Dr. ANIKET GINODIA, Dr. Sneha Batra, Dr. Partha Biswas, Dr. PREEYAM BISWAS
Abstracts
Aims :
The aim of our study is to know the duration of sterility of eye drops after it has been opened in various clinical settings (OPD, OT, Rural and Urban).
Methodology:
A prospective double blinded study was done with 250 freshly opened bottles of eye drops, consisting of anaesthetic(20), dilating(20), antibiotic(120), steroid(80), lubricating (10) eye drops. The total number of samples taken were 640. Samples were analyzed on the same day at department of ocular microbiology & molecular biology, at tertiary level eye care centre. Drops were divided into 4 groups, Group A from OT(0,3,6,9 hr), Group B from OPD(Day 1,3,5,7,10,14), Group C from post operative rural patients(Day 7), Group D from post operative urban patients(Day 7). In all the groups, the samples were taken from tip of the bottle, inner surface of the cap, eye drop inside the bottle for contamination examination. Microbiological assay was performed using aerobic culture medium.
Result:
Six out of 640 samples were found to be contaminated, out of which Micrococcus species was found in two and Staphylococcus epidermidis in four samples. The contamination was seen in 0/360 OPD samples, 1/30 OT samples, 5/80 post op samples (rural) and 0/80 post op samples (urban).
Conclusion:
Adequate training of hygienic handling of eye drops is of paramount importance and meticulous training should be given to health care providers, patients and patient’s attendants.
Introduction:
The eye drops are initial mainstay treatment for most of the eye conditions like infections, allergy, dry eye, glaucoma, etc. They are used by pre operative and post operative patients. It can be instilled by multiple dose bottles or single use bottle. Contamination of the solution in multiple dose bottles is of most important concern. Protection of multiple dose bottles against microbial contamination is usually achieved by addition of a suitable preservative such as benzalkonium chloride, methyl paraben, sodium perborate , chlorobutanol , stabilized thimerosal etc.
To keep the medications sterile from microorganisms and increase the shelf time of these drops[1]. Serious eye infections such as bacterial keratitis & endophthalmitis were found to be associated with the use of contaminated topical medications [2,3,4]. The eye drops can get infected by contaminated fingers, instruments, hands, common towels and dropper tip and cap in contact with eyelids, lashes, eyebrows, skin around eyes. Apart from the risk of infection, bacterial contamination of ophthalmic preparations may alter the pH of the preparation and therefore reduce the efficacy of the medication in the treatment of the intended diagnosis.[5]
The aim of our study is to estimate the sterility of eye drops after it has been opened in various clinical settings (OT, OPD, in rural and urban patients).
Methodology:
250 freshly opened bottles of eye drops were used in our study for microbial contamination. The eye drops used were as following: anaesthetic (20), dilating (20), antibiotic (120), steroid (80) and lubricating (10). A total of 640 samples were obtained. All the samples were taken to department of ocular microbiology & molecular biology at tertiary hospital, kolkata and were analyzed the same day. The samples after collection from the patients were enclosed in a sealed packet and labelled and transferred immediately to the microbiology laboratory to reduce the storage time.
| Eye Drops category used | No. of eye drops used– 250 | |
| Anesthetic (AN) | Proparacaine 0.5% | 20 |
| Dilating
(D) |
Tropicamide 0.8% + Phenylephrine 5% | 20 |
| Antibiotic
(AB) |
1. Moxifloxacin 0.5% | 100 |
| 2. Gatifloxacin 0.3% | 10 | |
| 3. Tobramycin 0.5%
|
10 |
|
| Steroid
(S) |
Prednisolone acetate 1%
|
80
|
| Lubricating
(L) |
Carboxymethylcellulose 0.5%
|
10 |
The Eye drops were divided into 4 Groups- A, B, C & D.
| Group A | Group B | Group C | Group D | |
| Source | Operation Theatre (OT) | OPD |
|
|
| Eye drops used | 1. Proparacaine 0.5%
2. Tropicamide 0.8% + Phenylephrine 5% 3. Moxifloxacin 0.5%
|
1. Proparacaine 0.5%
2. Tropicamide 0.8% + Phenylephrine 5% 3. Moxifloxacin 0.5% 4. Gatifloxacin 0.3% 5. Tobramycin 0.5% 6. CMC 0.5%
|
1. Prednisolone acetate 1%
2. Moxifloxacin 0.5%
|
1. Prednisolone acetate 1%
2. Moxifloxacin 0.5%
|
| No. of Eye Drops used | 30 ( 10 from each) | 60 ( 10 from each) | 80 (40 from each) | 80 (40 from each) |
| No. of samples taken | 120 | 360 | 80 | 80 |
| Sample schedule | at 0 hr, 3 hr, 6 hr, 9 hr from each eye drop after opening and then discarded the same day
|
At end of
Day 0,3,5,7,10,14 after opening and then discarded after 14 days |
Taken on Post op Day 7 and then discarded. | Taken on Post op Day 7 and then discarded. |
In all the groups, the samples were taken for contamination examination from tip of the bottle, inner surface of the cap & eye drop inside the bottle.
The samples then sent for microbiological assay using aerobic culture medium.
Media plate used were blood agar plate, chocolate agar plate & sabouraud dextrose agar plate.
Eye drops were administered by nursing staff, hospital personnel for inpatients and in an outpatient setting, and by patients themselves in post operative cases.
The specimens were obtained and cultured according to the following protocol:
A sterile cotton swab was moistened in sterile brain heart infusion (BHI) before wiping the nozzle tip of the eye drop containers and then used to inoculate the culture plates. The vials were inverted and one drop was directly inoculated on each of the media and then spread across the plates.
All media except the Sabouraud agar plates were incubated at 37°C for 48 hours and evaluated after 24 and 48 hours. The blood-agar, chocolate-blood agar plates were incubated in a microaerophile environment.
All culture media were obtained from HiMedia Laboratories, India.
Post operative rural patients (R) 40 in number were subdivided into 2 groups R1&R2 and urban patients (U) 40 in number were subdivided into 2 groups U1&U2, out of which 20(R1 &U1) were given normal routine post operative instructions and rest 20 were given additional instructions of proper handling, storage and installation technique of eye drops along with pamphlets to each patient.
Result
A total of 640 samples analysed of which one sample of proparacaine from OT sample and five samples of steroid (prednisolone) eye drops from post operative rural patients (R2 group) got contaminated at tip, inner surface of cap and from drop.
Overall 6/640 samples got contaminated with two micrococcus and four staphylococcus epidermidis species in our study.
One micrococcus species found in OT sample.
Discussion
In this study, we compare contamination of eye drops in OPD clinic, in OT, in both post operative rural and urban patients and in different groups of antibiotics (moxifloxacin, gatifloxacin, tobramycin).
We analyze eye drops used by post operative rural & urban patients with eye drops used by health care staffs on patients in our hospital for its contamination and we found that there was contamination seen in one OT samples which emphasizing the role of hygienic handling by paramedical staff and in post operative of rural patients (R1 group) but no contamination in post operative of rural patients (R2 group) which emphasizing the role of giving proper instructions and hygienic handling of eye drops at time of discharge along with pamphlet in their local language. There are no studies to the best of our knowledge which compare eye drops contamination by rural patients, urban patients, hospital personnel.
Livingstone et al study evaluate and compare the microbial contamination arising from 1 and 2 weeks use of eye drops by hospital inpatients and suggests increasing the period of use for eye drops in hospitals from 7 to 14 days would not present a clinically significant threat to patients’ health.[6]
Virani et al study did prospective study on the sterility of sixty multi-drop residual eye drops which were collected from the rural based patients, after at least one month of use and showed that eye drops may be used safely for a period of six weeks after opening.[7].
Nentwich et al studied on 101 eye drops for microbial examination after an average use of 2 weeks and found contamination rate of 6%, which is in the lower range of data published on the contamination of eye drops elsewhere (0.07% to 35.8%).[8]
The limitation of our study:
- drops were not divided into preservative and preservative free groups
- all categories of eye drops were not used
Conclusion
Adequate training of hygienic handling of eye drops is paramount importance and meticulous training to be given to the health care providers, patients and patient’s attendants. Importance of giving pamphlets (how to use eye drops properly) which significantly reduce the contamination rate. Eye drops may be safely used up to a period of 14 days from opening in the OPD setup.
References:
- Rajpal, R.K. and Glaser, S.R. 1997. Antiseptics and Disinfectants. In: Kooner KS, Sharir M, editors. Textbook of Pharmacology, Philadelphia: Lipppincott- Raven, 662-663.
- Geyer O, Bottone EJ, Podos SM, Schumer RA, Asbell PA. Microbial contamination of medications used to treat glaucoma. Br J Ophthalmol 1995;79:376‑9.
- Templeton WC 3rd, Eiferman RA, Snyder JW, Melo JC, Raff MJ.Serratia keratitis transmitted by contaminated eyedroppers. Am J Ophthalmol 1982;93:723‑6.
- Schein OD, Wasson PJ, Boruchoff SA, Kenyon KR. Microbial keratitis associated with contaminated ocular medications. Am J Ophthalmol 1988;105:361‑5.
- Perry HD, Donnenfeld ED. Issues in the use of preservative-free topicals. Manag Care. 2003;12:39–41.
- 6.Livingstone DJ, Hanlon GW, Dyke S.Evaluation of an extended period of use for preserved eye drops in hospital practice.British Journal of Ophthalmology 1998;82:473-475.
- Virani S, Rewri P, Vyas AMicrobiological Safety of Using Eye Drops After One Month: Contamination is A Rule or Mere Regulation ?.DJO 2016;26:176-179
- Nentwich MM, Kollmann KHM, Meshack J, Ilako DR, Schaller UC.Microbial contamination of multi-use ophthalmic solutions in Kenya . Br J Ophthalmol 2007; 91:1265–68.
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