Discussion
As RWD is increasingly used to generate evidence to make safety and
efficacy decisions, the challenges and lack of clarity associated with
incorporating medication use into analyses should be addressed. We
offered points to consider when developing medication use definitions,
with a focus on electronic health care data sources. These
considerations may help researchers understand the strengths and
limitations of different conceptual and operational approaches (e.g.,
selection of data sources, method of identifying medication) and
contextualize their findings. These points are intended to complement
considerations from existing rubrics, such as STaRT-RWE[6], the
ISPE-ISPOR Consensus Document[7], RECORD-PE[8], and the ENCEPP
Guide on Methodological Standards[9], which aid investigators in
designing, conducting, reporting on, and comparing across studies.
Our proposed points included considerations for investigators who
incorporate medication use into their study. We have shown the
importance of the considering context under which the medication is
being used in the analyses, the volume of medications formulas, dosages,
routes of administration, and the often-longitudinal nature of
medication use may influence a definition of medication use.
In summary, adopting and reporting on the use of the proposed
considerations may enhance the quality of pharmacoepidemiology research
and our ability to contextualize and interpret findings.
Funding statement: This activity is a project supported by the
Food and Drug Administration (FDA) of the U.S. Department of Health and
Human Services (HHS) as part of an award of $570,206 in federal funds
(100% of the project). The contents are those of the author(s) and do
not necessarily represent the official views of, nor an endorsement, by
FDA, HHS, or the U.S. Government. For more information, please visit
FDA.gov.
Conflict of interest disclosure: Anand P. Chokkalingam is an
employee of and own stock in Gilead Sciences. The rest of the authors
have no competing interests to declare that are relevant to the content
of this article.
Ethics approval statement: Because this wasn’t a research
activity it is exempt from review and the requirement for informed
consent.