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Medication errors (ME) are frequently encountered and present at every step of the therapeutic process. This study's aims were to take stock of the ME reported to the region's pharmacovigilance (CRPV) and poison control centers (CAPTV) and to identify potential regional actions. A 2-months (January and February 2017) prospective gathering of the calls to the CAPTV regarding the ME and of the ME declarations to the region's CRPV (Clermont-Ferrand, Grenoble, Lyon, Saint-Etienne) has been carried out. The place of occurrence, the event's description and its consequences and data regarding the patient were collected. In addition to that, the regional drug observatory OMEDIT analysis has allowed to determine the ME's types (REMED characterization, never event?) and to look for the results of a potential thorough analysis. The study reported 580 calls for 590 ME and 583 patients. ME mostly affected the ambulatory/domicile sector (76%), the medico-social sector (14%) and the healthcare facilities sector (7%). It usually was about dose errors, medication errors and patient errors with a different profile in each sector. The majority of errors (85%) occurred at the administration step. Almost all the observed ME were confirmed errors having reached the patient (99.5%) but only a few had serious consequences. One out of 5 ME was eligible for a thorough analysis but even less were subjected to that kind of analysis. The main never event concerned the unidose in the ambulatory sector. The health products involved were mostly a single medication (75%) and then the patient's full treatment (12%). The CRPV/CAPTV/OMEDIT's skills are complementary for the gathering, the analysis and the management of the ME. Training campaigns and support are to be considered for the professionals and especially within the medico-social facilities.

Context: Today, immunotherapy with Fab or F(ab′)2 fragments is considered as a gold standard treatment for patients bitten by vipers. We compared the efficiency of two antivenoms, Viperfav® and Vip...

International audience; Introduction The aim was to assess the impact of the COVID-19 pandemic on French Poison Control Centre (PCC) call characteristics. Methods Reported cases of xenobiotic exposures from 1 March to 30 April in 2018, 2019, and 2020 were extracted from the French National Database of Poisonings. The collected data included call, patient, and exposure characteristics for both general calls and for calls involving sentinel xenobiotic categories related to the COVID-19 pandemic. The 2020 exposures were compared to 2018-2019 exposures by using simple logistic models in order to provide effect size with odds ratios. Results From March to April 2020, 32,182 exposures were reported to French PCCs with an overall increase of 5.6% compared to exposures in the same time frame in 2018-2019. A similar increase in calls was observed in non-epidemic and epidemic COVID-19 areas with an increase in calls from the public (+13.6%) while calls from health-professionals decreased (-7.5%). Despite the increase in exposures, the incidence of symptomatic exposures remained stable (-0.4%) with a decrease in severity (moderate/severe -17.2%). A significant increase in exposures to home cleaning products containing biocides, essential oils, and alcohol-based hand sanitizers (odds ratio >1.3, p < .0001) was observed. Discussion and conclusion The COVID-19 pandemic altered calls to French PCCs with a small increase in calls during the study period and changes in the pattern of exposure. These changes possibly reflected the indirect consequences of the COVID-19 pandemic i.e., limited access to primary care, fear of contracting COVID-19 and anxiety related to home isolation.

International audience; Introduction: Ciguatera fish poisoning (CFP) is a common Poisoning in the tropical countries. France is directly concerned with French tourists in endemic area and with French citizens living in the French overseas territories. Method: Retrospective, descriptive study of CFP cases handled by the French Poison Control Centre Network from 2012 through 2019. Results: Fifty-two events were studied concerning 130 patients. The fish species was identified for 41 events, mainly belonging to five fish families: 14 groupers, 11 snappers, 5 jacks, 4 parrotfishes, 4 barracudas. The origin of the fish was the Atlantic Ocean (23 events), the Indian Ocean (17 events) and the Pacific Ocean (12 events). 91% of the poisonings occurring in the Atlantic Ocean began with gastrointestinal effects while in 44% of events occurring in the Pacific Ocean, the patients had no gastrointestinal effects (onset with neurological symptoms: paraesthesia and dysesthesia). The evolution of the 130 patients has been classic for CFP with persistent symptoms during 1 to 45 weeks. Numerous patients reported exacerbation of neurological signs several months after poisoning following consumption of alcoholic beverages (23 patients) or seafood (19 patients). Discussion: Medical practitioners in Europe must be trained to manage CFP as cases are reported with tourists returning from endemic areas but also with poisoned patients far from tropical areas after consumption of imported fish.

Summary Introduction To date, few studies have shown a significant association between off-label drug use and adverse drug reactions (ADRs). The main aims of this study is to evaluate the relationship between adverse drug reactions and unlicensed or off-label drugs in hospitalized children and to provide more information on prescribing practice, the amplitude, consequences of unlicensed or off-label drug use in pediatric inpatients. Methods In this multicenter prospective study started from 2013, we use the French summaries of product characteristics in Theriaque (a prescription products guide) as a primary reference source for determining pediatric drug labeling. The detection of ADRs is carried out spontaneously by health professionals and actively by research groups using a trigger tool and patients’ electronic health records. The causality between suspected ADRs and medication is evaluated using the Naranjo and the French methods of imputability independently by pharmacovigilance center. All suspected ADRs are submitted for a second evaluation by an independent pharmacovigilance experts. Strength and limitations of this study For our best knowledge, EREMI is the first large multicenter prospective and objective study in France with an active ADRs monitoring and independent ADRs validation. This study identifies the risk factors that could be used to adjust preventive actions in children's care, guides future research in the field and increases the awareness of physicians in off-label drug use and in detecting and declaring ADRs. As data are obtained through extraction of information from hospital database and medical records, there is likely to be some under-reporting of items or missing data. In this study the field specialists detect all adverse events, experts in pharmacovigilance centers assess them and finally only the ADRs assessed by the independent committee are confirmed. Although we recruit a high number of patients, this observational study is subject to different confounders.

To describe clinical consequences of risperidone medication errors in children of less than 13 years and to estimate a clinically relevant toxic dose.All cases of risperidone medication errors managed by French Poison Centres from 2001 to 2012 were analyzed. Inclusion criteria were a delay of at least 2 hours between ingestion and request to the FPC in asymptomatic children, an ingested dose above two-fold the maximal daily dose for children above 5 years or any symptomatic patient at the time of first contact.One hundred and sixty cases met our criteria. Median age was 8 years (range 0.9-12) and 28.1% were aged 5 years or less. Causes of the error were an incorrect dose in treated children (84.2%) or a dose given to a wrong child (15.8%). The median ingested dose was 0.1 mg/kg or 3.3-fold the maximum recommended dose. Overall, 59 children had no symptoms, 95 experienced minor symptoms and six moderate symptoms. Somnolence/sedation was the most common (73.3%). Of the 17 children who developed extrapyramidal disorders, all had minor or moderate symptoms and only five required a symptomatic treatment.Risperidone medication errors in children cause minimal effects. Somnolence and mild to moderate extrapyramidal reactions were the main features of toxicity, and significant cardiac or other neurological features were not observed. No case with severe toxicity was noted. At home surveillance can be proposed for children exposed to a dose ≤0.15 mg/kg.

Introduction Les billes de polymeres super-absorbants (PSA) ont la capacite d’absorber l’eau jusqu’a plusieurs centaines de fois leur poids sec. Developpees en milieu agricole avant de trouver d’autres applications, leur commercialisation sous forme d’elements decoratifs ou de jeux est recente. En raison de leur caractere attractif, le risque d’ingestion par les enfants est eleve. Notre objectif etait de decrire l’evolution du nombre de cas d’ingestion de billes de PSA en France et leur evolution clinique. Methodes Etude observationnelle retrospective sur une periode de 10 ans (du 1er janvier 2010 au 31 decembre 2019) portant sur tous les cas d’exposition par ingestion de billes de PSA collectes par les centres antipoison en France. Resultats Pendant la periode d’etude, les centres antipoison francais avaient collectes 1 924 143 cas toutes causes confondues, dont 968 735 (50,3 %) concernaient des enfants (âge Discussion Hormis ce cas de deces, les resultats de notre etude etaient comparables aux rares series publiees a l’international par les centres antipoison. L’ingestion d’une bille de PSA ne se complique que parfois de troubles digestifs benins et rapidement resolutifs [1] . Pourtant, certaines billes vendues comme jouets ont ete retirees du marche aux USA et en Australie suite a la survenue de cas d’occlusion intestinale aigue apres ingestion. Dans la litterature, nous avons retrouve 27 cas publies d’occlusion intestinale aigue ayant necessite une extraction endoscopique ou chirurgicale, dont 1 cas de deces. Il s’agissait toujours d’enfants en bas âge (âge median: 15 mois (6-22 mois)). L’analyse de ces cas souligne la difficulte diagnostique en raison du caractere radiotransparent de ces corps etrangers. L’interet d’examens d’imagerie tels que l’echographie et la tomodensitometrie abdominales et la prise en charge chirurgicale sont precises [2] . Conclusion Au cours des 10 dernieres annees, on observait une augmentation exponentielle du nombre de cas rapportes d’ingestion de billes de PSA en population pediatrique en France. Les complications etaient rares mais de gravite elevee. Apres revue de la litterature, nous expliquons comment predire le risque d’occlusion selon la taille de la bille et proposons une strategie de prise en charge en pratique clinique.

Objectif Le fomepizole est l’antidote preconise des intoxications a l’ethylene glycol (EG) ou au methanol. Les doses d’entretien (hors dialyse) et la concentration d’EG pour laquelle l’arret du traitement est recommande different selon les recommandations et resumes des caracteristiques des produits (RCP) francais, europeens et americains. Nous avons effectue une revue systematique de la litterature pour evaluer le niveau de preuve des differentes recommandations. Methode La base de donnees bibliographique Pubmed avec l’utilisation du filtre « clinical trial » et les ressources documentaires du service ont ete interrogees sans limitation de temps. Nous avons inclus les etudes cliniques prospectives evaluant l’interet du fomepizole comme antidote des intoxications a l’EG ou au methanol sur des criteres cliniques. Nous avons extrait les donnees concernant les caracteristiques des etudes, leurs resultats, et le schema therapeutique utilise. Resultats Parmi les 24 etudes cliniques identifiees, 20 ont ete exclues (3 : critere de jugement non clinique, 5 : volontaires sains, 8 : retrospectives, 3 : duplicata, 1 : case report). Parmi les 4 etudes incluses, 3 utilisaient une dose de charge de 15 mg/kg suivie de doses d’entretien de 10 mg/kg toutes les 12 h puis 15 mg/kg apres 48 h, jusqu’a une concentration d’EG (ou de methanol) Discussion Le schema therapeutique « Brent » propose de majorer les doses de fomepizole en raison d’un phenomene d’auto-induction enzymatique responsable d’une augmentation de l’elimination du fomepizole apres 30–48 h de traitement. A l’inverse, la preconisation d’une diminution progressive des doses dans le RCP francais semble etre justifiee par le fait que les doses administrees permettent d’atteindre des concentrations de fomepizole tres superieures aux concentrations estimees suffisantes par des etudes de pharmacotoxicocinetique. Nous n’avons cependant pas identifie d’etude prospective validant ces modifications, qui different des recommandations nord-americaines [1] . Par ailleurs, cette meme raison amenerait a proposer un arret du fomepizole pour un seuil d’EG de 0,3 g/L [2] , [3] , seuil actuellement a 0,2 g/L pour les RCP americain et europeen et a 0,1 g/L pour le RCP francais. Conclusion Differents schemas d’administration du fomepizole co-existent, pouvant preter a confusion lors de la prise en charge d’intoxications. Il serait interessant d’avoir acces aux donnees cliniques a l’origine du RCP francais pour comparer les niveaux de preuves des differents schemas, et ainsi poursuivre la recherche d’un consensus.

Objectif Aujourd’hui, l’immunotherapie par fragments Fab ou F (ab ‘) 2 est consideree comme le traitement de reference pour les envenimations viperines [1] , [2] . Nous avons compare l’efficacite de deux antivenins, Viperfav®(VF®) et Viperatab® (VT®), en France metropolitaine en 2017-2018 a partir des donnees du reseau des centres antipoison francais. Methode Les patients presentant une envenimation moderee (grade 2a et 2b) ou severe (grade 3) apres morsure de vipere et traites par antivenin ont ete inclus. Les criteres de jugement choisis etaient le risque d’exacerbation de l’envenimation apres antivenin, la duree de sejour a l’hopital et la presence d’une gene fonctionnelle persistante a J15. Les etudes statistiques etaient basees sur l’analyse de donnees multivariees. Resultats 297 cas ont ete inclus. 182 (61,3 %) patients ont recu VF® et 115 (38,7 %) ont recu VT®. Comparee a VF®, l’utilisation de VT® a significativement augmente le risque d’exacerbation de l’envenimation apres antivenin (VF 1 % vs VT 11 % ; OR= 12,1 ; IC 95 % [3,1 ; 46,7] ; p 48 h) et la gene fonctionnelle persistante a J15. VF® et VT® ont une securite d’emploi similaire (p > 0,21). Par ailleurs, la duree d’hospitalisation a ete significativement augmentee lorsque l’antivenin etait administre au-dela de 12 heures (OR= 2,70 ; IC 95 % [1,45–5,06] ; p = 0,002) ou lors d’une administration preventive d’HBPM, (OR= 6,6 ; IC 95 % [1,6–27,1] ; p = 0,02). Par ailleurs, les patients recevant la perfusion d’immunotherapie du grade 2b presentaient des symptomes exacerbes significativement plus frequents (OR* 4,0 ; IC 95 % [1,2–13,7] ; p = 0,028) apres l’administration d’antivenin par rapport au groupe de grade 2a. Discussion Bien que VF® et VT® aient tous deux une tres bonne securite d’emploi, cette etude montre que VT® etait associe a un risque plus eleve d’exacerbation de l’envenimation apres antivenin par rapport a VF®. En outre, cette etude confirme que l’antivenin doit etre administre le plus precocement possible et confirme la contre-indication des HBPM en preventif. Conclusions Alors qu’aucune difference significative entre ces antivenins n’a ete enregistree en ce qui concerne la duree du sejour a l’hopital et la gene fonctionnelle persistante a J15, l’utilisation de VT®, par rapport a VF®, a augmente de maniere significative le risque d’exacerbation de l’envenimation apres antivenin (OR* 12,1 ; IC 95 % [3,1 ; 46,7] ; p

Objectif L’enseignement de la pharmacotoxicologie clinique reste un defi [1] . Les donnees de la litterature disponibles presentent des niveaux de preuves variables. La modalite de cours dite « en classe inversee » pourrait ameliorer la formation des etudiants en sante [2] . Notre hypothese etait qu’une approche « en classe inversee » serait associee a une meilleure satisfaction des etudiants, concernant leur formation a la pharmacotoxicologie clinique, par rapport au cours dit « magistral ». Methodes Nous avons realise une etude transversale retrospective. Un questionnaire a ete envoye aux etudiants accueillis entre septembre 2017 et septembre 2019 dans le service de pharmacotoxicologie des hospices civils de Lyon (qui inclut les centres antipoison, de pharmacovigilance et d’addictovigilance de Lyon). Certains etudiants avaient eu l’opportunite de realiser un cours en classe inversee (recherche documentaire, synthese et presentation orale), d’autre d’assister a une presentation orale (modalite « cours magistral »), certains les deux. Un score « d’utilite et satisfaction » de 1 (pire) a 10 (meilleur) leur permettait d’evaluer leur ressenti concernant quatre domaines : l’acquisition de connaissances en pharmacotoxicologie clinique (objectif principal), et trois objectifs secondaires : developpement de competences en pharmacotoxicologie clinique, acquisition de connaissances sur les methodes de revues systematiques, developpement de competences pour l’interpretation du niveau de preuve. Les scores « d’utilite et satisfaction » attribues pour la realisation d’un cours en « classe inversee » etaient compares aux scores attribues pour la participation a un « cours magistral ». Resultats Dix-neuf reponses sur les 56 etudiants contactes etaient exploitables (2 non exploitables, taux de reponse : 37,5 %). La plupart etaient des etudiants en medecine. Concernant le critere de jugement principal, l’approche « en classe inversee » n’etait pas associee a une augmentation du score « d’utilite et satisfaction », compare a la modalite « cours magistral » (8,1 ± 2,0 vs 7,9 ± 1,2, respectivement, p = 0,59). Aucune difference n’etait significative pour les criteres de jugements secondaires (competences en pharmacotoxicologie : 7,4 ± 2,1 vs 7,1 ± 2,5, respectivement, p = 0,93 ; methode de revue systematique : 8,2 ± 1,8 vs 7,1 ± 1,4, respectivement, p = 0,15 ; interpretation du niveau de preuve : 6,9 ± 1,9 vs 7,3 ± 1,4, respectivement, p = 0,77). Discussion Notre etude presente plusieurs limites (risque de biais de confusion, de biais de non-reponse, de biais de memorisation). L’extrapolabilite des resultats est limitee. Cependant, le niveau global de satisfaction des etudiants apparait relativement satisfaisant. Conclusion Cette premiere etude pilote n’a pas permis de montrer un avantage de la classe inversee par rapport au cours magistral dans le ressenti des etudiants pour l’apprentissage de la pharmacotoxicologie clinique. D’autres etudes sont necessaires, sur l’acquisition de connaissances et de competences des etudiants et non seulement sur leur ressenti.

Objective Diphoterine® (Prevor Company, France) is an amphoteric hypertonic solution proposed for decontamination in case of cutaneous or ocular corrosive injury. Our Poison Information Center of Lyon (PIC Lyon) is regularly questioned by occupational health professionals about the benefit of diphoterine®. As new studies became available since the last review of Brent [1] , our aim was to assess systematically the available evidence on diphoterine®. Methods Non clinical studies and randomized or non-randomized trials in humans assessing the benefit of diphoterine® after cutaneous or ocular chemical burns were eligible. We searched Medline, Google and the Prevor website. After screening title and abstracts, relevant articles were selected, and the following data were extracted: study characteristics including quality assessment, type of controls and clinical outcomes (such as healing delay, burn severity), presence of potential conflict of interest. Results We identified 37 articles or abstracts of whom 12 original studies (6 sponsored by Prevor company) were included. Five controlled studies were conducted in animals (ocular exposures in three and skin in two). Sample size ranged from 16 to 30 animals. Two studies (one randomized) suggested an effect of diphoterine® use on ocular pH but not on clinical outcomes; one randomized study suggested a decrease of corneal injury; one randomized study observed a complete or almost complete healing of the burn injury in the five rats treated with diphoterine® compared to a detersion of eschar or a wound re-epithelization in the five rats treated with normal saline solution. However, these last studies reported multiple outcomes, without defining a principal, and did not correct for multiple testing. The last study, assessing the safety of diphoterine®, did not detect hypersensitivity reactions after skin exposure. Seven studies were conducted in humans with both eye and skin exposures. Sample size ranged from 5 to 180. Of the 3 retrospectives cases series, one uncontrolled study (24 subjects) did not detect adverse effects attributable to diphoterine® decontamination; one uncontrolled study (34 subjects) suggested a decrease in pain; the controlled study (131 subjects) did not show a decrease in the time to healing as compared to water (9.0 days in the diphoterine® group versus 7.0 in the non-diphoterine® group, P = 0.258). Of the 4 prospective studies, one was uncontrolled (5 subjects) and 3 compared diphoterine® to water and/or saline solution (from 65 to 180 subjects). Regarding the three controlled prospective trials, none of them were randomized; none of them controlled the alpha risk when reporting multiple outcomes; they suggested clinical benefits with less serious burns, decrease in pain or shorter time for recovery. Discussion We did not find acceptable level of evidence suggesting a clinical benefit of diphoterine®. Observations reported in the prospective clinical trials were at high risk of bias and at high risk of false positive results. Our results are consistent with previous systematic review [1] , [2] , [3] . We did not assess the financial cost of diphoterine®. Conclusion Compared to water or saline solution, the benefit of decontamination with diphoterine® is questionable. We believe that the decontamination should be performed as early as possible with the most easily accessible solution, and water should be the first option.

In the world, the impact of environmental conditions on the number of scorpion events was evaluated in North Africa,Middle East, and the Amazonian region but not in Europe. In mainland France, scorpion species described are Buthus occitanus (Amoreux, 1789), Belisarius xambeui (Simon, 1879) and 4 Euscorpiidae: Euscorpius concinnus (Koch, 1837), Euscorpius italicus (Herbst, 1800), Euscorpius tergestinus (Koch, 1837), and Tetratrichobothrius flavicaudis (De Geer, 1778). We aimed to describe the impact of environmental conduction on the number of scorpion events. For this, a retrospective multi-center study was conducted with data from the French poison control centers files about scorpion events between 1 January 2011 and 31 December 2020. During the study period, 975 incoming calls for scorpion events were recorded and 574 were related to scorpions native to mainland France and Corsica: B. occitanus (n = 86), Euscorpiidae species (n = 222), B. xambeui (n = 1), and undetermined species (n = 265). Cases were mostly reported along the Mediterranean coast, along rivers, and in cities with a trading port. The number of scorpion events was linked to the rivers' water level, rivers' flow, temperature, sunshine, and pluviometry (P < 0.05 for all variables). B. occitanus need warmest and driest environment than Euscorpiidae spp. A link between the severity of the envenoming and climatic condition or seasonality was not demonstrated.