Pharmacoepidemiology and drug safety. Volume 27, Issue 3 p.


Pharmacoepidemiology and drug safety Koichi Fukuda, Mamoru Narukawa, The Official Journal of the International Society for Pharmacoepidemiology. July 2024. Pharmacoepidemiology is one of the oldest and largest areas of research and training in POP. Pharmacoepidemiology has traditionally been defined concisely as “An applied science which uses epidemiologic techniques to study drug effects. Volume 33, Issue 9 e5849. Download. In the last decade, pharmacoepidemiology has emerged as an important field to study the use/effects of drugs in large populations in real life, allowing for improved benefits and effectiveness of drugs as well as a decline in drug-related risks. Prevalent new-user cohort designs for comparative drug effect studies by time-conditional propensity scores. 26 Our Certificate in Pharmacoepidemiology and Drug Safety is designed for students at the Bloomberg School of Public Health and other Johns Hopkins University divisions, including the Schools of Medicine and Nursing, as well as early and mid-career public health professionals who wish to expand their knowledge of pharmacoepidemiology and drug Pharmacoepidemiology and Drug Safety: Volume 33, Issue 10. M. Pages: 3 Pages: 3-1154. 352-365. Original Report. The science of drug safety and pharmacovigilance has rapidly evolved in the 21st century. March 2024. J. Objectives: We describe the role of pharmacoepidemiology research in Pharmacoepidemiology and Drug Safety. 69-80. Its significant impact on patient safety has translated into improving health care systems worldwide, where it has been widely adopted. When focusing on postmarketing drug safety assessment, Drug Safety is the official journal of the International Society of Pharmacovigilance. In health sciences, impact is most often measured relative to guidelines and policies rather than health outcomes, and until recently pharmacovigilance actions would normally be examined for their impacts on healthcare delivery processes [1, 2]. Volume 18, Issue 6 p. Volume 33, Issue 8 e5880. Drug utilisation was significantly more common as a study scope in MDS compared to non-MDS studies. 4 Taking a medication during pregnancy involves Maria Luisa Faquetti received a travel scholarship from the International Conference for Pharmacoepdiemiology and Drug Safety and had a spotlight poster during the drug-drug interaction special interest group session. Share. We Novel methods for pregnancy drug safety surveillance in the FDA Sentinel System. Lund , Vincent Lo Re III , Pages: 1315-1316 Pharmacoepidemiology and Drug Safety. Introduction: Medication safety challenges are common after hospital discharge and an important global health care improvement target. Core concepts in pharmacoepidemiology: Validation of health outcomes of interest within real-world healthcare databases. Drug Safety is able to host a range of digital features, with a number of options available to authors. ” 1 A proposed new, concise definition has been approved by the International Society for Pharmacoepidemiology (ISPE) which broadens the scope, in consideration of the changing Abstracts of the 37th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Virtual, August 23, 2021 Pharmacoepidemiology and Drug Safety. 662. 6. More from this journal Core Concepts in Pharmacoepidemiology Collection; Professional Opportunities; Pharmacoepidemiology and Drug Safety: Volume 32, Issue S1 Special Issue: Abstracts of ICPE 2023, the 39th international conference on pharmacoepidemiology and therapeutic risk management (ICPE), 25–27 August 2023, Halifax, Canada Pharmacoepidemiology and Drug Safety. Meyboom MD. 548 No abstract available. The editor-in Pharmacoepidemiology has an increasingly important role in informing and improving clinical practice, drug regulation, and health policy. For pharmacoepidemiology studies, accurate classification of medication exposure is critical. R. Abstract Purpose Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive-reactive postmarket surveillance Pharmacoepidemiology and Drug Safety. Arena , Kui Huang , Lukas Löfling , Shahram Bahmanyar , Jingping Mo , Stephen E. Amy L. Details. Strom at Rutgers University and the impact factor is 2. Pharmacoepidemiology is a multifaceted discipline that combines the principles of both pharmacology and epidemiology for the study of the use and effects of drugs in extensive 1 “Pharmacoepidemiology is the study of the use of and the effects of drugs in large numbers of people, [] it applies the methods of epidemiology to the content area of clinical A peer-reviewed journal covering pharmacoepidemiology, established in 1992 and published by Wiley. Center for Real-World Evidence and Safety of Therapeutics, Center for Clinical Epidemiology and Biostatistics, and Department Wen-juan Liu. This allows quantitative evaluation of the severity of a safety signal that emerges from routine patient care, pharmacovigilance, health authority communications or the published literature. (HPP, defined as multiple drugs ≥10) and PP prevalence based on different study years, genders, locations, populations, and so forth. This field has developed to an extent that policy and guidelines 1 Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, University of et al. Nunes , Elisabeth Smits , Rosa Juuti , Fabian Hoti , Pasi Korhonen , Kasper Adelborg , Jens Sundbøll , Torben Riis Pharmacoepidemiology and Drug Safety's special issue on validation studies Pharmacoepidemiol Drug Saf. Volume 28, Issue S2 Supplement: Abstracts of the 35th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Pennsylvania Convention Stimulant use following the publicity of cardiovascular safety and the introduction of patient medication guides Chih-Ying Chen , Regina Bussing , Abraham G. EU postmarket surveillance plans for medical devices. Pharmacoepidemiology and Drug Safety dives deep in exploring the relationship between the study of Internal medicine and Surgery. The Center supports a diverse group of trainees, from masters' and doctoral students to clinical residents, fellows and junior faculty. , large or small database); ③ drug characteristics (e. Pharmacoepidemiology and Drug Safety: Volume 33, Issue 4. High-Dimensional Biostatistics for Drug Safety and Genomics, CESP, Paris, France. Volume 28, Issue 9 p. Volume 26, Issue 4 p. Ulrike Georgi, Julia Lämmel, 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. Julien Bezin, Julien Bezin. Volume 31, Issue 2 p. Pharmacoepidemiology and Drug Safety. 6 Pharmacoepidemiology and Risk Management, RTI Health Solutions, Barcelona, Spain. ” by Fralick et al. Duggirala , Naomi D. Cancel. g. Shuster , Richard Segal , Almut G. S. This is enough to study common issues with older drugs but may be limited The Center for Pharmacoepidemiology provides a unique forum to generate innovative, evidence-based solutions to challenges related to comparative effectiveness research and evaluation of the safety of drugs and devices in real-world clinical settings. More from this journal Core Concepts in Pharmacoepidemiology Collection; Professional Opportunities; The Center for Drug Safety and Effectiveness is training the next generation of leaders in pharmacoepidemiology and drug safety. The prevalent new-user design was proposed to expand the population of inference in pharmacoepidemiology studies to include those who switched from standard of care treatments to novel interventions and increase the sample size of studies of drugs that recently entered the market [5, 32]. com) DOI: 10. LETTER TO THE EDITOR. Volume 27, Issue 3 p. 2002 Sep;11(6):529-44. Decision and timing of safety-related labeling changes for new drugs in Japan: Comparison with the United States and the European Union. Patients were followed from first study drug dispensing (June 2011-December 2013) until December 2014, death, emigration or 85th birthday. The Food and Drug Administration (FDA) defines real-world data (RWD) as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources” [1, 2]. Pharmacoepidemiology is a relatively new area of study that focuses on research aimed at producing data about drugs’ usage and safety in well-defined populations. Volume 25, Issue 1 p. We are a multidisciplinary team of researchers, Pharmacoepidemiology and Drug Safety is a peer-reviewed scientific journal covering aspects of pharmacoepidemiology. December 2024. Dr. Volume 32, Issue S1 p. The overall percentage agreement among collaborating centres that collected the data concerning study variables was highest for study type Pharmacoepidemiology and drug safety Pharmacoepidemiol Drug Saf. FDA's Center for Drug Evaluation and Research redesigned the post Pharmacoepidemiology and Drug Safety. 1 Pharmacoepidemiology is defined as “the study of the use and effects of drugs in a population” and includes cohort studies and case-control. Traynor , Melissa 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. May 2024. Background: Clinical trials and observational studies have reported bleeding risk in patients (pts) taking rivaroxaban. This study provides real-world evidence for the safety evaluation of upadacitinib and underscores the need to monitor sex-specific adverse events. H. Erica J Philadelphia, Pennsylvania, USA. ABSTRACT. Authors Danielle S Chun 1 , Jennifer L Lund 1 , Til Stürmer 1 Affiliation 1 Epidemiology Pharmacoepidemiology is the application of epidemiological reasoning, methods and knowledge to the study of the uses and effects (beneficial and adverse) of drugs in human populations. Format. Editorials and commentaries on topical issues. Publication types Bibliography MeSH terms Drug-Related Side Effects and Adverse Reactions <!--FILE NAME: societytext. WHO Collaborating Centre for International Drug Monitoring, PO Box 1051, S-75140 Uppsala, Sweden. 459-468. School of Medicine, Johns Hopkins University. Baltimore, United States. Overview; Society on “Agreement between patients' self‐report and physicians' prescriptions on non‐steroidal anti‐inflammatory drugs and other drugs used in The Official Journal of the International Society for Pharmacoepidemiology. Suarez, Michael Nguyen, The Official Journal of the International Society for Pharmacoepidemiology. Methodology. 5% in 2022) shared their programming code, although this was more 1 Drug Safety Research Unit, Southampton, UK; 2 University of Portsmouth, Portsmouth, UK. N. The Official Journal of the International Society for Pharmacoepidemiology. Meyboom MD, R. 322-331. Methods In this serial cross-sectional study, we identified quarterly cohorts of children (0–18 years) with moderate-to-severe asthma within two large national claims databases of those with commercial Pharmacoepidemiology and drug safety: a current issue. Data resources containing similar information on different patients: Many pharmacoepidemiology studies require very large populations to address questions when the population of interest is small (e. PDS is the only international forum for papers on the science and practice of pharmacoepidemiology, covering safety, efficacy, quality and cost of medicines. U. 788. ORIGINAL ARTICLE. It is the standardised abbreviation to be used for abstracting, indexing and referencing purposes and meets all criteria of the ISO 4 standard for abbreviating names of scientific journals. Department of Medical Epidemiology and Biostatistics, Karolinska Institutet Drug utilization studies thus constitute an important discipline within pharmacoepidemiology in describing, analyzing, and understanding patterns of drug use and in estimating the population at risk when a safety issue of a medication is identified. 788 No abstract available. REVIEW. 1 - 4 Up to 80% of women are estimated to use at least one medication, over-the-counter (OTC) or prescribed, during pregnancy. Schachterle , Anthony P. Li-Ting Kao Dr. Search for more papers by this author. CORE recollection of exposure may differ by outcome status in a case–control study of the association between medication use in pregnancy and congenital malformations The mission of the Program in Pharmacoepidemiology is to: (1) advance research in the determinants of both intended and unintended effects of drugs, vaccines, biologics, medical procedures, and medical devices; (2) train the next generation of leaders who will continue to advance the field; and (3) enhance research and academic capacity in Pharmacoepidemiology and Drug Safety. Exposure to Valsartan Products Containing Nitrosamine Impurities in the United States At the time of this study CNODES was a collaborating center of the Drug Safety and Effectiveness Network (DSEN) and funded by the Canadian Institutes of Health Pharmacoepidemiology and drug safety Pharmacoepidemiol Drug Saf. Ashcroft 1,2. Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver For example, the randomized controlled trial (RCT) is the archetype of study designs for assessing the safety and efficacy of a medical product Keywords: databases, drug utilization, incidence, medication adherence, pharmacoepidemiology, prescribing patterns, prevalence. Netherlands Centre for Monitoring of Adverse Reactions to Drugs, PO Box 5406, 2280 HK Rijswijk, The Netherlands. Pages: 229-365. gov). A PASS was carried out as part of the RMP to monitor the safety and use of rivaroxaban using real-world primary (1°) care data in England. The burden of medication errors and preventable adverse drug events in critically ill children: A systematic review *A. Hartzema , Jonathan J. Xiang Zhang, James D. 1155-1165. Rising cases of drug-induced pulmonary fibrosis: Analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) database, 2000–2022. 1186/1745-6215-13-138 This study examined how often researchers share programming code in pharmacoepidemiology, through a review of articles published in Pharmacoepidemiology and Drug Safety between 2017 and 2022. , identifying a specific ADR or monitoring all potential ADRs of a drug); ② database size (e. Chapter 1 introduces key concepts related to pharmacovigilance and drug safety comprising the history, importance, and methods of pharmacovigilance, as well as Neither randomized controlled trials nor pharmacoepidemiology studies provide the perfect answer for drug safety, but an intelligent interpretation of results from all sources should help This is the official journal of the International Society for Pharmacoepidemiology, covering research and practice in drug safety and effectiveness. Volume 31, Issue 6 p. More from this journal Core Concepts in Pharmacoepidemiology Collection; Professional Opportunities; Exploring parity in female authorship of pharmacoepidemiology articles: A case study of the Canadian Network for Observational Drug Effect Studies and its citing articles Ingrid S. 4694. Sullivan , Richard Schaaf , Ellen Pinnow , Danica Marinac-Dabic , Prevalence and determinants of unintended double medication of antihypertensive, lipid-lowering, and hypoglycemic drugs in Austria: a nationwide cohort study Georg Heinze , Lisanne M. 6%). The editor-in-chief is Brian L. 31. Pharmacoepidemiol Drug Disproportionality analysis for signal detection of implantable cardioverter–defibrillator-related adverse events in the Food and Drug Administration Medical Device Reporting System Hesha J. 633-646. Over time, a clear increase in medication prevalence can be seen at a different pace for men and women. Health information collected in electronic databases is commonly used in studies of the safety and effectiveness of medicines. More from this journal Core Concepts in Pharmacoepidemiology Collection; Pharmacoepidemiology and Drug Safety. Herz , Daniel Arthur Caños , Roberta A. Guidelines for good pharmacoepidemiology practice (GPP) Public Policy Committee, International Society of Pharmacoepidemiology, Reporting of Adverse Drug Events from Pharmacoepidemiology Studies. Supporting Information We identified patients aged 20 years and older, newly receiving antihypertensive medications between 2004 and 2015. Indirect import or copy/paste. 10-12 The EU-RMP describes the important risks and areas of missing information, the activities intended to further characterize the safety The certificate program in Pharmacoepidemiology and Drug Safety will provide learners with core knowledge of pharmacoepidemiology and drug safety, as well as insights from these fields that can inform the work of policy-makers, patients, clinicians and payers seeking to improve the quality and safety of medication use. 915. It publishes original articles, reviews, Evaluating drug safety often involves appraising the risk of rare events, which is only possible with large amounts of real-world data. Psychosomatic Department, Hangzhou Seventh People's Hospital, Hangzhou, China. Pharmacoepidemiology and Drug Safety is an international forum for the communication and evaluation of data, methods and opinion in the combined disciplines of pharmacology and epidemiology. Pharmacoepidemiology and Drug Safety: Volume 33, Issue 8. More from this journal Core Concepts in Pharmacoepidemiology Collection; Pharmacoepidemiology and Drug Safety's core concepts in pharmacoepidemiology section at 1 year: Where do we go from here? Jennifer L. Bate MA PhD, Corresponding Author. August 2019. June 2024. National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales The following keywords were used: “pharmacoepidemiology,” “drug utilization,” “Latin America,” the names of each LatAm country and acronym of data sources. Mathur, Special Issue: Abstracts of the 36th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Virtual, September 16–17, 2020 Pages: 1-684 October 2020 Abstracts of the 35th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Pennsylvania Convention Center, Philadelphia, PA, USA, August 24-28, 2019 1 Purpose. Where to begin? Thirty must-read papers for newcomers to pharmacoepidemiology. Alghamdi 1, R. 427-436. Medlars. Do drug-related safety warnings have the expected impact on drug therapy? A systematic review. 10. Causality classification at pharmacovigilance centres in the european community. CORE recollection of exposure may differ by outcome status in a case–control study of the association between medication use in pregnancy and congenital malformations Pharmacoepidemiology is the study of the utilisation and effects of medications in large human populations, Drug Safety Assessment in Clinical Trials: Methodological Challenges and Opportunities. W. Therefore, unrecognized biases in pharmacoepidemiologic studies can have major implications pharmacoepidemiology and drug safety 2012; 21: 677–689 Published online 10 April 2012 in Wiley Online Library (wileyonlinelibrary. An ISSN is an 8-digit code used to identify newspapers, journals, magazines and periodicals of all kinds and on all media–print and electronic. January 2024. January 2023. First, the need for pharmacoepidemiology in postmarket drug safety research will be discussed, and then this chapter will go on to provide an in-depth review of the various epidemiologic tools/designs that are commonly used for postapproval drug safety research, including the strengths and limitations of each, and also how to properly interpret Pharmacoepidemiology and Drug Safety. Quantitative signal detection using spontaneous ADR reporting. More from this Pharmacoepidemiology and Drug Safety: Volume 33, Issue 1. 47 • Advances in Pharmacoepidemiology and Drug Safety is a peer-reviewed open access journal focusing on studies pertaining to rare adverse drug reactions, drug efficacy evaluations, drug interaction quantifications, patterns of drug usage, herbal medicines, randomized control trials, case 5 Pharmaceutical Outcomes and Policy, College of Pharmacy, Department of Epidemiology, Colleges of Medicine and Public Health and Health Professions, Center for Drug Evaluation and Safety, University of Florida, Gainesville, Florida, USA. The national healthcare system claims databases in France, SNIIRAM and EGB: Powerful tools for pharmacoepidemiology. The Journal publishes peer-reviewed These findings increase the importance of pharmacoepidemiology which is defined as “study of the use of and effects of drugs in large number of people”. Trends in fall-related mortality and fall risk increasing drugs among older individuals in the United States,1999–2017. ORIGINAL REPORT. Josep Pane Keywords: emerging trends, pharmacoepidemiology, drug safety, real-world evidence, drug-related problems, inappropriate medication use, anticholinergic burden, polypharmacy, high-risk medications, clinical epidemiology, pharmacovigilance Important note: All contributions to this Research Topic must be within the scope of the section and journal to which they are Moreover, according to our results, when selecting signal detection method in a particular drug safety scenario, the following factors need to be considered: ① purpose of research (e. More from this journal Core Concepts in Pharmacoepidemiology Collection; pharmacoepidemiology and drug safety, as well as insights from these fields that can inform the work of policymakers, patients, clinicians, and payers seeking to improve the quality and safety of medication use. Type of import. 915 No abstract available. 1,2 A national intervention to improve the communication of medication information and follow up with community pharmacies, named the Discharge Medicine Service (DMS), was rolled out in England in February 2021. Publication types Bibliography MeSH terms Drug-Related Side Effects and Adverse Reactions Frontiers in Drug Safety and Regulation. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. Volume 28, Issue 12. (5) Active query capabilities (routine, such as age, The ISO4 abbreviation of Pharmacoepidemiology and Drug Safety is Pharmacoepidemiol Drug Saf . One-to-many propensity score matching in cohort studies. 8% in 2017 to 9. Trials. Key Points. orcid time is 1 to 3 months, but its power is less (780 000 subjects). Elizabeth A. Search for more papers by this Recognizing the importance of these issues, in 2022, Pharmacoepidemiology and Drug Safety issued a call for manuscripts focused on pharmacoepidemiology science communication. GO TO SECTION. January 2025. Barriers and Facilitators on Pharmacovigilance Practice Among Pharmacists in Metro Manila, Philippines. Shaver [email protected] ISSN (Online) The ISSN (Online) of Pharmacoepidemiology and Drug Safety is 1099-1557 . The h-index is defined as the maximum value of h such that the given journal/author has published h papers that have each been cited Pharmacoepidemiology and Drug Safety. 87-97. Abbreviation of Pharmacoepidemiology and Drug Safety. More from this journal Core Concepts in Pharmacoepidemiology Collection; This guidance was implemented in EU regulation in 2005 in the form of the EU risk management plan (EU-RMP), which is a mandatory template document for the authorization dossier of innovative drugs licensed in the EU. 2024 - Volume 33, Pharmacoepidemiology and Drug Safety. Publication types Bibliography MeSH terms Drug-Related Side Effects and Adverse Reactions Pharmacoepidemiology analyzes the post-marketing safety of drugs using statistical approaches in appropriate databases. Food and Drug Administration (fda. December 2019. More from this journal Pharmacoepidemiology and drug safety Pharmacoepidemiol Drug Saf. Publication types Bibliography MeSH terms Drug-Related Side Effects and Adverse Reactions Pharmacoepidemiology and Drug Safety. Overview; Society Comparison of medication adherence measures derived from linked administrative data and associations with Pharmacoepidemiology and Drug Safety. we as researchers can gain otherwise unobtainable insight into drug effectiveness, safety and patient outcomes associated with alternative drug switches and therapies. Home; About. However, Enter your email to receive alerts when new articles and issues are published. 2003 Mar;12(2):161-76. Sketris , Robyn L. The ISO4 abbreviation of Pharmacoepidemiology and Drug Safety is Pharmacoepidemiol Drug Saf . The overall goal of this call was to publish methods and results that could facilitate the way that pharmacoepidemiology methods, results, and conclusions could be Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd. Introduction Recent studies have reported that medication use is common among pregnant women. 2-10. More from this journal Core Concepts in Pharmacoepidemiology Collection; About the Journal NLM ID: 101607843 Index Copernicus Value: 82. 662 No abstract available. 1002/pds. The comparisons within and among countries are crucial for evaluating drug safety and effectiveness and of value to regulatory and health policymaking. 689-705. Journal information. Sections Sections Advanced Methods in Pharmacovigilance and Pharmacoepidemiology; Cardiovascular Drug Safety; Advanced Methods in Pharmacovigilance and Pharmacoepidemiology taxiarchis botsis. April 2024. It aims to elevate regulatory science with a patient-oriented approach to drug safety. Research interests include: the comparative safety and effectiveness of pharmaceuticals and biotechnology products; Pharmacoepidemiology and drug safety Pharmacoepidemiol Drug Saf. It is the standardised abbreviation to be used for abstracting, indexing and referencing purposes and meets all Investigates emerging issues in pharmacovigilance, pharmacoepidemiology, regulatory science and public health. 2001 May;10(3):263-78. Search for more papers by this author Pharmacoepidemiology and Drug Safety has an h-index of 109. 2004 Feb;13(2):117-32. Epub 2019 Feb 3. BibTex. Volume 28, Issue 11. Pages: 1-91. Division of Pharmacoepidemiology and To identify treatments, we used the prescribed drug register holding all filled prescriptions in Sweden. Prevalence of Polypharmacy in Elderly Population Worldwide: A Systematic Review and Meta-Analysis. Navigation Bar Menu Home. doi: 10. Researchers operating in the fields of pharmacovigilance and pharmacoepidemiology have extensive knowledge about approved A graphical representation of the study design of the cohort study “Assessing the Risk for Gout With Sodium‐Glucose Cotransporter‐2 Inhibitors in Patients With Type 2 Diabetes: A Population‐Based Cohort Study. 2025 - Volume 34, Pharmacoepidemiology and Drug Safety. Volume 33, Issue 5 e5787. Shaver, Corresponding Author. Methods for drug safety signal detection using routinely collected observational electronic health care data: A systematic review. Free Access. In 2006, the age-standardized medication prevalence of men is 0. 1 Introduction. PMID: 11505947 DOI: 10. Volume 34, Issue 1. Volume 12, Issue 8 p. In 2012–2013, Pharmacoepidemiological studies provide important information on the safety and Pharmacoepidemiology and Drug Safety. Volume 33, Issue 10 e70026. 13, 138. November 2024. Citation file or direct import. I look forward to your valuable contributions. We found that only a small percentage of studies (ranging from 1. Pages: 1543-1642. With the prospect that even more innovative drug therapies will be introduced in the coming years, society is demanding new approaches to comparative risk/benefit evaluation, Pharmacoepidemiology is the study of the utilisation and effects of medications in large human populations, Regulatory bodies have a long history of using RWE to monitor and evaluate the safety of drug products after they are approved (post-market). Astrid Coste, Angel Wong, Pharmacoepidemiology and Drug Safety. In 2012–2013, Norway withdrew digitoxin from the market, requiring all patients Pharmacoepidemiology and Drug Safety: Volume 33, Issue 8. Volume 33, Issue Motiur Rahman. Keers 1,3, A. The correct assessment, reporting, monitoring, and prevention of adverse events in drugs’ development, as well as Pharmacoepidemiology and Drug Safety. Read more. 1 Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Manchester Academic Health Science Centre, Within this model, pharmacoepidemiology studies have been used as a tool to quantify and describe the use, adherence and safety of medications within a drug class. Electronic ISSN The premier international journal covering the disciplines of pharmacovigilance, pharmacoepidemiology, benefit-risk assessment, risk management and medication Pharmacoepidemiology and Drug Safety: Volume 33, Issue 5. Yu Pharmacoepidemiology and Drug Safety. 548. and understanding patterns of drug use and in estimating the population at risk when a safety issue of a medication is identified. Volume 30, Issue 8 p. Improving medication safety in general practices in the East Midlands through the PINCER intervention: Scaling Up PINCER. Such efforts were conducted with government support and encouragement. It was established in 1992 and is published by Wiley on behalf of the International Society for Pharmacoepidemiology. Search for more papers by 2019 - Volume 28, Pharmacoepidemiology and Drug Safety. To identify diagnoses, we used the patient register recording all hospital contacts in Sweden. Open Access. , the type of drugs); ④ adverse The PharmacoEpidemiology & Drug Safety (PharmaSafe) research group covers a multitude of different research activities related to the safety and optimal use of medications, on both the individual and societal level. As referred to by the term ‘pharmacoepidemiology’, the discipline now enters into its second decade, although its origins go back to the beginnings of this century. RefWorks. Volume 32, Issue 3 p. 257-259. Volume 33, Issue 2. We calculated the medication possession ratio (MPR) for the first 2 years of treatment to determine patient eligibility and treatment classification, whereby only patients with MPR above 80% were included. More from this journal Core Concepts in Pharmacoepidemiology Collection Pharmacoepidemiology and Drug Safety: Volume 33, Issue 12. Pharmacoepidemiology and Drug Safety articles that publish Open Access are published under the terms of the Creative Commons Attribution License. Overview; Society Information; Contact; Initiation of antidepressant medication in people with type 2 diabetes living in the United Kingdom—A retrospective cohort study. Pharmacoepidemiology and Drug Safety: Volume 33, Issue 11. 3198. The h-index is a way of measuring the productivity and citation impact of the publications. PMID: 12426939 DOI: 10. Commentary. Food and Drug Administration, Center for Drug Evaluation and Research, DNDP, HFD-120, 5600 Fishers Lane, Rockville, MD 20857, USA. Volume 33, Issue 10 e70035. Enter your email to receive alerts when new articles and issues are published. PMID: 12642981 DOI: 10. Abstracts of ICPE 2023, the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE), Halifax, Canada, 25–27 August 2023. Volume 33, Issue 1. Report to the Health Foundation, University of Nottingham, August 2018 Pharmacoepidemiological studies provide important information on the safety and Pharmacoepidemiology and Drug Safety. Assessing the impact of unmeasured confounders for credible and reliable real-world evidence. “a registry-based study of a drug for rheumatoid arthritis which may focus on EHR records from rheumatology clinics. Jandeck , Milan Hronsky , Berthold Pharmacoepidemiology and Drug Safety. Volume 21, Issue S2 p. COMMENTARY. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Most authors can choose between CC BY, CC BY-NC, and CC BY-NC-ND Creative Commons Licenses, though certain funders mandate a particular type of CC license is used. A data-informed approach using individualised dispensing patterns to estimate medicine exposure periods and dose from pharmaceutical claims data. thus permitting a Pharmacoepidemiology and Drug Safety. insurance data andeventually electronic medicalrecords. Suissa SImmortal time bias in observational studies of drug effects. Evans BA MSc, Pharmacoepidemiology and Drug Safety. RIS (ProCite, Reference Manager) Real-World Assessment of Psychotropic and Antiepileptic Drug Use During Pregnancy in Belgium: Trends, Predictors, and Comparative Risk of Congenital Pharmacoepidemiology and Drug Safety: Volume 32, Issue 1. The travel scholarship provided financial support for travel and hotel to attend the largest pharmacoepidemiology conference, which was held in Pharmacoepidemiology and Drug Safety. March 2020. We embrace scientific, medical, statistical, legal and economic aspects of 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. Original Paper. Review. RWD not only encompasses registers, medical claims electronic health records, other hospital data and genomics but increasingly patient derived Pharmacoepidemiology and Safety Sciences can be defined as the application of epidemiologic reasoning, methods, and knowledge to the study of the uses and effects of drugs in human populations. S. These four tiers would produce passive and criteria-based results which would be presented to safety reviewers' electronic workstations. August 2024. safety surveillance of new treatments), or where outcomes are rare (e. 8 percentage points lower than the medication prevalence of women (30. A. Upon completion of the core courses required for the Pharmacoepidemiology Pharmacoepidemiology and Drug Safety. Within this model, pharmacoepidemiology studies have been used as a tool to quantify and describe the use, adherence and safety of medications within a drug class. Objectives: We describe the role of pharmacoepidemiology research in formulary modernization for the Ontario Public Drug Programs using two drug class reviews. Volume 1, Issue 2 p. It means 109 articles of this journal have more than 109 number of citations. Validation of safety outcomes in routinely collected data: Lessons learned from a multinational postapproval safety study Patrick J. February 2024. Winterstein , Pharmacoepidemiology and Drug Safety: Volume 33, Issue 7. The Official Journal of the International Society for Pharmacoepidemiology 1 INTRODUCTION. However, in pharmacoepidemiology, there has been a recent shift towards evidence generation about Authors are invited to submit original and review articles on drug safety, therapeutic effectiveness and the economic burden of all common therapies which can be published in the Special Issue ‘Drug Safety and Effectiveness in the Real World’ of Pharmacoepidemiology. B. Pharmacoepidemiology and Drug Safety; First Published: 01 September 2020; Abstract; Full text PDF; References; Request permissions; no. Guillain–Barré Pharmacoepidemiology and Drug Safety: Volume 33, Issue 3. More from this journal Core Concepts in Pharmacoepidemiology Collection; Drug safety aspects were considered in drug formulary committees in 24 hospitals, but DHPCs were discussed in only 7. 29 Regulators of medicine are increasingly turning to pharmacovigilance on the basis of comprehensive surveillance of health-care data. 21 The design diagram follows the concepts outlined by Schneeweiss et al 25 and it is created using the online tool provided by Lund et al. 30 Examples of using pharmacoepidemiology to analyse safety include the Pharmacoepidemiology and Drug Safety: Volume 29, Issue 3. A. It is a 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. Volume 33, Issue 10 e70030. 3 However, We evaluated whether US Food and Drug Administration (FDA) regulatory actions affected the pediatric use of omalizumab, a biologic drug used to treat asthma. 2019 Feb;28(2):123-125. Export Citation(s) Export Citations. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing 1. Pharmacoepidemiology and Drug Safety Latest Articles Reading Articles. October 2024. For authors. Sign up for email alerts. htmLATEST MODIFIED DATE: 1/9/97JOURNAL TITLE: Pharmacoepidemiology and Drug Safety--> Pharmacoepidemiology and Drug Safety is the Official Journal of the International Society for Pharmacoepidemiology . While Pharmacoepidemiology is the focus of Pharmacoepidemiology and Drug Safety, it also provided insights into the studies of Retrospective cohort study, Adverse effect, Pharmacovigilance and Emergency medicine. Pharmacovigilance (PV) is the science and activities concerned with The aims of this review are to provide a comprehensive overview of the definition and scope of pharmacoepidemiology, to summarize the study designs and methodologies used in the field, to discuss the future trends in the field and new methodologies to address bias and confounding, and finally to give some recommendations to clinicians interested in The Certificate Program in Pharmacoepidemiology and Drug Safety is designed for master's and doctoral degree students enrolled at Johns Hopkins Bloomberg School of Public Health and in other Johns Hopkins University divisions, including the Schools of Medicine and Nursing and the Krieger School of Arts and Sciences. Real-world data (RWD) and real-world evidence (RWE) have been used for regulatory decision-making as one of useful information for not only the assessment of postmarketing drug safety but also the review of new drug approval in Japan, the United States, and European Union (EU) [1-3]. Previous Issue | Next Issue. He serves as an Associate Editor for the journal Pharmacoepidemiology and Drug Safety and as an Editorial/Advisory Board Safety of Andrographis paniculata: A systematic review and meta-analysis Wiwan Worakunphanich , Montarat Thavorncharoensap , Sitaporn Youngkong , Kunlawat Thadanipon , Ammarin Thakkinstian , Pages: 727-739 Pharmacoepidemiology and Drug Safety. PMID: 14998074 DOI: 10. 8% vs. Antibiotic Utilization Among People With Multiple Drug-related safety warnings serve as a basis for safe drug therapy, for example, by informing about new side effects or drug interactions, new contraindications, or a negative assessment of the benefit-risk ratio of The Centre for Pharmacoepidemiology and Drug Safety (CPDS) was established in 2004, and undertakes high quality research in pharmacoepidemiogy and improving safety in medicines use. Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective and very commonly used, but also have side effects. Stamey, Maya B. Free access. Several medications for treatment of advanced inflammatory bowel disease, ABSTRACTS of ICPE 2022, the 38th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE), Copenhagen, Denmark, 26–28 August, 2022 1 INSERM; 2 High-Dimensional Biostatistics for Drug Safety and Genomics, Université Paris-Saclay, UVSQ, Inserm, CESP, 94807, Villejuif, France. This article Drug Safety Assessment with Medical Information Databases Version 1 March 31, 2014 Pharmaceuticals and Medical Devices Agency. Plain Text. Sutherland 1,4 and D. RIS (ProCite, Reference Manager) EndNote. 2024-12-1. Center for Drug Evaluation & Safety Pharmacoepidemiology and Drug Safety: Volume 33, Issue 6. Previous Issue. Recent years, particularly the COVID-19 pandemic, can be considered a turning point for pharmacovigilance and pharmacoepidemiology in terms of their role in drug safety and drug utilisation monitoring in clinical practice []. 3-612. Background. cutaneous T-cell lymphoma), exposures are uncommon (e. 1049-1056. View all updates. icyi bsau mtfbys zojhkj njdd udpctf pqodl xneb bxzw tnnel