Pharmacovigilance (PV) automation could be achieving so much more, according to the findings of research involving pharmaceutical organizations in the UK and US. The sector’s use of technology to capture adverse event data is immature and automation strategies are still very much stuck at first base. Dr John Price, life sciences regulatory and safety consultant and advisor to Arriello, digs deeper into the findings. He discovers the extent to which life science companies are failing to maximize the opportunities for automation – and highlights the next steps necessary for more sophisticated and effective automation.
Upholding the highest levels of patient safety demands that life sciences organizations 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.
Manual Processing
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 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.
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% 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.
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.
Current Process Automation
Clinical and medical information compilation (both mentioned by almost two thirds of respondents, rising to up to 80% 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.
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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 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 organization) stood in the way of automating these vast and largely manual workloads.
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.
Across all company sizes, the top three benefits of PV automation (jointly) were seen as improved compliance; higher reporting volumes; and speed.
SME Efficiency Benefits
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%) of all respondents cited the potential for resource redeployment as a target benefit.
It is clear that many businesses are missing an opportunity to manage PV workloads more effectively and cost-efficiently, while optimizing use of skilled resources. Data quality, speed and completeness of reporting could all be improved by automating adverse event data capture. Yet most respondents did not see an absence of PV automation as a disadvantage. In fact, only 6% of all respondents felt their organization would be ‘very disadvantaged’ by a lack of PV automation.
Inertia and IT Limitations
While it would appear that pharmaceutical companies don’t want to miss out on the promise of AE case intake automation, inertia and IT limitations may be preventing companies from transforming the performance and cost-efficiency of their PV operations – and from reassigning expensive professionals’ time to tasks that add greater value.
It appears to be very much the case that PV functions are widely viewed as a cost center rather than a function that could add value to the business. This is lamentable, given the scope for process transformation that today’s technology enables. Proven solutions exist now which could transform the efficiency, effectiveness and regulatory adherence of PV processes, without placing data at any risk of being compromised in any way.
Meanwhile global players often prefer to build their own customized solutions, keeping these shrouded in secrecy as though they might offer some kind of strategic advantage. This is puzzling. While Big Pharma clearly has the resources to develop its own solutions for adverse event case intake and processing, companies would surely be better off – financially and time wise – using ready-to-go tools which have been tried and tested many times over.
The research reveals that the 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 and business stakeholders. PV professional and solution providers may need to work together to communicate the numerous tangible benefits linked to capturing the high throughput of case data in an automated way.
Further Investigation Needed
The findings of this comprehensive transatlantic survey offers much food for thought. The topic also deserves further investigation, to discover why more companies are not proactively pursuing the chance to empower frontline people – including healthcare professionals and company personnel – to capture PV information directly into reporting systems, using smart digital data capture solutions.
The full report, Pharmacovigilance Automation Adoption Survey – UK & US - Key findings and discussion, is here https://www.arriello.com/automation/
Author Biography
John Price, owner and MD of John Price PharmaSolutions LLC, is a life sciences regulatory and safety veteran and consultant, and an advisor to PV managed service provider Arriello. www.arriello.com, [email protected]