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Study Protocol
Revised

Analysis of prescription pattern and adverse drug reactions of drugs used in Urinary Tract Infection in reproductive age group (15-44 years) women in a Tertiary Care Hospital in Central India: An observational retrospective study

[version 3; peer review: 1 approved, 2 not approved]
PUBLISHED 05 Aug 2025
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Abstract

Background

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.

Objectives

  • 1.

    To assess the prescribing patterns of antimicrobial and supportive drugs used for UTIs in women aged 15–44 years.

  • 2.

    To analyze the incidence, type, and severity of ADRs recorded during UTI treatment.

  • 3.

    To evaluate the use of fixed-dose combinations (FDCs) and combination antimicrobial therapy.

  • 4.

    To assess the extent of adherence to standard treatment guidelines.

Methods

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.

Keywords

Pattern, Prescription, urinary tract infection, adverse drug reaction, reproductive.

Revised Amendments from Version 2

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

Introduction

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.

Protocol

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.

Aim

To analyze the prescription pattern and adverse drug reactions of drugs used in urinary tract infections of reproductive age group (15-44).

Objectives

Primary objectives

  • 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.

Secondary objectives

  • 1. To evaluate the use of fixed-dose combinations (FDCs) and combination antimicrobial therapy for UTI treatment in this population.

  • 2. To assess the alignment of prescribed drugs with standard treatment guidelines (e.g., WHO, NLEM 2022).

Methods

Statistical analysis

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.

Inclusion criteria

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).

Exclusion criteria

  • Patients admitted to inpatient wards or ICU

  • Cases of complicated or hospital-acquired UTI

  • Incomplete or illegible case files

Study setting

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.

Sample size estimation

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.

Using the Daniel formula:

n=Z2×P(1P)/d2n=Z2×P(1P)/d2n=Z2×P(1P)/d2

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%)

n=(1.96)2×0.10×10.10/(0.05)2=138.3139patients

Final sample size: 139 prescription records

Study design

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.

Statistical methods

  • 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

Software used

All statistical analyses will be performed using SPSS Version 27.0 (IBM Inc., USA).

Data collection and procedure

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.

Table 1. Parameters and operational definitions used in data collection.

ParameterOperational definition
Age/SexAge in completed years; sex as recorded (female only included)
MRD No. /OPD No.Unique identifiers from the hospital medical records
DiagnosisDiagnosis of UTI recorded by treating physician, with or without supportive lab tests
Drugs UsedAll antimicrobial and supportive drugs prescribed
Dose & DurationAs per prescription record (in mg/day and number of days)
Irrational PrescriptionPrescriptions not adhering to NLEM 2022 or WHO treatment guidelines, including wrong drug choice, dose, duration, or unjustified combinations
Combination TherapyUse of two or more antimicrobials prescribed for the same UTI episode
Fixed Drug CombinationsPharmaceutical formulations with ≥2 active ingredients, e.g., Co-trimoxazole, Amoxicillin-Clavulanate; non-standard combinations (e.g., Nitrofurantoin + B6) excluded
Adverse Drug ReactionsAny documented undesirable event temporally related to a drug; classified as per hospital record using WHO-UMC system where available
ComorbiditiesPresence of any chronic illness (e.g., diabetes, hypertension) recorded in the medical record
Pregnancy StatusAs per documented clinical status during treatment
Recurrent Infections≥2 documented UTI episodes within 6 months or ≥3 in a year
Duration of IllnessDuration between onset of symptoms and resolution as noted in case file

Dissemination

The results of this study may contribute to future systematic reviews or meta-analyses focused on prescribing patterns and adverse drug reactions in urinary tract infections.

Study status

The study is yet to be started.

Discussion

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.

Ethical considerations

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.

Data availability

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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Version 4
VERSION 4 PUBLISHED 29 Apr 2024
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Patil G and Varma S. Analysis of prescription pattern and adverse drug reactions of drugs used in Urinary Tract Infection in reproductive age group (15-44 years) women in a Tertiary Care Hospital in Central India: An observational retrospective study [version 3; peer review: 1 approved, 2 not approved]. F1000Research 2025, 13:417 (https://doi.org/10.12688/f1000research.149264.3)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 3
VERSION 3
PUBLISHED 05 Aug 2025
Revised
Views
7
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Reviewer Report 26 Aug 2025
Abayeneh Girma, Mekdela Amba University, Tulu Awlya, South Wollo Zone, Ethiopia 
Not Approved
VIEWS 7
General comments 
The manuscript addresses an important topic—prescription patterns and adverse drug reactions (ADRs) in urinary tract infections (UTIs) among reproductive-age women in Central India. However, despite revisions, significant methodological and conceptual flaws persist, compromising the study's scientific rigor, ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Girma A. Reviewer Report For: Analysis of prescription pattern and adverse drug reactions of drugs used in Urinary Tract Infection in reproductive age group (15-44 years) women in a Tertiary Care Hospital in Central India: An observational retrospective study [version 3; peer review: 1 approved, 2 not approved]. F1000Research 2025, 13:417 (https://doi.org/10.5256/f1000research.185974.r402772)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Views
6
Cite
Reviewer Report 13 Aug 2025
Niels Frimodt-Møller, Copenhagen University Hospital, Copenhagen, Denmark 
Approved
VIEWS 6
The authors have responded adequately ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Frimodt-Møller N. Reviewer Report For: Analysis of prescription pattern and adverse drug reactions of drugs used in Urinary Tract Infection in reproductive age group (15-44 years) women in a Tertiary Care Hospital in Central India: An observational retrospective study [version 3; peer review: 1 approved, 2 not approved]. F1000Research 2025, 13:417 (https://doi.org/10.5256/f1000research.185974.r402774)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Version 2
VERSION 2
PUBLISHED 11 Feb 2025
Revised
Views
13
Cite
Reviewer Report 28 Jul 2025
Abayeneh Girma, Mekdela Amba University, Tulu Awlya, South Wollo Zone, Ethiopia 
Not Approved
VIEWS 13
General comments
The manuscript addresses an important topic—prescription patterns and adverse drug reactions (ADRs) in urinary tract infections (UTIs) among reproductive-age women. However, significant methodological and conceptual flaws persist despite revisions, as highlighted by previous reviewers. The study’s ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Girma A. Reviewer Report For: Analysis of prescription pattern and adverse drug reactions of drugs used in Urinary Tract Infection in reproductive age group (15-44 years) women in a Tertiary Care Hospital in Central India: An observational retrospective study [version 3; peer review: 1 approved, 2 not approved]. F1000Research 2025, 13:417 (https://doi.org/10.5256/f1000research.176032.r399331)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 09 Aug 2025
    DR. GAYATRI PATIL , Pharmacology, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India
    09 Aug 2025
    Author Response
    Response to Reviewer: Dr. Niels Frimodt-Møller
    COMMENT 1:
    “The calculation of sample size is not correct; With a prevalence of around 3% (and what does that mean?) of UTIs in ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 09 Aug 2025
    DR. GAYATRI PATIL , Pharmacology, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India
    09 Aug 2025
    Author Response
    Response to Reviewer: Dr. Niels Frimodt-Møller
    COMMENT 1:
    “The calculation of sample size is not correct; With a prevalence of around 3% (and what does that mean?) of UTIs in ... Continue reading
Views
17
Cite
Reviewer Report 13 Feb 2025
Niels Frimodt-Møller, Copenhagen University Hospital, Copenhagen, Denmark 
Not Approved
VIEWS 17
The authors' responses to the reviewers' suggestions seem a bit unclear, and it appears that my original comments may not have been fully addressed.
  • The calculation of sample size is not correct; With a prevalence of
... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Frimodt-Møller N. Reviewer Report For: Analysis of prescription pattern and adverse drug reactions of drugs used in Urinary Tract Infection in reproductive age group (15-44 years) women in a Tertiary Care Hospital in Central India: An observational retrospective study [version 3; peer review: 1 approved, 2 not approved]. F1000Research 2025, 13:417 (https://doi.org/10.5256/f1000research.176032.r365731)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 09 Aug 2025
    DR. GAYATRI PATIL , Pharmacology, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India
    09 Aug 2025
    Author Response
    Response to Reviewer: Dr. Niels Frimodt-Møller
    COMMENT 1:
    “The calculation of sample size is not correct; With a prevalence of around 3% (and what does that mean?) of UTIs in ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 09 Aug 2025
    DR. GAYATRI PATIL , Pharmacology, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India
    09 Aug 2025
    Author Response
    Response to Reviewer: Dr. Niels Frimodt-Møller
    COMMENT 1:
    “The calculation of sample size is not correct; With a prevalence of around 3% (and what does that mean?) of UTIs in ... Continue reading
Version 1
VERSION 1
PUBLISHED 29 Apr 2024
Views
20
Cite
Reviewer Report 13 Jul 2024
Vineetha Menon, Gulf Medical University, Ajman, United Arab Emirates 
Not Approved
VIEWS 20
1. Abstract: The abstract is too brief; lacks specificity and content. 
2. Introduction: The introduction lacks smooth flow and transitions between sections. There is some redundancy of information, grammatical errors, and formatting issues. There is no information given on ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Menon V. Reviewer Report For: Analysis of prescription pattern and adverse drug reactions of drugs used in Urinary Tract Infection in reproductive age group (15-44 years) women in a Tertiary Care Hospital in Central India: An observational retrospective study [version 3; peer review: 1 approved, 2 not approved]. F1000Research 2025, 13:417 (https://doi.org/10.5256/f1000research.163709.r297784)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 11 Feb 2025
    DR. GAYATRI PATIL , Pharmacology, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India
    11 Feb 2025
    Author Response
    1. Abstract: The abstract is too brief; lacks specificity and content. 
    Response:    Changes done in the abstract.

    2. Introduction: The introduction lacks smooth flow and transitions between sections. There ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 11 Feb 2025
    DR. GAYATRI PATIL , Pharmacology, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India
    11 Feb 2025
    Author Response
    1. Abstract: The abstract is too brief; lacks specificity and content. 
    Response:    Changes done in the abstract.

    2. Introduction: The introduction lacks smooth flow and transitions between sections. There ... Continue reading
Views
32
Cite
Reviewer Report 28 May 2024
Niels Frimodt-Møller, Copenhagen University Hospital, Copenhagen, Denmark 
Not Approved
VIEWS 32
The protocol by Patil et al concerns an interesting subject regarding antibiotic use in urinary tract infection (UTI) in women, but the protocol needs revision particluarly to be more strict and prescise.
1. It is not clear, whether the ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Frimodt-Møller N. Reviewer Report For: Analysis of prescription pattern and adverse drug reactions of drugs used in Urinary Tract Infection in reproductive age group (15-44 years) women in a Tertiary Care Hospital in Central India: An observational retrospective study [version 3; peer review: 1 approved, 2 not approved]. F1000Research 2025, 13:417 (https://doi.org/10.5256/f1000research.163709.r276370)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 11 Feb 2025
    DR. GAYATRI PATIL , Pharmacology, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India
    11 Feb 2025
    Author Response
    1. It is not clear, whether the investigation partakes on nosocomial (hospital derived) UTI or community associated UTI, or both? Define.
    RESPONSE: This study only focuses on prescription patterns so ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 11 Feb 2025
    DR. GAYATRI PATIL , Pharmacology, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India
    11 Feb 2025
    Author Response
    1. It is not clear, whether the investigation partakes on nosocomial (hospital derived) UTI or community associated UTI, or both? Define.
    RESPONSE: This study only focuses on prescription patterns so ... Continue reading

Comments on this article Comments (0)

Version 4
VERSION 4 PUBLISHED 29 Apr 2024
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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