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\def\RunningAuthor{Dheyaa J. Kadhim et al.}
\firstPage{129}
\articleType{Original Article}
\receivedDate{09.05.2019}
\acceptedDate{22.08.2019}
\revisedDate{16.08.2019}
\journalVolume{2020, 11}
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\title{\textbf{Fifth stage pharmacy students' knowledge and perceptions about generic medicines}}
\author{Dheyaa~J.~Kadhim\textsuperscript{*}\textsuperscript{1},  
            Fajir~I.~Ahmed\textsuperscript{2}, 
            Ronak~A.~Hussein\textsuperscript{2}~\\[5pt]{\textsuperscript{1}Department of clinical pharmacy, College of Pharmacy, University of Baghdad, Baghdad, Iraq}~\\{\textsuperscript{2}College of Pharmacy, University of Baghdad, Baghdad, Iraq}}

\begin{abstract}
The aim of the current study was to evaluate the knowledge and perception of the fifth stage pharmacy students (college of pharmacy/ University of Baghdad /Iraq) regarding generic medicines. This study is a cross-sectional study carried in a college of pharmacy /University of Baghdad during the period from (November 2018- March 2019). The number of students included in the current study was 168 undergraduate stager pharmacists. A questionnaire was used to collect data of the study. Nearly 86\% of the students said that they had heard of generic and brand medicines, and pharmacy was the main source of knowledge regarding generic medicines (66.7\%). About (33.3\%) of the respondents agreed that generic medicines are bioequivalent to brand medicine. However, (38.1\%) perceived generic medicines might not be the therapeutic equivalent of brand medicines. In addition, (35.1\%) of the respondents believed that generics are lower in quality, which is why they are cheap and produce more side effects. Moreover, (41.1\%) of the sample agreed that generic medicines should be avoided in life-threating situations. About (56.5 \%) of the students were found to have a poor level of perception regarding the use of generic medicines.\textbf{\space }The majority of the fifth stage pharmacy students (college of pharmacy/ University of Baghdad /Iraq) were found to have a good knowledge but a poor level of perception about the use of generic medicines.  
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Iraq,\newline generic medicines,\newline brand medicines,\newline pharmacy students,\newline perception
\end{keywords}
\twocolumn[ \maketitle {\printKwdAbsBox}]
\makeatletter{\raggedright\textsuperscript{*}Corresponding Author\par Name:\ Dheyaa~J.~Kadhim~\\ Phone:\ ~\\  Email:\ dhia\_pharma@yahoo.com
        \par}\vspace*{-11pt}\hrulefill\par{\fontsize{12}{14}\selectfont ISSN: 0975-7538}\par% 
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\section{Introduction}
According to the United States Food and Drug Administration (FDA), a generic drug is defined as a drug that has the same characteristics as a branded drug in active ingredient, strength, route of administration, safety, dosage form, performance, quality, and intended use. Generic drugs need to be bioequivalent to the branded drug to be licensed for marketing \unskip~\citep{602620:14037727}. Using generic medicines (GMs) is considered a cost-effective approach to curtail health care expenditures on pharmaceuticals, allowing substantial savings to both popu\-lation and the government \unskip~\citep{602620:14037720,602620:14037724}. Pharmacists now play a very important role in reducing medical expenses since it has been found that patients more commonly attend pharmacies (at a rate of 42\%) than hospitals and clinics in Malaysia \unskip~\citep{602620:14037715}. Study by Hassali et al. conducted in eight countries (the US, United Kingdom, Finland, Sweden, Australia, Japan, Malaysia, and Thailand) in 2013, as well as the study by Babar et al. conducted in Malaysia in 2010, suggest that pharmacists are generally in favor of promoting the use of GMs to their clients \unskip~\citep{602620:14037716,602620:14037723}. In another study in Australia, Hassali et al. noted that brand-name drugs on prescription can be substituted for GMs following advice from the pharmacist and assurances of efficacy \unskip~\citep{602620:14037725,602620:14037721}. 

Pharmacy students are the future health-care practitioners, and they are expected to have considerable knowledge about medicine. Therefore, it is crucial to taught the concept of GMs in their academic curricula, which in turn would be expected to positively influence the future practice as pharmacists \unskip~\citep{602620:14037714}. Studies done in Bangladesh \unskip~\citep{602620:14037726}, Australia \unskip~\citep{602620:14037722}, and Iraq \unskip~\citep{602620:14037729} on future medical and pharmacy practitioners showed knowl\-edge gaps and lack of understanding of important issues related to the GMs. It is, therefore, important to improve and update the knowledge of the future health-care practitioners and to promote the notion of GMs among them in order to rationalize and optimize the drug utilization in the community. 

Keeping in mind the importance of this problem, the aim of the current study was to evaluate the knowledge and perception of the fifth stage pharmacy students (college of pharmacy/ University of Baghdad /Iraq) regarding generic medicines.  
    
\section{Materials and Methods}
The current study is a cross-sectional study carried in a college of pharmacy /University of Baghdad during the period from (November 2018- March 2019). \textbf{\space }

\textbf{Study sample}

The number of students included in the current study was 168 undergraduate stager pharmacists. Criteria for inclusion in the current study were stager pharmacy students who willing to participate.  


\bgroup
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\centering \makeatletter\IfFileExists{images/dba43da1-e892-44d7-9c20-1427176c4866-upicture1.png}{\includegraphics{images/dba43da1-e892-44d7-9c20-1427176c4866-upicture1.png}}{}
\makeatother 
\caption{\boldmath {Categorical distribution of respondents' perception about generic medicines. [Poor perception (0{\textendash}3), Moderate perception (4{\textendash}6), Good perception (7{\textendash}10)]}}
\label{f-14871f63dc7a}
\end{figure}
\egroup
\textbf{Study tool} \textbf{\space }

A questionnaire was used to collect data of the current study. The questionnaire composed of three sections. The first one focused on the demography of the students (age and sex). The second section concerned on knowledge of GMs. The third section evaluates perceptions about GMs. A 5 item Likert scale was used to record perceptions. To calculate student perceptions in a measurable form, scoring of students' responses was done for each statement in section three. For items 3, 5, 6, 8, 9, and 10, disagree and strongly disagree were considered the answers that give a positive perception (`right' answers). In contrast, for items 1, 2, 4, and 7 agree and strongly agree were the (`right' answers). Every right answer is graded as 1 while answers showing negative perception (`wrong' answers), or if the respondent don't know, were graded as zero. In addition, the scores were divided into 3 levels. Those scoring (0{\textendash}3) were considered as poor perception. Those scoring (4{\textendash}6) were considered as a moderate perceptions, and those scoring (7{\textendash}10) were considered as a good perception about GMs \unskip~\citep{602620:14037726}. 

\textbf{Ethical approval } \textbf{\space }

The study protocol was approved by the Department of Clinical Pharmacy, Baghdad University, Baghdad, Iraq. In addition, verbal consent was also obtained from the students who participated in the study. 

\textbf{Statistical analysis} \textbf{\space }

Analysis of data was carried out using Microsoft-excel. Data were presented in simple measures of frequency, percentage, mean, standard deviation. 
    
\section{Results and Discussion}
A total of n = 168 respondents (out of 200) were willing to participate in the study, making a response rate of 84\%. Of these, 103 (61.3\%) were female, and 65 (38.7\%) were male, as shown in Table~\ref{tw-320df5919241}. 


\begin{table*}[!htbp]
\caption{\boldmath {Students' demographics and response rate} }
\label{tw-320df5919241}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.5554\linewidth-2\tabcolsep}p{\dimexpr.4446\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\textbf{Variable} & \textbf{Value}\\
\tblmidrule 
Response rate &
  (168/200) 84.0\%\\
Age (years), mean \ensuremath{\pm} SD &
  22.7 \ensuremath{\pm} 1.7\\
Gender &
  \\
 Female &
  103 (61.3\%)\\
 Male &
  65 (38.7\%)\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Students' general knowledge about generic medications and views about the definition of generic and brand medication } }
\label{tw-62a64d19dfc0}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.7976\linewidth-2\tabcolsep}p{\dimexpr.20240000000000002\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\textbf{``Have you ever heard of branded medicine (before this time)? ''} & \textbf{n (\%)}\\
\tblmidrule 
 No &
  22 (13.1\%)\\
 Yes &
  146 (86.9\%)\\
\textbf{``Have you ever heard of generic medicine (before this time)? '' } &
  \\
 No &
  23 (13.7\%)\\
 Yes &
  145 (86.3\%)\\
\textbf{``If you heard of generic medicine. What is the source? ''} &
  \\
 Teacher &
  22 (13.1\%)\\
 Book  &
  10 (6.0\%)\\
 Pharmacy  &
  112 (66.7\%)\\
 Social media &
  24 (14.3\%)\\
\textbf{``A drug that is produced and distributed without patent protection is? ''} &
  \\
 Generic &
  126 (75.0\%)\\
 Branded &
  42 (25.0\%)\\
\textbf{``A drug that is the property of the company that manufactures it through research and development and markets it under a patent. No other companies are allowed to produce it until the patent expires is? ''} &
  \\
 Generic &
  27 (16.1\%)\\
 Branded &
  141 (83.9\%)\\
\textbf{``Drugs manufactured by local/national pharmaceuticals companies are''} &
  \\
 Generic &
  120 (71.4\%)\\
 Branded &
  48 (28.6\%)\\
\textbf{``Drugs manufactured by multinational companies under propriety rights are''} &
  \\
 Generic &
  55 (32.7\%)\\
 Branded &
  113 (67.3\%)\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Students' perception about generic medicines} }
\label{tw-67f49275e745}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.3422\linewidth-2\tabcolsep}p{\dimexpr.1312\linewidth-2\tabcolsep}p{\dimexpr.0896\linewidth-2\tabcolsep}p{\dimexpr.13349999999999998\linewidth-2\tabcolsep}p{\dimexpr.1358\linewidth-2\tabcolsep}p{\dimexpr.1677\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\textbf{Statement} & \textbf{Strongly agree} & \textbf{Agree} & \textbf{Don't know} & \textbf{Disagree } & \textbf{Strongly disagree }\\
\tblmidrule 
``A generic medicine is bioequivalent to a brand-name medicine''. &
  13 (7.7\%) &
  56 (33.3\%) &
  34 (20.2\%) &
  54 (32.1\%) &
  11 (6.5\%)\\
``Generic products of a particular medicine are therapeutically equivalent to the innovator branded product''. &
  7 (4.2\%) &
  56 (33.3\%) &
  36 (21.4\%) &
  64 (38.1\%) &
  5 (3.0\%)\\
``Branded medicines are more safe than generic medicines because they have been tested through bioequivalence studies''. &
  53 (31.5\%) &
  64 (38.1\%) &
  20 (11.9\%) &
  31 (18.5\%) &
  0 (0\%)\\
``Generic medicines are in the same dosage form (e.g. tablet, capsule) as the brand-name medicine''. &
  27 (16.1\%) &
  76 (45.2\%) &
  31 (18.5\%) &
  29 (17.3\%) &
  5 (3.0\%)\\
``Medicines manufactured by multinational companies are more reliable than those manufactured by national firms''. &
  35 (20.8\%) &
  83 (49.4\%) &
  32 (19.0\%) &
  15 (8.9\%) &
  3 (1.8\%)\\
``Branded medicines should be preferred over generic medicine in life-threatening conditions''. &
  69 (41.1\%) &
  49 (29.2\%) &
  27 (16.1\%) &
  16 (9.5\%) &
  7 (4.2\%)\\
``Cost of treatment will be less if generic medicines are used''. &
  61 (36.3\%) &
  58 (34.5\%) &
  24 (14.3\%) &
  19 (11.3\%) &
  6 (3.6\%)\\
``Generic medicines are of inferior quality to brand-name drugs: that why they are less expensive''. &
  17 (10.1\%) &
  59 (35.1\%) &
  66 (39.3\%) &
  21 (12.5\%) &
  5 (3.0\%)\\
``Generic medicines produce more side effects than brand-name medicines''. &
  8 (4.8\%) &
  50 (29.8\%) &
  50 (29.8\%) &
  54 (32.1\%) &
  6 (3.6\%)\\
``Brand-name medicines are required to meet higher safety standards than generic medicines''. &
  42 (25.0\%) &
  58 (34.5\%) &
  37 (22.0\%) &
  28 (16.7\%) &
  3 (1.8\%)\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}
\textbf{Respondent general knowledge about generic medications}

Nearly 86\% of the students said that they had heard of brand and GMs, and pharmacy was the main source of knowledge about GMs (66.7\%). Four statements were given to the students to distinguish between brand and GMs. The majority of respondents were able to distinguish between brand and GMs based on patent and propriety issues. However, a lower percent was recorded regarding the manufacturing difference between GMs and brand medicines. The responses are shown in Table~\ref{tw-62a64d19dfc0}.  

\textbf{Students' perceptions of GMs } \textbf{\space }

Ten statements were used to assess the respondents' perceptions of GMs. It was noticed that about (33.3\%) of the respondents agreed that GMs are bioequivalent to brand medicine. However, about (38.1\%) perceived that GMs may not be therapeutically equivalent to brand medicines. In addition, about (35.1\%) of the respondents believed that GMs are inferior in quality, which is why they are cheap and have more side effects. Moreover, about (41.1\%) of the participants agreed that GMs should not be considered in life-threating situations (Table~\ref{tw-67f49275e745}). 

To quantify respondents' perceptions in a more measurable form, scoring of the responses were done. Most of the respondents (56.55\%) were found to have a poor level of perception about the use of GMs (Figure~\ref{f-14871f63dc7a}). 

Pharmacists play a key role in drug therapy and have a professional responsibility that can help patients in the selection of safe, effective, and inexpensive drug products. In addition, pharmacists having adequate knowledge, a positive attitude, and practice about GMs may influence the selection of pharmaceutical products and promote access to medicines \unskip~\citep{602620:14037717}. Healthcare students are the future prescribers, dispensers, and patients' advisors regarding medications, which makes them an important study target \unskip~\citep{602620:14037728}. 

Nearly 86\% of the students said that they had heard of brand and GMs, and pharmacy was the main source of knowledge about GMs (66.7\%). Of concern is that the low (13.1\%) of respondents who stated that teachers were their main source of knowledge about GMs, suggesting the need for incorporating such an important topic in the undergraduate study program. The pharmacy was the main source of knowledge about GMs may be due to that the problem of generic substitution is frequently encountered nowadays in the Iraqi community pharmacy were the students had been trained for two-period during the summer holiday. Nearly similar results were obtained in one study among medical and pharmacy students' in Bangladesh where 87\% heard branded medicine and 85.5\% heard GMs \unskip~\citep{602620:14037726}. However, lower percent (67.3\%) know that drugs produced by multinational companies under propriety rights are branded medicines.  

In addition to evaluating knowledge about GMs, another aim of this study was to evaluate the students' perceptions of GMs. The current study showed that only (33.3\%) of the respondents agreed that GMs are bioequivalent to brand medicine. This result was in line with the results of sharrad, \textit{et al}. among final year medical students in Iraqi, where more than 70\% of the respondents did not believe that GMs were therapeutically equivalent to the corresponding brand name medicines \unskip~\citep{602620:14037729}. This is due to bad experiences with regard to the GMs used in Iraq over the last 20 years. During this time, most medicines which have been imported into the country have not undergone a quality control check, due to the shortage of medicine as a result of an international embargo which has been in place since 1990' \unskip~\citep{602620:14037719} and the uncontrolled drug market following 2003 (invasion of Iraq).  

A generic drug is proven as bioequivalent to the innovator brand, where both delivered the active ingredient to the bloodstream at the same rate and to the same extent \unskip~\citep{602620:14037718}. 

In general, the current study showed that respondents were concerned more about the quality and safety of GMs. About 69.6\% of respondents perceived that brand medicines are more safe due to extensive bioequivalence studies. Almost the same number (70.2\%) preferred the use of brand medicines produced by multinational companies for reasons of reliability. Moreover, 69. 3\% of respondents were not in favor of recommending GMs in life-threatening situations. These findings agree with other studies that showed medical students' hesitation regarding the use of GMs based on the assumption that they are low in price, giving the belief that they are lower in quality and can produce more side effects than brand medicines \unskip~\citep{602620:14037714}.  In addition, (56.55\%) of respondents were found to have a poor perception level about the use of GMs. The findings of the current study are not in line with those of the previous study, where (63.29\%) of respondents were found to have a moderate perception level about the use of GMs \unskip~\citep{602620:14037726}. Pharmacy curricula should address all these issues, which will help build confidence in generic medicines and enhance the GMs use in Iraq. 
    
\section{Conclusions}
The majority of the fifth stage pharmacy students (college of pharmacy/ University of Baghdad /Iraq) were found to have a good knowledge but a poor level of perception about the use of GMs. 

\textbf{Limitations of the study} \textbf{\space }

This study has several limitations, limiting the research population to fifth stage pharmacy students (college of pharmacy/ University of Baghdad /Iraq), using the limited questions to evaluate knowledge, the unwillingness of some students to cooperate, and lack of enough researches conducted inside the country regarding the research topic. \textbf{\space }
    

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