Re: Social networks, social media, and social diseases
The otherwise comprehensive review by Coeira overlooks the potential of social networks in facilitating patient safety event reporting.
Patient-reported outcomes (PROs) encompass the full range of self-reporting, rather than only patient reports collected by clinicians using validated instruments. In recent years social media stimulated PROs have become increasingly important across the spectrum of healthcare and life sciences. Patient-centred models of care are integrating shared decision making and PROs at the point of care; comparative effectiveness research seeks to include patients as participatory stakeholders; and industry is expanding its involvement with patients and patient groups as part of the drug development process and safety monitoring. Additionally, recent pharmacovigilance legislation from regulatory authorities in the European Union (EU) and the United States (U.S.) calls for the inclusion of patient-reported information in benefit-risk assessment of pharmaceutical products. For patients, technological advancements have made it easier to be an active participant in one’s healthcare. Simplified internet search capabilities, electronic and personal health records, digital mobile devices, and PRO-enabled patient online communities are just a few examples of tools that allow patients to gain increased knowledge about conditions, symptoms, treatment options and side effects of products used to manage conditions.
Despite this increased attention and the perceived value of social media, their full potential has yet to be realised in pharmacovigilance. Current safety reporting and risk assessment processes remain heavily dependent on healthcare professionals, even in the face of known limitations such as underreporting and discordant perspective between patient reports and clinician perceptions of adverse outcomes.
We have proposed a framework  to differentiate patient populations which considers populations that are prespecified such as those in clinical trials, observational studies and some registries; and non-prespecified populations such as those in claims databases, PRO-enabled patient support sites, and social websites in general (Figure). While the main focus of this guidance is on post-approval PRO-AEs from both prespecified and non-prespecified population groups, PROSPER has also considered pre-approval, prespecified populations.
Because of the clinical relevance of real world data, social media have the potential to contribute important new knowledge about the benefits and risks of medicinal products, communicated through the voice of the patient.
Banerjee AK, Ingate S. Web based patient report outcomes in drug safety and risk management- challenges and opportunities? Drug Safety 2012; 35: 437–446
Competing interests: AKB convened and chaired the patient reported outcomes in safety event reporting (PROSPER) consortium, which has developed guidliens and a minimum data set for safety reports collected through social media