Each report must be assigned to one or more drugs and to one or more medical terms describing the reaction.
CLASSIFICATION OF ADR REPORTS
Each
report must be assigned to one or more drugs and to one or more medical terms describing
the reaction. There is a need for a distinction between a drug reported as
being suspected of causing the adverse effect and one that is simply
co-medication. This distinction made by the reporter of the reaction may not be
made correctly, especially when it is an interaction between drugs that is
causing the effect.
For
the value of the report to be optimal, both the trade name and the drug
substance name may need to be recorded separately. For initial statisti-cal
approaches to signal detection the drug substance name is the one that is used.
The
minimum information for a valid report is usually an identifiable (but not
necessarily identified) patient, a drug and a reaction. The reaction must be
classified using some form of medical dictionary. There are several different
dictionaries in wide use, including those from the Food and Drug
Adminis-tration (FDA) (COSTART) and the World Health Organisation (WHO)
(WHO-ART). In the United Kingdom, the Medicines Control Agency (MCA) use their
own Adverse Drug Reactions Online Information and Tracking (ADROIT) dictionary
and a project to unify these dictionaries, based partly on the ADROIT
dictionary has been carried out, resulting in the inter-nationally
(International Conference on Harmonisa-tion (ICH)) agreed MedDRA.
Most
of the dictionaries have a form of hierarchy from the widest grouping – ‘System
Order Class’, for exam-ple cardiovascular – through ‘High Level Terms’ to
‘Preferred Term’, for example myocardial infarction. A second type of
classification relates to the public health impact of a reaction classed as
fatal, serious or non-serious. The definition of ‘serious’ is not always
consistent between countries or dictionaries but within a particular database
it will (or should) be consistent.
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