Pharmacovigilance (PV) experts have called for implementation of a more effective PV process through use of right technology and digital media to improve patient safety.  The successful exploitation of innovative technologies and social media platforms will help pharmaceutical industry to lower the cost as well as adverse event (AE) detection timelines.

In a bid to improve patient safety, the pharma companies need to adopt three-pronged strategies-- making best use of available technology, engaging caregivers in shared decision making and incorporating patient voice, said Gunjan Jain, CEO & Founder, Vytal Healthtech Pvt Ltd.

Digitized medicines, patient apps, cloud based solutions, automation, artificial intelligence, big data, proactive PV are some of the innovations which needs to be adopted by drug companies to strengthen PV process at reasonable expense, said Jain.

Digitized medicines are smart pills with ingestible sensors. They can be used to track and collect patients’ health data, which can be used to run analytics for AE detection. Patient centric mobile apps can enable pharma companies to collect ADR data much more quickly. Cloud-based databases can enable pharma companies to collect data from multiple stakeholders to build an integrated ADR repository – even at a global level. Automation solutions will help pharma companies process structured data much more rapidly than via manual efforts. It can be employed for risk-benefit evaluation, signal assessment, social media surveillance, literature monitoring. Artificial intelligence will help pharma companies to move beyond basic automation by identifying patterns in unstructured data such as social media posts, sales representatives' notes, surveys, emails, patient apps, PDF articles, call centres, said Jain who is also Director - Strategic Advisory at Techsol Corp.

A future is likely to include additional requirements and increased emphasis on safety data gleaned from social media and industry sponsored websites, he opined.

Social media posts are crucial for augmentation of existing data sources for monitoring the safety of consumer health products. Big data analytics can help pharma companies use the vast amount of digital data available on the Internet (e.g., on Facebook and Twitter, and in patient forums) to supplement traditional data sources such as primary calls, electronic health record data, and claims data for AE detection.

He said companies need to adopt proactive PV approach which helps solve a problem before it actually becomes one. Robust IT solutions and advanced systems can help pharma companies monitor drug safety during the research and trials process and post-launch.

While sharing patient engagement initiatives of Europe and US in pharmacovigilance, he said “In Europe, WEB- RADR has been launched to detect new drug side effects by mining publicly available web and social media content. As part of WEB- RADR, three countries including UK, Croatia have launched a mobile application where patients will be able to directly report potential medicine side effects and also receive reliable information on their drugs, medicine manufacturers and regulators will be able to intervene earlier in case of adverse drug reactions (ADRs), and thus reduce potential harm to patients. Sentinel initiative has been launched in USA. The Sentinel System uses a distributed data infrastructure approach which allows the FDA to rapidly and securely access electronic healthcare data from over 193 mn patients from multiple data partners, while securing the privacy of patients.”

Dr Dave Lewis, Senior Adviser Pharmacovigilance, GDD, Novartis said “There is a great potential for signal detection using aggregated data from digital media sources. Sponsors are primarily using social media for commercial purposes to distribute information about medicines (to healthcare professionals and non-HCPs); diseases, and the treatment of disease; company matters including announcements; and to listen to patient and professional conversations about marketed medicines, and not to support clinical research.”

Seven of 10 social media posts contain adverse event information (0.68). It can increase to 100% with manual curation (varies by product). Marketing authorisation holders mainly uses digital media media for marketing and sales. A minority of companies use social media for patient engagement and patient recruitment and retention within clinical trials.

He said potential for two-way interactions is hard to ignore, so mobile reporting capabilities will increase. There are risks to manage but in return MAHs must offer real benefits or advantages to patients. He hoped MAHs will develop social media sites rapidly for PV.