Therapie最新文献

{"title":"Monitoring opioid analgesic misuse, abuse and dependence: What to the data from addictovigilance tell us about the situation in France?","authors":"Maryse Lapeyre-Mestre ,&nbsp;Celian Bertin ,&nbsp;Constança Jalles ,&nbsp;Thomas Soeiro ,&nbsp;Joëlle Micallef ,&nbsp;Anne Roussin","doi":"10.1016/j.therap.2024.11.008","DOIUrl":"10.1016/j.therap.2024.11.008","url":null,"abstract":"<div><div>The opioid epidemic has emerged in the USA in the late 1990s and widespread to Canada, Australia, and the UK to a lesser extent in the more recent years. At the European level, several studies performed in different European countries have highlighted that prescription opioid use increased substantially over the last decade, and several proxies for misuse show a parallel increasing trend. The French addictovigilance experience on opioid analgesics is a good example of a specific dedicated monitoring, taking into account in a global and multisource perspective, patterns of utilization, population involved in problematic use, ways of acquisition and health complications. The added value of this data triangulation is illustrated by the recent data on tramadol and oxycodone. The addictovigilance monitoring is particularly relevant to identify early signals of potential problematic use and to assess the impact of campaigns for opioid analgesics rational use and regulatory changes.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 2","pages":"Pages 241-251"},"PeriodicalIF":2.2,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877918","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}

{"title":"[Prevention of opioid misuse and overdose risk and distribution of naloxone: Current practices, needs and prospects among dispensing pharmacists].","authors":"Armelle Chan Soc Foh, Salim Mezaache, Franck Turlure, Nathalie Fredon, Stéphane Pichon, Laurent Peillard, Joelle Micallef, Elisabeth Frauger","doi":"10.1016/j.therap.2025.02.006","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.006","url":null,"abstract":"<p><strong>Introduction: </strong>Opioids are essential medicines, but their use is associated with risks. The POP program \"Prevention and risk reduction of Opioid-related overdoses in the PACA region\" aims to improve the management of patients at risk of overdose and the distribution of naloxone. We have conducted a survey of pharmacist with the aim was to assess their knowledge, practices, difficulties and needs concerning the management of opioid users and overdose prevention and naloxone diffusion, and to propose training materials adapted to their needs.</p><p><strong>Materials and methods: </strong>In the context of POP programme, pharmacists were approached via an online questionnaire (February-March 2024) and semi-structured interviews (April 2024).</p><p><strong>Results: </strong>A total of 107 pharmacists completed the questionnaire and 10 took part in the interviews. Seventy-four per cent said they had encountered patients with opioid misuse disorders. Awareness of the Prescription Opioid Misuse Index was low (92%). Only 37% of pharmacists said they were aware of the availability of take-home naloxone, and 87% were uncomfortable with the advice associated with it is dispensing. Actions in the event of misuse included contacting the prescriber (76%), refusing to dispense (76%), and adapting or splitting dispensing (60%). In terms of needs, 95% were interested in training, 44% in practical tools, and 41% in documents for patients. Based on the needs expressed, information and outreach actions were carried out.</p><p><strong>Conclusion: </strong>The results highlight the need to improve pharmacists knowledge on overdose risk and naloxone. Regular training and the dissemination of practical tools are essential.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143670957","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":"Encephalopathy associated with equimolar mixture of oxygen and nitrous oxide (EMONO) abuse: A case report.","authors":"Nathan Pierrat-Maury, Serghei Banari, Tanguy Taillefer de Laportalière, Anne Roussin, Louis Richaud, Etienne Very, François Montastruc","doi":"10.1016/j.therap.2025.02.005","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.005","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143721567","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":"Pharmacodynamic interaction between ginger and antiplatelet drugs: A case report.","authors":"Layal El Aridi, Hélène Jantzem, Corinne Guihard, Myriam Marteil, Greta Gourier","doi":"10.1016/j.therap.2025.02.004","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.004","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531815","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":"Validation of in-hospital diagnosis codes in one French hospital and out-hospital algorithm to identify skin ulcers in healthcare databases in France.","authors":"Clément Jambon-Barbara, N'dah Mathieu Ouattara, Claire Bernardeau, Frédéric Olive, Sophie Blaise, Jean-Luc Cracowski, Charles Khouri","doi":"10.1016/j.therap.2025.02.003","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.003","url":null,"abstract":"<p><strong>Purpose: </strong>This study has two main objectives: 1/ to validate the International Classification of Diseases, 10th revision (ICD-10) diagnostic codes of skin ulcer in one French hospital using medical charts; 2/ to validate an out-hospital algorithm against ICD-10 codes using a healthcare database.</p><p><strong>Methods: </strong>We first validated in-hospital ICD-10 codes for pressure, diabetic and vascular skin ulcers using the Grenoble University Hospital medical charts. Secondly, we assessed the validity of an out-hospital algorithm using dressing reimbursements, medical exams and comorbidities to identify skin ulcers using the French \"échantillon généraliste des benéficiaires\" database. We then compared the type of skin ulcers in patients hospitalized 1 year around the out-hospital skin ulcer identification date. We calculated specificity, sensitivity, positive predictive value (PPV) and negative predictive value (NPV).</p><p><strong>Results: </strong>The performances of ICD-10 codes for identifying patients with vascular, diabetic and pressure ulcers were all superior to 70%. The out-hospital identification of skin ulcers selected very different patients, younger and with less comorbidities than those hospitalized for skin ulcers. In patients hospitalized 1 year before or after the first dispensation of wound dressings, the concordance with ICD-10 codes was modest. Indeed, patients are wrongly classified as pressure ulcers, vascular ulcers and diabetic foot ulcers in respectively 27.7%, 52.0% and 48.8% of skin ulcers.</p><p><strong>Conclusion: </strong>We found that performances of the in-hospital identification of pressure, vascular and diabetic foot ulcers were high allowing to use them to conduct observational studies in healthcare databases. However, outpatient identification retrieved heterogeneous performance, we therefore advise researchers using the latter to perform a sensitivity analysis restricted to hospitalized patients.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504328","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":"[HOPIPRAC: Pharmacovigilance interface for detecting cases of adverse events in a hospital data warehouse].","authors":"Layal El Aridi, Hélène Jantzem, André Happe, Jean Michel Cauvin, Dominique Carlhant-Kowalski, Greta Gourier","doi":"10.1016/j.therap.2025.02.002","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.002","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Spontaneous reporting is the reference method for collecting data on adverse drug reactions (ADRs). However, it remains insufficient. Text search in the electronic medical record has opened up a new way of collecting ADRs. However, these methods have certain limitations. Data warehouses constitute a rich digital environment bringing together all the informations in an electronic medical record. The Clinical Data Centre (CDC) at Brest University Hospital has developed a pharmacovigilance tool, the HOPIPRAC interface, which provides autonomy in querying the entire hospital database to detect cases of suspected ADRs from computerised patient records.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Method: &lt;/strong&gt;The data source used was the CHU de Brest data warehouse. The IT tool was developed and tested between 2015 and 2018. A validation test of the tool was proposed, based on the choice of a positive signal from Brest's previous experience (valvulopathy with Benfluorex). The hospital data warehouse query tool can also be used to carry out other forms of interrogation to identify new risks, particularly with new drugs on the market, such as Nivolumab. The tool was tested to identify and analyse bullous toxidermia, described as the most severe and very often of a drug origin.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The validation test identified 98% of the historical cases recorded in the national pharmacovigilance database, as well as potential new cases not reported to the Brest CRPV. The nivolumab cohort identified 34 ADR cases. Of these cases, 82% were serious and some were unexpected at the time of extraction. The toxidermia query identified 137 cases, 56% of which had not been reported to the Brest CRPV. With regard to Stevens Johnson Syndrome (SJS), 28% of cases were associated with antineoplastics (7 cases), in particular tyrosine kinase inhibitors (sorafenib, vemurafenib, regorafenib) derived from advanced therapies, although this risk is described as rare in the summaries of product characteristics for these 3 drugs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;The HOPIPRAC interface is an innovative IT tool for assessing drug safety. It gives pharmacovigilants independent access to electronic hospital medical data. Its applications are: 1- amplification of a pharmacovigilance signal obtained by spontaneous notification; 2- monitoring of adverse reactions in cohorts of patients exposed to a specific drug; and 3- mapping of certain drug toxicities within hospital data. However, a number of limitations has been identified: the difficulty of identifying rare adverse events due to the low population representativeness of the surveyed warehouse, and the absence of certain data relevant to the exploration of adverse drug reactions.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;The HOPIPRAC interface gives pharmacovigilants autonomy in monitoring drug risk in healthcare institutions, in addition to spontaneous notification. Querying a more advanced warehouse that collect","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143516866","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":"Dealing with large packaging in algorithms using 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.2025.02.001","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504326","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":"Association between antidepressant drugs and falls in older adults: A mediation analysis in the World Health Organization's pharmacovigilance database.","authors":"Elise-Marie Minoc, Cédric Villain, Basile Chrétien, Soumia Benbrika, Marie Heraudeau, Claire Lafont, Clémence Béchade, Thierry Lobbedez, Véronique Lelong-Boulouard, Charles Dolladille","doi":"10.1016/j.therap.2025.01.004","DOIUrl":"https://doi.org/10.1016/j.therap.2025.01.004","url":null,"abstract":"<p><strong>Objectives: </strong>The objective is to investigate the association between antidepressant drugs intake and falls reporting, as well as the potential mediators in-between, in older adults.</p><p><strong>Methods: </strong>In VigiBase®, the World Health Organization's pharmacovigilance database, we performed a disproportionality analysis to probe the putative associations between each antidepressant drugs class (non-selective monoamine reuptake inhibitors [NSMRIs], selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], alpha-2-adrenergic receptor antagonists, and \"other antidepressants\") and reports of falls in people aged 65 and over (NCT05628467). The reporting odds ratios and their 95% confidence interval were derived from logistic regression models with adjustment for confounders. We studied the falls-inducing mechanisms (delirium, hyponatremia, hypotension) by using causal mediation analyses and by using a disproportionality analysis for the co-occurrence of falls and these events.</p><p><strong>Results: </strong>Our main analysis included 86,200 cases of falls reporting in older adults (of which 57% were 75 and over). A significant association was found between falls and every antidepressant drugs class, except for NSMRIs. According to causal mediation analysis, a direct effect on the falls reports was shown for alpha-2-adrenergic receptor antagonists and for \"other antidepressants\". According to the co-reports analyses, all antidepressant drugs classes except SNRIs were associated with the co-event fall-delirium; SSRIs, alpha-2-adrenergic receptor antagonists, and \"other antidepressants\" with fall-hypotension; all antidepressant drugs classes except NSMRIs with fall-hyponatremia.</p><p><strong>Conclusions: </strong>In multivariate disproportionality analyses, all antidepressant drugs classes were associated with signals of disproportionate reporting of falls in older adults, except for NSMRIs. In mediation analyses, a direct effect on the falls reports was only found for alpha-2-adrenergic receptor antagonists. Single-mediators based models seem insufficient to explain the diversity of clinical settings resulting in falls. These findings underline the necessity of a comprehensive analysis of all clinical and pharmacological features in older falling adults treated with antidepressant drugs.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143558138","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":"Photodistributed cutaneous vasculitis: An uncommon side effect for topical ketoprofen.","authors":"Nadia Fetoui Ghariani, Nour El Imene Ouni, Sawssen Layouni, Marwa Thabouti, Haifa Mkhinini, Maha Lahouel, Badreddine Sriha, Chaker Ben Salem, Najet Ghariani, Mohamed Denguezli","doi":"10.1016/j.therap.2025.01.003","DOIUrl":"https://doi.org/10.1016/j.therap.2025.01.003","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143410854","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":"[Infusion-related reactions with human polyclonal immunoglobulins: Analysis from the French National Pharmacovigilance Database].","authors":"Aurélie Bobet, Justine Bravo, Eyrian Aubin-Beale, Blandine Bertin, François Montastruc, Romain Barus","doi":"10.1016/j.therap.2025.01.002","DOIUrl":"https://doi.org/10.1016/j.therap.2025.01.002","url":null,"abstract":"<p><strong>Objectives: </strong>Infusion-related reactions to immunoglobulins are well documented. The objective of this study was to characterize these reactions using real-world data to provide clinically relevant information.</p><p><strong>Methods: </strong>This descriptive study analyzed cases of infusion-related reactions reported in the French National Pharmacovigilance Database for immunoglobulins administered via intravenous or subcutaneous routes up to December 27, 2023.</p><p><strong>Results: </strong>During the study period, 239 cases of infusion-related reactions were reported, primarily associated with intravenous immunoglobulins (97.4%). In over half of the cases (51%), the reactions presented as flu-like syndromes. These reactions typically occurred during the first cycle for IV immunoglobulins and the fourth cycle for SC immunoglobulins. Following the onset of an infusion-related reaction, the infusion was most commonly discontinued (87.7%) or the infusion rate reduced (9.1%). In 64 cases, resolution of the reaction allowed the continuation of treatment with reduced infusion rates (65%), premedication (28%), or both (7%). Resumption of the infusion did not lead to recurrence in 60% of cases. For subsequent cycles, administration of the same formulation (n=100) resulted in recurrence in 40% of cases, while switching to a different formulation (n=16) was associated with recurrence in 75% of cases.</p><p><strong>Conclusion: </strong>Infusion-related reactions to immunoglobulins most frequently present as flu-like syndromes or cardiovascular disturbances, which are typically resolved by reducing the infusion rate or discontinuing the infusion. Resumption of the infusion is feasible following resolution, using a reduced rate or premedication. The findings suggest that switching to a different formulation of the same administration route does not confer a practical advantage.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143383365","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}