A5071132650- Health Systems, Economic Evaluations, Quality of Life
- Pharmaceutical Practices and Patient Outcomes
- Pharmaceutical studies and practices
- Biosimilars and Bioanalytical Methods
- Medication Adherence and Compliance
- Pharmacovigilance and Adverse Drug Reactions
- Pharmaceutical Economics and Policy
- Biomedical Ethics and Regulation
- Mental Health Treatment and Access
- Schizophrenia research and treatment
- Atrial Fibrillation Management and Outcomes
- Statistical Methods in Clinical Trials
- Advanced Causal Inference Techniques
- Bipolar Disorder and Treatment
- Ethics in Clinical Research
- Cardiac Arrhythmias and Treatments
- Blood Pressure and Hypertension Studies
- Venous Thromboembolism Diagnosis and Management
- Acute Myocardial Infarction Research
- Healthcare cost, quality, practices
- Cardiac Health and Mental Health
- Treatment of Major Depression
- Child and Adolescent Psychosocial and Emotional Development
- Antibiotic Use and Resistance
- Heart Failure Treatment and Management
University Medical Center Utrecht
2016-2025
University of Iceland
2019-2025
Utrecht University
2016-2025
Pharmo Institute
2006-2025
National University Hospital of Iceland
2017-2022
Université de Tours
2021
Centre National de la Recherche Scientifique
2021
Centre Hospitalier Universitaire de Tours
2021
Reykjavík University
2020
Heidelberg University
2018
Studies on drug utilization usually do not allow direct cross-national comparisons because of differences in the respective applied methods. This study aimed to compare time trends BZDs prescribing by applying a common protocol and analyses plan seven European electronic healthcare databases.Crude standardized prevalence rates from 2001-2009 were calculated databases Spain, United Kingdon (UK), The Netherlands, Germany Denmark. Prevalence was stratified age, sex, BZD type [(using ATC codes),...
Suspected penicillin allergy (Pen-A) is often not verified or excluded by diagnostic testing.To assess the prevalence and impact of Pen-A registration in a Dutch University Medical Center.In prospective matched cohort study, all admitted patients (July 2013-July 2014) who underwent pharmacotherapeutic interview were selected. Patients with registered on age, sex, department admission up to 3 without Pen-A. Relative risks (RRs) receiving reserve antibiotic, death during hospitalization,...
Decentralized clinical trials (DCTs) have the potential to improve accessibility, diversity, and retention in by moving trial activities participants' homes local surroundings. In this study, we conducted semi-structured interviews with 20 European regulators identify regulatory challenges opportunities for implementation of DCTs Union. The key that were recognized include a reduced participation burden, which could facilitate underserved patients. addition, indicated data collected are...
The question whether patients actually start drug taking after having received a first antidepressant prescription is often overlooked.To determine the incidence of who do not fill or only single at pharmacy, and to identify associated patient characteristics.Retrospective study linking general practice pharmacy dispensing database.General in Netherlands.patients first-time from GP. Three groups were identified: did (non-fillers); filled (single Rx-fillers); least two consecutive...
Aims To assess the association between concurrent use of potential pharmacokinetic or pharmacodynamic interacting drugs and major bleeding among direct oral anticoagulant (DOAC) users. Methods We performed a case–control study nested in cohort new users DOACs (dabigatran etexilate, apixaban rivaroxaban). Data were obtained from UK Clinical Practice Research Datalink linked to Hospital Episode Statistics (2008–2015). Cases patients hospitalized having primary diagnosis bleeding. Up 4 controls...
Objective. To monitor whether biologic DMARD (bDMARD) home storage temperatures comply with the manufacturers' Summary of Product Characteristics (SmPC) recommendations. Methods. This observational study included consenting adult patients from eight Dutch pharmacies who received their bDMARDs a validated temperature logger. Patients were instructed to store packages according standard label instructions and return logger(s) after use. Primary outcome was defined as proportion that stored...
Aim: To identify activities that pharmacists undertake to reduce medication waste, and assess the extent which these are implemented, their importance for waste-reduction feasibility broad implementation. Methods: A two-phase survey was conducted among community hospital working in different developed countries. Phase one used an open-ended questionnaire undertaken by pharmacists. Answers were thematically analysed construct a list of waste-reducing activities. In phase two, disseminated...
Aims To estimate the incidence of direct oral anticoagulant drug (DOAC) use in patients with nonvalvular atrial fibrillation and to describe user treatment characteristics 8 European healthcare databases representing 6 countries. Methods Longitudinal utilization study from January 2008 December 2015. A common protocol approach was applied. Annual period incidences standardisation by age sex were performed. Dose adjustment related change renal function as well concomitant potentially...
Whereas storage conditions are regulated and closely monitored in every stage of the drug supply chain before dispensing, it is unknown if patients store drugs at home according to recommendations.The objective this study was investigate how older their prescription what extent they comply with recommendations.We conducted a cross-sectional between October 2015 March 2016. Forty-four participating Dutch community pharmacies selected four home-dwelling (aged ≥ 65 years) using least one drug....
Real‐world data/real‐world evidence (RWD/RWE) are considered to have a great potential complement, in some cases, replace the generated through randomized controlled trials. By tradition, use of RWD/RWE postauthorization phase is well‐known, whereas published pre‐authorization medicines development lacking. The primary aim this study was identify and quantify role (RWE signatures) during phase, as presented initial marketing authorization applications new centrally evaluated with positive...
Due to established teratogenicity of valproates, the EU risk minimisation measures (RMMs) with a pregnancy prevention programme (PPP) for valproate were updated in March 2018.To investigate effectiveness 2018 RMMs on utilisation five European countries/regions.A multi-database, times series study females childbearing potential (12-55 years) was conducted using electronic medical records from countries/regions (01.01.2010-31.12.2020): Denmark, Tuscany (Italy), Spain, Netherlands, and UK....
Real-world evidence (RWE) is increasingly used for medical regulatory decisions, yet concerns persist regarding its reproducibility and hence validity. This study addresses challenges associated with diversity across real-world data sources (RWDS) repurposed secondary use in pharmacoepidemiologic studies. Our aims were to identify, describe characterize practices, recommendations tools collecting reporting RWDSs, explore how leveraging could improve the quality of evidence.
Background Knowledge on factors related to preventable medication waste and waste-reducing interventions, including redispensing unused medications, is needed maximise effectiveness. Objective To assess patient associated with possibilities for medications. Setting Dutch community pharmacies. Methods In this cross-sectional study, pharmacy-staff registered characteristics of prescription medications returned 41 pharmacies during 1 week in 2014. Medications were classified as if the remaining...
Results from observational studies may be inconsistent because of variations in methodological and clinical factors that intrinsically related to the database (DB) where study is performed.The objectives this paper were evaluate impact applying a common protocol benzodiazepines (BZDs) (anxiolytics, hypnotics, drugs) risk hip/femur fracture (HFF) across three European primary care DBs investigate any resulting discrepancies.To measure HFF among adult users BZDs during 2001-2009, cohort nested...
Ideally, the objectives of a pharmacoepidemiologic comparative effectiveness or safety study should dictate its design and data analysis. This paper discusses how defining an estimand is instrumental to this process.
Use of Real-World Data (RWD) has gained the interest different stakeholders in cancer care. The aim this study was to identify and describe use RWD/RWE during pre-authorization phase products authorized by EMA 2018 2019 (n = 111), with focus on oncology medicines 24). Information extracted from European Public Assessment Report (EPAR) summaries recorded for 5 stages (11 categories) drug development lifecycle (discovery, early development, clinical registration/market launch, management)....
Marketing‐authorization holders evaluate the effectiveness of risk minimization measures (RMM) for medicines through conduct post‐authorization safety studies (PASS). Earlier show that concluding on RMM is challenging. The aim this study was to describe reported limitations associated with assessments industry‐sponsored PASS did not render a conclusion. We conducted thematic analysis extracted from assessment reports and finalized by Pharmacovigilance Risk Assessment Committee between 2018...
ABSTRACT Purpose Real‐world evidence (RWE) is increasingly considered in regulatory and health technology assessment (HTA) decision‐making, though perspectives on its relevance may vary. Expanding a recent review regarding decisions, this study aimed to identify factors influencing the need for RWE HTA confirm enrich with stakeholder views, evaluate similarities differences between needs. Methods Previous scoping methodology was used decision‐making. Semi‐structured interviews stakeholders...
ABSTRACT Purpose Fluoroquinolones are antibiotics associated with adverse events that prompted the European Medicines Agency to implement risk minimization measures (RMMs) in 2018/19 and 2020. Our aim is assess RMMs' impact on antibiotic prescriptions primary care during 2014–2023. Methods We assessed using CPRD GOLD (the United Kingdom, UK) PHARMO Netherlands, NL). Prescriptions were for fluoroquinolones alternative antibiotics. The of RMMs prescribing was interrupted time series (ITS)...