CPIC has been assigning “function” to pharmacogenetic alleles since its inception, and this led to a Delphi process and consensus publication on standardizing terms used for allele function and pharmacogenetic phenotypes for some genes. The unique contribution of CPIC is to assign an allele function that leads to a phenotype assignment that can drive clinical prescribing actionability. Now that CPIC has tackled several types of genes (pharmacokinetic and pharmacodynamic), it is timely to establish written SOPs that describe in more detail the criteria used for assigning function. In addition, it is clear that there are cases for which a “biochemical” functional assignment does not completely correspond to clinical function, and therefore we are distinguishing that the primary goal of the CPIC guideline authorship committees is to assign Allele Clinical Functional status, as described in detail in the draft SOP.
Based on feedback from CPIC members and others, the draft SOP has been revised.