Pie Chart 1. Retrospective review Adverse Reactions Jan

Report
Adverse Effects of Fluorescein Angiography
Miss Dania Al-Nuaimi, Mrs Rita McLauchlan, Mr. S. Mahmood
Telephone Survey of Fluorescein Dosage
Telephone Survey of Fluorescein Dosage
MREH
MREH administers
administers 625mg
625mg fluorescein
fluorescein (as
(as 2.5ml
2.5ml of
of
25%
fluorescein).OfOf
teaching
and
25%
fluorescein).
thethe
tenten
teaching
and
ten
ten
non-teaching
hospitals,
the
dose
of
non-teaching hospitals, the dose of fluorescein
fluorescein
administered
300mg to35%
administered
varied fromvaried
300mgfrom
to 1000mg.
1000mg.
hospitals 1000mg
administered
1000mg12 of
hospitals 35%
administered
fluorescein.
fluorescein.
12 of the
20 units (60%)
the 20 units (60%)
administered
500mg
administered
500mg
fluorescein.
One
unit
fluorescein. One unit administered 300mg
administered
300mg intravenous
fluorescein,
intravenous fluorescein,
with effect.
See Table 1.
with effect. See Table 1.
Table 1. Telephone survey of intravenous dosage of fluorescein
Retrospective
Retrospective Review
Review of
of Adverse Events
2080 fundus
fundus fluorescein
fluorescein angiographies
angiographies (FFAs)
(FFAs)
2080
were performed
performed during
during 2010.
2010. Records
Records for
for 2003 of
were
these were obtained. Of these, there were 101
2003 of these were obtained. Of these, there
adverse reactions during FFA, giving an overall
were
101
adverse
during
FFA, giving
rate of
5.04%.
Thereactions
commonest
adverse
reaction
an
overall
rate
of 5.04%. The
commonest
was
nausea,
experienced
by 73%
patients. One
adverse
reaction
experienced
by
respiratory
eventwas
wasnausea,
noted, giving
a serious
73%
patients.
event
adverse
eventOne
raterespiratory
of 0.04%. See
Piewas
Chart 1.
noted, giving a serious adverse event rate of
0.04%. See Pie Chart 1.
Green
Amber
Red
Total
Adverse
Event Rate
< 4.9%
4.9-6%
>6%
Nausea rate
< 3%
3-5%
>5%
Vomiting Rate
<1.8%
1.8-3%
>3%
Flushing/itching/
hives
<0.6%
0.6-2%
>2%
Serious adverse
event
0
0-0.5%
>0.5%
Results
The
Thedose
doseadministered
administeredatatManchester
Manchester
Royal
RoyalEye
EyeHospital
Hospitalwas
was2.5ml
2.5mlof
of25%
25%
fluorescein,
fluorescein,giving
givingaatotal
totaldose
doseofof625mg.
625mg.
Standard
Prospective Questionnaire
Prospective
Questionnaire
The questionnaire
was completed by 95 patients.
59%questionnaire
were male and
female. 41
(46%) patients
The
was41%
completed
by 95
had
had
an
FFA
before.
patients. 59% were male and 41% female.
41
anhad
FFAnot
before.
Of(46%)
thesepatients
patients,had
36 had
(88%)
had any
with their
previous
Ofproblems
these patients,
36 (88%)
hadangiogram.
not had
any
problems
previousan adverse event
60%
patientswith
whotheir
experienced
angiogram.
with their first FFA experienced an adverse event
withpatients
the subsequent
FFA. Thisan
compares
60%
who experienced
adverse to 13.8%
patients
an adversean
event on the
event
withwho
theirexperienced
first FFA experienced
subsequent
they had not experienced a
adverse
eventFFA,
withwhen
the subsequent
side-effect
the first to
time.
This
was statistically
FFA.
This compares
13.8%
patients
who
significant (p=0.0426).
experienced
an adverse event on the
subsequent FFA, when they had not
experienced a side-effect the first
time. This was statistically significant
(p=0.0426).
Anadverse
adverseevent
eventrate
rateof
of7%
7%during
during FFA
An
waswas
seen.
Nausea
waswas
the the
commonest
FFA
seen.
Nausea
adverse event seen (4.7%) See Table 2.
commonest adverse event seen
(4.7%) See Table 2.
Table 2. Prospective Review of Adverse Reactions.
The colour shows the result according to the standards set
Methods
used
to implement
audit:
Methods
used
to implement
thethe
audit:
1. Survey
of hospitals
determine
practice
1. Survey
of hospitals
to to
determine
UKUK
practice
of of intravenous
fluoresceinfluorescein
dosage. dosage.
intravenous
2. Retrospective
review
of reported
adverse
reactions
during
2. Retrospective
review
of reported
adverse
reactions
during
fluorescein
angiography.
fluorescein
angiography.
3. Prospective
review
of adverse
reactions.
3. Prospective
review
of adverse
reactions.
Sample/Population:
Sample/Population:
Method
1 - 110- 10
teaching
andand
10 10
non-teaching
hospitals
Method
teaching
non-teaching
hospitals
Methods 2 and 3 - Patients undergoing fluorescein
Methods 2atand
3 - Patients undergoing fluorescein angiography
angiography
MREH
at MREH
Data Collection:
Data Collection:
1. A telephone survey was performed of randomly selected
1. A telephone
survey
was
performed
of randomly
selected
ophthalmology
units
in the
UK.
The percentage
of
ophthalmology
units
the UK.
of fluorescein,
fluorescein,
volume
usedin(ml)
and The
totalpercentage
dosage of fluorescein
volume used
(ml)was
andelicited
total dosage
of unit.
fluorescein administered
administered
(mg)
for each
(mg) was elicited for each unit.
2. Retrospective review of the adverse effects logbook JanRetrospective review of the adverse effects logbook Jan-Dec
Dec2.2010
2010
3. Prospective Questionnaire - Data collected over a
3. Prospective Questionnaire - Data collected over a 4 week
4 week
period
10th October
period
from from
10th October
2011. 2011.
Patients attending for fluorescein angiography were given a
Patients attending
fluorescein
questionnaire
to fill infor
with
3 sectionsangiography
to fill in: were given a
questionnaire to fill in with 3 sections to fill in:
a. pre-angiogram.
a. pre-angiogram.
b. before leaving department.
b. before leaving department.
[Please provide contact no. if you are happy to be called for
[Please provide contact no. if you are happy to be called for
further feedback]
further feedback]
c. Phone call questionnaire 2 days post-treatment
c. Phone call questionnaire 2 days post-treatment
Outcome
Therecommended
recommendedadult
adultdosage
dosagequoted
quoted
The
by
bymany
manymanufacturers
manufacturersisis500mg,
500mg,either
either
packaged
as
5ml
of
10%
fluorescein
packaged as 5ml of 10% fluoresceinor
or2ml
of
25%
2ml
of fluorescein.
25% fluorescein.
1. There
The recommended
dosage
intravenous
are no officialadult
standards
or of
guidelines
fluorescein
angiography
quoted
bytomany
regarding for
adverse
effects rates
due
manufacturers
is 500mg. Therefore the following
fluorescein angiography.
2. standards
The following
expectedas
werestandards
drawn upwere
usingset
theforliterature
1-10
adverse
from the available the literature1-10
a basisevents
Methods
ToToestablish
establishcurrent
currentadverse
adverseevent
eventrates
ratesatat
MREHtotoconsider
considera case
a caseforforreducing
reducingamount
amount of
MREH
fluorescein
administered
intravenously
of fluorescein administered intravenouslyand
and
improvepatient
patientsafety.
safety.
improve
Standards
Thereare
areno
noofficial
officialguidelines
guidelinesregarding
There
regarding
dosage of intravenous
the
dosagethe
of intravenous
fluorescein as it
itfluorescein.
is unlicensed.
Aim
Thewater
watersoluble
solublefluorescein
fluoresceinsodium
sodiumis
The
used
forfor
fluorescein
angiography.
is used
fluorescein
angiography.
Results
Results
Introduction
Manchester Royal Eye Hospital, Central Manchester University Hospitals NHS Trust
Email Address: [email protected]
There is a wide variation in fluorescein dose throughout
There
a wide
variation
in fluorescein
dose
theisUK.
The dose
at MREH
exceeds manufacturer’s
throughout
the UK. The
dose at MREH
exceeds
recommendation
of 500mg.
Adverse
effects at MREH
manufacturer’s
recommendation
of
500mg.
Adverse
are higher than that quoted in the literature
and some
effects
at MREH
higher
that quoted in the
serious
eventsare
have
beenthan
noted.
literature and some serious events have been noted.
Recommendations
Action
Plan the dose used at MREH to 500mg in the first
• Reducing
Alter instance
dose with
effectevents.
to 500mg.
toimmediate
reduce adverse
Source a reduced concentration of fluorescein to allow
• Administer
of 25% to give a dose of 500mg.
further
reduction2ml
to 300mg.
• Source 10% fluorescein to facilitate dose reduction in
future.
Re-audit
in 2014.
Benefit
to Patient/Hospital
Services
• Re-audit
in 2014.
Patients
should
experience less Services
adverse events with
Benefit to Patient/Hospital
intravenous fluorescein administration.
• Patients
should
adverse
with
A saving
of £7,500
perexperience
annum byless
reducing
theevents
dose of
intravenous
fluorescein administration.
fluorescein
to 500mg.
• A saving of £7,500 per annum by reducing the dose of
fluorescein to 500mg.
References:
1.Justice JJ et al. Clinical Comparison of 10% and 25% Intravenous Sodium Fluorescein solutions Arch Ophthalmol 1977 95 2015-2016.
2.Lipson BK, Yannuzzi LA, Complications of Intravenous Fluorescein Injections International Ophthalmology Clinics 1989 29 200-205.
3.Butner RW, McPherson AR, Adverse Reactions in Intravenous Fluorescein Angiography Annals of Ophthalmology 1983 15 1084-1086.
4.Yanuzzi LA, Justice J, Baldwin HA, Effective differences in the formulation of intravenous fluorescein and related side-effects Am J Ophthalmol 1974 78 217-221.
5. Kalogeromitros DC et al. Skin testing and adverse reactions in fluorescein: A prospective study Allergy and Asthma Proceedings 2007 28 472-476.
6.Demirci G et al. Case Report of Bullous Pemphigoid following Fundus Fluorescein Angiography Case Reports in Ophthalmology 2010 1 1-4.
7.Butner RW, Alice McPherson ‘Adverse Reactions in Intravenous Fluorescein Angiography’ Annals of Ophthalmology 1983 15 1084-6.
8.Kwiterovitch KA et al. ‘Frequency of Adverse Systemic Reactions after Fluorescein Angiography’ Ophthalmology 1991 98 1139-1142.
9.Kwan et al. ‘Fluorescein angiography and adverse drug reactions revisited: the Lions Eye experience’ Clinical and Experimental Ophthalmology 2006 34 33–38.
10.McLauchlan et al. ‘Ethnic Variation in fluorescein angiography induced nausea and vomiting Eye 2001 15 159-162.
Hospital
Volume Fluorescein
used (ml)
Percentage
Fluorescein used (%)
Total Fluorescein dose
(mg)
1
3
10
300
2
5
20
1000
3
5
10
500
4
5
10
500
5
2.5
20
500
6
5
20
1000
7
5
20
1000
8
5
10
500
9
5
10
500
10
5
10
500
11
5
10
500
12
2.5
20
500
13
5
20
1000
14
5
20
1000
15
2.5
20
500
16
5
20
1000
17
5
20
1000
18
2
25
500
19
2.5
20
500
20
5
10
500
Table 1. Telephone survey of intravenous dosage of fluorescein
Pie Chart 1. Retrospective review
Adverse Reactions Jan - Dec 2010
1%
1%
6%
3%
Nausea
5%
Vomiting
4%
7%
Nausea and vomiting
itchy skin
73%
coughing
sneezing
skin rash
respiratory event
Adverse Reaction
During FFA (%)
Immediately post- After going Home
FFA (%)
(%)
Nausea
4.7
2.73
1.16
Vomiting
1.15
1.2
0
Headache
0
1.2
3.4
Other
1.15
0
5.88
Serious
0
0
1.16
Total
7
5.13
11.6
Table 2. Prospective Review of Adverse Reactions. The colour shows the result according to the
standards set.

similar documents