A nonsteroidal anti-inflammatory drug withdrawn in 2004 attracted a whopping $6 billion in financial damages. A similar drug recalled in 2005 resulted in $2 billion in damages.

There have been several instances where products were recalled for severe risk factors leading to penalties over a billion dollars. As newer treatment options (new chemical and biological entities) are being developed for various diseases, there is an increased focus by regulators to provide utmost safety to patients.

Question is, can these damages be preempted and corrective steps taken to save penalty and provide better patient safety?

Drugs go through a rigorous testing and evaluation mechanism during clinical trial and post market surveillance. Clinical trials, limited to a few thousand patients, do not provide enough information on all potential side effects of a particular drug. Data generated during post market surveillance directly from patients and healthcare practitioners help identify and evaluate associated side-effects of the drugs. However, this is at a stage where the damage has already reached a significant level. Clearly, there is a need to bring a reform to identify side-effects at an early stage leading to increased patient safety and decrease in losses.

Keeping this need in view, regulatory bodies are collaborating with websites and applications such as MedWatcher and PatientsLikeMe for safety reporting. These platforms, through free tools, give patients and physicians the power to submit adverse event reports to the FDA. These tools also provide rich information on drugs safety parameters. In addition to this, the safety ecosystem can further be strengthened by using social media based on availability of real time information on it.

While regulatory bodies have not yet structured the guidelines for monitoring adverse drug reactions (ADRs) using social media, there are concerted efforts in this direction. These bodies have started viewing social media as an important platform that connects various stakeholders including pharmaceutical companies, researchers, doctors and patients.

Companies need to develop their own strategies for sustainable engagement with consumers by framing guidelines for online interactions and messaging. An effective social media model will allow them to create a strategic pharmacovigilance practice that is less reactionary, process-intensive or resource-heavy. It will help them become a proactive agent for patient safety. Specifically, it will make them future-ready, once social media policies are mandated by regulatory bodies.

Powering Pharmacovigilance with Social Media Model

Pharmaceutical and biotechnology companies can leverage the growing popularity of social media business intelligence in identifying adverse events and respond in time. It is an excellent tool to listen into consumer conversations, feedback and complaints and take the right corrective action. Social media is also a powerful medium to educate consumers about products regarding their benefits as well as side effects. Such awareness will only go on to build trust and acceptance. Of course, all the adverse event data collected can be analysed to identify the key unmet need of the market and help research to identify areas to improve or innovate the products.

There are four main steps to creating a sustainable engagement with your consumers. The first is to identify the right keywords that your audience is using to search for you. Next, listen into their conversations and feedback keenly, and this can be done through social forums, blogs and other literature. Thirdly, leverage reporting and analytics on the captured data and finally, respond creatively and leverage this medium to generate awareness and address their problems.

The four pillars of social media-powered pharmacovigilance

Establish Keywords

• Understand the buying psyche of patients and physicians and how they are influenced by their peers
•  Identify KPIs and list keywords that reflect product-related side effects
• Input keywords in technology platform, Google Alerts, social media mentions
  

Listen

• Observe product related mentions and identify triggers
• Monitor real-time dashboards and segregate content
• Classify mentions into side effects and positives
•  Identify opportunities to engage

Engage

• Participate in conversations
• Identify users who could be reached to gather additional information
• Address concerns and provide required product information (within SLA terms)
•  Alert in case of escalation for early response and resolution

Reporting and Analytics

• Social CRM tracking
• Close to real time dashboards with intuitive insights and integrated view with internal safety data
• Risk identification and signal detection
• Support in fine-tuning marketing strategy

How can companies benefit from the model?

It is widely accepted that safety and efficacy of products gives companies a competitive advantage to increase market share. Engaging with consumers directly to address their complaints and issues regarding adverse events will ultimately allow companies to boost their patient safety policies. This will help them benefit from both, earning credibility as well as commercial aspects.

Simply put, adopting a social media strategy ensures the company’s future readiness to meet the regulatory body’s mandates for safety reporting, while it also helps them protect the brand’s reputation.

Identify early risk and signal detection

• Access to real time information related to product side effects, trending topics, influencers and competition actions
• Robust signal detection process by providing additional data from real world

Minimize Online Reputation Risk

•  Prompt identification and collection of published mentions across multiple sources
•  Minimization of potential of risk magnification to threats though prompt response
• Enhancing advocacy through real time resolution of concerns expressed

Manage Adverse Events

Converting side effects mentioned to adverse events by gathering the following additional information and reporting to internal system:

• Identifiable patient
• Identifiable reporter
• A specific drug or biologic involved in the event
• Adverse event or fatal outcome

Social media platforms are designed to increase human connections between companies and consumers. Companies must adopt an open approach that focuses on listening, spreading awareness, building trust, and improving health outcomes. This creates a win-win situation for both, the companies receiving signal detection as well as the consumers who get more access to information.