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Errors in Group Information Supplement and End Matter.

Corrections to Assessment of Variation in State Regulation of Generic Drug and Interchangeable Biologic Substitutions To the Editor In the primary data file for the Original Investigation titled “Assessment of Variation in State Regulation of GenericDrugandInterchangeableBiologicSubstitutions,”1 members of the study team discovered errors pertaining to the coding of policies for interchangeable biologic substitution relative to small-molecule generics, which resulted in the misclassification of some states. We therefore re-reviewed the statutes and regulations related to interchangeable biologic substitution, recoded the results, and identified necessary corrections. The corrected Table 2 and accompanying text show no differences in consent, refill, or cost rules for substitution of interchangeable biologics relative to small-molecule drugs. By contrast, 6 states made substitution permissive rather than mandatory; 8 states required additional patient notification; 45 states required additional physician notification; 1 state protected pharmacists from greater liability; and 19 states required US Food and Drug Administration rather than pharmacist determination of interchangeability. We further re-reviewed the statutes and regulations related to small-molecule generic substitution and identified a small number of misclassifications. The corrected Figures 1 and 2 and accompanying text show that 31 states and Washington, DC, mandated patient notification independent of the drug’s packaging and that 23 states noted a right of patients to refuse substitution without requiring that they consent. The identified errors do not affect the primary finding— that 45 states have imposed more stringent requirements for interchangeable biologic substitution—the interpretations of the results, or our conclusions that there is a need for optimizing state drug product selection laws to promote generic and interchangeable biologic substitution. I confirm that we have identified no other errors in the article, data, or analyses. My coauthors and I apologize to the readers and editors of the journal for these errors and any confusion this has caused, and we have requested that the article be corrected.2