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LITHUANIAN UNIVERSITY OF HEALTH SCIENCES FACULTY OF PUBLIC HEALTH ETHICAL ISSUES CONCERNING DRUG PROMOTION IN INDIA AND LITHUANIA Master Thesis Master of Public Health

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LITHUANIAN UNIVERSITY OF HEALTH SCIENCES

FACULTY OF PUBLIC HEALTH

ETHICAL ISSUES CONCERNING DRUG PROMOTION IN INDIA AND

LITHUANIA

Master Thesis

Master of Public Health

Student Haritha Dileepkumar Perumannu Kalarikkal Dileepkumar

Supervisor assoc. prof. dr. Gvidas Urbonas

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SUMMARY

Ethical issues concerning drug promotion in India and Lithuania Aim

The aim of the study was to explore and compare the ethical issues concerning the relationship between physicians and the pharmaceutical industries from the perspective of Lithuanian and Indian physicians.

Methods

A cross-sectional study was conducted in India in June 2018 and in Lithuania in January 2019. The population – physicians working at tertiary level health care centers in Lithuania and India. A convenience sampling method was used. A total of 300 surveys were distributed to the respondents and 179 surveys were received (response rate – 59.7%). An originally elaborated questionnaire was employed to gather socio-demographic variables as well as attitude and exposure of respondents. Statistical significance was evaluated if p < 0.05.

Results

Indians believed that medical representatives act unethically while promoting their drugs (84.5%) or while comparing their drugs with other (76.3%) companies‘ medicines, meanwhile significantly smaller proportions of Lithuanians expressed positive attitudes towards this: 43.4% and 38.6% respectively (p < 0.05). While Lithuanian doctors thought that it‘s OK to give or accept gifts, Indian doctors tended to think that such practices are not acceptable (p < 0.05). While Indians thought that gifts did not affect their prescribing behavior, Lithuanian doctors thought oppositely (p < 0.05). The most popular type of gift for Indian physicians was meals; 30-80% of Indian respondents were offered these gifts at least once per month, while 20% of Lithuanians respondents were offered meals at least once per month (p < 0.05). Large gifts highly correlated with local trips (0.84), international trips (0.91), and travels to conference (0.87). Symbolic gifts appeared to have average correlation with the attitude that accepting gifts is not OK (0.47) and small gifts appeared to have average correlation with the attitude that giving gifts is not OK (0.40). Age had weak correlation with meals (0.27), symbolic gifts (0.29), and the attitude that accepting gifts is not OK (0.39).

Conclusion

Lithuanian and Indian physicians‘ attitudes differed on different aspects of ethics in drug promotion. Indians were more negative towards giving and getting gifts, but also, they thought that gifts did not affect their decisions. Meanwhile, Lithuanians tended to think that there‘s nothing wrong in giving and accepting gifts, however, they felt that gifts effected their decisions. The more

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3 often the respondents were offered meals, symbolic and small gifts, the more they thought that it‘s not appropriate to either give or accept promotional gifts.

Keywords: drug promotion, professional ethics, medical doctors, India, Lithuania, ethical

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TABLE OF CONTENTS

LIST OF TABLES ... 5 LIST OF FIGURES ... 6 INTRODUCTION ... 7 ABBREVIATIONS ... 9

AIM AND OBJECTIVES ... 10

1. LITERATURE REVIEW ... 11

1.1. Ethical Criteria for Drug Promotion by WHO ... 11

1.2. Unethical Drug Promotion and Threats ... 11

1.3. Relationship between Physicians and the Pharmaceutical Industry ... 11

1.4. Ethical Standards for Marketing of Pharmaceutical Products ... 14

1.5. Comparison of Ethical Standards for Drug Marketing in Lithuania and India ... 15

1.5.1. Ethical Standards in Lithuania ... 15

1.5.2. Ethical Standards in India ... 17

2. METHODOLOGY... 19

2.1. Study Area, Design, and Population ... 19

2.2. Research Instrument ... 19

2.3. Statistical Data Analysis ... 19

2.4. Research Ethics ... 20

3. RESULTS ... 21

3.1. Social and Demographic Characteristics of Respondents ... 21

3.2. Attitudes of Physicians towards Drug Promotion ... 22

3.3. Factor Analysis of Doctors‘ Attitudes towards Ethics of Drug Promotion ... 28

3.4. Doctors‘ Exposure to Gifts from Pharmacy Representatives ... 31

3.5. Correlations between Exposure to Accepting Gifts and Attitudes towards Drug Marketing Ethics ... 35 4. DISCUSSION OF RESULTS ... 37 CONCLUSIONS ... 40 PRACTICAL RECOMMENDATIONS ... 41 LITERATURE ... 42 ANNEX 1 ... 46 ANNEX 2 ... 48

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LIST OF TABLES

Table 1.5.1. Comparison of ethical drug promotion in Lithuania and India ... 18

Table 3.1.1. Socio-demographic characteristics of respondents ... 21

Table 3.3.1. Rotated component matrix ... 29

Table 3.4.1. Type of gift and mean value... 34

Table 3.5.1. Correlation matrix of the variables age, attitudes towards drug promotion ethics and exposure to gifts. ... 35

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LIST OF FIGURES

Fig. 3.2.1. Opinion that MR often act unethically when comparing products with the products from

other companies... 22

Fig. 3.2.2. Opinion that even symbolic gifts distort the free drug market ... 22

Fig. 3.2.3. Opinion that drug companies usually act unethically when promoting drugs to doctors ... 23

Fig. 3.2.4. Opinion that MR visits must undergo strict supervision ... 23

Fig. 3.2.5. Opinion that it‘s appropriate to accept symbolic gifts from MR... 24

Fig. 3.2.6. Opinion that there‘s nothing wrong in allowing MR‘s visits during working hours ... 25

Fig. 3.2.7. Opinion that accepting gifts of high-value from MR is an offence ... 25

Fig. 3.2.8. Opinion that free samples from MRs are useful to help disadvantaged patients ... 26

Fig. 3.2.9. Opinion that symbolic gifts do not affect objectivity when recommending drugs ... 26

Fig. 3.2.10. Opinion that symbolic gifts have no effect on priorities when selecting drug alternatives 27 Fig. 3.3.1. Generalized attitudes towards the ethics in drug promotion ... 30

Fig. 3.3.2. Attitudes towards ethics in drug promotion by gender ... 30

Fig. 3.4.1. Meal as a form of promotional gift offered to doctors... 31

Fig. 3.4.2. Symbolic gifts as a form of promotions offered to doctors ... 31

Fig. 3.4.3. Small gifts as a form of promotion offered to doctors ... 32

Fig. 3.4.4. Large gifts as a form of promotion offered to physicians ... 32

Fig. 3.4.5. Local trips as a form of promotion for medical doctors ... 33

Fig. 3.4.6. International trips as a form of promotion to doctors ... 33

Fig. 3.4.7. Travel to conference as a form promotion to doctors ... 33

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INTRODUCTION

World Health Organization (WHO) defined drug promotion as material or information provided by drug manufacturers with the ultimate goal of increasing prescribing or purchasing of drugs. Gathering information about physician‘s attitude and behaviour towards drug promotion is essential as it provides insight into where relevant interventions are needed. Several studies have shown that peoples‘ attitudes towards promotion do not necessarily correspond with their behaviour.

The pharmaceutical promotion and marketing expenditure in the USA, in 2000 was $15.7 billion which was 20–30% of sales turnover and 2- to 3-times that of research and development (National Institute for Health Care Management, 2001). Half of this expenditure is directed to the price of medicine samples (50.3%) and detailing visits to physicians (25.5%). The latter has been an ethical focus of interest on the communication between pharmaceutical companies and physicians concerning drug promotion. These relations are sometimes helpful and sometimes have consequences for patients [1].

The failure to promote drugs results in loss of sales and lower profits, leading to a reduction in research and development (R&D) funding and ultimately putting the brakes on drug development.

It has been suggested that physicians who rely on drug company information, through drug detailers or promotional literature, prefer expensive brands, adopt newer medicines more quickly, show more inappropriate prescribing and write more prescriptions that their colleagues [2]. Drug company marketing strategies include a multitude of gifts and benefits ranging from low-cost gifts to expensive trips and grants. Although this phenomenon leads to suboptimal prescribing practices and promotes more expensive medical treatments with no evidence of therapeutic benefit over lower-cost options [3-5].

Ethical concerns have been raised about the impact that the pharmaceutical companies may have on physicians and pharmacists and the outcome it could bring on their prescribing and dispensing practice if they got used to receiving gifts [6].In view of growing amounts of money companies involved in this activity, it is becoming ever more important to understand the impact that drug promotion has no prescription and use of medicines. In the USA, US$21 billion was spent on drug promotion and US$26 million was spent on direct-to-customer- advertising (DCTA) in 2002 [7]. In the developing countries, the only source of medical information is medical representatives, where each physician may have as many [8]. Medical association codes might have stronger provisions, but are impracticable and depend on their moral suasion. Resource limits can be monitored by a small fraction of activities in the few countries in which promotion is controlled

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8 by the government [9]. There would be no concern when promotion leads to better prescription, rational use of medicines or improved cost efficacy. Although the evidence is not conclusive, there is a strong link between the use of prescription drugs and the less suitable overall use of these drugs [10]. High promotion of new drugs leads to extensive prescription and use before a full understanding of the safety profile of these products [11]. Therefore, we decided to estimate Lithuanian and Indian physicians‘ attitudes towards drug promotion ethics and their exposure to promotional gifts in this study.

Uncontrolled and unethical drug promotion has negative impacts on public health, as pharmaceutical companies tend distort free drug market while trying to increase sales by offering doctors incentives and gifts to prescribe those drugs for the patients. This causes burden to national health systems as patients, especially the disadvantaged ones, and states face the threat of losing money due to distorted market. Another public health problem is irrational drug use that might be promoted due to unethical drug marketing strategies [5][50]. Therefore, drug marketing must undergo strict governmental control and MRs as well as doctors‘ self-control.

In spite of the world-wide recognition of research ethics, very little data on the research ethics was available in both Lithuanian and Indian issues. The attitude of medical doctors on giving and accepting gifts about drug marketing ethics varies in different countries as this behavior has an impact on patient while prescribing drugs. Therefore, the main novelty of this research is that no studies were conducted that compared India and Lithuania in the context of drug promotion. This study is designed to contribute to previous national and international studies to evaluate the ethics in drug promotion.

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ABBREVIATIONS

WHO - World Health Organization R&D - Research and Development

DTCA - Direct‐to‐consumer advertising of prescription medicines CME - Continuing Medical Education

PSR - Pharmaceutical sales representatives MR - Medical Representatives

OPPI - Organization of Pharmaceutical Producers of India NIHCM - National Institute of Health Care Management

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AIM AND OBJECTIVES

The aim of the study was to explore and compare the ethical issues concerning the

relationship between physicians and the pharmaceutical industries from the perspective of Lithuanian and Indian physicians.

Objectives:

1. To explore Lithuanian and Indian physicians‘ attitudes towards ethical issues in drug promotion. 2. To explore Lithuanian and Indian physicians‗ exposure to promotional gifts.

3. To assess the relationship between physicians‘ attitudes towards drug promotion and their exposure to drug promotion activities.

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1. LITERATURE REVIEW

1.1. Ethical Criteria for Drug Promotion by WHO

Only drugs legally available in the country within a country should be actively promoted. Promotion should be consistent with national health policies and national regulations, and where there are voluntary standards. All claims concerning medicinal products should be reliable, accurate, true, informative, balanced, up-to-date, supportive and in good taste. Ethical criteria to promote drugs should provide the foundation for proper behavior in promoting medical drugs according to the search for truthfulness and justice. Thus, criteria should help to establish whether promotions of medical products meet acceptable ethical standards.

1.2. Unethical Drug Promotion and Threats

Pharmaceutical drug promotion is a way to earn money, thus pharmaceutical industries invest in the promotion of drugs than the research. I short ―drug promotion is a source to earn money‖. Doctors gather information about drugs from pharmaceutical sales representatives. Sales representative formulate the documents about the drugs and distribute free medicine samples with promotional gifts to increase the marketing of drugs. Misleading documents and information initiate health professionals in order to prescribe their products. Many studies suggest that doctors are offered many types of gifts (small gifts, large gifts, trips, payment etc.).

1.3. Relationship between Physicians and the Pharmaceutical Industry

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 doctor‘s community to practice in the limit of ethical and moral grounds‖ [12].

Many studies found that pharmaceutical sales representative‘s relationship with medical practitioners starts from their school itself. Meetings with pharmaceutical representatives were linked to physicians 'requests to add the drugs to the hospital form and changes in prescription practice. Drug company-sponsored continuing medical education (CME) preferentially highlighted the sponsor's drug(s) compared with other CME programs. Increased prescription rates of the sponsor‘s medication were associated with attending sponsored CME events and accepting gifts (travel, accommodation) for educational symposia. The non- rational prescription was also accompanied by attending prescriptions given by pharmaceutical representative speakers [10].

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12 Medical and pharmaceutical professionals are expressing serious concerns and disputes in both the medical industry and the general public [13,14]. It is clear that the association between the pharmaceutical industry and physicians influence their attitudes in relation to both clinical decisions and research. This might cause a risk to patients so that physicians should be careful during their dealings with the pharmaceutical industries. Transparency and openness between physicians and the pharmaceutical industry should be the major motto [15].

Doctors generally perceive how they practice being determined by knowledge and evidence, but the subtle all-encompassing effects of pharmaceutical promotion are often disregarded by commercial effects in therapeutic decisions. It is disturbing that some practitioners rely on representatives of pharmaceutical companies for their information. In spite of the fact that medical professionals often refuse it, there is considerable information that publicity affects the conduct of clinical decision-making. This leads to the prescribing of their drugs [16]. Medical doctors who are exposed to advertising are more likely to accept commercial and non-scientific opinions [2], and the advertising of a drug company is associated with the inability of certain doctors to identify false claims or a propensity to conduct in a non-rational way. A long-established culture in which gratuities, gifts and similar are expected, is the result of the current pattern of relationships between doctors and the pharmaceutical industry.

Pharmaceutical funding plays an important role in medical progress. Thus, clinical and academic research has been significantly commercialized [17]. The percentage of physicians with any relationship to industry is at 80% or even more [18, 19]. The primary reason for sponsorship by industry may be subtle psychological effects and expectations of reciprocity [20]. Material goods such as medicinal products or medicines can best be manufactured and distributed by market mechanisms, but social and personal relations should still be regulated by moral values [21].

The‖ presentation and donation among Australian pharmaceutical companies and medical experts examined the ―gift-relationship‖ between pharmaceutical companies and physicians: gifts are a controversial element in the relationship between the pharmaceutical sector and the medical industry [2,22,13,14]. The number of doctors donated and the number of their dealings with the industry are positively linked to doctors‘ requests for a company‘s drug products, despite less expensive generic formulas [13].

Many doctors receive multiple donations every year, and despite substantial evidence to the contrary, most doctors do not have their influence [13]. It is warranted for the pharmacists to assess the exposure and attitudes and acceptance of the use of drugs, to adopt a random, multiple sites and cross-sectional survey, and for physicians and pharmacists to complete surveys on the exposure, acceptance or skeptics of Saudi pharmaceutical professionals to drug promotion and the perception of appropriate drug promotion [23].

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13 Communications and interactions between pharmaceutical industries and physicians/pharmacists regarding drug promotion and marketing have been lately the focus of interest from an ethical view. These interactions are pervasive and often influential and beneficial for the patient but they may turn into some undesirable consequences [1]. Prior research has shown that medical practitioners receiving donations are more beneficial towards the company and are more likely to prescribe the product of company [24,23].

Nevertheless, physicians remarkably reported greater exposure than pharmacists. This is due to that industrial companies realize that physicians can be powerful advocates for their products but raises concerns regarding conflict-of-interest at medical centers. The majority of physicians or pharmacists participating in this study have offered gifts from pharmaceutical industries. The drug samples and printed educational materials are the most widely accepted gifts. [23]

Donations to physicians are being scrutinized, but no previous research has evaluated the effect of these gifts on confidence. The objectives of the study are to determine the patient awareness and impact of these interactions on trust and doctor-patient relationships between physicians and the pharmaceutical industries [25,13]. Pharmaceutical companies spend a large amount of money on doctors to promote their products. There is some evidence of physicians having negative impacts on their prescription patterns with pharmaceutical companies. There is evidence that physicians‘ interactions with pharmaceutical companies can lead to a conflict of interest [26] and decrease public trust in physicians and the healthcare system [27].

Medicines promotions by producers and distributors are defined by the World Health Organization as all the information and inspiring activities that influence medical drug prescribing, supplying, procuring and use [28]. The researchers classified ‗incentives‘ as objects donated to doctors that are of considerable value and are probably used for incentives. The study shows the industrialization of unethical and illegal drug promotion practices at the expense of drug companies and physicians [29].

―This review is to explore interactions and their impact on the attitude and prescription behavior of physicians and the pharmaceutical industry, including sales representatives, are the interactions between physicians and the sales representatives of the pharmaceutical industry‖. The interactions and acceptance of gifts from the pharmaceutical sales representatives by doctors have been found to affect medical prescription behavior and likely contribute to irrational drug prescription [30]. The acceptance of free samples was considered as more appropriate than any other gifts, samples were considered to have an influence on practices of prescription [31].

The troublesome relationship between physicians and pharmaceutical sale representatives in terms of the regular visits, the trust of medical practitioners in the information supplied by sales reps, gifts accepted, and the general influence of marketing strategies on physician decisions.

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14 Challenges remain, despite laws enacted to address the problem. These gifts are not against the law in Poland; under Polish pharmaceutical law (article 58, section 3, 2008) [32] and the Code of Pharmaceutical Marketing Ethics (article 9) [33] a doctor may accept a gift that might enhance his medical practice, up to the value of PLN 100 (equal to EUR 25 or USD 33). This research points out that despite recently sharpened Polish law on relations between doctors and pharmaceutical representatives, there still remain many challenges for both the medical profession and the medical companies [34].

Medical students are targeted by the medical companies and are exposed to their marketing strategies even in the preclinical years of study. The marketing strategies used by pharmaceutical companies with physicians are also applied to students, affecting their future prescribing behavior, and include low-cost non-educational gifts, travel expenses, and conferences registration fees. Their results suggest that medical students in Greece are notably exposed to pharmaceutical industry marketing and their conflicting answers demonstrate, they are inadequately prepared for this interaction.

1.4. Ethical Standards for Marketing of Pharmaceutical Products

Pharmaceutical organizations, which are made up of pharmacists who have the responsibility to maintain an ethical relationship within the company, are governed by their professional bodies. Their code of conduct requires them to ensure the upholding of ethical standards in large investment and stakeholders by pharmaceutical companies due to this, several countries not only regulate pharmacists but also pharmaceutical companies, as individuals that must respect the code of ethics.

In the marketing of their products, pharmaceutical industries use marketing representatives‘ services. These sales representatives must be trained adequately and have sufficient knowledge of medicine and technology to provide accurate and responsible information on the products. Not only should the sales representative be able to provide precise knowledge, but also not to exaggerate the capabilities of the product. He or she should be able to discuss the product properly or the mode of action of the medicine and potential side effects. It is a well-known practice for a sales representative to give free samples to physicians. All these free sample need to be accounted for by way of recording by the pharmaceutical company so that the traceability of the product can be maintained for the purpose of product recall.it is not ethical to give doctors other donations from pharmaceutical companies. Free travel board under the pretense of sponsorship for conferences or workshops is a good example. In this case, drug companies and the doctor are both responsible for misconduct under their own code of conduct.

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15 In many countries, pharmaceutical organizations have developed a code of marketing practices for their members. Recommendation included that all marketing activities under the code should comply with the current and applicable government laws governing pharmaceutical industry practice. The code stresses that members should have good management of complaints which documented procedures of investigation and with set time frames for processing each complaint lodged. The results of a complaint inquiry should also be documented in corrective and preventive way. The code also describes all potential problems in disclosure to medical and related professions of accurate fair and objective information, in order for rational decisions made on prescribed products. Members are required in the marketing of pharmaceutical products to follow high standards and professionalism. Such a code should have a committee of ethics that can hear, receive and discuss all ethical violations. This committee should establish sanctions for violation of the code and publish the names of companies found to be contravening the code that may adversely affect them [35].

The interactions with pharmaceutical industry centers around medical students, physicians, and nurse practitioners, and finds success on the part of industry in achieving their desired changes in attitudes and behaviors [36-38]. In 1988, the WHO published criteria for the ethical promotion of medications.

1.5. Comparison of Ethical Standards for Drug Marketing in Lithuania and India

1.5.1. Ethical Standards in Lithuania

According to the Code of Ethics for Pharmaceutical Marketing (2013):

The name ―safe‖ never should be used without proper qualification to describe a medical product.

 No product that has been generally available for more than one year or therapeutic indications that have generally been supported for over one year should be described or presented using the word ―new‖.

Companies should always uphold high ethical standards.

 Be of a nature that takes into account medicines and the recipients professional status, but never susceptible to an offense.

 The term ―appropriate‖, not in conflict with applicable laws and regulations of Republic of Lithuania, shall be considered complaint with this code. Any activities that presume that science and education are confusing with entertainment or other purposes must be avoided in those events.

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16  Most invitations originate outside Lithuania and it makes more logistical sense to hold the

event in another country, because of the countries of origin of the majority of invitations.  The organization in another country is more logistic in view of the location of the relevant

resource or expertise being the object or subject of the event.

 Healthcare professional cannot be offered, given or promised to any gift or financial advantage (in cash or in kind).

 Medical representatives must ensure that there is no inconvenience to healthcare professionals or to patients as regards frequency, timelines and time of visits to a medical professional by medical sales agents.

 The promotion of (sponsoring), before giving marketing permit, of the sale or supply or without its approved indications, of medical product is prohibited.

Promotion must comply with the specifics listed in the Medicinal Product‘s summary of product characteristics.

 Medical sales representatives must provide visitor(s) with a synopsis of the product features for each medicinal product they are presenting during every visit and subject to applicable laws and regulations.

 Medicines promoters may use samples of non-prescription medicines to promote medicinal products to healthcare professionals qualified to prescribe medical products. A medical product not for sale shall not exceed the smallest display of the medicinal product and shall be marked with the ―Free Sample‖ of the medicinal product. It is prohibited to leave samples of medical practitioners not intended for sale, to distribute them to public and to use them for healthcare.

 Companies must have appropriate control and accountability systems administrated y their representatives for samples of representatives for samples of non-selling medicines as well as all medicines.

 Companies may encourage medical professionals to participate in international scientific events organized by professional healthcare and scientific institutions in the Global, European, North American, Scandinavian and Baltic regions. The term ―sponsorship‖ includes sponsorship by medical institutions, healthcare professional unions, specialist societies, foreign subsidiary companies etc.

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1.5.2. Ethical Standards in India

According to the OPPI Code of Pharmaceutical Practices, 2012:

 Claims for usefulness of a drug must be based on an up-to-date evaluation of all the evidence.

 No new medicinal product or therapeutic indication, generally promoted in India, for more than 12 months.

The word ―safe‖ must not be used without any qualification or categorically specifies that a medicine does not have any side effects, toxic dangers or risk of addiction.

Medical professionals ‗names or photographs‘ should not be used in promotional material. Free drugs shall not be delivered to anyone not qualified to prescribe the drug.

 No gifts, financial benefits or benefits may be offered or promised by a drug company or any of its agents, to those who are qualified to prescribe or supply drugs.

 Travel facilities: Companies or their associations/representatives or any person acting on their behalf shall not extend any travel facility inside the country or outside to Health Care Professionals and their family members for vacation or for attending conference, seminars, workshops, CME programme etc. as a delegate. It is clarified here by if a medical practitioner participates as a delegate in any seminar, conference organized by a drug firm to promote a drug or to disseminate information, will be at own expense.

 Hospitality: under no pretext shall companies or their associations or representatives extend to healthcare workers and their family members any hospitality like hotel accommodation under any circumstances.

 Medical research funding may only be extended to approved institutions in a transparent manner by means of modalities provided in regulations guidelines adopted by these approved bodies. It is always fully communicated.

When summarizing the codes of ethical drug promotion in Lithuania and India we found that they cover the same aspects and regulate in similar ways (Table 1.5.1.).

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Table 1.5.1. Comparison of ethical drug promotion in Lithuania and India Sensitive Areas in Drug

Promotion

Lithuanian Code of Ethics Indian Uniform Code of Pharmaceuticals Marketing Practices

Ethical Criteria for Medicinal Drug Promotion by WHO

Gift Forbidden Forbidden Accepted

Free sample Forbidden Forbidden Accepted

Travelling Forbidden Forbidden Forbidden

Sponsor of an event Forbidden Forbidden Forbidden

Advertisements Forbidden Forbidden Accepted

Money Forbidden Forbidden Forbidden

Hospitality Forbidden Forbidden Accepted

To summarize, Lithuania and India cover all aspects provided in international documents and are even stricter compared to WHO.

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2. METHODOLOGY

2.1. Study Area, Design, and Population

A cross-sectional study was conducted in India in June 2018, and in Lithuania in January 2019. The population – physicians working at tertiary level health care service hospitals (Apex clinic and Metro healthcare in India and Lithuanian University of Health Sciences Kaunas Clinics in Lithuania). A convenience sampling [39,40] method was used to draw the sample of respondents for this survey. A total of 300 surveys were given to the respondents and 179 surveys were collected (response rate – 59.7 %).

The survey sample were medical doctors from cardiology, pediatrics, ENT, ICU, neurology, pediatrics, oncology and hematology, gynecology, dentistry clinics. The study was performed after getting the local authority permission in each institution.

2.2. Research Instrument

A questionnaire was elaborated to evaluate physicians‘ attitudes towards drug marketing ethics and their exposure to gifts they were offered by pharmacy representatives. The questionnaire consisted of three sections: (1) socio-demographic characteristics of respondents, (2) a set of questions used to estimate respondents‘ attitudes towards the ethics of drug promotion and (3) a set of questions to estimate how often respondents were offered different types of gifts from pharmaceutical companies‘ representatives (Appendix no 2). The attitudes of the respondents regarding drug promotion were estimated using a 5-point Likert scale ranging from „strongly disagree― to „strongly agree―, while the frequency of gifts being offered to doctors were estimated using 5-point Likert scale ranging from ―never to everyday ―.

2.3. Statistical Data Analysis

The obtained data were coded and analysed with a statistical program „IBM SPSS 20―. The data were analysed by using descriptive statistics methods (Chi-square, two-sample t-test). Also, in order to find the structure of the attitudes towards the ethics of drug marketing, the principal com-ponent analysis method was applied. As a result of factor analysis, regression factor scores were computed in order to detect differences in attitudes between Lithuanian and Indian physicians. In order to assess the relationships between attitudes towards drug promotion ethics and exposure to accepting gifts, Spearman correlations (0.00-0.19- very weak, 0.20-0.39-weak, 0.40-0.59- moderate,

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20 0.06-0.79- strong and 0.80-1.0 – very strong) [41] were calculated. P-value of 0.05 was used to find significance.

2.4. Research Ethics

All respondents of this study were under oral informed consent and received written information about the purpose of the study as well as the guarantee of confidentiality in the preamble of the questionnaire. All gathered information was kept in confidentiality and generalized so to prevent any identification of research participants.

The study project was presented to the Bioethics Centre of Lithuanian University of Health Sciences and the approval was received in 2018-11-16. The copy of approval is attached at the Appendix No. 2.

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3. RESULTS

3.1. Social and Demographic Characteristics of Respondents

We have collected data from various physicians of different age, gender, occupation, and specializations from different departments of various hospitals from India and Lithuania (Table 3.1.1.).

Table 3.1.1. Socio-demographic characteristics of respondents

Country, N (%) Total India Lithuania Gender Male 60 (61.9%) 28 (33.7%) 88(48.9%) Female 34 (38.1%) 55 (66.3%) 92(51.1%) Occupation

Head of the clinics 7 (7.2%) 1 (1.2%) 8(4.4%)

Medical doctor, professor 1 (1%) 5 (6%) 6(3.3%)

Medical doctor 82 (84.5%) 17 (20.5%) 99(55.0%) Medical resident 7 (7.2%) 60 (72.3%) 67(37.2%) Specialization Cardiology 2 (2.1%) 3 (3.6%) 5(2.8%) Surgery 1 (1.0%) 0 (0.0%) 1(0.6%) Pediatrics 23 (23.7%) 7 (8.4) 30(16.7%) Oncology 0 (0.0%) 8 (9.6%) 8(4.4%) General 16 (16.5%) 39 (47.0%) 55(30.6%) ENT 13 (13.4%) 0 (0.0%) 13(7.2%) General doc 7 (7.2%) 0 (0.0%) 7(3.9%) Orthopedics 13 (13.4%) 0 (0.0%) 13(7.2%) Endocrinology 1 (1.0%)) 0 (0.0%) 1(0.6%) Dentistry 2 (2.1%) 0 (0.0%) 2(1.1%) Dermatology 0 (0.0%) 7 (8.4%) 7(3.9%) ICU 3 (3.0%) 0 (0.0%) 3(1.7%) Pulmonology 16 (16.5%) 0 (0.0%) 16 (8.9%) Neurology 0 (0.0%) 19 (22.9%) 19 (10.6%)

Table 3.1.1. shows that 61.9% of men and 38.1% of women from India and 33.7% of men and 66.3% of Lithuanian women took part in survey. Physicians from various categories were participated in survey. Medical doctors responded more in India (84.5%) while in Lithuania medical residents (72.3%) were more participants. Physicians from pediatrics 23 (23.7%) responded more in India while in Lithuania general practitioners 39 (47.0%) and doctors from neurology 19 (22.9%) respondents were more.

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3.2. Attitudes of Physicians towards Drug Promotion

Concerns arise if promotion has a negative impact on the pattern of prescribing. Therefore, we provided doctors with a set of sentences concerning different aspects of ethics of drug marketing an asked to express their attitudes towards the phenomenon.

Higher proportion of Indians agreed with the statement that Medical representatives often act

unethically when comparing their products with the products from other companies (Fig. 3.2.1) as

compared to Lithuanians. Higher proportion of Lithuanians was neutral to the statement as compared to Indian doctors (* - p < 0.05).

Fig. 3.2.1. Opinion that MR often act unethically when comparing products with the products from other companies (* - p < 0.05, compared to Indians)

When analyzing doctors‘ attitudes towards symbolic gifts we found that more than a half of Indian doctors (55.7%) agreed that even symbolic gifts distort the free drug market (Fig. 3.2.2), while almost every second (51.8%) Lithuanian respondent was neutral towards the sentence.

Fig. 3.2.2. Opinion that even symbolic gifts distort the free drug market (* - p < 0.05, compared to Indians)

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23 Almost two times higher proportion of Indian physicians believed that drug companies

usually act unethically when promoting their drugs to doctors (Fig. 3.2.3.) as compared to

Lithuanian respondents (p<0.05). Meanwhile, five times higher proportion of Lithuanian doctors did not agree that drug companies act unethically while during promotional activities (p<0.05).

Fig. 3.2.3. Opinion that drug companies usually act unethically when promoting drugs to doctors (* - p < 0.05, compared to Indians)

Interesting results were found regarding the statement that the visits of pharmaceutical

representatives must undergo supervision (Fig. 3.2.4.). Almost every Indian and only every second

Lithuanian agreed with the sentence (p<0.05). 43.9% of Lithuanians answered as neutral to the statement and only 1% of Indians respectively. About 8.5% of doctors from Lithuania showed negative response towards the statement, while there were no Indian physicians who thought that strict supervision is not necessary.

Fig. 3.2.4. Opinion that MR visits must undergo strict supervision (* - p < 0.05, compared to Indians)

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24 More than half of Indian and one third of Lithuanian doctors (p<0.05) reacted negatively to the statement that it is appropriate to accept symbolic gifts from pharmaceutical representatives, if

legally allowed (Fig. 3.2.5.). Similar proportions of doctors from both countries thought that

accepting gifts is not bad if it does not go against the law.

Fig. 3.2.5. Opinion that it‘s appropriate to accept symbolic gifts from MR (* - p < 0.05, compared to Indians)

Almost every Indian (99.0%) negatively responded to the statement that there’s nothing

wrong in allowing pharmaceutical sales representative’s visits during my working hours (Fig.

3.2.6.), while one third of Lithuanians (p<0.05) were against being disturbed during working hours. Similar proportions of Lithuanians either had no opinion about pharmacists‘ visits (36.1%) or thought that there‘s nothing wrong for pharmacists to visit a doctor during working hours (28.9%).

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25

Fig. 3.2.6. Opinion that there‘s nothing wrong in allowing MR‘s visits during working hours (* - p < 0.05, compared to Indians)

Nearly all Indian physicians thought that accepting gifts of high-value from a pharmaceutical

sales representative is offence‖ (Fig. 3.2.7.), while only every second (56.6%) Lithuanian believed

the same, and even one fifth (20.5%) of Lithuanians expressed opposite opinion (p<0.05).

Fig. 3.2.7. Opinion that accepting gifts of high-value from MR is an offence (* - p < 0.05, compared to Indians)

For the statement “Free samples from the medical representatives are useful to help the

dis-advantaged patients” (Fig. 3.2.8.) both Indian and Lithuanian physicians shows a positive response

to the statement and a small one quarter of Lithuanians and a small proportion (8%) Indians were neutral to the statement, mean while there were few doctors who were negative towards statement.

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26

Fig. 3.2.8. Opinion that free samples from MRs are useful to help disadvantaged patients (* - p < 0.05, compared to Indians)

From the survey, Most physicians from India and Lithuania show positive attitude towards the statement ―Symbolic gifts do not affect my objectivity when recommending a drug to my patient‖ (Fig. 3.2.9.) were positive. But there was a group of doctors from both countries who didn‘t had any views, i.e. they were neutral towards the statement.

Fig. 3.2.9. Opinion that symbolic gifts do not affect objectivity when recommending drugs (* - p < 0.05, compared to Indians)

Results showed that, every physician from India and three fourths of Lithuanians (p < 0.05) thought that symbolic gifts have no effect on priorities when selecting drug alternatives” (Fig. 3.2.10.).

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27

Fig. 3.2.10. Opinion that symbolic gifts have no effect on priorities when selecting drug alternatives (* - p < 0.05, compared to Indians)

To summarize, Lithuanian and Indian physicians expressed very different attitudes towards the ethics in drug promotion. Indians believed that medical representative’s acts unethically while promoting their drugs, comparing their drugs with other products while Lithuanians showed an opposite attitude towards this. Indian doctors believed that accepting gifts distorts the drug free market while Lithuanians had no opinion towards this. On the other hand, both Lithuanian and Indian doctors had a positive attitude towards high valued gifts, i.e. high value gifts should not be accepted by physicians. So, this shows that Indian physicians expressed more ethical attitudes as compared to Lithuanians.

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28

3.3. Factor Analysis of Doctors’ Attitudes towards Ethics of Drug Promotion

The principal component analysis was applied to determine the structure of the attitudes of medical representatives towards the drug promotion (see Chapter 3.2.). The sample adequacy measurement (KMO = 0.764) and sphericity test by Bartlett‘s (χ2 = 361.217, df = 45, p < 0.05) indicated that factor analysis has been appropriate. The Kaiser rule (eigenvalue greater than one) was used to determine the number of factors. The Varimax rotation method was used to obtain orthogonal factors. Using this method, a three-factor structure was obtained that explained the total variance of 57.15%. Table 3.3.1. shows the obtained factor loadings.

The first factor was termed as ―Giving gifts is not OK‖, as it was related with the provision of information about giving gifts to the physicians, unethical acts while comparing drugs, giving symbolic gifts, unethical acts while promoting drug, visit should undergo strict supervision.

The second factor was termed as ―Accepting gifts is not OK‖, because it included such aspects as accepting gifts if legally allowed, sales representatives can visit during working hours, accepting gift of high value is offence.

The third factor was termed as ―Gifts do not affect prescribing behavior‖, because it includes the aspects of helps the disadvantaged patients, gifts will not affect recommending drug, gifts has no priorities while selecting alternative drugs. All three factors were medium correlated (Spearman r=0.45; p<0.05).

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29 Table 3.3.1. Rotated component matrix

INDICATORS FACTORS Giving gifts is not OK Accepting gifts is not OK

Gifts do not affect prescribing behavior Medical representatives often act unethically when

comparing their products with the products from other companies

0.765 -0.026 0.305

Even symbolic gifts (e.g., reminders, pens) distort the free drug market

0.724 0.017 -0.146

Drug companies usually act unethically when promotion their drugs to doctors

0.605 0.398 -0.076

The visits of pharmaceutical sales representatives must undergo strict supervision.

0.603 0.435 0.28

It is appropriate to receive symbolic gifts from pharmaceutical representatives, if legally allowed.

0.105 -0.737 0.274 I see nothing wrong in allowing pharmaceutical sales

representative‘s visits during my working hours. 0.185 -0.699 -0.264 Accepting gifts of high-value from a pharmaceutical sales

representative is an offence

0.305 0.681 0.337 Free samples from medical representatives are useful to

help the disadvantaged patients

0.086 0.056 0.686 Symbolic gifts do not affect my objectivity when

recommending a drug to my patient

0.086 -0.041 0.656 Symbolic gifts have no affect on my priorities when

selecting drug alternatives

0.243 0.234 0.615 Extraction Method: Principal Component Analysis.

Rotation Method: Varimax with Kaiser Normalization.

The next step of data analysis was to compare the means of factor scores according to the country and gender of respondents (Fig. 3.3.1). The results show that Indian and Lithuanian doctors expressed different, even opposite, views towards the ethics in drug promotion. Indians think that it‘s bad to give and accept gifts, but they believe that in their practice the gifts they obtain themselves have no influence on their clinical decisions. Lithuanians, on other hand, think that it is ok to accept and give gifts, but they also feel that gifts do have effect on their clinical decisions.

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30

Fig. 3.3.1. Generalized attitudes towards the ethics in drug promotion (* - p < 0.05, compared to Indians)

Male and female respondents appeared to have different views towards ethics in drug promotion (Fig. 3.3.2). The male respondents thought that its not ok to give and accept gifts and they believed that the gifts obtained from medical representatives affect prescribing behavior.

Fig. 3.3.2. Attitudes towards ethics in drug promotion by gender (* - p < 0.05 as compared to male respondents)

In comparison, female respondents considered that although giving and accepting gifts is not ok, but they anticipated that reciving gifts have no effect on prescribing behavior.

To summarize, Indians and Lithuanians had different, even opposite opinions towards ethics in drug promotions. Indians thought that it’s bad to give and accept gifts while Lithuaninans thought oppositely. Meanwhile, Indians believed that accepting gifts would not affect their

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31

prescribing behavior, but Lithuanians thought that accepting gifts affected their prescribing behaviour. Respondents of different gender also expressed different attitudes towards drug promotion ethics.

3.4. Doctors’ Exposure to Gifts from Pharmacy Representatives

Meals are common gifts in India and we found that more than 50% of Indians were offered meals at least once per month, while 85% of Lithuanians received meals once per year or less frequently (Fig. 3.4.1.).

Fig. 3.4.1. Meal as a form of promotional gift offered to doctors

We also found that 86% of Indians were offered symbolic gifts at least once per month. In case of Lithuanians, 80% of respondents were offered symbolic gifts once per year or never (Fig. 13). Only 1%of Indian medical doctors were not offered symbolic gifts as compared to Lithuanians.

Fig. 3.4.2. Symbolic gifts as a form of promotions offered to doctors

It is interesting that almost more than three quarters of Indians were offered small gifts at least once per year, while in case of Lithuanians only one quarter of medical practitioners were offered

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32 small gifts at the same time period (Fig. 3.4.3.), while more than three fourths of medical practitioners from Lithuanian reported that they were never offered any small gifts.

Fig. 3.4.3. Small gifts as a form of promotion offered to doctors

In case of large gifts, almost all the Indian physicians and more than three quarters of Lithuanians agreed that they were never offered large gifts. However, 3.8% of Lithuanian physicians confessed that they were offered large gifts every day in (Fig. 3.4.4.).

Fig. 3.4.4. Large gifts as a form of promotion offered to physicians

While in this case, in every second a small proportion of Lithuanian physicians were offered a local trip (3.7%) in (Fig. 3.4.5.) but, over three quarters of Lithuanian and Indian practitioners have been never offered local trips.

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33

Fig. 3.4.5. Local trips as a form of promotion for medical doctors

More than three fourths of respondents from both countries acknowledged that pharmaceutical representatives never offered international trips, but a small proportion of Lithuanian physicians accepted that once per year they were offered international trips (Fig. 3.4.6.).

Fig. 3.4.6. International trips as a form of promotion to doctors

Almost all Indians responded that they were never offered international trips, while one third of Lithuanian respondents were offered international trip in each second (Fig. 3.4.7.).

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34 Likewise, payments were not offered to almost all Indian and Lithuanian respondents, almost every day a few Lithuanian doctors were offered payments. (Fig. 3.4.8.).

Fig. 3.4.8. Payments as a form of promotion to physicians

Indian doctors were offered meals, symbolic gifts, and small gifts more often than Lithuanian doctors (Table 3.4.1.). Nevertheless rarely, but Lithuanian respondents were invited to international trips and conferences more often than Indian respondents (p<0.05).

Table 3.4.1. Type of gift and mean value

TYPE OF GIFT Mean ± SD T Df P India Lithuania Meals 2.55 ± 0.68 1.82 ± 0.90 6.01 177 <0.001 Symbolic gifts 3.1 ± 0.63 2.0 ± 0.99 8.77 177 <0.001 Small gifts 2.19 ± 0.61 1.5 ± 0.94 5.9 177 <0.001 Large gifts 1.0 ± 0.0 1.15 ± 0.77 -1.93 175 >0.05 Local trips 1.1 ± 0.35 1.2 ± 0.79 -1.11 177 >0.05 International trips 1.0 ± 1.4 1.4 ± 0.79 -2.85 177 <0.05 Travel to conference 1.0 ± 0.14 1.37 ± 0.82 -4.05 177 <0.001 Payments 1.0 ± 0.0 1.16 ± 0.79 -2.01 169 >0.05

To summarize, the most popular gifts offered to Indians were meals, symbolic gifts and small gifts: 30-80% of respondents were offered these gifts at least once per month. The frequencies of gifts offered to Lithuanian doctors were much lower and the most popular gift i.e. meals, symbolic gifts, small gifts were offered less to than 20% of respondents at least once per month.

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35

3.5. Correlations between Exposure to Accepting Gifts and Attitudes towards Drug Marketing Ethics

Statistically significant correlations were observed between attitudes towards drug promotion and frequency of getting gift from medical representatives of pharmaceutical companies (Table 3.5.1.).

Table 3.5.1. Correlation matrix of the variables age, attitudes towards drug promotion ethics and exposure to gifts.

Variables 1 2 3 4 5 6 7 8 9 10 11 12 1. Age 1 .27** .29** .17* -.14 -.12 -.14 -.17* -.15 .16* .39** .12 2. Meal 1 .44** .52** .42** .38** .31** .34** .43** .23** .08 .17* 3. Symbolic gifts 1 .62** .32** .39** .24** .10 .33** .29** .47** .16* 4. Small gifts 1 .48** .53** .38** .28** .48** .40** .27** .16* 5. Large gifts 1 .84** .91** .85** 1.0** -.02 -.15* -.15 6. Local trips 1 .77** .73** .84** .10 -.05 -.11 7. International trips 1 .84** .92** -.07 -.18* -.18* 8.Travel to conference 1 .87** -.15* -20** -.18* 9. Payments 1 -.02 -.15* -.16*

10. Giving gifts is not OK

1 .00 .00 11. Accepting gifts is

not OK

1 .00 12. Gifts do not affect

prescribing behavior

1 * - p < 0.05; ** - p < 0.001

Large gifts highly correlated with local trips (0.84), international trips (0.91), and travels to conference. It also showed that those who get large gifts they also receive payments. In case of local trips, it‘s highly correlated with international trips (0.76), travel to conference (0.73), those who get local trips also get more payments (1.0). The rates of international trips also correlated with payments (0.87).

An average size correlation (0.47) was observed between the rates symbolic gift offers and attitude towards attitude that accepting gifts is not OK: the more often the doctors were offered symbolic gifts the more critical they were while expressing their attitudes towards the ethics of

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36 getting gift. In case of meals, it‘s having moderate correlation with symbolic gifts (0.43), small gifts (0.51) and large gifts (0.42). An average correlation was also found between the small gifts and attitude of giving gifts is not OK (0.40).

Age has weak correlation with meals, symbolic gifts, and to the attitude of accepting gifts is not OK (0.39). The elderly population believes that accepting gifts is not OK.

To summarize, large gifts highly correlated with local trips, international trips and travel to conferences. It also showed that those who received large gifts, they also received payments as well. In case of local trips, travel to conference was highly correlated with international trips; those who receive local trips also receive payments. The more often symbolic gifts were offered to doctors, more critical they were as they expressed their attitudes towards the gift ethics.

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37

4. DISCUSSION OF RESULTS

According to our survey, we found that there exist different views regarding ethics in drug promotion. Indian physicians believe that pharmaceutical representatives act unethically while comparing their drugs with other products, while Lithuanian doesn‘t agree with that. Similarly, more than a half of Indian physicians think that symbolic gifts distort drug free market while half of Lithuanian physicians have no opinion towards this. Indians think that pharmaceutical agents act unethically while promoting their drugs while Lithuanian physicians did not agree that drug companies act unethically while during promotional activities. A small proportion of Lithuanians responded that strict supervision of pharmaceutical agents‘ visit is unnecessary, while Indians state that there should be strict supervision for medical representatives. Almost similar proportions of doctors from both countries thought that accepting gifts is not bad if it does not go against the law. Indian doctors strictly stated that visit during their working hours should be banned, while Lithuanian physicians thought that there‘s nothing wrong for pharmacists to visit a doctor during working hours. Physicians from both countries had the similar opinion that accepting gifts of high value is an offence, but there were a small proportion of Lithuanian physicians who were against that or had no opinion. Lithuanian and Indian doctors had positive attitude towards high valued gifts and on effect of symbolic gifts have, i.e. high value gifts should not be accepted by physicians. Physicians both countries also believed that free samples are helpful for the disadvantaged people. To summarize, Indian physicians more often agreed that drug promotion of pharmaceutical companies to doctors does have ethical issues as compared to Lithuanian doctors. Factor analysis also confirmed the results and showed that, nevertheless Lithuanian respondents believed that gifts affected their prescribing behavior; they thought that it‘s OK for pharmaceutical companies to give and for doctors to receive gifts. In contrasts, although Indian doctors believed that it‘s not OK to give or receive gifts, they assured that gifts did not have effect on their prescribing behavior. This entirely different behaviour of Indians from Lithuanians may be due to cultural differences as well as the age variable, because most Indian respondents were from elderly population, so they believed in ethics and thought that they had enough prescribing experience to resist bias due to promotions. Lithuanian sample consisted mainly of medical residents and they have less positive attitude towards ethics but same on same hand they believed that accepting samples, symbolic affected their objectivity and priority while choosing alternative drugs.

These results mirror some of the international findings. A German survey found, that physicians in private practice reported that ―92% of the doctors‖ received medical samples [41]. Most physicians had no objection to ―brand memoranda,‖ although they are ment to influence the prescription practice of the doctor. Many doctors thought that costly donations were acceptable [42,

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38 43]. Medical representatives encouraged doctors to prescribe their products and drugs to stock them and also provided support to pharmaceies in getting rid of unsold, slow-moving inventories [44]. A study in Bangladesh showed that, in spite of the favorable attitudes held towards several interactions with industry, nearly half of all participants recognized that some practices, e.g. receiving medical samples or taking part in research financed by industry, influence their prescribing patterns. A study from Mumbai, India was found, medical representatives have encouraged physicians to prescribe their products and pharmacies for stock, also acting as pharmaceutical intermediaries to remove unsold and slow-moving stocks [44].

In our survey, exposure towards drug promotion activities was described as accepting gifts like ―meals, symbolic gifts, small gifts, large gifts, local trips, international trips, travel to conferences, payments. We found that Indians were offered meals more often as compared to Lithuanians: more than a half of Indian physicians were offered meals at least once per month, but half Lithuanian doctors were never offered. Meals are a pretty common type of drug marketing in India, and this is confirmed by our results: Indians were more offered small as well as symbolic gifts as compared to Lithuania. A small number of Lithuanian physicians declared that they were high value gifts everyday. To summarize, Indians were offered more often small-value gifts, such as meals, symbolic gifts and small gifts, while the Lithuanians were more often offered high-value gifts, namely, international trips and payments. Some physicians reported they received gifts every day, this may be due to they did not understand the scale. It has been reported in several studies that show an increase in prescriptions of promoted drugs immediately after providing medical samples to physicians or inviting them to congresses and/or promotional trips [45]. The great majority of participants reported that accepting gifts or lunches does not affect their prescribing habits. For instance, many physicians believe that giving medical samples favors their patients, mainly those economically less favored. However, many studies show that patients that receive medical samples usually end up paying higher amounts of money for their medications in the long run [46]. Most participants from the Bangladesh study reported that their colleagues were influenced by the gifts which they received from the pharmaceutical sales representatives while prescribing medicine to patients [47].

It is interesting to note that there‘s inconsistency between beliefs and actions towards the ethics of drug marketing. On the level of cognition, Indians think that it is unacceptable to give and receive gifts but, in their practice, they believe that the gifts they obtain themselves has no effect on their clinical decisions. On other hand Lithuanians think positively, that it is ok to accept and give gifts, although they feel that gifts affect their clinical decisions.

In case of gender, the male respondents think that it is not ok to give and accept them and they believe that gifts they obtain themselves has effect on their clinical decisions. While female

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39 respondents agree less than men that it is not ok to give and take gifts, but think that gift obtained has no effect on their clinical decisions. In comparison, a study from Bangladesh found that female students who are offered gift like cloths, expensive gifts thought that gifts are inappropriate. While boys accept the gifts and they don‘t think it is inappropriate to receive gifts. Boys were more supportive or positive towards accepting gifts. But girls were not much positive [48]. Our survey also found that the more often doctors were offered low value gifts (meals, symbolic and small gifts) the more they thought that giving or getting gifts is not appropriate.

Strengths and limitations of the study

Cross-sectional study is a research tool used to capture data collected for a specific time point. The collected data comes from a pool of participants known as variables with varied characteristics and demographics. All examples of variables are age, gender, income, education, geographic locations, and ethnicity. The variables used in a single study, or demographics, are based on the type of research being conducted and what the study is intended to prove or validate. The findings of the research help to remove assumptions and replace them with actual data on the specific variables studied in the cross-sectional study during the time period.

Strengths:

1. It is not time consuming

2. Study is inexpensive due to convenience sampling method Limitations:

1. The study cannot be used for conduct analysis over time 2. Does not help to identify causes and effects

3. Convenience sample does not allow making generalizations about Lithuanian and Indian populations.

To summarize, the results of our study were concordant with the results from other surveys in that most of doctors were offered gifts and the majority of them accepted them as well as expressed rather positive attitudes towards the practice of getting and accepting promotional gifts. Indian doctors’ attitudes were distinct in that they believed that believed that it is not OK to accept and give gifts. Nevertheless, they also believed that accepting gifts was not affecting their prescribing behavior. Meanwhile, although Lithuanians, responded that accepting gifts and giving gifts is OK, they felt that gifts affected their prescribing behavior.

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40

CONCLUSIONS

1. Lithuanian and Indian physician‘s attitudes differed on the ethics in drug promotion. Indians were more negative towards giving and getting gifts, but they also thought that the gifts they obtain do not affect their decision. In contrast, Lithuanians thought that giving and accepting gift is not bad, but they themselves felt that gifts affected their clinical decisions.

2. Doctors in our survey reported that they were offered gifts for promotional purposes and the most common gifts were meals, small gifts, and symbolic gifts. Low-value gifts were offered more often to Indian respondents, while higher-value gifts, though seldom, were offered to Lithuanian physicians.

3. Correlational analysis showed that the more often the doctors were offered symbolic or small gifts the more critical they became while expressing attitudes towards the ethics of either accepting or giving promotional gifts. Age had a weak correlation with meals, symbolic gifts, and the opinion that accepting gifts is not OK. In addition, significant inter-correlations were observed among small-value (meal, symbolic and small gifts) and high-value gifts (large gifts, local and international trips, conferences and payments).

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41

PRACTICAL RECOMMENDATIONS

Recommendations for institutions

 Higher education institutions should train all medical and pharmacy students about drug promotion ethics.

 Hospital administrations should control pharmaceutical sales representatives‘ visits to doctors because the respondents think negatively about disturbing during working hours.

Recommendations to physicians

 Physicians should not accept high valued gifts and reduce their exposure to unethical deals.

 Physicians should restrict the visits of pharmaceutical representatives during their working hours.

Recommendations to pharmaceutical sales representatives

 Pharmaceutical sales representatives should not offer high value gifts, as it increases the doctors‘ exposure to unethical deals.

 Pharmaceutical sales representatives should not visit physicians during their working hours.

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42

LITERATURE

1. Hall KB, Tett SE, Nissen LM. Perceptions of the influence of priscription medicine samples on prescribing by family physicians. Med Care. 2006; 44: p. 383-387.

2. Lexchin J. Interactions between physcians and the pharmaceutical industry: what does literature say. CMAJ. 1993; 149: p. 1401-1407.

3. Austad KE, Avorn J, Kesselheim AS. Medical students exposure to and attitudes about the pharmaceutical industry. PLoS Med. 2011; 8(5).

4.Gagnon MA, J L. Cost of pushing pills: a new estimate of pharmaeutical promotion expenditures in the United States. PLoS Med. 2008; 5(1).

5.Spurling GK, Mansfield PR, Montgomery BD, J L, Doust j, Othman Nea. Information from pharmaceutical companies and the qualiy, quantity, and cost of phsicians prescribing. PLoS Med. 2010; 7(10).

6.Adair RF, R HL. Do dug samples influence resident prescribing behaviour? A randomized trial. Am. J. Med. 2005; 118: p. 881-884.

7.Anno BJ. Correctional Health Care: Guidelines for the Management of an Adequate Delivery System, 2001 edition. Chicago, IL: National Commission on Correctional Health Care. 2001.

8.Lexchin J. Description by design: Pharmaceutical promoton in third world. Penang:Consumers International. 1995.

9. Lexchin J, Kawachi I. Voluntry codes of pharmaceutical marketing : controlling promotion or licensing deception. 1996;: p. 221-235.

10.Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift. JAMA. 2000; 283: p. 373-380.

11.Lexchin J. Should doctors prescribe new drugs? International Journal Of Risk and Safety in Medicine. 2002; 15: p. 213-222.

12.Ahamed R, A S. Pharmaceutical drug promotion practices in Pakisthan. 2014; 20(11):p1630-1640. 13.Gibbons R, Landry F, D B. A comparision of physicians attitude towards pharmaceutical industrial gifts. J Gen Intern Med. 1998; 13: p. 151-154.

14.Manious AG, Hueston WJ, Rich EC. Patients perceptions of physcians of physcians acceptence of gifts from pharmaceutical industry. Arch Fam Med. 1998; 4: p. 335-339.

15.Waud DR. Pharmaceutical promotion- a free bride. 1992; 227: p. 351-353.

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