Pharmacogenetics: Policy needs for personal prescribing

Abstract

Pharmacogenetics involves genetic testing of individual patients to guide drug treatment. Proponents argue that pharmacogenetics will achieve major gains in drug safety and efficacy, and revolutionise marketing. Pharmacogenetics also raises several policy concerns, including the need for sound information for clinical decision-making on drug-genetic test combinations. Currently, the pharmacogenetics science base and the rate of emergence of clinical applications are uncertain. Most commentary on pharmacogenetics focuses on new compounds, yet older drugs cause most adverse events. Test regulation in the USA appears fundamentally different from Europe, where evidence of safety or efficacy may not be required. Genetics research is needed as part of post-marketing surveillance systems. In routine clinical practice, computer-based health records with relevant decision support systems will also be needed. Without health policy action, pharmacogenetics could produce a new generation of poorly evaluated tests and drugs, with medicine becoming significantly less evidence-based, leading to rising costs, patient hazard and exclusions of drug-related 'genetic minorities' from evaluated treatments. © The Royal Society of Medicine Press Ltd 2005.