{"title":"A new tool to study the effects of in utero medication exposure on neurodevelopment in children","authors":"Laurane Delteil , Caroline Hurault-Delarue , Catherine Arnaud , Dana Klapouszczak , Isabelle Lacroix , Malika Delobel-Ayoub","doi":"10.1016/j.therap.2025.06.009","DOIUrl":"10.1016/j.therap.2025.06.009","url":null,"abstract":"<div><div>Here we describe the implementation of a new tool that would allow to assess the risk of serious disability following in utero exposure to medications. The overall objective was to enrich the EFEMERIS database [<em>Évaluation chez la Femme Enceinte des MEdicaments et de leurs RISques</em> (evaluation in the pregnant woman of medications and their risques database] containing data on reimbursed medication prescriptions and pregnancy outcomes) with data from the Haute-Garonne childhood disability registry (RHE31). The EFEMERIS database included 97,350 children born between 2004 and 2014 who were still living in Haute-Garonne at the age of 8. After matching with the RHE31, we identified 908 children (58.8% of RHE31-eligible children) with pervasive developmental disorder (PDD)/autism spectrum disorder (ASD) and/or severe motor impairment, severe neurosensory impairment or intellectual disability (IQ<!--> <!--><<!--> <!-->50). Non-matched RHE31-eligible children did not differ significantly from matched children. Children diagnosed with PDD/ASD and/or severe disability were significantly more likely to have been exposed to certain ATC drug classes, particularly those in the “nervous system” class. Given the number of RHE31-children included, we can already envisage pharmacoepidemiologic studies to investigate the relationship between in utero medication exposure and the child's risk of neurodevelopmental disorders. This project, the first of its kind in France, will specifically improve data on the effects of medications on child neurodevelopment.</div></div><div>Here we describe the implementation of a new tool that would allow to assess the risk of serious disability following in utero exposure to medications. The overall objective was to enrich the EFEMERIS database [<em>Évaluation chez la Femme Enceinte des MEdicaments et de leurs RISques</em> (evaluation in the pregnant woman of medications and their risques database] containing data on reimbursed medication prescriptions and pregnancy outcomes) with data from the Haute-Garonne childhood disability registry (RHE31). The EFEMERIS database included 97,350 children born between 2004 and 2014 who were still living in Haute-Garonne at the age of 8. After matching with the RHE31, we identified 908 children (58.8% of RHE31-eligible children) with pervasive developmental disorder (PDD)/autism spectrum disorder (ASD) and/or severe motor impairment, severe neurosensory impairment or intellectual disability (IQ<!--> <!--><<!--> <!-->50). Non-matched RHE31-eligible children did not differ significantly from matched children. Children diagnosed with PDD/ASD and/or severe disability were significantly more likely to have been exposed to certain ATC drug classes, particularly those in the “nervous system” class. Given the number of RHE31-children included, we can already envisage pharmacoepidemiologic studies to investigate the relationship between in utero medication exposure and the child's r","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 3","pages":"Pages 234-243"},"PeriodicalIF":1.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2026-05-01Epub Date: 2026-02-14DOI: 10.1016/j.therap.2025.12.005
Amnuay Kleebayoon , Viroj Wiwanitkit
{"title":"Validation of in-hospital diagnosis codes to identify skin ulcers in healthcare databases: A correspondence","authors":"Amnuay Kleebayoon , Viroj Wiwanitkit","doi":"10.1016/j.therap.2025.12.005","DOIUrl":"10.1016/j.therap.2025.12.005","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 3","pages":"Page 284"},"PeriodicalIF":1.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147355058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2026-05-01Epub Date: 2025-07-25DOI: 10.1016/j.therap.2025.07.002
Louis Asselin , Edouard-Jules Laforgue , Mélanie Duval , Bruno Revol , Gwenaëlle Veyrac , Marie Grall-Bronnec , Caroline Victorri-Vigneau
{"title":"Drugs associated with behavioral addictions: Real world analysis using the WHO pharmacovigilance database","authors":"Louis Asselin , Edouard-Jules Laforgue , Mélanie Duval , Bruno Revol , Gwenaëlle Veyrac , Marie Grall-Bronnec , Caroline Victorri-Vigneau","doi":"10.1016/j.therap.2025.07.002","DOIUrl":"10.1016/j.therap.2025.07.002","url":null,"abstract":"<div><h3>Objectives</h3><div>Behavioral addictions (BA) are a newly recognized diagnostic entity. While some drugs are known to induce BA, some of them remains unknown. The aim of this study was to identify drugs for which B is not listed in the summaries of product characteristics.</div></div><div>Behavioral addictions (BA) are a newly recognized diagnostic entity. While some drugs are known to induce BA, some of them remains unknown. The aim of this study was to identify drugs for which B is not listed in the summaries of product characteristics.</div><div><h3>Methods</h3><div>We conducted a search on Vigibase to identify health professional's cases where drugs are “suspect” coded with the following preferred terms: (1) ‘behavioral addiction’, (2) ‘gambling disorder’, (3) ‘gaming disorder’, (4) ‘compulsive sexual behavior’, (5) ‘bulimia nervosa’, (6) ‘binge eating’ and (7) ‘compulsive shopping’. We selected drugs “suspect” in at least five cases for which the summaries of product characteristics do not mention BA. We applied a downward descriptive process (drug only suspect, positive dechallenge, well-documented cases) together with a disproportionality analysis and a PubMed search.</div></div><div>We conducted a search on Vigibase to identify health professional's cases where drugs are “suspect” coded with the following preferred terms: (1) ‘behavioral addiction’, (2) ‘gambling disorder’, (3) ‘gaming disorder’, (4) ‘compulsive sexual behavior’, (5) ‘bulimia nervosa’, (6) ‘binge eating’ and (7) ‘compulsive shopping’. We selected drugs “suspect” in at least five cases for which the summaries of product characteristics do not mention BA. We applied a downward descriptive process (drug only suspect, positive dechallenge, well-documented cases) together with a disproportionality analysis and a PubMed search.</div><div><h3>Results</h3><div>We identified 24 drugs across 7 pharmacological classes: antidepressants, antipsychotics, antiepileptics, benzodiazepines, psychostimulants, antidiabetics and retinoids. Olanzapine was the only accompanied by well-documented cases with positive dechallenges, exhibiting significant disproportionality analysis and associated with publications from the PubMed search.</div></div><div>We identified 24 drugs across 7 pharmacological classes: antidepressants, antipsychotics, antiepileptics, benzodiazepines, psychostimulants, antidiabetics and retinoids. Olanzapine was the only accompanied by well-documented cases with positive dechallenges, exhibiting significant disproportionality analysis and associated with publications from the PubMed search.</div><div><h3>Conclusion</h3><div>Our results highlights that several drugs and notably olanzapine are associated with BA. Further research using definitions enabling the diagnosis of addictive disorders for various BA is warranted.</div></div><div>Our results highlights that several drugs and notably olanzapine are associated with BA. Further research using definitions enabling","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 3","pages":"Pages 200-211"},"PeriodicalIF":1.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2026-05-01Epub Date: 2025-06-26DOI: 10.1016/j.therap.2025.06.004
Tristan Pillot , Anas Gahbiche , Xavier Duval , Vanessa Bloch , Aude Jacob
{"title":"Certification ISO 9001 : 2015 de l’unité des essais cliniques d’un centre hospitalier universitaire","authors":"Tristan Pillot , Anas Gahbiche , Xavier Duval , Vanessa Bloch , Aude Jacob","doi":"10.1016/j.therap.2025.06.004","DOIUrl":"10.1016/j.therap.2025.06.004","url":null,"abstract":"<div><h3>Objectifs</h3><div>Le domaine de la recherche clinique est en développement permanent dans les établissements de santé en France. Ce développement ne doit cependant pas se faire aux dépens de la qualité des études ni de la sécurité des patients impliqués dans les projets de recherche. Décrire la démarche de certification du système de management de la qualité de l’unité pharmaceutique des essais cliniques de l’hôpital Lariboisière–Fernand Widal (UPEC) selon la norme ISO 9001 : 2015 pour l’amélioration continue de la qualité.</div></div><div>Le domaine de la recherche clinique est en développement permanent dans les établissements de santé en France. Ce développement ne doit cependant pas se faire aux dépens de la qualité des études ni de la sécurité des patients impliqués dans les projets de recherche. Décrire la démarche de certification du système de management de la qualité de l’unité pharmaceutique des essais cliniques de l’hôpital Lariboisière–Fernand Widal (UPEC) selon la norme ISO 9001 : 2015 pour l’amélioration continue de la qualité.</div><div><h3>Méthodes</h3><div>Ce projet de certification à l’initiative du département médico-universitaire dont fait partie l’UPEC a été dirigé par un référent assurance qualité, accompagné par un consultant qualité et réalisé par les membres de l’équipe de l’UPEC. Un audit initial a permis de faire un état des lieux et un planning a structuré l’ensemble de la démarche en définissant des échéances.</div></div><div>Ce projet de certification à l’initiative du département médico-universitaire dont fait partie l’UPEC a été dirigé par un référent assurance qualité, accompagné par un consultant qualité et réalisé par les membres de l’équipe de l’UPEC. Un audit initial a permis de faire un état des lieux et un planning a structuré l’ensemble de la démarche en définissant des échéances.</div><div><h3>Résultats</h3><div>Obtenue en septembre 2023, la certification pour la gestion pharmaceutique des produits expérimentaux sur notre secteur s’est faite en déterminant les enjeux internes et externes, les parties intéressées, les risques et les opportunités liés à l’activité de l’UPEC. De plus, l’élaboration d’indicateurs de surveillance pertinent permettent d’évaluer l’efficacité du système de management de la qualité (SMQ). Enfin la priorisation des actions grâce aux conclusions du rapport d’audit initial a permis de progresser efficacement et d’aboutir à un SMQ conforme au référentiel ISO 9001 : 2015 en 21 mois.</div></div><div>Obtenue en septembre 2023, la certification pour la gestion pharmaceutique des produits expérimentaux sur notre secteur s’est faite en déterminant les enjeux internes et externes, les parties intéressées, les risques et les opportunités liés à l’activité de l’UPEC. De plus, l’élaboration d’indicateurs de surveillance pertinent permettent d’évaluer l’efficacité du système de management de la qualité (SMQ). Enfin la priorisation des actions grâce aux conclusions du rapport d’audit ini","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 3","pages":"Pages 256-267"},"PeriodicalIF":1.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144699626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2026-05-01Epub Date: 2025-07-10DOI: 10.1016/j.therap.2025.06.008
Amir Kallab Debbih , Christophe Cutarella , Elisabeth Jouve , Michel Spadari , Joelle Micallef , Elisabeth Frauger
{"title":"Mise en place d’un sevrage de benzodiazépines avec substitution par le prazépam : Étude rétrospective auprès de 86 patients","authors":"Amir Kallab Debbih , Christophe Cutarella , Elisabeth Jouve , Michel Spadari , Joelle Micallef , Elisabeth Frauger","doi":"10.1016/j.therap.2025.06.008","DOIUrl":"10.1016/j.therap.2025.06.008","url":null,"abstract":"<div><h3>Introduction</h3><div>En France, la consommation de benzodiazépines et apparentés (BZD) reste importante malgré des recommandations de la Haute autorité de santé (HAS). Différentes stratégies de sevrage sont recommandées : diminution progressive de la BZD ou substitution vers le diazépam dans certaines situations. Le prazépam peut être également une molécule intéressante (demi-vie longue, forme galénique buvable, moins de risque d’abus que le diazépam). L’objectif de ce travail est de décrire l’efficacité, la survenue d’effets indésirables et la faisabilité d’un programme de sevrage des BZD avec une substitution par le prazépam.</div></div><div>En France, la consommation de benzodiazépines et apparentés (BZD) reste importante malgré des recommandations de la Haute autorité de santé (HAS). Différentes stratégies de sevrage sont recommandées : diminution progressive de la BZD ou substitution vers le diazépam dans certaines situations. Le prazépam peut être également une molécule intéressante (demi-vie longue, forme galénique buvable, moins de risque d’abus que le diazépam). L’objectif de ce travail est de décrire l’efficacité, la survenue d’effets indésirables et la faisabilité d’un programme de sevrage des BZD avec une substitution par le prazépam.</div><div><h3>Matériel et méthode</h3><div>Les données ont été recueillies de façon rétrospective parmi les patients hospitalisés à la clinique Saint Barnabé en 2022 ayant reçu du prazépam pour sevrage. Le sevrage est considéré comme réussi à la sortie d’hospitalisation dans le cas d’une diminution de plus de 50 % de la posologie initiale de prazépam ou d’un arrêt total de prazépam.</div></div><div>Les données ont été recueillies de façon rétrospective parmi les patients hospitalisés à la clinique Saint Barnabé en 2022 ayant reçu du prazépam pour sevrage. Le sevrage est considéré comme réussi à la sortie d’hospitalisation dans le cas d’une diminution de plus de 50 % de la posologie initiale de prazépam ou d’un arrêt total de prazépam.</div><div><h3>Résultats</h3><div>Parmi les 86 patients, la majorité avait des comorbidités psychiatriques et addictologiques. Parmi eux, 55 % consommaient une BZD depuis plus d’un an, 36 % au moins deux BZD et 15 % à des doses supérieures à l’autorisation de mise sur le marché (AMM). À la sortie d’hospitalisation (médiane de 42<!--> <!-->jours), 62 % des patients avaient un sevrage réussi : 29 % ont été sevrés et 33 % ont diminué de plus de 50 % leur posologie. Le protocole a été adapté pour 38 % des patients et 27 % ont présenté des signes de sevrage. Plusieurs facteurs étaient significativement associés à un sevrage partiellement réussi ou échec : présence de trouble de la personnalité, hospitalisation dans un contexte de trouble d’usage de cocaïne, signes de sevrage et adaptation du protocole.</div></div><div>Parmi les 86 patients, la majorité avait des comorbidités psychiatriques et addictologiques. Parmi eux, 55 % consommaient une BZD depuis plus d’un an, 36 ","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 3","pages":"Pages 189-199"},"PeriodicalIF":1.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733431","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Review of spontaneous reports with positive rechallenge: Data of Toulouse Pharmacovigilance Center.","authors":"Elsa Trime, Joanna Lapalus, Eda Cankurtaran, Leila Chebane, Mathis Hugot, Adèle Le Guillou, Haleh Bagheri","doi":"10.1016/j.therap.2026.04.004","DOIUrl":"https://doi.org/10.1016/j.therap.2026.04.004","url":null,"abstract":"<p><strong>Introduction: </strong>Apart from observational studies, anecdotal reports can offer evidence that an event is causally linked to one or more drugs and then could contribute to a better assessment of a drug's benefit-risk ratio. These reports based on temporality and dechallenge/rechallenge data have a real value and help to make safety decision.</p><p><strong>Objective: </strong>The aim of our study was to describe the characteristics of positive rechallenge cases of adverse drug reactions (ADRs) reported to the Toulouse Pharmacovigilance Center (TPC), without restricting our analysis to any specific type of ADR or drug class. We described the drug class most commonly involved in the occurrence of serious ADRs following drug rechallenge.</p><p><strong>Method: </strong>Retrospective study using data from the Toulouse Pharmacovigilance Database from 1st January 2022 until 31st December 2024. All cases of vaccines-induced ADRs were excluded. A descriptive analysis was done for demographic data, nature of ADRs and outcome, suspected drugs. Furthermore, the cases reported by the Department of Allergology for patients who underwent allergological investigation following a suspected hypersensitivity reaction were analyzed separately.</p><p><strong>Results: </strong>Among the 8,196 ADR reports, 2,256 cases vaccine-related cases were excluded. Of the remaining 5,940 cases, 325 (5.5%) met the criteria for a positive rechallenge. The median age of patients was 57 years [35-72], mean 53.6 (±22.9) years and the sex ratio was 1.44. The outcome was fatal in three cases. The most drug class (more than 20 fold) involved in positive rechallenge cases was antineoplasic agents (n=105) and immunosuppressants (n=51), drugs of nervous system (n=95), systemic anti-infective agents (n=83), and cardiovascular drugs (n=54). A total of 187 cases concerned positive rechallenge for hypersensitivity reactions after allergological investigations.</p><p><strong>Conclusion: </strong>Case reports containing dechallenge/rechallenge data could be considerable value for improving knowledge to support optimal drug use, particularly in situations where no alternative is available. This preliminary study limited to the data of one pharmacovigilance center could be extended in national level.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147857215","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2026-04-21DOI: 10.1016/j.therap.2026.04.003
Paul Alfieri, Marie Landry, Rémy Boussageon
{"title":"[Efficacy of celecoxib, diclofenac, etoricoxib, ibuprofen, ketoprofen and naproxen in low back pain with or without nerve root pain: Systematic review of literature and meta-analysis of randomized controlled trials].","authors":"Paul Alfieri, Marie Landry, Rémy Boussageon","doi":"10.1016/j.therap.2026.04.003","DOIUrl":"https://doi.org/10.1016/j.therap.2026.04.003","url":null,"abstract":"<p><strong>Objectives: </strong>To assess the efficacy of naproxen, ibuprofen, ketoprofen, diclofenac, etoricoxib and celecoxib in low back pain with or without radiculalgia.</p><p><strong>Method: </strong>Systematic review and meta-analysis of randomised controlled trials (RCTs) using the REB method. Eligibility criteria were RCTs assessing the painkiller efficacy of the aforementioned non-steroidal anti-inflammatory drugs (NSAIDs) administered orally versus placebo, in acute and chronic low back pain with or without radiculalgia. The literature search was conducted on Medline, Cochrane Central Register of Controlled Trials, and ClinicalTrial.gov until 31/12/2024. The risks of bias were assessed using the tool Risk of Bias 2 (RoB2) from the Cochrane collaboration. In addition to the qualitative analysis using the REB method, a quantitative analysis was conducted using Review Manager v5.4. The standardised mean differences (SMD) were calculated with a 95% confidence interval (95% CI). Statistical significance was met if the P-value was<0.05.</p><p><strong>Results: </strong>A total of 11 RCTs were identified: 6 concerned acute low back pain and 5 chronic low back pain. Six were at low risk of bias for pain intensity, and 4 at low risk of bias for functional capacity; 5 were at high risk of bias for pain intensity and 5 at high risk of bias for functional capacity. Three thousand seven hundred eighty-four (3784) patients were included: 2142 suffered from chronic low back pain and 1642 from acute low back pain. The REB analysis concluded \"solid evidence of efficacy\" for diclofenac in acute low back pain. For the ibuprofen in acute low back pain without radiculalgia, the results were \"conclusive to be confirmed\". For the naproxen in acute low back pain with radiculalgia, the results were \"conclusive to be confirmed\". For the other treatments and indications, the conclusion was \"lack of evidence\".</p><p><strong>Discussion: </strong>This review has several limitations: a small number of trials that evaluated NSAIDs versus placebo, which limits the interpretation of possible publication bias by the interpretation of funnel plots. More than half of the selected trials aimed to evaluate a different active ingredient or treatment, with the NSAIDs studied primarily used as comparators. Only trials published in French and English were included, which may have introduced selection bias. Furthermore, the results of the RCTs often focused on secondary rather than primary endpoints. Of the 6 NSAIDs studied, only diclofenac showed solid evidence of efficacy on pain intensity in acute low back pain. Ibuprofen and Naproxen showed conclusive evidence requiring confirmation. For the other drugs, there was no evidence of efficacy according to the REB method. For all the analyses, the magnitude of the effect was small and not clinically relevant. It is necessary to conduct new RCTs to confirm the clinical interest of NSAIDs in acute and chronic low back pain.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2026-04-12DOI: 10.1016/j.therap.2026.04.002
Robin Lebas, Laurence Schadler, Claire Villeneuve, David Fontanier, Marie-Laure Laroche
{"title":"Medication errors in a residential care facility for adults with intellectual disabilities and in a psychiatric hospital.","authors":"Robin Lebas, Laurence Schadler, Claire Villeneuve, David Fontanier, Marie-Laure Laroche","doi":"10.1016/j.therap.2026.04.002","DOIUrl":"https://doi.org/10.1016/j.therap.2026.04.002","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147864441","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}