This blog delves into the following information:
- The management of pharmacovigilance work during COVID-19
- The transformation it underwent due to its impact
- The new strategies that have been drastically changed and are currently being followed.
Table of Contents:
- Overview
- Pharmacovigilance and pandemic
- Impact of COVID-19 on Pharmacovigilance operation
- Exploring into Innovation
- Conclusion
- References
Overview
I understand that for many of them reading this article, the COVID-19 pandemic was a completely novel experience, unlike anything we had ever encountered before.
The word “pandemic” itself may have been unfamiliar to some of us prior to its widespread use in the media.
The impact of the pandemic was far-reaching and brought about significant changes to our daily lives, leading to many unusual and unforgettable moments.
Overall, the pandemic was a unique and unprecedented experience for most of us.
Pharmacovigilance and pandemic
The COVID-19 pandemic has brought about significant changes in many aspects of our lives, including the way industries operate.
Before the pandemic, many industries were resistant to change and tended to stick to established practices.
This was also true for the pharmacovigilance industry, which was slow to embrace new ideas.
Yet, the pandemic has served as a catalyst for change, prompting a re-evaluation of established practices and a willingness to try new approaches.
As a result, we have seen significant changes in the way pharmacovigilance is practiced, with a greater emphasis on collaboration and innovation.
Overall, the pandemic has served as a wake-up call for many industries, including pharmacovigilance, and has spurred a much-needed transformation.
Here are some key factors that have impact on multiple industries in the wake of the pandemic:
- Remote Work
- New Risk Management
- Employee Mental Health
- Joblessness and Job Security
- Business continuity
- Regulatory impact
“In the face of unprecedented challenges, Covid times have revealed the resilience of humanity, uniting us with compassion, courage, and innovation. Together, we navigate the storm, seeking hope, and forging a brighter path towards a world reborn.”
Impact of COVID-19 on PV operations
The impact of COVID-19 on pharmacovigilance (PV) operations has been significant for both large enterprise (LE) and small and medium-sized enterprise (SME) companies, regardless of whether their portfolios were affected by the pandemic or not.
To The Large Enterprises
For LE companies with portfolios that were affected by COVID-19, the impact on PV operations varied.
Aggregate reporting, signal management, and risk management affected to varying degrees, with 56%, 78%, and 78% of affected companies reporting disruption in these areas, respectively.
For unaffected companies, the impact was less severe, with 67%, 67%, and 33% reporting disruption in these areas, respectively.
To The Small-Medium Sized Enterprises
SME companies with portfolios that affected by COVID-19 experienced significant disruption in all PV operations, including affiliates (100%), ICSR processing (100%), aggregate reporting (25%), signal management (0%), and risk management (0%). For unaffected SME companies, the impact was less severe, with 27%, 57%, 14%, 31%, and 29% reporting disruption in the respective areas.
Exploring into Innovation
The COVID-19 pandemic has transformed the way pharmacovigilance operates, leading to a greater reliance on AI and automation to manage the increased volume of adverse event reporting.
As predicted, the pandemic has resulted in a surge of adverse event reports, making it more important than ever to find innovative solutions to streamline the process.
This approach allows for reports to interpreted and presented quickly and accurately, reducing the burden on human resources and improving the overall efficiency of the pharmacovigilance system.
The pandemic has also underscored the need for companies to prepare for similar scenarios in the future.
As a result, many are exploring new ways to address the challenges posed by the pandemic, including developing new automation technologies and improving existing processes.
Another important concern that emerged during the pandemic was the high percentage of serious adverse events associated with COVID-19 vaccines.
With 67% of adverse event reports related to these vaccines being classified as serious, it is clear that there is a pressing need for ongoing monitoring and vigilance in the pharmacovigilance industry.
Additional information is that over 62% of experts prefer the involvement of AI in pharmacovigilance.
Conclusion
This is merely an awareness write-up, acknowledging that circumstances can change at any moment. The current shift is due to the pandemic, but the future holds uncertainties.
Evolution and changes are ongoing processes. It’s essential to remain prepared for anything. We’ve shared what we were aware of at the time of writing, and we’ll delve deeper into insights as we progress.
If you believe there are aspects that may change over time, especially after this pandemic, feel free to share your thoughts.
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