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Patient Understanding of the Neuropsychiatric Risks Associated with Branded Bupropion Hydrochloride Products Used for Smoking Cessation.
Ascher, John; Stemhagen, Annette; Stender, Monika; Win, Beta; Winter, Christina.
Afiliación
  • Ascher J; Classic and Established Medicines, US Medical Affairs, GSK, Research Triangle Park, NC, USA. john.a.ascher@gsk.com.
  • Stemhagen A; Safety, Epidemiology and Risk Management, UBC, Blue Bell, PA, USA.
  • Stender M; Real World Evidence and Epidemiology, GSK, Stockley Park, Uxbridge, Middlesex, UK.
  • Win B; Global Clinical Safety and Pharmacovigilance, GSK, Stockley Park, Uxbridge, Middlesex, UK.
  • Winter C; Global Clinical Safety and Pharmacovigilance, GSK, Stockley Park, Uxbridge, Middlesex, UK.
Drugs Real World Outcomes ; 5(3): 181-191, 2018 Sep.
Article en En | MEDLINE | ID: mdl-30105744
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.

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Etiology_studies / Observational_studies / Qualitative_research / Risk_factors_studies Idioma: En Revista: Drugs Real World Outcomes Año: 2018 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Suiza

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Etiology_studies / Observational_studies / Qualitative_research / Risk_factors_studies Idioma: En Revista: Drugs Real World Outcomes Año: 2018 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Suiza