翻开硬拷贝风险管理计划教材的新一页:数字化成为可能。

IF 2 4区 医学 Q4 MEDICAL INFORMATICS
Anabel Ng, Ayn Nova Celo, Beliz Fernandes
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引用次数: 0

摘要

风险管理计划教育材料"(RMP EMs)是额外的风险最小化措施(aRMMs),旨在预防或减少与接触药品相关的不良反应的发生,或降低其严重程度或对患者的影响。虽然医疗保健行业正在采用各种数字工具和平台进行教育和/或提高认识,但纸质材料仍是制药公司实施 aRMMs 的主要方法。诺华公司在新加坡进行了一项试点,研究分发电子版 RMP EM(e-RMP)的可行性。试点结束后,诺华新加坡公司正式实施了 e-RMP。e-RMP 推出一年后,对医疗保健专业人员(HCP)进行了一项调查,以了解最终用户的体验。调查结果显示,医护人员和患者都普遍倾向于使用 e-RMP。与传统的纸质程序相比,以数字方式提供教育性 aRMMs 具有很大的优势。这对于确保主治医生和患者/护理人员及时了解产品关键安全信息的更新,最终确保患者安全非常重要。要成功过渡到数字化解决方案,就需要医疗保健生态系统中的主要利益相关者(包括监管机构、制药公司、高级保健人员、患者和护理人员)之间开展有目的的合作。本文旨在通过新加坡的一个案例研究,深入探讨电子药品注册管理计划(e-RMP)的数字化历程,概述其价值以及在转型过程中面临的一些挑战。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Turning the Page on Hardcopy Risk Management Plan Educational Materials: Digitalization Made Possible.

'Risk Management Plan Educational Materials' (RMP EMs) are additional risk minimization measures (aRMMs) intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient. While the healthcare sector is embracing various digital tools and platforms for educational and/or awareness building purposes, paper-based materials have remained the mainstay approach for implementation of aRMMs by pharmaceutical companies. Novartis in Singapore conducted a pilot on the feasibility of distributing electronic copies of RMP EMs (e-RMP). Post-pilot, e-RMP was officially implemented in Novartis Singapore. A year following the launch of e-RMP, a survey was performed with healthcare professionals (HCPs) to understand end-users' experience. The survey responses revealed a general preference by both HCPs and patients towards e-RMP. Digital methods of delivering educational aRMMs offer great benefits over traditional paper-based programs. e-RMP significantly reduces the time needed for updated RMP EMs to reach HCPs and their patients/caregivers. This is important to ensure that HCPs and patients/caregivers are made aware of any updates in key safety messages of the products in a timely manner to ultimately ensure patient safety. The successful transition to digital solutions requires purposeful collaborations between key stakeholders of the healthcare ecosystem including regulatory authorities, pharmaceutical companies, HCPs, patients and caregivers. This article aims to provide insights on the digitalization journey of e-RMP, a case study in Singapore, outlining the value but also some of the challenges faced during this transformation.

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来源期刊
Therapeutic innovation & regulatory science
Therapeutic innovation & regulatory science MEDICAL INFORMATICS-PHARMACOLOGY & PHARMACY
CiteScore
3.40
自引率
13.30%
发文量
127
期刊介绍: Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health. The focus areas of the journal are as follows: Biostatistics Clinical Trials Product Development and Innovation Global Perspectives Policy Regulatory Science Product Safety Special Populations
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