Article thumbnail

A critical analysis of barriers to the clinical implementation of pharmacogenomics

By Ross A McKinnon, Michael B Ward and Michael J Sorich


Over recent decades, basic research has yielded a large volume of data on many potentially clinically relevant genetic determinants of drug efficacy and toxicity. Until recently, most examples involved genes encoding drug-metabolizing enzymes, particularly the cytochromes P450. More recently, rapid advances in genomic technologies have enabled broader, genome-wide searches for determinants of drug response. In parallel with these pharmacogenetic studies, a new drug discovery platform, termed pharmacogenomics, has emerged which utilises genetic information to guide the selection of new drugs most likely to survive increasingly demanding safety and efficacy assessments. Together, these advances are widely promoted as the basis of a new era of drug-based therapeutics tailored to the individual. The extent to which individualized or personalized medicine will emerge as a sustainable new therapeutic paradigm is, however, the topic of much debate. It is clear that an increasingly complex series of barriers must be overcome if we are to successfully harness genomic advances in the clinical setting. Potential barriers may include cost-effectiveness of the test, ethical concerns over the use of DNA, and required educational and equipment infrastructure. Although long overdue, many of these potential barriers are now being subjected to closer examination and as a result, a framework for successful clinical uptake of pharmacogenomics is emerging

Topics: Review
Publisher: Dove Medical Press
OAI identifier:
Provided by: PubMed Central

To submit an update or takedown request for this paper, please submit an Update/Correction/Removal Request.

Suggested articles


  1. (2005). A lay prescription for tailor-made drugs – focus group refl ections on pharmacogenomics. Health Policy,
  2. (2003). Additional SNPs and linkage-disequilibrium analyses are necessary for whole-genome association studies in humans.
  3. (2004). Advances in pharmacogenomics and individualized drug therapy: exciting challenges that lie ahead.
  4. (2003). An introduction to cost-effectiveness and cost-benefi t analysis of pharmacogenomics.
  5. (2000). Assessing the cost-effectiveness of pharmacogenomics.
  6. (2004). Criteria infl uencing the clinical uptake of pharmacogenomic strategies.
  7. (2000). Drug therapy and pharmacogenomics. APhA
  8. (2005). FDA seeks genome-based drug data.
  9. (2003). Further evidence of IBD5/CARD15 (NOD2) epistasis in the susceptibility to ulcerative colitis.
  10. (2003). Hairpin RNAs and retrotransposon LTRs effect RNAi and chromatin-based gene silencing.
  11. (2005). Hap Map Consortium.
  12. (2004). Haplotype diversity across 100 candidate genes for infl ammation, lipid metabolism, and blood pressure regulation in two populations.
  13. (1998). Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies.
  14. (2005). Pharmacogenetic testing for drug metabolizing enzymes: is it happening in practice? Pharmacogenet Genomics,
  15. (2004). Pharmacogenetics – fi ve decades of therapeutic lessons from genetic diversity.
  16. (2004). Pharmacogenetics-expectations and reality.
  17. (2001). Pharmacogenetics: the therapeutic drug monitoring of the future? Clin Pharmacokinet,
  18. (2003). Pharmacogenomics and “individualized drug therapy”: high expectations and disappointing achievements.
  19. (2005). Pharmacogenomics education: international society of pharmacogenomics recommendations for medical, pharmaceutical, and health schools deans of education.
  20. (2001). Pharmacogenomics, ethnicity, and susceptibility genes.
  21. (2001). Potential role of pharmacogenomics in reducing adverse drug reactions: a systematic review.
  22. (2003). Prediction of mammalian microRNA targets.
  23. (2003). Prospects and limits of pharmacogenetics: The thiopurine methyl transferase (TMPT) experience.
  24. (2005). Racializing drug design: implications of pharmacogenomics for health disparities.
  25. (2004). Selecting a maximally informative set of single-nucleotide polymorphisms for association analyses using linkage disequilibrium.
  26. (2003). SNP and haplotype variation in the human genome. Mutat Res,
  27. (2003). Statistical signifi cance for genomewide studies.
  28. (2002). The economics of gene therapy and of pharmacogenetics. Value Health,
  29. (2003). The human genome project: assessing confi dence in knowledge and training requirements for community pharmacists.
  30. (2004). Will tomorrow’s medicines work for everyone? Nature Genet,