Evaluation of industry sponsored educational events attended by physicians in pakistan

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Introduction

Pharmaceutical companies are supposed to update the healthcare providers with the latest information about drugs in order to ensure rational prescribing to the patients at large. One of the ways adopted by the pharmaceutical companies to provide this information is by organizing medical educational events for healthcare professionals. These events include professional meetings, lectures presented by some opinion leader or company paid healthcare professional, seminars, workshops, evening briefings over dinner, to weekend conference for hundreds of healthcare professionals 1.

Although pharmaceutical industry has a great contribution in improving the human health and well being as compare to any other industry. Control of tuberculosis, gastroenteritis, and diphtheria which were considered among the 10 leading death causes in the western world are examples of such contributions 2.Pharmaceutical industry also achieved various milestones by developing medicine to control of smallpox; plague and polio which were the most vulnerable threats and the major cause of death and disability in the past. It will be injustice not to accept contribution of the pharmaceutical industry to overcome these threats.Pharmaceutical sector has contributed by developing new medicine and educating doctors regarding new drugs and diseases. Despite all these achievements towards well being of humanity; the suffering caused by the pharmaceutical industry are not avoidable. Defining the female cycle as a disease 3, mandatory postmenopausal hormonal replacement therapy 4, redefining erectile dysfunction to increase the potential market 5 or the case of Rofecoxib (VIOXX®); can be considered good examples of industry caused problems for the society only for business 2, 6.

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The problem starts when the interaction of the pharmaceutical companies to update doctors about medicine is used as a tool for undue influence on medical practice even by manipulating the drug information 7. Stakeholders of health care services have shown very strong reservations against activities influencing decision making of the healthcare providers8. Some critics have alleged this issue, for example in psychiatry, the issue of influence on treatment decision is more sensitive. Usually practitioners choose to use psychoactive medicine prescribing instead of psychotherapy as their primary intervention. It is identified as an influence on the decision making of doctors implanted by promoters of particular drug 9.

During last few years, company sponsored educational events for medical professionals increased tremendously and in terms of expenses it has reached 65% of total revenue of CME program in United States of America (USA) 10. In USA and Canada, national guidelines on independent educational events must maintain scientific objectivity and independence of content 11. In developing countries, most of the prescribers' base their prescription on the information provided by the pharmaceutical companies 12. An other study conducted in 6 cities in two provinces of Pakistan during the year 2006 also concluded the same 13.

Direct contact of the pharmaceutical companies with the doctors; have been considered the most effective way of successful drug promotion in developing countries 14. Educational events by organizing or by supporting doctor financially to participate in national or international conferences and other events have been established as one of the promotional tool and a way of direct access to doctors for pharmaceutical marketing in Pakistan 15.

While international organizations like World Health Organization (WHO) and International federation of Pharmaceutical Manufacturers Association (IFPMA) in their code of ethics clearly demand such sponsorships without direct intention commitment for drug promotion 16, 17. Although Pakistan have regulations, but there no mechanism by the regulatory authorities to monitor drug promotion by the pharmaceutical companies due to unknown reasons 12. Despite the fact that there enough evidence of industry induced irrational use of medicine in developing countries.

In the context of continuous medical education (CME), pharmaceutical companies are sponsoring medical educational events both in developed and developing countries. This study, a first of its nature in developing countries, tried to demonstrate the various types and frequencies of sponsored educational events for medical community in Pakistan conducted during 2008.

Study Objectives

General: To identify and document variousmedical educational events attended by physicians in Pakistan.

Specific:

1. To evaluate the sponsored medical educational events for doctors, their organizers and types of expenses physicians received from the pharmaceutical companies to attend these events.

2. To evaluate awareness regarding existence of regulations and codes of conduct for ethical drug promotion among the medical practitioners.

Methods

Study design

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A cross sectional study design using structured questionnaire was undertaken with a representative sample of physicians in 4 major cities (Bahawalpur, Lahore, Loralai and Quetta) of Punjab and Balochistan respectively 15.

Reference documents:

The guidelines set by World Health Organization (WHO) Ethical Criteria 17 and International Federation of Pharmaceutical Manufacturers Associations (IFPMA) Code of Pharmaceutical Marketing Practices 18, Pakistan's Drug Act 1976 19, Drug Act Rules Schedule G (Pakistan) 20, were considered as main reference documents for criteria of organizing and sponsoring educational events for medical professionals .

Study tools

A well designed and tested data collection tool for "face-to-face" interview was used in this study. The tool was tested for validity (expert opinion) 21, 22 and reliability (Cronbach's coefficient Alpha ()=0.875; n=25) 23 after a pilot study.

Geographic selection

Population in Pakistan varies from one province to the other in this regard it is naturally distributed in two parts. Punjab and Sindh are considered as the heavily populated provinces of Pakistan likewise Balochistan and North Western Frontier Province (NWFP) are considered as low populated province. Due to limited availability of resources, time and complex nature of project the study is directed to the Punjab (as representation of heavily populated provinces) and Balochistan (as representation of low populated province) provinces. Study may be generalized because the same companies are operating throughout the country. Their marketing practices may vary in small provinces (Balochistan and NWFP) as compare to large province (Punjab and Sindh) but are almost same in the provinces having common characteristics (i.e. both small provinces are less developed, low in population, mountainous, largely cool in weather and both have tribal system). The selection of cities is made keeping in view that it ranges from heavily populated areas to low populated areas and covers both rural as well as urban population. Four cities selected are Lahore (provincial capital), Bahawalpur (a low populated city at 5:30 hours drive from the provincial capital); selected from Punjab, Quetta and Loralai (a low populated city at 5 to 5:30 hours drive from the provincial capital) from Balochistan.

Study respondents

Doctors, having minimum qualification MBBS, must be registered with Pakistan Medical and Dental Council (PMDC) and practicing medicine either prescribing only or dispensing/prescribing 15. Health agencies, national health authorities and relevant scientific and ethical committees are also contacted whenever and wherever required for gathering relevant information and guidance in achieving the target.

The classification of work status was done on the bases of respondents' qualification and practice nature. Those respondents having no additional qualification after their graduation (MBBS) were classified as GPs. GP/specialists were those who completed some specialty courses after their graduation and now practicing both as GP and specialist. The respondents having some advance specialty qualification (MCPS, FCPS, FRCS etc) 15 and practicing only according to their specialist were classified as "specialist" (tab. 1). While accessing the respondents in each selected city, the center and peripheries were taken into consideration to make sure uniform representation. The interviews were conducted in main public sector hospitals, private hospitals and private clinics.

Sample size

Convenient sampling method (technique of non probability sampling) was adopted to access the respondents. Total 250 doctors, practicing in Punjab and Balochistan province were interviewed. Further the sample was distributed among the selected cities as 35, 90, 35 and 90 in Bahawalpur, Lahore, Loralai and Quetta respectively. To reach the desired number (250), 383 practitioners were accessed.

Sampling Procedure

To access sample units, convenient sampling technique was adopted due to unavailability of population frame. The study was conducted in 4 cities (Bahawalpur, Lahore, Loralai and Quetta) from two provinces (Punjab and Balochistan) of Pakistan.

Data analysis

All the data were analyzed by using SPSS version15. Both descriptive (basic and cross tabulation) and inferential statistics (Chi-square, Fisher Exact test and Kruskal-Wallis Test) were used. A p value of <0.05 is considered to be of statistical significance in all the analyses. Chi-square test was used to assess association between two categorical variables i.e. work status of physicians, types of the events organizers and types of the expenses paid by the pharmaceutical companies for physicians to attend these events. Fisher Exact test was used where X2 was not fit to analyze the categorical data (where more then 25% cells had value less then 5 as result of applying X2).

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To find the association between continuous (frequency of the educational events) and categorical (work status of the respondents) variables, Kruskal-Wallis Test was applied. Spearman's rho test was applied to find any possible correlation.

Demographic data

The study was conducted in two provinces of Pakistan; Punjab and Balochistan. Total 250 doctors were interviewed for this study out of which 209 were male and 41 were female (tab. 1). According to their practice status; 125 were specialist, 79 were General Practitioner (GPs) and 46 were GPs/specialist.

Findings

Out of 250 interviewed physicians 173 (69.2%; p=<0.001) (tab. 2) attended 727 different educational events directly or indirectly sponsored by the pharmaceutical companies. Lectures were the highest attended event (n=222, 30.54%) by only 41 doctors, scientific conferences were the second highly attended event (n=207, 29.47%) by 131 doctors and most of them were those practicing as specialist (n=84; 67.2%). Doctors attended 112 (15.41%) drug launching ceremonies, 58 (7.98%) seminars, 38 (5.23%) were training courses and 29 (3.99%) were discussion forums.

It was found that doctors on average had 7.35 (+ 4.26) interactions with the medical representatives daily. It was also found that there is statistically significant co-relation between the number of the events attended by the doctors and number of the medical representative visits to their clinics (P<.001, r=0.218). Most of the respondents (94.8%, n=237) (tab. 5) were unaware of any regulation controlling pharmaceutical marketing, 98% (n=245) did not know about any self regulatory code by pharmaceutical industry to control marketing and promotion matters and 73.6% (n=184) had no information about any guidelines for doctors to interact with pharmaceutical industry. There was statistically significant negative correlation (P=.01, r=-.144) between total number of attended educational events and awareness about guidelines for doctors to interact with the pharmaceutical companies.

Most of the educational events were organized by professional organizations of the medical community and sponsored/co-organized by the pharmaceutical industry (n=115, 67.3%; p=0.001). Pharmaceutical companies' independently organized and sponsored (n=27, 15.8%). Pharmaceutical industry was the largest disclosed individual sponsor source for physicians (n=123, 71.9%) to attend these educational events.

The sponsorships covered various types of the expenses of the respondents which included Meals (n=162, 94.7%), accommodation (n=118, 96%; P<.001), air fare (n=96, 56%; P<.001), Registration fee (n=96, 56%; P<.001), taxi fare (n=75, 43.9%; P.01) and participation fee (n=14, 8.2%).

Many of the respondents received offer of the expenses for their spouse and children (n=65; P<.001) from the pharmaceutical companies to accompany them during participation in educational event at some national or foreign venue. Around half of the offers (n=30, 43.5% of received offers) were accepted and few (n=4, 5.8%) of them didn't shared the information about acceptance of the offer for the expenses for their spouse and children to accompany then during attending the educational events.

Sixty two respondents disclosed the source of offer for family expenses. National pharmaceutical companies were the main source of these offers (n=37, 59.7%), multinational pharmaceuticals offered to 21 (33.99%) doctors and 4 (6.5%) doctors received these offers from both national and multinational pharmaceutical companies.

Comments

This is the first study of its nature conducted in any developing country, particularly in Pakistan, providing statistics about the healthcare educational events organized by pharmaceutical companies. The findings of the study indicates that most of the physicians (n=173, 69.2%; p=<0.001) (tab. 2) had attended industry sponsored events. Many studies have proved the clear and significant influence of such type of educational activities on the prescribing behavior and decisions 14, 24-26 and due to this fact now regulatory authorities are emphasizing the mandatory disclosure of the educational events sponsored by the pharmaceutical companies to document the nature of the events and expenses paid to attend these events in countries like Australia 26, 27. It is also observed that physicians rate the pharmaceutical company sources as the most important source of information about the drugs 12. Furthermore, a majority of physicians were of the view that pharmaceutical marketing has significant influence on their prescribing practices 9. Total attended events by 173 physicians during one year were 727. It shows that each of 173 doctors attended on average 4.2 pharmaceutical industry sponsored events including scientific conferences, training courses, lectures, seminars, workshops, discussion forums and even now drug launching ceremonies (tab.2) are also considered as educational events which are purely for the sake of drug promotion. Most of the educational events were organized by professional organizations of the medical community and pharmaceutical companies (tab. 3). Pharmaceutical industry was the largest disclosed individual sponsor source for physicians (tab. 3). The type of expenses paid to attend these events were airfare, accommodation, taxi fare, event registration fee and the expense which most of the participants enjoyed was meal. The sponsored events were from drug launching ceremonies to overseas scientific conferences' a clear indication of the industry involvement in all aspects of the healthcare.

The study also found an interesting fact that there was a significant relation between the number of the events attended by the doctors and number of the medical representative visits to their clinics (P<.001, r=.218). Most of the respondents (94.8%, n=237) (tab. 5) were unaware of any regulation controlling pharmaceutical marketing, 98% (n=245) did not know about any self regulatory code by pharmaceutical industry to control marketing and promotion matters and 73.6% (n=184) had no information about any guidelines for doctors to interact with pharmaceutical industry. The statistically significant negative correlation (P=.01, r=-.144) between total number of attended educational events and awareness about guidelines for doctors to interact with the pharmaceutical companies indicate weak implementation of the existing regulations and codes of conduct to monitor doctors-industry relationship. In Pakistan all medicine related issues are controlled by the Drug Act and rules 1976. The part of Drug Act and Rules 1976 responsible for controlling is "The drug rules 1976, Schedule G". Regarding the educational events, the language of the rules is so vague that any person or firm can use it in his/her favor and can easily deceive regulatory bodies. Rule number 7 of schedule G is to deal with sponsorship of educational events, and there is no explanation about the nature and extent of the sponsorships. According to said rule "The intimation regarding scientific symposia, seminars, conferences and such meetings where sponsored by a pharmaceutical manufacturer or distributor shell be clearly communicated in advance. The invitation letter should accurately reflect the presentations and discussions to be held. Entertainment or other hospitality offered to member of medical and allied professions shell be secondary to the main purpose of the meeting and shell be kept to a modest level." 20 There is nothing about nature of the sponsorships and as a result one can observe that companies are also offering sponsorships for the families which is highly restricted in many code of conduct for the pharmaceutical companies. International Federation of Pharmaceutical Manufacturers Association (IFPMA) strictly prohibits sponsorship of accompanied person to attend any scientific event in paragraph 7.3, page 13 of its revised code of Marketing Practices. 16 World Health Organization (WHO) and IFPMA also explains that "any sponsorship provided to individual healthcare professionals must not be conditional upon an obligation to prescribe, recommend or promote any pharmaceutical product" 16, 17. But there is no mechanism to monitor the terms and contact between pharmaceutical companies and doctors regarding the sponsorships.

The drug promotion by the pharmaceutical companies has been changed tremendously, over the period of time as it was in early days. Initially the real intention of providing information by various means (educational events to literature) was exercise to keep the doctors up-to-date regarding medicine and their own products. But now it has become more commercialized relationship. It wouldn't be wrong if one says that it is now 100% based on commercial pursuits. We must accept the fact that pharmaceutical industry is driven by "quest of profit" and they can practice any thing like sponsorships of educational events, heavy investment on political campaigns, promotional activities, direct to consumers' advertisement etc 28 to make sure the earning and growth of their profits.

Conclusion

The high frequency of companies' sponsored so called educational events for healthcare professionals show that physicians are in very strong financial relation with the pharmaceutical industry. It is alarming sign, indicating weak enforcement or absence of well defined regulations and monitoring system by the regulatory bodies. At large it may lead to increase in irrational and over prescribing of medicine, this may increase risk of patient health and economy necessitating strict enforcement of well defined regulations and codes of conduct for both companies and medical community.

References:

1. Australia M. Educational Event Reports. Deakin ACT 2600 2008.

2. Braithwaite DJ. The corrupt industry. New Internationalist. 1986;165(November 1986).

3. Making The Female Cycle a Disease: The Pharmaceutical Industry Markets More Than Comfort Suite 101; 2008. http://womenshealth.suite101.com/article.cfm/making_the_female_cycle_a_disease. Updated Last Updated Date. Accessed Feb 6, 2010.

4. Notman MT, Nadelson C. The hormone replacement therapy controversy. Archives of Women's Mental Health. 2002;5(1):33-35.

5. Lexchin J. Bigger and Better: How Pfizer Redefined Erectile Dysfunction. PLoS Med. 2006;3(4):e132.

6. Wertheimer AI, Santella TM. Innovation and the WHO's essential medicines list: Giving credit where credit is due. Research in Social and Administrative Pharmacy. 2007;3(1):137-144.

7. Meier B. In guilty plea, OxyContin maker to pay $600 Million The New York Times May 10, 2007;Business.

8. Mitka M. Industry Funding. JAMA. December 10, 2008 2008;300(22):2599-.

9. Reist D, VandeCreek L. The Pharmaceutical Industry's Use of Gifts and Educational Events to Influence Prescription Practices: Ethical Dilemmas and Implications for Psychologists. Professional Psychology: Research and Practice. 2004;35(4):329-335.

10. Steinman MA, Baron RB. Is continuing medical education a drug-promotion tool?: YES. Can Fam Physician. October 1, 2007 2007;53(10):1650-1653.

11. Editorial. What's wrong with CME? CMAJ. March 16, 2004 2004;170(6):917.

12. Rohra DK, Gilani AH, Memon IK, et al. Critical evaluation of the claims made by pharmaceutical companies in drug promotional material in Pakistan J Pharm Pharmaceut Sci (www.cspsCanada.org) 9(1):50-59, 2006. 14 Feb 2006 2006:50 to 59.

13. Masood I, Anwar M. Common Promotional Materials and Medical Representatives: Are they really useful for doctors? Pharmacy in new era, 1st national conference on pharmaceutical sciences. Bahawalpur, Pakistan: Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur; 2007:12.

14. Rohra D, Bashir M, Khwaja U, Nazir M. Critical appraisal of apparently evidence-based written advertising in Pakistan. Pharmacy World & Science. 2008;30(3):216-221.

15. Rohra DK, Jawaid A, Tauseef-ur-Rehman, Sukkurwala AQ, Palanpurwala AS, Gangwani R. Prescription of New Drugs by General Practitioners in Pakistan: An Exploration into Information Sources, Prescription Influences and General Attitudes. Pakistan Journal of Medical Research. January to March 2007;46(1):5-10.

16. IFPMA. IFPMA Code of Pharmaceutical Marketing Practices. 1-1-2007 2007.

17. WHO. Ethical criteria for medicinal drugs promotion, endorsed by the 33rd world health assembly: World Health Organization; 1986.

18. IFPMA. IFPMA Code Of Pharmaceutical Marketing Practices. In: (IFPMA) IFoPMA, ed: IFPMA; 2006.

19. DCOMoH. Drugs (Licensing, Registering And Advertising) Rules, Drug Act 1976. Drug Act. Available at: http://www.dcomoh.gov.pk/regulations/drugrules2.php. Accessed July 28, 2009, 2009.

20. DCOMoH. Schedule G, The Drugs (Licensing, Registering and advertising) Rules, 1976. Vol 2006. Islamabad: Government of Pakistan; 1996:SRO (Solicitor's Remuneration Order) 1362(1361)/1396, dated 1328-1311-1996.

21. Radhakrishna RB. Tips for Developing and Testing Questionnaires/Instruments. Journal of Extension. Feb 2007 2007;45(1).

22. Alipour A, Ghaffari M, Jensen I, Shariati B, Vingard E. Reliability and validity study of Persian modified version of MUSIC (musculoskeletal intervention center) - Norrtalje questionnaire. BMC Musculoskeletal Disorders. 2007;8(1):88.

23. StatSoft I. Reliability and Item Analysis. In: StatSoft I, ed. Electronic Statistics Textbook: Tulsa, OK: StatSoft; 2010: http://www.statsoft.com/textbook/reliability-and-item-analysis/. Accessed.

24. Smith R. Curbing the Influence of the Drug Industry: A British View. PLoS Medicine. September 01, 2005 2005;2(9):e241.

25. Jawaid S, Jafary M. Relationship between the medical profession and the Pharma industry: Need for greater scrutiny, transparency and accountability. Pakistan Journal of Medical Sciences Oct. 2004 2004;20(4):283-291.

26. Science PLo. Drug Company-sponsored Events For Health Professionals Fail To Disclose Financial Ties, Analysis Finds. ScienceDaily Retrieved February 4, 2010. November 3 2009.

27. Robertson J, Moynihan R, Walkom E, Bero L, Henry D. Mandatory Disclosure of Pharmaceutical Industry-Funded Events for Health Professionals. PLoS Med. 2009;6(11):e1000128.

28. Shearer G, Duncan JM, Gadhia A. The Pharmaceutical Industry and Consumers --Key Factors Affecting Affordability of Prescription Drugs. Washington: Consumers Union; Feb 2003 2003.

Data Tables:

Table 1: Demographics data of the respondents

Work status of respondent

Total

GP only

GP cum specialist

Specialist only

Province wise distribution of the respondents

Punjab

33(13.2)

22(8.8)

70(29.0)

125(50.0)

Balochistan

46(18.4)

24(9.6

55(22.0)

125(50.0)

Gender wise distribution of the respondents

Male

71(28.4)

36(14.4)

102(40.8)

209(83.6)

Female

8(3.2)

10(4.0)

23(9.2)

41(16.4)

Total

79(31.6)

46(18.4)

125(50.0)

250(100)

Results' Tables

Table 2: Summary of total events attended by respective doctors' group

Conferences

Trainings/ course works

Lectures

Seminars

Workshops

Discussion forums

Drug launching ceremonies

Grand Total

Sum

207*

38*

222*

58*

61*

29*

112*

727*

Number of the physicians (n=250)

131 (52.4)**

23 (9.2)**

41 (16.4)**

25 (10.0)**

38 (15.2)**

07 (2.8)**

47 (18.8)**

173 (69.2)**

GPs*#

23(29.1)*#*

02 (2.5)

12(15.2)

05(6.3)

07(8.9)

01(1.3)

13(16.5)

41(51.9)

GPs/Specialists##

24(52.2)

05(10.9)

8(17.4)

05(10.9)

04(8.7)

03(6.5)

08(17.4)

33(71.7)

Specialists

84(67.2)

16(12.8)

21(16.8)

15(12.0)

27(21.6)

03(2.4)

26(30.8)

99(79.2)

Events attended by total number of doctors

173(69.2)

*Total number of events attended by the respondents during one year period

** Number of respondents attended mentioned events during one year period

*# General Practitioners (Doctors practicing with 1st degree only)

## Doctors specialist by qualification practicing as GP

*#*Percentage within the practice status

Table 3: Organizers of the events attended by the respondents during one year period

Work status of respondent

Total

GP only

GP cum specialist

Specialist only

GP only

Not disclosed

0(.0)

2(.8)

0(.0)

2(.8)

Pakistan Medical Association

0(.0)

0(.0)

1(.4)

1(.4)

Professional organization of doctors

21(8.4)

21(8.4)

72(28.8)

114(45.6)

Multinational Companies (MNC)

8(3.2)

4(1.6)

3(1.2)

15(6.0)

National Companies (NC)

2(.8)

1(.4)

4(1.6)

7(2.8)

MNC and PNC Both

2(.8)

1(.4)

2(.8)

5(2.0)

Non Government Organizations (NGOs)

4(1.6)

1(.4)

7(2.8)

12(4.8)

Government

4(1.6)

5(2.0)

8(3.2)

17(6.8)

None of above mentioned

38(15.2)

11(4.4)

28(11.2)

77(30.8)

Table 4: Type of expenses received by the respondents to attend the events during one year period

Work status of respondent

Total

P value

GP only

GP cum specialist

Specialist only

Airfare

12(12.5)

17(17.7)

67(69.8)

96(56.1)

P<.001*

Accommodation

19 (16.1)

21 (17.8)

78 (66.1)

118 (69.0)

P<.001*

Taxi

12 (16)

11 (14.7)

52 (69.3)

75 (43.9)

P<.012*

Registration fee

20 (16.9)

21 (17.8)

77 (65.3)

118 (69.0)

P=.001*

Participation fee

1(7.1)

1(7.1)

12 (85.7)

14 (8.2)

P =.104*

Meals

40 (24.7)

33 (20.4)

89 (54.9)

162 (94.7)

P=.18**

P<.05 is considered as statistical significance

* The p value for X2 test

** The p value for Fisher Exact test

Table 5: Awareness among doctors about existing codes conduct, regulations and guidelines to interact with pharmaceutical companies

n=250

Percentage of total

P value*

Awareness about regulations

13

5.2

NS

Awareness about codes conduct

5

2.0

NS

Awareness about guidelines

66

16.4

NS

* No statistical significance was observed