Abstract
Background: For diseases with a genetic cause genomics can deliver
improved diagnostics and facilitate access to targeted treatments. Drug
pharmacodynamics and pharmacokinetics are often dependent on genetic
variation underlying these processes. As pharmacogenomics comes of age
it may be the first way in which genomics is utilised at a population
level. Still required is guidance and standards of how genomic
information can be communicated within the health record, and how
clinicians should be alerted to variation impacting the use of
medicines. Methods: The Professional Record Standards Body commissioned
by National Health Service England developed guidance on using
pharmacogenomics information in clinical practice. We conducted research
with those implementing pharmacogenomics in England and internationally
to produce guidance and recommendations for a systems-based approach.
Results: A consensus viewpoint is that systems need to be in place to
ensure the safe provision of pharmacogenomics information that is
curated, actionable and up-to-date. Standards should be established with
respect to notification and information exchange, which could impact new
or existing prescribing and these must be in keeping with routine
practice. Alerting systems should contribute to safer practices.
Conclusion: Ensuring pharmacogenetics information is available to make
use of medicines safer will require major effort of which this guidance
is a beginning. Standards are required to ensure useful genomic
information within the health record can be communicated to clinicians
in the right format and times to be actioned successfully. A
multidisciplinary group of stakeholders must be engaged in developing
pharmacogenomic standards to support the most appropriate prescribing.