RESEARCH ARTICLE
A prospective observational study of ophthalmic adverse drug reactions in
a tertiary care hospital
Vasundara Krishnaiah
1, R S Umadevi
2, Leeyasid Shaik
11Department of Pharmacology, Kempegowda Institute of Medical Sciences, Bengaluru, Karnataka, India, 2Department of Ophthalmology,
Kempegowda Institute of Medical Sciences, Bengaluru, Karnataka, India
Correspondence to: R S Umadevi, E-mail: dr.leeyaimran@gmail.com Received: November 18, 2020; Accepted: December 09, 2020
ABSTRACT
Background: According to an epidemiological study, 1.7–25.1% of eye disease was drug induced, but the evidence of adverse drug reactions (ADRs) in ophthalmology is found to be scarce, as it is difficult in correlation between symptoms and ocular signs, and their causality assessment. Hence, the present study of ADR in ophthalmology is taken up. Aim and Objectives: The aim of the study was to assess the pattern of reported ophthalmic ADR due to ophthalmic or systemic drugs and systemic ADRs due to ophthalmic drugs and to assess the causality, severity, and preventability factors of reported ADRs. Materials and Methods: A prospective observational study enrolling 100 subjects with ocular ADRs due to ocular or systemic drugs, and systemic ADRs due to ocular drugs visiting KIMS Hospital and Research Centre, Bengaluru. Following Institutional Ethics Committee approval and clearance, and written informed consent from study subjects, 100 consecutive subjects fulfilling inclusion and exclusion criteria will be included for the study. The causality of ADRs is assessed by WHO-UMC and Naranjo’s causality assessment scale. The severity of ADR assessed using Modified Hartwig scale. The preventability of ADR assessed by Modified Schumock and Thornton scale follow-up will be done for severe ADRs. Results: The clinical spectrum of ADRs ranged from mild redness of the eyes, itching, lacrimation, blurred vision, and purulent discharge from the eyes and to loss of vision. The most common causative drugs were antimicrobials, anti-inflammatory agents, antiepileptics, and mydriatics. Majority of ADRs were probable in WHO-UMC causality assessment, mild in severity, and definitely preventable. No fatal cases were reported. Conclusion: The clinical pattern of reported ocular ADRs due to topical and systemic drugs from the ophthalmology department and in wards ranged from mild severity to moderately severe reactions requiring patient hospitalization.
KEY WORDS: Adverse Drug Reactions; Ophthalmic Adverse Drug Reaction; Ocular Adverse Drug Effects
INTRODUCTION
Adverse drug reaction (ADR) is a major health problem worldwide. Being an inevitable consequence of drug therapy, it is associated with increased morbidity and mortality.[1-4] Therefore, early detection and monitoring of
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DOI: 10.5455/njppp.2021.11.12350202009122020
National Journal of Physiology, Pharmacy and Pharmacology Online 2021. © 2021 R S Umadevi, et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creative commons.org/licenses/by/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix,
ADR is of importance for patient safety. The ophthalmic ADRs are frequent with estimated incidence of 1.7–25.1%, but found to lack detection, assessment, and systematization.[5-7]
Ophthalmic ADRs are very less detected and poorly reported to clinicians and vigilance. Suspecting and reporting ADRs in ophthalmology are found to be necessary and important for safe and rational ophthalmic practice.[8] Detecting and reporting
ophthalmic ADRs at institutional level can generate valid data regarding causality, preventability and severity of ADRs. The ADR in ophthalmology is heterogeneous. It includes three basic types; ocular ADR due to topical drugs, systemic
ADR due to topical ocular drugs, and ocular ADR due to systemic drugs. The ADR in ophthalmology can be due to drugs or preservatives in topical medications.
The specific delicate anatomy and physiology of eye are easily disrupted by an ADR with possible irreversible consequence like vision loss which adds to individual and social burden. Hence, timely detection and recognition of ADR in ophthalmology are of critical importance to reduce ocular complications as early detection, withdrawing of the offending drug, and early clinical management can reverse the ocular ADR.
In spite of large ophthalmic patient population in our country, there are few spontaneous reporting of ADR’s in ophthalmology with lack of clarity and causality assessment.[8-10] Hence, the
present study of ADRs in ophthalmology in a tertiary care hospital is taken up to generate some valid and useful data and to develop a national register of ophthalmic ADR in our country.
The main objectives of the study are:
1. To assess the pattern of reported ophthalmic ADR due to ophthalmic or systemic drugs and systemic ADRs due to ophthalmic drugs in KIMS hospital
2. To assess the causality, severity and preventability factors of reported ADRs.
MATERIALS AND METHODS
This prospective observational study was done to assess the pattern of reported ophthalmic ADRs due to ophthalmic or systemic drugs and systemic ADRs due to ophthalmic drugs in ophthalmic outpatient department (OPD) and as well as inpatients of all the departments. The ADRs assessed in terms of causality, severity, and preventability.
Study Subjects
The study subjects included patients visiting Ophthalmology department, KIMS Hospital and Research center, Bangalore presenting with ocular adverse effects due to drugs consumed systemically and also presenting with any adverse effects due to topically used ophthalmic drugs.
Study Period
The study was carried out between January 2018 and June 2019 (18 months).
Sampling
Hundred and above consecutive cases attending the ophthalmic OPD and inpatients admitted to KIMS Hospital and Research Centre with suspected ocular ADRs were included in the study.
Inclusion Criteria
The following criteria were included in the study:
a. All subjects both inpatients and outpatients above 18 years of age of either gender with suspected ADR b. ADR (ocular and extraocular) due to ophthalmic drugs
and ocular ADR due to systemic drugs
c. Willingness to give written informed consent and available for follow-up, if any.
Exclusion Criteria
Reactions due to over dosage of drugs, ADRs due to medicines of alternative systems suxh as Ayurveda, Homeopathy, and Unani were excluded from the study.
Study procedure: Following Institutional Ethics Committee approval and clearance, and written informed consent from study subjects, 100 and above consecutive subjects fulfilling inclusion and exclusion criteria were included for the study. Subjects with ocular ADRs due to ocular or systemic drugs, and systemic ADRs due to ocular drugs visiting KIMS Hospital and Research Centre, Bengaluru, were excluded from the study. Data of suspected ADR collected through ADR reporting form. For every patient with suspected ADR detailed history including drug, personal, family, medical, and history of previous drug allergy were documented. Clinical evaluation and scrutiny of data were done to assess the pattern, extent, severity, and duration of ADR and detect any underlying predisposing factor. The pattern of reported ADR was analyzed for their clinical types and causative drugs. The causality of ADRs was assessed by WHO-UMC and Naranjo’s causality assessment scale. The severity of ADR assessed using Modified Hartwig scale. The preventability of ADR assessed by Modified Schumock and Thornton scale. Follow-up was done for severe ADRs and with certain causality criteria.
Statistical Analysis
The data collected were analyzed using descriptive statistics, namely, mean and standard deviation and percentage. The results were depicted in the form of tables and graphs. Statistical software, namely, SPSS v21 was used for analysis of data and Microsoft Word and Excel to generate graphs and tables. P < 0.05 was considered to be significant. CTRI registration was done (CTRI CTRI/2018/05/014051).
RESULTS
Table 1 summarizes the demographic characteristics for age and gender of 104 subjects enrolled in the study. Other findings of the present study are described in Tables 2-6.
Table 1: Age distribution of study subjects (n=104)
Age group (in years) Male Female Total
n % n % n % 20–30 7 12.28 9 18.6 15 15 30–40 7 12.28 6 13.9 13 13 40–50 15 26.32 9 20.9 24 24 50–60 13 19.3 8 16.2 18 18 60–70 8 14.04 10 23.2 18 18 70–80 4 7.02 2 4.65 6 6 80–90 5 8.77 1 2.32 6 6 Total 59 100 45 100 100 100 Mean±SD 51.5±17 48±16.5 50±16.7
Table 2: Basic types of ophthalmic ADR (n=104)
Types Number of
subjects n (%)
Ocular ADR due to topical ophthalmic drug 28 (26.92) Systemic ADR due to topical ophthalmic drug 0 (0)
Ocular ADR due to systemic drug 76 (73.07)
ADR: Adverse drug reaction
Table 3: Presenting complaints
Ocular complaints Gender (n=104)
Male Female Total*
n % n % n %
Redness of both the eyes 20 21.05 26 27.36 46 24.21
Blurring of vision 20 21.05 15 15.78 35 18.42
Burning sensation and pain in the eyes 2 2.10 1 1.05 3 1.57
Itching and swelling of both the eyes 29 30.52 28 29.47 57 30
Dry eyes 2 2.10 1 1.05 3 1.57
Itching, lacrimation and foreign body sensation in both the eyes 20 21.05 23 24.21 43 22.63
Purulent discharge and pain in both the eyes 1 1.05 0 0 1 0.52
Blurring of vision, diplopia in right eye 1 1.05 0 0 1 0.52
Loss of color vision(green) in right eye 0 0 1 1.05 1 0.52
*Complaints overlap and total percentage may not add up to 100%
DISCUSSION
In the present study, the pattern of ophthalmic ADRs reported was studied with assessment of its causality, severity, and preventability in a tertiary care hospital. The subjects included in the study fulfilled the inclusion and exclusion criteria and were fully compliant with the study procedure.
Table 1 shows the frequency of age and gender distribution of the study subjects. Out of 104 subjects, majority (24%) of them were in the age group of 40–50 years reflecting increased occurrence of ophthalmic ADRs in this age group, followed by 18% in study subjects in both groups aged between 50–60 years and 60–70 years. This was followed by 15% of subjects aged between 20 and 30 years, 13% between 30 and 40 years,
and 6% in both study subjects aged between 70–80 and 80–90 years. The mean age of the study subjects was 50±16.7 years (51.5±17 for males and 48±16.5 for females).
In gender distribution, majority of the study subjects were males (59%) reflecting higher incidence of ophthalmic ADRs in males which are consistent with earlier study.[9]
Socio-economic status of the study subjects assessed based on Modified Kuppuswamy scale.[11] Majority of the subjects
(52%) were from lower middle probably reflecting the socioeconomic strata of the subjects visiting our tertiary care hospital followed by 30% from upper lower, 16% from upper middle, and 3% from lower socio-economic status while there were no study subjects from upper- and lower-class socioeconomic status.
Table 2 summarizes the basic types of ophthalmic ADRs reported. The most common was ocular ADR due to systemic drugs (73.07%), followed by ocular ADR due to topical ophthalmic drug in 26.92%. There were no systemic ADRs reported due to topical ocular drug in our study.
Table 3 summarizes the presenting ocular ADR complaints with gender distribution. The most common complaints were itching and swelling of both the eyes (30%). This was followed in descending order by redness of both the eyes (24.21%), itching, lacrimation and foreign body sensation in both the eyes (22.63%), blurring of vision (18.42%) majority in the right eye (80%), burning and painful eyes, dry eyes in 1.57% each, purulent discharge and painful eyes, blurred vision and diplopia, loss of color vision both complaints in right eye with 0.52% each. Complaints overlap and total percentage may not add up to 100%.
Table 4 shows the suspected therapeutic class of drugs, according to ATC classification (level 1), causing ophthalmic ADRs with gender distribution. In our study, majority of
Table 4: Anatomical and therapeutic classification of suspected drugs level-1 (n=104)
Suspected drugs based on ATC Gender (n=104)
Male Female Total
n % n % n %
Alimentary system and metabolism(A) 1 1.4 1 0 2 1
Cardiovascular system(C) 4 6 1 3 5 5
Dermatologicals(D) 1 1.4 3 9 4 4
Genitourinary system and sex hormones(G) 6 9 3 5.5 8 7.6
Systemic hormonal preparations(H) 2 3 2 5.5 4 4
Anti-infectives for systemic use (J)* 14 20 7 19 21 21
Anti-neoplastic agents(L) 3 4.4 2 5.5 5 5 Musculoskeletal system(M)* 11 16 5 14 17 16.3 Nervous System(N) 6 9 4 11 10 10 *Sensory(S) Ophthalmologicals 18 26 10 28 28 27 Total 66 100 38 100 104 100 *P<0.05, statistically significant
ophthalmic ADRs (27%) reported were caused due to drugs acting on sensory system (Ophthalmic). This was followed in descending order by anti- infectives for systemic use in 21% subjects, drugs acting on musculoskeletal system in 16.3%, drugs acting on nervous system in 10%, drugs acting on Genitourinary system and sex hormones in 7.6%, drugs acting on cardiovascular system, and anti-neoplastic agents each in 5%. This was followed by dermatologicals and systemic hormonal preparations in 4% and alimentary system and metabolism in 1% of the total reported ocular ADRs. The gender related differences in the suspected therapeutic class of drugs according to ATC classification causing ADRs was statistically significant with respect to anti-infectives for systemic use (J) and musculoskeletal drugs (M) (P < 0.05). ADRs due to sensory (S) ophthalmologicals and cardiovascular system (C) were more commonly seen in males but gender related difference was not statistically significant.
Table 5 shows suspected causal drug groups causing ADRs. Antimicrobial agents (40) were the most commonly suspected drug class, in contrast to a previous study which showed ophthalmic ADRs commonly due to antiglaucoma agents.[9]
This was followed in descending order by anti-inflammatory agents (28), antiepileptics (8), antihypertensives (5), antidiabetic (4), anti-neoplastics (5), mydriatics (4), antiglaucoma drugs (2), antipsychotics (2), hypolipidemics (2), anti-acne drugs (2), diuretics (1), and lubricants (1).
Among topical administration of antimicrobial (n = 40) drugs moxifloxacin (13) most commonly caused ADR followed by ciprofloxacin (3), gatifloxacin (2), and azithromycin in one study subject. In antimicrobials with oral/systemic administration suspected drugs amoxicillin-clavulanic acid combination (4) was common, which was followed in descending order by piperacillin, linezolid, and doxycycline each in three subjects, co-trimoxazole in two, and ceftriaxone, cefuroxime, cefotaxime, gentamicin, metronidazole, and cefoperazone in one study subject each.
In topical administration of anti-inflammatory drugs (n = 28), prednisolone and bromfenac caused ADR in one study subject each. In anti-inflammatory drugs with oral/ systemic administration prednisolone (8) most commonly caused ophthalmic ADR, followed in descending order by diclofenac in six, hydrochloroquinolones in fivr and naproxen, tramadol, paracetamol in two study subject each, and mesalamine in one study subject.
Antiepileptics (n = 8) with oral/systemic administration, phenytoin, and sodium valproate caused ophthalmic ADR each in three subjects followed by topiramate and levetiracetam in one study subject each.
Antipsychotics (n = 2) with oral/systemic administration quetiapine and olanzapine caused ADR in one subject each. Among antidiabetic (n = 4), the most common suspected drug was metformin-glimepiride combination caused ophthalmic ADRs in four study subjects.
Among antihypertensives (n = 5), telmisartan caused ophthalmic ADR in two study subjects, followed by amlodipine, amiodarone, and tamsulosin in one study subject each.
Among anti-neoplastic drugs (n = 5), methotrexate caused ophthalmic ADRs in three study subjects followed by tamoxifen and rituximab in one study subject each.
Anti-acne drugs (n = 2) with oral administration of isotretinoin and dermal silver sulfadiazine on hands and legs caused ophthalmic ADR in one study subject each.
In topical administration of antiglaucoma drugs (n = 2), latanoprost and timolol caused ophthalmic ADR in one study subject each.
Table 5: Drugs suspected to be associated with the ophthalmic ADRs (n=104)
Causal drug groups Suspected drug
Topical Oral/systemic administration
Antimicrobials (40) Ciprofloxacin (3), Moxifloxacin (13), Gatifloxacin (2), Azithromycin (1) Piperacillin (3), Cefotaxime (1), Linezolid (3),
Amoxicillin with clavulanic acid (4), Cefoperazone (1), Gentamicin (1), Doxycycline (3), Ceftriaxone (1), Metronidazole (1), Co-trimoxazole (2), Cefuroxime (1) Anti-inflammatory drugs (n=28) Prednisolone (1),
Bromfenac (1) Prednisolone (8),Mesalamine (1),
Hydrochloroquinolones (5), Diclofenac (6),
Paracetamol (2), Naproxen (2), Tramadol (2)
Antiepileptics (n=8) Sodium valproate (3),
Phenytoin (3), Levetiracetam (1), Topiramate (1)
Antipsychotics (n=2) Quetiapine (1),
Olanzapine (1)
Anti-diabetics (n=4) Metformin with glimepiride (4)
Antihypertensives (n=5) Amlodipine (1),
Amiodarone (1), Telmisartan (2), Tamsulosin (1)
Anti-neoplastic drugs (n=5) Methotrexate (3),
Tamoxifen (1), Rituximab (1)
Anti-acne drugs (n=2) Isotretinoin (1),
Silver sulfadiazine (1) Antiglaucoma drugs (n=2) Latanoprost (1), Timolol (1)
Diuretics (n=1) Mannitol (1)
Hypolipidemics (n=2) Rosuvastatin (1), Ursodeoxycholic acid (1)
Lubricants (n=1) Carboxymethyl cellulose (1)
Mydriatics (n=4) Tropicamide (4)
Among diuretics (n = 1), mannitol caused ophthalmic ADR in one study subject. Among hypolipidemics, rosuvastatin, and ursodeoxycholic acid caused ADR in one study subject each.
In topical administration of drugs among lubricants (n = 1) carboxymethyl cellulose caused ophthalmic ADR in one study subject.
Among mydriatics (n = 4) most common drug was tropicamide induced ADR in four study subjects.
Table 6 summarizes the list of ADRs and the causative drugs. Moxifloxacin was responsible for most of the antimicrobial related ophthalmic ADRs. Prednisolone was the most
common offending drug among anti-inflammatory drugs in causing raise in intraocular pressure in oral/systemic administration and blurring of vision on topical use. Most of the drugs caused redness, itching of both the eyes and gentamicin, linezolid caused loss of color vision (green) in right eye.
Among topical antimicrobials, moxifloxacin (32.5%) was the most common offending drug in this group causing redness and burning pain in both the eyes. This was followed in descending order by amoxicillin-clavulanic acid combination (redness with foreign body sensation of both the eyes) in 10% of subjects, piperacillin (periorbital edema and itching of eyes), linezolid (loss of color vision in right eye), doxycycline, ciprofloxacin (itching and foreign body
sensation of both the eyes), ceftriaxone (redness of the eyes), metronidazole (blurred vision) in 7.5% study subjects each, co-trimoxazole (redness of both the eyes), and gatifloxacin (periorbital edema and painful eyes) in 5% study subjects each, azithromycin (blurred vision in right eye), cefotaxime, cefoperazone (burning and painful of both the eyes), gentamicin (loss of color perception-green in right eye), and cefuroxime (redness of both the eyes) 2.5% in study subjects each [Tables 4 and 6].
The most common anti-inflammatory drugs causing ophthalmic ADRs were systemically used. Among systemically used anti-inflammatory drugs prednisolone (28.57%) caused raise in intra ocular pressure and retinopathy which was followed in descending order by diclofenac (21.42%) induced hypersensitivity reactions such as periorbital edema, itching, lacrimation, burning and painful eyes, and hydrochloroquinolones (18%) induced blurred vision, retinopathy, and maculopathy. In topical administration among anti-inflammatory drugs prednisolone (11%) caused burning and painful eyes. This was followed in descending order by paracetamol, naproxen and tramadol (hypersensitivity reactions such as periorbital edema, itching, lacrimation, burning, and painful eyes) in 7.14% study subjects each. Bromfenac and mesalamine induced periorbital edema, blurred vision in 4% study subjects each. Sodium valproate and phenytoin induced redness of both the eyes with pain and purulent discharge in each constituted
ADRs Causative drugs
Purulent discharge Phenytoin (3), Paracetamol (2), Diclofenac (3) Itching and periorbital
edema Phenytoin (3),Paracetamol (2), Diclofenac (3) Periorbital edema and
headache Telmisartan (2),Tropicamide (3), Silver sulfadiazine (1), Cefotaxime (2), Cefoperazone (1), Moxifloxacin (7),
Amoxicillin with clavulanic acid (3), Timolol (1),
Latanoprost (1), Ciprofloxacin (4) Watering of eyes Ursodeoxycholic acid (1),
Doxycycline (1),
Dry eyes Isotretinoin (1),
Tamsulosin (1), Naproxen (1), Amoxicillin with clavulanic acid (2), Amiodarone (1)
*Complaints overlap and total percentage may not add up to 100%
Table 6: (Continued)
ADRs Causative drugs
Redness of the eyes Phenytoin(4), Piperacillin(4), Paracetamol(3), Mannitol(1), Ursodeoxycholic acid(1), Diclofenac sodium(5), Tropicamide(3), Tramadol(1), Rituximab(1), Cefoperazone(1), Moxifloxacin(3),
Moxifloxacin with bromfenac(4), Amoxicillin with clavulanic acid (3), Timolol (1),
Latanoprost(1), Ciprofloxacin (4), Prednisolone (4) Foreign body sensation Phenytoin (1),
Piperacillin (2), Paracetamol (1) Ursodeoxycholic acid (1), Diclofenac sodium (3), Tropicamide (1), Tramadol (1), Moxifloxacin (7),
Amoxicillin with clavulanic acid (1), Timolol (1),
Latanoprost (1), Ciprofloxacin (4) Blurring of vision HCQs (4),
Metformin with glimepiride (3), Azithromycin (1), Gentamicin (1), Omnacortil (3), Olanzapine (1), Telmisartan (2), prednisolone (3), Rosuvastatin (1), Metronidazole (1), Bromfenac (2), Levetiracetam (2) Burning and Painful eyes Telmisartan (2),
Tropicamide (3), Silver sulfadiazine (1), Cefotaxime (2), Cefoperazone (1), Moxifloxacin (7),
Amoxicillin with clavulanic acid (3), Timolol (1),
Latanoprost (1), Ciprofloxacin (4) Increase in Intra-Ocular
Pressure Gatifloxacin with prednisolone (3),Moxifloxacin with prednisolone (2), Amlodipine (2),
prednisolone (5) Color vision defect Linezolid (1),
Gentamicin (1)
Diplopia Paracetamol (3),
Methotrexate (2), Rituximab (1)
Table 6: List of adverse drug reactions and causative drugs (n=104)
37.5% of ophthalmic ADRs due to antiepileptics, followed in descending order by levetiracetam and topiramate induced blurred vision and redness of the eyes in 12.5% study subjects each.
There was one case of each quetiapine and olanzapine induced ophthalmic ADRs in males and females induced blurred vision, redness of the eyes with foreign body sensation. The gender related differences in antipsychotics causing ADRs was not statistically significant.
Metformin with glimepiride induced blurred vision in both eyes in two study subjects each in males and females. The gender related differences in antidiabetic causing ADRs was not statistically significant.
Telmisartan induced blurred vision in both the eyes in two study subjects (40%), followed by amlodipine, amiodarone and tamsulosin induced blurred vision, dry eyes and periorbital edema in 20% study subjects each. The gender related differences in cardiovascular drugs causing ADRs was not statistically significant.
There was methotrexate induced retinopathy and maculopathy in three study subjects leading to blindness in one study subject. This was followed by tamoxifen and rituximab induced blurred vision, itching with redness of the eyes in one study subject each. Mannitol induced periorbital edema was seen in one male study subject.
Isotretinoin accounted for dry eyes and congestion in one female subject, followed by silver sulfadiazine on topical application of hands and legs in case of burns caused periorbital edema and itching of both the eyes in one male subject. Rosuvastatin induced blurred vision and watering of eyes and ursodeoxycholic acid induced redness and foreign body sensation of both the eyes accounted for ophthalmic ADR in one male and female subject each, respectively.
Most common drugs reported were latanoprost and timolol induced dry eyes, itching, and congestion of both the eyes in one study subject each.
The most offending drug was tropicamide, which caused burning, redness, and lacrimation in one male and three in female study subjects.
Adverse drug effects was reported due to lubricant Carboxy methyl cellulose which caused redness and periorbital edema in one subject.
Ophthalmic ADRs assessed according to WHO causality assessment, majority of ADRs were probable (46.15%) which is consistent with previous study,[9] which was
followed by possible (38.46%), unlikely (9.61%), and certain
(5.76%). The six cases which were assessed as certain were ADRs due to phenytoin (2) induced periorbital edema, redness of the eyes with purulent discharge, carboxymethyl cellulose (1) induced itching, burning and painful eyes, bromfenac (1) induced redness and lacrimation of the eyes, and tropicamide (2) induced burning and redness of the eyes. In the above certain category of ADR, the adverse effect repeated following accidental rechallenge of the offending drug and recovery was noted following drug dechallenge. There is no statistically significant gender-based distribution in the causality assessment (P = 0.269).
Ophthalmic ADRs assessed according to Naranjo’s probability scale. Majority were possible (63.46%), which is not similar to a previous study in which probable category was most common.[5] This was followed by probable (35%)
and definite (2%). There is no statistically significant gender-based distribution in the causality assessment (P = 0.653). Severity of ophthalmic ADRs based on Modified Hartwig severity assessment scale. Majority were of mild severity constituting 53.84%, in accordance to previous study,[9]
followed by moderate 45.19% and severe 1%. One case of loss of vision in both the eyes was reported due to systemic methotrexate. No deaths were reported in our study. There is no statistically significant gender-based distribution in the severity assessment (P = 0.187).
The preventability of suspected ophthalmic ADRs as assessed by Modified Schumock and Thornton criteria. Majority were definitely preventable (57%) followed by probably preventable (46.26%). There were no cases reported of not preventable ADRs in our study. The occurrence of definitely and probably preventable ADR was more in males which was not statistically significant.
The assessment of causality using WHO-UMC showed that the majority of ADRs were probable. The Naranjo’s probability scale assessment revealed that majority of ADRs was possible. The majority of ADRs were mild in severity and definitely preventable.
Limitation of the present study is limited number of study subjects enrolled in the study. The incidence of ADR reporting could have been increased by regular ADR awareness and motivational programs. Long-term follow-up of ADRs was to be done. The denominator data, indicative of the total number of patients exposed to a particular drug which caused an ADR, would have been more informative in calculating the incidence rate of ADRs in our hospital.
CONCLUSION
The clinical pattern of reported ocular ADRs due to topical and systemic drugs from the ophthalmology department and
in wards ranged from mild severity to moderately severe reactions requiring patient hospitalization. No fatalities due to ADR were reported.
The prominent causative drugs were antimicrobials, anti-inflammatory agents, antiepileptics, and mydriatics.
The majority of ADRs were possible in Naranjo’s causality assessment scale, mild in severity, and definitely preventable. REFERENCES
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How to cite this article: Krishnaiah V, Umadevi RS, Shaik L. A prospective observational study of ophthalmic adverse drug reactions in a tertiary care hospital. Natl J Physiol Pharm Pharmacol 2021;11 (Online First). DOI: 10.5455/ njppp.2021.11.12350202009122020
