CHAPTER I

INTRODUCTION

The sale of over the counter (OTC) medicines from pharmacies represents an
opportunity for people to self-medicate and manage their own symptoms. However,
some OTC medicines have the potential for being used incorrectly or abused, and
there have been increasing concerns about risks associated with some medicines.1

Over-the-counter (OTC) drugs are medicines that may be sold directly to a

consumer without a prescription from a healthcare professional, as compared to
prescription drugs, which may be sold only to consumers possessing a valid
prescription. In many countries, OTC drugs are selected by a regulatory agency to
ensure that they are ingredients that are safe and effective when used without
a physician's care. OTC drugs are usually regulated by Active pharmaceutical
ingredients (APIs), not final products. By regulating APIs instead of specific drug
formulations, governments allow manufacturers freedom to formulate ingredients, or
combinations of ingredients, into proprietary mixtures2.

The term over-the-counter may be somewhat counterintuitive, since, in many

countries, these drugs are often located on the shelves of stores like any other
packaged product. In contrast, prescription drugs are almost always passed over a
counter from the pharmacist to the customer. Some drugs may be legally classified as
over-the-counter (i.e., no prescription is required), but may only be dispensed by a
pharmacy employee after an assessment of the patient's needs and/or the provision
of patient education. In many countries, a number of OTC drugs are available in
establishments without a pharmacy, such as general stores, supermarkets, gas stations,
etc. Regulations detailing the establishments where drugs may be sold, who is
authorized to dispense them, and whether a prescription is required vary considerably
from country to country.2

In India, any drug not included in the list of ‘prescription-only’ drugs is

considered a ‘non-prescription,’ or ‘over the counter’ (OTC) drug. Because the
prescription-only drug list is relatively small when compared to the number of over
the counter drugs, hundreds of potentially addictive drugs (ie. painkillers, depressants,
stimulants, etc.) are readily available in the market. There are very few legal restraints

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on the OTC drug market, pharmacists; those permitted to sell drugs without
permission from a Registered Medical Practitioner, May illegally distribute OTC
drugs at their own digression. 3

The proper use of over-the-counter drugs (OTCs), the importance of drug

information has been stressed many times and a counseling role for the pharmacist is
becoming more widely recognized. A community pharmacy study determined what
kind of information was given about OTC drugs and subsequently whether this
information was adjusted to the informational needs of the patient. Drug information
was given both verbally and in writing by means of a patient package inserts (36%
and 63% of the purchases, respectively). In most instances information was provided
even though not requested by the patients. When interviewed at home, patients said
they were satisfied with the information received from pharmacists. It appeared that
the information provided in the pharmacy was adjusted to the informational needs of
the persons who use OTC drugs. Only when asked about the information concerning
the use of OTC drugs in general, did patients' informational needs and drug informing
behavior seem to be greater? The study findings suggest that a patient package insert
is an important information source for patients at the moment they use OTCs, and
therefore has to be delivered consistently. Further, the fact that the patients seldom
asked for drug information at the pharmacy increases the importance of providing
patient package inserts4.

A number of surveys have examined use of OTC drugs in India. However,

there are limited Indian data on use of over-the-counter (OTC) medicines in the
population. The main aims of this study were to examine self-medication practices
and to find association between socio-demographic and knowledge data. The lives of
millions of people worldwide are at risk because they do not have the information,
skills, and support to guide them.

Need for the study:

Over-the-counter (Nonprescription) drugs play an increasingly vital role in

Indian health care system. Today, six out of every ten medications bought by
consumers are OTC drugs.5

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 OTC drugs are defined as drugs that are safe and effective for use by the
general public without seeking treatment by a health professional. Self medication is
defined as the conjunction of medicinal products with the purpose of treating diseases
or symptoms, or even promoting health, without prescription provided by a medical
professional. The prevalence of self medication’s practice depends on many factors
like nature of disease , educational qualification of person , non availability of
specialized person .etc., in study it was seen that 87% of chest symptomatic initiated
medications on their own for getting relieve and this was significantly more in urban
people i.e. 93.9% compared to rural subjects 80.6%.6

Inappropriate self medication results in irrational use of drugs, wastage of

recourses, increased resistance of pathogens, entails serious health hazards such as
adverse reaction and prolonged suffering. If action is not taken, the danger of drug
interactions and side effects could increase. Safety in self medications depends upon
four factors- drug itself, formulation, information, available with all purchasers and
patient compliance.7

A number of reasons could be enumerated for the rise of self medication. One
of the reasons being the increase in chronic diseases and their incidence as raise from
30% to 80%. Other reasons which are responsible for self medications in developing
countries are urge of self care, feeling of sympathy towards family members in
sickness, lack of health services, poverty, ignorance, misbelieves, extensive
advertisement, use of drugs from informal sectors such as open markets and quacks,
illegal purveyors of drugs.8

Some researchers are of the view that self medication can be practiced and
they consider it appropriate for short term relief of symptoms where accurate
diagnosis is unnecessary, uncomplicated cases of some chronic and recurrent diseases.
However, people should be properly educated about the practice of self medication in
order to prevent harmful effects caused by the practice. The increasing self
medications will require more and better education of both the public and health
professionals to avoid the complications arising from the practice.9

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 There has not yet been any systematic research conduct to asses the prevalence
of self medication in community. Thus, self medication in modern pharmaceuticals
seems to be a field in which information is scarce.

FDA's review of OTC drugs is primarily handled by CDER's Office of Drug

Evaluation IV, Over-the-Counter Drug Products. The Nonprescription Drug
Advisory Committee meets regularly to assist the Agency in evaluating issues
surrounding these products. This committee has played a major role in the growth of
prescription to OTC switches in recent years. Because there are over 300,000
marketed OTC drug products, FDA reviews the active ingredients and the labeling of
over 80 therapeutic classes of drugs, for example analgesics or antacids, instead of
individual drug products. For each category, an OTC drug monograph is developed
and published in the Federal Register. OTC drug monographs are a kind of "recipe
book" covering acceptable ingredients, doses, formulations, and labeling. New
prescription drugs, on the other hand, require pre-approval before they can go on the
market. These monographs define the safety, effectiveness, and labeling of all
marketing OTC active ingredients. New products that conform to a final monograph
may be marketed without further FDA review. Those that do not conform must be
reviewed by the New Drug Application process. A drug company may also petition
to change a final monograph to include additional ingredients or to modify labeling.10

During community posting, we experienced that the people have lack

knowledge about OTC drugs. So, we decided to do this study to asses and improve
the knowledge of people in family in selected area.

To the best of our knowledge there is no research so far conducted to reveal

the extent of this problem in India. Therefore we believed that this research may show
the magnitude of problem in India so as to initiate intervention by the concerned
authorities and community as well.

People in community and family play an important role for future population. There is
need to provide such service and undertake research in understanding general health.

Early intervention can alter pattern of behavior that would have placed these
people at risk in later life. Therefore promoting good health is essential and also felt
need of people.

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Statement of the Problem:

“An investigation into the Knowledge on practice of using an OTC drugs among the
people in age group of 40 – 80 years. Of a selected community area, Uttrakhand.”

Objectives:

1. To assess the level of knowledge on practice among people those in age

group (40 – 80 years) regarding using an OTC drugs.
2. To find out the relationship with their knowledge level and socio-
demographic data among people those in age group (40 – 80 years).

Conceptual Definitions:

1. Investigation:

Investigation is the process of inquiring into a matter through research, follow-

up, study, or formal procedure of discovery.

2. Knowledge on Practice:

It refers to information and level of understanding regarding day today life

activities.

3. OTC Drug:

“Over the counter” drug is the type of medication you can purchase at your
local pharmacy without doctor’s prescription.

4. Family:

"One or more persons related by blood, adoption, or marriage, living and

cooking together as a single housekeeping unit, exclusive of household
servants.

Operational Definitions:

1. Investigation:

It is the work inquiring into the subjects thoroughly and systematically about
usage of OTC drugs.

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2. Knowledge& Practice:

It refers to information and level of understanding regarding OTC drugs and

their usage frequency of drugs in day to day life.

3. OTC drug:

(OTC) drugs are medicines that may be sold directly to a consumer without
prescription from a healthcare professional, as compared to prescription drugs,
which may sold only to consumers possessing a valid prescription.

4. Family:

The collective body of persons who live in one house, and under one head or
manager; a household, including parents, children, and servants, and, as the
case may be, lodgers or boarders.

Hypothesis:

H1 – There will be a significant association between their level of knowledge and

selected socio-demographic variables.

Delimitations:

The study was limited to the people who were:

1. Using an OTC drug.

2. Willing to participate in study.

3. The age group of (40 – 80) years.

4. Present during the period of data collection.

Summary:

This chapter has dealt with introduction, need for the study, and statement of problem,
objectives, operational definitions, hypothesis and delimitations.