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Improving and Scaling Pharmacovigilance with Modern Technologies
By Jennifer Markey
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Pharmacovigilance organisations are struggling to meet greater demand with increasing adverse events from multiple sources and greater patient and regulatory scrutiny. New approaches to safety combined with modern technologies can scale pharmacovigilance processes to handle larger volumes of adverse events, make compliance easier, and improve decision-making. Innovation in artificial intelligence, cloud technologies, and unified safety solutions are making a big impact on pharmacovigilance by driving greater efficiencies and better leveraging of safety data.
Between 2009 and 2019, the number of adverse events (AEs) recorded by the FDA Adverse Event Reporting System (FAERS) increased more than 300%, from 409,040 to 1.66 million cases.[1] Given the growth in case volume, the expanding number of sources for potential adverse events, and the complexity of new therapies – there is a significant opportunity to use innovative technology to improve efficiency in pharmacovigilance.
Untapped Potential of Artificial Intelligence and Automation
In a recent survey, 90% of life sciences’ executives recognised that artificial intelligence (AI) is important in driving innovation and achieving new levels of efficiency. [2] Safety surveillance needs to go beyond data mining of spontaneous reporting systems (SRSs) and medical literature. Internal data sources can be supplemented with real world data from electronic health records (EHRs), insurance claims, social media, and online communities. However, with traditional pharmacovigilance approaches, it is challenging – if not impossible – to incorporate, review, and analyse all these data in a timely manner.
Automating many manual and repetitive processes, AI can enable greater consistency as well as provide valuable insights for data scientists, medical reviewers, and physicians. They can understand their data in a much more comprehensive and extensive way that has not been possible before. AI can have a huge impact on pharmacovigilance and ultimately provide valuable information to protect patients by improving data quality, providing real time data insights during processing, and enabling faster and more proactive signal detection. As drug safety shifts focus from operational tasks to more proactive risk management and greater data transparency among pharma, patient, and providers – AI will become more essential.
Simpler and More Efficient Unified Safety Solution
Many pharmacovigilance systems are fragmented with multiple tools and technologies from different vendors that often do not work well together. Significant resources
are spent developing and maintaining integrations, assuring compliance, and carrying out manual activities, such as moving or copying data and content between the siloed systems. With complex processes, there are many opportunities for errors, tasks not being completed in a timely manner, and other compliance risks. Modern pharmacovigilance applications are built on a single cloud platform, operating as a unified solution to enable seamless processes, reduce or eliminate manual activities, and provide a single source of safety data and content. With case intake, case processing, operational reporting and analytics, aggregate reporting, coding, content management, and submissions in one solution, it is much easier to track and complete activities, process adverse events from intake to submissions, and analyse data for potential signals. Unifying pharmacovigilance data with relevant information from intake to post-market surveillance allows for better risk mitigation and improves safety decision-making. It also provides more opportunities for the AI engine to learn from decisions. Making it easier to connect data points that, when considered together, can enable earlier identification of safety signals – improves determination of a drug’s benefit-risk profile and shifts companies to more proactive and predictive pharmacovigilance.
Easily Scaling and Collaborating with Cloud Technologies
Modern safety solutions are a unified suite of applications that are delivered as a cloud service. They automatically scale with more data or activity and the environment is continually monitored to ensure expected performance. With true cloud solutions, all customers are on the same version while still having the flexibility to customise workflows, field names, etc. Vendors can allocate more resources to innovation instead of managing and maintaining old software releases. Cloud applications have several small releases a year compared to a major release every few years for legacy systems that can take 12 or more months to upgrade. With more frequent updates, companies can keep up to date with changing regulatory requirements and leverage new capabilities earlier. Modern cloud vendors reduce the validation burden for customers by performing and documenting all elements of infrastructure qualification (IQ) and operational qualification (OQ) for each major version. They also provide sandbox and test environments, and user acceptance testing (UAT) scripts that can be leveraged for performance qualification (PQ).[3] Customers can choose when to enable specific features – minimising impact and providing some control to each company. Designed to bring together stakeholders while keeping administration simple, cloud solutions enable greater collaboration. Biotech / pharma companies and their CROs or service providers can securely access and use the same safety system for better alignment, real-time data visibility, and oversight.[4] Granular security and flexible workflows control what each party can see and tasks they can perform in the system. For example, some service providers can process and review cases, while others can only view them without changing the record. Companies can also streamline cross-functional safety processes by adopting regulatory, quality, and clinical applications built on the same cloud platform.
Improving and Scaling Pharmacovigilance with Modern Technologies
AI, cloud technologies, and unified solutions have made great strides in many other areas of life sciences. For pharmacovigilance, it is increasing operational efficiencies and making it easier for companies to scale with growing data volumes, changing regulations, and expansion into new markets. With effective collaboration and real-time visibility, pharmacovigilance teams can perform more timely benefit-risk evaluation and decision-making and improve compliance. Continuing technology innovation will allow companies to realise even greater value from their safety data and eliminate more and more tedious or duplicate tasks to increase focus on higher-value activities for patients.
References:
[1] https://fis.fda.gov/sense/app/d10be6bb-494e-4cd282e4-0135608ddc13/sheet/7a47a261-d58b-4203-a8aa6d3021737452/state/analysis [2] Kent, Evelyn. Five AI Trends in Life Sciences. Retrieved at https://lucidworks.com/post/ai-trends-life-sciences/ [3] Veeva White Paper, “9 Key Considerations When Evaluating
Safety Solutions,” FDANews, September 2020. [4] J. Kratz and K. Traverso, “Modernizing Pharmacovigilance
Outsourcing,” Xtalks, January 11, 2021.
Jennifer Markey
VP Vault Safety Strategy, Europe Veeva Systems
