In pharmacoepidemiologic studies of COVID-19, there were concerns about bias from residual confounding. We investigated the effects of inhaled corticosteroids (ICS) on COVID-19 outcomes, applying high-dimensional propensity scores (HDPS) to adjust for unmeasured confounding.

The COVID-19 pandemic caused unprecedented disruptions in healthcare delivery, and changes in medication utilization patterns. While previous studies examined specific therapeutic classes or populations, there is limited longitudinal evidence on medication trends among young adults throughout and beyond the pandemic.

To identify the best method for selecting index dates when constructing external comparator arms (ECAs) from real-world data for comparison with single-arm trials (SATs).

Ascertaining migraine in electronic healthcare data is challenging because of likely diagnosis underrecording and treatment with over-the-counter analgesics, which cannot be used as disease proxies. Algorithm-identified migraine prevalence may depend on algorithm characteristics and target population.

Randomized clinical trials show that subcutaneous semaglutide is modestly superior to dulaglutide in reducing HbA1c and body weight, but no trial has compared their effectiveness on hard cardiovascular outcomes. This study aimed to examine whether semaglutide and dulaglutide differ in cardiovascular effectiveness.

Anticholinergic medications and alcohol each independently increase the risk of community-acquired pneumonia (CAP). Whether non-anticholinergic neurocognitively active medications also increase risk, and if alcohol modifies these associations, remains unclear.

To apply various dimensionality reduction techniques for propensity score (PS) estimation in high-dimensional data and evaluate their performance against more conventional approaches in achieving covariate balance and confounding control in pharmacoepidemiological studies using claims data.

Electronic health records (EHR) offer clinical details not available in claims data, which are typically used for studies of medications during pregnancy. Historically, medication prescriptions rather than fills have been documented in EHR. However, linked EHR-pharmacy databases incorporate medication fill information and could be used for perinatal medication safety studies.

The aim of this study was to compare the efficacy and safety of monoclonal antibodies (mAb) for moderate-to-severe atopic dermatitis (AD).

Medications associated with acute liver injury (ALI) are primarily identified by case reports. High-throughput screening of real-world data could be leveraged to detect hepatotoxicity signals.

Pharmacotherapy during pregnancy should be approached with caution due to the potential risk of adverse effects, including birth defects, in the fetus. Appropriate post-marketing surveillance and perinatal pharmacoepidemiology are essential to ensure the safety of pharmacotherapy during pregnancy. However, due to limited research infrastructure in pharmacoepidemiology, collecting reliable data on drug safety in pregnant women and infants remains a challenge in Japan. Thus, we examined the suitability (fitness for purpose) of Japanese medical databases for perinatal studies to establish infrastructure in this field.

Key changes in the pharmacoepidemiological research environment had a significant influence on the activities of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) over the last decade. These changes included the SARS-CoV-2 pandemic, the increased access to anonymized real-world data (RWD) sources, the integration of real-world evidence (RWE) into regulatory and public health decision-making, and the emergence of new technologies and methods. This paper describes how ENCePP has evolved in this changing environment to strengthen pharmacoepidemiological methods and practice in Europe and globally. It also provides future perspectives for the network. Through a collaborative approach in non-interventional research, ENCePP will collectively continue to promote excellence for RWE generation, supporting the safe and effective use of medicines.

The self controlled case series (SCCS) is one of the most promising methods for drug safety signal detection using real world data (RWD), and incorporating active comparators could potentially improve its performance by addressing time-varying confounding by indication. The 'Système National des Données de Santé' (SNDS) is a large nationwide administrative claims database, which has not been used extensively for drug safety signal detection. While comparable in size to other RWD sources, it is unclear to what extent the performance of SCCS correlates with that in other sources.

Pharmacoepidemiologic studies on deprescribing are challenging to implement, yet little guidance exists on methods to avoid bias and minimum reporting for replicability and appraisal. We developed consensus recommendations for the methods and reporting of observational studies that aim to examine the effects of deprescribing.

Combined oral contraceptives (COCs) are contraindicated in migraine with aura due to stroke risk, and some hormone therapy for menopause guidelines recommend caution in this population. However, this guidance is informed by sparse or older evidence reflective of higher doses than typically prescribed today. This study aimed to describe modern-day utilization of COCs and hormone therapy among female individuals with migraine with aura from 2000 to 2024.

Long-term antidepressant use may reduce the risk-benefit profile due to the increased likelihood of withdrawal symptoms and higher incidence of side effects. This epidemiological study investigates historical trends in long-term antidepressant use, which was defined as maintaining continuous antidepressant use for at least 365 days, allowing for gaps in dispensing of up to 60 days in the Australian community from 2014 to 2023.

Self-medication carries the potential for significant adverse events when practiced irresponsibly. The indiscriminate use of medicines notably intensified during the COVID-19 pandemic. This study aimed to investigate the epidemiological profile of exogenous intoxications due to self-medication among Brazilians from 2014 to 2023.

Drug-related admissions (DRAs) remain highly prevalent and are linked with increased morbidity and mortality. Rapid and accurate identification is key to both their acute management and secondary prevention. To this end, two clinical decision rules (CDRs) were recently developed to identify the causal adverse drug event (ADE-CDR) or the underlying adverse drug reaction (ADR-CDR). The aim of this study was to assess the diagnostic accuracy of both CDRs in a new patient cohort.

Despite testing of epidemiological methods in US Claims databases for signal detection, such data sources have not become a routine capability. The Self Controlled Case Series (SCCS) is one of the most promising methods for drug safety signal detection using Real World Data, and incorporating active comparators could potentially improve its performance by addressing confounding by indication.

This study aimed to assess the risk of Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN) among patients treated with immune checkpoint inhibitors (ICIs), compared to those receiving molecularly targeted therapies or conventional chemotherapy, using real-world data.