Decisions regarding public health safety rely on scientific expertise, yet their impact hinges on how well they are understood and accepted by society as a whole. This article, drawn from the work of the Scientific Council (CS) of the ANSM, examines the conditions that facilitate better public engagement with these decisions. It highlights the tensions between knowledge production, its synthesis, political demands, and social expectations, particularly in the context of health crises that may amplify uncertainties and public perception of them. The analysis underscores that transparency alone is insufficient; it must be accompanied by clear communication about the inherent uncertainty in scientific data. Two key areas of reflection are thus proposed: enhancing the visibility and credibility of scientific discourse in the public sphere, and improving our understanding of citizens' perceptions. The article also emphasizes the value of an earlier and more collaborative dialogue between scientific expertise and society, supported by social sciences and an education in scientific knowledge.

PURPOSE:While most patients on cancer treatment receive their injection in a conventional hospital setting, Hospital At Home (HAH) is an alternative solution. This research aims to describe the management of care involving HAH, highlight the expectations and needs of each stakeholder, and identify the key elements of home cancer care compared to the conventional hospital setting. METHODS:Qualitative, prospective, and exploratory study between patients with active multiple myeloma treated exclusively in a day hospital setting versus patients alternating between a day hospital and HAH. It was based on semi-structured interviews conducted in several hospitals, in the community, and at home with patients, informal caregivers, and healthcare professionals. Grounded Theory was used for analysis. RESULTS:Five main dimensions of management of care emerged from the 35 interviews: (i) the hospital decided on patient care regardless of location, (ii) cancer care excluded general practitioners but the HAH intervention improved their involvement, (iii) strong collaboration required between HAH and the hospital for quality and safety of care, (iv) HAH, a way to stay at home but with a complex organization (v) the profile of patients potentially eligible for home cancer injection. CONCLUSION:Our study highlights the benefits and drawbacks of home-based care delivery from the perspective of patients with multiple myeloma, informal caregivers, and healthcare professionals. To promote home-based cancer injections, primary care services should be strengthened in relation to hospitals to achieve an optimal logistical organization for home delivery of care, and to better identify patients eligible for transfer to HAHs.

Les décisions en matière de sécurité sanitaire reposent sur l’expertise scientifique, mais leur impact dépend de leur compréhension et de leur acceptation par l’ensemble de la société. Cet article, issu des travaux du Conseil scientifique (CS) de l’ANSM, examine les conditions qui favorisent une meilleure appropriation de ces décisions par le public. Il met en lumière les tensions entre la production de connaissances, leur synthèse, les exigences politiques et les attentes sociales, notamment dans les contextes de crises sanitaires qui peuvent exacerber les incertitudes et leur perception. La transparence ne suffit pas par elle-même. Elle doit être accompagnée d’une communication claire sur l’incertitude inhérente aux données scientifiques. Deux axes de réflexion sont ainsi proposés: renforcer la visibilité et la crédibilité de la parole scientifique dans l’espace public, et mieux comprendre les perceptions citoyennes. L’article insiste également sur l’intérêt d’un dialogue plus précoce et étroit entre expertise scientifique et société, appuyé sur les sciences sociales et une éducation aux savoirs scientifiques.

OBJECTIVE:We aimed to describe the medications prescribed to people aged ≥90 years. DESIGN:A cohort study was performed using data from the year 2022. SETTING AND PARTICIPANTS:Using data from the French National Health Data System, people aged ≥90 years affiliated with the general insurance scheme were included. METHODS:Medications dispensed, polypharmacy (≥5 drugs), and hyperpolypharmacy (≥10 drugs) were described in the total population and according to sex, age group (90-94 years, 95-99 years, ≥100 years), and place of residence. All analyses were conducted by quarter because of the high mortality rate in this population. RESULTS:In total, 696,498 subjects were included in the study. Among them, 73.2% were women, 75.9% were aged 90-94 years, and 2.9% were ≥100 years. Treatment for hypertension was prescribed to 77%, 50.4% had cardiovascular disease, and 17.7% had dementia. During the first quarter, 77.7% experienced polypharmacy. The most prescribed drugs were antihypertensive medications (73.8%), analgesics (58.8%), antithrombotics (55.3%), vitamin D (51.1%), and psychotropics (42%). There was a decrease in preventive drugs and an increase in symptom management drugs with increasing age. Subjects in nursing homes were more likely to take psychotropics and less likely to receive cardiovascular drugs. The results for the other quarters were similar. CONCLUSIONS AND IMPLICATIONS:Our results suggest a progressive, but probably insufficient decrease in the prescription of certain medications with age and to a lesser extent, in nursing homes. The discontinuation of treatments should be discussed in the context of short life expectancy to avoid the harmful effects of polypharmacy.

Les nonagénaires vont voir un fort accroissement de leur nombre sans que notre société se soit préparée à cette progression. La littérature sur le sujet est éparse et les données souvent insuffisantes. Avec la compression de la morbidité aux âges les plus avancés de la vie nous allons être confrontés à de nombreux problèmes de prise en charge, à des problèmes socio-économiques et éthiques. Il est essentiel que la recherche se développe depuis la génétique jusqu’aux aux sciences humaines et sociales en passant par la clinique et l’épidémiologie. Cette population est laissée pour compte dans la recherche thérapeutique et l’évaluation des médicaments. Tous ces travaux sont nécessaires pour répondre le mieux possible à ces défis de santé publique que nous lancent les nonagénaires. Toutes nos actions ne peuvent pas s’exclure de la dimension environnementale (de l’habitat, de la cité mais aussi de la pollution et du climat) ni de la réflexion éthique d’autant que cette population aborde sa dernière décennie.

Artificial intelligence tools promise transformative impacts in drug development. Regulatory agencies face challenges in integrating AI while ensuring reliability and safety in clinical trial approvals, drug marketing authorizations, and post-market surveillance. Incorporating these technologies into the existing regulatory framework and agency practices poses notable challenges, particularly in evaluating the data and models employed for these purposes. Rapid adaptation of regulations and internal processes is essential for agencies to keep pace with innovation, though achieving this requires collective stakeholder collaboration. This article thus delves into the need for adaptations of regulations throughout the drug development lifecycle, as well as the utilization of AI within internal processes of medicine agencies.

Introduction Les personnes âgées de 90 ans et plus présentent souvent de nombreuses pathologies nécessitant une prise en charge thérapeutique complexe tant à domicile qu'en établissement d'hébergement pour personnes âgées dépendantes (EHPAD). L’évaluation du bénéfice de certains traitements reste très limitée dans cette population, peu de données existent concernant leur consommation médicamenteuse. L'objectif était de décrire la consommation médicamenteuse des personnes âgées de 90 ans et plus. Méthodes En utilisant le Système national de données de santé français, la prévalence de la consommation médicamenteuse des personnes âgées de 90 ans et plus, affiliées au régime général a été décrite. Les sous-groupes pharmacologiques définis selon la classification ATC (niveau 2 ou 3 ou 4) ont été décrits. Cette description a également été réalisée selon le sexe, les classes d’âge (90-94 ans; 95-99 ans et 100 ans et plus) et le lieu de vie. Les résultats ont été décrits par trimestre pour l'année 2022 en raison du taux mortalité élevé dans cette population. Résultats La population d’étude comprenait 696 498 sujets, avec 73,2 % (n=509 972) de femmes, 75,9 % (n=528 526) des sujets avaient entre 90-94 ans, 21,2 % (n=147 728) entre 95 et 99 ans et 2,9 % (n=20 244) avaient 100 ans et plus; 74,8 % (n=521 504) vivaient à domicile. Au premier trimestre, 77,7 % (n=540 983) des sujets avaient 5 médicaments et plus. Les médicaments les plus souvent prescrits étaient : les antihypertenseurs (73,8 %), les analgésiques (58,8 %), les antithrombotiques (55,3 %), la vitamine D (51,1 %), et les psychotropes (42 %). Des résultats similaires ont été décrits pour les autres trimestres de l'année 2022. Avec l'augmentation de l'âge, on observait une diminution des médicaments à visée préventive notamment cardiovasculaire et une augmentation des médicaments de gestion des symptômes. Les sujets en Ehpad avaient plus souvent des psychotropes et moins souvent des médicaments cardiovasculaires. Conclusion Nos résultats suggèrent une déprescription progressive avec l’âge mais possiblement insuffisante. La prescription des médicaments dans cette population complexe et multimorbide mérite des études répétées et des actions de santé publique.

Purpose Potentially inappropriate medications (PIMs) have become a major issue in improving prescribing practices and reducing the risk of adverse drug events in older people. However, very few studies have compared exposition to PIMs controlling for differences in demographic and health between nursing home residents (NHRs) and community-dwelling older adults (CDOAs). This study aimed to assess the prescribing pattern of PIMs between NHRs and CDOAs.Methods We conducted a cross-sectional study over three months in 2019 using the French Health Insurance databases. The study population included 274 971 NHRs and 4 893 721 CDOAs aged 75 years or over. The prevalence ratio (PR) between NHRs and CDOAs of 17 PIM indicators, based on the Beers and STOPP criteria lists, was assessed using multivariable robust Poisson regression adjusted for age, sex, diseases, and polypharmacy.Results During the study period, 54% of NHRs and 29% of CDOAs received at least one PIM. After adjustment, the prevalence of PIMs was 33% higher among NHRs compared to CDOAs (aPR = 1.33; 95% CI [1.33-1.34]). NHRs received PIMs related to benzodiazepines (aPR = 1.43; 95% CI [1.42-1.43]), anticholinergic drugs (aPR = 1.29; 95% CI [1.27-1.31]), and at least three central nervous system-active drugs (aPR = 1.94; 95% CI [1.92-1.96]) more frequently. Prevalence of PIMs related to non-steroidal anti-inflammatory drugs (aPR = 0.50; 95% CI [0.48-0.52]) and long-acting benzodiazepines (aPR = 0.84; 95% CI [0.82-0.85]) was lower among NHRs.Conclusion The NHRs were at greater risk for PIM than CDOAs, although differences exist according to the category of PIMs. As the population is aging, it is essential to promote and evaluate interventions in NHs and the community to enhance medication optimization.

Nanomaterials are present in a wide variety of health products, drugs and medical devices and their use is constantly increasing, varying in terms of diversity and quantity. The topic is vast because it covers nanodrugs, but also excipients (that includes varying proportions of NMs) and medical devices (with intended or not-intended (by-products of wear) nanoparticles). Although researchers in the field of nanomedicines in clinical research and industry push for clearer definitions and relevant regulations, the endeavor is challenging due to the enormous diversity of NMs in use and their specific properties. In addition, regulatory hurdles and discrepancies are often cited as obstacles to the clinical development of these innovative products. The scientific council of the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) undertook a multidisciplinary analysis encompassing fundamental, environmental and societal dimensions with the aim of identifying topics of interest for regulatory assessment and surveillance. This analysis allowed for proposing some recommendations for approximation and harmonization of international regulatory practices for the assessment of the risk/benefit balance of these products, considering as well the public expectations as regards efficacy and safety of nanomaterials used in Health products, in terms of human and environmental health.

Correspondence to Dr Laëtitia Belgodère; laetitia. belgodere@ ansm. sante. fr © Author(s) (or their employer(s)) 2023. Reuse permitted under CC BYNC. No commercial reuse. See rights and permissions. Published by BMJ. INTRODUCTION In France and Europe, medicine and healthcare products regulatory agencies have been proactively engaging in health democracy for the last decade. Since 2002, the French legislation has evolved to guarantee the rights of healthcare system’s users. Thus, eligible patients and health system user organisations are systematically represented in French health agencies as in some other countries. Beyond the integration of their representatives as members of committees and as part of its transparency policy, the French National Agency for Medicines and Health Products Safety (ANSM) is striving to involve patients at the various stages of the assessment and decisionmaking processes, but also all people concerned with health products. These are members of the public having different profiles, such as patients, users of the health system, caregivers, victims, patient representatives, support organisations and patient partners. Regulatory agencies are responsible for the benefit–risk (BR) assessment associated with the use of health products throughout their life cycle, from clinical development to market approval and the continuous reassessment of the BR balance thereafter. The assessment processes are driven by patient risk management, enabling the Agency to make decisions in a public health policy. ANSM is particularly willing and attentive to health democracy following the crises it has had to face. The involvement of the public and patients in a scientific and medical approach raises questions about the necessary adaptation of the BR assessment processes. To improve the BR assessment according to the approach of health democracy, the ANSM’s Scientific Advisory Board has formalised an approach to strengthen ‘people concerned’ involvement in the activities of regulatory agencies SUMMARY BOX

While most patients receive anticancer injection in a conventional hospital, some are treated in hospital at home. Given the lack of data, we seek to determine the clinical characteristics and care pathways of patients benefiting from hospital at home (HAH) for anticancer injection. A longitudinal scheme was conducted about patients with multiple myeloma (MM) starting bortezomib-based regimens in HAH in 2015 with a follow-up to September 2019. 154 patients received bortezomib at home with a mean age of 70.6 years, 72.7% over 65y-old and, a median Karnofsky Performans Status of 70. One-third of the elderly lived alone, 16.1% required domestic help. After a 24-month follow-up, 77.9% of patients were alive. The median overall survival was not reached at 4 years. Between 42.1% and 48.1% of patients returned to HAH for a new line of treatment. Patients were mainly independent and "fit." The involvement of HAH was achieved without safety issues nor compromise long-term outcomes. However, the real-world patterns highlighted that only a small proportion of patients returned to HAH for a new treatment line.

Background The adaptation of living environments can preserve functional independence among older people. A few studies have suggested that this would only benefit the most impaired. But conceptual models theorize that environmental pressure gradually increases with functional decline. Objectives We examined (1) how far different environmental barriers increased difficulties and favoured resort to assistance; (2) at what stage in functional decline environmental barriers begin to matter. Methods We used the French cross-sectional survey CARE (2015), including 7,451 participants (60+) with at least one severe functional limitation (FL). Multinomial logistic regressions models were used to compare predicted probabilities for outdoor activities of daily living (OADL) difficulties (no OADL difficulties; difficulties but without assistance; use of assistance) among individuals with and without environmental barriers (self-reported or objective), in relation to the number of FLs. Results Poor-quality pedestrian areas and lack of places to rest were associated with a higher probability of experiencing OADL difficulties, whatever the number of FLs; the association increased with the number of FLs. Up to 6 FLs, individuals with these barriers were more likely to report difficulties without resorting to assistance, with a decreasing association. Living in cities/towns with high diversity of food outlets was associated with a lower probability of reporting assistance, whatever the number of FLs, but with a decreasing association. Discussion Overall, the results suggest that environmental barriers increasingly contribute to OADL difficulties with the number of FLs. Conclusions differed as to whether they tended to favour resort to assistance, but there was a clear association with food outlets, which decreased with impairment severity. The adaptation of living environments could reduce difficulties in performing activities from the early stages of decline to the most severe impairment. However, the most deteriorated functional impairments seem to generate resort to assistance whatever the quality of the environment.

Abstract Background There are few studies reporting on self-medication, perceptions or difficulties older adults have with their medications. This study aimed to describe the uses and the perceptions of medications among older adults in France and to identify patient groups based on that information. Methods We used data from the 2020 ‘French Health Barometer’ – a nationally-representative cross-sectional survey. We assessed polypharmacy (five or more medications), self-medication, and patient perceptions of medications. Robust Poisson regression was used to investigate socio-demographic and health-related factors associated with the outcomes. Latent class analysis was used to identify patient groups classified by the use and the perceptions of medications. Factors associated with group assignment were investigated by multinomial logistic regression. All analyses were weighted. Results The study sample comprised 1,623 respondents aged 70–85 years. Polypharmacy and self-medication were reported in 23.5 and 48.7% of the older population, respectively. Polypharmacy was associated with increasing age, low education, and impaired health status. Self-medication was associated with female sex and high education. Among individuals taking at least 1 medication, 8.2% reported not to understand all their medications, and 9.7% having difficulty taking medications as prescribed. Among individuals taking at least 2 medications, 23.2% thought that they took too many medications. Three patient groups were identified: ‘Non-polypharmacy, positive perceptions’ (62.5%), ‘Polypharmacy, positive perceptions’ (28.0%), and ‘Negative perceptions’ (9.5%). Conclusions Polypharmacy and self-medication are common in French older adults. One segment of people reported negative perceptions of their medications regardless of their polypharmacy status. This underlines the difference between the objective and perceived measures of polypharmacy.

Abstract Background Potentially Inappropriate Medications (PIMs) and polypharmacy are widely used indicators of suboptimal prescribing in older people. These indicators have been associated with an increased risk of adverse drugs event, hospitalization and healthcare use. However there is no recent evaluation of the evolution of these indicators in France. The aim of this study was to describe the prevalence of PIM and polypharmacy and its evolution among older people between 2011 and 2019 in France. Methods A repeated cross sectional study was conducted every two calendar years between 2011 and 2019 using the French health insurance data system. People aged 75 years and over and not deceased in a given study year were included. Sixteen PIM criteria from the 2015 Beers or STOPP lists were assessed. Moderate polypharmacy (5 to 9 drugs) and hyper-polypharmacy (≥10 drugs) were defined based on the average number of drugs dispensed per quarter. Age and sex-standardized prevalence of PIMs and polypharmacy were assessed and stratified by age (75 to 84/85+) and sex. To estimate trends over time, the Annual Percent Change (APC) was calculated with linear regression models. Results The study population included 5,777,645 individuals in 2011 and 6,328,155 in 2019. The prevalence of PIMs decreased from 49.6% to 39.6% over the study period (APC=-1.2%). Benzodiazepines were the most frequent PIMs (APC=-1.3%), followed by drugs with anticholinergic effects (APC=-2.1%), oral non-steroidal anti-inflammatory drugs (APC=-2.0%), and antihypertensive drugs (APC=-1.1%). Overall, women and individuals aged 85 years and older were more likely to receive PIMs. The prevalence of hyper-polypharmacy decreased from 30.5% to 25.9% over the study period. Conclusions Prevalence of PIMs and hyper-polypharmacy declined in France between 2011 and 2019 and may reflect an improvement in prescribing practices. Still, suboptimal prescribing remains frequent in older people and often involves benzodiazepines. Key messages The prevalence of most potentially inappropriate medications decreased between 2011 and 2019 in France, consistently with trends previously reported in European countries, although still high. The observed diminution of hyper-polypharmacy over the study period also sends a positive and original signal.

Because of insufficient data about their benefit–risk ratio in real life, drugs used for Alzheimer’s disease (AD; cholinesterase inhibitors and memantine) were withdrawn from the list of reimbursable drugs in France on 1 August 2018. In this context, this study aimed to investigate the effects of the removal of AD drugs from the list of reimbursed drugs among patients followed in memory centres in France, in terms of prevalence and factors associated with drug discontinuation and evolution of disease management and cognition after drug discontinuation. This is an observational study based on data from the National Alzheimer Data Bank (‘Banque Nationale Alzheimer’ [BNA]), which centralizes information about patients consulting in memory centres. The drug discontinuation rate was estimated among patients receiving AD drugs at the last visit before the end of reimbursement. Factors associated with drug discontinuation were investigated among sociodemographic and disease characteristics, as well as among the use of healthcare resources before the end of reimbursement. We compared the evolution of disease management (psychotropic drugs and non-pharmacological interventions) and Mini-Mental State Examination (MMSE) score during the year following the end of reimbursement among patients with a diagnosis of AD. Among the 19,380 patients of the study sample (62.5% females, mean age 81 years, 86.8% with a diagnosis of AD), 19.5% discontinued their treatment after the end of reimbursement. The main factors associated with drug discontinuation were the type of dementia and lower MMSE level. Compared with patients with a diagnosis of AD, those with vascular dementia were more likely to stop their treatment, whereas those with dementia with Lewy bodies were less likely to discontinue. Among patients with a diagnosis of AD, drug discontinuation was associated with increased use of psychotropic medications, especially antidepressants, and non-pharmacological interventions afterwards, but there was no difference regarding the evolution of MMSE score. This study provides real-life information about the use of AD drugs after they were withdrawn from reimbursement in France and shows that drug discontinuation was limited among patients followed in memory centres and accompanied by increased use of other healthcare resources.

Pharmakon , du grec ancien, est à l’origine des mots « pharmacie », « pharmacologie » et a plusieurs sens : celui de remède, de poison et aussi de bouc émissaire. Ces trois éléments se retrouvent tout particulièrement quand nous étudions les médicaments dans les populations âgées. Cette population est en effet forte consommatrice de médicaments (du fait des polypathologies chroniques fréquentes à ces âges) qui sont responsables d’une iatrogénie importante dont nous verrons les mécanismes. Bien utilisés, ils sont des remèdes, mais ils peuvent devenir des poisons et contribuer à une médiatisation négative préjudiciable pour les patients (perte de chance d’être traité). Parmi les effets indésirables, il paraît important pour tout psychologue de connaître leur incidence sur le fonctionnement cognitif.