The definitions of key pharmacovigilance concepts apply to all European pharmacovigilance and are set out in Title I of Directive 2001/83/EC.
DEFINITIONS
The
definitions of key pharmacovigilance concepts apply to all European
pharmacovigilance and are set out in Title I of Directive 2001/83/EC. The
Commission provides guidance on their interpretation in Volume 9.
An
‘adverse reaction’ is a response to a medic-inal product which is noxious and
unintended and which occurs at doses normally used in humans for the
prophylaxis, diagnosis or therapy of disease or for the restoration, correction
or modification of physi-ological function. Volume 9 advises that an adverse
reaction, contrary to an adverse event, is characterised by the fact that a
causal relationship between the drug and the occurrence is suspected.
A
‘serious adverse reaction’ means an adverse reaction which results in death, is
life threaten-ing, requires inpatient hospitalisation or prolonga-tion of
existing hospitalisation, results in persistent or significant disability or
incapacity or is a congen-ital anomaly/birth defect. Volume 9 advises that a
serious adverse reaction also includes serious adverse clinical consequences
associated with use outside the terms of the Summary of Product Characteristics
(including, e.g. prescribed doses higher than those recommended), overdoses or
abuse. Important adverse reactions that are not immediately life threatening or
do not result in death or hospitalisation, but may jeop-ardise the patient,
should be considered as ‘serious’.
An
‘unexpected adverse reaction’ means an adverse reaction, the nature, severity
or outcome of which is not consistent with the Summary of Product
Char-acteristics. Volume 9 advises that this includes reac-tions related to the
class of products within which the particular product falls, which are
mentioned in the Summary of Product Characteristics but which are not
specifically described as occurring with the product.
For
nationally authorised products, the relevant Summary of Product Characteristics
is that approved by the competent authority in the Member State to whom the
reaction is being reported. For centrally authorised products, the relevant
Summary of Product Character-istics is that authorised by the European Commission.
‘Abuse
of medicinal products’ means the persistent or sporadic, intentional excessive
use of medicinal products which is accompanied by harmful physical or
psychological effects.
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