{"title":"Concilier régulation du médicament et démocratie sanitaire : rôle des conseillers patient ou professionnel de santé à l’ANSM","authors":"Patrick Maison , Trystan Bacon , Pascale Daynes , Christophe Decoene , Roseline Mazet , Thierry Vial , Stéphane Vignot , Laetitia Belgodère , Wahiba Oualikene-Gonin , Christelle Ratignier-Carbonneil","doi":"10.1016/j.therap.2024.06.002","DOIUrl":"10.1016/j.therap.2024.06.002","url":null,"abstract":"<div><div>L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) est une agence réglementaire et de santé publique. Ses actions de régulation, de police sanitaire et de protection de la santé publique imposent une parfaite adéquation avec le terrain et les différents acteurs concernés par l’utilisation des produits de santé. Depuis 2019, l’ANSM a adapté son organisation afin de promouvoir et améliorer ses interactions dans le cadre de sa politique d’ouverture à la société civile. Afin d’accompagner cette ambitieuse mutation et soutenir ses agents, l’Agence a recruté des conseillers reflétant les principaux profils d’utilisateurs de produits de santé : médecins, pharmaciens et patients. En collège ou individuellement, ils apportent un regard du « terrain » à chaque étape des processus de décision. Ils peuvent participer à l’évaluation des signalements et demandes comme aux validations de rapports ou aux instances d’échanges avec les parties prenantes. Ils interviennent notamment lorsque l’analyse nécessite une expertise au-delà des aspects scientifiques ou réglementaires. Ils peuvent aider à prendre en compte certains aspects du soin et les difficultés de terrain. Les conseillers participent à la lisibilité et à l’adéquation entre l’expertise réglementaire et/ou scientifique et le vécu des utilisateurs. Au-delà de l’aspect scientifique et thérapeutique, le médicament est aussi un objet économique, social et politique. Ainsi, sa régulation est particulièrement concernée par le besoin de démocratie sanitaire dont les conseillers sont les facilitateurs. Celle-ci impose une participation active des professionnels de santé, des patients et plus largement de la société civile dans la prise de décision. Dans ce contexte, la prise en compte de la pluralité des points de vue dans la régulation des produits de santé est nécessaire mais complexe. Elle peut être facilitée par l’adaptation des organisations, comme l’intégration de conseillers.</div></div><div><div>The French National Agency for Health Products (ANSM) is a regulatory and public health agency. Its regulatory, health policing and public health protection activities require a perfect fit with the field and the various people involved in the use of health products. Since 2019, the ANSM has adapted its organisation, procedures and processes to encourage and improve interaction with its stakeholders, as part of its policy of openness towards civil society. To accompany this ambitious change and to support its staff, the Agency has recruited advisors corresponding to the main users of health products: prescribers (doctor's hospital and outpatient), pharmacists and patients. Working as a group or individually, they provide a “lived” user perspective on health products at each stage of the evaluation process. They may be involved in the assessment of dossiers, signals or applications received by the Agency, in the internal validation of reports or in discussions with stakeholders. ","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 311-317"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141545304","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2025-05-01DOI: 10.1016/j.therap.2024.07.003
Florian Lemaitre , Lidvine Boland , Camille Tron , Matthieu Grégoire , Véronique Lelong-Boulouard , Peggy Gandia , Françoise Goirand , Nicolas Gambier , Christelle Boglione-Kerrien , Bénédicte Franck , Sébastien Lalanne , Arnaud Devresse , Sebastien Briol , Vincent Haufroid , Marie-Clémence Verdier , SFPT Therapeutic Drug Monitoring, Treatment Personalization group (STP-PT) of the French Society of Pharmacology, Therapeutics (SFPT)
{"title":"A biological pharmacology network to secure the risk of drug–drug interaction with nirmatrelvir/ritonavir","authors":"Florian Lemaitre , Lidvine Boland , Camille Tron , Matthieu Grégoire , Véronique Lelong-Boulouard , Peggy Gandia , Françoise Goirand , Nicolas Gambier , Christelle Boglione-Kerrien , Bénédicte Franck , Sébastien Lalanne , Arnaud Devresse , Sebastien Briol , Vincent Haufroid , Marie-Clémence Verdier , SFPT Therapeutic Drug Monitoring, Treatment Personalization group (STP-PT) of the French Society of Pharmacology, Therapeutics (SFPT)","doi":"10.1016/j.therap.2024.07.003","DOIUrl":"10.1016/j.therap.2024.07.003","url":null,"abstract":"<div><div>Nirmatrelvir/ritonavir is a protease inhibitor antiviral drug indicated in the treatment of severe acute respiratory syndrome coronavirus-2 infections in high-risk patients for a severe disease. Unfortunately, ritonavir, used to boost nirmatrelvir pharmacokinetics, can also inhibit or induce the metabolism of other co-administered drugs substrates. This may lead to a subsequent risk of adverse drug reaction and lack of efficacy. In this study, we aimed at describing the expert advices provided by the biological pharmacology network of the SFPT (i.e., the therapeutic drug monitoring specialists working in the laboratories of the pharmacology departments in France/Belgium). From February to August 2022, we collected all specialized advices provided by the biological pharmacology network of the SFPT. Seven pharmacology departments actively participated in the study (Brussels Saint-Luc Hospital in Belgium, Caen, Dijon, Nantes, Nancy, Rennes and Toulouse in France). We collected the following data: patient's age, date of nirmatrelvir/ritonavir initiation, clinical department requiring the expert advice, patient's treatments, and advice provided. One hundred and six expert advice on 753 drugs were provided during the seven months of data collection. Two centers provided 83% of all the expert advice (around 8/month). Patients originated form a transplantation department in 65% of the cases. The most common request were for cardiac drugs (28%), immunosuppressive drugs (24%) and endocrine drugs (18%). The advice were distributed as follows: treatment continuation, treatment discontinuation during the antiviral course, dosage adjustment, and treatment switch in 59%, 28%, 11%, and 1.6% of the cases, respectively. Only 2 pieces of advice (0.3%) constituted treatment contra-indications. Drug monitoring was proposed in 10% of prescription lines. Expert advice provided by the biological pharmacology network of the SFPT allows securing the combination of nirmatrelvir/ritonavir with other concomitant drugs. Most of eligible patients to the antiviral drug can benefit from it despite the risk of drug–drug interaction.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 327-332"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141852462","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2025-05-01DOI: 10.1016/j.therap.2024.07.004
Laurine Robert , Ali Laraba , Amélie Bruandet , Alexandra Royer , Pascal Odou , Bertrand Décaudin , Chloé Rousselière
{"title":"Utilisation d’un système d’aide à la décision pharmaceutique dans la valorisation des séjours hospitaliers : évaluation à travers 3 exemples en collaboration avec le département de l’information médicale","authors":"Laurine Robert , Ali Laraba , Amélie Bruandet , Alexandra Royer , Pascal Odou , Bertrand Décaudin , Chloé Rousselière","doi":"10.1016/j.therap.2024.07.004","DOIUrl":"10.1016/j.therap.2024.07.004","url":null,"abstract":"<div><h3>Introduction</h3><div>Les systèmes d’aide à la décision en pharmacie (SADP) permettent d’aider le pharmacien clinicien dans la prévention et la détection des événements indésirables médicamenteux. Le codage des séjours, par le département d’information médicale (DIM), nécessite une expertise car il conditionne les recettes des hôpitaux et les données épidémiologiques transmises via le programme de médicalisation des systèmes d’information. L’objectif était d’étudier l’intérêt et la faisabilité de l’utilisation d’un SADP, en collaboration avec le DIM, pour aider au codage des séjours hospitaliers.</div></div><div><h3>Méthodes</h3><div>Sur 5 mois, trois règles ont été implémentées dans le SADP pour détecter la goutte, la maladie de Parkinson et les candidoses oropharyngées. Les alertes du SADP ont été analysées par un interne en pharmacie puis transmis au DIM, qui a analysé les séjours pour voir si le codage de la maladie correspondant à l’alerte était présent ou non. L’absence de codage a été évaluée et tracée, avec le changement de sévérité et la valorisation induite.</div></div><div><h3>Résultats</h3><div>Trois cent dix-neuf alertes issues du SADP ont été analysées et envoyées au DIM, représentant 211 séjours et 309 résumés standardisés de séjour (RSS) en MCO. Deux cent huit (67,3 %) RSS n’avaient pas le codage correspondant à l’alerte. Pour la majorité de ces RSS, hormis la précision du diagnostic, il n’y a pas eu d’impact sur la valorisation des séjours. Pour 4 RSS, l’ajout du code diagnostic a permis une valorisation du séjour et l’augmentation de la sévérité des groupements homogènes de malade. La revalorisation totale correspondant à cette modification était de 5416 €.</div></div><div><h3>Discussion</h3><div>L’utilisation du SADP a aidé dans la précision du codage des diagnostics et la valorisation des séjours. Ce résultat est à pondérer face au temps investi pour l’analyse des alertes et des codages associés. Une amélioration de la détection des maladies et du traitement des données est nécessaire pour pouvoir être réalisable en pratique en considérant les plus de 227 600 RSS réalisés par an au sein de notre établissement.</div></div><div><h3>Introduction</h3><div>Pharmacy decision support systems (PDSS) help clinical pharmacists to prevent and detect adverse drug events. The coding of hospital stays by the department of medical information (DMI) requires expertise, as it determines hospital revenues and the epidemiological data transmitted via the French national hospital database. The aim was to study the interest and feasibility of using a PDSS, in collaboration with the DMI, to help with the coding of hospital stays.</div></div><div><h3>Methods</h3><div>Over 5 months, three rules were implemented in the PDSS to detect gout, Parkinson's disease and oro-pharyngeal candidiasis. The PDSS alerts were analyzed by a pharmacy resident and then forwarded to the DMI, who analyzed the stays to see whether or not the coding for the diseas","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 319-326"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142081621","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2025-05-01DOI: 10.1016/j.therap.2024.09.001
Joaquim Verdaguer , Laurent Chouchana , Marion Robert , Sandrine Bergeron , François Montastruc , Romain Barus
{"title":"Ischemic cardiopathy induced by capecitabine in gastric cancer: The role of dihydropyrimidine dehydrogenase metabolites","authors":"Joaquim Verdaguer , Laurent Chouchana , Marion Robert , Sandrine Bergeron , François Montastruc , Romain Barus","doi":"10.1016/j.therap.2024.09.001","DOIUrl":"10.1016/j.therap.2024.09.001","url":null,"abstract":"<div><h3>Objectives</h3><div>Fluoropyrimidine-based therapies, 5-fluorouracil (5-FU) and its oral prodrugs, capecitabine and tegafur/oteracil/gimeracil (S-1), are pivotal drugs to treat gastric cancer. Fluoropyrimidines are associated with cardiotoxicity including ischemic cardiopathy. The mechanisms of ischemic cardiopathy are considered to be multifactorial, potentially involving metabolites of 5-FU generated by the dihydropyrimidine dehydrogenase (DPD). By using Vigibase®, the World Health Organization pharmacovigilance database, we aimed to investigate the implication of the 5-FU metabolites induced by DPD in the occurrence of ischemic cardiopathy in patients with gastric cancer using capecitabine.</div></div><div><h3>Methods</h3><div>In Vigibase®, we included serious reports of ischemic cardiopathy with capecitabine and S-1 from January 1st, 2013, to September 16th, 2023. Among patients with gastric cancer, we calculated the reporting odds ratio (ROR) of ischemic cardiopathy to compare capecitabine (a prodrug without DPD antagonist) with S-1 (a prodrug associated with a DPD antagonist). The ROR was also calculated regardless of the drug indication. An ancillary analysis based on the French pharmacovigilance database was also performed. We evaluated the ROR of serious cardiac disorders induced by 5-FU intravenous infusion according to the DPD status (no deficiency versus complete or partial deficiency).</div></div><div><h3>Results</h3><div>In gastric cancer, 1843 reports (including 23 ischemic cardiopathy) for capecitabine and 2225 reports (including 17 ischemic cardiopathy) for S-1 were included. Median time-to-onset was 7 (3–26) days for capecitabine and 22 (13.25–30) days for S-1. Capecitabine was associated with an increased ROR of ischemic cardiopathy compared with S-1 in gastric cancer (ROR<!--> <!-->=<!--> <!-->1.6; [95% CI<!--> <!-->=<!--> <!-->1.5–1.8]) and regardless of the indication (7.3; [95% CI<!--> <!-->=<!--> <!-->6.6–8.0]). In the ancillary analysis, among 5-FU users, the lack of DPD deficiency increased the ROR for cardiac disorders (2.1; [95% CI<!--> <!-->=<!--> <!-->1.9–2.3]) compared to the DPD deficiency.</div></div><div><h3>Conclusion</h3><div>This work supports the role of toxic 5-FU metabolites generated by dihydropyrimidine dehydrogenase in the occurrence of ischemic cardiopathy among patients with gastric cancer using capecitabine.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 305-309"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508625","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2025-05-01DOI: 10.1016/j.therap.2025.04.005
Jean-Louis Montastruc
{"title":"Drugs and patient's dissatisfaction reporting: From a disproportionality pharmacovigilance analysis to social pharmacology.","authors":"Jean-Louis Montastruc","doi":"10.1016/j.therap.2025.04.005","DOIUrl":"https://doi.org/10.1016/j.therap.2025.04.005","url":null,"abstract":"<p><strong>Introduction: </strong>Patient satisfaction is a key element in medical practice. Few studies have investigated patient satisfaction or dissatisfaction with their drug treatment.</p><p><strong>Method: </strong>Using the World Health Organization (WHO) global pharmacovigilance database, we investigated, through disproportionality analyses, potential associations between exposure to drugs and \"patient dissatisfaction with treatment\" reports. All reports of \"patient dissatisfaction with treatment\" in adults until 31/12/2024 were included.</p><p><strong>Results/discussion: </strong>Results are expressed as reporting odds ratio (ROR). Among 506 reports, three quarters came from consumers, involving mainly women aged between 45 and 64. The main coreported term was drug inefficacy (before adverse drug reactions). The first anatomical therapeutic chemical (ATC) group was dermatological drugs (25.5%) followed by alimentary tract and metabolism (24.3%), nervous system (22.5%) drugs. A significant association was found with 22 drugs with the highest ROR values for plecanatide, efinaconazole and avatrombopag.</p><p><strong>Conclusion: </strong>Despite its mandatory limitations (underreporting, selective reporting…), this study shows that pharmacovigilance data could help to understand some aspects of social pharmacology, here, patient dissatisfaction with their drug treatment.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144086849","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":"Case report of a slow-metabolism of CYP2D6 which led to a misuse of codeine: How can we detect it and how can we take care?","authors":"Deborah Montmeat , Xavier Declèves , Laurence Labat , Alicja Puszkiel , Serge Perrot , Anne-Priscille Trouvin","doi":"10.1016/j.therap.2024.07.002","DOIUrl":"10.1016/j.therap.2024.07.002","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 338-341"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141789139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2025-05-01DOI: 10.1016/j.therap.2024.07.006
Paul Gautier , Cécile Vindis , Meyer Elbaz , François Montastruc
{"title":"Impact of new drug releases on heart failure management and hospitalizations in France: A repeated cross-sectional study between 2014 and 2023","authors":"Paul Gautier , Cécile Vindis , Meyer Elbaz , François Montastruc","doi":"10.1016/j.therap.2024.07.006","DOIUrl":"10.1016/j.therap.2024.07.006","url":null,"abstract":"<div><div>Real-life data on the impact of sacubitril-valsartan and sodium-glucose cotransporter type 2 (SGLT-2) inhibitors on heart failure (HF) in France is lacking. Using French health insurance databases, we examined the ten-year evolution in HF medication use, focusing on SGLT-2 inhibitors and sacubitril/valsartan, and incidence of HF hospitalizations during the same period. We conducted a repeated cross-sectional study using medical-administrative data from French health insurance databases between 2014 and 2023. These included “OpenMedic” for outpatient medication reimbursements and “ScanSanté” for annual hospitalization data. Medications were classified using ATC codes, and hospitalizations were identified using ICD-10 codes. Statistical analyses encompassed annual rates of users and boxes dispensed for HF medications, along with HF, ischemic heart disease and ischemic stroke hospitalization rates. Prevalence of SGLT-2 inhibitors and sacubitril-valsartan use was also studied regionally, with direct standardization by age and sex, with the French population as the standard population. Between 2014 and 2023, HF drug use increased significantly, with beta-blockers and ACE inhibitors/ARBs leading in prevalence of use. ARNi and SGLT-2 inhibitors, introduced later, showed remarkable rises: +506% and +3766% in users since their market introduction, respectively. Meanwhile, HF hospitalizations slightly increased by +3.6% between 2016 and 2019, followed by a notable decline of −12.5% during 2019–2023, coinciding with the introduction of SGLT-2 inhibitors. In contrast, hospitalizations for ischemic heart disease rose by 11.6% over the period 2016–2019 and by +5.2% over the period 2019–2023, and hospitalizations for ischemic stroke rose by 8.2% over the period 2016–2019 and declined by −0.6% over the period 2019–2023. We observed regional disparities in SGLT-2 inhibitors use, with prevalence ranging from 0.9% in Bretagne to 1.5% in Hauts-de-France. The data suggests a temporal correlation between the increase in SGLT-2 inhibitors use and the decline in HF hospitalizations since 2019. More studies are needed to measure real life effectiveness of SGLT-2 inhibitors in heart failure.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 253-258"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142037105","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}