{"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":"10.1016/j.therap.2025.02.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 496-499"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","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}
Pub Date : 2025-07-01DOI: 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 , on behalf of the SFPT Pharmacoepidemiology Working Group
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.
{"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 , on behalf of the SFPT Pharmacoepidemiology Working Group","doi":"10.1016/j.therap.2024.12.005","DOIUrl":"10.1016/j.therap.2024.12.005","url":null,"abstract":"<div><div>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 (<span><span>https://frenchpharmacoepi.org/</span><svg><path></path></svg></span>), 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.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 417-423"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","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}
Pub Date : 2025-07-01DOI: 10.1016/j.therap.2024.09.003
Alice Deschenau , Benoit Trojak , Georges Brousse , Lisa Blecha , Julien Azuar , Mathieu Chappuy , Benjamin Touchon , Margaux Kosim , Benjamin Rolland
Aim
The long-acting buprenorphine Buvidal® is a recent type of opioid agonist treatment (OAT) used for opioid use disorder (OUD). It was initially suggested to preferentially use Buvidal® for specific OUD populations, including people in prison, or patients in recovery and on sublingual buprenorphine. We conducted a national study to examine whether the profile of patients treated with Buvidal® in France matched these initial recommendations.
Methods
A retrospective cross-sectional study was conducted in 13 national addiction centers (outside prison), using the individual medical records of patients initiated on Buvidal®. Baseline characteristics were collected and described, including sociodemographic features, comorbid medical conditions, concurrent substance use and prescription drug misuse, and OAT features before Buvidal® initiation, respectively.
Results
In total 101 patients (72.3% males, mean age 43.9 ± 11.3 years) were identified, which corresponded to one sixth of all patients treated with Buvidal® in France at the time of the study. Of them, 36 (36.4%) of them were professionally active, 35 (35.4%) were durably inactive, and the rest in an intermediary situation. Furthermore, 90 (90.0%) patients had at least one medical comorbidity (all types), and 83 (83.0%) at least one psychiatric comorbidity. Most frequent non-psychiatric comorbidities were chronic pain (n = 20, 20.0%) and chronic viral infection (n = 16, 17.8%). Current use of psychoactive substances included cocaine and crack (n = 43, 42.6%), heroin (n = 19, 18.8%), but also misuse of prescription drugs (n = 20, 20%), mainly opioid analgesics. Moreover, 99 (98.0%) patients had an OAT before Buvidal® initiation, including 7 (8.1%) patients on methadone.
Conclusion
The profile of patients initiated on Buvidal® in France was extremely similar to that of patients treated for OUD in France, either in terms of social or clinical features. While initial recommendations essentially underlined the interest of Buvidal® for some niche populations, the on-the-ground practice reveals a more widespread use, including for unrecovered patients, or patients treated with methadone.
{"title":"Characteristics of patients who are initiated on long-acting buprenorphine (Buvidal®) in France: A retrospective cross-sectional study","authors":"Alice Deschenau , Benoit Trojak , Georges Brousse , Lisa Blecha , Julien Azuar , Mathieu Chappuy , Benjamin Touchon , Margaux Kosim , Benjamin Rolland","doi":"10.1016/j.therap.2024.09.003","DOIUrl":"10.1016/j.therap.2024.09.003","url":null,"abstract":"<div><h3>Aim</h3><div>The long-acting buprenorphine Buvidal® is a recent type of opioid agonist treatment (OAT) used for opioid use disorder (OUD). It was initially suggested to preferentially use Buvidal® for specific OUD populations, including people in prison, or patients in recovery and on sublingual buprenorphine. We conducted a national study to examine whether the profile of patients treated with Buvidal® in France matched these initial recommendations.</div></div><div><h3>Methods</h3><div>A retrospective cross-sectional study was conducted in 13 national addiction centers (outside prison), using the individual medical records of patients initiated on Buvidal®. Baseline characteristics were collected and described, including sociodemographic features, comorbid medical conditions, concurrent substance use and prescription drug misuse, and OAT features before Buvidal® initiation, respectively.</div></div><div><h3>Results</h3><div>In total 101 patients (72.3% males, mean age 43.9<!--> <!-->±<!--> <!-->11.3<!--> <!-->years) were identified, which corresponded to one sixth of all patients treated with Buvidal® in France at the time of the study. Of them, 36 (36.4%) of them were professionally active, 35 (35.4%) were durably inactive, and the rest in an intermediary situation. Furthermore, 90 (90.0%) patients had at least one medical comorbidity (all types), and 83 (83.0%) at least one psychiatric comorbidity. Most frequent non-psychiatric comorbidities were chronic pain (<em>n</em> <!-->=<!--> <!-->20, 20.0%) and chronic viral infection (<em>n</em> <!-->=<!--> <!-->16, 17.8%). Current use of psychoactive substances included cocaine and crack (<em>n</em> <!-->=<!--> <!-->43, 42.6%), heroin (<em>n</em> <!-->=<!--> <!-->19, 18.8%), but also misuse of prescription drugs (<em>n</em> <!-->=<!--> <!-->20, 20%), mainly opioid analgesics. Moreover, 99 (98.0%) patients had an OAT before Buvidal® initiation, including 7 (8.1%) patients on methadone.</div></div><div><h3>Conclusion</h3><div>The profile of patients initiated on Buvidal® in France was extremely similar to that of patients treated for OUD in France, either in terms of social or clinical features. While initial recommendations essentially underlined the interest of Buvidal® for some niche populations, the on-the-ground practice reveals a more widespread use, including for unrecovered patients, or patients treated with methadone.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 359-366"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508624","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}
Pub Date : 2025-07-01DOI: 10.1016/j.therap.2025.02.004
Layal El Aridi , Hélène Jantzem , Corinne Guihard , Myriam Marteil , Greta Gourier
{"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":"10.1016/j.therap.2025.02.004","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 499-502"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","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}
Pub Date : 2025-07-01DOI: 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 , Mehdi Benkebil
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.
{"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 , Mehdi Benkebil","doi":"10.1016/j.therap.2024.11.002","DOIUrl":"10.1016/j.therap.2024.11.002","url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 429-437"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","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}
Pub Date : 2025-07-01DOI: 10.1016/j.therap.2024.10.061
Ruxandra Burlacu , Venceslas Bourdin , Patrick Blin , Fabrice Camaioni , Béatrice Clairaz , Michel Lantéri-Minet , Françoise Laroche , François Raineri , Serge Perrot , Jean-Paul Stahl , Nicolas H. Thurin , Stéphane Mouly
Les anti-inflammatoires non stéroïdiens (AINS) sont la deuxième classe d’antalgiques la plus utilisée en France derrière le paracétamol. Certains AINS sont disponibles sans ordonnance, sur conseil du pharmacien, donc à « prescription médicale facultative » (PMF). Les AINS ont récemment fait l’objet d’alertes de sécurité de la part de l’Agence nationale de sécurité du médicament et des produits de santé (ANSM) mettant en avant un risque d’aggravation de certaines infections bactériennes. Ce signal n’a pas été confirmé par Agence européenne du médicament (EMA) sans exclure un « risque de complications dues au masquage des symptômes d’infection ». Ces messages divergeant peuvent être source de confusions pour les professionnels de santé. Cette revue de la littérature, basée sur l’analyse de près de 200 publications scientifiques, examine la place des AINS dans la prise en charge en PMF de la migraine, des céphalées de tension, de l’analgésie postopératoire, des douleurs aiguës musculosquelettiques et articulaires, des dysménorrhées, des infections respiratoires virales, y compris le coronavirus 2 du syndrome respiratoire aigu sévère (SARS-CoV-2) ainsi que leur toxicité. Elle s’intéresse également au rôle du pharmacien dans la dispensation des AINS sans ordonnance. Les AINS permettent une prise en charge rapide et efficace de la douleur dans un contexte de difficulté croissante d’accès aux soins. Leur profil de sécurité est rassurant et globalement bien établi, mais pourrait être renforcé par la conduite d’une étude ad hoc pour statuer définitivement sur le signal de sécurité émanent de l’ANSM. Les pharmaciens disposent des connaissances et des outils pour sécuriser la dispensation et veiller à l’utilisation rationnelle des AINS avec ou sans ordonnance. La mise en place de mesures de minimisation de risque telles que des outils d’aide à la décision pourraient permettre d’aller plus loin dans la sécurisation de leur dispensation en PMF.
Non-steroidal anti-inflammatory drugs (NSAIDs) are the second most widely used class of analgesics in France, after paracetamol. Some NSAIDs are available over the counter (OTC), without a prescription, on the advice of a pharmacist. NSAIDs have recently been the subject of safety alerts from France's Agence nationale de sécurité du médicament et des produits de santé (ANSM), highlighting a risk of worsening certain bacterial infections. This signal has not been confirmed by the European Medicines Agency (EMA) although a “risk of complications due to masking of symptoms of infection” has not been ruled out. These divergent messages can be confusing for healthcare professionals. This literature review, based on an analysis of nearly 200 scientific publications, considers the place of NSAIDs in the OTC management of migraine, tension headaches, postoperative analgesia, acute musculoskeletal and joint pain, dysmenorrhea, viral respiratory infections, including severe acute respiratory syndro
{"title":"Anti-inflammatoires non stéroïdiens en prescription médicale facultative : mise au point dans la prise en charge de la douleur aiguë","authors":"Ruxandra Burlacu , Venceslas Bourdin , Patrick Blin , Fabrice Camaioni , Béatrice Clairaz , Michel Lantéri-Minet , Françoise Laroche , François Raineri , Serge Perrot , Jean-Paul Stahl , Nicolas H. Thurin , Stéphane Mouly","doi":"10.1016/j.therap.2024.10.061","DOIUrl":"10.1016/j.therap.2024.10.061","url":null,"abstract":"<div><div>Les anti-inflammatoires non stéroïdiens (AINS) sont la deuxième classe d’antalgiques la plus utilisée en France derrière le paracétamol. Certains AINS sont disponibles sans ordonnance, sur conseil du pharmacien, donc à « prescription médicale facultative » (PMF). Les AINS ont récemment fait l’objet d’alertes de sécurité de la part de l’Agence nationale de sécurité du médicament et des produits de santé (ANSM) mettant en avant un risque d’aggravation de certaines infections bactériennes. Ce signal n’a pas été confirmé par Agence européenne du médicament (EMA) sans exclure un « risque de complications dues au masquage des symptômes d’infection ». Ces messages divergeant peuvent être source de confusions pour les professionnels de santé. Cette revue de la littérature, basée sur l’analyse de près de 200 publications scientifiques, examine la place des AINS dans la prise en charge en PMF de la migraine, des céphalées de tension, de l’analgésie postopératoire, des douleurs aiguës musculosquelettiques et articulaires, des dysménorrhées, des infections respiratoires virales, y compris le coronavirus 2 du syndrome respiratoire aigu sévère (SARS-CoV-2) ainsi que leur toxicité. Elle s’intéresse également au rôle du pharmacien dans la dispensation des AINS sans ordonnance. Les AINS permettent une prise en charge rapide et efficace de la douleur dans un contexte de difficulté croissante d’accès aux soins. Leur profil de sécurité est rassurant et globalement bien établi, mais pourrait être renforcé par la conduite d’une étude ad hoc pour statuer définitivement sur le signal de sécurité émanent de l’ANSM. Les pharmaciens disposent des connaissances et des outils pour sécuriser la dispensation et veiller à l’utilisation rationnelle des AINS avec ou sans ordonnance. La mise en place de mesures de minimisation de risque telles que des outils d’aide à la décision pourraient permettre d’aller plus loin dans la sécurisation de leur dispensation en PMF.</div></div><div><div>Non-steroidal anti-inflammatory drugs (NSAIDs) are the second most widely used class of analgesics in France, after paracetamol. Some NSAIDs are available over the counter (OTC), without a prescription, on the advice of a pharmacist. NSAIDs have recently been the subject of safety alerts from France's Agence nationale de sécurité du médicament et des produits de santé (ANSM), highlighting a risk of worsening certain bacterial infections. This signal has not been confirmed by the European Medicines Agency (EMA) although a “risk of complications due to masking of symptoms of infection” has not been ruled out. These divergent messages can be confusing for healthcare professionals. This literature review, based on an analysis of nearly 200 scientific publications, considers the place of NSAIDs in the OTC management of migraine, tension headaches, postoperative analgesia, acute musculoskeletal and joint pain, dysmenorrhea, viral respiratory infections, including severe acute respiratory syndro","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 449-468"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628696","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}
By recovering data in an ordered manner and at the right time, clinical decision support systems (CDSSs) are designed to help healthcare professionals make decisions that improve patient care.
Objectives
The aim of the present study was to translate the REMEDI[e]s tool's explicit criteria, France's first reference list of potentially inappropriate drugs for the elderly, into seminatural language, in order to implement these criteria as alert rules and then enable their computer coding in a CDSS.
Methods
This work was carried out at Lille University Hospital by a team of clinical pharmacists with expertise in the use of pharmaceutical decision support systems, in collaboration with the authors of the REMEDI[e]s tool. A total of 3 multi-professional consensus meetings were required to discuss the construction of each rule in seminatural language and the coding choices.
Results
All REMEDIES criteria (n = 104) were translated into seminatural language. This study is the first to have translated the 104 REMEDI[e]s explicit criteria into seminatural language.
Conclusions
One of the study's strengths relates to the close collaboration between the authors of the REMEDI[e]s tool and experts in CDSS programming rules; this ensured the exactitude of the seminatural language translations and limited (mis)interpretations.
{"title":"Translation of the REMEDI[e]S (Review of potentially inappropriate MEDIcation pr[e]scribing in Seniors) explicit criteria into seminatural language for use in prescription support systems: A multidisciplinary consensus","authors":"Romane Freppel , Anaïs Barbier , Mathilde Dambrine , Laurine Robert , Chloé Rousselière , Estel Cuneo , Pascal Odou , Sophie Gautier , Jean-Baptiste Beuscart , Marie-Laure Laroche , Bertrand Décaudin","doi":"10.1016/j.therap.2024.09.002","DOIUrl":"10.1016/j.therap.2024.09.002","url":null,"abstract":"<div><h3>Background</h3><div>By recovering data in an ordered manner and at the right time, clinical decision support systems (CDSSs) are designed to help healthcare professionals make decisions that improve patient care.</div></div><div><h3>Objectives</h3><div>The aim of the present study was to translate the REMEDI[e]s tool's explicit criteria, France's first reference list of potentially inappropriate drugs for the elderly, into seminatural language, in order to implement these criteria as alert rules and then enable their computer coding in a CDSS.</div></div><div><h3>Methods</h3><div>This work was carried out at Lille University Hospital by a team of clinical pharmacists with expertise in the use of pharmaceutical decision support systems, in collaboration with the authors of the REMEDI[e]s tool. A total of 3 multi-professional consensus meetings were required to discuss the construction of each rule in seminatural language and the coding choices.</div></div><div><h3>Results</h3><div>All REMEDIES criteria (<em>n</em> <!-->=<!--> <!-->104) were translated into seminatural language. This study is the first to have translated the 104 REMEDI[e]s explicit criteria into seminatural language.</div></div><div><h3>Conclusions</h3><div>One of the study's strengths relates to the close collaboration between the authors of the REMEDI[e]s tool and experts in CDSS programming rules; this ensured the exactitude of the seminatural language translations and limited (mis)interpretations.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 477-493"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508626","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}
Pub Date : 2025-07-01DOI: 10.1016/j.therap.2025.02.012
Annie-Pierre Jonville-Bera , Joëlle Micallef
Depuis plusieurs années, les centres régionaux de pharmacovigilance alertent sur le risque d’aggravation des infections bactériennes cutanées ou pulmonaires à streptocoques pyogènes ou à pneumocoques, après la prise d’anti-inflammatoires non stéroïdiens (AINS), notamment l’ibuprofène. Une nouvelle expertise présentée à l’Agence du médicament en 2024 a colligé en 4,5 ans, 216 cas d’infections bactériennes graves (162 avec ibuprofène, 54 avec kétoprofène) après la prise d’AINS pour fièvre ou douleur aiguë, soit environ 21 % des effets indésirables graves avec l’ibuprofène (8 % pour le kétoprofène). Les infections streptococciques étaient majoritaires pour l’ibuprofène (62 % des cas d’infection bactérienne graves ; 44 % pour le kétoprofène). Ces infections streptococciques étaient invasives (97 %), à type de sepsis sévère/choc toxinique, de pleuropneumopathie, de méningite/méningoencéphalite et de dermohypodermite nécrosante. Les études de pharmaco-épidémiologie suggèrent toute une association entre l’exposition à un AINS et une augmentation du risque de complications pleuropulmonaires avec une estimation du risque compris entre 1,8 et 8. Plusieurs données mécanistiques sont également en faveur d’un effet délétère spécifique sur la gravité des infections invasives streptococciques, par un effet propre, intrinsèque des AINS sur l’amplification de la diffusion des streptocoques (via la vimentine). Des études expérimentales, chez l’animal, démontrent également ce risque, même quand l’AINS est associé à un antibiotique. En conclusion, en présence d’une infection streptococcique, qu’elle soit diagnostiquée ou non, la prise d’un AINS pour fièvre ou douleur aiguë, même sur une courte durée, et même associée à un antibiotique est une pratique à risque. Elle favorise l’évolution vers une infection streptococcique plus grave, non seulement en retardant la prise en charge de l’infection, mais surtout en favorisant la dissémination du streptocoque. Dans la mesure où les infections invasives à Streptococcus pyogenes sont un réel problème de santé publique, tout facteur de risque potentiel d’aggravation doit être pris en compte.
For several years, regional pharmacovigilance centers have been warning about the risk of worsening bacterial skin or lung infections caused by Streptococcus pyogenes or Pneumococcus after taking non-steroidal anti-inflammatory drugs (NSAIDs), particularly ibuprofen. A new report submitted to the French Medicines Agency in 2024 documented 216 cases of serious bacterial infections (162 with ibuprofen, 54 with ketoprofen) over 4.5 years following the use of NSAIDs for fever or acute pain. This represents about 21% of serious adverse events with ibuprofen (8% with ketoprofen). Streptococcal infections were most common with ibuprofen (62% of serious bacterial infections; 44% with ketoprofen). These streptococcal infections were invasive (97%) and included severe sepsis/toxic shock, ple
{"title":"Impact délétère d’un anti-inflammatoire non stéroïdien pris pour fièvre ou douleur aiguë en cas d’infection streptococcique","authors":"Annie-Pierre Jonville-Bera , Joëlle Micallef","doi":"10.1016/j.therap.2025.02.012","DOIUrl":"10.1016/j.therap.2025.02.012","url":null,"abstract":"<div><div>Depuis plusieurs années, les centres régionaux de pharmacovigilance alertent sur le risque d’aggravation des infections bactériennes cutanées ou pulmonaires à streptocoques pyogènes ou à pneumocoques, après la prise d’anti-inflammatoires non stéroïdiens (AINS), notamment l’ibuprofène. Une nouvelle expertise présentée à l’Agence du médicament en 2024 a colligé en 4,5 ans, 216 cas d’infections bactériennes graves (162 avec ibuprofène, 54 avec kétoprofène) après la prise d’AINS pour fièvre ou douleur aiguë, soit environ 21 % des effets indésirables graves avec l’ibuprofène (8 % pour le kétoprofène). Les infections streptococciques étaient majoritaires pour l’ibuprofène (62 % des cas d’infection bactérienne graves ; 44 % pour le kétoprofène). Ces infections streptococciques étaient invasives (97 %), à type de sepsis sévère/choc toxinique, de pleuropneumopathie, de méningite/méningoencéphalite et de dermohypodermite nécrosante. Les études de pharmaco-épidémiologie suggèrent toute une association entre l’exposition à un AINS et une augmentation du risque de complications pleuropulmonaires avec une estimation du risque compris entre 1,8 et 8. Plusieurs données mécanistiques sont également en faveur d’un effet délétère spécifique sur la gravité des infections invasives streptococciques, par un effet propre, intrinsèque des AINS sur l’amplification de la diffusion des streptocoques (via la vimentine). Des études expérimentales, chez l’animal, démontrent également ce risque, même quand l’AINS est associé à un antibiotique. En conclusion, en présence d’une infection streptococcique, qu’elle soit diagnostiquée ou non, la prise d’un AINS pour fièvre ou douleur aiguë, même sur une courte durée, et même associée à un antibiotique est une pratique à risque. Elle favorise l’évolution vers une infection streptococcique plus grave, non seulement en retardant la prise en charge de l’infection, mais surtout en favorisant la dissémination du streptocoque. Dans la mesure où les infections invasives à <em>Streptococcus pyogenes</em> sont un réel problème de santé publique, tout facteur de risque potentiel d’aggravation doit être pris en compte.</div></div><div><div>For several years, regional pharmacovigilance centers have been warning about the risk of worsening bacterial skin or lung infections caused by <em>Streptococcus pyogenes</em> or <em>Pneumococcus</em> after taking non-steroidal anti-inflammatory drugs (NSAIDs), particularly ibuprofen. A new report submitted to the French Medicines Agency in 2024 documented 216 cases of serious bacterial infections (162 with ibuprofen, 54 with ketoprofen) over 4.5 years following the use of NSAIDs for fever or acute pain. This represents about 21% of serious adverse events with ibuprofen (8% with ketoprofen). Streptococcal infections were most common with ibuprofen (62% of serious bacterial infections; 44% with ketoprofen). These streptococcal infections were invasive (97%) and included severe sepsis/toxic shock, ple","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 424-428"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143670947","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}
Une rupture d’approvisionnement en dronabinol a eu lieu entre décembre 2023 et février 2024 imposant aux patients douloureux chroniques d’interrompre ce traitement. Nous avons évalué l’impact de cette pénurie sur les patients de notre établissement.
Méthodes
Une étude observationnelle rétrospective a été menée auprès des patients traités par dronabinol. Les données recueillies comprenaient des données sociodémographiques, pharmacologiques et cliniques. L’intensité et la description de la douleur, l’intensité des autres dimensions de la douleur (humeur, relation aux autres…) et la qualité du sommeil ont été recueillis avant la rupture (posologie de dronabinol équilibrée, M0) et à la fin de la rupture (dronabinol arrêté depuis plusieurs semaines, M3). Le ressenti du patient de l’évolution de son état de santé a été recueilli à la fin de la rupture.
Résultats
Une dégradation de leur état de santé a été rapportée par 86 % des patients après 3 mois de rupture. L’intensité de la douleur et son interférence avec la vie quotidienne des patients a augmenté de façon significative. Le sommeil des patients s’est significativement dégradé. Le nombre de patients avec des douleurs permanentes a été multiplié par 5 (n = 2 à M0 et n = 10 à M3). Le nombre de patients avec plus de 20 crises douloureuses par 24 heures a été multiplié par 2 (n = 2 à M0 et n = 4 à M3).
Conclusion
Bien que les données concernant l’efficacité du dronabinol soient aujourd’hui limitées, cette rupture d’approvisionnement a eu des conséquences cliniques négatives chez nos patients. Les pénuries de médicaments se multipliant ces dernières années, la commercialisation de nouvelles spécialités et donc la présence d’alternatives thérapeutiques pourrait permettre chez ces patients douloureux chroniques réfractaires, de diminuer l’impact clinique d’une éventuelle nouvelle rupture de dronabinol.
Objective
A supply shortage of dronabinol occurred between December 2023 and February 2024, forcing chronic pain patients to discontinue this treatment. We assessed the impact of this shortage on patients in our hospital.
Method
A retrospective observational study of patients treated with dronabinol was conducted. Collected data included socio-demographic, pharmacological and clinical data. Pain intensity and its interference, the intensity of other pain dimensions (mood, relationship with others, etc.) and quality of sleep were collected before discontinuation (dronabinol dosage balanced, M0) and at the end of discontinuation (dronabinol stopped for several weeks, M3). The patient's perception of his state of health evolution was collected at the end of the shortage.
{"title":"Impact d’une rupture de dronabinol sur une population de patients douloureux chroniques : étude observationnelle rétrospective","authors":"Salomé Winckel, Laurie Ferret, Laure Dujardin, Amélie Boursier","doi":"10.1016/j.therap.2024.12.010","DOIUrl":"10.1016/j.therap.2024.12.010","url":null,"abstract":"<div><h3>Objectif</h3><div>Une rupture d’approvisionnement en dronabinol a eu lieu entre décembre 2023 et février 2024 imposant aux patients douloureux chroniques d’interrompre ce traitement. Nous avons évalué l’impact de cette pénurie sur les patients de notre établissement.</div></div><div><h3>Méthodes</h3><div>Une étude observationnelle rétrospective a été menée auprès des patients traités par dronabinol. Les données recueillies comprenaient des données sociodémographiques, pharmacologiques et cliniques. L’intensité et la description de la douleur, l’intensité des autres dimensions de la douleur (humeur, relation aux autres…) et la qualité du sommeil ont été recueillis avant la rupture (posologie de dronabinol équilibrée, M0) et à la fin de la rupture (dronabinol arrêté depuis plusieurs semaines, M3). Le ressenti du patient de l’évolution de son état de santé a été recueilli à la fin de la rupture.</div></div><div><h3>Résultats</h3><div>Une dégradation de leur état de santé a été rapportée par 86 % des patients après 3 mois de rupture. L’intensité de la douleur et son interférence avec la vie quotidienne des patients a augmenté de façon significative. Le sommeil des patients s’est significativement dégradé. Le nombre de patients avec des douleurs permanentes a été multiplié par 5 (<em>n</em> <!-->=<!--> <!-->2 à M0 et <em>n</em> <!-->=<!--> <!-->10 à M3). Le nombre de patients avec plus de 20 crises douloureuses par 24<!--> <!-->heures a été multiplié par 2 (<em>n</em> <!-->=<!--> <!-->2 à M0 et <em>n</em> <!-->=<!--> <!-->4 à M3).</div></div><div><h3>Conclusion</h3><div>Bien que les données concernant l’efficacité du dronabinol soient aujourd’hui limitées, cette rupture d’approvisionnement a eu des conséquences cliniques négatives chez nos patients. Les pénuries de médicaments se multipliant ces dernières années, la commercialisation de nouvelles spécialités et donc la présence d’alternatives thérapeutiques pourrait permettre chez ces patients douloureux chroniques réfractaires, de diminuer l’impact clinique d’une éventuelle nouvelle rupture de dronabinol.</div></div><div><h3>Objective</h3><div>A supply shortage of dronabinol occurred between December 2023 and February 2024, forcing chronic pain patients to discontinue this treatment. We assessed the impact of this shortage on patients in our hospital.</div></div><div><h3>Method</h3><div>A retrospective observational study of patients treated with dronabinol was conducted. Collected data included socio-demographic, pharmacological and clinical data. Pain intensity and its interference, the intensity of other pain dimensions (mood, relationship with others, etc.) and quality of sleep were collected before discontinuation (dronabinol dosage balanced, M0) and at the end of discontinuation (dronabinol stopped for several weeks, M3). The patient's perception of his state of health evolution was collected at the end of the shortage.</div></div><div><h3>Results</h3><div>Health deterioration was repo","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 469-476"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143012200","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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