Pharmacovigilance (or PV) is a major part of drug safety, dealing with the detection, assessment, and monitoring of drug effects on the human body. With updated regulations and technological advancements, the pharmaceutical industry is facing pressure to automate PV systems—optimizing spending costs while also improving risk management.
By doing so, PV systems would be better suited to create personalized medicine. Automation would also help promote transparent data sharing between patients and healthcare providers as well as regulatory agencies. In this way, those pursuing pharmaceutical studies can expect automation to significantly change the pharmaceutical industry.
Here’s a closer look at how PV systems can be automated, paying particular attention to the benefits and inhibitors involved.
Understanding Different Pharmacovigilance Automation Methods
PV automation aims to enhance the pharmaceutical industry, improving clinical, safety, and regulatory operations. This can feature basic process automation—involving tracking, monitoring, and data collection to enhance reporting and optimize workflows with multiple roles—as well as robotic process automation (RPA), which is designed to reduce or completely eliminate manual tasks.
This type of automation can also be combined with Natural Language Processing (NLP) to help with human-based decision-making processes. Similarly, artificial intelligence (AI) and Machine Learning (ML) can be used to fully automate processes that rely on large amounts of data. On that note, pharmaceutical organizations might also explore automation through:
- Implementing cloud-based solutions
- Relying on big data analytics
The Benefits of Pharmacovigilance Automation for Those in Pharmaceutical Training
It should be noted that PV automation comes with numerous benefits. By accurately capturing and filtering data, organizations are better positioned to identify and analyze important information—increasing Adverse Event (AE) reporting. This directly improves vigilance, providing reliable data that contributes to patient safety.
Students taking pharmaceutical courses might be interested to know that PV automation is also believed to improve efficiency, compliance, and speed. According to research by Arriello, which surveys 200 respondents at the manager-level (or above) from pharmaceutical organizations in both the UK and the US, small and large pharmaceutical organizations perceive the benefits of PV automation differently. The data has found that:
- Small and Medium-sized Entities (SMEs) cited “efficiency” as the primary benefit and “speed of turnaround” as the secondary benefit
- Large companies viewed “keeping pace with peers” and “compliance” as top benefits
- 35% of all respondents rated “resource deployment as a target benefit”
The Inhibitors Preventing Pharmacovigilance Automation
Despite these benefits, Arriello’s study found that many pharmaceutical organizations don’t view the lack of PV automation as a disadvantage. Only 6% of respondents felt the lack of PV automation would be “very” disadvantageous while only 30% felt they would be “somewhat” disadvantaged. This means that PV automation is not high “on the radar” of the senior management or business stakeholders—implying a need to increase technological awareness and understanding in the industry.
Those in pharmaceutical training might be curious to know that IT-related challenges were ranked amongst the top three barriers to automation efforts of pharmaceutical organizations. In Arriello’s survey, respondents described those three challenges as:
- An inability to validate new systems (cited by 41%)
- A lack of familiarity with available AE technology options (indicated by 41%)
- Having an “inadequate IT infrastructure” (cited by 38% across all sizes of organization)
These results provide a unique insight into the pharmaceutical industry, painting a clearer picture of the industry’s potential future and the key elements standing in the way of its technological growth.
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