Dispensed drugs during pregnancy in outpatient care between 2015 and 2021 in Switzerland: a retrospective analysis of Swiss healthcare claims data.

AIM OF THE STUDY We aimed to evaluate the utilisation of all prescribed drugs during pregnancy dispensed in outpatient care in Switzerland between 2015 and 2021. METHODS We conducted a descriptive study using the Swiss Helsana claims database (2015-2021). We established a cohort of pregnancies by identifying deliveries and estimating the date of the last menstrual period. We analysed the drug burden during a 270-day pre-pregnancy period, during pregnancy (overall and by trimester), and during a 270-day postpartum period. Subsequently, we quantified 1) the median number of drug dispensations (total vs. unique drug claims); and 2) the prevalence of exposure to at least one dispensed drug and the number of dispensed drugs (0, 1, 2, 3, 4, and ≥5); and 3) the 15 most frequently dispensed drugs were identified during each period, overall and stratified by maternal age. RESULTS Among 34,584 pregnant women (5.6% of all successful pregnancies in Switzerland), 87.5% claimed at least one drug (not including vitamins, supplements, and vaccines), and 33.3% claimed at least five drugs during pregnancy. During trimester 1 alone, 8.2% of women claimed at least five distinct drugs. The proportion of women who claimed prescribed drugs was lower pre-pregnancy (69.1%) and similar postpartum (85.6%) when compared to during pregnancy (87.5%). The most frequently claimed drugs during pregnancy were meaningfully different during pregnancy than before and after. CONCLUSIONS This study suggests that 8 of 10 women in Switzerland are exposed to prescribed drugs during pregnancy. Most drugs dispensed during pregnancy are comparatively well investigated and are considered safe. However, the high drug burden in this vulnerable patient population underlines the importance of evidence on the benefit-risk profile of individual drugs taken during pregnancy

Mental health status of pregnant and breastfeeding women during the COVID‐19 pandemic—A multinational cross‐sectional study

INTRODUCTION Evidence on perinatal mental health during the coronavirus disease 2019 (COVID-19) pandemic and its potential determinants is limited. Therefore, this multinational study aimed to assess the mental health status of pregnant and breastfeeding women during the pandemic, and to explore potential associations between depressive symptoms, anxiety, and stress and women's sociodemographic, health, and reproductive characteristics. MATERIAL AND METHODS A cross-sectional, web-based study was performed in Ireland, Norway, Switzerland, the Netherlands, and the UK between 16 June and 14 July 2020. Pregnant and breastfeeding women up to 3 months postpartum who were older than 18 years of age were eligible. The online, anonymous survey was promoted through social media and hospital websites. The Edinburgh Depression Scale (EDS), the Generalized Anxiety Disorder seven-item scale (GAD-7), and the Perceived Stress Scale (PSS) were used to assess mental health status. Regression model analysis was used to identify factors associated with poor mental health status. RESULTS In total, 9041 women participated (including 3907 pregnant and 5134 breastfeeding women). The prevalence of major depressive symptoms (EDS ≥ 13) was 15% in the pregnancy cohort and and 13% the breastfeeding cohort. Moderate to severe generalized anxiety symptoms (GAD ≥ 10) were found among 11% and 10% of the pregnant and breastfeeding women. The mean (±SD) PSS scores for pregnant and breastfeeding women were 14.1 ± 6.6 and 13.7 ± 6.6, respectively. Risk factors associated with poor mental health included having a chronic mental illness, a chronic somatic illness in the postpartum period, smoking, having an unplanned pregnancy, professional status, and living in the UK or Ireland. CONCLUSIONS This multinational study found high levels of depressive symptoms and generalized anxiety among pregnant and breastfeeding women during the COVID-19 outbreak. The study findings underline the importance of monitoring perinatal mental health during pandemics and other societal crises to safeguard maternal and infant mental health

Bon usage des antidépresseurs ISRS durant la grossesse – le défi de l'évaluation de la balance bénéfice-risque

Studies report that between 6 and 13% of women experience symptoms of depression during pregnancy and the postpartum period. The abundant data available make selective serotonin reuptake inhibitors (SSRIs) the first line treatment in pregnancy when a pharmacological treatment is required. Risks associated with the use of SSRIs during pregnancy are limited (moderate effect size) and are often not distinguishable from those inherent to the mother's disease. Yet, several questions regarding the SSRI safety profile for the unborn child are still under debate or require additional epidemiological data. The decision of SSRI use during pregnancy needs an individual evaluation of the risk-benefit balance

Mit dem Zipperlein direkt in die Apotheke: Konzeption und Umsetzung eines Clinical Skills Trainings für Student:innen der Pharmazie

Bei der Neukonzeption von Studiengängen ist die Pflicht, den Paradigmen der Good Evidence Medical Education zu folgen, gleichzeitig auch eine Gelegenheit. Vor diesem Hintergrund und der gesetzlich geforderten Kompetenzorientierung der Medizinalberufe der Schweiz beschreiben wir die Konzeption eines Clinical Skills Unterrichts im 2. Studienjahr in neuen Masterstudiengang Pharmazie an der Universität Bern. Dank des niederschwelligen Zugangs ("walk-in") sind Apotheken ideale Anlauf- und Orientierungsstellen bei gesundheitlichen Problemen und erfüllen in diesem Sinne neben der Angabe von Medikamenten ähnlich wie die Hausarztmedizin Aufgaben in der ambulanten Gundversorgung und Prävention. In diesem Sinne müssen Apotheker:innen immer auch Triage-Entscheidungen treffen, also vor Ort in der Offizin beraten, behandeln und/oder in ärztliche Behandlung weiterweisen. Ein multiprofessionelles Team aus Pharmazeut:innen und Ärzt:innen war bei der Konzepterstellung und konkreten Umsetzung aufgeboten. Als Grundlage für die inhaltliche Ausgestaltung wurden der Schweizerische Lernzielkatalog Pharmazie gemäss MedBG und Quellen des Schweizerischen Apothekerverbandes herangezogen. In der Offizin erfahrene Dozent:innen halfen, die Inhalte auf konkrete Lern- bzw. Unterrichtsinhalte zu operationalisieren. So wurden die Themengebiete «Injektion und Impfen», «Blutentnahme», «BLS-AED», «Wundversorgung», wie auch die körperliche Untersuchung der HNO, der Augen, der Haut und die Bestimmung der Vitalparameter identifiziert. Der Unterricht ist eng mit weiteren theoretischen Veranstaltungen (Vorlesungen zur Triage) und praktischen Übungen (Kommunikationstraining mit Simulationspatient:innen) verschränkt. Die didaktische Umsetzung setzt praktische Demonstrationen und Übungen in den Fokus, weswegen die Vorbereitung mit Skript und Lehrfilmen obligat ist. Die Themengebiete werden dann in Präsenz unterrichtet, in einem ersten Termin mit Demonstration und Trockenübungen, in einem zweiten Termin aneinander und/oder mit (teils moulagierten) Simulationspatient:innen/Simulatoren anhand konkreter Fallszenarien, die sich an praktischen Beratungsanlässen der Offizin orientieren. Weitere Fälle wurden für das selbständige Üben im SkillsLab erstellt, wo auch Simulatoren und Materialien bereitstehen. Ergänzt wird dieser Unterricht durch einen formativen OSCE zur Jahresmitte. Die Masterprüfung beinhaltet eine summative OSCE Prüfung, bevor für die Zulassung als Apotheker:in auch noch die Eidgenössische Prüfung Pharmazie mit Wissensprüfung und OSCE erfolgreich absolviert werden müssen. Im Vortrag werden beispielhafte Tagesabläufe, erste Evaluationsergebnisse und Erfahrungen der Dozent:innen präsentiert

A population pharmacokinetic model for escitalopram and its major metabolite in depressive patients during the perinatal period: Prediction of infant drug exposure through breast milk.

Escitalopram (SCIT) is frequently prescribed to breastfeeding women. Available information on SCIT excretion into breast milk is based on heterogeneous and incomplete data. A population pharmacokinetic model that aimed to better characterize maternal and infant exposure to SCIT and its metabolite was developed. The study population was composed of women treated by SCIT or racemic citalopram and enrolled in the multicenter prospective cohort study SSRI-Breast Milk study (ClinicalTrial.gov NCT01796132). A joint structural model was first built for SCIT and S-desmethylcitalopram (SDCIT) in plasma using NONMEM and the milk-to-plasma ratio (MPR) was estimated by adding the drug breast milk concentrations. The effect of different influential covariates was tested and the average drug exposure with variability through breastfeeding was predicted under various conditions by simulation. The study enrolled 33 patients treated with SCIT or racemic citalopram who provided 80 blood and 104 milk samples. Mean MPR for both parent drug and metabolite was 1.9. Increased milk fat content was significantly associated with an increased drug transfer into breast milk (+28% for SCIT and +18% for SDCIT when fat amount doubles from 3.1 to 6.2 g/100 mL). Simulations suggested that an exclusively breastfed infant would ingest daily through breast milk 3.3% of the weight-adjusted maternal SCIT dose on average. The moderate between-subject variability in milk concentration of SCIT and the limited exposure to escitalopram through breast milk observed provide reassurance for treated mothers of breastfed healthy infants