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.