Using social media as the patient's voice in the benefit-risk assessment of drugs: Are we ready?

Toussi, Massoud; James, Lisa Chamberlain; Breckenridge, Sir Alasdair

doi:10.1179/2047480615z.000000000289

Cited by 2 publications

(3 citation statements)

References 7 publications

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“…MAHs may ‘listen to’ user-generated content from key healthcare opinion leaders or patient group representatives for a defined period of time [ 36 ]. Other examples are patient-reported outcomes from web-based sources, which are becoming increasingly important since they provide opportunities for pharmaceutical industry and medicines regulators to understand the benefits and risks of medicines in a real-world context [ 15 ]. These trends are indicative of an increasing use of social media to support safety monitoring and for which a regulatory framework is needed (see Sect.…”

Section: Discussionmentioning

confidence: 99%

“…The use of social media and associated regulatory challenges are becoming widely discussed. Whilst some experts believe that monitoring of the safety of medicines via social media could prove to be an efficient and expeditious means of post-market safety surveillance overcoming limitations of traditional ADR reporting systems [ 14 ], others stress that ADR reporting methodologies could add social media as a source of information for the benefit–risk evaluation of medicines [ 15 ].…”

Section: Introductionmentioning

confidence: 99%

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Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe

Brosch¹,

Ferran

Newbould³

et al. 2019

Drug Saf

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The Innovative Medicines Initiative (IMI) WEB-RADR (Web-Recognising Adverse Drug Reactions) project looked at opportunities and challenges in using social media in pharmacovigilance as a rapidly evolving source of large, real-time data, which could provide new information on the actual use of medicines and potential safety issues. Two of the objectives were to develop principles for continuous monitoring of the safety of medicines without overburdening established pharmacovigilance systems and to propose a regulatory framework on the use of social media in pharmacovigilance. As a starting point, a review of existing legal requirements and regulatory guidance on social media use in pharmacovigilance was performed based on a survey conducted in 2014–2015. Furthermore, input from two large stakeholder workshops and evidence gathered from the research performed by WEB-RADR on the analysis of social media data were taken into consideration. Whilst analytical results of WEB-RADR indicated limited value of social media in detecting or confirming signals for a majority of the drugs studied, it is important to establish a regulatory framework for the use of social media in pharmacovigilance. Thus, the screening and reporting of suspected adverse reactions remains an important pillar in monitoring the safety and efficacy of medicines and the identification of new safety issues. Principles as to how social media can be used in pharmacovigilance are absolutely needed to provide clarity to patients, healthcare professionals, medicines regulators and the pharmaceutical industry. Electronic supplementary material The online version of this article (10.1007/s40264-019-00811-8) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe

Brosch¹,

Ferran

Newbould³

et al. 2019

Drug Saf

View full text Add to dashboard Cite

show abstract

“…17 Traditional research on beliefs and attitudes relies on surveys, 18,19 interviews, or focus groups. 9 However, social media may allow the patient voice to be heard 20 as well as provide additional data from a wider patient perspective and include patients reluctant to participate in research. In addition, social media posts can be collected in almost real time and are spontaneous; thus, they may be more likely to reflect true beliefs than research, which relies on interrogation.…”

Section: Introductionmentioning

confidence: 99%