Effect of Risk Evaluation and Mitigation Strategies (REMS) on utilization of thiazolidinediones in a Medicaid population

Objectives: To examine the longitudinal impact of the FDA's Risk Evaluation and Mitigation Strategy (REMS) medication guide program on the contraindicated and non-contraindicated utilization of thiazolidenediones (TZDs) among Type 2 Diabetes Mellitus patients in Mississippi Medicaid.;Methods: A retrospective quasi-experimental interrupted time-series design was conducted in MS Medicaid data for 2008-2012. TZD use in T2DM patients with and without prior heart failure diagnosis were defined as contraindicated and non-contraindicated use, respectively, and were the outcomes of interest. The date of the medication guide REMS introduction for rosiglitazone and pioglitazone were the primary interventions studied.;Results: After adjusting for autoregressive and moving average trends in the data, a month-to-month decrease for contraindicated and non-contraindicated use was observed prior to REMS and persisted following the REMS program for new and total contraindicated TZD use. REMS for rosiglitazone and pioglitazone did not result in a significant change in contraindicated TZD use. However, REMS for rosiglitazone resulted in a significant month-to-month decline in the overall and new non-contraindicated rosiglitazone (overall=-4.53, p<0.01; new=-64.61, p=0.02) and pioglitazone (overall=-7.58, p=0.01; new=-99.9, p=0.01) use.;Conclusions: REMS programs, when preceded by safety warnings and media attention, may not only have a lasting impact on mitigating contraindicated utilization but may also have an effect on overall utilization, including non-contraindicated use. This implies that physicians, regulators and insurance providers may act out of an abundance of caution and find alternatives to products with safety concerns rather than reconsider appropriate utilization patterns.