INTRODUCTION:

Over the Counter (OTC) medicines are drugs that can be sold without the prescription of a registered medical practitioner. The phrase “OTC” has no legal recognition in India; all the drugs not included in the list of “prescription-only drugs” are considered to be non-prescription drugs (or OTC drugs). Hence “OTC Drugs means drugs legally allowed to be sold “Over the Counter” by pharmacists, i.e. without the prescription of a Registered Medical Practitioner. Prescription-only drugs are those medicines that are listed in Schedules H and X of the Drug and Cosmetics Rules. Drugs listed in Schedule G (mostly antihistamines) do not need prescription to purchase but require the following mandatory text on the label: “Caution: It is dangerous to take this preparation except under medical supervision”^1-2. With the reclassification of certain drugs, the public can buy preparations that were previously available only on prescription. More than 100,000 over-the-counter (OTC) products are now sold in drugstores, convenience stores, and supermarkets³. ‘Over-the-counter’ medicines are much more widely available than ever before, whether or not Governments sanction them. In U.S. more than 3 lakhs over the counter products⁴ are currently available in the market (FDA). The medicines once available without prescriptions are now restricted as per 21 CFR Part 330. OTC drugs are generally recognized as safe and effective and not misbranded and those which were restricted are also available as OTC drugs in the market now (FDA). Unregulated or unrestricted availability of OTC drugs in the market increases the risk of drug resistance adverse drug reaction and drug interactions. Studies have reported that there is increased or potential risk for misuse or drug abuse of the products^{1, 5}. Regulation of Over-the-Counter Derivatives under the Consumer Protection Act includes the divisions of the regulation of the OTC derivatives market between “SWAPS” regulated by the CFTC and “Security-Based Swaps” regulated by the SEC based on the characteristics of the underlying instrument or interest. The dividing line between the categories, however, is not entirely clear. The complexity of the task and the potential jurisdictional conflicts make coordination essential, and such coordination is in fact mandated under the Derivatives Title. People prefer OTC drugs for common symptoms like; Back Pain and Joint Pain, Runny Nose, Head Ache, Cough, Fever, Wound Care, Skin Problem, Throat infection/ sore throat, Diarrhea, Vomiting, Acidity, Eye Infection, Tooth Pain, Difficult to Breath, Constipation, Mouth Ulcer. 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 (i.e. painkillers, depressants, stimulants, etc.) are readily available without the consent of a doctor. There are very few legal restraints on the OTC drug market. And pharmacists, those permitted to sell drugs without permission from a Registered Medical Practitioner, may legally distribute OTC drugs at their own digression. Among the various categories of O. T. C. in India, the ones that are known for spending the maximum amount for brand building on T. V. are as follows: analgesic or cold tablets like; Crocin, D’cold total, Disprin, Stopache, Triaminic, Vicks Vaporub..etc. Regulation of over the counter drugs in India is especially difficult. According to the Organization of Pharmaceutical Producers of India, "There is at present no system of national chains of supermarkets or drugstores / pharmacies, and retailing is dominated by small independent shops Chain pharmacies haven't been able to make any significant gains in garnering share of market." Because there are no chain supermarkets and drugstores, most drugs are acquired through private drug dealers and "pharmacist."The menace of OTC in India becomes more widespread every day. For more information on the science and treatment of these types of drugs. Patients generally had poor knowledge of the potential side-effects of their medication. However, this appeared not to affect their ability to identify adverse drug reactions (ADRs)⁶. Misuse of OTC drug by consumer is through overuse, taking several drugs concurrently and using home remedies to treat potentially serious diseases⁷. People often think that prescription and OTC drugs are safer than illicit drugs, but that’s only true when they are taken exactly as prescribed and for the purpose intended. When abused, prescription and OTC drugs can be addictive and put abusers at risk for other adverse health effects, including overdose—especially when taken along with other drugs or alcohol⁸. Use of OTC drugs as self-medication for conditions like fever, pain, cold are more common among undergraduate medical students⁹.Right from preclinical level it is the responsibility of health care professional students to incorporate knowledge attitude and practices towards OTC. Awareness developed among them will help to lead better medical practices and prevents any untoward medical occurrence. Medical education should empower doctors, nurses and pharmacists to convert the knowledge imparted to them during their education to their practice of treating and curing patients.

Methodology used for Survey:

The study design and sample size followed World Health Organization guidelines for Investigation of therapeutic practice¹⁰. Accordingly a sample of 10 pharmacy stores was selected randomly from Kasegaon, using simple random sampling technique. A Questionnaire consisted of predefined series of questions used to collect information from individuals was each pharmacy after explaining the purpose of the study and taking informed consent. The study questionnaire was adapted from various similar studies conducted. Any ambiguities in the questions or responses were removed before its implementation. The questionnaire was administered in English used to collect the information. The study consisted of a survey of the use of over the counter medication to ascertain

1. Prevalence of use of OTC drugs

2. Categories of medications preferred

3. Safety priority of using the drugs

4. Knowledge of use of OTC drugs

The prevalence of use of OTC drugs was determined as percentage of all users out of the total Sample.

Study Population:

Various Pharmacy background People and non-Pharma people are observed and selected for short interview at different drug stores.

Sample Size:

50 People from Pharmacy knowledge background similarly 50 from Non-Pharma background.

Study Design:

This is a cross sectional study conducted among Various Pharmacy background People and non-Pharma people. After obtaining informed consent, each Individual was provided with a questionnaire regarding over the counter drugs. An anonymous questionnaire containing both open ended and close-ended questions (like demographic details, health conditions and over the counter medicine use, its frequency, precaution measures taken etc.) was asked to each Individual. The data obtained was subjected to statistical analysis using appropriate method. Questionnaire was asked to the participants and requested to answer it in the presence of any one of the investigators to avoid any missing responses, solving individual’s queries while completing the questionnaire. The filled Questionnaire was collected back and checked by the investigator for any missing responses. The questionnaires were returned back by all participants and later submitted for further data analysis.

OBJECTIVES OF STUDY:

Primary Objectives:

To study the impact of knowledge and attitude on the usage of drugs among Pharmacy background people and general citizens on their purchase practices of OTC medicines in India

Secondary Objectives:

· To determine the extent of Self Medication and attitude towards OTC drugs.

· To find out the preference of Brands among OTC drugs.

· To find out for what health ailments OTC drugs are purchased.

· To identify the key influencers for purchase of OTC medicines among Pharmacy background people and general citizens.

· To analyze the role of pharmacists in purchase of OTC drugs.

SCOPE OF THE STUDY:

The results obtained would create awareness about the irrational use of OTC drugs among pharmacy background and non-pharmacy community. Data will be useful for educating the orientation programs creating awareness to lead better medical practices and prevent any untoward medical occurrences.

Analysis and interpretation:- I) About Pharmacy Background People:-

Fig.no.1.1 Qualification; among all pharma people 67% are with B.Pharm qualification while 27% are with D.Pharm.

Fig.no.1.2

Interpretation:

Use of OTC drugs as self-medication for conditions like fever, pain, cold is more common among all. From the above diagram it is inferred that the maximum no (67%) of respondents choose OTC drugs for Cough and cold as well as Headache, where as only 7% of the respondents choose OTC drug for fever. The above data indicate that body pain seems to be the most frequent ailment followed by cough and cold and fever for which OTC drugs are taken. We can say that the OTC drugs prove very handy for simple ailments like body pain and common cold for which doctors are not consulted by the respondents.

Fig.no.1.3

Interpretation:

From above diagram it inferred that among total pharma background people equal no. of people knows having information about branded and generic medicines.

Fig.no.1.4

Interpretation:

From above diagram it inferred that among total pharma background people 60% knows about brand name of medicine while 34% doesn’t knows about the same.

Fig.no.1.5

Interpretation:

From above diagram it inferred that among total pharma background people 47% have information about API, while 53% doesn’t know about it.

Fig.no.1.6

Interpretation:

From above diagram it inferred that among total pharma background people 27% have information about MOA of that drug while 67% doesn’t know about the same.

Fig.no.1.7

Interpretation:

From above diagram it inferred that among total pharma background people 40% have information about side effects of that drug while 53% doesn’t know about the same.

Fig.no.1.8

Interpretation:

From above diagram it inferred that 67% have favor towards branded drugs while 27% prefers the generic.

Fig.no.1.9

Interpretation: From above diagram it inferred that majority i.e. 67% of the respondents says that Cipla is their favorite brand while 13% of the respondents are says Mankind and Ranbaxy. From the above data, it is clear that Cipla seem to be the dominant OTC drug brands. Both Ranbaxy and Cipla are India-based drug brands.

Fig.no.1.10

Interpretation:

From above diagram it inferred that among total pharma background people 33% have information about Substitutes while 60% are doesn’t have any information about substitutes for the same.

Fig.no.1.11

Interpretation: From above diagram it inferred that to get cure from ailments 67% people approaches towards the doctor while13% prefer OTC medicines similarly 13% approaches home remedies.

II) About Non-pharmacy People:-

(Fig.no.2.1)

Interpretation:

Use of OTC drugs as self-medication for conditions like fever, pain, cold are more common among undergraduate medical student. From the above diagram it is inferred that the maximum no (45%) of respondents choose OTC drugs for Hyperacidity whereas only 9% of the respondents choose OTC drug for diarrhea. The above data indicate that Hyperacidity seems to be the most frequent ailment followed by Fever and Bodyach and fever for which OTC drugs are taken. We can say that the OTC drugs prove very handy for simple ailments like Hyperacidity and common cold for which doctors are not consulted by the respondents.

Fig.no.2.2

Interpretation:

From the above diagram it is inferred that 63% people know about the brand name of the medicine whichever purchased by them while 36% doesn’t knows about these same.

Fig.no.2.3

Interpretation:

From the above diagram it is inferred that 27% people knows about the side effect of medicine while 72% doesn’t knows the side effect.

Fig.no.2.4

Interpretation:

From the above diagram it is inferred that 45% people do check the expiry date of the medicine whichever purchased by them while 54% doesn’t check the expiry date.

Fig.no.2.5

Interpretation:

From the above diagram it is inferred that to get cured from certain ailments 63% people do consult with physician, while 36% people doesn’t consult with physician.

(Fig.no.2.6)

Interpretation:

From the above diagram it is inferred that 63% people do check the medicines after purchasing for the seck of authentication while,36% doesn’t do the same.

(Fig.no.2.7)

Interpretation:

Only 36% of the pharmacists give advice regarding the use of the drugs while purchasing the OTC drugs and 63% of the pharmacists are not giving any advice. From the above diagram it is inferred that only 31% of the respondents are asking the advice if pharmacist forgets to tell and 61% of the respondents are not asking for advice if pharmacist forgets to tell. This indicates that to some extent pharmacists are confident about the awareness of the usage of OTC drugs among the patients even though many patients are not very confident about the usage of OTC drugs.

(Fig.no.2.8)

Interpretation:

From the above diagram it is inferred that to get cure 72% people approach towards the doctor while, 27% prefer OTC medicine, similarly 5% approaches home remedies.

Fig.no.2.9

Interpretation:

From the above diagram it is inferred that 90% of the respondents prefer OTC drugs while 9% prefer OTC due to popularity of brands whereas only 9%, also 12% prefer because of the popularity of OTC drugs and 14% of the respondents prefer OTC drug for its efficacy.

RESULTS AND DISCUSSION:

The survey is conducted in rural area among the Pharmacy retail store visiting Non Pharma community and people with Pharma background in order to check the knowledge OR information about OTC drugs. There information obtained from has been tabulated as follows

Table No.1:- Ailments for taking OTC drugs by individuals

General Ailments	Percentage(%)
General Ailments	Pharmacy background people	Non-Pharmacy background people
Fever	6.67%	27.27%
Coughand Cold	66.67%	9.09%
Diarrhea	13.34%	9.09%
Body ache	26.67%	27.27%
Headache	66.67%	9.09%
Itching	-	9.09%
Hyperacidity	-	45.45%

Table No. 2. Some basic information regarding over the counter medications obtained from Pharmacy background people.

Questions	Percentage(%)
Questions	Pharmacy background people
	Yes	No
1)Generally what you prefer in ailments?(self medication)	93.34%	7%
2)Do you have any information about brand name?(Yes)	60%	33.34%
3) Do you know any information about ADR of purchased medicine?	40%	53.34%
4) Do you know any information about API?	46.67%	53.34%
4) Did you check expiry date?	100%	-
5) Do you have any information about difference in Branded and generics?	50%	50%
6)Did you know about MOA of particular drug?	26.66%	66.67%
7)Information about Substituent’s?	33.34%	60%

Table No. 3. Some basic information regarding over the counter medication obtained from Non- Pharmacy background people.

Questions	Percentage(%)
Questions	Non- Pharmacy background people
	Yes	No
1)Generally what you prefer in ailments?(self medication)	63.63%	37%
2)Do you have any information about brand name?	36.36%	63.63%
3) Do you know any information about ADR of purchased medicine?	27.27%	72.72%
4) Did you check expiry date?	45.45%	54.54%
4) Did consult with physician?	63.63%	36.36%
5) Did you check medicines after Purchasing?	63.63%	36.36%
6)Any advice given by the Pharmacist?	36.36%	63.63%