Upper Respiratory Tract Infections (URTIs) are the most common infectious diseases affecting humans worldwide, representing a massive burden on healthcare systems. Among URTIs, throat infections primarily acute pharyngitis, acute tonsillitis, and pharyngotonsillitis account for a significant proportion of outpatient visits in both pediatric and adult populations. [1]

The etiology of acute throat infections is predominantly viral, with viruses such as Rhinovirus, Adenovirus, Influenza, Parainfluenza, and Coronavirus accounting for approximately 70% to 85% of cases. The most common bacterial cause is Group A Beta-Hemolytic Streptococcus (GABHS), also known as Streptococcus pyogenes, which is responsible for only 10% to 15% of adult cases and 20% to 30% of pediatric cases. Despite standard medical guidelines recommending supportive care for viral infections and reserving antibiotics specifically for confirmed or highly suspected GABHS infections, antibiotics are prescribed in up to 70% to 80% of clinical encounters for throat infections. [1]

The Crisis of Antimicrobial Resistance (AMR)

The irrational and disproportionate use of antibiotics is the primary driver of antimicrobial resistance (AMR). AMR has been declared by the World Health Organization (WHO) as one of the top ten global public health threats facing humanity. When broad-spectrum antibiotics are used to treat self-limiting viral throat infections, it places immense selective pressure on both pathogenic and commensal flora, leading to the emergence of resistant bacterial strains. [1]

Beyond resistance, the inappropriate use of antimicrobials exposes patients to unnecessary risks of adverse drug events, such as gastrointestinal disturbances, allergic reactions, and the disruption of normal microbiome flora, potentially leading to secondary infections like Clostridioides difficile. Furthermore, the economic burden placed on patients and healthcare systems due to unnecessary drug expenditures is profound, particularly in developing nations where out-of-pocket healthcare spending is high. [1,2]

Concept of Drug Utilization Evaluation (DUE)

To address the challenges of irrational prescribing, continuous monitoring of prescription practices is essential. The WHO defines drug utilization as "the marketing, distribution, prescription, and use of drugs in a society, with special emphasis on the resulting medical, social, and economic consequences." Drug Utilization Evaluation (DUE) is an ongoing, systematic, criteria-based evaluation of drug use that will help ensure that medicines are used appropriately at the individual patient level.

By employing WHO core prescribing indicators, researchers and clinical pharmacologists can objectively quantify clinical practices. These indicators measure the degree of polypharmacy, the tendency to prescribe antibiotics and injections, and the adherence to generic prescribing and essential medicine lists. [1,2]

Objectives of the Study

Despite existing clinical guidelines, a gap remains between evidence-based recommendations and real-world clinical practice regarding throat infections. Therefore, this study was designed with the following primary objectives:

1. To evaluate the demographic profiles and morbidity patterns of patients presenting with throat infections.
2. To assess the drug utilization patterns of antimicrobial agents prescribed for these patients.
3. To analyze the prescriptions using standard WHO core prescribing indicators.
4. To identify the most commonly prescribed classes of antibiotics and evaluate their rationality based on current standard treatment guidelines.

Study Design and Setting A prospective, cross-sectional, observational study was conducted in the Otorhinolaryngology (ENT). Outpatient Departments (OPD) of Maheshwara Medical College and Hospital. The study spanned a period of six months, from December 2025 to May 2026. Ethical Approval Prior to the commencement of the study, the research protocol was submitted to and approved by the Institutional Ethics Committee (IEC). Written informed consent was obtained from all adult patients and from the parents or legally authorized representatives of pediatric patients prior to data collection. Patient confidentiality was strictly maintained throughout the research. Study Population and Sample Size A total of 542 prescriptions were collected during the study period based on a convenience sampling method, ensuring all patients meeting the inclusion criteria during the six-month window were approached. Inclusion Criteria: • Patients of all ages and both genders attending the OPD. • Patients clinically diagnosed with throat infections (e.g., acute/chronic pharyngitis, acute/chronic tonsillitis, pharyngotonsillitis, laryngitis). • Patients who consented to participate in the study. Exclusion Criteria: • Patients with comorbid respiratory conditions requiring specialized antibiotic therapy (e.g., tuberculosis, pneumonia). • Patients requiring immediate hospitalization or intensive care (IPD patients). • Pregnant or lactating women. • Patients with incomplete prescription data. Data Collection Procedure Data were extracted directly from the patients' outpatient prescription slips and clinical case sheets using a specially designed, pre-validated Case Record Form (CRF). The CRF captured the following variables: • Patient demographics: Age, gender, weight, and date of visit. • Clinical data: Presenting symptoms, duration of illness, and clinical diagnosis. • Drug data: Name of the prescribed drugs (generic or brand), drug class, dose, dosage form, route of administration, frequency, and duration of therapy. WHO Core Prescribing Indicators The collected prescriptions were systematically analyzed using the WHO Core Prescribing Indicators to evaluate the rationality of drug use: 1. Average number of drugs per encounter: Calculated by dividing the total number of drugs prescribed by the total number of encounters. (Evaluates polypharmacy). 2. Percentage of encounters with an antibiotic prescribed: Calculated by dividing the number of patient encounters in which at least one antibiotic was prescribed by the total number of encounters, multiplied by 100. 3. Percentage of encounters with an injection prescribed: Calculated by dividing the number of patient encounters in which at least one injection was prescribed by the total number of encounters, multiplied by 100. 4. Percentage of drugs prescribed by generic name: Calculated by dividing the number of drugs prescribed by generic name by the total number of drugs prescribed, multiplied by 100. 5. Percentage of drugs prescribed from the Essential Medicines List (EML): Calculated by dividing the number of drugs prescribed from the National List of Essential Medicines (NLEM) by the total number of drugs prescribed, multiplied by 100. [1] Statistical Analysis The recorded data were entered into Microsoft Excel and subjected to descriptive statistical analysis using IBM SPSS Statistics for Windows, Version 26.0 (IBM Corp., Armonk, N.Y., USA). Continuous variables (such as age and number of drugs) were expressed as mean and standard deviation (SD). Categorical variables (such as gender, diagnoses, and antibiotic classes) were expressed as frequencies and percentages.

Demographic Distribution

A total of 542 patients with throat infections were included in the study. The gender distribution revealed a slight male predominance, with 292 males (53.8%) and 250 females (46.2%).

An analysis of age distribution indicated that throat infections were most prevalent among young adults. The highest number of cases was observed in the 18–35 years age group (41.3%), followed by the 36–50 years age group (24.7%). Pediatric patients (0–17 years) accounted for 19.9% of the total study population, while the geriatric population (>50 years) constituted 14.1%.

Morbidity Pattern

The clinical diagnoses were categorized based on physician assessments. Acute pharyngitis was the most frequently encountered condition, followed by acute tonsillitis. A detailed breakdown of the morbidity patterns is presented in Table 1.

Table 1: Distribution of Clinical Diagnoses (N = 542)

Analysis of Prescribing Indicators

A total of 1,845 drugs were prescribed across the 542 patient encounters. The assessment of prescriptions using WHO Core Prescribing Indicators revealed an average of 3.4 drugs per encounter, which indicates a tendency toward polypharmacy.

Notably, antimicrobial agents were prescribed in a vast majority of the encounters (82.1%). Generic prescribing was found to be low, with only 28.5% of total drugs prescribed by their generic names. However, adherence to the National List of Essential Medicines (NLEM) was commendably high at 91.2%. The results of the WHO prescribing indicators are summarized in Table 2.

Table 2: WHO Core Prescribing Indicators

Utilization Pattern of Antimicrobial Agents

Out of the 542 patients, 445 patients (82.1%) received at least one antimicrobial agent. In total, 468 antimicrobial agents were prescribed (some patients received more than one antibiotic, though dual antibiotic therapy was rare and mostly seen in complicated chronic tonsillitis cases).

The most frequently prescribed class of antimicrobial agents was Macrolides (44.9%), overtaking Penicillins. Beta-lactam antibiotics (including Penicillins and Cephalosporins) constituted the second and third most common classes, respectively.

Table 3: Distribution of Prescribed Antimicrobial Classes (N = 468)

When analyzing individual antimicrobial agents, Azithromycin was the clear drug of choice, accounting for 41.5% (n=194) of all prescribed antibiotics. This was followed by the Amoxicillin + Clavulanic Acid combination at 26.9% (n=126). Among Cephalosporins, Cefixime (9.4%, n=44) and Cefpodoxime (4.5%, n=21) were commonly utilized. Fluoroquinolones, primarily Levofloxacin, were reserved for older adults or treatment-failure cases.

Dosage Forms and Routes of Administration

The oral route was the most preferred route of administration, accounting for 94.5% of the total prescribed drugs, which is expected in an outpatient setting. Tablets and capsules were the most common dosage forms (76%), followed by syrups and suspensions (18.5%), predominantly prescribed for pediatric patients. Injectables accounted for a mere 4.8% of the prescriptions, reflecting good adherence to oral therapy guidelines for uncomplicated outpatient infections.

Concomitant Medications

Because throat infections commonly present with symptoms such as fever, throat pain, cough, and rhinitis, a variety of concomitant medications were prescribed. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and antipyretics were prescribed in 92% of the encounters, with Paracetamol and Aceclofenac being the most common. Antihistamines (e.g., Levocetirizine) and decongestants were prescribed in 65% of cases. Antacids or proton pump inhibitors (PPIs), such as Pantoprazole, were co-prescribed in 45% of patients receiving antibiotics, presumably to counter potential gastrointestinal side effects.

The present study provides critical insights into the real-world clinical management of throat infections in a tertiary care outpatient setting. Throat infections are generally benign, self-limiting conditions. Yet, they are universally recognized as a primary source of antibiotic misuse. Evaluating prescribing behavior is the first vital step in curbing antimicrobial resistance. Demographics and Morbidity Our findings indicated a higher prevalence of throat infections in males (53.8%) compared to females (46.2%). The highest incidence was noted in the young adult demographic (18–35 years). This pattern correlates with the high mobility, social interaction, and occupational exposure typical of this age group, increasing their susceptibility to droplet infections. Acute pharyngitis emerged as the dominant clinical diagnosis (52.7%), which aligns with global epidemiological data suggesting that inflammation of the pharyngeal mucosa is the most common presentation of URTIs. [3,4] Assessment of WHO Core Prescribing Indicators Polypharmacy The average number of drugs prescribed per encounter in this study was 3.4. The WHO recommends a standard of 1.6 to 1.8 drugs per encounter. Our value significantly exceeds the optimal limit, indicating a trend of polypharmacy. This is largely driven by the symptomatic management approach adopted by physicians. A single prescription for a throat infection frequently contained an antibiotic, an antipyretic (Paracetamol), a non-steroidal anti-inflammatory drug (NSAID) for throat pain, an antihistamine/decongestant combination, and often a gastric acid suppressant (PPI) to prevent NSAID-induced gastritis. While symptomatic relief is necessary, excessive prescribing increases the risk of adverse drug-drug interactions and non-compliance due to high pill burdens. [1,5] Generic Prescribing A concerning finding was the low rate of generic prescribing, standing at only 28.5%, falling drastically short of the WHO optimal value of 100%. The reliance on brand-name drugs is a multifaceted issue. It often stems from aggressive pharmaceutical marketing, physician perceptions regarding the superior efficacy and quality control of branded medicines over generics, and ingrained prescribing habits. Low generic prescribing directly inflates the cost of healthcare for the patient, which is a critical issue in resource-limited settings. Continuous Medical Education (CME) and strict institutional policies are required to encourage physicians to prescribe generic names. [5,6] Antibiotic Prescribing Rate The most alarming metric identified in this study was the antibiotic prescribing rate of 82.1%. The WHO's optimal standard for antibiotic prescribing in general outpatient settings is between 20.0% and 26.8%. While our study specifically targeted patients with throat infections (a cohort more likely to receive antibiotics than general OPD patients), a rate of 82.1% points toward massive over-prescription. Medical literature establishes that up to 80-85% of acute pharyngitis cases are viral. Standard treatment guidelines, including those from the Infectious Diseases Society of America (IDSA), recommend antibiotics only for laboratory-confirmed GABHS infections or patients scoring high on clinical prediction rules like the Centor or McIsaac scores. In typical busy OPD settings, rapid antigen detection tests (RADT) or throat cultures are rarely performed due to time constraints, cost, and lack of immediate availability. Consequently, physicians often resort to empirical antibiotic therapy to prevent rare suppurative complications (e.g., peritonsillar abscess) and non-suppurative complications (e.g., acute rheumatic fever), or simply to satisfy patient expectations for a "quick cure." [7] Drug Utilization Patterns of Antimicrobials When antibiotics were prescribed, Macrolides were the most popular class (44.9%), with Azithromycin dominating the prescription charts. The preference for Azithromycin can be attributed to its favorable pharmacokinetic profile. It requires only a once-daily dosage for a short duration (usually 3 to 5 days), which ensures high patient compliance compared to antibiotics requiring multiple daily doses over 7 to 10 days. Additionally, its broad spectrum of activity covers atypical respiratory pathogens. However, this widespread use of Azithromycin is a significant concern. Global guidelines recommend Penicillin V or Amoxicillin as the first-line therapy for streptococcal pharyngitis due to their narrow spectrum, proven efficacy, and low cost. Macrolides should ideally be reserved for patients with severe penicillin allergies. The overuse of Azithromycin exerts profound selection pressure, and macrolide-resistant Streptococcus pyogenes strains are increasingly being reported worldwide. Amoxicillin + Clavulanic Acid (Co-amoxiclav) was the second most prescribed antimicrobial (26.9%). While beta-lactamase inhibitors broaden the spectrum against resistant bacteria, GABHS does not produce beta-lactamase. Therefore, the use of Co-amoxiclav for uncomplicated throat infections is generally unwarranted and constitutes a misuse of a broad-spectrum agent, further promoting beta-lactam resistance among commensal gastrointestinal and respiratory flora. Cephalosporins (predominantly 3rd generation like Cefixime) accounted for 16.0% of prescriptions. Oral third-generation cephalosporins have a very broad spectrum and are potent inducers of resistance and C. difficile infections. Their use as a primary agent for standard throat infections deviates significantly from rational prescribing guidelines. [8-10] Strengths and Limitations of the Study The strength of this study lies in its prospective nature and the utilization of validated WHO indicators, allowing for standardized benchmarking against global data. It provides a real-time snapshot of prescribing behaviors in a high-volume clinical setting. However, the study has certain limitations. First, it was confined to a single tertiary care center, which may limit the generalizability of the findings to primary healthcare settings or other geographic regions. Second, the study did not correlate prescribing patterns with microbiological data (throat swab cultures), as these were rarely ordered by the prescribers. Therefore, it was not possible to definitively categorize which antibiotic prescriptions were clinically justified versus inappropriate based on bacterial confirmation. Finally, clinical outcomes and patient compliance post-prescription were not monitored. Recommendations Based on the findings of this evaluation, several interventions are recommended: 1. Implementation of Antimicrobial Stewardship Programs (AMSP): Hospitals must enforce strict AMSPs to monitor and audit antibiotic prescriptions, particularly in outpatient departments. 2. Diagnostic Interventions: Making Rapid Antigen Detection Tests (RADT) for Streptococcal infections affordable and routinely available in OPDs would drastically reduce empirical antibiotic prescribing. 3. Adherence to Clinical Scoring: Physicians should be encouraged to utilize validated clinical criteria, such as the Modified Centor Score, to identify patients who truly warrant antibiotic therapy. 4. Continuing Medical Education (CME): Regular workshops focusing on rational prescribing, the dangers of AMR, and the importance of generic prescribing should be mandated for all prescribers.

This drug utilization evaluation highlights a significant deviation from rational prescribing principles in the management of throat infections. The average number of drugs prescribed per encounter reflects a tendency toward polypharmacy. Most critically, the empirical prescription of antimicrobial agents in 82.1% of patients, coupled with the heavy reliance on broad-spectrum antibiotics like Azithromycin and Amoxicillin-Clavulanic acid, underscores a widespread overuse of antibiotics for conditions that are predominantly viral.

Furthermore, the low rate of generic prescribing places an unnecessary economic burden on patients. While adherence to the essential medicines list was satisfactory, the overarching patterns suggest an urgent need for behavioral shifts among prescribers. To preserve the efficacy of existing antimicrobials and curb the escalating threat of antimicrobial resistance, it is imperative to implement robust antimicrobial stewardship programs, enhance the use of rapid diagnostic tests, and enforce strict adherence to standard treatment guidelines in outpatient settings.

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