Otitis media (OM) is one of the most common inflammatory disorders of the middle ear and remains a major global health problem, particularly among young children. The World Health Organization (WHO) estimates that approximately 709 million cases of acute otitis media (AOM) occur annually, with nearly half affecting children under five years of age [1]. Chronic suppurative otitis media (CSOM), a more persistent and severe form, is especially prevalent in low- and middle-income countries and is associated with long-term complications such as conductive hearing loss and impaired quality of life [2,3]. OM accounts for a substantial proportion of outpatient visits, antimicrobial prescriptions, and surgical interventions in otorhinolaryngology practice [4]. Its high incidence is influenced by recurrent upper respiratory infections, allergic conditions, genetic predisposition, and socio-economic factors such as overcrowding and limited access to healthcare [5]. AOM is a leading indication for antibiotic use in children, contributing to the rise of antimicrobial resistance (AMR), while CSOM often requires prolonged treatment targeting resistant organisms [6]. If inadequately managed, OM may lead to mastoiditis, tympanic membrane perforation, intracranial infections, and irreversible hearing loss, underscoring the need for timely and evidence-based interventions [7,8]. Etiological agents vary by subtype, with AOM commonly caused by Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, whereas CSOM typically involves more resistant pathogens such as Pseudomonas aeruginosa and Staphylococcus aureus [6]. Inappropriate antibiotic use—such as empirical therapy without confirmation of bacterial infection—remains a major driver of AMR, particularly in settings with limited diagnostic resources [7–9]. Deviations from treatment guidelines, lack of standardized protocols, and unnecessary prescribing further complicate management and increase healthcare costs [10–12]. Drug utilization studies play a crucial role in evaluating prescribing patterns and assessing adherence to rational antimicrobial use [13–15]. Such evaluations are especially important in tertiary care hospitals, where treatment decisions influence broader prescribing practices. The present study investigates antimicrobial drug utilization patterns in patients with otitis media in a tertiary care hospital, with the aim of identifying prescribing trends, evaluating guideline adherence, and supporting antimicrobial stewardship efforts to improve clinical outcomes.

This observational cross-sectional study was conducted over nine months in the Department of Otorhinolaryngology at Parul Sevashram Hospital, a tertiary care centre affiliated with the Parul Institute of Medical Sciences and Research (PIMSR), Limda, Gujarat. The study aimed to analyse antimicrobial drug utilization patterns in patients diagnosed with otitis media. Ethical approval was obtained from the Institutional Ethics Committee (IEC) of Parul University. Informed consent was secured from all participants or their guardians, and confidentiality was maintained throughout the study. Study Participants Patients of all age groups clinically diagnosed with acute otitis media (AOM), chronic otitis media (COM), or otitis media with effusion (OME) and prescribed antimicrobial therapy were included. Patients with non–otitis media ear disorders, those previously treated with antimicrobials elsewhere, incomplete medical records, or comorbidities likely to confound outcomes were excluded. Sampling and Data Collection A convenience sampling method was used, with consecutive eligible patients enrolled from outpatient and inpatient units during the data collection period. Data were collected retrospectively using a structured form capturing demographic details, clinical diagnosis, comorbidities, and complete prescription information, including antimicrobial type, dose, route, duration, and combination therapy. Guideline adherence was assessed based on WHO and national protocols. Outcome Measures Primary outcomes included the frequency and pattern of antimicrobial prescriptions across different forms of otitis media. Secondary outcomes involved assessment of guideline adherence, prescription appropriateness, and documentation of adverse drug reactions or recurrence. Statistical Analysis Data were entered into Microsoft Excel and analysed using SPSS version 28.0. Descriptive statistics (frequency, percentage, mean, and standard deviation) were used to summarize antimicrobial utilization trends.

The present observational study included 350 patients diagnosed with otitis media over the period of nine months with inclusion and exclusion criteria. Table 1: Demographic Profile of Study Participants Variable Category Frequency (n) Percentage (%) Age Group <5 years 40 11.43 5–15 years 65 18.57 16–30 years 110 31.43 31–50 years 85 24.29 >50 years 50 14.29 Gender Male 200 57.14 Female 150 42.86 The demographic profile showed that the 16–30 years age group constituted the largest proportion of cases (31.43%), followed by individuals aged 31–50 years (24.29%). Pediatric patients aged 5–15 years accounted for 18.57%, while those under 5 years represented 11.43% of the study population. Patients aged over 50 years comprised 14.29%, indicating that otitis media affected a broad age range but was predominantly observed among young adults. A male predominance was noted, with 57.14% males and 42.86% females. Table 2. Clinical Characteristics of Otitis Media Patients Parameter Category Frequency (n) Percentage (%) Type of OM AOM 130 37.14 CSOM 140 40.00 OME 60 17.14 Others 20 5.71 Laterality Right Ear 120 34.29 Left Ear 100 28.57 Bilateral 130 37.14 Symptoms Ear discharge 220 62.86 Ear pain 180 51.43 Hearing loss 160 45.71 Fever 90 25.71 Tinnitus 40 11.43 Vertigo 25 7.14 Comorbidities URTI 85 24.29 Diabetes mellitus 50 14.29 Hypertension 40 11.43 Allergic Rhinitis 30 8.57 Asthma 15 4.29 Regarding clinical characteristics, CSOM was the most frequently diagnosed type (40%), followed by AOM (37.14%), and OME (17.14%), with a minority of cases classified as other forms (5.71%). Bilateral ear involvement was slightly more common (37.14%) than unilateral involvement, with right-sided affection in 34.29% and left-sided in 28.57% of patients. The most commonly reported presenting symptoms were ear discharge (62.86%), ear pain (51.43%), and hearing loss (45.71%), while fever, tinnitus, and vertigo were less frequently observed. Among comorbidities, upper respiratory tract infections (24.29%) were most prevalent, followed by diabetes mellitus (14.29%) and hypertension (11.43%). Table 3. Antimicrobial Utilization Overview Parameters % of Prescriptions Antimicrobial Class Beta-lactams 34.29 Fluoroquinolones 22.86 Aminoglycosides 14.29 Cephalosporins 10.00 Macrolides 8.57 Others 10.00 Route Oral 51.43 Topical 28.57 Parenteral 8.57 Combination 11.43 Analysis of antimicrobial utilization revealed that beta-lactams were the most commonly prescribed antimicrobial class (34.29%), followed by fluoroquinolones (22.86%) and aminoglycosides (14.29%). Cephalosporins (10%), macrolides (8.57%), and other agents constituted the remaining prescriptions. The oral route was the predominant mode of drug administration (51.43%), followed by topical therapy (28.57%); parenteral therapy (8.57%) and combination routes (11.43%) were used less frequently. Table 4: Most Prescribed Individual Antimicrobials Drug Name Frequency (n) % Amoxicillin-clavulanate 60 17.14 Ciprofloxacin (topical/systemic) 50 14.29 Gentamicin 40 11.43 Cefixime 30 8.57 Azithromycin 20 5.71 Others 150 42.86 Among individual drugs, amoxicillin–clavulanate was most frequently prescribed (17.14%), followed by ciprofloxacin (14.29%) and gentamicin (11.43%). Table 5. Antimicrobial Prescribing Pattern Based on Type of Otitis Media Antimicrobial Agent AOM (n = 130) CSOM (n = 140) OME (n = 60) Amoxicillin–Clavulanate 50 30 20 Ciprofloxacin 20 40 15 Gentamicin 10 30 10 Cefixime 10 15 5 Antimicrobial prescribing patterns varied by otitis media subtype. Amoxicillin–clavulanate was predominantly prescribed in AOM, whereas ciprofloxacin was mainly used in CSOM, reflecting its role in managing chronic, often perforated ear infections. Cefixime was commonly administered in OME cases. Table 6. Treatment Characteristics Parameters % of Prescriptions Duration of Antimicrobial Therapy ≤5 days 60 17.14 6–10 days 220 62.86 >10 days 70 20.00 Number of Drugs per Prescription 1 130 37.14 2 150 42.86 ≥3 70 20 Assessment of treatment characteristics indicated that most patients (62.86%) were prescribed antimicrobials for 6–10 days, aligning with standard therapeutic recommendations. Shorter treatment durations (≤5 days) were seen in 17.14% of cases, whereas 20% received therapy for more than 10 days, typically associated with chronic or recurrent infections. Polypharmacy analysis showed that 42.86% of prescriptions contained two drugs, 37.14% included a single drug, and 20% involved three or more medications. Table 7. WHO Core Prescribing Indicators Indicator Value Average number of drugs per prescription 1.83 % drugs prescribed by generic name 60.00 % encounters with an antimicrobial 88.57 % drugs prescribed from Essential Drug List 80.00 Evaluation using the WHO core prescribing indicators demonstrated that the average number of drugs per prescription was 1.83, consistent with WHO recommendations. However, only 60% of drugs were prescribed by generic name, indicating scope for improved adherence to rational prescribing norms. Antimicrobials were prescribed in 88.57% of patient encounters, and 80% of prescribed drugs were from the Essential Drug List. Table 8. Adverse Drug Reaction (ADR) Profile ADR Type Frequency (n) Percentage (%) Rash 6 1.71 Nausea/Vomiting 5 1.43 Diarrhea 4 1.14 Dizziness 3 0.86 Others 2 0.57 Total ADRs 20 5.71 A total of 20 adverse drug reactions (5.71%) were recorded. The most common ADR was rash (1.71%), followed by nausea/vomiting (1.43%), diarrhea (1.14%), and dizziness (0.86%). Table 9. ADRs per Specific Antimicrobial Antimicrobial Rash GI Upset Dizziness Total ADRs Amoxicillin-clavulanate 3 2 1 6 Ciprofloxacin 1 3 1 5 Cefixime 1 2 1 4 Gentamicin 0 1 2 3 Azithromycin 1 1 0 2 Drug-specific analysis showed that amoxicillin–clavulanate accounted for the highest number of ADRs (n = 6), primarily rash and gastrointestinal disturbances. Ciprofloxacin (5 ADRs) and cefixime (4 ADRs) also demonstrated notable adverse effects, while gentamicin was associated mainly with dizziness, consistent with its known vestibulotoxicity. Azithromycin accounted for two ADRs.

This study assessed antimicrobial prescribing patterns in patients with otitis media in a tertiary care setting. The predominance of young adults (16–30 years: 31.43%) and individuals aged 31–50 years (24.29%) contrasts with traditional epidemiological trends that identify otitis media primarily as a pediatric condition. This adult predominance may reflect delayed diagnosis, chronic progression of CSOM, or greater healthcare utilization among young and middle-aged adults. A higher proportion of male patients (57.14%), consistent with previous reports [16,17], suggests biological and sociocultural factors influencing susceptibility and care-seeking behavior. CSOM emerged as the most common clinical subtype (40%), followed by AOM (37.14%) and OME (17.14%). The high CSOM burden mirrors findings from Indian studies [18,19] and likely reflects inadequate early management, recurrent URTI, and socioeconomic determinants. In contrast, Western studies report higher AOM prevalence, attributed to improved hygiene and timely intervention [20]. Bilateral involvement (37.14%) and predominant symptoms—ear discharge, ear pain, and hearing loss—align with established clinical patterns [21]. Frequent comorbidities such as URTI, diabetes mellitus, and allergic conditions further support previously identified risk factors [22-24]. Beta-lactams were the most frequently prescribed antimicrobial class (34.29%), particularly amoxicillin–clavulanate, consistent with guideline recommendations for AOM and early CSOM management. Fluoroquinolones, especially ciprofloxacin (22.86%), were widely used in CSOM, reflecting their efficacy against Pseudomonas and Staphylococcus species [25-27]. Gentamicin use also aligned with previous studies [28], though its ototoxic potential requires careful monitoring. Oral therapy predominated (51.43%), with topical preparations used extensively in CSOM, consistent with evidence supporting local delivery in cases with tympanic membrane perforation [29,30]. Duration of therapy (6–10 days in 62.86% of cases) and antimicrobial choice across OM subtypes generally adhered to recommended practices. Polypharmacy was identified in 20% of prescriptions, similar to findings by Roy et al. [31], highlighting the need for stewardship efforts to limit unnecessary multidrug regimens. WHO prescribing indicators revealed an average of 1.83 drugs per prescription, moderate generic prescribing (60%), high antimicrobial use (88.57%), and satisfactory adherence to the Essential Drug List (80%), comparable to previous studies [32,33]. Adverse drug reactions were infrequent (5.71%), mainly mild cutaneous or gastrointestinal events. Amoxicillin–clavulanate, ciprofloxacin, and cefixime were the most commonly implicated agents, consistent with earlier reports [34]. However, the potential for underreporting warrants consideration, particularly regarding aminoglycoside-induced ototoxicity. This study provides a concise overview of real-world antimicrobial prescribing in otitis media and demonstrates reasonable adherence to guideline-based practices. Key areas for improvement include enhanced generic prescribing, minimization of polypharmacy, and integration of microbiological data to guide therapy. Future multicentric studies incorporating culture sensitivity profiles and treatment outcomes are recommended to strengthen antimicrobial stewardship initiatives.

This study demonstrates an adult predominance of otitis media and a high prevalence of CSOM in a tertiary care setting. Antimicrobial use was largely rational, with beta-lactams and fluoroquinolones serving as the main agents and oral or topical routes commonly preferred. Although adherence to essential drug guidelines was satisfactory, limited generic prescribing and reliance on empirical therapy highlight the need for stronger antimicrobial stewardship. The low incidence of adverse reactions supports the safety of current regimens, though improved pharmacovigilance and routine culture-sensitivity testing are advised. Multicentric studies incorporating microbiological data are recommended to further refine evidence-based prescribing practices.

1. Monasta L, Ronfani L, Marchetti F, Montico M, Vecchi Brumatti L, Bavcar A, Grasso D, Barbiero C, Tamburlini G. Burden of Disease Caused by Otitis Media: Systematic Review and Global Estimates. PLoS One. 2012;7(4):e36226. doi: 10.1371/journal.pone.0036226. 2. Acuin J. World Health Organization. Chronic Suppurative Otitis Media: Burden of Illness and Management Options, 2004. 3. Lieberthal AS, Carroll AE, Chonmaitree T, Ganiats TG, Hoberman A, Jackson MA, Joffe MD, Miller DT, Rosenfeld RM, Sevilla XD, Schwartz RH, Thomas PA, Tunkel DE. The diagnosis and management of acute otitis media. Pediatrics. 2013 Mar;131(3):e964-99. doi: 10.1542/peds.2012-3488. Epub 2013 Feb 25. Erratum in: Pediatrics. 2014 Feb;133(2):346. 4. Hardani AK Sr, Moghimi Esfandabadi F, Delphi M, Ali Samir M, Zamiri Abdollahi F. Risk Factors for Otitis Media in Children Referred to Abuzar Hospital in Ahvaz: A Case-Control Study. Cureus. 2020 Aug 15;12(8):e9766. doi: 10.7759/cureus.9766. PMID: 32944478; PMCID: PMC7489764. 5. Schilder AG, Chonmaitree T, Cripps AW, Rosenfeld RM, Casselbrant ML, Haggard MP, Venekamp RP. Otitis media. Nat Rev Dis Primers. 2016 Sep 8;2(1):16063. doi: 10.1038/nrdp.2016.63. 6. Danishyar A, Ashurst JV. Acute Otitis Media. [Updated 2023 Apr 15]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK470332/ 7. García Carretero R. Cerebellar abscesses, infective endocarditis, and bacteraemia due to a rare pathogen: Streptococcus constellatus. BMJ Case Rep. 2017 Sep 01;2017 8. Acuin J, World Health Organization. Chronic suppurative otitis media. World Health Organization; 2004. Accessed on [08-07-2025] https://iris.who.int/bitstream/handle/10665/42941/9241591587.pdf 9. World Health Organization: WHO. Antimicrobial resistance 2023. https://www.who.int/news-room/fact-sheets/detail/antimicrobialresistance#:~: text=Antimicrobial%20Resistance%20(AMR)%20occurs%20when, organ%20transplantation%20and%20other%20surgeries. 10. Perveen S, Naqvi SB, Fatima A. Antimicrobial susceptibility pattern of clinical isolates from cases of ear infection using amoxicillin and cefepime. Springerplus. 2013 Jul 1;2:288. doi: 10.1186/2193-1801-2-288. PMID: 23961387; PMCID: PMC3731673. 11. ICMR, Bhargava B, ICMR, Gopalkrishnan R, Ohri VC, Walia K. Treatment guidelines for antimicrobial use in common syndromes. Indian Council of Medical Research; 2019. 12. Hersh AL, Shapiro DJ, Pavia AT, Shah SS. Antibiotic prescribing in ambulatory pediatrics in the United States. Pediatrics. 2011 Dec;128(6):1053-61. doi: 10.1542/peds.2011-1337. Epub 2011 Nov 7. PMID: 22065263. 13. Rasmussen L, Wettermark B, Steinke D, Pottegård A. Core concepts in pharmacoepidemiology: Measures of drug utilization based on individual-level drug dispensing data. Pharmacoepidemiol Drug Saf. 2022 Oct;31(10):1015-1026. doi: 10.1002/pds.5490. Epub 2022 Aug 11. PMID: 35819240; PMCID: PMC9545237. 14. Meena DK, Jayanthi M. Drug utilization research: a review. Int J Basic Clin Pharmacol [Internet]. 2019 Jan. 24 [cited 2025 Jul. 9];8(2):354-61. Available from: https://www.ijbcp.com/index.php/ijbcp/article/view/2892 15. Sweileh WM. Global research publications on irrational use of antimicrobials: call for more research to contain antimicrobial resistance. Global Health. 2021 Aug 24;17(1):94. doi: 10.1186/s12992-021-00754-9. PMID: 34429128; PMCID: PMC8383246. 16. Mishra A, Yadav SP, Gupta A. Gender-based clinical profile of chronic suppurative otitis media. Int J Otorhinolaryngol Clin. 2020;12(2):45–49. 17. Singh P, Prakash R, Ankit. Demographic and clinical evaluation of patients with otitis media: a hospital-based study. Indian J Otol. 2016;22(1):17–21. 18. Rajeev A, Shrestha B, Amatya RC. Clinical profile and management of otitis media in a tertiary care center. JNMA J Nepal Med Assoc. 2016;54(202):20–24. 19. Goyat D, Singh J, Kaushik V. Comparative study of topical and systemic antibiotic therapy in chronic suppurative otitis media. Int J Otorhinolaryngol Head Neck Surg. 2018;4(1):68–72. 20. Smith JA, Thompson K, Whelan M. Shifts in otitis media prevalence and antimicrobial resistance in a post-vaccination era. Clin Otolaryngol. 2020;45(2):183–189. 21. Lalwani A, Singh S, Mahajan A. Clinical spectrum and management outcome of otitis media: an observational study. J Otolaryngol ENT Res. 2020;12(2):42–46. 22. Ahmed A, Shamsi H. Epidemiology and treatment approaches in chronic otitis. J Pediatr Otolaryngol. 2022;16(3):199-205. 23. Kumar R, Shinde A, Arora D. Correlation of diabetes mellitus with chronic suppurative otitis media: a prospective study. J Clin Diagn Res. 2017;11(5):MC01– MC03. 24. Kolo ES, Salisu AD, Yaro AM. Association of allergic rhinitis and asthma with otitis media with effusion. Ann Med Health Sci Res. 2016;6(2):85–89. 25. Bose A, Roy S, Banerjee S. Pattern of antimicrobial therapy in otitis media: a prospective study. J Otolaryngol ENT Res. 2018;9(3):187–191. 26. Patel M, Trivedi A, Bhatt R. A study on prescribing pattern of antibiotics in ENT outpatient department. Int J Basic Clin Pharmacol. 2019;8(2):237–240. 27. Raghunathan A, Sinha A, Singh A. Efficacy of ciprofloxacin in chronic suppurative otitis media: clinical and microbiological perspective. Indian J Otol. 2015;21(4):250–254. 28. Sharma D, Nandwani S, Mangal N. Acute otitis media in pediatric age group: clinical profile and management. Int J Contemp Pediatr. 2019;6(1):145–149. 29. Jamal A, Alsabea A, Tarakmeh M, Safar A. Etiology, Diagnosis, Complications, and Management of Acute Otitis Media in Children. Cureus. 2022 Aug 15;14(8):e28019. doi: 10.7759/cureus.28019. PMID: 36134092; PMCID: PMC9471510. 30. Taneja N, Sharma M, Kumar A. Empirical antimicrobial use in otolaryngology in Indian tertiary hospitals: A focus on rational prescribing. Indian J Pharmacol. 2016;48(6):644–648. 31. Roy R, Chakrabarti S, Das S. Polypharmacy in ENT prescriptions: pattern and rationality. Int J Pharm Sci Res. 2017;8(4):1692–1696. 32. Sinha A, Chatterjee S, Dey S. Generic prescribing patterns among physicians in India: a cross-sectional study. Int J Med Public Health. 2020;10(1):18–21. 33. Das S, Sen S, Roy D. Assessment of rational use of antibiotics in ENT outpatient setting. Indian J Pharmacol. 2019;51(2):123–128. 34. Narayan S, Patel P, Joshi N. Age-wise comparison of antibiotic usage pattern in otitis media. J Drug Deliv Ther. 2020;10(5):189–192.