Artificial Intelligence (AI)  is a fast emerging technology, dealing with the development and study of intelligent machines and software, which is becoming increasingly sophisticated over the last decade, and it is possible to employ it in a variety of new fields. AI might also be applied to support the global drug safety and pharmacovigilance (PV) industry. However, the impact it could have is not yet entirely clear.

What is pharmacovigilance (drug safety)? It is the field of science that monitors, detects, and strives to prevent adverse drug reactions (ADR). This is very important, as it is the field that identifies whether new and existing medications and drugs might have negative side effects and might be unsafe. Pharmacovigilance begins during the development process, the clinical trials, and continues once the drug has been approved by the Food and Drug Administration (FDA). Traditionally, pharmacovigilance is done through manual data sorting but the currently existing volumes of data, patient diversity, increased drug interactions, and more push the boundaries of the field (1).

The pharmacovigilance industry has a growing need to process the increasing amounts of data it receives from individual case safety reports (ICSRs). If there is more data, assistive technologies, such as AI, could help improve the processing and the analysis of said data. However, this could significantly change the way in which drug safety professionals work and how their career develops. Pharmacovigilance has not changed significantly in the past decades, but this could be a big change. AI could provide opportunities for professionals to focus on valuable work for higher efficiency and accuracy, and for better decision-making. An ongoing concern is that the use of the AI could make people obsolete and replace humans eventually, especially with the use of machine learning that allows the AI to learn, adapt, and improve on its own (2).

The question of how obsolete drug safety professionals would become years after the widespread implementation of an AI remains. Some professionals believe it would lead to job losses, while others suggests it would help create new jobs. However, it is likely to change the landscape of pharmacovigilance. If the AI is used mainly for doing the basic work, while leaving the more difficult, nuanced processes to people, it could significantly improve the field and  lead to faster and better results (2).

Healthcare sectors are currently using AI technology to make a better and faster analysis than humans. There have been experiments showing that machine learning can be applied to the field of medicine, identification of specific types of data, and other elements with great success. An AI can be utilized for complex tasks that involve existing datasets, and it is likely to have a wide variety of applications. An AI can also be trained to do many things, and the technology is there today, so this matter is not only a theoretical one (3).  Since medical care supplies and healthcare equipment supplies are becoming more and more important, medical equipment supply companies and medical supplies companies pay more and more attention on the quality and logistics on medicine.

According to a report by the Pharmavoice suggests that over 50% of pharmaceutical executives expect AI to be widely adopted by 2025. AI-based solutions are likely to produce significantly more revenue in the following years, rising to $2.1 billion by 2022. Other reports suggest that the U.S. AI market in healthcare will exceed $10 billion by 2024. The COVID pandemic, in particular, has propelled the industry forward and has encouraged people to seek new solutions via AI. For instance, it is being employed to test existing drugs and their effectiveness for the coronavirus (4).

Moreover, AI presents a lot of opportunities for pharmaceutical companies, providing significant benefits for their operations and revenue. An AI can boost productivity and lead to better outcomes. Furthermore, AI is one of the issues that many companies are considering most in 2020 and have focused significant recruitment efforts on the field. This can be seen with top pharmaceutical companies like Bayer, GSK, and others. AI is being used  not only for pharmacovigilance but for improving the process of searching for treatments, expediting research, and much more (4).

However, at the moment, there are also significant barriers to the development of the field. The first one is the  limited number of AI researchers and experts. The availability and the demand are mismatched, especially in regards to AI safety risks. While there are around 300 thousand researchers working in the field, the demand is for millions, not thousands. Another barrier is the concern for safety and supervision of AI results, which also implies a higher demand for individuals who can implement these processes and who can ensure that safety and risks are minimized (4). One might also consider additional challenges, like data privacy, and how these can be addressed. With cyberattacks becoming more dangerous, there has never been a better way to adopt Artificial Intelligence-driven security tools. These tools are capable of protecting valuable data from being accessed or damaged by an unauthorized person.

At the moment, there are available solutions for the pharmacovigilance industry. One of these is the Veeva Vault Safety, an AI that automates data to make the medical professionals’ job easier. People can focus on verifying the data, while the AI handles intake processes and data, which is likely to enhance efficiency. Veeva is among the first of many suites striving to provide AI solutions for the field (5).

At the moment, it is clear that the field of pharmacovigilance, like other medical fields, is likely to incorporate AI in its daily operations. This process has started and is likely to continue. There are good reasons for this, AI can handle massive amounts of data, can learn, can increase efficiency and results, expediting many processes that are currently done by hand. There are some important challenges and questions that are not yet clear. First, how will the implementation of AI change the landscape of drug safety careers and development? Will an AI make these professionals obsolete or will it create new jobs? Will it serve as a support for the medical professionals in the field or will it replace them? Other issues involve a lack of AI researchers to fill the existing demands and concerns about procedures, implementation, and safety. However, one thing is clear, AI technology has the potential to change pharmacological industry in the long term, which will become more of a presence in pharmacovigilance, bringing new possibilities and challenges to the field.

About the Author:

Lin Zhang, M.D., senior director of a health care industry company in the United States. With the experience in clinical medicine, biotechnology, health industry and other fields, he is responsible for the research and development of plant medicine, functional food and health products. He was a clinician and worked for the National Cancer Institute, FDA and the National Cancer Center of Japan for many years.

References

1. Basile, A. et al  (2019). Trends In Pharmacological Sciences, 40(9), 624-635.

2. Danysz, K., et al (2019). Drug safety, 42(4), 491–497.

3. Sidey-Gibbons, et al (2019). BMC Medical Research Methodology, 19(1).

4. PharmaVOICE Staff.  (2020). Artificial Intelligence: Driving Drug Innovation With AI.  

5. Veeva. (2019). Veeva Brings Artificial Intelligence to Drug Safety.