Therapie最新文献

{"title":"The contribution of addictovigilance data to the French medical cannabis experimentation.","authors":"Emilie Bouquet, Emilie Jouanjus, Stéphanie Pain, Anne Batisse, Céline Eiden, Cécile Chevallier","doi":"10.1016/j.therap.2024.10.060","DOIUrl":"https://doi.org/10.1016/j.therap.2024.10.060","url":null,"abstract":"<p><p>In France, cannabis is the most widely used illicit psychoactive substance. Recently, a new market for cannabidiol (CBD) products has emerged called \"cannabis light\" or \"cannabis well-being\". In parallel, the experimentation of medical cannabis began on March 26, 2021, for specific indications. Some clinical effects of cannabis have been put forward for medical purposes; however, these are counterbalanced by adverse events (AEs). Data from addictovigilance and international literature on the risks associated with non-medical cannabis use have helped establish exclusion criteria for patients at risk of complications when using medical cannabis (such as those with psychotic disorders, severe cardiovascular, renal, or liver conditions). This also enables the early identification of AEs. Cannabis-based medications are composed of cannabidiol (CBD) and/or delta-9-tetrahydrocannabinol (THC) in varying concentrations. We aimed to present the contribution of the addictovigilance data regarding cannabis-related reports to the ongoing French experimentation on cannabis used for medical purposes, to anticipate potential adverse drug reactions in the treated patients. Among the 3164 patients included in the French experimentation, 1186 of them presented at least one AE. Some of the AEs reported in addictovigilance surveys on non-medical cannabis and CBD were observed during the experimentation of medical cannabis such as cardiovascular AEs (myocardial infarction, strokes, transient ischemic attack), psychiatric AEs (suicidal idea and attempt, depression), worsening of epilepsy, cognitive and/or sedative disorders. Given the potential for pharmacodependence of cannabis medications, it seems important for clinicians to gather the addiction history of their patients (past or present), particularly the use of non-medical cannabis (illicit) and non-medical CBD, to prevent and early detect any risk of abuse. The generalization of the use of medical cannabis was adopted and defined in the 2024 Social Security Financing Act. These medications will be accessible to patients by medical prescription for defined indications. Addictovigilance as well as pharmacovigilance monitoring is crucial in this context of continuing to make medical cannabis available in France. Adverse effects of interest will need to be monitored in particular, including neurological disorders (epilepsy exacerbation, cognitive disorders), psychiatric disorders (substance use disorder, suicidal behaviour), and cardiovascular disorders as well as any unexpected AEs. Close addictovigilance monitoring contributes to increasing the awareness of professionals involved in the clinical management of patients treated with medical cannabis.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142639954","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":"[Over-the-counter non-steroidal anti-inflammatory medications: Focus on the management of acute pain].","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":"https://doi.org/10.1016/j.therap.2024.10.061","url":null,"abstract":"<p><p>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 syndrome coronavirus 2 (SARS-CoV-2) and their toxicity. The role of the pharmacist in dispensing NSAIDs without a prescription is also addressed. NSAIDs offer rapid and effective pain management in a context of increasingly challenging access to care. Their safety profile is reassuring and generally well established but could be strengthened by conducting an ad hoc study to rule on the safety signal issued by the ANSM definitively. Pharmacists have the knowledge and tools to ensure the safe dispensing and rational use of NSAIDs, with or without a prescription. The introduction of risk minimization measures, such as decision-support tools, could enable further progress in ensuring the safe dispensing of OTC NSAIDs.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-10-23","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}

{"title":"DRAMES and DTA databases: Complementary tools to monitor drug-related deaths in France.","authors":"Bruno Revol, Théo Willeman, Marc Manceau, Véronique Dumestre-Toulet, Jean-Michel Gaulier, Alexandra Boucher, Célian Bertin, Hélène Eysseric-Guérin, Nathalie Fouilhé Sam-Laï","doi":"10.1016/j.therap.2024.10.059","DOIUrl":"https://doi.org/10.1016/j.therap.2024.10.059","url":null,"abstract":"<p><strong>Introduction: </strong>The DRAMES (décès en relation avec l'abus de médicaments et de substances) registry is a French database of drug-related deaths (medications or illicit drugs) among drug users. The DTA (décès toxiques par antalgiques) registry is a French database of analgesic-related deaths among people without a history of drug abuse. Both registries are based on the collection of data on deaths for which forensic toxicology experts have performed analyses.</p><p><strong>Material and methods: </strong>In the present study, we included drug- and analgesic-related deaths occurring from January 2013 to December 2022 in France. Subject demographic characteristics and medical history, forensic autopsy findings and toxicology reports were evaluated.</p><p><strong>Results: </strong>Among drug users (DRAMES registry), opioids used alone or in combination were the main contributor to drug-related deaths in France, as they are in most countries. However, licit methadone was the leading cause of opioid-related deaths (ahead of heroin) during the study period. The main trend was the dramatic increase in cocaine-related mortality. Among medical users of analgesics (DTA registry), tramadol was the leading cause of deaths throughout this period.</p><p><strong>Conclusion: </strong>A large-scale naloxone distribution program is urgently needed in France to prevent opioid overdoses, including among licit methadone users. However, our data do not support the hypothesis of an opioid crisis in France, although close monitoring is still required, particularly for oxycodone.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628701","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":"Inputs of pharmacoepidemiology in addictovigilance: How do they fit together?","authors":"Thomas Soeiro, Amélie Daveluy, Caroline Victorri-Vigneau, Maryse Lapeyre-Mestre, Joëlle Micallef","doi":"10.1016/j.therap.2024.10.058","DOIUrl":"https://doi.org/10.1016/j.therap.2024.10.058","url":null,"abstract":"<p><p>The French Addictovigilance Network has been using data from the French Heath insurance since the late 1990s to assess prescription drug abuse. In this narrative review, we illustrate the inputs of pharmacoepidemiology in addictovigilance based on the experience of the French Addictovigilance Network. The review focuses on pharmacoepidemiology using the French National Health Data System. We propose three examples: the MEGADOSE study, which aimed to conduct the first nation-wide, systematic, repeated assessment of doctor shopping; the DANTE study, which aimed to assess trends in analgesic use, focusing on the prevalence of use and the demographic profiles of analgesic users by age and sex; and the ZORRO study, which aimed to assess the impact of secure prescription forms on the use of zolpidem and other sedatives. These examples show how pharmacoepidemiology fits in the multifaceted monitoring conducted by the French Addictovigilance Network and complements the other data sources of this framework. This approach improves signal detection, confirmation, and quantification. It also makes it possible to overcome the limitations of each data source taken individually.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628719","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":"From regional signal to alert in addictovigilance.","authors":"Amélie Daveluy, Justine Perino, Valérie Gibaja, Reynald Le Boisselier, Anne Batisse, Ghada Miremont-Salamé, Alexandre Peyré, Alexandra Boucher, Elisabeth Frauger, Joëlle Micallef, Hélène Peyrière","doi":"10.1016/j.therap.2024.10.056","DOIUrl":"https://doi.org/10.1016/j.therap.2024.10.056","url":null,"abstract":"<p><p>France has several monitoring systems that form the foundation of its health safety surveillance. This system is designed for the early detection of signals and their swift into an action system that enables timely, appropriate, and effective interventions to protect public health. These signals are considered alerts when sufficiently validated after an initial risk assessment and if they represent a potential threat to public health, necessitating an appropriate response. The French Addictovigilance Network (FAN) was established specifically to address complications associated with the use of psychoactive substances (PAS), both medicinal and non-medicinal, excluding alcohol and tobacco. This system, unique in Europe, provides information on one of the most complex vigilance systems due to its scope, and the risks associated with it are becoming an increasingly significant public health issue. FAN is at the forefront of identifying potential signals. It has been working closely with regional partners since 1990, particularly through a multi-source approach that combines data from various sources, in collaboration with local professionals. After outlining the missions of the addictovigilance centres and the general principles of signal detection in addictovigilance, this article will present recent examples involving similar products but different identifications or modes of consumption: synthetic cannabinoids, nitazene, pregabalin, methylphenidate. These examples demonstrate that while there are regional disparities, the risk of occurrence in other French regions should not be overlooked, and information should be rapidly communicated at the national level for preventive action.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628714","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":"Monitoring misuse and abuse of psychoactive substances in France: Insights from substance abuse treatment facilities through the OPPIDUM program.","authors":"Clémence Lacroix, Elisabeth Frauger, Elisabeth Jouve, Hélène Peyrière, Joëlle Micallef","doi":"10.1016/j.therap.2024.10.054","DOIUrl":"https://doi.org/10.1016/j.therap.2024.10.054","url":null,"abstract":"<p><p>The OPPIDUM program was first created in 1990. It is an annual, repeated, cross-sectional, nationwide, multicenter program. Data are provided directly from users of psychoactive substances (PAS) seen in substance abuse treatment facilities. The OPPIDUM program includes sociodemographic data, data on the first PAS used and leading to dependence, data on PAS use in the week prior the interview and the modality of use. The OPPIDUM program contributes to characterize patterns of SPA use and detect changes in modalities of use or/and in users profiles. It relies on the acceptability and adhesion of the growing number of participating substance abuse treatment facilities for more than 30years, giving informative data at the national and regional level. In 2023, the OPPIDUM program gathers data from about 117,822 participants describing 239,959 patterns of PAS use (with more than 5000 participants each year). In this article, we reviewed the success of the oldest program of the French Addictovigilance Network (history, development, evolution and contribution) for the assessment and surveillance of substance abuse.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628721","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":"ASOS, a national monitoring study to assess narcotic prescriptions and indications in France since 2001.","authors":"Joelle Perri-Plandé, Ghada Miremont-Salamé, Maryse Lapeyre-Mestre, Justine Perino, Valérie Gibaja, Amélie Daveluy","doi":"10.1016/j.therap.2024.10.055","DOIUrl":"https://doi.org/10.1016/j.therap.2024.10.055","url":null,"abstract":"<p><strong>Introduction: </strong>Analgesics are among the most widely used drugs worldwide. The French Addictovigilance Network (FAN) established the antalgiques stupéfiants et ordonnances sécurisées (ASOS [narcotic analgesics and secure prescriptions]) survey in order to assess the dissemination of tamper-resistant prescription forms for narcotic analgesic within the medical community, as well as the nature and evolution of the prescriptions. After outlining the missions of the FAN, this article will describe the population treated with narcotic analgesics in France, their therapeutic indications and how the data have evolved since 2007.</p><p><strong>Methods: </strong>A cross-sectional, national, multicentre survey study was conducted that included surveys taken every year from 2007 to 2023 in a national sample of 1500 randomly selected dispensing pharmacies.</p><p><strong>Results: </strong>The mean age of patients, mostly women (around 60%), remained stable over the study period (63.2years in 2007, 67.6years in 2023). Most prescriptions involved morphine, oxycodone and fentanyl. Morphine and fentanyl were the reference molecules for prescribing opioid analgesics, but the sharp increase in oxycodone prescriptions between 2007 and 2015 impacted their usage. Cancer and rheumatologic pains were the main indications, with an increase in neurological indications in recent years. A focus on fentanyl and oxycodone highlights misuse patterns that are difficult to identify in other surveys.</p><p><strong>Conclusions: </strong>This study demonstrates how narcotic opioids are prescribed in France, thanks to the active participation of health professionals, and confirms the striking increase in the prescription of oxycodone and the misuse of fentanyl.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142688889","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":"From the first pilot initiatives in the early 1990s to the national OSIAP survey in the 2020s: More than 30years of insight in medication diversion phenomenon in France.","authors":"Maryse Lapeyre-Mestre, Florence Fabre, Emilie Jouanjus","doi":"10.1016/j.therap.2024.10.053","DOIUrl":"https://doi.org/10.1016/j.therap.2024.10.053","url":null,"abstract":"<p><p>This article proposes to trace back the timeline of the monitoring of falsified medical prescriptions in France as part of the French Addictovigilance System's toolbox. It examines the genesis of the OSIAP survey (Suspect Prescriptions Indicator of Possible Abuse), which has been held at the national level since 2001 but was created in the early 1990s, and its development until the current situation with a continuously confirmed yearly increasing trend. Understanding the birth and development of OSIAP and some other Addictovigilance tools that continue to be useful after more than 30 years of existence requires to review key historical benchmarks including the principles and missions of the former French National Commission on Narcotic and Psychotropic Drugs. Even though the OSIAP survey is part of a specific toolbox developed and routinely explored by the Addictovigilance network in a multidimensional approach, it has also been the sole data source, which identified some problematic drug uses, such as the early detection of tropicamide eye drop misuse in France or the diversion of codeine cough syrups after July 2017. Nevertheless, findings obtained from this data source should be checked against other complementary sources. Close monitoring of falsified prescriptions should be maintained in France, and the recent evolutions are plaid for supporting this survey. It is still being determined whether the constant increase of false prescription forms recorded in the OSIAP survey results from an increase in the absolute number of falsified prescriptions or whether pharmacists have become more vigilant with time. Still, the acceleration of these falsifications is also in line with the deployment of teleconsultations and the democratisation of digital techniques such as copying prescriptions or generating false QR codes. The forging techniques will likely evolve again in the future, possibly by adapting to stricter requirements such as the implementation of dematerialised prescriptions.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628717","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":"Attentes méthodologiques pour la démonstration de l’efficacité des produits de santé par les études observationnelles.","authors":"Michel Cucherat, Olivier Demarcq, Olivier Chassany, Claire Le Jeunne, Isabelle Borget, Cécile Collignon, Vincent Diebolt, Marion Feuilly, Béatrice Fiquet, Clémence Leyrat, Florian Naudet, Raphaël Porcher, Nathalie Schmidely, Tabassome Simon, Matthieu Roustit","doi":"10.1016/j.therap.2024.10.052","DOIUrl":"https://doi.org/10.1016/j.therap.2024.10.052","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628699","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":"Éthique et recherche clinique : quelles évolutions pour les CPP et les comités d’éthique de la recherche ?","authors":"Driss Berdaï, Aurélie Guérin, David Pérol, Cécile Girault, Mathieu Molimard, Philippe Amiel, Hélène Beaussier, Pierre-Henri Bertoye, Catherine Cornu, Dominique Deplanque, Didier Dreyfuss, Luc Duchossoy, Cécile Fouret, Thibaud Haaser, Anne Le Louarn, Soraya Rifai, Jean-Pierre Thierry","doi":"10.1016/j.therap.2024.10.051","DOIUrl":"https://doi.org/10.1016/j.therap.2024.10.051","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628704","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}