Assessment of Antibiotics Prescribing Using WHO/ INRUD Indicators and AWaRe Classification in an Indian Regional Hospital

INTRODUCTION

In hospitals, drugs are critical to patient care, impacting immediate and long-term health outcomes. They are important in treating acute conditions, managing chronic diseases, supporting surgical procedures, providing specialized treatments such as chemotherapy and immunotherapy, preventing infections, and improving patient ease and quality of life. Antibiotics are among the most commonly prescribed drugs used in health care. They occupy a critical position due to their life-saving role in reducing mortality from infectious diseases. Before antibiotics, many common infections were often fatal. Thus, antibiotics established themselves as powerful medications and greatly aid doctors in their treatment processes in healthcare globally. Their discovery is considered one of the most significant medical advancements of the 20^th century, by turning potentially fatal infections into manageable conditions.

Antibiotics are antimicrobial products used to treat bacterial infections by either killing the bacteria or preventing their growth. Although the target of antibiotics is bacteria, some antibiotics also attack fungi, protozoan infections, and some viruses. Doctors prescribing the right drug at the right time to individual patients is a mandate of their profession. However, in cases of antibiotic prescribing, it is important to consider not only cures for infections but also for curbing antibiotic resistance. Antimicrobial resistance (AMR) is defined as inherited or acquired characteristics of microorganisms to survive and multiply in the presence of antimicrobial concentrations that would either kill or inhibit them. In a simplified manner, AMR is the resistance of bacteria, viruses, fungi, and parasites to antimicrobial medicines. AMR is a natural process primarily driven over time through genetic changes in microorganisms. Human activities triggered its emergence and spread by the misuse and overuse of antimicrobial drugs in humans and animals. This growing health concern is compromising the ability to treat common infectious diseases, leading to prolonged illness, disability, and increased risk of death.

The increasing antimicrobial resistance in the world is challenging. It is important to consider that implementing strategies only in healthcare facilities is not sufficient to prevent this problem [1]. This is due to the root causes of antimicrobial resistance lie in the usage of antibiotics in agriculture to treat bacterial infections in crops. They are used to treat infections in animals that we consume as food [2]. Thus, antimicrobial resistance is transferred to humans through the food chain. To prevent this, the government should establish stringent restrictions on the use of antibiotics in agriculture. Also, healthcare policies that benefit future generations in the long term should be implemented. In this way, our study focuses on addressing all ongoing problems and attempts to explain the need to strengthen the healthcare system. If irrational prescribing practices by physicians, inadequate surveillance, and monitoring of antimicrobial resistance are one problem, the other is the excess use of over-the-counter drugs, self-medication, and poor infection control and hygiene practices, especially in regional healthcare settings.

In this study, using a set of indicators developed by the World Health Organization in collaboration with the International Network of Rational Use of Drugs (INRUD) and AWaRe classification, we are measuring the performance of antibiotic drug utilization in a regional healthcare facility [3]. In developing countries such as India, implementing WHO/INRUD indicators in healthcare facilities will help bridge disparities, highlight gaps in antibiotic access, and contribute to enhancing their performance. The current study provides an overview of the healthcare practices currently in India and the actions required to fortify the healthcare system. The study suggests that regional hospitals adopt better protocols, strengthen laboratory diagnostics, and improve infection prevention and control measures. Addressing local antibiotic resistance patterns is essential for creating evidence-based interventions tailored to specific populations. This approach enhances patient care, public health outcomes, and supports national and global efforts to combat antimicrobial resistance (AMR). Rational use of medicines is key for quality health outcomes, particularly for antibiotics, as resistance continues to escalate and the armamentarium of new antibiotics in the market remains limited. Studies identifying how substantially irrational medication use is happening are the first step toward managing it. This study's main emphasis is on raising problems surrounding antibiotic misuse and strategies to tackle those issues.

MATERIALS AND METHODS

Study Setting, Design, and Period

A hospital-based Prospective Observational study was carried out in a 550-bed tertiary care hospital for Six Months in Warangal, Telangana, India. The study was conducted in the hospital's different departments (General Medicine, Gastroenterology, Neurology, Cardiology, Orthopedics, Nephrology, Urology, Neurosurgery, General Surgery, Gynecology, Burns & Plastic Surgery). Each hospital department is staffed with specialists, general practitioners, nurses, and other healthcare providers. However, there were no clinical pharmacy services in any hospital department.

Source of Study Population                   

Our study population consisted of all hospitalized patients in various departments who met the inclusion criteria during our study period.

Eligibility Criteria                           

The study included patients of both sexes, aged 18 years and above, admitted to various hospital wards and receiving antibiotic treatment. Pediatrics, pregnant, and lactating women were excluded due to ethical, safety, and practical concerns. These groups have special prescribing guidelines due to different metabolic rates, hormonal changes, and unpredictable drug responses. Furthermore, certain antibiotics are contraindicated in those populations, which could affect study results.

Study Variables

The study is dependent on antibiotic prescription patterns using WHO/INRUD core drug use indicators (World Health Organization & International Network of Rational Use of Drugs)

Data Collection Tools and Procedure

Patients admitted during the study period were strictly followed during their course of treatment. Data were collected from the case sheets of hospitalized patients, which included demographic details, disease condition, past medical history, social history, and the drugs prescribed for each patient's condition, especially antibiotics.

Statistical Analysis      

Microsoft Excel and SPSS 2 are descriptive statistical analytical software used for the collected data due to their convenience and easy accessibility. Results are expressed in percentages and mean-standard deviation.

RESULTS AND DISCUSSION

Socio-Demographic Characteristics

From the (n=306) study population, the total number of drugs prescribed was 1581, out of which 670 were antibiotics. Most of the patients were admitted in the age group of 61-80 years, and from gender-wise distribution, 172 males and 134 females were included in the study.

Table 1 Showing Patient demographic details of study participants.

NOTE: [List of Abbreviations from Table2] 1) General Medicine: LRTI - Lower respiratory tract infections, UTI - Urinary tract infections, DSH - Deliberate self-harm (Cases such as Tablets & Organophosphorus poisonings), AFI- Acute febrile illness; 2) Gastroenterology: DCLD - Decompensated liver disease, PAD - Peptic ulcer disease; 3) Neurology: CVA - Cerebrovascular accident; 4) Cardiology: CAD - Coronary artery disease, ACS indicates Acute coronary syndrome, AWMI - Anterior wall myocardial infarction, PTCA - Percutaneous transluminal coronary angioplasty with stent (a surgical procedure to treat aneurysm), narrowing arteries, LVF - Left Ventricular Failure, CCF - Congestive heart failure; 5) Neurosurgery: PVID - Prolapsed herniated or extruded intervertebral disc; 8) Nephrology: CKD - Chronic Kidney disease, MHD - Maintenance Hemodialysis

Table 2 Showing the most standard diagnosis/indication that led to antibiotic prescription.

During our study period, some patients were admitted with two health conditions, such as LRTI with AFI, UTI, typhoid fever, gastroenteritis with dengue and typhoid fever, and CAD with severe metabolic acidosis, respiratory distress, and anemia [4].

Figure 1 illustrates the distribution of antibiotic usage, with Cephalosporins 61%, Nitroimidazoles 13%, Aminoglycosides 9%, Tetracyclines 6%, Pencillins 4%, Macrolides 3%, Quinolones 2%, and Carbapenems 1.2%

Among all groups of antibiotics, cephalosporins were found to be prescribed in large numbers with 61%, Nitroimidazoles with 13%, Aminoglycosides 9%, Tetracyclines 6%, Pencillins 4%, Macrolides 3%, Quinolones 2%, Carbapenems 1.2% other minor groups are Anti-viral drugs 0.4%, Anti T.B drugs 0.1%, Anti-fungal drugs 0.1% and other antibiotics occupy 0.2% respectively. This classification helps to understand the prescribing pattern from various antibiotic categories [6, 7].

Figure 2 illustrates a representation of the different types of antibiotic prescribing frequency from each department in a Tertiary Regional hospital, India

As this study was examined department-wise, a bar graph showing different categories of antibiotics that were prescribed during our study period is shown in Figure 2. In the 306-study population, in almost all departments, cephalosporins were prescribed in high quantities. But in gastroenterology, burn and plastic surgery departments, nitroimidazoles were prescribed in high quantities, whereas in the urology department, aminoglycosides were given in high amounts. In neurosurgery, orthopedics, gynecology, burn, and plastic surgery departments also aminoglycosides were also given in good amounts. In the neurosurgery department, penicillins were given in good amounts after cephalosporins and aminoglycosides. All other category drugs were given in smaller quantities to the patients in various departments during our study period. To know in detail about what antibiotics were prescribed during our study period, refer to Table 4, which mentions a list of drugs prescribed from all classes of antibiotics. Adherence to antibiotic guidelines varies among different departments, and factors such as patient population, clinical urgency, and complexity of cases contribute to it. We observed that each department is failing to adjust therapy based on culture results due to limited access to this diagnostic tool in the hospital. Time-sensitive decision-making is seen in emergency and critically ill patients, leading to empirical antibiotic prescribing. Department-specific interventions should be established in each hospital to combat AMR.

WHO Indicators

Prescribing Indicators

A comprehensive assessment using WHO prescribing Indicators is given in Table 3, which might help health institutions measure the performance of healthcare providers in fostering responsible utilization of medications. The average (mean) number of drugs prescribed per encounter is 7.5, which not only exceeds WHO's optimal value of ≤ 3, and reports from similar studies. The percentage of the overall antibiotics prescribing rate per encounter is 42.3%. This also exceeds the standard endorsed by the WHO of ≤ 30%, which indicates that our hospital prescribes antibiotics at a high rate. The percentage of antibiotics prescribed from the National Essential Drugs List (EDL) is 49.85%, which deviates from meeting the target endorsed by their national EML of 100%. This suggests that hospitals at the regional level in India do not function as per the national standard therapeutic guidelines. The percentage of antibiotic prescriptions with the parenteral route via injections is 66%. This value is much higher than the optimal value of 13.4%-24.1%, which could be explained by the fact that our study mostly focused on hospitalized patients who are typically prescribed a high number of injections. The percentage of antibiotic prescriptions through the oral route is 34%. The percentage of antibiotics prescribed by generic name is 83.1%, which couldn’t reach the WHO's optimal target of 100%.

Some other prescribing indicators not from the WHO list are also used to assess and learn more about antibiotic usage in the hospital. Some of them include the percentage of patients who received antibiotic prescriptions as monotherapy was 50%, dual therapy at 35.3%, and triple therapy at 14.7%, i.e., patients who received three or more antibiotic prescriptions while in the hospital. The purpose of this evaluation was to find out whether antibiotics were overly prescribed. Another finding is that the % of antibiotics with Beta-lactamase inhibitors combination was 40%. This combination approach is particularly for treating infections caused by resistant bacterial strains. Antibiotics are co-administered with beta-lactam inhibitors to prevent bacteria from disabling these antibiotics using their enzymes. To prevent resistance and for effective clinical outcomes in patients’ beta-lactam antibiotics such as penicillins and cephalosporins are combined with β-lactamase inhibitors like clavulanic acid, sulbactam, and tazobactam. The increasing use of beta-lactamase combination antibiotics is an indication of escalating antimicrobial resistance [1].

Our study also found that 85.53% of antibiotics used were broad-spectrum, while narrow-spectrum usage was 14.45%. Broad-spectrum antibiotics target a wide range of organisms, killing harmful and beneficial bacteria, disrupting normal bacterial flora, and promoting resistant bacteria or opportunistic pathogens that grow unchecked in the human body. The empirical misuse of these broad-spectrum antibiotics facilitates the development of AMR. Because patients are becoming more resistant to antibiotics, physicians can cure only if broad-spectrum antibiotics are prescribed. Assessing antibiotics based on their spectrum of activity is an attempt to request physicians to limit the prescribing of broad-spectrum antibiotics. Their use can be reduced by performing culture and sensitivity tests in hospitals, which involve identifying the specific pathogen responsible for an infection, thereby helping in prescribing targeted antibiotics to the patients. Through this study, as mentioned in the list of hospital care indicators (Table 4), no such tests are being conducted. Therefore, we suggest that hospital upgrade their functioning capability by conducting culture and sensitivity tests. This diagnostic tool helps physicians to reduce irrational prescribing of antibiotics and combat globally threatening AMR.

Hospital and Patient Care Indicators

Assessing hospital performance was done using hospital and patient care indicators. This revealed that the hospital does not have a fully functional Drug and Therapeutic Committee (DTC) to evaluate, manage, and develop proper policies for drugs being used in the hospital. So, through our study, we recommend actively functional DTC in hospitals. There is a copy of the National Standard Therapeutic Guidelines (STG) and National Essential Medicine List (EML), but the hospital does not follow them. So, we recommend that hospitals function in compliance with national standards. We also recommend institutional EML or a list of hospital Formulary medicines, especially for infectious diseases, to avoid antimicrobial resistance. During our study period, the availability of essential antibiotics in the hospital was 65.2%, which proves that some key antibiotics were not readily available. Not performing culture and sensitivity tests proves that all antibiotics were prescribed empirically.

In the hospital, we observe certain barriers adhering to hospital and patient care indicators. Through government support, training healthcare professionals, and including clinical pharmacists in ASPs, we can overcome these challenges. We propose some feasible steps the hospital can take to create Standard Therapeutic Guidelines. Firstly, form a multidisciplinary DTC, conduct baseline assessment studies, and then, through group discussions and survey results, establish evidence-based practices by using global and national standards as reference. Focus on tailoring the guidelines to local epidemiology, patient population, and resource availability. Ensure clear, concise, accessible guidelines and include diagnostic tools as a mandate to the patients while prescribing antibiotics. Hospitals should regularly be up-to-date with new evidence, shifts in resistance patterns, and feedback from clinical practice. Conduct pilot studies in selected departments and implement guidelines. Establishing monitoring and feedback mechanisms, such as an audit system to track adherence to STGs and patient outcomes [9]. With advancements in healthcare globally, countries such as India should begin integrating STGs into Electronic Medical Records, which facilitate the efficiency of healthcare services [3].

In India, the problem is that cultural and systemic factors significantly influence antibiotic prescribing practices. High patient expectations for prompt symptom relief often pressure healthcare providers to prescribe antibiotics, even for viral infections. Additionally, the easy availability of antibiotics without prescriptions in some settings contributes to misuse. Systemic challenges such as limited access to diagnostic facilities, time constraints in busy clinical practices, and inconsistent regulatory enforcement exacerbate inappropriate prescribing [10]. Cultural beliefs about medicine’s potency and reliance on informal healthcare providers further complicate the issue, contributing to widespread AMR [11].

AWaRe Classification

In 2017 WHO Expert Committee developed the AWaRe classification for the Selection and Use of Essential Medicines. In this classification, antibiotics are classified into access, watch, and reserve groups. This categorization is updated every 2 years and serves as a tool for monitoring antibiotic consumption, establishing targets, and assessing the effects of antimicrobial stewardship initiatives globally [12]. In this study, 30% of antibiotics used were from the access group, 69.25% from the watch group, and 0.05% from the reserve group, as shown in Table 5.