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\def\RunningAuthor{Yamuna Devi M. S. et al.}
\firstPage{1276}
\articleType{Original Article}
\receivedDate{02 Feb 2021}
\acceptedDate{22 Mar 2021}
\revisedDate{19 Mar 2021}
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\title{\textbf{Awareness among consumers on adverse drug reaction reporting system in India - A cross-sectional questionnaire-based study}}
\author{Yamuna~Devi~M.~S\textsuperscript{*}\textsuperscript{1},  
            Saratha~Muthukumar\textsuperscript{2}, 
            Kaavya~S\textsuperscript{1}~\\[5pt]{\textsuperscript{1}Department of Pharmacology, Saveetha Medical College, Chennai {\textendash} 602105, Tamil Nadu, India}~\\{\textsuperscript{2}Saveetha Medical College, Chennai {\textendash} 602105, Tamil Nadu, India}}

\begin{abstract}
The adverse drug reaction (ADR) reporting system in India came into existence in 2010 through an initiative by the Government, the Pharmacovigilance Programme of India (PvPI), considering the social and economic consequences of drug effects. Though the system is functioning effectively for almost a decade, there has been a lacuna in reporting due to the lack of awareness among the patients who are the direct consumers. Medicine side-effects reporting is the newest initiative started in 2014 by PvPI, and the forms for consumer reporting is made available in over 10 different Indian languages like Tamil, Hindi, etc. It is imperative to determine the level of awareness among the public regarding drug side-effects and the existence of a National Programme to monitor the same, especially in a country like India with a population of nearly 1.38 billion. The aim of this study was to determine the awareness among the general population about the ADR reporting system in India. This cross-sectional study was done over a period of one year amongst the general public in South India. Data was collected from about 338 participants using a standardized questionnaire and analyzed descriptively using SPSS statistical software version 24. The overall response rate was 93.8\%, and the mean age was 35.62 \ensuremath{\pm} 10.43 years. Though the respondents had sufficient knowledge (66\%) about ADRs, their awareness about the reporting system was very poor (19\%). Reporting through phone (78\%) was preferred over-reporting through specific forms (10\%). To conclude, our study emphasizes that public participation and awareness are crucial in strengthening the existing system of Pharmacovigilance. 
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Adverse drug reaction (ADR),\newline Pharmacovigilance,\newline Awareness,\newline Side-effects
\end{keywords}
\twocolumn[ \maketitle {\printKwdAbsBox}]
\makeatletter{\raggedright\textsuperscript{*}Corresponding Author\par Name:\ Yamuna~Devi~M.~S~\\ Phone:\ 9865943043~\\  Email:\ dr.yamuna14@gmail.com
        \par}\vspace*{-11pt}\hrulefill\par{\fontsize{12}{14}\selectfont ISSN: 0975-7538}\par% 
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\section{Introduction}
Globally, adverse drug reactions continue to be one of the major causes of mortality and morbidity \unskip~\citep{1057545:21854675,1057545:21853360}. Drugs, when invented, were considered a boon to the mankind as it fights against disease and lessens suffering. However, like other useful things, medicines come with potential risks called Adverse Drug Reactions (ADRs). The severity of such reactions may be mild or severe, and they may lead to disability or even death. ADRs are often referred to as ``a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man'' \unskip~\citep{1057545:21853348}. A study done in North India showed that ADRs were the cause of admissions in 6.89\% of hospitalized patients, and around three-fourth of them were found to be of moderate severity. 

The median length of hospital stay was around 5 days and the average cost incurred per patient was around 6000 INR (150 USD), thus confirming that ADRs prolong the stay in the hospital, adding to the treatment cost and increasing the economic burden. Of the total ADRs reported, a whopping 59\% were found to be avoidable \unskip~\citep{1057545:21853363}.

A recent meta-analysis verifies that preventable ADRs are a greater burden to healthcare globally. Among both out-patients and in-patients, around 50\% of ADRs were preventable, emphasizing the importance of preventive strategies \unskip~\citep{1057545:21853362}. Spontaneous reporting system (SRS) of ADRs is the most essential component of drug safety. Under-reporting of ADRs is dauntingly enormous and has become a serious health concern both globally and nationally. 

In a study done among physicians in Kolkata, the majority of them quoted the reason for not reporting as lack of time \unskip~\citep{1057545:21853350}. Consumers also have a major role to play in the Pharmacovigilance. Globally about 44 countries have the system of ADR reporting by consumers.

However, their contribution is much less when compared to those reported by health care professionals. It is even more less in India, making only up to 01 \% of the total ADRs reported \unskip~\citep{1057545:21853345}.

Furthermore, Increase in use of over-the-counter drugs and counterfeit medications in the country also increases the risk of adverse effects. Considering such an alarming situation in India, it is vital to increase the awareness among the general public about the system of Pharmacovigilance. Though there a number of studies that assessed the awareness among health care professionals, only a very few studies have assessed the same among consumers. 

Hence, the objective of this study was to determine the awareness about the adverse drug reaction reporting system in our country among the consumers.
    
\section{Materials and Methods}
This questionnaire-based cross-sectional study was done in and around Saveetha Medical College\& Hospital, Thandalam, Chennai, over a period of 08 months between September 2019 to April 2020 after the approval of the Institutional Review Board. The study included the general population in South India who were {\textgreater}18 years of age, inclusive of both genders, while those who refused consent were excluded. 

The participation was purely voluntary, and confidentiality was maintained throughout the course of the study. All the participants who consented were briefed about the study. A pre-tested semi-structured self-administered questionnaire containing 20 questions relating to adverse drug reactions and ADR reporting was used to assess the awareness of the participants. 

The resultant data was analyzed descriptively using SPSS statistical software version 24 and results interpreted. 
    
\section{Results and Discussion}
A total of 360 participants were recruited and given questionnaires and around 338 completed questionnaires were received. The overall response rate was 93.8\%. 


\begin{table*}[!htbp]
\caption{\boldmath {Demographical Details} }
\label{tw-19e099fab101}
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\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack  S. No. & \cAlignHack Parameters & \cAlignHack  & \cAlignHack Percentage\\
\tblmidrule 
\multicolumn{1}{p{\dimexpr(.109\linewidth-2\tabcolsep)}}{\multirow{3}{\linewidth}{\cAlignHack 1. }} &
  \multicolumn{1}{p{\dimexpr(.38269999999999996\linewidth-2\tabcolsep)}}{\multirow{3}{\linewidth}{\cAlignHack Age }} &
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  \cAlignHack 10.65 \\
 &
   &
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 &
   &
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\multicolumn{1}{p{\dimexpr(.109\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{\cAlignHack 2.}} &
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 &
   &
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\multicolumn{1}{p{\dimexpr(.109\linewidth-2\tabcolsep)}}{\multirow{4}{\linewidth}{\cAlignHack 3.}} &
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 &
   &
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   &
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   &
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   &
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   &
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 &
   &
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   &
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   &
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   &
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\end{table*}
Table~\ref{tw-19e099fab101} shows the demographic details of the study sample. Among the respondents, 44\% were males, and 55\% were females, and their age group ranged between 21 and 68 years with a mean age of 35.62 (SD = 10.43) years. The majority of them were graduates, married and were employed in a non-health care related jobs. Almost half of the respondents were residing at locations less than 5 km from the health care facility.

Table~\ref{tw-c017435ff7dd} summarizes the responses provided by the participants reflecting their awareness about the ADR reporting system in India. It was surprising to find that more than 80\% of the study population was unaware of the PvPI, but nearly three-fourth of them had the knowledge about ADRs, and more than half of them felt that it was harmful. 

Similar results were demonstrated in a study where it was found that \textless\ 05\% of participants had heard of Pharmacovigilance, and 97.1\% felt it is essential to report ADRs. Counselling by pharmacists was the preferred way of public education (25.6\%). \unskip~\citep{1057545:21853351}

Our results were also consistent with a similar study done in the country, which showed that 98.8 percent of consumers lacked awareness about PvPI. The preferred method of reporting was through the toll-free number. \unskip~\citep{1057545:21853346}

A majority (39\%) of them preferred asking their doctors about these adverse reactions. It was shocking to find that the physicians / pharmacists of 54\% of respondents never educated them about ADR reporting. Reporting through the phone was the preferred method of reporting by more than 75\% of the participants. These results were consistent with a study done in AIIMS, New Delhi, where they found 74\% awareness among consumers, but only 8.9 \% had the idea of reporting ADRs, and 73\% felt only doctors are responsible to report the same. \unskip~\citep{1057545:21853345}.

Although 98\% of the respondents in our study felt that it is important to report ADRs and 95\% thought that it will help the community, only 26 \% were aware of the availability of medicine side-effect reporting form. Almost all (98\%) the respondents were of the opinion that it is important to instruct the patients about ADR and more than three-fourth of them had the habit of asking their physicians about it (Figure~\ref{f-b5914be7ad63}).

When questioned about the ways to improve the reporting of ADRs, more than half of them felt that increasing the awareness will improve the system, and 15\% wanted to make the report process easier. (Figure~\ref{f-0c734b32fe4a})

Figure~\ref{f-848954401733} summarizes the obstacles people face while reporting, where we found that the majority lacked the time to report, and 22\% were unaware of the reporting process.

Though the NCC has launched the facility of reporting through a toll-free number and a mobile App, 19\% of the population had no awareness about the telephonic reporting, and 89\% dint know about the PvPI Android application. A recent review shows that, though India has more than 200 ADR monitoring centres, our contribution to the WHO-UMC database was only about 0.2\% which needs to be improved. Positive experiences were seen in countries where patients / consumers were involved in the pharmacovigilance. Less than 12\% of the ADRs reported to PvPI comes from consumers, which is meagre \unskip~\citep{1057545:21853349}.

Another study found the reporting by non-HCPs to be only 0.016\%, and the reasons quoted for non-reporting included inadequate knowledge, lack of feedback and financial incentives etc., which was consistent with our findings \unskip~\citep{1057545:21853344}. 

In contrast to this, another study showed that almost 80\% of participants dint feel that financial incentives could improve the process \unskip~\citep{1057545:21853352}. 

A small study sample confined to a specific region of South India limits the scope of our study. However, this is one among the very few studies done in South India. Every participant was educated about ADR and the reporting process at the end of the survey; interestingly, many found this study useful and wanted to report ADRs in near future (97\%).


\begin{ThreePartTable}

\centering 
\begingroup
\makeatletter\if@twocolumn\@ifundefined{theposttbl}{\gdef\TwoColDocument{true}\onecolumn\onecolumn}{}\fi\makeatother 
\begin{TableNotes}\footnotesize 
    
\item{*PvPI - Pharmacovigilance Programme of India; **ADR-Adverse Drug Reaction}
\end{TableNotes}\setlength\LTcapwidth{\textwidth}
\begin{longtable}{p{\dimexpr.09040000000000001\linewidth-2\tabcolsep}p{\dimexpr.3677\linewidth-2\tabcolsep}p{\dimexpr.4331\linewidth-2\tabcolsep}p{\dimexpr.10879999999999999\linewidth-2\tabcolsep}}
\caption{\boldmath {Questionnaire} }
\label{tw-c017435ff7dd}
\def\arraystretch{1.1}\\\endfirsthead \hline \noalign{\vskip3pt} \noalign{\textit{Table \thetable\ continued}} \noalign{\vskip3pt} 
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack S. No. & \cAlignHack Questions & \cAlignHack Response & \cAlignHack Percentage (\%)\\
\tblmidrule \endhead \hline \noalign{\vskip3pt} \noalign{\textit{\hfill Continued on next page}} \noalign{\vskip3pt} \endfoot \insertTableNotes \endlastfoot 
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack S. No. & \cAlignHack Questions & \cAlignHack Response & \cAlignHack Percentage (\%)\\
\tblmidrule 
\cAlignHack 1. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{Have you heard about the PvPI*?}} &
  Yes &
  \cAlignHack 19\\
\cAlignHack  &
   &
  No &
  \cAlignHack 81\\
 &
   &
   &
  \\
\cAlignHack 2. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{4}{\linewidth}{ADR** means?}} &
  Any untoward consequence from the medication  &
  \cAlignHack 15\\
\cAlignHack  &
   &
  Unforeseen reaction after taking the normal dose &
  \cAlignHack 66\\
\cAlignHack  &
   &
  Predictable response after taking the normal dose &
  \cAlignHack 08\\
\cAlignHack  &
   &
  No idea &
  \cAlignHack 11\\
 &
   &
   &
  \\
\cAlignHack 3. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{4}{\linewidth}{Do you think that an ADR is harmful?}} &
  Very harmful &
  \cAlignHack 31\\
\cAlignHack  &
   &
  Somewhat serious &
  \cAlignHack 57\\
\cAlignHack  &
   &
  Not harmful &
  \cAlignHack 02\\
\cAlignHack  &
   &
  No idea &
  \cAlignHack 10\\
 &
   &
   &
  \\
\cAlignHack 4. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{4}{\linewidth}{Which age group can be harmed from ADR?}} &
  Children &
  \cAlignHack 31\\
\cAlignHack  &
   &
  Adult &
  \cAlignHack 15\\
\cAlignHack  &
   &
  Elderly &
  \cAlignHack 24\\
\cAlignHack  &
   &
  No idea &
  \cAlignHack 30\\
 &
   &
   &
  \\
\cAlignHack 5. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{Is it significant to gather any information connected to ADR?}} &
  Yes &
  \cAlignHack 98\\
\cAlignHack  &
   &
  No &
  \cAlignHack 02\\
 &
   &
   &
  \\
\cAlignHack 6. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{If you suffer from a non-serious ADR, would you report that?}} &
  Yes &
  \cAlignHack 74\\
\cAlignHack  &
   &
  No &
  \cAlignHack 26\\
 &
   &
   &
  \\
\cAlignHack 7. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{Do you think that our community will profit from ADR reporting?}} &
  Yes &
  \cAlignHack 95\\
\cAlignHack  &
   &
  No &
  \cAlignHack 05\\
 &
   &
   &
  \\
\cAlignHack 8. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{Is it important to instruct patients about ADR and how to report one?}} &
  Yes &
  \cAlignHack 98\\
\cAlignHack  &
   &
  No &
  \cAlignHack 02\\
 &
   &
   &
  \\
\cAlignHack 9. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{Do you ask about the adverse effects of your medications?}} &
  Yes &
  \cAlignHack 76\\
\cAlignHack  &
   &
  No &
  \cAlignHack 24\\
 &
   &
   &
  \\
\cAlignHack 10. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{5}{\linewidth}{Which of the following resources do you use to search about an ADR? (Select any if applicable)}} &
  Asking your doctor who prescribed the drug &
  \cAlignHack 39\\
\cAlignHack  &
   &
  Asking the pharmacist who dispensed the drug &
  \cAlignHack 07\\
\cAlignHack  &
   &
  From books or magazines &
  \cAlignHack 15\\
\cAlignHack  &
   &
  From Internet &
  \cAlignHack 25\\
\cAlignHack  &
   &
  From the pamphlet that comes with the medication &
  \cAlignHack 15\\
 &
   &
   &
  \\
\cAlignHack 11. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{Does your physician or pharmacist ask you to report any ADR that may happen to you?}} &
  Yes &
  \cAlignHack 46\\
\cAlignHack  &
   &
  No &
  \cAlignHack 54\\
 &
   &
   &
  \\
 &
   &
   &
  \\
 &
   &
   &
  \\
\cAlignHack 12. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{4}{\linewidth}{Which of the following ways do you prefer to report ADRs? (Select any if applicable)}} &
  By phone &
  \cAlignHack 78\\
\cAlignHack  &
   &
  Fill a specific form and send it manually &
  \cAlignHack 10\\
\cAlignHack  &
   &
  By using the internet &
  \cAlignHack 04\\
\cAlignHack  &
   &
  Using a specific application on smartphones &
  \cAlignHack 08\\
 &
   &
   &
  \\
\cAlignHack 13. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{4}{\linewidth}{Who should be notified about any serious ADR? (Select any if applicable)}} &
  Doctor &
  \cAlignHack 95\\
\cAlignHack  &
   &
  Pharmacist &
  \cAlignHack 02\\
\cAlignHack  &
   &
  Nurses &
  \cAlignHack 02\\
\cAlignHack  &
   &
  Pharmacovigilance Center &
  \cAlignHack 01\\
 &
   &
   &
  \\
\cAlignHack 14. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{Are you aware of the Medicine side-effect reporting form available for consumers to report ADRs?}} &
  Yes &
  \cAlignHack 26\\
\cAlignHack  &
   &
  No &
  \cAlignHack 74\\
 &
   &
   &
  \\
 &
   &
   &
  \\
\cAlignHack 15. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{Are you aware of the availability of the ADR PvPI android App to report ADRs?}} &
  Yes &
  \cAlignHack 11\\
\cAlignHack  &
   &
  No &
  \cAlignHack 89\\
 &
   &
   &
  \\
 &
   &
   &
  \\
\cAlignHack 16. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{3}{\linewidth}{Who is responsible to report any possible ADR to PvPI?}} &
  Health care workers &
  \cAlignHack 51\\
\cAlignHack  &
   &
  Consumers (patients) &
  \cAlignHack 25\\
\cAlignHack  &
   &
  Both &
  \cAlignHack 24\\
 &
   &
   &
  \\
\cAlignHack 17. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{4}{\linewidth}{How to motivate the consumers to report any ADR? (Select any if applicable)}} &
  Make the reporting process easier &
  \cAlignHack 15\\
\cAlignHack  &
   &
  Increase the awareness about ADR reporting system &
  \cAlignHack 53\\
\cAlignHack  &
   &
  Make it mandatory for patients &
  \cAlignHack 13\\
\cAlignHack  &
   &
  Provide a 24/7 Toll-free number to report any ADR &
  \cAlignHack 19\\
 &
   &
   &
  \\
\cAlignHack 18. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{7}{\linewidth}{What prevents you from reporting ADRs? (Select any if applicable)}} &
  The ADR resolved &
  \cAlignHack 12\\
\cAlignHack  &
   &
  The ADR is not serious &
  \cAlignHack 12\\
\cAlignHack  &
   &
  Common ADR &
  \cAlignHack 08\\
\cAlignHack  &
   &
  Does not know about the reporting system &
  \cAlignHack 22\\
\cAlignHack  &
   &
  Lack of feedback on ADRs submitted  &
  \cAlignHack 07\\
\cAlignHack  &
   &
  Difficulty with the reporting process &
  \cAlignHack 07\\
\cAlignHack  &
   &
  Lack of time to report &
  \cAlignHack 32\\
 &
   &
   &
  \\
\cAlignHack 19. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{5}{\linewidth}{What advantages the community can get from the ADR reporting system? (Select any if applicable)}} &
  Improves drug safety &
  \cAlignHack 15\\
\cAlignHack  &
   &
  Increase the awareness about ADRs among the community &
  \cAlignHack 29\\
\cAlignHack  &
   &
  Improves our quality of life &
  \cAlignHack 47\\
\cAlignHack  &
   &
  A solution for the low reporting issue &
  \cAlignHack 4\\
\cAlignHack  &
   &
  Protecting the human's rights &
  \cAlignHack 6\\
 &
   &
   &
  \\
\cAlignHack 20. &
  \multicolumn{1}{p{\dimexpr(.3677\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{Will you report any ADR in future?}} &
  Yes &
  \cAlignHack 97\\
\cAlignHack  &
   &
  No &
  \cAlignHack 3\\
\tblbottomrule 
\end{longtable}
\endgroup
\end{ThreePartTable}

\makeatletter\@ifundefined{TwoColDocument}{}{\twocolumn}\makeatother 

\bgroup
\fixFloatSize{images/28e70593-688c-461a-abd6-2cb974043b70-upicture1.png}
\begin{figure}[!htbp]
\centering \makeatletter\IfFileExists{images/28e70593-688c-461a-abd6-2cb974043b70-upicture1.png}{\includegraphics{images/28e70593-688c-461a-abd6-2cb974043b70-upicture1.png}}{}
\makeatother 
\caption{\boldmath {Attitude of participants towards ADR reporting}}
\label{f-b5914be7ad63}
\end{figure}
\egroup

\bgroup
\fixFloatSize{images/31ff11b8-1090-4c28-b655-a6108825000c-upicture2.png}
\begin{figure}[!htbp]
\centering \makeatletter\IfFileExists{images/31ff11b8-1090-4c28-b655-a6108825000c-upicture2.png}{\includegraphics{images/31ff11b8-1090-4c28-b655-a6108825000c-upicture2.png}}{}
\makeatother 
\caption{\boldmath {Ways to improve ADR reporting}}
\label{f-0c734b32fe4a}
\end{figure}
\egroup

\bgroup
\fixFloatSize{images/b4f8880e-623d-49c1-ad1e-562160a43d3a-upicture3.png}
\begin{figure}[!htbp]
\centering \makeatletter\IfFileExists{images/b4f8880e-623d-49c1-ad1e-562160a43d3a-upicture3.png}{\includegraphics{images/b4f8880e-623d-49c1-ad1e-562160a43d3a-upicture3.png}}{}
\makeatother 
\caption{\boldmath {Obstacles in reporting ADRs}}
\label{f-848954401733}
\end{figure}
\egroup

    
\section{Conclusion}
Every marketed drug comes with the potential to cause unpredicted side effects. The role of consumers in ADR reporting cannot be ignored. Though they cannot replace the existing reporting system, they may definitely be relied upon to strengthen the system. Patients' inability to recognise ADRs and causally link them to the drug is one of the most important reasons for under-reporting, which is evident from our study, which clearly shows that though the participants had a fair knowledge of ADRs and showed a positive attitude towards ADR reporting, their awareness about pharmacovigilance was very poor. This largely emphasizes the need for educating the general public about the detection and reporting of ADRs through health programmes, thus improving drug safety.

\textbf{Funding Support}

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

\textbf{Conflict of Interest}

The authors declare that they have no conflict of interest for this study.
    

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