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

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.