A Principles Framework for Digital Provision of Medical Information for Healthcare Professionals.

IF 3.1 Q2 PHARMACOLOGY & PHARMACY Pharmaceutical Medicine Pub Date : 2023-03-01 DOI:10.1007/s40290-023-00464-0
Susan Mohamed, Sarah Dunnett, Angela Flores, Eva Loew, Stefne Pienaar
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引用次数: 1

Abstract

European pharmaceutical companies have a legal requirement to provide non-promotional medical information (MI) services to support healthcare professionals (HCPs) using their medicinal products. While we are seeing an increased HCP preference and expectation towards digital channels, the lack of a compliance framework relating to the provision of non-promotional MI services is a key factor complicating and compromising the ability for companies to meet this need. Meanwhile, the internet is dominated by a large volume of unregulated, easy access, and potentially low-quality information from diverse sources. The Medical Information Leaders in Europe (MILE) association is therefore proposing a framework of principles to support pharmaceutical companies with the digital provision of MI services; these relate to digital access to non-promotional, medicinal product information to support clinical decision making and patient care. The three established European national MI associations have already considered the framework and expressed their endorsement. MILE continues to invite stakeholders, including pharmaceutical companies, regulators, national industry associations and healthcare professional bodies to engage and help refine and implement this framework. This publication does not constitute legal advice; decision making and accountability remains with each pharmaceutical company.

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医疗保健专业人员数字化医疗信息提供的原则框架。
欧洲制药公司有法律要求提供非促销性医疗信息(MI)服务,以支持医疗保健专业人员(hcp)使用其药品。虽然我们看到HCP对数字渠道的偏好和期望越来越高,但缺乏与提供非促销性MI服务相关的合规框架是使公司满足这一需求的能力复杂化和妥协的关键因素。与此同时,互联网被大量不受监管的、容易获取的、来自不同来源的潜在低质量信息所主导。因此,欧洲医疗信息领导者协会(MILE)正在提出一个原则框架,以支持制药公司以数字方式提供医疗信息服务;这些涉及非促销药品信息的数字化访问,以支持临床决策和患者护理。三个已成立的欧洲国家MI协会已经审议了该框架并表示赞同。MILE继续邀请包括制药公司、监管机构、国家行业协会和医疗保健专业机构在内的利益相关者参与并帮助完善和实施这一框架。本出版物不构成法律意见;决策和问责仍然由每个制药公司负责。
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来源期刊
Pharmaceutical Medicine
Pharmaceutical Medicine PHARMACOLOGY & PHARMACY-
CiteScore
5.10
自引率
4.00%
发文量
36
期刊介绍: Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
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