Pub Date : 2024-09-01DOI: 10.1016/j.therap.2023.12.003
Background
Considering data from the literature in favor of active educational intervention to teach pharmacovigilance, we describe an innovative model of distance learning clinical reasoning sessions (CRS) of pharmacovigilance with 3rd year medical French students.
Methods
The three main objectives were to identify the elements necessary for the diagnosis of an adverse drug reaction, report an adverse drug reaction and perform drug causality assessment. The training was organized in 3 stages. First, students practiced clinical reasoning (CRS) by conducting fictive pharmacovigilance telehealth consultations. Second, students wrote a medical letter summarizing the telehealth consultation and analyzing the drug causality assessment. This letter was sent to the teacher for a graded evaluation. In the third stage was a debriefing course with all the students.
Results
Of the 293 third-year medical students enrolled in this course, 274 participated in the distance learning CRS. The evaluation received feedback from 195 students, with an average score of 8.85 out of 10. The qualitative evaluation had only positive feedback. The students appreciated the different format of the teaching, with the possibility to be active.
Conclusion
Through distance CRS of pharmacovigilance, medical students’ competences to identify and report adverse drug reactions were tested. The students experienced the pharmacovigilance skills necessary to detect adverse drug reactions in a manner directly relevant to patient care. The overall evaluation of the students is in favor of this type of method.
{"title":"Teaching pharmacovigilance to French medical students during the COVID-19 pandemic: Interest of distance learning clinical reasoning sessions","authors":"","doi":"10.1016/j.therap.2023.12.003","DOIUrl":"10.1016/j.therap.2023.12.003","url":null,"abstract":"<div><h3>Background</h3><div>Considering data from the literature in favor of active educational intervention to teach pharmacovigilance, we describe an innovative model of distance learning clinical reasoning sessions (CRS) of pharmacovigilance with 3rd year medical French students.</div></div><div><h3>Methods</h3><div>The three main objectives were to identify the elements necessary for the diagnosis of an adverse drug reaction, report an adverse drug reaction and perform drug causality assessment. The training was organized in 3 stages. First, students practiced clinical reasoning (CRS) by conducting fictive pharmacovigilance telehealth consultations. Second, students wrote a medical letter summarizing the telehealth consultation and analyzing the drug causality assessment. This letter was sent to the teacher for a graded evaluation. In the third stage was a debriefing course with all the students.</div></div><div><h3>Results</h3><div>Of the 293 third-year medical students enrolled in this course, 274 participated in the distance learning CRS. The evaluation received feedback from 195 students, with an average score of 8.85 out of 10. The qualitative evaluation had only positive feedback. The students appreciated the different format of the teaching, with the possibility to be active.</div></div><div><h3>Conclusion</h3><div>Through distance CRS of pharmacovigilance, medical students’ competences to identify and report adverse drug reactions were tested. The students experienced the pharmacovigilance skills necessary to detect adverse drug reactions in a manner directly relevant to patient care. The overall evaluation of the students is in favor of this type of method.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 5","pages":"Pages 553-558"},"PeriodicalIF":2.2,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139538881","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 : 2024-09-01DOI: 10.1016/j.therap.2023.12.004
<div><div>Le centre d’investigations cliniques plurithématique (CIC-P) a pour principaux objectifs de faciliter la mise à disposition de nouveaux médicaments pour les patients, de renforcer la visibilité et l’attractivité de la recherche clinique française, d’améliorer la qualité des essais de phases précoces, et de valoriser la recherche académique en évaluant les molécules dans les maladies rares. Depuis 2017, le CIC-P, s’est engagé dans une démarche qualité, en lançant en 2018 sa première enquête de satisfaction sur la prise en charge des patients et sur la gestion des essais cliniques de l’ensemble de ses collaborateurs. Une seconde enquête de satisfaction ciblée par métier devait voir le jour en 2020, en vue des exigences de la norme ISO 9001:2015, mais celle-ci a été interrompue suite à la pandémie du <em>coronavirus disease 2019</em> (COVID-19). La réorganisation réussie de l’activité du CIC-P au cours du premier confinement de la pandémie du Covid-19 a été possible grâce à la mise en place d’un système de management de la qualité favorisant l’amélioration continue par l’organisation et l’implication de l’ensemble du personnel. Cette démarche volontaire et participative a motivé le CIC-P à postuler pour le sésame organisationnel. La certification ISO 9001:2015 a pour but d’accroître ses performances, de satisfaire ses clients et d’inscrire pleinement ses activités dans une démarche d’amélioration continue selon les exigences de cette norme internationale, à travers notamment le déploiement d’outils de la qualité tels que : la roue de Deming (<em>plan, do, check, act</em> [PDCA]), outil indispensable pour la transformation et la réorganisation ; l’analyse de l’environnement par l’outil d’analyse <em>strengths, weakness, opportunities, threats</em> (SWOT) ; l’analyse et la gestion des risques par la méthode AMDEC, et le tout avec des indicateurs de performances (spécifiques, mesurables, acceptables, réalistes, et temporellement définis - SMART) et des objectifs précis à chaque étape d’un projet/processus. La mise en place de questionnaires de satisfaction demeure l’outil essentiel permettant d’évaluer les attentes et besoins des parties intéressées mais également d’améliorer la qualité des activités et services du CIC-P. Tous ces outils mis en place ont permis l’amélioration continue des moyens de production et l’amélioration constante de notre organisation.</div></div><div><div>The main objectives of multidisciplinary clinical investigation center (CIC-P) are to facilitate the availability of new drugs for patients, to enhance the visibility and attractiveness of French clinical research, to improve the quality of early phase trials, and to enhance the value of academic research by evaluating molecules in rare diseases. Since 2017, the CIC-P has been committed to a quality approach process, launching in 2018 its first satisfaction survey on patient care and clinical trial management of all its employees. A second satisfaction survey targete
{"title":"Chronologie de la certification ISO 9001:2015 et enquête de satisfaction au sein du centre d’investigations cliniques plurithématique (CIC-P) de l’historique hôpital Saint-Louis en période de pandémie du COVID-19","authors":"","doi":"10.1016/j.therap.2023.12.004","DOIUrl":"10.1016/j.therap.2023.12.004","url":null,"abstract":"<div><div>Le centre d’investigations cliniques plurithématique (CIC-P) a pour principaux objectifs de faciliter la mise à disposition de nouveaux médicaments pour les patients, de renforcer la visibilité et l’attractivité de la recherche clinique française, d’améliorer la qualité des essais de phases précoces, et de valoriser la recherche académique en évaluant les molécules dans les maladies rares. Depuis 2017, le CIC-P, s’est engagé dans une démarche qualité, en lançant en 2018 sa première enquête de satisfaction sur la prise en charge des patients et sur la gestion des essais cliniques de l’ensemble de ses collaborateurs. Une seconde enquête de satisfaction ciblée par métier devait voir le jour en 2020, en vue des exigences de la norme ISO 9001:2015, mais celle-ci a été interrompue suite à la pandémie du <em>coronavirus disease 2019</em> (COVID-19). La réorganisation réussie de l’activité du CIC-P au cours du premier confinement de la pandémie du Covid-19 a été possible grâce à la mise en place d’un système de management de la qualité favorisant l’amélioration continue par l’organisation et l’implication de l’ensemble du personnel. Cette démarche volontaire et participative a motivé le CIC-P à postuler pour le sésame organisationnel. La certification ISO 9001:2015 a pour but d’accroître ses performances, de satisfaire ses clients et d’inscrire pleinement ses activités dans une démarche d’amélioration continue selon les exigences de cette norme internationale, à travers notamment le déploiement d’outils de la qualité tels que : la roue de Deming (<em>plan, do, check, act</em> [PDCA]), outil indispensable pour la transformation et la réorganisation ; l’analyse de l’environnement par l’outil d’analyse <em>strengths, weakness, opportunities, threats</em> (SWOT) ; l’analyse et la gestion des risques par la méthode AMDEC, et le tout avec des indicateurs de performances (spécifiques, mesurables, acceptables, réalistes, et temporellement définis - SMART) et des objectifs précis à chaque étape d’un projet/processus. La mise en place de questionnaires de satisfaction demeure l’outil essentiel permettant d’évaluer les attentes et besoins des parties intéressées mais également d’améliorer la qualité des activités et services du CIC-P. Tous ces outils mis en place ont permis l’amélioration continue des moyens de production et l’amélioration constante de notre organisation.</div></div><div><div>The main objectives of multidisciplinary clinical investigation center (CIC-P) are to facilitate the availability of new drugs for patients, to enhance the visibility and attractiveness of French clinical research, to improve the quality of early phase trials, and to enhance the value of academic research by evaluating molecules in rare diseases. Since 2017, the CIC-P has been committed to a quality approach process, launching in 2018 its first satisfaction survey on patient care and clinical trial management of all its employees. A second satisfaction survey targete","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 5","pages":"Pages 519-531"},"PeriodicalIF":2.2,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139634144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1016/j.therap.2024.01.003
<div><div>Les pharmacies d’officine représentent un service de proximité, idéal pour un accès à l’éducation thérapeutique en milieu rural. Les personnes âgées, peu mobiles, diabétiques de type 2, sont de plus en plus nombreuses et nécessitent un accompagnement éducatif relatif à leur pathologie. L’objectif de ce travail était de mettre en place une intervention éducative courte, dite « flash », coordonnée par des pharmaciens d’officine et de l’évaluer à Issoudun dans l’Indre, ville rurale française d’environ 10 000 habitants. Une fois les priorités éducatives établies, le projet a été présenté aux diverses instances de santé ainsi qu’aux professionnels de santé locaux. Les officines d’Issoudun ont recruté les patients accompagnés ou non d’un aidant. L’intervention éducative de 2<!--> <!-->h portait sur 4 objectifs pédagogiques : connaître le diabète, ses complications et leur surveillance, comment réagir face à une hypoglycémie, comprendre ses traitements et l’hémoglobine glyquée. L’impact de la séance éducative a été évalué par un questionnaire de connaissances avant la réunion, après et à 6 mois. Quarante-cinq patients de 71<!--> <!-->±<!--> <!-->6 ans avec 14<!--> <!-->±<!--> <!-->6 ans de diabète ont été recrutés sur 6 mois. De fausses croyances ont été mises en évidence avant l’intervention. La séance a permis une amélioration significative du taux de bonnes réponses (avant : 60,3 %<!--> <!-->±<!--> <!-->7,5, après : 99 %<!--> <!-->±<!--> <!-->0,4, <em>p</em> <!-->=<!--> <!-->0,0002) et à 6 mois (99,5 %<!--> <!-->±<!--> <!-->0,3, <em>p</em> <!-->=<!--> <!-->0,0002) par rapport à l’état des connaissances initiales des participants. Les fausses croyances ont été rectifiées en quasi-totalité par l’intervention et les participants ont su replacer le mécanisme d’action de leur médicament à l’aide d’un schéma « clé-serrure ». Ce modèle d’intervention éducative « flash » coordonnée par les pharmaciens d’officine a démontré son efficacité et son intérêt auprès des patients. Il pourrait être étendu à d’autres communes rurales et déserts médicaux.</div></div><div><div>The number of elderly people with type 2 diabetes (T2D) is increasing worldwide. Community pharmacies, thanks to their proximity, provide more easy access to therapeutic education for rural patients. Populations living in isolated areas require specific educational resources related to their condition. The aim of this project was to perform a short (FLASH) educational intervention, coordinated by community pharmacists, and then evaluate the impact of this intervention on patient knowledge of their disease. The study was performed in Issoudun, a rural French town of approximately 10,000 inhabitants. Educational priorities were defined and the project was presented to health authorities and local health professionals. Pharmacies in Issoudun recruited patients, either alone or accompanied by their caregivers. The educational intervention lasted 2<!--> <!-->h and focused on 4 teaching object
{"title":"Intérêt d’une séance éducative « flash » coordonnée par des pharmaciens d’officine pour des patients âgés diabétiques de type 2 en milieu rural","authors":"","doi":"10.1016/j.therap.2024.01.003","DOIUrl":"10.1016/j.therap.2024.01.003","url":null,"abstract":"<div><div>Les pharmacies d’officine représentent un service de proximité, idéal pour un accès à l’éducation thérapeutique en milieu rural. Les personnes âgées, peu mobiles, diabétiques de type 2, sont de plus en plus nombreuses et nécessitent un accompagnement éducatif relatif à leur pathologie. L’objectif de ce travail était de mettre en place une intervention éducative courte, dite « flash », coordonnée par des pharmaciens d’officine et de l’évaluer à Issoudun dans l’Indre, ville rurale française d’environ 10 000 habitants. Une fois les priorités éducatives établies, le projet a été présenté aux diverses instances de santé ainsi qu’aux professionnels de santé locaux. Les officines d’Issoudun ont recruté les patients accompagnés ou non d’un aidant. L’intervention éducative de 2<!--> <!-->h portait sur 4 objectifs pédagogiques : connaître le diabète, ses complications et leur surveillance, comment réagir face à une hypoglycémie, comprendre ses traitements et l’hémoglobine glyquée. L’impact de la séance éducative a été évalué par un questionnaire de connaissances avant la réunion, après et à 6 mois. Quarante-cinq patients de 71<!--> <!-->±<!--> <!-->6 ans avec 14<!--> <!-->±<!--> <!-->6 ans de diabète ont été recrutés sur 6 mois. De fausses croyances ont été mises en évidence avant l’intervention. La séance a permis une amélioration significative du taux de bonnes réponses (avant : 60,3 %<!--> <!-->±<!--> <!-->7,5, après : 99 %<!--> <!-->±<!--> <!-->0,4, <em>p</em> <!-->=<!--> <!-->0,0002) et à 6 mois (99,5 %<!--> <!-->±<!--> <!-->0,3, <em>p</em> <!-->=<!--> <!-->0,0002) par rapport à l’état des connaissances initiales des participants. Les fausses croyances ont été rectifiées en quasi-totalité par l’intervention et les participants ont su replacer le mécanisme d’action de leur médicament à l’aide d’un schéma « clé-serrure ». Ce modèle d’intervention éducative « flash » coordonnée par les pharmaciens d’officine a démontré son efficacité et son intérêt auprès des patients. Il pourrait être étendu à d’autres communes rurales et déserts médicaux.</div></div><div><div>The number of elderly people with type 2 diabetes (T2D) is increasing worldwide. Community pharmacies, thanks to their proximity, provide more easy access to therapeutic education for rural patients. Populations living in isolated areas require specific educational resources related to their condition. The aim of this project was to perform a short (FLASH) educational intervention, coordinated by community pharmacists, and then evaluate the impact of this intervention on patient knowledge of their disease. The study was performed in Issoudun, a rural French town of approximately 10,000 inhabitants. Educational priorities were defined and the project was presented to health authorities and local health professionals. Pharmacies in Issoudun recruited patients, either alone or accompanied by their caregivers. The educational intervention lasted 2<!--> <!-->h and focused on 4 teaching object","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 5","pages":"Pages 589-601"},"PeriodicalIF":2.2,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139635355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1016/j.therap.2023.12.006
Purpose
The safety profile of methimazole (MMI) seems to be better than propylthiouracil in the management of hyperthyroidism. It is therefore advisable to use IMM as the first choice in Graves’ patients. It is important to keep this drug in patients regardless of minor side effects. We report a case series of MMI-induced urticaria and provide a stepwise protocol for the safe re-administration of MMI.
Methods
It was a retrospective case series including all patients having manifested urticaria following MMI intake for hyperthyroidism; notified to the Pharmacovigilance Unit of the Clinical Pharmacology Department (March 2013–January 2022).
Results
We have included 11 patients (SR: 0.22). The median time interval between the start of MMI and the onset of urticaria averaged 14.5 days. The median daily dose of MMI was 40 mg. MMI was interrupted in all patients. Urticaria has progressively resolved after drug interruption and antihistamine intake. Reintroduction of MMI was performed in 10/11 patients as follows: one quarter of the daily dose on the first day, half of the daily dose on the 4th day, the three quarters of the daily dose on the 7th day, to reach the scheduled total dose on the 10th day. Cetirizine was added at the time of reintroduction and withdrawn 2 weeks later. All the patients were successfully controlled.
Conclusion
Given the importance of this drug in the management of hyperthyroidism, MMI should not be withdrawn in cases of urticaria. After the resolution of urticaria, a gradual reintroduction of MMI should be attempted with concomitant antihistamine therapy.
{"title":"Methimazole-induced urticaria in hyperthyroid patients: A safe re-administration protocol","authors":"","doi":"10.1016/j.therap.2023.12.006","DOIUrl":"10.1016/j.therap.2023.12.006","url":null,"abstract":"<div><h3>Purpose</h3><div><span><span>The safety profile of methimazole (MMI) seems to be better than </span>propylthiouracil in the management of </span>hyperthyroidism<span><span>. It is therefore advisable to use IMM as the first choice in Graves’ patients. It is important to keep this drug in patients regardless of minor side effects. We report a case series of MMI-induced </span>urticaria and provide a stepwise protocol for the safe re-administration of MMI.</span></div></div><div><h3>Methods</h3><div>It was a retrospective case series including all patients having manifested urticaria following MMI intake for hyperthyroidism; notified to the Pharmacovigilance<span> Unit of the Clinical Pharmacology Department (March 2013–January 2022).</span></div></div><div><h3>Results</h3><div>We have included 11 patients (SR: 0.22). The median time interval between the start of MMI and the onset of urticaria averaged 14.5 days. The median daily dose of MMI was 40<!--> <span><span>mg. MMI was interrupted in all patients. Urticaria has progressively resolved after drug interruption and antihistamine intake. Reintroduction of MMI was performed in 10/11 patients as follows: one quarter of the daily dose on the first day, half of the daily dose on the 4th day, the three quarters of the daily dose on the 7th day, to reach the scheduled total dose on the 10th day. </span>Cetirizine was added at the time of reintroduction and withdrawn 2 weeks later. All the patients were successfully controlled.</span></div></div><div><h3>Conclusion</h3><div>Given the importance of this drug in the management of hyperthyroidism, MMI should not be withdrawn in cases of urticaria. After the resolution of urticaria, a gradual reintroduction of MMI should be attempted with concomitant antihistamine therapy.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 5","pages":"Pages 559-563"},"PeriodicalIF":2.2,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139889388","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 : 2024-09-01DOI: 10.1016/j.therap.2024.01.006
In recent years, the increase in cannabidiol (CBD) sales in Europe has raised questions regarding the legal status of this product, as well as its safety of use. Consumers seem to be looking for solutions to various health issues. However, the scientific reality is much more nuanced. The European CBD market emerged in Switzerland in 2016 and subsequently expanded across the continent. This expansion has been facilitated by the establishment of delta-9-tetrahydrocannabinol (THC) concentration limits for these products. However, the current market offers a diverse range of CBD products, often lacking clear information on raw materials, product concentrations and recommended dosages. Regulating these products is challenging, as the appropriate classification of CBD remains uncertain. CBD products are in high demand worldwide, with many people seeking alternative treatments for medical conditions or general health and well-being benefits. However, the use of CBD products often relies on self-medication and lacks sufficient scientific evidence. Improved communication between patients and healthcare professionals is needed to ensure informed decisions and address potential interactions with other medications. Scientific evidence on CBD is currently limited and the efficacy of CBD-containing products has only been proven in clinical trials for Epidyolex® as an add-on therapy. There is no consensus on the long-term safety, appropriate dosage, schedules or administration routes for CBD. Health claims associated with CBD are not consistent with the available scientific research, which is still in its early stages. Further clinical research is needed to establish the efficacy and safety of CBD in various medical conditions. The enthusiasm surrounding CBD-based products should be tempered by the limited scientific evidence of their efficacy, the inadequacy of patient expectations, regulatory concerns and potential drug interactions.
{"title":"Cannabidiol (CBD): Confronting consumers’ expectations of therapeutic benefits with pharmacological reality","authors":"","doi":"10.1016/j.therap.2024.01.006","DOIUrl":"10.1016/j.therap.2024.01.006","url":null,"abstract":"<div><div><span>In recent years, the increase in cannabidiol<span> (CBD) sales in Europe has raised questions regarding the legal status of this product, as well as its safety of use. Consumers seem to be looking for solutions to various health issues. However, the scientific reality is much more nuanced. The European CBD market emerged in Switzerland in 2016 and subsequently expanded across the continent. This expansion has been facilitated by the establishment of delta-9-tetrahydrocannabinol (THC) concentration limits for these products. However, the current market offers a diverse range of CBD products, often lacking clear information on raw materials, product concentrations and recommended dosages. Regulating these products is challenging, as the appropriate classification of CBD remains uncertain. CBD products are in high demand worldwide, with many people seeking alternative treatments for medical conditions or general health and well-being benefits. However, the use of CBD products often relies on self-medication and lacks sufficient scientific evidence. Improved communication between patients and healthcare professionals is needed to ensure informed decisions and address potential interactions with other medications. Scientific evidence on CBD is currently limited and the efficacy of CBD-containing products has only been proven in clinical trials for Epidyolex® as an add-on therapy. There is no consensus on the long-term safety, appropriate dosage, schedules or administration routes for CBD. Health claims associated with CBD are not consistent with the available scientific research, which is still in its early stages. Further </span></span>clinical research is needed to establish the efficacy and safety of CBD in various medical conditions. The enthusiasm surrounding CBD-based products should be tempered by the limited scientific evidence of their efficacy, the inadequacy of patient expectations, regulatory concerns and potential drug interactions.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 5","pages":"Pages 497-504"},"PeriodicalIF":2.2,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139890123","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 : 2024-09-01DOI: 10.1016/j.therap.2024.04.005
{"title":"Propofol infusion syndrome: Analysis of French pharmacovigilance and World Health Organization Pharmacovigilance (VigiBase®) databases from 2020 to 2023","authors":"","doi":"10.1016/j.therap.2024.04.005","DOIUrl":"10.1016/j.therap.2024.04.005","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 5","pages":"Pages 611-614"},"PeriodicalIF":2.2,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141260204","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 : 2024-09-01DOI: 10.1016/j.therap.2024.03.004
Dans le contexte de la préparation d’une nouvelle version du site internet du Centre de référence sur les agents tératogènes (CRAT), une évaluation de la satisfaction de ses utilisateurs a été réalisée. Une invitation à remplir un questionnaire en ligne couvrant les différentes dimensions du site internet (apparence, contenu, interactivité, facilité d’utilisation, performance technique) a été transmise en avril 2022 aux professionnels de santé ayant sollicité le CRAT pour une expertise clinique au cours des deux années précédentes. Après envoi de 3224 invitations individuelles par mail, 758 évaluateurs ont rempli entièrement le questionnaire (taux de réponse : 23,5 %). L’évaluation a mis en évidence un haut niveau de satisfaction globale des utilisateurs du site (98,0 % très satisfait ou satisfait). La satisfaction relative à l’apparence du site était également élevée, mais des commentaires évoquaient un design internet peu moderne. Les évaluateurs soulignaient dans leurs réponses le caractère fiable, pertinent, actualisé du contenu de cette ressource en ligne publique et gratuite, indépendante de l’industrie pharmaceutique. Sur la base de ces éléments d’appréciation très favorables, avec un contenu plébiscité et des axes d’amélioration retenant l’attention des utilisateurs du site (évolution de son apparence et de l’outil de recherche, mise en place d’un site mobile), une nouvelle version du site www.lecrat.fr a été lancée fin 2023.
In preparation for a new version of the CRAT (Centre de référence sur les agents tératogènes) website, an evaluation of user satisfaction was carried out. An invitation to complete an online questionnaire covering the various dimensions of the website (appearance, content, interactivity, ease of use, technical performance) was sent in April 2022 to healthcare professionals who referred to CRAT for clinical expertise over the previous two years. After sending out 3224 individual e-mail invitations, 758 evaluators completed the questionnaire in full (response rate: 23.5%). The evaluation revealed a high-level of overall satisfaction among site users (98.0% very satisfied or satisfied). Satisfaction with the site's appearance was also high, although comments were made about the site's lack of a modern web design. Health professionals recognized in their responses the reliable, relevant and up-to-date nature of the content of this free, public online resource, independent of the pharmaceutical industry. On the basis of these highly favorable assessments, with content that has been widely acclaimed and areas for improvement that have caught the attention of site users (evolution of its appearance, of the search tool, implementation of a mobile site), a new version of www.lecrat.fr was launched in the fall of 2023.
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Pub Date : 2024-09-01DOI: 10.1016/j.therap.2024.02.001
Background
Overusing medication for primary headaches or other medical conditions can lead to dependency and medication-overuse headache (MOH) as an adverse drug reaction (ADR).
Objectives
To analyse reports of ADRs associated with MOH recorded in the French national pharmacovigilance database (FPVD).
Methods
This retrospective study selected all MOH cases reported in the FPVD from January 2000 to June 2023. A search of the High-Level Group Term “headache” was performed for drugs classified under ATC codes for the musculoskeletal and nervous systems. Specific keywords were searched in report narratives to further reduce their number. Voluntary intoxication reports were excluded. Only MOH cases according to the International Classification of Headache Disorders or with a medical diagnosis of MOH were considered.
Results
Among the 2674 reports associated with the HLGT “headache”, for 649 ATC drug codes, only 234 reports correspond to MOH, primarily notified by physicians. The median age was 45 years (IQR: 32–56), with 74.4% females and approximately 61.0% having pre-existing primary headaches. In all, 53.4% of the reports were classified as serious. Among patients, 84.2% had an isolated “headache” as the ADR. One drug was suspected in 47.4% of cases, two drugs in 29.1%, and three or more in 23.5%. In total, 473 suspected drugs, corresponding to 104 active ingredients, were involved, including analgesics (63.0%), in particular, acetaminophen-containing drugs, opioids, triptans and ergots, and non-steroidal anti-inflammatory drugs (12.7%). Antiepileptics and psycholeptics were found in 6.6% and 6.1% of cases, respectively. Drug withdrawal was successful in 84.6% of drug-discontinuation cases. Warnings about MOH are mentioned in the summary of product characteristics (SmPCs) for triptans, ergots, and certain acetaminophen-containing drugs, but not other drug classes.
Conclusions
Certain drug classes show a high reporting rate of MOH and caution should be exercised when prescribing these drugs. Notably, warnings about MOH must be mentioned in the SmPC of all concerned drug classes.
{"title":"Medication-overuse headache: A pharmacovigilance study in France","authors":"","doi":"10.1016/j.therap.2024.02.001","DOIUrl":"10.1016/j.therap.2024.02.001","url":null,"abstract":"<div><h3>Background</h3><div>Overusing medication for primary headaches or other medical conditions can lead to dependency and medication-overuse headache<span> (MOH) as an adverse drug reaction (ADR).</span></div></div><div><h3>Objectives</h3><div>To analyse reports of ADRs associated with MOH recorded in the French national pharmacovigilance database (FPVD).</div></div><div><h3>Methods</h3><div>This retrospective study selected all MOH cases reported in the FPVD from January 2000 to June 2023. A search of the High-Level Group Term “headache” was performed for drugs classified under ATC codes for the musculoskeletal and nervous systems. Specific keywords were searched in report narratives to further reduce their number. Voluntary intoxication reports were excluded. Only MOH cases according to the International Classification of Headache Disorders or with a medical diagnosis of MOH were considered.</div></div><div><h3>Results</h3><div>Among the 2674 reports associated with the HLGT “headache”, for 649 ATC drug codes, only 234 reports correspond to MOH, primarily notified by physicians. The median age was 45 years (IQR: 32–56), with 74.4% females and approximately 61.0% having pre-existing primary headaches. In all, 53.4% of the reports were classified as serious. Among patients, 84.2% had an isolated “headache” as the ADR. One drug was suspected in 47.4% of cases, two drugs in 29.1%, and three or more in 23.5%. In total, 473 suspected drugs, corresponding to 104 active ingredients, were involved, including analgesics (63.0%), in particular, acetaminophen-containing drugs, opioids, triptans and ergots, and non-steroidal anti-inflammatory drugs (12.7%). Antiepileptics and psycholeptics were found in 6.6% and 6.1% of cases, respectively. Drug withdrawal was successful in 84.6% of drug-discontinuation cases. Warnings about MOH are mentioned in the summary of product characteristics (SmPCs) for triptans, ergots, and certain acetaminophen-containing drugs, but not other drug classes.</div></div><div><h3>Conclusions</h3><div>Certain drug classes show a high reporting rate of MOH and caution should be exercised when prescribing these drugs. Notably, warnings about MOH must be mentioned in the SmPC of all concerned drug classes.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 5","pages":"Pages 565-575"},"PeriodicalIF":2.2,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140065925","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 : 2024-09-01DOI: 10.1016/j.therap.2024.04.003
{"title":"Drug–drug interaction and inadequate exposure to voriconazole in critically ill patients with multiple organ failure: A pediatric case study","authors":"","doi":"10.1016/j.therap.2024.04.003","DOIUrl":"10.1016/j.therap.2024.04.003","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 5","pages":"Pages 616-619"},"PeriodicalIF":2.2,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140778424","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 : 2024-09-01DOI: 10.1016/j.therap.2024.01.008
Aim
Patients with chronic non-cancer pain are referred to pain centres to improve their pain treatment. The discontinuation of pain medications in case of poor efficacy can be difficult to accept for patients, particularly opioid analgesics. Previous research has described that from the patients’ perspective, the psychological relief of a negative effect of chronic pain and withdrawal symptoms of prescription opioids represent drivers of persistent use and first stage of opioid use disorder, despite insufficient pain relief. There is no validated tool to investigate this psychological dependence. This study aimed to assess discordance between patients and pain specialists in their perception of dependence on pain medication and investigate associations with characteristics of patients, type of pain and iatrogenic pharmacodependence.
Methods
Self-administered questionnaires (patients and physicians) were administered in six pain centres in France. A question on perceived dependence on pain medications was addressed to the patient and the physician in a matched pair. Discordance between them was evaluated by the Cohen kappa coefficient. Demographics, pain, anxiety and depression, pain medication withdrawal symptoms, diverted use, and craving represented variables studied in a multivariate model as potentially associated with patient-physician discordance.
Results
According to the 212 pairs of completed questionnaires, a perceived dependence was reported by the majority of patients (65.6%) and physicians (68.4%). However, the concordance was fair (kappa = 0.38; CI [95%]: 0.25–0.51). Almost all patients (89.3%) were treated with an opioid analgesic. A higher likelihood of discordance was observed when patients suffered from nociplastic pain (odds ratio [OR]: 2.72, 95% [CI]: 1.29–5.84).
Conclusion
Medical shared-decision for changing pain treatment could be improved by taking into account the perception of patient dependence on medications for pain relief and or psychoactive effects, particularly in nociplastic pain for which the treatment is challenging.
{"title":"Discordance between pain specialists and patients on the perception of dependence on pain medication: A multi-centre cross-sectional study","authors":"","doi":"10.1016/j.therap.2024.01.008","DOIUrl":"10.1016/j.therap.2024.01.008","url":null,"abstract":"<div><h3>Aim</h3><div>Patients with chronic non-cancer pain are referred to pain centres to improve their pain treatment. The discontinuation of pain medications in case of poor efficacy can be difficult to accept for patients, particularly opioid analgesics. Previous research has described that from the patients’ perspective, the psychological relief of a negative effect of chronic pain and withdrawal symptoms of prescription opioids represent drivers of persistent use and first stage of opioid use disorder, despite insufficient pain relief. There is no validated tool to investigate this psychological dependence. This study aimed to assess discordance between patients and pain specialists in their perception of dependence on pain medication and investigate associations with characteristics of patients, type of pain and iatrogenic pharmacodependence.</div></div><div><h3>Methods</h3><div>Self-administered questionnaires (patients and physicians) were administered in six pain centres in France. A question on perceived dependence on pain medications was addressed to the patient and the physician in a matched pair. Discordance between them was evaluated by the Cohen kappa coefficient. Demographics, pain, anxiety and depression, pain medication withdrawal symptoms, diverted use, and craving represented variables studied in a multivariate model as potentially associated with patient-physician discordance.</div></div><div><h3>Results</h3><div>According to the 212 pairs of completed questionnaires, a perceived dependence was reported by the majority of patients (65.6%) and physicians (68.4%). However, the concordance was fair (kappa<!--> <!-->=<!--> <!-->0.38; CI [95%]: 0.25–0.51). Almost all patients (89.3%) were treated with an opioid analgesic. A higher likelihood of discordance was observed when patients suffered from nociplastic pain (odds ratio [OR]: 2.72, 95% [CI]: 1.29–5.84).</div></div><div><h3>Conclusion</h3><div>Medical shared-decision for changing pain treatment could be improved by taking into account the perception of patient dependence on medications for pain relief and or psychoactive effects, particularly in nociplastic pain for which the treatment is challenging.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 5","pages":"Pages 543-551"},"PeriodicalIF":2.2,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140772796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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