PharmaceuticalOutsourcingQ42020 - 20

CONTRACT MANUFACTURING

Streamlining Pharmacovigilance
with Enhanced Adverse
Event Capture
John Price
John Price PharmaSolutions LLC
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/supplychain 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.

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.

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.

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.

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.

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

Pharmaceutical Outsourcing |

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| October/November/December 2020
PharmaceuticalOutsourcingQ42020

Table of Contents for the Digital Edition of PharmaceuticalOutsourcingQ42020
