Validation of a common data model for active safety surveillance research

Systematic analysis of observational medical databases for active safety surveillance is hindered by the variation in data models and coding systems. Data analysts often find robust clinical data models difficult to understand and ill suited to support their analytic approaches. Further, some models do not facilitate the computations required for systematic analysis across many interventions and outcomes for large datasets. Translating the data from these idiosyncratic data models to a common data model (CDM) could facilitate both the analysts' understanding and the suitability for large-scale systematic analysis. In addition to facilitating analysis, a suitable CDM has to faithfully represent the source observational database. Before beginning to use the Observational Medical Outcomes Partnership (OMOP) CDM and a related dictionary of standardized terminologies for a study of large-scale systematic active safety surveillance, the authors validated the model's suitability for this use by example

Challenges and issues in drug utilization research identified from the Latin American and African regions

Background: Despite advancements in drug utilization research (DUR), these have not been universal. Some regions such as the Latin America (LatAm) and African regions are facing challenges that are impeding the development of DUR. Objectives: To identify the main challenges and issues for DUR in the LatAm and African regions Methods: A collaborative initiative by the International Society of Pharmacoepidemiology Global Development Committee in partnership with the Latin America Drug Utilization Group and the Medicines Utilization Research in Africa Group was undertaken. A comprehensive literature review was conducted to identify local and international DUR publications. A core group of investigators and experts in DUR reviewed the publications and identified the main methodological challenges and issues. Subsequently, the group exchanged materials, participated in WebEx discussions, and reviewed the draft document. Results: Main issues: 1) Socioeconomic: high unemployment rate with poor standard of living, socioeconomic inequalities, low literacy levels, urban segregation, high migration rates, high rates of violent crime including drug trafficking and possession. 2) Healthcare-related: Disparities of social determinants of health, differences in the quality of public and private health sectors; and epidemiologic transition from communicable diseases to non-communicable diseases. Most health care systems are fragmented with variable access to medical care and medicines, and substandard record keeping. 3) Drug utilization-related: Inappropriate use of medicines including the elderly; limited infrastructure to reliably collect DU data; over-prescription of antimicrobials; polypharmacy; high rates of self-medication; and poor patient adherence (e.g. HIV/AIDS, diabetes mellitus and hypertension). Planning for DUR is affected by the multiplicity of drug distribution channels; trading in sub-standard, counterfeit medicines and insufficient quality control centers. Some publications are generated by local investigators, often suffering of methodological issues such as lack of representativeness of the population, limited data validity, and small sample sizes. Conclusions: There are common challenges for DUR when working within the LatAm and African regions. Based on our findings, the group is developing Guidance on Good Practices of Drug Utilization Research in those regions to assist researchers with issues pertaining to the planning, conduct, and evaluation of DUR