (188 OE with at least one error/2653 TOE) for the experimental group and 6.23% (210 OE with at least one error/3373 TOE) for the control group (p = 0.192). Identified risk factors (patient age, nurses’ experience, nurses’ workload, unit exposition, and interruption) were not associated with the error rate. The main error type observed for both groups was wrong dosage-form. Most errors had no clinical impact for the patient and the interruption rates were 15.04% for the experimental group and 20.75% for the control group. Conclusions The intervention vest had no impact on medication administration error or interruption rates. Further studies need to be performed taking into consideration the limitations of our study and other risk factors associated with other interventions, such as nurse’s training and/or a barcode system. Trial registration The PERMIS study protocol (V2–1, 11/04/2017) was approved by institutional review boards and ethics committees (CPP Ile de France number 2016-A00211–50, CNIL 21/03/2017, CCTIRS 11/04/2016). It is registered at ClinicalTrials.gov (registration number: NCT03062852, date of first registration: 23/02/2017).

Objectives A commercial barcode-assisted medication administration (BCMA) system was integrated to secure the medication process and particularly the dispensing stage by technicians and the administration stage with nurses. We aimed to assess the impact of this system on medication dispensing errors and barriers encountered during integration process. Methods We conducted a controlled randomized study in a teaching hospital, during dispensing process at the pharmacy department. Four wards were randomized in the experimental group and control group, with two wards using the system during 3 days with dedicated pharmacy technicians. The system was a closed loop system without information return to the computerized physician order entry system. The two dedicated technicians had a 1-week training session. Observations were performed by one observer among the four potential observers previously trained. The main outcomes assessed were dispensing error rates and the identification of barriers encountered to expose lessons learned from this study. Results There was no difference between the dispensing error rate of the control and experimental groups (7.9% for both, p = 0.927). We identified 10 barriers to pharmacy barcode-assisted system technology deployment. They concerned technical (problems with semantic interoperability interfaces, bad user interface, false errors generated, lack of barcodes), structural (poor integration with local information technology), work force (short staff training period, insufficient workforce), and strategic issues (system performance problems, insufficient budget). Conclusion This study highlights the difficulties encountered in integrating a commercial system in current hospital information systems. Several issues need to be taken into consideration before the integration of a commercial barcode-assisted system in a teaching hospital. In our experience, interoperability of this system with the electronic health record is the key for the success of this process with an entire closed loop system from prescription to administration. BCMA system at the dispensing process remains essential to purchase securing medication administration process.

International audience; Objectives: To evaluate the return on investment (ROI) and quality improvement after implementation of a centralized automated-dispensing system after 8 years of use.Design: Prospective evaluation of ROI; before and after study to evaluate dispensing errors; user satisfaction questionnaire after 8 years of use.Setting: The study was conducted at a French teaching hospital in the pharmacy department, which is equipped with decentralized automated medication cabinets in the wards.Participants: Pharmacy staff (technicians and residents).Intervention(s): Implementation of a centralized automated-dispensing robot.Main outcome measure(s): The true ROI was prospectively and annually compared to estimated returns calculated after implementation and upgrade of the robot; dispensing errors determined by observation of global deliveries and the satisfaction of users based on a validated questionnaire were evaluated.Results: Following the upgrade, we found little difference for the ROI (+1.86%). The payback period increased by almost 3 years. There was a significant reduction of dispensing errors, from 2.9% to 1.7% (P < 0.001). User satisfaction of the robot by the pharmacy staff was reported (score of 5.52 ± 1.20 out of 7).Conclusions: These systems are worthwhile investments and largely contribute to improving the quality and safety of the medication process.

International audience; Objective: To compare the costs and benefits of an automated-drug dispensing cabinet (ADC) versus traditional floor stock storage (TFSS).Design: A quasi-experimental multicenter study conducted during 2015.Setting: A teaching hospital (814 beds) equipped with 43 ADCs and a not-for-profit teaching hospital (643 beds) equipped with 38 TFSS systems, in Paris, France.Participants: All the wards of the two hospitals were included in the study.Intervention(s): ADC versus TFSS.Main outcome measure(s): A composite outcome composed of cost and benefits.Results: The total cost with payback period was substantially higher for the ADCs (574 006€ for 41 ADCs) than TFSS (190 305€ for 30 TFSS systems). The mean number of costly drugs and units were significantly higher for ADCs (P < 0.001). There was no significant difference in the mean number of overall drugs and units. There were significantly fewer urgent global deliveries with ADCs than TFSS units. Nurses' satisfaction with ADCs was high and the prevalence of medication process errors related to ADCs was low. No event due to storage errors was reported for ADCs and nine events were reported for TFSS units. On the contrary, informatic-related events increased with the use of ADCs, as expected.Conclusions: Overall, ADCs are well-established in wards and are particularly appreciated by nurses. A significant difference in the initial investment cost was confirmed, but it must be adjusted over time. This difference is offset in the long-term by gains in preparation time and fewer medication process errors, securing the medication process.

Aims of the study This study assesses clinical interventions by pharmacists prospectively collected from medical and surgical wards, notably the acceptance of interventions, computerised physician order entry (CPOE)related problems, the potential impact of interventions on patient safety evaluated by a multidisciplinary committee, and their evolution over the 10 years since a first assessment. Methods A prospective observational study covering 13 months was conducted in a French teaching hospital with a patient information system that integrates an electronic health record (EHR) with a CPOE. Interventions by pharmacists were prospectively recorded using CPOE. All interventions were reviewed by two pharmacists. We assessed the interventions, the possible implications of the CPOE in prescribing errors, and the acceptance of interventions by physicians. A committee reviewed the potential clinical impact for patients. The results were compared with the same outcomes collected 10 years ago in the same hospital. Results A total of 2141 interventions by pharmacists were reviewed. Among them, 1589 (74.1%) were accepted by physicians. Regarding the potential clinical impact, a total of 1136 (53%) interventions concerned prescriptions that were potentially significant or serious for patients and 42 (2%) of them were potentially life-threatening. Ten years earlier, the acceptance rate was 23%. Moreover, 14.7% of errors were attributed to the use of the software, whereas 10 years earlier the rate of errors was 49%. Conclusions The acceptance rate and frequency of CPOE-related errors were better than 10 years before, which is encouraging and shows the importance of regular training and collaboration with healthcare givers to reduce errors. The routine analysis of interventions by pharmacists with medical staff feedback should continue to improve their relevance and effectiveness.

Background and objectives Serious medication administration errors are common in hospitals. Various interventions, including barcode-based technologies, have been developed to help prevent such errors. This systematic review and this meta-analysis focus on the efficacy of interventions for reducing medication administration errors. The types of error and their gravity were also studied. Methods MEDLINE, EMBASE, the Cochrane Library and reference lists of relevant articles published between January 1975 and August 2014 were searched, without language restriction. Randomized controlled trials, interrupted time-series studies, non-randomized controlled trials and controlled before-and-after studies were included. Studies evaluating interventions for decreasing administration errors based on total opportunity for error method were included. Nurses administering medications to adult or child inpatients were considered eligible as participants. Two reviewers independently assessed studies for eligibility, extracted data and assessed the risk of bias. The main outcome was the error rate without wrong-time errors measured at study level. A random effects model was used to evaluate the effects of interventions on administration errors. Results 5312 records from electronic database searches were identified. Seven studies were included: five were randomized controlled trials (including one crossover trial) and two were non-randomized controlled trials. Interventions were training-related ( n =4; dedicated medication nurses, interactive CD-ROM program, simulation-based learning, pharmacist-led training program), and technology-related ( n =3; computerized prescribing and automated medication dispensing systems). All studies were subject to a high risk of bias, mostly due to a lack of blinding to outcome assessment and a risk of contamination. No difference between the control group and the intervention group was found (OR=0.72 [0.39; 1.34], p =0.3). No fatal error was observed in the three studies evaluating the gravity of errors. Conclusions This review did not find evidence that interventions can effectively decrease administration errors. In addition, most studies had a high risk of bias. More evaluation studies with stronger designs are required.

ObjectivesThe relationship between high dietary sodium intake and hypertension is well established. Some drugs are associated with high-sodium content, particularly effervescent tablets (ETs). Despite a possible cardiovascular risk associated with the use of such drugs, observational data describing exposure to ETs in ambulatory subjects are lacking.This study aims to estimate the prevalence of exposure to ETs and to highlight factors associated with this exposure in a large French health check-up population.DesignThis was a cross-sectional study.Setting and participantsParticipants were French individuals who underwent medical check-ups at the Investigations Préventives et Cliniques centre between April and June 2017.ResultsIn total, 1043 subjects were included in the study. The prevalence of exposure to ETs in the last 30 days was 26.9% (95% CI 24.2% to 29.6%). Exposure was frequent (ie, two ETs per week or more in the last 30 days) for 7.3% of subjects. Self-medication was the major source of exposure (93.8%). Paracetamol, aspirin, vitamins and betaine accounted for 95.3% of the ETs used. The factors associated with this exposure by multivariate analysis were: male gender, Overseas French origin, depression and body mass index ≥25 kg/m2. A diagnosis of hypertension or treatment with diuretics were not protective factors against exposure to ETs.ConclusionExposure to ETs is frequent in the general population, particularly through self-medication. Clinical conditions associated with low-salt requirements were not associated with lower exposure to ETs, suggesting a lack of awareness by practitioners and patients about this iatrogenic issue.

Commentary on: Douglass AM, Elder J, Watson RA, et al . Randomized Controlled Trial on the Effect of a Double Check on the Detection of Medication Errors. Ann Emerg Med . 2018 Jan;71(1):74–82.e1. Administration errors can be caused by prescription mistakes (dose errors) and/or dispensing errors (storage mistakes).1 Several interventions have been developed to reduce medication errors, such as barcode-assisted medication administration (BCMA) systems2 and the double-check. Double-checking requires two qualified health professionals to check the medication. The majority of publications focused on professionals’ beliefs concerning double-check effect. A systematic review published in 2012 …

Introduction A l’initiative de l’equipe pluridisciplinaire (medecins du service d’hepato- gastro-enterologie (HGE) et pharmaciens) de notre etablissement, il est prevu de mettre en place une offre de soin educative a destination des patients du service d’HGE ayant une Maladie Inflammatoire Chronique de l’Intestin (MICI). L’objectif principal de cette enquete etait de faire un recueil des besoins exprimes en education therapeutique (ETP) par les patients atteints d’une MICI et suivis dans notre etablissement en HGE. Ceci correspond a l’etape initiale a la structuration d’un programme d’ETP. Materiels et methode Depuis 2000, le service d’HGE prend en charge une cohorte de 1412 patients ayant une maladie de Crohn et 953 ayant une rectocolite hemorragique. L’enquete regroupait 8 thematiques d’ateliers presentees sous forme de questions structurees en 4 items. Le questionnaire a ete propose aux patients par une externe en pharmacie de fevrier a mars 2018 lors de consultation ou d’hospitalisation de jour en HGE. Resultats et discussion Parmi les 39 patients interroges, 22 etaient des hommes. 56 % (n = 22) etaient interesses pour participer au futur programme d’ETP, 31 % (n = 12) etaient interesses par certains themes. La majorite des patients (57 %, n = 17/39) n’avait pas de preference sur le type de seance (individuelle ou collective), et 30 % (n = 9/39) preferaient les seances collectives. Trois thematiques ont ete jugees comme indispensables : maladie (50 %, n = 13/26), nutrition (46 %, n = 12/26), chirurgie/examen colique (60 %, n = 9/15). Quatre thematiques ont ete majoritairement jugees interessantes : symptomes (59 %, n = 13/22), traitement (81 %, n = 25/31), grossesse (65 %, n = 13/20), vie professionnelle et sociale (60 %, n = 12/20). La thematique du tabac n’a evoque aucun interet chez les patients questionnes. 26 patients (67 %) ont suggere d’autres thematiques. Les plus recurrentes etaient « Se projeter a long terme : maladies annexes et traitement a vie » (42 %, n = 11/26), l’accompagnement psychologique (15 %, n = 4/26), l’avancee de la recherche (15 %, n = 4/26) et la gestion du stress (12 %, n = 3/26). Les attentes particulieres des patients pour ce futur programme ont ete decrites : Apprendre/comprendre (33 %, n = 9/27), les echanges et le collectif (26 %, n = 7/27), trouver du soutien (22 %, n = 6/27). Parmi les 5 jeunes patients ayant d’abord ete suivis a l’hopital pediatrique, la confrontation a l’hopital adulte a ete brutale et destabilisante pour 4 d’entre eux avec pour consequence le sentiment d’etre plus malade et une chute de l’observance. Conclusion Bien que limitee a un seul centre, cette enquete nous a permis de cibler les thematiques prioritaires et d’identifier les enjeux du programme : l’accompagnement du patient des son entree dans le parcours de soin et lors de la transition de l’hopital pediatrique vers l’hopital adulte. Ces resultats seront compares aux resultats de l’enquete des besoins des patients exprimes par les equipes soignantes educatives. Les besoins des patients devront etre reevalues regulierement et le programme adapte aux evolutions des besoins exprimes.

Introduction Des armoires a pharmacie informatisees (API) ont ete implantees dans le but d’optimiser la gestion du medicament et de reduire les erreurs medicamenteuses relatives au picking pour la preparation et l’administration par les infirmiers. En 16 ans, 43 armoires de type Omnicell ® ont ete installees au sein d’un meme hopital. L’objectif de cette etude multicentrique est d’evaluer l’impact en termes de temps passe a la gestion du medicament dans les unites de soins. Materiels et methode Une etude quasi experimentale comparative de type ici-ailleurs a ete menee dans 2 hopitaux universitaires en 2015 ; le premier equipe d’API (800 lits, 43 API) et le deuxieme equipe d’armoires a pharmacie classiques (APC) (600 lits, 37 APC). Seuls les services de soins ayant des durees moyennes de sejour de plus de 24 h, les services d’urgences et les soins intensifs ont ete inclus dans cette etude. Les donnees ont ete extraites avec la meme methodologie dans les logiciels Pharma ® et Omnicell ® . Une journee d’observations chronometrees des reapprovisionnements a ete realisee dans chaque hopital par un interne en pharmacie, et le nombre de demandes urgentes (DU) comptabilise sur une periode de 3 mois. Resultats et discussion Quarante et un API et 30 APC ont ete incluses dans l’etude. Le nombre moyen de reapprovisionnements par armoire et par an est de 99 pour les API et de 54 pour les APC soit, 45 reapprovisionnements pour les API. Le nombre moyen de lignes reapprovisionnees par armoire et par an est de 3174 et 4038 respectivement soit 864 lignes pour les API. Le nombre moyen de lignes par reapprovisionnement pour une API est de 35 et de 54 pour une APC. Le nombre de DU en moyenne par service sur les 3 mois observes est de 57 dans les services equipes d’API et de 167 dans les services equipes d’APC soit 110 DU pour les API. Le temps moyen de reapprovisionnement par ligne est de 1,43 min pour les API et de 1,90 min pour les APC soit 0,47 min par ligne pour les API. Le temps moyen d’un reapprovisionnement est donc de 50 min pour une API et de 102,6 min pour une APC, soit par an et par armoire 4950 min et 5540,4 min respectivement (–590,4 min ou 9,84 heures gagnees pour les API). Conclusion Les API generent plus de reapprovisionnements mais ne mobilisent pas plus de ressources du fait d’une gestion plus rapide de la ligne. De plus, le moindre recourt aux demandes urgentes laissent presager une meilleure adequation aux besoins du service, et donc une meilleure prise en charge medicamenteuse du patient (moins de risque d’omission therapeutique). Ces donnees observationnelles doivent etre repetees afin de consolider ces premiers resultats. Cette etude sera completee par des donnees explorant les aspects economiques, de satisfaction et securitaires de ces armoires.

Objective The main objective of this study was to assess the diagnostic performances of an alert system integrated into the CPOE/EMR system for renally cleared drug dosing control. The generated alerts were compared with the daily routine practice of pharmacists as part of the analysis of medication orders. Materials and methods The pharmacists performed their analysis of medication orders as usual and were not aware of the alert system interventions that were not displayed for the purpose of the study neither to the physician nor to the pharmacist but kept with associate recommendations in a log file. A senior pharmacist analyzed the results of medication order analysis with and without the alert system. The unit of analysis was the drug prescription line. The primary study endpoints were the detection of drug dose prescription errors and inter-rater reliability (Kappa coefficient) between the alert system and the pharmacists in the detection of drug dose error. Results The alert system fired alerts in 8.41% (421/5006) of cases: 5.65% (283/5006) “exceeds max daily dose” alerts and 2.76% (138/5006) “under-dose” alerts. The alert system and the pharmacists showed a relatively poor concordance: 0.106 (CI 95% [0.068–0.144]). According to the senior pharmacist review, the alert system fired more appropriate alerts than pharmacists, and made fewer errors than pharmacists in analyzing drug dose prescriptions: 143 for the alert system and 261 for the pharmacists. Unlike the alert system, most diagnostic errors made by the pharmacists were ‘false negatives’. The pharmacists were not able to analyze a significant number (2097; 25.42%) of drug prescription lines because understaffing. Conclusion This study strongly suggests that an alert system would be complementary to the pharmacists’ activity and contribute to drug prescription safety.

ContextDrug administration in the hospital setting is the last barrier before a possible error reaches the patient.ObjectivesWe aimed to analyze the prevalence and nature of administration error rate detected by the observation method.Data sourcesEmbase, MEDLINE, Cochrane Library from 1966 to December 2011 and reference lists of included studies.Study selectionObservational studies, cross-sectional studies, before-and-after studies, and randomized controlled trials that measured the rate of administration errors in inpatients were included.Data extractionTwo reviewers (senior pharmacists) independently identified studies for inclusion. One reviewer extracted the data; the second reviewer checked the data. The main outcome was the error rate calculated as being the number of errors without wrong time errors divided by the Total Opportunity for Errors (TOE, sum of the total number of doses ordered plus the unordered doses given), and multiplied by 100. For studies that reported it, clinical impact was reclassified into four categories from fatal to minor or no impact. Due to a large heterogeneity, results were expressed as median values (interquartile range, IQR), according to their study design.ResultsAmong 2088 studies, a total of 52 reported TOE. Most of the studies were cross-sectional studies (N=46). The median error rate without wrong time errors for the cross-sectional studies using TOE was 10.5% [IQR: 7.3%-21.7%]. No fatal error was observed and most errors were classified as minor in the 18 studies in which clinical impact was analyzed. We did not find any evidence of publication bias.ConclusionsAdministration errors are frequent among inpatients. The median error rate without wrong time errors for the cross-sectional studies using TOE was about 10%. A standardization of administration error rate using the same denominator (TOE), numerator and types of errors is essential for further publications.

Background Medication errors can occur at any of the three steps of the medication use process: prescribing, dispensing and administration. We aimed to determine the incidence, type and clinical importance of drug administration errors and to identify risk factors. Methods Prospective study based on disguised observation technique in four wards in a teaching hospital in Paris, France (800 beds). A pharmacist accompanied nurses and witnessed the preparation and administration of drugs to all patients during the three drug rounds on each of six days per ward. Main outcomes were number, type and clinical importance of errors and associated risk factors. Drug administration error rate was calculated with and without wrong time errors. Relationship between the occurrence of errors and potential risk factors were investigated using logistic regression models with random effects. Results Twenty-eight nurses caring for 108 patients were observed. Among 1501 opportunities for error, 415 administrations (430 errors) with one or more errors were detected (27.6%). There were 312 wrong time errors, ten simultaneously with another type of error, resulting in an error rate without wrong time error of 7.5% (113/1501). The most frequently administered drugs were the cardiovascular drugs (425/1501, 28.3%). The highest risks of error in a drug administration were for dermatological drugs. No potentially life-threatening errors were witnessed and 6% of errors were classified as having a serious or significant impact on patients (mainly omission). In multivariate analysis, the occurrence of errors was associated with drug administration route, drug classification (ATC) and the number of patient under the nurse's care. Conclusion Medication administration errors are frequent. The identification of its determinants helps to undertake designed interventions.

Background Explicit criteria for determining potentially inappropriate medication consumption in elderly were elaborated by Beers et al. These lists have been used worldwide to evaluate medical prescriptions but there is little epidemiologic evidence demonstrating negative consequences of inappropriate medication use. It has been reported that some drugs could increase the risk of falls, which are a frequent and serious problem in elderly population. We aimed to evaluate the association between the use of potentially inappropriate medications and the risk of falls. Methods The 3C Study is a multicentre prospective cohort study conducted in France with 4 years of follow-up. Non-institutionalized men and women aged 65 years or over (N = 6343) were randomly selected from electoral rolls. Data on socio-demographic, medical characteristics and medication use (based on self-reports and data from the national healthcare insurance) were collected. Use of inappropriate medication for elderly was defined from established criteria. Data about falls were collected at the two follow-up examinations (2 years and 4 years after baseline). The association between the exposure to inappropriate medications and the risk of falls was evaluated using multivariate models (Cox model and logistic regression). Results 32% of subjects reported inappropriate medication use at baseline and 29% at least two of the three examinations; 22% had fallen 2 times or more during follow-up. Overall, inappropriate medication users had an increased risk of falling. This increase was mainly due to the use of long-acting benzodiazepines (adjusted odds ratio (OR) = 1.4, 95% confidence interval: [1.1–1.8], in both occasional and regular users), other inappropriate psychotropics (adjusted OR = 1.7 [1.7–2.7] in regular users), or medication with anticholinergic properties (adjusted OR = 1.6 [1.2–2.1] in regular users). Neither occasional, nor regular use of short- or intermediate-acting benzodiazepines was associated with an increased risk of falling. Further analysis in long-acting benzodiazepines users did not show any dose-effect relation between the number of prescriptions filled over a 3-year period and the risk of falling. Conclusion Our study showed that use of inappropriate medications was associated with an increased risk of falling in elderly persons. This increase was mainly due to long-acting benzodiazepines and other inappropriate psychotropics, and to medications with anticholinergic properties.