Hot trends in pharmacovigilance
By: Annette Williams | January 19, 2017
How automation, harmonization and outsourcing are changing the way the industry conducts pharmacovigilance.
Innovations in technology, access to more sources of data and increased global regulatory requirements are driving a number of new trends in the pharmacovigilance space. Safety professionals have been under pressure to continually deliver more and increase their overall response time while utilizing either the same or declining resources. “Doing more with less” is a key tenant fueling these noted trends. Several of these trends will be discussed at the upcoming DIA Pharmacovigilance and Risk Management Strategies Conference, in Washington D.C., January 23-25, where I will be facilitating a round-table discussion on ‘Pharmacovigilance Outsourcing Decision-Making.’
Here are three trends that will have a significant impact on pharmacovigilance in the coming years:
Social media and other new avenues for gathering data have put increasing burden on safety professionals to spend more time finding and assessing whether partial bits of data constitute safety events. In many cases these reports are incomplete – i.e. a clinical trial participant tweets about having a headache with no other context – and they use informal language that doesn’t align with conventional safety event reporting. Despite the limited information, pharmacovigilance teams still need to retrieve, warehouse and report the data, which is adding time, cost and burden to the overall monitoring process.
To minimize this burden, new automated tools are being developed that use artificial intelligence and machine learning to remotely scan literature, social media and other data sources to flag potential adverse events. This allows safety professionals to focus on analyzing the outputs to determine whether the data is relevant and how best to react. Companies are also developing add-on automation features, all designed to increase throughput while potentially increasing quality and compliance through the minimization of human error. Some automation examples include the ability to intake source data (structured and unstructured) from varied sources, write narratives and transcribe content, and proactively scan reports for inconsistencies and errors. While some innovations (i.e. natural language processing and machine learning) are still in the early stages, there is no doubt that as they mature and universal adoption grows, these enhancements will drive time and cost efficiencies across the entire space. Ultimately, a more efficient review of data can lead to safer medicines for patients without increasing costs.
While many of the fundamental aspects of pharmacovigilance are embraced globally, many countries continue to enact their own nuanced adverse event reporting requirements and response procedures. This adds time and complexity for safety professionals who need to maintain global compliance while addressing these local requirements.
Several regulatory institutions are currently working to overcome these obstacles by pursuing global harmonization practices for safety reporting. For example, the FDA, EMA and PMDA all have adopted the ICH E2B R3 standards for electronic reporting as a way to allow for regional differences while ensuring that safety data can be easily and reliably transmitted across borders. There are still many challenges in achieving global harmonization goals that include defining who owns what data, determining how to meet patient privacy expectations and what rules are needed to enable information-sharing and reporting on a global scale. This will require significant change management and a willingness to collaborate across all regulatory bodies. This shift will benefit the industry, regulators and patients by making global safety reporting faster, easier and more effective.
Years ago, pharmacovigilance was considered a proprietary process and thus conducted entirely in-house by a dedicated team. But, as with many aspects of the drug development process, biopharma companies have begun to realize the benefits of outsourcing this important step in the research process. Working with external partners gives biopharma companies access to state-of-the-art technology, dedicated experts and varied monitoring strategies, thereby striking the right balance between capacity and capability for their organizations.
Many biopharma companies began this trend on a small scale, by outsourcing select aspects of their pharmacovigilance for mature products (i.e. ICSR data entry). As these projects proved successful and demonstrated tangible benefits, companies expanded their use of pharmacovigilance outsourcing to include other activities such as signal detection and risk management programs for larger portions of their product portfolios. Now 70 percent of global biopharma companies outsource at least part of their pharmacovigilance work, according to a 2014 report from ISR, and it is not uncommon for some emerging biotech companies to have entirely virtual pharmacovigilance programs.
Companies interested in pursuing outsourcing models for pharmacovigilance must be certain that they have the right processes and training in place to effectively monitor outsourced programs, as oversight is critical to their success.
We will be exploring the topic of outsourcing in more depth during the roundtable forum at the DIA meeting. I’m personally excited to reconnect with colleagues and peers at the conference to discuss pharmacovigilance strategies and best practices. This should be an informative event with industry professionals from around the world and I look forward to seeing you there.