DISPENSING OF ANTIBIOTICS WITHOUT PRESCRIPTION

AMONG THE COMMUNITY PHARMACIES IN RUPANDEHI

DISTRICT OF NEPAL

(A Thesis for Bachelor’s Degree)

A Thesis submitted to Pokhara University in a Partial Fulfillment for the Degree of

Bachelor of Pharmaceutical Sciences

Submitted by:

Binita Paudel
Gajendra Narayan Chaudhary
Keshav Prasad Chaudhary
Puspa Pant
Shivendra Kumar Jaiswal

Submitted to:

Department of Pharmacy
Crimson College of Technology, Faculty of Health Sciences,
Pokhara University, Nepal

2022
 THESIS APPROVAL
The thesis entitled “Dispensing of antibiotics without prescription among the
community pharmacies in Rupandehi district of Nepal” submitted by Miss Binita
Paudel, Mr. Gajendra Narayan Chaudhary, Mr. Keshav Prasad Chaudhary, Miss
Puspa Pant and Mr. Shivendra Kumar Jaiswal in a partial fulfillment of the
requirements for the degree of Bachelor of Pharmaceutical Sciences has been evaluated
and approved.

…………………..
………………………

Mr. Nim Dangi chhetri Date

(External Examiner)
Assistant Professor
School of Health and Allied Sciences,
Pokhara University

………………………. …………………………….

Mr. Gautam Prasad Chaudhary Date

(Internal Examiner)

……………………… …………………………

Mr. Mohammad Mustafa Date

(Supervisor)

i
 DECLARATION
The results presented in the thesis entitled “Dispensing of antibiotics without
prescription among community pharmacies in Rupandehi district of Nepal” has
been entirely carried out under the guidance and supervision of Lecturer Mr.
Mohammad Mustafa, Department of Pharmaceutical Sciences, Crimson College of
Technology, Pokhara University, Devinagar, Rupandehi, Nepal.

We hereby declare that this work is our own work and that it contains no materials
which previously published. We have not used its materials for the award of any kind
and any other degree. Where other author’s sources of information have been used, they
have been acknowledged.

……………… ………………
Name: Binita Paudel Name: Gajendra Narayan Chaudhary
PU Reg. No. : 2017-04-75-0086 PU Reg. No. : 2017-04-75-0092
Symbol No. : 18170045 Symbol No. : 18170051

……………… ………………….
Name: Keshav Prasad Chaudhary Name: Puspa Pant
PU Reg. No. : 2017-04-75-0095 PU Reg. No. : 2017-04-75-0105
Symbol No. : 18170054 Symbol No. : 18170064

……………………

Name: Shivendra Kumar Jaiswal

PU Reg. No. : 2017-04-75-0112

Symbol No. : 18170072

ii
 CERTIFICATION
This is to certify that the thesis entitled “Dispensing of antibiotics without
prescription among the community pharmacies in Rupandehi district of Nepal”
submitted by Miss Binita Paudel, Mr. Gajendra Narayan Chaudhary, Mr. Keshav
Prasad Chaudhary, Miss Puspa Pant and Mr. Shivendra Kumar Jaiswal in a partial
fulfillment of the requirements for the degree of Bachelor of Pharmaceutical Sciences
was carried out under my guidance and supervision during all stages of planning,
execution and analysis.

The result of this work has not been previously submitted to any institution to acquire
any other academic degree or diploma.

……………………..

Mr. Mohammad Mustafa

Supervisor
Lecturer
Department of Pharmaceutical Sciences
Crimson College of Technology
Butwal-13, Devinagar
Pokhara University
Date:…………………

iii
 ACKNOWLEDGEMENT

We would like to express our gratitude to all the personalities whose precious help and
support made us able to successfully conduct this research.

Firstly, with immense pleasure, we express our sincere gratitude3 to our supervisor
Lecturer Mr. Mohammad Mustafa, Department of Pharmaceutical Science, Crimson
College of Technology, Pokhara University for his supervision guidance and support.

We would like to give our grateful to the PURC for the research approval and staffs who
were present in the community pharmacies for co-operating with us.

Our humble gratitude goes to Mr. Devi Bhandari, Principal, Crimson College of
Technology for his valuable support during our research work. We are very much
thankful to Coordinator of Pharmacy Department, Mr. Mukesh Kumar Chaudhary
Mr. Jitendra Pandey, Mr. Gautam Prasad Chaudhary, Mrs. Manju Kc Gyawali,
Mr. Asgar Ali Mikrani, Mr. Arjun Bhandari and all the health science department
staffs of Crimson College of Technology for their kind help. We sincerely thank all the
staffs of the community pharmacies which were we visited during our research for their
kind cooperation.

Finally, we would like to take this opportunity to thank all the persons who directly or
indirectly help us in our research work.

Sincerely,

Binita Paudel
Gajendra Narayan Chaudhary
Keshav Prasad Chaudhary
Puspa Pant
Shivendra Kumar Jaiswal

iv
 Table of Contents
ABSTRACT.....................................................................................................................vii
1 INTRODUCTION......................................................................................................1
1.1 Background..........................................................................................................1
1.2 Problem Statement...............................................................................................2
1.3 Rationale of the study..........................................................................................3
1.4 Objectives............................................................................................................5
1.4.1 General Objectives.......................................................................................5
1.4.2 Specific Objectives.......................................................................................5
2 LITERATURE REVIEW...........................................................................................6
2.1 Introduction.........................................................................................................6
2.2 Methods for the data collection used in the study:..............................................7
2.2.1 Self-Administrative Questionnaire...............................................................7
2.2.2 Simulated Clients method............................................................................7
2.2.3 Qualitative Structured Interview method.....................................................8
2.2.4 Semi-Structured Interview Scheduled method.............................................8
2.3 Antibiotic Resistance...........................................................................................9
2.3.1 Types of antibiotic resistance.......................................................................9
2.3.2 Factors causing Antibiotic Resistance........................................................10
2.4 Studies carried out.............................................................................................12
2.5 Studies on dispensing of antibiotics without prescription among community
pharmacies....................................................................................................................13
3 METHODOLOGY...................................................................................................20
3.1 Study design......................................................................................................20
3.2 Study site...........................................................................................................20
3.3 Study duration....................................................................................................20
3.4 Sample size........................................................................................................20
3.4.1 Inclusion criteria.........................................................................................21
3.4.2 Exclusion criteria........................................................................................21

v
 3.5 Sampling technique...........................................................................................21
3.6 Data collection technique..................................................................................22
3.7 Data collection tool/Study material...................................................................22
3.8 Method...............................................................................................................22
3.8.1 PHASE-I.....................................................................................................22
3.8.2 PHASE-II...................................................................................................23
3.8.3 PHASE-III..................................................................................................25
3.9 Operational definition........................................................................................26
4 RESULT...................................................................................................................27
4.1 Socio-Demographic Characteristics..................................................................27
4.1.1 Location......................................................................................................27
4.1.2 Qualification of the staffs present in the pharmacies.................................27
4.1.3 Distribution of working experiences of personnel.....................................30
4.1.4 Consultant Physician availability in pharmacy during visit (n=94)...........32
4.2 Cases (diseases) involved in our study..............................................................32
4.3 Dispensed drugs.................................................................................................33
4.4 Number of encounters that dispensed drugs......................................................33
4.5 Stages at which antibiotics were dispensed.......................................................34
4.6 Stages at which antibiotics dispensed (UTI, Diarrhea).....................................35
4.7 Drug categories based on the requirement of prescription................................36
5 DISCUSSION..........................................................................................................39
6 CONCLUSION........................................................................................................42
7 LIMITATIONS........................................................................................................43
8 RECOMMENDATION...........................................................................................44
9 REFERENCES MATERIALS.................................................................................45
9.1 References..........................................................Error! Bookmark not defined.
9.2 Annex (es)..........................................................................................................50

vi
ABSTRACT

Background

Antibiotics resistance is worldwide issue that is increasing at assorted rate in different

regions of the world. As per the Drugs act 2035, clause 17 and 27 of Nepal antibiotics
should be only prescribed by the medical doctor or Physician. Misuse of antibiotics has
commonly seen in our country due to self medication, improper dispensing and
prescribing pattern. The main aim of this study was to document the extent of and
motivation behinds non prescribed sale of antibiotics among the community pharmacies
in Rupandehi district.

Method

Cross study was conducted in community pharmacies of Rupandehi district using

simulated clients method. Two clinical cases scenarios uncomplicated UTI and watery
diarrhea was used. Data was collected by five simulated clients (three male watery
diarrhea and two female UTI) final year pharmacy student which were not identifiable
by the dispenser.

Result

Most of the pharmacies were located in urban areas. Among 94 pharmacies that we
selected, 82 pharmacies (dispensed at least one antibiotics without prescription in
community pharmacies. As soon as the symptoms were explained to the dispenser, the
majority of the dispenser (53.65%) dispensed the antibiotics without
prescription .Ciprofloxacin was the most commonly dispensed antibiotics.

vii
Conclusion

Majority of the pharmacies dispensed the antibiotics without prescription.

Approximately half of the dispensers dispensed antibiotics as soon as the symptoms of
the infections were explained to them. Majority of dispensers did not suggest for the
medical checkup.

Keywords: Antibiotic, Dispensing of antibiotics, Simulated studies, without

prescription.

viii
 LIST OF TABLES

Table 1: Studies on dispensing of antibiotics among community pharmacies................13

Table 2: Working experiences of the personnel...............................................................31

Table 3: Present of consultant in the pharmacy...............................................................32

Table 4: Antibiotics which are dispensed at different stages in UTI...............................35

Table 5: Antibiotics dispensed at different stages in Watery diarrhea.............................36

Table 6: Drugs categorization based on the requirement of prescription.........................36

Table 7: Drugs dispensed in UTI and Watery Diarrhea...................................................38

ix
 LIST OF FIGURES

Figure 1: Framework of the procedure.............................................................................24

Figure 2: Location wise distribution of number of pharmacies.......................................27
Figure 3: Qualification of the staffs in bar diagram.........................................................28
Figure 4: Qualification of dispensers...............................................................................29
Figure 5: Designation of the dispensers...........................................................................30
Figure 6: Working experience of dispensers....................................................................31
Figure 7: Diseases involved in our study.........................................................................32
Figure 8: Number of pharmacy that dispensed drugs......................................................33
Figure 9: Distributions of antibiotics dispensed in different stages.................................34

x
 LIST OF ABBREVIATIONS

DDA Department Of Drug Administration

DNA Deoxy ribonucleic Acid

FIP International Pharmaceutical Ferderation

MIC Minimum Inhibitory Concentration

MS- EXCEL Microsoft Excel

NAMCS National Ambulatory Care Services

ORS Oral Rehydration Salt

OTC Over The Counter

POM Prescription Only Medicine

PURC Pokhara University Research Centre

USA United States Of America

UTI Urinary Tract Infection

xii
 1 INTRODUCTION

1.1 Background
Antibiotic resistance is the major public health problem facing globally due to
irrational use of antibiotics and self- medication (Chang et al, 2017).
Antimicrobial resistance has not only increased the cost of health facility but
also accelerated the rate of morbidity and mortality. Due to lack of structured
observation, the status of antibiotics resistance and its drawbacks in the present,
in low and middle income countries is not identified but likely to be tolerable;
designated increasing bundle of communicable diseases (Nepal et al, 2020).
Community pharmacists play an important role for the dispensing of antibiotics
worldwide. It was reported that inappropriate and unnecessary medication with
antibiotics has increased anti-microbial resistance (Aziz et al, 2021). The
increasing use of antibiotics has been found majorly on developing countries
(Chang et al, 2017). Irrational dispensing is directly related to anti-microbial
resistance. As per the drug act 2035, clause 17 and 27 of Nepal, antibiotics
should be only prescribed by medical doctors and should only be dispensed or
sold by a pharmacy professional. Pharmacists working in community are the first
point of contact to the individuals who are striving for healthcare (Jha et al,
2020).
A study on prescribing and dispensing way shows the ability of health
professionals to determine and select the best drug therapy with minimum
unwanted side effects for the patient among the various choices (Pakhile, 2004).
The role of pharmacists of Nepal is not well understood. People supposed
community pharmacists as medicine traders only and they buy medications from
medical shops alike of buying food items from groceries stores (Ansari, 2016).
Community pharmacies are the cheapest source of healthcare

1
 facility rather than that of hospital visit as hospital visit is time consuming as
well as more expensive (Hadi et al, 2016). WHO recommends about educating
the general population about right use of antibiotics and disincline self-
medication (Jamhour et al, 2017). It is estimated that, globally about more than
50% of antibiotics are purchased privately without prescription (Shi et al, 2020).
International Pharmaceutical Federation (FIP) developed Good Pharmacy
Practice guidelines as a reference3 to be implemented by the pharmacists while
imparting services to patients in pharmaceutical organization (Shrestha and
Ghal, 2018). Since 2004, medical antibiotics use has been restricted without
prescription. It is illegal to dispense antibiotics without a valid prescription (Shi
et al, 2020). The quality service of community pharmacy is in the hand of
pharmacists. Substandard pharmacy practices will provide a route to therapeutic
failure and even health of the patients will get worsened (Shrestha and Ghale ,
2018). The WHO developed the theme of ‘Combat Drug Resistance: no action
today, no care tomorrow’ for World Health Day 2011 (Chang et al, 2017). As
compared to the high economic countries, there is a bigger problem of the
misuse of antibiotics in low and middle income countries (Kotb and Elbagoury ,
2018).
During this study we came across numerous studies on dispensing pattern of
antibiotics conducted in different countries of the world including Nepal. In
Nepal, there is a common practice of self-medication. No any rule has been
implemented for the control of the misuse of antibiotics. Mostly community
pharmacies are failing to enhance the appropriate use of antibiotics.
Consequently, the principle objective of this study is to determine the extent of
dispensing of antibiotics among community pharmacy in Rupandehi district of
Nepal.

1.2 Problem Statement

Development of antibiotic resistance is one of the major problems caused by
inappropriate use of antibiotics as compare to other various drawbacks like side
2
 effects, increased duration of therapy and cost (Moorthi et al, 2011). The rate of
antibiotic consumption is correlated closely with rates of antimicrobial resistance
at national level, including both the hospital environment and outpatient settings
(Toleman and Walsh , 2011). The use of wise and strong spectrum antibiotics for a
long term can lead to the development of antibiotic resistance in the patients that
can cause a great expansion of multi- drugs resistant organisms (Sharma, 2016).

Self-medication is the common practices in most of the developing countries and

this also leads to the antibiotic resistance. The two main source of self-medication
include the use of left-over antibiotics from previous courses of treatment and the
acquisition from pharmacies without prescription ( Toleman and Wash , 2011).
About 80% of all antibiotics are estimated to be used in the community, where
prescribing and dispensing antibiotics without prescription are commonly seen
(Thiruthopu et al , 2014). Without proper diagnosis and proper test mostly
community pharmacies dispensed antibiotics. Recent antibiotic use is one of the
risk factors for infection with antibiotic resistant organisms (World Health
Organization, 1984). Mostly antibiotic resistance has been seen in pediatric and
geadiatric population in the world. The inappropriate antibiotic use was about 50%
and 85% in USA and Canada respectively which has been showed by the study
conducted in the pediatric population in these countries (Zhang et al, 2008).
According to National Ambulatory Medical Care (NAMCS), `antibiotics are the
second most prescribed for the treatment of infectious diseases (World Health
Organization 2018).

The aim of our study is to derive a precise data on the dispensing of antibiotics
without prescription.

1.3 Rationale of the study

Antibiotic guidelines are standard set of guidelines for the treatment of infectious
diseases based on local culture sensitivity data. Therefore for ensure of safety and
cost-effective therapy, antibiotic guidelines are required in all pharmacy, drug
3
store and hospitals (Bahta et al, 2020). In developing countries like Nepal,
although dispensing of antibiotics without prescription is prohibited, regulations
are frequently not enforced (Aziz et al, 2021). Analysis of the properly selected
sample of pharmacies would expose the extent use of antibiotics without
prescription and it will help in the assessing the extent of health as well as cost
wastage due to irrational use of antibiotics (Almaaytah et al, 2015). Appropriate
drug utilization studies play a vital role to evaluate whether the drugs are utilized
properly in terms of medical, social and economic aspects (Venkatswaramurthy et
al, 2013). Therefore, it is important to study the utilization pattern of antibiotics .
The detection of problems with the use of antibiotics in health care system is the
first step in evaluating the underlying causes and taking suitable useful actions.

With this study, we are targeted towards promoting the implementation of

standard antibiotics dispensing guidelines in order to minimize irrational
dispensing of antibiotics without prescription as well as to reduce the development
of antibiotics resistance among the patients of the Rupandehi district.

4
1.4 Objectives

1.4.1 General Objectives

1.4.1.1 To determine the dispensing practice of antibiotics without prescription among

community pharmacies.

1.4.2 Specific Objectives

1.4.2.1 To analyze the socio-demographic characteristics of dispensers.

1.4.2.2 To characterize the personnel who are involved in the dispensing of antibiotic
without prescription.

1.4.2.3 To identify the antibiotics which are most commonly dispensed without
prescription .

1.4.2.4 To determine the percentage of pharmacies that dispensed antibiotics without

prescription

5
 2 LITERATURE REVIEW

2.1 Introduction
Antibiotic is the chemical substance produced by the various micro-organisms
which are used to prevent and treat bacterial substance. Antibiotic resistance
occurs when bacteria change in response to the use of these medicines (Almaaytah
et al, 2015).

Antibiotic resistance has become a major public health concern worldwide.

Antibiotic resistance is a global health threat (determinant of antibiotic). And to
tackle this problem, in World Health Organization (WHO), in its 68th world health
Assembly, passed a resolution based on the global action plan, instructs all
member states to develop a national strategic plan on combating antimicrobials
resistance (World Health Organization, 2002).

A community pharmacy is a professional term often referred to as a medical shop

or store or a retail pharmacy in Nepal and other developing countries as well.
Dispensing of non-prescribed antibiotics through these channels (community
pharmacy) is a common phenomenon ( Bhoj, 2015).

Antibiotic resistance became the major problem and it was found antibiotic
resistance was seen due to the dispensing of antibiotic without prescription (Lusini
et al, 2009). In developing countries it was widely grown problem than developed
countries. In Spain, the prevalence of antibiotic dispensing without prescription is
64.7% (Van Boeckel et al, 2014), (Foster, 1991). In Tanzania, Ethiopia and
Zambia, recorded the highest prevalence of non-prescribed sale of antibiotics as
92.3%, 94.4% and 100% respectively (World Health Organization, 1995),
(Alakhali and Khan , 2013), (Toleman and Walsh , 2011).

6
 Still, no studies have been conducted to evaluate the knowledge, attitudes, and
practices regarding dispensing of non-prescribed antibiotics using simulated client
method among community pharmacy in Rupandehi district of Nepal. Thus, we
performed the present study to fill this research gap.

2.2 Methods for the data collection used in the study:

2.2.1 Self-Administrative Questionnaire

It is a structured form that consists of a series of closed-ended and open-ended
questions. It is called self-administrated as the respondents fill it in themselves,
without an interviewer.
This method is inexpensive, no interviewer bias but this have a low response
rate.

2.2.2 Simulated Clients method

This method was first detailed in the family planning literature in 1985.
Simulated client method is one of the most widely method for conducting the
research in which consist of sending the clients to a service provider to request
information without revealing their identity. In this study, at first consent was
taken from randomly selected pharmacies. After some time interval gap the
actual data collection was carried. In this study, five simulated well trained
clients (three male and two female final year pharmacy students) were acting
with the case watery diarrhea and UTI respectively.

2.2.2.1 Advantages:
1. It always gives a more accurate result.
2. It helps us to identify bottlenecks in material, information and product flows.
3. It allows us to explore ‘what if’ questions and scenario.

7
2.2.2.2 Disadvantages:
1. It is time consuming and expensive.
2. It requires proper handling and care.

2.2.3 Qualitative Structured Interview method

It is a data collection method that relies on asking questions in a set order to
collect data on a certain topic. These are systematized and mostly closed-ended
type of interview.

2.2.3.1 Advantages:
1. Reduced bias
2. Increased credibility reliability and validity
3. Simple, cost-effective and efficient

2.2.3.2 Disadvantages:
1. Limited flexibility
2. Limited scope

2.2.4 Semi-Structured Interview Scheduled method

Semi-structured Interview is a mix of structured and unstructured interviews.
This method is often open-ended.

2.2.4.1 Advantages:
1. Comparable and reliable data
2. No distractions

2.2.4.2 Disadvantages:
1. Low validity
2. High risk of bias
3. Difficult to make good semi-structured interview questions

8
 Among all those methods mentioned above, we selected simulated client method
over other methods because it is the only method which will provide accurate data
without baisedness.

2.3 Antibiotic Resistance

Antibiotic resistance is a major public health concern and control of it is a global
priority. On World Health Day in April 2011, the WHO appealed to all member
countries to ‘combat drug resistance: no action today, no cure tomorrow’ (O’Neil ,
2014). It is defined as the ability of bacteria to resist antibiotic agents (Read and
Woods , 2014).
Antibiotic resistance occurs when bacteria change and adapt to the antibiotics in
response to the use of them. It develops overtime on excess use of antibiotics.
When antibiotic is bought to use without a prescription, the emergence and spread
of resistance is made worse. Thus, the world needs to change urgently the way it
prescribes and uses antibiotics. Even if new medicines are developed, without
behavior change, antibiotic resistance will remain a major treat (Luyt and
Brechot , 2014). As per the review of Antimicrobial resistance held in 2014, it is
estimated that the current annual mortality attributable to Antibiotic microbial
Resistance is 700,000 and may rise to 10 million by 2050 if immediate action is
not taken to reduce inappropriate use of antibiotics (Erku and Aberra, 2018).
Antibiotics are considered among the most commonly prescribed drugs worldwide
with the majority of these prescriptions are being sold and prescribed outside the
hospital and specifically by community pharmacies. Antibiotic resistance has been
directly linked to high level of antibiotic consumption within the community
(Lusini and Lapi, 2009).

2.3.1 Types of antibiotic resistance

There are different types of antibiotic resistance and they are classified as
follows:

9
2.3.1.1 Clinical Resistance
The minimum inhibitory concentration (MIC) of the drug for a particular strain
of bacteria exceeds threshold of safety in vivo. It is due to:
- By mutation in the gene that determines sensitivity or resistance to the agent.
- By acquisition of extra chromosomal DNA (plasmid) carrying resistance
gene.

2.3.1.2 Cross resistance

A single mechanism confers resistance to multiple antimicrobial agents,
commonly seen with closely related antimicrobial agents.

2.3.1.3 Multiple resistance

It implies to multiple mechanisms involved for the resistance to one or more
antibiotics, seen with unrelated antimicrobial agents.

2.3.2 Factors causing Antibiotic Resistance

Antibiotic misuse is currently a global public health threat that warrants
immediate global intervention. This misuse can lead to the development of
bacterial resistance, increasing the burden of chronic diseases, development of
adverse side effects and rising cost of health services. There are several factors
which may influence antibiotic resistance and some of them are:

2.3.2.1 Overuse
Overuse of antibiotics is one of the major factors of evolution of antibiotic
resistance. Epidemiological studies have shown a direct relationship between the
consumption and spreading of resistant bacteria strains (Erku and Aberra , 2018)

2.3.2.2 Inappropriate Prescribing

Inappropriate Prescribing of antibiotics also contribute to the promotion of
resistant bacteria (Golkar and Bagazara , 2014). Different studies have shown
that treatment indication, choice of agent or duration of antibiotic therapy is
incorrect in 30% to 50% of cases (Bartlett and Gilbert , 2013), (Wright, 2014).

10
2.3.2.3 Self-medication
According to the recent multi-country public awareness survey conducted by
WHO, 93% of people got their most recently taken antibiotics from the
community pharmacy without valid prescription. Due to the high cost, and other
reasons people don’t go through the physician and they choose community
pharmacy for their easiness (Piddock , 2012).

2.3.2.4 Extensive agricultural use

The antibiotics used in livestock are ingested by humans when they consume
food (Piddock, 2012). From the farm animals, bacteria transfer to humans was
first noted before 35 years, when high rates of antibiotic resistance were found in
the intestinal flora of both farm animals and farmers (Gould and Bal, 2013).

2.3.2.5 Availability of new antibiotics

Development of antibiotic is no longer considered to be an economically wise
investment for the pharmaceutical industry (Gould and Bal, 2013). Antibiotics
are used for relatively short time of periods and are often curative, antibiotics are
not as profitable as drugs that used to treat chronic diseases such as diabetes,
asthma etc (World Health Organization, 1995-2005), (Sisay and Abdela, 2017),
(Prestinaci and Pezzotti, 2015).

2.3.2.6 Regulatory hindrance

For the development of new antibiotics, regulatory approval is necessary and
pursing the discovery of new antibiotics, obtaining approval is often an difficult
(Sisay and Abdela, 2017), (Prestinaci and Pezzotti, 2015). Difficulties in
pursuing regulatory approval that have been noted as: bureaucracy, absence of
clarity, differences in clinical trial requirements among the countries, changes in
regulatory and licensing rules and ineffective channels of communication.

11
2.4 Studies carried out
Xian, Changsha and Nanjing cities of China recorded the prevalence of the non-
prescription sale of antibiotics as approximately 73.70%, 31.00% and 57.70%
respectively. In Spain, the prevalence of antibiotic dispensing without prescription
is 64.70%. Western Spain, Lebanon, Republic of Srpska, Sri Lanka, Gipuzkoa,
reported the lowest prevalence of antibiotic dispensing without prescription
ranging from 17% to 42% (Van and Gandra , 2014), (Akinayandeu and
Akinyandeu, 2014), (Simba and Kakoko, 2016).

In Tanzania, Ethiopia and Zambia, recorded the highest prevalence of non-

prescribed sale of antibiotics as 92.3%, 94.4% and 100% respectively (World
Health Organization, 1995), (Alakhali and Khan , 2013), (Toleman and Walsh,
2011).

Over the past decade, more than half of outpatients in China have been prescribed
antibiotics far above the level recommended by the WHO (less than 30%). 79.50%
of the pharmacies in the pediatric case, while almost all pharmacies (97.30%) in
an adult case, had dispensed antibiotics without prescription. In the African region,
irrational use of antibiotics is largely in the form of non-prescribed sale of
antibiotics (Di and Tay ,2011).

In Pakistan, it is estimated that 80% of medicines are distributed through

community pharmacies and reported the prevalence about 80.60% of antibiotic
dispensing without prescription. In India, prevalence rate of antibiotic dispensing
without prescription were recorded as 66.70% and 55.60% of pharmacies
dispensed at the first level of demand (Kalungia and Burger, 2016).

As the consequences of antibiotic dispensing without prescription rise the

irrational use of antibiotics and its resistance rapidly.

12
2.5 Studies on dispensing of antibiotics without prescription among
community pharmacies
Some of the similar kinds of studies as ours i.e. on dispensing of antibiotics
without prescription are listed in the table below:

Table 1: Studies on dispensing of antibiotics among community pharmacies

SN. Authors Study type Area of Objectives Major findings

research

1. Bahta M. Cross- Retail To explore the Dispensing of

Tesfamariam sectional outlets of dispensing antibiotics
S. et al(2020) investigational Eritrea practice of without
study antibiotics prescription was
without found to be
prescription in 87.6%.
community
pharmacies

2. Almaaytah Jordan To access the Dispensing

A. percentage of practice of
Mukattash T. pharmacies that antibiotics
Haial J. dispense without
(2015) antibiotics prescription was
presceription found to be
without 74.3%.

3 Al-Faham Z. Cross- Damascus To determine the 87% antibiotics

Habboub G. sectional city, Syria percentage of were dispensed
Takriti F. study antibiotics without
(2011) dispensing prescription.

13
 without
prescription in
Syria.

4. Erku D. 2 phase mixed Ethiopia To determine the The sale of

Aberra S. et method study actual practice of antibiotics in
al pharmacy staff community
while dispensing medicine retail
antibiotics outlets without
without licensed
prescription. pharmacy
personnel was
87%.

Observational
Spain To ascertain the
Cachaferio . study Several
attitudes of
5. M Gonzalez attitudes with
community
C.et al(2014 dispensing of
pharmacist
antibiotics
related to
without
inappropriate
prescription
antibiotic
were identified
dispensing.
to be 64.7%.

6. Kavatha D. Cross Greece To determine the No comment

Antoniadou sectional use of antibiotics was made
A. et al study without during the most

14
 (2008) prescription and cases of the
link in antibiotic indication of
resistance chain. antibiotic
dispensed,
administration
of ineffective
antibiotic and
inadequate
treatment was
found.

7. Abdulhak A. Cross Riadh,Saud To determine the High observed

Tannir M. et sectional i Arabia percentage of rate of
al (2011) study pharmacies who antibiotic sales
sell antibiotics without
without medical prescription and
prescription antibiotic
examining the aasociated risks
peotential risks were for
allergic
reactions.

8. Chang J. Cross- China To quantify the Easy acquisition

Jiang M. et sectional sales of of antibiotics
al (2017) study antibiotics for treatment of
without a medical minor ailments
prescription and from
to access the community
quality of pharmacies
pharmacy service without

15
 in relation to the prescription was
antibiotics sold. observed to be
55.9% - 77.7%.

9. Shet A. Cross India To determine the Dispensing of

Sundaresan sectional prevalence of antimicrobial
S. Forsberg observational non-prescription drugs without
B. (2015) study sale of prescription by
antimicrobial pharmacies was
drugs by found to be
pharmacies 66.7%.

10. Aziz M. Cross Pakistan To evaluate the High incidence

Haider F. et sectional practice of of dispensing of
al (2021) study dispensing of non-prescribed
non-prescribed sales of
sales of antibiotics in
antibiotics among community
the community pharmacies was
pharmacies. found to be
81.5%.

11. Jha N. Cross- Nepal To evaluate Irrational

Shrestha S. sectional antibiotic dispensing
Shankar R P. study dispensing practice for
Khadka A. practices among antibiotics was
Ansari M. community found.
Sapkota B. pharmacies.

12. Ahmad A. Cross- Uttar To determine the Prevalance of

Patel I. et al sectional Pradesh extent of self- self medication

16
 (2012) study India medication with with antibiotics
antibiotics and its among the
relation to other community
demographic pharmacies was
characteristics found high.

13. Kotb M, Qualitative Alexandria, To explore the Customers

Elbagoury M study Egypt underlying causes demand, owners
et al (2018) of the sales of expectations
antibiotics and weak
without regulatory
prescriptions. mechanism
were found to
be
nonprescription
of antibiotics.

Unprescribed
Nadaki
Cross- antibiotics are
14. M ,Mushi F.
sectional To evaluate the commonly
et al (2021) Tanzania
study dispensing of dispensed and
antibiotics sold in
without community
prescription. pharmacies and
ADDOs across
the country.
15. Cross-
70% of the
Hadi A.M, sectional Makkha
patients were
Karami A.N study provience,
not aware that
et al (2016) Saudi To evaluate
DaWP is illegal

17
 Arabia Knowledge, practice.
attitude and
practices of
community
pharmacist.

16. Nepal. A, 69.9% of

Hendrie. D et To explore patients with
Qualitative Rupandehi,
al (2019) Knowledge, lack of
survey
Nepal attitude and willingness to
practices of consult a
antibiotics. physician for a
non serious
infection.

Good
17.
Ansari. M To evaluate the knowledge
Cross-
(2017) Saudi status of about antibiotic
sectional,
Arabia community use.
Prospective
pharmacies, their
study
staff and practices
about dispensing
antibiotic.

Several issues
18.
To understand the regarding the
Exploratory Iraq
Alkadhimi dispensing irrational use of
study
A, Dawod practice of

18
 T.O, Hassalu antibiotics and antibiotic.
A.M (2020). pharmacists
perception about
dispensing
antibiotics
without
prescription.

To determine the Dispensing of

Horumpende extent of non- antibiotics
19. Crosssectional United
G.P, Sonda prescription without
survey with Kingdom
B.T, antibiotic prescription was
Simulated
Zwetselarr dispensing a common in
client method
V.M, Antony practices, community
L.M et al dispensing of pharmacy.
(2018) incomplete
Overall
antibiotic dose.
proportion of
antibiotic
dispensing
encounter
without
prescription was
92.3%.

3 METHODOLOGY

3.1 Study design

A descriptive cross-sectional study was conducted in Rupandehi district of Nepal.
The data were collected through simulated client method from the lists of

19
 pharmacies which were registered in DDA. This method consists of sending
clients to a service provider to request information without revealing their identity.

3.2 Study site

Registered community pharmacies from the list of pharmacies provided by the
Department of Drug Administration of Nepal were selected as sites of our study.
This study included around 70 pharmacies which were open to the public during
the study period. The dispensers of these drug retail outlets during the visit were
considered as the study population.

3.3 Study duration

The study was carried out for a time period of 3 months from Shrawan 2079 to
Ashwin 2079.

3.4 Sample size

The sample size around 70 was calculated using systematic random sampling
method but for the best result we take 110 pharmacies by using systematic random
sampling method with the help of MS-Excel 2020 software. Among them only 94
pharmacies gave us consent for our research work. The pharmacies were selected
based on the following inclusion and exclusion criteria.

N = Z2PQ÷ (d) 2 where, N = Sample size

Z =standard normal value at the level of confidence
P = Prevalance
Q = (1-P)
d = Tolerable error (10% of P)

Z=1.96
P= 0.85
Q= 0.15

20
 d= 0.085 (10% of P)
Now,
N = Z2PQ÷ (d)2
= (1.96)2× 0.85 ×0.15 ÷ (0.085)2
= 67.79~68.0

3.4.1 Inclusion criteria

 The community pharmacies which give us consent were included in this study.

3.4.2 Exclusion criteria

 The hospital pharmacies were excluded in our study.
 The community pharmacies which were denied to give us consent were
excluded.
 Those pharmacies which were not found were excluded.
 Those pharmacies which were closed during our visit were not included in our
study.

3.5 Sampling technique

In this study, systematic random sampling method was adopted. For this, the data
of randomly selected community pharmacies was collected over a time period of 2
months. This was done with interacting with the staffs present in the respective
pharmacy.

3.6 Data collection technique

For this study, simulated client method was adopted, under which researcher
themselves act as a patients and data taken from the respective pharmacy without
any baiseness.

21
3.7 Data collection tool/Study material
Pharmacies information form was used for data collection which included criteria
like date, registered pharmacist’s name qualification, age, sex and information
related antibiotic dispensing which included dispensed drug’s name, their dose,
frequency with level of demand were used for the data collection.

3.8 Method
The entire study was carried out in three phases over a time period of 2 months.
The detailed information on the phases is as described below:

3.8.1 PHASE-I

3.8.1.1 Pilot study and literature review

A Pilot study was carried out for the first week to find out the feasibility of our
study in our selected community pharmacies. After ensuring the feasibility, a
study protocol was designed. Along with that, an application letter and a
proposal were made and submitted to the PURC for the permission to conduct
our study.

3.8.1.2 Procurement of consent

For any kind of study to be carried out in a healthcare facility by the scholar of
pharmacy practice department, the approval of dean/director is mandatory. Also,
the approval must be intimated to all the health professions of healthcare facility.
For this, initially a study protocol was designed. Also, an application letter to the
directors and proposal was prepared and submitted including necessary
information like proposed title of the study, introduction, objectives, study site,
study duration and a brief methodology. The staffs present in the respective
pharmacy were informed about the study and provide them consent form for the
detail understanding of our research and it was finally approved by the staffs
present in the pharmacy through signed in the consent form.

22
3.8.1.3 Literature survey
A literature survey was carried out on “Dispensing of antibiotics without
prescription among community pharmacies in Rupandehi district of Nepal”.
The literatures were assessed from different reliable sources including Journals
like Journal of Antimicrobial Chemotherapy, International Journal of
Pharmaceutical sciences, PLOS ONE Journal, etc.

3.8.2 PHASE-II

3.8.2.1 Data collection

The data collected was carried out for a time period of approximately 2 months
(Shrawan to Bhadra 2079), during which, a total around 94 pharmacies’ data
were collected. Among 110 pharmacies, only 94 pharmacies gave us consent and
9 pharmacies denied us to give consent and 6 pharmacies were not found during
our research visit. The pharmacies were selected based on the inclusion area i.e.
registered pharmacies which gave us consent. Systematic random sampling
technique was used.

Data was collected by five simulated clients (three male and two female final
year pharmacy students), which were not identifiable by the dispensers. The
clients were well-trained to ensure uniform presentation on symptoms of diseases
and consistency on their level of demand. The clients replicate the same case
with same signs and symptoms and provided compatible answer for queries
raised by the dispensers. Female simulated clients were acting as patients with a
case of uncomplicated urinary tract infection (UTI) presenting with the
symptoms of “burning sensation during urination, lower abdominal pain and low

Observe the environment of the community pharmacy

23
 Ask some medicine for the symptoms as we will be trained (demand
level-1)

Explain symptoms if further pharmacist/dispenser ask

Pharmacist/Dispenser recommended medication

(If antibiotics will not recommend)

Require some antibiotics (demand level-2) If antibiotic will be given

(If antibiotic will be given) (If antibiotics will not recommend)

Ask for the specific antibiotics (demand level-3)

(If antibiotics will not recommend)

Memorize pharmacy practice and keep audio record

Buy or not the medicine

Fill the data collection form within 15 minutes after the visit.

Figure 1: Framework of the procedure

fever for 3 days”. On the other hand, the male simulated clients were acting as
patients with watery diarrhea experiencing “loose watery stool, weakness for 2
days”. If dispensers ask further history, male clients answered of vomiting, fever
and abdominal tenderness. These two cases were selected because they were

24
 commonly found in our locality, antibiotics may not prescribed in all patients
with those symptoms and if needed to prescribed laboratory test and prescription
was needed before antibiotic dispensing.

Each pharmacy was visited twice ( one for consent and one for data collection as
a patient) with a reasonable time gap so that they were unknown about us that we
visited the pharmacy as a simulated clients, this helps to avoid suspicion from
dispensers. Once male clients visited for consent in pharmacy and female clients
visited as simulated patients in those pharmacies. Similarly, female clients
visited for consent and male clients visited as simulated patients in those
pharmacies. Three gradually stages were used to persuade the staff present in the
pharmacy to get an antibiotics without prescription. The framework of our data
collection are depicted in Figure 1.

The data recording form include information related to the pharmacy, socio-
demographic characteristics and the response of the dispenser to the request of
the simulated clients and comments. The data gathered were included in the
analysis since no change was made on the data recording form and data
collection approach.

3.8.3 PHASE-III

3.8.3.1 Data entry

The data were collected in the community pharmacies for a time period of 2
months from Shrawan to Bhadra 2078. This was done by taking into consideration
our inclusion and exclusion criteria. The data thus collected in data collection form
was then evaluated prospectively and entered in MS-Excel 2020 software if the
following variables were fulfilled.

1. Socio- Demographic data of the registered pharmacist/assistant pharmacist

2. Response of the dispenser
3. Drugs which were dispensed with their dose, frequency and duration

25
 4. Antibiotic prescribed or not
5. Stages at which antibiotics were dispensed

3.8.3.2 Data analysis

The complete data were entered in MS-Excel 2020 was then evaluated for
different aspects. The necessary information regarding socio-demographic
characteristics, response of the dispenser towards simulated clients, drugs
prescribed during visit, antibiotics dispensed, level of demand was derived and
evaluated.

3.9 Operational definition

Staff Qualification & Designation
Training oriented health worker Orientation pharmacist, ANM , CMA
Health workers with course of 3 years Staff nurse, CMLT
Pharma technician Diploma in pharmacy
Pharmacy degree B.pharm, M.Pharm, Pharm D
Medical degree M.B.B.S, M.D
Non related to health B.com operator, civil engineer, veterinary

Dispensers Qualification & Designation

Pharmacy degree B.pharm, M.pharn, pharm D
Pharna technician Diploma in pharmacy
Non pharmacist Personnel who don’t have pharmacy
background in detail

4 RESULT

In our study, 94 pharmacies were visited and data were collected by using simulated
clients method. The results obtained are described below.

26
4.1 Socio-Demographic Characteristics

4.1.1 Location
Altogether 94 pharmacies were included in our study. In this study, most of the
pharmacies were located in Urban area i.e. 85 (90.43%) number of pharmacies
located in urban area, whereas 9 (9.57%) number of pharmacies were located in
rural area.

Location of the community pharmacies (n=94)

Rural Urban

10%

90%

Figure 2: Location wise distribution of number of pharmacies

4.1.2 Qualification of the staffs present in the pharmacies
In present study, total 150 personnel were waged in the pharmacies. The
qualification of the staffs working in these pharmacies is given in the table
below.

27
 Qualification of staffs (n=150)

60 57(38.00%)

50
44(29.33%)
40

30
18(12.00%) Number of staffs
20 15(10.00%)
9(6.00%)
10 5(3.34%)
2(1.33%)
0
Training Health Pharmacy Pharmacy Health Medical Non related
oriented workers technician degree assistant degree to health
Health with course
workers of 3 years.

Figure 3: Qualification of the staffs in bar diagram

Most of the personnel involved in the pharmacies were pharmacy technician i.e.
57 (38.00%) in number followed by training oriented health workers
44(29.33%), pharmacy degree (12.00%), health assistant 15 (10.00%), health
workers with course of 3 years 9 (6.00%), non-related to health 5 (3.34%) and
Medical degree 2 (1.33%). Interestingly, it was found that the qualification of
some personnel were Bachelor in Science (B.sc), Bachelor in Computer
Operator, Vetenary and Civil engineering.

94 numbers of staffs were concerned with dispensing of medicine to simulated

clients who visited the pharmacies for data in our research. The qualification of
these personnel is given below in the figure.

28
 60.00%
48(51.06%)
50.00%

40.00%

30.00%
21(22.34%)
20.00%
11(11.70%) 9(9.57%)
10.00%
1(1.06%) 1(1.06%) 2(2.12%) 1(1.06%)
0.00%
rs rs e t l
ke a an re an ica lth n
r ye ici eg is st d he
a ow
o hn e kn
w
of
3
e c yd as M to U n
at
h t ac th ed
he se ac
y m al at
our ar He l
ed c ar
m Ph -re
nt ith Ph
n
ir e No
o sw
in
g ker
a in or
Tr w
a lt h
He

Percent of Dispenser's Qualification

Figure 4: Qualification of dispensers

The above figure shows that the around half of the dispenser’s qualification were
found to be pharmacy technician 48(51.06%) followed by training oriented
health workers 21 (22.34%), pharmacy degree 11 (11.70%), health assistant 9
(9.57%), non-related to health 2 (2.12%) and health related with course of 3
years, medical, unknown 1 (1.06%).

The highest number of personnel were the pharma technician i.e. 48 (51%) who
dispensed medicines, followed by pharmacists 11 (12%) and the least number 35
(37.23%) were the personnel who belongs to other backgrounds not related to
pharmacy.

29
 The designation of all these 94 dispensers is described below in the figure.

Designations of dispensers(n=94)
Pharmacist
12%

Non-
pharma-
cist
37%
Pharma
technician
51%

Figure 5: Designation of the dispensers

4.1.3 Distribution of working experiences of personnel

The detail of working experience of the staffs is given in table below:

Out of 150 staffs working in the community pharmacies, the highest number of
staffs i.e.72 (48.00%) were having working experience of 1 to 5 years. On the
other hand, the lowest number of staffs i.e. 6 (4.00%) were having working
experience of 11 to 15 years.

The working experience of dispensers is given below.

Table 2: Working experiences of the personnel (n=150)

Working experience of the Number of staffs Percent (%)

30
 personnel(years)
<1 17 11.33
1-5 72 48.00
6-10 29 19.33
11-15 6 4.00
16-20 11 7.34
>20 15 10.00

Working experience of dispensers ( n = 94)

80
72(48.00%)
70

60

50

40
29(19.33%)
30
15(10.00%)
20 11(7.34%)
17(11.33%)
10 6(4.00%)

0
0-1 1-5 6-10 11-15 16-20 More than 20

Number of dispensers

Figure 6: Working experience of dispensers

The highest number of personnel had working experience of 1-5 years i.e. 72
(48.00%) whereas the lowest number of personnel had working experience of
11-15 years i.e. 6(4.00%)

4.1.4 Consultant Physician availability in pharmacy during visit (n=94)

31
Table 3: Present of consultant in the pharmacy

Consultant Physician Number Percent(%)

Present 60 63.83
Absent 34 36.17
Total 94

There were 60 (63.83%) pharmacies where the consultant services were available
and 34 (36.17%) pharmacies didn’t had facility of consultant.

4.2 Cases (diseases) involved in our study

Pharmacies visited by simulated clients were having two different diseases i.e.
UTI and watery diarrhea are given below in the figure.

Number of Pharmacies visited (n=94)

UTI Watery diarrhea

48%
52%

Figure 7: Diseases involved in our study

A total 49 (52.12%) cases were of UTI and 45 (47.87%) cases were of watery
diarrhea.

32
4.3 Dispensed drugs
Altogether, 278 drugs were dispensed in 94 pharmacies in our study. Among these
drugs, antibiotics and non-antibiotics dispensed were 82 (29.49%) and 196
(70.50%) respectively.

4.4 Number of encounters that dispensed drugs

Among 94 pharmacies, 82 pharmacies dispensed antibiotics and 12 pharmacies
didn’t dispense any antibiotics. The response of pharmacies regarding the
dispensing of drugs to the simulated clients is given below.

Number of pharmacies dispensed drugs (n=94)

Dispensed antibiotics Non-dispensed antibiotics
13%

87%

Figure 8: Number of pharmacy that dispensed drugs

33
4.5 Stages at which antibiotics were dispensed
Among 278 drugs dispensed, 82 were antibiotics and the number of antibiotics
which were dispensed as soon as the symptoms were explained was found to be 44
(53.65%). Similarly, the antibiotics dispensed after asking for some antibiotics was
found to be 37 (45.12%) and finally only 1 (1.21%) antibiotic dispensed after
asking for specific antibiotics.

Numberof anibiotics dispensed in different

stagess(n=82)
50 Demand level
44(53.65%)
1= antibiotic
45
dispensed as
40
soon as symp-
37(45.12%) toms were ex-
35 plained.
Demand level
30 2= antibiotics
dispensed after
25 asking for some
antibiotics.
20
Demand level
15 3= antibiotic

10

5
1(1.23%)
0

Figure 9: Distributions of antibiotics dispensed in different stages

As soon as patients clarify symptoms to the staffs if dispensers give antibiotics

which means demand level one. Whereas if patient asked for some antibiotics to
dispenser called demand level two and if patient asked for specific antibiotic to
dispenser indicate demand level three.

34
4.6 Stages at which antibiotics dispensed (UTI, Diarrhea)
Among dispensed antibiotics, 82 different antibiotics were obtained in three
different stages in two different cases i.e. UTI and watery diarrhea

In case of UTI, three stages were used for obtaining the antibiotics.

As soon as the symptoms were explained, the highest class of antibiotic dispensed
was fluoroquinolones (Ciprofloxacin). After asking for some antibiotics, highest
class of antibiotic dispensed was fluroqinolones(Ciprofloxacin) and lowest was
macrolides (Azithromycin). After asking for specific antibiotics, only one drug
was dispensed by pharmacy. And in case of watery diarrhea, two different stages
were used for obtaining antibiotics. As soon as the symptoms were explained,
ciprofloxacin was dispensed highest in number. After asking for some antibiotic,
the highest number of antibiotics dispensed was ciprofloxacin whereas lowest was
norfloxacin.

Table 4: Antibiotics which are dispensed at different stages in UTI

Antibiotics Frequency of Frequency of Frequency of Total

antibiotics antibiotics antibiotics
dispensed when dispensed when dispensed when
directly telling directly asking for asking for specific
our symptoms antibiotics antibiotics
(Demand level (Demand level 2) (Demand level 3)
1)
Ofloxacin 1 1
Ciprofloxacin 14 10 24
Norfloxacin 5 5
Nitrofurantoin 4 3 1 8
Levofloxacin 1 1
Cefixime 7 4 11
Azithromycin 1 1 2
Tinidazole 1 1
Total 53

35
Table 5: Antibiotics dispensed at different stages in Watery diarrhea

Frequency of Frequency of Frequency Total

Antibiotics antibiotics antibiotics of antibiotics
dispensed when dispensed when dispensed when
directly telling directly asking asking
our symptoms for antibiotics for specific
(Demand level (Demand level antibiotics
1) 2) (Demand level
3)
Ciprofloxacin 8 18 26
Ornidazole 2 2
Norfloxacin 1 1
Total 29

4.7 Drug categories based on the requirement of prescription

Among total dispensed drugs, the categorization of drug according to “Drug
Categorization Rule 2043” of Nepal, there was no drugs from group ‘Ka’ whereas
82 number of drug were from group ‘Kha’, finally the number of drug from group
‘Ga’ were 196.

Table 6: Drugs categorization based on the requirement of prescription

Group Categorization of Number Percent (%)

drugs
Group ‘Ka’ - - -
Group ‘Kha’ Cefixime 11 3.95
Ofloxacin 1 0.35
Ciprofloxacin 48 17.26
Nitrofurantoin 10 3.59
Norfloxacin 6 2.17
Levofloxacin 1 0.35
Azithromycin 2 0.71
Tinidazole 1 0.35

36
 Ornidazole 2 0.71
Paracetamol 1 0.35
Group ‘Ga’ Pantoprazole 14 5.03
Hyoscine 15 5.39
butylbromide
Metronidazole 41 14.74
Ascorbic acid 1 0.35
Diloxanide furate 41 14.74
ORS 18 6.47
Aceclofenac 1 0.35
Mefanamic acid 2 0.71
Bacillus 1 0.35
Disodium hydrogen 44 15.82
citrate
Drotaverine 1 0.35
Flavoxate 12 4.31
Ketrolac 1 0.35
Domperidone 3 1.07
Total 278

Among 278 drugs dispensed by pharmacies without prescription, 17 pharmacies

dispensed POM drugs in UTI, whereas only 3 pharmacies dispensed POM in
watery diarrhea. In case of UTI, 53 pharmacies dispensed antibiotics whereas 29
pharmacies dispensed antibiotics without prescription in watery diarrhea. In case
of UTI, 72 pharmacies dispensed OTC medicines whereas 104 pharmacies OTC
drugs in the case of watery diarrhea

37
Table 7: Drugs dispensed in UTI and Watery Diarrhea

UTI Watery Diarrhea

Antibiotics Name of drugs Frequency Name of drugs Frequency
(n=82) Azithromycin 2
Cefixime 11
Ciprofloxacin 22 Ciprofloxacin 26
Nitrofurantoin 10
Norfloxacin 5 Norfloxacin 1

Levofloxacin 1
Ofloxacin 1
Tinidazole 1
Ornidazole - Ornidazole 2
Total 53 Total 29
POM/Non- Domperidone 3
antibiotics Drotaverine 1
(n=20) Ketrolac 1
Aceclofenac 1
Mefenamic acid 2
Flavoxate 12
Total 17 Total 3
OTC Paracetamol 1
(n=176) Pantoprazole 12 Pantoprazole 2
ORS 1 ORS 17
Hyoscine butylbromide 13 Hysocine butylbromide 2
Bacillus - Bacillus 1
Ascorbic acid 1
Disodium hydrogen citrate 44
Diloxanide furoate - Diloxanide furoate 41
Metronidazole - Metronidazole 41
Total 72 Total 104

38
 5 DISCUSSION

Community pharmacies remain the first point of contact for seeking healthcare for the
patients. Dispensing antibiotics without prescription in community pharmacies of
Rupandehi district was found to be commonly practiced which shows that easy access to
antibiotics that accelerate the development of antibiotic resistance (Nepal et al, 2017).
This study revealed that about 87% of pharmacies dispensed antibiotics without
prescription which was similar to another study in Europe which reported that about
88% of antibiotics were used without prescription. This might be due to competitive
business and lack of adherence to the rules and regulations. Similarly, in 1996, Benjamin
et al. carried out study about the patterns of drugs dispensing without prescription and
found that, around 50.4% antibiotics were sold without prescription on the request of
customers. A result obtained from a study done in Albania (80%) was comparatively
consistent with findings of the current study but higher results were observed in studies
done in Zambia (100%) (WHO,2002). In Greece, antibiotics without prescription
dispensed from >70% pharmacies when rhinosinusitis case was simulated (Nepal et al,
2017). In Spain, 64.7% pharmacies dispensed antibiotics when UTI was simulated. In
urban cities of China, result observed that 66.8% pharmacies dispensed antibiotics
without prescription (Shi et al, 2020).

The highest number of pharmacies were located in urban areas 85 (90%) as compared to
that of rural areas 9 (10%) which could be because of lesser pharmacies situated in rural
area.

The majority of the staffs working in the community pharmacies were pharma
technicians. The reason might be the lesser number of pharmacists working in
community pharmacies. Nearly half i.e. (51.06%) were the pharmacy technician who
dispensed the antibiotics without prescription in community pharmacies among total
dispensers (Jha et al, 2020). Most of them had working experience of 1-5 years. They
were dispensing antibiotics themselves without consulting physician despite the

39
availability of physician. Similarly, study in Kathmandu and Lalitpur districts of Nepal
recorded the highest working experience of 5 to 10 years (50%). This could be due to
higher staffs were of younger age and recently joined (Jha et al, 2020).

The availability of pharmacist matters in the procedure of dispensing antibiotics without

prescription. The consultant availability in pharmacy during visit seemed to be higher
i.e. 63.82%. This is because most of the pharmacies were located in urban area and
provide physician services.

This study used simulated illnesses that were most likely viral in etiology i.e. UTI
52.12%and watery diarrhea 47.87%. The reason behind the selection of these two
diseases was the prevalence of such disease in our community. The time period during
our research was the period in which the water pollution, dry warm environment was
more encountered that leads to diarrhea.

Similarly, a survey conducted worldwide (35 survey five continents) recorded that 19-
100% antibiotics were dispensed without prescription outside of Northern Europe and
North America (World Health Organization, 2002). In developing countries like
Tanzania, Nepal result was relatively higher in dispensing antibiotics without
prescription as compared to developed countries like Spain (Chang et al, 2017),
(Shrestha and Ghale , 2018), (World Health Organization, 2002).

A total 278 drugs were dispensed by 94 pharmacies. Different types of drugs like
antibiotics, POM and OTC drugs were dispensed. Antibiotics were handed over to
simulated client in highest number as soon as the details of symptoms of disease were
explained. Ciprofloxacin was the most frequently dispensed antibiotics without
prescription in both cases. It was observed that most of the pharmacies dispensed at least
one antibiotic in each simulated case. Oral route of drug administration was more
common. Altogether 82 antibiotics were dispensed from those selected 94 pharmacies.
The highest antibiotic dispensed was ciprofloxacin and the lowest was norfloxacin in
case of watery diarrhea. In Europe, the frequently dispensed antibiotics were

40
ciprofloxacin (47.8%) and cotrimoxazole (37.5%) i.e. cotrimoxazole (53.6%) in acute
watery diarrhea and ciprofloxacin (56.7%) in uncomplicated UTI (Lusini et al, 2009).
Similar study in China, recorded that higher percentage of antibiotics dispensed without

prescription was cotrimoxazole (Chang et al, 2017). The reason of antibiotics

dispensing without prescription were financial interest of pharmacists and lack of rules
and regulations.

A similar type of study was conducted in Riyadh, explained lack of enforcement of the
national regulations, sub optional compliance to the code of ethics and professionalism
among community pharmacies and financial interests of community pharmacist were the
main reasons of antibiotics sales without prescription (Abdulhan et al 2011) .

Wrong choices of antibiotics and inadequate dose to customers were well recognized to
result from non-prescription dispensing of antibiotics. Such convention results in serious
adverse reactions and disguise of basal infections which apart from that could have been
easily detected and properly treated at early phase (Kotb and Elbagoury, 2018). Proper
guidelines and policies should be implemented for the proper dispensing of antibiotics.
Public awareness program must be carried out regarding the rational use of drugs and
proper knowledge should be given to the patients about antibiotics resistance by the
pharmacist. Patients were also responsible for increasing the rate of antibiotics
dispensing without prescription so patient needs to educate about harmful impact of
irrational use of drugs. Government should focus on the pharmacy and bad impacts
regarding antibiotics resistance in the country due to the irrational use of drugs.

41
 6 CONCLUSION
In conclusion, there is an irrational dispensing of antibiotics in the pharmacies of
Rupandehi district which can lead to antibiotics resistance.

Most of the pharmacies were located in Urban areas. Half of the dispenser’s
qualification who dispensed antibiotics without prescription in community pharmacies
were pharmacy technician. Interestingly one- third of pharmacies dispensed antibiotics
by the personnel not related to pharmacy background. Nearly half of the dispenser had
working experience of (1-5) years, which may be the reason of dispensing of antibiotics
without prescription which may be due to lack of knowledge of good dispensing
practice. This condition may lead to antibiotics resistance. The most commonly
dispensed antibiotics in case of watery diarrhea and UTI is Ciprofloxacin. Interestingly
Azithromycin is dispensed in case of UTI which is not commonly dispensed in such
case. Nepal as well as worldwide is facing the burning issue of inappropriate and
irrational use of antibiotics. The role of pharmacist and the health care services provided
by community pharmacies was critically appraised.

Moreover, a stringent law and policy enforcement regarding the sale of antibiotics
without a valid prescription should be in place so as to make sure that pharmacy
practices are in line with national guidelines for good dispensing practice. Hence, we can
conclude that there is still a long way to go for the study to meet standard guidelines for
dispensing of antibiotics. Due to rampant use of antibiotics without doing culture of
antibiotics, it leads to antibiotics resistance which is more dangerous for human being.
Antibiotics resistance must be noticed and controlled in time.

42
 7 LIMITATIONS

Our study was not multicentered and only one district was selected which is why
the result cannot be taken as a representative of the total pharmacies of Nepal
and thus the datas cannot be totally generalized.
Some of the pharmacies denied to gave us consent. Pharmacies name and address
were changed now but not updated in DDA, so it was difficult to perform
research in some pharmacies of rural areas. Due to these reasons we are unable to
collect data from our randomly selected sample size.
The major limitation of this study includes small number of participants and
short duration. The large number of pharmacies cannot be enrolled in our study
so it might not give the true reflection of the overall trend of dispensing of
antibiotics without prescription in community pharmacy in Rupandehi districts.

43
 8 RECOMMENDATION

Pharmacists are highly recommended to follow the standard guidelines while

dispensing antibiotics to the patients. Pharmacists are recommended to follow
standard guidelines for rational dispensing of antibiotics. “Drug Categorization
Rule 2043” of Nepal, the dugs is classified as group ‘Ka’, ‘Kha’ and ‘Ga’. In
our research group kha durgs is being dispensed without prescription which is
against the law. DDA should make and implement the strict rules and regulation
regarding dispensing of antibiotics without prescription. The patient awareness
programme should be conducted frequently by pharmacist with collaboration of
NGO and INGO regarding the antibiotics resistance. The punishment regarding
the violation of Drug act 2035 is not strict. The inspection by DDA in the
pharmacies is not carried out properly and if found guilty during inspection the
punishment is not so strict. It is highly recommended to make law and implement
strictly regarding the compulsion of pharmacist in each and every pharmacy.
Renting of license of pharmacy should be strictly monitored and influences of
political party in the decision making as well as punishment must not be carried
out.

44
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49
9.1 Annex (es)
Data collection form

Background Information Related to Pharmacy.

Pharmacy name: Address: Locality

(rural/urban):

1. Registered pharmacist/ Assistant pharmacist

Name: Age: Sex: Address:

Qualification: Working experience: License Number:

2. Staffs involved
S.No. Name Address Age/Sex Qualificatio Working Work
n Experience Time

3. Was the registered pharmacist /assistant pharmacist present during the visit?

Data collected by: Date:

Time:

50
 Information Related To Antibiotics Dispensing.
Name of the Pharmacy:
Name of the dispensers:

Symptoms of Response Drugs Antibiotics Demand level

Diseases

Other Suggestions:

51
Drugs Dose Frequency Duration Comments/Suggestions

Data collected by: Date:

Time:

52
INFORMED CONSENT FORM
This informed consent form is for the pharmacist or other assistant present in the
pharmacy in Rupendehi district of Nepal.
Name of the Investigators: Binita Paudel, Gajendra Kumar Choudhary, Keshav
Kumar Choudhary, Puspa Pant, Shivendra Kumar Jaiswal, Mohammad Mustafa
Name of the Organization: Registered Community Pharmacy
Name of the Sponser: None
Title: Dispensing of Antibiotics without prescription among the community
pharmacies in Rupendehi district of Nepal.
Introduction
We are the students of Crimson College of Technology. We are doing research
on dispensing of antibiotics without prescription among community pharmacy of
Rupendehi and Nawalparasi district. We are going to give you the information
and request you to be a part of the research. You have to decide today whether or
not you will participate in the research.
Purpose of the Research
The purpose of our research is to gain the knowledge on the current status of
dispensing antibiotics without prescription. This study requires a registered
pharmacist or other staffs to co-operate and give us information related to our
research. No other intervention will be done to pharmacist. It is your sole choice
to voluntarily take part in the research. It will take around 10-15 minutes. The
information provided by participants will be kept confidential. Your secrecy and
anomity is ensured and maintained. You can contact me at my mobile number:
9866575113
Type of the research intervention
The research will not involve any type of intervention to the pharmacist or other
staffs. Demographic data of patients will only be asked. The information about
the medicines and therapies that you provided to us will be recorded. And all the

53
provided information will be kept strictly secret. Pharmacy selection .We select
registered community pharmacy which are eligible for the study.
Procedure and Protocol
1. We will explain to you all about the research including it benefits and there is
no risk about this study. We will also answer, all the queries that you have.
2. Then we will consent from you.
3. After getting consent from you, we will ask you the following information;
(Name, address, age, gender, qualification, license number, Working experience)
of registered pharmacist or assistant pharmacist. If there is a presence of staff in
your pharmacy, we will ask the staff for the following information; (Name,
address, age, gender, working experience, qualification).
4. And then we will explain you about further process of our research and
provide data recording form that contain background information of pharmacy.
5. Then after few days with further questions and information other researcher
will visit your pharmacy.
6. All the information that we receive will be kept secret.
Duration: We will be taking 10-15 minutes only for getting the information
about pharmacy and pharmacist or assistant pharmacist or staff if there. And for
the further information other researcher will visit after few days.
Risk: Since the study does not involve any intervention by the researcher and all
the data will be kept strictly secret, there is no risk to you.
Benefits: If you take part in this research, you will get knowledge about the
current status of the antibiotics dispensing and there is more benefit for our
community. Government starts to implement the rule and policy for the
dispensing of antibiotics without prescription. There may be a chance of
decreasing self- medication practice of antibiotics.
Reimbursement:
We are sorry to inform you that you will not be providing any type of financial
assistance.

54
Confidentiality:
All the information we receive will be kept strictly confident.

55
Certificate of consent

Title of the research: Dispensing of antibiotics without prescription among the

community pharmacies in Rupandehi district of Nepal.
Name of the pharmacist/assistant pharmacist: : Age:
Address: Mobile number:
The content of the information sheet dated ………………. that was provided
have been read carefully by me /explained in detail to me, in a language that I
comprehend, and have fully understood the contents. I confirm that I have had
the opportunity to ask questions. The nature and purpose of the study and its
potential risks/ benefit and expected duration of the study, and other relevant
details of the study have been explained to me in detail. I understand that my
participation is voluntary and that I am free to withdraw at any time, without
giving any reason, without my medical care or legal right being affected. I
understand that the information collected about and my pharmacy from my
participation in this research and sections of any of my medical notes may be
looked at by responsible individuals. I give permission for these individuals to
have access to my record. I hereby give consent to take part in the above study. I
also consent for medical photographs of my medical record and I have been
informed that these photographs will be used without revealing the identity.
The consent form has been signed by me when I was not under the influence of
any drugs.
Name of the pharmacy:
Name of the pharmacist/assistant pharmacist:
Signature of the pharmacist/assistant pharmacist:
Date:
Signature of Researcher: ________________ Date:
_______________________

56
शीर्षकः नेपालको रुपन्देही जिल्लाका सामुदायिक औषधि पसलहरूमा विना प्रिस्क्रिप्शन एन्टिबायोटिक औषधि वितरण ।

फार्मासिस्ट / सहायक फार्मासिस्टको नामः

उमेर / लिङ्गः

मोबाइल नम्बरः

मितिको जानकारी पानाको सामग्री ……………………………….. उपलब्ध गराइएका कुराहरू मैले ध्यानपर्वू क पढेको/विस्तृत

रूपमा व्याख्या गरे को, मैले बझु ेको भाषामा, र सामग्रीहरू पर्णू रूपमा बझु ेको छु । म पष्टि
ु गर्छु कि मैले प्रश्न सोध्ने मौका पाएको छु ।

अध्ययनको प्रकृ ति, उद्देश्य, यसको सम्भावित जोखिम / लाभ र अध्ययनको अपेक्षित अवधि, अध्ययनका अन्य सान्दर्भिक विवरणहरू
मलाई विस्तृत रूपमा व्याख्या गरिएको छ । म बझ्ु छु कि मेरो सहभागिता स्वैच्छिक हो । म बझ्ु छु कि यस अनसु न्धानमा मेरो र मेरो
फार्मेसीको बारे मा सक
ं लित जानकारी र मेरा मेडिकल नोटहरू जिम्मेवार व्यक्तिहरूले हेर्न सक्छन् । म यी व्यक्तिहरूलाई मेरो रे कर्डमा पहुचँ
गर्न अनमु ति दिन्छु ।

म यसद्वारा माथिको अध्ययनमा भाग लिन स्वीकृ ति दिन्छु । म तिनीहरूको भ्रमणको क्रममा अडियो रे कर्डको लागि पनि सहमत छु । मलाई
सचि
ू त गरिएको छ कि अडियो रे कर्डहरू आवश्यक पर्दा पहिचान नखल
ु ाई प्रयोग गरिनेछ । म कुनै पनि औषधि वा दवाबको प्रभावमा
नपरे को बेला मद्वारा सहमति फारममा हस्ताक्षर गरिएको हो ।

57
फार्मेसीको नामः

फार्मासिस्ट/सहायक फार्मासिस्टको नामः

फार्मासिस्ट/सहायक फार्मासिस्टको हस्ताक्षरः

सहभागीको थम्ब प्रिन्टः

दायाँ बायाँ

नोटः सचि
ू त सहमति फारम अग्रं ेजी भाषामा र अनसु न्धान सहभागीहरूलाई उपयक्त
ु भाषामा(जस्तैः नेपाली) पेश गर्नुपर्छ ।

58
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