Why aren’t more companies automating PV data capture?
If ever there was a function within pharmaceutical operations that could benefit from smart technology use, it is safety and pharmacovigilance, So, why is the discipline lagging in its application of intelligent IT, asks John Price, a life sciences regulatory and safety consultant and advisor to Arriello.
The pressures on safety and pharmacovigilance (PV) teams to ingest, vet, interpret and report vast quantities of real-world data about any untoward effects of human medicinal products – and to do this accurately and within a tight timeframe - are immense, and growing. Yet, compared with other functions across the pharmaceutical product lifecycle, PV teams are the least likely to be drawing on smart technology to help lighten the load - which is puzzling.
Going back more than a couple of decades to what was happening at the UK Regulatory Authority (MHRA), there is no doubt that value was seen in using technology to streamline reporting processes. The existence of the Medical Dictionary for Regulatory Activities (MedDRA) dictionary is testament to this. MedDRA was the culmination of ambitious attempts to overhaul ADR reporting from a paper-based system (accessible on a remote government server once a week), to a more accessible and usable safety tracking platform. But such developments date back to the 1990s.
Since then, advances in PV IT appear to have been less revolutionary. This is surprising given that life sciences companies today are spending a disproportionate amount of their PV budget just amassing reports of suspected drug reactions - when many of these reports are of very low quality, meeting only minimum criteria for validity or lacking key clinical information. The effort that goes into processing this information is effort that is not being expended on analysing safety information - so that it can be used to enhance the safe use of drugs by patients.
A matter of priority
So, what is holding companies back from proactive investment in solutions that could help them? A common explanation for firms’ lack of investment in smart solutions, certainly among organisations that lack the scale and internal IT resources to develop their own, is PV’s perceived lack of strategic priority compared to pre-marketing authorisation activities such as clinical trials.
Here, technology is seen as a means of accelerating products’ speed to market, expanding the target opportunity, and bringing in new revenue. PV, by contrast, is seen as a ‘cost centre’; a public health obligation which adds little value for 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.
Major global players still prefer to build their own customised solutions.
Among the large household Pharma names, technology developments probably are taking place, but internally. Typically, the major global players still prefer to build their own customised solutions, keeping these shrouded in secrecy as though they might offer some kind of strategic advantage and competitive edge. Yet this approach is perplexing. While Big Pharma clearly has the resources to develop its own solutions for adverse event (AE) case intake and processing, companies would surely be better off spreading cost, and increasing speed to effective solutions, by using ready-to-go tools which have been designed to cater for most needs - many of which have been tried and tested many times over.
Ultimately, there is little competitive differentiation in tasks that are first and foremost a Public Health activity designed to protect patients, as well as a Regulatory necessity - so why reinvent the wheel?
Quality over quantity
To fulfil their responsibilities, stay the right side of regulators, and maintain public trust, companies have no choice but to do PV well, and report AE cases promptly. Without technology, this is a highly labour-intensive undertaking. It also requires specialist skills. Beyond life-science and healthcare qualifications, PV demands the ability to interpret complex medico-scientific data – sorting significant and meaningful findings from distracting ‘noise’. The perfect blend of pharma and data science skills is relatively scarce, as demonstrated by the difficulty companies report in recruiting qualified personnel. It is imperative, then, that companies apply that expertise economically and where it is needed most: to identifying and evaluating incoming signals, and addressing safety issues.
Even if organisations do see PV first and foremost as a cost centre, it is one that warrants investment as a means of providing services more cost-efficiently – without compromising PV quality or integrity.
PV demands the ability to interpret complex medico-scientific data.
To put this need into perspective, financial market watchers such as Grandview Research and Market Watch estimate that the annual global spending on external PV solutions and services - currently $5bn - is expected to more than double over the next few years. That’s a substantial outlay, making services very expensive - and with a limited return on investment.
In an industry as competitive and cost-laden as the global pharmaceutical industry, organisations would do well to free up a healthy proportion of that resource, to channel into developing new drugs – as long as they can do so without risking patient safety; that is, without cutting corners.
Let intelligent IT take the strain
In the right hands, advanced technology can reduce errors to drive up PV accuracy while simultaneously driving down operational costs over time. Efficiency gains of between 60%-70% have been predicted where companies are targeting largely manual and resource-intensive processes with intelligent automation, and higher efficiencies are perfectly possible; the kinds of innovation which don’t require a wholesale overhaul of firms’ existing PV systems. This includes case intake solutions which frontline professionals can use on the go, to capture AE details for straight-through processing.
As a rule-based activity, AE case processing lends itself perfectly to automation. There is no reason why a report made by a healthcare provider, patient or drug company representative via a smartphone app, for instance, couldn’t be triaged, databased and routed automatically - according to the information in the report - to company staff or regulators, with minimal human intervention.
AE case processing lends itself perfectly to automation.
The added benefit of such an application (in-the-moment computer-aided collection of information from the reporter) would be the promotion of ‘right-first-time’ capture of comprehensive, high-quality case information at source - reducing the need for case follow-up. The convenience of such a system would save time for all involved, and enable more effective PV.
So where should firms go from here?
For now, applications that automate discrete PV activities, available from specialist PV IT providers, offer opportunities for incremental efficiencies to smaller companies with modest budgets who could otherwise be left behind in the imminent PV automation revolution. As long as large pharma brands continue to focus their resources on developing their own customised PV solutions, mid-sized and smaller firms have a chance to peruse the market for off-the-shelf solutions or managed services which employ such aids to improve the quality and value of PV delivery.
This potential could be short-lived, however. By the time these solutions have realised their potential, demand may already have consumed all the available capacity of technology service providers. So it is well worth executing a strategy for advanced tech adoption sooner rather than later.
About the author
John Price, owner and MD of John Price PharmaSolutions LLC, is a life sciences regulatory and safety veteran and consultant. Formerly holding leading safety roles at Alexion, Johnson & Johnson, and Pfizer, and now an advisor to PV managed service provider Arriello, John has in-depth experience of the evolution of pharmacovigilance, extending back to the late 1980s/early 1990s. This includes a rich understanding of industry best practice, and the potential of intelligent automation in the drive towards high-quality, compliant AE reporting and improved patient safety.