European Journal of Cardiovascular Medicine

Diabetes mellitus (DM) is a chronic metabolic disorder characterized by persistent hyperglycemia, resulting from defects in insulin secretion, insulin action, or both. The global burden of diabetes has increased dramatically over the last few decades. According to the International Diabetes Federation, the number of adults living with diabetes rose from 151 million in 2000 to 463 million in 2019, and this number is projected to rise to 700 million by 2045¹. India, in particular, bears a significant burden and is often referred to as the “diabetes capital of the world”².

Type 2 diabetes mellitus (T2DM), which accounts for more than 90% of diabetes cases, is strongly linked to lifestyle and genetic factors. Pharmacological treatment becomes necessary when lifestyle modifications are insufficient to maintain glycemic control³. The therapeutic options for T2DM have expanded significantly, with a range of oral hypoglycemics and injectables now available, including biguanides, sulfonylureas, DPP-4 inhibitors, GLP-1 analogs, SGLT2 inhibitors, and insulin preparations⁴.

Inappropriate drug prescribing can lead to adverse drug reactions, increased healthcare costs, poor adherence, and ineffective therapy⁵. Rational prescribing, as defined by the World Health Organization (WHO), includes prescribing the right drug, at the right dose, for the right duration, and at the lowest cost to the patient⁶. Prescription pattern studies help evaluate the appropriateness of drug use and inform policymakers and healthcare providers⁷.

The outpatient department (OPD) serves as the first point of contact for chronic disease management in most hospitals. A prescription audit in such settings can reflect the trends in drug selection, the use of combination therapies, and adherence to clinical guidelines. Prior studies have noted wide variability in prescribing practices across institutions and regions, influenced by prescriber preference, availability of medications, and socioeconomic factors⁸.

Understanding the prescribing patterns in a tertiary care teaching hospital is particularly important because these settings serve as models for healthcare delivery and medical training⁹. Evaluation of these patterns helps identify gaps in practice and opportunities for improvement through continuing medical education and institutional policy changes¹⁰.

This study aims to assess the pattern of antidiabetic drug prescriptions among OPD patients in a tertiary care teaching hospital, using WHO prescribing indicators as a benchmark. It also aims to compare findings with existing literature to provide a comprehensive understanding of the rationality of current practices and propose recommendations to optimize diabetic care.

This cross-sectional, observational study was carried out in the outpatient department of a tertiary care teaching hospital over a period of three months (January–March 2024). Ethical approval was obtained from the Institutional Ethics Committee.

Study Population

All patients diagnosed with type 2 diabetes mellitus attending the general medicine OPD and receiving at least one antidiabetic medication were included.

Inclusion Criteria

• Patients aged 18 years and above
• Diagnosed with type 2 diabetes mellitus
• Attending the outpatient department
• Prescribed at least one antidiabetic drug

Exclusion Criteria

• Type 1 diabetes mellitus
• Gestational diabetes
• Pregnant or lactating women
• Incomplete or illegible prescriptions
• Hospitalized or emergency patients

Data Collection

A total of 600 prescriptions were randomly collected and analyzed. Data were recorded on a structured data collection form including:

• Patient demographics (age, sex)
• Number of drugs per prescription
• Drug class and individual drugs prescribed
• Route and frequency
• Generic or brand name
• Use of fixed-dose combinations
• Adherence to National List of Essential Medicines (NLEM)

Data Analysis

Data were entered into Microsoft Excel and analyzed using SPSS version 20. Descriptive statistics were used to calculate frequencies, means, and percentages. WHO core prescribing indicators were used to assess rationality:

1. Average number of drugs per prescription
2. Percentage of drugs prescribed by generic name
3. Percentage of prescriptions with antibiotics/injectables
4. Percentage of drugs from NLEM.

Table 1: Demographic Distribution of Patients

Table 2: Frequency of Antidiabetic Drugs Prescribed

Table 3: Combination vs Monotherapy

Table 4: Generic vs Brand Name Usage

Table 5: Route of Administration

Table 6: WHO Prescribing Indicators

This study highlights the current prescription patterns of antidiabetic medications in the outpatient department of a tertiary care teaching hospital. The predominant use of metformin (78.3%) as monotherapy or in combination confirms its status as the first-line drug for type 2 diabetes, consistent with international and Indian guidelines¹¹. This aligns with previous studies by Rajesh et al. and Bhosale et al., which also reported metformin as the most prescribed antidiabetic agent¹²,¹³.

Combination therapy (65%) was more common than monotherapy (35%), with dual therapy (metformin + sulfonylurea or DPP-4 inhibitor) being the most prevalent. This trend reflects current clinical practice, where combination therapy is employed to achieve glycemic targets more effectively, especially in patients with longstanding or poorly controlled diabetes¹⁴. A similar pattern was observed by Kannan et al. and Sultana et al., where more than half of the prescriptions involved two or more drugs¹⁵,¹⁶.

Sulfonylureas (36.5%) were the second most prescribed class, especially gliclazide and glimepiride, likely due to their affordability and familiarity. However, their risk of hypoglycemia compared to newer agents like DPP-4 inhibitors necessitates careful use, particularly in the elderly¹⁷. The inclusion of DPP-4 inhibitors (22.1%) suggests a gradual shift toward newer agents in urban tertiary care settings, similar to findings by Sahoo et al.¹⁸.

The use of insulin (18.7%), primarily in patients with poor glycemic control or complications, was comparable to other Indian studies reporting insulin usage between 15–25% in outpatient settings¹⁹,²⁰. While injectables were used appropriately, the high cost and patient resistance often limit their usage²¹.

The average number of drugs per prescription was 2.4, within WHO’s recommended range of 1.6–2.5²². However, only 33.3% of drugs were prescribed by generic names, indicating a strong inclination toward brand-name prescribing. This is below WHO standards and suggests the need for prescriber education on cost-effective therapy²³.

Another important finding is that 82.5% of drugs were from the National List of Essential Medicines (NLEM), which reflects fairly good adherence to standard treatment protocols. Nonetheless, increased efforts are needed to ensure full compliance to improve rational drug use²⁴.

Limitations of the study include its single-center design and short duration. Additionally, the study did not assess patient outcomes or adherence, which are critical for evaluating the effectiveness of prescribed regimens.

In comparison to other prescription audits conducted in Indian tertiary care hospitals, the results here are largely consistent, affirming the increasing complexity of diabetes management and the growing reliance on combination therapies²⁵. The use of newer agents alongside traditional drugs shows a dynamic prescribing environment, driven by clinical need and availability.

In conclusion, while the overall prescription patterns appear rational, especially in terms of drug selection and adherence to NLEM, issues like low generic prescribing and polypharmacy need attention. Educational interventions and regular audits can improve prescription quality and promote evidence-based practice.

The study revealed that metformin remains the cornerstone of antidiabetic therapy in outpatient settings. Combination therapy is more frequently prescribed than monotherapy, reflecting a practical approach to diabetes management. Although there is moderate adherence to WHO prescribing indicators and NLEM, the low rate of generic prescribing and rising trend of polypharmacy warrant concern. Continuous medical education and regular prescription audits are essential to promote rational drug use and ensure patient safety in diabetes care.

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