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International Journal of Research in Economics and Social Sciences (IJRESS) Available online at: http://euroasiapub.org Vol. 7 Issue 7, July- 2017, pp. 531~535 ISSN(o): 2249-7382 | Impact Factor: 6.939

International Journal of Research in Economics & Social Sciences

Email id: [email protected], http://www.euroasiapub.org (An open access scholarly, online, peer-reviewed, interdisciplinary, monthly, and fully refereed journal)

531

A Detailed study on Regulatory Affairs followed by Retail pharmacist

Dr. Neha Garg

Abstract

In today’s competitive environment the reduction of the time taken to reach the market is critical to

a product’s and hence the company’s success. The proper conduct of its Regulatory Affairs activities

is therefore of considerable economic importance for the company. Pharmacists, also known as

druggists or chemists, are healthcare professionals who practice in pharmacy, the field of health

sciences focusing on safe and effective medication use. The role of the pharmacist has shifted from

the classical "lick, stick, and pour" dispensary role (that is, "lick & stick the labels, count the pills &

pour liquids"), to being an integrated member of the health care team directly involved in patient

care. Pharmacists undergo university-level education to understand biochemical mechanisms of

action of drugs, drug uses and therapeutic roles, side effects, potential drug interactions, and

monitoring parameters. This is mated to education in anatomy, physiology, and pathophysiology.

Professional interpretation and communication of this specialized knowledge to patients, physicians,

and other health care providers are functions which pharmacists provide, and are central to the

provision of safe and effective drug therapy.

Keyword: Economic, Healthcare professionals, Biochemical mechanisms, Pathophysiology.

Introduction

Various laws and ethics govern pharmacy operations. While the laws are the legal framework within

which a pharmacy and its personnel can operate, ethics are professional regulations, which govern a

pharmacist in operating a pharmacy. The legal aspects related to the retail purchasing, stocking and

selling or dispensing products/ medicines in a pharmacy are prescribed and governed by various

laws.These laws have been devised because purchasing, stocking and dispensing the right medicines

directly affect a patient's treatment or health. A slight error could become a matter of life and death

for the patient. All pharmacists and other staff must thus ensure that the entire pharmacy operates

within the legal framework of these laws.Adhering to laws is essential for providing optimum health

care by minimizing errors. Thus, carrying out duties according to the laws highlights

professionalism, and wins the respect and confidence of the public/ or of clients.

Laws regulate and lay down standards of conduct for the pharmacy trade/ profession. Legislation

ensures that the patients receive drugs of required quality, tested and evaluated for safety as well as

efficacy for the intended use.

Research Methodology

Research Methodology is a way to systematically solve the research problem. It may be understood

as a science of studying how research is done scientifically. In it we study the various steps that are

generally adopted by researcher in studying his research problem along with the logic behind them.

Objectives of Study

• To understand the laws related to pharmacy practice in India.

International Journal of Research in Economics and Social Sciences (IJRESS) Vol. 7 Issue 7, July- 2017 ISSN(o): 2249-7382 | Impact Factor: 6.939



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• To know how Regulatory Affairs help pharmacists to manage retail medical stores..

Hypothesis

H0-There is no need to follow the laws related to pharmacy practices by the retail pharmacist.

H1- There is need to follow the laws related to pharmacy practices by the retail pharmacist.

Data analysis

Statistical tools

The statistical tools implemented in this study are

1. Tabulation: The table for the demographic distribution for collecting the samples as per the

criteria under the objectives of this study.

2. Reliability Test Analysis: Cronbach’s alpha reliability test is used to check the internal

consistency of items under consideration of a subject.

3. Validity Test Analysis: Data pre-processing is performed to check any outliers falling beyond

1-5 rating against each factor response and to fill the missing values of the responses by using

KNN technique.

4. Descriptive Analysis: Graphical tools of bar charts are used to identify the trend on each item

under consideration.

5. Inferential Analysis: Hypothesis testing is conducted using Independent Sample T-Test for

given dimension.

Statistical Analysis

Step 1:

Tabulation: The tables for the demographic distribution reflect the sample to be collected as per the

criteria under the objectives of this study. This fair distribution helps in performing the hypothesis

testing considered under this study.

Step 2:

Reliability Test Analysis: The 5 point Likert’s scale is used to collect the responses where every

Likert’s item is provided the given weights: 1-Strongly agree, 2-Agree,3-Neither agree nor disagree

and 4- Disagree.

To test the reliability of the format, design a pre survey test is necessary before executing the overall

study. Cronbach’s Alpha reliability co-efficient normally ranges between 0 and 1 however; there are

actually no lower limit to the co-efficient. The closer Cronbach’s Alpha co-efficient is to 1.00 the

greater the internal consistency of the items in the scale. Cronbach’s Alpha is calculated by following

formula:

𝛼 =𝑘

𝑘 − 1(1 −

∑ 𝜎𝑌𝑖2𝑘

𝑖=1

𝜎𝑋2 )

.

Where : K= number of different items administered to each subject.

𝜎𝑌𝑖2 = Variance of different items administered to each subject.

𝜎𝑥2 = Variance of total raw scores of each sample respondent.




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George & Mallory (2003) provides the following techniques: If is

a. > 0.90 = Excellent

b. 0.80 - 0.89 = Good

c. 0.70 - 0.79 = Acceptable

d. 0.60 - 0.69 = Questionable

e. 0.50 - 0.59 = Poor

f. < 0.50 = Unacceptable

Step 3:

Validity Test Analysis: After passing the above test the overall study can be conducted where the

data is then complied in the required format. Data preprocessing is performed to check any outliers

falling beyond 1-5 rating against each factor response and to fill the missing values of the responses

by using KNN technique. After the completion of data pre-processing an equal justice can be

examined for each factor under consideration for the 6 categories of respondents.

Step 4:

Descriptive Analysis: Based the percentage of the 5 point Likert’s scale a graphical representation

can provide a clear amount of percentage which agrees the fact under consideration. The

comparative results of the responses received from all the 2 categories of respondents can also be

tabulated to determine the facts numerically.

Step 5:

Using the interpretations determined in Inferential analysis an overall conclusion is drawn as to

support the hypothetical statement under consideration.

SPSS Table:

One Way ANOVA test using SPSS tool provides an ANOVA table, the 7th column of Sig. provides the p.

value which depends on the F value of the 6th column. We can set the following rules at 5% level of

significance:

If p value >0.05, then the model is non-significant model and support the statement of the null

hypothesis. This means, Good Pharmacy Practices does not play an important role in Retail Medical

Stores Management

If p value 0.05, then the model is significant model to determine the statement of alternative

hypothesis. This means, Good Pharmacy Practices play an important role in Retail Medical Stores

Management

This chapter deals with the data analysis, interpretation & major findings of the study. The primary

data that was collected after conducting the survey with respondents was tabulated and analysed.

For arriving at conclusion of the study, a detailed analysis of all key parameters was important. These

parameters, as presented below, were selected & taken into consideration while choosing the tool of

analysis.

Interpretation of Pharmacist Questionnaire:

The questions were asked on the basis of following scale:

The total counts that were taken into consideration were sum of the responses of:

1. Very Important

2. Somewhat important and




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3. 50% of responses of neither important nor unimportant

Here researcher agrees upon a standard value of 60% & above responses, which are sufficient to hold

the hypothesis true. Total sample sizes are 100 pharmacists. By using the method of descriptive

statistics & with the help of MS Excel-2007 all the results were drawn & further tested through

ANOVA Test.

Conclusion

1. The Drugs and Cosmetic Act, 1940(D & C Act), was enacted to regulate the import, manufacture,

sale and distribution of drugs and cosmetics. The Act includes laws governing the setting up and

operation of a pharmacy.

• The Act applies to all goods and services unless specifically exempted by the Central

Government.

• The Act intends to Monitor the licenses of premises from which medicines are sold/

distributed.

2. Narcotic Drugs and Psychotropic Substances Act (NDPS Act) And Rules, 1985 has been enacted

to make stringent provisions for the control and regulation of operations relating to narcotic

drugs and psychotropic substances (NDPS).

3. The Drugs Prices Control Order, 1995, is an order that lays down rules with respect to the

fixation of prices of bulk drugs and formulations.

4. The Consumer Protection Act, 1986 enshrines certain rights of the consumers and provides for

the setting up of Consumer Protection Councils in the Centre and the states. The objective of

these Consumer Protection Councils will be to promote and protect the rights of the consumers.

5. The Infant Milk Substitutes, Feeding Bottles And Infant Foods (Regulation Of Production, Supply

And Distribution) Act, 1992 provides for the regulation of production, supply and distribution

of infant milk substitutes, feeding bottles and infant foods with a view to protect and promote

breastfeeding and ensure the proper use of infant foods. Under this Act, “Health care system”

means an institution or organization engaged, either directly or indirectly, in health care for

mothers, infants or pregnant women, and includes health workers in private practice, in a

pharmacy, in a drug store and any association of health workers

Recommandation

Pharmacist is an important servant for complete health care and he is top professional in the

developed world. However, in Indian health care system, Pharmacists are under-utilised.

Community Pharmacists are merely involved in 'Pharma Trading' and not in services of 'Pharma

Care'. Hence continuous education is the only solution for updating pharmacists, which not only

builds the confidence in the practicing pharmacists but they can accept challenges of ‘chain

shoppies’.

1. Pharmacists should maintain Patient Medication Record (PMR) of each individual. This is

beneficial in avoiding drugs interaction that is possible due to multi-therapy from one or

more physicians, or simultaneous administration of OTC and prescription drug.

Information about health history allergic reactions etc., help Pharmacists to check

suitability of medicines for the Patient and also for patient counseling.




535

2. The pharmacist or person in charge of the retail outlet should maintain records of

Continuing Education programs attended. These could be on the-job training programs or

special programs conducted by manufacturers, industry associations or other institutions.

These could also be in-house training programs conducted by the registered pharmacist

for the assistants and other staff working in the retail outlet. The relevant certificate for

having attended such programs or documentation is support of having conducted in-house

training programs should be retained.

3. One to one interaction with the patient can thoroughly assess the patient knowledge and

improve understanding about therapy.

4. Single pharmacist cannot sale and counsels the patients in busy shop, all the staff should

be adequately trained. Therefore, pharmacists should organize and attend seminars on the

therapeutic issue, adverse effects, etc.

Reference

1. AHFS Drug Information 2000 American Hospital Formulary Services, U.S.A..

2. Delhi State Essential Drugs Formulary National Capital Territory of Delhi 1997, Govt. of Delhi.

3. Banned and Bannable Drugs Unbiased Drug Information Essential Drugs and Rational Drug

Policy 5th

Revised Edition Dr. Mira Shiva and Dr. Wishvas Rane VHAI (Voluntary Health

Association of India), New Delhi, India.

4. A Report on Challenges & Opportunities for Pharmacists in Health Care in India, SEARPharm

Forum, New Delhi, India.

5. Textbook of Homoeopathic Pharmacy Dr. D. D. Banerjee.

6. Case Studies in Over-the-Counter, Therapeutics Edited by Bruce H. Woolley, John M.

Bulgin.Clinical Pharmacy Practice Edited by Charles W. Blissit, O. Lynn Webb, Walter F.

Stanaszek.

7. Communication Skills in Pharmacy Practice William N. Tindall, Robert S. Beardsley,

Carole L. Kimberlin.

8. British National Formulary (BNF 46) Royal Pharmaceutical Society of Great Britain.

9. Drugs and Cosmetics Act 1940 and Rules 1945; Govt. of India.

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