Pharmacoepidemiology and Drug Safety

Article	Citations
Issue Information	72
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Exposure to Valsartan Products Containing Nitrosamine Impurities in the United States, Canada, and Denmark	40
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”	37
Data Resource Profile: The Danish National Hospital Medicine Register	32
Management of epilepsy in Lebanon: Medication reviews and drug‐related problems	31
Antibiotics and Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Syndrome: Analysis of Brazilian Pharmacovigilance Registries	30
Mixed Impact of Direct Healthcare Professional Communications When Considering Proximal Outcomes and the Targeted Population: A Systematic Review	28
Validation of Chronic Inflammatory Demyelinating Polyradiculoneuropathy Coding in US Claims Data	27
Validation of diagnosis codes for chorioamnionitis in medical encounter data, 2013–2018	27
External validity in distributed data networks	26
Hepatitis B vaccine and risk of acute myocardial infarction among individuals with diabetes mellitus	26
Optimizing therapeutic decision‐making for off‐label medicines use: A scoping review and consensus recommendations for improving practice and research+	24
Comparison of drug prescribing before and during the COVID‐19 pandemic: A cross‐national European study	23
Quantitative Benefit–Risk Assessment of Vaccination Against COVID‐19: A Systematic Review	23
Letter to the Editor	23
International trends in prescription opioid sales among developed and developing economies, and the impact of the COVID‐19 pandemic: A cross‐sectional analysis of 66 countries	22
Issue Information	22
Predicting obesity and smoking using medication data: A machine‐learning approach	22
Uncommon side effects of common drugs in patients with familial dysautonomia	19
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Trends in the Dispensing of Oral Anti‐Cancer Medications Across Australia Over 10 Years	18
Use of gastrointestinal prokinetics and the risk of parkinsonism: A population‐based case‐crossover study	18
Performance characteristics of code‐based algorithms to identify urinary tract infections in large United States administrative claims databases	18

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Prenatal and Early‐Life Anti‐Infectives and Obesity at Age 7 Years	17
Comment on: Exploring the impact of design criteria for reference sets on performance evaluation of signal detection algorithms: The case of drug–drug interactions	17
Valproate utilisation trends among women of childbearing potential in Ireland between 2014 and 2019: A drug utilisation study using interrupted time series	17
Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe	16
Validity of ICD‐10‐based algorithms to identify patients with influenza in inpatient and outpatient settings	16
Pharmacological and epidemiological considerations while constructing treatment episodes using observational data: A simulation study	15
A comparison of confounder selection and adjustment methods for estimating causal effects using large healthcare databases	15
Comorbidity influence in observational studies: Why ignore the real world?	15
Comparing survival in trial‐ versus routine‐care advanced urothelial cancer patients on immune checkpoint blockade	15
Advancing Research Transparency and Reproducibility in Pharmacoepidemiology	15
Validation of a Major and Clinically Relevant Nonmajor Bleeding Phenotyping Algorithm on Electronic Health Records	14
Use of Potentially Nephrotoxic Drugs in Type 2 Diabetes Patients on SGLT2i: A Trajectories Analysis	14
Core concepts in pharmacoepidemiology: Violations of the positivity assumption in the causal analysis of observational data: Consequences and statistical approaches	13
Hazard Ratios and Alternative Effect Measures: An Applied Illustration	13
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The European Drug–Drug Interaction (EuroDDI) Study Protocol: A Cross‐Country Comparison of Drug–Drug Interaction Prevalence in the Older Community‐Dwelling Population	13
Validity of claims‐based algorithms to identify neurodevelopmental disorders in children	13
Validation of new medication use algorithms as proxies for worsening disease activity in patients with juvenile idiopathic arthritis	13
An Emulated Target Trial Case Study of Real‐World Overall Survival With Second‐Line Maintenance Niraparib Versus Active Surveillance in Patients With Recurrent Ovarian Cancer	13
Letter to the Editor re Davis et al., 2023: BELpREG, the first of its kind real‐world data source on medication use in pregnancy in Belgium	12
Classification and visualization of longitudinal patterns of medication dose: An application to interferon‐beta‐1a and amitriptyline in patients with multiple sclerosis	12
Federated analyses of multiple data sources in drug safety studies	12
Validation of alopecia coding in US claims data among women of childbearing age	12
The impact of hydrocodone rescheduling on utilization, abuse, misuse, and overdose deaths	12
Probabilistic precision calculations for the planning of studies assessing negative binomial rates	12
Pre‐ and post‐stroke oral antithrombotics and mortality in patients with ischaemic stroke	12
An individual segmented trajectory approach for identifying opioid use patterns using longitudinal dispensing data	12
Impact of Lookback Duration on the Performance of a Claims‐Based Frailty Proxy in Women With Stage I–III Breast Cancer	11
Development and validation of an electronic health records‐based opioid use disorder algorithm by expert clinical adjudication among patients with prescribed opioids	11
Hypertension medication from guidelines to practice: A cohort study in western Iran	11
Impact of Antibiotic Shortages on Antibiotic Utilisation in the Community	11
Effectiveness and use of reverse transcriptase polymerase chain reaction point of care testing in a large‐scale COVID‐19 surveillance system	10
Using pooled electronic health records data to conduct pharmacoepidemiology safety studies: Challenges and lessons learned	10
Post‐Market Evidence for Cancer Medicines in Regulatory and Clinical Decision‐Making: A Scoping Review	10
Characterization of SARS‐CoV‐2 Diagnostic Tests and Liver Function Tests Among Patients With COVID‐19 Diagnosed in Outpatient Settings Using Administrative Healthcare	10
Use of Omalizumab for Pediatric Asthma After US Food and Drug Administration Expanded Indications	10
Drug interactions in hospital prescriptions in Denmark: Prevalence and associations with adverse outcomes	10
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Adherence to prescription proton pump inhibitor therapy amongst individuals diagnosed with Barrett's esophagus	10
Association between pre‐admission anticoagulation and in‐hospital death, venous thromboembolism, and major bleeding among hospitalized COVID‐19 patients in Japan	10
Studying the Impact of European Union Regulatory Interventions for Minimising Risks From Medicines: Lessons Learnt and Recommendations	10
Validation of an algorithm to identify fractures among patients within the Veterans Health Administration	10
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Consistency between the National Patient Register and the Swedish Cancer Register	10
Assessing medical product safety during pregnancy using parameterizable tools in the sentinel distributed database	10
Core concepts in pharmacoepidemiology: Key biases arising in pharmacoepidemiologic studies	9
The risk of miscarriage after COVID‐19 vaccination before and during pregnancy	9

Prevalence of Polypharmacy in Elderly Population Worldwide: A Systematic Review and Meta‐Analysis	9
A drug utilization study of thiocolchicoside‐containing medicinal products for systemic use in France and Italy: A cross‐sectional electronic medical records database study	9
Perinatal pharmacoepidemiology: How often are key methodological elements reported in publications?	9
Valproic Acid‐Induced Congenital Disorders, an Analysis in EudraVigilance and a Literature Review of Valproic Acid Utilization During Pregnancy	9
Issue Information	9
ISPE20 Author Index	9
Risk of clinically relevant hyperglycemia with metoprolol compared to carvedilol in older adults with heart failure and diabetes	9
RE: Gout and sodium‐glucose cotransporter‐2 inhibitors	9
Validation of diagnostic coding for bronchiectasis in an electronic health record system in Hong Kong	9
Issue Information	9
Trends in clomiphene citrate and gonadotropins use in women with infertility between 2010 and 2017: A population‐based study in France	9
Utilization of drugs with reports on potential efficacy or harm on COVID‐19 before, during, and after the first pandemic wave	9
Dipeptidyl Peptidase‐4 Inhibitors and Risk of Heart Failure in Patients With Type 2 Diabetes Mellitus and End‐Stage Renal Disease Requiring Dialysis	9
Percutaneous left atrial appendage occlusion and risk of stroke, hospitalized bleeding and death in Medicare beneficiaries	8
Descriptive analysis on disproportionate medication errors and associated patient characteristics in the Food and Drug Administration's Adverse Event Reporting System	8
Detecting and Dating Early Non‐live Pregnancy Outcomes: Generation of a Novel Pregnancy Algorithm From Norwegian Linked Health Registries	8
Core concepts in pharmacoepidemiology: Measures of drug utilization based on individual‐level drug dispensing data	8
Adverse drug reaction signal detection methods in spontaneous reporting system: A systematic review	8
Sex‐specific incidence of hepatitis B virus flares among Bcr‐Abl tyrosine kinase inhibitor users in Taiwan	8
Validation Assessment of Privacy‐Preserving Synthetic Electronic Health Record Data: Comparison of Original Versus Synthetic Data on Real‐World COVID‐19 Vaccine Effectiveness	8
Background rates of five thrombosis with thrombocytopenia syndromes of special interest for COVID‐19 vaccine safety surveillance: Incidence between 2017 and 2019 and patient profiles from 3	8
Use of antidepressants and risk of repeat self‐harm in older adults 75+ with nonfatal self‐harm: A 1‐year prospective national study	7
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Signal detection of COVID‐19 vaccines adverse events using spontaneous reports from South Korea	7
A framework for the use of biological medicines in the free state province, South Africa	7
A meta‐analysis assessing the prevalence of drug–drug interactions among hospitalized patients	7
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Development and Validation of Claims‐Based Algorithms for Conjunctivitis and Keratitis	7
A methodology to assess the population size and estimate the needed resources for new licensed medications by combining clinical and administrative databases: The example of glycated haemoglobin in ty	7
ABSTRACTS of the 2024 ISPE Annual Meeting, Berlin, Germany, 24–28 August 2024	7
Issue Information	7
Core Concepts in Pharmacoepidemiology: Principled Use of Artificial Intelligence and Machine Learning in Pharmacoepidemiology and Healthcare Research	7
Rescheduling gabapentinoids had negligible effects on prescribing behaviour by general practitioners in England	7
Prescribing of valproate and oral antiepileptics for women of childbearing age and during pregnancy in Germany between 2010 and 2020	7
Corrigendum	7
The Effect of Isoniazid for Tuberculosis Prevention on Pregnancy Risk Among Women Living With HIV on Antiretroviral Treatment and Progestin‐Based Hormonal Contraception	6
Using administrative healthcare database records to study trends in prescribed medication dispensed during pregnancy in Belgium from 2003 to 2017	6
Comparison of record linkage software for deduplicating patient identities in California's Prescription Drug Monitoring Program	6
The Effects of Removing the Requirement for Prior Reimbursement Approval on Anticoagulant Use in Ireland: A Cross‐Sectional Study	6
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Use of Causal Framework to Evaluate Effect of Abuse Deterrent Properties of Extended‐Release Oxycodone on Tampering in a Real‐World Settings	6
To wait or not to wait: Weighing the pros and cons of early identification of safety concerns for medications used in pregnancy	6
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Opioid Use After Hip Fracture and Subsequent Fracture Outcomes: A Self‐Controlled Case Series Design	6
Core Concepts: Self‐Controlled Designs in Pharmacoepidemiology	6
Opioid tapering and mental health crisis in older adults	6
Patterns of filled prescriptions and the association with risk of drug‐induced death. A population‐based nested case‐control register study	6
SUPPLEMENTARY ABSTRACTS of ICPE 2021, the 37th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE), 23–25 August, 2021 (virtual)	6
INSIGHT: A Tool for Fit‐for‐Purpose Evaluation and Quality Assessment of Standardized Observational Data Sources for Real World Evidence on Medicine and Vaccine Safety	6
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Severe Cutaneous Adverse Reactions in Hospitalized Children: A Pilot Validation Study	6
Response to letter to the editor regarding “Development and validation of a predictive model algorithm to identify anaphylaxis in adults with type 2 diabetes in U.S. administrative claims d	6
Evaluation of Medication Adherence Among Prevalent Users in Hypertension, Dyslipidemia, and Diabetes Using Health Insurance Claims: A Population‐Based Cohort Study in Japan	6
Accuracy of identifying diagnosis of moderate to severe chronic kidney disease in administrative claims data	6
Accuracy and validity of reported opioid prescription days' supply	6
A review of the sampling methodology used in studies evaluating the effectiveness of risk minimisation measures in Europe	6
Correction to “A data‐informed approach using individualised dispensing patterns to estimate medicine exposure periods and dose from pharmaceutical claims data”	6
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Moxifloxacin monotherapy for treatment of uncomplicated pelvic inflammatory disease: A systematic review and meta‐analysis with trial sequential analysis of randomized controlled trials	5
Association of Benzodiazepine Prescription With Short‐Term Prognosis in Elderly Patients Attended in Emergency Department: Results From the EDEN PROJECT	5
Sampling in the case‐time‐control design among drug users when outcome prevents further treatment	5
The Awareness of and Adherence to the Pregnancy Prevention Program for Oral Retinoids: A Questionnaire Survey in Denmark	5
Core Concepts in Pharmacoepidemiology: Quantitative Bias Analysis	5
Biases associated with epidermal necrolysis reporting in pharmacovigilance: An exploratory analysis using World Health Organization VigiBase	5
Mobile apps for quick adverse drug reaction report: A scoping review	5
ABSTRACTS of the virtual 2nd Annual African Regional Interest Group Meeting (AfRIG), 11–13 July, 2022	5
ISPE MidYear 2021	5
Tell me what you want, what you really really want: Estimands in observational pharmacoepidemiologic comparative effectiveness and safety studies	5
Use patterns of systemic immunomodulators in the United States before and after dupilumab approval in adults with atopic dermatitis	5
The use of uncertain exposure—A method to define switching and add‐on in pharmacoepidemiology	5
Real world prescription of beta‐blockers in patients with asthma	5
Joint longitudinal trajectories of pain intensity and opioid prescription in veterans with back pain	5
Overview of global real‐world data sources for pediatric pharmacoepidemiologic research	5
Validation studies of Japanese administrative health care data: A scoping review	5
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Examining the potential direct cardiovascular benefit of tumor‐necrosis factor inhibitor in rheumatoid arthritis: Natural and controlled direct effect analyses	5

Association of Pharmacist Interventions With Adverse Drug Events and Potential Adverse Drug Events	5
Prevalence of self‐medication practices among pregnant women in India: A systematic review and meta‐analysis	5
The impact of more restrictive hydrocodone rescheduling on unintentional pediatric opioid exposures	5
Method used to identify adenomyosis and potentially undiagnosed adenomyosis in a large, U.S. electronic health record database	5
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Myopericarditis following COVID‐19 mRNA vaccination	4
More extreme duplication in FDA Adverse Event Reporting System detected by literature reference normalization and fuzzy string matching	4
Risk of Suicidal Ideation and Behavior Following Early‐Onset Idiopathic Restless Legs Syndrome Treatment	4
Achieving comparability in glycemic control between antidiabetic treatment strategies in pregnancy when using real world data	4
Utilization of opioid versus non‐opioid analgesics in Medicaid and CHIP enrolled children with current asthma	4
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 Informati	4
Clarifying the causal contrast: An empirical example applying the prevalent new user study design	4
Pain‐related hospitalization and emergency room visit following initial analgesic prescription after outpatient surgery	4
Real‐world treatment patterns and outcomes for patients with advanced melanoma treated with immunotherapy or targeted therapy	4
Staging and clean room: Constructs designed to facilitate transparency and reduce bias in comparative analyses of real‐world data	4
Use of sedating medications around nursing home admission in Denmark	4
Antidepressant Use Trajectories and Risk of Discontinuation After Adolescents and Young Adult Cancer Diagnosis	4
Development of a multivariate prediction model to identify individual case safety reports which require clinical review	4
Impact of Regulatory Action on Dose Maximalization for Vitamin B6 Dietary Supplements on the Reporting Pattern for Neuropathy	4
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The Medicines Intelligence Data Platform: A Population‐Based Data Resource From New South Wales, Australia	4
Impact on In‐ and Out‐of‐Hospital Drug Prescriptions of Including a More Expensive Me‐Too Antidepressant in a Hospital Drug Formulary: a Controlled Longitudinal Study	4
Pharmacoepidemiology and Drug Safety's core concepts in pharmacoepidemiology section at 1 year: Where do we go from here?	4
Association between methylphenidate and risk of myocardial infarction: A multinational self‐controlled case series study	4
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Risk of ischemic stroke associated with direct oral anticoagulants discontinuation on patients with non‐valvular atrial fibrillation	4
Gout and sodium‐glucose cotransporter‐2 inhibitors	4
Kidney function and prescribed dose in middle‐aged and older patients starting selective serotonin reuptake inhibitors	4
Potentially inappropriate medication use by level of polypharmacy among US Veterans 49–64 and 65–70 years old	4
A Two‐Step Framework for Validating Causal Effect Estimates	4
Lessons learned from a multi‐data source research collaboration: The mirabegron post‐authorization safety study program	4
Implementation of risk minimization measures to reduce the risk of tuberculosis among tumor necrosis factor medication users	4
Where to begin? Thirty must‐read papers for newcomers to pharmacoepidemiology	4
Prescriber Adherence to Antihypertensive Prescription Guidelines and the Impact of Patient Socioeconomic Factors: A Cross‐Sectional Study Using Data From the Irish Longitudinal Study on Ageing	4
Maternal cyclobenzaprine exposure and risk of birth defects in the National Birth Defects Prevention Study (1997–2011) and Birth Defects Study to Evaluate Pregnancy exposureS (2014–2018)	4
Validity of claims data for identifying cancer incidence in the Japan public health center‐based prospective study for the next generation	4
STUDENT ABSTRACTS of ISPE's 2024 Mid‐Year Meeting, Orlando, Florida, USA, 14–16 April 2024	4
Core concepts in pharmacoepidemiology: Fundamentals of the cohort and case–control study designs	4
Stratified analysis in comparative effectiveness studies that emulate randomized trials	4
Comparative Effectiveness and Safety of Torsemide Versus Furosemide in Older Adults With Heart Failure	4
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Hydrochlorothiazide Use and Risk of Skin Cancer: A Population‐Based Retrospective Cohort Study	4
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Prevalence, Associated Risk Factors, and Adverse Cardiovascular Outcomes of Statins Discontinuation: A Systematic Review	3
MetaLAB‐HOI: Template standardization of health outcomes enable massive and accurate detection of adverse drug reactions from electronic health records	3
Decision and timing of safety‐related labeling changes for new drugs in Japan: Comparison with the United States and the European Union	3
Initiation of antidepressant medication in people with type 2 diabetes living in the United Kingdom—A retrospective cohort study	3
Trend adjustment of the sequence difference when performing sequence symmetry analyses	3
Altered liver function test after Covid‐19 vaccines: A retrospective control group study	3
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A Real‐World Pharmacovigilance Study of FDA Adverse Event Reporting System Events for Obeticholic Acid	3
High‐throughput screening for prescribing cascades among real world statin initiators	3
Use of electronic health record data to examine administrations of pro re nata analgesics during hip fracture post‐acute care	3
Accuracy of administrative claims prescription fill data to estimate glucocorticoid use and dose in patients with rheumatoid arthritis	3
The marked oscillatory pattern in prescription opioid utilization in Canada since 2000: Selected observations and questions for outcomes and policy	3
Artificial intelligence in pharmacovigilance: Do we need explainability?	3
Peer Review of Real‐World Data Studies and Open Science—Connecting the Last Mile	3
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Quantitative Measurement of the Direct Public Health Impact of Medicines Withdrawals in Europe: Development of a Modelling Method and Proof‐of‐Concept Study to Estimate the Morbidity and Mortality Pre	3
ISPE AfRIG Conference—Abstracts for PDS Publication, June 10–14, 2024, Mombasa, Kenya	3
A European, Observational, 3‐Year Cohort Comparative Study on the Safety of the Fixed Dose Combination Pravastatin 40 mg/Fenofibrate 160 mg vs. Statin Alone in Real Clinical Practice: The POSE	3
A Real‐World Study on Adverse Reactions of Belimumab Based on the FDA Adverse Event Reporting System Database	3
Role of private prescriptions in the long‐term use of benzodiazepines and Z‐drugs: A patient‐related follow‐up study	3
Performance of an automated deep learning algorithm to identify hepatic steatosis within noncontrast computed tomography scans among people with and without HIV	3
Exploring parity in female authorship of pharmacoepidemiology articles: A case study of the Canadian Network for Observational Drug Effect Studies and its citing articles	3
Prevalence of prescription opioid use during pregnancy in eight US health plans during 2001–2014	3
Pain Medication and Pain Intensity Following Hip Fractures—Analyses Based on the ProFem Cohort Study	3
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Longitudinal effects of using and discontinuing central nervous system medications on cognitive functioning	3
Combining Super Learner with high‐dimensional propensity score to improve confounding adjustment: A real‐world application in chronic lymphocytic leukemia	3
Safety and effectiveness of ambrisentan in real clinical practice in pulmonary arterial hypertension: Results from the Korean post‐marketing surveillance	3
Categorization of COVID‐19 severity to determine mortality risk	3
Ileus in patients treated with immune checkpoint inhibitors: A retrospective, pharmacovigilance study using Food and Drug Administration Adverse Event Reporting System database	3
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Validation of an ICD‐10 case‐finding algorithm for endometrial cancer in US insurance claims	3
Cost‐effectiveness analysis of treatment with varenicline for nicotine dependence compared with smoking cessation without pharmacotherapy in the real world	3
Statin persistence and adherence among older initiators: A nationwide cohort study using the national health insurance claims database in Japan	3
Sex disparities in medication changes after metformin initiation are associated with small, clinically non‐relevant, sex differences in HbA1c levels during follow‐up	3
Antibiotic use in children before, during and after hospitalisation	3
Assessment of pharmacovigilance guidelines in the Southern African Development Community: A document review	3
Obituary: Professor Joerg Hasfrod	3
Association Between β‐Adrenoreceptor Agonists and Antagonists and Parkinson's Disease: Systematic Review and Meta‐Analysis	3
Is it possible to identify risk factors for adverse drug reactions using a pharmacovigilance database based on spontaneous reporting?	3
Oxymorphone and Oxycodone Pharmacy Purchases in US Counties: Prelude to the Largest Rural Human Immunodeficiency Virus Outbreak in US History	3
Utility of fertility procedures and prenatal tests to estimate gestational age for live‐births and stillbirths in electronic health plan databases	3
An algorithm‐based approach to ascertain patients with rare diseases in electronic health records using hypereosinophilic syndrome as an example	3
IncidencePrevalence: An R package to calculate population‐level incidence rates and prevalence using theOMOPcommon data model	3
Multiple Perspectives on the Need for Real‐World Evidence to Inform Regulatory and Health Technology Assessment Decision‐Making: Scoping Review and Stakeholder Interviews	3
An investigation on the association between sodium glucose co‐transporter 2 inhibitors use and acute pancreatitis: A VigiBase study	3
Have People Treated With Antihypertensives Been Diagnosed With Hypertension? A Cross‐Sectional Study in Stockholm, Sweden	3
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Risk of acute pancreatitis among new users of empagliflozin compared to sulfonylureas in patients with type 2 diabetes: A post‐authorization safety study	3