Translation of the REMEDI[e]S (Review of potentially inappropriate MEDIcation pr[e]scribing in Seniors) explicit criteria into seminatural language for use in prescription support systems: A multidisciplinary consensus.

Background: By recovering data in an ordered manner and at the right time, clinical decision support systems (CDSSs) are designed to help healthcare professionals make decisions that improve patient care.

Objectives: The aim of the present study was to translate the REMEDI[e]s tool's explicit criteria, France's first reference list of potentially inappropriate drugs for the elderly, into seminatural language, in order to implement these criteria as alert rules and then enable their computer coding in a CDSS.

Methods: This work was carried out at Lille University Hospital by a team of clinical pharmacists with expertise in the use of pharmaceutical decision support systems, in collaboration with the authors of the REMEDI[e]s tool.

Beta-blockers and breastfeeding: a real-life prospective study.

Purpose: At Lille University Hospital, a pregnancy heart team including cardiologists, obstetricians, pediatricians, anesthetists, geneticists, and pharmacologists discusses about treatment compatibility taken during breastfeeding in pregnant women (or those wishing to be pregnant) with complex cardiovascular pathologies. Beta-blockers are among the drug most often used in these patients, and data are missing or suggest a risk to the breastfed child. The aim of this study was to evaluate the proportion of women treated with beta-blockers, identified during the multidisciplinary meeting, who breastfed and to monitor adverse effects (AEs) in newborns.

COVACPREG, a French prospective cohort study of women vaccinated against COVID-19 during pregnancy.

The objective of this cohort study was to describe the French population of pregnant women vaccinated against coronavirus disease 2019 (COVID-19), their pregnancy outcomes and the health status of their newborns (malformation rate, neonatal diseases, etc.), and to proactively collect and analyze reported adverse reactions over time. We conducted a prospective study using an online questionnaire.

[Bariatric surgery and drugs: Review of the literature and Adverse Drug Reactions analysis in French National Pharmacovigilance Database].

Introduction: Bariatric surgery is the only treatment for severe obesity (BMI>35kg/m) currently recognized as effective both in achieving tangible and lasting weight loss, and in improving obesity-related comorbidities such as type 2 diabetes, hypertension, and cardiovascular complications. Bariatric surgery, like any other surgery of the digestive tract, can have an impact on nutrient absorption, as well as on drug absorption. The literature on drug management in bariatric surgery patients concerned mainly of case reports and retrospective studies involving a small number of patients.

Patient's reporting of adverse drug reactions: Which added value in 2023?

Several studies were focused on the qualitative and quantitative analysis of serious adverse drug reactions (ADRs) leading to hospitalisation or death. These figures do not take into account ADRs in ambulatory patients affecting their quality of life. Patient reporting has the advantages of bringing novel information about ADRs.

Increase in hospitalisation-associated methadone intoxication in France following first COVID-19 lockdown.

Objectives: At the beginning of the COVID-19 pandemic, the French Addictovigilance Network drew attention to the need to facilitate access to methadone while ensuring its safe use, in order to avoid the occurrence of overdoses and deaths. The objectives of the study were to assess the impact of the lockdowns on the incidence of methadone-use-related hospitalisations (MUHs) and describe the characteristics of patients and hospitalisations.

Study Design: An interrupted time series using the unobserved components model was performed to predict the monthly incidence of MUHs in 2020 on the basis of previous years' data and compared with MUHs observed.

UMSARS Versus Laryngoscopy-Based Assessment of Dysphagia.

Background: Multiple System Atrophy (MSA) dysphagia is routinely assessed by the Unified Multiple System Atrophy Rating Scale (UMSARS) part I-item 2.

Objective: To compare the UMSARS part I-item 2 with an ear/nose/throat (ENT) expert physician assessment.

Methods: We retrospectively analyzed the data of MSA patients who underwent an ENT assessment (nasofibroscopic and radioscopic exam) and an annual UMSARS assessment.

Patterns, predictors, and outcomes of frailty trajectories in community-dwelling older adults: Results from the FREEDOM Cohort Study.

Objectives: To identify subgroups of people with distinct frailty trajectories, identify baseline characteristics associated with these trajectories, and determine their coincident clinical outcomes.

Design: This study examined the longitudinal database from the FREEDOM Cohort Study.

Setting And Participants: All 497 participants of the FREEDOM (French Acronym for "FRagilitéEtEvaluation àDOMicile" / In English "Frailty and Evaluation at Home") cohort requested a comprehensive geriatric assessment.

The ongoing structuring of human papillomavirus (HPV) vaccination in middle schools in Nouvelle-Aquitaine, France.

Context: As is the case throughout France, vaccination coverage against human papillomavirus (HPV) infections in the Nouvelle-Aquitaine region is too low to limit viral circulation and to have an impact on the incidence of virus-induced pathologies.

Intervention Methodology: The Nouvelle-Aquitaine Regional Health Agency (ARS) has decided to set up a large-scale vaccination action in the 7th-grade classes of all 643 Nouvelle-Aquitaine middle schools during the 2023-2024 school year. This public health intervention targeting 11-to-13-year-olds shall bring together national education, health Insurance, the regional center for pharmaco-vigilance, and private health professionals.

Pharmacovigilance signals from active surveillance of mRNA platform vaccines (tozinameran and elasomeran).

Introduction: Two severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA) vaccines, tozinameran/BNT162b2 (Comirnaty®, Pfizer-BioNTech) and elasomeran/mRNA-1273 (Spikevax®, Moderna), were approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) at the end of 2020, less than a year after the start of the coronavirus disease 2019 (COVID-19) pandemic. In France, the health authorities have requested an intensive vaccination campaign, accompanied by a reinforced and active pharmacovigilance surveillance. This surveillance and analysis of real-life data, based on spontaneous reports received by the French Network of Regional PharmacoVigilance Centers (RFCRPV), has enabled to identify numerous pharmacovigilance signals.

Overview of literature monitoring practice of clinical trials vigilance units in French institutional sponsors - A study from the REVISE working group.

Introduction: The evaluation of clinical trial (CT) safety is the main task of CT vigilance units. In addition to the management of adverse events, the units must review the literature to identify information that may impact the benefit-risk assessment of studies. In this survey, we investigated the literature monitoring (LM) activity of French Institutional Vigilance Units (IVU) from the working group "REflexion sur la VIgilance et la SEcurite des essais cliniques" (REVISE).

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.

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.

Pulmonary toxicity of mTOR inhibitors. Comparisons of two populations: Solid organ recipients and cancer patients.

Introduction: Mammalian target of rapamycin (mTOR) inhibitors-associated pneumonitis (mTOR-IP) has long been described in solid organ recipients (T) patients but more recently in cancer (K) patients. Its overall characteristics have never been compared between these 2 populations. The aim of this study was to compare them in terms of presentation, severity and outcome in T and in K patients.

Development and validation of a case-finding algorithm for the identification of non-small cell lung cancers in a region-wide Italian pathology registry.

Purpose: To develop and validate a case-finding algorithm for the identification of Non-Small Cell Lung Cancer (NSCLC) cases in a region-wide Italian pathology registry (PR).

Materials And Methods: Data collected between 2009 and 2017 in the PR and the Pharmacy Database of the University Hospital of Siena and the PR of Tuscany region were used. A NSCLC-identification algorithm based on free-text keywords and SNOMED morphology and topography codes was designed and tested on data from Siena: indication for drug use (i.

Validation of Artificial Intelligence to Support the Automatic Coding of Patient Adverse Drug Reaction Reports, Using Nationwide Pharmacovigilance Data.

Introduction: Adverse drug reaction reports are usually manually assessed by pharmacovigilance experts to detect safety signals associated with drugs. With the recent extension of reporting to patients and the emergence of mass media-related sanitary crises, adverse drug reaction reports currently frequently overwhelm pharmacovigilance networks. Artificial intelligence could help support the work of pharmacovigilance experts during such crises, by automatically coding reports, allowing them to prioritise or accelerate their manual assessment.