Background and importance We developed a clinical decision support system (CDSS) to monitor high-risk situations related to drugs from electronic health records. It involves clinical rules (CR) that trigger alerts to clinical pharmacists based on drug prescriptions, laboratory values, vital signs, and medical problems (eg, vitamin K antagonists + international normalised ratio (INR) ≥4). Aim and objectives We describe a methodology to select CR to extend our approach to the paediatric department. Material and methods CR were identified with a literature review and scored by 14 senior physicians (expert) divided in two groups (A: general/specialised paediatrics; B: neonatology/intensive care) for two criteria: criticality (low, moderate, high, extreme—risk); relevance (no, need to be adapted to be, highly, very—relevant). The pharmacist in charge of CDSS scored CR technical feasibility (no, hardly, easily, very easily—feasible). 'Very relevant' and 'easily feasible' CR were retained if average criticality score was 'high' when applicable for different specialties (assessed by numerous experts) or 'extreme' when applicable for a specific specialty (assessed by only one expert). Results Fifty-six CR potentially relevant for children were selected from the literature and divided into five risk classes: drug contraindicated (34%), medication and abnormal laboratory value (27%), drug–drug interaction (19%), inadequate administration mode (11%) and prescription omission (9%). Twenty-four CR were retained after expert assessment, 8 (33.3%) concerned both groups, 14 (58.3%) were specific for group A and 2 (8.3%) for group B. The three most critical CR involved prescribing potassium and hyperkalaemia, glucose-lowering drugs and hypoglycaemia, and vancomycin not adjusted to renal function. Development in CDSS was assessed as 'very easily' feasible for 5 CR (21%) including 3 CR (12.5%) concerning both groups. Conclusion and relevance We identified 24 CR in five risk classes that could be monitored using our CDSS. Assessment based on expert opinion according to risk (criticality), clinical practice (relevance) and technical consideration (feasibility) allowed CR prioritisation to be developed. One-fifth of CR would be immediately implementable with some likely to cover the entire paediatric department since they are common to both groups. A pilot study using these CR will assess the workload associated with this new practice. References and/or acknowledgements 1. Fox et al. BJCP 2016. Conflict of interest No conflict of interest
Background and importance A robotised system was acquired to automate part of the chemotherapy production. Continuous training of operators is a challenge and we observed an increase of disparity in operators' knowledge over time. Less trained operators became reluctant to use the system. Aim and objectives To create a short, playful, standardised and sustainable training on the robot and to evaluate its impact on our operators. Material and methods The Kern cycle was used to set up the training created with LearningDesigner software. Participants answered a survey on their knowledge about technology. Knowledge about the robot was assessed by a 0-to-24 scale questionnaire. Operators were classified as mentor or apprentice. Motivation and confidence were recorded on 0-to-100 scales. These three criteria were also assessed after the training and after 6 months. Satisfaction was collected on a six-point Likert scale. Results Three games were created for a 1 hour 30 min training with pairs of players. (1) Game 'knowing the manufacturing steps': the 16 steps of the process were printed on cards to put back in the right order. (2) Game 'knowing the criteria for using a molecule with the robot': fake Pokémon cards presenting a molecule and its specificities (stability, viscosity, usual dosage, etc.) were created. Teams should guess if the molecule can be used with the robot and why. (3) Game 'knowing how to handle errors during production': inspired by the 'Who Wants to Be a Millionaire?' TV show. Four answers were suggested, issued from real-life problems. A debriefing followed every game. Seven mentor/apprentice teams participated. Participants strongly agreed that objectives, structure and subject were appropriate (80%), playful and interactive (83%). Table a presents the results (p is for before/after or before/6 months. ns, non-significant). Conclusion and relevance For this complex tool, we created a short and playful training appreciated by operators. We showed an improvement of knowledge with a remembrance until 6 months. Confidence and motivation slightly decreased over time, highlighting the importance of adding a coaching during daily practice. References and/or acknowledgements Conflict of interest No conflict of interest
The goal of this study was to develop a method for the simultaneous quantification of 23 commonly used antineoplastic drugs in a hospital pharmacy, using ultra-high pressure liquid chromatography separation coupled to tandem mass spectrometry detection (UHPLC-MS/MS). The following drugs were investigated: 5-fluorouracil, cytarabine, ganciclovir, gemcitabine, dacarbazine, methotrexate, pemetrexed, busulfan, topotecan, rentitrexed, ifosfamide, cyclophosphamide, etoposide, irinotecan, doxorubicin/epirubicin, vincristine, docetaxel, paclitaxel, daunorubicin, idarubicin, vinblastine, oxaliplatin and carboplatin. The chromatographic separation was performed on a phenyl-hexyl column (2.1 x100 mm, 1.7 mu m) with a gradient elution of methanol and water containing 10 mM ammonium formate adjusted to pH 4.9. All compounds were analyzed in less than 13 min and detected with a triple quadrupole mass spectrometer operating in MRM mode. Limits of detection (LODs) and limits of quantification (LOQs) were comprised between 0.01 and 5 ng.mL(-1), and between 0.5 and 5 ng.mL(-1), respectively. Accuracies ranged between 117% and 83% at the LOQ, intermediate and upper LOQ concentrations, with relative standard deviations (RSD) inferior to 8%, for all the antineoplastic drugs. Finally, the UHPLCMS/MS method was successfully applied to the analysis of surface samples to evaluate the chemical contamination by these highly toxic compounds in a chemotherapy preparation unit in a hospital pharmacy with the purpose of monitoring the exposure of health care professionals.
A case of alpha chain disease, involving the stomach only, is reported in an Algerian man suffering from epigastric pains. Upper digestive tract fibreoptic endoscopy showed two antral ulcers and an ulcerative gastritis pattern, which promptly disappeared with cimetidine treatment. Antral biopsies at a distance from the ulcers, but not of the ulcer crater itself, disclosed a dense infiltration of antral lamina propria by mature or sometimes atypical plasma cells. On transmural surgical antral biopsy, the infiltrate spread to the superficial part of the submucosa. No other localisation of the disease was found in spite of multiple biopsies obtained by endoscopy, with a peroral capsule and during staging laparotomy. The alpha chain disease protein was absent from serum and urine, but found in the gastric juice and in the cytoplasma of the cellular infiltrate (alpha 1 subclass). A complete clinical, endoscopic, histological and immunological remission was observed after a six months9 course of oral tetracycline.
Background and importance In the internal medicine department of our hospital, medication review provided by pharmacists during medical rounds is offered to only a fraction of the 200 inpatients, due to limited resources. In order to detect high risk situations potentially leading to adverse drug events, we developed PharmaCheck, an electronic tool that screens all patient electronic health records (EHR) in real time, by aggregating drug prescriptions, laboratory values, vital signs and medical problems. Aim and objectives To determine the impact of PharmaCheck in the identification of high risk situations and on the clinical pharmacist's interventions. Material and methods PharmaCheck was set to screen 20 situations distributed into four risk classes: a drug prescription with an abnormal laboratory value, a contraindication, a drug–drug interaction (DDI) and an inadequate administration mode. For 150 days (February to August 2020), PharmaCheck performed a daily screen of patients' EHR, admitted to the internal medicine department. As soon as an alert was triggered, the clinical pharmacist analysed the patient's clinical context to suggest a treatment adjustment when needed. An observational prospective study was performed to assess the distribution of each risk class, the predictive positive value of each alert (PPV: proportion of situations associated with an intervention) as well as the acceptance rate by the prescribers. Results 430 alerts were triggered for 387 patients (3.3±1.9 alerts/day) with a global PPVof 19.3% (n=83/430). Regarding risk classes, PPVs were 25.6% (n=58/226) for abnormal laboratory value, 3.10% (4/127) for contraindications, 28.2% (20/71) for DDIs and 16.7% (1/6) for inadequate administration mode. The approval rate of treatment adjustment suggestions was 71.1% (n=59/83); rejections were related to an acceptable risk–benefit balance (n=20) or an unknown cause (n=4). Conclusion and relevance PharmaCheck identified a significant number of high risk situations. By contextualising these alerts the clinical pharmacist selected the most relevant ones to suggest treatment adjustment, mostly accepted by physicians. Beyond the clinical context, the relevance of alerts depends on the informative quality of the triggering elements, explaining a low PPV for some risk classes (eg, contraindication, depending on unstructured textual medical problems). PharmaCheck expands the coverage of the clinical pharmacist for selected situations and we plan to transpose this strategy to other, more fragile, patient populations (eg, geriatrics, paediatrics, oncology). References and/or acknowledgements Conflict of interest No conflict of interest
Background Several decontamination methods are currently available to reduce the occupational exposure of hospital facilities to conventional anti-neoplastic drugs. Alcohol-based microbicides are not sufficiently efficient in removing chemical contamination and data are lacking on many marketed biocides. Recent data confirm that using a specific chemical decontamination solution is helpful in removing traces of contaminants. Purpose To perform a literature review in order to help pharmacists in choosing a chemical decontamination solution to implement in their compounding unit. Material and methods Articles were searched on Pubmed using the following requests: 'antineoplastic agents AND cleaning' or 'antineoplastic agents AND chemical degradation' or 'antineoplastic agents AND chemical decontamination'. Criteria used to classify the performance and usability of decontamination solutions were: decontamination efficiency, number and nature of tested contaminants, hazardousness of the decontamination solution, implementation difficulties and respect of the aseptic environment. Results Two-hundred and seventy-four articles were retrieved following the request application. Two-hundred and fifty-seven articles were discarded for different reasons leading to the analysis of 17 articles. Fifty-nine methods were tested as degradation (n=19) or desorption methods (n=40) with various decontamination efficiencies ranging from ≤10% to 100%. Applying the selection criteria, three decontamination solutions were chosen: sodium hypochlorite, admixture of 10-2 M sodium dodecyl sulfate (SDS) and 70% isopropanol (80/20), marketed two steps towelettes kit (1. Quaternary ammonium solution, 2. Isopropanol). Their inertness to facilities' surfaces is different and sodium hypochlorite solutions oxide metals. Solutions involving tension-active agents such as SDS may form a film on the facilities surface, which may alter the sterility environment. Conclusion The applied selection criteria led to select only three decontamination solutions. Their application modalities are also to be discussed regarding the biological and chemical facilities' monitoring. As the solutions were assessed with various methodologies, further studies are necessary to compare them in the same conditions. Because each solution has been tested with different contaminants, new studies are required to confirm their ability to decontaminate other conventional anti-neoplastic drugs. References and/or acknowledgements Vasseur, et al. EJHP 2017;24(Suppl 1):A218. doi:10.1136/ejhpharm-2017–000640.485 Vasseur, et al. PLos One 2018. No conflict of interest.
Expérimental/mécanismes cellulaires et moléculaires. Les guidelines de l’ESPGHAN/ESPEN/ESPR sur la nutrition parentérale pédiatrique (NPP) recommandent l’administration de la cystéine aux enfants prématurés. Le besoin de cet acide aminé (AA) semi-essentiel est dû à l’immaturité biochimique de ces patients qui résulte dans l’incapacité de synthétiser de la cystéine endogène depuis la méthionine et la sérine. Le précurseur soluble N-acétyle-cystéine (NAC) permet de supplémenter la NPP avec de la cystéine car il est facilement fractionné en sa forme biodisponible. Mais il peut aussi s’oxyder en son dimer N,N-diacétyle-cystine (DAC) durant le processus de fabrication. Les buts de cette étude sont la compréhension du processus de dégradation de la NAC en DAC et ses déclencheurs et l’évaluation de la criticité et la concentration limite de la DAC dans des NPP. Des solutions d’AA contenant la NAC ont été passées à l’autoclave après avoir injecté différents volumes d’air (2, 8, 16 mL) dans l’espace de tête primaire. Une partie des échantillons contenaient des absorbeurs d’oxygène dans l’emballage secondaire. Les concentrations d’oxygène ont été mesurées dans la solution et dans les espaces de tête des emballages primaires et secondaires à des intervalles de temps différents (0, 7, 13, 45 jours). Aux mêmes intervalles, les concentrations de DAC ont été analysées par HPLC. Les bilans molaires démontrent que la NAC se dégrade exclusivement en DAC. Les concentrations de DAC augmentent considérablement dans les échantillons sans absorbeur d’oxygène. Dans ce cas, après 45 jours, aucune stabilisation de la dégradation de NAC n’a pu être observée car le taux d’oxygène est saturé aux trois points de mesure (solution et espaces de tête primaire et secondaire). Dans les échantillons avec absorbeurs, les taux d’oxygène sont drastiquement réduits aux trois points de mesure. La durée nécessaire pour absorber tout l’oxygène dépend du volume d’air initialement présent. Les concentrations de DAC augmentent en fonction des taux d’oxygène dans la solution et l’espace de tête primaire. Tout d’abord, il faut noter qu’à notre connaissance, il n’y a aucune publication dans la littérature ni sur les mécanismes de cette dégradation, ni sur la toxicité de DAC dans les NPP. Les analyses réalisées confirment une corrélation entre la concentration d’oxygène et la dégradation de NAC en DAC en fonction du temps permettant ainsi d’établir des cinétiques de formation de la DAC. Il est nécessaire de limiter la quantité d’oxygène en contact avec la NAC dans le cas d’emballages semi perméables. L’utilisation d’absorbeurs d’oxygène est un moyen efficace de réduire le taux de l’oxygène dans la solution et les espaces de tête des emballages primaires et secondaires. Il n’y a pas d’évidence de non-sécurité et/ou toxicité de la DAC dans les NPP. D’autres recherches sur les effets de la DAC par voie veineuse sur l’être humain sont nécessaires.
Background Hospital pharmacy preparedness to support activities overload in case of emergency and disaster situations is increasingly needed even in relatively safe developed countries. In 2016, the International Pharmaceutical Federation (FIP) published guidelines to help pharmacists to prepare and respond to natural disasters.1 Purpose To review how European hospital pharmacies are prepared for disasters in compliance with the FIP guidelines. Material and methods An electronic survey (SurveyMonkey) based on the FIP guidelines was conducted with the support of the European Association of Hospital Pharmacists in European hospital pharmacies. Some additional questions were added to improve the general knowledge on disaster preparedness in our continent. Descriptive statistics were used to analyse the results. Results Three-hundred and seven surveys were completed in 28 countries. France (20%) and Spain (19%) were the countries with the highest numbers of answers. Half of the responders analysed their regional disaster’s risk but 65% of responders never practised emergency drills. Fifteen per cent of pharmacies have experienced at least one major event in the past 5 years. Fifty-six per cent of those pharmacies created and promoted internal guidelines for impending emergency versus 23% for those who have not experienced disasters. Among pharmacies having experienced disaster, 70% judged their emergency procedures appropriate for the needs of such situations and 40% organised post-disaster debriefing to improve their future response. Conclusion These results highlight that most European hospital pharmacies are not fully compliant with the FIP guidelines. However, the pharmacies having experienced disaster are more likely to create and promote internal disaster standard operating procedures. Further analysis and benchmarking are warranted worldwide, as well as promotion of the FIP guidelines. Reference and/or acknowledgements International Pharmaceutical Federation (FIP). Responding to Disaster: Guidelines for Pharmacy 2016. The Hague: International Pharmaceutical Federation. 2016. No conflict of interest.
L’exercice de la pharmacie est en pleine évolution et son contexte législatif doit être constamment adapté. Étude descriptive qualitative et transversale. L’objectif principal est de comparer et de discuter des similitudes et des différences entre les dispositions législatives encadrant les activités réservées au pharmacien dans la francophonie. L’étude cible quatre environnements juridiques francophones : le Canada (Québec) sachant que le droit professionnel est de compétence provinciale, la France, la Suisse (le canton de Genève), sachant que le droit professionnel varie d’un canton à l’autre et la Belgique. Un panel d’experts est formé. À partir de la liste définitive des activités réservées élaborée par le panel d’experts, nous avons établi un portrait du cadre juridique applicable à l’exercice de la pharmacie. Le nombre d’activités réservées autorisées par entité juridique est respectivement de 21 pour le Canada (Québec), de 20 pour la France, 17 pour la Suisse et de 17 pour la Belgique. Quatorze des 24 activités recensées sont également partagées dans les quatre juridictions ; trois des 24 activités sont partagées entre trois juridictions ; quatre des 24 activités sont partagées entre deux juridictions et deux activités ne sont accessibles qu’à une juridiction ; une seule activité réservée est interdite aux pharmaciens pour le moment. Cette étude présente une démarche originale comparant les activités réservées au pharmacien au Canada (Québec), en France, en Suisse (Genève) et en Belgique. Ces données illustrent l’élargissement progressif du rôle du pharmacien pour permettre une pleine utilisation de son expertise et de ses compétences afin d’assurer des services et soins pharmaceutiques de qualité aux patients de chaque entité juridique. Il existe des similitudes et des différences entre les activités réservées aux pharmaciens. The practice of pharmacy is evolving and its legal frame must adapt. Qualitative and cross-sectional descriptive study. The main objective is to compare and discuss the similarities and differences between the legislative provisions governing activities reserved to pharmacists in the francophonie. The study targets four French legal environments: Canada (Quebec), knowing that the professional law falls under provincial jurisdiction, France, Switzerland (the canton of Geneva), knowing that the professional law varies from one canton to another, and Belgium. A panel of experts was formed. From the definitive list of reserved activities established by the panel of experts, we have drawn a portrait of the legal framework applicable to the practice of pharmacy. The number of reserved activities authorized per legal entity is respectively 21 for Canada (Quebec), 20 for France, 17 for Switzerland and 17 for Belgium. Fourteen of the 24 identified activities are also shared across the four jurisdictions; three of the 24 activities are shared among three jurisdictions; four of the 24 activities are shared between two jurisdictions and two activities are only accessible to one jurisdiction; only one reserved activity is prohibited for pharmacists at the moment. This study presents an original approach comparing activities reserved to pharmacists in Canada (Quebec), France, Switzerland (Geneva) and Belgium. This data illustrates the gradual expansion of the pharmacist's role allowing full use of his expertise and skills to provide quality pharmaceutical services and care to patients in each legal entity. There are similarities and differences between the activities reserved to pharmacists.
Aim: Epidemiological data on the incidence and risk factors of extravasation of peripheral intravenous catheters (PIVC) in neonates and children are scarce and that is what this study explored. Methods: This was a one-year retrospective study of all neonates and paediatric intensive care patients with at least one recorded PIVC at the Geneva University Hospitals, Switzerland, in 2013. The extravasation rate was determined for all patients, including neonates below 28 days, and for all PIVCs. Multivariate analysis of the associated risk factors was performed. Results: We analysed 1300 PIVC in 695 paediatric patients with a median age of 1.5 years. The overall extravasation incidence was 17.6% for all patients and 11.7% for PIVC. The overall incidence rate of PIVC extravasation was 4.5 per 100 catheters days, and the risk was highest in the 201 neonates, at 28.4%. The incidence rate four days after insertion of the PIVC was around three times higher than on day one. Neonates and the in situ duration of PIVCs were associated risk factors (p < 0.001). Conclusion: Extravasation was frequent and neonates were particularly at risk. Younger age and longer in situ PIVC duration were independent risk factors for extravasation.
Background Drug dispensing is traditionally carried out manually, with a significant risk of errors. While medication preparation and administration accounts for 16% of nurses’ activity, more than a quarter of interruptions occur at these moments. Any distraction during these activities may increase the risk of errors. Purpose Compare the rates of dispensing errors with and without an automated dispensing cabinet, and evaluate the influence of interruptions on the reliability of this activity. Material and methods In a simulation environment, volunteer nurses had to prepare 12 pillboxes from a conventional pharmacy (CP, ScanCell®) and an automated dispensing cabinet (ADC, Pyxis MedStation®). Six standardised interruptions (INT) were generated: noise, discussion (x2), oral prescription, telephone call and physical intrusion. The management of these distracting events were categorised (multitasking, task-switching, break of attention, suspending task, sub-optimal performance, no interruption). Errors were also classified (omission, wrong drug, dosage, patient, time). The contribution of interfacing the ADC with the prescription was estimated. Results A total of 2808 doses were prepared by 18 volunteer nurses. With CP, the error rate was 4.13% (2.07% without INT, 2.07% INT), compared to 3.28% with ADC not connected to the prescription (1.28% without INT, 1.99% INT) (p=0. 112). With a connexion to the prescription, the error rate oscillated between 0.71% and 1.85% (p<0. 05). Wrong doses (CP:46%, ADS:34%) and wrong pharmaceutical forms (PC:42%, ADS:43%) were the most frequent errors. The interruptions’ management were similar with the two systems in case of noise (no INT), oral prescription/telephone call (change of task to answer) and discussion (multi-tasks). During physical intrusion, 50% of the volunteers on ADC refused to be interrupted (8% on CP). The incidence of errors increased by 61% when interrupting tasks on ADC. Conclusion With an average rate of 4% on a CP, errors are mainly related to dose confusion and lack of knowledge of pharmaceutical forms. This rate can be reduced with an ADC connected to the electronic prescription. Task interruptions tend to increase the risk of error with ADC, but this effect can potentially be reduced once nurses become accustomed with this tool. No conflict of interest
•Training by pharmacists in hospital settings is a major expectation of physicians.•Many divergences exist between pharmacists and physicians regarding drug-training.•Pharmacists think they contribute more to physician training than physicians do.•Participants agree that current training needs better defining.
Donner ou recevoir des soins de santé repose sur de nombreux intervenants et une variété de processus de soins. Cette prestation n’est pas sans risque et les organisations de santé doivent mettre en place un processus de gestion des risques. L’objectif de cet article est de présenter une approche commentée par étape pour réaliser une AMDEC dans le cadre du circuit du médicament. Il s’agit d’un recensement des meilleures pratiques fondées sur l’expérience. À partir de quelques ouvrages pivots, les étapes d’une AMDEC ont été identifiées, incluant des stratégies visant l’application de ces connaissances. Le canevas proposé pour la réalisation d’une AMDEC comporte 17 étapes successives avec un total de 91 conseils et astuces applicables à ces différentes étapes. De plus, trois échelles de cotation sont proposées pour la fréquence, la sévérité et la détectabilité. Un diagramme d’Ishikawa est également proposé pour illustrer le profil des modes de défaillance. Cet article présente une approche originale, commentée par étape, pour réaliser une AMDEC dans le cadre du circuit du médicament. Bien qu’il existe plusieurs ouvrages sur le sujet, peu de pharmaciens ont commenté leur expérience dans la réalisation d’AMDEC. Un partage des astuces peut contribuer à favoriser la réalisation de ce type d’analyse dans le circuit du médicament. Providing or receiving health care relies on many providers and a variety of care processes. This provision is not without risk and health organizations need to put in place a process of risk and quality management. The objective of this article is to present a step-by-step approach to achieve a failure mode effect analysis (FMEA) as part of the drug circuit. This is a concise review of best practices as well as our experience to achieve a FMEA. From a few key books and pivotal documents, we have identified the steps of a FMEA including strategies to insure knowledge transfer. The proposed framework for the implementation of a FMEA relies on 17 successive steps. Our research team has identified 91 tips and tricks applicable to these different steps. In addition, three rating scales are proposed for frequency, severity and detectability. An Ishikawa diagram is also proposed to illustrate the profile of failure modes. This article presents an original approach, with commented steps, to realize a FMEA as part of the drug circuit. Although there are several books on the subject, few pharmacists have commented and published about their experience in FMEA. A sharing of these tips can help promote the realization of this type of analysis in the drug circuit.
Background Our chemotherapy production unit decided to rethink its organisational strategy and to revise its production processes through lean methodology to meet growing activity, in the context budget constraints that limit the increase in staff. Purpose To evaluate the impact of a lean management approach on the efficiency of a chemotherapy unit. Material and methods A five-step lean methodology approach was applied with a team of 12 technicians and five pharmacists supported by a lean expert, from January 2015 to July 2016: DEFINE: objectives, value stream mapping, process flows. MEASURE: steps, process duration, use of stock. ANALYSE: added-value steps, waste, waiting time and causes. IMPLEMENT: imagine and implement solutions. CONTROL: efficiency, performance, satisfaction. Results The team identified 73 items impacting the efficiency of the process during the 'Measure' phase. During the 'Analyse' step, 18 opportunities divided into four main themes were proposed to improve the organisation: Flow: smoothing the activity and reducing the early morning peak (–12% between 7 and 9 am), producing continuously according to demand of the day ('Just in time' eight maximum ongoing preparations), improving occupancy rates of isolators (+25% between 10 and 12 am, and +20% between 1 and 4 pm), revising the steps of double–control and using mistake–proofing resulted in a decrease in crossing time of manufacturing from 9 hour 45 min to 1 hour 45 min. bull; Space: reorganisation with a reduction of unnecessary movements. bull; Management: creation of a position of 'coordinator of the day', and daily meetings ('Obeya') to reassign tasks. bull; Stock and control: rationalisation of storage and orders. A net gain of 40% full-time equivalent was reached. The satisfaction survey showed a positive acceptance of the project and its conduct. Conclusion The application of a lean methodology allowed the optimisation of the management of our chemotherapy production unit and saved human resources. The main actions were to eliminate waiting time, to smooth daily activity, and to reorganise roles, spatial organisation and storage. The positive impact on the efficiency of our facility and the satisfaction of the team proved that lean methodology is a relevant tool in the hospital pharmacy. No conflict of interest
What is known Potentially inappropriate medication (PIM) is a risk factor for drug-related problems (DRPs) and an important inpatient safety issue. PIM-Check is a screening tool designed to detect PIM in internal medicine patients. ObjectiveMethodThis study aimed to determine whether PIM-Check could help to identify and reduce DRPs. Prospective interventional study conducted on patients admitted to internal medicine wards in a university hospital between 1 September 2015 and 30 October 2015. Adult patients were included if they were hospitalized for more than 48hours. Patients received either usual care (period 1=control) or usual care plus medication screening by the wards' chief residents using PIM-Check (period 2=intervention). An expert panel, composed of a clinical pharmacist, a clinical pharmacologist and two attending physicians in internal medicine, blinded to patient groups, identified DRPs. ResultsWhat is new and conclusionA total of 297 patients were included (intervention: 109). The groups' demographic parameters were similar. The expert panel identified 909 DRPs (598: control; 311: intervention). The mean number of DRPs per patient was similar in the control (3.2; 95% CI: 2.9-3.5) and intervention groups (2.9; 95% CI: 2.4-3.3) (P=.12). PIM-Check displayed 33.4% of the 311 DRPs identified in the intervention group. In this study, PIM-Check had limited value, as the average number of DRPs per person was similar in both groups. Although one-third of DRPs counted in intervention group had been identified by PIM-Check, this did not lead to a reduction in DRPs. This lack of impact of PIM-Check on drug prescription may be explained by the number of alerts displayed by the application and hospital physicians' reluctance to modify the treatments for chronic conditions previously prescribed by general practitioners.
Background Chemotherapy preparation units have to face an increasing activity with constant staff. Safety is therefore compromised. Purpose The purpose of our experiment was to measure the effect of a work overload on preparations, accuracy and occurrence of errors. Materials and Methods Our work was performed in a real working environment using simulated preparations and two tracer drugs (phenylephrine or lidocaine). Twenty-one operators participated in three preparation sessions and had to produce an increasing number of syringes (8, 16 and 24) within a same time period (1 hour). Syringes were assayed by a validated capillary electrophoresis method. Results were analysed according to qualitative (choice of wrong stock solution, diluents and labelling) and quantitative (dose deviation from the target concentration: accurate,<5%; weakly accurate, 5% to 10%; inaccurate, 10% to 30%; wrong,>30%) criteria. Results A statistically significant decrease in the preparation time per syringe was observed when workload increased (p<0.0001). The average time per preparation was 279 s (95% CI: 246 to 312), 193 s (95% CI: 173 to 214) and 158 s (95%: CI: 138 to 178) for the sessions with 8, 16 and 24 syringes, respectively. The mean accuracy of the doses in the syringes was not statistically different between the three workloads (mean=98.1% (95% CI: 89.6 to 108.6) of the target concentration). The distribution of the doses was: accurate 45% to 51%, inaccurate 23% to 26%, weakly accurate 22% to 29%, and 2% to 4% wrong. Thirty-nine errors of preparations were observed: 30 wrong doses (>30% deviation), six mislabelling, two wrong diluents and one wrong drug. The overall error rate increased with the number of preparations performed in 1 hour: 1.8% for eight preparations, 2.7% for 16% and 5.4% for 24 (p<0.05). The study also showed a strong heterogeneity in the dose accuracy between operators (p<0.0001) and between the preparations for the same operator (p<0.0001). Conclusion Our study demonstrated that operators can increase their production speed without impacting the mean dose accuracy. However, the acceleration of manual production rate is associated with a greater probability of error's occurrence. These results must strongly encourage cytotoxic production unit managers to take actions to smooth the workload over the day. Acknowledgements No conflict of interest
What is knownPotentially inappropriate medication (PIM) is an important issue for inpatient management; it has been associated with safety problems, such as increases in adverse drugs events, and with longer hospital stays and higher healthcare costs. ObjectiveTo compare two PIM-screening toolsSTOPP/START and PIM-Checkapplied to internal medicine patients. A second objective was to compare the use of PIMs in readmitted and non-readmitted patients. MethodA retrospective observational study, in the general internal medicine ward of a Swiss non-university hospital. We analysed a random sample of 50 patients, hospitalized in 2013, whose readmission within 30days of discharge had been potentially preventable, and compared them to a sample of 50 sex- and age-matched patients who were not readmitted. PIMs were screened using the STOPP/START tool, developed for geriatric patients, and the PIM-Check tool, developed for internal medicine patients. The time needed to perform each patient's analysis was measured. A clinical pharmacist counted and evaluated each PIM detected, based on its clinical relevance to the individual patient's case. The rates of screened and validated PIMs involving readmitted and non-readmitted patients were compared. ResultsAcross the whole population, PIM-Check and STOPP/START detected 1348 and 537 PIMs, respectively, representing 13.5 and 5.4 PIMs/patient. Screening time was substantially shorter with PIM-Check than with STOPP/START (4 vs 10minutes, respectively). The clinical pharmacist judged that 45% and 42% of the PIMs detected using PIM-Check and STOPP/START, respectively, were clinically relevant to individual patients' cases. No significant differences in the rates of detected and clinically relevant PIM were found between readmitted and non-readmitted patients. What is new and conclusionInternal medicine patients are frequently prescribed PIMs. PIM-Check's PIM detection rate was three times higher than STOPP/START's, and its screening time was shorter thanks to its electronic interface. Nearly half of the PIMs detected were judged to be non-clinically relevant, however, potentially overalerting the prescriber. These tools can, nevertheless, be considered useful in daily practice. Furthermore, the relevance of any PIM detected by these tools should always be carefully evaluated within the clinical context surrounding the individual patient.
Background Despite the use of closed system drug transfer devices (CSTDs), residual contamination by antineoplastic drugs is still retrieved inside isolators.1 Improving the chemical decontamination process has been proposed to reduce this contamination more efficiently. Purpose This study aimed to assess the decontamination efficiency inside isolators of two different decontamination processes associated with a CSTD. Material and methods A comparative and prospective study was performed in a new opening compounding unit. Compounding was performed with a CSTD (BD-Phaseal, Becton-Dickinson). 8 drugs (cyclophosphamide, cytarabine, dacarbazine, fluorouracil, gemcitabine, ifosfamide, irinotecan and methotrexate) were monitored daily for 14 consecutive weeks in 3 locations inside the isolators: gloves, workbench and window. Drugs were alternatively compounded in one or the other isolator on even and odd days. In one isolator (C), the cleaning process was performed daily with a standard biocide solution (Anioxyspray, Anios). In the other (I), a weekly decontamination with an admixture of sodium dodecyl sulfate 10-2 M/isopropanol (70/30) was added.2 Monitoring was performed by a validated LC-MS/MS method. The results are presented as OR of contamination between the two groups and as overall decontamination efficiency (EffQ%) in each group. This latter parameter was computed according to Anastasi, as follows: EffQ=1–(sum of all contaminations after decontamination process (ng)/sum of all contaminations before decontamination process (ng)). The proportion of EffQ >90% was compared using Fisher's exact test. Results The overall contamination rates (CR) after the daily cleaning/decontamination process were significantly different between the two groups: CRC=25.3% versus CRI=10.4% (OR=0.341; p<0.0001). The mean overall EffQ was significantly higher in the intervention group (I: 61.0±41.5% vs C: 42.4±37.3%), but was very variable depending on the drug analysed. Decontamination was more effective for both cyclophosphamide and gemcitabine. The proportion of days with an EffQ >90% was higher in the intervention group (I: 42.9% vs C: 7.1%; p=0.077). Conclusion Combining a decontamination protocol including a tensioactive agent to a CSTD leads to better control of contamination inside isolators. Improving decontamination frequency will be further studied. References and/or acknowledgements Simon, et al. PLOS One2016. Anastasi, et al. Ann Occup Hyg2015. Conflict of interest: Corporate sponsored research or other substantive relationships: The study was funded by Becton-Dickinson laboratories. Data analysis and interpretation and the writing of all scientific communications were performed independently of the funder.
Le risque d’erreurs médicamenteuses est accru à l’admission d’un service de soins. L’interface ville/hôpital expose à un risque de discontinuité dans la prise en charge médicamenteuse en induisant des divergences non intentionnelles de prescription (DNI) entre traitements habituels et hospitaliers. L’objectif de cette étude était d’évaluer l’incidence des DNI et de mesurer l’impact d’une réconciliation médicamenteuse à l’admission sur la justesse de la prescription hospitalière en médecine interne. Étude interventionnelle de 2 mois réalisée à l’admission des patients en médecine interne dans le cadre du projet national « Progress ! La sécurité de la médication aux interfaces ». Tous les patients admis étaient éligibles et étaient inclus après la rédaction de la prescription initiale hospitalière (PIH). Un pharmacien réalisait la meilleure anamnèse médicamenteuse possible (MAMP), puis procédait à l’identification des divergences de prescription par la comparaison de ces données aux traitements de la PIH. L’intentionnalité des divergences était déterminée par une concertation avec les prescripteurs et les DNI étaient évaluées pour leur type et les classes thérapeutiques qu’elles concernaient. Vingt-sept patients (59 % femmes) ont été inclus. L’âge moyen était de 64,6 ± 17,5 ans. En moyenne, la MAMP durait 1 heure, était effectuée dans un intervalle de 1,4 jours après l’admission et permettait l’identification de 7,6 ± 4,9 lignes de traitements par l’exploitation de 2 sources d’information (le plus souvent le patient et son officine). Un total de 54 divergences, dont 42 DNI concernant 17 patients ont été identifiées (1,6 DNI par patient). Les DNI étaient des omissions de prescription (n = 32), des erreurs de posologie (n = 7), des erreurs de modalités d’administration (n = 2) et une erreur de nom de spécialité. Les DNI intéressaient 11 classes thérapeutiques et 81 % (n = 34) concernaient 5 classes, (système digestif, nerveux, respiratoire, cardiovasculaire et organes sensoriels). La concertation avec le prescripteur a permis la rectification de 52 % des DNI (n = 22). Les divergences de prescription sont fréquentes à l’admission et la réconciliation médicamenteuse peut permettre l’interception et la correction des DNI. L’impact de cette dernière pourra être mieux estimé par une appréciation de la gravité clinique potentielle des DNI par un groupe d’experts indépendants (médecins, pharmacien clinicien). Un impact positif serait un argument en faveur d’une intervention plus systématique des pharmaciens en amont de la rédaction de la PIH, afin de prévenir la survenue des DNI.