The European Drug-Drug Interaction (EuroDDI) Study Protocol: A Cross-Country Comparison of Drug-Drug Interaction Prevalence in the Older Community-Dwelling Population.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-01-01 DOI:10.1002/pds.70092

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

{"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":null,"url":null,"abstract":"Background: 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.Objective: 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.Methods: 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.Results: 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.Conclusion: The EuroDDI study will develop a harmonised method to measure and compare DDI prevalence across health-related databases in Europe.","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70092"},"PeriodicalIF":2.4000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706702/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmacoepidemiology and Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/pds.70092","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

Abstract

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusion: The EuroDDI study will develop a harmonised method to measure and compare DDI prevalence across health-related databases in Europe.

查看原文本刊更多论文

欧洲药物-药物相互作用（EuroDDI）研究方案：老年社区居民中药物-药物相互作用流行率的跨国比较。

背景：药物-药物相互作用（ddi）在老年人中非常普遍，可导致可避免的药物相关伤害。通常涉及心血管和中枢神经系统（CNS）药物。迄今为止，对于如何衡量ddi没有达成共识，这使得各国之间的比较具有挑战性。目的：(i)建立一个通用数据模型（CDM）来测量三个欧洲国家老年人（≥70岁）社区居民的DDI患病率；（ii）比较和描述这些国家心血管和中枢神经系统DDI患病率。方法：这项跨国研究将采用统一的DDI识别和分析方法，使用世卫组织ATC分类系统和来自三个欧洲国家（爱尔兰、意大利、西班牙）的国家药房索赔数据。将从每个国家的国家数据库中确定2016年分配了≥2种药物的≥70岁患者。“严重”心血管和中枢神经系统ddi（即可能导致危及生命的事件/永久性有害影响）将使用英国国家处方集和斯托克利药物相互作用来确定。每个数据库将根据所报销的每种药物分别列出两份“严重”DDIs清单：(i)与每个国家相关的DDIs，（ii）与所有三个国家相关的DDIs。ddi将被定义为共同分配（当天）和同时分配（±7天）。结果：将报告每个国家的描述性统计数据，包括DDI患病率和95%置信区间。在可行的情况下，将使用随机效应模型和元回归对各国的流行情况进行汇总和比较。结论：EuroDDI研究将开发一种统一的方法来测量和比较欧洲健康相关数据库中的DDI患病率。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.