Restrictive reimbursement policies: bias implications for claims-based drug safety studies.

Restrictive reimbursement policies-including those based on non-formulary drug status and prior authorizations-can create situations in which patients' use of prescription medications is not fully captured in administrative claims data. This can create bias in drug safety studies that depend solely on these data. An analysis in two Canadian provinces found that primary administrative databases captured only 61 % of dispensations of drugs for which restrictive reimbursement policies were in place. A subsequent simulation study found that, in certain circumstances bias due to exposure misclassification resulting from restrictive reimbursement policies can be quite large in analyses comparing outcomes between drug exposure groups. Investigators need to be knowledgeable about the data they analyze and know whether restrictive reimbursement policies are in place that might affect the capture of drugs of interest. It is also critical to understand the mechanisms by which restrictive reimbursement might cause bias in claims-based drug safety studies, the direction and magnitude of the potential bias, and strategies that could be used to mitigate such bias.