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\def\citeauthor{~Samiksha~Sharma,
              ~Kulsum~Ateeq}
\def\citetitle{\textbf{Evaluation of Dose Adjustment of Antibiotics in Renal Impaired Patients in a Tertiary Care Hospital}}
\def\copyrightstmt{This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial- ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.}
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\def\RunningAuthor{Samiksha Sharma and Kulsum Ateeq}
\firstPage{140}
\articleType{Original Article}
\receivedDate{15 Oct 2022}
\acceptedDate{02 Nov 2022}
\revisedDate{01 Nov 2022}
\journalVolume{2}
\journalIssue{4}
\copyrightYear{2022}
\eISSN{2583-0953}
\journalDoi{10.26452/ijcpms.v2i4.443}
\def\authorCount{2}
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\def\journalTitle{International Journal of Clinical Pharmacokinetics and Medical Sciences}

\title{\textbf{Evaluation of Dose Adjustment of Antibiotics in Renal Impaired Patients in a Tertiary Care Hospital}}
\author{Samiksha~Sharma\textsuperscript{*}, 
            Kulsum~Ateeq~\\[5pt]{Malla Reddy College of Pharmacy (Affiliated to Osmania University), Dhulapally, Secunderabad, Telangana-500100, India}}

\begin{abstract}
Patients having renal impairment may have altered excretion of antibiotics and their metabolites leading to its excessive accumulation in the body. These patients are more prone to adverse effects and other complications and, in some cases, may even lead to fatality.  Dose adjustment of antibiotics is necessary to avoid these effects. This study aims to evaluate the dosage adjustments of antibiotics in renal impaired patients. This is  a prospective observational study performed in the department of nephrology at Malla Reddy Narayana multi-speciality hospital on 100 subjects who were selected based on inclusion and exclusion criteria. Statistical clarification was done to decode the unbiased analysis and final conclusions were drawn.  According to the study findings, 72\% of the antibiotics prescribed were adjusted and the rest 28\% were unadjusted. Amoxicillin clavulanate was found to be the most unadjusted antibiotic followed by meropenem, ciprofloxacin and ceftriaxone. 5 ADRs because of unadjusted antibiotic doses were observed.  Understanding the need for dose adjustment in renal impaired patients will help reduce the dosing errors in such patients. Lack of dose adjustment of antibiotics can lead to life-threatening complications and even morbidity and mortality. Hence, the role of the clinical pharmacist is important in understanding the need for dose adjustment to optimize therapeutic efficacy and minimize toxicity. 
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Adverse effects,\newline Antibiotics,\newline Dose adjustment,\newline Renal impairment
\end{keywords}
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\makeatletter{\raggedright{\Large$^\ast$}Corresponding Author\par Name:\ Samiksha~Sharma~\\ Phone:\ +91 9182289784~\\  Email:\ samiksha2023@gmail.com
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\section{Introduction}
Regardless of the underlying cause, chronic kidney disease (CKD) is defined as "a decrease in glomerular filtration rate (GFR) 60mL/minute /1.73m2 for 3 months" and categorized into five stages based on GFR. Over 10\% of the world's population is suffering from CKD, making it one of the most prevalent public health issues \unskip~\cite{1917303:27941984}. Kidney illnesses have been estimated to be the cause of 5 to 10 million deaths annually \unskip~\cite{1917303:27941985}. 

The primary structures in charge of controlling homeostasis, acid-base balance, and electrolytes are the kidneys. Most medications are predominantly eliminated by the kidneys, especially water-soluble medications and their metabolites. Therefore, renal function has a significant impact on drug dose. To absorb and eliminate several medications as well as potential active metabolites, proper kidney function must be maintained. Numerous investigations have revealed that many patients with renal impairment receive several inadequate drug doses, even if the dosage of some drugs in renal impairment is important. Contrary to patients with normal kidney function, renal impairment might result in adverse drug reactions (ADRs) if doses are not lowered or renally adjusted \unskip~\cite{1917303:27941982}.

People with chronic kidney disease, especially elderly people, are more likely to experience drug toxicity. Additionally, age-related declines in renal function and the use of several drugs to address co-morbidities rendered them a more vulnerable population in terms of the development of severe disease and associated adverse events \unskip~\cite{1917303:27941980}. The therapeutic efficacy, toxicity, and cost of drugs for individuals with renal impairment can all be improved with the right dose \unskip~\cite{1917303:27941981}.

Based on renal function, which is measured by the Glomerular Filtration Rate (GFR) or Creatinine Clearance (CrCl), dosages of medications cleared by the kidneys are determined. The drug prescribing guideline book Drug Prescribing in Renal Failure: Dosing Guidelines for Adults \unskip~\cite{1917303:27941979}  and other literatures include dosage recommendations for certain medications. Less than 10 mL/min/1.73 m2, 10 to 50 mL/min/1.73 m2, and more than 50 mL/min/1.73 m2 are the three GFR categories that make up the recommendations, which include a 10-fold range in renal function \unskip~\cite{1917303:27941980}. In patients with renal impairment, medications include antibiotics, digoxin, H2-receptor antagonists, and ACE-I often need to be dosage adjusted \unskip~\cite{1917303:27941983}.

\textbf{Aim }

The aim of this study was to evaluate the appropriateness of the drug dose adjustment in hospitalized patients with kidney dysfunction.

\textbf{Objectives}
  
  \begin{enumerate}
  \item \relax To evaluate the dose adjustment of antibiotics \& assess their antibiotic usage pattern in renal impaired patients
  \item \relax To determine the clinical outcomes due to unadjusted dose of antibiotic.
  \item \relax To estimate the prevalence of drug interactions \& adverse effects.
  \end{enumerate}
  
    
\section{METHODOLOGY}
The data was collected in specially designed pro-forma. A well-designed case record form was used to collect the data of the patients and information regarding age, sex, weight, renal function test, diagnosis, drug profile and relevant data.

\textbf{Study Design }

The study design was Prospective Observational cross-sectional study.

\textbf{Sample Size}

In this study, 100 patients fulfilling the inclusion and exclusion criteria were included.

\textbf{Study Period}

This study was conducted over a period of 6 months.

\textbf{Study Area}

The study was conducted at Malla Reddy Narayana Multispecialty Hospital, which is a tertiary care hospital.

\textbf{Inclusion Criteria}


  
  \begin{enumerate}
  \item \relax Patients who are willing to participate in the study
  \item \relax Patients of age 18 and above of either sex
  \item \relax Hospitalized patients diagnosed with renal impairment along with other co-morbidities
  \item \relax Patients having creatinine clearance less than or equal to 60ml/min
  \end{enumerate}
  \textbf{Exclusion Criteria}


  
  \begin{enumerate}
  \item \relax Pregnant and lactating women are not considered. 
  \item \relax Patients who do not fulfil the inclusion criteria
  \end{enumerate}
  \textbf{Materials used}


  
  \begin{enumerate}
  \item \relax Data Collection Form
  \item \relax Standard Antibiotic Dosing Guidelines
  \item \relax Standard formulas
  \end{enumerate}
  
\begin{table*}[!htbp]
\caption{\boldmath {Distribution of Subjects according to Creatinine Clearance (ml/min)} }
\label{tw-1f474867967f}
\def\arraystretch{1.1}
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\tbltoprule \rowcolor{kwdboxcolor}Creatinine Clearance (ml/min) & No. of Subjects & Percentages (\%) & P value\\
\tblmidrule 
60-70 &
  4 &
  4\% &
  \multicolumn{1}{p{\dimexpr(.24\linewidth-2\tabcolsep)}}{\multirow{7}{\linewidth}{  0.04}}\\
50-60 &
  4 &
  4\% &
  \\
40-50 &
  9 &
  9\% &
  \\
30-40 &
  6 &
  6\% &
  \\
20-30 &
  22 &
  22\% &
  \\
10-20 &
  26 &
  26\% &
  \\
0-10 &
  29 &
  29\% &
  \\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Antibiotic distribution pattern in Dialysis \& Non-Dialysis Patients} }
\label{tw-e77719ce4e54}
\def\arraystretch{1.1}
\ignorespaces 
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\begin{tabulary}{\linewidth}{p{\dimexpr.25\linewidth-2\tabcolsep}p{\dimexpr.26\linewidth-2\tabcolsep}p{\dimexpr.22669999999999998\linewidth-2\tabcolsep}p{\dimexpr.26330000000000002\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Dialysis & No. of Subjects & Percentage (\%) & P value\\
\tblmidrule 
Dialysis &
  30 &
  30\% &
  \multicolumn{1}{p{\dimexpr(.26330000000000002\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{0.011*}}\\
Non-Dialysis &
  70 &
  70\% &
  \\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Antibiotics - Category wise Distribution} }
\label{tw-1db7eb52153b}
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\tbltoprule \rowcolor{kwdboxcolor}Antibiotics  & Frequency of \mbox{}\protect\newline Antibiotics  & Percentages (\%) & P value \\
\tblmidrule 
Penicillin &
  53 &
  27\% &
  \multicolumn{1}{p{\dimexpr(.26\linewidth-2\tabcolsep)}}{\multirow{14}{\linewidth}{  0.04}}\\
Cephalosporins &
  68 &
  36\% &
  \\
Macrolides &
  8 &
  4\% &
  \\
Lincomycin &
  8 &
  4\% &
  \\
Polymyxin &
  1 &
  0.5\% &
  \\
Sulphonamides &
  4 &
  2.1\% &
  \\
Tetracycline &
  5 &
  2.5\% &
  \\
Fluoroquinolone &
  15 &
  8\% &
  \\
Rifamycin &
  2 &
  1.\% &
  \\
Glycylcycline &
  1 &
  0.5\% &
  \\
Glycopeptide &
  10 &
  5\% &
  \\
Oxazolidinone &
  5 &
  2.5\% &
  \\
Quinolones &
  1 &
  0.5\% &
  \\
Aminoglycosides &
  5 &
  2.5\% &
  \\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Assessment of Individual Antibiotics: Adjusted / Unadjusted} }
\label{tw-acf70a22c498}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.21060000000000002\linewidth-2\tabcolsep}p{\dimexpr.18939999999999998\linewidth-2\tabcolsep}p{\dimexpr.20\linewidth-2\tabcolsep}p{\dimexpr.20\linewidth-2\tabcolsep}p{\dimexpr.20\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Antibiotics & Total & Adjusted & Unadjusted & P Value\\
\tblmidrule 
Amikacin &
  4 &
  2 &
  2 &
  \multicolumn{1}{p{\dimexpr(.20\linewidth-2\tabcolsep)}}{\multirow{15}{\linewidth}{}}\\
Amoxicillin Clavulanate &
  22 &
  9 &
  13 &
  \\
Ampicillin Sulbactam &
  1 &
  1 &
  0 &
  \\
Azithromycin &
  5 &
  5 &
  0 &
  \\
Cefazolin &
  1 &
  1 &
  0 &
  \\
Cefepime &
  7 &
  2 &
  5 &
  \\
Cefoperazone &
  15 &
  14 &
  1 &
  \\
Cefotaxime &
  4 &
  2 &
  2 &
  \\
Cefpodoxime &
  4 &
  2 &
  2 &
  \\
Ceftazidime &
  1 &
  0 &
  1 &
  \\
Ceftriaxone &
  35 &
  28 &
  7 &
  \\
Ciprofloxacin &
  20 &
  12 &
  8 &
  \\
Clarithromycin &
  3 &
  2 &
  1 &
  \\
Clindamycin &
  8 &
  7 &
  1 &
  \\
Colistimethate &
  1 &
  0 &
  1 &
  \\
Doxycyclin &
  4 &
  2 &
  2 &
  \multicolumn{1}{p{\dimexpr(.20\linewidth-2\tabcolsep)}}{\multirow{11}{\linewidth}{0.001*}}\\
Gentamycin &
  1 &
  1 &
  0 &
  \\
Levofloxacin &
  2 &
  1 &
  1 &
  \\
Linezolid &
  5 &
  5 &
  0 &
  \\
Meropenem &
  11 &
  2 &
  9 &
  \\
Minocycline &
  1 &
  1 &
  0 &
  \\
Nafcillin &
  1 &
  1 &
  0 &
  \\
Piperacillin Tazobactam &
  18 &
  16 &
  2 &
  \\
Rifaximin &
  2 &
  2 &
  0 &
  \\
Tigecycline &
  1 &
  1 &
  0 &
  \\
Vancomycin &
  10 &
  5 &
  5 &
  \\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Sample size exhibiting Drug Interactions classification wise} }
\label{tw-b2fe02d1649e}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.2334\linewidth-2\tabcolsep}p{\dimexpr.2666\linewidth-2\tabcolsep}p{\dimexpr.25\linewidth-2\tabcolsep}p{\dimexpr.25\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Drug Interactions & Frequency  & Percentage & P value\\
\tblmidrule 
Major &
  105 &
  24.8 \% &
  \multicolumn{1}{p{\dimexpr(.25\linewidth-2\tabcolsep)}}{\multirow{3}{\linewidth}{0.001*}}\\
Moderate &
    288 &
  61.4 \% &
  \\
Minor &
    46 &
  13.9 \% &
  \\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Major Drug Interactions} }
\label{tw-c4acc292d97a}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.2584\linewidth-2\tabcolsep}p{\dimexpr.1681\linewidth-2\tabcolsep}p{\dimexpr.1735\linewidth-2\tabcolsep}p{\dimexpr.20\linewidth-2\tabcolsep}p{\dimexpr.20\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Diagnosis & Severity & Drug & Drug & Outcome\\
\tblmidrule 
AKI with hypovolemia &
  MAJOR &
  Ciprofloxacin &
  Furosemide &
  Nephrotoxicity\\
ESRD with \mbox{}\protect\newline Septic Shock &
  MAJOR &
  Ceftriaxone &
  Calcium &
  Precipitation in lungs and Kidneys\\
ESRD with \mbox{}\protect\newline Septic Shock &
  MAJOR &
  Ciprofloxacin &
  Ondansetron &
  Bradyarrhythmia, Increase QTc Interval\\
ESRD with Hypertensive Nephrosclerosis &
  MAJOR &
  Clarithromycin &
  Ciprofloxacin &
  Increase Qt C interval\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {ADRs because of Drug Interactions} }
\label{tw-48317ebd4c9c}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.25\linewidth-2\tabcolsep}p{\dimexpr.2567\linewidth-2\tabcolsep}p{\dimexpr.2433\linewidth-2\tabcolsep}p{\dimexpr.25\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Diagnosis & Drug & ADR Found & Clinical Presentation \\
\tblmidrule 
ESRD \mbox{}\protect\newline  &
  Ceftriaxone + calcium &
  Precipitation in Lungs &
  Patchy consolidation in lungs \mbox{}\protect\newline \\
ESRD with Septic Shock &
  Ceftriaxone + calcium &
  Precipitation in Lungs &
  Patchy consolidation in lungs\\
SEPSIS WITH AKI &
  Meropenem + \mbox{}\protect\newline Tramadol &
  Seizures &
  Increased Frequency of seizures\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {ADRs Due to Unadjusted Doses} }
\label{tw-a8b342886360}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{LLLL}
\tbltoprule \rowcolor{kwdboxcolor}Diagnosis & Drug & ADR Found & Clinical Presentation\\
\tblmidrule 
ESRD with Hypertensive Nephrosclerosis &
  Clarithromycin \mbox{}\protect\newline  &
  Ototoxicity \mbox{}\protect\newline  &
  Tinnitus and Visual Hallucinations \mbox{}\protect\newline \\
AKI on CKD &
  Ceftriaxone &
  Nephrotoxicity &
  Increase in creatinine levels \& BUN\\
AKI with Ig A Nephropathy &
  Levofloxacin \mbox{}\protect\newline  &
  Hematuria , Proteinuria &
  Blood in urine\\
AKI on CKD &
  Meropenem &
  Bleeding ( Black coloured stools) &
  Malena  \mbox{}\protect\newline \\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\bgroup
\fixFloatSize{images/fa2518a6-2aff-4b73-8364-7e9412a65b6f-upicture1.png}
\begin{figure}[!htbp]
\centering \makeatletter\IfFileExists{images/fa2518a6-2aff-4b73-8364-7e9412a65b6f-upicture1.png}{\includegraphics{images/fa2518a6-2aff-4b73-8364-7e9412a65b6f-upicture1.png}}{}
\makeatother 
\caption{\boldmath {Age-Wise Distribution}}
\label{f-b5fe63d3924a}
\end{figure}
\egroup

\bgroup
\fixFloatSize{images/faea7727-e0e9-4605-8a0b-0be3c49a864c-upicture2.png}
\begin{figure}[!htbp]
\centering \makeatletter\IfFileExists{images/faea7727-e0e9-4605-8a0b-0be3c49a864c-upicture2.png}{\includegraphics{images/faea7727-e0e9-4605-8a0b-0be3c49a864c-upicture2.png}}{}
\makeatother 
\caption{\boldmath {Pattern of Supportive Drugs}}
\label{f-df6cb9d47af3}
\end{figure}
\egroup
\textbf{Study Procedure}


  
  \begin{enumerate}
  \item \relax This prospective observational study was undertaken in the Department of Nephrology in Malla Reddy Narayana Multispecialty Hospital for a period of six months from January 2022 to June 2022.
  \item \relax 100 subjects fulfilling the inclusion and exclusion criteria were included in the study. 
  \item \relax The creatinine clearance of the participants was calculated using the Cockcroft Gault equation.
  \item \relax The relevant data of the patients were recorded and documented in the data collection form. 
  \item \relax The dose of the antibiotics prescribed to the patients was compared with Standard antimicrobial dosing reference in renal impairment with their respective creatinine clearance values and was concluded as ``Adjusted'' or ``Unadjusted''.
  \item \relax Follow up on the patients was done to check for any adverse effects and drug interactions. 
  \end{enumerate}
  \textbf{Statistical Analysis }

The data was analyzed using SPSS version 22.0 (SPSS, Inc., Chicago, IL). Chi-Square Test was used to calculate the P value. P value {\textless}0.05 was considered statistically significant.
    
\section{RESULTS \& DISCUSSION}
A total of 100 patients were included in the study. Figure~\ref{f-b5fe63d3924a}  represents age wise distribution of renal impaired patients in the sample population. Most number of patients was found in the age group 60-70 years and least number of patients was found in 80-90 years. Coming to the gender-wise distribution of sample population, proportion of Males (67\%) is higher than Females (33\%). Table~\ref{tw-1f474867967f}  represents the Distribution of subjects according to creatinine Clearance (ml/min). Maximum No. of subjects had their creatinine clearance value in the range 0-10 ml/min. Table~\ref{tw-e77719ce4e54}  determines the Prevalence Rate of Dialysis and Non- Dialysis Patients in the Sample Population. Antibiotics segregated Category wise prescribed in Renally Impaired Patients in the Sample Population in Table~\ref{tw-1db7eb52153b}.

In this study, most patients received Antibiotics as Dual therapy (42) followed by Monotherapy (33), Triple Therapy (21) and Quadruple Therapy (4).  Statistically P value is {\textless}0.05 i.e., significant (0.045). Coming to the total antibiotics based on adjusted/ unadjusted 72\% of antibiotics were adjusted and 28\% were found unadjusted. Statistically P value is {\textless}0.05 i.e., significant (0.01). Table~\ref{tw-acf70a22c498}  defines the assessment of adjusted/unadjusted antibiotics individually.

Figure~\ref{f-df6cb9d47af3}  represents supportive drugs indicated in Renally Impaired Subjects. Anti-Hypertensive (25\%) were mostly prescribed, followed by Gastro-Hepato Protectants and Vitamin Supplements. Table~\ref{tw-b2fe02d1649e}  sorts the Sample size exhibiting Drug Interactions classified into Major, Moderate and Minor Categories. 

Around 61.4\% of moderate drug interactions, 24.8\% and 13.9\% of major and minor drug interactions were found respectively. Out of the 104 Major Interactions calculated, 07 Major Interactions caused by Antibiotics were displayed in detail in Table~\ref{tw-c4acc292d97a}. ADRs because of Drug Interactions were described in Table~\ref{tw-48317ebd4c9c}. 

ADRs  due to Unadjusted Doses were given in Table~\ref{tw-a8b342886360}. In the 104 Major Interactions calculated, 4 of them were clinically manifested in patients. Of the 71 Unadjusted Antibiotic doses, 5 of them were found to cause adverse drug reactions in patients (Clarithromycin: Ototoxicity, Ceftriaxone: Nephrotoxicity, Meropenem: Malena, Levofloxacin: Hematuria).
    
\section{CONCLUSION}
Dosing errors in antibiotics were observed in the management of infections in renal impaired patients. Of 71 antibiotic doses unadjusted, 5 of them were found to cause adverse drug reactions in patients (Clarithromycin: Ototoxicity, Ceftriaxone: Nephrotoxicity, Meropenem: Malena, Levofloxacin: Hematuria). That's why understanding the need of dose adjustment in renally impaired patients, awareness about the pharmacokinetics/pharmacodynamics association and the standard dosing guidelines will help reduce the dosing errors in such patients. Proper attention must be given while selecting the appropriate antibiotic with the appropriate dose. Lack of dose adjustment of antibiotics can lead to life threatening complications like increased hospital stay, increased healthcare costs, adverse drug events, and even morbidity and mortality. Hence, there is a need for antibiotic dose adjustment to optimize therapeutic efficacy and minimize toxicity.
    
\section{Acknowledgement}
We articulate our sincere and wholehearted gratitude to our guide Dr. I.S.V MANVITHA ma'am,  assistant professor, PharmD, Malla Reddy College of Pharmacy for her relentless help, supervision, assistance and sincere efforts that made our study a success. We are very thankful and extent our heartfelt gratitude to Dr. SURYA NARAYAN MONDAL sir, Nephrologist, renal transplant physician, MBBS, MD, DNB nephrology in Malla Reddy Narayana multi speciality Hospital for guiding us in this project. He has been the pivotal person in approving, guiding and completion our study.

\textbf{Conflict of interest}

No authors declared conflict of interest.

\textbf{Funding}

None.
    
\balance 

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