Economic burden of hospital admissions for adverse drug reactions in France: The IATROSTAT-ECO study.

AIMS: Hospitalizations for adverse drug reactions (ADR-HA) have increased over the last decade, but the impact of ADR-HA has rarely been evaluated. The aim of this study was to estimate the economic burden of ADR-HA in France. METHODS: A partial economic evaluation from the viewpoint of French public health insurance was performed, based on a previous pharmacovigilance study (IATROSTAT) performed in 2018 in public hospital medical units. The cost included direct medical costs, collected retrospectively, from the French hospital discharge database. The economic burden was estimated by calculating the total cost per ADR-HA patient (cost of hospital stays, additional daily cost of specific stays, such as in a resuscitation, intensive care or continuous surveillance unit, drug products and medical devices in addition to Healthcare Resource Group-based tariffs, and specific outpatient consultations and other clinical and technical medical procedures, over 3 months as from the first day of ADR-HA). The robustness of the results was assessed using a one-way deterministic sensitivity analysis of cost factors applying tariffs from 2023 instead of 2018. RESULTS: According to the 2018 tariffs (vs. 2023), the mean total cost per patient with ADR-HA was estimated at €5208 ± €3719 (vs. €5974 ± €4232) ranging from €514 to €23 355 (vs. €618 to €27 380). The total cost for 196 patients with ADR-HA admitted to a sample of French public hospitals was estimated at €1 020 549 (vs. €1 170 960). It could be estimated at €1.3 billion at the national level. CONCLUSIONS: In addition to the increase in the number of expensive drugs, the ageing population and polypharmacy, the economic impact of serious ADR-HA weighs heavily on healthcare spending.

Variability in the prevalence of inappropriate medication use among older adults: A review highlighting the importance of screening methods and database types.

AIMS: The global older population is growing rapidly, and the rise in polypharmacy has increased potentially inappropriate medication (PIM) encounters. PIMs pose health risks, but detecting them automatically in large medical databases is complex. This review aimed to uncover PIM prevalence in individuals aged 65 years or older using health databases and emphasized the risk of underestimating PIM prevalence due to underutilization of detection tools. METHODS: This study conducted a broad search on the Medline database to identify articles about the prevalence of PIMs in older adults using various databases. Articles published between January 2010 and June 2023 were included, and specific criteria were applied for study selection. Two literature reviews conducted before our study period were integrated to obtain a perspective from the 1990s to the present day. The selected papers were analysed for variables including database type, screening method, adaptations and PIM prevalence. The study categorized databases and original screening tools for clarity, examined adaptations and assessed concordance among different screening methods. RESULTS: This study encompassed 48 manuscripts, covering 58 sample evaluations. The mean prevalence of PIMs within the general population aged over 65 years was 27.8%. Relevant heterogeneity emerged in both the utilized databases and the detection methods. Adaptation of original screening tools was observed in 86.2% (50/58) of cases. Half of the original screening tools used for assessing PIMs belonged to the simple category. About a third of the studies employed less than half of the original criteria after adaptation. Only three studies used over 75% of the original criteria and more than 50 criteria. CONCLUSIONS: This extensive review highlights PIM prevalence among the older adults, emphasizing method intricacies and the potential for underestimation due to data limitations and algorithm adjustments. The findings call for enhanced methodologies, transparent algorithms and a deeper understanding of intricate rules' impact on public health implications.

Deprescribing in older adults in a French community: a questionnaire study on patients' beliefs and attitudes.

BACKGROUND: General practitioners (GPs) have a central role to play on reduction of polypharmacy and deprescribing. This study aimed to assess beliefs and attitudes towards deprescribing in patients, aged 65 years or older in primary care, and to identify factors associated with deprescribing and their willingness to stop medication. METHODS: A questionnaire study was performed between 23 May and 29 July 2022 on patients aged 65 years or older attending a GP's surgery in a French area. We used the French version of the revised Patients' Attitudes Towards Deprescribing self-report questionnaire (rPATD), which measures four subscales ("Burden", "Appropriateness", "Concerns about stopping" and, "Involvement"), patients' willingness to stop one of their regular medicines, and patients' satisfaction with their current medicines. RESULTS: The study enrolled 200 patients. Median age was 76 years old (IQR 71-81), 55% were women, and 42.5% took 5 or more medications per day. Although most patients (92.5%) were satisfied with their current medicines, 35% were reluctant to stop medications they had been taking for a long time, and 89.5% were willing to stop medication if asked to by their GP. Patients aged less than 75 years old reported more concerns about stopping. Women and patients with higher educational attainment showed significantly higher involvement in medication management. CONCLUSIONS: The majority of older adults were willing to stop one or more of their regular medicines if asked to do so by their GP. GPs should address deprescribing into their current practice.

Incidence and preventability of hospital admissions for adverse drug reactions in France: A prospective observational study (IATROSTAT).

AIMS: In the last French study in 2007, the incidence of hospital admissions (HAs) related to adverse drug reactions (ADRs) was 3.6%. The objective was to assess the current ADR-HA incidence in France and to describe both its characteristics and preventability. METHODS: A prospective multicentre study was conducted among randomly selected French public hospital medical wards (April-July 2018). Patients admitted during a week period were included. ADR-HA cases were collected by the French Regional Pharmacovigilance Centres network. An independent committee validated potential cases and ADR preventability. RESULTS: ADR-HA incidence was 8.5% (95% confidence interval [CI]: 7.6-9.4%), increasing with age (3.3% [95%CI: 1.8-5.5%] ≤16 y vs. 10.6% [95%CI: 9.3-12.0%] ≥65 y). The most common ADRs were haemorrhagic events (8.8%), haematological disorders (6.5%), acute renal failure (6.3%), fluid and electrolyte disorders (6.0%), and falls (5.2%). New drugs were involved: targeted therapies (22.8% of antineoplastics), direct oral anticoagulants (29.6% of antithrombotics) and incretin-based drugs (20.0% of antidiabetics). ADRs were preventable in 16.1% of cases because the drugs involved had not been used in accordance with monographies, package leaflets or other therapeutic guidelines. The main situations of noncompliance addressed either dose or duration of use (27.9%), warning (23.2%), use precaution (18.6%) and inappropriate self-medication or misuse by patients (11.6%). CONCLUSION: In France, ADR-HA incidence dramatically increased over the last decade. A significant proportion was related to new pharmacological classes and considered as preventable. These findings should lead to in-depth thought on preventive actions on at-risk drug classes.

Adverse drug reaction related to drug shortage: A retrospective study on the French National Pharmacovigilance Database.

AIM: Drug shortages are a growing global health issue. The aim of the study was to evaluate the consequences of drug shortages on patient safety based on data recorded in the French National Pharmacovigilance Database. METHODS: All cases involving drug shortages reported from 1985 to the end of 2019 were extracted from the database. RESULTS: Following the selection process, 462 cases were included. The number of cases increased significantly from 2004 to 2019. Cases mainly involved drugs from the nervous system (22.1%, 95% confidence interval [CI] 17.5-27.0%), the cardiovascular system (16.4%, 95% CI 11.9-21.4%) and anti-infectives for systemic use (14.3%, 95% CI 9.7-19.2%) ATC classes. Most of the cases reported an adverse drug reaction (ADR) belonging to the SOC nervous system (21%, 95% CI 18-24%), skin and subcutaneous (14%, 95% CI 11-17%), general (13%, 95% CI 10-17%) and gastrointestinal (8%, 95% CI 5-11%) disorders. Disease worsening was observed in 15.9% of the cases, mostly related to a lack of efficacy of the replacement drug. Half of the cases were considered as serious. Evolution was favourable in 79.4% of the cases. Death and/or life-threatening situations were reported in 5.8% of the cases. Medication errors (MEs) were identified in 51 cases (11%), mostly occurring at the administration step and involving a human factor. CONCLUSION: This study emphasizes the clinical impact of drug shortage in terms of ADRs, ME and inefficiency. These observations underline the importance of a global health policy programme to limit the occurrence of drug shortages and to reinforce the information provided to patients and health care professionals in this context to limit risk.

Attitudes and beliefs of older adults and caregivers towards deprescribing in French-speaking countries: a multicenter cross-sectional study.

PURPOSE: Successful deprescribing requires understanding the attitudes of older adults and caregivers towards this process. This study aimed to capture these attitudes in four French-speaking countries and to investigate associated factors. METHODS: A multicenter cross-sectional study was conducted by administrating the French version of the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire in Belgium, Canada, France, and Switzerland. Community-dwelling or nursing home older adults ≥ 65 years taking ≥ 1 prescribed medications and caregivers of older adults with similar characteristics were included. Multivariate logistic regressions were carried out to examine factors associated with willingness to deprescribe. RESULTS: A total of 367 older adults (79.3 ± 8.7 years, 63% community-dwelling, 54% ≥ 5 medications) and 255 unrelated caregivers (64.4 ± 12.6 years) of care recipients (83.4 ± 7.9 years, 52% community-dwelling, 69% ≥ 5 medications) answered the questionnaire. Among them, 87.5% older adults and 75.6% caregivers would be willing to stop medications if the physician said it was possible. Reluctance to stop a medication taken for a long time was expressed by 46% of both older adults and caregivers. A low score for the factor "concerns about stopping" (older adults: aOR: 0.21; 95% CI: 0.07-0.59), and a high score for the factor "involvement" (older adults: aOR: 2.66; 95% CI: 1.01-7.07; caregivers: aOR: 11.28; 95% CI: 1.48-85.91) were associated with willingness to deprescribe. CONCLUSIONS: A significant proportion of older adults and caregivers of French-speaking countries are open to deprescribing. Despite this apparent willingness, deprescribing conversations in clinical practice remains marginal, emphasizing the importance of optimizing the integration of existing tools such as rPATD.

Frailty and functional dependence in older population: lessons from the FREEDOM Limousin - Nouvelle Aquitaine Cohort Study.

BACKGROUND: Monitoring frailty indicators in elderly people is recommended to identify those who could benefit from disability prevention programs. To contribute to the understanding of the development of frailty in the elderly, we have created the FREEDOM-LNA cohort constituting an observational study of ageing in general population. Here, we described the characteristics of a cohort of elderly subjects who are followed for determination of frailty and loss of independence trajectories. RESULTS: The cohort was composed of 1085 subjects in advanced age (mean: 83.7 ± 6.0 years) and of women in majority (68.3%). Cardiovascular risk factors were present in 88.4% of subjects. Abnormal musculoskeletal signs were reported in 44.0% and neurologic signs in 31.9%. There were 44.8% of subjects at risk of malnutrition (MNA <24) and 73.3% (668/911) at risk of mobility-related disability (SPPB ≤9); 39% (384/973) of subjects had impaired cognitive function (MMSE< 24, adjusted on education) and 49.0% (397/810) had signs of depression (GDS >9); 31.8% (240/753) were frail and 58.3% were pre-frail. Most subjects had at least one disability in ADL (66.9%) and IADL (85.1%). The SMAF indicated a loss of independence in 59.6%. Overall, 59.9% of subjects could not stay at home without at least some help. Consequently, a medical consultation was proposed in 68.2 and 42.1% social supports. CONCLUSIONS: A large part of this cohort was frail or pre-frail and presented signs of loss of independence, which may be explained by multiple factors including impaired health status, poor physical performance, cognition, isolation, depression, or nutrition. This cohort will help to determine factors that adversely influence the trajectory of physical frailty over time.

Risk factors of frailty and functional disability in community-dwelling older adults: a cross-sectional analysis of the FREEDOM-LNA cohort study.

BACKGROUND: Frailty is a geriatric syndrome associated with disability and negative health outcome. To determine the factors associated with frailty and functional disability in older participants living in community in France. We included 753 community-dwelling old participants with available frailty data at baseline. RESULTS: Overall, 31.9% were frail, 58.3% were prefrail, and 9.8% were robust. The SMAF (French acronym for Functional Autonomy Measurement System) score was significantly lower (mean ± standard deviation: -25.8 ± 11.2) in frail participants compared to prefrail (-14.3 ± 9.7) or robust participants (-8.1 ± 7.0); 82% of frail older participants had limitation in at least one ADL and 97.5% in at least one IADL compared to 54.2 and 76.8%, respectively of pre-frail and 29.7 and 47.3% of robust participants. Age, depression, impaired cognition and diabetes were significantly associated with higher odds of frailty. These variables were also strongly associated with functional disability. Female gender, polypharmacy, and smoking were additional variables significantly associated with degraded SMAF and/or ADL/IADL. CONCLUSIONS: This study showed that functional disability increased proportionally to frailty, and depression, cognitive decline and diabetes are modifiable risk factors significantly associated with frailty and functional disability.

Effectiveness and cost-effectiveness of a telemedicine programme for preventing unplanned hospitalisations of older adults living in nursing homes: the GERONTACCESS cluster randomized clinical trial.

OBJECTIVE: The GERONTACCESS trial evaluated the utility and cost-effectiveness of a gerontological telemedicine (TLM) programme for preventing unplanned hospitalisation of residents living in nursing homes (NHs) in regions lacking medical facilities and/or qualified medical providers ("medical deserts"). DESIGN: GERONTACCESS was a 12-month, multicentre, prospective cluster-randomised trial conducted in NHs. The intervention group underwent TLM assessments every 3 months. The control group received the usual care. In both groups, comprehensive on-site assessments were conducted at baseline and the final visit. Care requirements were documented throughout the study. SETTING AND PARTICIPANTS: NH residents aged ≥ 60 years with multiple chronic diseases. METHODS: The study outcomes were the proportion of patients who experienced avoidable and unplanned hospitalisation, and the incremental cost savings per quality-adjusted life years from baseline to the 12-month follow-up. RESULTS: Of the 426 randomised participants (mean ± standard deviation age, 87.2 ± 7.6 years; 311 [73.0%] women), 23.4% in the intervention group and 32.5% in the control group experienced unplanned hospitalisation (odds ratio [OR] = 0.73, 95% confidence interval [CI] 0.43 to 0.97; p = 0.034). Each avoided hospitalisation in the intervention group saved $US 3,846. CONCLUSIONS AND IMPLICATIONS: The results of GERONTACCESS revealed that our gerontological, preventative TLM program significantly reduced unplanned hospitalisations. This innovative intervention limited disease progression and promoted a healthy lifestyle among NH residents. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02816177, registered June 28, 2016.

REview of potentially inappropriate MEDIcation pr[e]scribing in Seniors (REMEDI[e]S): French implicit and explicit criteria.

PURPOSE: To establish a consensus on both explicit and implicit criteria in order to identify potentially inappropriate prescribing (PIP) in French older people aged 75 years and over or 65 years and over with multimorbidity. METHODS: Fifteen experts in geriatrics, general practice, pharmacy, and clinical pharmacology were involved in a two-round Delphi survey to assess preliminary explicit and implicit criteria based on an extensive literature review and up-to-date evidence data. Experts were asked to rate their level of agreement using a 5-level Likert scale for inclusion of criteria and also for rationale and therapeutic alternatives. A consensus was considered as reached if at least 75% of the experts rated criteria as "strongly agreed" or "agreed." RESULTS: The new tool included a seven-step algorithm (implicit criteria) encompassing the three main domains that define PIP (i.e. overprescribing, underprescribing, and misprescribing) and 104 explicit criteria. Explicit criteria were divided into 6 tables related to inappropriate drug duplications (n = 7 criteria), omissions of medications and/or medication associations (n = 16), medications with an unfavourable benefit/risk ratio and/or a questionable efficacy (n = 39), medications with an unsuitable dose (n = 4) or duration (n = 6), drug-disease (n = 13), and drug-drug interactions (n = 19). CONCLUSION: The REMEDI[e]S tool (REview of potentially inappropriate MEDIcation pr[e]scribing in Seniors) is an original mixed tool, adapted to French medical practices, aimed at preventing PIP both at the individual level in clinical practice and the population level in large-scale studies. Therefore, its use could contribute to an improvement in healthcare professionals' prescribing practices and safer care in older adults.