Case Study: Streamlining literature monitoring for pharmacovigilance
How Embase and its PV Wizard enabled a pharmacovigilance and risk management group to take control of literature monitoring
A major manufacturer of generic drugs outsourced their literature monitoring for adverse events. However, they still had to devote considerable time for creating search strings and checking their effectiveness. The team chose Embase and its PV Wizard, which helped them to streamline the creation of search strings, and gave them the confidence to bring their literature monitoring back in-house, saving resources.
With over 150 products, the Pharmacovigilance and Risk Management Group of this rapidly growing generics manufacturer had a large workload. They have to monitor the biomedical literature for adverse events and ensure that they kept strict FDA deadlines for reporting. They are also responsible for providing clinical summaries, information for clinical trials and other safety-related information to internal groups.
One of the biggest challenges in pharmacovigilance is that search strings must be targeted enough to filter out unnecessary results, but still give a 100% retrieval rate so that nothing relevant is missed. When the team tests a search string, if they discover that it has missed some articles, then they have to go back to the drawing board. It used to take the team up to two weeks to create a search string, so discovering problems with its performance would slow down the work substantially. Even for those companies that outsource the monitoring of medical and scientific literature, there is still a considerable amount of time needed to discuss and define the search string.
The Pharmacovigilance and Risk Management Group started using Embase in 2016 after identifying that its database has the most comprehensive coverage of biomedical literature. They were also persuaded by the fact that some regulatory authorities recommend Embase for literature monitoring.
The PV Wizard query builder has proven to be an extremely helpful tool for the group, as it has made it easy to design search strings and has saved a significant amount of time. The team uses PV Wizard every day to perform many different searches. For instance, they can create search strings to monitor for adverse events, search for answers to regulatory questions related to clinical trials and submissions, and get the information needed for clinical summaries.
"With PV Wizard, it’s so easy to create a successful search string: we just need to select a few key parameters." Manager of Pharmacovigilance and Risk Management Group
Before Embase and PV Wizard, it used to take one person two weeks to create a single search string. Now the team simply selects a few key parameters. Since PV Wizard is a dedicated tool for pharmacovigilance search string creation, they don’t need to worry about defining all the parameters. While they can’t quantify the amount of time and money they’ve saved from using PV Wizard, they are certain it’s enormous.
Overall, the PV Wizard gave the team much more confidence with their literature monitoring. In fact, they even convinced their organization to bring the screening activity back in-house because the team was so confident about their ability to remain compliant.
Embase and the PV Wizard have greatly benefitted our organization.