With more and more safety data to capture, and a window of just 15 days to assess and report serious adverse events to health authorities, the case for automating the most labour-intensive aspects of pharmacovigilance (PV), is strong. So, what is holding companies back from investing in process transformation?
1.A lack of suitable solutions
Look at most other industries, especially those that are highly regulated, and use of IT systems tends to be highly evolved. That’s because organisations have long realised the inefficiency (in cost, time and resources) of using people to manually input data into core business systems, and then physically re-enter the information in adjacent systems in other departments.
Yet in pharma core database systems tend to stand alone. In some cases the issue is that PV departments lack access to relevant technology expertise and knowledge, to appreciate what’s available or possible. Meanwhile, larger companies may feel they need to find the budget to build any tools themselves.
Given that some very intuitive and easy-to-integrate PV data capture tools already exist in the external market, it is surprising that manufacturers/sponsors do not make more use of them – especially as the time and cost savings associated with digital solutions are shown to exceed 60 per cent.
Concerns about inadvertent non-compliance are understandable. These concerns are easily addressed, however. When choosing data capture tools, or managed services which make strategic use of them, PV professionals simply need to check for certification/documentation showing that any solution has been validated as meeting regulatory criteria. For the longer-term, continued validation and system lifecycle management will be down to the provider’s support process.
3.Fear of the unknown
To ensure they stay the right side of regulators, PV teams often like to play it safe and do things the way they always have – especially if the organisation has scant internal IT capabilities.
However industries and companies that fail to get on board with process digitisation will lose ground to more nimble competitors, so it is well worth life sciences organisations investing in at least some internal IT resource – if only to be able to collaborate with external partners.
Since post-marketing surveillance does not tend to attract big budgets, any investment in PV IT needs to be tightly targeted, and seen to deliver improved results with greater efficiency – freeing up skilled professionals for other critical tasks, such as promoting and selling new medicines in the case of drug reps, or seeing patients in the case of healthcare professionals. Data processors, meanwhile, could expedite reporting if they didn’t have to keep going back to check or complete details missing from adverse event (AE) reports passed onto them.
Taking advantage of a pre-existing, pre-tested tool that’s ready to implement today, and accessible on demand via a software-as-a-service delivery model, is an economically prudent option too – especially if there is no associated support burden, because the provider takes care of everything.
Most companies are wary of change, which may require staff retraining. Tools’ intuitive ease of use is paramount in overcoming this barrier, whether the data inputters are clinicians or drug sales reps on the front line, or back-room data clerks working for the PV department or a service provider.
The key is to make the new experience as convenient and natural for busy people to engage with as part of their daily work. If users were able to capture patient information directly via a smartphone app - even by speaking information directly into each required field - this could be transformational for those called upon to report adverse events and provide the fullest picture they can about the patient’s experience.
Discrete tools such as the example above are a good way for life sciences firms to test the potential of process automation and amass some experience. Certainly, embracing greater automation is going to be essential as PV reporting requirements continue to multiply, paving the way to great efficiency gains once companies are able to overcome ingrained inertia.
About the author
Peter Kohut is Director of Drug safety at Arriello and an experienced EU QPPV. Arriello is a leading provider of risk management and compliance services to the Life Sciences industry. Peter.firstname.lastname@example.org