Adoption of artificial intelligence in Pharmacovigilance during Covid-19 Pandemic. Will the case processors benefit from the novel technologies of ChatGPT and NLP? A case study among the Leading CROs in Ireland

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Somasekharan Nair, Swetha
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Pharmacovigilance (PV) is an area that was extensively impacted due to Covid-19. The

organizations handling PV activities had to incorporate many new technologies to cope with the stress. The finding of this research highlights how the adoption of Artificial Intelligence (AI) has impacted the PV field during and after the COVID-19 pandemic. The participants were

provided with surveys and interviews and their views on the topic were collected and

recorded. The finding of the study was compared to the secondary research findings and

conclusion were made. Several benefits of the adoption of AI tools were showcased by the

case processors who participated in the survey and interviews. It was observed how AI tools can be utilized for enhancing the daily productivity of case processors and also, how new AI tools such as ChatGPT can be incorporated into different steps for providing efficient case

processing techniques. However, there were some concerns raised by the individuals performing case processing activities. Handling patient data with AI tools does come with a

certain amount of risks. So, it was proposed that the case processors should be provided with

adequate and systematic training to overcome the risks associated with it. The participants have put forward many suggestions on how the case processors can prepare themselves to participate in case processing without posing any threat to the patient data which is handled. The suggestions from the participants would help in enhancing the case processing techniques and thereby play a vital role in improving patient safety. The significance of monitoring the drug once it is marketed is very important. Unfortunately, due to a plethora of reasons the drug safety information reported is very limited. This is where the role of PV activities becomes inevitable. As defined by WHO, PV is the branch of science that deals with the detection, assessment, evaluation, and prevention of adverse drug

reactions (ADR) (WHO, 2021). An ADR is any noxious or unprecedented reaction that occurs in humans and has a causal relation to the drug used usually in normal doses administered to humans. It is alarming that around 4% of hospitalizations are due to ADRs caused by the prescribed drugs. This shows the importance of ADR monitoring in the day-to-day scenario (Lee and Chen, 2019) (Surendra and Garlapati, 2020) (Lathifa and Aman-Ullah, 2022).

The market for AI on a global scale reached $10.4 billion in 2021 and is projected to grow at a Compound annual growth rate of 38% by 2030 (Shirer, 2022) (Market Analysis Report, 2023). Both developed and developing nations have seen a considerable impact of automation on healthcare. AI can be described as the technology and science of developing machines with intelligence that perform tasks similar to the human brain. Machine Learning (ML) and Natural Language Processing (NLP) are the two main subsets of AI where AI algorithms were first implemented (Zayas-Cabán et al., 2022) (Ball and Dal Pan, 2022).

ChatGPT is another cutting-edge technology that utilises NLP and ML to help the users to initiate useful interactions with virtual assistants. ChatGPT is a chatbot developed by OpenAI that can comprehend and react to intricate data in a natural human-like way. It is created to be exceptionally intelligent and accessible to the normal people. ChatGPT is remodelling the ways by which humans interact with technologies so that a new era of AI can be made possible for the coming generation (King, 2023).

In a world that continues to grow progressively data-driven, the volume of PV data being generated is continually increasing (Mittu et al., 2016). This leads to resource capacity restrictions as well as an unmeasured "human error" rate in PV. Larger pharmaceutical companies in particular are being prompted by this to explore PV technologies that are more effective. During the pandemic season, the utilization of AI became more obvious due to the need of developing the vaccine in a very short period. The pandemic made an obvious statement on AI is a slowly but steadily evolving tool that PV companies should utilize to manage PV activities in a safer way

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