Pharmacoepidemiology and Drug Safety最新文献

{"title":"Success of the German Cystic Fibrosis Registry.","authors":"Lutz Naehrlich, Manuel Burkhart","doi":"10.1002/pds.70076","DOIUrl":"https://doi.org/10.1002/pds.70076","url":null,"abstract":"<p><p>The German Cystic Fibrosis (CF) Registry (GCFR) is a national General Data Protection Regulation-compliant centralised database sponsored by the German Cystic Fibrosis Association (Mukoviszidose e.V.) and based on informed consent for each participating patient, ethical approval, and data protection votes. The aims of the GCFR are to optimise quality of care for CF at the centres, generate epidemiologic overviews, address research questions related to improved CF care, and inform caregivers, patients (aimed at patient empowerment), and health authorities and industry (aimed at care planning and pharmacovigilance). Established in 1995, the Registry has captured data on > 9600 individuals with a combined total of more than 140 000 annual assessments with an estimated coverage rate of > 90%. Patient data are collected after informed consent and confirmed diagnosis of CF, or a CFTR-related disorder, or a screening-positive inconclusive diagnosis of CF (i.e., CFSPID). The registry collects core, encounter, and annual health data. Data include demographics, anthropometrics, lung function, microbiology, CF-specific complications and chronic medications, hospitalisations, demand-oriented antibiotic therapies, and outcomes (death and transplants). Real world and pharmacovigilance studies have been published and additional research underway; there is a formal process for requesting access to the GCFR.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70076"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706667/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142952123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Have People Treated With Antihypertensives Been Diagnosed With Hypertension? A Cross-Sectional Study in Stockholm, Sweden.","authors":"Indre Treciokiene, Tomas Forslund, Thomas Kahan, Katja Taxis, Björn Wettermark","doi":"10.1002/pds.70075","DOIUrl":"10.1002/pds.70075","url":null,"abstract":"<p><strong>Purpose: </strong>Studies on antihypertensive treatment are important, as hypertension remains the major risk factor for cardiovascular morbidity and premature death. However, antihypertensive medicines are also used for other conditions, and the use of these medicines as a proxy for a diagnosis of hypertension might lead to misclassification in pharmacoepidemiological studies. This study aimed to investigate to what extent people dispensed antihypertensive medicines have been diagnosed with hypertension.</p><p><strong>Methods: </strong>Cross-sectional study with data covering all healthcare and all dispensed prescriptions of antihypertensive medicines 2019 and diagnoses recorded 2015-2019 from the Stockholm Region, Sweden. Multinomial logistic regressions were used to assess the probability of having hypertension concerning age, sex, and antihypertensive drug class.</p><p><strong>Results: </strong>A total of 386 860 individuals were included, 49% men, 12% incident users, and 80% of all had a recorded diagnosis of hypertension. In 73% of incident users, only one antihypertensive drug class was dispensed, as compared to 36% of prevalent users. A total of 38% of incident users and 9% of prevalent users had none of the diagnoses selected for the study recorded in any health record during 5 years. Prevalent and older users over the age of 65 from high (50%-79%) to very high (80% and more) probability of a recorded diagnosis of hypertension. Patients on antiadrenergic agents, high-ceiling diuretics, aldosterone antagonists, or beta receptor blockers had a lower probability of having a recorded diagnosis of hypertension than patients dispensed angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or calcium channel blockers.</p><p><strong>Conclusion: </strong>Most patients dispensed antihypertensive medicines have a diagnosis of hypertension. However, caution is needed using data on dispensed medicines to classify incident antihypertensive users and younger patients as having a diagnosis of hypertension.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70075"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706671/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142952836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Glucagon-Like Peptide 1 Receptor Agonists and Chronic Lower Respiratory Disease Among Type 2 Diabetes Patients: Replication and Reliability Assessment Across a Research Network.","authors":"Mitchell M Conover, Yasser Albogami, Jill Hardin, Christian G Reich, Anna Ostropolets, Patrick B Ryan","doi":"10.1002/pds.70087","DOIUrl":"10.1002/pds.70087","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study is to use observational methods to evaluate reliability of evidence generated by a study of the effect of glucagon-like peptide 1 receptor agonists (GLP-1RA) on chronic lower respiratory disease (CLRD) outcomes among Type-2 diabetes mellitus (T2DM) patients.</p><p><strong>Research design and methods: </strong>We independently reproduced a study comparing effects of GLP-1RA versus dipeptidyl peptidase-4 inhibitors (DPP4-i) on CLRD outcomes among patients with T2DM and prior CLRD. We reproduced inputs and outputs using the original study data (national administrative claims) and evaluated the robustness of results in comparison to alternate design/analysis decisions. To evaluate generalizability, we applied an analysis protocol and conducted a meta-analysis across a research network that includes a diverse array of populations and data sources. We also produced additional analyses evaluating individual drugs within the GLP-1RA class and CLRD outcomes.</p><p><strong>Results: </strong>We confirmed alignment of study inputs and outputs and closely reproduced effect estimates and sensitivity analyses. Adjusted effect estimates were robust to empirical calibration. Network meta-analysis confirmed original findings but indicated weaker effects than originally published. Meta-analysis of drugs within the GLP-1RA class against DPP4-i provided evidence that effects vary within the GLP-1RA class, indicating stronger effects for exenatide and weaker effects of dulaglutide.</p><p><strong>Conclusions: </strong>This study supports and establishes the reliability of the original study by (1) producing consistent findings in a range of alternate databases and populations, (2) demonstrating effects for multiple drugs within the GLP-1RA class, and (3) independently confirming the reproducibility of the original study and its findings. This reliability evaluation provides the beginnings of a broader framework for using standardized tools and distributed data networks to systematically interrogate the reliability of findings generated using observational data.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70087"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11730806/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143056091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"High-Dose Cyproterone Acetate and Intracranial Meningioma: Impact of the Risk Minimisation Measures Implemented in France in 2018-2019.","authors":"Noémie Roland, Anke Neumann, Bérangère Baricault, Pauline Dayani, Lise Duranteau, Sylvie Fontanel, Isabelle Yoldjian, Sébastien Froelich, Mahmoud Zureik, Alain Weill","doi":"10.1002/pds.70078","DOIUrl":"10.1002/pds.70078","url":null,"abstract":"<p><strong>Purpose: </strong>To measure the impact of national regulatory actions implemented in France in August 2018 and June 2019 to reduce the risk of meningioma associated with the use of cyproterone acetate (CPA).</p><p><strong>Methods: </strong>Using the French National Healthcare database, we calculated the monthly number of CPA users among cisgender women, men and transgender women in 2010-2021, the monthly proportion of users with cerebral imaging screening, and the annual rate of meningioma surgery associated with CPA use. CPA discontinuations and switches were analysed.</p><p><strong>Results: </strong>Between 2018 and 2021, the number of individuals exposed to CPA fell by 85% (55 000 in August 2018 versus 7900 users of high-dose CPA in December 2021), corresponding to two waves of decrease in both use and initiation. This drop was greater among cisgender women (88%) than men (69%) or transgender women (50%). Cerebral imaging screening increased from 11% in June 2018 to 70% in June 2021 for ciswomen (13%-51% for men, 9%-60% for transwomen). After CPA discontinuation, no massive shift to a single product was observed, but, instead, dispersion towards other hormonal therapies. The overall annual rate of meningioma surgery associated with CPA exposure spectacularly decreased between 2017 and 2021 (-93% for ciswomen and -86% for men).</p><p><strong>Conclusion: </strong>In France, high-dose CPA use sharply decreased after the implementation of national regulatory measures without a massive switch to other hormonal therapies. The increase in cerebral imaging screening did not result in an increase in meningioma surgery associated with CPA, but rather a massive drop of over 90%.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70078"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706701/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142952840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient and Public Involvement in Pharmacoepidemiological Research: An Environmental Scan of an Emerging Area.","authors":"Rigoureau Julie, Busnel Yael, Havet Anaïs, Termoz Anne, Haesebaert Julie, Viprey Marie","doi":"10.1002/pds.70080","DOIUrl":"https://doi.org/10.1002/pds.70080","url":null,"abstract":"<p><strong>Background: </strong>Patient and public involvement (PPI) in research is required to improve the relevance, feasibility, and interpretability. However, research on PPIs in pharmacoepidemiology (PE) is still limited. This study aimed to provide an overview of PPI implementation in pharmacoepidemiology through an environmental scan.</p><p><strong>Methods: </strong>The environmental scan combined systematic reviews and expert interviews. A systematic review was conducted in MEDLINE, EMBASE, and the Cochrane Library from January 1, 2010, to June 30, 2023, to identify PE studies in which PPIs were mentioned. An additional review covered British Medical Journal's (BMJ) original articles from January 1, 2019, to June 30, 2023, via a similar method. In parallel, a cross-sectional study was conducted with a standardized questionnaire for French PE research teams, involving interviews via videoconference.</p><p><strong>Results: </strong>We identified 3615 references for screening, among which 232 were selected for full-text screening. However, no studies have reported the use of PPIs in PE studies. The additional BMJ review identified 1058 references, 74 of which met the full-text selection criteria, and eight were included. Of 13 French PE research teams surveyed, three had prior PPI experience, and 12 affirmed the relevance of PPI in PE. The respondents identified barriers such as PE's complexity (n = 9). They suggested training for patients (n = 9) and collaboration with specialist teams (n = 5) to facilitate PPI.</p><p><strong>Conclusion: </strong>Our environmental scan highlighted the emergence and relevance of PPIs in PE studies, even though they are still uncommon. Tools are needed to acculture and assist PE researchers in engaging in PPIs.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70080"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706696/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142951653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Core Concepts: Self-Controlled Designs in Pharmacoepidemiology.","authors":"Sophie H Bots, Jeremy Brown, Angel Y S Wong, Ivonne Martin, Ian Douglas, Olaf H Klungel, Anna Schultze","doi":"10.1002/pds.70071","DOIUrl":"10.1002/pds.70071","url":null,"abstract":"<p><p>One of the key challenges in pharmacoepidemiological studies is that of uncontrolled confounding, which occurs when confounders are poorly measured, unmeasured or unknown. Self-controlled designs can help address this issue, as their key comparison is not between people, but periods of time within the same person. This controls for all time-stable confounders (genetics) and in the absence of time-varying confounding negates the need for an external control group. However, these benefits come at the cost of strong assumptions, not all of which are verifiable. This review briefly introduces the reader to different types of self-controlled study designs, their terminology and highlights key publications through an annotated reference list. We include a practical description of how these designs can be implemented and visualised using recent examples, and finish by discussing recent developments. We hope this review will serve as a starting point for researchers looking to apply self-controlled designs in their own work.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70071"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11729261/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142979492","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-Term Opioid Therapy and Risk of Opioid Overdose by Derived Clinical Indication in North Carolina, 2006-2018.","authors":"Bethany L DiPrete, Shabbar I Ranapurwala, Audrey E Pettifor, Kimberly A Powers, Paul L Delamater, Naoko Fulcher, Brian W Pence","doi":"10.1002/pds.70090","DOIUrl":"10.1002/pds.70090","url":null,"abstract":"<p><strong>Purpose: </strong>Long-term opioid therapy (LTOT) has been shown to be associated with opioid overdose, but the definition of LTOT varies widely across studies. We use a rigorous LTOT definition to examine risk of opioid overdose by duration of treatment.</p><p><strong>Methods: </strong>Data were from a large private health insurance provider in North Carolina linked to mortality records from 2006-2018. Eligible patients were adults (18-64) newly initiating opioid therapy after a pain diagnosis or surgery. We defined LTOT as ≥ 1 opioid prescription per month totaling ≥ 60 days' supply within 90 days. We used inverse probability (IP)-weighted cumulative incidence functions to estimate three-year risk of opioid overdose and IP-weighted Fine-Gray models to estimate sub-distribution hazard ratios, comparing LTOT to short- to medium-term opioid therapy (SMTOT). We also examined modification by derived indication of acute pain or surgery versus chronic pain.</p><p><strong>Results: </strong>We identified 491 369 patients, and 1.7% were exposed to LTOT. The three-year risk of opioid overdose was 0.3 percentage points (RD_w = 0.003, 95% CI: 0.001, 0.005) higher in LTOT patients compared to patients with SMTOT. The weighted hazard of opioid overdose was 4.4 times as high (HR_w 4.42, 95% CI 2.41, 8.11) among patients exposed to LTOT versus SMTOT. We did not find meaningful modification by clinical indication for opioid therapy.</p><p><strong>Conclusions: </strong>Exposure to LTOT was associated with increased risk of opioid overdose in this population of privately insured patients using a rigorous definition of LTOT. These findings confirm the importance of guidelines to minimize duration of opioid therapy whenever possible.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70090"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12034376/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142979444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multiple Perspectives on the Need for Real-World Evidence to Inform Regulatory and Health Technology Assessment Decision-Making: Scoping Review and Stakeholder Interviews.","authors":"Marieke S Jansen, Olaf M Dekkers, Saskia le Cessie, Lotty Hooft, Helga Gardarsdottir, Anthonius de Boer, Rolf H H Groenwold","doi":"10.1002/pds.70074","DOIUrl":"10.1002/pds.70074","url":null,"abstract":"<p><strong>Purpose: </strong>Real-world evidence (RWE) is increasingly considered in regulatory and health technology assessment (HTA) decision-making, though perspectives on its relevance may vary. Expanding on a recent review regarding regulatory decisions, this study aimed to identify factors influencing the need for RWE in HTA decision-making, confirm and enrich factors with stakeholder views, and evaluate similarities and differences between regulatory and HTA needs.</p><p><strong>Methods: </strong>Previous scoping review methodology was used to identify factors influencing the need for RWE in HTA decision-making. Semi-structured interviews with stakeholders were conducted to confirm and enrich literature-derived factors for both regulatory and HTA contexts. Insights from the reviews and interviews were combined to explore similarities and differences in RWE needs across these domains.</p><p><strong>Results: </strong>The HTA review, featuring 118 articles, revealed two major themes and six subthemes, encompassing 45 factors. The need for RWE depended on (1) questions addressable with RWE, and (2) contextual factors. Stakeholder interviews confirmed literature-derived factors. While contextual factors aligned between regulatory and HTA decision-making, question-related factors partly differed. Unlike the benefit-risk assessment in regulatory decision-making, RWE serves as direct input for the HTA, and involves specific details and a broader scope. Regulators require RWE for orphan status submissions, alternative approval pathways and to evaluate the impact of risk minimization measures, whereas HTA uses RWE to guide comparator selection, evaluate treatment implementation, quality of care and general healthcare impacts.</p><p><strong>Conclusion: </strong>Contextual factors that influence the need for RWE are similar between regulatory and HTA decision-making, with variations seen in questions addressable with RWE.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70074"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706668/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142951569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Drug-Drug Interactions in Pharmacoepidemiologic Research.","authors":"Cheng Chen, Thanh Phuong Pham Nguyen, John E Hughes, Sean Hennessy, Charles E Leonard, Todd A Miano, Antonios Douros, Joshua J Gagne, Katsiaryna Bykov","doi":"10.1002/pds.70088","DOIUrl":"10.1002/pds.70088","url":null,"abstract":"<p><p>Drug-drug interactions (DDIs) represent a significant concern for clinical care and public health, but the health consequences of many DDIs remain largely underexplored. This knowledge gap underscores the critical need for pharmacoepidemiologic research to evaluate real-world health outcomes of DDIs. In this review, we summarize the definitions commonly used in pharmacoepidemiologic DDI studies, discuss common sources of bias, and illustrate through examples how these biases can be mitigated.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70088"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12074612/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142979422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The European Drug-Drug Interaction (EuroDDI) Study Protocol: A Cross-Country Comparison of Drug-Drug Interaction Prevalence in the Older Community-Dwelling Population.","authors":"John E Hughes, Enrica Menditto, Sara Mucherino, Valentina Orlando, Aida Moreno-Juste, Antonio Gimeno-Miguel, Beatriz Poblador-Plou, Mercedes Aza-Pascual-Salcedo, Francisca González-Rubio, Ignatios Ioakeim-Skoufa, Kathleen Bennett, Caitriona Cahir","doi":"10.1002/pds.70092","DOIUrl":"10.1002/pds.70092","url":null,"abstract":"<p><strong>Background: </strong>Drug-drug interactions (DDIs), highly prevalent amongst the elderly, can lead to avoidable medication-related harm. Cardiovascular and central nervous system (CNS) drugs are commonly implicated. To date, there is no consensus on how to measure DDIs, making comparisons across countries challenging.</p><p><strong>Objective: </strong>To (i) establish a common data model (CDM) to measure DDI prevalence in the older (aged ≥ 70 years) community-dwelling population of three European countries and (ii) compare and describe cardiovascular and CNS DDI prevalence rates across these countries.</p><p><strong>Methods: </strong>This cross-country study will apply a harmonised method of DDI identification and analysis using the WHO ATC classification system and national pharmacy claims data from three European countries (Ireland, Italy, Spain). Patients aged ≥ 70 years dispensed ≥ 2 medications during 2016 will be identified from each country's national database. 'Severe' cardiovascular and CNS DDIs (i.e., may result in a life-threatening event/permanent detrimental effect) will be identified using the British National Formulary and Stockley's Drug Interactions. Two separate lists of 'severe' DDIs, per medications reimbursed, will be applied to each database: (i) DDIs relevant to each individual country and (ii) DDIs relevant to all three countries. DDIs will be defined as co-dispensed (same day) and concomitantly (±7 days) dispensed.</p><p><strong>Results: </strong>Descriptive statistics, including DDI prevalence and 95% confidence intervals, will be reported for each country. Prevalence will be pooled and compared across countries using random effects models and meta-regression, where feasible.</p><p><strong>Conclusion: </strong>The EuroDDI study will develop a harmonised method to measure and compare DDI prevalence across health-related databases in Europe.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70092"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706702/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142952715","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}