Automating pharmacovigilance

Risk management and compliance services provider to the Life Sciences, Arriello (www.arriello.com) reveals that lack of IT proficiency is proving the biggest hurdle to automating pharmacovigilance case intake in both the UK and the US according to its latest survey.

In an online Censuswide survey carried out for Arriello in late June 2020 with 200 respondents at manager level and above in pharmacovigilance (PV), drug safety and product safety departments of life sciences companies in the UK and the US, it was found that while the majority of organizations professed to have implemented some form of PV automation, or plan to do so over the next 12 months, most lack sufficient IT insight and capability to automate AE case intake.

While 48% of all respondents (rising to 61% working for large pharma organizations), claimed they already had some form of standalone PV automation solution in place, and a further 42% of all companies expressed plans to implement something over the coming year, follow-up questioning suggested that these capabilities were likely to be fairly basic – and unconnected to AE data capture. The fact that a similar proportion of companies professed to have implemented PV automation as part of a wider solution offered a first clue to this.

Of those already on the path to automation, just a fifth (20%) of companies said they had capabilities specifically for AE case intake, mostly at large pharmaceutical companies. This figure was substantially lower that the proportion of respondents claiming to have automated adjacent activities - such as medical information and clinical documentation management; standard form and report compilation; product quality compliance information and regulatory intelligence management; and literature screening (all of which were already in place at half of companies on average – on a sliding scale of 64 down to 44% cent across this list of use cases).

While most respondents said they are planning an automated solution for AE case intake within the next 12 months, the survey went on to reveal a number of practical barriers that were likely to inhibit progress – the top three being IT-related challenges.  Respondents revealed that an inability to validate new systems (cited by 41%), a lack of familiarity with AE case intake technology options (by 41%), and inadequate IT infrastructure (cited by 38%) stood in the way of automating these vast and largely manual workloads – more so than concerns about cost, or fear of human jobs being replaced.

More telling, though, was the finding that the vast majority of respondents did not feel that a lack of AE case intake automation put them at a disadvantage.  This suggests that IT solution providers have failed to communicate the huge potential efficiency savings, as well as the scope for improved data quality and accelerated reporting, that come with the ability to capture case data in an automated way.

“Data like this inevitably warrants further investigation,” comments Dr John Price, a life sciences regulatory and safety consultant and advisor to Arriello.  “On the face of it, it looks as though pharmaceutical companies don’t want to miss out on the promise of AE case intake automation.  Yet many may not appreciate how quickly they could transform their PV operations and redeploy expensive professionals’ time - with a potentially huge ROI – if they automated manual AE case intake.  This can be achieved by enabling frontline people – including healthcare professionals and company personnel – to capture information directly into reporting systems.”