OBJECTIVE:To describe the implementation, certification and five-year experience of an ISO9001:2015-compliant quality management system (QMS) within a university hospital Department of Pharmacotoxicology encompassing pharmacovigilance, addictovigilance, toxicovigilance and telephone-based emergency response activities, and to analyse the benefits and limitations of this approach. METHODS:The QMS was deployed from 2018 using a structured approach integrating context and stakeholder analysis, process mapping, documentation system formalisation, non-conformity management, internal and external audits, process and management reviews, and monitoring of quality indicators. RESULTS:Initial ISO9001:2015 certification was obtained in January 2021, followed by two surveillance audits and recertification in February 2024. Over five years, 111 non-conformities were reported by 23 staff members, generating 214 improvement actions, of which 156 (73%) were completed. QMS implementation was accompanied by the deployment of structuring tools, including a dedicated operational software solution, and enabled continuity of activity during a major health crisis. Satisfaction surveys showed high levels of satisfaction among service users (clarity of information: 99.2%; quality of medical advice: 97.6%; response times: 95.1%) and regulatory authorities. No major risks were identified during audits. CONCLUSION:Implementing an ISO9001:2015-based QMS in a Pharmacotoxicology ward is both feasible and beneficial. It supports a robust and agile organisational framework, strengthens regulatory compliance, traceability and constitutes a key driver for institutional dialogue. This experience provides a transferable model for other vigilance structures.
Background and aims: Sodium-glucose cotransporter 2 inhibitors (SGLT-2i), developed for type 2 diabetes mellitus (T2DM), have been approved in symptomatic heart failure (HF). Comparison of their safety profiles between T2DM and HF remain scarce. Using international pharmacovigilance data, reported adverse events (AEs) with SGLT-2i were compared between T2DM and HF indications.Methods: Individual case safety reports (ICSRs) involving dapagliflozin or empagliflozin, both approved for T2DM and HF, were collected from the World Health Organization’s pharmacovigilance database up to September 30, 2024. Five AEs of interest were specifically investigated including ketoacidosis, genitourinary infection, Fournier’s gangrene, amputation and kidney failure. Reporting odds ratio (ROR) and 95% confidence interval (CI) were calculated to compare reported AEs between T2DM and HF indication.Results: Of the 47,804 ICSRs selected, only 10.0% involved HF patients. Serious AEs accounted for 41.0% of cases in T2DM patients and 44.2% in HF patients. As expected, ketoacidosis (14.6% vs 4.1%), Fournier’s gangrene (2.3% vs 1.8%), and amputation (0.5% vs 0.3%) were significantly more reported in T2DM and kidney failure was more reported in HF (6.1% vs 3.8% in T2DM). The differences were illustrated by significant ROR. However, no difference was evidenced for genitourinary tract infections between the two indications. Median time to onset of AEs was shorter in HF (111.5 days ± 198.7 vs 264.9 ± 664.9 in T2DM, p <0.001) and AEs leading to death were more frequently reported in this subgroup.Conclusion: SGLT2 inhibitor safety profiles differ across indications, shaped in part by patient characteristics. In heart failure, the reporting of unexpected serious events, such as ketoacidosis, and a higher proportion of fatal outcomes sharply reinforces the need for intensified safety surveillance.
Le traitement par buprénorphine est régulièrement utilisé pour le traitement du trouble de l’usage d’opioïdes, et le recours à ses formes d’action prolongée est croissant. Ceci soulève des interrogations chez les professionnels de santé lorsqu’une prise en charge antalgique s’avère nécessaire, en raison de ses propriétés pharmacologiques. Cet article propose une synthèse des données pharmacologiques actuelles et de leur impact sur la gestion de la douleur, aiguë ou chronique, programmée ou non. Des mises au point pratiques sont formulées selon le type de douleur, la galénique utilisée (buccale ou sous-cutanée), et les contextes cliniques.Les données disponibles confortent le maintien de la buprénorphine dans la majorité des situations, y compris en contexte chirurgical et suggèrent qu’un recours raisonné à une antalgie multimodale permet une prise en charge efficace et sécurisée. L’arrêt de la buprénorphine, longtemps recommandé pour laisser la place à une antalgie conventionnelle par opioïde agoniste complet, apparaît désormais comme une option minoritaire, à réserver à des cas exceptionnels et anticipés.La prise en charge des patients recevant de la buprénorphine ne doit pas être perçue comme une contrainte, mais comme une situation d’adaptation pharmacologique fondée sur des principes aujourd’hui bien établis.
Severe cutaneous adverse drug reactions (SCARs), comprising mainly Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis, generalized bullous fixed drug eruption (GBFDE), are rare adverse reactions to drugs, hampered by a significant morbidity and mortality. Due to their unpredictable nature, they completely disrupt the benefit-risk balance of drug prescription. Nonetheless, a partial predictability is emerging. Firstly, all drugs do not carry the same risk for SCARs. Drugs carrying the higher risk are allopurinol, carbamazepine, lamotrigine, iodinated contrast media, and antibiotics, particularly sulfonamides and aminopenicillins. In addition, main risk factors comprise genetic polymorphisms of the HLA system and increased drug dosage. A targeted HLA genetic screening together with drug avoidance in case of high risk allowed to reduce the incidence of SCARs associated with carbamazepine and allopurinol. Similarly, a progressive titration of lamotrigine dose allowed to reduce the incidence of SCARs associated with lamotrigine.Pharmacovigilance databases allow the quick identification of culprit drugs, together with the implementation of whistle-blowing policies. Nonetheless, they present with quantitative and qualitative limitations and their own particular biases. Pharmacoepidemiologic databases allow the computation of SCAR incidences and confirm previously identified associations between drugs and SCARs. They may also allow help to identify the main clinical risk factors, e.g., chronic renal disease and Asian ethnicity for allopurinol. Nonetheless, they are limited by measure bias and lack of clinical and biological data. Ultimately, clinical and pharmacogenomic databases allow the identification of more precise risk factors, comprising precise genetic polymorphisms, drug dosage and impaired metabolism.The combination of all allows to establish a personalized risk stratification across SCARs subtypes and drug prescriptions. Ultimately, this allows the establishment of prescribing policies and the decrease of SCARs incidence.
Objectif: Décrire la mise en œuvre, la certification et le retour d’expérience sur cinq ans d’un système de management de la qualité (SMQ) conforme à la norme ISO 9001:2015 au sein d’un service hospitalo-universitaire de pharmacotoxicologie regroupant des activités de pharmacovigilance, d’addictovigilance, de toxicovigilance et de réponse téléphonique à l’urgence, et analyser les bénéfices et les limites de cette démarche.Méthodes: Le SMQ a été déployé à partir de 2018 selon une approche structurée intégrant l’analyse du contexte et des parties intéressées, la cartographie des processus, la formalisation du système documentaire, la gestion des non-conformités, les audits internes et externes, les revues de processus et de direction, ainsi que le suivi d’indicateurs qualité.Résultats: La certification initiale ISO 9001:2015 a été obtenue en janvier 2021, suivie de deux audits de surveillance et d’un renouvellement de certification en février 2024. Sur cinq ans, 111 non-conformités ont été déclarées par 23 membres du personnel, générant 214 actions d’amélioration, dont 156 (73 %) ont été clôturées. La mise en œuvre du SMQ s’est accompagnée du déploiement d’outils structurants, notamment un logiciel métier dédié, et a permis le maintien de l’activité en situation de crise sanitaire. Les enquêtes de satisfaction ont montré un haut niveau de satisfaction des demandeurs (clarté de l’information : 99,2 % ; qualité des avis médicaux : 97,6 % ; délais de réponse : 95,1 %) ainsi que des autorités de tutelle. Aucun risque majeur n’a été identifié lors des audits.Conclusion: La mise en place d’un SMQ ISO 9001:2015 dans un service de Pharmacotoxicologie est faisable et bénéfique. Elle favorise une organisation robuste et agile, renforce la conformité réglementaire, la traçabilité et constitue un levier structurant pour le dialogue institutionnel. Cette expérience offre un modèle transposable à d’autres structures de vigilance.
Purpose.- Anhedonia is defined as inability to experience pleasure or enjoyment from activities normally pleasurable. Role of drugs in occurrence of anhedonia is little known. The study was performed to investigate, first associations between anhedonia and exposure to neuropsychotropics and, second potential pharmacodynamic mechanisms of this adverse drug reaction.Methods.- The first part of the study used individual case safety reports (ICSRs) in adults registered in the global pharmacovigilance database, Vigibase®, between 01/01/2000 and 31/12/2024 with neuropsychotropics. Results are shown as reporting odds ratios (ROR) with their 95%CI. Second, we performed a pharmacovigilance-pharmacodynamic study using linear regression analyses to explore the association between anhedonia with antidepressants and binding affinities for their monoamine transporters.Results.- Among 24,913,179 ICSRs, 1,123 reported anhedonia with neuropsychotropics, mainly in females (52.5%) and between 18-44 years (55.6%). Significant associations were found with psycholeptics [ROR=1.23 (1.14-1.33), including second generation of antipsychotics and anxiolytics], psychoanaleptics [ROR=1.66 (1.52-1.82), including serotonin reuptake inhibitors and venlafaxine but not other antidepressants] and some other drugs like naltrexone, varenicline, duloxetine, clonazepam or oxycodone. No association was found for anesthetics, other analgesics, other antiepileptics, hypnotics/sedatives, or antiparkinsonians. Direct drug comparisons found significant ROR values for psychoanaleptics versus psycholeptics [1.35 (1.20-1.51)], for antidepressants versus antipsychotics [2.63 (2.24-3.09)] and for antidepressants versus anxiolytics [1.27 (1.11-1.45)]. No significant association was found between monoamine pKi values and occurrence of anhedonia with antidepressants.Conclusion.- Among neuropsychotropics, serotonin reuptake inhibitors, benzodiazepine anxiolytics and antipsychotics are associated with anhedonia reports. We were unable to find any correlation between anhedonia reports with antidepressants and their direct effects on monoamine transporters.
BACKGROUND:The "Centre Ressource Lyonnais des Addictions Médicamenteuses" (CERLAM), i.e., Lyon Resource Center for Prescription Drug Addiction, is a specialized addiction unit for all types of prescription drug use disorders. Using the structured initial assessment of the center, the specific profile of patients with prescription opioid (OUD) or benzodiazepine use disorder (BUD) was explored. METHODS:The structured initial CERLAM assessment includes age, gender, international standardized classification of education (ISCED), DSM-5 criteria for OUD or BUD, Hospital Anxiety and Depression Scale (HADS), World Health Organization Quality of Life - 26-item version (WHOQOL-BREF), and Pittsburgh Sleep Quality Inventory (PSQI), respectively. Two multivariable logistic regression models explored the profile of OUD (vs. non-OUD) patients and BUD (vs. non-BUD patients), providing adjusted odds ratios and their 95% confidence intervals (aOR[95%CI]). RESULTS:One hundred and eighty-four patients were included (54.9% females; mean age 44.7±13.4 years), among whom 107 (58.2%) had an OUD, and 86 (46.7%) a BUD. When compared with non-OUD patients, those with prescription OUD were more frequently females (aOR=1.97 [1.04-3.73]), had a lower ISCED (aOR=0.55 [0.42-0.72]), and a lower physical WHOQOL-BREF score (aOR=0.93 [0.88-0.99]). By contrast, when compared with non-BUD patients, those with BUD had a greater ISCED (aOR=2.04 [1.54-2.72]), reduced psychological (aOR=0.93 [0.87-0.99]) and social (aOR=0.86 [0.76-0.96]) WHOQOL-BREF scores, greater HAD depression (aOR=1.10 [1.03-1.18]) and PSQI (aOR=1.13 [1.04-1.23]) scores, respectively. CONCLUSION:In patients with prescription drug use disorders, those with BUD and those with OUD exhibit specific sociodemographic and psychological features, that need to be identified and treated independently.
Pruritus (itch) is defined as an unpleasant sensation provoking the urge to scratch and can be understood both as a symptom and, when lasting more than six weeks, as a disease entity termed chronic pruritus (CP). CP is characterized by complex neurobiological changes and can persist independently of the initial trigger, significantly impairing quality of life. Advances since the 1990s in understanding itch pathophysiology have led to the development of numerous targeted therapies, although many treatments remain off-label. Pruritus is classified into dermatological, systemic, neuropathic, and psychogenic categories, often with overlapping etiologies. Effective management prioritizes identifying and treating the underlying cause. Pathophysiologically, itch originates from specialized peripheral sensory neurons (pruriceptors), which transmit signals through histaminergic and non-histaminergic pathways. While histamine plays a role mainly in urticaria, chronic itch is largely mediated by non-histaminergic mechanisms involving cytokines, neuropeptides, proteases, transient receptor potential (TRP) channels, and Mas-related G-protein-coupled receptors (MRGPRs). Keratinocytes, mast cells, and immune mediators such as IL-31, IL-4, and IL-13 actively participate in itch signaling, creating neuroimmune feedback loops. Peripheral and central sensitization, spinal disinhibition, and altered pain-itch interactions sustain chronic itch and the itch-scratch cycle, particularly in chronic prurigo (CPG), a distinct disease model for CP. Therapeutic strategies target multiple levels of itch processing. Traditional treatments include antihistamines, topical anesthetics, calcineurin inhibitors, antidepressants, gabapentinoids, and immunosuppressants, though efficacy varies. Recent breakthroughs include biologics targeting TH2 pathways (dupilumab, nemolizumab), JAK inhibitors, κ-opioid receptor agonists (difelikefalin), and IBAT inhibitors (for cholestatic pruritus). Novel targets under investigation include MRGPRs, PARs, KIT receptors, OX-40, and sodium channels.
AIMS:The objective of this study was to assess the prevalence and determinants of self-medication among military personnel deployed on surface ships of the French Navy. METHODS:A cross-sectional observational monocentric study was conducted from April to September 2024 using self-administered questionnaires distributed on board five surface ships from the Toulon naval base. The data collected covered sociodemographic characteristics and self-medication behaviors. Statistical analyses were performed using R software (version 4.0.3; 2020). RESULTS:Among the 405 participants included, 54.1% reported having used at least one medication in self-medication during the mission. First-line painkillers were the most commonly used drugs (85.8%), mainly for headaches (82.2%). Independent predictive factors for self-medication were female sex, being a crew member or petty officer over 25 years old, longer mission duration, and history of self-medication practices. Adverse drug reactions were reported by 2.8% of participants. CONCLUSION:Self-medication appears to be a common practice among naval personnel, probably favored by isolation, culture of the performance, and desire to maintain operational skills. These findings highlight the need for better education and supervision regarding self-medication use at sea, the development of guidelines for a reasonable self-medication, and a stronger preventive role for onboard medical staff.
Objectif: Évaluer l’efficacité du naproxène, de l’ibuprofène, du kétoprofène, du diclofénac, de l’étoricoxib et du célécoxib dans les lombalgies avec ou sans radiculalgie.Méthode: Revue systématique de la littérature et méta-analyse des essais cliniques randomisés (ECR) selon la méthode REB. Les critères d’éligibilité étaient les ECRs évaluant l’efficacité antalgique des anti-inflammatoires non stéroïdiens (AINS) susmentionnés administrés per os versus placebo, dans les lombalgies aiguës ou chroniques avec ou sans radiculalgie. Les recherches bibliographiques ont été menées sur Medline, Cochrane Central Register of Controlled Trials et ClinicalTrial.gov, jusqu’au 31/12/2024. Les risques de biais des essais inclus ont été évalués avec l’outil risk of bias 2 (RoB2) de la collaboration Cochrane. En plus de l’analyse qualitative selon la méthode REB, une analyse quantitative a été faite à l’aide du logiciel Review Manager version 5.4. Les différences de moyennes standardisées (SMD) ont été calculées avec leurs intervalles de confiance à 95 % (IC95). La signification statistique a été établie si la valeur de p était < 0,05.Résultats: Au total, 11 essais ont été identifiés : 6 concernaient la lombalgie aiguë et 5 la lombalgie chronique. Parmi ces essais 6 étaient à bas risque de biais pour l’intensité de la douleur et 4 à bas risque de biais pour la capacité fonctionnelle, tandis que 5 étaient à haut risque de biais pour l’intensité de la douleur et 5 à haut risque de biais pour la capacité fonctionnelle. Trois mille sept cent quatre-vingt-quatre (3 784) patients ont été inclus : 2 142 souffraient de lombalgie chronique et 1 642 de lombalgie aiguë. L’analyse selon REB a conclu à une « preuve d’efficacité solide » pour le diclofénac dans les lombalgies aiguës. Pour l’ibuprofène dans les lombalgies aiguës sans radiculalgie les résultats étaient « probants à confirmer ». Pour le naproxène dans les lombalgies aiguës avec radiculalgie les résultats étaient « probant à confirmer ». Pour les autres médicaments et les autres indications, la conclusion était « absence de preuve ». Pour tous les essais la quantité d’effet était inférieure à la différence minimale cliniquement pertinente (DMPCP) prédéfinie (< 10 sur EVA 100 mm).Discussion: Cette revue présente plusieurs limites : un faible nombre d’essais ayant évalué les AINS versus placebo, ce qui limite l’interprétation d’un éventuel biais de publication par l’interprétation des funnel plots. Plus de la moitié des essais sélectionnés avaient pour objectif l’évaluation d’un principe actif ou d’un traitement différent, les AINS étudiés ayant été essentiellement utilisés comme comparateurs. Seuls les essais publiés en français et en anglais ont été inclus, ce qui a pu entraîner un biais de sélection. De plus, les résultats des ECRs étaient souvent sur des critères de jugement secondaires et non principaux. Sur les 6 AINS étudiés, seul le diclofénac avait un niveau de preuve solide d’efficacité sur l’intensité de la douleur dans les lombalgies aiguës. L’ibuprofène et le naproxène avaient des résultats probants qui nécessitaient une confirmation. Pour les autres médicaments, il n’y avait pas de preuve d’efficacité selon la méthode REB. Pour toutes les analyses, la quantité d’effet observée était faible et non cliniquement pertinente.
OBJECTIVE:To describe the characteristics of medication errors (MEs) occurring in the hospital care and medico-social sectors, both caring for individuals with mental health disorders, and operating under different medication-use regulations. METHODS:We conducted a retrospective cross-sectional study using ME reports from a psychiatric hospital (hospital care sector) and a specialized residential care facility for individuals with intellectual disabilities (medico-social sector) in France (2014-2021). MEs were analyzed using the ALARM method to identify their types, stages of occurrence and interception, consequences, drugs involved, and root causes. Prevalence odds ratios were calculated to assess the risks of specific types of MEs based on care setting. RESULTS:In the hospital care sector, MEs occurred most frequently at the prescribing stage (55.4%), with a higher proportion of potential error or risk of error (55.7%), and were predominantly intercepted during medication order review by the pharmacist (78.1%). The most common ME types were wrong dose (31.3%) and wrong drug (29.4%) errors, and severity was low (A-C classification: 75.3%), however, three deaths were reported. In the medico-social sector, MEs occurred predominantly at the administration stage (75%) and were mostly actual errors (81.6%), including wrong resident (43.4%), omissions (21.1%), and wrong time (17.1%) errors. No harmful or fatal MEs occurred, most required monitoring without harm (67.1%). Being a resident in the medico-social sector was associated with significantly higher risks of wrong resident errors (POR: 5.44; 95% CI: 3.25-9.11), particularly among those with cognitive impairment (112.50; 95% CI: 55.54-239.3), errors at the administration stage (6.58; 95% CI: 3.84-11.62), wrong time (5.30; 95% CI: 2.48-11.01), especially involving psychotropic drugs (3.98; 95% CI: 2.35-6.93). CONCLUSION:This study highlights major differences in the types and circumstances of MEs between the hospital care and medico-social sectors for individuals with mental health disorders. Regulatory and organizational frameworks in the medico-social sector should evolve, as in hospitals, to enhance medication safety.
BACKGROUND:Fluoroquinolones (FQ) are broad-spectrum antibiotics effective against various infections. However, their use has been progressively restricted by guidelines due to safety concerns, leading to repeated reassessments of their indication. Despite a marked decline in prescriptions, misuse remains a concern. This study aimed to assess FQ prescribing indications in general practice in France and analyse their evolution between 2014 and 2023 in light of changing guidelines. METHODS:We conducted a descriptive observational study using data from the THIN® (The Health Improvement Network) database, managed by CEGEDIM-GERS DATA. This European database collects anonymized electronic health records from private practitioners in seven countries, including France since 2014. In 2023, the French panel included over 3 million patients and approximately 2000 general practitioners (GPs). Available data include administrative and medical information. Oral FQ prescriptions for patients aged≥20years were analyzed in 2014, 2019 and 2023 for compliance with five frameworks: marketing authorization (MA), SPILF 2015 (French Infectious Diseases Society), HAS 2016 (French National Authority of Health) and EMA 2018/2019 (European Medicines Agency). Results were stratified by sex, age, molecule and indication category. RESULTS:FQ prescriptions by GPs declines by 59% between 2014 and 2023. Compliance varied by reference: approximately 75% according to MA and SPILF versus less than 25% with more recent guidelines (HAS 2016 and EMA 2018/2019). Compliance was lower in women and patients aged≥75years. In 2023, the largest misuse was observed for urinary and prostate infections (from approximately 94% to 24%) due to changes affecting uncomplicated urinary tract infections in women. For respiratory or ear nose and throat (ENT) infections, compliance remained low (20-40%) across all references. CONCLUSIONS:Despite decreasing FQ use in general practice, many prescriptions remain non-compliant with updated recommendations, highlighting a persistent gap between clinical practices and evolving guidelines.
BACKGROUND:Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are widely used in the treatment of advanced breast cancer. While a reversible increase in serum creatinine is a recognized class effect, the spectrum and severity of renal adverse events (AE) associated with these agents remain incompletely characterized. METHODS:We conducted a retrospective analysis of the French national pharmacovigilance database from 2016 to January 2024 to identify reports of renal AE associated with the CDK4/6 inhibitors, palbociclib, abemaciclib, and ribociclib. Cases were classified as pseudo-renal failure, renal failure in the context of dehydration, or renal failure without dehydration. RESULTS:Among 42 cases of renal AE identified, abemaciclib was implicated in 48%, palbociclib in 33%, and ribociclib in 19%. Pseudo-renal failure, attributed to inhibition of tubular creatinine transporters, was observed in one case. Seventeen cases of renal failure occurred in the context of dehydration, predominantly associated with abemaciclib and gastrointestinal toxicity. Twenty-four cases occurred without dehydration, with some confirmed as acute tubular necrosis (ATN) or tubulo-interstitial nephritis (TIN) on biopsy. Most cases were serious and required hospitalization. Renal replacement therapy was needed in three cases. CDK4/6 inhibitor was discontinued in 85% of the cases with a favorable outcome in the majority of the cases. A positive rechallenge was observed in 4 cases including true acute kidney injury in 2 cases. CONCLUSIONS:CDK4/6 inhibitors may cause functional and true renal impairment, ranging from mild, reversible creatinine increases to severe acute kidney injury. When performed, renal biopsy showed ATN and TIN. Close monitoring of renal function including cystatine-C based GFR evaluation and characterization of renal injury are essential to optimize patient safety.
Les lombalgies communes aiguës avec ou sans radiculalgie sont une pathologie fréquente en médecine générale. En pratique, les myorelaxants sont utilisés. Pourtant leur efficacité est controversée. Une méta-analyse d’essais contrôlés randomisés (ECR) de 2021 concluait à une efficacité possible avec faible niveau de preuve.Objectifs : Le but de cet essai est d’évaluer l’efficacité de 3 myorelaxants (thiocolchicoside, méthocarbamol et diazépam) disponibles et utilisés en France pour l’amélioration de la douleur et de la fonctionnalité dans les lombalgies aiguës avec ou sans radiculalgie par une revue systématique des ECR avec évaluation du niveau de preuve selon la méthode REB (rebuild the evidence base).Méthodes : Une recherche bibliographique dans 3 bases de données (Medline, Cochrane et Embase), le registre ClinicalTrials.gov jusqu’au 31/03/2024 a été réalisée. Le risque de biais a été évalué avec l’outil RoB2. Les critères de jugement étaient l’amélioration de la douleur et de la fonctionnalité. La méthode REB a été utilisée pour évaluer le niveau de preuve de l’efficacité de chaque molécule. PROSPERO Protocol: CRD42024564738Résultats : Huit essais ont été inclus : thiocolchicoside (4 ECR, 604 patients), méthocarbamol (2 ECR, 223 patients), diazépam (2 ECR 164 patients). Les ECR évaluant le thiocolchicoside étaient tous à haut risque de biais. Pour le méthocarbamol 1 ECR était à faible risque de biais et retrouvait une amélioration fonctionnelle de 2,8 points en faveur du placebo (IC95 % : 0,0 à 5,7), non significatif.Pour le diazépam, 1 ECR était à faible risques de biais et retrouvait une amélioration fonctionnelle en faveur du placebo de + 0,3 point (IC 95 % : –2,8 à 3,5), non significatif.Conclusion : Selon la méthode REB, aucune des trois molécules n’a démontré d’efficacité dans les lombalgies communes avec ou sans radiculalgie.
R & eacute;sum & eacute; Consciente de l'importance des produits de sant & eacute; dans notre soci & eacute;t & eacute;, des difficult & eacute;s d'acc & egrave;s & agrave; une information fiable dans un contexte num & eacute;rique en pleine expansion, et du r & ocirc;le essentiel de la litt & eacute;ratie en sant & eacute; pour permettre aux citoyens de faire des choix & eacute;clair & eacute;s, la table ronde a & eacute;t & eacute; organis & eacute;e afin d'identifier des leviers visant & agrave; renforcer l'& eacute;ducation et la compr & eacute;hension des produits de sant & eacute; au sein de la population. Apr & egrave;s avoir & eacute;chang & eacute; sur la d & eacute;finition de la litt & eacute;ratie en sant & eacute; ainsi que sur des initiatives d & eacute;j & agrave; mises en oe uvre, les participants ont formul & eacute; dix recommandations (R) pour am & eacute;liorer la litt & eacute;ratie sur les produits de sant & eacute; : d & eacute;finir un socle commun de connaissances minimales sur les m & eacute;dicaments, valid & eacute; par consensus, pour harmoniser les bases de compr & eacute;hension du public (R1) ; d & eacute;velopper une information multimodale et coordonn & eacute;e aux niveaux national, local et individuel (R2) ; inscrire les interventions sur la dur & eacute;e, en r & eacute;p & eacute;tant et adaptant les messages selon l'& acirc;ge et le contexte (R3) ; intervenir pr & eacute;cocement en milieu scolaire en int & eacute;grant les produits de sant & eacute; dans les enseignements et le service sanitaire (R4) ; construire une & eacute;ducation de qualit & eacute; en prenant en compte les comp & eacute;tences psychosociales et en coconstruisant les messages avec le public (R5) ; occuper activement l'espace num & eacute;rique pour rendre visibles des contenus fiables (R6) ; valoriser et diffuser les initiatives et contenus existants & agrave; plus grande & eacute;chelle (R7) ; mettre en place une structure de confiance centralisant les contenus valid & eacute;s (R8) ; int & eacute;grer les ordonnances comme support d'information personnalis & eacute;e (R9) ; et contribuer & agrave; la r & eacute;flexion nationale sur la lutte contre la d & eacute;sinformation (R10). (c) 2025 Publie par Elsevier Masson SAS au nom de Societe franc & cedil;aise de pharmacologie et de therapeutique.
