Department of Pharmacy, University of Copenhagen, Copenhagen Centre for Regulatory Science, Universitetsparken 2, 2100, Copenhagen, Denmark.
Department of Pharmacy, University of Copenhagen, Social and Clinical Pharmacy, Copenhagen, Denmark.
Ther Innov Regul Sci. 2020 May;54(3):631-639. doi: 10.1007/s43441-019-00097-z. Epub 2020 Jan 6.
Despite the regulatory requirement for cooperation between marketing authorization holders (MAHs) and European Medicines Agency (EMA) in the direct healthcare professional communication (DHPC) preparation, no literature has explored DHPCs from an industry-regulator perspective. This constitutes a significant knowledge gap as any possibility of improving current DHPC effectiveness depends on decisions in the cooperative preparation phase. Thus, this EU-centered study explores differences in perceptions and experiences of DHPCs of European MAHs and EMA.
European MAHs ([Formula: see text]) and EMA representatives ([Formula: see text]) were interviewed. The verbatim transcripts were coded into themes using NVivo software. Interview analysis was performed following a phenomenological approach of meaning condensation.
The DHPC process was perceived as burdensome by the industry. One company stated the process was time-consuming either due to EMA's internal lengthy approval process or the translation activities with local company affiliates and national competent authorities. Three companies stated that DHPCs were not effective. One company stated that DHPCs are sent out due to legal Obligations and not because of their use as a risk minimization measure (RMM). Newly emerged safety concerns were found difficult to phrase. Optimization proposals included improved timelines, scrutinization of healthcare professionals and better communication tools in clinical practice.
DHPCs were not perceived as optimal, although the most effective intervention as it targets healthcare professionals directly. Continuous evaluation by EMA of DHPCs and evaluation on how to reach healthcare professionals are necessary. It is believed that industry perceptions from this study can support EMA with improved regulatory decision making to benefit public health.
尽管监管要求营销授权持有人（MAHs）与欧洲药品管理局（EMA）在直接医疗专业人员沟通（DHPC）准备方面进行合作，但没有文献从行业监管者的角度探讨 DHPC。这构成了一个重大的知识空白，因为任何提高当前 DHPC 效果的可能性都取决于合作准备阶段的决策。因此，这项以欧盟为中心的研究探讨了欧洲 MAHs 和 EMA 对 DHPC 的看法和经验差异。
对欧洲 MAHs（[公式：见文本]）和 EMA 代表（[公式：见文本]）进行了访谈。使用 NVivo 软件将逐字记录的转录本编码为主题。访谈分析遵循意义浓缩的现象学方法进行。
DHPC 流程被业界视为繁琐。一家公司表示，由于 EMA 内部冗长的审批流程或与当地公司分支机构和国家主管当局的翻译活动，该过程耗时耗力。有三家公司表示 DHPC 效果不佳。一家公司表示，DHPC 是出于法律义务发出的，而不是因为将其用作风险最小化措施（RMM）。新出现的安全问题难以措辞。优化建议包括改善时间表、审查医疗保健专业人员以及在临床实践中使用更好的沟通工具。
DHPC 虽然是直接针对医疗保健专业人员的最有效干预措施，但并未被视为最佳措施。EMA 有必要对 DHPC 进行持续评估，并评估如何接触医疗保健专业人员。相信这项研究中的行业观点可以支持 EMA 做出改进的监管决策，造福公众健康。
