Importance Drug production not meeting the demand leaves affected patients in a vulnerable position. Objective To describe incidence and prevalence of medicines with suggested shortages in at least one European country Design We performed a descriptive cohort study between 2010 in a network of databases which have mapped their data to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). Setting Setting included primary care, secondary care, and various disease registries whose previously collected data was leveraged. Participants We included all patients with at least 365 days of history on the database. Exposures We investigated all medicines with a suggested shortage in at least one European country for more than 365 days (n=18). Furthermore, we assessed their alternatives as well (n=39). Main outcomes and measures We estimated annual incidence rates and period prevalence of all medicines with suggested shortages and their alternatives. A drop in incidence or prevalence of more than 33% after the shortage announce by the European Medicines Agency was considered confirmation of a shortage. Results Among 41 databases from Europe and the United States, we observed shortages according to incidence for 12 drugs and shortages according to prevalence for 4 drugs. The drugs varenicline, cetrorelix, and amoxicillin plus clavulanate were in shortage in the most countries. Conclusion and relevance We compiled and analysed data of annual incidence and prevalence of 57 medicines among 41 databases in Europe and the United States. We detected shortages of several drugs and suggest monitoring and stewardship for drug availability.

BACKGROUND Aligned with the European Health Data Space (EHDS), the HealthDCAT-AP metadata model has been designed to support the semantic description of health datasets and to make them findable and interoperable across EU-level catalogues. However, context-specific requirements, driven by disease areas, data models, should be incorporated on a per-project basis. OBJECTIVE As part of the IDERHA project, which is establishing a federated data space for the secondary use of heterogeneous health data with an initial focus on lung cancer, we aim to tailor a custom metadata model based on the HealthDCAT-AP specifications to address these needs. METHODS We derived IDERHA metadata profile based on HealthDCAT-AP specification by: (i) adopting all mandatory classes and properties (Dataset, Catalog, Distribution, Data Service, Agent) and selecting a preferred subset of recommended and optional properties based on working-group input and compatibility with current ELIXIR Luxembourg data-catalog metadata specifications and data holders’ requirements; (ii) modeling legal bases and conditions of use using DPV and mapping them to DISH concepts; (iii) extending the profile with OMOP CDM–derived statistics and data-quality indicators; and (iv) adding clinical and imaging measures. The metadata model is represented with a JSON Schema, and Protégé 5.6 was used to develop a semantic metadata model incorporating the ontologies. RESULTS The resulting model organizes metadata into five categories: (1) HealthDCAT-AP-derived dataset descriptors; (2) OMOP statistics and data quality; (3) data privacy/conditions of use (DPV-compatible); (4) clinical statistics; and (5) study metadata. Implementation is provided via a JSON Schema for provider adoption and an OWL ontology that imports DCAT-AP v3, DPV, and DQV, and adds IDERHA-specific classes and data properties. This custom profile enables coherent, machine-readable descriptions across participating IDERHA data providers and supports publishing and further discoverability in the IDERHA data catalog. CONCLUSIONS The proposed custom metadata model is aligned with EHDS goals by ensuring interoperability with other catalogues and improving dataset discoverability through the IDERHA community data catalog. The approach and metadata profile can be reused for other diseases or domain-specific community data infrastructures.

Real-world evidence on the direct healthcare costs of patients with KRASG12C-mutant non-small-cell lung cancer (NSCLC) is limited. Multicenter, observational, retrospective study in patients newly diagnosed with advanced-stage NSCLC harboring the KRASG12C mutation within real-world clinical practice in Spain. Patient characteristics, treatment patterns, outcomes, and direct healthcare costs were collected from medical records and administrative databases between January 1, 2016, and March 9, 2022. 127 patients were included in the study, with global and disease-related economic data available for 125 and 104 patients, respectively. Most patients (97.6%) were current or former smokers. The most prevalent co-mutations or genetic alterations at baseline involved TP53 (38.2%), ATM (20.0%), and STK11 (15.4%) genes. 94 patients (74.0%) received systemic therapy. Chemotherapy was the most common first-line (63.8%) and immunotherapy the most common second-line therapy (64.6%). Median progression-free survival (95% CI) for the first, second and third treatment lines was 4.6 (2.8-7.8), 3.8 (1.5-8.2), and 2.2 (0.1-9.9) months, respectively. Median overall survival (95% CI) was 7.7 (4.9-11.0), 9.0 (3.0-14.3), and 8.9 (0.1-19.7) months, respectively. Total global cost over the study period amounted to €5,706,820 (€46,023 per patient), with pharmacological costs totaling €2,353,299 (€18,978 per patient). Disease-related costs were €4,219,410 (€40,965 per patient), with disease-related pharmacological costs of €2,157,627 (€20,948 per patient). These real-world data highlight the limited outcomes for most NSCLC patients with KRASG12C mutations, underscoring the significant clinical and economic burden associated with their care. The evaluation of the impact of novel and effective targeted therapies is therefore warranted.