Mapping the Bulgarian Diabetes Register to OMOP CDM: Application Results.

Background: The Bulgaria Diabetes Register (BDR) contains more than 380 millions of pseudonymized outpatient records with proprietary data structures and format.

Objectives: This paper presents the application results and experience acquired during the process of mapping such observational health data to OMOP CDM with the objective of publishing it in the European Health Data and Evidence Network (EHDEN) Portal.

Methods: The data mapping follows the activities of the well-structured Extract-Transform-Load process.

Drug Utilisation Patterns of Alternatives to Ranitidine-Containing Medicines in Patients Treated with Ranitidine: A Network Analysis of Data from Six European National Databases.

Introduction: Ranitidine, a histamine H-receptor antagonist (HRA), is indicated in the management of gastric acid-related disorders. In 2020, the European Medicines Agency (EMA) recommended suspension of all ranitidine-containing medicines in the European Union (EU) due to the presence of N-nitrosodimethylamine (NDMA) impurities, which were considered to be carcinogenic. The aim of this study was to investigate the impact of regulatory intervention on use patterns of ranitidine-containing medicines and their therapeutic alternatives.

Impact of European Union Label Changes for Fluoroquinolone-Containing Medicinal Products for Systemic and Inhalation Use: Post-Referral Prescribing Trends.

Introduction: Concerns of the persistence and severity of the adverse effects of fluoroquinolones, mainly involving the nervous system, muscles and joints, resulted in the 2018 referral procedure led by the European Medicines Agency (EMA). They advised to stop prescribing fluoroquinolones for infections of mild severity or of a presumed self-limiting course and for prevention of infections, plus to restrict prescriptions in cases of milder infections where other treatment options are available, and restrict in at-risk populations. We aimed to examine whether the impact of EMA regulatory interventions implemented throughout 2018-2019 had an impact on fluoroquinolone prescribing rates.

Incidence of second primary malignancies in relapsed/refractory B-cell non-Hodgkin's lymphoma patients in England.

Background: Treatments for relapsed/refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL) may be associated with an increased risk of second primary malignancies (SPMs). Currently available SPM incidence benchmarks are unreliable due to small sample sizes.

Methods: The Cancer Analysis System (CAS), a population-level cancer database in England, was used to identify patients with incident B-cell NHL diagnosed during 2013-2018 with evidence of r/r disease.

Should cholangiography be part of the management of every patient with percutaneous cholecystostomy?

Introduction: Percutaneous cholecystostomy (PCC) is a well-established treatment in patients with high surgical risk and those who failed conservative treatment. However, the role of cholangiography in the management of PCC patients is not clear. In our medical center, cholangiography is routinely performed before discharging patient with PCC.