European Journal of Cardiovascular Medicine

Chronic Obstructive Pulmonary Disease (COPD) has been described by The Global Initiative for Chronic Obstructive Lung Disease (GOLD) as “a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction.” [1].

In accordance with WHO, COPD ranks as the fourth highest cause of mortality globally, resulting in 3.5 million fatalities in 2021 approximately 5% of all global deaths. COPD is the eighth leading cause of poor health worldwide (measured by disability-adjusted life years) Nearly 90% of COPD deaths in those under 70 years of age occur in low and middle-income countries (LMIC) [2]. The present-day “prevalence of COPD in India is 7.0%,” which is less than the “global prevalence rate of 10.7%to 12.1%” [3].

Pharmacotherapy for COPD typically entails the administration of multiple medications, therefore elevating the likelihood of “adverse drug events (ADEs)” proportionately.

In COPD, medication is administered to alleviate symptoms, diminish the occurrence as well as intensity of exacerbations, and enhance health status. Bronchodilators constitute the cornerstone of pharmacological treatment for COPD. “Short-acting bronchodilators” provide rapid symptomatic relief, whereas a number of “Long-acting bronchodilators, such as long-acting beta-2 agonists (LABAs) or Long-acting muscarinic antagonists (LAMAs)”, are utilized for ongoing maintenance therapy for those having “moderate to severe COPD management” [4, 5].

“Inhaled corticosteroids (ICS)” are fundamental in the medical management of asthma; nevertheless, their function in the therapy of COPD remains contentious [6]. In COPD, the primary function of ICS is to mitigate the likelihood of exacerbations.

The updated GOLD strategy advocates for the incorporation of an additional bronchodilator for those exhibiting “moderate airflow obstruction”, while limiting the addition of inhaled corticosteroids in conjunction with a long-acting beta-agonist and/or long-acting muscarinic antagonist for those with “severe or very severe airflow obstruction and/or two or more exacerbations of COPD annually [7,8].

However, research indicates that “prescriptions” are not consistently aligned with “GOLD guidelines” or any national guidelines, leading to a significant number of patients receiving ICS treatment inappropriately while being placed at the risk of adverse effects inappropriately [9]. Role of antibiotics is also crucial in the management of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in most the patients, particularly with associate infection and other co-morbidities. Many antibiotics like drugs belonging to cephalosporins, macrolide and fluoroquinolones class has demonstrated efficacy in reducing the frequency of AECOPD in this population [10].

The irrational use of medications and improper prescriptions can result in elevated medical expenses, ADR, tolerance to medications, and fatality. Consequently, DUS have emerged as a viable method for assessing medical facilities. Treatment of COPD typically entails multiple medications, potentially increasing the risk of adverse drug events (ADEs).

Therefore, the objective of “pharmacotherapy” is not merely to “prescribe a risk-free regimen” but to minimize the hazards associated with “drug therapy” as much as feasible. Accurate information regarding the harmful effects of medications assists physicians in prescribing pharmaceuticals while weighing the benefits against the risks [11-13].

Drug utilization studies are important because they offer evidence-based insights on therapeutic results, prescription trends, and possible medication abuse or overuse [14, 15].DUS enables healthcare systems to solve problems such as polypharmacy, antibiotic resistance, and the inappropriate use of expensive or high-risk medications by spotting departures from accepted treatment recommendations. This, therefore helps to promote the application of evidence-based medicine (EBM), which combines clinical knowledge and patient values with the best available research evidence to maximize patient care and decision-making [16-19]. Many studies have been conducted in the past on respiratory diseases, however to our knowledge published data particularly focused on COPD especially in India is limited. It was hypothesized that “With a possible over-reliance on some classes of medications (e.g., bronchodilators or corticosteroids) and underutilization of others (e.g., long-acting muscarinic antagonist or combination therapies), the way drugs are used in COPD patients differs greatly and may not always follow evidence-based recommendations.”

This study aims to assess the drug utilization patterns for managing Chronic Obstructive Pulmonary Disease (COPD) in a General Medicine outpatient setting. It focuses on evaluating prescriptions using WHO drug use indicators, identifying prevailing prescribing trends, analyzing the cost burden associated with current drug choices, and offering data-driven recommendations to enhance therapeutic effectiveness and cost-efficiency for COPD patients.

This prospective cross-sectional observational study was conducted over 18 months at Narayan Medical College and Hospital, Jamuhar Sasaram, Bihar, involving COPD-diagnosed patients from the General Medicine OPD. Approved by the Institutional Human Ethics Committee (via letter no: NMCH/IEC/2023/112), the study adhered to international ethical guidelines and ensured informed consent through a locally explained Participant Information Sheet. Data were sourced from hospital records with proper authorization, and the study was jointly carried out by the Departments of Pharmacology and General Medicine.

Study Population: This study includes COPD patients aged 30 to 70 years, diagnosed according to GOLD guidelines, attending the outpatient department, and willing to provide informed consent. It excludes individuals outside the age range, those from emergency or inpatient settings, patients with significant co-morbidities, pregnant or lactating women, those with immunocompromising conditions or other respiratory illnesses, and anyone unwilling or unable to comply with the study protocol.

Sample Size: The study enrolled 108 COPD patients using a consecutive sampling method, based on eligibility criteria. The sample size was determined using a 7% estimated prevalence rate of COPD in India (as per Verma et al., 2021) [3], applying standard calculations for observational studies with 95% confidence, 0.05 alpha value and a 5% precision level. The initial sample size came to 100 (using the formula: n= Z²₁₋_α₂ * p * (1 - p) / d²), and with an anticipated 8% non-response rate, the final sample size was adjusted to 108.

METHODOLOGY

The study involved collecting detailed demographic data of COPD patients—such as age, gender, smoking history, disease duration, and comorbidities—along with prescribed medicines, their types, and cost ranges. It analyzed drug prescriptions, including bronchodilators, corticosteroids, antibiotics, and adjunct therapies, and evaluated them using WHO drug use indicators like average drug count, generic prescribing, use of injections, antibiotics, and essential drugs. These indicators were then compared against WHO standards and the National List of Essential Medicines (2022), to assess the quality and appropriateness of prescribing practices [20].

The study assessed COPD drug prescribing patterns by analyzing the average and maximum number of medications per patient, the proportion on monotherapy versus combination therapy, and the usage trends across different drug classes. It also evaluated the sequence and frequency of drug use. Additionally, a cost analysis was conducted using hospital pharmacy or market prices to determine the financial impact on patients, including calculations of percentage cost variation and average cost per dose to highlight pricing disparities among prescribed therapies.

Statistical Analysis: Data collected throughout the study were entered into Microsoft Excel and subjected to statistical analysis using appropriate software. The statistical methods used in the study include descriptive statistics to summarize the distribution of COPD patients across various demographic and clinical parameters. Chi-square (χ²) tests were employed to assess the significance of categorical variables, such as age group, gender, community, socio-economic strata, smoking status, and COPD staging, with p-values reported to determine statistical significance at p<0.05.

Out of 108 subjects, 39 (36.11%) belonged to grade 1 COPD, 54 (50%) to grade 2 COPD, 12 (11.11%) to grade 3, and 3 (2.78%) to grade 4 COPD.

Table 1: Comparison of Baseline Demographic and Clinical Characteristics

The baseline comparison reveals that COPD patients across all stages (COPD 1 to 4) were most commonly aged between 41–60 years, with the highest concentration in the 41–50 range. Males slightly outnumbered females (61 vs. 47), and over half had a smoking history. Chronic bronchitis dominated as the most frequent COPD type, while emphysema and small airway disease showed stage-specific variation—emphysema being most prevalent in advanced COPD. Socio-economic distribution leaned toward lower middle and poor strata, suggesting economic challenges may correlate with disease progression or access to care [Table 1].

Table 2: Signs & Symptoms mentioned in the prescriptions of COPD Patients

Shortness of breath (96 cases) and cough (101 cases) were the most frequent symptoms. Advanced stages showed more severe symptoms like hemoptysis and chest pain. GI upset was notably common, possibly due to medication side effects or comorbidities [Table 2].

Table 3: List of Drugs prescribed to COPD Patients under study

Bronchodilators (e.g., levosalbutamol), mucolytics (e.g., ambroxol), and leukotriene antagonists (e.g., montelukast) were widely used. Antibiotics like azithromycin were prescribed moderately (14 cases), while IV drugs (e.g., ceftriaxone) were reserved for severe stages [Table 3].

Table 4: Assessment of WHO Prescribing indicators

The average drugs per encounter (6.67) exceeds WHO standards (1.6–1.8). Only 13.49% of drugs were prescribed generically, and antibiotic use (9.17%) was below the recommended range (20–26.8%), indicating deviations from ideal practices [Table 4].

The present study included 108 patients with COPD attending the Medicine outdoor of the tertiary care hospital of South-west Bihar. This study focused on the discussion on prescription and utilization patterns in the case of COPD patients in accordance to WHO core prescribing indicators and GOLD criteria. In this study, a male (58.1%) preponderance over females (41.9%) was found in 1.3:1 ratio. Jochmann et al (2012), Niffy et al (2017), and Jain et al (2011) also had the similar observations in their study [21-23].

Our study found a male predominance (61 vs. 47 females), contrasting with Bajracharya M (2024) where females constituted 58%. Age distribution in our cohort (41–60 years) differed from Bajracharya’s (70–79 years), possibly due to regional smoking patterns or healthcare access disparities [24]. Shortness of breath (25.93–50%) and cough (wet/dry) were most common, aligning with Bajracharya (77.5% dyspnea, 50% cough) and Park HJ (2024), reinforcing dyspnea as a hallmark symptom [25]. Advanced stages in our study showed severe symptoms (hemoptysis, chest pain), consistent with disease progression. Our study highlighted levosalbutamol (oral/inhaled) and montelukast as primary therapies, whereas Bajracharya reported tiotropium (52.5%) and ICS-LABA combinations [24]. Park HJ (2024) emphasized LABA-LAMA efficacy in reducing exacerbations, suggesting our underuse of LAMA (e.g., tiotropium in only 10 cases) may reflect guideline non-adherence [25].

Azithromycin was moderately prescribed (14 cases), contrasting with Bajracharya’s high use (52.5%) [24]. Our low antibiotic rate (9.17% vs. WHO’s 20–26.8%) may indicate cautious use or underprescribing in early-stage COPD.

ICS use in our study was limited (e.g., budesonide in 9 cases), while Bajracharya reported hydrocortisone (68.5%) and prednisolone (49.5%) dominance. Taraneh Bahremand (2021) and Hamid Tavakoli (2019) noted excessive ICS use (45–50%), contrary to GOLD’s recommendation for reserved use in high-risk patients [26, 27].

Our study reported 6.67 drugs per encounter, exceeding WHO standards (1.6–1.8), similar to Bajracharya (10.82 drugs/prescription) and Despolerodiakonou (2021) (52.2% polypharmacy) [11, 24]. This highlights a global trend of polypharmacy in COPD, linked to comorbidities and ADR risks. Only 13.49% of drugs were generic in our study, lower than Bajracharya’s 7.78% and Jyothi’s (2020) findings, indicating systemic issues in cost-effective prescribing [24, 28]. Our EDL adherence (36.11%) was comparable to Bajracharya (37.72%) but suboptimal, reflecting institutional formulary gaps [24]. Like Taraneh Bahremand (2021) and Hamid Tavakoli (2019), our study noted ICS use in mild-moderate COPD, contradicting GOLD’s step-up approach [26, 27]. Machado-Duque (2024) reported rising LAMA use (53.6%) [29], whereas our study underutilized tiotropium (10 cases), mirroring Jyothi’s (2020) findings of poor LAMA adoption [28]. Jiang (2022) found premature triple therapy use (32.5% initial prescriptions) [30], while our study reserved it for severe cases (e.g., COPD 3–4), aligning better with guidelines. The study underscores regional disparities in COPD management, with overreliance on oral bronchodilators and mucolytics over inhalers (e.g., LAMA). High polypharmacy and low generic prescribing raise concerns about cost burdens and ADRs. Deviations from GOLD guidelines (e.g., ICS overuse, LAMA underuse) suggest educational gaps among prescribers. Comparative data emphasize the need for standardized, guideline-driven practices to optimize outcomes and reduce exacerbations. While our findings align with global trends in symptom prevalence and polypharmacy, they reveal critical gaps in guideline adherence, particularly in inhaler selection and antibiotic stewardship. Future interventions should focus on provider education, EDL reinforcement, and deprescribing strategies to ali

The majority of patients were middle-aged, with a higher prevalence among males and smokers, and chronic bronchitis was the dominant COPD type. Shortness of breath and cough were the most common symptoms, while advanced stages exhibited severe manifestations like hemoptysis and chest pain. Drug utilization analysis showed widespread use of bronchodilators, mucolytics, and leukotriene antagonists, with intravenous antibiotics reserved for severe cases. However, deviations from WHO prescribing standards were noted, including a high average number of drugs per encounter and low generic prescribing rates. These findings underscore the need for adherence to evidence-based guidelines to optimize therapeutic outcomes and ensure rational drug use in COPD management.

1. Celli B, Fabbri L, Criner G, Martinez FJ, Mannino D, Vogelmeier C, Montes de Oca M, Papi A, Sin DD, Han MK, Agusti A. Definition and Nomenclature of Chronic Obstructive Pulmonary Disease: Time for Its Revision. Am J Respir Crit Care Med. 2022 Dec 1;206(11):1317-1325. doi: 10.1164/rccm.202204-0671PP.
2. World Health Organization, Chronic obstructive pulmonary disease. News Room Fact Sheet, 6 November 2024. [Visited on 4 May 2025] Availablefrom: https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd)
3. Verma A, Gudi N, Yadav UN, Roy MP, Mahmood A, Nagaraja R, Nayak P.Prevalence of COPD among population above 30 years in India: A systematic review and meta-analysis. J Glob Health. 2021 Aug 21;11:04038. Doi:10.7189/Jogh.11.04038.
4. Sunil S, Gigi A, Hepzhiba P. et al. Drug utilization evaluation in chronic obstructive pulmonary disease patients-A prospective study. World J Pharm and Pharm Sci. 2015;5:1133-43.
5. Adil MS, Khan MA, Khan N. EMPADE Study: Evaluation of Medical Prescriptions and Adverse Drug Events in COPD Patients Admitted to Intensive Care Unit. J Clin Diag Res. 2015;9(11):5-8.
6. Barnes PJ. Inhaled corticosteroids in COPD: a controversy. Respiration. 2010;80(2) 89 – 95. doi: 10.1159/000315416
7. Maio S, Baldacci SF, Martini F. COPD management according to old and new GOLD guidelines: an observational study with Italian general practitioners. Curr Med Res Opi. 2014;30(6):1033-42
8. Alaga K, Palot A, Sofalvi T. Long-acting muscarinic receptor antagonists for the treatment of chronic airway diseases. Ther Adv Chronic Dis. 2014;5(2):85-98.
9. Rajnoveanu RM, Rajnoveanu AG, Ardelean AB, Todea DA, Pop CM, Antoniu SA, Motoc NS, Chis AF, Fildan AP, Man MA. Pulmonologists Adherence to the Chronic Obstructive Pulmonary Disease GOLD Guidelines: A Goal to Improve. Medicina (Kaunas). 2020 Aug 20;56(9):422. doi: 10.3390/medicina56090422.
10. Al-Hasan MN, Al-Jaghbeer MJ. Use of Antibiotics in Chronic Obstructive Pulmonary Disease: What is Their Current Role in Older Patients? Drugs Aging. 2020 Sep;37(9):627-633. doi: 10.1007/s40266-020-00786-7.
11. Lerodiakonou D, Theodorou E Sifaki- Pistolla D, Bouloukaki l, AntonoPoulou M, Poulorinakis l, Tsakountakis N, Voltiraki F, Chilverosk, Tsiligiannil. Clinical characteristics and outcomes of Polypharmacy in COPD Patients; A cross sectional study from crete. Greece. Clin Respir J. 2021 Dec; 15(12):1310-1319. doi:10.1111/CRI.13434.
12. Naranjo CA, Busto U, Sellers EM. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30:239-45.
13. Maqusood M, Khan FA, Kumar M. A Study of Prescription Pattern in the Management of COPD in a Tertiary Care Hospital. Ann Int Med Den Res. 2016;2(3):159-63.
14. Dukes MNG. Drug utilization studies: methods and uses. World Health Organization, Regional Office for Europe; 1993. Available from: https://iris.who.int/handle/10665/260517
15. World Health Organization. Introduction to drug utilization research. Geneva: World Health Organization; 2003. Available from: https://apps.who.int/iris/handle/10665/42627
16. Jandu JS, Mohanaselvan A, Dahal R, et al. Strategies to Reduce Polypharmacy in Older Adults. [Updated 2024 Aug 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK574550.
17. S, C. F. BM, A. P, Yadav K. AC. A study of drug utilization pattern using WHO prescribing indicators in pediatric patients. Int J Res Med Sci [Internet]. 2023 Apr. 29 [cited 2025 May 3];11(5):1775-9. Available from: https://www.msjonline.org/index.php/ijrms/article/view/11976.
18. Mamo DB, Alemu BK. Rational Drug-Use Evaluation Based on World Health Organization Core Drug-Use Indicators in a Tertiary Referral Hospital, Northeast Ethiopia: A Cross-Sectional Study. Drug Healthc Patient Saf. 2020 Jan 16;12:15-21. doi: 10.2147/DHPS.S237021.
19. Dhanshree Mohite*, Kavita Saner, P. N. Sable, Nirmala Parmar, Manisha Sirvi, Vikas Mohite, Promoting Rational Use of Medicines: A Multifaceted Approach, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 12, 2677-2684. https://doi.org/10.5281/zenodo.14539011
20. Central Drugs Standard Control Organization. Essential Medicines [Internet]. New Delhi: Ministry of Health & Family Welfare, Government of India; [cited 2025 May 08]. Available from: https://cdsco.gov.in/opencms/opencms/en/consumer/Essential-Medicines/
21. Jochmann A, Scherr A, Jochmann DC, Miedinger D, Török SS, ChhajedPN, Tamm M, Leuppi JD. Impact of adherence to the GOLD guidelines on symptom prevalence, lung function decline and exacerbation rate in the Swiss COPD cohort. Swiss Med Wkly. 2012 Apr 5;142:w13567. doi: 10.4414/smw.2012.13567.
22. Niffy A, Vikneswari A, Sunny N, Sherlet G. Analysis of Prescribing Pattern Of Drugs In Obstructive Lung Diseases. EJPMR. 2017;2:710–714.
23. Jain NK, Thakkar MS, Jain N, Rohan KA, Sharma M. Chronic obstructive pulmonary disease: Does gender really matter? Lung India 2011;28(4):258-62
24. Bajracharya M, Bajracharya D. A Prospective Study of Utilization Pattern of Drugs Used in Chronic Obstructive Pulmonary Disease Patients at Tertiary Care Teaching Hospital. Int J Adv Multidiscip Res Stud. 2024;4(2):1491-1496. DOI: https://doi.org/ 10.62225/2583049X.2024.4.2.2711
25. Park HJ, Lee JU, Jeon S, Lee HS, Kim BY, Chae YJ, et al. Prescription patterns and effectiveness of medications for chronic obstructive pulmonary disease: A retrospective study of real-world settings. PLoS ONE. 2024;19(6):e0304362. DOI: https://doi.org/10.1371/journal.pone.0304362.
26. Bahremand T, Etminan M, Roshan-Moniri N, De Vera MA, Tavakoli H, Sadatsafavi M. Are COPD Prescription Patterns Aligned with Guidelines? Evidence from a Canadian Population-Based Study. Int J Chron Obstruct Pulmon Dis. 2021 Mar 25;16:751-759. doi:10.2147/COPD.S290805.
27. Tavakoli H, Johnson KM, FitzGerald JM, Sin DD, Gershon AS, Kendzerska T, Sadatsafavi M. Trends in prescriptions and costs of inhaled medications in chronic obstructive pulmonary disease: a 19-year population-based study from Canada. Int J Chron Obstruct Pulmon Dis. 2019 Sep 3:14:2003-2013. doi:10.2147/COPD.S210897.
28. Jyoti DB, et al. A Prospective Study on Prescription Pattern in COPD. Maedica (Bucar). 2020 Mar;5(1):37-44. doi: 10.26547/Maedica.2020.,15.1.37.
29. Machado-Duque ME, Gaviria-Mendoza A, Valladales-Restrepo LF, González-Rangel A, Laucho-Contreras ME, Machado-Alba JE. Patterns and Trends in the Use of Medications for COPD Control in a Cohort of 9476 Colombian Patients, 2017–2019. Int J Chron Obstruct Pulmon Dis. 2023;18:1601-1610. DOI: 10.2147/COPD.S391573.
30. Jiang L, Kendzerska T, Aaron SD, Stukel TA, Stanbrook MB, Tan W, Pequeno P, Gershon AS. Prescription pathways from initial medication use to triple therapy in older COPD patients: a real-world population study. COPD J Chronic ObstrPulm Dis. 2022;19(1):315-323. doi: 10.1080/15412555.2022.2087616.