Pub Date : 2025-07-01DOI: 10.1016/j.therap.2024.11.005
Nada Saout , Ouafa Atouf , Malika Essakalli
<div><div>Les laboratoires d’analyses médicales jouent un rôle essentiel dans le diagnostic médical, leurs résultats influencent jusqu’à 70 % des décisions. Cela signifie que la qualité des prestations du laboratoire est un facteur principal de la qualité des soins médicaux. Cependant, au Maroc la certification et l’accréditation ne sont pas encore obligatoires, seul le guide de bonne exécution des analyses de biologie médicale (GBEA) publié en 2011 régie l’organisation des laboratoires. Le service de transfusion sanguine et d’hémovigilance (STSH) du centre hospitalier universitaire Ibn Sina (CHUIS) de Rabat s’est engagé dans une démarche de certification ISO 9001V2015 pour but d’accroître ses performances et de satisfaire ses parties intéressées. Cette démarche lancée en 2018 s’est déroulée en deux phases principales. La première consistait à se conformer à la réglementation en vigueur, tandis que la seconde impliquait une évaluation par rapport au référentiel ISO 9001V2015. Conformément à la logique de la roue de Deming, le service a élaboré sa politique qualité, établi ses objectifs et a entrepris la formation et la sensibilisation du personnel. Les processus, ainsi que les risques et opportunités afférents, ont été identifiés et représentés. Le système documentaire, ainsi que le système de signalement et de traitement des non-conformités, ont été mis en œuvre et dématérialisés. Des indicateurs de performance et d’activité ont été définis pour chaque processus. Enfin, le système d’écoute client a été étendu à toutes les parties prenantes, permettant ainsi d’évaluer leur perception et de détecter les axes d’amélioration. Malgré la pandémie mondiale de COVID-19, ce travail a su intégrer avec succès la norme ISO 9001:2015 dans les pratiques du STSH en déclarant sa conformité en 2022 par un organisme certificateur.</div></div><div><div>Medical analysis laboratories play an essential role in medical diagnosis, with their results influencing up to 70% of decisions. This means that the quality of laboratory services is a key factor in the quality of medical care. However, certification and accreditation are not yet compulsory in Morocco, and only the Guide to the Good Execution of Medical Biology Analyses (GBEA) published in 2011 governs the organisation of laboratories. The Blood Transfusion and Hemovigilance Service (STSH) at the Ibn Sina University Hospital (CHUIS) in Rabat has embarked on an ISO 9001:2015 certification process, with the aim of improving its performance and satisfying its interested parties. This process, which was launched in 2018, was carried out in two main phases. The first phase consisted of complying with current regulations, while the second phase involved an evaluation based on the ISO 9001:2015 standard. In accordance with the logic of the Deming wheel, the department developed its quality policy, set its objectives, and undertook staff training and awareness activities. The processes, along with the associated risks and
{"title":"Certification ISO 9001 : expérience du laboratoire d’immunologie et de thérapie cellulaire du CHU Ibn Sina, Rabat","authors":"Nada Saout , Ouafa Atouf , Malika Essakalli","doi":"10.1016/j.therap.2024.11.005","DOIUrl":"10.1016/j.therap.2024.11.005","url":null,"abstract":"<div><div>Les laboratoires d’analyses médicales jouent un rôle essentiel dans le diagnostic médical, leurs résultats influencent jusqu’à 70 % des décisions. Cela signifie que la qualité des prestations du laboratoire est un facteur principal de la qualité des soins médicaux. Cependant, au Maroc la certification et l’accréditation ne sont pas encore obligatoires, seul le guide de bonne exécution des analyses de biologie médicale (GBEA) publié en 2011 régie l’organisation des laboratoires. Le service de transfusion sanguine et d’hémovigilance (STSH) du centre hospitalier universitaire Ibn Sina (CHUIS) de Rabat s’est engagé dans une démarche de certification ISO 9001V2015 pour but d’accroître ses performances et de satisfaire ses parties intéressées. Cette démarche lancée en 2018 s’est déroulée en deux phases principales. La première consistait à se conformer à la réglementation en vigueur, tandis que la seconde impliquait une évaluation par rapport au référentiel ISO 9001V2015. Conformément à la logique de la roue de Deming, le service a élaboré sa politique qualité, établi ses objectifs et a entrepris la formation et la sensibilisation du personnel. Les processus, ainsi que les risques et opportunités afférents, ont été identifiés et représentés. Le système documentaire, ainsi que le système de signalement et de traitement des non-conformités, ont été mis en œuvre et dématérialisés. Des indicateurs de performance et d’activité ont été définis pour chaque processus. Enfin, le système d’écoute client a été étendu à toutes les parties prenantes, permettant ainsi d’évaluer leur perception et de détecter les axes d’amélioration. Malgré la pandémie mondiale de COVID-19, ce travail a su intégrer avec succès la norme ISO 9001:2015 dans les pratiques du STSH en déclarant sa conformité en 2022 par un organisme certificateur.</div></div><div><div>Medical analysis laboratories play an essential role in medical diagnosis, with their results influencing up to 70% of decisions. This means that the quality of laboratory services is a key factor in the quality of medical care. However, certification and accreditation are not yet compulsory in Morocco, and only the Guide to the Good Execution of Medical Biology Analyses (GBEA) published in 2011 governs the organisation of laboratories. The Blood Transfusion and Hemovigilance Service (STSH) at the Ibn Sina University Hospital (CHUIS) in Rabat has embarked on an ISO 9001:2015 certification process, with the aim of improving its performance and satisfying its interested parties. This process, which was launched in 2018, was carried out in two main phases. The first phase consisted of complying with current regulations, while the second phase involved an evaluation based on the ISO 9001:2015 standard. In accordance with the logic of the Deming wheel, the department developed its quality policy, set its objectives, and undertook staff training and awareness activities. The processes, along with the associated risks and ","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 367-377"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142847972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-01DOI: 10.1016/j.therap.2025.02.005
Nathan Pierrat-Maury , Serghei Banari , Tanguy Taillefer de Laportalière , Anne Roussin , Louis Richaud , Etienne Very , François Montastruc
{"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":"10.1016/j.therap.2025.02.005","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 502-505"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","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}
In the general population, there has been a noticeable rise in the dispensing of gabapentinoids in recent years. The aim of this study was to provide an overview of all available data on the use and safety of gabapentinoids during pregnancy.
Methods
A systematic review was performed in PubMed and Reprotox using the search terms: “gabapentin”, “pregabalin”, “antiepileptic drugs” and terms associated with pregnancy. We included all studies in English that reported on the use and safety of gabapentin and pregabalin during pregnancy. We excluded abstracts, literature reviews, case reports and studies involving fewer than 5 exposures. Descriptive analyses and narrative syntheses were performed.
Results
A total of 27 high-quality studies were described. The prevalence of gabapentinoid use during pregnancy remained very low, at less than 1%. Five studies reported significant findings with increased risks of overall congenital anomalies, specific anomalies (nervous system, eyes, oro-facial clefs, urinary and genital system), miscarriage, stillbirth and specific neurodevelopmental outcomes after exposure to pregabalin during pregnancy. Concerning exposure to gabapentin, increased risks of preterm birth, preeclampsia, small-for-gestational-age and NICU admission were reported in two studies.
Conclusions
Prenatal exposure to pregabalin is associated with an increased risk of congenital anomalies and long-term neurodevelopmental outcomes while gabapentin exposure was associated with an increased risk of preeclampsia, preterm birth and small-for-gestational age. Larger studies are needed to confirm these data and explore additional outcomes. The combined evidence from this systematic review and animal studies raises concerns about the safety of using gabapentinoids during pregnancy. Careful evaluation of the benefit–risk balance for both mother and fetus/infant is essential when these medications cannot be avoided during pregnancy.
{"title":"Systematic review of gabapentinoid use during pregnancy and its impact on pregnancy and childhood outcomes: A ConcePTION study","authors":"Anna-Belle Beau , Jingping Mo , Xavier Moisset , Justine Bénévent , Christine Damase-Michel","doi":"10.1016/j.therap.2024.10.049","DOIUrl":"10.1016/j.therap.2024.10.049","url":null,"abstract":"<div><h3>Objective</h3><div>In the general population, there has been a noticeable rise in the dispensing of gabapentinoids in recent years. The aim of this study was to provide an overview of all available data on the use and safety of gabapentinoids during pregnancy.</div></div><div><h3>Methods</h3><div>A systematic review was performed in PubMed and Reprotox using the search terms: “gabapentin”, “pregabalin”, “antiepileptic drugs” and terms associated with pregnancy. We included all studies in English that reported on the use and safety of gabapentin and pregabalin during pregnancy. We excluded abstracts, literature reviews, case reports and studies involving fewer than 5 exposures. Descriptive analyses and narrative syntheses were performed.</div></div><div><h3>Results</h3><div>A total of 27 high-quality studies were described. The prevalence of gabapentinoid use during pregnancy remained very low, at less than 1%. Five studies reported significant findings with increased risks of overall congenital anomalies, specific anomalies (nervous system, eyes, oro-facial clefs, urinary and genital system), miscarriage, stillbirth and specific neurodevelopmental outcomes after exposure to pregabalin during pregnancy. Concerning exposure to gabapentin, increased risks of preterm birth, preeclampsia, small-for-gestational-age and NICU admission were reported in two studies.</div></div><div><h3>Conclusions</h3><div>Prenatal exposure to pregabalin is associated with an increased risk of congenital anomalies and long-term neurodevelopmental outcomes while gabapentin exposure was associated with an increased risk of preeclampsia, preterm birth and small-for-gestational age. Larger studies are needed to confirm these data and explore additional outcomes. The combined evidence from this systematic review and animal studies raises concerns about the safety of using gabapentinoids during pregnancy. Careful evaluation of the benefit–risk balance for both mother and fetus/infant is essential when these medications cannot be avoided during pregnancy.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 378-416"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142682911","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.2024.12.009
Sophie Gautier , Julie Truong-Minh , Johana Béné , Johanna Temime , Maxime Granier , Benjamin Hennart , Sandrine Bergeron , Emmanuelle Jaillette
Objective
Metformin-associated lactic acidosis (MALA) is a rare but serious adverse drug reaction (ADR). The aim of the study was to identify clinical situations associated with the onset of MALA in patients hospitalised in the Nord Pas de Calais regional intensive care units (ICUs), and to assess its preventability.
Material and methods
We included all cases of MALA, identified by metformin accumulation > 2.3 mg/dL and lactate > 2.2 mmol/L, reported by the regional ICU physicians to the Regional Centre of Pharmacovigilance and registered in the French Pharmacovigilance Database between 1 January 2017 and 30 December 2018.
Results
One hundred and ninety-eight (198) cases of MALA were included. 38 patients died in direct association with MALA (19.2%). There was a correlation between metformin plasma accumulation and acute renal failure and with the severity of MALA (P < 0.0001). All patients presented an acute intercurrent event favouring MALA, dehydration for 87 (43.9%) patients, severe infection for 65 (32.8%) patients. For 172 patients (86.7%), the prescription was not adapted to the intercurrent medical situation as recommended. Seventy (40.5%) patients consulted their general practitioner for the acute intercurrent event, 1 temporarily stopped metformin and 34.3% had been referred directly to hospital. The remaining 65.7% presented to the hospital around 4 days later due to worsening symptoms. MALA was identified as preventable in 160 patients (80.8%).
Conclusions
MALA in ICUs often follow acute dehydration or infection, and these high-risk situations must be signals to prevent this serious ADR. Specific education programmes for physicians and patients could also reduce this risk.
{"title":"Lactic acidosis with metformin accumulation in the intensive care units of the Nord Pas de Calais region: A known serious adverse event that can be better prevented","authors":"Sophie Gautier , Julie Truong-Minh , Johana Béné , Johanna Temime , Maxime Granier , Benjamin Hennart , Sandrine Bergeron , Emmanuelle Jaillette","doi":"10.1016/j.therap.2024.12.009","DOIUrl":"10.1016/j.therap.2024.12.009","url":null,"abstract":"<div><h3>Objective</h3><div>Metformin-associated lactic acidosis (MALA) is a rare but serious adverse drug reaction (ADR). The aim of the study was to identify clinical situations associated with the onset of MALA in patients hospitalised in the Nord Pas de Calais regional intensive care units (ICUs), and to assess its preventability.</div></div><div><h3>Material and methods</h3><div>We included all cases of MALA, identified by metformin accumulation ><!--> <!-->2.3<!--> <!-->mg/dL and lactate ><!--> <!-->2.2<!--> <!-->mmol/L, reported by the regional ICU physicians to the Regional Centre of Pharmacovigilance and registered in the French Pharmacovigilance Database between 1 January 2017 and 30 December 2018.</div></div><div><h3>Results</h3><div>One hundred and ninety-eight (198) cases of MALA were included. 38 patients died in direct association with MALA (19.2%). There was a correlation between metformin plasma accumulation and acute renal failure and with the severity of MALA (<em>P</em> <!--><<!--> <!-->0.0001). All patients presented an acute intercurrent event favouring MALA, dehydration for 87 (43.9%) patients, severe infection for 65 (32.8%) patients. For 172 patients (86.7%), the prescription was not adapted to the intercurrent medical situation as recommended. Seventy (40.5%) patients consulted their general practitioner for the acute intercurrent event, 1 temporarily stopped metformin and 34.3% had been referred directly to hospital. The remaining 65.7% presented to the hospital around 4 days later due to worsening symptoms. MALA was identified as preventable in 160 patients (80.8%).</div></div><div><h3>Conclusions</h3><div>MALA in ICUs often follow acute dehydration or infection, and these high-risk situations must be signals to prevent this serious ADR. Specific education programmes for physicians and patients could also reduce this risk.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 438-448"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"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}
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