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\def\citeauthor{~Pulimi~Divya~Priyanka,
              ~Vithya~T,
              ~Shoba~Rani~Rajeev~Hiremath,
              ~Shankar~Prasad}
\def\citetitle{\textbf{Assessing the Patterns and Occurrence of Adverse Drug Reactions in a Tertiary Care Hospital: An Observational Study}}
\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{Pulimi Divya Priyanka et al.}
\firstPage{10}
\articleType{Original Article}
\receivedDate{05 Jan 2022}
\acceptedDate{18 Jan 2022}
\revisedDate{06 Jan 2022}
\journalVolume{2}
\journalIssue{1}
\copyrightYear{2022}
\eISSN{2583-0953}
\journalDoi{10.26452/ijcpms.v2i1.253}
\def\authorCount{4}
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\def\journalTitle{International Journal of Clinical Pharmacokinetics and Medical Sciences}

\title{\textbf{Assessing the Patterns and Occurrence of Adverse Drug Reactions in a Tertiary Care Hospital: An Observational Study}}
\author{Pulimi~Divya~Priyanka\textsuperscript{*}\textsuperscript{1},  
            Vithya~T\textsuperscript{1},  
            Shoba~Rani~Rajeev~Hiremath\textsuperscript{1}, 
            Shankar~Prasad\textsuperscript{2}~\\[5pt]{\textsuperscript{1}Department of Pharmacy Practice, Al Ameen College of Pharmacy, Bangalore, Karnataka, India}~\\{\textsuperscript{2}St. Philomena's Hospital, Bangalore, Karnataka, India}}

\begin{abstract}
For more than a decade, adverse medication responses have been a significant problem in healthcare. It is the obligation of healthcare providers to use rational drugs for their patients. The study's goal was to find out how often ADRs are in a tertiary care hospital, as well as the most common Therapeutic Class of Drugs that cause ADR and the most common Organ System impacted by ADR. Between January and August 2016, a prospective, observational study was done in the wards of St. Philomena's Hospital in Bangalore. During their admission, all in-patients were checked for ADRs. A total of 274 adverse drug reactions (ADRs) were documented in 700 individuals during the course of the 12-month research. Female patients had more ADRs than male patients (52.9 percent). The majority of the reactions were gastrointestinal (70\%) and fluid and electrolyte imbalance (48\%) respectively (17.51 percent). Antibiotics were the most commonly related therapeutic classes with ADRs, accounting for 84 percent (30.65 percent), followed by antihypertensive medicines, accounting for 63 percent (22.99 percent). The majority of ADRs (34.67 percent) were dealt with by stopping the implicated drug. The Naranjo's Scale algorithm was used to analyse the causation of the ADRs, and the majority of them were determined to be probable 133. (48.5percent). In a hospital setting, continuous monitoring by a clinical pharmacist will reduce the occurrence of ADR and increase patient safety. 
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Adverse Drug Reaction,\newline Causality Assessment,\newline Clinical Pharmacist,\newline Patient Safety
\end{keywords}
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\makeatletter{\raggedright{\Large$^\ast$}Corresponding Author\par Name:\ Pulimi~Divya~Priyanka~\\ Phone:\ ~\\  Email:\ divya.pulimi04@gmail.com
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\section{Introduction}
Medication-related adverse events, generally known as adverse drug reactions (ADRs), are serious side effects generated by a medicine. The World Health Organization (WHO) defines adverse drug reactions (ADRs) as "a response to a medication that is toxic and undesired applied in man to treat" \unskip~\cite{1393879:24770502}. ADRs may arise as a consequence of a preventable medication mistake, such as a side effect following pharmaceutical administration, or an unforeseen error, such as an allergic response \unskip~\cite{1393879:24770509,1393879:24770512}.

ADRs might have a substantial influence on patients' quality of life while also placing a pressure on the healthcare system. ADRs are one of the top causes of morbidity and death globally, and they will continue to be a significant public health problem as medicine grows increasingly complex to treat multiple illnesses in an ageing population. According to a recent research, ADRs account for roughly 3.5 percent of hospital admissions \unskip~\cite{1393879:24770508,1393879:24770505}. Furthermore, ADRs were responsible for around 197,000 deaths in Europe each year \unskip~\cite{1393879:24770502}.

Adverse medication reactions are frequently complicated and multi-factorial in origin. Dose/drug-related, allergy, and idiosyncratic responses are the three categories of adverse reactions that could occur. Dosage-related and drug-related adverse drug reactions are typically associated to the medication's dose and are usually expected, although not always \unskip~\cite{1393879:24770511,1393879:24770506}. It is extremely reliant on the patient's sensitivity to the drug and the medications taken in combination. It does not usually result in serious ADR, but it is rather prevalent. An allergic drug response happens when a patient has an unpleasant reaction to a medicine that may have been prevented with a pre-medication skin test or effective primary care institutions and patients should consult and communicate effectively. Idiosyncratic adverse drug reactions are a form of adverse medication reaction that is poorly understood and whose intensity is often unpredictable. This affects a smaller number of persons, and the cause of the negative reaction could be genetically determined \unskip~\cite{1393879:24770507}.

ADRs have become a big concern among persons taking several medicines, such as the elderly. According to one research, up to 75 percent of all elderly care patients reported medication discrepancies after transitioning from a hospital to a primary care setting \unskip~\cite{1393879:24770511}.\ensuremath{^{}} In general practise the majority of adverse drug occurrences are linked to prescription errors. According to a major retrospective case review research \unskip~\cite{1393879:24770510}, medications mistakes in general practise occur at a rate of 5\% in England. With the integration of technology into the healthcare system, computerised prescribing systems have a range of medication mistake rates that can result in mild to severe adverse drug reactions \unskip~\cite{1393879:24770500,1393879:24770503}. 

To reduce the danger of adverse medication events in primary care, this research looked into the forms of ADRs, the important drug classes related with the responses, their prevalence, and the effects of encountering ADRs. This will provide clinicians with a better understanding of adverse occurrences and the drug classes that are linked to them. Patient safety could be improved by targeted educational programmes that address these deficiencies. Researchers, healthcare providers, and policymakers will benefit from this research in developing treatments to prevent adverse medication responses in today's primary care.
    
\section{METHODOLOGY}
During the months of January to December 2018, a prospective, observational research was undertaken in the wards of St. Philomena's Hospital in Bangalore. With the authorization of the Institutional Ethics Committee and the consent of the research population, all in-patients of both genders who had an ADR were recruited in the study. Criteria for study all in-patients of both genders who experienced ADR during their hospital stay were included. Patients admitted to the hospital owing to an ADR are excluded.


\begin{table*}[!htbp]
\caption{\boldmath {Elements of a Patient's Medication History that may Aid in the Clinical Assessment of an ADR} }
\label{tw-9fba2ca4c309}
\centering 
\begin{threeparttable}

\def\arraystretch{1.1}
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\begin{tabulary}{\linewidth}{p{\dimexpr.14529999999999998\linewidth-2\tabcolsep}p{\dimexpr.4525\linewidth-2\tabcolsep}p{\dimexpr.4022\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}S.No & Question & Clinical Relevance\\
\tblmidrule 
1. &
  Have you ever taken this medication before and experienced any side effects? &
  Although tolerating treatment before may make high susceptibility reactions less likely, prior drug exposure does not completely exclude out an ADR.\\
2. &
  Other than the suspected drug, did anything else change around the time of the alleged ADR? (eg other treatments, over-the-counter medicines, disease progression) &
  Examine whether there are any other causes (besides the suspected substance) that could have produced the reaction on their own.\\
3. &
  Is it true that the reaction happened just after the medicine was started? &
  While not all ADRs occur immediately or early in therapy (e.g., on drug challenge), an impact happening prior to drug exposure is strong evidence.\\
4. &
  When the medicine was withdrawn (or a specific remedy was offered), did the reaction go away? &
  Unless an irreversible reaction occurs, effects that subside when therapy is stopped (de-challenge) may raise suspicion of an ADR.\\
5. &
  Was the medicine ever used intentionally or unintentionally after an ADR? &
  The likelihood of a causal association increases when an ADR occurs after re-exposure to a drug.\\
\tblbottomrule 
\end{tabulary}\par 
\begin{tablenotes}\footnotesize 
    
\item{Based on original criteria described by Naranjo et al. (1981) \unskip~\cite{1393879:24770501}.}
\end{tablenotes}
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\begin{table*}[!htbp]
\caption{\boldmath {Causality Assessment of ADR'S} }
\label{tw-f6738c5b8b06}
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\begin{tabulary}{\linewidth}{p{\dimexpr.1967\linewidth-2\tabcolsep}p{\dimexpr.18009999999999998\linewidth-2\tabcolsep}p{\dimexpr.20830000000000002\linewidth-2\tabcolsep}p{\dimexpr.19\linewidth-2\tabcolsep}p{\dimexpr.22490000000000002\linewidth-2\tabcolsep}}
\tbltoprule 
Series 1 &
  Definite &
  Doubtful &
  Possible &
  Probable\\
Series 2 &
  55 (20\%) &
  26 (9.4\%) &
  60 (21.89\%) &
  133 (48.5\%)\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

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\caption{\boldmath {Occurrence of ADR's Based on Gender}}
\label{f-f49a974bf4d4}
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\centering \makeatletter\IfFileExists{images/e8580073-d667-41eb-9e3c-4107e7038997-upicture2.png}{\includegraphics{images/e8580073-d667-41eb-9e3c-4107e7038997-upicture2.png}}{}
\makeatother 
\caption{\boldmath {Frequency of ADR Based on Organ System}}
\label{f-db5d025bf1db}
\end{figure}
\egroup
\textbf{Data Collection }

Over the course of two years, the researchers monitored all patients admitted to participating hospitals until they were discharged. Patients who were discharged within 24 hours and/or transferred from other hospitals or wards within the study hospitals were excluded from the research. Prior medical history, socio-demographic characteristics, admission and discharge diagnoses, length of stay (LOS), laboratory tests, instrumental procedures, therapies administered (before admission and during hospital stay), medications prescribed at discharge, as well as dosage, frequency, route, and indication of drug use, were all gathered.

\textbf{Analysis of ADR'S}

A Depending on the data acquired, all patients were separated into three groups based on whether or not they had developed at least one ADR (patients with ADRs that occurred during hospitalisation and patients with ADRs that caused hospitalisation) based on the data obtained (patients without ADR). Naranjo's scale was used to determine the severity of adverse medication reactions. According to Naranjo's causality rating scale, a score of {\textgreater} 9 indicated a clear causal correlation between the drug and the ADR; 5-8 indicated a plausible relationship; 1-4 indicated a potential relationship; and a score of 0 indicated an improbable relationship (Table~\ref{tw-9fba2ca4c309}). 


\bgroup
\fixFloatSize{images/67375aff-781e-49c9-b40f-d303364ab219-upicture3.png}
\begin{figure}[!htbp]
\centering \makeatletter\IfFileExists{images/67375aff-781e-49c9-b40f-d303364ab219-upicture3.png}{\includegraphics{images/67375aff-781e-49c9-b40f-d303364ab219-upicture3.png}}{}
\makeatother 
\caption{\boldmath {ADR Frequency Based on Drug Class}}
\label{f-3eaed100a16a}
\end{figure}
\egroup

    
\section{RESULTS AND DISCUSSION}
A total of 274 (39.14) ADRs were recorded in 700 subjects over the course of the 12-month research. Female patients had a greater rate of ADRs, with 145 (52.9\%) reported in Figure~\ref{f-f49a974bf4d4}. Gastrointestinal reactions accounted for 70 (25.5\%) of all cases, followed by fluid and electrolyte imbalance 48 (17.51\%), dermatological reaction 44 (16.05\%), neurologic 40 (14.59\%), haematological 37 (13.5\%), hepatic difficulties 20 (7.2\%), and cardiac problems 15 (5.4\%) depicted in Figure~\ref{f-db5d025bf1db}. The findings of the study were comparable to those of Wei Yew W~et al. \unskip~\cite{1393879:24770504}. Antibiotics were the most commonly related therapeutic classes with ADRs (84.65\%), followed by antihypertensive medications (63.2\%), analgesics (52.9\%), corticosteroids (40.59\%), antacids (26.48\%), and thrombolytic agents (3.2\%), as shown in Figure~\ref{f-3eaed100a16a}. The majority of ADRs [95 (34.67\%)] were treated by stopping the implicated drug. The Naranjo's Scale algorithm was used to analyse the causality of the ADRs, and the bulk of them were judged to be definite 41 (32.28 percent) as shown in Table~\ref{tw-f6738c5b8b06}.
    
\section{CONCLUSION}
In the United States, adverse drug reactions (ADRs) are a primary cause of morbidity and mortality. In general, prescription errors are to blame for the bulk of adverse medication reactions. Continuous medication monitoring by a clinical pharmacist in a hospital setting will surely reduce the occurrence of adverse drug reactions and increase patient safety by minimising adverse drug reactions and antibiotic resistance.

\textbf{Funding Support}

The authors declare that they have no funding support for this study.

\textbf{Conflict of Interest}

The authors declare that there is no conflict of interest.
    
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