The evolution of pharmacovigilance ecosystems: does Moore‘s law invite
the use of Ockam’s razor?
Abstract
“Pharmacovigilance is the science and activities relating to the
detection, assessment, understanding and prevention of adverse effects
or any other medication-related problem”, according to the WHO. With
the increasing volume of legislation, pharmacovigilance systems have
shifted from reactive (responding to emerging risks), to planned,
active, risk-proportionate approaches operating throughout the lifecycle
of medicines. Whilst medicines are beneficial to society, adverse
reactions represent a significant cause of concern. They are a major
cause of failed regulatory authorizations, and withdrawal from the
marketplace post-approval. Evaluation of real-world data plays an
increasingly important role in pharmacovigilance. There is great
interest on the part of the regulators, MAHs, academia and patients in
optimizing the use of safety data. Innovative approaches, including
pharmacogenetics and passive measures (sensors), will lead to increased
complexity in data collation and evaluation, and inevitably to an
increase in the volume of case reports. There is a multiplicity of
regulations and guidelines on how to manage these data, with an inherent
lack of harmonization. We summarize the current characterization of
safety data types, sources, and the classification of these data. Using
this benchmark, we discuss the future requirements of an effective
pharmacovigilance ecosystem, keeping the principle of parsimony in mind.