Book: Pharmaceutical Drug Promotion in Pakistan

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Title Pharmaceutical Drug Promotion in Pakistan Subtitle Issues in Ethical and Non-Ethical Practices Course Pharmaceutical Marketing Author Rizwan Raheem Ahmed Year 2012 Pages 208 Archive No. V276715 ISBN (eBook) 978-3-656-70074-6 ISBN (Book) 978-3-656-70209-2 Biography of Author: Dr. Rizwan Raheem Ahmed holds B.Sc. (Hons.), M.Sc. in Applied Statistics and Master of Science (MAS) in Human Resource Management from University of Karachi. He also earned MBA (Marketing) from PAF-KIET and MBA (General Management) from Institute of Business Administration, Karachi. He also holds MS (Management Sciences) from SZABIST and M.Phil. (Financial Economics) from Hamdard University, Karachi. Dr. Rizwan earned his Ph.D. in Pharmaceutical Marketing from Hamdard University, Karachi. Dr. Rizwan Raheem Ahmed carries more than 19 years of Professional Experience at Senior Management Positions in Sales and Marketing with prestigious National & Multinational Organizations in Pharmaceutical Industry. He has been associated with Indus University since September 2013 as Professor for Business Administration & Commerce department. He has been visiting Faculty for SZABIST for several years. More than 40 Publications (Peer reviewed research articles) are on his credit in reputed National & international Journals including ISI Thomson Reuters indexed & impact factor Journals also. He is also an author of several News articles, which have published in DAWN, Karachi and Business Recorder, Karachi.


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© Copyright Reserved 2014 All rights reserved. No part of this publication may be reproduced, stored, in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, reordering or otherwise, without the prior permission of the publisher. Archive No. V276715 ISBN (eBook) 978-3-656-70074-6 ISBN (Book) 978-3-656-70209-2


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PHARMACEUTICAL DRUG PROMOTION IN

PAKISTAN: ISSUES IN ETHICAL AND NON-ETHICAL

PRACTICES

ABSTRACT

Common People and government authorities are usually concerned about the

unethical pharmaceutical marketing practices in Pakistan, therefore; the researcher

examines the unethical pharmaceutical marketing practices in Pakistan, and selected

Karachi City as Case study for this purpose and analyze the impact of unethical

marketing practices in pharmaceutical industry.

This study not only evaluates the responsible variables for the unethical

pharmaceutical marketing practices but also compare who is more responsible for

these unethical pharmaceutical marketing practices in Pakistan. This study also

examines, who has initiated these unethical pharmaceutical marketing practices in

Pakistan and who is responsible for the continuation of these practices in Pakistan.

In this study researcher focuses six variables that can be a major cause of unethical

pharmaceutical marketing practices in Pakistan i.e. Pharmaceutical marketing and

Sales personnel, doctors’ community, retail and whole sales pharmacies,

government and private hospitals personnel, government officials and patients or

their attendants’. All these six variables have been taken and gathered the data

through survey questionnaire, compile and analyze through Statistical tools like

descriptive and inferential Statistics both and conclude the main cause of unethical

pharmaceutical marketing practices in Pakistan.

In the under taken study four different hypotheses were developed and tested

through Z and F test and also analyze the data through descriptive Statistics, for the

descriptive Statistics four different parameters were developed and presented in the

form of graphs and tables. The conclusion of the study was that initially

pharmaceutical industry was responsible to introduce the unethical marketing


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practices to their customers i.e. doctors community, and hospitals and later on

unethical pharmaceutical marketing practices became the norm of the

pharmaceutical industry. Now the doctors are the main cause or reason for the

continuation of these unethical pharmaceutical marketing practices in Pakistan.

It is further concluded in the study that foreign visits are more common tools in

order to get maximum output from the doctor community and now doctors have

become more demanding and they ask themselves regarding the foreign and local

tours and conferences. Cash incentive and home appliances are another form of

unethical practices in the pharmaceutical industry. Clinic and home decoration are

also the findings of unethical pharmaceutical marketing practices in the under taken

study. However, it is also found that some demands from the doctors’ community or

the offers by the pharmaceutical companies are quite ethical genuine regarding the

scientific meeting and local & international scientific conferences.

It is further concluded that all the stakeholders are agreed that these unethical

pharmaceutical marketing practices can be stopped. They are also agreed non-

qualified doctor’s practice should be eradicated. Pharmaceutical companies should

strictly abide the rules and regulations, which are already mentioned and given in the

pharmaceutical marketing code of ethics, at the same time Pakistan Medical

Association and Pakistan Medical and Dental Association should restrict to the

doctors community to practice in the limit of ethical and moral grounds.

Governmental agencies are also responsible to enforce the prevailing laws with their

true spirit on pharmaceutical companies. If any further legislation is required in

order to stop these unethical pharmaceutical marketing practices then further

legislation should be taken place and strict laws should be made and implemented.


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A C K N O W L E D G E M E N T

My deepest gratitude and profound admiration are due firstly to my supervisor Dr.

Ahmad Saeed for his help and cooperation in the smooth completion of my Ph. D.

studies at Hamdard University.

My special thanks go to Prof. Dr. Syed Abdul Aziz, Director, Hamdard Institute of

Education and Social Sciences, Hamdard University Karachi for his encouragement

and continuous support during the research and course work.

I am also thankful to my friends, colleagues and well wishers, who constantly pray

for my success. Special thanks to Mr. Abid & Mr. Sajid who supported me

whenever they are asked for any support and help during my research work.

I would like to express my special thanks to all those who participated in this study

and whom I could not mention the names in the list of gratitude.

In last but not lease I appreciate the encouragement and countless help of my wife

during my studies and my parents who always supported me during every step of my

career.

RIZWAN RAHEEM AHMED


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TABLE OF CONTENTS Abstract … … … … … … … … … i Acknowledgement … … … … … … … … ii Table of Contents … … … … … … … … iii Chapter I: INTRODUCTION 01 1.1 Background of the Study … … … … … 01 1.2 An Overview of Pakistani Pharmaceutical Industry … … 04 1.3 Statement of the Problem … … … … … 10 1.4 Research Hypotheses … … … … … … 10 1.5 Purpose of the Study … … … … … … 11 1.5.1 General Purpose … … … … … … 11 1.5.2 Specific Purpose … … … … … … 11 1.6 Scope of the Study … … … … … … 12 1.7 Justification … … … … … … … 12 1.8 Definition of Key Words & Phrases… … … … 13 Chapter II: REVIEW OF THE LITERATURE 16 Chapter III: RESEARCH METHODOLOGY 44 3.1 Data, Sample and Methodology … … … … 44 3.2 Total Population … … … … … … 44 3.3 Targeted Population … … … … … … 45 3.4 Sample Size … … … … … … … 46 3.5 Pharmaceutical Sales & Marketing Personnel … … 47 3.5.1 Multinational/National Pharmaceutical Personnel … … 47 3.6 Doctors Community … … … … … … 47 3.6.1 General Practitioners (Both Rural & Urban) … … … 47 3.6.2 MOs & RMOs of Public & Private Hospitals … … … 47 3.6.3 Consultants of All Specialties… … … … … 47 3.7 Hospitals … … … … … … … 47 3.7.1 Public Hospitals … … … … … … 47 3.7.2 Private Hospitals … … … … … … 48 3.8 Pharmacies … … … … … … … 48 3.8.1 Retail Pharmacies … … … … … … 48 3.8.2 Whole Sales Pharmacies … … … … … … 48 3.9 Government Officials … … … … … … 48 3.9.1 Federal/Provincial Government Officials… … … … 48 3.10 Patients or their attendants’ … … … … … 49 3.10.1 Outdoor Patients & their attendants’ … … … … 49 3.10.2 Indoor Patients & their attendants’ … … … … 49 3.11 Plan of Data Analysis … … … … … … 49 Chapter IV: DATA ANALYSIS 50 4.1 Survey Findings …. … … … … … 50


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4.1.1 Gender … … … … … … … 50 4.1.2 Age … … … … … … … … 51 4.1.3 Experience … … … … … … … 52 4.1.4 Education … … … … … … … 52 4.1.5 Respondents … … … … … … … 53 4.1.6 Pharmaceutical Personnel… … … … … … 54 4.1.7 Consultants … … … … … … … 55 4.1.8 General Practitioners … … … … … … 56 4.1.9 RMO / MO … … … … … … … 58 4.1.10 Government & Private Hospitals Officials… … … … 59 4.1.11 Retail Pharmacies … … … … … … 60 4.1.12 Whole Sales Pharmacies … … … … … 62 4.1.13 Outdoor Patients … … … … … … 63 4.1.14 Indoor Patients … … … … … … 64 4.1.15 Government Officials (Federal & Provincial)… … … 66 4.2 Hypotheses Testing … … … … … … 67 4.2.1 Hypothesis No. 1 … … … … … … 67 4.2.2 Hypothesis No. 2 … … … … … … 69 4.2.3 Hypothesis No. 3 … … … … … … 71 4.2.4 Hypothesis No. 4 … … … … … … 73 4.3 Qualitative Analysis … … … … … … 75 4.3.1 Tools of Unethical Drug Practices… … … … … 76 4.3.2 Drug Promotion to Non-qualified Doctors … … … 77 4.3.3 Legislation for Unethical Drug Promotion … … … 78 4.3.4 Eradication of Unethical Drug Promotion … … … 79 Chapter V: SUMMARY, CONCLUSIONS AND RECOMMENDATIONS 80 5.1 Summary & Conclusions … … … … … 80 5.2 Recommendations … … … … … … 90 5.3 Suggested Areas of Further Research … … … 92 Appendix – I: 94 Questionnaire … … … … … … … … … 94 Appendix – II: 97 Cross-Tabulation … … … … … … … … 97 Appendix – III: 103 Code of Ethics for Pharmaceutical Marketing … … … … 103 Appendix – IV: 161 The New Pharma Code on Interactions with Healthcare Professionals… … 161 REFERENCES … … … … … … … … 195


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CHAPTER ONE

INTRODUCTION

1.1 BACKGROUND OF THE STUDY

Unethical marketing practices have become an essential part of the pharmaceutical

industry in Pakistan and roots are so strong that it may not be possible to reverse the

same (Parmar & Jalees, 2004). However the previous study has a limitation. It was a

case study on pharmaceutically industry in Hyderabad. In view of the findings of

that study there was a need to carry out the same on larger basis. Thus this research

has been undertaken with this objective in mind.

The phenomenon of the unethical drug practices is common worldwide but its

severity is deep rooted in developing countries. Unethical drug practices have two

dimensions. One is drug related, and other is drug promotion related. Extensive

research on drug related unethical practices has been carried out internationally.

However, the author was not able to find any empirical study on unethical drug

promotion practices except the one that was carried out by (Parmar, Jalees, 2004) in

Pakistan. Parmar and Jalees (2004) in their study observed that pharmaceutical

industry spends a substantial portion of its budget on market research but do not

carry out the research on unethical drug promotion practices. One of the reasons is

that the industry itself is indulged in this practice therefore it does not find any need

to carry out the research on this issue.


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Lack of research on the subject does not mean that unethical drug promotion

practices do not exist. The pre-survey and focus groups discussions indicate that

unethical pharmaceutical marketing practices have become an acceptable norm of

the pharmaceutical diligence, and it is also well supported by more or less all the

pharmaceutical groups with the cooperation of government hospitals, private

hospitals, doctors and health allied organizations including pharmacies on patients’

interests. All the entities as discussed above appear to be corrupted; therefore, it may

not be fair to blame any one of them, including pharmaceutical industry.

Doctors and other entities as discussed above have become greedy; therefore, these

are vulnerable to Pharmaceutical industry for unethical drug promotion practices.

The Pharmaceutical companies fund nearly all symposiums and educational actions

of doctors; therefore, the industry uses the forum to pursue its goals, which at times

may not be the same as the purpose and objective of the conferences. Pakistan

Medical Journalists Association (PMJA) has published a few articles on this issue.

But this has not affected the prevailing unethical drug promotion practices (Zaidi

et.al, 1995).

The focus of the subject study was to identify the intensity and trends of unethical

drug promotion practices in Pakistan. Ascertaining the contribution of the doctors,

health related institutions and the pharmaceutical industry in promoting such

practices. Unethical marketing practices have now an integral part of drug

promotion. Unethical practices could be classified into two segments. One is related

to the medical side of the drug i.e. the trial of the drug both on animals and the

human, and registration of indications and patent period in different countries.


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According to the prominent scholar and eminent physician of the country, Dr Sania

Nishtar (2007), the unreliable news of bribery and dishonesty in this pharmaceutical

circle have to be given watchful investigation. Health system of Pakistan must have

an effect with these corruption practices. These practices can entail together

supervisory body and private sector. The process of registration, authorization and

pricing criteria, procurement and sales & marketing of drugs are all involve with

these types of practices. These all bad practices has their roots for the commercial

safety of the pharmaceutical companies, who pay heavy cost and struggle to avoid

dealings for the enlistment of their products, accelerate the endorsement procedure,

and catch flattering prices of their products.

The astringent method for procuring medicines proffer money-spinning resource for

most of the bureaucrats and thus suppliers intend to pay bribes, and paying them

through excess in billing and invoicing. In Pakistan, we can find the similar

behaviors in almost every public hospital through unreliable data.

Consequently, healthcare prerequisite rely on a system, which proficiently joins

fiscal and individual assets to deliver system of check and balance, good

management and effective services. Conversely, in our country bad management and

dishonesty in health system are symptoms of a wider system trend. These issues

need be address and entails consent and right both inside and outside of the health

sector system (Nishtar, 2007).


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1.2 AN OVERVIEW OF PAKISTANI PHARMACEUTICAL INDUSTRY

There are about 650 leading Nationals and Multinational pharmaceutical companies

operating in Pakistan. Of this total 23 are multinationals and rests of companies are

local companies. The companies here could be categorized in three groups:

1. Manufacturing plant

2. Importers (bring finished medicines from abroad)

3. Franchisers

Franchisers are those companies that have all the marketing setup and facilities.

These companies obtain the rights of marketing of the drugs of other companies on

profit sharing basis. Total current market volume (March 2010) is of Rs.137.7

billion. (IMS, Q3, 2010)

GRAPH – 1

Pakistan Pharmaceutical Market (PKR in Billion)

Source: IMS – PKPI Q2 2010 (MAT)


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In the year 2009 the industry realized a high degree of fluctuation in the growth rate.

One of the major reasons for such a trend was merger and acquisition, and glutting

the market by local pharmaceutical industry. However on an average the growth

rate in the year 2009-10 was about 15.4% per annum. Comparatively the growth rate

in the year 2008-09 was about 12% (IMS, Q2 & Q3, 2010).

A tough competition exists between the multinationals and nationals, day-by-day

nationals are taking up the share and in the last six years they have taken around 7%

share in value. The gap between multinationals and nationals narrows further during

2009-10 with multinationals losing another 1.7% share to nationals. At present

multinationals hold 46.9% share of the market while the nationals have captured

53.1% of the pharmaceutical business. From around 80% share in the

pharmaceutical retail market, the MNCs have lost around 29% during the last twenty

years as the nationals continue to improve their performance in the market place.

Almost an identical trend is observed in units as well, nationals having 54.05% as

compared to multinationals 45.95% (IMS, Q1 & Q2, 2010).

GRAPH – 2 Top 10 Pharmaceutical Companies (PKR in Millions)



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The overall market dynamics are tilted in favour of national companies as they are

continuously launching new products at a much faster rate than MNCs, a trend that

is becoming increasingly evident. In terms of new product market in value, the sales

contribution gap between multinational and national companies has also increased

over the last five years. The products launched before 1991 are dominated by the

multinationals while after 1991 it is shifting towards the nationals. However, the

leading 20 products of the industry are still those products, which are launched by

the MNCs between 1970 and 1990 (IMS, Q2 & Q3, 2010).

Of the total markets size of 137.7 billion, the top 20 corporations contribute around

60% of total business, 34% of market concentrated among the top 5 corporations.

The rest 40% of the market is distributed amongst 630 corporations in Pakistan. For

the purpose of calculation in terms of value, the top 15 corporations make up 54%,

top 35 corporations make up 75.09%, and top 75 corporations make up 90.91%,

while the remaining corporations are competing for approximately 9% market share

(IMS, Q1 & Q2, 2010).

The drugs prices of the national pharmaceutical companies are cheaper, as they have

choice of procuring the raw material from those countries where it is available at a

cheaper rate. The other reason for the price differential is that the national

pharmaceutical industry does not invest in research and development compare to

multinationals. Multinational companies invest a huge amount of their net profit in

R & D, therefore, when they introduce a new molecule into the market they have

already invested billions of dollars for a new product, therefore, the price of the new


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product keeps high in order to meet the total cost of the drug in a certain time period

because after patent period any company can make its Me too or imitation at cheaper

rate. So, the national companies have twice leverage to set their prices at the lower

level i.e. first they did not invest a single penny on Research & Development and

secondly they are having cheaper raw material resources (Ahmed & Jalees, 2008).

Another, important point in price difference is that national companies are not bound

to pay certain amount of profit to any other body, whereas, multinational companies

are paying certain percentage of profit to their parent companies. Moreover, national

companies do not have huge overhead expenses; in contrast, multinational

companies allocate huge overhead expenses in different fields at the beginning of

every fiscal year for every product in a certain ratio, therefore, the cost of goods

(COG) are different in national and multinational companies. In order to maintain all

these costs they are bound to set a high price, otherwise bottom line will be very low

and business would not be feasible any more.

The connection among pharmaceutical companies, doctors and health officials is

also very significant. Commissions may be the reason behind weakness of this

sector, to prevent from corruption strict rules and regulations are needed. Heavily

regulation is indispensable toward safety and protection of peoples in opposition to

inferior and unjustly price of medicines. Another reason for such regulations is to

guarantee that industrial strategies fortify the effective economic development and

improvement in the pharmaceutical sector. These two intentions at times decline

each other’s. If regulators are coercing by pharmaceutical companies, healthiness


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can be compromised. Charitable campaign and contributions both politically and

socially by pharmaceutical companies are instances of these demands offered to

doctors for stipulating fastidious medicines and specific brand. These behaviors are

very un-ethical as well as illegal in many countries. Most of the companies may

make use of underhand procedure to masquerade such bribe (American College of

Physicians, 1990, 1995-2002).

In recent years, the problem of illegal and unethical pharmaceutical practices for

marketing of medicines has acknowledged an enormous covenant of awareness,

indicating from different pharmaceuticals and doctors association who already keep

noticing of this problem. Some of them have conceded set of codes and ethical

course of action for selling of pharmaceuticals (Ahmed & Jalees, 2008).

There is another kind of practices that reflect corruption happens during clinical

trials. Many pharmaceutical companies are paid to doctors to take patients for

clinical trials. Many universities have research assessment committees who are

engaging in exposure of strategies and actions concerning divergence of interest

(Avorn & Hartley, 1982).

Furthermore, there is discussion on whether confession is adequate: must

researchers permissible to carry out studies and research for organization wherein

they contain finances?


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Pakistani pharmaceutical industry also growing at rapid pace over last many years

and reached to Rs. 137.7 Billion in 2010 (IMS Q2 2010) in this growth major chunk

came from generic drugs manufacturer or generic drugs in Pakistan.

GRAPH – 3

Generic (Copy) Drugs (% Share of Total Market)


Above graph shows that market share of generic drugs in Pakistan in continuously

increases over the years reach to 53.1% market share and likely to cross 55% market

by the end of this year. This can also validated by the number of generic drugs

making company in top ten pharmaceutical in Pakistan Getz Pharma, Hilton Pharma,

Sami Pharma & Searle are top four generic drugs making companies listed in top 10

pharmaceutical companies in Pakistan.


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GRAPH – 4 Research (Branded) Drugs (% Share of Total Market)


While looking at the research drugs, market share in Pakistan continuously

decreasing compare to the local/ generic drugs making companies in Pakistan more

than 53% market share in year 2010 (IMS Q2 2010).

1 . 3 S T A T E M E N T O F T H E P R O B L E M

Is unethical drug promotion practice is common in Pakistan? Who initiated unethical

drug promotion practice in Pakistan? Who is responsible for the continuation of the

same?

1.4 RESEARCH HYPOTHESES

Based on the theoretical framework, focus group and problem statement the

following hypotheses statements have been developed:

H1o: The level of unethical drug promotion practices in pharmaceutical

industry is high (at least 4) on the scale of (5 to 1)

H1A: The level of unethical drug promotion practices in pharmaceutical

industry is less than 4 on the scale of (5 to 1)


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H20: The levels of unethical drug promotion practices are high in rural

areas.

H2A: The levels of unethical drug promotion practices are not high in rural

areas.

H30: There is no significant difference on the opinions of doctor,

pharmaceutics companies, hospitals and pharmacies on who initiated

unethical drug promotion practices in Pakistan.

H3A: There is significant difference on the opinions of doctor,

pharmaceutics companies, hospitals and pharmacies on who initiated

unethical drug promotion practices in Pakistan.

H40: The contribution of the pharmaceutical industry in continuation of

unethical drug promotion practices is higher than the doctors.

H4A: The contribution of the pharmaceutical industry in continuation of

unethical drug promotion practices is not higher than the doctors.

1.5 PURPOSE OF THE STUDY

1.5.1 General Purpose

The overall purpose of the study is to analyze the unethical pharmaceutical drug

promotion practices in Pakistan and its impact on common people of the Country.

1.5.2 Special Purpose

Most specifically the study will address the following questions:


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1. Is there any relationship between unethical pharmaceutical drug promotion

practices & under taken stakeholders i.e. pharmaceutical companies, doctors,

hospitals and pharmacies etc?

2. Who is the most responsible for these unethical pharmaceutical drug

promotions in Pakistan?

3. How common people are affected by these unethical pharmaceutical drug

promotion practices in the Country?

4. Is there any further legislation is required by the government in order to stop

these unethical practices?

5. How different stakeholders can play their role in order to stop these unethical

practices?

1.6 SCOPE OF THE STUDY

The scope of the study will be limited to all the concerned bodies of the government,

pharmaceutical companies, doctor’s community, hospitals, pharmacies and the

common people of the Country, which provides the knowledge about the unethical

drug promotion practices in Pakistan. Moreover, it will also provide the basis to the

government to take some suitable measures to stop these unethical pharmaceutical

drug promotion practices from Pakistan and to provide ease to the common people

of the Country in order to get better health facilities at nominal cost.

1.7 JUSTIFICATION

The study is justified on the following grounds:


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1. The results of the study can be used by the government and some suitable

measures and actions can be taken to improve the legislation in order to stop

unethical pharmaceutical drug promotion practices in Pakistan on the basis

of the results of the under taken study.

2. The medical facilities can be provide at nominal cost by improving the

atmosphere of unethical pharmaceutical drug promotion practices for the

common people by taking corrective measures against the responsible

stakeholders of the study.

3. To provide the knowledge of actual situation of unethical pharmaceutical

drug promotion practices to all the concerned bodies who are directly or

indirectly involved in these practices and to realize them that they should

fulfill their social responsibilities in order to improve the situation.

4. To give the awareness to the common people of the Country that in the light

of study they should play their role in order to rectify the situation.

5. The pharmaceutical ethical committees on local & multinational

pharmaceutical companies should implement the new or existing code of

conduct with its true spirit after reviewing the results of this study.

6. The concerned bodies’ of government sector should make further effective

legislation and to enforce the rules and regulations in order to stop these

unethical pharmaceutical drug promotion practices in Pakistan.

7. In the light of result of this study, the Pakistan Medical & Dental Committee

(PMDC) and Pakistan Medical Association (PMA) should make some

effective code of conduct for the doctors’ community in order to stop these

unethical pharmaceutical drug promotion practices in Pakistan.


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1.8 DEFINITION OF KEY WORDS & PHRASES

• Unethical Promotion

The promotion of pharmaceutical drugs by avoiding the set of rules &

regulations, which are given by the ethical, bodies Worldwide & the local bodies

& government.

• Pharmaceutical Drugs

The medicines are being produced and sold by the pharmaceutical companies for

human beings.

• Unethical Practices

The unusual and absurd ways of marketing & selling tactics to sell the

pharmaceutical drugs.

• MNCs & Local Companies

The Multinational pharmaceutical companies, which operate more than one

Country, whereas, the companies, which are only operating in Pakistan.

• Whole Sales & Retail Pharmacies

The medicines shops, which procure the pharmaceutical drugs in bulk quantity

from distributors and fulfill the requirement of retail pharmacies, whereas, retail

pharmacies are those pharmacies where the consumers purchase pharmaceutical

drugs directly.


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• Government Officials

The government servants who are employed in those Provincial or Federal

governments deportments, which are directly relevant to the pharmaceutical

drugs, pharmaceutical companies & the pharmacies.

• Public & Private Hospitals

The public hospitals are owned and run by the federal, Provincial or district

governments, whereas, the private hospitals are owned and run by the individual

or group of people.

• Indoor & Outdoor Patients

Those patients’ who are admitted in hospitals due to their illnesses are called the

indoor patients, whereas, the walk in patients or just come to the doctor and get

the prescription and go to home or called outdoor patients.

• Patients & Attendants’

The person who has suffered in any illness is known as patient, whereas, those

patients who admitted in hospital and they have been taken care by their

relatives’ or friends during the treatment are called their attendants’.

• Consultants, Medical Officers & General Practitioners

The doctors who has done post graduation after their medical graduation are

known as Consultants, whereas, those doctors who has started their career as


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doctor after their medical graduation in any private or government hospital, are

called Medical Officers or Resident medical doctors and finally those medical

graduates who does open their own clinics in different areas are known as

General Practitioners.

CHAPTER TWO

REVIEW OF THE LITERATURE


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The pre-survey and focus groups discussions indicate that unethical pharmaceutical

marketing practices have become an acceptable norm of the pharmaceutical

diligence, and it is also well supported by more or less all the pharmaceutical groups

with the cooperation of government hospitals, private hospitals, doctors and health

allied organizations including pharmacies on patients’ interests.

A report on practices for pharmaceutical companies has published by Lexchin J.

(1995) in Consumer International (CI). CI scrutinized that 20 main worldwide

medicines companies of the world have developed their own codes of ethics

conducts, which are highly biased in their favor.

Pharmaceutical companies exercise immoral and dishonorable marketing devices to

persuade doctors to recommend their medicines and also delicately to convince

customers to use them. The findings are based on the marketing practice of world

top most 20 pharmaceutical companies. The report contends, “Pharmaceutical

companies are advancing their medicines through patients set, student and internet

chat places to avoid the interdict on promoting excluding doctors” (Lexchin, 1995).


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The authors of the report have also the opinions that the subject companies create

imprecise declares regarding protection and effectiveness of their medicines.

Moreover, the companies also offer enticements to stipulate and uphold medicines

including bribes, donations, expensive promotional gift items, free drug samples and

conferring contracts. The authors pointed out that several organizations encompass

concerned in non-aggressive policies (Lexchin, 1992, 1995).

In September 2009, Pfizer was fined US$2.9 billion dollars for deceitful marketing

practices. This was done because the company was promoting medicines for

unapproved uses or “off-label uses”. Pfizer deliberately encouraged doctors to

prescribe four medicines to treat symptoms the drugs were not approved by the FDA

to treat. The settlement also settles allegations that Pfizer induced doctors to

promote these "off-label" uses by paying for their meals and subsidizing their travel.

This is the third settlement that Pfizer has signed a “corporate integrity” agreement

(Gibbons et al., 1998).

This is just an example of the deceitful and underhanded marketing practices that

has occurred. This wrongdoing was done due to the fact that it takes approximately

US$1 billion to develop and test a new drug. In recovering their spending, the

companies want healthcare professionals to subscribe their drugs as widely as

possible (Gibbons et al., 1998).

Another example is that of Johnson & Johnson unlawfully and successfully

promoted Propulid off-label for kids regardless of inner objection complaining


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safety issues. The side effects of this drug include serious cardiac arrhythmias

including ventricular tachycardia; ventricular fibrillations have been reported in

patients taking Propulid (generic name: Cisapride). This product is no longer

available in the United States (Sibbald H., 2004).

Other companies have gotten in trouble over off-sales promotion and withholding of

critical information. In 2004, the medicine title Vioxx manufactures by the Merck &

Co. pharmaceutical company was inhibited from the market. Merck willingly

removed the medicine by reason of serious unease on cardiovascular side effects.

Allegedly the company knew that the drug may perhaps raise the probability of heart

attacks in cardiac patients from 2000 and has been charges of engineering research

outcomes to minimize the threat. In the United States, above 6,000 court cases have

been filed by public who suffer from this medicine (Boseley, S., 2006).

Again in 2004, GlaxoSmithKline (GSK) was faced a court case for preservation off-

putting data on their medicine Paxil (Paroxetine). GlaxoSmithKline decided to an

arrangement to make public regarding results of all clinical trial reviews on its

website (Sibbald H., 2004).

The case happened following a secret GSK memorandum disclosed to press

acknowledged a clinical trial in 1998 so as to wrap up paroxetine had refusal

outcome in the handling of young people. AstraZeneca faced a class action lawsuit

alleging that it was misleading in its promotion of its top-selling ulcer treatment

Nexium. The lawsuit was brought on behalf of trade union healthcare providers in


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New York who paid for the drug on behalf of their members. It demanded the return

of profits made on Nexium, which had sales of US$3.3bn. It claimed that Nexium is

an end to useful than Prilosec, AstraZeneca's older ulcer drug, which is considerably

low price as it is no more secluded from opposition by copyrighter (Tomlinson H.,

2004).

Gifts that are given by the pharmaceutical industry to healthcare professionals are

controversial. Approximately, US$11billion is spent on promotion and marketing

each year towards doctors (Gibbons et al., 1998).

A case was inspected against GlaxoSmithKline (GSK) from Italian and German

official for supposed corruption of distributing illegal gifts to doctors and other

officials, and approximate €228m from 1999 to 2002. After that, GSK has formed

marketing ethical codes for his employees, which are compulsory to all new

employees to clear an evaluation test. In 2001, a report was public and pointed out

87 employees was terminated or voluntarily departed after violation of these codes

(Boseley, S., 2006).

Charges were implicated in opposition to AstraZeneca for unsuitable use of gifts and

promotions. In a promotional campaign they invited doctors to attend this

seminar/conference free of cost, and they bear their hotel, flights and other charges

(Boseley, S., 2006).


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Studies were carried out to uncover the impact of relation between physician and

medical representatives of pharmaceutical industry. Doctors meeting with

pharmaceutical representatives linked with requirements by doctors to put in

medicines to the hospital formulary and there was a change in prescribing practice

of the doctor (Tomlinson H., 2004).

Overall, residents and physicians have the same attitude towards pharmaceuticals

representatives. Physicians believed that they offer precise data regarding the

medicines that they promote. They also believe that pharmaceuticals representatives

may perhaps offer precise data on recognized or substitute medicines. On the other

hand, the majority considers that representative’s precedence the promotion of

product over the wellbeing of the patient and use unethical practices to do this

(Tomlinson H., 2004).

In the United States, once a medical student comes into school, the pursuance of

pharmaceutical companies is significant. Free promotional gift items, medical

manuals, journal subscription payments, lunches, and gifts are provided to the

medical student. These all are become a component of daily medical practice. The

sales representatives from pharmaceutical companies are good-looking, likeable and

imminent. From an early stage in the doctors’ career, the pharmaceutical companies

have an influence on the medical student (Sibbald H., 2004).

Another study (Zaidi et al., 1995) explores the connection involving in physicians

and the pharmaceutical industry. The author while criticizing the pharmaceutical


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industry observed that the industry is responsible for corrupting the medical

profession. The report further indicated that this habit is very widespread in the

urbanized countries as well as developing countries.

The author further alleged that the anticipation and requisite of physicians/doctors

has increased manifold. The attitude of doctors has changed, and some of the

commonly demanded requests are presented below:

• The doctors frequently ask for free travel and hotel accommodation.

• The doctors demands donations for various issues and threaten to not

entertain Medical Representatives, if they fail to provide the same.

• Group of doctors have formed companies. The doctors do not manufacture

the medicine in this company, but they have obtained the marketing rights

from the other companies. Subsequently these doctors heavily prescribe their

products.

• The liaison between doctors and chemists has increased tremendously. In

this kind of relationship the doctors prescribe those medicine that carry

heavy discounts, which are then shared by the doctor and chemist as per pre

agreed arrangement.

• It is a common practice of doctors asking cash for each recommendation of

medicines.

• Demand for renewal of hospitals and clinics.

Zaidi, et al., (1995) observed that in the 13th national psychiatric conference held at

Abbottabad in September, nine papers were read by different doctors; however,


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most of the papers were not on the subject issue but were mainly focused on their

experience of administrating specific drugs to the patients. Incidentally, some of the

foreign guests thought that the conference was not on psychiatric issue but it was

more on the specific drug promotion activity. Two inferences could be drawn from

this incidence. One, the doctors are so much involved in the unethical drug practices

that they did not realized what was the objective of the conference. Second is that

the doctors did not spend considerable time for developing the appropriate paper for

the conference.

Zaidi, et al., (1995) in the same report pointed out about an incidence of the 17th

International Gastroenterology conference held at Rawalpindi. In this conference

about a dozen of local doctors’ presentations were on a particular drug that belonged

to the pharmaceutical company that was sponsoring the event. The foreign delegates

became so frustrated with the proceeding that they left the conference by stating that

their purpose of the visit was to gain insight and share their views on the issue

“gastroenterology”. However, the conference appears to be one directional with

objective of promoting the drugs of the sponsoring company.

Zaidi et al. (1995) also pointed out that unethical drug practices was originally

initiated by multinationals as they were in the position to afford this unethical

practices due to huge resources at their possession. Subsequently, the local national

companies also followed the suit, and now it has become the norm of the industry.


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In Nepal, a study conceded Giri, BR., Shankar, PR., (2005) also observed that

doctors recommend such drugs that are keenly promoted by representative. The

authors observed that the pharmaceutical companies use conferences and seminars

for entertaining doctors, unethical demand of traveling, and lodging etc.

According to Fisher et al., 1993, “It is immoral for research journals that issue

information on psycho-Pharmacology to recognize medicine company money for

everything. Similarly, it is unethical that the American Psychiatric Association

permits Medicines Company financially supported symposia as part of its yearly

meetings” (Fisher, Bryant & Kent, 1993).

According to the WHO Ethical Criteria for Medicinal Promotion, the nastiest

immoderation of deceptive and unprincipled promotion of drug keep on in

developing countries, where parameters for pharmaceutical industry are very weak

(American College of Physicians, 1990).

Promotion can be defined as “the information whose intention is to promote or

market a product and for itself it has an inbuilt unfairness in favor of the product in

the finest doable way. Worldwide, an enormous disparity in the funds obtainable for

promotional against existence of self-governing information (Lexchin, 1995).

Another study of Lexchin pointed out that the Companies which prop up

tranquilizers and antidepressant medicines through similes of women are nonentity

to flout the agreed product tagging, but they probably to give a well-acknowledged

setback of unsuitable stipulation of psychotropic medicines to women (Lexchin,

1992).


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The Lexchin further concluded in the study that most of the countries rely a lot on

overseas multinational pharmaceutical companies, through exports and local

production. Promotional actions must focus to parameters according to the

company’s origin country. “Promotional materials and labeling should be required

to be acceptable in both countries, i.e. to adhere to the higher of the two standards.

This would put more of an onus on governments in industrialized countries to

prevent messages with negative health consequences from being provided overseas

by multinational companies with head offices in their country” (Lexchin, 1992).

Arun Phatak studies concluded that pharmaceutical industry is already profit taking

and intends at giving utmost profit to share owners. The pharmaceutical industry is

not worried about their consumers, or else the market would not be swamped by

illogical formulations. In United States, it obtains $9.4 million to build up a fresh

medicine and catch its approval. The only approach to give back this is through

forceful promotion. An expected 20% of drug companies’ funds are used up on

marketing of drugs; and of this amount, 20% is used up on retaining and instructing

medical representatives, 30% for publicity media, and 50% for unusual schemes

which involves dinner meeting for doctors and other medical staff, printing &

publication of books and other materials (Phatak, 1998).

Arun further concluded here can be no doubt of getting a handsome profit in this

industry. The obnoxious is taking advantage by deceitful ways:


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• Imperfect and insufficient product information provided by medical

representatives. However, it is the solitary resource of information related to

drugs for most of the practitioners.

• Support for educational actions can be suitable if it is exclusive of filaments

and the event’s planners is the only decision making authority of each and

every portion of the event: Donations should be given to the institutions, and

the charges of speaker should be pay back by the proficient, not by the

pharmaceutical company.

• Funding should be handed to institutions and certified bodies not to

individual persons.

• The practitioners must worry about fake information and advertisements in

the media for drug injurious to the health. They prohibit on advertisements of

alcohol, child milk substitutes and feeding bottles are examples of this

concern. Medicine companies also publicize their drugs in research journals

and publications. It has to be making sure that incorrect information and

messages are not given, and ridiculous medicines are not promoted through

advertisements.

• The medicine companies convince doctors to recommend specific medicines

by giving gifts or payments. In Pakistan, where poverty stripe of people is

40%, the payments and gifts connection infringe the moral values of loyalty

and non-maleficence. Medicines companies like LOCOST, who do not

involve in unprincipled marketing and promotional activities of their

medicines, are capable to offer valuable and standard medicines under

common names at half price as compare to market rates (Phatak, 1998).


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Daniella, & Michael studied the interaction between medicine companies’

representatives and physician in training sitting. According to them contact with

medicine companies’ representatives were widespread among locals. Most of the

trainees experienced that the connections were suitable while other think that their

own prescribing could be predisposed by gifts or relations, but were more possible

to deem that others' prescribing could be inclined. Occupant prescribing was linked

with pharmaceutical representative appointments and the accessibility of medicines

samples. A range of rules and instructive interferences come into view to sway local

mind-sets toward relations with pharmaceutical companies, though information on

the durable possessions of these interferences is inadequate. In general, locals

reported deficient exercises in this area (Daniella & Michael, 2005).

Finally they concluded that the drug industry has a noteworthy existence for the

period of placement training, has added on the whole receiving of trainees, and

come into views to control prescribing activities. Training sessions can promote

from policies and curriculum that educate residents about industry manipulate and

traditions in which to gravely assess information that they are provided.

Komesaroff and Kerridge (2002) evaluate numerous issues regarding the connection

between medical practitioners and the drug industry, highlighting that planning

between doctors and drug companies have to be transparent and obvious. They

recognize the key sources for concern and inspect ways in which unusual phases of

the medical profession are missing susceptible to sleaze. Furthermore they

recommended the points, which are as follows:


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• Drug companies and medical practitioners serve each other interests that

occasionally overlie and clash.

• There is sturdy proof that relations between drug industry and medical

practitioners manipulate the last actions in relation to clinical decision-

making as well as carry out of research.

• Present the jeopardy of concession relationships with patients and the

honesty of the research process, physicians must work out in their

communication with pharmaceutical industry.

• The basic philosophy for the behavior of physicians with respect to drug

companies must directness and lucidity.

• Evidently uttered measures should be constructed to deal with precise

problems such as traveling expenses, delivery of gifts, funding of

conferences and seminars and enduring education activities.

According to Bodenheimer (2000) and Mathieu (1999) Doctors and the drug

companies carve up a number of common interests. For example, both are anxious

with heartening effectual and accountable utilization of accessible medicines in

handling and care, their usage monitoring, and pioneering research. But both parties

have different importance and having different center of attention. Doctors are

concerned mainly in patient health care and scientific advance, while companies are

interested first and foremost in financial benefits. The resemblances and

dissimilarities between participants and their interests generate both a requirement

for dialogue and the possible for differences. The contribution for medical

knowledge and practice done by drug industry has been considerable. The cost of


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development of a fresh medicine is between US$300 to $600 million, nearly all is

provided by pharmaceutical industry. Clinical research is also luxurious: last year, in

the United States, about US$6 billion was used up on clinical research, out of which

70% came directly from drug industry. The total amount used for research and

development is still much superior. In spite of these clear mutual benefits and

interests of cooperation, both the medical profession and the community have

expressed concerns of an ethical nature. There are three main concerns:

1. The probability of connection between physicians and medicine companies

may dole out commercial purposes of industry and greedy interests of

clinicians more willingly than lawful thinking, research and educational

objectives, thus compromising the main moral compulsion of doctors to

patients, dividing the faithfulness of physicians and discouragement the

fundamental belief on which clinical relations depend.

2. The hazard that medicines promotion will unsuitably pressurize physician’s

decisions.

3. The risk that industry participation in research and development of new

drugs will lead to deformations in scientific confirmation and stop self-

governing appraisal of information.

Parmar and Jalees, 2004, developed the distinctions between ethical and unethical

drug promotions practices based on the focus group discussions. “The acceptable

norms of promoting drugs through doctors are visiting them, giving a presentation

on the merits and demerits of the drugs. Explicitly, pointing out the side effects of

drugs, giving nominal quantity of drugs sample. These gifts and give away must not


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be highly expensive and restricted to items such as dairies, calendar, year planner,

etc.” (Parmar & Jalees, 2004).

“The drugs thus prescribed to the patients on the merits of drugs with focus on the

well being of the patient will fall in the category of ethical drug promotion

practices.”

“Comparatively, unethical drug promotion practices are prescribing drugs to the

patients based on the monetary considerations, and ignoring the well being of the

patients. The commonly used monetary rewards for unethical promotion of the drugs

are discussed below” (Parmar and Jalees, 2004).

(i) Monetary Reward

The crudest type of immoral medicine promotion is financial return. In this type, the

cash payment is associated with the quantity of the medicine prescriptions by the

physicians. The rewards are given on quarterly or monthly basis.

(ii) Visits With in Country

In this category, the drug companies manage seminars and conferences for the

physicians in those cities where doctors are not domiciled. The purpose of such

arrangement may be to keep informed physicians on the current advances in the

industry, but the actual intention is to offer effusive paid medicines. The drug

companies manage the travelling expenses, accommodation expenses in posh hotels.

This paid medicine may possibly for the physicians their families. Doctors travel to


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other cities for personal reasons. The pharmaceutical firms entertain the doctors by

arranging the air traveling with lodging & boarding expenses of the doctors’

personal visits.

(iii) Foreign Visits

Drug companies organize overseas visits of the physicians. Like in country

travelling, these visits are managed in the setting of conferences and seminar, but

again actual aim is to offer paid medicines.

(iv) Gifts & Give away

a) Medical Equipments: Drug companies offer medical instruments like

stethoscope, thermometers, surgical kits and other expensive medical

equipments.

b) Personal Use Items: Drug companies provide personal use items such as

mobile, laptop, air-conditioned, and even cars.

(v) Chamber Decoration

In this category, the drug companies refurnish the physician’s clinics, as well as

provide air-conditioners, furniture, display boards, computers etc.

(vi) Home Decoration

The arrangements for the home display is alike to the physician’s clinics decorations

as mentioned above.


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One author has suggested in the study (Brennan et.al, 2006), that doctors record their

attachment with medical companies. Actually, data given to the people who are most

expected to be debilitated looks most rational. Drug companies promote their

medicines to doctors, patients, and facilities for health care in turn to boost sales and

reinforce sales revenues. Literature shows many marketing models, which deal with

the control distressing: What are the conditions at which companies and peoples

select medicine for their use (Aaker & Williams; 1998, Bar-On & Parker; 2000,

Curcura, 1999; Gonul et al., 2001; Mintzes, 1998, 2002; Tutor2u, 2004; Wolfe,

2002).

In many research papers, we can easily find literature regarding the control of

Medicine Company fully funded gifts and paid education for medical students,

practicing expenses of experience and naïve doctors (Avorn et al., 1982; Curcura,

1999; Gonul et al., 2001; Stolberg & Gerth, 2000; Wazana, 2000).

Pharmaceutical companies used approximate more than 11 billion USD per year for

their marketing and promotion budget, between 5 to 8 billion USD set off to

promotion of medicines through their sales staff (Greene, 1999, 2000), and for

doctors a projected 8-13 thousand USD per year used up (Gibbons et al., 1998;

Greene, 1999, 2000; Wazana, 2000; Westfall, McCabe, & Nicholas, 1997, 1998).

Medical students, experience and naïve doctors fully confessed that listeners in

seminars and conferences latently fewer incase of lack of lunch and gifts (Steiman,

Shlipak & McPhee, 2001; Wazana, 2000).


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According to an article published in New York Times, which shows the explication

of investigation by Federal Department. It engages different pharmaceutical

manufacturers for example Schering-Plough, Bristol-Myers Squibb, Johnson and

Johnson, and Wyeth (Coleman, J., Katz, E., Menzel, H., 1968)

In the course of an assessment of interrogation with doctors and managements of

drug manufacturers, the government has acknowledged unsuitable, incongruence

and unlawful promotional campaigns. It comprises of financial payback and

appreciating medical doctors to invoice intermediary payers for medicines delivered

to physicians with no cost (Harris, 2004).

In recent years, different medicines companies have pled blameworthy to elicit

accuse connecting the promotion of their medicines and even paid some fines. In

2001 TAP Company paid 875 million USD, while in 2003 Astra Zeneca paid 355

million USD. Beside this a multinational Pharmaceutical company Pfizer settled to

pay 430 million USD against fines. These all are beseech culpable to unlawful

allegation of dishonesty for heartening doctors to tab government against free

medicines, which these companies delivered to doctors (Harris, 2004).

A question has been lifted due to these problems related to unprincipled influence

those programs which could cover doctors’ stipulated observations (Avorn et al.,

1982; Curcura, 1999; Gonul et al., 2001; Wazana, 2000, Wolfe, 2002). A number of

investigation claimed that students and residents of at medical universities

considerably undervalue the control medicine organization fully funded education


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has on their prescribing practices (Steinman et al., 2001; Wazana, 2000; Waud,

1992).

A research shows that 46% of doctors stated that medical company sales and

marketing persons be fairly significant in pressurizing their set down practices

(Avorn et al., 1982). Other researchers claimed that 61 percent of residents at

medical universities affirmed that marketing and promotions by pharmaceutical

companies did not weight their own selection of medicines, on the other hand the

remaining 16 percent understood other doctors to be also uninfluenced (Steinman et

al., 2000).

In 2002, survey conducted by the journal Medical Economics found that 71% of

doctor’s respondents did not consider that accepting gifts, trips or hospitality weaken

their objectivity (Murray, 2002). Murray reports, “Indeed, many physicians found

the suggestion that they may be influenced insulting” (Murray, 2002).

For the treatment of hypertension “Chew & Colleagues” researched in year 2000, if

the sample was obtainable in the office to hand out a patient, over 90% of doctors

would distribute a sample that different from their chosen medicine options.

According to Industry estimate in 2000, 7.2 billion USD values of free medical

samples were distributed in 2000 (IMS Health, 2002).

Westfall et al. (1997) found that 96% of physicians and their staff had taken drug

samples for personal and family utilization in last year. The authors projected that


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the value of these drugs is about USD 10,000. Westfall, et al. further states: “The

use of whatever medication is available on the sample shelf (usually the more

expensive of several options) is contrary to the development of good prescribing

habits that will be necessary for success in practice”.

In 1995, Hodges observed exchanges between medical company representatives and

psychiatry residents and confine in 7 teaching hospitals in Canada. Findings

illustrated an association between the receipt of promotional marketing materials

and a conviction that conversation with the medical representatives did not pressure

doctor’s prescribing. The more promotional gift items the resident or intern had

received, the less likely he or she was to consider the medical representative

prejudiced his or her prescribing (Hodges, 1995).

In 1997, a team from University of Chicago studies advertising heading for medical

students and the students’ approach towards medical company’s representatives. The

study instituted that 90% of the students had received one or more medical books

from medical company’s representatives. The medical students whispered that the

medical company’s representatives to be obliging and edifying and also affirmed

that they felt compelled to take note to the medical company’s representatives

informational sales ground once they had received a free gift or meal (Sandberg,

Carlos, Sandberg E., & Roizen, 1997).

Wang et al. (1999) found that there was a considerable boost in doctor’s demands

for specific medicine to be placed on their hospital’s pharmacy after attending an


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educational conference/program funded by the drug manufacturing company. In

parallel Wazana (2000) reported a conclusion from 29 articles found in the peer-

reviewed literature linked attitudes towards, the connection between doctors and the

drug manufacturing industry and its outcomes on the attitudes, knowledge and

behaviors of doctors.

Haxby (1995) inspects medicines samples circulated by drug manufacturing

companies to the Oregon Health Sciences family medical clinic more than 14

months and found that the medical clinic received a total of 1117 separate visits,

ensuing in 331 different medicine samples from 43 different drug manufacturing

companies. A good number of the clinic’s health care providers confessed they

didn’t know in fact what was distributed when they signed for drug samples. A lot of

the medicine samples delivered were found to be medicines that were not stocked by

the clinic’s pharmacy and even not an approved drug at the clinic (Haxby,

Rodriguez, Zenchnich, Schuff, & Tanigawa, 1995).

These results have lead to the progress of numerous nonprofit companies focusing

the importance of doctors and drug manufacturing company’s representative contact

and on any unsuitable marketing and promotional activities. An internal medicine

doctor Goodman from New York founded one such company, No Free Lunch. The

company’s message is “Our quarrel is not with the pharmaceutical industry, but with

pharmaceutical industry promotion. The time has come to eliminate its influence

from our practices” (No Free Lunch, 2002a). The supporters and membership of ‘No

Free Lunch’ are listed as “physicians, pharmacists, dentists, nurses, physician

assistants, medical ethicists and others” (No Free Lunch, 2002a). The company


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provides indication lists from main pharmaceutical-physician studies, a forum for

concerned health care professionals and a power point presentation, which is also

downloadable on the topic of drug manufacturing company’s influence, gifts and

promotions. The site sells paraphernalia such as tee shirts and coffee mugs to hoist

income for its effort. The web site also encloses a pledge that physicians may take if

they are dedicated to being free of pharmaceutical company influence. The pledge

states:

“I, __________________, am committed to practicing medicine in the best interest

of my patients and on the basis of the best available evidence, rather than on the

basis of advertising or promotion. I therefore pledge to accept no money, gifts, or

hospitality from the pharmaceutical industry; to seek unbiased sources of

information and not rely on information disseminated by drug companies; and to

avoid conflicts of interest in my practice, teaching, and/or research” (No Free

Lunch, 2002b).

In 1999, a research was conducted by Kessenich and Westbrook focused on the

relationship of nursing and pharmaceutical sales persons’ and other reason that

could create impact on prescribing practices by taking interview from 6 Nurse

Practitioners in the New England area. According to Kessenich and Westbrook, the

Nurse Practitioners were asked about:

1. Medicine data from drug manufacturing company sales persons.

2. Basis of upcoming medicines,

3. Approval of medicines samples,

4. Providing gratis medicines samples,


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5. The professed pressure medicines samples their selections,

6. Approval of hand-outs

7. Attendance at pharmaceutical company sponsored events,

8. Concentration to drug manufacturing organization marketing campaigns

Of the sample population, 100% of the Nurse Practitioners had participated drug

manufacturing company’s funded educational programs and all of them had taken

free sample medications for their patients. 4 out of 6 Nurse Practitioners i.e. 67%

had get verbal or written communication about pharmaceutical products during

pharmaceutical company encounters for example office lunches, they believed the

accessibility of sample medications might have influenced their prescribing choices.

All 6 Nurse Practitioners had read medicine’s advertisements in medical

professional journals and 100% of the Nurse Practitioners believed that drug

manufacturing companies influenced their prescribing behaviors, “even in a

subliminal manner” (Kessenich & Westbrook, 1999).

New technique of marketing is to target the patient consumer rather than the MD,

NP, or PA. Since the early 1990’s, drug manufacturing’s companies have been

publicity directly to the consumer (DTC) through different media advertisement

such as television advertisements, billboards and gifts, mass market publications that

attract the patient to ask for specific medicine when they see their healthcare

provider (Manning & Masia, 2001). A lot of the advertisements hire popular media

personality to pitch their medicines including Olympic Gold Medalist ice skater

Dorothy Hamill advertising for the arthritis medication Celebrex and Senator Bob


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Dole extolling the virtues of Viagra. These advertisements lean to show the

medicine as the most excellent, effective and latest for the complaint. Many

conclude that if the patients’ doctor is not prescribing this medication for them, they

are not receiving the best possible recovery of their illness (Ingelfinger, 1972;

Mintzes, 1998; Mixed Reaction to Consumer Advertising, 2003). These tactics

encourage the patient to request the medical doctor or Nurse Practitioners about the

medicine and occasionally to point out the advertised medicine instead of besides

their current medications (Mintzes, 1998; Wolfe, 2002). Patient asks for precise

medicine has been acknowledged to impinge on doctor’s choice of prescription for

the patient (Mixed Reaction to Consumer Advertising, 2003; Steinman et al., 2001).

Wolfe notes, “There is evidence that many drug advertisements are not balanced or

accurate and duped gatekeepers may not adequately resist patients’ exhortations to

write a prescription” (2002, p. 525).

In general, budget for promotion on prescription medicines mounted to 15.7 billion

USD in 2000, rise from 13.9 billion USD in 1999 and only 9.2 billion USD in 1996

(National Institute for Health Care Management, 2001, 2002). An anticipated 2.5

billion USD were used up on direct to consumer advertising in 2000 up from 1.8

billion USD in 1999 and 791 million USD in 1996 (National Institute for Health

Care Management, 2002). Sales amplify of 50 medicine most profoundly advertised

to consumers were conscientious for almost 47.8% (Half) of the 20.8 billion USD

rise in spending in 2000 (National Institute for Health Care Management, 2002). In

2000, a pharmaceutical company Merck spent 161 million USD on promotion and

advertising for Vioxx, a new medicine for respite of arthritis pain. Explicitly over


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Anheuser-Busch spent advertising Budweiser beer (146 million USD) or Pepsico

spent advertising its soft drink, Pepsi Cola (125 million USD). The boost in Vioxx

sales in 2000 accounted for 5.7% of the one-year rise in medicine spending in the

United States (National Institute for Health Care Management, 2001, 2002).

In the beginning of 1990, apprehension arose by American College of Physicians

related to persuasion by drug manufacturing unit’s funded institutional events and

offering for doctors and students’ recommended observations (American College of

Physicians, 1990; American Medical Association, 1991; Wazana, 2000). According

to their research they pointed out prospective persuasion from drug manufacturing

organizations might affect doctors recommended observations. Regardless the report

from past more than 10 years, and American Medical Associations and the

American College of Physicians’ suggestions so it subsist conversed among

residents & students, and after the discussion the studies demonstrated that merely

23 - 50 percent of medical residents familiar with current statement (Gibbons et al.,

1998). The information related to the manipulation that drug manufacturing

organization fully funded edification has on the recommended observations of

students and residents has consequence in a recent American College of Physicians

position statement released on March 5, 2002 (Coyle, 2002a; 2002b). According to

this, restated the necessitate in support of consciousness of the insinuation of drug

manufacturing organization fully funded edification and its control on recommended

observations and suggested that the entire doctors, student and residents has to get

teaching on this matter (Coyle, 2002b). In 2002, the existing declaration exclusively

spoken to conscientiousness who have completed their education and who have not,


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universities have to make sure that neutral edifying substance has offered and

universities course of actions be primed to recognize suitable & deplorable

connections with the drug manufacturing organizations equally for practicing

doctors and for medical students (Coyle, 2002a; 2002b).

Similar guidelines are formed from different professional medical associations

regarding relations of doctors and sales persons of pharmaceutical companies and

are recognized by Royal College of Physicians and Surgeons of Canada, Canadian

Medical Association, Academy of Medicine and American College of Physicians

and United State Medical Association (Wazana, 2000). Despite their position

regarding the influence of drug manufacturing companies, the American Medical

Association persists headed for 20 million USD in a year by advertising

comprehensive professional and personal data on all physicians working in US for

utilizing medical company’s doctors prescribing databases (Stolberg & Gerth, 2000).

Different researches have explained, and direction from U.S. Department of Health,

professional medical associations, Human Services’ Office of Inspector General

(OIG) and different industry trade associations mirrors distress that, the prospective

that the promotional efforts by pharmaceutical companies could have a unswerving

and thoughtful consequence on doctors prescribing practices, which may brunt

medical finding (Hemminki, 1975). This conflict of interest is not only receiving

substantial concentration in the media but it is also making news in the form of

enforcement actions and legislation. In consideration of the surprising costs linked

with these marketing practices approx. 90% of the 21 billion USD marketing


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finances of the drug manufacturing industry are heading for doctors, in spite of a

staged augment in direct-to-consumer advertising (Holmer, 1999). The apparent

incapability to manage increasing healthcare costs, it is not shocking that

pharmaceutical company’s gift-giving and other promotional and marketing

practices have get nearer under strict scrutiny and interest by federal and state

enforcement agencies and also self regulation by the pharmaceutical companies,

doctors and hospitals (Catlin et al., 2007).

Current study focused the suggestion of JAMA article’s related the association

between drug manufacturing companies and medical doctors and related

professionals. In April 2007, a nationwide research published in the New England

Journal of Medicine (Campbell et al., 2007) set up that in United States about 94%

of physicians stated a number of relationships with the pharmaceutical industry, and

78% receiving free medicines samples while 83% of these connections concerned

getting food in the place of work.

The investigation finally concluded that drug companies were expected to offer

payments and gifts to doctors who were recurrent recommended those companies’

medicines as compare to those who were less prescriber (PhRMA, 2002a, 2002b).

Ahmed & Jalees (2008) have conducted a study on the same topic and concluded

that both doctors and pharmaceutical companies are equally responsible for

unethical drug promotion practices in Pakistan. But most important and interesting

findings were, "basically pharmaceutical companies are responsible for initiating


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these unethical drug practices in Pakistan but now in continuation of these practices

the doctor’s community is actually responsible for these unethical drug promotion

practices in Pakistan. Now the doctors have become demanding and pharmaceutical

companies are responsible to fulfill their ethical and unethical demands. Now, this

has become an acceptable norm of the pharmaceutical industry and doctor’s

community for the promotion of drugs in unethical ways. The monetary rewards,

local and foreign visits in the name of scientific activities offered by the

pharmaceutical companies for unethical promotion of the drugs are extensively used

as a tool of promotion of their drugs".

The study further concluded, the focus groups discussions and survey findings

suggest that strong legislation must be developed, implemented and enforced by the

government. However, the regulations and legislation actually works when they are

supported by the norms and values of the society (Ahmed & Jalees, 2008).

In this particular case, these unethical practices are considered as the norms of the

pharmaceutical industry and the doctor’s community; therefore, it could only be

addressed by educating both the segments for realizing their social responsibilities

with the focus on the patients’ well being. Furthermore, there must be strong check

and monitoring by the Ministry of Health both on pharmaceutical industry and the

doctors (Ahmed & Jalees, 2008).

According to Nishtar Sania (2007), immoral practice can engage private sectors as

well as authorizing bodies and could involve drug supply chain process, which starts


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from registration, licensing and official approval of prices, sales and marketing of

medicines with procurements. This sector involved in corruption from its base in the

profitable benefits of the non-genuine drug companies, who uncover observance

with set of laws pricey and attempt to avoid rules and procedures to obtain

registration of their products, accelerate endorsement method, and obtain own

choice rates of their products.

The further conclusion of this research stated that the process of contracting for

purchase of medicines offers a well-paid supply of income for dishonest bureaucrat

and contractor through kickbacks and excess invoicing. During procurement, the

most actively fraudulent practices include conspiracy among bidders, kickbacks

from drug suppliers and bidders to minimize contest, and bribes to government

officials. They also involved in procuring below standard medicines and get money

for the suitable drugs. It is also reported that a number of medicines and other

supplies are stolen from hospital stores and are abstracted for resale. The reason

behind this is to encourage commission and corruption, which engage a lot of

medical practices such as wrong documentation, supply of medicines to ‘ghost

patients’, embed and stuffing of bills, witty book observance, additional payment for

medical supplies, extra billing and over invoicing. There is other form of

mismanagement and fraud crop up due to inadequate check and balance system; e.g.

supplies do not congregate demanding standards, partial delivery, or selling poor

standard, over date, fake and injurious medicines at lower cost. The process of

registering pharmacies can also be besmirched. Above all, the most important


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problem is violent medicines promotional and marketing strategies, which can show

the way to the unethical promotional activities.

In Pakistan, above 450 drug companies manufacture registered approximately

45,000 drugs. Such huge competition joined with hospitality based strong marketing

can lead to unprincipled marketing practices, which have the prospective influence

on medical practice and handling doctors decisions (Nishtar Sania, 2007).

A report Bowman (1988) put into noticed that drug companies are infringing moral

regulations when they test their drugs in emerging countries. Manufacturer

GlaxoSmithKline has unethically tested a breast cancer drug in India, says the

Wemos Foundation, an Amsterdam-based lobbying organization on international

health issues.

According to Bowman, M. A., & Pearle, D. L. (1988), GSK has tested an untried

medicine for breast cancer on women in India, which is also available in the

Netherlands. According to WEMOS this performance flout ethical standards.

WEMOS is initiating a campaign to encourage principled exploration in developing

countries such as India. Non developing countries are extensively used for

researching and testing products that are eventually inspired in Western countries.

GlaxoSmithKline (GSK) is tinted as the main perpetrator in a report published today

by the Centre for Studies in Ethics and Rights, based in Mumbai, India (Bowman &

Pearle, 1988).


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CHAPTER THREE

RESEARCH METHODOLOGY

3.1 DATA, SAMPLE AND METHODOLOGY

The total population, and targeted population has been given as under and on the

basis of targeted population researcher has selected sample size which has also been

elaborated as under, moreover, following research methodology will be adopted in

order to conduct this research study.

3.2 TOTAL POPULATION

The total population of undertaken study is the following:

• All Sales & Marketing Personnel of all Pharmaceutical Companies, which

are operating in Pakistan including Multinational & National Companies.

• All the doctor community whether they are General practitioner in rural or

urban area or Medical Officers & Resident Medical Officers of Government

& Private hospitals or the Consultants of all specialties whether they are

working in Government or Private Hospitals.

• All the Retail Pharmacies' of the Country.

• All the whole sales pharmacies of the Country.

• All the Public & Private Hospitals of the Country.

• All the indoor & outdoor patients & their attendants' during the data

collection time period.


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• Government Offices & Officials, which are directly or indirectly involved in

order to implement & ensure the law enforcement which are related to the

subject matter of undertaken study.

3.3 TARGETED POPULATION

The targeted population of undertaken study is the following:

• Sales & Marketing Personnel of top 10 (according to IMS) Pharmaceutical

Companies, which are operating in Pakistan including Multinational &

National Companies. These top 10 players have more than 80% share of total

pharmaceutical volume, which include GSK, Abbott, Sanofi-Avantis,

Novartis, Pfizer, Merck-Serrano, Buyer-Schering, Getz, Hilton, and Bosch

Pharmaceuticals.

• The undertaken study is a case study of Karachi city; therefore, the data has

been collected from peripheral and urban areas of Karachi City. General

practitioner in rural (peripheral) and urban areas, Medical Officers &

Resident Medical Officers of Government & Private hospitals or the

Consultants of all specialties whether they are working in Government or

Private Hospitals have been taken for this study. According to IMS Karachi

city is contributing more than 35% of total pharmaceutical market of

Pakistan.

• Karachi city will be taken for the data collection of the Retail Pharmacies' of

the study. According to IMS, Karachi city is contributing more than 40% of

total pharmacies of the country.


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• Karachi city will be taken for the data collection of the wholesale

Pharmacies' of the study. According to IMS, Karachi city is contributing

more than 50% of total wholesale pharmacies of the country.

• Karachi city will be taken for the data collection of the public and private

hospitals for this study. According to IMS, Karachi city is contributing more

than 28% of total public and private hospitals of the country.

• Karachi city will be taken for the data collection of the indoor and outdoor

patients & their attendants during the data collection time period, which cater

more than 20% of total market.

• Karachi city will be taken for the data collection of government offices &

Officials, which are directly or indirectly involved in order to implement and

ensure the law enforcement, which are related to the subject matter of the

undertaken study.

3.4 SAMPLE SIZE

Probability sampling technique will be used because the research study based on

quantitative analysis. For the sampling purpose the Cluster sampling technique will

be used, another reason to use this sampling technique is, the overall population is

very much scattered and spread in a larger geographical area of the city, moreover,

the overall population is heterogeneous. Therefore, for sampling purpose different

clusters will be collected from different areas of Karachi city. Researcher has used

following six variables in order to conduct the undertaken study and to draw

statistical analysis & conclusions. The total sample of 300 has been extracted from

following six different variables.


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3.5 PHARMACEUTICAL SALES & MARKETING PERSONNEL

3.5.1 Multinational / National Pharmaceuticals Personnel

Since 10 MNCs will be taken and total 60 samples have been drawn from sales and

marketing teams of these companies, so, in this way the total 60 personnel will be

taken randomly.

3.6 DOCTORS COMMUNITY

3.6.1 General Practitioners (Both Rural & Urban)

Total 30 General Practitioners have been taken from different areas of Karachi city

for sampling purpose randomly.

3.6.2 Medical Officers & Resident Medical Officers of Public & Private

Hospitals

Total 30 samples of MO & RMO have been recruited randomly.

3.6.3 Consultants of All the Specialties of Public & Private Hospitals

Total 30 consultants from Public hospitals & Private hospitals of different

specialties will be recruited randomly.

Therefore, the sample size of doctors' community will be of 90 respondents'.

3.7 HOSPITALS

3.7.1 Public Hospitals Including Provincial & Federal Hospitals


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The sample of 10 has been taken from Provincial & Federal hospitals from Karachi

City.

3.7.2 Private Hospitals

Total 15 private hospitals have been taken randomly for this study from Karachi

City.

Therefore, the sample size of Hospitals will be of 25 hospital respondents'.

3.8 PHARMACIES

3.8.1 Retail Pharmacies

Total 25 retail pharmacies have been selected from different areas of Karachi City.

3.8.2 Whole Sales Pharmacies

Total 25 wholesale pharmacies have been selected from different areas of Karachi

City.

Therefore, the sample size of total pharmacies will be of 50 respondents'.

3.9 GOVERNMENT OFFICIALS

3.9.1 Federal / Provincial Government Officials

Total 15 government officials have been taken from Karachi City.

Therefore, the sample size of Government officials will be of 15 respondents'.


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3.10 PATIENTS OR THEIR ATTENDANTS'

3.10.1 Outdoor Patients & Their Attendants'

Total 30 Outdoors patients or their attendants' from Public hospitals and private

hospitals have taken randomly from different areas hospitals.

3.10.2 Indoor Patients & Their Attendants'

Total 30 Indoor patients or their attendants' from Public hospitals and private

hospitals have taken randomly from different areas hospitals.

Therefore, the sample size of Patients or their attendants' will be of 60 respondents'.

3.11 PLAN OF DATA ANALYSIS

Both descriptive and inferential statistical techniques will be used through SPSS and

Megastat. The data will be presented in tables and charts. The statistical hypothesis

will be tested with the help of z-test (involving two groups) and F-test (involving

more than two groups) of significance. The graphical analysis will also be presented

wherever it is needed.

CHAPTER FOUR


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DATA ANALYSIS

4.1 SURVEY FINDINGS

The survey findings were analyzed linearly, cross sectionally in order to have a

better comprehension and understanding between the relationship of dependent and

independent variables, moderating, and intervening variables. The empirical results

or the survey findings and interpretations of the study are discussed as below. The

total sample of 300 has been extracted from following six different variables. The

demographic information of these 300 respondents as follow:

4.1.1 Gender

TABLE 1 FEMALES MALES TOTAL

88 212 300 Major samples collected from Male respondents (Total 212, 70.67%) total samples

size responded to the research while Female doctors (Total 88, 29.33%) of sample

size.

GRAPH – 5 Gender


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The above graphical representation shows the gender recruitment of respondents in

the under taken study, which clearly demonstrate that the overwhelming majority of

respondents are male.

Following table shows the age brackets of different respondents who have

participated in the study.

4.1.2 Age

TABLE 2 < 30 30-40 40-50 > 50 TOTAL 81 76 78 65 300

It is clearly indicated from the above table the majority of respondents belongs to the

age group of less than 30 years and then followed by between 40-50 years and so on.

Following is the graphical representations of different age groups of were

participated in the study.

GRAPH - 6

Age (In Years)


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4.1.3 Experience

TABLE 3

< 5 5--10 10—15 > 15 TOTAL 47 57 67 129 300

Major respondents i.e. 129 fall under the category of more than 15 years experiences

& then followed by 67 respondents have 10-15 years of experience in their field. 57

respondents belong to 5-10 years experience and 47 respondents have less than 5

years experience. Moreover, following graph shows the distribution of experiences

according to their ages of all the respondents who have participated in the under

taken study.

GRAPH - 7

Experience (In Years)

4.1.4 Education TABLE 4

Post Graduates Graduates Intermediate Metric 105 140 33 22


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The above table shows that 140 respondents were graduates and 105 respondents

were post-graduates, whereas, only 33 respondents have received intermediate

education and 22 have obtained Matriculation certification. So, it is concluded that

majority of respondents i.e. 245 were graduate or post-graduate. Following graph

shows the pictorial diagram of this data.

GRAPH - 8

Education of Respondents

4.1.5 Respondents

TABLE 5

Consulta

nt RMO/M

O GPs Govt.

Officials Pharma.

Personnel Govt. Hosp Personnel

30 30 30 15 60 10

If we analyze the whole respondents then we come to know that there were 30

consultants and 30 MO/RMOs, & 30 general practitioners who have participated in

that study. Whereas, 60 pharmaceutical personnel have been recruited for the under

taken study. The pharmaceutical personnel were either from sales or from


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marketing. Moreover, 15 government officials were also taken as respondents for

this study and 10 hospital employees were participated in the study as well.

TABLE 6

Private Hosp. Personnel

Retail Pharmacies

Wholesale Pharmacies

Outdoor Patients

Indoor Patients

15 25 25 30 30 Moreover, 15 private hospitals personnel were also taken as respondents for this

study and 25 each retail and wholesale pharmacies taken randomly for the

undertaken study. Outdoor and indoor patients were taken 30 each. Following is the

graphical representation of the above data.

GRAPH – 9 RESPONDENTS

4.1.6 Pharmaceutical Personnel

TABLE 7 Gender Age Experience

Male Female < 30 30 – 40 40 - 50 > 50 < 5 5--10 10--15 > 15 37 23 29 20 8 3 16 16 18 10

The pharmaceutical personnel who were taken as sample for the under taken study

the further break up was as:

There were 37 males and 23 females who were participated for the study and age

bracket of less than 30 were 29 participant and 20 between 30-40 years. Only 8


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respondents were of age between 40-50 years. Whereas, the experience was less

than 5 years between 5-10 years for 16 respondents each, 18 respondents have 10-15

years experience and 10 respondents have more than 5 years experience.

TABLE 8

Education Graduate Post Graduate

25 35

As far as education was concerned all the respondents from pharmaceutical industry

were well educated, in which 25 were graduates and 35 were post-graduates.

Following is the graphical representation of all above data & tables.

GRAPH – 10

Pharmaceutical Personnel

4.1.7 Consultants

TABLE 9

Gender Age (Yrs) Experience (Yrs) Education


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Male Female > 50 40 - 50 > 15 10--15 Post Graduates 28 2 16 14 27 3 30

The consultants who were taken as sample for the under taken study the further

break up was as:

There were 28 males and 2 females only who were participated for the study and age

bracket of less than 50 years were 16 participant and 14 between 40-50 years.

Whereas, 27 respondents have more than 15 years experience and only 3 were have

10-15 years experience. Moreover, all the 30 respondents were post-graduates who

were participated in the under taken study.

GRAPH – 11 Consultants

4.1.8 General Practitioners

TABLE 10 Gender Age Experience

Male Female < 30 30 – 40 40 - 50 > 50 < 5 5--10 10--15 > 15 23 7 1 10 14 5 1 2 10 17


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General Practitioners who were taken as sample for the under taken study the further

break up was as:

There were 23 males and 7 females only who were participated for the study and age

bracket of less than 30 years was only 1 participant and 10 between 30-40 years, and

there are 14 respondents of age bracket 40-50 years. Whereas, 5 respondents have

more than 50 years age group. As far as experience was concerned there were two

participants who have 5-10 years experience, only 1 respondent who has less than 5

years experience. There were 10 respondents who had 10-15 years experience and

17 participants had more than 15 years experience.

TABLE 11

Education Graduation Post Graduation

28 2

There were 28 respondents who had graduation and 2 general practitioners were post

graduated who participated in the under taken study. Following is the graphical

representation of the above data.

GRAPH – 12

General Practitioners


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4.1.9 RMO / MO

TABLE 12

Gender Age Experience Education Male Female < 30 30 - 40 < 5 5--10 10—15 Graduation

12 18 25 5 15 12 3 30

RMOs / MOs who were taken as sample for the under taken study the further break

up was as follows:

There were 12 males and 18 females who were participated in the study and age

bracket of less than 30 years were 25 participants and 5 between 30-40 years. As far

as experience was concerned there were five participants who have more than 5

years experience, only 3 respondents who have between 10-15 years experience. All

30 participants were graduated who participated in the study.

GRAPH – 13 RMO / MO


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4.1.10 Govt. & Private Hospitals Officials

TABLE 13

Gender Age Experience Male Female < 30 30 – 40 40 - 50 > 50 < 5 5--10 10--15 > 15

19 6 3 6 11 5 2 1 8 14 Government and private hospitals officials who were taken as sample for the under

taken study the further break up was as follows:


bracket of less than 30 years were only 3 participants and 6 between 30-40 years, 11

participants were between 40-50 years of age and 5 respondents were more than 50

years. As far as experience was concerned there were only two participants who

have less than 5 years experience, only 1 respondent who has between 5-10 years

experience, 8 respondents have between 10-15 years experience and 14 participants

have more than 15 years of experience.

TABLE 14

Education Intermediate Graduation Post graduation


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1 14 10 One respondent was intermediate only, 14 were graduated and 10 respondents were

post graduated who have participated in the under taken study.

GRAPH - 14

Government and Private Hospitals Officials

4.1.11 Retail Pharmacies

TABLE 15

Gender Age Experience Male Female < 30 30 - 40 40 - 50 > 50 < 5 5--10 10--15 > 15

7 18 9 10 4 2 6 8 6 5

Retail pharmacies personnel who were taken as sample for the under taken study the

further break up was as follows:


bracket of less than 30 years were 9 participants and 10 between 30-40 years, 4


years. As far as experience was concerned there were five participants who have


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less than 5 years experience, eight respondents who have between 5-10 years



TABLE 16

Education Metric Intermediate Graduation Post Graduation

3 1 15 6 Three participants were matriculated, one respondent was intermediate only, 15

were graduated and 6 respondents were post graduated who have participated in the

under taken study.

GRAPH – 15 Retail Pharmacies

4.1.12 Wholesales Pharmacies


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TABLE 17


25 0 2 4 11 8 1 2 5 17

Wholesales pharmacies personnel who were taken as sample for the under taken

study the further break up was as follows:

There were 25 males and none of female who were participated in the study and age



years. As far as experience was concerned there was only one participant who has

less than 5 years experience, 2 respondents who have between 5-10 years



TABLE 18

Education Intermediate Graduation Post Graduation

13 10 2 There were 13 respondents who were intermediate, 10 were graduated and 2

respondents were post graduated who have participated in the under taken study.

GRAPH – 16

Wholesale Pharmacies


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4.1.13 Outdoor Patients

TABLE 19


23 7 11 8 6 5 6 10 5 9 Outdoor patients or their attendants who were taken as sample for the under taken





years. As far as experience was concerned there were 10 participants who have

between 5-10 years of experience, 5 respondents have between 10-15 years

experience and 9 participants have more than 15 years of experience.

TABLE 20

EDUCATION Matric Intermediate Graduation Post graduation


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8 12 4 6 There were eight respondents who were Matriculated, 12 respondents who were

intermediate, 4 were graduated and 6 respondents were post graduated who have

participated in the under taken study.

GRAPH – 17

Outdoor Patients

4.1.14 Indoor Patients

TABLE 21

Gender Age Experience Male Female 30 – 40 40 – 50 > 50 5--10 10--15 > 15

23 7 8 8 14 2 7 21

Indoor patients or their attendants who were taken as sample for the under taken



bracket between 30-40 years were 8 participants and 8 between 40-50 years, and 14


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respondents were more than 50 years. As far as experience was concerned there

were 2 participants who have between 5-10 years of experience, 7 respondents have

between 10-15 years experience and 21 participants have more than 15 years of

experience.

TABLE 22

Education Metric Intermediate Graduation Post Graduation

11 6 6 7

There were 11 respondents who were Matriculated, 6 respondents who were

intermediate, 6 were graduated and 7 respondents were post graduated who

have participated in the under taken study.

GRAPH – 18 Indoor Patients

4.1.15 Govt. Officials (Provincial & Federal)

TABLE 23


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Gender Age Experience Male Female < 30 30 - 40 40 - 50 > 50 5--10 10--15 > 15

13 2 1 5 2 7 4 2 9

Provincial and Federal government officials who were taken as sample for the under

taken study the further break up was as follows:


bracket between 30-40 years were 5 participants and 2 between 40-50 years, and 7

respondents were more than 50 years, whereas, less than 30 years were only one

participant. As far as experience was concerned there were 4 participants who have

between 5-10 years of experience, 2 respondents have between 10-15 years

experience and 9 participants have more than 15 years of experience.

TABLE 24

Education Graduation Post Graduation

8 7

There were eight respondents who were graduated and 7 respondents were post

graduated who have participated in the under taken study.

Following is the graphical representation of Provincial and Federal government

officials who were participated in the study:

GRAPH – 19

Government Officials (Provincial & Federal)


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4.2 HYPOTHESES TESTING

Four different hypotheses were developed and tested using Z-test, simple ANOVA

and F-test. The result and interpretation of the four developed hypotheses are

presented below:

4.2.1 Hypothesis No. I

H1o: The level of unethical drug promotion practices in pharmaceutical

industry is high (at least 4) on the scale of (5 to 1)

H1A: The level of unethical drug promotion practices in pharmaceutical

industry is less than 4 on the scale of (5 to 1)

The statistical representation of the above hypothesis is presented below:


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H10: µ ≥ 4

H1A: µ ˂ 4

The above hypothesis was tested through Z-test and the summarized result is

presented below:

TABLE 25

Level of Unethical Drug Promotion Practices

Mean 4.220 Standard Deviation 0.887 Hypothesized mean 4.00 Confidence level 0.95 Critical value one tail 1.645 Critical value two tail 1.96 Z-Calculated value 4.29 N 300 confidence interval 95.% lower 4.120 confidence interval 95.% upper 4.320 p-value (two-tailed) 1.76E-05 std. error 0.051 half-width 0.100

The hypothesis relating to high level of unethical drug promotion practices (at least

4 on the scale of 5-1) was substantiated. At 95% confidence level, Z critical value is

-1.645, and Z-calculated value is 4.29 that fall in the non-critical region.

So, it is concluded that the null hypothesis is accepted because 4.29 lies in non

critical region and it is further concluded that the level of unethical pharmaceutical

marketing practices is high (at least 4) on the scale of (5 to 1).

4.2.2 Hypothesis No. 2


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Focus group discussions indicate that the level of unethical drug promotion practices

is high in rural areas. Therefore the hypothesis developed in this context is

presented below:

H20: The levels of unethical drug promotion practices are equally higher in

rural areas as compared to the urban areas.

H2A: The levels of unethical drug promotion practices are not equally

higher in rural areas as compared to the urban areas.


H20: µ1 ≥ µ2

H2A: µ1 ˂ µ2

Above test was carried out through by Z-two samples variables analysis, and the

summarized result is presented below:

TABLE 26

Level of Unethical Drug Promotion Practices In Rural Area

Rural Urban Mean 4.03 3.50 Standard Deviation 1.01 1.21 Observations 300 300 Hypothesized Mean Difference 0 Z 5.81 p-value (one-tailed, lower) 1.0000 z Critical one-tail 1.645 P(Z<=z) two-tail 0 z Critical two-tail 1.95 difference (Rural - Urban) 0.527 standard error of difference 0.091

The hypothesis relating to higher level of unethical drug promotion practices in rural

areas was substantiated. At 95% confidence level the Z-critical value taken from


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table is -1.645 and Z-calculated value is 5.81 that fall in the non-critical region.

Therefore, it is further concluded that the levels of unethical drug promotion

practices are higher in rural areas as compared to the urban areas.

TABLE 27

Unethical Practices (5 to 1) Common in Karachi Higher in Rural areas Equally higher in Urban areas

4.22 4.03 3.5

Following is the graphical representation of unethical pharmaceutical marketing

practices in overall Karachi and Urban & Rural areas, which clearly demonstrate

that according to the respondents, unethical marketing practices are more common

in rural areas as compared to the urban areas.

GRAPH – 20

UNETHICAL MARKETING PRACTICES IN KARACHI

4.2.3 Hypothesis No. III


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An important aspect is who was responsible for initiating the unethical drug

promotion practices in Pakistan. Doctor, pharmaceutical companies, hospitals,

pharmacies, Govt. Officials and Patients all have different opinions. In view of this

disparity the developed hypothesis is presented below:

H30: There is no significant difference on the opinions of doctor,

pharmaceutics companies, hospitals, pharmacies, Govt. Officials and

Patients on who initiated unethical drug promotion practices in

Pakistan.

H3A: There is significant difference on the opinions of doctor,

pharmaceutics companies, hospitals, pharmacies, Govt. Officials and

Patients on who initiated unethical drug promotion practices in

Pakistan.


H30: µ1 = µ2 = µ3 = µ4 = µ5 = µ6

H3A: µ1 ≠ µ2 ≠ µ3 ≠ µ4 ≠ µ5 ≠ µ6

The above hypothesis was tested through simple ANOVA, and the summarized

results are presented below:

TABLE 28


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Opinion on Who Initiated the Unethical Drug Promotion Practices

Groups Count Sum Average Variance Pharmaceutical company 300.00 439.00 3.59 2.62 Doctors 300.00 294.00 2.39 3.16 Hospitals 300.00 148.00 1.19 0.49 Pharmacy 300.00 140.00 1.11 0.19 Govt. Officials 300.00 140.00 2.11 1.29 Patients 300.00 140.00 2.29 2.31

Source of Variation SS df MS F P-value F crit

Bt. Groups 521.56 5.00 178.95 106.24 0.00 2.62 Within Groups 747.93 476.00 1.67

Total 1,269.48 479.00

The hypothesis relating to no significant difference of opinions on who initiated

unethical drug promotion practices in Pakistan was rejected. At 95% confidence

level and (5, 476) df the calculated F value of 106.24 is greater than F- critical

values of 2.62.

TABLE 29

Unethical Practices (5 to 1) Groups Average Variance

Pharmaceutical companies 3.59 2.62 Doctors 2.39 3.16 Hospitals 1.19 0.49 Pharmacies 1.11 0.19 Govt. Officials 2.11 1.29 Patients 2.29 2.31

GRAPH – 21 LEVEL OF UNETHICAL PRACTICES


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The above analysis also indicates that the pharmaceutical industry were found to be

the entity that has initiated unethical drug promotion practices in Karachi with a

mean of 3.59, followed by doctors with a mean of 2.39.

4.2.4 Hypothesis No. IV

In the previous hypothesis, it was found out that the pharmaceutical industry

initiated unethical drug promotion practices, in Pakistan. However, an important

issue is that who is more responsible for the continuation of this practice. Based on

the previous hypothesis the following hypothesis was developed.

H40: The contribution of the pharmaceutical industry in continuation of

unethical drug promotion practices is equal or higher than the doctors.

H4A: The contribution of the pharmaceutical industry in continuation of

unethical drug promotion practices is not equal or higher than the

doctors.



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H40: µ1 ≥ µ2

H4A: µ1 ˂ µ2

Above test was carried out through by Z-two samples variables analysis, and the

summarized result is presented below:

TABLE 30

Opinion on Who Continued the Unethical Drug Promotion Practices

Pharmaceutical Company Doctors Mean 2.94 3.81 Known Variance 3.52 2.61 Observations 300.00 300.00 Hypothesized Mean Difference 0

Z (4.39) P(Z<=z) one-tail 0.00 Z Critical one-tail 1.645 P(Z<=z) two-tail 0.00 Z Critical two-tail 1.96

The hypothesis relating to a higher contribution of pharmaceutical industry in

unethical drug promotion practices was rejected. At 95% confidence level, the Z

critical value is -1.645 and Z-calculated value is -4.39 that falls in the critical

region. So, it is further concluded that the doctor community is more responsible for

the continuation of unethical pharmaceutical practices.

TABLE 31

Pharmaceutical companies Doctors Mean 2.94 3.81 Known Variance 3.52 2.61

GRAPH – 22


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CONTINUATION OF UNETHICAL PRACTICES

Therefore, it is further concluded that the pharmaceutical companies do not have

more contribution than the doctors in order to continue the unethical pharmaceutical

marketing practices. In other words doctors’ community is more responsible for the

continuation of unethical marketing practices in the industry.

4.3 QUALITITVE ANALYSIS

The qualitative analyses of determinants such as (a) tools of unethical drug

promotion practices (b) drug promotion to the non-qualified doctors (c) Legislation

for unethical drug promotion (d) eradication of unethical drug promotion is given as

below:

4.3.1 Tools of Unethical Drug Practices


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As was discussed in the literature survey that the commonly used tools for unethical

drug practice was, monetary rewards, local visits, and foreign visits etc. The

summarized results are presented below:

TABLE 32

Monetary Rewards

Local visits

Foreign Visits

Personalized gifts

Chamber decoration

Home decoration

4.24 4.33 4.59 3.88 2.77 1.31

GRAPH 23

It was discussed in earlier section that the doctors are the ones that are responsible

for the continuation of unethical drug promotion practices. The above table and

graphs shows that foreign visits with a mean of 4.59 are more in demand and local

visits being the second. The reasons for high preferences for local visits and foreign

visits are that pharmaceutical industry could justify these expenses by linking it with

the conference.

4.3.2 Drug Promotion to Non-Qualified Doctors


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Opinions on drug promotion to non-qualified doctors were obtained. Ethically, the

firms should not promote their drugs through them. The respondents’ opinions are

presented below:

TABLE 33

Pharma Personnel Doctors Hospital Pharmacies Govt. Officials Patients

3.29 4.45 3.53 3.11 3.23 3.44

GRAPH 24

Majority of respondents’ of all the segments such as doctors, Pharmaceutical

companies, hospitals, pharmacies, Govt. Officials and Patients were strongly against

drug promotion to the non-qualified doctors. However, despite their opinions it is a

fact that the drugs are being promoted through non-qualified doctors.

4.3.3 Legislation for Unethical Drug Promotion


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Respondents’ opinions were obtained on the prospects of strong legislation against

unethical drug promotion practices. The respondents’ opinions are presented below:

TABLE 34

Pharma Personnel

Doctors

Hospital Pharmacies

Govt. Officials Patients

3.96 3.91 4.12 4.35 3.34 3.72

GRAPH 25

Inference could be drawn from the above that the majority of respondent are

strongly in the favor of making some strong legislation against the unethical drug

promotional practices in Pakistan. Although some legislation is already available but

this research showed there is no implementation of that legislation, therefore,

majority of respondent demanded that there must be strong legislation to stop this

unethical drug promotion in Pakistan.

4.3.4 Eradication of Unethical Drug Promotion


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Opinions on eradication of drug promotion in Pakistan were obtained from the

respondents’. The respondents’ opinions are presented below:

TABLE 35

Pharma Personnel

Doctors

Hospital Pharmacies

Govt. Officials Patients

1.98 2.12 1.77 1.91 2.91 2.22

GRAPH 26

Above graph shows that the majority of the respondents’ i.e. doctors, pharmaceutical

personnel, hospitals, pharmacies, Govt. Officials and Patients strongly disagree

about the opinion that the unethical drug promotion practices cannot be stopped now.

Majority of respondents’ agreed upon that these unethical practices can still be

stopped.

CHAPTER FIVE


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SUMMARY, CONCLUSIONS AND

RECOMMENDATIONS

The major findings and recommendations are discussed below:

5.1 SUMMARY & CONCLUSIONS

The researcher has concluded the overall results and found that both doctors and

pharmaceutical companies are equally responsible for unethical drug promotion

practices in Pakistan. But most important and interesting findings are, basically

pharmaceutical companies are responsible for initiating these unethical drug

practices in Pakistan but now in continuation of these practices the doctor’s

community is actually responsible for these unethical drug promotion practices in

Pakistan. Now the doctors have become demanding and pharmaceutical companies

are responsible to fulfill their ethical and unethical demands. Now, this has become

an acceptable norm of the pharmaceutical industry and doctors community for the

promotion of drugs in unethical ways. The monetary rewards, local and foreign

visits in the name of scientific activities offered by the pharmaceutical companies

for unethical promotion of the drugs are extensively used as a tool of promotion of

their drugs. The entire above conclusion is evident from the four hypotheses that

were tested through Simple ANOVA, F-tests and Z-tests.


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The results of tested hypothesis and their conclusions are presented below:

1. The hypothesis relating to high level of unethical drug promotion practices

(at least 4 on the scale of 5-1) was substantiated. At 95% confidence level, Z

critical value is -1.645, and Z-calculated value is 4.29 that fall in the non-

critical region.

So, it is concluded that the null hypothesis is accepted because 4.29 lies in

non critical region and it is further concluded that the level of unethical

pharmaceutical marketing practices is high (at least 4) on the scale of (5 to 1).

It may be pointed that the level of unethical drug promotion practices as was

ascertained by (Parmar and Jalees, 2004) in their research was 3.56. The

reason could be that the study of (Parmar and Jalees) was case study of

Hyderabad, where as this study is Karachi based, and the sample drawn was

a more representative sample.

The above data clearly shows that the severity and intensity of unethical

pharmaceutical marketing practices have grown intensively in Pakistan. Now, it has

become an acceptable norm for both pharmaceutical industry and doctors’

community. Unfortunately, pharmaceutical companies are very much active in these

unethical practices; some how national and multinational companies are competing

each other in order to do these illegal and unethical pharmaceutical marketing

practices. These companies are just bothering for their profits and expansion of


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businesses. These companies are least bother about the patients’ well being and their

economic burden and care.

At the cost of the patient these companies are offering every kind of social or

scientific activities, local and international CMEs and Conferences and doctor’s

personal obligations in the form of cash, local or foreign trips, home or clinical

appliances. The doctors’ community is equally responsible for these unethical

pharmaceutical marketing practices across Pakistan by accepting all sorts of

activities whether these are ethical or unethical. So, because of both parties

cooperation the level of unethical practices has escalated beyond imagination and

crossed all limits and subsequently patients are suffering enormously.

2. The hypothesis relating to higher level of unethical drug promotion practices

in rural areas was substantiated. At 95% confidence level the Z-critical value

taken from table is -1.645 and Z-calculated value is 5.81 that fall in the non-

critical region. Therefore, it is further concluded that the levels of unethical

drug promotion practices are higher in rural areas as compared to the urban

areas.

In above hypothesis it is clearly demonstrated the level of unethical pharmaceutical

marketing practices are very high in rural areas as compared to urban areas. It does

not mean the level of unethical practices is very low in urban areas but

comparatively it is more severe in rural areas. The reason is very simple, in rural

areas there is almost zero check and balance by the regulating and law enforcing

agencies. Therefore, the pharmaceutical companies are free to offer anything to the


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doctors community in rural and suburb areas, even in slum areas of big cities the

level of unethical pharmaceutical marketing practices are very high as compared to

the main city areas. The doctors who are practicing in rural or suburb areas are very

much greedy and taking cash incentives for every prescription of medicine. They

have their attached Pharmacies with their clinics and it is very convenient to

prescribe and consume all unknown, substandard, unregistered and counterfeit drugs.

The reason is simple there is very low check and balance of regulating and law

enforcing agencies of medicines in rural and slum areas. The government drug

inspectors are also very much involved in for corruption for those areas as well.

The sale of free sample is also very common in rural and suburb areas, whereas, the

sales of free samples is illegal but due to these attached pharmacies samples are

being prescribed and sold to the patients. Another horrible fact is that almost 80%

fake doctors who do not have medical degree and medical license; they also do

illegal practice in these areas. So, there is two-dimension problem in rural areas, the

fake medicines and the fake doctors. This could be a strong reason for more

unethical practices in the rural areas as compared to the main cities. Ironically, both

pharmaceutical companies and doctors are playing with the health of poor people in

all those rural, suburbs and slum areas.

An important aspect is who was responsible for initiating the unethical drug

promotion practices in Pakistan. Doctor, pharmaceutical companies, hospitals and

pharmacies all have different opinions. In view of this disparity the developed

hypothesis is presented below:


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3. The hypothesis relating to no significant difference of opinions on who

initiated unethical drug promotion practices in Pakistan was rejected. At

95% confidence level and (5, 476) df the calculated F value of 106.24 is

greater than F- critical values of 2.62.

The above analysis also indicates that the pharmaceutical industry were

found to be the entity that has initiated unethical drug promotion practices in

Pakistan with a mean of 3.59, followed by doctors with a mean of 2.39.

The result of above hypothesis clearly demonstrated that the pharmaceutical industry

was the responsible for the cultivation of these unethical norms in Pakistan. Actually,

initially multinational companies have started these practices in big cities with

international conferences. Multinational companies have provided the opportunities

to the consultants for abroad trips in the name of international conference and

subsequently national conferences and personalized activities as well. After

emergence of national companies, the unethical practices span has increased many

folds because national companies have targeted family physicians and

comparatively junior doctors at mass level.

Another reason for phenomenal increase of unethical practices was the margin of

profits. Since the national companies have more margins and these companies have

larger field force and coverage of doctors is tremendous across Pakistan. These

national companies have diversified product portfolios and commonly used products;

therefore, their reach is also very vast to the doctors. So, they spread these unethical


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pharmaceutical marketing practices rapidly to every corner of the Country. They

also introduced new dimensions of unethical practices like cash incentives, family

trips, home appliances and foreign trips with family as well.

In the previous hypothesis, it was found out that the pharmaceutical industry

initiated unethical drug promotion practices, in Pakistan. However, an important

issue is that who is more responsible for the continuation of this practice.

4. The hypothesis relating to a higher contribution of pharmaceutical industry

in unethical drug promotion practices was rejected. At 95% confidence level,

the Z critical value is -1.645 and Z-calculated value is -4.39 that falls in the

critical region.

Therefore, it is further concluded that the pharmaceutical companies do not

have more contribution than the doctors in order to continue the unethical

pharmaceutical marketing practices. In other words doctors’ community is

more responsible for the continuation unethical marketing practices in the

industry.

The result of above hypothesis clearly shows that after initiation of pharmaceutical

marketing practices by the pharmaceutical companies, now it has become an

acceptable norm. Now, the doctors’ community thinks, this is the right of doctor to

ask their share of the profit from the pharmaceutical companies. Therefore, now,

they have become more demanding and bluntly ask for different obligations without

any hesitation. Pharmaceutical companies also fulfill their demands happily without


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asking any question, even there is a competition amongst the companies to fulfill

their demands. So, now, the doctors are asking for cash incentives for per

prescription and other lucrative incentives from the pharmaceutical companies

themselves.

Doctors clearly ask from the pharmaceutical companies, if they prescribe their

products then what sort of benefits they will be getting. They dictate and blackmail

to the pharmaceutical companies, if companies will not fulfill their demands then

they will stop their prescription and make deals with other companies. They totally

forget the patients’ stakes and their economic burden and their well-being.

The qualitative analyses of determinants such as (a) tools of unethical drug

promotion practices (b) drug promotion to the non-qualified doctors (c) Legislation

for unethical drug promotion (d) eradication of unethical drug promotion is given as

below:

a) As was discussed in the literature survey that the commonly used tools

for unethical drug practice was, monetary rewards, local visits, and

foreign visits etc. The summarized results are presented below:

It was discussed in earlier section that the doctors are the ones that are

responsible for the continuation of unethical drug promotion practices.

The Qualitative analysis shows that foreign visits with a mean of 4.59 are

more in demand and local visits being the second. The reasons for high


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preferences for local visits and foreign visits are that pharmaceutical

industry could justify these expenses by linking it with the conference.

The above qualitative analysis clearly demonstrated that the foreign visits are the

most common practice, which is being used by the pharmaceutical industry in order

to please and oblige the doctors. Whereas, the local visits are the second one tool to

oblige the doctors. Foreign and local visits are the most demanding and practicing

by the pharmaceutical industry to please or to oblige doctors for unethical marketing

practice. Initially, the multinational companies in the name of international

conferences have started foreign visits and they selected consultants from the main

cities of the Country. They were not only providing boarding, lodging, air tickets

and registration but also arrange sight seeing as well. After entrance of national

companies the quantum of foreign and local visits have increased substantially.

Local companies have also offered these visits to family physicians and junior

doctors as well. Mainly, national and multinational companies are linking these local

and foreign tours with national and international conferences. Local companies have

forwarded one step ahead and they started Continuing Medical Education (CMEs)

and in the name of CMEs these national companies arrange international tours for

doctors and their families. In those international tours these companies are providing

all sort of recreational activities to the doctors and families that is why the

international tours are in more demand by the doctors community.


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b) Opinions on drug promotion to non-qualified doctors were obtained.

Ethically, the firms should not promote their drugs through them. The

respondents’ opinions are presented below:

The Qualitative analysis shows that the majority of respondents’ of all

the segments such as doctors, Pharmaceutical companies, hospitals,

pharmacies, govt. officials or Patients were strongly against drug

promotion to the non-qualified doctors. However, despite their opinions

it is a fact that the drugs are being promoted through non-qualified

doctors.

The above opinion is very logical and interesting which is obtained from doctors,

pharmaceutical companies, hospitals and pharmacies. All the respondents are very

much agreed upon that the promotion of pharmaceutical drugs should be prohibited

to the non-qualified doctors. However, the ground realities are entirely different than

their opinions because most of the pharmaceutical companies are promoting their

drugs to non-qualified doctors in order to boost up their sales, especially in rural,

suburbs, and slum areas because the major chunk of doctors are non-qualified in all

these areas. Patients’ of those areas also visit non-qualified doctors because of

unviability of qualified doctors and for economic reasons as well. All the

pharmacies of those areas freely selling their medicines to the patients on the

prescription of non-qualified doctors. Only qualified doctor’s opinion could be taken

validated because these non-qualified doctors are competitors of degree holder

doctors.


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c) Respondents’ opinions were obtained on the prospects of strong

legislation against unethical drug promotion practices. The respondents’

opinions are presented below:

Inference could be drawn from the Qualitative analysis that the majority

of respondents are strongly in the favor of making some strong

legislation against the unethical drug promotional practices in Pakistan.

Although some legislation is already available but this research showed

there is no implementation of that legislation, therefore, majority of

respondent demanded that there must be strong legislation to stop this

unethical drug promotion in Pakistan.

The above qualitative analysis clearly shows that all the respondents are agreed upon,

further legislation should be taken place in order to stop these unethical

pharmaceutical marketing practices. However, prevailing laws are more than

sufficient for the eradication of these practices, but the problem is true

implementation of these laws. The laws and code of conduct is already there for

ethical marketing practices for pharmaceutical companies. There are numerous

government bodies and agencies who are supposed to implement these laws on

pharmacies, pharmaceutical companies and doctors community but unfortunately

government officials are indulged themselves in the corruption. So, if there will be

made any new law, then who will implement that law.


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d) Opinions on eradication of drug promotion in Pakistan were obtained

from the respondents’. The respondents’ opinions are presented below:

The Qualitative analysis shows that the majority of the respondents’ i.e.

doctors, pharmaceutical personnel, hospitals, pharmacies, govt. officials

and Patients strongly disagree about the opinion that the unethical drug

promotion practices cannot be stopped now. Majority of respondents’

agreed upon that these unethical practices could still be stopped.

Above qualitative analysis shows that these unethical practices could be stopped, but

there is a big question how? Who will take the responsibility to stop these practices?

The pharmaceutical companies? These are busy in making huge profits from these

practices. The doctors’ community? They are getting unmatched and enormous

benefits from the pharmaceutical companies. Government officials are taking

bribery in order to support all these unethical practices. Actually, everybody is

involved in that unethical practice; therefore, everybody should realize their moral

responsibility and take their own part in order to stop these unethical practices from

the society. Otherwise, hundreds of thousands laws and regulations could not be

stopped these unethical practices.

5.2 RECOMMENDATIONS

The focus groups discussions and survey findings suggest that strong legislation

must be developed, implemented and enforced by the government. However, the


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regulations and legislation actually works when they are supported by the norms and

values of the society.

In this particular case, these unethical practices are considered as the norms of the

pharmaceutical industry and the doctors community; therefore, it could only be

addressed by educating both the segments for realizing their social responsibilities

with the focus on the patients’ well being.

Furthermore, there must be strong check and monitoring by the Ministry of Health

and other monitoring agencies both on pharmaceutical industry and the doctors.

It is also strongly recommended that there should be strong legislation by the

healthcare authorities and government agencies to stop or at least minimize these

unethical pharmaceutical marketing practices both by the doctor community and the

pharmaceutical industry.

There must be strong enforcement of existing rules and regulations by the relevant

government departments and autonomous bodies whom responsible to implement

and ensure these rules and regulations both on pharmaceutical industry and the

doctors’ community.

It is also recommended to the doctors’ community that this is also their prime and

ethical responsibility to avoid getting unethical benefits from pharmaceutical

companies while they are prescribing their products.


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The pharmaceutical industry should also restrict itself up to ethical marketing offers

and discourage healthcare professionals if they would ask any thing, which is

unethical according to the ethical pharmaceutical practices guidelines.

Most importantly every stakeholder should realize their responsibility and take their

own part in order to stop these unethical pharmaceutical practices from the society.

Pharmaceutical companies should abide the prevailing laws and regulations for

marketing their drugs to the doctors and draw a thick line between ethical and non-

ethical pharmaceutical marketing practices and do not cross that line at any cost.

Doctors’ community should also realize their moral and ethical responsibility and do

not demand for unethical benefits from the pharmaceutical companies and restrict

themselves within the ethical limits. Doctors’ community is known as the most

sophisticated and literate group of people of the society; therefore, they have a more

responsibility to behave seriously in order to stop these unethical practices. They

should discourage pharmaceutical companies if they offer some unethical benefits

because if they accept then they would also be expected to be unethical some point.

They should care their patients and their well-being and do not put economical

burdens on their shoulders at the expense of their own benefits.

Government should increase check and balance on their agencies and employees and

reprimand those officials who are involved in bribery and corruption. If government

will keep on checking and giving punishments then eventually prevailing laws and


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regulations will be started to work and quantum of these unethical practices will be

diminishing and one day these unethical practices will completely be eradicated

from the society.

5.3 SUGGESTED AREAS OF FURTHER RESEARCH

• Since the under taken study was a case study of Karachi City only, therefore,

it could not be concluded that the result of the study if which would be

conducted on country-wide would be the same as, therefore, further research

can be conducted on Pan-Pakistan basis for more representative sample.

• Another dimension is to segregate the specialties and then could be

conducted the study in order to analyze whether the results of different

specialties are same or different.

• Since in this study only promotional or the marketing aspect of

pharmaceutical industry is been covered, other areas of pharmaceutical

industry like medical, production and procurement could also be covered.

• In this study few variables have been incorporated whereas, in further

research more variables can be incorporated in order to have more clear and

accurate results.


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APPENDIX - I

Annexure – A

Pharmaceutical Drug Promotion in Pakistan: Issues in Ethical and Non-Ethical Practices

QUESTIONNAIRE

Unethical pharmaceutical marketing PRACTICES: It means to promote the product by ignoring the ethical values and principles of PHARMACEUTICAL marketing & SALES:

Q1. Gender � Male � Female Q2. Age? (in years) � Less than 30 � 30-40 � 40-50 � More than 50 Q3. Professional Experience? (in years) � Less than 5 � 5-10 � 10-15 � More than 15 Q4. Respondent? � General

Practitioner � Govt. Official � Consultant � Patient or

Attendant

� Pharmacy � MO or RMO � Hospital � Pharmaceutical Personnel

Q6. Education? � Primary � Secondary � Metric � Intermediate � Graduate � Post Graduate � Ph.D. � Others Q7. Income? (in Thousands) � Less than 5 � 6 to 10 � 11 to 15 � 16 to 20 � 21 to 25 � 26 to 50 � 51 to 100 � More than 100 Q8. Affiliated Institute or Organization?* � Govt. Office (F/P) � Govt. Hospital � Private Hospital � GP

(Urban/Rural) � Pharma. (MNC) � Pharma.

(Local) � Pharmacy (W.

Sale) � Pharmacy

(Retail) � Private Service � Govt.

Employee � Self Employed � Any Other ___


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Annexure – B

Please Rate the following questions on the scale of 5 to 1 (5 being high and 1 being low) as described follows: Strongly Agree = 5 Agree = 4 Do not Know = 3 Disagree = 2 Strongly Disagree = 1 Q9. Unethical drug promotion practice is common in Pakistan 5 4 3 2 1 Q10. Unethical drug practices are higher in Rural areas: 5 4 3 2 1

Q11. Unethical drug practices are equally higher in Urban areas: 5 4 3 2 1

Q12. The unethical drug practices was initiated by: (a) Pharmaceutical Companies 5 4 3 2 1 (b) Doctors 5 4 3 2 1 (c) Hospitals 5 4 3 2 1 (d) Pharmacies 5 4 3 2 1 Q13. Who are the responsible for the continuation of unethical drug practices? (a) Pharmaceutical Companies 5 4 3 2 1 (b) Doctors 5 4 3 2 1 (c) Hospitals 5 4 3 2 1 (d) Pharmacies 5 4 3 2 1 Q14. Tools which are being used in unethical drug promotion: (a) Monetary Rewards 5 4 3 2 1 (b) Local Visits 5 4 3 2 1 (c) Foreign Visits 5 4 3 2 1 (d) Precious Personalized Gifts 5 4 3 2 1 (e) Chamber’s Decoration 5 4 3 2 1 (f) Home Decoration 5 4 3 2 1 (g) Specify if any Other ___________________________________ 5 4 3 2 1


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Q15. Do you support to promote the drugs to Non-Qualified Doctors? (a) Pharmaceutical Companies 5 4 3 2 1 (b) Doctors 5 4 3 2 1 (c) Hospitals 5 4 3 2 1 (d) Pharmacies 5 4 3 2 1 (e) Govt. Official 5 4 3 2 1 (f) Patients or Attendants’ 5 4 3 2 1 Q16. Should it be any strong legislation by the government to stop this malpractice? (a) Pharmaceutical Companies Personnel 5 4 3 2 1 (b) Doctors 5 4 3 2 1 (c) Hospital's Influencer 5 4 3 2 1 (d) Pharmacy's Spokesperson 5 4 3 2 1 (e) Govt. Official 5 4 3 2 1 (f) Patients or Attendants’ 5 4 3 2 1 Q17. Is it difficult to stop unethical promotion practices in Pakistan? (a) Pharmaceutical Companies Personnel 5 4 3 2 1 (b) Doctors 5 4 3 2 1 (c) Hospital's Influencer 5 4 3 2 1 (d) Pharmacy's Spokesperson 5 4 3 2 1 (e) Govt. Official 5 4 3 2 1 (f) Patients or Attendants’ 5 4 3 2 1

Abbreviations: F = Federal P = Provincial Pharma = Pharmaceutical Company MNC = Multinational Local = National Pharmaceutical Company W. Sale = Whole Sale Pharmacies GP = General Practitioner MO = Medical Officer RMO = Resident Medical Officer Consultant = Post Graduate in any Specialty

Thank you very much for your valuable time and Cooperation


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APPENDIX - II

CROSS-TABULATION

i. AGE

TABLE

Age (Years) Respondents’ < 30 81

30-40 76 40-50 78 > 50 65

TOTAL 300

TABLE

Cross-tabulation Respondents’ 81 76 78 65 300 Total

Age Observed 1 1

Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00

O - E 0.83 -0.17 -0.17 -0.17 -0.17 -0.17 0.00

(O - E)² / E 4.17 0.17 0.17 0.17 0.17 0.17 5.00

% of chi sq 13.9% 0.6% 0.6% 0.6% 0.6% 0.6% 16.7%

% of row 100.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100.0%

% of column 100.0% 0.0% 0.0% 0.0% 0.0% 0.0% 16.7%

% of total 16.7% 0.0% 0.0% 0.0% 0.0% 0.0% 16.7%

< 30 Observed 1 1

Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00

O - E -0.17 0.83 -0.17 -0.17 -0.17 -0.17 0.00

(O - E)² / E 0.17 4.17 0.17 0.17 0.17 0.17 5.00

% of chi sq 0.6% 13.9% 0.6% 0.6% 0.6% 0.6% 16.7%

% of row 0.0% 100.0% 0.0% 0.0% 0.0% 0.0% 100.0%

% of column 0.0% 100.0% 0.0% 0.0% 0.0% 0.0% 16.7%

% of total 0.0% 16.7% 0.0% 0.0% 0.0% 0.0% 16.7%

30-40 Observed 1 1

Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00

O - E -0.17 -0.17 0.83 -0.17 -0.17 -0.17 0.00

(O - E)² / E 0.17 0.17 4.17 0.17 0.17 0.17 5.00

% of chi sq 0.6% 0.6% 13.9% 0.6% 0.6% 0.6% 16.7%

% of row 0.0% 0.0% 100.0% 0.0% 0.0% 0.0% 100.0%

% of column 0.0% 0.0% 100.0% 0.0% 0.0% 0.0% 16.7%

% of total 0.0% 0.0% 16.7% 0.0% 0.0% 0.0% 16.7%

40-50 Observed 1 1

Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00

O - E -0.17 -0.17 -0.17 0.83 -0.17 -0.17 0.00

(O - E)² / E 0.17 0.17 0.17 4.17 0.17 0.17 5.00

% of chi sq 0.6% 0.6% 0.6% 13.9% 0.6% 0.6% 16.7%

% of row 0.0% 0.0% 0.0% 100.0% 0.0% 0.0% 100.0%

% of column 0.0% 0.0% 0.0% 100.0% 0.0% 0.0% 16.7%


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% of total 0.0% 0.0% 0.0% 16.7% 0.0% 0.0% 16.7%

> 50 Observed 1 1

Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00

O - E -0.17 -0.17 -0.17 -0.17 0.83 -0.17 0.00

(O - E)² / E 0.17 0.17 0.17 0.17 4.17 0.17 5.00

% of chi sq 0.6% 0.6% 0.6% 0.6% 13.9% 0.6% 16.7%

% of row 0.0% 0.0% 0.0% 0.0% 100.0% 0.0% 100.0%

% of column 0.0% 0.0% 0.0% 0.0% 100.0% 0.0% 16.7%

% of total 0.0% 0.0% 0.0% 0.0% 16.7% 0.0% 16.7%

TOTAL Observed 1 1

Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00

O - E -0.17 -0.17 -0.17 -0.17 -0.17 0.83 0.00

(O - E)² / E 0.17 0.17 0.17 0.17 0.17 4.17 5.00

% of chi sq 0.6% 0.6% 0.6% 0.6% 0.6% 13.9% 16.7%

% of row 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% 100.0%

% of column 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% 16.7%

% of total 0.0% 0.0% 0.0% 0.0% 0.0% 16.7% 16.7%

Total Observed 1 1 1 1 1 1 6

Expected 1.00 1.00 1.00 1.00 1.00 1.00 6.00

O - E 0.00 0.00 0.00 0.00 0.00 0.00 0.00

(O - E)² / E 5.00 5.00 5.00 5.00 5.00 5.00 30.00

% of chi sq 16.7% 16.7% 16.7% 16.7% 16.7% 16.7% 100.0%

% of row 16.7% 16.7% 16.7% 16.7% 16.7% 16.7% 100.0%

% of column 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0%

% of total 16.7% 16.7% 16.7% 16.7% 16.7% 16.7% 100.0% 30.00 chi-square 25 df .2243 p-value 2.236 Phi coefficient .913 Coefficient of Contingency 1.000 Cramér's V Fisher Exact Probability can only be calculated for a 2 x 2 table.

ii. EXPERIENCE

TABLE

Experience (Years) Respondents’ < 5 47

5—10 57 10—15 67

> 15 129 TOTAL 300

TABLE

Cross-tabulation

Respondents’ 47 57 67 129 300 Total


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Experience Observed 1 1

Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00

O - E 0.83 -0.17 -0.17 -0.17 -0.17 -0.17 0.00

(O - E)² / E 4.17 0.17 0.17 0.17 0.17 0.17 5.00

% of chi sq 13.9% 0.6% 0.6% 0.6% 0.6% 0.6% 16.7%

% of row 100.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100.0%

% of column 100.0% 0.0% 0.0% 0.0% 0.0% 0.0% 16.7%

% of total 16.7% 0.0% 0.0% 0.0% 0.0% 0.0% 16.7%

< 5 Observed 1 1

Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00

O - E -0.17 0.83 -0.17 -0.17 -0.17 -0.17 0.00

(O - E)² / E 0.17 4.17 0.17 0.17 0.17 0.17 5.00

% of chi sq 0.6% 13.9% 0.6% 0.6% 0.6% 0.6% 16.7%

% of row 0.0% 100.0% 0.0% 0.0% 0.0% 0.0% 100.0%

% of column 0.0% 100.0% 0.0% 0.0% 0.0% 0.0% 16.7%

% of total 0.0% 16.7% 0.0% 0.0% 0.0% 0.0% 16.7%

5—10 Observed 1 1

Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00

O - E -0.17 -0.17 0.83 -0.17 -0.17 -0.17 0.00

(O - E)² / E 0.17 0.17 4.17 0.17 0.17 0.17 5.00

% of chi sq 0.6% 0.6% 13.9% 0.6% 0.6% 0.6% 16.7%

% of row 0.0% 0.0% 100.0% 0.0% 0.0% 0.0% 100.0%

% of column 0.0% 0.0% 100.0% 0.0% 0.0% 0.0% 16.7%

% of total 0.0% 0.0% 16.7% 0.0% 0.0% 0.0% 16.7%

10—15 Observed 1 1

Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00

O - E -0.17 -0.17 -0.17 0.83 -0.17 -0.17 0.00

(O - E)² / E 0.17 0.17 0.17 4.17 0.17 0.17 5.00

% of chi sq 0.6% 0.6% 0.6% 13.9% 0.6% 0.6% 16.7%

% of row 0.0% 0.0% 0.0% 100.0% 0.0% 0.0% 100.0%

% of column 0.0% 0.0% 0.0% 100.0% 0.0% 0.0% 16.7%

% of total 0.0% 0.0% 0.0% 16.7% 0.0% 0.0% 16.7%

> 15 Observed 1 1

Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00

O - E -0.17 -0.17 -0.17 -0.17 0.83 -0.17 0.00

(O - E)² / E 0.17 0.17 0.17 0.17 4.17 0.17 5.00

% of chi sq 0.6% 0.6% 0.6% 0.6% 13.9% 0.6% 16.7%

% of row 0.0% 0.0% 0.0% 0.0% 100.0% 0.0% 100.0%

% of column 0.0% 0.0% 0.0% 0.0% 100.0% 0.0% 16.7%

% of total 0.0% 0.0% 0.0% 0.0% 16.7% 0.0% 16.7%

TOTAL Observed 1 1

Expected 0.17 0.17 0.17 0.17 0.17 0.17 1.00

O - E -0.17 -0.17 -0.17 -0.17 -0.17 0.83 0.00

(O - E)² / E 0.17 0.17 0.17 0.17 0.17 4.17 5.00

% of chi sq 0.6% 0.6% 0.6% 0.6% 0.6% 13.9% 16.7%

% of row 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% 100.0%

% of column 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% 16.7%

% of total 0.0% 0.0% 0.0% 0.0% 0.0% 16.7% 16.7%

Total Observed 1 1 1 1 1 1 6

Expected 1.00 1.00 1.00 1.00 1.00 1.00 6.00

O - E 0.00 0.00 0.00 0.00 0.00 0.00 0.00

(O - E)² / E 5.00 5.00 5.00 5.00 5.00 5.00 30.00


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% of chi sq 16.7% 16.7% 16.7% 16.7% 16.7% 16.7% 100.0%

% of row 16.7% 16.7% 16.7% 16.7% 16.7% 16.7% 100.0%

% of column 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0%

% of total 16.7% 16.7% 16.7% 16.7% 16.7% 16.7% 100.0%

30.00 chi-square

25 df

.2243 p-value

2.236 Phi coefficient

.913 Coefficient of Contingency

1.000 Cramér's V

Fisher Exact Probability can only be calculated for a 2 x 2 table

iii. INCOME

TABLE

Income (in thousands)

Income (Thousands) Respondents’

< 5 8 6—10 12

11—15 21 16—20 44 21—25 59 26—50 49

51—100 51 > 100 56

TOTAL 300

TABLE Cross-tabulation

Respondents’ 8 12 21 44 59 49 51 56 300 Total Income (Thousands) Observed 1 1

Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00

O - E 0.90 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 0.00

(O - E)² / E 8.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 9.00

% of chi sq 9.0% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 10.0%

% of row 100% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100%

% of column 100% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0%


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% of total 10.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% < 5 Observed 1 1

Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00

O - E -0.10 0.90 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 0.00

(O - E)² / E 0.10 8.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 9.00

% of chi sq 0.1% 9.0% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 10.0%

% of row 0.0% 100% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100%

% of column 0.0% 100% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0%

% of total 0.0% 10.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% 6—10 Observed 1 1

Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00

O - E -0.10 -0.10 0.90 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 0.00

(O - E)² / E 0.10 0.10 8.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 9.00

% of chi sq 0.1% 0.1% 9.0% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 10.0%

% of row 0.0% 0.0% 100% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100%

% of column 0.0% 0.0% 100% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0%


Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00

O - E -0.10 -0.10 -0.10 0.90 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 0.00

(O - E)² / E 0.10 0.10 0.10 8.10 0.10 0.10 0.10 0.10 0.10 0.10 9.00

% of chi sq 0.1% 0.1% 0.1% 9.0% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 10.0%

% of row 0.0% 0.0% 0.0% 100% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100%

% of column 0.0% 0.0% 0.0% 100% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0%


Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00

O - E -0.10 -0.10 -0.10 -0.10 0.90 -0.10 -0.10 -0.10 -0.10 -0.10 0.00

(O - E)² / E 0.10 0.10 0.10 0.10 8.10 0.10 0.10 0.10 0.10 0.10 9.00

% of chi sq 0.1% 0.1% 0.1% 0.1% 9.0% 0.1% 0.1% 0.1% 0.1% 0.1% 10.0%

% of row 0.0% 0.0% 0.0% 0.0% 100% 0.0% 0.0% 0.0% 0.0% 0.0% 100%

% of column 0.0% 0.0% 0.0% 0.0% 100% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0%


Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00

O - E -0.10 -0.10 -0.10 -0.10 -0.10 0.90 -0.10 -0.10 -0.10 -0.10 0.00

(O - E)² / E 0.10 0.10 0.10 0.10 0.10 8.10 0.10 0.10 0.10 0.10 9.00

% of chi sq 0.1% 0.1% 0.1% 0.1% 0.1% 9.0% 0.1% 0.1% 0.1% 0.1% 10.0%

% of row 0.0% 0.0% 0.0% 0.0% 0.0% 100% 0.0% 0.0% 0.0% 0.0% 100%

% of column 0.0% 0.0% 0.0% 0.0% 0.0% 100% 0.0% 0.0% 0.0% 0.0% 10.0%


Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00

O - E -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 0.90 -0.10 -0.10 -0.10 0.00

(O - E)² / E 0.10 0.10 0.10 0.10 0.10 0.10 8.10 0.10 0.10 0.10 9.00

% of chi sq 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 9.0% 0.1% 0.1% 0.1% 10.0%

% of row 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100% 0.0% 0.0% 0.0% 100%

% of column 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100% 0.0% 0.0% 0.0% 10.0%



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Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00

O - E -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 0.90 -0.10 -0.10 0.00

(O - E)² / E 0.10 0.10 0.10 0.10 0.10 0.10 0.10 8.10 0.10 0.10 9.00

% of chi sq 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 9.0% 0.1% 0.1% 10.0%

% of row 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100% 0.0% 0.0% 100%

% of column 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% 0.0% 0.0% 10.0%

% of total 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% 0.0% 0.0% 10.0% > 100 Observed 1 1

Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00

O - E -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 0.90 -0.10 0.00

(O - E)² / E 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 8.10 0.10 9.00

% of chi sq 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 9.0% 0.1% 10.0%

% of row 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100% 0.0% 100%

% of column 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100% 0.0% 10.0%

% of total 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% 0.0% 10.0% TOTAL Observed 1 1

Expected 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 1.00

O - E -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 -0.10 0.90 0.00

(O - E)² / E 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 8.10 9.00

% of chi sq 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 9.0% 10.0%

% of row 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100% 100%

% of column 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100% 10.0%

% of total 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% 10.0% Total Observed 1 1 1 1 1 1 1 1 1 1 10

Expected 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 10.00

O - E 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

(O - E)² / E 9.00 9.00 9.00 9.00 9.00 9.00 9.00 9.00 9.00 9.00 90.00

% of chi sq 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 100.0%

% of row 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 100.0%

% of column 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%

% of total 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 10.0% 100.0%

90.00 chi-square 81 Df .2313 p-value 3.000 Phi coefficient .949 Coefficient of Contingency 1.000 Cramér's V Fisher Exact Probability can only be calculated for a 2 x 2 table


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APPENDIX – III

CODE OF ETHICS FOR PHARMACEUTICAL MARKETING

Governing pharmaceutical marketing and relations with pharmaceutical

professionals and healthcare professionals as well as relations between the

pharmaceutical industry and patient organisations applicable to companies engaged

in pharmaceutical marketing in Lithuania

Approved by IFPA and VGA (2012 revision)

Approved at the general meeting of VGA members on 31 May 2012

Approved at the general meeting of IFPA members on 7 June 2012

INTRODUCTION

The Code for Pharmaceutical Marketing has been adopted at the will and upon

common agreement of IFPA and VGA – associations of companies engaged in

pharmaceutical marketing in Lithuania. It seeks to ensure that member

pharmaceutical companies engage in an ethical promotion, restraining from deceitful

practices and potential conflicts of interest with healthcare professionals, whilst

complying with applicable laws and regulations. Thus the Code seeks to enable an

environment where the general public may be sure that the choices regarding their

medicinal products are made based on the merit of each product and the patients’

clinical needs. This Code does not aim at restraining the promotion of medicinal


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products in such a way as to hinder free competition or limit interaction with

healthcare professionals.

Lithuanian Association of Innovative Pharmaceutical Industry (hereinafter referred

to as IFPA) is the association of companies engaged in the development and/or

marketing of medicines in Lithuania. IFPA is member of the institution representing

the pharmaceutical industry in Europe, the European Federation of Pharmaceutical

Industries and Associations (EFPIA).

The Pharmaceutical Manufacturers’ Association (hereinafter referred to as VGA) is

the association of companies which develop, produce and/or are engaged in the

marketing of medicines and their representatives in Lithuania.

Both associations (IFPA and VGA) contribute to EFPIA mission – to promote

pharmaceutical research and development and the best conditions in Europe for

companies to bring to patients new medicines that improve human health and the

quality of life around the world.

Members of IFPA and VGA are aware of the importance of providing accurate, fair

and objective information about medicinal products enabling people to make

informed decisions about the use of specific medicinal products. Building upon this

goal, IFPA and VGA approved the Code of Ethics for Pharmaceutical Marketing,

which governs pharmaceutical marketing and relations with pharmaceutical

professionals and healthcare professionals as well as relations between the


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pharmaceutical industry and patient organisations (hereinafter referred to as Code).

The Code has been developed according to the Code of Ethics adopted in Lithuania

in 2004 in compliance with the provisions of the EFPIA code and general ethical

principles as amended on 24 June 2010 and on 14 June 2011. It also reflects the

requirements of the EU Council Directive 2001/83/EC, as amended, (hereinafter

referred to as Directive) concerning the use of medicinal products for human use.

The Code is consistent with the general provisions of the Directive, which

acknowledge voluntary control over promotion of medicinal products implemented

through organisations/institutions, which represent the pharmaceutical industry

sector by providing the opportunity to apply to such organisations when complaints

occur. In addition, the Code incorporates the principles set out in the Law on

Pharmaceutics of the Republic of Lithuania (Official Gazette, 2006 No. 78-3056),

the Law on Advertising of the Republic of Lithuania (Official Gazette, 2000, No.

64-1937, 2002, No. 123-5508) and the Law on Provision of Information to the

Public of the Republic of Lithuania (Official Gazette 1996, No. 71-1706, 2000, No.

75-2272, 2006, No. 82-3254).

SCOPE OF THE CODE OF ETHICS FOR PHARMACEUTICAL

MARKETING

This code for pharmaceutical marketing (hereinafter referred to as Code) covers the

marketing of medicines (both prescription-only and over-the-counter) and

relationships between healthcare professionals and pharmaceutical companies as

well as relationships between the pharmaceutical industry and patient organisations.


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The Code applies to companies engaged in pharmaceutical marketing in Lithuania

and to their representatives (hereinafter referred to as companies).

Companies shall be liable for their obligations under the Code even when they

contract other parties (e.g. companies providing sales services, consultants, market

research companies, advertising agencies) to design, implement and conduct the

activities covered by the Code on their behalf. Furthermore, companies must take

reasonable steps to ensure that any other parties that they commission to design or

implement the activities covered by the Code but which do not act on behalf of the

company (e.g. joint ventures, licensees) comply with the Code.

The Code covers all methods of promotion, including but not limited to oral and

written promotion activities, co-operation, advertising in specialised journals for

healthcare professionals and direct mail advertising, the activities of medical sales

representatives (defined in section 17.1), advertising over the Internet and other

electronic media using audio and video systems, e.g. films, video recordings, data

storage services and the like, as well as the supply of free drug samples, distribution

of gifts and hospitality events.

The Code also applies to relations between companies and healthcare professionals

to govern, including but not limited to, relations emerging from research and

contracts (including clinical trial studies, non-interventional studies and advice, as

well as consultations). Furthermore, this Code governs relations between companies

and patient organisations, which are subject to the requirements set out in Annex C


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hereto – “The Code of Ethics on the Relations between the Pharmaceutical Industry

and Patient Organisations “

The Code does not aim to restrain or govern provision of non-promotional medicinal,

scientific or factual information.

The Code does not apply to:

- the labelling on medicinal products and accompanying package leaflets

which are subject to Title V of the Directive;

- Correspondence, possibly accompanied by non-promotional material,

required to answer to a specific question on a specific medicinal product;

- factual, informative announcement and reference material relating, for

example, to pack changes, adverse reaction warnings, trade catalogues and

price lists, provided they include no product characteristics;

- non-promotional information regarding human health and diseases;

- non-promotional, general information about companies (such as information

directed to investors or to current/prospective employees), including

financial data, descriptions of research and development programs, and

discussion of regulatory developments affecting the company and its

products.

Attached to the Code are: Annex A − “Implementation and Procedure Rules”, which

is binding upon and obligates members of the association and other committed

companies as well as those with specific guidelines in place to implement the Code


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to examine complaints and administrate sanctions which may be applied to

pharmaceutical companies; Annex B − “Guidelines for Internet Websites Available

to Healthcare Professionals, Patients and the Public in the EU”, which provide

guidance for pharmaceutical companies with respect to the content of their websites

containing information on medicinal products, and Annex C − “Code of Ethics on

the Relations between the Pharmaceutical Industry and Patient Organisations”.

APPLICABILITY OF THE CODE

The Code sets out the key ethical standards, which are considered binding upon the

companies. IFPA and VGA must comply and ensure their members’ compliance

with the Code and legislative provisions. IFPA and VGA must have specific

procedures in place to ensure compliance with all the codes referred to above by

both their member companies and other companies.

Provisions of the Code must be followed both in spirit and by letter. For example,

companies should follow consistent standards while interacting with healthcare

professionals, in particular as far as gifts and hospitality are concerned. IFPA and

VGA also encourage, on a needs basis, to adhere to the Code of Pharmaceutical

Marketing Practices of the International Federation of Pharmaceutical

Manufacturers and Associations (IFPMA).

The Code for Pharmaceutical Marketing, its content, structure and order may be

revised only upon common agreement between RFA and VGA associations. The


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Ethics Committee may recommend revisions of the Code, its content, structure and

order based on its experience. The Code shall be reviewed and revised at the

initiative of the Ethics Committee, IFPA and VGA, also following revisions of the

effective Lithuanian laws and regulations (where in conflict with provisions of the

Code) or in the EFPIA Code.

To avoid ambiguities, the term “company” for the purposes of this Code means any

legal entity that organises or sponsors promotion or, within the limits of the Code,

maintains relationships with healthcare professionals or patient organisations in

Lithuania whether such entity be a parent company (e.g. the headquarters, principal

office or controlling company of commercial enterprise), subsidiary company or any

other form of enterprise or organisation.

To ensure proper compliance with the provisions of the Code, IFPA and VGA must

inter alia introduce appropriate procedures for the lodging and examination of

complaints as well as a procedure for imposing sanctions for violations of the Code.

Furthermore, the relevant local subsidiary of the company must be notified in

advance of all international events organised abroad (as provided in Section 9.2 of

the Code) or must be consulted locally.

TERMS EMPLOYED

Participation in an international conference is understood as arrival of the

healthcare professional to the venue of the conference not earlier than one day

before the conference starts and departure not later than one day after the event,


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registration and payment of the fee, participation in scientific meetings and

acquisition of a participant’s certificate.

Extravagant venues means venues, which are lavish and deluxe, and the visiting of

which could be prejudicial to the image of healthcare professionals/patient

organisations or of the pharmaceutical industry.

Medical Sales Representative means a person appointed by a pharmaceutical or any

other company engaged in the marketing of medicinal products in Lithuania for the

promotion of medicinal products, provision of relevant, precise and evidence-based

information about medicinal products and medical aids and about innovations of the

medical and the pharmaceutical industries, including personnel retained by way of

contract with third parties, any other company representatives who call on healthcare

professionals, pharmacies, hospitals or other healthcare facilities aiming to provide

relevant, precise and evidence-based information about medicinal products and

medical aids and about innovations of the medical and the pharmaceutical industries

and to promote medicinal products. The qualification and competence of the

Medical Sales Representative to carry out the above-listed functions falls within the

responsibility of the company they represent.

Company means pharmaceutical or any other company engaged in pharmaceutical

marketing in Lithuania.


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Entertainment venues means places for leisure and entertainment which advertise

their entertainment facilities on promotional leaflets, also publicly in the press or on

the Internet and which are intended primarily for recreation and/or entertainment, i.e.

entertaining activities rather than professional/business meetings.

Promotion for the purposes of this Code is consistent with the definition provided in

the Law on Pharmaceutics.

Healthcare professionals for the purposes of this Code means general practitioners,

including other members of the medical, dental, pharmacy or nursing profession or

any other persons who in the course of their professional activities may prescribe,

purchase, supply or administer any medicinal products.

Medicinal product for the purposes of the Code shall bear the meaning defined in

Article 1 of the Directive: (a) any substance or combination of substances presented

for treating or preventing disease in human beings; or (b) any substance or

combination of substances which may be administered to human beings with a view

to making a medical diagnosis or to restoring, correcting or modifying physiological

functions in human beings.

Provisions of the Code of Ethics for Pharmaceutical Marketing

Article 1. Marketing Authorisation


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1.1. A medicinal product must not be promoted prior to the grant of the marketing

authorisation, which permits its sale, or placing on the market, also when promotion

of medicinal products does not meet the approved indications for medicinal products.

1.2. Promotion of a medicine must be consistent with the particulars listed in its

summary of product characteristics.

Article 2. Information that should be Made Available

2.1. Subject to relevant Lithuanian laws and regulations, all promotional materials

must include the following basic information clearly and legibly:

a) essential information consistent with the summary of product characteristics,

indicating the date on which such essential information was generated (if the text

was not revised) or last revised;

b) the classification of the medicinal product placed on the market (prescription-only

or over-the-counter medicinal product);

c) when appropriate, the selling price or indicative price of the various presentations

and the conditions for reimbursement by social security bodies.

2.2. Requirements for the information provided in the advertisement of medicinal

products are set out in Lithuanian laws and regulations governing promotion of

medicinal products.


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2.3. Subject to relevant Lithuanian laws and regulations, where an advertisement is

intended only as a reminder, the requirements of Section 2.1 above need not be

complied with, provided that the advertisement includes no more than the name of

the medicinal product or its international non-proprietary name, if any, or the

trademark.

Article 3. Promotion and Its Substantiation

3.1. Promotion must be accurate, balanced, fair, objective and sufficiently complete

to enable the recipient to form his or her own opinion of the therapeutic value of the

medicinal product concerned. It should be based on an up-to-date evaluation of all

relevant evidence and reflect that evidence clearly. It must not mislead by distortion,

exaggeration, undue emphasis, omission or in any other way.

3.2. Promotion must be capable of substantiation, which must be promptly provided

in response to reasonable requests from pharmaceutical professionals or healthcare

professionals. In particular, promotional claims about side effects must reflect

available evidence or must be capable of substantiation by clinical experience.

Substantiation need not be provided, however, in relation to the validity of elements

approved in the marketing authorisation.

3.3. Promotion must encourage the rational use of medicinal products by presenting

them objectively and without exaggerating their properties. Claims must not imply


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that a medicinal product, or an active ingredient, has some special merit, quality or

property unless this can be substantiated.

3.4. When promotion refers to publish studies, clear references should be given.

3.5. Any comparison made between different medicinal products must stem from

relevant and comparable aspects of the products based on published scientific

evidence. Comparative advertising must not be misleading or disparaging.

3.6. All artwork, including graphs, illustrations, photographs and tables taken from

published studies included in promotional material should:

a) clearly indicate the source(s) of the artwork;

b) be faithfully reproduced; except where adaptation or modification is required in

order to comply with any Applicable Code(s), in which case it must be clearly stated

that the artwork has been adapted and/or modified.

Particular care must be taken to ensure that artwork included in promotion does not

mislead about the nature of a medicine (for example whether it is appropriate for use

in children) or mislead about a claim or comparison (for example by using

incomplete or statistically irrelevant information or unusual scales).

3.7. The words “safe” must never be used to describe a medicinal product without

proper substantiation.


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3.8. The word “new” must not be used to describe any product or presentation which

has been generally available or any therapeutic indication which has been generally

promoted, for more than one year.

3.9. It must not be stated that a product has no side effects, toxic hazards or risks of

addiction or dependency.

Article 4. Use of Quotations in Promotion

4. 1. Quotations from medical and scientific literature or from personal

communications must be faithfully reproduced (except where adaptation or

modification is required in order to comply with any Applicable Code(s), in which

case it must be clearly stated that the quotation has been adapted and/or modified)

and the precise sources identified.

Article 5. Acceptability of Promotion

5.1. Companies must comply with high ethical standards at all times. Promotion

must: a) never be such as to bring discredit upon, or reduce confidence in, the

pharmaceutical industry; b) always be of a nature which recognizes the special

nature of medicines and the professional standing of the recipient(s); c) never cause

offence to the competitors.


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Article 6. Distribution of Promotion

6.1. Promotion should only be directed at those persons whose need for, or interest

in, the particular information can reasonably be assumed.

6.2. Promotional mailing lists must be kept up-to-date. Requests by healthcare

professionals to be removed from promotional mailing lists must be complied with.

6.3. Subject to the relevant Lithuanian laws and regulations, the use of fax, e-mail,

automated calling systems, text messages and other electronic data communication

for promotion of prescription-only medicinal products is allowed only upon

obtaining prior consent of the healthcare professional.

Article 7. Transparency of Promotion

7.1. Promotion must not be disguised.

7.2. Clinical assessments, post-marketing surveillance and experience programmes,

post-authorisation studies (including those that are retrospective in nature) must not

be disguised promotion. They must be conducted with a primarily scientific or

educational purpose.


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7.3. When a pharmaceutical company pays for, or otherwise secures or arranges the

publication of promotional material in journals, such material must not resemble

independent editorial matter.

7.4. Materials supported by the company referring to its medicinal products and their

use, no matter if they are or not of promotional nature must clearly indicate that the

company sponsored the materials.

Article 8. Limitations Regarding the Advice on Personal Medical Matters

8.1. In the case of requests from individual members of the general public for advice

on personal medical matters, the enquirer should be advised to consult a healthcare

professional.

Article 9. Events and Hospitality

9.1. All promotional, scientific or professional meetings, congresses, conferences,

symposia, and other similar events (including but not limited to advisory board

meetings, visits to production sites or research laboratories, planning meetings,

education (courses) or investigator meetings for clinical or non-interventional

studies), hereinafter referred to as events, organised on behalf of or sponsored by the

company must be held in an appropriate venue that is conducive to the main purpose

of the event and may only offer hospitality when such hospitality is appropriate and

otherwise complies with the provisions of any Applicable Codes. The term


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“appropriate” is understood as compliant with the provisions of Sections 9.5 and 9.6

of this Code and not in conflict with the relevant Lithuanian laws and regulations.

9.2. No company may organise or sponsor an event that takes place in another

country, unless provided in Section 13.2 of this Code.

9.3. Promotional material which is displayed or provided as hand-out materials at

international events may, unless prohibited or otherwise regulated by local laws and

regulations, refer to medicinal products (or their use) which are not registered in the

country where the event takes place, or which are registered under different

conditions, so long as: (i) any promotional material (excluding promotional aids) is

accompanied by a suitable statement indicating countries where the product is

registered and making clear that the product is not registered or used locally, and (ii)

any such promotional material which refers to the prescribing information

(indications, warnings, etc.) authorised in a country or countries where the medicinal

product is registered must be accompanied by an explanatory statement indicating

that registration conditions differ internationally.

9.4. The provision of hospitality is limited to the healthcare professionals attending

the event who are true (registered) participants of the event (where registration is

required). It may not extend to the persons accompanying the healthcare

professionals attending the event.


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9.5. All forms of hospitality offered to healthcare professionals shall be reasonable

in level and strictly limited to the main purpose of the event. Hospitality costs

should not exceed those allocated to the scientific part of the event. At promotional

events of medicinal products hospitality must be strictly limited to the main purpose

of the event and must not extend beyond participating healthcare professionals

and/or pharmaceutical professionals. Payment of travel, accommodation and other

costs for those professionals is prohibited. The term of promotional events is

understood as defined in the relevant Lithuanian laws and regulations. At

professional/scientific events hospitality must be secondary to the main purpose of

the event. The cost reimbursement of healthcare professionals attending such events

shall be limited to travel, accommodation, catering and/or registration fee.

9.6. Hospitality must not extend to sponsorship or organising of any entertainment

(e.g. sporting or leisure) events. Companies should avoid venues known as

“entertainment venues” or which are “extravagant”. “Entertainment venues” are

understood as places for leisure and entertainment which advertise their

entertainment facilities on promotional leaflets, also publicly in the press or on the

Internet and which are intended primarily for recreation and/or entertainment, i.e.

entertaining activities rather than professional/business meetings. “Extravagant

venues” are understood as places, which are lavish and deluxe, and the visiting of

which could be prejudicial to the image of pharmaceutical professionals, healthcare

professionals, patient organisations or of the pharmaceutical industry.


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9.7. Companies should follow the guideline relating to the term “appropriate” in the

meaning used in Article 9 hereof or subject to the provisions of any of the

Applicable Codes.

Article 10. Gifts

10.1. Companies are prohibited to supply, offer or promise to healthcare

professionals gifts, any kind of pecuniary advantage or benefit in kind as an

inducement to prescribe, recommend, supply, sell or buy a medicinal product.

10.2. Subject to Section 10.1 above, when medicinal products are being promoted to

healthcare professionals, objects intended for reminder advertising may be supplied,

offered or promised to such persons only if they are inexpensive and relevant to the

practice of medicine or pharmacy. The term “inexpensive” means that the item cost

the company not more than 35 litas, including VAT, the attached logo and other

extra costs. Section 10.2. does not govern giving of medical literature to healthcare

professionals.

10.3. Except where they carry all the information stipulated in Section 2.1 above,

objects intended for reminder advertising may bear no more than the name and logo

of the company and the name of the medicinal product, or its international non-

proprietary name, if any, or the trademark.


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10.4. Gifts for the personal benefit of pharmaceutical professionals or healthcare

professionals (such as tickets to cultural events or of other entertainment media) are

prohibited.

10.5. Companies should follow the guideline relating to the term “inexpensive” in

the meaning used in Article 10 hereof as indicated in the provisions of any of the

Applicable Codes or related instruments.

Article 11. Sponsorship and Charity for Healthcare or Research Purposes

11.1. The provision of sponsorship and charity to institutions, organisations or

associations that are comprised of pharmaceutical professionals or healthcare

professionals and/or that provide healthcare or conduct behavioural research (that

are not otherwise covered in the Code on the Relations between the Pharmaceutical

Industry and Patient Organisations) is only allowed if: (i) they are made for the

purpose of supporting healthcare or research; (ii) they are documented and kept on

record by the company; (iii) they do not constitute an inducement to recommend,

prescribe, buy, supply, acquire or administer any medicinal product. Sponsorship

and charity to individual healthcare professionals based on this section are not

allowed. Companies’ sponsorship of healthcare professionals attending international

events is governed in Article 13 of the Code. Companies are encouraged to publicize

information about provided sponsorships and charity as defined in this Section 11.1.


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Article 12. Fees for Services

12.1. Contracts between companies and institutions, organisations or associations of

pharmaceutical professionals or healthcare professionals under which such

institutions, organisations or associations provide any type of services on behalf of

companies (or any other type of funding by the company not otherwise covered by

Article 11 or the Code) are only allowed is such services (or other funding): (i) are

made for the purpose of supporting healthcare or research; (ii) do not constitute an

inducement to recommend, prescribe, buy, supply, acquire or administer any

medicinal product.

Article 13. Sponsorship of Healthcare Professionals

13.1. Companies must comply with criteria governing the selection and sponsorship

of healthcare professionals to attend trainings or events as provided in the provisions

of any Applicable Codes or related instruments. Funding must not be offered to

compensate merely for the time spent by healthcare professionals in attending events.

In the case of international events funded by the company, where attended by the

healthcare professional and if any kind of funding is provided to that particular

healthcare professional under the provisions of this Section 13.1, such funding shall

be subject to the procedure of the jurisdiction where the said healthcare professional

is engaged in his/her practice otherwise than the jurisdiction of the location of the

event. For the avoidance of doubt, Section 13.1 of this article is not intended to


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prohibit the extension of hospitality to healthcare professionals in accordance with

Article 9 hereof.

13.2. A company may sponsor participation of healthcare professionals in

international scientific events arranged by Global, European, North American,

Scandinavian and Baltic professional organisations of healthcare professionals and

scientific institutions.

13.3. When deciding whether or not to sponsor participation of healthcare

professionals in international scientific events in Europe, it is recommended to check

the preliminary evaluation of the corresponding event in the EFPIA database at

www.efpia-e4ethics.eu. It should be noted that the said EFPIA review shall in no

instance be interpreted as an evaluation of the event’s scientific content or

qualification of lecturers. Each company shall decide independently whether or not

to sponsor participation of healthcare professionals in international professional

events, but the decision should take account of the relevant rules and references of

the Code of Ethics.

13.4. The company must report such sponsorship of healthcare professionals to the

Pharmaceutical Marketing Ethics Committee within 30 calendar days following the

end of events, indicating:

a) name, venue and time of event;

b) speciality and number of sponsored pharmaceutical professionals or

healthcare professionals;


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c) full names of sponsored pharmaceutical professionals or healthcare

professionals.

Information about the sponsorship of association members will be announced

publicly on the website of the Pharmaceutical Marketing Ethics Committee. The

term “sponsorship” includes sponsorship through healthcare facilities,

pharmaceutical or medical trade unions, specialty societies, company subsidiaries

operating in other countries, etc.

Article 14. The Use of Consultants

14.1. Healthcare professionals may be used as consultants and advisors, whether in

groups or individually, for services such as speaking at and chairing meetings,

involvement in scientific/medical studies, clinical trials or training services,

participation at advisory board meetings, and participation in market research where

such participation involves remuneration and/or travel. The arrangements, which

cover these genuine consultancy or other services, must, to the extent relevant to the

particular arrangement, fulfil all the following criteria:

a. A written contract or agreement must be agreed in advance which specifies the

nature of the services to be provided and, subject to condition (g) below, the basis

for payment of those services.

b. A legitimate need for the services must be clearly identified in advance of

requesting the services and entering into arrangements with the prospective

consultants.


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c. The criteria for selecting consultant must be directly related to the identified needs

and the persons responsible for the selecting of consultants must have the expertise

necessary to evaluate whether the particular healthcare professionals meet those

criteria.

d. The number of pharmaceutical professionals or healthcare professionals retained

must not be greater than the number reasonably necessary to achieve the identified

need.

e. The contracting company must maintain records concerning and make appropriate

use of, the services provided by consultants.

f. The hiring of the healthcare professional to provide the relevant service must not

be an inducement to recommend, prescribe, buy, supply, acquire or administer any

medicinal products.

g. The compensation for the services must be reasonable and reflect the fair market

value of the services provided. In this regard, token consultancy arrangements must

not be used to justify compensating healthcare professionals.

14.2. In their written contracts with consultants, companies are strongly encouraged

to include provisions regarding the obligation of the consultant to declare that he/she

is a consultant to the company whenever he/she writes or speaks in public about a

matter that is the subject of the agreement or any other issue relating to that


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company. Similarly, companies that employ, on a part-time basis, healthcare

professionals that are still practising their profession are strongly encouraged to

ensure that such persons are obliged to declare their employment arrangement with

the company whenever they write or speak in public about a matter that is the

subject of the employment or any other issue relating to that company. The

provision of Section 14.2 of this article also apply to general information of non-

promotional nature about companies which does not fall under the scope of the Code.

14.3. Limited market research, such as one-off telephone interviews or

mail/email/Internet questionnaires is excluded from the scope of this Article 14,

provided that the healthcare professional is not consulted in a recurring manner

(either with respect to the frequency of the calls to the same healthcare professional

generally or of calls relating to the same research) and the compensation for such

consultations is minimum (i.e. does not exceed the level of what a doctor would earn

doing his/her primary job within the time scale he/she spent doing market research).

14.4. If a healthcare professional attends an international event in a consultant or

advisory capacity the relevant provisions of Article 9 and the declaration procedure

in Section 13.2 apply.

Article 15. Non-interventional Studies of Marketed Medicines

15.1. A non-interventional study of a marketed medicine is a study where the

medicine is prescribed in the usual manner in accordance with the terms of its

marketing authorisation. The assignment of the patient to a particular therapeutic


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strategy is not decided by a study protocol but falls within current practice and the

prescription of the medicine is clearly separated from the decision to include the

patient in the study. No additional diagnostic or monitoring procedures are applied

to the patients and epidemiological methods are used for the analysis of collected

data.

15.2. Non-interventional studies that are prospective in nature and involve the

collection of patient data on behalf of a healthcare professional or a group of

healthcare professionals for a scientific purpose must comply with all the following

criteria:

a. The study is conducted for scientific purposes.

b. (i) There must be a written protocol and (ii) written contract between the

healthcare professionals and/or the institutes at which the study will take place, on

the one part, and the pharmaceutical company sponsoring the study, on the other

part, which specify the nature of the services to be provided and, subject to section

(c) below, the basis for the payment for those services.

c. Any remuneration must be reasonable and reflect the fair market value of the

work.

d. The study protocol must be submitted to the ethics committee for review as

prescribed by Lithuanian laws and regulations.


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e. Applicable Lithuanian laws and regulations on the protection of personal data

(including collection and use of personal data) must be complied with.

f. The study must not constitute an inducement to recommend, prescribe, buy,

supply, acquire or administer a medicinal product.

g. The company’s scientific service must approve the study protocol and must

supervise the conduct of the study as described in Section 17. 2 (a).

h. The study results must be analysed by the contracting company or any other entity

acting on its behalf and summaries must be made available within a reasonable

period of time to the company's scientific service (as described in Section 17.2 (a)),

which service shall maintain records of such reports. The company must send the

summary reports to the ethics committee which reviewed the study protocol (where

requested by the committee or required by law) and to the healthcare professionals

who participated in the study, and make them available to industry self-regulation

bodies and/or committees responsible to the supervision of Applicable Codes, at

their request. If the study results are important for the assessment of benefit-risk, the

summary report should be immediately forwarded to the State Medicines Control

Agency.

i. Medical sales representatives may only be involved in an administrative capacity

and such involvement must be under the supervision of the company’s scientific


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service which will also ensure that the representatives are adequately trained. Such

involvement must not be linked to the promotion of any medicine or product for

medical use.

In Lithuania, non-interventional studies involving compensated medicines are

allowed only if this does not contravene applicable Lithuanian laws and regulations.

15.3. Companies are encouraged to follow the same principle in applying Section

15.2 to all other types of studies that are subject to Section 15.1, including

epidemiological studies and registries and other studies of retrospective nature.

Whatever is the case, Section 12.1 applies to such studies.

Article 16. Samples

16.1. When promoting medicinal products to healthcare professionals qualified to

prescribe medicinal products, promoters of medicines may use samples of medicinal

products which are not intended for sale. A sample of the medicinal product not

intended for sale must correspond to the smallest package of the medicinal product

of the same title, form and strength and the package must bear the sign “Free

medical sample – not for resale”. Leaving of samples of medicinal products not

intended for sale with healthcare professionals, distributing them to pharmaceutical

professionals and to the general public and using them for healthcare purposes are

prohibited.


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16.2. Companies must have adequate systems of control and accountability for

samples of medicinal products not intended for sale handled by their representatives.

Article 17. Staff of the Pharmaceutical Company

17.1. Medical Sales Representatives must ensure that the frequency, timing and

duration of visits aiming to meet just one or two pharmaceutical professionals or

healthcare professionals and to pharmacies, hospitals or other healthcare facilities,

together with the method of presentation used by Medical Sales Representatives, do

not cause inconvenience to healthcare professionals or patients.

Each company shall ensure that its representatives, including personnel retained by

way of contract with third parties, and any other company staff who call on

healthcare professionals, pharmacies, hospitals or other healthcare facilities in

connection with the promotion of medicinal products (hereinafter referred to as

“Medical Sales Representatives”) are familiar with the relevant requirements of

Applicable Codes and with the provisions of all relevant Lithuanian laws and

regulations, and are adequately trained and have sufficient scientific knowledge to

be able to provide precise and complete information about the medicinal products

they promote.

a) Medical Sales Representatives must comply with the requirements of all

Applicable Codes, and all relevant laws and regulations. Heads of companies are

responsible for ensuring their compliance.


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b) Medical Sales Representatives must approach their duties responsibly and

ethically.

c) During each visit, having regard to the provisions of applicable laws and

regulations, Medical Sales Representatives must hand to visited persons, or have

available for them, a summary of the product characteristics for each medicinal

product they represent.

d) Medical Sales Representatives must transmit to the medical department of their

companies forthwith any information they receive in relation to the use of their

company's medicinal products, particularly reports of side effects.

e) Medical Sales Representatives must ensure that the frequency, timing and

duration of visits to healthcare professionals, pharmacies, hospitals or other

healthcare facilities, together with the manner in which they are made, comply with

the procedure laid down by law.

f) Medical Sales Representatives must not use any inducements or subterfuge to gain

a call. In an interview, or when seeking an appointment for an interview, Medical

Sales Representatives must, from the outset, take reasonable steps to ensure that they

do not mislead a healthcare professional they are addressing as to their identity or

that of the company they represent.


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g) The provisions of Section 15.2(i) also apply to the activities of Medical Sales

Representatives.

17.2. All members of the company’s staff, and any personnel retained by way of

contract with third parties, who are concerned with the preparation or approval of

promotional material or activities must be fully conversant with the requirements of

all Applicable Codes and relevant laws and regulations.

a) Each company must establish a scientific service in charge of information about

the company’s medicines and products for medical use, as well as of approval and

supervision of non-interventional studies. Companies may decide by themselves

about the best way to organise these services according to Section 17.2 (i.e. whether

a single service will be responsible for both duties or whether two services will be

established with clearly defined responsibilities), taking into account their resources

and structure. This department must include at least one doctor or, where appropriate,

a pharmacist who will be responsible for approving any promotional material before

release. Such person must certify that he/she has examined the final form of the

promotional material and that in his/her belief it is in accordance with the

requirements of all Applicable Codes and advertising laws and regulations, is

consistent with the summary of product characteristics and is fair, equal and truthful

representation of the proofs about the medicinal product. Furthermore, the scientific

service must include a doctor or pharmacist in charge of the supervision of any non-

interventional studies (including supervision of any responsibility in connection with

such studies, particularly where such responsibility is undertaken by Medical Sales


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Representatives). Such a person must confirm that he/she examined the protocol of

non-interventional studies and that in his/her belief the protocol is consistent with

the requirements of this Code and of other Applicable Codes.

b) Each company must appoint at least one senior employee who shall be

responsible for the supervision of the activities of the company and its subsidiaries

to ensure compliance with the standards of all Applicable Codes.

17.3. Companies engaged in pharmaceutical marketing in Lithuania cannot employ

healthcare professionals who work simultaneously at healthcare facilities.

Article 18. Enforcement

18.1. IFPA and VGA must, within current applicable rules and legislation, enforce

the provisions of this Code. In the event that a breach is established pursuant to the

procedures of the National code, each IFPA, VGA or any other company which has

joined enforcement of the Code shall require from the offending company an

immediate cessation of the offending activity and a signed undertaking by the

company to prevent recurrence.

18.2. The procedure for the examination of violations of this Code and sanctions for

violations of the Code are set out in Annex A hereto.


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Article 19. Awareness and Education

19.1. IFPA and VGA must, within current applicable rules and legislation facilitate

companies’ awareness of and education about the Code, including by providing

guidance to companies in order to prevent breaches of the Code.

Annex A

Pharmaceutical Marketing Ethics Committee

INTRODUCTION

Supervision of the Code of Ethics for Pharmaceutical Marketing, which governs

pharmaceutical marketing and mutual relations with pharmaceutical professionals

and healthcare professionals as well as relations between the pharmaceutical

industry and patient organisations (hereinafter referred to as the Code) is performed

by the Pharmaceutical Marketing Ethics Committee (hereinafter referred to as

Committee). The names of reporting individuals outside the pharmaceutical industry

are kept confidential. In special cases the company specified in the report to the

Committee needs to know the identity of the reporting person to be able to examine

the case adequately. Even in such cases the identity of the reporting person shall be

disclosed only after obtaining his/her consent. The Committee shall submit the

number of processed violation reports to members of IFPA and VGA on a quarterly

basis.


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The Committee shall ensure that industry and non-industry complaints are processed

in the same manner, without regard to who has made the complaint.

STRUCTURE AND RESPONSIBILITY

1. The Pharmaceutical Marketing Ethics Committee is responsible for:

1.1. Organisation of the Committee’s procedures and selection of the required

technical staff, resources and consultants;

1.2. Supervision of the Code, including advice, comments and guidance related to

the application and enhancement of the Code;

1.3. Examination of reported violations of the Code;

1.4. Imposition and enforcement of sanctions for violations of the Code;

1.5. Supervision of the Committee’s website.

2. Structure of the Pharmaceutical Marketing Ethics Committee

2.1. The Committee is accountable to IFPA and VGA. On an annual basis the

Committee shall generate its operational report, which the Chairperson of the


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Committee shall present separately at the general meetings of IFPA and VGA

members. The Committee’s annual report shall be posted on its website.

2.2. IFPA and VGA each delegate 3 members to the Committee.

2.3. The Committee shall be elected for the period of one year. Within at least one

month before expiration of this term, IFPA and VGA shall approve members of the

Committee for the next term of office. The Committee is composed of 7 members,

including the Chairperson. If a member of the Committee in person or the company

he/she represents violates the CEPM more than once over one year, the Chairperson

of the Committee may, at the Committee’s decision, file a proposal to the

association to replace the Committee member concerned.

2.4. The Committee shall be chaired by an individual outside the pharmaceutical

sector. The Chairperson of the Committee shall be approved by IFPA and VGA

upon common agreement.

2.5. Decisions shall be adopted by majority voting. The votes of the Chairperson (or

in the absence of same, his/her deputy) and three members shall form the quorum.

At least one member must represent VGA or IFPA. In the event of equal distribution

of votes, the vote of the Chairperson (or in the absence of same, his/her deputy) shall

be decisive.


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2.6. The deputy to the Chairperson of the Committee shall be elected by rotation

from Committee members representing IFPA or VGA for the entire term of office of

the Committee.

2.7. The Committee shall have the right to obtain the material required for the

examination of the reported violation of the Code from pharmaceutical companies

suspected of violating the Code. The company may refuse to provide the

information which constitutes its commercial secret.

3. Operating and Funding Procedure of the Pharmaceutical Marketing Ethics

Committee

3.1. The Committee shall hold meetings upon receiving violation reports or

whenever intending to address any other matters in connection with the Code or the

Committee’s area of responsibility. Each Committee member shall have the right of

initiative to convene a Committee meeting. Committee meetings shall be convened

at the decision of the Chairperson of the Committee (or in the absence of same,

his/her deputy).

3.2. At meetings of the Committee minutes shall be taken. The draft minutes shall be

emailed to members of the Committee for information and comments. The minutes

shall be signed by the Chairperson and Secretary of the meeting. The Chairperson of

the Committee shall be responsible for storage of minutes and other materials of the

Committee.


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3.3. The Committee may seek assistance from experts. Advising experts may be

invited to attend Committee meetings without the right to vote.

3.4. To prevent conflicts of interest it is required that prior to examination of the

violation members of the Committee name all interests related to the violation. The

Chairperson (deputy) shall then determine whether such a member can participate in

the examination of the reported violation. Where a member of the Committee is

related to the complainant or to the respondent, he/she shall suspend himself/herself

(the Committee shall decide which parties may attend the meeting) from the

adoption of the relevant decision as long as the Committee examines that particular

violation report.

3.5. While the Committee examines the violation report, both the complainant and

the respondent may be invited to attend or be represented at its meeting. At a

Committee meeting, the company may not be represented by the same individual

who is member of the Committee, even if he/she has suspended himself/herself from

the case.

3.6. Where it is impossible to adequately identify the circumstances of the violation

report between the complainant and the respective company based solely on the

report, the Committee shall have the right to invite directly related persons to attend

the meeting as well as to provide and receive information in oral form.


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3.7. The costs of the Committee shall be covered from the IFPA and VGA budget in

equal contributions which ensure the activities of the Committee. When compiling

the budget, IFPA and VGA must include funds on a separate line according to the

planned cost estimate provided in advance by the Committee.

3.8. The Committee may incur costs in connection with the remuneration of the

Committee member outside the pharmaceutical industry and with the hiring of

experts whose opinions are reasonably required to examine specific reports, but

without exceeding the estimated budget funds. The Committee shall report its

expenditure to IFPA and VGA Boards in the form of a financial statement.

PROCEDURE FOR LODGING AND PROCESSING VIOLATION REPORTS

4. Lodging of Violation Reports

4.1. Reports of potential violations of the Code may be lodged by representatives of

pharmaceutical companies, pharmaceutical or healthcare professionals,

representatives of patient organisations, representatives of legal entities and natural

persons. After receiving information about a potential violation(s) of the Code, the

Committee may initiate ex-officio investigations.

4.2. Violations of this Code (unless the Committee initiates an ex-officio

investigation) shall be reported in writing to the Chairperson of the Committee. The


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Committee Secretary shall register the received report and notify members of the

Committee thereof.

4.3. A report of a potentially committed violation of the Code must include:

4.3.1. The full name, postal address, email address (if any) and phone number of the

reporting person;

4.3.2. The institution, company or organisation represented by the reporting person;

4.3.3. Information about the violation and available evidence (place, time,

circumstances and persons involved);

4.3.4. The articles and sections of the Code whose provisions were violated under

the circumstances specified in the Report. A violation report lodged by a

pharmaceutical company must be signed by the company’s manager or his/her

authorised person indicating the clauses of the Code which in the company’s belief

have been breached;

4.3.5. The Report shall be accompanied by documentation and other evidence which

substantiate the circumstances named in the Report.

4.4. Reports of potential violations of the Code may be provided in writing, by email

or through the section “Write us” on the Committee’s website.


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4.5. Anonymous reports shall not be processed.

5. Actions upon Receiving a Violation Report

5.1. Suspected violations of the Code must be reported in writing accompanied by

all information about the violation and with the available evidence. Upon receipt of

a report of a potential violation, the Chairperson of the Committee shall within 10

(ten) business days following receipt convene a Committee meeting to review the

received material and to establish whether the report of a violation of the Code falls

within the scope of the Code. The matter may be settled by an email voting by

members of the Committee. If no responses “AGAINST” are received within 5

business days, the Committee shall be deemed to have agreed that the report falls

within the scope of the Code. After deciding that the violation report falls within the

scope of the Code, the Committee shall notify the complainant and respondent

thereof.

5.2. Where the Committee decides that the report of a violation of the Code does not

fall within the scope of the Code, the reporting person shall be notified thereof.

5.3. The Committee shall apply to the manager of the relevant company suspected of

breaching the respective provisions of the Code in writing (the letter must be faxed,

emailed or posted by registered mail to the company’s headquarters) asking to

comment on the material stated in the report and shall establish the term for

providing responses and comments.


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5.4. Upon receipt of the Committee’s appeal regarding a potential violation, the

relevant company shall furnish the Committee with a written response within 5

business days following dispatch of the Committee’s letter by fax or email. Where

the response is posted by registered mail, on the sending date it must also be faxed

or emailed to the Committee. Failing to receive the company’s response within 5

business days following dispatch of the appeal, the Committee shall examine the

violation without waiting for the response.

5.5. In the process of examining the report, the Commission may apply to public

authorities requesting information available to them required to investigate the

circumstances stated in the report or ask those authorities to carry out an

investigation within their purview and to provide the obtained information to the

Committee.

5.6. After the Committee has collected sufficient information about the potential

violation, but not later than within 6 (six) weeks following receipt of the violation

report, a Committee meeting shall be convened to adopt a decision regarding the

violation of the Code. Where the meeting fails to adopt a decision, another meeting

must be arranged within 2 (two) weeks to arrive to the final decision.

5.7. The violation report must be examined in substance and the final decision must

be adopted within not more than 8 (eight) weeks following receipt thereof.


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5.8. The Committee’s decision may be appealed against to a competent court of the

Republic of Lithuania in accordance with the law within 15 (fifteen) calendar days.

The Committee’s decision shall come into effect only following expiry of the

defined appeal term. During the said appeal term implementation of the

Committee’s decision and enforcement of imposed sanctions shall be suspended.

5.9. The Committee and its members undertake to protect any information received

from companies during the examination of the violation as confidential information

and to refrain from using it for any purposes other than its primary purpose.

6. Decisions of the Pharmaceutical Marketing Ethics Committee

6.1. Where the Committee decides that the Code was breached, this shall be

communicated to the complainant and the respondent indicating causes for adopting

such a decision.

6.2. Where the Committee decides that the Code was breached, it may impose on the

relevant company one or more (depending on the severity of the violation) sanctions:

a) a written warning;

b) notifying the company’s principal office;

c) notifying IFPA and VGA members;

d) reporting the violation to EU member associations;

e) proposing to the general meeting of IFPA or VGA members to exclude the

breaching company from the association;


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f) forwarding the case for further examination by public authorities;

6.3. The Committee shall publish effective decisions on its website:

1) in the case of severe or recurrent violations, indicating the company’s name and

details of the violation;

2) in the case of minor violations, providing details of the violation without

indicating the company’s name.

6.3. Where the Committee finds that no breach occurred, such a decision of the

Committee shall not be announced subject to informing only the complainant and

the respondent companies.

Annex B

Guidelines for Internet Websites Available to Healthcare Professionals,

Patients and the Public in the EU

The Guidelines for Internet Websites Available to Healthcare Professionals, Patients

and the Public in the EU set forth herein are intended as a supplement to the

provisions of the Code for Pharmaceutical Marketing (hereinafter referred to as the

Code).


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Section 1. Transparency Of Website Origin, Content And Purpose

Each website shall clearly identify:

a) the identity and physical and electronic addresses of the sponsor(s) of the

website;

b) the source(s) of all information included on the website, the date of

publication of the source(s) and the identity and credentials (including the

date credentials were received) of all individual/institutional providers of

information included on the website;

c) the procedure followed in selecting the content included on the website;

d) the target audience of the website (e.g. healthcare professionals, patients and

the general public, or a combination thereof); and;

e) the purpose or objective of the website.

Section 2. Content of Websites

a) Information included in the website shall be regularly updated and shall clearly

display, for each page and/or item, as applicable, the most recent date as of which

such information was updated.

b) Examples of the information that may be included in a single website or in

multiple websites are: (1) general information on the company; (2) health education

information; (3) information intended for healthcare professionals (as defined in the


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Code); (4) non-promotional information intended for patients and the general public

about specific medicinal products marketed by the company.

1) General information on the company

Websites may contain information that would be of interest to investors, the news

media and the general public, including financial data of the company, description of

research and development programmes, discussion of regulatory developments

affecting the company and its products, information for prospective employees, etc.

The content of this information is not regulated by these guidelines or provisions of

the medicines advertising law.

2) Health education information

Websites may contain non-promotional health education information about the

characteristics of diseases; methods of prevention and screening and treatments, as

well as other information intended to promote public health. They may refer to

medicinal products, provided that the discussion is balanced and accurate. Relevant

information may be given about alternative treatments, including, where appropriate,

surgery, diet, behavioural change and other interventions that do not require use of

medicinal products. Websites containing health education information must always

advise persons to consult a healthcare professional for further information.


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3) Information for healthcare professionals

Any information on websites directed to healthcare professionals that constitutes

promotion (as defined in the Code) must comply with the Code and Lithuanian law.

Such information must be clearly identified as information for healthcare

professionals. In addition, access to such information must be technically restricted

for patients and for the general public and shall be made available only subject to

request from a healthcare professional.

4) Non-promotional information for patients and the general public

Subject to any national laws and regulations, websites may include non-promotional

information for patients and the general public on products distributed by the

company (including information on their indications, adverse effects, interactions

with other medicines, proper use, reports of clinical research, etc.), provided that

such information is balanced, accurate and consistent with the approved summary of

product characteristics. For each product that is discussed, the website must contain

full, unedited copies of the applicable summary of product characteristics and

patient leaflet. These documents should be posted in conjunction with other

information about the products or be connected with that discussion by a prominent

link advising the reader to consult them. In addition, the website may provide a link

to the full, unedited copy of any public assessment report issued by the Committee

for Medicinal Products for Human Use or the State Medicines Control Agency.

Brand names should be accompanied by international non-proprietary names. The


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website may include links to other websites containing reliable information on

medicinal products, including websites maintained by government authorities,

medical research bodies, patient organisations, etc. The website must always advise

persons to consult a healthcare professional for further information.

Section 3. Email Enquiries

A website may invite electronic mail communications from healthcare professionals

and patients or the general public seeking further information regarding the

company’s products or other matters (e.g., feedback regarding the website). The

company concerned may reply to such communications in the same manner as it

would reply to enquiries received by post, telephone or other media. In

communications with patients or members of the general public, discussion of

personal medical matters must be avoided. If personal medical information about the

specific individual’s health problems is revealed, it must be held in confidence and

not published. Where appropriate, replies shall recommend that a healthcare

professional be consulted for further information.

Section 4. Links from Other Websites

Links may be established to a company-sponsored website from websites sponsored

by other persons, but companies should not establish links from websites designed

for the general public to company-sponsored websites that are designed for

healthcare professionals. Based on the same principle, links may be made to


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individual websites, including websites sponsored by the company or other persons.

Links should ordinarily be made to the home page of a website or otherwise

managed so that the reader is aware of the identity of the website.

Section 5. Website Addresses on Packaging

Subject to any applicable national laws and regulations, the addresses of company-

sponsored websites that comply with these guidelines may be included in packaging

of medicinal products.

Section 6. Scientific Review

Companies should ensure that scientific and medical information prepared by them

for inclusion in their websites is reviewed for accuracy and compliance with the

relevant code(s). The scientific service established within the company pursuant to

those provisions of the Applicable Code that adapt the Section 13.2 of the Code may

perform this function, or it may be entrusted to other appropriately qualified

professionals.

Section 7. Privacy

The website must conform to legislation and Applicable Codes of conduct

governing the privacy, security and confidentiality of personal information.


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Annex C

Code of Ethics on the Relations between the Pharmaceutical Industry and

Patient Organisations

INTRODUCTION

The pharmaceutical industry recognises that it has common interests with patient

organisations, which represent and/or support the needs of patients and/or caregivers.

In order to ensure that relationships between the pharmaceutical industry and patient

organisations are ethical and transparent, IFPA and VGA have adopted the Code of

Ethics on the Relations between the Pharmaceutical Industry and Patient

Organisations, which is considered as an integral part of the Code of Ethics for

Pharmaceutical Marketing governing pharmaceutical marketing and relations with

healthcare professionals as well as relations between the pharmaceutical industry

and patient organisations (hereinafter referred to as the Code).

The present Code builds upon the following principles:

1. The independence of patient organisations, in terms of their political

judgement, policies and activities, shall be assured.

2. All partnerships between patient organisations and the pharmaceutical

industry shall be based on mutual respect with the views and decisions of

each partner having equal value.


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3. The pharmaceutical industry shall not request, nor shall patient organisations

undertake, the promotion of a particular prescription-only medicine.

4. The objectives and content of any partnership shall be transparent. Financial

and nonfinancial support provided by the pharmaceutical industry shall

always be clearly acknowledged in a proper way.

5. The pharmaceutical industry welcomes funding of patient organisations from

multiple sources.

Scope

The provisions of this Code shall apply to relations between IFPA and VGA

member companies operating in Lithuania and their affiliates or hired third parties as

well as to other parties acceded to this Code and patient organisations.

Patient organisations are defined as any non-profit organisation (including the

umbrella organisations that integrate patient associations), composed of patients

and/or caregivers, the main activity and objectives of which are expressed in

supporting the needs of patients and/or caregivers.

Application

Pharmaceutical companies must comply with this Code and any laws and

regulations that apply to them; and:


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(a) In the case of partnerships or other mode of joint activity with a patient

organisation in Lithuania, this Code and Lithuanian laws and regulations

shall apply;

(b) In the case of cross-border partnerships and activities, the industry code of

the country where the patient organisation has its principal headquarters shall

apply. In the event of discrepancies between the codes, more stringent

provisions of a code shall apply.

Activity as referred to above shall mean any interaction between a pharmaceutical

company and a patient organisation, including financial support.

Provisions

Article 1 Non-promotion of prescription-only medicines

Promotion of prescription-only medicinal products to the general public is

prohibited, unless permitted by Lithuanian law.

Article 2 Written agreements

Any financial support, significant indirect support and/or other forms of significant

non-financial support from a pharmaceutical company to a patient organisation shall

be provided basing on written agreement. The agreement must specify the amount of

funding/non-financial support as well as its purpose (e.g. unrestricted grant, specific

meeting or publication, etc.). In addition, a description of significant indirect and

significant non-financial support (e.g. time allocation for a public relations campaign

and the nature of participation) must be provided. When support is provided to a


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patient organisation in another country, the agreement must specify the codes of

ethics that apply to cooperation relations in the home countries of the

pharmaceutical company and of the patient organisation. Each pharmaceutical

company must have an approval process in place for such agreements.

An example of a written agreement is provided in Annex I.

Article 3 Use of logos and proprietary materials of patient organisations

The public use of patient organisation’s trademark (logos and/or its proprietary

materials) by a pharmaceutical company requires written permission from the

patient organisation. The provision of such permission shall be based on a written

statement of the specific purpose and the way the trademark (logo) and/or the

proprietary materials will be used.

Article 4 Editorial control

Companies must not influence the reference materials made by a patient

organisation they sponsor in a manner favourable to their own commercial interests.

This prohibition does not preclude companies from correcting factual inaccuracies in

materials.


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Article 5 Transparency

a. Each company must make publicly available a list of patient organisations to

which it provides financial support and/or significant indirect/non-financial

support. This should include a description of support that is sufficiently

complete and clear to enable an average reader to gain an understanding of

the meaning of support. The description must include the monetary value of

financial support and of invoiced costs. For significant non-financial support

that cannot be assigned a meaningful monetary value the description must

clearly describe the non-monetary benefit that the patient organisation

receives. This information shall be provided on a national and European

level. In Lithuania information about financial support and/or significant

indirect/non-financial support shall be provided to the Pharmaceutical

Marketing Ethics Committee once per calendar year before February 1 of the

following year.

b. Companies must ensure that their sponsorship is always clearly

acknowledged and apparent from the outset.

c. Each company must make publicly available a list of patient organisations

that it has engaged to provide significant contracted services. This should

include a description of services provided that does not disclose confidential

information but is sufficiently complete to enable the average reader to gain

an understanding of the nature of the arrangement. Each company shall also

make public the total amount paid per patient organisation over the reporting

period in accordance with the procedure and timeframe described above.


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Article 6 Contracted Services

Contracts between companies and patient organisations where under the latter

provide any type of services to companies are only allowed if such services are

provided for the purpose of supporting healthcare or research.

Members of patient organisations may be invited to deliver presentations or to

provide expert or advisory services for a compensation at company-sponsored

events or advisory boards. Arrangements that cover consultancy or other services

must, to the extent relevant to the particular arrangement, meet each of the following

criteria:

a. A written contract or agreement is agreed in advance specifying the nature of

the services to be provided, and, subject to clause (g) below, the basis of

payment for those services;

b. A legitimate need for the services has been clearly identified and

documented in advance of requesting the services and entering into the

agreements;

c. The criteria for selecting services are directly related to the identified need

and persons in charge of selecting the service have the expertise required to

evaluate whether the particular experts and advisors meet those criteria;

d. The scope of the service is not greater than is reasonably necessary to meet

the identified need;


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e. The contracting company keeps records of and makes appropriate use of the

services;

f. The engaging of patient organisations into paid activities is not an

inducement to recommend a particular medicinal product;

g. The compensation for the services is reasonable and does not exceed the fair

market value of the services provided. In this regard the payment of

compensation to patient organisations may not be justified with symbolic or

formal agreements for consulting and other services;

h. In their written contracts with patient organisations companies are strongly

encouraged to include provisions regarding an obligation of the patient

organisation to declare that they have provided paid services to the company

whenever they write or speak in public about a matter than is the subject of

the agreement or any other issue relating to that company;

i. Each company must make publicly available a list of patient organisations

that it has engaged to provide paid services – please refer to Article 5(c)

above.

Article 7 Single company funding

No company may demand the conditions of being the sole sponsor of the respective

patient organisation or any of its major programmes.


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Article 8 Events and hospitality

All events sponsored or organised by a company must be held in an appropriate

venue that is conductive to the main purpose of the event, avoiding those that are

renowned for their entertainment facilities or are extravagant“. “Entertainment

venues” are understood as places for leisure and entertainment which advertise their

entertainment facilities on promotional leaflets, also publicly in the press or on the

Internet and which are intended primarily for recreation and/or entertainment, i.e.

entertaining activities rather than professional/business meetings. “Extravagant

venues” are understood as places which are lavish and deluxe and the visiting of

which could be prejudicial to the image of patient organisations or of the

pharmaceutical industry.

All forms of hospitality of the pharmaceutical company offered to patient

organisations and their members must be “reasonable” and must not override the

principal purpose of the event whether organised by a patient organisation or a

pharmaceutical company.

Hospitality must be limited to the funding of return travel to the event, catering,

accommodation and registration fees.

Hospitality may only be extended to persons who are invited to and participate in an

event in their right of a participant. In exceptional cases, in case of apparent health


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needs (e.g. disability), travel, catering and accommodation expenses and the

registration fee of the accompanying person considered a carer can be covered.

All forms of hospitality offered to patient organisations and their representatives

shall be adequate and related to the purpose of the event.

Hospitality shall not include sponsoring or organising entertainment (e.g. sporting or

leisure events).

No company may organise or sponsor an event that takes place outside its country of

incorporation, unless:

a) most of the invitees are from other countries (other than the state of registration of

the company organising the event) and, given the countries of origin of most of

the invitees it makes greater logistical sense to hold the event in another country;

b) given the location of the relevant resource or expertise that is the object or subject

matter of the event, it makes greater strategic/logistical sense to hold the event in

another country.

Article 8 Enforcement and implementation

Ensuring supervision over the Code of Ethics on the Relations between the

Pharmaceutical Industry and Patient Organisations and compliance with the


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provisions of this Code respectively shall be controlled by the Pharmaceutical

Marketing Violation Committee, as defined in Annex A of the Code. The procedure

for lodging and examining violation reports shall be the same as that of the Code of

Ethics for Pharmaceutical Marketing (Annex A).

Annex I

201.... Declaration of Interest

of member of the Pharmaceutical Marketing Ethics Committee

......................................................................(full name)

1. Have you been engaged in any kind of financial relationships with

pharmaceutical manufacturers other than your represented company (employment

relations, the pharmaceutical manufacturer paid for your participation in a

conference, congress, consultation, symposium, etc., paid you a honorarium for a

presentation, copyright work, letter, advice or studies, you were involved in clinical

trails conducted by the pharmaceutical manufacturer or received gifts the value of

which exceeded 1 MSL and the like) in the past 5 years?

YES

NO

If “YES”, please provide more detailed information specifying the nature of

interest, name of the pharmaceutical manufacturer,

etc. .………………………………………………………...........................................

...............................


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2. Are there any other circumstances that could affect your objectivity and integrity

of decision-making as member of the Code of Ethics for Pharmaceutical Marketing

Violation Committee?

YES

NO

If “YES”, please provide more detailed information specifying the nature of

interest, name of the pharmaceutical manufacturer,

etc. ………………………………………………………............................................

...............................

3. If your answer to at least one of the questions was “YES”, due to a potential

conflict of interest the Committee may propose that you do not participate in the

consideration of related matters or voting.

I confirm that the above is true and complete information. Should any of the details

provided in this declaration change, I commit to provide changes within 20 days. I

agree that my declaration is communicated to IFPA or VGA members.

----------------------- ----------------------------------------------------------------

(signature and full name of the person who completed the declaration and

completion date)

The declaration is completed once a year before 1 March of the current year

and is provided to the Chairperson of the Committee.

----------------------------------------------------------------------------------------

(signature and full name of the person who accepted the declaration and date)


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Annex II

Template of a written agreement between the pharmaceutical industry and

patient organisations

Any financial support, significant indirect support and/or other forms of significant

non-financial support from a pharmaceutical company to a patient organisation shall

be provided basing on written agreement.

Below please find the key elements of a written agreement. The agreement must

directly indicate its subject, i.e. what the parties agree about, consistent with the

requirements of the Code of Ethics on the Relations between the Pharmaceutical

Industry and Patient Organisations.

• Name of activity

• Name of partnering organisations (pharmaceutical company, patient

organisation and, where applicable, third parties that will be brought in to

help , as agreed between both the pharmaceutical company and the patient

organisation)

• Type of activity (e.g. whether agreement relates to unrestricted grant,

specific event, publication, etc.)

• Objectives

• Envisaged role of the pharmaceutical company and the patient organisation

• Time-frame


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• Amount of funding

• Description of significant indirect/non-financial support (e.g. the donation of

public relations agency, free courses)

• Country codes valid in the home countries of the pharmaceutical company

and of the patient organisation that apply to cross-border cooperation

relations between patient organisations and pharmaceutical companies.

All parties must be well aware that support must be clearly indicated and known

from the onset.

Applicable Code(s) of ethics:

Contracting parties:

Contract date:


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APPENDIX - IV

THE NEW PHRMA CODE ON INTERACTIONS WITH HEALTHCARE

PROFESSIONALS

(Effective January 1, 2009)

The recently released PhRMA Code scheduled to take effect January 1, 2009

is an extension and amplification of the Code that became effective July 1, 2007.

The Codes are remarkably similar, and focus on perceived abuses of pharmaceutical

industry interactions with healthcare professionals (HCPs).

In both cases, there is a clear distinction between legitimate pharmaceutical

promotion and possible inappropriate interactions with HCPs. Traditional product

promotion is not addressed in either of the Codes, but gifts from pharmaceutical

manufacturers, their representatives, and other manufacturer interactions with HCPs

are covered in detail.

Both the 2002 Code and the 2009 Code can be seen as influenced by the

anti-kickback statutes issued by the OIG. The new Code is designed to eliminate

inappropriate inducements to HCPs to prescribe specific products. In general,

outright gifts lacking medical relevancy may be correctly viewed as improper

inducements. On the other hand, advertising placed in traditional medical

advertising media (medical publications, prescription forms, patient record services,

etc.) is designed to persuade through education.


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Items that are obviously intended for the personal benefit of HCPs “…such

as floral arrangements, artwork, music CDs, or tickets to a sporting event…” are

deemed unacceptable in both the 2002 and 2009 Codes. (See Item 7.c in the 2002

Code and Item 10 in the 2009 Code.)

The major difference between the Codes that occurs with regard to

promotional items (i.e., gifts) comes in the change from the previous Code where

“Items of minimal value may be offered by a company if they are primarily

associated with the HCP’s practice (pens, notepads, and similar ‘reminder’ items

bearing a corporate or brand logo).” (These items have been routinely referred to as

“medically relevant.”)

The new Code places a more restrictive boundary in this area, relegating

items of “medical relevance” that provide neither professional nor patient education

to the level of unacceptability. The new Code requires that brand presentations (via

personal and/or non-personal media) have an HCP or patient education component.

Both Codes refer specifically to interactions between pharmaceutical

companies and HCPs in terms of what may be “offered” or “given” to HCPs by

pharmaceutical representatives. Personal and/or non-personal media must have a

HCP or patient education component. Both Codes seek to eliminate any appearance

of impropriety in the interaction between pharmaceutical representatives and

physicians (and their staffs). Replacing “medically relevant” with “items of an


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educational nature” is one way to circumscribe the types of materials individual

pharmaceutical companies may appropriately provide to physicians.

It is useful to note the first paragraph from Item #10 of the new Code

(emphasis added): “Providing items for HCPs’ use that do not advance disease or

treatment education—even if they are practice-related items of minimal value (such

as pens, note pads, mugs and similar “reminder” items with company or product

logos)—may foster implications that company interactions with HCPs are not based

on informing them about medical and scientific issues. Such non-educations items

should not be offered to HCPs or members of their staff, even if they are

accompanied by patient or physician educational materials.”

The 2009 Code expands the definition of inappropriate “gifts to physicians” as it

was initially outlined in the 2002 Code.

A distinction may also be made between gifts to physicians and the inclusion

of traditional product promotion in services to which they may subscribe. This

includes prescription forms, patient record services, and similar services physicians

request to receive (and expect to receive) regardless of support from any given

company or brand. Medical publications and third-party services provided to

physicians are not initiated by any particular company or brand, and constitute usual

and customary promotion activity.


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Health Care Ethics

ETHICAL DECISION MAKING IN HEALTH CARE

Medical ethics, more commonly referred to today as biomedical ethics, is not a new

area of inquiry. The first code of ethics for medicine was credited to Hippocrates in

the 5th century B.C. In many ways, his code is timeless. For example, his direction

that no physician should “give a deadly drug to anybody if asked for it, nor . . . make

a suggestion to this effect” (Edelstein, 1967, p. 6) provides one moral perspective on

the contemporary issue of assisted suicide. What has changed over the past decade

or so is the attention given to biomedical ethics in the professional and scientific

literature and by health professions schools. In pharmacy, for example, surveys were

conducted in 1963 and again in 1980 to determine the state of ethics instruction in

schools of pharmacy. The 1963 survey found that only 8 of 65 schools that

responded required a formal, separate course in ethics; 19 schools offered no

required or elective course that included ethics as an explicit part. In the 1980 study,

the numbers were still worse: only 2 of 52 schools required an ethics course, and 32

schools did not offer one (Smith and Smith, 1981).

Today, most pharmacy, nursing, and medical schools require some instruction in

biomedical ethics. Haddad and colleagues, reporting on a 1991 survey of ethics

instruction at pharmacy schools, said, “While the quantity of ethics instruction has

not increased, there are encouraging signs that the quality and depth of ethics

education is improving” (Haddad et al., 1993, p. 35S). No one factor is responsible


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for the heightened attention given to the study of ethics in health care. Several

factors, however, are certainly important contributors. First is the explosion of

biotechnology. Medical professionals now have available to them an arsenal of

weapons to fight disease. The ability to sustain life, deal with premature birth, and

treat conditions that heretofore were thought to be untreatable has generated new

ethical dilemmas. When we were unable to sustain the life of a person in a persistent

vegetative state, then the question of whether or not to “pull the plug” did not arise.

Likewise, when no treatment existed for dealing with prematurity, cancer, or

cardiovascular disease, the ethical questions associated with those treatments did not

need to be answered. The second factor is the rapidly rising cost of health care in the

United States. The United States spends a greater proportion of its gross domestic

product on health care than any other nation, yet leaves many of its citizens without

adequate access to care, as in the case of Leo and his family. As Howard Hiatt (1975)

has described, we have only limited resources to spend on health care; how much we

spend, and how we allocate it within health care, is a vital question we must answer

as a society. These financial concerns give rise to questions of limiting access,

rationing, and denial of care.

Biotechnology and costs are not the only factors that have led to this increased

emphasis on ethics instruction and research, but they are clearly major contributors.

Whatever the reason, ethical considerations play a very significant role in health

care delivery as we begin the new millennium. This chapter discusses health care

ethics from a practical perspective by introducing ethical “tools” that health care

professionals can use in their daily practice. These tools include ethical theories and


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principles, moral rules, and codes of ethics. Special emphasis is given to the ethical

aspects of pharmacy practice.

“MACRO” VERSUS “MICRO” ETHICAL SITUATIONS

Ethical situations in health care can be divided into two broad categories: “macro”

and “micro.” Macro situations involve issues that are not specific to a given health

care practitioner (such as the pharmacist); these situations involve issues that must

be addressed by all health care practitioners and society in general (such as abortion,

assisted suicide, genomics, rationing of and access to health care, organ

transplantation, and in vitro fertilization). Micro situations are those that may

confront individual practitioners in the course of their daily practice. In the case of

pharmacists, they include the use of placebos, patient confidentiality (for example,

revealing information about a patient’s medications to members of his or her family),

informed consent (such as what and how much information about a medication

should be disclosed to a patient), and as illustrated in Leo’s situation, providing

necessary medications to those who are uninsured and unable to pay.

Sometimes, macro issues are manifested in micro situations. This is especially true

with socially controversial issues like abortion and assisted suicide. For example, a

pharmacist may receive a prescription for a drug that is known to be intended for use

in an assisted suicide. The pharmacist must deal not only with the legal issues

involved but also with his or her ethical responsibility as a health care professional.

A further complication in this and similar situations is what—if any—influence the


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pharmacist’s (or other health care professional’s) personal beliefs should have on his

or her course of action.

COMPETENCE, TRUSTWORTHINESS, AND CARING

Any discussion of health care ethics must begin by describing the basic moral

responsibilities health care practitioners have toward their patients. Berger (1993)

has attempted to describe the characteristics that a pharmacist should possess. First,

pharmacists must be competent. They must possess a knowledge base that at least

minimally allows them to carry out their functions as reliable therapeutic experts.

However, competency is more than simply having an adequate base of knowledge.

Skills that allow the pharmacist to appropriately time and organize patient

counseling information, or that include the patient as a partner in his or her own care,

are of equal importance in evaluating a pharmacist’s competence.

Second, pharmacists must be trustworthy. Patients must know that they can

confidentially seek the advice and assistance of their pharmacist and that their

wishes will be carried out. As Berger notes, “Being seen as trustworthy by the

patient is connected to the ethical covenant made between the pharmacist and the

patient. Once the pharmacist and patient identify what each is responsible for, trust

becomes a measure of the patient’s perception of how well and how consistently the

pharmacist upholds his or her end of the covenant” (Berger, 1993, p. 2401).


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Third, pharmacists must care for and about their patients. The American Pharmacists

(formerly Pharmaceutical) Association (APhA) code of ethics (1995) directs, “A

pharmacist places concern for the wellbeing of the patient at the center of

professional practice.” Unfortunately, pharmacists do not always effectively

communicate that they care about their patients’ welfare. All too often, patients

perceive just the opposite. Busy practitioners who fail to spend adequate time

interacting with their patients do little to alter this perception. Conversely,

pharmacists who do spend time with their patients and attempt to understand

patients’ concerns are much more likely to be viewed as caring. As Berger points

out, “Probably nothing is more powerful in communicating caring than

understanding, and thus legitimizing, the concerns of the patient” (Berger, 1993, p.

2401).

These characteristics of pharmacists described by Berger also hold true for all health

professionals. Physicians, nurses, physical therapists, and others should—within the

moral and professional parameters of their own profession—strive to be competent,

trustworthy, and caring (McCarthy, 1996c).

THE HEALTH PROFESSIONAL–PATIENT RELATIONSHIP: CONSUMERISM

VERSUS PATERNALISM

Not long ago, when patients were instructed by their physician or pharmacist to have

an operation, go for a laboratory test, or take a medication, they did so without

question. Medical paternalism—the belief that the health care professional knew


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best—was accepted as standard practice by most health care professionals and their

patients. The medical rights of patients were not as widely recognized as other rights

(such as suffrage or due process).

Today, patients have become true consumers of medical care. Patients wish—and

have a right—to be informed and to be asked for their consent. To do otherwise

would be both unprofessional and unethical—not to mention the potential legal

ramifications. Patients expect a certain level of service. As with sellers of other

goods and services, health professionals who fail to meet the demands of health care

consumers may lose customers or experience legal problems (McCarthy, 1996c).

MORAL RIGHTS VERSUS LEGAL RIGHTS TO HEALTH CARE

It is important in any discussion of health care ethics to be clear about what is meant

by the term rights. In contemporary U.S. society, one frequently refers to the legal

rights of individuals. These are rights that are guaranteed fundamentally in the U.S.

Constitution (such as the right of free speech and the right of assembly) or are

provided by laws and regulations promulgated at the federal, state, or local level. We

sometimes confuse what is really a legal duty (such as providing free elementary

and secondary school education) with our moral obligation to do something (such as

our responsibility to ensure that the next generation of Americans is provided with

an adequate education).


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Moral rights may be reinforced by laws, but their basis lies not in the law, but in

ethical principles. Such rights might include the right to live without fear of harm

and the right to food and adequate shelter. More recently, Americans have grappled

with the question of health care as a moral right. Do Leo and his children, for

example, have a moral right to adequate health care? As one might expect, moral

rights and legal rights may be in conflict. There is disagreement over whether issues

like abortion involve moral rights or legal rights. The question of the right to die has

been played out in the media across the country. Dr. Jack Kevorkian and his so-

called suicide machine have forced this society to deal with a moral question in legal

terms.

PATIENTS’ RIGHTS

When patients seek the care of health care providers, what rights do they have?

What can they reasonably expect from health care providers? Patients can expect

that clinicians will employ their knowledge and experience in caring for them. As

autonomous individuals, patients can expect that health care providers will respond

to their wishes about their treatment.

At first glance, the American health care system seems fundamentally based upon

ensuring the rights of patients. Patients generally choose their own physician,

pharmacy, and hospital. Patients are allowed to choose from multiple options for

treatment when they exist (such as surgery versus drug therapy). Patients must give

their approval, through the process of informed consent, prior to the initiation of


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care. All of the preceding presupposes that treatment is available and that the patient

has the economic wherewithal to pay for that treatment. For patients who are

uninsured or lack the ability to pay (like Leo), the right to choose the nature of their

health care is meaningless. As Mappes and Zembaty argue, the United Nations (UN)

Declaration of Human Rights may state “that all persons have a right to medical

treatment” (1991, p. 36), but “A citizen of the United States . . . cannot walk into a

hospital, demand and receive treatment simply on the basis of the claim that the UN

Declaration proclaims his or her right to such care” (1991, p. 37). Patients also have

a right to treatment that is both safe and effective within given parameters. The

fundamental question that must be posed prior to considering any medical or

surgical treatment for a patient is, “Is the treatment safe and effective?” Such a legal

standard for drugs has been in effect since the early part of last century (Musto,

1987). Not only must a drug be shown to be effective—that is, able to produce the

effect for which it was administered—but it must do so with a certain degree of

safety.

HEALTH CARE PRACTITIONERS’ DUTY TO THEIR PATIENTS

What is the responsibility of health care practitioners? As Mappes and Zembaty

point out, “The [Hippocratic] oath requires physicians to act so as to ‘benefit’ the

sick and ‘keep them from harm’” (1991, p. 45). Some might argue that health care

providers have a Hippocratic responsibility to their patients and that this

responsibility focuses solely on what is best for the patient, irrespective of the

consequences to others.


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This view is supported by the Code of Ethics of the APhA, which states, “A

pharmacist promotes the good of every patient in a caring, compassionate, and

confidential manner” (APhA, 1995, p. 2131). The code suggests that pharmacists

have a moral obligation to do whatever they deem necessary in the interest of their

patients. But the code goes on to state, “A pharmacist serves individual, community

and societal needs.” Therefore, how far does a pharmacist’s or another health care

professional’s duty to his or her patients go? Is it the health care professional’s

moral obligation to care for patients without exception?

LEGAL RESPONSIBILITY VERSUS MORAL OBLIGATION

Rem Edwards provides an example of a radical interpretation of the Hippocratic

Oath when he asserts that medical professionals have an obligation to do whatever is

necessary to relieve the pain and suffering of their patients (Edwards, 1984).

Edwards’ contention, although seemingly laudatory, has serious flaws when applied

to medical practitioners. All health care professionals practice under the constraints

of law, which may limit their doing “whatever is necessary.”

As a result, the patient’s rights and the practitioner’s responsibilities may sometimes

be in conflict not on ethical grounds but on legal ones. To direct that health care

professionals should assume an individualistic approach and take an illegal, yet

ethical, action for their patients despite the legal consequences is asking them to

unrealistically subjugate their own interests to those of their patients.


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ETHICAL RESPONSIBILITY IN PHARMACY: PHARMACEUTICAL CARE

In their landmark paper, the members of the Commission to Implement Change in

Pharmaceutical Education stated their belief “that the mission of pharmacy practice

is to render pharmaceutical care. Pharmaceutical care focuses pharmacists’ attitudes,

behaviors, commitments, concerns, ethics, functions, knowledge, responsibilities

and skills on the provision of drug therapy with the goal of achieving definite

outcomes toward the improvement of a patient’s quality of life” (Commission to

Implement Change in Pharmaceutical Education, 1993, p. 376).

Pharmaceutical care, therefore, changes the focus of pharmacy practice and

broadens the professional responsibility of pharmacy practitioners. In traditional

pharmacy practice, both the legal and ethical obligations of pharmacists centered

around ensuring that the proper medication as ordered by the prescriber was

delivered to the patient. Physicians, and not pharmacists, were the health care

professionals who held ultimate responsibility for monitoring the patient’s progress

and ensuring that the desired outcome was achieved. Pharmaceutical care directs

that this responsibility is to be a shared obligation between the prescriber and the

pharmacist (McCarthy, 1996c; for further reading, see Chapter 3).

VEATCH’S FRAMEWORK FOR ETHICAL ANALYSIS


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Robert Veatch (1989) has suggested a framework for ethical analysis that health care

professionals can use to determine the ethical course of action to follow in a given

situation. His four-step approach involves ensuring adequate knowledge of all the

pertinent facts involved in a given situation (step 1), and the application of moral

rules (step 2), ethical principles (step 3), and ethical theories (step 4). When faced

with a situation involving ethical decision making, health care practitioners should

begin with step 1 and continue along Veatch’s continuum, through steps 2, 3, and 4,

if needed, until a decision is made

Veatch contends that ethical situations can sometimes be solved without the

application of moral rules, ethical principles, or ethical theories. Sometimes an

ethical dilemma can be solved by simply ensuring that all the facts are known about

a case (step 1). For example, a question of whether to break patient confidentiality

might be moot if it is determined that the patient has agreed to allow the health

professional to divulge such information.

If step 1 does not provide an answer, step 2 involves the application of moral rules.

The rules of confidentiality and/or consent (informed consent) may offer some

guidance. If a dilemma still exists, ethical principles may be employed (step 3).

These include autonomy, beneficence, no maleficence, veracity, fidelity, and justice.

Sometimes there may be a conflict among two or more moral rules or ethical

principles. In such cases, one should determine whether one rule or principle or

combination of rules or principles has precedence in the given situation; if not, an

ethical theory should be employed. According to Veatch, ethical theories (step 4) are

the ultimate arbiter of ethical dilemmas (see Exhibit 7–1).


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ETHICAL THEORIES

A number of ethical theories have been described. The two most prominent types in

the modern period are teleological (consequentialist) theories and deontological

(nonconsequentialist) theories. There are other approaches to ethics that have

applicability to the biomedical field, such as virtue-based and feminist theories.

However, most contemporary biomedical texts focus on teleological and

deontological theories.

Teleological theories, such as utilitarianism, state that the rightness or wrongness of

an action depends on the consequences produced. According to Beauchamp and

Childress: “Consequentialism is the moral theory that actions are right or wrong

according to their consequences rather than any intrinsic features they may have,

such as truthfulness or fidelity” (1989, p. 25). Utilitarianism, as a consequentialist

theory, directs that the most appropriate course of action is that which will produce

the “greatest good for the greatest number” when the consequences of all

alternatives in a given situation are weighed.

Conversely, deontological theories, such as Kantian ethical theory, argue that the

rightness or wrongness of an action is independent of the consequences produced.

According to Beauchamp and Childress, “Deontologists maintain that the concepts

of obligation and right are independent of the concept of good and the right actions

are not determined exclusively by the production of good consequences” (1989, p.


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26). Deontologists maintain that factors other than consequences, such as integrity

and truth telling, should be included when determining the ethical acceptability of a

given action (Beauchamp and Childress, 1989).

For example, consider the question of whether a health care professional ought to

tell an elderly patient she is terminally ill despite pleas from her children that she not

be told. A utilitarian would consider the consequences of the available options (tell

or not tell), while the Kantian would consider factors including the health care

professional’s obligation to be truthful with the patient.

A more detailed discussion of ethical theories is beyond the scope of this chapter,

especially given that ethical principles and moral rules are more likely to be the

“tools” used by health care practitioners on a daily basis as they face ethical

situations.

ETHICAL PRINCIPLES AND MORAL RULES

Medical practitioners have an ethical obligation to care for their patients. Ethical

principles and moral rules provide guidance for practitioners about what this

obligation entails. When faced with an ethical dilemma, health care professionals

should first consider whether or not moral rules are applicable and helpful in

determining an acceptable course of action (step 2). If not, they should move to the

level of ethical principles (step 3) for guidance.


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Autonomy

The principle of autonomy states that an individual’s liberty of choice, action, and

thought is not to be interfered with. As Beauchamp and Childress have noted,

“Autonomy has . . . been used to refer to a set of diverse notions including self-

governance, liberty rights, privacy, individual choice, liberty to follow one’s will,

causing one’s own behavior, and being one’s own person” (1989, pp. 67–68). In

health care, we think of autonomy as the right of individuals to make decisions

about what will happen to their bodies (for example, whether or not to have surgery),

what choice will be made among competing options (such as surgery versus medical

management), and what they choose to take or not take into their bodies (for

example, compliance versus noncompliance with prescribed medications). We also

allude to questions of autonomy when we refer to choice among health care

providers (such as physicians, hospitals, and pharmacies) and the choice to refuse

medical treatment (such as decisions about the right to die and assisted suicide)

(McCarthy, 1996b).

There are two ethically justifiable exceptions to the principle of autonomy: weak

paternalism and the harm principle. The concept of medical paternalism is in direct

conflict with the principle of patient autonomy. Medical paternalism suggests that

physicians and other health care professionals—because of their education and

training—know what is best for their patients. As a result, health care professionals

believe they are justified in overriding a patient’s autonomy. Medical paternalism

dominated Western medical practice until the last several decades, when the primacy


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of patients’ rights and the concept of medical consumerism became recognized.

Nevertheless, a form of medical paternalism, “weak paternalism,” has remained

generally ac-accepted as a justifiable exception to the principle of autonomy. Weak

paternalism allows an individual’s autonomy to be violated if that individual is not

or does not appear to be autonomous, or if minimal intervention is necessary to

determine whether the patient is autonomous. It might be argued that given the stress

caused by his current situation, Leo is not an autonomous individual and is thus

unable to make a rational decision whether to enter a clinical trial or end his life.

Some have argued that weak paternalism is not paternalism. If a person cannot make

an autonomous decision because he or she lacks the capacity to do so, then how can

that individual’s autonomy be overidden? Strong paternalism—the violation of

another’s autonomy because they are making the wrong decision or a decision that

will cause harm to themselves—is not considered an ethically justifiable reason to

override a patient’s autonomy. Consequently, to override Leo’s decision to end his

life based on strong paternalism would be unethical.

Under the harm principle, one is justified in overriding another’s autonomy if, in the

exercise of that autonomy, harm may come to others. In Leo’s situation, one could

argue that he should be prevented from ending his life (i.e., his autonomy should be

overridden) because of the emotional harm such an act would inflict upon his

children.


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Informed Consent

The principle of autonomy is a vital component of informed consent. For example,

when one provides informed consent to an individual contemplating participation in

a clinical research trial, one respects that individual’s right to make an autonomous

decision. The rule of informed consent directs that patients must be fully informed

about the benefits and risks of participating in a clinical trial, taking a medication, or

electing to have surgery; this disclosure is followed by their autonomous consent.

For legal and ethical reasons, informed consent is always obtained through a written

form in situations such as clinical research and surgery. In the case of clinical

research, these documents are usually drafted by the investigator or research sponsor

(e.g., pharmaceutical manufacturer) and subsequently approved by the institutional

review board (IRB) at the institution where the research will take place.

Informed consent is also obtained informally in some instances. For example,

whenever a pharmacist counsels a patient and dispenses a medication to a patient, a

type of informal informed consent is occurring. The patient is informed about the

benefits and risks of the drug and then decides whether or not to take it.

Informed consent is composed of five elements: disclosure, understanding,

voluntariness, competence, and consent (McCarthy, 1996b). Disclosure directs that

all the pertinent information necessary for an informed decision be made available to

the patient. Understanding requires that the patient fully understand what he or she is

consenting to, including any benefits or hazards. Voluntariness instructs that patients


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must choose to enroll in a research endeavor or be compliant with a medication free

from coercion. (It might be argued that Leo would not be making a voluntary

decision to enroll in the clinical trial given his financial circumstances.) Competence

requires that patients be autonomous individuals, who functionally have the ability

to make decisions for themselves. Consent is the final legal and moral criterion that

must be met in order to ensure that informed consent has been obtained. It provides

the patient with a point of decision.

Confidentiality

The rule of confidentiality, much like informed consent, is an application of the

principle of autonomy. When a health care professional keeps information private

from others, unless given permission to do so by the patient, the professional

respects the individual’s autonomous decision. Medical confidentiality need not be

expressed explicitly by the patient. All medical information, by nature, is generally

considered to be confidential unless released with the patient’s approval.

The terms confidentiality and privacy are often used interchangeably, yet, in

actuality, they are not the same. Confidentiality is the act, by a health care

professional, of keeping information private from others, unless given the

permission to reveal such information by the patient. In contrast, privacy is the act of

keeping information from others who do not have our consent, or even the right, to

access such information. A violation of confidentiality occurs when a health care

professional inappropriately discloses patient information, either purposefully or

accidentally, to others after being given access to such information. A violation of


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privacy occurs when an individual (e.g., a computer hacker) gains inappropriate

access to private information. Given this distinction, the primary focus of

biomedical ethicists is on confidentiality.

In health care, it is sometimes unclear which members of the health care team

should have access to confidential medical records without express consent of the

patient. Should a pharmacist or physical therapist caring for a patient have the same

access to medical records afforded the patient’s physician or hospital nurse?

Generally, these individuals do have access to such records, absent specific

instructions from the patient or patient’s family that they should not.

Another difficult ethical situation involves a patient who explicitly expresses a

desire not to have information divulged to a member of the health care team. For

example, a patient may divulge to a pharmacist his or her decision to alter a

prescribed therapeutic regimen but request that the pharmacist not disclose this

information to the physician.

Confidentiality has the same two ethically justifiable exceptions as does the

principle of autonomy: the harm principle and weak paternalism. As with autonomy,

a health care professional may be ethically justified in violating a patient’s

confidentiality if, by keeping information private, harm may come to others (harm

principle) or if the patient lacks autonomy (weak paternalism).


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Confidentiality is an example of an ethical precept that has found its way into our

legal system. The Health Insurance Portability and Accountability Act (HIPAA) of

1996, though primarily focused on the portability of employer-based health

insurance, codified health care professionals’ responsibility to maintain patient

confidentiality. The provision of this law relating to the security and privacy of

health information was only fully effective in early 2003 (Giacalone and Cacciatore,

2003). Consequently, the impact of the HIPAA on health care delivery in the United

States is still to be determined. Nevertheless, it is already clear that HIPAA will

dramatically change the way health care professionals handle patient-sensitive

information. The concern is whether HIPPA, while protecting patient confidentiality,

may result in new ethical problems involving limiting access to patient information

that may impair a health care professional’s ability to care for their patient.

Beneficence/Nonmaleficence

Beneficence and nonmaleficence are ethical principles that, in a sense, are

complementary. To act in a beneficent manner indicates that one will act to “do

good” for another. Nonmaleficence refers to “avoiding harm” or “taking due care.”

Beauchamp and Childress compare these related principles:

The word nonmaleficence is sometimes used more broadly to include the prevention

of harm and the removal of harmful conditions. However, because prevention and

removal require positive acts to assist others, we include them under beneficence


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along with the provision of benefit. Nonmaleficence is restricted . . . to the

noninfliction of harm. (1989, p. 194)

A practical example of the difference between beneficence and nonmaleficence

might be as follows: While driving down the street one day, you notice an elderly

woman crossing the street. Stopping your car to allow her to cross safely is an

example of practicing nonmaleficence, while getting out of your car to assist her

across the street exemplifies beneficence. Similarly, in health care, a pharmacist who

refuses to fill a prescription because of a drug interaction is practicing

nonmaleficence. The same pharmacist contacting the prescriber for an alternative

medication is demonstrating beneficence.

Fidelity

The principle of fidelity requires that health care professionals act in such a way as

to demonstrate loyalty to their patients. A type of bond or promise is established

between the practitioner and the patient. This professional relationship places on the

health professional the burden of acting in the patient’s best interest. Health care

professionals have a fidelity obligation to all their patients, regardless of the length

of the professional relationship. In community pharmacy, for example, practitioners

have the same obligation to show fidelity to an occasional patient as they do to a

“regular” customer (McCarthy, 1996c).


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Ethicists sometimes describe two types of fidelity obligations: contractual and

covenantal. Contractual fidelity is that which occurs as the result of an agreement—

a contract—between two parties. It refers to the obligations that might exist between,

for example, a building contractor and a client or an employer and an employee.

Covenantal fidelity, on the other hand, implies a much deeper or spiritual

commitment such as that which exists between a husband and wife or a member of

the clergy and his congregation. Contractual and covenantal fidelity lie on opposites

end of a continuum. Fidelity obligations may be contractual or covenantal in nature

or may lie some where between the two on the continuum. Where the relationship

between pharmacist and patient falls along the continuum is a point of much

discourse. This is important from a practical perspective when one considers the

level of obligation health care professionals have to their patients. How far should

medical practitioners go to ensure that their patient’s needs and desires are met? In

Leo’s case, what level of fidelity do his physician and other health care professional

have?

Veracity is the ethical principle that instructs practitioners to be honest in their

dealings with patients. There may be times when the violation of veracity is ethically

justifiable (for example, the use of placebos to benefit a patient), but the violation of

this principle for non-patient-centered reasons would appear to be unethical. In a

professional relationship based upon professional fidelity, patients have a right to

expect that health care professionals will be forthright in dealing with them

(McCarthy, 1996c).


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Distributive Justice

Distributive justice refers to the equal distribution of the benefits and burdens of

society among all of society’s members. We often think of distributive justice in

terms of our health care delivery system. This principle is frequently used as a

justification for providing health care as a right to all Americans.

Health professionals do not always provide care with equal fervor to all patients.

Justice instructs health care providers to demonstrate an equivalent amount of care

toward all their patients. Unfortunately, issues such as the patient’s socioeconomic

status often affect the level and intensity of care provided by health care

professionals. Medicaid patients are sometimes provided a much lower quality of

care than cash paying customers or patients who have a “Cadillac” drug benefit plan.

All too often, the care provided by a health care professional is viewed in terms of

the personal reward for the professional—that is, the level of reimbursement that the

care is likely to reap. Justice demands that the health care professional focus on the

patient and his or her medical needs, not on the financial impact on the health care

professional.

As the United States examines the possibility of significantly reforming its health

care system, equal access to quality care for those like Leo and his family must be

the cornerstone of any reform effort (McCarthy, 1996c).


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ETHICAL CODES

Ethical principles that apply to medical practice and research—such as autonomy,

beneficence, and justice—have long served as the basis for a system or code of

ethical conduct. Western medical ethics is primarily based on the Hippocratic code

established by the Greek philosopher Hippocrates in the 5th century B.C. Medicine

(American Medical Association) and pharmacy (Philadelphia College of Pharmacy)

developed codes of conduct for their practitioners in 1847 (American Medical

Association, 2000) and 1848, respectively. As Montagne notes, “The guiding

principles of these codes were a respect for human life and service to humanity”

(1992, p. 303).

The Holocaust during World War II, and the subsequent Nuremberg trials, prompted

the first major development of a code dealing specifically with experimentation on

human subjects. After Nuremberg, several other codes of medical ethics were

established. In 1949, the World Medical Association drafted the Geneva Convention

Code of Medical Ethics, a contemporary version of the Hippocratic Oath. In the

1960s, the same organization established an ethical code on clinical research. The

Declaration of Helsinki was adopted in 1964 (and revised in 1975); this was based

upon the Nuremberg principles (Montagne, 1992). In 1972, the American Hospital

Association issued a “Statement on a Patient’s Bill of Rights.” In 1977, the

Declaration of Hawaii provided ethical guidelines for clinical research in psychiatry

(Montagne, 1992). Nurses are guided by the “Code of Ethics for Nurses,” most

recently revised by the American Nurses Association in 2001. Physicians follow the

“Principles of Medical Ethics,” revised by the American Medical Association in


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2001. In 1992, the National Association of Boards of Pharmacy issued a revised

“Pharmacy Patient’s Bill of Rights” (Buerki and Vottero, 2002).

These codes provide health care professionals with standards to guide their practice.

However, ethical principles and codes cannot provide health care professionals with

answers to every moral question that may arise in the course of their practice.

Ethical questions in health care involve decision making that is usually situation-

specific. The purpose of such principles and codes is not to provide practitioners

with right and wrong answers but to offer them a framework to use when faced with

ethical questions. As Montagne points out, “The formulation of an oath or ethical

code does not remove the moral choices and the need to carefully consider each

individual situation and the alternative actions or decisions that can be made” (1992,

p. 304).

APhA Code of Ethics

The code of ethics of the American Pharmacists (formerly Pharmaceutical)

Association (APhA) is the only one that specifically guides the practice of pharmacy.

A careful examination of the evolution of the code since its inception in 1852 shows

both a greater degree of responsibility to the patient expected of the pharmacist and

a greater respect for the autonomy of patients.


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The first APhA code reflected the wide acceptance of medical paternalism or the

attitude that the “physician knows best.” In Article 5 of the 1852 code, for example,

is the following:

As physicians are liable to commit errors in writing their prescriptions . . . the

apothecary should always, when he deems an error has been made, consult the

physician before proceeding. . . . It is his duty, when possible to accomplish the

interview without compromising the reputation of the physician. . . . When

apothecaries commit errors . . . the physician . . . should feel bound to screen them

from undue censure, unless the result of a culpable negligence (APhA, 1865, p. 25).

Amazingly, the 1852 code suggests that errors by physicians or pharmacists, unless

made negligently, need not—in fact should not—be revealed to patients.

The 1952 code clearly outlined the duties of a pharmacist, which were quite in

conflict with what is accepted practice today. The preamble begins: “The primary

obligation of pharmacy is the service it can render to the public in safeguarding the

preparation, compounding, and dispensing of drugs and the storage and handling of

drugs and medical supplies” (APhA, 1952, p. 721).

The pharmacist refuses to prescribe or diagnose; he refers those needing such

service to a properly licensed practitioner. . . . The pharmacist does not discuss the

therapeutic effects or composition of a prescription with a patient. When such

questions are asked, he suggests that the qualified practitioner is the proper person

with whom such matters should be discussed (APhA, 1952, p. 722).


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By the 1969 revision, the code was significantly shorter, enabling it to be placed on

a placard suitable for display in pharmacies. The 1981 code was gender neutral; “he”

was replaced by “a pharmacist.”

The 1994 code, much less prescriptive than earlier versions, speaks to the

“covenantal relationship between the patient and the pharmacist” and the obligation

of pharmacists to promote “the good of every patient in a caring . . . manner” (APhA,

1995, p. 2131). The elements of pharmaceutical care appear throughout and are

consistent with the new mission of pharmacy (see Exhibit 7–2; see Chapter 3).

ETHICAL ISSUES IN HEALTH CARE

Law and Ethics

Many of the laws, regulations, and other rules that govern our daily life are an

outgrowth of our morality and ethics. Laws that prohibit homicide, robbery, and

similar offenses are simply a codification of the values we share as members of

society. Unfortunately, laws and regulations cannot be promulgated to cover every

eventuality, nuance, condition, or situation. They are created in such a way as to

provide legal guidelines for the “usual” or “most common” situation. What should

be done, then, when the legal course of action is inconsistent with the ethical course

of action (for example, when a person commits homicide in self-defense)?


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Conflicts of this kind occur routinely in medicine. For example, what should a

pharmacist do when a patient’s prescription for heart medicine has been depleted, no

refills remain, and the prescriber is unavailable? Clearly, most pharmacists would do

the ethical thing and provide the patient with a few doses to hold the patient over

until a new prescription can be obtained, even though this course of action is illegal.

To follow the example a bit further, what if the medication is a controlled substance

used for pain control in a terminally ill patient? A pharmacist might be more

reluctant to dispense a few doses, even though the patient might be in just as much

need, due to potential legal ramifications from drug enforcement authorities.

Rationing

As the cost of providing health care services continues to grow, some have

suggested and even attempted to implement a system that would ration the

availability of health care (for example, the Oregon Plan). American health care

policy makers have tried to avoid this approach because it contradicts a long-

standing implicit belief that all that can be done for each patient ought to be done.

Medical insurance providers, both publicly and privately funded, have attempted to

support this traditional ideal. But the lack of cost containment has resulted in rising

insurance rates, thereby driving individuals out of the health insurance system and

threatening the viability of governmental programs.

The consequence of this policy is seen in increasing numbers of individuals who are

unable to afford health insurance. Fewer people have access to health care and


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others have decreased choices of where they can receive health care (such as

municipal hospitals, free clinics). As McDermott points out:

Approximately 15% of our people [Americans] have no health insurance coverage at

any one time, and at least 57 million nonelderly Americans lack health insurance for

some part of the year. This does not even include the underinsured and those on

Medicaid whose coverage cannot begin to provide them with access that is

consistent with good health care (1994, p. 782).

As a result, the United States may not in theory ration health care, but in practice it

certainly does. As Light argues in reference to the arbitrary way private insurance

companies often make coverage decisions:

Surely, criteria for rationing should be developed openly and with fairness to all. So

far, the American health care system has relied on myriad private companies to

make not only these decisions but also related ones on the use of resources, using

hundreds of proprietary systems with different forms and different, unsubstantiated

methods (1994, p. 498).

For at least the present, most American health care planners have determined that

rationing of care, in any manner, is not a viable alternative for dealing with our

current crisis. At the same time, however, there is a shared determination by the

government and the public at large that reform is essential and that whatever

changes are made must ensure universal access to health care while controlling costs


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and reducing fraud (you will recall the discussion of distributive justice and equal

access to health care earlier in this chapter). As Friedman notes, “High health care

costs breed medical indigence; if one is to be fixed, so must the other” (1993, p.

2438).

Assisted Suicide

Although medical euthanasia (“mercy killing”) has long been an ethical issue, it has

only been in recent years that the question of assisted suicide has been examined.

The activities of Dr. Jack Kevorkian (frequently referred to as “Dr. Death” for his

activities assisting terminally and chronically ill patients to end their life) have

spurred a great deal of public and professional discussion of this issue. Several states

have considered the legality of assisted suicide. Some have rejected it (Washington),

while others have accepted it within strict guidelines (Oregon). In 1997, the U.S.

Supreme Court ruled that assisted suicide is nota constitutionally granted right,

while upholding state laws in New York and Washington banning the practice.

However, the Court left to individual states the option of legalizing assisted suicide.

From an ethical perspective, the key issue remains whether assisted suicide violates

the Hippocratic responsibilities of health care practitioners to “do no harm.” Those

who advocate its availability to patients suggest that allowing a patient to continue

to experience unrelenting pain is to do harm. They suggest that patients have the

right to make an autonomous decision to end their life; opponents worry that legal

assisted suicide would be abused (such as might be the case with Leo).


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Human Drug Experimentation

As discussed earlier, a number of ethical codes have been established by the medical

community since 1945. Several of these codes deal with research on human subjects,

including the testing of drugs. Two important ethical aspects of human drug

experimentation are the role of the institutional review board (IRB) and the use of

placebos.

The IRB is the body responsible for overseeing all clinical research conducted

within a given institution. Traditionally, most clinical drug research was conducted

in hospital settings. However, with the shift in the locus of health care delivery from

the inpatient to the ambulatory setting, IRBs are now found in managed care

organizations and other ambulatory facilities. The IRB has two primary

responsibilities. The first is to ensure the integrity and scientific rigor of the

proposed research study. The IRB evaluates risks versus benefits to study

participants. If the risks outweigh benefits, the IRB would likely reject the proposal.

The board acts as somewhat of a “subject advocate” to ensure that the patient-

subject’s rights and welfare are protected (Gallelli, Hiranaka, and Grimes, 1986, p.

487). The IRB’s second major responsibility is to evaluate and approve informed

consent forms used in conjunction with the research? Such forms should be drafted

in a manner consistent with the elements of informed consent discussed previously.

IRBs vary in their size and representation. Their membership may include

physicians, nurses, other allied health professionals (including pharmacists),


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institutional administrators, attorneys, clergy, medical ethicists, and community

members (McCarthy, 1996b).

Placebos have generally had two roles in medicine: (1) in clinical drug research, and

(2) as a means of decreasing the dose of or weaning a patient off a drug to which a

patient has become dependent. The use of placebos has long been an integral

component of clinical drug research. Whether the drug being tested is a new drug

compound or an existing drug under study for a new indication, placebos have

served as a point of comparison for determining therapeutic efficacy. Although the

use of placebos in some instances has been shown to provide therapeutic usefulness

(such as for pain control), placebos—by definition—are agents devoid of

pharmacologic activity. Patient-subjects who receive placebos as a component of

their participation in a clinical drug study can generally not hope to derive any

benefit (beneficence) from these substances. This raises the question of whether the

use of placebos in drug research, despite the obvious scientific advantages, is ethical.

This question is further complicated by the expectation that placebos will be

employed in clinical research. A Food and Drug Administration regulator has stated:

“It is desirable to include some placebo controlled studies unless it is considered

unethical to do so” (Freedman, 1990, p. 2). This suggests that the use of placebos is

ethical in certain instances but unethical in others (McCarthy, 1996b). In a meeting

in the fall of 2000, representatives of the World Medical Association approved a

change in the 1964 Declaration of Helsinki stating “that the use of placebos in

medical experiments is unethical when treatments are available for the diseases that


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are under study” (McMillen, 2000). Though this action does not have legal force in

the United States, it does carry considerable ethical weight worldwide.

The use of placebos to address genuine or perceived dependence is even more

ethically problematic. The belief that the health care practitioner knows best and,

therefore, is justified in practicing medical paternalism has been a long-standing

component of the “medical authority” model of practice. Under this model, the

patient’s perceptions and desires are subjugated to the judgment of the health care

professional. This type of thinking would be used, for example, as justification for a

practitioner to shift a patient judged to be drug dependent to a placebo without the

patient’s knowledge. Today, such use of placebos with-out patient knowledge and

consent might be judged to be un-ethical—a direct violation of patient autonomy

and informed consent.

Drug Formularies

A drug formulary is a list of drugs that are approved for use either within an

institution (such as a hospital) or for reimbursement by a third-party payer. Its

purpose is to eliminate therapeutic duplication and provide patients with the best

drug at the lowest cost (see Chapter 22). In their early days, formularies were used

by hospitals to control drug inventories and provide prescribers with a list of “drugs

of choice” for various conditions. However, a drug’s absence from the formulary

was not usually a great barrier to a prescriber’s obtaining it for a patient. The


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prescriber could make a special request to a member of the hospital’s pharmacy and

therapeutics committee and, usually, the drug would be obtained.

When managed care organizations and pharmacy benefit management companies

began to employ formularies, circumventing them became much more difficult. This

restrictive nature of formularies has led to a number of important ethical questions.

For example, does the use of generics or therapeutic substitution violate the

autonomy of the patient or prescriber? Is the use of such substitution a violation of

informed consent? Does the use of formularies violate the ethical principles of

beneficence (“do good”) and nonmaleficence (“avoid harm”) (McCarthy, 1996a)?

However, one could argue that the use of formularies and the resultant constraint on

drug costs helps to ensure affordable access to quality health care for more people

(distributive justice).


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