|Year : 2021 | Volume
| Issue : 1 | Page : 60-65
Evaluation of corticosteroid use pattern and their adverse effects in patients visiting the dermatology department of a tertiary care teaching hospital in Warangal, India
Gogula Archana Reddy1, Samreen Ayesha1, Masood Ali Sheema1, Bandaru Sheshagiri Sharvana Bhava1, Valupadas Chandrashekar2, Eggadi Venkateshwarlu1
1 Department of Clinical Pharmacy and Pharm D, Vaagdevi College of Pharmacy, Kakatiya University, Warangal, Telangana, India
2 General Medicine, Kakatiya Medical College (KMC)/Mahatma Gandhi Memorial Hospital, Warangal, Telangana, India
|Date of Submission||14-Dec-2020|
|Date of Acceptance||03-Feb-2021|
|Date of Web Publication||16-Mar-2021|
Dr. Eggadi Venkateshwarlu
Department of Clinical Pharmacy and Pharm D, Vaagdevi College of Pharmacy, Kakatiya University, Warangal- 506001, Telangana.
Source of Support: None, Conflict of Interest: None
Introduction: Corticosteroids have become a mainstay of pharmacotherapy in dermatology because of their anti-inflammatory and immunosuppressive properties. However, misuse and sudden cessation of these drugs may render a patient to develop numerous adverse effects (AEs). Adverse drug reactions (ADRs) are important causes of mortality in both hospitalized and ambulatory patients. Early detection, evaluation, and monitoring of ADRs are essential to reduce harm to patients. Therefore, to achieve optimum benefit with the least AEs, safe and effective use of these agents is very crucial. Objective: To examine the corticosteroid use pattern, to assess the frequency of misuse and the associated AEs that are encountered in dermatological practice. Materials and Methods: A prospective observational study was conducted in the dermatology department of a tertiary care teaching hospital, Warangal for a period of six months. All patients using at least one corticosteroid either topically or systemically were included in the study. Informed consent was taken from patients. Results: A total of 151 participants were included in the study. Among them, 56% of females developed ADRs compared with males (44%). Among patients using topical corticosteroids (TCs), the most frequently reported ADRs include facial erythema (7.31%), acne (17.07%), and hyperpigmentation of the face (2.43%). The AEs associated with oral corticosteroids include weight gain (19.51%) and taenia corporis (19.5%). Conclusion: Corticosteroids have extreme importance in dermatological practice. However, inappropriate and prolonged users render a patient to develop several AEs. Precise drug regimens and proper patient counseling can help in minimizing and managing the AEs associated with inappropriate use.
Keywords: Acne, corticosteroids, erythema, hyperpigmentation, taenia corporis
|How to cite this article:|
Reddy GA, Ayesha S, Sheema MA, Bhava BS, Chandrashekar V, Venkateshwarlu E. Evaluation of corticosteroid use pattern and their adverse effects in patients visiting the dermatology department of a tertiary care teaching hospital in Warangal, India. MGM J Med Sci 2021;8:60-5
|How to cite this URL:|
Reddy GA, Ayesha S, Sheema MA, Bhava BS, Chandrashekar V, Venkateshwarlu E. Evaluation of corticosteroid use pattern and their adverse effects in patients visiting the dermatology department of a tertiary care teaching hospital in Warangal, India. MGM J Med Sci [serial online] 2021 [cited 2021 Apr 14];8:60-5. Available from: http://www.mgmjms.com/text.asp?2021/8/1/60/311392
| Introduction|| |
Corticosteroids are synthetic analogs of human hormones that are usually released by the adrenal cortex, which includes glucocorticoids and mineralocorticoids. These represent the most important and widely used class of drugs because of their anti-inflammatory and immunosuppressive properties in dermatological practice. They are highly efficacious; however, their improper and long-term use is associated with multiple AEs. The ADRs rank among the top 10 leading causes of mortality in both hospitalized and ambulatory patients. Thus, there is a need to identify ADRs as early as possible to reduce harm to patients. Systemic (oral or parenteral) Corticosteroids (e.g., prednisolone, prednisone, methyl prednisolone, dexamethasone) possess anti-inflammatory, immunomodulatory, and antineoplastic properties that are used to treat numerous clinical conditions such as auto-immune diseases and allergic reactions. Well-known AEs associated with systemic corticosteroid use include osteoporosis, cardiovascular disease, impaired immune response and wound healing, alterations in glucose and lipid metabolism, and psychiatric disturbances. Potent TCs are easily available over the counter at a low price; their misuse has been noticed among the general population, producing many adverse effects. The amount and potency of corticosteroid that is prescribed, dispensed, and applied should be considered carefully because too little steroid can lead to poor response, and too much can increase the risk of AEs. Therefore, to achieve the optimum benefit with the least AEs, safe and effective use of these agents is very crucial. To our knowledge, despite being a common problem, no study has investigated the misuse of corticosteroid products in Mahatma Gandhi Memorial Hospital (MGMH). This study was conducted among individuals visiting the dermatology department of MGMH, to assess the frequency of corticosteroid misuse, the reasons behind it, and the most common AEs resulting from corticosteroid misuse.
| Materials and methods|| |
A prospective observational spontaneous reporting study with both Active (Pharmacist actively seeking suspected ADRs) and Passive (Stimulating clinicians to report suspected ADRs) was carried out in the dermatology department at the MGMH, a 1000-bed tertiary care teaching hospital in Warangal, India. Approval from the Ethical Committee was obtained for the study [IHEC/VCOP/PHARMD/2019–20/NCT13]. Informed consent was taken from the patients.
Patients with various dermatological conditions such as Systemic Lupus Erythematosus, Pemphigus Vulgaris, Pemphigus foliaceous, Hansens’s disease, etc who were visiting MGMH, a 1000-bed tertiary care teaching hospital, Warangal and who were prescribed corticosteroid as a pharmacotherapy regimen, were considered as study participants. A total of 151 participants who were currently using at least one corticosteroid and who met our inclusion criteria were approached and asked to participate in the study. We included the following participants: Patients of all ages using corticosteroids, patients using at least one corticosteroid at the time of data collection, and patients with a history of steroid intake were enrolled in the study. Patients with concomitant usage of drugs with similar AEs of corticosteroids, as well as patients who had been already diagnosed with clinical conditions similar to the AEs of corticosteroids were excluded from the study.
Data collection tools were graded questionnaires. First, we used a demographic questionnaire that includes personal characteristics such as age, sex, weight, occupation, region, duration of steroid use, social history, educational status, and comorbidities. The causality assessment of ADRs was done by using scales. The scales used include Naranjo Algorithm, Hartwig’s Severity Assessment Scale. The Naranjo Algorithm is a questionnaire designed by Naranjo et al. for determining the likelihood of whether an ADR is actually due to the drug rather than the result of other factors. Probability is assigned via a score termed definite, probable, possible, or doubtful. Scoring for the Naranjo Algorithm: If the score is >9, it is termed as definite ADR; 5–8 = probable ADR; and 1–4 = possible ADR. The severity assessment of ADRs was done by using Hartwig’s Severity Assessment Scale. Hartwig SC, Siegel J, and Schneider PJ categorized ADRs into seven levels as per their severity. Levels 1 and 2 fall into the mild category; levels 3 and 4 fall into the moderate category; and levels 5, 6, and 7 fall into the severe category.
The data were analyzed by using Microsoft Excel 2013.
| Results|| |
Sample-wise distribution of ADRs in patients using corticosteroids
Out of 151 patients, the various types of AEs observed include Acne (19.51%), Blurred Vision (4.87%), Burning Sensation over the face (2.43%), Cataract (2.43%), Depression (2.43%), Facial Erythema (7.31%), Facial Puffiness (7.31%), Hyperpigmentation of face (2.43%), Myopathy (7.31%), Profuse Sweating (4.87%), Taenia Corporis (19.51%), and Weight Gain (19.51%) [Table 1] and [Figure 1].
|Table 1: Sample-wise distribution of ADRs in patients using corticosteroids|
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Gender-wise prevalence of ADRs in patients using corticosteroids
In our study, out of 151 participants, most of ADRs were found in females (56%) compared to males (44%) [Table 2].
|Table 2: Gender-wise prevalence of ADRs in patients using corticosteroids|
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Age-wise distribution of ADRs in patients using corticosteroids
Among the age groups listed next, the majority of the patients fell into the 35 to 44 year age group. The mean population age was found to be 39.86 years [Table 3].
|Table 3: Age-wise distribution of ADRs in patients using corticosteroids|
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Region-wise distribution of patients using corticosteroids
In the study, out of 151 patients, the rural population percentage was 72%, whereas the urban population percentage was 28% [Table 4].
Educational-wise distribution of patients using corticosteroids
In this study, out of 151 patients, the educated people comprised 32% whereas the uneducated population comprised 68% [Table 5].
Social habit-wise distribution of patients using corticosteroids
In this study, out of 151 patients, 37.74% of the population were alcoholics, 11.92% of the population were smokers, and 50.33% had no social habits [Table 6].
Corticosteroid type-wise distribution of patient population
In this study, out of 151 patients, the systemic corticosteroid user’s population percentage was 55.62% whereas the topical user’s population percentage was 44.37% [Table 7].
Occupational status-wise distribution of patients using corticosteroids
In this study, out of 151 patients, 37.74% of the population were farmers, 13.24% were students, 11.92% were housewives, 29.08% were daily wage workers, and 8.6% were unemployed [Table 8].
Distribution of ADRs based on weight bands in patients using corticosteroids
In the study, the majority of patients were in the 41 to 50kg weight band. The mean weight was found to be 45.5kg [Table 9].
|Table 9: Distribution of ADRs based on weight bands in patients using corticosteroids|
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Causality assessment of ADRs by Naranjo scale
Among 41 adverse drug reactions noticed, 12ADRs (29.26%) were possible-type, 18ADRs (43.90%) were probable-type, and 11ADRs (26.82%) were definite-type reactions [Table 10].
Hartwig’s Severity Assessment Scale
According to the Hartwig severity assessment scale among 41 adverse drug reactions, 18 ADRs (43.90%) belong to the mild category, and 23 ADRs (56.09%) belong to the moderate category [Table 11].
Acne (19.51%) was seen with the continuous usage of Betnovate-N (15g) and Clobeta-GM (10g) topical ointment used for fairness purposes for an average period of three months. Blurred vision (4.87%) was due to the usage of oral Prednisolone, 30mg for an average period of six months for oral lesions. Cataract (2.43%) was due to the usage of oral Prednisolone, 30mg for an average period of 3.5 yrs for Systemic Lupus Erythematosus. Depression (2.43%) was due to the usage of oral Prednisolone, 20mg for an average period of three years for Lichen Amyloidosis. Facial Erythema (7.31%) was due to the usage of Betnovate N (15g) and Clobeta GM (10g) for an average period of two months for acne. Facial puffiness (7.31%) was due to the usage of oral Prednisolone, 30mg for an average period of one year for Pemphigus foliaceous and Pemphigus Vulgaris. Hyperpigmentation of the face (2.43%) was due to the usage of Monate cream (10g) for one year for fairness purposes. Myopathy (7.31%) was due to the usage of oral Prednisolone, 30mg for an average period of six months for Hansen’s disease. Profuse sweating (4.87%) was due to the usage of oral Prednisolone, 15mg for an average period of three years for Pemphigus Vulgaris. Taenia corporis (19.51%) was due to the usage of Betnovate N, 15g for an average period of three months for allergy. Weight gain (19.51%) was due to the usage of oral Prednisolone, 30mg for six months for Hansen’s disease.
| Discussion|| |
Corticosteroids are one of the most frequently used drug classes in dermatological practice for short-term as well as long-term drug therapy. However, their improper use is associated with several serious adverse effects. Corticosteroids’ rational use, however, can minimize the systemic as well as cutaneous side effects. It is the prime responsibility of the physician to prescribe the corticosteroid that will treat the dermatological condition with maximum therapeutic benefits and least possible adverse effects. The study was designed to evaluate corticosteroid use in various dermatological diagnoses. Overall, 151 patients who received corticosteroids were evaluated. Of the total patients receiving corticosteroids, 44.37% received topical steroids and 55.62% received oral steroids similar to the study conducted by Shakya et al.In this study, the majority of patients were within the 35 to 44 yr age group; the mean population age was 39.85 yrs, which was in accordance with the study conducted by Shakya et al.
Among the patients using topical corticosteroids, the most frequently reported ADRs include facial erythema, acne, hyperpigmentation of the face, and burning sensation of the face, which were found to be similar to the study conducted by Abhijeet et al. Among the 151 patients using corticosteroids in our study, 26% are of the urban population and 72% are of the rural population.
Causality assessment of all ADRs was done by using Naranjo’s causality assessment scale. Out of 41 ADRs, 12 ADRs (29.26%), which include cataract, myopathy, and taenia corporis, were of the “Possible” type; 18 ADRs (43.90%), which include blurred vision, burning sensation of the face, depression, facial erythema, hyperpigmentation, and weight gain, were of the “Probable” type; and 11 ADRs (26.82%), which include acne, facial puffiness etc., were of the “Definite” type.
On examining the severity assessment of ADRs by using the modified Hartwig and Siegel scale, 18 ADRs (43.90%) belong to the “Mild” category, and 23 ADRs (56.09%) belong to the “Moderate” category. Out of 151 patients, steroid use was appropriate in 110 patients; 41 patients showed adverse effects due to continuous usage of corticosteroids for a longer period.
| Conclusion|| |
Corticosteroid has extreme importance clinically, especially in dermatological practice. Despite their effectiveness, their inappropriate and prolonged use in various dermatological conditions renders a patient to develop several mild to severe adverse effects. Hence, the doses of corticosteroids should be tapered gradually over time in a way such that the symptoms of the disease for which they are given should not aggravate and the adverse effects should not occur. Precise drug regimens and proper patient counseling can help in minimizing and managing the adverse effects associated with improper use and with the sudden withdrawal of corticosteroids.
The authors are grateful to the Secretary of Viswambhara Educational Society for allowing them to work and providing the necessary facilities to carry out this research work.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient(s) has/ have given his/ her/ their consent for his/ her/ their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [INLINE 1]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10], [Table 11]