On April 7th, Advera Health Analytics moderated a roundtable discussion with drug safety industry experts to discuss the challenges in pharmacovigilance caused by the COVID-19 crisis.
COVID-19 is affecting all aspects of workflow including adverse event reporting, case intake and processing, and signal detection and management. To address these challenges, we brought together an all-star panel to openly discuss the challenges and offer some solutions and guidance.
The panel included:
Catherine Baldridge, Principal Consultant and Owner of Essential Pharmacovigilance, a company dedicated to providing expert consultancy, training, and services for companies who need assistance with their Clinical Safety & Pharmacovigilance activities.
Dr. Siva Kumar Buddha, an ER physician by training and a PV subject matter expert and safety physician at Indegene, a company that enables global healthcare organizations to address complex challenges and drive better health and business outcomes.
Dr. Murali Doraiswamy, a physician and highly cited clinical trials and pharmacovigilance researcher at Duke University School of Medicine where he serves as Professor of Psychiatry and Medicine.
Brian Overstreet, President and Founder of Advera Health Analytics, a company that provides Evidex, a cloud-based, software-as-a-service signal detection and management platform.
Suneet Walia, CEO and Founder of Soterius, a company that provides global safety, medical affairs, regulatory, and technology enabled solutions.
Dr. Sheila Weiss, the President and Founder of Avigilan, a small boutique consultancy that provides scientific and regulatory expertise and services that are required to identify, quantify, evaluate, articulate, and manage risks of regulated products.
Several main points were surfaced during the discussion:1. The transition to virtual and telemedicine is expected to slow adverse event reporting. We won’t see the effects immediately, but there could be real implications for patient safety
2. COVID-19 symptoms will increase the difficulty of adverse event reporting. The disease can mask potential drug side effects or a symptom could be mistaken for an adverse event. Mild symptomatic patients who haven’t been tested could further confound reporting.
3. When marketing authorization holders (MAH) are collecting adverse event reports, it is vital to collect as much information as possible. Follow up reporting will be difficult with reduced staff and patients with disease.
4. Pharmacovigilance operations are being forced to adapt to remote work. Business continuity plans are being tested, often for the first time. Everyone will have a lot of learnings on how the crisis affects operations. Both successes and failures need to be documented so that standard operating procedures can be adjusted.
5. National regulators are increasingly flexible with routine processes. However, documentation of all circumstances around reporting delays need to occur. Also, SOPs for delays need to be created and followed to ensure nothing slips through the cracks. While flexible now, future regulatory inspections will examine how the crisis was handled.
6. The transition to a distributed workforce is likely to continue, at least in part, as new waves of the crisis emerge. Further, as a result of COVID-19 companies will realize that full-time remote work is possible, even for mission critical roles such as pharmacovigilance. Could this help alleviate the talent shortage our industry is facing?
7. Organizations that have implemented SaaS and Cloud technologies for all aspects of pharmacovigilance workflow are better positioned than their peers who are relying on unstable VPN connections and not-fit-for-purpose tools. Those that don’t have the right systems in place will look to do so as we emerge from the crisis.
These are just some of the takeaways from the discussion. I encourage you to watch the entire recording. Please let us know if there are any questions or if Advera can help in any way.