An important start for modernizing safety operations is the need for a step-wise approach. Some may consider pharmacovigilance to be a commodity, with case processing and signal detection/management as necessary, rote processes. This mindset can result in a lesser focus on innovation. There are, however, steps that can be taken to optimize pharmacovigilance operations and maximize patient safety.
Artificial intelligence (AI) and machine learning (ML) are two areas of focus for improving pharmacovigilance processes. Regulatory bodies have also shown a willingness to encourage these advancements. There are four essentials to modernizing your pharmacovigilance services.
- Reaching Data Thresholds. The first step in maximizing the effectiveness of these new technologies and approaches is to reach a certain quantity of data to “train” them. This data will also need to be high enough quality to be usable
- Parallel System Build. It will often be necessary to build your new system in parallel to your fully traditional systems until you can verify that the new system is consistently producing reliable and valid results
- Cross-Organizational Collaboration. Collaboration is required to institute change across an organizational process. Business leads and even technical staff won’t always fully understand the pain points experienced by the pharmacovigilance and safety teams and where AI and ML can improve daily activities. Open lines of communication and multidisciplinary team collaboration are needed to ensure success. The role of quality assurance is also critical to avoid undue stress when instituting safety improvements.
- Start Small. By identifying clear, addressable steps towards improvement that can be automated with a low coding burden, the change starts and momentum builds. Over time, your pharmacovigilance function will see clear benefits and improvement.
UBC’s approach to Safety and Risk Management stems from our epidemiological, multidisciplinary foundation. Our commitment to Patients First has driven us to balance high-tech solutions with a personalized, experienced touch in our services. To start a discussion around our Safety and Epidemiology Consulting, Pharmacovigilance, or REMS services, click here.
About the Author
Michael Bulgrien is a Data Analytics Project Manager at UBC. With over 21 years of experience in healthcare software, Michael applies his healthcare data analytics expertise to designing and implementing code-based algorithms that utilize administrative claims, EMR, and spontaneous adverse event reporting data sets.