INTRODUCTION increased resistance is a result of


Internationally, the most frequently purchased drugs are
antimicrobials1. They are
indispensable treatments especially in countries like India, where the
infectious disease burden is among the highest in the world2. The success of antimicrobial therapy critically
depends on the use of drugs which are active and effective against common pathogens.
Hence, the outcome is beneficial for the patient when antimicrobial drugs are
used against a vulnerable pathogen3.
Nevertheless, habitual use of antimicrobials at the population level is linked
to the rise of bacterial resistance, narrowing the effective range of the
available drugs 4,5.

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The increased resistance is a result of many factors, but
the leading cause is the overall volume of antibiotic consumption6. With each use, whether
appropriate or not, the probability of the development and spread of
antibiotic-resistant bacteria escalates7.
In developing countries antibiotics can be obtained easily from private retail
pharmacies without prescription and pharmacists also advise and dispense
antibiotics to patients8.
Hence, self-medication is rampant and inappropriate antimicrobial use is
persistent. To prevent this problem, an all-inclusive method is advised which
includes proper awareness and education of the public regarding self-medication9.  Recognizing the reasons and rationale of
individuals for consumption of self-prescribed antimicrobials enables the
formation of effectual strategies that directly tackle these key influences of
non-prescription antimicrobial use.

Maintenance of antimicrobial success is a universally shared
responsibility but the actions needed to achieve this goal cannot be decided
globally. Each region must adopt approaches adapted to its own conditions.
Hence this study brings to light the factors driving individuals to purchase
antibiotics without a prescription or oversight by healthcare professionals in
Karaikal, Puducherry.


The primary objective of this study is to determine the
factors driving individuals to acquire over the counter antibiotics without a
prescription in Karaikal.

Secondarily, this study ascertains the prevalence and
practice of consumption of non-prescribed antibiotics in Karaikal to depict the
situation in this particular region.


Study Design: A
Cross Sectional Study

Data Collection
Period: 1st May 2018 to 31st July 2018 (3 Months)

Sample Size Calculation: Assuming that the prevalence rate of purchase
of antibiotics without prescriptions is 11.6%10, confidence interval of 99.9% and 5% absolute
precision, the estimated sample size is 444, calculated using Open Epi Software
3.01 version. Taking into account a non-response rate of 10%, sample size will
be 488; rounded off to 500.


Study Population: Patients
and their relatives visiting the Out-Patient Departments in the Karaikal
General Hospital

Sampling Technique: Convenience

Selection Criteria:

1.       Adults
(above the age of 18), living in Karaikal, who visit the Karaikal GH OPD during
the data collection period, with no disabilities that would hamper their
understanding the questionnaire.

2.       Individuals
from medical and paramedical fields are going to be excluded from the study to
evade selection bias.

3.       Purchase
and usage of non-prescribed antibiotics only in the last 6 months shall be
judged in order to avoid recall bias.

Data collection
procedures & instruments used

First a brief introduction
of the study shall be given to the participant. After receiving verbal consent
to carry out the study, a written consent form shall be given to the
participant to obtain written consent as well. Data will be collected using a
structured validated questionnaire. The questionnaire will be divided into 5

Sociodemographic Details

Prevalence of purchase of non-prescription

Reasons for purchasing antibiotics without

Signs and symptoms for which antibiotics were

Attitude of the participant towards this

The questionnaire shall also be back-translated to Tamil,
the regional language, so that participants can have the option to respond in
either Tamil or English. Their responses, if in Tamil, will be translated back
to English while recording the data.

Quality control: The
questionnaire will be developed through a series of focus group discussions
with subject experts (two pharmacologists, two clinical pharmacists and one
internal medicine specialist) and review of literature11,12. The translated questionnaire will be back
translated into English for accuracy of translation.

Confidentiality: Confidentiality
shall be maintained.

Plan of Analysis/ Statistical Tools: Data analysis will be done using SPSS version 24. Means and
proportions will be calculated and Pearson Chi-square test of significance will
be used to identify association among the variables.


Ethical Considerations:
Ethics approval will be obtained from the IEC. Verbal and written informed
consent shall be taken from all of the participants and only those who agree
willingly to participate in the study shall be registered.



After identifying the reasons that trigger individuals to
buy antibiotics with neither prescriptions nor  
superintendence of healthcare professionals, a context specific guideline
can be drawn for Karaikal which shall be very effective in reducing the rate of
non-prescribed antimicrobial use, ultimately lowering the pace of antimicrobial
resistance in the area.

From a broader perspective, this information could be used
to form and enforce strict regulations and form structured educational
campaigns for the public to control and limit sales of antibiotics without

Lastly, this project gives me not just experience in
research but the opportunity to work on a distressing medical topic that
profoundly preoccupies my mind.