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Health data: Regionalised access is a priority challenge for building a secure, transparent and innovative national health data repository 卫生数据:区域获取是建立安全、透明和创新的国家卫生数据存储库的一项优先挑战。
IF 2.2 4区 医学
Therapie Pub Date : 2025-01-01 DOI: 10.1016/j.therap.2024.12.008
Daniel Szeftel , Vianney Jouhet , Gilles Duluc , Cécile Charle-Maachi , Thomas Sejourné , Jérôme Fabiano , Hélène Guimiot , Aurore Gaignon , Caroline Germain , Quentin Demanet , Emmanuel Merieux , Thomas Rapp
{"title":"Health data: Regionalised access is a priority challenge for building a secure, transparent and innovative national health data repository","authors":"Daniel Szeftel ,&nbsp;Vianney Jouhet ,&nbsp;Gilles Duluc ,&nbsp;Cécile Charle-Maachi ,&nbsp;Thomas Sejourné ,&nbsp;Jérôme Fabiano ,&nbsp;Hélène Guimiot ,&nbsp;Aurore Gaignon ,&nbsp;Caroline Germain ,&nbsp;Quentin Demanet ,&nbsp;Emmanuel Merieux ,&nbsp;Thomas Rapp","doi":"10.1016/j.therap.2024.12.008","DOIUrl":"10.1016/j.therap.2024.12.008","url":null,"abstract":"<div><div>France has been engaged in a legal and organisational transition for many years. It has had to adapt its national framework to the legal requirements of personal data protection, European ambitions and international competition. From the Data Protection Act of 1978 to the Healthcare System Transformation Act of 2019, reforms have strengthened requirements in terms of personal data protection, while opening the way to innovative uses. Recent European regulations, such as the AI Act (2024) and the European Health Data Area (2024), aim to reinforce this dynamic, ensuring a secure, transparent and competitive framework for the sharing and use of health data. How can we ensure that the re-use of healthcare data is truly effective, while respecting the fundamental rights of citizens? How can we reconcile national and European ambitions with the technical and organisational realities of the healthcare system, in clinical and research teams, and as close as possible to patients and users in our territories? These questions are essential, because access to and use of health data are seen as major levers for improving the quality of care, supporting innovation and boosting the competitiveness of the French healthcare system. The impact study on the 2019 reform stresses that the transformation of the healthcare system will have to be based on taking better account of the needs of patients and professionals by encouraging local initiatives. In this context, France faces a priority to establish greater coordination between the national and local levels, while preserving the trust of users. This precious trust is essential if we are to make the transition to achieving national and European objectives for the scientific and economic use of data.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 1","pages":"Pages 125-134"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143012199","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}
引用次数: 0
How can the reform of the activity-based payment system (T2A) help in financing innovative health products? 基于活动的支付系统(T2A)的改革如何有助于创新卫生产品的融资?
IF 2.2 4区 医学
Therapie Pub Date : 2025-01-01 DOI: 10.1016/j.therap.2024.10.063
Xavier Armoiry , Nejma Saidani , Martine Aoustin , Dorothée Camus , Auriane Cano-Chancel , Sophie Carlier , Albane Degrassat-Théas , Anne-Aurélie Epis de Fleurian , Anne Grumblat , Aurélie Lavorel , Mégane Lesaignoux , Tess Martin , Adrien Michaud , Jonathan Morizot , Nathalie Préaubert , Valery-Pierre Riche , Isabelle Durand Zaleski
{"title":"How can the reform of the activity-based payment system (T2A) help in financing innovative health products?","authors":"Xavier Armoiry ,&nbsp;Nejma Saidani ,&nbsp;Martine Aoustin ,&nbsp;Dorothée Camus ,&nbsp;Auriane Cano-Chancel ,&nbsp;Sophie Carlier ,&nbsp;Albane Degrassat-Théas ,&nbsp;Anne-Aurélie Epis de Fleurian ,&nbsp;Anne Grumblat ,&nbsp;Aurélie Lavorel ,&nbsp;Mégane Lesaignoux ,&nbsp;Tess Martin ,&nbsp;Adrien Michaud ,&nbsp;Jonathan Morizot ,&nbsp;Nathalie Préaubert ,&nbsp;Valery-Pierre Riche ,&nbsp;Isabelle Durand Zaleski","doi":"10.1016/j.therap.2024.10.063","DOIUrl":"10.1016/j.therap.2024.10.063","url":null,"abstract":"<div><div>In France, the short-stay activities of public and private sector healthcare facilities have been financed since 2004 by activity-based pricing (T2A). The principle is to allow for payment determined primarily by the nature and volume of activities. T2A has enabled a major transformation compared to the old financing system, chiefly for public sector facilities that used to operate under a general allocation, and convergence between payment methods in the public and private sectors. However, official reports and public pronouncements by many hospital healthcare stakeholders have also highlighted the limits of this method of financing, leading to several reform projects. With that in mind, round table 3 of the Giens Workshops, including experts from academia and/or hospitals, institutions, and industry, questioned the impact of the new T2A reforms on access to innovative health care products in hospitals. After scoping out the issue and drawing up observations, the round table proposed six general recommendations that would be avenues for improving access to innovative health care products for hospital service users.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 1","pages":"Pages 77-92"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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. 乳酸酸中毒与二甲双胍积累在北加来海峡地区的重症监护病房:一个已知的严重不良事件,可以更好地预防。
IF 2.2 4区 医学
Therapie Pub Date : 2024-12-27 DOI: 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}
引用次数: 0
Shaping the future of pharmacoepidemiology in France: Recommendations from the SFPT Pharmacoepidemiology Working Group. 塑造法国药物流行病学的未来:SFPT药物流行病学工作组的建议。
IF 2.2 4区 医学
Therapie Pub Date : 2024-12-14 DOI: 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}
引用次数: 0
[ISO 9001 certification: Experience of the immunology and cell therapy laboratory at Ibn Sina University Hospital, Rabat]. [ISO 9001 认证:拉巴特伊本-西纳大学医院免疫学和细胞疗法实验室的经验]。
IF 2.2 4区 医学
Therapie Pub Date : 2024-12-04 DOI: 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}
引用次数: 0
The enhanced national pharmacovigilance system implemented for COVID-19 vaccines in France: A 2-year experience report. 法国针对COVID-19疫苗实施的强化国家药物警戒系统:2年经验报告
IF 2.2 4区 医学
Therapie Pub Date : 2024-11-14 DOI: 10.1016/j.therap.2024.11.002
Samuel Crommelynck, Aurélie Grandvuillemin, Claire Ferard, Céline Mounier, Nathalie Gault, Evelyne Pierron, Baptiste Jacquot, Tiphaine Vaillant, Isabelle Parent du Chatelet, Alexis Jacquet, Francesco Salvo, Martine Alt, Haleh Bagheri, Joëlle Micallef, Antoine Pariente, Sophie Gautier, Marie-Blanche Valnet-Rabier, Marina Atzenhoffer, Marion Lepelley, Judith Cottin, Isabelle Lacroix, Valérie Gras, Nathalie Massy, Alban Dhanani, Philippe Vella, Youssef Shaim, Laurence Baril, Annie-Pierre Jonville-Béra, Mehdi Benkebil
{"title":"The enhanced national pharmacovigilance system implemented for COVID-19 vaccines in France: A 2-year experience report.","authors":"Samuel Crommelynck, Aurélie Grandvuillemin, Claire Ferard, Céline Mounier, Nathalie Gault, Evelyne Pierron, Baptiste Jacquot, Tiphaine Vaillant, Isabelle Parent du Chatelet, Alexis Jacquet, Francesco Salvo, Martine Alt, Haleh Bagheri, Joëlle Micallef, Antoine Pariente, Sophie Gautier, Marie-Blanche Valnet-Rabier, Marina Atzenhoffer, Marion Lepelley, Judith Cottin, Isabelle Lacroix, Valérie Gras, Nathalie Massy, Alban Dhanani, Philippe Vella, Youssef Shaim, Laurence Baril, Annie-Pierre Jonville-Béra, Mehdi Benkebil","doi":"10.1016/j.therap.2024.11.002","DOIUrl":"https://doi.org/10.1016/j.therap.2024.11.002","url":null,"abstract":"<p><p>In March 2020, World Health Organization recognized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emergence as a public health emergency of international concern. One of the major preventative measures developed against coronavirus disease 2019 (COVID-19) was vaccines. To monitor their use and safety of vaccines from the first utilization in humans during clinical development phases to implementation for the general population, an enhanced national pharmacovigilance system was enabled by the French National Agency for Medicines and Health Products Safety in collaboration with the 30 Regional Pharmacovigilance Centres. Here, we review the significant outcomes from a 2-year collaboration experience between the French National Agency for Medicines and Health Products Safety, the 30 Regional Pharmacovigilance Centres, disease-related experts and the pharmacovigilance and risk assessment committee at the European medicine agency. In France, until January 2023, over 155 million doses of COVID-19 vaccines were administrated, and 190,000 adverse events following immunizations (25% classified as serious) were analysed. Altogether 53 potential safety signals were reported to the Pharmacovigilance and Risk Assessment Committee at the European Medicine Agency by the French National Agency for Medicines and Health Products Safety: 13 were confirmed, 24 are still under investigation and 16 were not confirmed. The enhanced national PV system contributed actively better to define the safety profile of the newly developed vaccines, and the French National Agency for Medicines and Health Products Safety continues to monitor the benefit and risks of the COVID-19 vaccines.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786791","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}
引用次数: 0
Physicians, pharmacists and take-home naloxone: What practices? The SINFONI study 医生、药剂师和带回家的纳洛酮:有哪些做法?SINFONI 研究
IF 2.2 4区 医学
Therapie Pub Date : 2024-11-01 DOI: 10.1016/j.therap.2024.07.001
Mélanie Duval , Aurélie Aquizerate , Emmanuelle Jaulin , Morgane Rousselet , Emmanuelle Kuhn , Alain Guilleminot , Isabelle Nicolleau , Solen Pele , Thomas Herault , Pascal Artarit , Eleni Soulidou-Jacques , Edouard-Jules Laforgue , Caroline Victorri-Vigneau
{"title":"Physicians, pharmacists and take-home naloxone: What practices? The SINFONI study","authors":"Mélanie Duval ,&nbsp;Aurélie Aquizerate ,&nbsp;Emmanuelle Jaulin ,&nbsp;Morgane Rousselet ,&nbsp;Emmanuelle Kuhn ,&nbsp;Alain Guilleminot ,&nbsp;Isabelle Nicolleau ,&nbsp;Solen Pele ,&nbsp;Thomas Herault ,&nbsp;Pascal Artarit ,&nbsp;Eleni Soulidou-Jacques ,&nbsp;Edouard-Jules Laforgue ,&nbsp;Caroline Victorri-Vigneau","doi":"10.1016/j.therap.2024.07.001","DOIUrl":"10.1016/j.therap.2024.07.001","url":null,"abstract":"<div><h3>Objective</h3><div>For several years, both the French Addictovigilance Network and French health authorities have consistently emphasized the need to provide opioid users with take-home naloxone (THN), the specific antidote for opioid overdoses. In March 2022, the French Health Authority recommended systematically assessing the appropriateness of prescribing THN to all opioid users, regardless of the context, and identified 8 high-risk situations. However, at present, THN distribution remains limited, particularly among primary care healthcare professionals. This study, conducted by the Pays de la Loire Centre for Evaluation and Information on Drug Dependence-Addictovigilance and supported by the Regional Health Agency, aims to explore healthcare professionals’ practices and perceptions of these high-risk situations.</div></div><div><h3>Methods</h3><div>An ad-hoc questionnaire was distributed via mail by the project's regional institutional partners to the target healthcare professionals: pharmacists, general practitioners (GPs), physicians practicing in specialities other than general medicine (SPs: algologists, psychiatrists and addictologists). It was completed online from 20/10/2022 to 30/12/2022.</div></div><div><h3>Results</h3><div>Out of the 355 participants (158 pharmacists, 167 GPs and 30 SPs), nearly all were managing patients on opioids. In total, 47.7% of physicians and 27.8% of pharmacists reported experiencing difficulties in dealing with the risk of overdose when prescribing or dispensing opioids to their patients. In the 12<!--> <!-->months preceding the study, only 8 pharmacists and 34 physicians had prescribed/dispensed THN, primarily due to a lack of awareness of its existence (52% of pharmacists and 72% of physicians) and challenges in addressing the eight overdose risk situations listed by the HAS (ranging from 54% to 83% for all professionals). The best-trained healthcare professionals were those who prescribed the most THN (<em>P</em> <!-->&lt;<!--> <!-->0.001).</div></div><div><h3>Conclusion</h3><div>The identification of barriers related to THN distribution in the regional SINFONI study, conducted among primary care healthcare professionals managing patients on opioids, highlights the need to develop a training tool specifically tailored for these professionals.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 6","pages":"Pages 623-633"},"PeriodicalIF":2.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141715325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Exposure assessment of titanium dioxide via drugs available on the French market: A nationwide descriptive study 通过法国市场上的药物接触二氧化钛的评估:全国性描述性研究。
IF 2.2 4区 医学
Therapie Pub Date : 2024-11-01 DOI: 10.1016/j.therap.2024.07.005
Manon Cairat , Inge Huybrechts , Agnès Fournier
{"title":"Exposure assessment of titanium dioxide via drugs available on the French market: A nationwide descriptive study","authors":"Manon Cairat ,&nbsp;Inge Huybrechts ,&nbsp;Agnès Fournier","doi":"10.1016/j.therap.2024.07.005","DOIUrl":"10.1016/j.therap.2024.07.005","url":null,"abstract":"<div><h3>Purpose</h3><div>Based on potential adverse health effects including genotoxicity concerns, the European Union banned titanium dioxide (TiO<sub>2</sub>) as a food additive in 2022, but food-grade TiO<sub>2</sub> can still be used in pharmaceutical products.</div></div><div><h3>Methods</h3><div>This study described the presence of TiO<sub>2</sub> in drugs available on the French market and estimated the population exposure to TiO<sub>2</sub> through drug consumption. We used annual drug claim data aggregated at the national level together with data on the TiO<sub>2</sub> content of pharmaceutical products available on the French market in 2001–2020.</div></div><div><h3>Results</h3><div>Of the 17 171 pharmaceutical specialties identified on the French market between 2001 and 2020, 38% contained TiO<sub>2</sub>. That figure reached 95% for capsules, 92% for film-coated tablets, 74% for coated tablets and 66% for soft capsules. Only 1% of non-oral specialties contained TiO<sub>2</sub>. The median TiO<sub>2</sub> amount in one common dispensing unit was 1.5<!--> <!-->mg for oral specialties containing TiO<sub>2</sub>. We estimated that the mean exposure to TiO<sub>2</sub> per inhabitant through the consumption of reimbursed drugs between 2012 and 2020 was 1.71<!--> <!-->mg per day, with women (1.81<!--> <!-->mg/d) slightly more exposed than men (1.54<!--> <!-->mg/d) and people older than 59 years (4.00<!--> <!-->mg/d) much more exposed than younger people (1.24 and 0.21<!--> <!-->mg/d for 20–59 and<!--> <!-->&lt;<!--> <!-->20 years old individuals, respectively).</div></div><div><h3>Conclusion</h3><div>This study highlights a widespread presence of TiO<sub>2</sub> in drugs on the French market. The health impact of exposure to TiO<sub>2</sub> through drug consumption should be evaluated in future epidemiological studies.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 6","pages":"Pages 718-729"},"PeriodicalIF":2.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142037104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Judiciarisation des produits à base de cannabidiol au Brésil : une analyse de 2019 à 2022 巴西大麻二酚类产品的司法化:2019 至 2022 年分析
IF 2.2 4区 医学
Therapie Pub Date : 2024-11-01 DOI: 10.1016/j.therap.2024.10.023
Ronaldo Portela Portela , Mariana Dias Lula , Maria Laura Silva , Cristina Mariano Ruas
{"title":"Judiciarisation des produits à base de cannabidiol au Brésil : une analyse de 2019 à 2022","authors":"Ronaldo Portela Portela ,&nbsp;Mariana Dias Lula ,&nbsp;Maria Laura Silva ,&nbsp;Cristina Mariano Ruas","doi":"10.1016/j.therap.2024.10.023","DOIUrl":"10.1016/j.therap.2024.10.023","url":null,"abstract":"<div><h3>Introduction</h3><div>L’étude a analysé les poursuites judiciaires des patients qui ont sollicité l’accès à des produits à base de cannabidiol (CBD) au système national santé (universel) brésilien durant la période de 2019 à 2022, en décrivant les caractéristiques sociodémographiques, cliniques et juridiques.</div></div><div><h3>Matériels et méthode</h3><div>Il s’agit d’une étude transversale composée de l’évaluation des notes techniques émises par le Centre d’appui technique du pouvoir judiciaire (NatJus), qui soutiennent les décisions judiciaires. Les données ont été obtenues à partir du système e-NatJus, du ministère la Justice au Brésil, en utilisant des techniques de Web scraping. Une régression logistique a été utilisée pour estimer les <em>odds ratio</em> (IC 95 %).</div></div><div><h3>Résultats</h3><div>Nous avons analysé 1115 notes techniques des plaignants CBD, soit 54,7 % des patients de sexe masculin, d’âge moyen 18,4 ans, provenant de la région sud du pays (38,8 %), dont 49,6 % dans le cadre du traitement pour l’épilepsie. En ce qui concerne les actes avec avis favorable : 28,8 % n’avaient aucune preuve scientifique ; 26,5 % plaidaient pour des produits sans enregistrement auprès de l’Agence nationale de sécurité des médicaments et produits de santé du Brésil (ANVISA) ; 25,3 % plaident pour des produits enregistres à l’ANVISA mais n’était pas conformes à l’indication thérapeutique sollicitée.</div></div><div><h3>Conclusion</h3><div>Les patients de la région nord-est avaient une chance augmentée de 3,0 fois d’obtenir un avis favorable et ceux diagnostiqués avec une épilepsie de 2,3 fois. Les avis d’experts qui ont soutenu les magistrats pour les décisions judiciaires concernant les demandes des patients pour des produits à base de cannabidiol au Brésil étaient pour la plupart conformes aux preuves scientifiques, dénotant l’importance de NatJus dans la qualification de l’accès aux médicaments dans le pays.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 6","pages":"Page 749"},"PeriodicalIF":2.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142699022","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}
引用次数: 0
Évaluation de la consommation de substances psychoactives avant incarcération : données de l’enquête OPPIDUM 入狱前精神药物使用情况评估:OPPIDUM 调查提供的数据
IF 2.2 4区 医学
Therapie Pub Date : 2024-11-01 DOI: 10.1016/j.therap.2024.10.036
Zeinab Abbas , Sabrine Mouas , Clémence Lacroix , Elisabeth Jouve , Céline Eiden , Hélène Peyrière , Réseau français des centres d’addictovigilance
{"title":"Évaluation de la consommation de substances psychoactives avant incarcération : données de l’enquête OPPIDUM","authors":"Zeinab Abbas ,&nbsp;Sabrine Mouas ,&nbsp;Clémence Lacroix ,&nbsp;Elisabeth Jouve ,&nbsp;Céline Eiden ,&nbsp;Hélène Peyrière ,&nbsp;Réseau français des centres d’addictovigilance","doi":"10.1016/j.therap.2024.10.036","DOIUrl":"10.1016/j.therap.2024.10.036","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Introduction&lt;/h3&gt;&lt;div&gt;Les troubles de l’usage (TLU) de substances psychoactives (SPA) sont des enjeux majeurs de santé publique, et les sujets incarcérés sont particulièrement exposés à ces risques &lt;span&gt;&lt;span&gt;[1]&lt;/span&gt;&lt;/span&gt;. La connaissance des habitudes de consommation avant l’incarcération permet un meilleur accompagnement des patients &lt;span&gt;&lt;span&gt;[1]&lt;/span&gt;&lt;/span&gt;. Notre objectif était d’analyser les données de l’enquête OPPIDUM (Observation des produits psychotropes illicites ou détournés de leur utilisation médicamenteuse), réalisée auprès de sujets incarcérés.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Matériel et méthodes&lt;/h3&gt;&lt;div&gt;Les données ont été extraites de l’enquête annuelle, multicentrique et transversale, OPPIDUM &lt;span&gt;&lt;span&gt;[2]&lt;/span&gt;&lt;/span&gt;, réalisée auprès d’usagers de SPA vus dans des centres spécialisés, sur la période 2013–2022. Les sujets incarcérés ont été questionnés sur leur usage de SPA la semaine précédant leur incarcération. Deux groupes de sujets ont été comparés : ceux ayant déclaré un usage simple de SPA et ceux avec TLU.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultats&lt;/h3&gt;&lt;div&gt;Au total, 2626 individus ont répondu à l’enquête, représentant 5352 substances. La comparaison des données usage simple/TLU a été réalisée chez 1142 participants (hommes 91,3 %) pour lesquels l’information était disponible, correspondant à 3674 produits, avec un âge moyen de 33,6&lt;!--&gt; &lt;!--&gt;±&lt;!--&gt; &lt;!--&gt;8,9 ans. Les substances significativement (&lt;em&gt;p&lt;/em&gt; &lt;!--&gt;&lt;&lt;!--&gt; &lt;!--&gt;0,001) plus fréquemment consommées dans le groupe TLU/usage simple sont le cannabis (30 %/6,5 %), la cocaïne/crack (16,3 %/3,3 %), les benzodiazépines (10,1 %/5,4 %) et l’héroïne (9,2 %/0,8 %) : sur la période, une stabilité des SPA impliquées dans les TLU est observée. Un traitement de substitution aux opioïdes (TSO) était présent dans 51,1 % des sujets pour la méthadone et 48,7 % pour la buprénorphine.&lt;/div&gt;&lt;div&gt;Plusieurs variables sont associées à un risque significativement augmenté de TLU : la consommation de tabac (OR : 2979 ; IC&lt;sub&gt;95 %&lt;/sub&gt; : 1,5–5,8, &lt;em&gt;p&lt;/em&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;0,001), d’alcool (OR : 2,08 ; IC&lt;sub&gt;95 %&lt;/sub&gt; : 1,5–2,7, &lt;em&gt;p&lt;/em&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;0,001), de SPA injectables (OR : 2805, IC&lt;sub&gt;95 %&lt;/sub&gt; :1,6–4,9, &lt;em&gt;p&lt;/em&gt; &lt;!--&gt;&lt;&lt;!--&gt; &lt;!--&gt;0,0001), l’acquisition illégale des SPA (OR : 13,8, IC&lt;sub&gt;95 %&lt;/sub&gt; : 8,9–21,3, &lt;em&gt;p&lt;/em&gt; &lt;!--&gt;&lt;&lt;!--&gt; &lt;!--&gt;0,0001) et une consommation quotidienne ou hebdomadaire par rapport à une consommation mensuelle (OR : 6,730, IC&lt;sub&gt;95 %&lt;/sub&gt; : 4,7–9,7, &lt;em&gt;p&lt;/em&gt; &lt;!--&gt;&lt;&lt;!--&gt; &lt;!--&gt;0,0001 et OR : 4,789, IC&lt;sub&gt;95 %&lt;/sub&gt; : 3,2–6,9, &lt;em&gt;p&lt;/em&gt; &lt;!--&gt;&lt;&lt;!--&gt; &lt;!--&gt;0,0001). À l’inverse, des variables ont été associées à un risque plus faible de TLU : suivre un protocole TSO (OR : 0,617, IC&lt;sub&gt;95 %&lt;/sub&gt; : 0,475–0,802, &lt;em&gt;p&lt;/em&gt; &lt;!--&gt;&lt;&lt;!--&gt; &lt;!--&gt;0,0001) et une antériorité plus faible de la consommation jours/semaines (OR : 0,251, IC&lt;sub&gt;95 %&lt;/sub&gt; : 0,125–0,506, &lt;em&gt;p&lt;/em&gt; &lt;!--&gt;&lt;&lt;!--&gt; &lt;!--&gt;0,0001) et mois/années (OR : 0,495, IC&lt;s","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 6","pages":"Pages 755-756"},"PeriodicalIF":2.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142698286","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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