Abstract

LAMOTRIGINE SAFETY CONCERNS: A CROSS-SECTIONAL STUDY

Eduardo Han, Pricilla Shinaba, Summer Perrine, Jessica Lyons, Bisrat Hailemeskel*

Abstract

Introduction: The aim of this study was two folds. The first one is to review black box warnings using lamotrigine as an example. The second aim was to evaluate first-year pharmacy students' knowledge of lamotrigine’s safety concerns, including Black Box Warnings, key safety risks, and monitoring requirements. The study sought to assess the students’ familiarity with the clinical use of lamotrigine and explore how factors such as educational background and work experience influenced their understanding of these critical safety considerations. Methods: This study employed a cross-sectional method combining knowledge-based and opinion-based surveys. Firstyear pharmacy students were asked to respond to questions regarding lamotrigine’s safety risks, including serious dermatological reactions, pregnancy-related risks, drug interactions, and the need for monitoring concurrent anticonvulsants. First-year students were chosen to assess their baseline knowledge of critical drug safety concepts, as they are in the early stages of their pharmacy education and have not yet been extensively exposed to clinical training. Evaluating their understanding at this point provides valuable insights into the effectiveness of prepharmacy coursework and helps identify potential gaps that can be addressed through curriculum enhancements. Moreover, studying first-year students allows for a clearer analysis of how foundational knowledge aligns with professional expectations and can highlight areas requiring targeted interventions to better prepare students for advanced pharmacy practice. Data were analyzed using descriptive statistics, mean scores, standard deviations, and the Chi-square test. Results: A total of 46 first-year pharmacy students participated in the survey. Among respondents, 87% correctly identified the risk of serious skin reactions, and 78% were aware of significant drug interactions. However, only 43% recognized the pregnancyrelated risks, and 39% understood the necessity of routine serum anticonvulsant level monitoring, highlighting notable knowledge gaps. Students with more than three years of work experience demonstrated a significantly higher level of knowledge, with 92% identifying both pregnancy risks and monitoring requirements compared to 35% of those with less experience (p < 0.05). Opinion-based questions revealed strong consensus, with 91% emphasizing the importance of monitoring for skin reactions, 85% agreeing on the need to avoid alcohol during treatment, and 78% favoring the use of generic lamotrigine to reduce costs. The survey revealed significant knowledge gaps among first-year students, particularly on pregnancy-related risks and anticonvulsant monitoring. These findings underscore the need for targeted curriculum improvements to strengthen understanding of high-risk medications early, building a solid foundation for future clinical practice. Conclusions: This study highlights critical gaps in pharmacy students' knowledge of Black Box Warnings using lamotrigine’s safety concerns and monitoring requirements as an example, emphasizing the need for targeted educational interventions. Incorporating case-based learning and experiential education into the pharmacy curriculum may help address these gaps, ensuring that students are better equipped with the knowledge and skills necessary for safe and effective medication management in clinical practice.

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