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?

Shiffman, Saul; Sweeney, Christine T.

doi:10.1016/j.healthpol.2007.08.006

Cited by 65Smoking Behavior and CessationPharmaceutical Economics and PolicyHealthcare Regulation

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?

Shiffman, Saul, Sweeney, Christine T.·2008·Health Policy

DOI 10.1016/j.healthpol.2007.08.006

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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.

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Authors: Shiffman, S., & Sweeney, C. T.
Affiliations: Pinney Associates (United States) (US)
Corresponding author: Shiffman, Saul
Venue: Health Policy
Publisher: Elsevier BV
Published: 2008-04
Volume: 86
Issue: 1
Pages: 17-26
ISSN: 0168-8510 (ISSN-L)
DOI: 10.1016/j.healthpol.2007.08.006
OpenAlex: W2008165838
Cited by: 65
References: 74
Citations by year: 2026: 1 · 2025: 1 · 2024: 3 · 2023: 2 · 2022: 1 · 2021: 1 · 2020: 3 · 2019: 4 · 2018: 1 · 2017: 4 · 2016: 3 · 2015: 6 · 2014: 3 · 2013: 3 · 2012: 12
FWCI: 0.47
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Health Policy (publishedVersion)
PubMed (publishedVersion)
RePEc: Research Papers in Economics (submittedVersion)
Funders: GlaxoSmithKline
Topics: Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
Keywords: nicotine replacement therapy, over-the-counter drugs, prescription-to-over-the-counter switch, smoking cessation, drug safety, post-marketing surveillance, physician engagement, behavior therapy, public health benefits
MeSH terms: Nonprescription Drugs, Humans, Nicotine, Drug Prescriptions, Tobacco Use Disorder, United States, Smoking Cessation

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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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