TherapiePub Date : 2025-03-01DOI: 10.1016/j.therap.2024.11.008
Maryse Lapeyre-Mestre , Celian Bertin , Constança Jalles , Thomas Soeiro , Joëlle Micallef , Anne Roussin
{"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 , Celian Bertin , Constança Jalles , Thomas Soeiro , Joëlle Micallef , 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}
TherapiePub Date : 2025-02-12DOI: 10.1016/j.therap.2025.02.003
Clément Jambon-Barbara, N'dah Mathieu Ouattara, Claire Bernardeau, Frédéric Olive, Sophie Blaise, Jean-Luc Cracowski, Charles Khouri
{"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}
TherapiePub Date : 2025-02-08DOI: 10.1016/j.therap.2025.02.002
Layal El Aridi, Hélène Jantzem, André Happe, Jean Michel Cauvin, Dominique Carlhant-Kowalski, Greta Gourier
{"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":"<p><strong>Introduction: </strong>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.</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Conclusion: </strong>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}
TherapiePub Date : 2025-02-04DOI: 10.1016/j.therap.2025.01.004
Elise-Marie Minoc, Cédric Villain, Basile Chrétien, Soumia Benbrika, Marie Heraudeau, Claire Lafont, Clémence Béchade, Thierry Lobbedez, Véronique Lelong-Boulouard, Charles Dolladille
{"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":"[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}
TherapiePub Date : 2025-01-18DOI: 10.1016/j.therap.2024.12.013
Viktoryia Prontskus, Anne Lise Pinault, Lucie-Marie Scailteux, Marie-Noelle Beyens, Audrey Fresse, Nadine Petitpain
{"title":"Lichenoid drug eruption and apalutamide: Analyses from pharmacovigilance databases and disproportionality analysis.","authors":"Viktoryia Prontskus, Anne Lise Pinault, Lucie-Marie Scailteux, Marie-Noelle Beyens, Audrey Fresse, Nadine Petitpain","doi":"10.1016/j.therap.2024.12.013","DOIUrl":"https://doi.org/10.1016/j.therap.2024.12.013","url":null,"abstract":"<p><strong>Introduction: </strong>Apalutamide is an oral androgen receptor pathway inhibitor used to treat non-metastatic castration-resistant prostate cancer at high risk of developing metastases. Skin toxicity of apalutamide is documented, including a few cases of lichenoid drug eruptions (LDE). The objective of our study is to qualitatively and quantitatively describe LDE associated with apalutamide using data from the French Pharmacovigilance Database (FPVD) and Vigibase.</p><p><strong>Methods: </strong>FPVD and Vigibase were queried on August 5, 2024, for reports of LDE associated with apalutamide. Disproportionality analysis was performed using VigiBase®, calculating the reporting odds ratio (ROR) and Bayesian confidence propagation neural network information components (IC).</p><p><strong>Results: </strong>Qualitatively, we identified and analyzed 16 cases of apalutamide related-LDE. The average age of male patients was 75 years. The median time to LDE onset was 4 months. Clinically, LDE presented as maculopapular rashes, lichenified aspects, lichen planus, lichenoid keratosis, and psoriasiform aspects. Management typically involved apalutamide discontinuation (81,2%) and corticosteroid therapy (56,2%), with favourable outcomes in 10 cases (62,5%). Quantitatively, disproportionality analysis showed significant ROR and IC for LDE and apalutamide (ROR 6.5, 95% CI 6.0-7.0; IC 2.4, IC025 1.6-3.3).</p><p><strong>Conclusion: </strong>Skin rash and pruritus reactions are frequently observed with apalutamide, possibly because of its chemical structure. Our qualitative and quantitative analysis of LDE cases observed among apalutamide exposed patients support a safety signal. LDE generally resolved with topical corticosteroids, but often required the discontinuation of apalutamide. When faced with a LDE, clinicians should consider exposure to apalutamide as one of the potential causes.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143256688","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 : 2025-01-10DOI: 10.1016/j.therap.2024.12.011
Emilien Ezine, Angélique Da Silva, Safa Idoudi, Céleste Lebbe, Basile Chrétien, Marion Sassier, Joachim Alexandre, Charles Dolladille
{"title":"BRAF and MEK inhibitors rechallenge after an adverse drug reaction in patients with cancer: A pharmacovigilance cohort study.","authors":"Emilien Ezine, Angélique Da Silva, Safa Idoudi, Céleste Lebbe, Basile Chrétien, Marion Sassier, Joachim Alexandre, Charles Dolladille","doi":"10.1016/j.therap.2024.12.011","DOIUrl":"https://doi.org/10.1016/j.therap.2024.12.011","url":null,"abstract":"<p><strong>Importance: </strong>The safety profile of a rechallenge with BRAF inhibitors (BRAFi) or a combination of BRAF and MEK inhibitors (MEKi) following an adverse drug reaction (ADR) remains largely unexplored.</p><p><strong>Objective: </strong>To identify the reported recurrence rate of the same ADR after a BRAFi±MEKi targeted therapy (TT) rechallenge in patients with cancer and to identify factors associated with recurrence.</p><p><strong>Design, setting, and participants: </strong>In this observational, pharmacovigilance study, ADR reports were sourced from VigiBase, the World Health Organization database. The inclusion criteria encompassed all BRAFi cases (with or without MEKi) through September 01, 2023, irrespective of the primary cancer diagnosis.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was the reported recurrence rate of the same initial ADR following TT rechallenge. Secondary outcomes measures included were identification of variables associated with recurrence among informative rechallenges, defined as those with known recurrence status.</p><p><strong>Results: </strong>Out of 21,339 ADR cases linked to TT, 4771 (22.4%) reported a rechallenge, with 563 yielding informative data (11.8%). Recurrence of the initial ADR was reported in 223 cases, resulting in a reported recurrence rate of 39.6% (95% CI: 35.7-43.7). The highest recurrence rates in a rechallenge were observed for pyrexia (47%, 95% CI: 39-55), renal failure (46%, 95% CI: 32-60), and musculoskeletal disorders (44%, 95%CI: 33-56). There was no significant influence of factors such as TT regimen (either BRAFi monotherapy or any TT combination), age, sex, or the type of cancer on reported recurrence rate.</p><p><strong>Conclusions and relevance: </strong>In real-world settings, approximately two-fifths of cases with notified TT rechallenges led to a reporting of recurrence of the same initial ADR. The primary determinant of reported recurrence seems to be the nature of the initial ADR rather than the TT regimen, or any other baseline patient characteristic.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143041675","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":"COVID-19 infection and risk of adverse drug reactions: Cohort study.","authors":"Paul-Benoît Fargier, Marlène Damin-Pernik, Manon Launay, Amandine Gagneux-Brunon, Florelle Bellet, Marie-Noëlle Beyens","doi":"10.1016/j.therap.2024.12.012","DOIUrl":"https://doi.org/10.1016/j.therap.2024.12.012","url":null,"abstract":"<p><strong>Aim: </strong>During coronavirus disease 2019 (COVID-19), the incidence rate of adverse drug reactions (ADRs) in hospitalized patients seemed higher than before the pandemic. Severe inflammation triggered by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was cited as an explanation. We aimed to determine whether COVID-19 infection was associated with a higher risk of ADRs compared to other infectious diseases.</p><p><strong>Methods: </strong>A monocentric historic cohort, \"exposed/unexposed\" study, was conducted in the university hospital of Saint-Étienne (inclusion period from March 05, 2020 to April 16, 2020 for \"COVID-19\" and from January to December 2019 for \"non-COVID-19\"). All ADRs reported in patients' medical records were retrospectively assessed using Bégaud et al.'s algorithm. A multivariable Cox regression was performed to assess the hazard ratio (HR).</p><p><strong>Results: </strong>The incidence rate of 4.64 ADRs per person-month in the \"COVID-19\" group did not differ from the 3.52 ADRs per person-month in the \"non-COVID-19\" group (multivariable adjusted HR 1.29, 95% confidence interval [CI], 0.91-1.81, P=0.1436). COVID-19 patients had more hepatobiliary disorders whereas non-COVID-19 patients had more renal and urinary disorders. Classes of drugs mostly involved in ADRs occurrence were antibiotics, followed by antithrombotics in both groups. Compared to patients with no ADR, patients with ADRs had higher C-reactive protein (CRP) levels and a lower estimated glomerular filtration rate (eGFR).</p><p><strong>Conclusion: </strong>In this study, the incidence rate in hospitalized patients with COVID-19 was not statistically different from that in the group with another infection. High CRP levels, as well as low eGFR, were the main risk factors for the occurrence of ADRs and should be considered in further ADR prevention strategies.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143024777","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 : 2025-01-01DOI: 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":"10.1016/j.therap.2024.11.010","url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 1","pages":"Pages 103-112"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","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}