Objective: Review the history of the Rx-to-OTC switch of nicotine replacement therapy (NRT) in the US, outlining concerns expressed before the switch, discussing how concerns were addressed, and presenting data on the actual experience in the decade following the switch.
Methods: Literature review of studies examining trends in NRT utilization pre- and post-switch, the efficacy and safety of NRT in the OTC setting, and patterns of OTC NRT use.
Results: OTC availability of NRT increased access to and utilization of treatment. Studies show that OTC NRT has been used safely and effectively, without substantial misuse or abuse, and with continued physician engagement and wide access to proven behavioral treatment.
Conclusions: With other medications that challenge the traditional OTC paradigm being proposed for OTC switch, the NRT case study serves as a useful example in highlighting the potential role that Rx-to-OTC switch can play in addressing public health challenges. The NRT experience suggests that advance identification and analysis of concerns, implementation of plans to manage concerns, including appropriate marketing and post-marketing surveillance, can ensure that OTC switch of medications for behavior change and disease prevention can help minimize risks and maximize public health benefits.