LS&HC Horizons 2023 - Flipbook - Page 50
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Cross-jurisdictional
50
Pharmacovigilance on digital media
The impact of digital channels on health
communication has grown enormously,
as social media has become a common
place for exchanging information on health
issues and, therefore, a potential source
of pharmacovigilance-relevant information.
The European Medicine Agency’s (EMA)
guidelines on good pharmacovigilance
practices (GVP) address pharmacovigilance
on digital channels, introducing the obligation
for marketing authorization (MA) holders to
treat reports from social media as spontaneous
reports and to regularly screen digital media
under their management or responsibility
for potential reports of suspected adverse
reactions. For non-company-sponsored digital
media, the MA holder only has to take action
if it becomes aware of a report that qualifies
for submission as a safety report.
In the UK, GVP continues to apply directly in
Northern Ireland and with some modifications
in Great Britain post-Brexit. The Association
of the British Pharmaceutical Industry has
published practical guidance on managing
safety information and product complaints
from digital activities.
In the United States, FDA expects application
holders to treat reports from social media as
spontaneous reports. In addition, FDA has
indicated that it is considering ‘social listening’
as a means to aid in safety signal detection
and, in the future, data from social media
may be relevant in aggregate form to identify
macro trends.
Lynn Mehler
Partner, Washington, D.C.
Digital pharmacovigilance has limitations, for
example, regarding the quality of data collected
(e.g., posts usually do not describe symptoms
using the appropriate medical terminology
and accuracy), the effective management of
follow-ups and the costs of surveillance of large
volumes of data.
The European Commission’s research on the
value of social media in pharmacovigilance
concluded that in certain areas (e.g., drug use
during pregnancy or drug abuse), data from
social media could be a valuable complement
to traditional pharmacovigilance methods and
sources. However, the use of social media for
extensive, untargeted collections of reports
risks being overly time-consuming compared
to the results it can yield. This may change as
algorithms capable of ‘reading’ online reports
more effectively are developed.
The performance of pharmacovigilance
activities on the internet and digital media,
and their regulation by competent authorities,
will become increasingly necessary as social
media offers opportunities to analyze patient
perspectives of medication use that might not
otherwise be communicated to health care
professionals, as well as the potential to detect
medicinal product safety concerns earlier than
by traditional means.
Jane Summerfield
Partner, London
Giuseppe Aminzade
Counsel, Milan
Angelo Forte
Trainee Solicitor, Milan
