Keywords
Pattern, Prescription, urinary tract infection, adverse drug reaction, reproductive.
Urinary tract infection (UTI) is a frequent bacterial infection among women of reproductive age. Inappropriate and irrational prescribing of antibiotics—such as the use of unapproved fixed-dose combinations or empirical broad-spectrum therapy—has contributed to growing antimicrobial resistance. Adverse drug reactions (ADRs) further complicate treatment outcomes, yet remain underreported, especially in routine outpatient practice. Therefore, an assessment of current prescribing patterns and ADRs is essential to promote rational drug use.
To describe the prescribing patterns of drugs used for urinary tract infections (UTIs) among women of reproductive age (15–44 years).
To evaluate the incidence, type, and severity of adverse drug reactions (ADRs) associated with these prescriptions, as documented in hospital records.
To assess the prescription of fixed-dose combinations (FDCs) and combination antimicrobial therapy in relation to standard treatment guidelines (WHO, NLEM 2022).
This is a retrospective observational study based on outpatient department (OPD) prescriptions for women aged 15–44 years diagnosed with community-acquired, uncomplicated UTIs at a tertiary care hospital in Central India. Data from 139 prescription records will be retrieved from the medical record section and analyzed. Prescribing indicators, documented ADRs, and use of FDCs will be assessed against national guidelines using descriptive statistics, chi-square tests, and logistic regression analysis.
Pattern, Prescription, urinary tract infection, adverse drug reaction, reproductive.
In this version, the study objectives were refined for clarity, particularly in relation to adverse drug reactions (ADRs) and fixed-dose combinations (FDCs). The Methods section was revised to specify a fully retrospective design, remove mention of telephonic follow-up, and define the population as women with community-acquired, uncomplicated UTIs. While the sample size remains at 139, limitations of subgroup analysis have been noted. The statistical analysis section was expanded to describe descriptive methods, chi-square testing, regression, handling of missing data, and use of SPSS v27. Ethical aspects were strengthened with Institutional Ethics Committee approval details, a waiver of consent, and permission from the Chief Medical Superintendent. Table 1 was updated with operational definitions. Although no new sentences were added to the Introduction or Discussion, consistency with Central India resistance data was confirmed and addressed in the response. These changes enhance clarity, methodological transparency, and critical synthesis, while maintaining the study’s original focus.
See the authors' detailed response to the review by Niels Frimodt-Møller
See the authors' detailed response to the review by Vineetha Menon
See the authors' detailed response to the review by Abayeneh Girma
Urinary tract infection (UTI) is the most prevalent bacterial infection among women of reproductive age (15–44 years) because of their anatomical and physiological properties like shorter urethra, sexual activity, contraceptive use, and delayed micturition.1,2
UTIs are symptomatically differentiated into uncomplicated or complicated, and primary or recurrent, the most common uropathogen being Escherichia coli followed by Klebsiella, Staphylococcus, Streptococcus, and Pseudomonas species.3
A Karnataka, India, study conducted by Mahadevamma and Sarala (2011) revealed ciprofloxacin (23.8%), norfloxacin (14.3%), and ceftriaxone (13.3%) to be frequently prescribed in patients with UTI.4 Likewise, Chiang et al. (2019) indicated that fluoroquinolones (36.4%), nitrofurantoin (31.8%), and trimethoprim-sulfamethoxazole (26.3%) were the most frequently prescribed drugs for UTIs among women in a US-based review of 44.9 million prescriptions.5
Antibiotic resistance increases, especially to fluoroquinolones and third-generation cephalosporins, in Indian environments,6,7 leading to a change to nitrofurantoin and sulfonamides as first-line therapy.
Although ADRs are an important concern in antimicrobial treatment, they remain underreported in retrospective hospital records, particularly in resource-poor environments. Nitrofurantoin is known to cause gastrointestinal disturbance, pulmonary toxicity, and liver damage.8 Sulfonamides are responsible for hypersensitivity reactions, hepatotoxicity, Stevens–Johnson syndrome, and hematologic toxicity.9
In spite of the availability of guidelines like the National List of Essential Medicines (NLEM 2022) and WHO procedures, irrational prescribing continues in the form of long-term use of broad-spectrum antibiotics and irrational fixed-dose combinations (FDCs).10
There is an obvious lack of Indian data on prescribing patterns and ADRs in reproductive-age women specifically.
Nowadays, it is necessary to evaluate prescriptions due to the rapid changes in the prescriptions of diseases.
To analyze the irrational and inappropriate use of drugs this study is necessary.
For the improvement of patient compliance and to find out what type of adverse reactions are seen in reproductive age group female (15-44yrs) UTI patients due to prescribed drugs.
To analyze the prescription pattern and adverse drug reactions of drugs used in urinary tract infections of reproductive age group (15-44).
• To describe the prescribing patterns of drugs used for urinary tract infections (UTIs) among women of reproductive age (15–44 years).
• To evaluate the incidence, type, and severity of adverse drug reactions (ADRs) associated with these prescriptions, as documented in hospital records.
• To assess the prescription of fixed-dose combinations (FDCs) relevant to UTI management (e.g., Co-trimoxazole, Amoxicillin–Clavulanate) and their adherence to standard treatment guidelines (WHO, NLEM 2022).
Data will be entered and analyzed using SPSS version 27.0. Descriptive statistics will be used to summarize baseline characteristics such as age, drug type, and comorbidities (mean ± SD or frequencies as appropriate).
Chi-square test will be used to examine associations between drug class and adverse drug reactions.
If the sample permits, binary logistic regression analysis will be performed to identify predictors of ADRs (e.g., age, pregnancy status, polypharmacy, comorbidity).
Missing data will be excluded from inferential analysis, and the extent of missingness will be reported.
A p-value < 0.05 will be considered statistically significant.
The study included prescription records of female patients aged 15–44 years diagnosed with community-acquired, uncomplicated UTI by a physician.
Diagnosis was based on documented clinical symptoms (e.g., dysuria, frequency, urgency, suprapubic pain) with or without supporting urine culture reports.
Outpatient records of women aged 15–44 years with a diagnosis of community-acquired uncomplicated UTI.
This is a retrospective observational study conducted at a rural tertiary care hospital in Central India. Data were collected exclusively from outpatient records. No telephonic follow-up or direct patient contact was performed.
Calculated using a 10% ADR prevalence assumption → 139 records.
Subgroup analyses may be underpowered; however, the study is adequately powered for primary objectives.
Since the primary outcome of interest includes the analysis of adverse drug reactions (ADRs), the sample size is estimated based on the expected prevalence of ADRs in UTI drug prescriptions.
Where:
• Z = 1.96 for 95% confidence
• P = 0.10 (assumed 10% prevalence of ADRs based on prior studies e.g., Fatima et al., 2015)
• d = 0.05d = 0.05 (desired precision = 5%)
Final sample size: 139 prescription records
This is a retrospective observational study using OPD records of women with UTI in the reproductive age group.
No patient contact or follow-up will be conducted.
No data will be taken from inpatients, ICU, or hospital-acquired infections.
Data will be analyzed using SPSS version 27.0.
• Descriptive statistics: Means ± SD for continuous variables, frequencies (%) for categorical variables.
• Chi-square test: To assess association between drug class and ADR occurrence.
• Logistic regression: To evaluate predictors of ADRs (e.g., age, comorbidity, drug class).
• Records with missing variables will be excluded from respective analyses. A p value <0.05 will be considered statistically significant.
We will collect recorded files of patients of reproductive age group female (15-44yrs) UTI patients from the medical record section. And Analyze prescriptions and adverse drug reactions of patients. Table 1 details the parameters included in the study. Prescriptions were reviewed for demographics, diagnosis, prescribed drugs, comorbidities, FDCs, and ADRs (if documented).
Today irrational and in appropriate use of drugs is a serious issue. Irrational drug use can lead to adverse effects such as drug resistance and drug side effects.11,12 Nitrofurantoin, Trimethoprim-Sulfamethoxazole, and Fluoroquinolones are the drugs most frequently used to treat UTI.13 In this study we will examine the prescriptions of the drugs that will be prescribed for UTI.
This research will close that gap by assessing actual prescribing practice and pharmacovigilance in outpatient UTI care. This research is anticipated to underscore irrational prescribing and under-reporting of ADRs in the care of UTIs, which lead to antibiotic resistance and suboptimal patient outcomes.6,7
The earlier research has reported poor compliance with guidelines and excessive use of combination therapy in Indian practice.4,10 Lack of systematic monitoring of ADR can further hamper rational use of drugs, particularly among rural patients who have limited diagnostic facility access.8,9
By analyzing prescription audit and ADR patterns, this paper will help support local antimicrobial stewardship and inform future policy.
For the improvement of patient compliance, it is very important to analyze prescription patterns and adverse drug reactions (ADRs). The benefits of our research will be patient care improvement and risk assessment and lesser events of adverse drug events associated with the prescribed drugs. Also, we will be analyzing the rationality of prescribing FDC and combination therapy. As well as their overall impact on the outcome of treatment.
This analysis is for the use of evidence-based medicine in tertiary care centers, to fulfill the drug information needs of the physician and also for improvement in the quality of healthcare by giving feedback to prescribers. This is an observational, retrospective study that will aim at the analysis of drug prescription patterns and adverse drug reactions due to drug prescription in urinary tract infections at tertiary health care centers.
The study was approved by the Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (Deemed to be University) (Reference No: DMIHER (DU)/IEC/2024/159).
As this was a retrospective record-based study, informed consent was waived. Institutional permission was obtained from the Chief Medical Superintendent (CMS) and the Medical Records Section to access anonymized.
No data are associated with this article at this stage. Data will be made available upon completion of the study, subject to institutional approval and journal policy.
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Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Microbiology
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Clinical microbiology, urinary tract infections, E.coli pathogenesis, antibiotic activity in vitro and in vivo
Is the rationale for, and objectives of, the study clearly described?
No
Is the study design appropriate for the research question?
No
Are sufficient details of the methods provided to allow replication by others?
No
Are the datasets clearly presented in a useable and accessible format?
No
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Microbiology
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Clinical microbiology, urinary tract infections, E.coli pathogenesis, antibiotic activity in vitro and in vivo
Is the rationale for, and objectives of, the study clearly described?
No
Is the study design appropriate for the research question?
Yes
Are sufficient details of the methods provided to allow replication by others?
No
Are the datasets clearly presented in a useable and accessible format?
No
References
1. Saber S, Yasmin N, Alam M, Hossain M, et al.: Study on Urinary Tract Infection Among Females of Reproductive Age Group in Tertiary Care Teaching Hospital, Dhaka, Bangladesh. European Journal of Medical and Health Sciences. 2021; 3 (1): 85-89 Publisher Full TextCompeting Interests: No competing interests were disclosed.
Reviewer Expertise: Geriatrics, Medication safety management
Is the rationale for, and objectives of, the study clearly described?
No
Is the study design appropriate for the research question?
No
Are sufficient details of the methods provided to allow replication by others?
No
Are the datasets clearly presented in a useable and accessible format?
No
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Clinical microbiology, urinary tract infections, E.coli pathogenesis, antibiotic activity in vitro and in vivo
Alongside their report, reviewers assign a status to the article:
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