(167) Updated Core Competencies in Pharmacoepidemiology to Inform Contemporary Curricula and Training for Academia, Government, and Industry

Publication Number: 1212

Background: The first paper to specify the core content of pharmacoepidemiology as a profession was published by an ISPE workgroup in 2012 (Jones JK et al. PDS 2012; 21(7):677-689). Pharmacovigilance, analysis of exposure data, epidemiologic methods, and communication skills were the original core competency groups identified from this work. Due to the broad and evolving scope of pharmacoepidemiology, it is important to identify, update and expand the core competencies to inform curricula of education programs to provide well trained pharmacoepidemiologists across academic, government, and industry positions. This will also inform the future direction and focus of the field.

Objectives: One aim of the working group project was to update the core competencies in pharmacoepidemiology and this abstract presents the progress of that specific aim.

Methods: An ISPE-funded work group was led by members of the ISPE Academic Council. To ensure applicability of findings to multiple areas, the working group consisted of 14 ISPE members with positions in academia, industry, government, and other settings. Experience ranged from early to advanced career professionals, representing multiple countries across 4 continents. All competencies outlined by Jones et al were extracted from the manuscript and presented to the work group. Expert-based judgements were collated and used to identify consensus; the work group were asked to consider which competencies could still be considered “core” and whether any further competencies should be added to the list. In addition, the work group proposed five core domains based on the competencies presented and subsequently mapped all core competencies to these domains.

Results: The five core domains proposed by the working group were (1) Epidemiology, (2) Clinical Pharmacology, (3) Regulatory Science, (4) Communication and other professional skills, and (5) Statistics, analysis and data science. In comparison to the original work by Jones et al, this presented a shift over the past 10 years. In total, 53 individual competencies were proposed by the workgroup, of which many overlapped with the original competencies but also included some new competencies (e.g. basic principles of digital health). These individual competencies were considered after core domains were defined, though there was scope to revise the core domains if they did not accurately reflect individual competencies.

Conclusions: While many core competencies in pharmacoepidemiology have remained the same over the past 10 years, there have also been several updates to reflect new and emerging concepts in the field. This confirms the original working group assertion that these competencies are likely to evolve over time, highlighting the need to review and update based on priority areas.