Pharmacovigilance case intake: why the hesitation to automate?

Why is it, with all of the advanced technology available to them, many pharma company PV departments are failing to automate data capture – especially in the context of adverse event reporting? An exclusive new Censuswide survey has sought to provide some answers. Peter Kohut, Arriello’s director of drug safety, discusses the findings.

Life sciences companies are required to track and report on adverse reactions to drugs, information which could come in via frontline healthcare professionals, manufacturers/supply-chain partners, directly from patients, or indirectly via patient forums online. They must capture the detail, assess its significance and report it in a timely manner to the authorities.

Given the diverse ways this information is submitted, and the huge volumes of data there is to go through and analyse, it might be assumed that pharma companies would harness the latest technology to capture and process these substantial pharmacovigilance (PV) workloads. Today, the available technology aids are proven in their reliability and are highly cost-efficient. 

So why aren’t more pharmaceutical companies capitalising on these tools? Arriello recently commissioned a transatlantic survey to find out. The online Census wide survey, ‘Pharmacovigilance Automation Adoption Survey – UK & US - Key findings and discussion’ was conducted in the summer of 2020, among 200 respondents in senior PV, drug safety and product safety roles across a broad spectrum of life sciences companies. 

The status quo

Claims by a high proportion of respondents that their use of advanced technology in PV is already strong, or imminent, do not bear out in our experience, especially in relation to adverse event data capture which remains predominantly manual. 

Surprisingly, just under half of all respondents said their organisations were using some form of robotic process automation (RPA) today, and a further third said they had plans to adopt such capabilities over the coming year. Companies in the UK appear to be ahead with this – for now.

Yet these findings aren’t as conclusive as they might seem. When asked whether they thought their organisations were already using automated case intake solutions, or planned to do so over the year ahead, only a fifth of respondents said they already had such a capability, while almost half said any plans were at least six to nine months off – if in place at all.

Just under half of all respondents said their organisations were using some form of robotic process automation.

Comparing these findings with the earlier claims made about high levels of existing PV automation suggests that respondents are making blanket references to solutions used across the whole spectrum of PV operations. 

These could include basic electronic data capture (EDC) in clinical development; auto-narrative generation (dropping data into pre-defined templates); programmed summary tabulations; and listings for aggregate reports and so on, which are often included in the applications/services provided by safety vendors. 

While all of these productivity aids are useful, they do not add new value to the PV function. So the findings could mask relative immaturity in AE case intake automation.

IT-related inhibitors

Although most respondents claimed their organisations were planning an automated solution for AE case intake within the next year, the survey indicated a number of practical barriers 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 (indicated again by 41%), and inadequate IT infrastructure (cited by 38% across all sizes of organisation) stood in the way of automating these vast and largely manual workloads. 

Over a third (35%) of all respondents indicated that a lack of available solutions is a barrier to automation.

Larger companies, generally more like to develop bespoke solutions, seemed to be especially held back by limitations with IT infrastructure. 

Over a third (35%) of all respondents indicated that a lack of available solutions is a barrier to automation, suggesting that technology vendors have some work to do in changing perceptions. 

For SMEs, cost was the most prohibitive barrier to progress, followed by concerns about ease of use and what greater automation might mean for people’s jobs. Product safety teams were most likely to be concerned about cost and a lack of familiarity with the technology.

Advantages of PV automation

PV professionals tend to see automation leading to a rise in AE reporting volumes - a perceived benefit. The greater an organisation’s capability for capturing reliable information quickly, efficiently and effectively, the higher the volumes of data that teams will be able to process - and the greater the likelihood of important cases being identified and analysed. 

As long as technology is helping to capture the right information efficiently, and filter out any ‘noise’, this will result in greater vigilance and the ability to report findings quickly, at any scale - and ultimately a stronger safety profile and better outcomes for patients. Interestingly, however, improved data quality did not register in the top three perceived benefits of PV automation.

Across all company sizes, the top three benefits of PV automation (jointly) were seen as improved compliance, higher reporting volumes and speed. 

There were differences in perception between small and large pharmaceutical organisations, however.

The top three benefits of PV automation were seen as improved compliance, higher reporting volumes, and speed.

Over half of respondents from SME rated improved efficiency as the primary benefit, followed by speed of turnaround. For large companies, keeping pace with peers and meeting compliance targets were deemed the main advantages. Surprisingly, only just over a third (35%) of all respondents cited the potential for resource redeployment as a target benefit.

More remarkable still was the finding that the vast majority of respondents did not see an absence of PV automation as disadvantageous. This is despite PV functions still being seen predominantly as a cost centre rather than a value-added contributor to the business. 

It suggests the broader benefits of letting advanced technology take the strain of AE data capture and PV information processing and reporting aren’t fully on the radar of senior management/wider business stakeholders. Only 6% of all respondents felt their organisation would be ‘very disadvantaged’ by a lack of PV automation.

Scope for further investigation

The survey’s findings suggest that pharmaceutical companies - large and small, and on both sides of the Atlantic – may be missing an important opportunity to manage soaring PV workloads more effectively and cost efficiently, while optimising use of skilled resources. 

Certainly the current research will serve as an interesting benchmark from which to monitor shifting attitudes towards and ongoing progress in PV automation over time.

About the author

Peter Kohut is director of drug safety at Arriello and an experienced EU QPPV. He began his career in biochemical research, before entering the pharmaceutical industry where he has worked in both clinical trials and post-marketing safety roles. Arriello is a global provider of innovative, high-impact market access, regulatory affairs & pharmacovigilance solutions and services for pharma and biotech firms primarily in Europe and North America.

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