The COVID-19 pandemic is ravaging the world in so many ways. It has affected and hit hard how clinical trials were done and managed in pre-COVID times. While the direct impact is definitely on patient recruitment and patient care, other areas like data collection, data safety, data analysis, and overall trial management are hugely impacted. While new guidance is getting issued for better management of clinical trials, it also means that sponsors need to be more vigilant and proactive in maintaining patient safety.
The COVID-19 infodemic
At this point, when a pandemic has taken over the world, monitoring drug safety is the topmost priority for the pharmacovigilance community. In the recent past, we also saw how the pandemic led to infodemic and intense media attractions for drugs approved for other indications that could have potential efficacy in the prevention or treatment of COVID-19.
For example, certain drugs like Favipiravir (RNA-dependent RNA polymerase inhibitor), Chloroquine, and Hydroxychloroquine gained enough media attention claiming it to be “game-changers.” Without the lack of enough research evidence, the false media propagation created an illusion in many people that these drugs completely cure and prevent COVID-19 infection. In scenarios like this, pharmacovigilance practitioners need to be more vigilant about these risks and do the needful to ensure patient safety.
COVID-19 and safety reporting
Safety reporting is another area that demands mention. The safety reporting across the globe is highly diversified. While many countries have shifted to electronic reporting methods like portal entry, email, and E2B gateways, many agencies are still using traditional methods of paper reporting. This has been severely impacted during the pandemic due to prolonged lockdowns, delay in courier companies, failed deliveries due to reduction or complete stoppage of international flights, recipient office closures, government restrictions, and so on. However, whatever method each agency uses, it requires efficient coordination and communication among all the stakeholders concerned, including the pharmacovigilance teams, local teams for portal entry in the local language, local legal representatives, and so on.
The lesson learned
The pandemic has made us realize the necessity of building a robust business continuity process plan that includes global pharmacovigilance teams, proactive intelligence management processes, along with embracing efficient and robust technology solutions. For example, to analyze and understand the potential usage of any drugs that can be used to treat COVID-19, we need to collect and record sufficient information about the efficacy and adversity of different medications, preferably in a centralized system. And we need to do this fast.
While the pandemic has made us aware of building a strong system for pharmacovigilance, it has also emphasized pharmacovigilant teams to focus and work on digital solutions for better data exchange for patient safety. For example, we need to set up a dedicated team for safety intelligence, leveraging different communication channels with authorities, supporting the local team during crisis times. The need of the hour is to set up prompt and proactive communication channels leveraging technology.
The key takeaways from the pandemic are:
Centralized portals: The epidemic has made us aware that we need to have a centralized system in place that can perform automated reporting assessment, generate reports for prioritizing tasks, can communicate with all the partners promptly, and remove all the challenges of negating the crises arisen from a pandemic while minimizing the scope for human errors.
Switch to electronic reporting: The pandemic has also brought the importance of electronic reporting over paper reporting to the forefront. It is high time that we adapt to it.
Sharing and collaboration: We need to collaborate and share our knowledge and methodologies with pharmacovigilance experts worldwide, especially with peers from low-income countries. We also need to collaborate and share data with other scientific organizations and healthcare centers to collaboratively tackle the situation.
A final few words
The pandemic has created an unprecedented global challenge. While governments and healthcare professionals are fighting hard to tackle the situation, we cannot ignore our responsibilities to protect the public from vulnerability. The pharmacovigilance community worldwide has a critical role to play more than ever to protect patients’ safety across the globe.