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Medicine utilization studies in Australian individual‐level dispensing data: A blinded, multi‐center replicated analysis Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-03-13 Malcolm B. Gillies, Chrianna Bharat, Ximena Camacho, Benjamin Daniels, Kelly Hall, Thu‐Lan Kelly, Erin Kelty, Jialing Lin, Melisa Litchfield, Derrick Lopez, Firouzeh Noghrehchi, Jacques Raubenheimer, Bianca Varney, Nicole Pratt
PurposeMedicine dispensing data require extensive preparation when used for research and decisions during this process may lead to results that do not replicate between independent studies. We conducted an experiment to examine the impact of these decisions on results of a study measuring discontinuation, intensification, and switching in a cohort of patients initiating metformin.MethodsFour Australian
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An open‐source implementation of tree‐based scan statistics Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-03-08 Massimiliano Russo, Shirley V. Wang
PurposeWe develop an open‐source R package to implement tree‐based scan statistics (TBSS) analyses.MethodsTBSS are data mining methods used by the United States Food and Drug Administration and the Centers for Disease Control. They simultaneously screen thousands of hierarchically aggregated outcomes to identify unsuspected adverse effects of drugs or vaccines, accounting for multiple comparisons.
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Comparing the Centers for Medicare and Medicaid Services (CMS) enrollment data death dates to the National Death Index (NDI) Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-03-07 Dinci Pennap, Richard S. Swain, Sandia Akhtar, Jiemin Liao, Yuqin Wei, Jiaqi Li, Michael Wernecke, Thomas E. MaCurdy, Jeffrey A. Kelman, Andrew D. Mosholder, David J. Graham
PurposeIn the United States, the National Death Index (NDI) is the most complete source of death information, while epidemiologic studies with mortality outcomes often rely on U.S. Medicare data for outcome ascertainment. The purpose of this study was to assess the agreement of death information between the Centers for Medicare & Medicaid Services (CMS) Medicare enrolment data and NDI.MethodsUsing
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Effect of statin treatment on the risk of cancer in patients with heart failure: A target trial emulation study Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-03-07 Chengsheng Ju, Wallis C. Y. Lau, Pinkie Chambers, Kenneth K. C. Man, Martin D. Forster, Isla S. Mackenzie, Charlotte Manisty, Li Wei
PurposeA recent observational study suggested statins could reduce cancer diagnosis in patients with heart failure (HF). The findings need to be validated using robust epidemiological methods. This study aimed to evaluate the effect of statin treatment on the risk of cancer in patients with HF.MethodsWe conducted two target trial emulations using primary care data from IQVIA Medical Research Database‐UK
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Is the sequence ratio an unbiased estimate of the incidence rate ratio? A simulation study Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-03-07 Thomas Delvin, Sofie Egsgaard, Jesper Hallas, Helene Kildegaard, Lars Christian Lund, Martin Torp Rahbek
PurposeWe aimed to evaluate the conditions under which the sequence ratio (SR) obtained from a sequence symmetry analysis is an unbiased estimate of the true incidence rate ratio (IRR).MethodsWe simulated cohorts of 1 million individuals who could initiate an exposure drug and experience a very rare, rare, common, or frequent outcome of interest. The outcome rate among exposed individuals was modified
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Risk of fall or fracture with concomitant use of prescription opioids and other medications in osteoarthritis patients Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-02-29 Nazleen F. Khan, Katsiaryna Bykov, Jeffrey N. Katz, Robert J. Glynn, Seanna M. Vine, Seoyoung C. Kim
BackgroundOsteoarthritis (OA) patients taking prescription opioids for pain are at increased risk of fall or fracture, and the concomitant use of interacting drugs may further increase the risk of these events.AimsTo identify prescription opioid‐related medication combinations associated with fall or fracture.Materials & MethodsWe conducted a case‐crossover‐based screening of two administrative claims
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How glaucoma patients balance between the advantages and disadvantages of acceptance to the recommended treatment regimen in real‐life: Perspectives from a middle‐income country Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-02-29 Guilherme Samomiya Motta, Julia da Costa Andrade, Niro Kasahara
PurposePatients with primary open‐angle glaucoma (POAG) are required to take long‐term treatments with topical medications to halt disease progression. This cross‐sectional survey aimed to describe the level of acceptance of Brazilian patients toward the long‐term treatment with eyedrops and to find possible correlates of high acceptance.MethodsPOAG patients were recruited from the Glaucoma Service—Santa
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Adverse drug reaction signal detection methods in spontaneous reporting system: A systematic review Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-02-29 Xue‐Feng Jiao, Libin Pu, Shan Lan, Hailong Li, Linan Zeng, Huiqing Wang, Lingli Zhang
BackgroundA series of signal detection methods have been developed to detect adverse drug reaction (ADR) signals in spontaneous reporting system. However, different signal detection methods yield quite different signal detection results, and we do not know which method has the best detection performance. How to choose the most suitable signal detection method is an urgent problem to be solved. In this
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Staging and clean room: Constructs designed to facilitate transparency and reduce bias in comparative analyses of real‐world data Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-02-29 Paul Muntner, Rohini K. Hernandez, Shia T. Kent, James E. Browning, David T. Gilbertson, Kathleen E. Hurwitz, Susan S. Jick, Edward C. Lai, Timothy L. Lash, Keri L. Monda, Kenneth J. Rothman, Brian D. Bradbury, M. Alan Brookhart
PurposeWe describe constructs designed to protect the integrity of the results from comparative analyses using real‐world data (RWD): staging and clean room.MethodsStaging involves performing sequential preliminary analyses and evaluating the population size available and potential bias before conducting comparative analyses. A clean room involves restricted access to data and preliminary results,
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Prescriber perceptions of boxed warnings: A qualitative study Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-02-29 Rachel N. Ingersoll, Elise T. Bui, Blair Coleman, Esther H. Zhou, Sara Eggers
PurposeTo explore how boxed warning (BW) information fits within the context of prescribers' overall treatment decision‐making and communication with patients.MethodsIn‐depth interviews (N = 52) were conducted with primary care providers and specialists. Participants were presented with one of two prescribing scenarios: (1) estrogen vaginal inserts to treat vulvovaginal atrophy (VVA) associated with
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Where are the data to assess the safety of paternal drug exposure? A systematic review of secondary databases: A contribution from IMI concePTION Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-02-15 Sneha Gaitonde, Yola Moride, Elizabeth Suarez, Sandra Lopez-Leon
Most studies assessing the safety of parental drug exposures during pregnancy and around the time of conception describe the effects of maternal exposure. Recent publications have raised awareness of the need for additional research regarding the safety of paternal drug exposures on pregnancy outcomes.
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Using machine learning to predict the bleeding risk for patients with cardiac valve replacement treated with warfarin in hospitalized Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-02-15 Yixing Hu, Xuemeng Zhang, Meng Wei, Tongtong Yang, Jinjin Chen, Xia Wu, Yifan Zhu, Xin Chen, Sheng Lou, Junrong Zhu
Distinguishing warfarin-related bleeding risk at the bedside remains challenging. Studies indicate that warfarin therapy should be suspended when international normalized ratio (INR) ≥ 4.5, or it may sharply increase the risk of bleeding. We aim to develop and validate a model to predict the high bleeding risk in valve replacement patients during hospitalization.
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Patterns of filled prescriptions and the association with risk of drug-induced death. A population-based nested case-control register study Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-02-15 Ellen J. Amundsen, Ingvild Odsbu, Svetlana O. Skurtveit, Linn Gjersing
Opioid analgesics (OA) and other pharmaceuticals have been associated with drug-induced deaths. However, there is a lack of knowledge regarding patterns of use of these pharmaceuticals in the population and regarding such associations. We identify and describe subgroups of people with different patterns of filled prescriptions of OA and other relevant pharmaceuticals and examine associations with drug-induced
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Pain-related hospitalization and emergency room visit following initial analgesic prescription after outpatient surgery Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-02-15 Abhishek A. Nair, Jennifer L. Placencia, Harold J. Farber, Rajender R. Aparasu, Michael Johnson, Hua Chen
Our study examined the association between outpatient postsurgical analgesic prescription and risk of insufficiently managed pain characterized by pain-associated hospital admission and emergency room (ER) visit.
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Prescribing trends of proton pump inhibitors and histamine blockers among children in the United Kingdom (1998–2019): A population-based assessment Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-01-29 Reem Masarwa, Pauline Reynier, Claire Lefebvre, Robert W. Platt, Joseph A. C. Delaney, Kristian B. Filion
To describe the prescribing trends of proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs) among children with gastroesophageal reflux in the United Kingdom between 1998 and 2019.
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Dispensing pharmacy chains and direct anticoagulants: Potential associations with patient outcomes Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-01-25 Steven Kozlowski, Ellen Tworkoski, Sai Dharmarajan, Natasha Flowers, Andrew Kwist, Shanlai Shangguan, Yoganand Chillarige, Michael Wernecke, Tom MaCurdy, Jeffrey A. Kelman, David J. Graham
Pharmacy chains can differ with respect to the characteristics of their patient populations as well as their nonprescription products, services, and practices, and thus may serve as a surrogate for potential unmeasured confounding in observational studies of prescription drugs. This study evaluates whether a single-source drug can have different patient outcomes based on the dispensing pharmacy chain
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Probabilistic precision calculations for the planning of studies assessing negative binomial rates Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-01-25 Jonatan Hedberg, Stefan Franzén
Outcome variables that are assumed to follow a negative binomial distribution are frequently used in both clinical and epidemiological studies. Epidemiological studies, particularly those performed by pharmaceutical companies often aim to describe a population rather than compare treatments. Such descriptive studies are often analysed using confidence intervals. While precision calculations and sample
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The FAIRification of research in real-world evidence: A practical introduction to reproducible analytic workflows using Git and R Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2024-01-03 Janick Weberpals, Shirley V. Wang
Transparency and reproducibility are major prerequisites for conducting meaningful real-world evidence (RWE) studies that are fit for decision-making. Many advances have been made in the documentation and reporting of study protocols and results, but the principles for version control and sharing of analytic code in RWE are not yet as established as in other quantitative disciplines like computational
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The marked oscillatory pattern in prescription opioid utilization in Canada since 2000: Selected observations and questions for outcomes and policy Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-12-29 Benedikt Fischer, Tessa Robinson
Key Points Canada has undergone a marked “rise-and-fall” oscillation pattern in prescription opioid utilization since 2000. The initial multifold increases in prescription opioid utilization do not appear to be associated with improvements in chronic pain prevalence or care outcomes. It is unclear which particular system-level interventions drove the reversal in prescription utilization. It is plausible
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Use of pembrolizumab among older adults with cancer in the United States, before and after FDA approval of its tumor-agnostic indication Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-12-29 Yoon Duk Hong, Lindsey Enewold, Michael T. Halpern, Chris Zeruto, Angela B. Mariotto
Pembrolizumab, an anticancer immunotherapy agent, has received multiple approvals since its first approval by the U.S. Food and Drug Administration (FDA) in 2014. Limited data exist on its real-world use and shifts post tumor-agnostic approval in 2017 for the treatment of patients with any microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) solid tumors. This study analyzes pembrolizumab's
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Descriptive analysis on disproportionate medication errors and associated patient characteristics in the Food and Drug Administration's Adverse Event Reporting System Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-12-29 Victor Pera, Frauke van Vaerenbergh, Jan A. Kors, Erik M. van Mulligen, Rowan Parry, Marcel de Wilde, Lies Lahousse, Johan van der Lei, Peter R. Rijnbeek, Katia M. C. Verhamme
Medication errors (MEs) are a major public health concern which can cause harm and financial burden within the healthcare system. Characterizing MEs is crucial to develop strategies to mitigate MEs in the future.
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Assessing cumulative effects of medication use: New insights and new challenges Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-12-27 Michal Abrahamowicz
Key Points Weighted cumulative exposure (WCE) allows an accurate assessment of cumulative effects of time-varying drug exposures, while accounting for their recency. Real-world pharmacoepidemiological applications demonstrate that the WCE approach often improves the model's fit to data, and may be essential to establish an association between the use of a drug and a health outcome. Flexible cubic spline
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New antipsychotic prescription and recurrent infections among adult sepsis survivors: A population-based cohort study Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-12-21 Augusto Ferraris, Alejandro G. Szmulewicz, Lisa Burry, Amanda Phipps, Hannah Wunsch, Damon C. Scales, Federico Angriman
Antipsychotic agents, which may increase the risk of infection through dopaminergic dysregulation, are prescribed to a fraction of patients following critical illness. We compared the rate of recurrent sepsis among patients who filled a prescription for antipsychotics with high- or low-D2 affinity.
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Extracting forced vital capacity from the electronic health record through natural language processing in rheumatoid arthritis-associated interstitial lung disease Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-12-19 Bryant R. England, Punyasha Roul, Yangyuna Yang, Daniel Hershberger, Harlan Sayles, Jorge Rojas, Grant W. Cannon, Brian C. Sauer, Jeffrey R. Curtis, Joshua F. Baker, Ted R. Mikuls
To develop a natural language processing (NLP) tool to extract forced vital capacity (FVC) values from electronic health record (EHR) notes in patients with rheumatoid arthritis-interstitial lung disease (RA-ILD).
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Antifungal medication use during pregnancy and the risk of selected major birth defects in the National Birth Defects Prevention Study, 1997–2011 Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-12-19 Eleni A. Papadopoulos, Meredith M. Howley, Sarah C. Fisher, Alissa R. Van Zutphen, Martha M. Werler, Paul A. Romitti, Marilyn L. Browne
Recent studies suggest increased birth defect risk associated with maternal use of specific oral antifungals. We estimated associations between first-trimester antifungal use and selected non-cardiac birth defects using National Birth Defects Prevention Study (NBDPS) data.
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To retrieve values of albuminuria to define the size of CKD patients eligible to SGLT-2Is: An explorative analysis using a primary care database Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-12-19 Francesco Lapi, Ettore Marconi, Gaetano Piccinocchi, Gerardo Medea, Carlo Piccinni, Aldo Pietro Maggioni, Claudio Cricelli
To address missingness of albuminuria values, which establish the eligibility to SGLT-2Is for patients with CKD, using the multiple imputation (MI) method.
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Predicting risk of suicidal behavior from insurance claims data vs. linked data from insurance claims and electronic health records Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-12-19 Gregory E. Simon, Susan M. Shortreed, Eric Johnson, Zimri S. Yaseen, Marc Stone, Andrew D. Mosholder, Brian K. Ahmedani, Karen J. Coleman, R. Yates Coley, Robert B. Penfold, Sengwee Toh
Observational studies assessing effects of medical products on suicidal behavior often rely on health record data to account for pre-existing risk. We assess whether high-dimensional models predicting suicide risk using data derived from insurance claims and electronic health records (EHRs) are superior to models using data from insurance claims alone.
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Adherence to riluzole therapy in patients with amyotrophic lateral sclerosis in three Italian regions—The CAESAR study Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-11-28 Sabrina Giometto, Marco Finocchietti, Olga Paoletti, Niccolò Lombardi, Maria Grazia Celani, Francesco Sciancalepore, Ersilia Lucenteforte, Ursula Kirchmayer
Amyotrophic lateral sclerosis (ALS) is a rare neurodegenerative disease. Riluzole may increase survival and delay the need for mechanical ventilation. The CAESAR project (‘Comparative evaluation of the efficacy and safety of drugs used in rare neuromuscular and neurodegenerative diseases’, FV AIFA project 2012-2013-2014) involves evaluating prescribing patterns, and analysing effectiveness and comparative
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Risk of ischemic stroke associated with direct oral anticoagulants discontinuation on patients with non-valvular atrial fibrillation Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-11-27 T. Álvaro Thomsen, J. Mesa Guadalupe, C. Huerta, A. de Burgos, L. Cea Soriano
Although direct oral anticoagulants' (DOACs) prescriptions have experienced immense growth in the last decade, the proportion of discontinuers is still common yielding an increased risk of ischemic stroke (IS) onset.
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Computational phenotyping within electronic healthcare data to identify transgender people in the United States: A narrative review Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-11-27 Theo G. Beltran, Elle Lett, Tonia Poteat, Juan M. Hincapie-Castillo
With the expansion of research utilizing electronic healthcare data to identify transgender (TG) population health trends, the validity of computational phenotype (CP) algorithms to identify TG patients is not well understood. We aim to identify the current state of the literature that has utilized CPs to identify TG people within electronic healthcare data and their validity, potential gaps, and a
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A descriptive analysis of postmarketing requirement studies and clinical trials Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-11-23 Lauren Choi, Beverly Etchey, Monisha Billings, Cathryn Lee, Kathleen M. Weil, Debra Boxwell, Helen Edelberg
Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA has the authority to require applicants to conduct postmarketing studies or clinical trials. These postmarketing requirements (PMRs) provide additional data on the safety of the drug product. The purpose of the study was to conduct a descriptive analysis of FDAAA PMRs and the resulting regulatory actions.
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Is it possible to identify risk factors for adverse drug reactions using a pharmacovigilance database based on spontaneous reporting? Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-11-20 Yoshihiro Noguchi,Tomoaki Yoshimura
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Successful implementation of a stakeholder engagement program for pharmacoepidemiologic research Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-11-20 Sara J. Cromer, Barbara Steiner, Cassie York, Julianna Mastrorilli, Gillian A. Lake, Sherry Leibowitz, Leigh Simmons, Jeanne Steppel-Reznik, Greg Low, Michael A. Fischer, Elisabetta Patorno, Deborah J. Wexler
Rigorously conducted pharmacoepidemiologic research requires methodologically complex study designs and analysis yet evaluates problems of high importance to patients and clinicians. Despite this, participation in and mechanisms for stakeholder engagement in pharmacoepidemiologic research are not well-described. Here, we describe our approach and lessons learned from engaging stakeholders, of varying
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Optimizing large real-world data analysis with parquet files in R: A step-by-step tutorial Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-11-20 Abdullah I. Abdelaziz, Kent A. Hanson, Charles E. Gaber, Todd A. Lee
The use of open-source programming languages can facilitate open science practices in real-world evidence (RWE) studies. Real-world studies often rely on using big data, which makes using such languages complicated. We demonstrate an efficient approach that enables RWE researchers to use R to undertake RWE analysis tasks from cohort building to reporting.
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Drug-induced orthostatic hypotension: Cluster analysis of co-prescription patterns in older people in UK primary care Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-11-16 Cini Bhanu, Irene Petersen, Mine Orlu, Daniel Davis, Reecha Sofat, Juan Carlos Bazo-Alvarez, Kate Walters
Over 250 medications are reported to cause orthostatic hypotension, associated with serious adverse outcomes in older adults. Studies suggest a harmful cumulative risk of orthostatic hypotension with multiple medication use. However, there is limited evidence on the potential for harm in practice, particularly which drugs is co-prescribed and may increase risk of orthostatic hypotension.
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An observational post-authorization safety study (PASS) of naloxegol drug utilization in four European countries Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-11-15 Gunnvald Kvarstein, Anna MS Kindlundh-Högberg, Mounir Ould Setti, Rafik Namane, Ruvimbo Muzwidzwa, Hartmut Richter, Katja M. Hakkarainen
Naloxegol has been shown to be an efficient alternative to treat opioid-induced constipation (OIC). This study aimed at describing the characteristics of naloxegol users and assessing patterns of naloxegol use and associated factors.
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The risk of miscarriage after COVID-19 vaccination before and during pregnancy Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-11-09 Maud de Feijter, Marleen M. H. J. van Gelder, Lieke C. M. Vissers, Agnes C. Kant, Petra J. Woestenberg
Pregnant women are at higher risk of severe illness and adverse pregnancy outcomes due to a SARS-CoV-2 infection, which can be prevented by vaccination. Observational studies are needed to ascertain the safety of COVID-19 vaccination during pregnancy. We aimed to determine whether COVID-19 vaccination before and during pregnancy is associated with the risk of miscarriage.
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Beta-blocker use and survival after pancreatic cancer surgery: A nationwide population-based cohort study Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-11-09 Jakob Kirkegård, Deirdre Cronin-Fenton, Andrea Lund, Frank Viborg Mortensen
We examined the association between use of beta-blockers and survival in pancreatic cancer patients after curative-intent surgery.
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Adherence and persistence of HIV pre-exposure prophylaxis use in the United States Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-11-08 Carter D. McCormick, Patrick S. Sullivan, Dima M. Qato, Stephanie Y. Crawford, Glen T. Schumock, Todd A. Lee
To describe medication adherence and persistence of HIV PrEP overall and compare between sex and age groups of commercially insured individuals in the United States.
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Trend adjustment of the sequence difference when performing sequence symmetry analyses. Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-11-01 Martin Torp Rahbek,Jesper Hallas,Lars Christian Lund
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Oral phosphodiesterase type 5 inhibitors and priapism: A VigiBase analysis Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-11-01 Behzad Abbasi, Nathan M. Shaw, Jason L. Lui, Nizar Hakam, Behnam Nabavizadeh, Benjamin N. Breyer
To explore the differences of priapism events among a diverse cohort taking erectogenic medicines (i.e., phosphodiesterase type 5 inhibitors [PDE5i] and intracavernousal drugs).
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Application of the waiting time distribution in a nationwide screening of real-world dermatology drug utilization for aberrant use patterns Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-10-27 Thomas Delvin, Anette Bygum, Lars Christian Lund, Jacob Harbo Andersen, Jesper Hallas
Inappropriate use of medicines may have critical consequences from individual, public health, and economic perspectives. Discovering wrongful medicine use may require intentional surveillance or screening.
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Validation of an algorithm for identifying incident cancer cases based on long-term illness and diagnosis related group program data from the French National Health Insurance Information System (SNDS) Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-10-26 Hélène Goulard, Julie Homère, Sylvain Maurisset, Gaëlle Coureau, Gautier Defossez, Tania d’Almeida, Bénédicte Lapôtre-Ledoux, Anne-Valérie Guizard, Véronique Bouvier, Simona Bara, Sandrine Plouvier, Alain Monnereau
Three generic claims-based algorithms based on the Illness Classification of Diseases (10th revision- ICD-10) codes, French Long-Term Illness (LTI) data, and the Diagnosis Related Group program (DRG) were developed to identify retirees with cancer using data from the French national health insurance information system (Système national des données de santé or SNDS) which covers the entire French population
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IncidencePrevalence: An R package to calculate population-level incidence rates and prevalence using the OMOP common data model Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-10-25 Berta Raventós, Martí Català, Mike Du, Yuchen Guo, Adam Black, Ger Inberg, Xintong Li, Kim López-Güell, Danielle Newby, Maria de Ridder, Cesar Barboza, Talita Duarte-Salles, Katia Verhamme, Peter Rijnbeek, Daniel Prieto Alhambra, Edward Burn
Real-world data (RWD) offers a valuable resource for generating population-level disease epidemiology metrics. We aimed to develop a well-tested and user-friendly R package to compute incidence rates and prevalence in data mapped to the observational medical outcomes partnership (OMOP) common data model (CDM).
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Addendum to “Prescribing of valproate and oral antiepileptics for women of childbearing age and during pregnancy in Germany between 2010 and 2020” Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-10-25
Scholz K et al. Prescribing of valproate and oral antiepileptics for women of childbearing age and during pregnancy in Germany between 2010 and 2020. Pharmacoepidemiol Drug Saf; July 2023. The cited literature 10 (doi: https://doi.org/10.5281/zenodo.7074588) is now available as publication Abtahi S., et al. Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on utilisation
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Stratified analysis in comparative effectiveness studies that emulate randomized trials Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-10-25 Phyo T. Htoo, Robert J. Glynn, Shirley Wang, Julie M. Paik, Sebastian Schneeweiss, Alexander M. Walker, Elisabetta Patorno
For observational cohort studies that employ matching by propensity scores (PS), preliminary stratification by consequential predictors of outcome better emulates stratified randomization and potentially reduces variance and bias through relaxed dependence on modeling assumptions. We assessed the impact of pre-stratification in two real-life examples. For both, prior evidence from placebo-controlled
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The futility of adverse drug event reporting systems for monitoring known safety issues: A case study of myocardial infarction with rofecoxib and other drugs Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-10-22 François Haguinet, Andrew Bate, Jens-Ulrich Stegmann
Key Points The crucial role of spontaneous reporting systems (SRSs) in identifying safety signals is expected to remain; however, processing of spontaneous reports incurs considerable resources. Pharmacovigilance strategies based on real-world data around the world, like for instance the Sentinel Initiative in the United States (US), are in principle more suitable for the surveillance of known adverse
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When can real-world data generate real-world evidence? Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-10-19 Motiur Rahman, Gerald Dal Pan, Peter Stein, Mark Levenson, Stefanie Kraus, Aloka Chakravarty, Donna R. Rivera, Richard Forshee, John Concato
Key Points The terms real-world data (RWD) and real-world evidence (RWE) are often used inconsistently or interchangeably, including in submissions to the US Food and Drug Administration (FDA) involving RWE to evaluate the effectiveness of drugs and biologic products. Although a misconception sometimes exists that only non-interventional studies utilize RWD to generate RWE, the spectrum of study designs
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How to account for early overly small risk sets in the analysis of pregnancy outcome data?—Comparison of different methods for stabilizing the Aalen-Johansen estimator Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-10-18 Regina Stegherr, Anne-Katrin Fietz, Maria Hoeltzenbein, Katarina Dathe, Jan Beyersmann
In analyzing pregnancy data concerning drug exposure in the first trimester, the risk of spontaneous abortions is of primary interest. For estimating the cumulative incidence function, the Aalen–Johansen estimator is typically used, and competing risks such as induced abortion and livebirth are considered. However, the delayed study entry can lead to overly small risk sets for the first events. This
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Landscape review of global real-world data sources for studying medication use in pregnancy and lactation that support regulatory decision making Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-10-18 Kourtney Davis, Emily Yost, Jacquelyne Brauneis, Alexis Krumme, Anja Geldhof, Astrud Tuck, Shirley Sylvester, Sara Ephross
Most pregnant people take at least one medication during gestation or while breastfeeding, however data are lacking on the safety of medication use in these populations. We conducted a landscape review of real-world data sources specific to medication use in pregnancy and breastfeeding populations that have met, or have potential to meet, health authorities' requirements for post-authorization safety
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Correction to “A data-informed approach using individualised dispensing patterns to estimate medicine exposure periods and dose from pharmaceutical claims data” Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-10-13
Bharat, C, Degenhardt, L, Pearson, S-A, et al. A data-informed approach using individualised dispensing patterns to estimate medicine exposure periods and dose from pharmaceutical claims data. Pharmacoepidemiol Drug Saf. 2023;32(3):352-365. doi:10.1002/pds.5567 In this article by Bharat and colleagues (PDS 2022;353, doi: 10.1002/pds.5567, published 8 Nov 2022), there was an error in the labelling of
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An individual segmented trajectory approach for identifying opioid use patterns using longitudinal dispensing data Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-10-10 Stanley Xu, Komal J. Narwaney, Anh P. Nguyen, Ingrid A. Binswanger, David L. McClure, Jason M. Glanz
The aim of this study is to use electronic opioid dispensing data to develop an individual segmented trajectory approach for identifying opioid use patterns. The resulting opioid use patterns can be used for examining the association between opioid use and drug overdose.
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Correction to “Effect of tramadol and DOACs with special attention to dabigatran on concomitant use, on the risk of mayor bleeding using BIFAP database in Spain” Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-10-10
Burgos-Gonzalez A, Huerta C, Peñalver MJ, Sordo L, Pulido J, Soriano LC. Effect of tramadol and DOACs with special attention to dabigatran on concomitant use, on the risk of mayor bleeding using BIFAP database in Spain. Pharmacoepidemiol Drug Saf. 2023;32(4):397–406. doi: https://doi.org/10.1002/pds.5525 The figures in the published paper are displayed erroneously. The problem is that Figure 1 has
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Trajectories of opioid consumption as predictors of patient-reported outcomes among individuals attending multidisciplinary pain treatment clinics Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-10-06 Adriana Angarita-Fonseca, Anaïs Lacasse, Manon Choinière, Jean-Luc Kaboré, Marie-Pierre Sylvestre, Gillis Delmas Tchouangue Dinkou, Julie Bruneau, Marc O. Martel, Richard Hovey, Aude Motulsky, Elham Rahme, M. Gabrielle Pagé
This study aimed to identify opioid consumption trajectories among persons living with chronic pain (CP) and put them in relation to patient-reported outcomes 6 months after initiating multidisciplinary pain treatment.
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Incomplete capture of apremilast in Clinical Practice Research Datalink Aurum: An example of exposure misclassification of specialty treatments in United Kingdom general practice databases Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-10-02 Rebecca Persson, Susan Jick
Nearly all apremilast users captured in Clinical Practice Research Datalink (CPRD) Aurum have only one prescription, which is inconsistent with its prescribing pattern. The goal of this study was to assess capture of apremilast prescriptions in CPRD Aurum by comparison to CPRD GOLD and general practitioner (GP) questionnaires.
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STUDENT ABSTRACTS of ISPE's 2023 Mid-Year Meeting, Reykjavik, Iceland, 23-25 April 2023. Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-10-01
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Comparison of record linkage software for deduplicating patient identities in California's Prescription Drug Monitoring Program Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-10-01 Susan L. Stewart, Andrew Crawford, Aaron B. Shev, Garen Wintemute, Iraklis Erik Tseregounis, Stephen G. Henry
To help prevent overdose deaths involving prescription drugs, accurate linkage of prescription drug monitoring program (PDMP) records for individual patients is essential.
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Trajectories of P2Y12 inhibitor adherence in patients with acute coronary syndromes Pharmacoepidemiol. Drug Saf. (IF 2.6) Pub Date : 2023-09-29 Jungyeon Moon, Aya F. Ozaki, Alice Chong, Maneesh Sud, Jiming Fang, Peter C. Austin, Dennis T. Ko, Cynthia A. Jackevicius
P2Y12 inhibitors (P2Y12i) reduce cardiac events after acute coronary syndromes (ACS). However, suboptimal P2Y12i adherence persists. We aimed to examine P2Y12i non-adherence using group-based trajectory methods and to identify adherence predictors.