Pharmacoepidemiology and Drug Safety最新文献

{"title":"Core Concepts in Pharmacoepidemiology: New-User Designs.","authors":"Qoua L Her, Julie Rouette, Jessica C Young, Michael Webster-Clark, John Tazare","doi":"10.1002/pds.70048","DOIUrl":"10.1002/pds.70048","url":null,"abstract":"<p><p>In this article, we review the history and key reasons for new-user comparisons in pharmacoepidemiology, highlighting the target trial framework as a unifying framework. We describe three distinct pharmacoepidemiological new-user study designs: (1) new-user versus non-user; (2) active comparator new-user; (i.e., ACNU) and (3) prevalent new-user (i.e., PNU) designs, and discuss how each relates to key issues of defining time zero, choosing appropriate comparator groups, and potential sources of bias they do and do not account for. We use a clinical example of hormone replacement therapy and the risk of coronary heart disease to illustrate practical considerations surrounding the application of the three designs presented.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70048"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11588434/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142716664","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":"Barriers and Facilitators on Pharmacovigilance Practice Among Pharmacists in Metro Manila, Philippines.","authors":"Rogie Royce Carandang, Justin Gabriel Gumop-As, Salve Regina Andoloy, Faye Louise Daguman, Leona Jenn Jose, Marielle Villarino, Peter Quilala","doi":"10.1002/pds.70072","DOIUrl":"https://doi.org/10.1002/pds.70072","url":null,"abstract":"<p><strong>Purpose: </strong>The underreporting of adverse drug reactions (ADRs) remains a significant challenge in the Philippines. Pharmacists play a crucial role in ensuring medication safety, improving patient outcomes, and enhancing the overall effectiveness of pharmacovigilance (PV) systems. This study explored the barriers and facilitators affecting PV practices among pharmacists in Metro Manila.</p><p><strong>Methods: </strong>This study employed qualitative research through in-depth interviews using a semi-structured topic guide. Researchers interviewed pharmacists until data saturation was reached, where no new insights emerged. Qualitative data were analyzed inductively, utilizing Braun and Clarke's thematic analysis to identify key themes. MAXQDA was used to facilitate coding and analyzing the qualitative data.</p><p><strong>Results: </strong>A total of 40 pharmacists (72.5% female) participated in this study, evenly distributed across various practice areas and geographic locations in Metro Manila. The analysis identified four main themes related to pharmacists' nonreporting of ADRs: competency gaps, organizational challenges, reporting issues, and workplace constraints. Pharmacists' limited knowledge of ADRs and lack of experience in ADR reporting appear to be the primary barriers, along with environmental factors. Conversely, critical strategies for improving ADR notifications include capacity building, motivation and rewards, and work optimization.</p><p><strong>Conclusion: </strong>Pharmacists recognize the importance of reporting ADRs and view it as a professional responsibility. By prioritizing knowledge enhancement, training, and system improvements, the identification and reporting of ADRs can be strengthened, ultimately enhancing patient safety and PV practices. This positive attitude toward ADR reporting lays the groundwork for interventions designed to overcome barriers and promote a culture of active reporting among pharmacists.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70072"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142854725","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":"Oxymorphone and Oxycodone Pharmacy Purchases in US Counties: Prelude to the Largest Rural Human Immunodeficiency Virus Outbreak in US History.","authors":"Chris Delcher, Anna L Smith, Frank Romanelli, Logan Gaskill, Hilary L Surratt","doi":"10.1002/pds.70066","DOIUrl":"10.1002/pds.70066","url":null,"abstract":"<p><strong>Purpose: </strong>The largest rural outbreak of human immunodeficiency virus (HIV) in the US was centered in Scott County, Indiana, and linked to injection practices involving the opioid Opana ER (oxymorphone extended release [ER] reformulated). We examined supply trends using pharmacy transactions of Opana ER in Scott and all US counties from January 2007 to December 2019.</p><p><strong>Methods: </strong>We calculated the monthly morphine milligram equivalents (MME) of Opana ER (and its competitor OxyContin) in pharmacies using the Automation of Reports and Consolidated Orders System (ARCOS) database from the Washington Post. We modeled the MME rate per capita in Scott County and five geographic comparators in seven distinct time periods including the market introduction of abuse deterrent formulations of both drugs and the HIV outbreak period (circa 2014).</p><p><strong>Results: </strong>After Opana ER introduction, transaction rates surged in Scott County, where annual OxyContin MMEs were already seven-fold higher than Indiana overall (CY2009: 46.8 vs. 6.8 MME/pop., respectively). Immediately after OxyContin's reformulation, the Opana ER growth rate in Scott County surpassed all geographic comparators modeled (~27 times faster than the US, 1.28 vs. 0.047 MME/pop/month, respectively). By 2012, prior to the outbreak, MMEs from Opana ER almost perfectly replaced the diminishing OxyContin supply. When Opana ER with INTAC was subsequently introduced, pharmacy transactions declined precipitously by nearly 50%, persisting through the HIV outbreak period and market withdrawal.</p><p><strong>Conclusions: </strong>Opana ER rapidly supplanted OxyContin in a vulnerable population that was at heightened risk for HIV who subsequently faced an immediate supply shock after its reformulation. Pharmacy transactions are critical for suspicious order monitoring and pharmacovigilance by US and international agencies especially during deleterious supply shocks in legal and illicit drug markets.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70066"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142771190","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":"Patient Characteristics and Practice Variation Associated With New Community Prescription of Benzodiazepine and z-Drug Hypnotics After Critical Illness: A Retrospective Cohort Study Using the UK Clinical Practice Research Datalink.","authors":"Elizabeth T Mansi, Christopher T Rentsch, Richard S Bourne, Bruce Guthrie, Nazir I Lone","doi":"10.1002/pds.70056","DOIUrl":"10.1002/pds.70056","url":null,"abstract":"<p><strong>Purpose: </strong>Survivors of critical illness are often affected by new or worsened mental health conditions and sleep disorders. We examined the incidence, practice variation and factors associated with new benzodiazepine and z-drug community prescriptions among critical illness survivors.</p><p><strong>Methods: </strong>A retrospective cohort study using the UK Clinical Practice Research Datalink data included 52 846 adult critical care survivors hospitalised in 2010 and 2018 who were not prescribed benzodiazepines or z-drugs before hospitalisation. We performed multilevel multivariable logistic regression to assess patient factors associated with new (any prescription within 90 days) and with new-and-persistent (2+ prescriptions within 180 days) benzodiazepine or z-drug prescribing, and to evaluate variation by primary care practice.</p><p><strong>Results: </strong>5.2% (2769/52846) of treatment-naïve survivors (95% CI 5.1-5.4) were prescribed a benzodiazepine or z-drug, and 2.5% (1311/52846) had new-and-persistent prescribing. A history of insomnia (adjusted OR 1.96; 95% CI 1.74-2.21), anxiety or depression (adjusted OR 1.40; 95% CI 1.28-1.53) and recent prescription opioid use (adjusted OR 1.47; 95% CI 1.34-1.61) were associated with new community prescription. Sex was not associated with new prescriptions and older patients were less likely to receive a prescription. 2.6% of the variation in new prescribing and 4.1% of the variation in new-and-persistent prescribing were attributable to the prescribing practice.</p><p><strong>Conclusions: </strong>One in twenty critical illness survivors receive a new community benzodiazepine or z-drug prescription. Further research is needed to understand where in the patient care pathway initiation occurs and the risk of adverse events in survivors of recent critical illness.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70056"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11602247/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142739578","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":"Determining Line of Therapy from Real-World Data in Non-Small Cell Lung Cancer.","authors":"Connor B Grady, Wei-Ting Hwang, Joshua E Reuss, Wade Iams, Amanda Cass, Geoffrey Liu, Devalben Patel, Stephen V Liu, Gabriela Liliana Bravo Montenegro, Tejas Patil, Jorge J Nieva, Amanda Herrmann, Kristen A Marrone, Vincent K Lam, William Schwartzman, Jonathan Dowell, Liza C Villaruz, Kelsey Leigh Miller, Jared Weiss, Fangdi Sun, Vamsidhar Velcheti, D Ross Camidge, Charu Aggarwal, Lova Sun, Melina E Marmarelis","doi":"10.1002/pds.70049","DOIUrl":"10.1002/pds.70049","url":null,"abstract":"<p><strong>Introduction: </strong>Determining lines of therapy (LOT) using real-world data is crucial to inform clinical decisions and support clinical research. Existing rules for determining LOT in patients with metastatic non-small cell lung cancer (mNSCLC) do not incorporate the growing number of targeted therapies used in treatment today. Therefore, we propose rules for determining LOT from real-world data of patients with mNSCLC treated with targeted therapies.</p><p><strong>Methods: </strong>LOT rules were developed through expert consensus using a real-world cohort of 550 patients with ALK+ or ROS1+ mNSCLC in the multi-institutional, electronic medical record-based Academic Thoracic Oncology Medical Investigators Consortium's (ATOMIC) Driver Mutation Registry. Rules were subsequently modified based on a review of appropriate LOT determination. These resulting rules were then applied to an independent cohort of patients with EGFR+ mNSCLC to illustrate their use.</p><p><strong>Results: </strong>Six rules for determining LOTs were developed. Among 1133 patients with EGFR mutations and mNSCLC, a total of 3168 regimens were recorded with a median of 2 regimens per patient (IQR, 1-4; range, 1-13). After applying our rules, there were 2834 total LOTs with a median of 2 LOTs per patient (IQR, 1-3; range, 1-11). Rules 1-3 kept 11% of regimen changes from advancing the LOT. When compared to previously published rules, LOT assignments differed 5.7% of the time, mostly in LOTs with targeted therapy.</p><p><strong>Conclusion: </strong>These rules provide an updated framework to evaluate current treatment patterns, accounting for the increased use of targeted therapies in patients with mNSCLC, and promote standardization of methods for determining LOT from real-world data.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70049"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11588435/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142716686","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":"Severe Cutaneous Adverse Reactions in Hospitalized Children: A Pilot Validation Study.","authors":"Bahar Javdan, Siddharth Marwaha, Cindy Wassef, Amy Pappert, Daniel B Horton","doi":"10.1002/pds.70061","DOIUrl":"10.1002/pds.70061","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70061"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11694326/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142739706","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":"Determining Targets for Antiretroviral Drug Concentrations: A Causal Framework Illustrated With Pediatric Efavirenz Data From the CHAPAS-3 Trial.","authors":"Michael Schomaker, Paolo Denti, Andrzej Bienczak, David Burger, Iván Díaz, Diana M Gibb, Ann Sarah Walker, Helen McIlleron","doi":"10.1002/pds.70051","DOIUrl":"10.1002/pds.70051","url":null,"abstract":"<p><strong>Background: </strong>Determining a therapeutic window for maintaining antiretroviral drug concentrations within an appropriate range is required for identifying effective dosing regimens. The limits of this window are typically calculated using predictive models. We propose that target concentrations should instead be calculated based on counterfactual probabilities of relevant outcomes and describe a counterfactual framework for this.</p><p><strong>Methods: </strong>The proposed framework is applied in an analysis including longitudinal observational data from 125 HIV-positive children treated with efavirenz-based regimens within the CHAPAS-3 trial, which enrolled children < 13 years in Zambia/Uganda. A directed acyclic graph was developed to visualize the mechanisms affecting antiretroviral concentrations. Causal concentration-response curves, adjusted for measured time-varying confounding of weight and adherence, are calculated using g-computation.</p><p><strong>Results: </strong>The estimated curves show that higher concentrations during follow-up, 12/24 h after dose, lead to lower probabilities of viral failure (> 100 c/mL) at 96 weeks of follow-up. Estimated counterfactual failure probabilities under the current target range of 1-4 mg/L range from 24% to about 2%. The curves are almost identical for slow, intermediate and extensive metabolizers and show that a mid-dose concentration level of ≥ 3.5 mg/L would be required to achieve a failure probability of < 5%.</p><p><strong>Conclusions: </strong>Our analyses demonstrate that a causal approach may lead to different minimum concentration limits than analyses that are based on purely predictive models. Moreover, the approach highlights that indirect causes of failure, such as patients' metabolizing status, may predict patients' failure risk, but do not alter the threshold at which antiviral activity of efavirenz is severely reduced.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70051"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11614751/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142771188","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":"Identification of Chronic Hypertension in Pregnancy in Three Administrative Data Sources Among Medicaid-Funded Births in California.","authors":"Erin Delker, Rebecca J Baer, Christina D Chambers, Gretchen Bandoli","doi":"10.1002/pds.70059","DOIUrl":"10.1002/pds.70059","url":null,"abstract":"<p><strong>Purpose: </strong>Administrative data sources are used to describe the epidemiology of chronic hypertension in pregnancy and its consequences. Differences in identification across sources may affect research estimates. We compared identification of chronic hypertension in birth certificate records, hospital discharge records, and Medi-Cal claims in the same individuals.</p><p><strong>Methods: </strong>We used data from 820 140 2016-2020 California Medi-Cal covered births. We identified chronic hypertension on birth certificates using the prepregnancy hypertension check box and in hospital discharge records and Medi-Cal claims using ICD codes. We compared the prevalence of chronic hypertension and identified predictors of agreement. We also compared absolute and relative estimates of racial/ethnic disparities in chronic hypertension and associations with neonatal outcomes.</p><p><strong>Results: </strong>The prevalence of chronic hypertension was 0.7% in birth records, 2.1% in hospital discharge records, and 3.9% in Medi-Cal claims. There was low to fair agreement between birth certificate records and hospitalization records (kappa = 0.36) and Medi-Cal claims (kappa = 0.25). Characteristics associated with the worst agreement were eligibility for Women Infant and Children benefits, US-born, and normal body mass index. Estimates of the relative risk for racial/ethnic disparities and associations with preterm birth and SGA age at delivery were similar across sources. Estimates of risk differences were larger in hospitalization and Medi-Cal claims data.</p><p><strong>Conclusions: </strong>Reliance on birth certificate data may contribute to underestimated prevalence estimates and biased causal estimates. Epidemiologic research and public health surveillance of chronic hypertension and its consequences should incorporate data from multiple data sources to improve validity of estimates.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70059"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11634560/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813928","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":"Commentary/Response to Damkier et al.","authors":"Liana Martirosyan, Maria Giovanna Satta, Juan Garcia Burgos, Ulla Wändel-Liminga, Sabine Straus","doi":"10.1002/pds.70058","DOIUrl":"https://doi.org/10.1002/pds.70058","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70058"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142771187","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":"Regulatory Impact of Selected U.S. FDA Postmarketing Safety Registries Conducted for Drugs Used to Treat Inflammatory or Autoimmune Conditions.","authors":"Zakaridja Guiriansoro, Tatiana Oussova, Joel Weissfeld","doi":"10.1002/pds.70034","DOIUrl":"https://doi.org/10.1002/pds.70034","url":null,"abstract":"<p><strong>Purpose: </strong>Assess the regulatory impact of selected FDA postmarketing safety registries on drug product labeling updates.</p><p><strong>Methods: </strong>Postmarketing safety studies were identified in internal record repositories for the Center for Drug Evaluation and Research, U.S. FDA, in March and September 2021. Studies eligible for review included prospectively enrolling patient registry studies conducted to assess the safety of drug products used to treat inflammatory or autoimmune conditions. These studies were requested between 1999 and 2011.</p><p><strong>Results: </strong>This paper analyzed 10 safety (non-pregnancy) registries and four pregnancy registries (n = 14). Only four safety registry studies were successful in reaching their targets for both patient enrollment and patient follow-up or drug exposure. These registries were either multi-center, multinational studies or studies using participants from a health insurance or health maintenance organization. None of the safety registries led to safety labeling updates, regardless of targets' achievement for study enrollment and follow-up: six did not detect a new safety signal and four provided inconclusive results. Two pregnancy registries reached their targets for patient enrollment, and all four resulted in safety labeling updates, as required by the Pregnancy and Lactation Labeling Rule guidance.</p><p><strong>Conclusions: </strong>While six non-pregnancy registries did not detect a new safety signal, four did not produce safety results considered sufficiently robust to warrant specific regulatory action including safety-related labeling updates. The lack of safety signal detection in these observational studies should not imply the absence of safety signals. Appropriately designed, prospective, randomized controlled safety studies are the most reliable way to obtain interpretable safety data.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 12","pages":"e70034"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11609129/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142771191","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}