When it comes to identifying patient safety issues relating to drugs, scientific and medical literature is a crucial resource. Get pharmacovigilance literature monitoring wrong, and you could draw the wrong conclusions about patient safety issues – or delay making decisions – in a way that could lead to patients being harmed. The challenge is knowing how to deploy literature monitoring resources more effectively without affecting the literature monitoring process.
Regulators typically expect marketing authorizations holders (MAHs) to screen scientific literature for three things: 1) Individual case safety reports (ICSRs), which look for an identifiable patient, reporter, suspect drug and adverse event; 2) aggregate reports, such as the Periodic Safety Update Report, which focuses on a drug’s safety profile; and 3) new safety signals, which provide information on new adverse events.
Because each of these three aspects of literature monitoring requires a different skillset, they present MAHs with a resourcing challenge. Spotting the four criteria that make up a valid ICSR is a relatively straightforward and tedious analysis task. But deciding whether safety information in the literature is relevant for an aggregate report requires higher-level knowledge and expertise. And identifying potential new safety signals requires yet more skill. To make things even more complex, ICSRs need to be monitored to aggressive timescales, while reviewing for aggregate reports or safety signals is not under the same time pressure.
Even with precision search in place, only 1-5% of the articles retrieved by searches have ICSR criteria. About 5% have aggregate reporting safety criteria and only 0.1% have new signals included. So, the amount of “noise” in the literature review process is very high.
Some MAHs are organized to have product safety specialists review the literature for all three areas simultaneously. However, as MAHs struggle with growing drug safety workloads, these skilled specialists are in great demand. Asking them to assess ICSRs is arguably not the best use of their time. And with time-sensitive ICSRs added to their already-challenging aggregate report and safety signal workloads, product safety specialists may not have enough time to complete any of the tasks to a satisfactory standard.
Other companies create two workstreams, sending each reference in two directions: to literature reviewers to check for ICSRs and to product safety specialists for aggregate reports and safety signals. The downside here is that every reference has to be reviewed twice, increasing costs enormously. And it also poses a dilemma for product safety specialists. What if they spot an ICSR when they’re looking for aggregate reports and safety signals? Do they trust the literature reviewer to have seen it – or should they spend time double-checking?
The good news is that there is a more resource-efficient way to deal with this problem. With our pharmacovigilance literature review software, Drug Safety Triager, literature reviewers can first assess references for ICSRs and eliminate those that are irrelevant for safety. With this workflow in place, Drug Safety Triager directs only 20-30% of the references to product safety specialists, cutting their literature review time by up to 80%. Because reviews for aggregate reports and safety signals are 4-5 times more expensive than ICSR reviews, the potential savings are huge.
Watch the video for a more in-depth explanation of how deploy literature monitoring resources more effectively:
To find out more about Drug Safety Triager and how Dialog Solutions can help you deploy literature monitoring resources efficiently, get in touch with us here.