Educational initiatives for medical and pharmacy students about drug promotion:

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Educational initiatives for medical and pharmacy students about

drug promotion:

an international cross-sectional survey

Barbara Mintzes

October 2005

European Community

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This document has been produced with the financial assistance of the European Community. The views expressed herein are those of the author and can therefore in no way be taken to reflect the official opinion of the European Community.

© World Health Organization and Health Action International, 2005

The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization and Health Action International concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.

The mention of specific companies or of certain manufacturersʹ products does not imply that they are endorsed or recommended by the World Health Organization and Health Action International in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.

All reasonable precautions have been taken by the World Health Organization and Health Action International to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either express or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization or Health Action International be liable for damages arising from its use.

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Acknowledgements

The World Health Organization (WHO) and Health Action International (HAI) wish to thank the European Commission (Directorate‐General Development) and donors of HAIʹs Global Programme of Work (Netherlands Ministry of Foreign Affairs, Finland Ministry for Foreign Affairs and the Swedish International Development Cooperation Agency) for their support in funding this project.

WHO and HAI thank Barbara Mintzes (Canada), principal investigator and author of this report, for her invaluable expertise and guidance.

We are grateful to the following people who contributed their time and expertise in reviewing material and managing the project:

Project management: Margaret Ewen, HAI Europe and Richard Laing, Department of Medicines Policy and Standards, World Health Organization;

Project members: Bob Goodman (USA), Andy Gray (South Africa), Peter Mansfield (Australia), Nancy Olivieri (Canada), Sri Suryawati (Indonesia), José Terán (Ecuador) and Liliana Ziganshina (Russia);

Questionnaire distribution, data entry and survey support: Sonia Zweegers and Rose de Groot, HAI Europe;

Editorial and design support: Kath Hurst and Monique Renevier, Department of Medicines Policy and Standards, World Health Organization.

Lastly, but most especially, WHO and HAI thank everyone who responded to the questionnaires – over 700 deans of medical and pharmacy schools who provided the names of those teaching on drug promotion in their institutions, and in addition over 260 educators who provided the detailed information found in this report. Without their support we would have been unable to examine the extent to which medical and pharmacy students are being educated about drug promotion.

This survey report is the first outcome of the project. The second outcome will be a practical guide for medical and pharmacy students on understanding and responding to pharmaceutical promotion. The guide will be tested by students in 2006. WHO and HAI intend to publish and distribute the manual to all medical and pharmacy schools worldwide in mid‐2007.

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Executive summary

Introduction

Increasing attention is being paid to the relationship between health professionals and the pharmaceutical industry. Education of medical and pharmacy students has a crucial role to play in preparing future practitioners to respond appropriately to drug promotion. This is the first international survey to examine the extent to which medical and pharmacy students are being educated about drug promotion.

Methods

A global list of pharmacy and medical schools was developed based on relevant Internet sites as well as information supplied by the World Health Organization (WHO). Deans of these institutions were contacted from July to December 2004 to ask whether or not the institutions were educating students about drug promotion (e.g. critical evaluation and responses to promotion); if so, contact information for educators was requested.

Additionally, notices were placed on e‐mail listserves with a focus on pharmaceutical policy or drug promotion.

A more detailed questionnaire was sent to educators between January and April 2005. The questionnaire covered the following issues: amount of time spent on this type of education, placement in the curriculum, types of promotional activities, regulatory and ethical issues covered, educational techniques, materials developed, evaluation, judgment of success and identification of barriers to success. English, French and Spanish versions of the questionnaire were produced. Non‐respondents received up to two follow‐up questionnaires at 10‐day intervals. Replies were included if they reported educating medical or pharmacy students about responses to any aspect of drug promotion. Those only reporting education about how to promote products, for example training for sales representatives, were excluded. The analysis of results is descriptive. Responses were classified by health profession (pharmacy or medicine) and by location within a WHO region. Exploratory chi square analysis was carried out to identify potential differences between pharmacy and medical faculty responses, using EpiInfo 2000. These differences should be interpreted as generating hypotheses for further study.

Results

The initial faxed survey reached 1014 medical and pharmacy faculties in 110 countries. We received 710 contact names in 91 countries from the initial faxed query and e‐mail listserve postings. Of these, 564 were individuals involved in education on drug promotion. We sent a detailed questionnaire to all of them. Two hundred and sixty two (46%) responded, of whom 34 (13%) were excluded (duplicates or not teaching about drug promotion). Results are based on 228 respondents from 64 countries, 91 from pharmacy schools and 137 from medical schools. Responses were classified by WHO region. There were 92 respondents from Europe,

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56 from the Americas, 31 from the Western Pacific, 20 each from Africa and South‐East Asia, and 9 from the Eastern Mediterranean.

Nearly three‐quarters of respondents, 165 (72%), reported that education about drug promotion is part of the required curriculum at their institution, and over half reported more than one type of course on promotion. However, nearly one‐third of medical and one‐fifth of pharmacy respondents reported only 1‐2 hours of education on promotion within the required curriculum. Total reported educational time, in all types of courses, was significantly greater at pharmacy than medical schools: 50 (55%) reported more than 10 hours of education on promotion in total, as compared with 39 (28%) of medical faculty respondents.

Over half the respondents were educating students on one or more of the following issues:

advertisements, sales representatives, sponsored conferences and seminars, promotional

‘research’, gifts and industry funded journals. More pharmacy than medical respondents covered promotion on the Internet (59% vs. 29%) and patient requests for advertised medicines (50% vs. 33%).

Three‐quarters of respondents, 170 (75%) covered the regulation and/or ethics of drug promotion, with the highest proportion of these reporting that they discussed national government regulation of promotion, followed by professional codes, and the ethics of interactions with the industry.

The most commonly reported educational technique was lectures, 192 (84% overall), followed by small group discussions in tutorials and workshops (65%). Those who allocated one‐half day or less to education on drug promotion were highly likely to list lectures as the only type of educational technique used. Most of those spending 10 hours or more used small group discussions as well as lectures, and more than half also carried out critical analyses of sample advertisements.

The involvement of sales representatives in education can help students to better understand the types of promotional techniques used and to respond appropriately. Only 15% of respondents involved sales representatives, more often pharmacists than physicians: 20% vs.

12%.

The survey included questions on what educators were aiming to achieve: the most common aims were to teach critical appraisal of promotion, increase students’ use of independent information sources, and to improve prescribing or dispensing after graduation. As one medical educator from the Americas stated, “I am trying to open their eyes so they can see for themselves and will be more sceptical in the future.”

Inclusion of questions on drug promotion in student examinations provides a signal that the topic is considered important. Overall, half of respondents said that questions on promotion were included in exams, but this was much more frequent among pharmacy than medical faculty respondents: 68% vs. 37%. Only a small minority of educators systematically evaluated the effectiveness of education: 19% overall. This was most often a written or oral course appraisal soliciting students’ opinions about a session (15% of respondents). Effects

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What was respondents’ judgment of the degree of success of education on drug promotion in meeting its intended goals? There was no difference in the likelihood that pharmacy or medical faculty respondents judged the programme to be successful. However, those devoting at least 4 hours to education were more likely to judge their work to be at least somewhat successful than those devoting a half day or less: 70% vs. 41%. The most frequently cited barrier was lack of integration into the curriculum, followed by inadequate time allocation, lack of continuation during clinical training, and lack of interest from other university faculty. Those who spent 4 hours or less on the issue were more likely than others to judge inadequate time allocation as a barrier to success.

Respondents were asked what types of course materials they had developed. The most common type listed was PowerPoint presentations (55%). Course materials were rarely available on the Internet, and usually only in sites with limited access.

Discussion and conclusions

The results of this survey provide a first environmental scan of the aims and extent of education about drug promotion within medical and pharmacy faculties. In most cases, education on promotion was included within the required curriculum, but students devoted one half day or less to this topic during their professional training; in nearly one‐third of cases, medical faculties devoted only 1‐2 hours, often within a broader course on pharmacology, clinical pharmacology or therapeutics. Those spending less time on the topic were less likely to use interactive educational techniques, to include questions on drug promotion in examinations, or to judge the education to be successful.

The content of coursework was remarkably similar by health profession and region, with a primary focus on critical appraisal skills, followed by sales representatives. Few respondents mentioned education on how to respond to patient requests for advertised drugs, although direct‐to‐consumer advertising of prescription drugs and other promotional techniques targeting the public, such as video news releases or celebrity endorsements, are becoming increasingly prevalent. There were few differences by WHO region in content or approach to this education; this lack of overall difference may reflect the wide variety of national experiences within as well as between regions.

Although these survey results are exploratory, they provide a snapshot of the type of education that is being provided, subject matter, techniques and aims. The number of responses far outweighed the published literature describing educational initiatives for medical and pharmacy students on drug promotion. On the other hand, the respondents often described a single one or two hour lecture. Lack of integration and inadequate time allocation were frequently mentioned as barriers to success.

In conclusion, we found that many medical and pharmacy educators recognize the need for education about drug promotion and have incorporated this topic into their work, often integrating it into curricula on therapeutics, pharmacology, or professional ethics. Although many barriers to success were identified, there was broad interest in further development and work in this area.

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Introduction

Increasing attention is being paid to the relationship between health professionals and the pharmaceutical industry, and the role of drug promotion in prescribing, dispensing and drug use decisions.(Anon, 2001; Wazana, 2000) Education of medical and pharmacy students has a crucial role to play in preparing future practitioners to respond appropriately to drug promotion and to ensure that their own interactions with the pharmaceutical industry meet a high ethical standard and are consistent with regulatory norms. This is the first study to examine the extent to which medical and pharmacy students are being educated about drug promotion.

With the global withdrawal of rofecoxib (Vioxx®) in September 2004, potential negative public health implications of promotion received extensive media attention. Rofecoxib was no more effective than alternative non‐steroidal anti‐inflammatory drugs in treating the symptoms of arthritis (Garner, Fidan, Frankish and Maxwell 2005). It was largely promoted as safer. However, the first study to establish gastro‐intestinal benefits, published in 2000, also found an increased risk of heart disease (Bombardier, 2000). Additional evidence of cardiac toxicity eventually led to the product’s global withdrawal. Rofecoxib’s success is a testament to the triumph of marketing over science: a drug that was no more effective, riskier and much more expensive than alternatives reached and maintained blockbuster status – with over 80 million prescriptions worldwide – although during four of its five years on the market evidence existed of an unfavourable balance of benefit versus risk. A U.S.

congressional investigation describes the ‘spin’ used by sales representatives to avoid presenting evidence concerning cardiac risks to the health professionals they visited (Waxman, 2005). In an extrapolation based on clinical trial evidence and the rate of rofecoxib use, David Graham, a senior FDA official, estimated a U.S. death toll of 35,000 and 45,000 (Graham, 2005).

In terms of the public health consequences of drug promotion, rofecoxib’s success is undoubtedly an extreme case. However, it highlights the need to ensure that health professionals are adequately prepared to evaluate promotional claims, and to assess and understand interactions with the pharmaceutical industry. Health Action International (HAI) and WHO carried out an international survey of medical and pharmacy faculties on initiatives to educate students about drug promotion. The aim was to undertake an

‘environmental scan’ to find out what students are being taught and any evaluation of the effectiveness of this education. The survey covered all aspects of drug promotion, including the role of advertisements, samples, gifts and the use of opinion leaders on medical and pharmacy practice, research, ethical issues, regulation, and how to evaluate marketing materials in order to make the right decisions for patient care (Garner, 2005).

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Methods

A global list of pharmacy and medical schools was developed based on relevant Internet sitesⁱ as well as information supplied by the WHO. An initial form was developed in English, French and Spanish asking whether or not the institution was educating students about drug promotion (e.g. critical evaluation and responses to promotion); if so, contact information for educators was requested. These initial requests were sent by fax to the offices of deans of medicine or pharmacy, between July 2004 and December 2004. If there was no initial response, the fax was repeated two additional times. Additionally, notices were placed on e‐

mail list‐serves with a focus on pharmaceutical policy or drug promotion, such as e‐drug, e‐

med, nofreelunch, and haieuropromo, requesting contact information for those involved in education about drug promotion.

Based on a series of review articles developed from the WHO/HAI drug promotion database on interactions between health professionals and the pharmaceutical industry and on educational initiatives to date, a draft questionnaire was prepared (author: BJM). This questionnaire was circulated for comment to an international team of physicians and pharmacists with experience and expertise in education on drug promotion. The questionnaire covered the following issues: amount of education, placement in the curriculum, types of promotional activities, regulatory and ethical issues covered, educational techniques, materials developed, evaluation, judgment of success and identification of barriers to success. See Appendix I for a copy of the questionnaire.

The questionnaire was produced in English and translated into French and Spanish. It was sent out by e‐mail whenever possible, or by fax. The survey was carried out from January to the end of April 2005. Non‐respondents received up to two follow‐up questionnaires at 10‐

day intervals.

Responses were included if respondents stated that they educated medical or pharmacy students about drug promotion (any aspect) within the required curriculum, elective courses, specialty/residency training, and/or in other ways, such as workshops or seminars.

Responses were excluded if they reported on education about how to promote products, for example within a course preparing them to work as a sales representative for a pharmaceutical company. If duplicate entries were received describing the same course provided by the same institution, the information provided was compiled into a single entry (duplicate responses excluded).

A random sample of 20% of questionnaires was checked for data entry errors. The error rate was less than 1% (0.68%) and errors were mainly concentrated on specific questions. These questions were checked and corrected, as needed, on all of the questionnaires.

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The analysis of results is descriptive. Responses were classified by health profession (pharmacy or medicine) and by location within a WHO region. Exploratory chi square analysis was carried out to identify potential differences between pharmacy and medical faculty responses, using EpiInfo 2000. These differences should be interpreted as generating hypotheses for further study, rather than necessarily being indicative of broader underlying trends.

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Results

The initial faxed survey reached 1014 medical and pharmacy faculties in 110 countries.

Another 1047 potential respondents (43 additional countries) could not be reached because of incorrect contact information and fax transmission difficulties.

Table 1: Initial faxed survey to request names of educators: who did we contact?

Medical

faculties

Pharmacy faculties

Total

Contact information available for faculty 1532 153 countries

548 82 countries

2061 153 countries Number of faculties successfully contacted * 741 (48%) 273 (50%) 1014 (49%)

Number of countries in which one or more faculties were contacted*

107 (70%) 47 (57%) 110 (72%)

*Fax or and/or e‐mail transmission went through successfully within three attempts

We received 710 contact names in 91 countries from the initial faxed query and from e‐mail list‐serve postings in which we asked for names of contacts who were educating medical or pharmacy students about drug promotion. These are described in Table 1a.

Of these 710 responses, 564 were names of individuals who were involved in education on drug promotion; the remaining 146 were responses stating that the medical or pharmacy faculty was not involved in education about drug promotion. Messages on listserves led to 94 responses, 58 of whom responded to an initial query by sending us contact names. These are included in the breakdown by region in Table 1a.

Table 1a: Responses to initial fax survey, by WHO region and whether education about drug promotion was provided

WHO Region

Promotion on curriculum?

Yes No

Total responses

Europe 258/320 (81%) 62/320 (19%) 320

Americas 119/143 (83%) 24/143 (17%) 143

W. Pacific 68/102 (67%) 34/102 (33%) 102

Africa 43/50 (86%) 7/50 (14%) 50

E. Mediterranean 35/50 (70%) 15/50 (30%) 50

S.E. Asia 41/45 (91%) 4/45 (9%) 45

Total 564 146 710

We faxed a detailed questionnaire (see Appendix 1) to these 564 contacts, 199 of whom were educators in schools of pharmacy, 333 in schools of medicine and 28 unsure (for example in colleges of health sciences; further information required for clarification). The remaining four were consumer or public interest group contacts.

There were 262 responses (46%). Thirty‐four (13%) of these were excluded, either because they were duplicate responses describing a single course (n=12), they were not involved in

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any education on drug promotion (n=18), they were only educating students about how to be sales representatives (n=2), or they were not involved in education of medical or pharmacy students (n=2).

The results below are based on the 228 respondents from 64 countries who stated that they or their institution were involved in educating medical or pharmacy students about drug promotion in one or more ways.

Sample characteristics

Table 1b describes the breakdown of respondents by WHO region and whether they were educators in a pharmacy or medical faculty. For full country listings and a breakdown of countries per WHO region, see pages 41 and 42.

Table 1b: Responses to survey questionnaire by WHO region

* proportion of those who were sent the survey questionnaire (‘yes’ column, Table 1 above)

How is education on drug promotion included within the curriculum?

Nearly three‐quarters of respondents reported that education about drug promotion is part of the required curriculum at their institution, and over half reported more than one type of course on promotion, for example both inclusion within the required curriculum and within an elective or specialty/residency training. (Table 2) As noted in Table 2a, inclusion in most cases within the required curriculum was the norm rather than the exception across different regions. However these findings cannot be confidently generalized to non‐respondents because institutions which do not provide education about drug promotion may have tended not to respond to our questionnaire.

Pharmacy Medical Total Response rate*

Europe 22 (24%) 70 (51%) 92 (40%) 92/258 (36%)

Americas 30 (33%) 26(19%) 56 (25%) 56/119 (47%)

Western Pacific 10 (12%) 21(15%) 31 (14%) 31/68 (46%)

Africa 12 (13%) 9 (6%) 20 (9%) 20/43 (47%)

South‐East Asia 9 (10%) 11 (8%) 20 (9%) 20/41 (49%)

Eastern Mediterranean 8 (9%) 1 (1%) 9 (4%) 9/35 (26%

Total 91 (100%) 137 (100%) 228 (100%) 228/564 (40%)

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Table 2: Educational activities*

Pharmacy n=91

Medical n=137

Combined n=228 Part of the required curriculum 64 (70%) 101 (74%) 165 (72%) Included within an elective course 29 (32%) 32 (23%) 61 (27%) Within specialty/residency training 21 (23%) 38 (28%) 59 (26%)

In other ways 44 (48%) 63 (46%) 107 (47%)

How many types of courses were listed?

One 37 (41%) 71 (52%) 108 (47%)

Two 42 (46%) 38 (28%) 80 (35%)

Three or four 12 (13%) 28 (20%) 40 (18%)

*Note: for list of names of courses and types of specialties, see page 44

Table 2a: Educational activities by region

Europe (n=92)

Americas (n=56)

W Pacific (n=31)

Africa (n=20)

SE Asia (n=20)

E Mediterr (n=9) Part of required curriculum 69 (75%) 36 (64%) 25 (81%) 17 (85%) 13 (65%) 5 (56%) In elective course 26 (28%) 21 (38%) 5 (16%) 2 (10%) 4 (20%) 3 (33%) Specialty/residency training 25 (27%) 14 (25%) 4 (13%) 6 (30%) 6 (30%) 4 (44%) In other ways 37 (40%) 32 (57%) 13 (42%) 10 (50%) 12 (60%) 3 (33%) How many types of courses were listed?

One 45 (49%) 22 (39%) 19 (61%) 8 (40%) 10 (50%) 4 (44%)

Two 32 (35%) 22 (39%) 8 (26%) 9 (45%) 5 (25%) 4 (44%)

Three or four 15 (16%) 12 (21%) 4 (13%) 3 (15%) 5 (25%) 1 (11%)

Amount of education

Table 3 describes the amount of time spent in education on drug promotion. Nearly one‐

third of medical faculty respondents reported only 1 to 2 hours spent on drug promotion within the required curriculum. When promotion was covered within electives, usually a minority of students took the elective. The proportion did not differ between medical and pharmacy faculties.

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Table 3: How many hours are spent educating students about drug promotion?

Within the required curriculum

Medical n=137

Combined n=228

1 to 2 hours 16 (18%) 43 (31%) 59 (26%)

3 to 7 hours 31 (34%) 48 (35%) 79 (35%)

8 or more hours 18 (20%) 11 (8%) 29 (13%)

Promotion not included in required curriculum 26 (29%) 35 (26%) 61 (27%)

Within elective courses Pharmacy

n=29

Medical n=32

1 to 2 hours 7 (24%) 13 (41%) 20 (33%)

3 to 7 hours 14 (48%) 11 (34%) 25 (41%)

8 or more hours 8 (28%) 8 (25%) 16 (26%)

Elective is the only form of instruction mentioned 6 (21%) 6 (19%) 12 (20%) How many students take this elective?

Less than 10% 10 (34%) 11 (34%) 21 (34%)

10‐25% 10 (34%) 8 (25%) 18 (30%)

26‐50% 5 (17%) 5 (16%) 10 (16%)

More than 50% 3 (10%) 8 (25%) 11 (18%)

In specialty/ residency training Pharmacy

(n=21)

Medical (n=38)

Combined (n=59)

1 to 2 hours 3 (14%) 16 (42%) 19 (32%)

3 to 7 hours 10 (48%) 16 (42%) 26 (44%)

8 or more hours 8 (38%) 6 (16%) 14 (24%)

Specialty/residency training is the only form of instruction mentioned 2 (10%) 4 (10%) 6 (10%)

In other ways Pharmacy

(n=44)

Medical (n=63)

Combined (n=107)

1 to 2 hours 13 (29%) 29 (46%) 42 (39%)

3 to 7 hours 16 (36%) 19 (30%) 35 (33%)

8 or more hours 11 (25%) 8 (13%) 19 (18%)

‘Other’ is the only form of instruction mentioned 8 (18%) 15 (23%) 23 (21%)

Total reported time spent in education about drug promotion, from all types of courses combined, varied from 1 to 2 hours to over 40 hours. To facilitate analysis, total educational time was categorized into terciles. The lower third consisted of people reporting one half day or less of education about promotion in total; the middle third 4 to 9 hours; and the upper third of those reporting more than 10 hours of education. As shown in Table 3a below, nearly twice as many medical as pharmacy respondents reported educational time in total of one half day or less. There was little difference by region in the breakdown of time allocation.

Table 3a: Total time in education about drug promotion– all types of courses

Educational time by health profession

Medical n=137*

One half day or less 18 (20%) 51 (37%) 69 (30%)

> 4 and < 9 hours 23 (25%) 43 (31%) 66 (29%)

10 or more hours 50 (55%)** 39 (28%) 89 (39%)

* 3 responses missing on this question

**pharmacy vs. medical responses differed significantly, p<.05, chi square analysis

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Table 3b: Total educational time – by region

Educational time by region

Europe n=92*

Americas n=56*

W Pacific n=31*

Africa n=20

SE Asia n=20

E Mediterr n=9 One half day or less 28 (30%) 18 (32%) 12 (39%) 5 (25%) 4 (20%) 3 (33%)

> 4 and < 9 hours 26 (28%) 18 (32%) 8 (26%) 5 (25%) 7 (35%) 2 (22%) 10 or more hours 37 (40%) 19 (34%) 10 (32%) 10 (50%) 9 (45%) 4 (44%)

* One missing response per region

Types of promotion covered

Table 4 describes the type of promotion covered in educational initiatives, in order of frequency within the combined sample. Table 4a provides a breakdown by region. The large majority of coursework included advertisements, followed by sales representatives. In most cases pharmacy and medical faculty respondents reported that they covered similar types of content. The two exceptions were patient requests for medicines and the use of the Internet by patients: pharmacy faculties had more of an emphasis than medical faculties on these topics. This may in part reflect a much greater influence on pharmacy practice of patient‐

directed advertising for over‐the‐counter drugs.

Table 4: What types of promotion are covered in education about drug promotion?

Medical n=137

Advertisements 79 (87%) 111 (81%) 190 (83%)

Sales representatives 66 (72%) 100 (73%) 166 (73%)

Sponsored conferences and seminars 50 (55%) 88 (64%) 138 (61%)

Promotional ‘research’ 54 (59%) 81 (59%) 135 (59%)

Gifts 47 (52%) 76 (56%) 123 (54%)

Industry‐funded medical or scientific journals 47 (52%) 68 (50%) 115 (50%)

Use of ‘opinion leaders’ 41 (45%) 69 (50%) 110 (48%)

Industry‐funded research published in peer‐reviewed journals 46 (51%) 62 (45%) 108 (47%)

Free samples 48 (53%) 59 (43%) 107 (47%)

Use of the Internet for promotion* 54 (59%) 39 (29%) 93 (41%)

Patient requests for advertised drugs* 45 (50%) 45 (33%) 90 (40%)

Other 10 (11%) 16 (12%) 26 (11%)

* pharmacy and medical school responses differed significantly, p<.05, chi square analysis

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Table 4a: Types of promotion covered – by region

Europe (n=92)

Americas (n=56)

W Pacific (n=31)

Africa (n=20)

SE Asia (n=20)

E.Mediterr (n=9) Advertisements 75 (82%) 49 (88%) 26 (84%) 17 (85%) 17 (85%) 6 (67%) Sales representatives 66 (72%) 44 (79%) 23 (74%) 16 (80%) 13 (65%) 4 (44%) Free samples 32 (35%) 34 (61%) 16 (52%) 14 (70%) 8 (40%) 3 (33%) Use of ‘opinion leaders’ 45 (49%) 31 (55%) 19 (61%) 8 (40%) 6 (30%) 1 (11%) Sponsored conferences and seminars 53 (58%) 34 (61%) 23 (74%) 13 (65%) 11 (55%) 4 (44%) Promotional ‘research’ 52 (57%) 40 (71%) 19 (61%) 13 (65%) 10 (50%) 1 (11%)

Gifts 44 (48%) 35 (63%) 21 (68%) 11 (55%) 10 (50%) 2 (22%)

Patient requests for advertised drugs 25 (27%) 35 (63%) 11 (36%) 9 (45%) 6 (30%) 4 (44%) Use of the Internet for promotion 34 (37%) 24 (43%) 12 (39%) 12 (60%) 6 (30%) 5 (56%) Industry‐funded medical or scientific

journals 50 (54%) 32 (57%) 13 (42%) 8 (40%) 9 (45%) 3 (33%)

Industry‐funded research in peer‐

reviewed journals 40 (44%) 32 (57%) 17 (55%) 10 (50%) 6 (30%) 3 (33%)

Table 4b: Explanation for ‘other’

Africa

Medical Animation of continuing education (CE) lectures by experts from drug companies or importers Americas

Pharmacy Marketing techniques used to promote products Publications of the public university

Trips/vacations abroad including other entertainment activities Medical Use of patient advocacy groups

Politics and the pharmaceutical industry

Where to find unbiased (or at least less biased) information on drugs Ghostwriting, scandals, lobbying

We do NOT have a comprehensive approach to this subject Europe

Pharmacy Criteria for rational use Communication in marketing

Medical Direct‐to‐consumer advertising (DTCA)

We are teaching to chose the prescribing drugs according to evidence‐based studies in literature and to compare the prices of drugs in different and same groups

Research promotion: use of case studies such as rofecoxib (VIOXX) from arzneimitel telegramm, Washington Post, to learn about manipulation of data

Poll on actual practice/market survey ʺABC of marketing techniquesʺ

Mass media spin, contacts with political organizations, Lobbying activities

Choice of analysis method, intention‐to‐treat vs. per protocol, choice of endpoint, generalizability South‐East Asia

Pharmacy how to evaluate advertisements in patient information

Medical We just make general statements touching all the above subjects Western Pacific

Pharmacy Trade shows, direct marketing Communication in marketing Medical Encouragement of disease awareness

Expansion of disease definitions & scope to increase indications for drugs (disease ʹcreationʹ) Company sponsorship of attendance in local and international conferences

DTCA

E. Mediterranean

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Regulation and ethics of drug promotion

Three‐quarters of respondents reported that they covered the regulation and/or ethics of drug promotion, with the highest proportion of these reporting that national government regulation of promotion was covered (see Table 5). There was little coverage of international standards such as the WHO Ethical Criteria for Medicinal Drug Promotion or the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Marketing Practices.

Many countries do not have a functioning drug regulatory agency or other national private or public sector organizations responsible for overseeing drug promotion. However, companies that are members of the IFPMA, the international pharmaceutical industry association, are subject to the IFPMA Code.

Table 5a describes responses by region. Differences would be expected by region, given the differences in national approaches to regulation and/or resources available for drug regulation. It is unsurprising, for example, that fewer European respondents mentioned the IFPMA Code than respondents from Africa, as in Europe national regulations are more likely to be in place.

Table 5: Regulation and ethics of drug promotion

Medical n=137

Combined n=228 Are regulation and ethics covered? 70 (77%) 100 (73%) 170 (75%)

No response 4 (5%) 5 (4%) 9 (4%)

By region

Africa 11 (92%) 7 (88%) 18 (90%)

Western Pacific 7 (70%) 20 (95%) 27 (87%)

Americas 23 (77%) 21 (81%) 44 (79%)

South‐East Asia 7 (78%) 8 (73%) 15 (75%)

Europe 17 (77%) 45 (64%) 62 (67%)

Eastern Mediterranean 5 (63%) 0 5 (56%)

Types of regulation covered Pharmacy

n=91

Medical n=137

Combined n=228 National government regulation of promotion* 62 (68%) 66 (48%) 128 (56%) Professional codes on interactions w/ industry 52 (58%) 62 (45%) 114 (50%) Ethical issues – interactions with industry 40 (44%) 59 (43%) 99 (43%) National industry self‐regulatory codes 32 (35%) 32 (23%) 64 (28%)

WHO Ethical Criteria 20 (22%) 27 (20%) 47 (21%)

IFPMA Code of Marketing Practices 11 (12%) 7 (5%) 18 (8%)

Other 2 (2%) 10 (7%) 12 (5%)

Most responses to ‘other’ specified categories above, such as the American Medical Association code, Swedish Regulatory Committee, etc. ; one on gifts (ethical)

* pharmacy and medical school responses differed significantly, p<.05

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Table 5a: Types of regulation covered – by region

Europe (n=92)

Americas (n=56)

W. Pacific (n=31)

Africa (n=20)

SE Asia (n=20)

E. Mediterr (n=9) National government

regulation of promotion 51 (55%) 31 (55%) 19 (61%) 13 (65%) 10 (50%) 4 (44%) Professional codes on

interactions w/ industry 41 (45%) 37 (66%) 15 (48%) 12 (60%) 7 (35%) 2 (22%) Ethical issues – interactions

with industry 31 (34%) 30 (54%) 22 (71%) 11 (55%) 3 (15%) 2 (22%) Industry self‐regulatory

codes 23 (25%) 20 (36%) 11 (36%) 6 (30%) 3 (15%) 1 (11%)

WHO Ethical Criteria 12 (13%) 7 (13%) 7 (23%) 9 (45%) 10 (50%) 2 (22%) IFPMA Code of Marketing

Practices 5 (5%) 3 (5%) 3 (10%) 3 (15%) 4 (20%) 0

Educational techniques

Table 6 describes the types of educational techniques used, in order of frequency of reports.

Lectures and small group discussions in tutorials or workshops were the most frequently reported educational techniques. Similar proportions of pharmacy and medical school respondents reported using each of the listed techniques.

Table 6: Types of educational techniques

Medical n=137

Lectures 82 (90%) 110 (80%) 192 (84%)

Small group discussions in tutorial/workshop 58 (64%) 89 (65%) 147 (65%) Critical analysis of sample advertisements 42 (46%) 57 (42%) 99 (43%)

Response to case scenarios 25 (28%) 35 (26%) 60 (26%)

Role playing 13 (14%) 14 (10%) 27 (12%)

Other 11 (12%) 16 (12%) 27 (12%)

Table 6a describes the types of techniques used by total reported educational time. There were no significant differences in the proportion who reported using lectures, role playing or response to case scenarios by the amount of time allocated to educational initiatives. The proportion reporting use of small group discussions in tutorials or workshops and critical analysis of sample advertisements did differ, with less use of these techniques among those educating for one half day or less.

Table 6a: Educational techniques used – by time allocated to education about promotion

One half day or less (n=69)

Four to nine hours (n=66)

10 or more hours (n=89)

Lectures 55 (80%) 55 (83%) 78 (88%)

Small group discussions in tutorial/workshop 26 (38%) 43 (65%) 75 (84%) Critical analysis of sample advertisements 15 (22%) 33 (50%) 49 (55%)

Response to case scenarios 12 (17%) 17 (26%) 30 (34%)

Role playing 4 (6%) 12 (18%) 10 (11%)

Other 7 (10%) 8 (12%) 11 (12%)

(23)

Table 6b lists the educational techniques described other than those listed in the questionnaires.

Table 6b: If they marked "other", what did they say?

Africa

Pharmacy Attachment to a Drug Information Service in order to respond to various types of queries involving drug literature evaluation

Medical Critical analysis of materials given to health professionals by sales representatives Americas

Pharmacy Clerkship rotation for 2‐3 students a year Field or video observation

Small group discussions on experiential rotation

Written assignment necessitating research of DTCA. Students report back on pros and cons and then indicate and defend their position on the practice (referenced)

Medical Debates with pharmaceutical representatives/executives on the topics of drug promotion, and clinical research ethics/publication bias

Formal evaluation of an interaction with a sales representative in a large group format One activity involves a panel discussion with faculty and pro‐ and anti‐industry representation. Another activity drug company representatives detail a faculty member in front of students, which leads to discussion

Europe

Pharmacy Evaluations of research articles from peer‐reviewed journals Individual advice

Medical Case studies, e.g. rofecoxib, videos about pharm representatives from UK, India, Australia Problem‐based group discussions; discussions following lectures

WHO video plus exercises

South‐East Asia

Pharmacy Practice to explore some information by computer (internet)

Medical By auditing prescriptions the students can get an idea about how many drugs are prescribed as innovator brands, rather than generics

Course is problem‐based Learning course. Begins with small group discussion in response to case scenario, followed by mini lecture and Q and A from studentʹs learning objectives set during small group discussion session

Fixed learning material. Students are given ads, WHO and national ethical criteria, and the British National Formulary and asked to compare and contrast

Western Pacific Pharmacy Small group assignments and projects

Develop a set of guidelines for Australian pharmacists and their interactions with the industry during a practical session

Medical Analysing impact of funding agency or sponsoring agency or affiliation of authors especially if it involves pharmaceutical industry during critical appraisal or published literature involving drug trials

Clinical attachments

Opportunistic discussions on ward rounds and in clinics Provision of current references from literature

(24)

Involvement of pharmaceutical sales representatives

Given the importance of pharmaceutical sales representatives in terms of promotional spending, involvement of representatives in the course can help students to better understand the types of promotional techniques that are used and to respond appropriately.

Interestingly, fewer physicians than pharmacists reported use of sales representatives. The rate at which sales representatives were included in course work increased with increasing teaching time. Table 7a describes how sales representatives were involved.

Table 7: Involvement of sales representatives

Group Sales reps involved

n (%)

Entire sample (n=228) 33 (15%)

Pharmacy (n=91) 17 (20%)

Medical (n=137) 16 (12%)

Time allocated to education

Half day or less (n=69) 6 (9%)

4‐9 hours (n=66) 10 (15%)

More than 10 hours (n=89) 17 (19%)

Region

Europe (n=92) 11 (12%)

Americas (n=56) 14 (25%)

Western Pacific (n=31) 3 (10%)

South‐East Asia (n=20) 3 (15%)

Africa (n=20) 1 (5%)

E. Mediterranean (n=9) 1 (11%)

Table 7a: How are representatives involved?

Africa

Pharmacy They are brought onto campus and talk about their products and then these are evaluated by staff afterwards

Americas

Pharmacy A promotional presentation by a rep is given and then we discuss what and how they presented

Clinical education consultants discuss outcomes research Involved when conferences and seminars are organized

Not involved directly but an industry drug information pharmacist lectured about some aspects to pharmacy students

One or more guest lectures a year

Reps discuss day‐to‐day activities as well as non‐proprietary techniques used in their interactions with healthcare professionals

Reps invited to discuss role of manufacturer in providing drug information to pharmacists and physicians. Promotion is not directly addressed but some of the issues are discussed ‐ Pharmaceutical Advertising Advisory Board , Code of Manufacturing Practice.

Medical Debate format, or round‐table discussion format

Drug company reps detail a faculty member in front of students, which leads to discussion Drug Fair ‐ organized meeting with sales reps

We have pharmacists play the role of sales reps Panel discussion

They participate in a process in which we formally evaluate them

Educational initiatives for medical and pharmacy students about drug promotion: