Therese Lundin
Pharmacovigilance Specialist, Global Services ,
Pharmacovigilance Specialist, Global Services ,
Uppsala Monitoring Centre
WHO Collaborating Centre for International Drug Monitoring
WHO Collaborating Centre for International Drug Monitoring
Sweden
Global
patient safety in focus
The Uppsala Monitoring Centre (UMC) is a WHO
Collaborating Centre which has provided scientific leadership and operational
support to the World Health Organization’s Programme for International Drug
Monitoring (WHO PIDM) for almost 40 years. As an independent, non-profit
foundation, we build global and regional partnerships that bring together
resources, expertise, and a shared vision of patient safety. UMC focuses on building global pharmacovigilance
capacity by providing access to adequate tools and services as well as
tailor-made support and guidance, especially to member countries of the WHO
PIDM.
The start of this global pharmacovigilance
network came about already in the 1960s, when children in many countries were
born with serious deformities as a result of their mothers having taken
thalidomide while they were pregnant. At this time, there was no system in
place to collect and globally share information about adverse reactions. To
prevent future tragedies of this kind, the WHO set up a pilot project in Geneva
with the collaboration of a small group of countries in 1968. This was later
made permanent as the WHO PIDM and operational activities transferred to the
foundation WHO Collaborating Centre for International Drug Monitoring, set up
in Uppsala, Sweden in 1978.
In the mid-90s the field-name Uppsala
Monitoring Centre was adopted, and today one hundred people are employed
working in different ways with pharmacovigilance support, education, research,
signal detection and development and maintenance of tools, services and medical
reference sources to support patient safety work world-wide. The WHO
PIDM is also a platform for dialogue at global level, and UMC works actively to
encourage networking and collaboration between national pharmacovigilance
centres and other players in the patient safety arena.
At the core of UMC activities and the WHO PIDM
is the WHO global database of Individual Case Safety Reports, VigiBase®,
which is hosted by the UMC. Member countries of the WHO PIDM contribute to
VigiBase by sharing data from their own post-marketing safety surveillance
systems, and currently the database contains over 14 million reports of adverse
drug reactions.
National pharmacovigilance centres can search
and analyse this global data and compare to national or regional data in their
efforts to identify patient safety issues, which potentially need to be
addressed. UMC is also regularly screening VigiBase for new potential safety
issues and communicates the findings to WHO PIDM members for further
investigation and decision on appropriate actions.
More than 11% of
VigiBase reports are from low resource countries and the numbers are increasing
significantly every year. Numbers are important, but even more important to
remember is that behind every report there is a person, who in one way or
another suffered from something unexpected and, in many cases, avoidable. UMC
strives to raise awareness and efficiently communicate the relevance of
medicines safety monitoring as an integral part of the health care system. We
stress the importance to have political support, legislation, sustainable
funding for activities, training of students and healthcare professionals, as
well as collaboration with many different stakeholders.
Here, you will for example find links to our
recorded web lectures on a wide variety of pharmacovigilance topics, available
free of charge. You will also find information about how to access summarized
data from VigiBase via an easy-to-use interface, VigiAccess™ (www.vigiaccess.org), and about the recently developed
awareness campaign for reporting adverse drug reactions, Take&Tell™ (www.takeandtell.org).
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