REPORTING ADVERSE
DRUG
REACTIONS
Definitions of Terms and Criteria for their Use
Vision Disorders
Introduction
The eye is a
highly developed sense organ in which minimal impairment
can produce a
substantial effect upon function. The field is difficult with
regard to ADR
reporting, for many non-specific terms have to be used if
special methods
of investigation are not available.
The following
descriptors are unsatisfactory as clinical or ADR reporting
terms, and
further development of this terminology is necessary.
Terms
Cataract
Cataracts may result from a number of
processes and are mainly agerelated.
Cataract is responsible for about 35 per
cent of cases of visual impairment and is one of the largest single causes of
blindness world-wide. Cataracts usually progress slowly, but are frequently
only detected when they reach a certain extent. Thus, even a ‘‘sudden
appearance’’ could result from a pre-existing condition. Care should be taken
in evaluating apparent association between these lesions and drug therapy.
Symptoms may include glare, blurred vision, altered colour perception, change
of
refraction, and monocular diplopia.
Definition
A cataract is a
congenital or acquired lack of clarity of the lens.
Basic
requirements for use of the term
Demonstration of
lack of lens clarity, normally by ophthalmoscopy with
dilation of the
pupil. For confirmation, characterization and localization
of a cataract,
slit-lamp examination of the lens is usually required.
Keratitis
The
term keratitis without qualification is undesirable in ADR reporting.
Keratitis may be
caused by many factors, including physical exposure of
the cornea;
bacterial, viral or fungal infection; toxic agents or foreignbodies; and local
exposure of the eye to drugs or the concentration of drugs
in the lachrymal
fluid. lt may be associated with decreased corneal
sensitivity.
Definition
The non-specific term keratitis is
used to describe a wide variety of lesions
of the cornea.
Basic
requirements for use of the term
The demonstration of corneal
appearances satisfying the definition.
Specific terms describing the
pathological nature of the lesion are to be
preferred.
Retinal disorder
Many retinal disorders, especially those
of the macula, lead to visual
impairment, which may ultimately be
irreversible. Drugs have been
implicated in a wide variety of retinal
lesions. Macular lesions may include
degeneration, oedema, and pigmentary
changes. Other retinal lesions may
include detachment, vascular disorders
(e.g., hypertensive, diabetic, and
other forms of retinopathy)
inflammation, haemorrhage, deposits,
degeneration, and pigmentary changes. An
exact diagnosis should be
established whenever possible.
Definition
All abnormalities of the retina are included
in the term retinal disorder.
Basic
requirements for use of the term
Fundoscopy, usually with dilation of the
pupil, is necessary.
Vision abnormal
The term vision abnormal is non-specific
and therefore undesirable inADR
reporting. If the use of the term is
unavoidable, then careful follow-up or
referral should be
considered in order to establish a definitive diagnosis.
Definition
Vision abnormal is a change,
usually a deterioration, in visual function or
perception.
Basic
requirements for use of the term
A report of vision abnormal
should lead to the establishment and reporting
of a specific diagnosis.
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