Abstract
Background: The benefits of using social media for Adverse Drug Reaction (ADR) reporting are slowly becoming recognised, not just amongst regulatory authorities but also the pharmaceutical industry stakeholders and Healthcare Professionals (HCPs). If utilized correctly, ADR reporting and monitoring via social media could potentially prove to be an efficient and expeditious means of post-market safety surveillance and overcome limitations of traditional ADR reporting systems such as under-reporting. Objectives: The purpose of the study was to determine the attitude and behaviour of the pharmaceutical industry, HCPs and the general public towards the concept of using social media as a tool for ADR reporting and monitoring. Methods: A cross-sectional study was carried out on 17 pharmaceutical companies, 46 HCPs, and 100 members of the general public. Surveys were distributed, comprising of questions designed to elicit significant responses from the participants, in relation to the concept of using social media for Pharmacovigilance purposes. Results: 83% of the general public participants agreed that patients would be more inclined to report suspected ADRs via social media, if the correct measures were in place. 63% of the HCPs believed that the concept of utilising social media for patient safety purposes would be feasible. 71% of the pharmaceutical companies stated they would consider this concept feasible from a legislative and industry perspective. Ethical and confidentiality issues were of the most common concerns amongst the various populations. Conclusion: The results from the study indicate that a collaborative effort is required between the pharmaceutical industry, HCPs and the public before social media can reach its full beneficial potential as a tool in Pharmacovigilance. The study also shows that there is still a need to promote the importance of ADR reporting to the general public while additional regulatory guidelines may also be required to ensure the engagement of HCPs and pharmaceutical companies in reporting and monitoring ADRs on social media.
Highlights
BackgroundPost-marketing safety surveillance involves a framework of various stakeholders that work together to optimise patient safety
An essential aspect to determining the attitude of the general public, was to ascertain which key patient-safety stakeholders would they feel comfortable utilising health information which they have posted online. 72 (72%) of the total respondents stated that they would be comfortable giving consent to Healthcare Professionals (HCPs), 51 (51%) said they would give consent to health authorities, while only 34 (34%) said they would be comfortable with pharmaceutical companies using their posted information. 16 (16%) expressed that they would not feel comfortable giving consent to any of these individuals or organisations to utilise their health-related information (Figure 1)
Recent advances in data analytics and the introduction of the WebRADR initiative will facilitate the tracking of trends from data captured in digital and social media
Summary
Post-marketing safety surveillance involves a framework of various stakeholders that work together to optimise patient safety This includes regulatory authorities, pharmaceutical companies and HCPs. Regulatory authorities provide legislation and guidelines on the reporting requirements of ADRs for Marketing Authorisation Holders (MAHs). It is well established that post-marketing safety surveillance relies heavily on spontaneous adverse event reporting [2] This method of reporting has been associated with many limitations, primarily being a causative factor for the significant under-reporting of ADRs [3]. Regulatory authorities and the pharmaceutical industry have mainly relied on these traditional systems in pharmacovigilance, but in recent years, there has been development in implementing new techniques and safety tools for ADR monitoring and reporting. The benefits of using social media for Adverse Drug Reaction (ADR) reporting are slowly becoming recognised, not just amongst regulatory authorities and the pharmaceutical industry stakeholders and Healthcare Professionals (HCPs). ADR reporting and monitoring via social media could potentially prove to be an efficient and expeditious means of post-market safety surveillance and overcome limitations of traditional ADR reporting systems such as under-reporting
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