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Pharmacoepidemiol Drug Saf. 2013 Jul;22(7):705-15. doi: 10.1002/pds.3400. Epub 2013 Jan 24.

The effectiveness of varenicline medication guide for conveying safety information to patients: a REMS assessment survey.

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OptumInsight Epidemiology, Waltham, MA 48108, USA.



Risk Evaluation and Mitigation Strategies (REMS) include various mechanisms to enhance safe use of medications, including a patient medication guide (MG) that provides key information regarding the potential risks associated with the medication. To evaluate the effectiveness of the varenicline MG as a REMS tool for educating patients, we undertook a survey among patients who were dispensed varenicline.


Varenicline recipients within the Optum Research Database, a large U.S. administrative claims database, were invited to participate in a self-administered survey. Survey questions were general (receipt and reading of the MG) and specific regarding patient's understanding of the potential varenicline risks outlined in the MG (neuropsychiatric symptoms, skin reactions, and allergic reactions).


From 3568 varenicline recipients invited, 640 (18%) responded, with 633 completing at least one of three risk-comprehension questions. The majority (93%) indicated receiving the MG, and 86% read all or part of it. Ninety-one percent, 41%, and 53% correctly answered at least one question on neuropsychiatric symptoms, skin reactions, and allergic reactions, respectively. A higher proportion who read the MG had correct responses to the risk-comprehension questions than those who did not read it.


The varenicline MG was widely received and read among survey respondents, and the information conveyed was generally well understood regarding potential risk of neuropsychiatric symptoms. This study provides an assessment of the effectiveness of the varenicline MG in communicating information about potential risks associated with varenicline. This assessment method may apply to the evaluation of the effectiveness of other MGs.


REMS; medication guide; pharmacoepidemiology; risk management; risk mitigation evaluation; smoking cessation; survey; varenicline

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