Pharmacovigilance and the digital world in Italy: presentation of the results of a national survey.
Pharmacovigilance and the digital world in Italy: presentation of the results of a national survey.
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DOI：
10.1177/2042098620985991
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发表时间：
2021
影响因子：
4.4
通讯作者：
Romano S
中科院分区：
文献类型：
--
作者：
Stagi L;Bocchi I;Bianco S;Sirizzotti G;Bernardini D;Calderazzo V;Pirisino G;Grisoni I;Romano S
近年来，数字世界经历了一次根本性的变革，使得信息的轻松共享成为可能，包括与药物警戒以及药品和其他医疗保健产品安全性相关的信息。这些新的互动方式给医疗保健/制药公司带来了机遇和挑战。意大利药物医学学会（SIMeF）药物警戒工作组“Ernesto Montagna”决定开展一项调查，以更好地了解药物警戒在数字活动中的作用。药物警戒工作组“Ernesto Montagna”通过计算机辅助网络访谈（CAWI）技术向药物警戒工作组成员（N = 257）发送了一份调查问卷。该问卷由四个集群的11个问题组成，探讨：（i）医疗保健/制药公司实施的数字渠道和项目;（ii）数字渠道和项目的治理工具;（iii）从数字渠道和项目收集的不良事件的管理;（iv）人工智能对药物警戒活动的影响。“Ernesto Montagna”小组的93名成员填写了调查表。结果显示，在意大利医疗保健/制药公司的全景中，数字化活动正在进行中，但仍存在不确定性：药物警戒团队何时应该参与，治理工具以及用于确保数字化项目有效治理的指南。在一个发展非常迅速的情况下，一个关键因素是是否有具体的和最新的条例。科学协会，如SIMeF和Farmindustria，意大利国家制药公司协会，可以与主管当局一起为制定适当的指导意见作出宝贵的贡献。 意大利药物警戒和数字世界调查的结果背景：数字世界允许并使信息共享变得容易，包括与患者健康状况和药物副作用有关的信息。医疗保健/制药公司面临着患者和医疗保健专业人员之间这种新的互动方式所带来的机遇和挑战。意大利药物医学学会（SIMeF）的药物警戒工作组“Ernesto Montagna”进行了一项调查，以更好地了解药物警戒在数字活动中的作用。方法：药物警戒工作组“Ernesto Montagna”向药物警戒工作组的257名成员分发了一份调查问卷。调查问卷由11个问题组成，探讨了：（i）公司实施的数字渠道和项目;（ii）数字渠道和项目的治理工具;（iii）从数字渠道和项目收集的不良事件的管理;（iv）人工智能对药物警戒活动的影响。结果：93名成员完成了问卷调查。结果显示，意大利医疗保健/制药公司正在进行数字化活动。尽管如此，仍然存在不确定性，特别是：药物警戒团队何时应该参与，以及用于确保数字项目有效治理的工具和指南。结论：在快速发展的情况下，一个重要因素是直接和更新的制药法规和指南的可用性。科学协会，如SIMeF和Farmindustria，意大利国家制药公司协会，可以与合格的当局一起为制定适当的指导意见做出宝贵的贡献，以便协调和标准化制药公司之间的方法。
The digital world has undergone an essential metamorphosis in recent years, making the easy sharing of information possible, including those related to pharmacovigilance and the safety aspects of pharmaceutical and other healthcare products. These new interactive ways pose both opportunities and challenges to healthcare/pharmaceutical companies. The Pharmacovigilance Working Group “Ernesto Montagna” of the Italian Society of Pharmaceutical Medicine (SIMeF) decided to carry out a survey to gain a better understanding of the role of pharmacovigilance in digital activities. The Pharmacovigilance Working Group “Ernesto Montagna” sent a questionnaire via Computer-Assisted Web Interview (CAWI) technology to the members of the Pharmacovigilance Working Group (N = 257). The questionnaire was composed of 11 questions in four clusters exploring: (i) digital channels and projects implemented by the healthcare/pharmaceutical companies; (ii) governance tools in place for digital channels and projects; (iii) management of adverse events collected from digital channels and projects; (iv) impact of artificial intelligence on pharmacovigilance activities. Ninety-three members of the Group “Ernesto Montagna” completed the questionnaire. The results show that, in the panorama of Italian healthcare/pharmaceutical companies, digital activities are ongoing, but there are still areas of uncertainty: on when a pharmacovigilance team should be involved, on the governance tools and on the guidance to be used to ensure effective governance of digital projects. In a scenario which is evolving very quickly, a critical factor is the availability of specific and updated regulations. Scientific societies, such as SIMeF and Farmindustria, the Italian national Pharma-Companies Association, could give a valuable contribution to the development of appropriate guidance together with the competent authorities. Results of an Italian survey on pharmacovigilance and digital world Background: The digital world allows and makes the sharing of information easy, including information related to the health status of patients and side effects of drugs. Healthcare/pharmaceutical companies are faced with both opportunities and challenges provided by such new ways of interaction among patients and healthcare professionals. The Pharmacovigilance Working Group “Ernesto Montagna” of the Italian Society of Pharmaceutical Medicine (SIMeF) carried out a survey to gain a better understanding of the role of pharmacovigilance in digital activities. Methods: The Pharmacovigilance Working Group “Ernesto Montagna” distributed a questionnaire to the 257 members of the Pharmacovigilance Working Group. The questionnaire was composed of 11 questions exploring: (i) digital channels and projects implemented by the companies; (ii) governance tools in place for digital channels and projects; (iii) management of adverse events collected from digital channels and projects; (iv) impact of artificial intelligence on pharmacovigilance activities. Results: Ninety-three members completed the questionnaire. The results show that digital activities are ongoing in the Italian healthcare/pharmaceutical companies. Despite this, there are still areas of uncertainty, in particular: on when pharmacovigilance team should be involved and on the tools and guidance to be used to ensure effective governance of digital projects. Conclusion: In a scenario that is evolving very quickly, an important factor is represented by the availability of straightforward and updated pharma-regulations and guidelines. Scientific societies like SIMeF and Farmindustria, the Italian national Pharma-Companies Association, could give a valuable contribution to the development of appropriate guidance together with the qualified authorities, in order to coordinate and standardize the approach among pharmaceutical companies.