Vergani Hayley M, Calvini Giulia, Mangini Gloria, Mattioli Francesca, Parodi Aurora, Burlando Martina, Bodini Giorgia, Martelli Antonietta
Int J Clin Pharmacol Ther. 2020 Apr;58(4):208-213. doi: 10.5414/CP203628.
To help identify adverse events (AEs) in new biologic therapies and to spread the culture of pharmaceutical surveillance among patients affected by psoriasis or inflammatory bowel disease (IBD).
This active pharmacovigilance program provided all patients with telephone follow-ups (FU), carried out by a clinical pharmacologist for a total duration of 1 year. Collected AEs were classified according to the MedDRA dictionary.
21 patients with psoriasis and 10 patients with IBD were enrolled. In our sample, the AEs reported were frequent but mild, underlining the crucial role of active pharmacovigilance in detecting minor AEs rarely spontaneously reported by the patients.
According to our experience, a multidisciplinary team is recommended to manage complex therapies improving AE reporting and promoting greater therapeutic adherence.
帮助识别新型生物疗法中的不良事件（AE），并在银屑病或炎症性肠病（IBD）患者中传播药物监测文化。
该主动药物警戒项目为所有患者提供电话随访（FU），由临床药理学家进行，总时长为1年。收集到的不良事件根据MedDRA词典进行分类。
纳入了21例银屑病患者和10例IBD患者。在我们的样本中，报告的不良事件较为常见但程度较轻，凸显了主动药物警戒在检测患者很少自发报告的轻微不良事件方面的关键作用。
根据我们的经验，建议组建多学科团队来管理复杂疗法，以改善不良事件报告并促进更高的治疗依从性。
