If it isn’t documented, it doesn’t exist. As far as regulators are concerned, this is true for any of the drug safety literature monitoring search alerts that a marketing authorisation holder (MAH) is required to hold. The challenge for organisations with a large product range is the sheer volume of alerts that need to be managed and documented. But the problem of keeping alerts up to date affects all MAHs and is particularly acute for large portfolios.
Regulators such as the FDA in the US and the EMA in Europe require that the strategies behind search alerts are not only fit for purpose – they must also be reviewed at least once every 12 months. This is because the terminology used in databases such as MEDLINE and Embase can change. There may be new drug trade names, or other thesaurus changes such as for the adverse events terms that are included in the adverse event hedge of a search strategy. Embase, for example, updates its thesaurus terms three times a year. So, there’s a chance that just months after its first use, any search strategy behind an alert will not be fit for purpose.
Keeping search alerts up to date as part of drug safety literature monitoring can be a tortuous and time-consuming process. First, the individual alert must be amended to include the new term, and the change must then be documented and archived to provide evidence to the regulator that the alert has been updated.
Imagine a MAH with 1,000 products in its portfolio. With each alert taking at least ten minutes to amend and document, one individual could be fully employed for a month on this task alone. Plus, as with any repetitive manual process, it’s highly prone to error.
But the consequences of mistakes can be severe, potentially inviting a regulatory inspection finding whose severity depends on how out-of-date the alert is, what was missed, and whether it has been flagged before. Incorrect alerts are taken very seriously by regulators because they mean MAHs may miss important references that include patient safety issues. And this could lead them to draw the wrong conclusions or take action less effectively.
If there is an inspection finding, it has to be remediated with corrective and preventative actions (CAPAs), which trigger another series of tedious administrative tasks. MAHs have to correct the search strategy and also perform a retrospective search. And if the remedial work unearths patient safety issues, it may mean that ICSRs are late or that aggregate reports need to be updated and submitted.
In short, maintaining search alerts can be a headache – but the consequences of failing to maintain them can be anywhere on a scale from a headache to a significant expense.
Fortunately, technology now has an answer to this issue. Using robotic process automation (RPA), Dialog Alerts Manager can make bulk changes to search strategies that need to be updated, so the ten-minute update can be instantly applied across potentially thousands of alerts, saving huge amounts of time. The system also automatically creates and archives a record of each update, building a complete audit trail for every alert since it was set up. Records are easy to retrieve for compliance purposes.
For MAHs, this not only confers all the typical benefits of automation, such as time and cost saving and increased accuracy – it also means regulatory audits are quicker and more efficient, and it minimises the chance of inspection findings and associated CAPAs.
Learn more about the role Dialog Alerts Manager plays in our drug safety literature monitoring solution here.
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