Almost every industry has embraced the unique opportunities offered by social media to engage their customers and community in a two-way conversation while implementing innovative, real-time marketing initiatives. So, why are many pharmaceutical companies reluctant to join the social media party?
Social media participation is still surrounded by a number of question marks for the heavily regulated pharmaceutical industry. The industry’s regulator, the Food and Drug Administration (FDA), and their equivalents in Europe and Asia have yet to provide clear guidance on how the rules currently in place (most of which were originally drafted without social media in mind) apply in a social media context. The complexity for global pharmaceutical companies is further multiplied by the very varied regulatory approaches in different markets.
Despite this, some pharmaceutical companies have already taken the leap into listening to social media conversations, having realized that there’s a huge amount of value to be gained from having a real-time, unvarnished view of medical professionals’ experiences of working with them and the patient journey surrounding different therapeutic areas. In doing so, they have ensured that they have the right listening tools and processes in place to satisfy Adverse Event reporting requirements.
Find Out Where Patients Are Discussing Your Products
Find out where your community lives, and listen. Social media provides a unique new platform and opportunity for learning about patients safety concerns, questions or comments. Patients are turning to open-access chats such as health advocacy group sites, Facebook, and Twitter to share stories, symptoms, and reviews on various products. Listen to the chats and conversations – and look for any red flag mentions of your products or services. You can capture patient data of interest; but you can also capture additional data that may include safety-related information, which may need to be reported as adverse events.
Children with Diabetes is an online community for parents, children, adults, and families living with type 1 diabetes. The site offers advice from health professionals, gives updates on research progress and provides care suggestions. A forum with over 600,000 conversations is available for visitors.
Implement An Alerting System For Adverse Events
Use a monitoring solution that is capable of implementing a system of automatic alerts based on chosen keywords. These alerts will notify the department in charge of pharmacovigilance immediately – allowing them to take the necessary measures quickly.
UCB‐Sponsored Patients Like M e Epilepsy Community deployed a system for finding and reporting adverse events found in their online community to FDA “UCB has an ethical and legal responsibility to report adverse events associated with our drugs. If adverse events for any UCB drugs are mentioned on the site, UCB is required to report these directly to the U.S. Food and Drug Administration (FDA). Therefore, we are working to develop and deploy a solution that will allow us to assess and process potential adverse events, report them to the FDA, and capture them in the UCB safety database.” — Peter Verdru, MD, UCB’s Vice President of Clinical Research
Develop An Adverse Event Decision Tree
Create an adverse event decision tree to give your team a clear process; define what adverse events are, and provide the questions to ask to find out which mentions are adverse events, and solid instructions on when to report an adverse event.