Rational use of antibiotics at primary & secondary healthcare facilities in district Panchkula, Haryana, North India: A cross-sectional study

Materials & Methods

This cross-sectional study was conducted by the department of Community Medicine and School of Public Health, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India, from September 2021 to March 2022. The study was approved by the Institute Ethics Committee of PGIMER.

Sampling technique

A total of 75,000 prescriptions (about 12500 per CHC, 3000 per rural HWC, 2500 per urban HWC) were estimated to be prescribed in these health facilities in a month, with approximately 45,000 (60%) prescriptions expected to contain at least one antimicrobial drug. These estimates were obtained through consultation with respective facility in charge and pharmacy logs at each site. We used stratified sampling technique to collect 295 prescriptions from three types of health facilities to meet the desired sample size. To ensure proportional representation, probability proportional to size (PPS) sampling¹⁶ was used to determine the number of prescriptions to be collected from each facility type, i.e., 148 from each CHC (n=2), 37 from each rural HWC (n=8), and 30 from each urban HWC (n=10) (Fig. 1). Trained researchers were posted at the pharmacy counter and approached every patient exiting with a prescription during regular OPD hours. Prescriptions that contained at least one oral or injectable antibiotic were included till the desired sample size for that facility was achieved. This approach does not constitute classical probability sampling from a fully defined sampling frame, as prescriptions were not selected from a centralised database. Instead, prescriptions were collected consecutively from eligible patients during routine OPD hours until the facility-specific target sample size was reached. This method assumes that the arrival of patients with antimicrobial prescriptions occurs randomly over the survey period, and that prescriptions collected early or late in the sampling window are not systematically different in prescribing characteristics. While this may introduce a risk of sampling bias, it is considered a pragmatic and acceptable approach in field-based health systems research¹⁷. Measures were taken to minimise provider awareness and influence by collecting prescriptions at the pharmacy counter post-consultation, without engaging prescribers directly.

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Fig. 1.

Flow diagram depicting probability proportional sampling technique used to select the prescriptions from primary and secondary care health facilities (n=20).

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Results

The background characteristics of the patients (whose prescriptions were assessed) are given in table I. The median age of paediatric patients (n=125) and adult patients was 5 and 35 yr, respectively. Paediatric prescriptions had 1.36 times higher odds of being irrational compared to adult prescriptions,

A total of 945 prescriptions were collected from CHCs (n=297), rural HWCs (n=298), and urban HWCs (n=350). Four out of 945 (0.4%) prescriptions were found to be in the medium category of comprehensiveness, and 941/945 in low category as per the scoring criteria. The lack of comprehensiveness was mainly due to incomplete recording of the information required for antibiotic rationality assessment including dose of antibiotic (680/945,72%), lab investigations (614/945, 65%), diagnoses (851/945, 90%), and co-morbidities (849/945, 90%). Only 647/945 (68%) of prescriptions had the symptoms or diagnosis recorded on them (Fig. 2).

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Fig. 2.

Proportion (%) of prescriptions reporting key information items as per AmPAT indicators (n=945).

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Among the prescriptions that had sufficient information to assess rationality (647/945), antibiotic therapy was clinically indicated in 44 per cent (285/647). However, within these prescriptions, 31 per cent (199/647) lacked correct information on dosage (either it was missing or inaccurate). Based on the rationality scoring criteria (maximum score 13), only 3.5 per cent (33/945) of prescriptions scored above 11, 20.2 per cent (191/945) scored between 8-10, and 76.3 per cent (721/945) scored below 8. Information regarding drug interactions, follow up visits, and instructions regarding the consumption of antibiotics was not mentioned in any prescription (Fig. 3).

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Fig. 3.

Flow diagram of rationality assessment using Antimicrobial Prescription Assessment Tool (n=945).

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The most common symptoms patients presented with were respiratory ailments (46%), followed by dental problems and gastrointestinal diseases (n=113, 12%; Table II). Irrationality was reported in prescriptions irrespective of the presenting symptoms (Range 38.8%-100%). Patients who were advised only medicines without diagnostic tests had 1.72 times higher odds of receiving irrational prescriptions (OR 1.72, 95% CI 1.23-2.41, P=0.02) suggesting that lack of diagnostic support may contribute to inappropriate antibiotic use. Amoxicillin (n=302, 32%) was the most prescribed antibiotic, followed by fluoroquinolones (n=252, 27%), macrolides (n=209, 22%), and cephalosporins (n=87, 9%). The majority (99%) of the antibiotics were prescribed by generic name. Prescriptions containing combination drugs such as amoxicillin-clavulanic acid or ofloxacin-ornidazole were prescribed to 6.5 per cent of patients and had greater odds of being irrational (aOR 1.1, 95% CI 0.9-1.3). Irrational prescriptions were maximum in respiratory (95.4%), gastrointestinal (92.9%), and dermatological cases (77.8%; Table II).

Table III shows doctors’ prescribing patterns according to the respective ailment. Maximum irrationality was reported in the prescriptions for respiratory ailments (93%), followed by gastrointestinal (91%) and dermatology (71%). It was observed that macrolides (azithromycin), followed by amoxicillin/amoxicillin-clavulanic acid, were the most prescribed antibiotics to patients with respiratory ailments.

The duration of therapy and range of defined daily doses were analysed in older (n=163) and paediatric age group prescriptions (n=125) for various illnesses and antibiotics. The DDD observed did not align with the WHO’s recommendations for all prescribed antibiotics. The duration of therapy was inappropriate for amoxicillin, azithromycin, and cefadroxil when the patient presented with respiratory symptoms (Table IV).

Discussion

This study provided evidence on the antibiotic prescribing practices of generalist medical doctors in primary and secondary healthcare facilities to identify current practice gaps, which have implications on the rationality of antimicrobial use on antimicrobial resistance. The high proportion (76.3%) of irrational antibiotic prescriptions at primary and secondary healthcare facilities indicates an urgent need for implementing antimicrobial stewardship programmes in primary and secondary healthcare settings in low- and middle-income countries, including India.

The high proportion of irrational antibiotic prescriptions reported by our study is consistent with existing scientific literature. A study conducted in public health facilities in Pakistan (2018) reported a very high irrational antibiotic prescription rate (83.6%)²⁴, while an Ethiopian study found 86.6 per cent²⁵. In India, Kotwani et al²⁶ (2012) reported inappropriate antibiotic prescribing in the public sector (43%) and private sector (69%) by family physicians. Our study has reported that 31.5 per cent of prescriptions were ineligible for rationality assessment, with diagnosis missing 90 per cent of the prescriptions. Similarly, an Ethiopian study (2013) highlighted missed diagnoses in 99 per cent of prescriptions²⁷. The incompleteness of the prescriptions led to low rationality as information like diagnosis is necessary to assess whether the prescribed antibiotic is correct.

The proportion of irrational prescriptions was significantly higher among paediatric patients (89.6%) as compared with the adults (74.3%) (P<0.001) in this study. Antibiotics were frequently prescribed for conditions like upper respiratory tract infections or diarrhoea, which are unnecessary. A systematic review (2014) reported that treatment errors are more common among paediatric patients²⁸. Studies indicate irrational antibiotic treatment is prevalent in cough, cold, or diarrhoea cases. A study in Iran (2023) reported that 60 per cent of prescriptions did not meet scientific criteria for antibiotic prescribing²⁹. Similarly, Kotwani et al²⁶ (2012) reported that at least one antibiotic was prescribed to children with diarrhoea at public health facilities, with higher rates in the private sector (69%) than in the public sector (65%). Between 2000 and 2015, the defined daily doses (DDD) calculated to assess antibiotic consumption had increased by 65 per cent³⁰. If the policies remain unchanged, consumption can increase by up to 200 per cent by 2030³⁰. Low- and middle-income countries significantly drive this alarming consumption rate³⁰. The DDD of all the antibiotics prescribed in our study was high compared to the DDD recommended by WHO²³. Our study reported antibiotic prescribing practices for respiratory infections, diarrhoea, skin, and soft tissue infections, which were not in line with national treatment guidelines²¹, similar to the study conducted in Ujjain, India³¹.

The lack of adequate laboratory facilities at the primary healthcare level is a significant contributor to the irrational antibiotic prescribing practice. Our study reported low use (33%) of laboratory diagnostic measures, which could be one of the factors in primary healthcare physicians’ irrational antibiotic practices in the district of Panchkula, Haryana. A qualitative study by Kotwani et al³² revealed that diagnostic uncertainty about whether the infection is bacterial or viral leads to irrational antibiotic prescribing. Providing basic diagnostic test facilities or promoting point-of-care testing at primary healthcare facilities could help in making better diagnoses and lead to better prescribing practices.

The use of broad-spectrum antibiotics like cephalosporins at primary healthcare facilities is another cause of concern. More than 10 per cent of prescriptions had cephalosporins in respiratory or gastrointestinal ailments, which are not recommended as per the national treatment guidelines. Increased use of cephalosporins is leading to an increase in resistant strains of various organisms, and in case of continuation, it might lead to a rise in antimicrobial resistance³³.

The strength of this study lies in its unique approach. In contrast to retrospective analyses based on electronic databases or pharmacy sales records, the real-time prescription data collection approach employed in this study offers several methodological advantages. It facilitates the capture of complete prescription information, including clinical details and medications that may not have been dispensed, elements often absent in routine health information systems. This approach also enables the application of validated assessment tools such as AmPAT, which require contextual data on diagnosis, dosage, duration, and treatment indication to determine the rationality of antimicrobial use, information typically unavailable in secondary data sources. The objective of this study was to evaluate the clinical rationality and appropriateness of antimicrobial prescriptions in real-world primary and secondary care settings, which required a more granular, prescription-level assessment tool. Therefore, AmPAT was selected for its ability to comprehensively assess the rationality of prescribing practices at the point of care.

We recognise the potential for observer effect (Hawthorne effect), whereby prescribers may modify their behaviour in the presence of data collectors, potentially leading to an underestimation of irrational prescriptions. To minimise this, prescriptions were collected passively at the pharmacy counter without direct interaction with clinicians. In contrast, database-based analyses, while free from this observer bias, often lack key clinical and diagnostic information required to assess rationality, especially in public sector settings without electronic health records. The choice of real-time prescription assessment was guided by the objective of capturing prescribing behaviour as it occurs in routine settings, while enabling a comprehensive evaluation of appropriateness, indication, and completeness, which is not feasible through databases alone. The study data were collected from rural and urban primary healthcare settings to be more representative of the population in the different settings and increase the generalisability of the findings. This study presents the data for antibiotic prescribing patterns for all kinds of infections in outpatient primary and secondary healthcare settings, unlike other studies that reported data on one or two diseases, such as upper respiratory tract infections or diarrhoea. However, no data on the experience of the prescriber were collected. There were few limitations of this study. Firstly, the prescription was collected directly from the patient, and no information regarding the doctor’s justification for prescribing antibiotics was recorded. Secondly, the social desirability bias cannot be ruled out due to the presence of researchers in health facilities affecting the behaviour of doctors. The use of consecutive sampling, while operationally feasible, might introduce selection bias if the arrival of patients is not truly random over time. Data were collected over multiple days to help mitigate this risk.

Our findings highlight a critical gap in the rational use of antimicrobials at the first point of care and underscore the urgent need for context-specific standard treatment guidelines (STGs) tailored to the primary healthcare level. There is a compelling need to develop tier-specific antimicrobial prescribing guidelines that reflect the clinical realities and resource constraints at different levels of the healthcare system, including those low-resource, high-volume settings. These should be supported by regular in-service training, point-of-care diagnostic tools, and prescription audit-feedback mechanisms. The adoption of standardised prescription templates or digital tools may further improve prescribing practices and documentation quality. District health authorities should establish routine prescription audits and community-based surveillance systems, led by antimicrobial stewardship committees with representation across primary, secondary, and tertiary levels. These measures are essential to promote rational antimicrobial use and curb the spread of antimicrobial resistance.