TherapiePub Date : 2024-12-27DOI: 10.1016/j.therap.2024.12.009
Sophie Gautier, Julie Truong-Minh, Johana Béné, Johanna Temime, Maxime Granier, Benjamin Hennart, Sandrine Bergeron, Emmanuelle Jaillette
{"title":"Lactic acidosis with metformin accumulation in the intensive care units of the Nord Pas de Calais region: A known serious adverse event that can be better prevented.","authors":"Sophie Gautier, Julie Truong-Minh, Johana Béné, Johanna Temime, Maxime Granier, Benjamin Hennart, Sandrine Bergeron, Emmanuelle Jaillette","doi":"10.1016/j.therap.2024.12.009","DOIUrl":"https://doi.org/10.1016/j.therap.2024.12.009","url":null,"abstract":"<p><strong>Objective: </strong>Metformin-associated lactic acidosis (MALA) is a rare but serious adverse drug reaction (ADR). The aim of the study was to identify clinical situations associated with the onset of MALA in patients hospitalised in the Nord Pas de Calais regional intensive care units (ICUs), and to assess its preventability.</p><p><strong>Material and methods: </strong>We included all cases of MALA, identified by metformin accumulation >2.3mg/dL and lactate >2.2mmol/L, reported by the regional ICU physicians to the Regional Centre of Pharmacovigilance and registered in the French Pharmacovigilance Database between 1 January 2017 and 30 December 2018.</p><p><strong>Results: </strong>One hundred and ninety-eight (198) cases of MALA were included. 38 patients died in direct association with MALA (19.2%). There was a correlation between metformin plasma accumulation and acute renal failure and with the severity of MALA (P<0.0001). All patients presented an acute intercurrent event favouring MALA, dehydration for 87 (43.9%) patients, severe infection for 65 (32.8%) patients. For 172 patients (86.7%), the prescription was not adapted to the intercurrent medical situation as recommended. Seventy (40.5%) patients consulted their general practitioner for the acute intercurrent event, 1 temporarily stopped metformin and 34.3% had been referred directly to hospital. The remaining 65.7% presented to the hospital around 4 days later due to worsening symptoms. MALA was identified as preventable in 160 patients (80.8%).</p><p><strong>Conclusions: </strong>MALA in ICUs often follow acute dehydration or infection, and these high-risk situations must be signals to prevent this serious ADR. Specific education programmes for physicians and patients could also reduce this risk.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972202","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 : 2024-12-20DOI: 10.1016/j.therap.2024.11.010
Céline Verstuyft, Dominique Dewolf, Olivier Blin, Virginie Florentin, Laurent Mesnard, Boris Chaumette, Estelle Ayme-Dietrich, Laure Raymond, Marie Lang, Antonin Lamazière, Béatrice Allard, Laurence Samelson, Liliane Lamezec, Marie-Anne Loriot, Antoine Le Bozec, Nicolas Picard
{"title":"How to facilitate the wider use of pharmacogenetic tests?","authors":"Céline Verstuyft, Dominique Dewolf, Olivier Blin, Virginie Florentin, Laurent Mesnard, Boris Chaumette, Estelle Ayme-Dietrich, Laure Raymond, Marie Lang, Antonin Lamazière, Béatrice Allard, Laurence Samelson, Liliane Lamezec, Marie-Anne Loriot, Antoine Le Bozec, Nicolas Picard","doi":"10.1016/j.therap.2024.11.010","DOIUrl":"https://doi.org/10.1016/j.therap.2024.11.010","url":null,"abstract":"<p><p>4P medicine (personalized, preventive, predictive, and participatory) is experiencing a remarkable rise, and pharmacogenetics is an essential part of it. However, several obstacles are hindering its deployment. This round table brought together a group of experts to take stock of the situation, reflecting on ways to facilitate the prescription of these tests and the dissemination of the results on a national scale. The experts looked at the methods of prescribing and communicating pharmacogenetic data in the current situation as well as in the coming years, with the arrival of artificial intelligence software. The questions relating to the reimbursement of tests - as topical as ever - were also discussed, as this is a way to allow all patients to access these tests. Numerous recommendations have been formulated on these various points, aimed at facilitating prescription management for healthcare professionals, and ensuring the retention and use of the results throughout the patient's life. Finally, better patient information was recommended, as well as strengthening the involvement of healthcare professionals and industry stakeholders in this process, with insistence on the necessary training and commitment to ensure its success.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142955594","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 : 2024-12-14DOI: 10.1016/j.therap.2024.12.005
Thomas Soeiro, Marion Allouchery, Johana Bene, Julien Bezin, Charles Dolladille, Jean-Luc Faillie, Lamiae Grimaldi, Florentia Kaguelidou, Charles Khouri, Margaux Lafaurie, Bérenger Largeau, François Montastruc, Lucas Morin, Lucie-Marie Scailteux, Antoine Pariente
{"title":"Shaping the future of pharmacoepidemiology in France: Recommendations from the SFPT Pharmacoepidemiology Working Group.","authors":"Thomas Soeiro, Marion Allouchery, Johana Bene, Julien Bezin, Charles Dolladille, Jean-Luc Faillie, Lamiae Grimaldi, Florentia Kaguelidou, Charles Khouri, Margaux Lafaurie, Bérenger Largeau, François Montastruc, Lucas Morin, Lucie-Marie Scailteux, Antoine Pariente","doi":"10.1016/j.therap.2024.12.005","DOIUrl":"https://doi.org/10.1016/j.therap.2024.12.005","url":null,"abstract":"<p><p>The drug authorization process is shifting towards a policy aimed at shortening time-to-market. While this policy facilitates early access to new treatments, it can also result in potentially insufficient knowledge of both efficacy and safety at the time of marketing. The latter is particularly true for long-term outcomes or in specific populations (e.g., children and the elderly). Yet, French pharmacoepidemiology is currently not designed to address these challenges, despite recognized expertise. In this context, we aim: (i) to define a strategy for strengthening pharmacoepidemiology in France; and (ii) to identify the associated human, technical, and financial requirements to ensure its success. In this paper, we present the French Pharmacoepidemiology Initiative (https://frenchpharmacoepi.org/), i.e. a network of independent academic teams to complement existing institutions. It will provide coordinated expertise and a workforce to meet national and regional needs for pharmacoepidemiological monitoring and drug-related decision-making. Leveraging the existing expertise of university hospital pharmacoepidemiology units would enable rapid operational deployment to inform the decisions and policies of national regulatory agencies.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142873004","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 : 2024-12-05DOI: 10.1016/j.therap.2024.10.062
Michel Cucherat, Olivier Demarcq, Olivier Chassany, Claire Le Jeunne, Isabelle Borget, Cécile Collignon, Vincent Diebolt, Marion Feuilly, Béatrice Fiquet, Clémence Leyrat, Florian Naudet, Raphaël Porcher, Nathalie Schmidely, Tabassome Simon, Matthieu Roustit
{"title":"Methodological expectations for demonstration of health product effectiveness by observational studies.","authors":"Michel Cucherat, Olivier Demarcq, Olivier Chassany, Claire Le Jeunne, Isabelle Borget, Cécile Collignon, Vincent Diebolt, Marion Feuilly, Béatrice Fiquet, Clémence Leyrat, Florian Naudet, Raphaël Porcher, Nathalie Schmidely, Tabassome Simon, Matthieu Roustit","doi":"10.1016/j.therap.2024.10.062","DOIUrl":"https://doi.org/10.1016/j.therap.2024.10.062","url":null,"abstract":"<p><p>The issue of assessing the effectiveness of health technologies (drugs, devices, etc.) through observational studies is becoming increasingly important as registration and market access agencies consider them in their evaluation process. In this context, observational studies must be able to provide real demonstrations of a level of reliability comparable to those produced by the conventional randomized controlled trial (RCT) approach. The objective of the roundtable was to establish the acceptability criteria for an observational study (non-randomized, non-interventional study) to be able to provide these demonstrations, and possibly serve as a confirmatory study for registration and market access authorities, the construction of therapeutic strategies or the development of recommendations. In order to do this, the study must be a real confirmatory study respecting the hypothetical-deductive approach and guaranteeing the absence of HARKing and p-hacking by attesting to the establishment of a protocol and a statistical analysis plan, recorded before any inferential analysis. It must also be part of a formalized approach to causal inference and demonstrate that it correctly identifies the causal estimand sought. The study should ensure that there is no residual confusion bias by taking into account all confounding factors affecting the comparison, which should be determined by a formal approach (such as a graphical causality approach, DAGs). Residual confusion bias diagnoses by forgery and nullification analysis should be non-existent. The study shall be at low risk of bias, in particular selection bias, among others by using a target test emulation design. Overall type I error risk should be strictly controlled. The absence of selective publication of results and selection bias should be ensured.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142855076","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 : 2024-12-05DOI: 10.1016/j.therap.2024.12.001
Alexandre Destere, Alexandre O Gérard, Diane Merino, Elliot Ewig, Fanny Rocher, Nouha Ben Othmann, Benjamin Hennart, Jean Dellamonica, Hervé Hyvernat, Milou-Daniel Drici
{"title":"Polyintoxication with cenobamate, perampanel, and carbamazepine: A complex case report.","authors":"Alexandre Destere, Alexandre O Gérard, Diane Merino, Elliot Ewig, Fanny Rocher, Nouha Ben Othmann, Benjamin Hennart, Jean Dellamonica, Hervé Hyvernat, Milou-Daniel Drici","doi":"10.1016/j.therap.2024.12.001","DOIUrl":"https://doi.org/10.1016/j.therap.2024.12.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142855084","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 : 2024-12-04DOI: 10.1016/j.therap.2024.11.005
Nada Saout, Ouafa Atouf, Malika Essakalli
{"title":"[ISO 9001 certification: Experience of the immunology and cell therapy laboratory at Ibn Sina University Hospital, Rabat].","authors":"Nada Saout, Ouafa Atouf, Malika Essakalli","doi":"10.1016/j.therap.2024.11.005","DOIUrl":"https://doi.org/10.1016/j.therap.2024.11.005","url":null,"abstract":"<p><p>Medical analysis laboratories play an essential role in medical diagnosis, with their results influencing up to 70% of decisions. This means that the quality of laboratory services is a key factor in the quality of medical care. However, certification and accreditation are not yet compulsory in Morocco, and only the Guide to the Good Execution of Medical Biology Analyses (GBEA) published in 2011 governs the organisation of laboratories. The Blood Transfusion and Hemovigilance Service (STSH) at the Ibn Sina University Hospital (CHUIS) in Rabat has embarked on an ISO 9001:2015 certification process, with the aim of improving its performance and satisfying its interested parties. This process, which was launched in 2018, was carried out in two main phases. The first phase consisted of complying with current regulations, while the second phase involved an evaluation based on the ISO 9001:2015 standard. In accordance with the logic of the Deming wheel, the department developed its quality policy, set its objectives, and undertook staff training and awareness activities. The processes, along with the associated risks and opportunities, have been identified and represented. The documentation system, as well as the system for reporting and handling non-conformities, has been implemented and dematerialised. Performance and activity indicators have been defined for each process. Finally, the customer feedback system has been expanded to include all interested parties, thus allowing for an evaluation of their perceptions and the identification of areas for improvement. Despite the global pandemic of COVID-19, this work has successfully integrated ISO 9001:2015 into STSH's practices, with compliance being declared by a certification body in 2022.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142847972","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}
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