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Harnessing Social Media Monitoring for Pharmacovigilance Laura Calao Jean Christophe Lahary Agenda 1. Pharmacovigilance in a nutshell 2. Social media monitoring and pharmacovigilance • Why take an interest? • What are the concrete benefits? 3. Social media monitoring – Best practices 4. Questions & answers LexisNexis – The Information Specialists 2 What is pharmacovigilance? “the science and activities related to the detection, assessment, understanding and prevention of adverse drug effects or any other possible drug-related problems” --WHO Patients • Improving the care given to patients and patient management • Keeping patients safe while using medication and during medical and paramedical procedures Public health • Protecting the health and safety of communities in the use of medication Risk assessment • Taking part in an assessment of the benefits, harmfulness, effectiveness and risks of medicines Communication • Promoting knowledge and medical training and encouraging communication intended for (and between) healthcare professions and the general public LexisNexis – The Information Specialists 3 A strict regulatory framework 1963: First pharmacovigilance centre founded at the 16th assembly of the WHO 1995: 2004: 2010: 2012: Founding of the EMA Regulation 726/2004 Directive 2010/84/EU New European directive with regulation 1235/2010 and directive 2010/84/EU 2016: Work on the role of social media and the Internet 1906: 1938: 1962: 1997: 2014: Founding of the FDA Federal Food, Drug and Cosmetic Act Kefauver-Harris amendment Erice declaration Draft of the directive on social media LexisNexis – The Information Specialists 4 Intense pressure from the media LexisNexis – The Information Specialists 5 Examples for pharmaceutical market exits LexisNexis – The Information Specialists 6 A subject that remains complex 5% of feedback comes from the patients Globalisation • Globalisation of production, distribution and consumption E-commerce • Uncontrolled sale of drugs Safety and openness Education Developing generic products Emerging countries Social media • Change in practices and uses within society • Promoting good practices and sharing of information between stakeholders • Control of interactions and surveillance • Disparity in pharmacovigilance practices • New vigilance directives LexisNexis – The Information Specialists 7 Social media monitoring What for? What are the benefits? LexisNexis – The Information Specialists 8 Content created every 60 seconds LexisNexis – The Information Specialists 9 The Internet has changed our relationship with health Likelihood of sharing positive and negative health experiences via social media* Care received at hospital/ medical facility 44% Experience with medication/ treatment 43% Specific doctor, nurse, healthcare provider 42% Health insurer customer service 40% Cost of health insurance 37% Coverage by health insurer 36% Cost of care at a hospital/ healthcare provider 36% Positive Negative 40% 38% 35% 37% 35% 34% 35% *Consumers responding likely or very likely to share an experience using social media N = 1060 Source: PwC HRI Social Media Consumer Survey, 2012 LexisNexis – The Information Specialists 10 PV and SMM: similar bases • Better knowledge of product benefits and risks • Improved strategies for risk evaluation • Faster identification and communication of potential risks • Optimised communication in the event of a crisis, incorrect information about a product or detection of potential risks • Better educating healthcare professionals and customers • Improving relations between pharmaceutical companies, laboratories and patient communities LexisNexis – The Information Specialists 11 Benefits compared to “conventional” sources of information Actual conversations about what is being said of a brand, a competitor, or even a treatment area or a drug. Indirect and unguided conversations. Unlike in a conventional study, nobody guides the conversation. It is spontaneous. Millions of opinions can be heard in real time. The quantity of information available and the speed at which the information is accessed will never be possible in conventional studies. It is possible to detect weak signals and track opinionformers, critics and whistle-blowers LexisNexis – The Information Specialists 12 Social media monitoring Challenges and good practices to apply LexisNexis – The Information Specialists 13 Understanding the working of Social Media Monitoring USUAL CONVERSATIONS Questions, histories, crises, products, services, events, campaigns, disasters, etc. FLOW OF ACTIVITY & CONVERSATIONS SOCIAL MEDIA EXTRACTION OF INFORMATION TOOLS SOCIAL MEDIA MONITORING (SMM) DATA AGGREGATION ENHANCEMENT & STANDARDISATION DASHBOARD LexisNexis – The Information Specialists 14 Key stages to control Collection Which technologies? What enhancement? Which data? Which sources? Processing Analysis Which know-how? LexisNexis – The Information Specialists 15 Use good expertise LexisNexis – The Information Specialists 16 Go beyond known SM Do not get your sources wrong, because your conclusions will be incorrect as well. Monitoring Twitter is not enough... Rheumatoid arthritis Diabetes LexisNexis – The Information Specialists 17 Summary of good practices 1 2 3 4 5 Monitor your regulatory environment Look out for whistle-blowers and weak signals Do not stop at automatic analyses Pay attention to methodologies Use good expertise and train up your providers LexisNexis – The Information Specialists 18 Thank you for your attention Laura Calao LexisNexis [email protected] Jean Christophe Lahary LexisNexis [email protected]
