Background

Suggate, D. Layton, D. Brown.

Patient adverse event reports (PAER) reports have been shown to positively contribute to the ongoing benefit: risk versus assessment of medicines. In response to the rapid expansion of social media, PAER from web-based sources have the potential to be exploited as alternative sources that may, if extracted and analysed appropriately, provide complementary data to that obtained from routine pharmacovigilance (PV) activities.

Objectives

To collect and assess the attitudes of PV professionals regarding the utilisation of safety data from social media for PV purposes.

Methods

A cross-sectional survey was conducted between August to September 2014 inclusive using web-based tool (Survey MonkeyTM) using a format of open/closed and Likert scale based questions, to gather anonymous information at an international level of PV professional characteristics (profession, work place and PV experience) and opinions on the value, quality, benefits and challenges of utilising PAER data obtained via social media. For PV professionals working in pharmaceutical industry (pharma), information was also requested on operational activities such as how such data were being gathered. The University of Portsmouth Science Faculty Ethics Committee (ref 17/7/14) provided study approval. Eligible participants comprised 5329 PV professionals from pharma, regulator and academic backgrounds registered on a mailing contact database. Data confidentiality was assured by the survey being managed by the database manager independent of the investigators. Data analysis comprised qualitative thematic evaluation and quantitative descriptive statistics.

Results

197 participants (3.7% eligible) responded from a wide range of professional backgrounds – the most frequent being from academia (n=44, 22.3% responders), from pharmaceutical industry sector (n=143, 72.6%), and with less than 10 yrs experience (n=118, 59.8% responders). Where specified, 74.8% (107/143) believed PAER data obtained via the internet have the potential to contribute valuable information to the benefits and risks of medicines in a real-world context; 68.2% (118/173) agreed that such data provided an opportunity to increase the amount of safety data and also specifically inform on how adverse events affect quality of life. Concerns included data quality, burden on resourcing and relevant guidance. Of 112 PV pharma professionals, 34 (30.4%) reported awareness of their company engaging in activities such as searching non-company sponsored websites (digital ‘listening’).

Conclusion

197 participants (3.7% eligible) responded from a wide range of professional backgrounds – the most frequent being from academia (n=44, 22.3% responders), from pharmaceutical industry sector (n=143, 72.6%), and with less than 10 yrs experience (n=118, 59.8% responders). Where specified, 74.8% (107/143) believed PAER data obtained via the internet have the potential to contribute valuable information to the benefits and risks of medicines in a real-world context; 68.2% (118/173) agreed that such data provided an opportunity to increase the amount of safety data and also specifically inform on how adverse events affect quality of life. Concerns included data quality, burden on resourcing and relevant guidance. Of 112 PV pharma professionals, 34 (30.4%) reported awareness of their company engaging in activities such as searching non-company sponsored websites (digital ‘listening’).