Patient Understanding of the Neuropsychiatric Risks Associated with Branded Bupropion Hydrochloride Products Used for Smoking Cessation

Abstract

Background: Bupropion hydrochloride (Zyban) is an effective aid to smoking cessation; however, its use has previously been associated with neuropsychiatric adverse events. Here we report results of the patient Knowledge, Attitudes, and Behavior survey that forms part of the Year 7 Risk Evaluation and Mitigation Strategy (REMS) assessment for Zyban.

Objective: Assess participants' understanding of the neuropsychiatric risks associated with branded bupropion hydrochloride products that are used for smoking cessation, as described in the Medication Guides.

Methods: A cross-sectional study was conducted among patients ≥ 18 years of age, who had used or filled a prescription for branded bupropion hydrochloride for smoking cessation in the past 6 months. Participants were recruited through an online panel, pharmacy network, or by healthcare provider referral, and invited to complete a survey containing questions regarding the risks associated with the use of branded bupropion hydrochloride products, and whether they had received and read the Medication Guide. The study aimed for ≥ 80% of participants to respond correctly to each question regarding neuropsychiatric risks.

Results: From the 50,985 survey invitations distributed, 1017 participants responded, of whom 144 were eligible and 142 completed the survey. Over 80% of participants correctly responded to most neuropsychiatric risk questions. Approximately three-quarters of participants received the Medication Guide when they last filled their prescription, of whom over half read the Medication Guide at that time.

Conclusions: Participants enrolled in this Year 7 REMS survey had good understanding of the neuropsychiatric risks associated with using branded bupropion hydrochloride products for smoking cessation.

Fig. 1

Flow diagram of survey administration. ^aRespondents who discontinued the survey before completing all eligibility questions were classified as respondents with undetermined eligibility

Fig. 2

Proportion of participants who responded correctly to questions regarding neuropsychiatric risks associated with the use of branded bupropion hydrochloride products for smoking cessation (Completed Survey population). Different colors represent different numbered questions within the survey. HCP healthcare provider. ^aQuestions were simplified for inclusion in the figure. Full questions are available in the Online Supplementary Materials

Fig. 3

Summary of participant responses to questions^a regarding reading of the Medication Guide (Completed Survey population). ^aQuestions were simplified for inclusion in the figure. Full questions are available in the Online Supplementary Materials. ^bParticipants who previously answered “No” or “Can’t recall” to Question 8 were not asked this question. ^cParticipants who previously answered “Yes” to Question 9 were not asked this question. ^dParticipants who previously answered “No” or “Can’t recall” to Question 8 or Question 9 were not asked this question

Fig. 4

Summary of how thoroughly participants reported having read the Medication Guide the first time and the most recent time they read it (Completed Survey population^a). ^aParticipants who previously answered “No” or “Can’t recall” to Question 10a or 10b were not asked this question