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Objective To describe the off-label medication use in a cohort of pregnant women. Material and methods We performed a multicenter prospective longitudinal observational study in the Haute-Vienne department (France) called the NeHaVi cohort ("Ne en Haute-Vienne" meaning "born in Haute-Vienne"). Women who had given birth to a viable baby in one of three maternity wards in the Haute-Vienne were included in the study after giving their informed consent. Data on the progress and outcome of pregnancies, childbirth, and drug or toxic exposure during pregnancy were collected. Drugs were classified, according to the labeling of the summary of product characteristics (SmPC) regarding the use in pregnancy, as follows: on-label, off-label at risk, and off-label contra-indicated. Results During their pregnancy, the 397 included women gave birth to 400 viable babies (209 boys, 191 girls, 3 sets of twins). All women had used at least 1 health product: 3,533 (92%) drugs, 298 (7.5%) homeopathic products, and 18 (0.5%) herb derivatives. The mean number of different drugs taken was 8.9 ± 5.3 (min 1, max 31). All pregnant women used at least 1 drug either with a license or considered as safe to take during pregnancy. Among the 2,538 (71.6%) on-label drugs, the most frequently used were analgesics (n = 611, 24.1%) (acetaminophen (n = 566)), antianemia preparations (n = 528, 20.8%), drugs for functional gastrointestinal disorder (n = 269, 10.6%), vitamins (n = 192, 7.5%), drugs for acid-related disorders (n = 148, 5.8%), and antibacterials (n = 118, 4.6%). In total, 321 (80.9%, 95% CI: 77.0 - 84.7) pregnant women used at least 1 off-label drug; and more precisely, 285 (71.8%, 95% CI: 67.4 - 76.2) used at least 1 off-label high-risk drug, and 189 (47.6%, 95% CI: 42.7 - 52.5) at least 1 contra-indicated drug. Among the 995 off-label drugs (28.2%), 760 (21.5%) were considered high-risk, including vasoprotectives (n = 156, 20.5%) (treatment of hemorrhoids (n = 147)), antithrombotic agents (n = 91, 11.6%) (heparins (n = 88)), and calcium channel blockers (n = 88, 11.6%). Lastly, 235 (6.7%) off-label drugs used were contraindicated medications (non-steroidal anti-inflammatory drugs during the 3rd trimester (n = 231)). Five babies were born with malformations not related to the drugs used during pregnancy. Conclusion We showed for the first time the magnitude of off-label prescription during pregnancy in France. Women and health professionals should be made more aware of the potential drug-induced risk during pregnancy. Drug adverse effects during pregnancy should be evaluated through an improved notification in pharmacovigilance and appropriate pharmacoepidemiologic studies in order to change SmPC labelings as early as possible, when necessary.

Objectives The aims of the study were to describe medication errors (MEs) involving older adults reported to the French Medication Error Guichet and to compare them with MEs in younger adults, in each of the hospital and community settings. Methods Retrospective secondary data analysis of MEs reported throughout 2013 to 2017 was performed. Descriptive and multivariate analyses were performed to compare actual and potential ME reports between older adults (aged ≥60 y) and younger adults (aged ≥18, Results We analyzed 4979 reports. In older adults, both in hospital (n = 1329) and community (n = 1264) settings, antithrombotic agents were frequently reported in MEs and were significantly more likely to be associated with reported MEs in older adults compared with younger adults. In hospital setting, antibacterials for systemic use (adjusted odds ratio [aOR] = 1.87, 95% confidence interval [CI] = 1.19-2.93) and antineoplastic agents (aOR = 2.22, 95% CI = 1.34-3.69), whereas in community setting, psycholeptics (aOR = 1.43, 95% CI = 1.04-1.98) and drugs used in diabetes (aOR = 6.01, 95% CI = 3.21-11.2) were more likely to be associated with reported MEs in older adults. In both settings, wrong dose and wrong drug were the most frequently reported error types in older adults; however, wrong technique error type (aOR = 2.06, 95% CI = 1.30-3.28) in hospital setting and wrong patient (aOR = 2.17, 95% CI = 1.30-3.60) in community setting were more likely to be associated with reported MEs in older adults. Conclusions We identified specific ME patterns for older adults, including antithrombotic agents in both settings; antibacterials for systemic use, antineoplastic agents, and wrong technique in hospital setting; and psycholeptics, drugs used in diabetes, and wrong patient in community setting. These findings inform future studies investigating population-specific medication safety strategies.

International audience; 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.

To analyze the process from the prescription of the drug to the health outcome, from a medical and pharmaceutical perspective, to prevent the occurrence of drug-related problems (DRPs) in older adults. A mapping of a logical process of drug use from the perspective of physicians, pharmacists, and patients has been established, but many fields remain unexplored (e.g. off-label use, substance use disorders, therapeutic failure), especially in some settings (e.g. home-dwelling) as little data is available in older adults. Prevention of DRPs imperatively requires taking into account the opinions of all healthcare professionals as well as those of patients and their caregivers. To lay the fundamentals of drug-related problems (DRPs) in older adults, and to organize them according to a logical process conciliating medical and pharmaceutical approaches, to better identify the causes and consequences of DRPs. A narrative overview. The causes of DRPs may be intentional or unintentional. They lie in poor prescription, poor adherence, medication errors (MEs) and substance use disorders (SUD). Poor prescription encompasses sub-optimal or off-label drug choice; this choice is either intentional or unintentional, often within a polypharmacy context and not taking sufficiently into account the patient’s clinical condition. Poor adherence is often the consequence of a complicated administration schedule. This review shows that MEs are not the most frequent causes of DRPs. SUD are little studied in older adults and needs to be more investigated because the use of psychoactive substances among older people is frequent. Prescribers, pharmacists, nurses, patients, and caregivers all play a role in different causes of DRPs. The potential deleterious outcomes of DRPs result from adverse drug reactions and therapeutic failures. These can lead to a negative benefit-risk ratio for a given treatment regimen. Interdisciplinary pharmacotherapy programs show significant clinical impacts in preventing or resolving adverse drug events and, suboptimal responses. New technologies also seem to be interesting solutions to prevent MEs. Better communication between healthcare professionals, patients and their caregivers would ensure greater safety and effectiveness of treatments.

Resume Le pharmacien d’officine est bien souvent un acteur de sante de premier recours pour la personne âgee face a son traitement. Comprendre les principaux facteurs de risque de survenue des effets indesirables chez les seniors permet d’ameliorer le bon usage des medicaments dans cette population.

Rooibos is consumed worldwide and its use considered safe. It contains scavengers of free radicals and is so is deemed to be a liver protector. Nevertheless, hepatic toxicity exists even if rare. It is probably underdiagnosed and clinicians should think about it in case of acute hepatitis. We report a case of liver injury attributed to Rooibos.