1M.Pharm., Department of Pharmacy practice, KMCH College of pharmacy, Coimbator.
2M.Pharm., Ph.D., Professor, Department of Pharmacy Practice,KMCH College of Pharmacy, Coimbatore
3M.B.B.S, M.D, Emergency Medicine, Kovai Medical Center and Hospital, Coimbatore
4Pharm.D., Assistant Professor, Department of Pharmacy Practice, KMCH College of Pharmacy, Coimbatore
Background:Steroid stewardship encompasses the process of pre-prescription screening, judicious prescription, and provision of medical care during corticosteroid use, and diligent monitoring following discontinuation of corticosteroid therapy. Objective: This study aims to evaluate the glycemic levels and adverse events of corticosteroids in emergency care patients for various respiratory conditions at a tertiary care hospital. Materials and methods: A prospective cross-sectional study was conducted for six months in emergency care patients after obtaining ethical approval. Results: Totally 72 were enrolled with varoius respiratory disease, among them 18 patients were diabetic and 54 patients were non-diabetic receving various formulations of steroids. The glycemic levels were assessed using random blood sugar (RBS) which is in relation to steroid administration. The results show that 4 patients developed hyperglycemia (>200 mg/dl) after receiving steroids. Statistical analysis shows that there was no significant difference (p>0.05%) in RBS levels during before and after steroid administration in both diabetic and non-diabetic patients but, episodes of hyperglycemia after steroid administration was observed in both diabetic and non-diabetic patients with pneumonia and AECOPD. Conclusion: We conclude that steroid stewardship program is essential in monitoring and controlling glycemic levels, especially for diabetic patients presenting with infections.
Glucocorticoids are anti-inflammatory mediactions widely used in clinical practice to treat autoimmune, respiratory, and dermatological disorders. They can cause various side effects, such as abnormal glucose metabolism.[1] When corticosteroids are utilized for extended periods of time, negative effects can occur. The methodical process of rationally prescribing and monitoring of glucocorticoids is known as steroid stewardship. It includes pre-prescription screening, rational prescription, medical care during corticosteroid use, and appropriate monitoring following cessation of corticosteroid use .[2] Components of stero?d stewardsh?p program includes pre- prescr?pt?on, dur?ng usage and post usage assessment. Pre- prescr?pt?on includes clarity of indication for use, laboratory test result screening. Dur?ng usage comprised type of steroid, dosage and mode of administration, duration of therapy and expected dose changes, monitoring for potential adverse effects tapering and weaning off from steroids and post usage includes laboratory test result screening, minimization of long- term adverse effects. Corticosteroids exacerbate hyperglycemia by disrupting glucose metabolism, impairing insulin signalling, and inducing insulin resistance in skeletal muscle, liver, and adipose tissue. It also reduces insulin-stimulated glucose uptake and glycogen synthesis while increasing glucose production, causing hyperglycemia in susceptible individuals.[3.4] The deterioration of glycemic regulation in the context of pre-existing diabetes mellitus is referred to as glucocorticoid-induced hyperglycemia, whereas hyperglycemia in the absence of pre-existing diabetes is referred to as glucocorticoid-induced diabetes. Corticosteroids are the main cause of drug-induced hyperglycemia with the prevalence of 64% to 86% in hospitalized patients. Of these, almost 70% of patients had blood glucose levels higher than 180 mg/dL from the consensus reports of the American Diabetes Association (ADA).[5,6,7] Diagnostic tests for glucocorticoids-induced diabetes include a random blood glucose level of ≥200 mg/dL (≥11.1 mmol/L) with hyperglycemia symptoms or a glucose level of ≥200 mg/dL at 2 hours following a 75-g glucose tolerance test. Random blood glucose checks should be performed in the afternoon or two hours after a meal for patients on chronic steroid therapy, as the dose is typically administered in the morning.[8] The research objective is to estimate the glycemic level and assess the prescribing pattern of corticosteroids usage patients in Pneumonia, AECOPD and Asthma and to identify the associated adverse events. Corticosteroids were classified based on their duration of action as short acting (Hydrocortisone), intermediate acting (prednisolone) and long acting (Dexamethasone).[9] When it comes to adverse effects, corticosteroids can have similar profile, which includes osteoporosis, diabetes, hyperglycemia, myopathy, glaucoma, weight gain, cataracts, skin bruising, sleep problems, immunosuppressant effects, and psychiatric disturbances.
MATERIALS AND METHODS
A prospective cross-sectional study was conducted for six months at emergency department in a multi-speciality hospital, with the 25% prevalence of hyperglycemia after steroid administration from previous studies was used to determine sample size with confidence interval of 95%.[10] The sample size actually obtained for this study was 72. Patients who were admitted in ED above 18 years of age, prescribed with corticosteroids for respiratory conditions, tested with RBS and willing to participate were included in the trial. Individuals who were previously on corticosteroids or medication that cause hyperglycemia were excluded.
Ethical consideration
The study protocol was approved by the Institutional Human Ethics committee (Ref.No. EC/AP/1124/02/2024). A written informed consent was provided from all individual prior to their enrollment.
Study Procedure
Based on inclusion criteria patients who were prescribed with corticosteroids in ED for respiratory disease conditions were enrolled. A data collection form was designed to collect necessary information for the study that included patient demographics, diagnosis, the type of steroid, dosage, mode of administration, duration of therapy and laboratory test results (HbA1c, RBS and FBS). Primarily, RBS was used as a relatable marker to identify steroid induced hyperglycemia during before and after steroid intake. Monitoring of potential adverse effects from using corticosteroids using WHO-UMC causality assessment scale.
Statistical analysis
Data were analyzed using Statistical Package for the Social Sciences software (SPSS version 25.0). Categorical variables were indicated as frequency (n) and percentage (%).Frequency analysis was performed for all sociodemographic variables and chi square goodness fit and chi square test of association was performed to determine the relation between steroids and hyperglycemia. P value <0.05 were considered as statistically significant.
RESULTS
Totally 72 patients were included based on inclusion criteria among them 46 (63.4%) were male and 26 (63.4%) were female. Overall, 53 individuals were in age group of 61-80 years followed by 15 individuals were between the age group of 41-60 years. Based on BMI values, one patient was obese and 9 patients were considered as overweight in this study. Among total study population 18 (23.9%) patients were known to be diabetic. Diagnosis in emergency department (ED) included pneumonia in 28 patients (39.4%) asthma in 25 patients (33.8%) and AECOPD in 19 (26.8%). The demographic data of study population are shown in Table 1.
Table1.Demographic Variables (n=72)
|
Demographic variables |
Categories |
Frequency (n) |
Percentage of Patients (%) |
|
Gender |
Male |
46 26 |
63.4% 36.6% |
|
Female |
|||
|
Age in years |
20 - 40 |
1 15 53 3 |
1.4% 19.7% 74.6% 4.2% |
|
41 - 60 |
|||
|
61 - 80 |
|||
|
81 – 100 |
|||
|
BMI |
<18 |
1 61 9 1 |
1.4% 84.5% 12.7% 1.4% |
|
18.5-24.9 |
|||
|
25-29.9 |
|||
|
>30 |
|||
|
Diabetes |
Male Female |
12 6 |
17.8% 6.1% |
|
Diagnosis |
AECOPD |
19 28 25 |
26.8% 39.4% 33.8% |
|
Pneumonia |
|||
|
Asthma |
BMI: Body Mass Index; AECOPD:Acute Exacerbation of COPD.
Assessment of corticosteroids prescription pattern in ED for respiratory disease conditions reveals that inhaled budesonide and intravenous hydrocortisone was prescribed in combination for 48 patients (66.8%) while budesonide alone is prescribed only for 22 patients (33.2%). Among total population 22 patients received 0.5mg of budesonide and only 2 patients received 1mg of budesonide as nebulization. About 28 patients received combination doses of intravenous hydrocortisone (100mg) plus budesonide (0.5mg) and 9 patients received 0.5mg of budesonide and 200mg of hydrocortisone respectively mentioned in Table 2.
Table 2. Prescribing pattern of corticosteroids among AECOPD, Pneumonia, Asthma patients (n=72)
|
Steroids
|
Dosage form
|
Dose |
No. Of Patients (n=72) |
Percentage of patients |
|
Budesonide (n=24) |
Respules
|
0.5mg 1 mg |
22 2 |
30.5% 2.7% |
|
Budesonide + Hydrocortisone sodium succinate (n=48) |
Respules + I.V
|
0.5mg+50mg 0.5mg+100mg 0.5mg+200mg 1mg+100mg 1mg+200mg |
2 28 9 4 5 |
2.7% 38.8% 12.5% 5.5% 6.9% |
While performing disease based catergorization, 28 patients were presented with pneumonia, 25 patients with asthma and 19 patients with AECOPD. To all the patients, mostly inhalation budesonide with dose ranging from 0.5-1mg was prescribed alone or in combiantion with intravenous hydrocortisone in ED with doses ranging from 50-200mg as mentioned in Table 3.
Table 3. Prescription of steroids in respiratory disease conditions
|
Variables |
Steroid |
Dose |
No. Of patients (n=72) |
Percentage |
|
AECOPD (n=19) |
Budesonide |
0.5mg |
2 |
2.7% |
|
Budesonide+ hydrocortisone Sodium succinate |
0.5mg+50mg 0.5mg+100mg 0.5mg+200mg 1mg+100mg 1mg+200mg |
1 7 4 2 3 |
1.3% 9.7% 5.5% 2.7% 4.1% |
|
|
Pneumonia (n=28) |
Budesonide |
0.5mg |
16 |
22.2% |
|
Budesonide+ hydrocortisone Sodium succinate |
0.5mg+50mg 0.5mg+100mg 0.5mg+200mg 1mg+200mg |
1 8 2 1 |
1.3% 11.1% 2.7% 1.3% |
|
|
Asthma (n=25) |
Budesonide |
0.5mg 1mg |
5 2 |
6.9% 2.7% |
|
Budesonide+ hydrocortisone Sodium succinate |
0.5mg+100mg 0.5mg+200mg 1mg+100mg 1mg+200mg |
12 3 2 1 |
16.6% 4.1% 2.7% 1.3% |
AECOPD:Acute Exacerbation of COPD.
Glycemic levels were monitered, primarily RBS was used as predictor for hyperglycemia. RBS levels reveales that totally four (5.5%) patients developed hyperglycemia (>200mg/dl) after steroid administartion. Among them two were non diabetic and two were diabetic. Hyperglycemic episodes were observed more in pneumonia patients with 4.1% (n=3). Only one COPD patient developed hyperglycemia and no asthma patients experienced hyperglycemic episodes mentioned in Table 4.The statistical results showed that there was no significant difference (p< 0.05) in glycemic levels before and after initiation of steroids in both diabetic and non-diabetic patients but hyperglycemic episodes were observed in both diabetic and non-diabetic patients with equal proportion after initiating corticosteroids in ED.
Table 4. Glycemic levels before and after administration of steroids.
|
Variables |
Non-Diabetic patients |
Diabetic patients |
||||
|
RBS |
Before |
After |
RBS |
Before |
After |
|
|
AECOPD |
<120 121-140 141-160 161-180 >180 |
4 2 3 1 0 |
3 5 2 0 0 |
<140 141-160 161-180 181-200 >200 |
4 0 0 0 1 |
2 0 0 1 2 |
|
Pneumonia |
<120 121-140 141-160 161-180 >180 |
8 3 0 0 2 |
8 3 2 0 4 |
<140 141-160 161-180 181-200 >200 |
1 2 0 0 2 |
0 2 0 0 3 |
|
Asthma |
<120 121-140 141-160 161-180 >180 |
5 0 1 1 0 |
3 2 2 0 0 |
<140 141-160 161-180 181-200 >200 |
1 1 0 2 3 |
2 2 1 2 2 |
|
P-value |
0.076 |
0.317 |
P-value |
0.111 |
0.402 |
|
AECOPD: Acute Exacerbation of COPD.
DISCUSSION
In this study, a trial on implemetation of steroid stewardship programme in emergency department (ED) was carried out. Assesment of prescribing pattern of corticosteroid usage for the treatment of AECOPD (Acute Exacerbation of Chronic obstructive Pulmonary Disease), Pneumonia and Asthma also estimated their glycemic levels before and after the administration of steroid. This study was designed with the aim to evaluate the effectiveness of steroid stewardship on glycemic control in emergency department among AECOPD, pneumonia and asthma patients by using the three components of steroid stewardship process which includes pre- prescription screening, judicious prescription, and medical management during corticosteroid administration and after discontiunation of corticosteroid. About 72 patients were included in this study based on inclusion criteria of which 46 (73%) were male and 26 (27%) were female patients there were similar to the studies conducted by Rana et.al.,[10] and Aryal et.al.,[9] in which males were predominant with 61.3% and 58.4% respectively. Based on age wise distribution, 53 patients were between the age group of 61-80 years which correlates with the study conducted by Gouda et.al.,[11] Prescription pattern shows that inhalational budesonide in combination with hydrocortisone was prescribed at higher percentage of 66.4% whereas in the study conducted by Aryal et.al.,[9] the combination was prescribed to 35.19% of total study population. While evaluating hyperglycemia, in this study totally 4 patients (5.5%) developed hyperglycemia after steroid administration which relates with the study by price et.al.,[12] where 5% of patients developed hyperglycemia after steroid administartion.
CONCLUSION
This study aimed at evaluation of steroid stewardship effectiveness that fosters glycemic control in emergency care patients who were treated with various corticosteroids. Through a prospective cross-sectional study design, the majority of patients treated with corticosteroids were diagnosed with pneumonia, asthma and acute exacerbation of COPD. RBS levels were monitored before and after steroid administration. Patients who experienced hyperglycemia were suitably managed with insulin. This study concludes that there was no significant difference (p > 0.05) in RBS levels before and after steroid initiation. Though statistical values cannot be achieved, several episodes of hyperglycemia (>200mg/dl) was observed in both diabetic and non-diabetic patients who were presented with pneumonia and AECOPD. Prescribing pattern analysis of corticosteroids was performed, which showed that inhaled budesonide (0.5mg) in combination with hydrocortisone (50mg) was prescribed in higher frequencies for not more than five days in emergency department, while hyperglycemia is more observed in patients who received intravenous hydrocortisone. Thus, implementation of steroid stewardship program on glycemic control concludes that, glycemic levels need to be monitored periodically after steroid administration especially in diabetic patients whereas for non-diabetic patients’ awareness about hyperglycemia can be educated to prevents diabetes. So, we suggest that steroid stewardship program has a vital role in improving therapeutic outcomes, minimizing ADR and benefits patients’ adherence in using corticosteroids.
ACKNOWLEDGEMENT
The authors are thankful to the management of KMCH College of Pharmacy and Kovai Medical Center and Hospital for the continuous encouragement, support and facilities to carry out this study.
REFERENCES
Murugesan Ragunathan, Sivadasan Shalini*, Kumar Dhilipan, Murugesan Karthick, Vasugi Iswar Raja, A Prospective Study on Effectiveness of Steroid Stewardship on Glycemic Control Among Emergency Care Patients at A Tertiary Care Hospital, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 4, 535-541. https://doi.org/10.5281/zenodo.15148353
10.5281/zenodo.15148353
