Exploring the Changing Approach to Drug Safety

February 17, 2023

Contributed Commentary by Bruce Palsulich, VP of Safety, Oracle Health Sciences  

February 17, 2023 | Pharmacovigilance plays a critical role in drug safety. Pharmaceutical companies monitor the effects of newly licensed drugs, evaluate previously unreported adverse reactions, and balance how effective a drug is at treating disease against any adverse side effects. Over the last century, technology, methods, regulations, and how we think about drug safety have evolved into present-day pharmacovigilance practices.  

Public outcry following the deaths of 100 people due to contaminated antibiotics resulted in the passage of the Federal Food, Drug, and Cosmetic Act of 1938, which required new drugs to demonstrate they were safe before being released to the market. Support for these regulations increased in 1968 when Dr. Frances Kelsey, a Food and Drug Administration medical officer, halted the approval and marketing of Thalidomide, which caused severe congenital disabilities in thousands of babies born in Western Europe.  

Over the next two decades, new regulations and innovations expanded consumer protections against unknown and potentially harmful drug side effects. For example, in 1972, an over-the-counter drug review was launched to enhance the safety, effectiveness, and appropriate labeling of drugs sold without prescriptions. And in 1987, new investigational drug regulations expanded access to experimental drugs for patients with serious diseases and no alternative treatment options (Therapeutic Innovation & Regulatory Science, DOI: 10.1177/2168479017694850). 

As new regulations were introduced, pharmaceutical companies needed a way to manage adverse events reporting when they introduced new drugs. In 1990, the US unveiled the Vaccine Adverse Event Reporting System and soon other regions followed suit to protect patients and help regulators keep pharmaceutical companies accountable.  

While pharma has traditionally seen the pharmacovigilance process as a cost center, it is now a foundational component for any organization. The information gleaned from safety processes is used to achieve the fundamental goal of drug safety: to reduce the risk of adverse events by informing doctors of potential side effects and protecting patients. 

Over time, pharmacovigilance has become more intense. Data about adverse events are collected faster, more cases are filed, and more questions are asked about the collected data. According to market intelligence provider International Data Corporation, safety caseloads are increasing by an average of 30% to 50% each year, so pharmacovigilance teams are looking for ways to process cases more quickly and efficiently.  

Automation Eases Volume Crunch  

As with many industries, one of the biggest changes is how events are tracked. The early days of pharmacovigilance were filled with paper trails and filing cabinets. Every adverse event had a form. In the early 2000s, software and data centers paved the way for electronic tracking. Over the last decade, the cloud and automation have taken center stage.   

Today, safety case volume increases, and flat budgets mean new efficiencies must be gained without sacrificing quality, security, or data privacy. Cloud-based platforms and standardization will help lower costs through faster and easier implementations and upgrades. 

Going forward, the adoption of artificial intelligence (AI) and machine learning have the potential to eliminate repetitive work and augment and enhance complex strategies so organizations can focus on safety, not IT. An automated approach allows human experts to focus on critical cases, so existing resources are used most effectively as the overall volume of data increases with real-world evidence and social media added to the case-processing load. 

A Look to the Future  

In the future, we’ll see pharma adopt automated platforms to collect anonymous, real-time patient data, improve collaboration, and efficiently accelerate clinical research and development. For example, data can show us which patients should be prescribed certain drugs while also demonstrating which drugs are helping and which are not.  

To process this vast and growing amount of data, technology will be used to move beyond augmenting human work to touchless case processing. This would include automating all aspects of the safety process, from intake to report generation. While the touchless approach has yet to be fully adopted, certain aspects of safety case processing are currently more suitable for greater degrees of touchless automation. For example, products that have been in the market for a considerable amount of time and are well understood naturally require less human intervention because the safety profiles are well-known.  

It is important to note that while automation and AI hold great promise, they have yet to take over all aspects of safety case processing. Human intervention is still required and will be for some time. However, studies have shown that the combination of AI and human intervention provides a much lower rate of error than either one by itself.  

As various system capabilities improve over time, more widespread use of touchless processing will become more feasible. Given that, companies can begin to plan for a touchless case processing system. The key is to adopt a stepwise approach, implementing and validating each automation area one at a time to build an end-to-end automated process with confidence.  

As we look forward to a new era of pharmacovigilance, cloud and AI technology have provided an opportunity for continued innovation and a way to bring new drug treatments to market faster and serve more people safely. With so much data and the technology to analyze it, there is no doubt we are evolving from the manual processes used in the early days of drug safety to an era of precision pharmacovigilance—a personalized approach to drug safety that will help maximize the reach of new drugs and minimize the number of adverse events people experience.  

Bruce Palsulich is the vice president of safety product strategy at Oracle Health Sciences. His portfolio includes Argus Safety, the industry-leading adverse event case processing and analytics solution, and Empirica Signal, the standard for signal detection and risk management. He has more than 30 years of experience in the healthcare and life science industry, including 25 years in pharmacovigilance. He can be reached at bruce.palsulich@oracle.com.