Pharmacovigilance has now been established as a science that has some specific aspects.
Spontaneous
Reporting in Germany
INTRODUCTION
Pharmacovigilance
has now been established as a science that has some specific aspects. On the
one hand, it is a combination of research in basic life sciences, diagnostic
procedures or biotechnological tools, clinical pharmacology and medical
practice, biostatistics and epidemiology, and on the other hand, it includes
development as well as implementation and use of procedures. This is well
reflected in the World Health Organisation (WHO)1 definition of
pharma-covigilance: The overall aim is to protect patients, or rather, users,
taking medicinal products from harm. Activities in pharmacovigilance are not
restricted to actual pharmacological treatments or diagnostic procedures but
also have links to many areas in the overall healthcare systems established
nationally, including communication.
Because
pharmacovigilance has emerged as a science and its complexity – and
uncertainties – have become more and more clear, much progress has been made to
identify and describe the different fields and aspects in more detail and to
further develop crite-ria and principles for activities in the field of
pharma-covigilance. On the European Union (EU) level, this has resulted in a
large body of regulations, directives, guidelines and many other documents
setting stan-dards for pharmacovigilance practice. These rules have now been
largely implemented into national legislation. Today, we are operating within a
widely different pharmacovigilance system than 15 years ago. Nevertheless,
there are, and will remain, differences in the national health and
pharmacovigilance systems, and experiences from different countries should be shared
to improve the system in general without neglecting national medical
traditions.
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