Streamlining Pharmacovigilance: Why the Inertia?

September 10, 2020
Peter Kohut

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.

Peter Kohut analyses the findings of a survey on how life sciences companies are capitalizing on opportunities to transform workload and data quality management using the latest smart technology.

A new Censuswide survey, conducted with regulatory professionals on both sides of the Atlantic, explores to what extent life sciences companies are capitalizing on opportunities to transform workload and data quality management using the latest smart technology, for example, in adverse event capture. In this article, Peter Kohut analyses the findings and pinpoints some critical opportunities companies may be missing as they strive to balance targets and resources.

Meeting pharmacovigilance (PV) targets is a huge undertaking for life sciences organizations. Upholding the highest levels of patient safety demands that companies track and report on adverse reactions to drugs as these are reported in the real world — information which could come in via frontline healthcare professionals, manufacturers/supply-chain partners, directly from patients, or indirectly via patient forums online. It is incumbent on pharmaceutical brands to capture this information, assess its significance, and report it in a timely manner to the authorities so that safety information can be updated and, if appropriate, additional action can be taken.

Given the diverse ways this information is submitted, and the huge volumes of data there is to go through and analyze, it might be assumed that pharma companies would harness the latest technology to capture and process the workloads. Today, the range of technology options to help with all of this is considerable; they are proven in their reliability and are highly cost-efficient.

To determine whether or not life sciences companies are capitalizing on these tools, Arriello recently commissioned a transatlantic survey into life sciences companies’ attitudes towards and plans for PV automation, particularly for case intake and reporting. The online Censuswide survey with companies in the UK and US took place in late June 2020, polling 200 respondents in senior roles across the pharmacovigilance (PV), drug safety and product safety departments of life sciences companies of different scale and focus.

The state of play today

Surprisingly, a high proportion of respondents claimed their use of advanced technology in PV was already strong, or imminent. This is at odds with general observations of pharmaceutical companies, certainly when it comes to managing adverse event data capture which tends to be predominantly manual. Just under half of all respondents said their organizations 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.

Almost two-thirds of respondents at large pharma companies claimed to use some form of standalone PV automation solution today, and almost half of SMEs said the same. Conversely the proportion of respondents who said they had no imminent plans to implement PV automation was negligible.

Yet these findings aren’t as conclusive as they might seem.

Automation of AE reporting specifically

When asked whether they thought their organizations 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 6-9 months off — if in place at all. UK companies appeared to be significantly more ambitious here. Only 10 per cent of US respondents said they already had automated AE reporting, and just a fifth has imminent plans to adopt an IT solution for this.

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.

What other PV activities have companies automated?

To determine how far along organizations are with PV automation generally, and the specific areas they have advanced the most, the research asked what else companies had automated or planned to automate within the PV function.

Clinical and medical information compilation (both mentioned by almost two thirds of respondents, rising to up to 80 per cent among respondents in product safety roles) emerged as the most advanced areas for process automation, with almost two-thirds of all respondents saying facilities for this were already in place. Use of automation in standard document compilation and product quality compliance information was also common, cited as being in place at over half of companies. Automated solutions for managing regulatory intelligence information, literature screening, and auto-narrative generation were prevalent for more than four in 10 organizations.

IT limitations prove the biggest barrier

While most respondents claimed their organizations 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 3 being IT-related challenges. Respondents revealed that an inability to validate new systems (cited by 41 per cent), a lack of familiarity with AE case intake technology options (indicated again by 41 per cent), and inadequate IT infrastructure (cited by 38 per cent across all sizes of organization) stood in the way of automating these vast and largely manual workloads.

Larger pharmaceutical companies were found to favor range and depth of features in their preferred automation solutions, whereas smaller companies are looking for simplicity and ease of use. This finding is consistent with the tendency of larger organizations to use internal IT departments to build bespoke capabilities, while companies with more modest in-house capabilities are more likely to lean on solutions from third parties, or delivered as part of external services.

As a consequence of this, larger companies appear more likely to run into limitations with IT infrastructure. This was the number one barrier cited by large pharma organizations.

Over a third (35 per cent) of all respondents indicated that a lack of available solutions is an inhibitor to automation, again suggesting that 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.

Matters of quantity & quality

There is a strong perception, especially among PV professionals, that PV automation equates to a rise in AE reporting volumes. A follow-up question confirmed that respondents see this as a benefit of automation. The greater an organization’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 analyzed.

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.

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 organizations, however. 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 per cent) 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 center 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 six per cent of all respondents felt their organization would be ‘very disadvantaged’ by a lack of PV automation.

Conclusion

Evidently, pharmaceutical companies - large and small, and on both sides of the Atlantic - have work to do to bring their PV capabilities in line with the latest technology. Currently they are missing a clear opportunity to manage soaring PV workloads more effectively and cost-efficiently, while optimizing use of skilled resources.

The current survey will serve as an interesting benchmark from which to monitor shifting attitudes towards and ongoing progress in PV automation: a topic to be revisited.

The full report, Pharmacovigilance Automation Adoption Survey UK & US — Key findings and discussion, is available here.

Peter Kohut (Peter.kohut@arriello.com​) is Director of Drug Safety at Arriello​ ​.

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