TherapiePub Date : 2024-07-01DOI: 10.1016/j.therap.2023.10.015
{"title":"Validation d’une version française de l’outil AT-HARM10 pour la détection des hospitalisations liées au médicament","authors":"","doi":"10.1016/j.therap.2023.10.015","DOIUrl":"10.1016/j.therap.2023.10.015","url":null,"abstract":"<div><p>Les admissions des personnes âgées pour cause d’évènement iatrogène médicamenteux sont fréquentes à l’hôpital. Cependant, il n’existe pas à ce jour de méthode validée en langue française pour les identifier. L’objectif de ce travail a été de valider la version francophone de l’outil AT-HARM10 pour une utilisation à l’admission des patients dans nos structures de soins. Il se présente sous la forme de 10 questions fermées. Une réponse positive à l’une des 3 premières questions met en évidence une admission non liée au médicament. Une réponse positive à l’un des 7 items suivants définit une cause iatrogène probablement en lien avec l’hospitalisation. Nous avons effectué une validation sémantique et linguistique par validation croisée sous forme d’allers-retours entre experts. Pour valider cliniquement le questionnaire, nous avons réalisé une étude rétrospective sur les dossiers de patients de plus de 65 ans admis en unité d’hospitalisation de courte durée (UHCD) et en chirurgie orthopédique et traumatologie au sein de deux établissements hospitaliers. La fiabilité inter-opérateur était élevée (taux d’accord initial entre évaluateurs<!--> <!-->=<!--> <!-->87 %, coefficient kappa de Cohen<!--> <!-->=<!--> <!-->0,75). Nous avons analysé 266 dossiers de 166 patients admis en UHCD (âge moyen 86,0<!--> <!-->±<!--> <!-->5,7 ans; sexe ratio 0,66; nombre moyen de médicaments prescrits 7,7<!--> <!-->±<!--> <!-->3,8) et 100 patients admis dans les services de chirurgie orthopédique et traumatologie (âge moyen 85,2<!--> <!-->±<!--> <!-->6,1 ans; sexe ratio 0,43 ; nombre moyen de médicaments prescrits 6,4<!--> <!-->±<!--> <!-->3,6). Nous avons identifié 55 % d’admissions en lien probable avec le médicament en UHCD et 76 % dans les unités d’orthopédie (<em>P</em> <!--><<!--> <!-->0,05). L’item du questionnaire le plus représenté était P5 dans les deux groupes. L’outil AT-HARM10 validé est désormais intégré à nos pratiques de pharmacie clinique et des bilans de médication sont proposés en priorité aux patients admis pour motif iatrogène.</p></div><div><p>Admissions of the elderly related to medication errors are frequent in hospital, more than half would be avoidable, but there is currently no validated method in French to identify them. The objective of this work was to validate the French version of the AT-HARM10 tool in order to use it for patients admitted in our healthcare facilities. The tool has 10 questions. A positive response to any of the first 3 questions identify admissions that are unlikely to be drug-related. A positive response to one of the following 7 questions identify possible medication-related admissions. For semantic and linguistic validation, we performed cross-validation with forward-backward translation. To clinically validate the method, we conducted a retrospective study including patients over 65 admitted to short-stay units (UHCD) and to orthopedic surgery units in two French hospitals. Two hundred and sixty-six (266) pati","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 4","pages":"Pages 461-467"},"PeriodicalIF":2.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138441310","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 : 2024-07-01DOI: 10.1016/j.therap.2023.10.002
{"title":"Green tea and nadolol interaction: A risk of therapeutic inefficiency, a case report and extensive review","authors":"","doi":"10.1016/j.therap.2023.10.002","DOIUrl":"10.1016/j.therap.2023.10.002","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 4","pages":"Pages 482-485"},"PeriodicalIF":2.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89719610","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 : 2024-07-01DOI: 10.1016/j.therap.2023.10.001
{"title":"Apport des tests cutanés dans le cas d’un exanthème flexural et symétrique induit par la pristinamycine","authors":"","doi":"10.1016/j.therap.2023.10.001","DOIUrl":"10.1016/j.therap.2023.10.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 4","pages":"Pages 491-493"},"PeriodicalIF":2.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135661106","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 : 2024-07-01DOI: 10.1016/j.therap.2023.10.003
{"title":"Élaboration d’une activité éducative ciblée en addictologie : de la conception à l’utilisation dans les structures spécialisées de la région Normandie","authors":"","doi":"10.1016/j.therap.2023.10.003","DOIUrl":"10.1016/j.therap.2023.10.003","url":null,"abstract":"<div><h3>Objectif</h3><p>La réduction des risques et des dommages est un enjeu de santé publique et permet de considérer l’addiction comme une pathologie chronique dans laquelle les patients ont l’opportunité de devenir acteurs de leur prise en charge, philosophie de soins partagée avec l’éducation thérapeutique. Dans ce contexte, notre objectif est de développer un outil adapté aux populations de patients/usagers accueillies en structures spécialisées, répondant aux critères d’une activité éducative ciblée, pour leur permettre une meilleure compréhension et gestion de leur addiction aux opiacés au quotidien.</p></div><div><h3>Méthode</h3><p>Dans un cadre pluriprofessionnel, associant pharmaciens, médecins et infirmiers, une phase exploratoire a été conduite afin de cerner la thématique, le public cible et le format de l’outil. Puis, l’outil a été construit et validé avec l’ambition de répondre pédagogiquement aux problématiques rencontrées quotidiennement par les patients/usagers.</p></div><div><h3>Résultats</h3><p>L’outil pédagogique, dénommé « Le QUIZZ à moindre risque », comporte 51 questions catégorisées en 2 parties structurées sur la réduction des risques liés à la consommation des opiacés et aux médicaments de substitution. Centré sur les problématiques des patients/usagers, il permet de les accompagner vers une plus grande autonomie en santé et une meilleure qualité de vie, avec et malgré la maladie. Le format proposé en fait un outil librement consultable par les patients/usagers selon leurs pratiques et leurs besoins ; il peut également être utilisé dans des ateliers collectifs menés avec les soignants.</p></div><div><h3>Conclusion</h3><p>L’outil développé vise à (i) permettre aux consommateurs d’opiacés d’acquérir des compétences pour mieux gérer leur consommation et les risques encourus et (ii) renforcer la communication entre patients/usagers et soignants en leur offrant l’opportunité d’être acteurs de leur soin. L’outil est actuellement testé et évalué dans de nombreuses villes normandes et son optimisation permettra une amélioration dans la prise en soins à la hauteur des enjeux et des besoins.</p></div><div><h3>Objective</h3><p>Risk and damage reduction is a public health issue and allows to consider addiction as a chronic pathology in which patients have the opportunity to become actors of their own care, a philosophy shared with Therapeutic Education. In this context, our objective is to develop a tool adapted to the populations of patients/users in specialized structures, meeting the criteria of a Targeted Educational Activity, to allow them a better understanding and management of their addiction to opiates on a daily basis.</p></div><div><h3>Method</h3><p>In a multi-professional setting, involving pharmacists, doctors and nurses, an exploratory phase was conducted in order to identify the theme, the target population and the tool format. Then, the tool was built and validated with the ambition of responding pedagogically to ","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 4","pages":"Pages 407-417"},"PeriodicalIF":2.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136152890","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":"[Balancing drug regulation and health democracy: The role of patient and healthcare professional advisors at the ANSM].","authors":"Patrick Maison, Trystan Bacon, Pascale Daynes, Christophe Decoene, Roseline Mazet, Thierry Vial, Stéphane Vignot, Laetitia Belgodère, Wahiba Oualikene-Gonin, Christelle Ratignier-Carbonneil","doi":"10.1016/j.therap.2024.06.002","DOIUrl":"https://doi.org/10.1016/j.therap.2024.06.002","url":null,"abstract":"<p><p>The French National Agency for Health Products (ANSM) is a regulatory and public health agency. Its regulatory, health policing and public health protection activities require a perfect fit with the field and the various people involved in the use of health products. Since 2019, the ANSM has adapted its organisation, procedures and processes to encourage and improve interaction with its stakeholders, as part of its policy of openness towards civil society. To accompany this ambitious change and to support its staff, the Agency has recruited advisors corresponding to the main users of health products: prescribers (doctor's hospital and outpatient), pharmacists and patients. Working as a group or individually, they provide a \"lived\" user perspective on health products at each stage of the evaluation process. They may be involved in the assessment of dossiers, signals or applications received by the Agency, in the internal validation of reports or in discussions with stakeholders. They are particularly involved when the analysis requires expertise that goes beyond the technical, scientific or regulatory aspects. They may also work with ANSM staff to explain certain processes and difficulties in the field. Advisors help to ensure that regulatory and/or scientific expertise is clear and consistent with user experience. In addition to their scientific and therapeutic aspects, medicines are also economic, social and political issues. Their regulation is therefore particularly affected by the need for health democracy. This requires the active participation of health professionals, patients and, more broadly, civil society in the decision-making process. Civil society is a space occupied by a wide range of actors who exert pressure from different ideological positions to influence the regulation of health products. In this context, taking into account a plurality of viewpoints in the regulation of health products is necessary and complex, but its operation can be facilitated by the collective efforts of the actors and the adaptation of organisations, such as the integration of advisors.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141545304","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":"COVACPREG, a French prospective cohort study of women vaccinated against COVID-19 during pregnancy.","authors":"Isabelle Lacroix, Anthony Caillet, Laurane Delteil, Hadjer Ameur, Nassima Padelli, Caroline Hurault-Delarue, Judith Cottin","doi":"10.1016/j.therap.2024.06.003","DOIUrl":"https://doi.org/10.1016/j.therap.2024.06.003","url":null,"abstract":"<p><p>The objective of this cohort study was to describe the French population of pregnant women vaccinated against coronavirus disease 2019 (COVID-19), their pregnancy outcomes and the health status of their newborns (malformation rate, neonatal diseases, etc.), and to proactively collect and analyze reported adverse reactions over time. We conducted a prospective study using an online questionnaire. Women vaccinated during pregnancy who wanted to participate were asked to complete an inclusion questionnaire (dates of pregnancy and vaccination COVID-19, etc.), a questionnaire on the potential occurrence of adverse reactions (time of onset, type of adverse reaction, etc.) of the vaccination, sent 1 month after the injection, and a final questionnaire on the outcome of the pregnancy and the health status of the child. A total of 938 women were prospectively included in this first French study. A total of 132 women reported having had at least 1 adverse reaction following vaccination during pregnancy (14.1%), including few 'serious' adverse reaction (5.3%). There were no signals of adverse reactions during continuous monitoring. Among the 938 pregnant women, 22.4% received the vaccination COVID-19 during the first trimester, 64.2% during the second and 33.4% during the third trimester (some women have had several injections in different trimesters). Among the 938 women, 4.3% developed gestational hypertension and 13.9% diabetes; 3.3% had intrauterine growth restriction and 7.8% threatened preterm delivery. These rates are comparable to those observed in the French general population. Among live births, the rate of preterm birth was 5.1%. We reported a prevalence of major malformations of 3.9%, which is comparable to that reported by European Surveillance of Congenital Anomalies (EUROCAT), with a rate of 3.5% of major malformations in the general population of mainland France. In conclusion, our study did not demonstrate any particular safety signals in the event of vaccination with a Covid-19 vaccine during pregnancy.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141601799","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":"What is the best source for searching drug with CIP codes in the French health reimbursement data system (SNDS) database?","authors":"Sylvain Couderc, Sabrina Crépin, Marc Labriffe, Caroline Monchaud, Hélène Roussel, Alexandre Garnier, Aurélie Prémaud, Claire Villeneuve, Clément Benoist, Jean-Baptiste Woillard, Pierre Marquet","doi":"10.1016/j.therap.2024.05.001","DOIUrl":"https://doi.org/10.1016/j.therap.2024.05.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141535349","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 : 2024-06-05DOI: 10.1016/j.therap.2024.05.006
Louis Lebreton, Benjamin Hennart, Sarah Baklouti, Aurélien Trimouille, Jean-Christophe Boyer, Laurent Becquemont, Claire-Marie Dhaenens, Nicolas Picard
{"title":"[Pharmacogenetics of aminoglycoside ototoxicity: State of knowledge and practices - Recommendations of the Francophone Network of Pharmacogenetics (RNPGx)].","authors":"Louis Lebreton, Benjamin Hennart, Sarah Baklouti, Aurélien Trimouille, Jean-Christophe Boyer, Laurent Becquemont, Claire-Marie Dhaenens, Nicolas Picard","doi":"10.1016/j.therap.2024.05.006","DOIUrl":"https://doi.org/10.1016/j.therap.2024.05.006","url":null,"abstract":"<p><p>The administration of aminoglycosides can induce nephrotoxicity or ototoxicity, which can be monitored through pharmacological therapeutic drug monitoring. However, there are cases of genetic predisposition to ototoxicity related to the MT-RNR1 gene, which may occur from the first administrations. Pharmacogenetic analysis recommendations have recently been proposed by the Clinical Pharmacogenetics Implementation Consortium (CPIC). The Francophone Pharmacogenetics Network (RNPGx) provides a bibliographic synthesis of this genetic predisposition, as well as professional recommendations. The MT-RNR1 gene codes for mitochondrial 12S rRNA, which constitutes the small subunit of the mitochondrial ribosome. Three variants can be identified: the variants m.1555A>G and m.1494C>T of the MT-RNR1 gene have a 'high' level of evidence regarding the risk of ototoxicity. The variant m.1095T>C has a 'moderate' level of evidence. The search for these variants can be performed in the laboratory if the administration of aminoglycosides can be delayed after obtaining the result. However, if the treatment is urgent, there is currently no rapid test available in France (a 'point-of-care' test is authorized in Great Britain). RNPGx considers: (1) the search for the m.1555A>G, m.1494C>T variants as 'highly recommended' and the m.1095T>C variant as 'moderately recommended' before the administration of an aminoglycoside (if compatible with the medical context). It should be noted that the level of heteroplasmy detected does not modify the recommendation; (2) pharmacogenetic analysis is currently not feasible in situations of short-term aminoglycoside administration, in the absence of an available analytical solution (rapid test to be evaluated in France); (3) the retrospective analysis in case of aminoglycoside-induced ototoxicity is 'recommended'; (4) analysis of relatives is 'recommended'. Through this summary, RNPGx proposes an updated review of the MT-RNR1-aminoglycoside gene-drug pair to serve as a basis for adapting practices regarding pharmacogenetic analysis related to aminoglycoside treatment.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141321705","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}