Pharmacoepidemiology and Drug Safety最新文献

{"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}

{"title":"Use of Causal Framework to Evaluate Effect of Abuse Deterrent Properties of Extended-Release Oxycodone on Tampering in a Real-World Settings.","authors":"Karilynn M Rockhill, Hannah Burkett, Richard Dart, Joshua C Black","doi":"10.1002/pds.70085","DOIUrl":"10.1002/pds.70085","url":null,"abstract":"<p><strong>Purpose: </strong>To assess whether exposure to an extended-release (ER) oxycodone with abuse deterrent properties (ADF) reduced tampering of oxycodone in a real-world, postmarket setting to address the thinking behind Category 4 labeling by the FDA.</p><p><strong>Methods: </strong>Data from an observational cross-sectional study of the general adult population (2022) was used under a causal framework to estimate the confounding-adjusted odds of tampering oxycodone after exposure to two types of ADF ER oxycodone. The tampering behaviors of those who used only single entity immediate-release (SE-IR) oxycodone was used as a comparison. The tampering outcome was defined as use by snorting, smoking, or injecting any oxycodone (ER or SE-IR). A directed acyclic graph was used to identify covariates. Average treatment effect among the treated was estimated using inverse propensity score weighting combined with survey weights in a regression.</p><p><strong>Results: </strong>In 2022, 0.14% and 3.0% among the general population reported using the two ER oxycodone groups, while 2.4% used SE-IR oxycodone. Propensity score analyses with both comparators (common support > 98%) balanced demographic, health, and drug use covariates. After adjustment for selection and confounding bias, among those who used ER oxycodone group 1 the odds ratio of tampering with any form of oxycodone was elevated but not statistically significant (2.25; 95% CI: 0.94, 5.39). The odds ratio of tampering by users of ER oxycodone group 2 was significantly elevated (1.90; 95% CI: 1.08, 3.19).</p><p><strong>Conclusions: </strong>Tampering of ER oxycodone products by individuals was rare. We found evidence suggestive of elevated odds of tampering behaviors with use of an ADF ER oxycodone.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70085"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142952748","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating an ICD-10 Based Proxy for Date of Birth in Electronic Health Record Data.","authors":"Sara Burns, Ariel Mueller, Matthew Smith, Timothy Houle, Michaela K Farber, Tanzeema Hossain, Justin Manjourides","doi":"10.1002/pds.70083","DOIUrl":"https://doi.org/10.1002/pds.70083","url":null,"abstract":"<p><strong>Purpose: </strong>To comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, many real-world data providers mask a patient's date of birth by supplying only year of birth to data users. The lack of granularity around patient age is a challenge when using RWD, especially for pediatric research studies. In this study, a proxy for patient date of birth is evaluated using electronic health record (EHR) data.</p><p><strong>Methods: </strong>This validation study leverages a retrospective cohort of EHR data from Mass General Brigham (MGB) patients born between January 1, 2018, and December 31, 2022, to assess the use of the date of a patient's first observed International Classification of Diseases 10th Revision Clinical Modification (ICD-10-CM) day-of birth code (Z37* or Z38*) as a proxy for date of birth. Alternative proxy measures such as date of first other infancy-related ICD-10-CM code and date of first clinical activity were also assessed.</p><p><strong>Results: </strong>Of 82 398 patients born during the five-year study period, 58 047 (70.4%) had an ICD-10-CM birth code and were included in the primary analysis. The mean difference between true date of birth and first observed birth code was 0.3 days with a standard deviation of 15.0 days. The first observed birth code occurred within 30 days of the true date of birth in 99.9% of cases.</p><p><strong>Conclusion: </strong>Results from this study suggest that the date of the first day-of ICD-10-CM birth code can be used as a proxy for true patient date of birth in pediatric RWD studies.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70083"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142952834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characterization of SARS-CoV-2 Diagnostic Tests and Liver Function Tests Among Patients With COVID-19 Diagnosed in Outpatient Settings Using Administrative Healthcare Data and Data From Commercial Laboratories.","authors":"Ayad K Ali, Aidan Baglivo, Priya Govil, Liza R Gibbs, Marie C Bradley, Keith E Campbell, Aloka Chakravarty, Tamar Lasky, Victoria Derbyshire, Elizabeth M Garry","doi":"10.1002/pds.70094","DOIUrl":"10.1002/pds.70094","url":null,"abstract":"<p><strong>Purpose: </strong>To characterize select laboratory tests ordered versus reported for patients diagnosed with COVID-19 in administrative healthcare and commercial laboratory data.</p><p><strong>Methods: </strong>Among patients with an outpatient COVID-19 diagnosis claim in HealthVerity data (01/01/2021-12/31/2022), this study described baseline characteristics and descriptively compared SARS-CoV-2 diagnostic tests and liver function tests from administrative healthcare (insurance claims and hospital billing data) and commercial laboratories, overall and by code type (e.g., CPT, LOINC). Select liver function tests were also described by method-specific and methodless LOINC.</p><p><strong>Results: </strong>Among 214 998 patients with COVID-19, 46.1% had a SARS-CoV-2 molecular diagnostic test recorded within 7 days of diagnosis (in either administrative or laboratory data); 44.5% had a corresponding CPT in medical claims, while only 10.0% had a corresponding LOINC in laboratory data. In contrast, the six most common liver function tests (albumin, aspartate aminotransferase, total protein, alkaline phosphatase, alanine aminotransferase, and total bilirubin) were identified in 55.7%-56.6% of patients via LOINC, but only in 3.2%-4.2% via CPT claims. Of the total count of select liver function tests performed in the laboratory data, 99.7% of aspartate aminotransferase, 96.1% of direct bilirubin, and 82.9% of lactate dehydrogenase were reported by methodless LOINC rather than method-specific LOINC.</p><p><strong>Conclusions: </strong>Important differences were identified between orders for SARS-CoV-2 diagnostic tests and liver function tests, as well as missingness of LOINC method, highlighting challenges related to completeness of laboratory data in real-world data sources. These challenges underscore a need to improve data quality when considering the utility of laboratory data for research.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70094"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142979410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Descriptive Comparative Analysis of Safety Concerns Outlaid in the Risk Management Plans of the European Union and Japan.","authors":"Teruyuki Honda, Mamoru Narukawa","doi":"10.1002/pds.70097","DOIUrl":"10.1002/pds.70097","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to obtain a better understanding of the characteristics of the risk management plans (RMP) and the background regulatory policies governing them, in the European Union (EU) and Japan. This was done by descriptively comparing the safety concerns (SCs) listed in the RMP and examining their relationships with product labeling.</p><p><strong>Methods: </strong>Information regarding SCs was collected from the published RMP of both the EU and Japan for the targeted products-all of which were commonly approved in both regions. The concordance rate of the SCs for each product between the EU- and Japan-RMP was calculated. The warning information for each product was collected from the product labeling, summary of product characteristics for the EU, and package insert for Japan, and compared with the SCs listed in the corresponding RMP.</p><p><strong>Results: </strong>A total of 259 products that were approved for sale in both the EU and Japan (1998-2023), for which RMP were available in both regions, were analyzed. While 51.0% of the SCs labeled as important identified risks (IIRs) in the EU-RMP were concordant with those in the Japan-RMP, 20.4% of the SCs listed as IIRs in the Japan-RMP were concordant with those in the EU-RMP. The concordance rate between the SCs identified as IIRs and the warning information was 18.6% for the EU-RMP and 88.4% for the Japan-RMP.</p><p><strong>Conclusions: </strong>The low SC concordance rate between the EU- and Japan-RMP indicates a different approach to selecting RMP SCs by the two regulatory authorities.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":"e70097"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142979461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}