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 assess the prescribing patterns of antimicrobial and supportive drugs used for UTIs in women aged 15–44 years.
To analyze the incidence, type, and severity of ADRs recorded during UTI treatment.
To evaluate the use of fixed-dose combinations (FDCs) and combination antimicrobial therapy.
To assess the extent of adherence to standard treatment guidelines.
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 response to reviewer comments, several key changes were made to strengthen the scientific clarity and methodological rigor of the study. The sample size was recalculated using a 10% prevalence of adverse drug reactions (ADRs) rather than urinary tract infection prevalence, resulting in a final sample size of 139 patients. The study design was revised to a purely retrospective observational format, and all references to telephonic follow-up were removed. Inclusion criteria were restricted to female patients aged 15–44 years with community-acquired, uncomplicated UTIs seen in the outpatient department. The study objectives were rewritten for clarity, especially regarding ADR analysis and fixed-dose combination (FDC) evaluation. The statistical analysis section was expanded to include descriptive statistics, chi-square tests, and logistic regression using SPSS version 27, along with an explanation for handling missing data. The introduction was rewritten to include Central Indian antimicrobial resistance data and to better contextualize the study. The discussion was updated with a critical reflection on irrational prescribing, underreporting of ADRs, and study limitations. Operational definitions were added to the data collection table for clarity and replicability. The ethics section was updated to reflect that the study received institutional approval (DMIHER IEC/2024/159), with a waiver of consent for retrospective data use and administrative permission from hospital authorities.
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).
1. To assess the prescribing pattern of antibiotics and supportive drugs used in the treatment of community-acquired urinary tract infections (UTIs) in reproductive-age women (15–44 years).
2. To analyze the incidence, type, and documented severity of adverse drug reactions (ADRs) associated with these prescriptions as recorded in hospital OPD case sheets.
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 will include prescription records of female patients aged 15–44 years attending the outpatient department (OPD) with a diagnosis of uncomplicated, community-acquired urinary tract infection (UTI).
This retrospective study will be conducted in the Department of Pharmacology at a Rural Tertiary Care Teaching Hospital in Central India, using prescription records retrieved from the hospital’s Medical Record Section.
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.
• Descriptive statistics: Frequencies, means, and standard deviations
• Chi-square test: To assess associations between drug classes and ADRs
• Logistic regression: To evaluate predictors of ADR occurrence (e.g., age, comorbidity)
• Handling of missing data: Records with missing critical variables will be excluded from analysis
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.
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), with reference number DMIHER (DU)/IEC/2024/159.
As this is a retrospective observational study received an Ethics Committee waiver of informed consent. Institutional permission was also obtained from the Chief Medical Superintendent (CMS) and the Medical Records Section for access to anonymized historical outpatient prescription data.
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.
Views | Downloads | |
---|---|---|
F1000Research | - | - |
PubMed Central
Data from PMC are received and updated monthly.
|
- | - |
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:
Invited Reviewers | |||
---|---|---|---|
1 | 2 | 3 | |
Version 4 (revision) 01 Sep 25 |
|||
Version 3 (revision) 05 Aug 25 |
read | read | |
Version 2 (revision) 11 Feb 25 |
read | read | |
Version 1 29 Apr 24 |
read | read |
Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. Consider the following examples, but note that this is not an exhaustive list:
Sign up for content alerts and receive a weekly or monthly email with all newly published articles
Already registered? Sign in
The email address should be the one you originally registered with F1000.
You registered with F1000 via Google, so we cannot reset your password.
To sign in, please click here.
If you still need help with your Google account password, please click here.
You registered with F1000 via Facebook, so we cannot reset your password.
To sign in, please click here.
If you still need help with your Facebook account password, please click here.
If your email address is registered with us, we will email you instructions to reset your password.
If you think you should have received this email but it has not arrived, please check your spam filters and/or contact for further assistance.
Comments on this article Comments (0)