Editor?s note: This guest post is the second in a series from Larry Taber, BP3?s Digital Strategy Officer for Life Sciences and Pharma.?Larry has over 32 years of deep pharmaceutical and biotech expertise ranging from discovery research to business development. He has over 17 years of leadership of international teams successfully partnering with over 100 companies. Larry is a proven business process problem-solving professional and trainer. He has completed Master Black Belt, Black Belt, and Malcolm Baldrige National Quality Award /Performance Excellence Examiner certifications. He is passionate about the incredible advances in medical science and the enablement that is being made possible for patients through digital technologies. He holds a M.S. in Medical Biochemistry from Indiana University Medical School and a B.S. in Chemistry (Magna Cum Laude) from Purdue University.]
Long gone are the days of phoning a call center or even the long wait until your next visit to your doctor to describe that you are not feeling quite right on your medications. Like 500+ million people around the globe, you now you swipe across to your favorite social media healthcare site to see what others say about the medication you are taking and what they are experiencing.
Suddenly, pharmacovigilance professionals, long frustrated by under-reported adverse events and too little data to understand how patients experience medicines in the real world, are finding themselves with the opposite problem. Too much data too fast!
Since the World Economic Forum in 2016, the focus of leaders from countries around the world is that we are now experiencing a fusion of physical, digital, and biological systems of exponential proportions. As Klaus Schwab, Founder and Executive Chairman, World Economic Forum, explains, experts believe this is a disruptive force for change far greater than the combined impacts of the prior industrial revolutions and unimaginable advances for humankind.
" target="_blank" rel="noopener">Industrial Revolution 4.0 World Economic Forum
Nowhere has this been more evident than in the field of health care. For pharmacovigilance, the digital capabilities explosion created an initial period of rapid expansion and divergence which is now being followed by convergence.
The initial divergence is evidenced in a plethora of websites and services that have emerged for Adverse Event (ADE) reporting, case tracking, and also by a proliferation of pharmacovigilance databases. A 2016 review Adverse event reporting systems: a systematic review Br. J Clin Pharmacol found 108 ADE reporting systems containing 1782 unique reporting fields. The sheer numbers of players and systems have and will continue to contribute to the growth in ADEs reported.
And now, again enabled by digital technology, a new trend toward convergence and harmonization has picked up steam over the past 3 to 5 years. The above study and many others have created widespread agreement for the need to develop standardized ADE reporting, data collection, and safety surveillance practices. Numerous efforts are underway to assimilate and intelligently aggregate data which will accelerate convergence.
All of this is happening while the core process of pharmacovigilance itself is being turned inside out by the newest digital technologies, such as:? chat bots, robotic process automation, end-to-end digitization, cognitive routing and classification, natural language processing, machine learning, artificial intelligence, and more.
When a wearable device combined with electronic health records and real-time patient-reported symptoms or events is shared across healthcare providers and pharma companies, Industry 4.0 becomes ?Pharma 4.0?. This is the convergence of physical, digital, and biological systems that will transform pharmacovigilance. It will altogether change how we ensure patient safety and expand our knowledge about positive patient experiences at a speed we have never seen before.
For more on Pharmacovigilance register for our upcoming webinar:?Next Generation Pharmacovigilance, happening Wednesday, October 3 at 10 AM (CST). We will present a variety of quick wins that can immediately improve quality, speed, accuracy, risk management and more. Click?here?to sign up.