Practical considerations in genomic decision support: The eMERGE experience

Abstract

Background:Genomic medicine has the potential to improve care by tailoring treatments to the individual. There is consensus in the literature that pharmacogenomics (PGx) may be an ideal starting point for real-world implementation, due to the presence of well-characterized drug-gene interactions. Clinical Decision Support (CDS) is an ideal avenue by which to implement PGx at the bedside. Previous literature has established theoretical models for PGx CDS implementation and discussed a number of anticipated real-world challenges. However, work detailing actual PGx CDS implementation experiences has been limited. Anticipated challenges include data storage and management, system integration, physician acceptance, and more.Methods:In this study, we analyzed the experiences of ten members of the Electronic Medical Records and Genomics (eMERGE) Network, and one affiliate, in their attempts to implement PGx CDS. We examined the resulting PGx CDS system characteristics and conducted a survey to understand the unanticipated implementation challenges sites encountered.Results:Ten sites have successfully implemented at least one PGx CDS rule in the clinical setting. The majority of sites elected to create an Omic Ancillary System (OAS) to manage genetic and genomic data. All sites were able to adapt their existing CDS tools for PGx knowledge. The most common and impactful delays were not PGx-specific issues. Instead, they were general IT implementation problems, with top challenges including team coordination/communication and staffing. The challenges encountered caused a median total delay in system go-live of approximately two months.Conclusions:These results suggest that barriers to PGx CDS implementations are generally surmountable. Moreover, PGx CDS implementation may not be any more difficult than other healthcare IT projects of similar scope, as the most significant delays encountered were not unique to genomic medicine. These are encouraging results for any institution considering implementing a PGx CDS tool, and for the advancement of genomic medicine.

Pharmacogenomics‐Based Point‐of‐Care Clinical Decision Support Significantly Alters Drug Prescribing

“…We do not, however, propose that an entirely passive pharmacogenomic CDS approach is optimal, and in fact, we are currently studying ways to re-engineer our system to combine passive and active(41) alerts to maximize adoption. These concepts deserve close attention as institutions develop pathways and procedures for the delivery of genomic results in increasingly crowded EMRs(42–44). …”

Integrating pharmacogenomics into electronic health records with clinical decision support

“…various databases for drug-drug interactions); pharmacogenomic implementations to date have consisted of customized rule built by the institutions themselves. 4,24,26,28–40 These initial pharmacogenomic CDS models illustrate the feasibility of establishing procedures to 1) translate pharmacogenomic data into a predicted phenotype and clinical recommendation, 2) represent these data discretely in the EHR to allow pharmacogenomic knowledge to be presented as both passive (e.g. patient data reports, clinical consult notes) and active CDS (e.g.…”

“…26 However, EHR vendor support for pharmacogenomics is still emerging and is currently limited, which results in substantial local institutional effort compared to some other types of CDS. This is especially a problem for organizations without substantial genomics expertise or clinical informatics support.…”

Leveraging the learning health care model to improve equity in the age of genomic medicine

“…For example, the burgeoning ubiquity of genomic information in the clinical setting, from the increased use of genetic tests as an element of clinical care to direct to consumer testing results provided by patients, has galvanized efforts to integrate these data into the medical record . This surge has also spurred the development of means of providing of relevant clinical knowledge and patient‐specific information related to medical genomics, known as genomic clinical decision support (CDS) . However, the foundations for most integration and genomic CDS efforts, and indeed for the basis for many clinical genetic tests, rests in a body of work severely limited by the diversity of its participant populations .…”