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Ten years after the Rx-to-OTC switch of nicotine replacement therapy: What have we learned about the benefits and risks of non-prescription availability?

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  • Shiffman, Saul
  • Sweeney, Christine T.

Abstract

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.

Suggested Citation

  • Shiffman, Saul & Sweeney, Christine T., 2008. "Ten years after the Rx-to-OTC switch of nicotine replacement therapy: What have we learned about the benefits and risks of non-prescription availability?," Health Policy, Elsevier, vol. 86(1), pages 17-26, April.
  • Handle: RePEc:eee:hepoli:v:86:y:2008:i:1:p:17-26
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    References listed on IDEAS

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    1. Thorndike, A.N. & Biener, L. & Rigotti, N.A., 2002. "Effect on smoking cessation of switching nicotine replacement therapy to over-the-counter status," American Journal of Public Health, American Public Health Association, vol. 92(3), pages 437-442.
    2. Hays, J.T. & Croghan, I.T. & Schroeder, D.R. & Offord, K.P. & Hurt, R.D. & Wolter, T.D. & Nides, M.A. & Davidson, M., 1999. "Over-the-counter nicotine patch therapy for smoking cessation: Results from randomized, double-blind, placebo-controlled, and open label trials," American Journal of Public Health, American Public Health Association, vol. 89(11), pages 1701-1707.
    3. Theodore E. Keeler & Teh‐wei Hu & Alison Keith & Richard Manning & Martin D. Marciniak & Michael Ong & Hai‐Yen Sung, 2002. "The benefits of switching smoking cessation drugs to over‐the‐counter status," Health Economics, John Wiley & Sons, Ltd., vol. 11(5), pages 389-402, July.
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    1. Kurko, Terhi & Linden, Kari & Vasama, Mari & Pietilä, Kirsi & Airaksinen, Marja, 2009. "Nicotine replacement therapy practices in Finland one year after deregulation of the product sales--Has anything changed from the community pharmacy perspective?," Health Policy, Elsevier, vol. 91(3), pages 277-285, August.
    2. Bell, Kirsten & Keane, Helen, 2014. "All gates lead to smoking: The ‘gateway theory’, e-cigarettes and the remaking of nicotine," Social Science & Medicine, Elsevier, vol. 119(C), pages 45-52.
    3. Kurko, Terhi & Silvast, Antti & Wahlroos, Hannes & Pietilä, Kirsi & Airaksinen, Marja, 2012. "Is pharmaceutical policy evidence-informed? A case of the deregulation process of nicotine replacement therapy products in Finland," Health Policy, Elsevier, vol. 105(2), pages 246-255.

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