In 1999, the Australian Government provided financial incentives for the uptake of computers by Australian general practitioners. This was followed by an increased proportion of GPs writing prescriptions with the aid of a computer, from around 50% in 1999 to more than 90% in 2004.1 One prescribing software package (Medical Director) achieved market dominance; it is the only Australian prescribing software containing pharmaceutical advertisements.
Medicines Australia’s Code of Conduct sets standards for the ethical marketing and promotion of prescription pharmaceutical products in Australia.2 Compliance with the Code is the responsibility of the pharmaceutical companies, not the software company. We aimed to assess the location, frequency and type of advertisements for prescription pharmaceuticals appearing in Medical Director, and their compliance with the relevant sections of the Medicines Australia Code of Conduct and associated guidelines.2,3 In addition, views on this topic posted to the General Practice Computer Group email discussion list (GPCG_talk)4 were thematically analysed. The GPCG is the peak body for general practice computing, established in 1997, funded by the Australian Government Department of Health and Ageing, auspiced by the Australian Medical Association until 2001, and then by the Royal Australian College of General Practitioners.
Advertisements were found in 24 clinical functions of Medical Director (Box 1). Some advertisements appeared randomly, while others were targeted toward the particular clinical function in use.
The generic name was judged illegible by one or more reviewers in 44 of 79 (56%) advertisements, representing a potential breach of Section 3.10.6 of the Code (Box 2). Some animated advertisements were also adjudicated to be in potential breach of Section 3.10.7 (Box 2). Sixty advertisements made a promotional claim, including 41 (69%) of the banner advertisements and 19 (95%) of the large advertisements. If a claim is made, the Code requires additional information to be present. Fifty-seven (95%) advertisements appeared noncompliant with one or more of these requirements (Box 3).
Most promotional claims included broad slogans such as “Your first choice CCB”, “Power Plus”, “Power you can trust”, “You can’t keep a good woman down”. We did not systematically assess the accuracy of all claims. However, certain claims (Box 4 and Box 5) appeared to be in breach of Section 1.3 (Box 2). In addition, advertisements positioned in clinical functions designed to be shared with patients appeared to be in potential breach of Section 3.10.10 (Box 2).
The topic of “Ads in EHR software” on GPCG_talk attracted 29 contributors, primarily GPs, who posted 174 emails on this topic over 4 weeks. Initial coding of the debate indicated that, with one exception, there was little support for advertisements in clinical software. However, some contributors were worried that legislative measures to remove pharmaceutical promotion from prescribing software would increase its price. Others noted that software with equivalent functionality is available at a similar cost but, in the absence of standards for electronic health records, it is not easy to change software. There was support for balancing the selective information provided by promotional material with more objective sources of therapeutic information such as Therapeutic guidelines12 and the Australian medicines handbook13 and the Australian adverse drug reactions bulletin.14
Subsequently, more detailed analysis revealed five major themes (Box 6). Views were expressed in support of both sides of each of these themes.
Our analysis of pharmaceutical advertisements in prescribing software raised a number of methodological issues. Assessment of legibility proved problematic, as reviewers of differing age and visual acuity varied in their assessment. Nevertheless, all agreed that up to half the advertisements had illegible generic names. The Code states that information in advertisements should be legible, but provides no legibility criteria for electronic media. Like others, we believe that the generic name (and other important information) should be reproduced at the same size, font, colour and background as the brand name in all advertisements, labelling, product and consumer information.15,16
Lack of appropriate PBS listing information was a particular concern, as Medicines Australia and its member companies agreed to implement an initiative in the 2002 federal budget that all pharmaceutical promotional items would include detailed PBS information.3
Although direct-to-consumer advertising of prescription pharmaceuticals to consumers is prohibited in the Therapeutic Goods Act 1989 (Cwlth), the Code appears to condone it in Section 3.10.10 (Box 2). Many clinical functions in Medical Director, if shared and discussed with patients, are likely to assist them. However, most of these functions contain advertisements for prescription pharmaceuticals.
Given the array of problems we found, it seems that many pharmaceutical companies may not be providing advertisements in compliance with the Code, despite the efforts of Medicines Australia. In addition, finalised Code complaints show that some companies have been associated with repeated code breaches over several years, despite the sanctions applied by Medicines Australia.17-19 This failure of the self-regulatory process has important public health implications. Pharmaceutical promotion has been shown to influence physicians’ prescribing20 and to result in PBS cost blowouts due to prescribing of more expensive drugs.21 Pharmaceutical promotion in prescribing software, occurring at the time of physician–patient decision-making, may be more powerful than promotion in medical journals, gimmicks and give-aways.
Similar concerns about pharmaceutical promotion in prescribing software were posted to the GPCG_talk discussion forum. Those who contribute opinions to the GPCG_talk forum are a self-selected group of computer enthusiasts who are not shy of engaging in an often robust exchange of views; although they are unlikely to be representative of all GPs, their opinions are of value. The Australian Consumers’ Association (ACA) has also conducted an online poll of consumers on this subject, and this revealed a high level of disquiet.22 The ACA poll can be criticised for asking leading questions and being subject to manipulation by people voting more than once. Regardless, both GPCG_talk and the ACA poll show that we are not the only ones perturbed by pharmaceutical promotion in prescribing software.
Our concern is not just the apparent violations and Code inconsistencies, although we hope that Medicines Australia will address these issues. We are also concerned that an industry that spends 2–3 times as much money on marketing as on research and development23 distorts the information flow to health professionals and consumers, creating unhealthy and expensive prescribing habits as well as consumer expectations of a “pill for every ill”.24 A Dutch study concluded that, on balance, pharmaceutical marketing is welfare-negative because it results in doctors prescribing more expensive drugs.25 Just as public health campaigns have progressively reduced promotional avenues for the tobacco and alcohol industries, we believe the same should happen with pharmaceutical promotion — drug advertisements in clinical software are a good place to start. Without such action, the current unsustainable growth of PBS costs is unlikely to moderate.
1 Clinical functions accompanied by advertisements
Program installation
Prescribing, including select drug by class, dose calculator, print prescription
Physical activity prescription
Record blood pressure
Cardiovascular risk calculator
Record height/weight/waist circumference
Record blood glucose
Record INR (international normalised ratio)
Calculate respiratory function
Gestation calculator
Mental state examination
Renal function calculator
Travel medicine
Pathology ordering
Medical imaging ordering
Antibiogram
Depression recovery scale
Asthma action plan
Care plan
Diabetic record
Pain assessment
Drug resource lookup; ie, MDRef (drug list), MIMS PI (drug information), MIMS CMI (consumer medicine information)
Patient education material
Medication/diagnosis suggests cardiac problems
2 Extracts from the Medicines Australia Code of Conduct2
1.3 False or misleading claims
3.10 Advertising in electronic prescribing software packages
4 Examples of potential breaches of Section 1.3 of the Medicines Australia Code of Conduct (false or misleading claims)
Avandia is well tolerated with no clinically relevant drug interactions |
|||||||||||||||
A large body of evidence showing no significant increase in cardiovascular risk |
|||||||||||||||
6 Representative comments from the GPCG_talk electronic discussion forum, grouped into themes
Received 12 April 2005, accepted 21 June 2005
- Ken J Harvey1
- Agnes I Vitry2
- Elizabeth Roughead3
- Rosalie Aroni4
- Nicola Ballenden5
- Ralph Faggotter6
- 1 School of Public Health, La Trobe University, Bundoora, VIC.
- 2 School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA.
- 3 Monash Institute of Health Services Research, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, VIC.
- 4 Australian Consumers’ Association, Marrickville, NSW.
- 5 Kings Park, SA.
Heather Jones and Deborah Monk from Medicines Australia provided helpful information on regulatory matters. Contributors to the General Practice Computer Group Talk (GPCG_talk) email discussion forum provided vigorous and thoughtful opinions on the topic. In particular, we thank Dr Andrew Magennis, Medical Director, Health Communication Network (HCN) for responding to the debate and making a copy of HCN’s prescribing software (Medical Director) available for evaluation.
K J H, A I V and R F are members of Healthy Skepticism (www.healthyskepticism.org), an organisation that aims to improve health by reducing harm from misleading drug promotion. K J H has had a long relationship with Therapeutic Guidelines Limited as author, Chairman of the Antibiotic Writing Committee and Board Member. He was also a member of a World Health Organization Expert Working Party that devised WHO Ethical Criteria for Medicinal Drug Promotion. A I V is a Consultant Editor at the Australian Medicines Handbook. E R is a Board Member of Therapeutic Guidelines Limited and a subscriber to Healthy Skepticism.
- 1. General Practice Computing Group. PIP (Practice Incentives Program). February 2004 update. Available at: http://www.gpcg.org/topics/pip.html (accessed May 2005).
- 2. Medicines Australia. Code of Conduct. Edition 14. Canberra: Medicines Australia Inc, 2003. Available at: http://www.medicinesaustralia.com.au/html/coc_full.asp (accessed May 2005)
- 3. Medicines Australia. Code of Conduct. Edition 14 Guidelines. Version 3. Canberra: Medicines Australia Inc, 2004. Available at: http://www.medicinesaustralia.com.au/html/coc_full.asp (accessed May 2005).
- 4. General Practice Computing Group. Listservs: GPCG_talk. Available at: http://www.gpcg.org/listservs/index.html (accessed May 2005).
- 5. De Schryver ELLM, Algra A, van Gijn J. Dipyridamole for preventing stroke and other vascular events in patients with vascular disease. Cochrane Database Syst Rev 2002; (2): CD 001820.
- 6. Hussein Z, Wentworth JM, Nanverkis AJ, et al. Effectiveness and side effects of thiazolidinediones for type 2 diabetes: real-life experience from a tertiary hospital. Med J Aust 2004; 181: 536-539. <MJA full text>
- 7. Therapeutics Goods Administration. Potential safety risks with Celebrex. Media statement. 18 December 2004. Available at: http://www.tga.gov.au/media/2004/041220_celebrex.htm (accessed Jun 2005).
- 8. Burton B. Pfizer Australia is fined for misleading promotion of celecoxib. BMJ 2005; 330: 1230.
- 9. Therapeutic guidelines: antibiotic. Version 12. Melbourne: Therapeutic Guidelines Ltd, 2003.
- 10. Therapeutic guidelines: psychotropic. Version 5. Melbourne: Therapeutic Guidelines Ltd, 2003.
- 11. Prescribing benzodiazepines . . . ongoing dilemma for the GP. NPS News 2002; No. 24. Available at: http://www.nps.org.au/resources/NPS_News/news24/news24.pdf (accessed Jun 2005).
- 12. Therapeutic guidelines. Melbourne: Therapeutic Guidelines Ltd, 2005.
- 13. Australian medicines handbook. Adelaide: Australian Medicines Handbook Pty Ltd, 2005.
- 14. Adverse Drug Reactions Advisory Committee. Australian adverse drug reactions bulletin. Canberra: Therapeutic Goods Administration, 2005. Available at: http://www.tga.gov.au/adr/aadrb.htm (accessed May 2005).
- 15. Hassali A, Stewart K. Quality use of generic medicine. Aust Prescriber 2004; 27: 80-81.
- 16. Gould-Hurst P. Quality use of generic medicine [letter]. Aust Prescriber 2005; 28: 30-31.
- 17. Medicines Australia. Code of Conduct Committee outcomes July–December 2004. Canberra: Medicines Australia Inc, 2005. Available at: http://www.medicinesaustralia.com.au/html/coc_full.asp (accessed May 2005).
- 18. Medicines Australia. Code of Conduct. Annual report 2004. Canberra: Medicines Australia Inc, 2004. Available at: http://www.medicinesaustralia.com.au/html/coc_full.asp (accessed May 2005).
- 19. Medicines Australia. Code of Conduct. Annual report 2003. Canberra: Medicines Australia Inc, 2003. Available at: http://www.medicinesaustralia.com.au/html/coc_full.asp (accessed May 2005).
- 20. Avorn J, Chen M, Hartley R. Scientific versus commercial sources of influence on the prescribing behaviour of physicians. Am J Med 1982; 3: 4-8.
- 21. Dowden J. Coax, COX and cola. Med J Aust 2003; 179: 397-398. <MJA full text>
- 22. Australian Consumers’ Association. Prescribing software (and poll). Sydney: Australian Consumers’ Association, 2005. Available at: http://www.choice.com.au/viewArticle.aspx?id=104588&catId=100386&tid=100008&p=1 (accessed May 2005).
- 23. Profiting from pain: where prescription drug dollars go. Families USA Publication No. 02-105. Washington, DC: Families USA, 2002. Available at: http://www.familiesusa.org/site/DocServer/PPreport.pdf?docID=249 (accessed May 2005).
- 24. United Kingdom House of Commons Health Committee. The influence of the pharmaceutical industry. London: Stationery Office, 2005. Available at: http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf (accessed May 2005).
- 25. de Laat E, Windmeijer F, Douven R. How does pharmaceutical marketing influence doctors’ prescribing behaviour? The Hague: CPB Netherlands Bureau for Economic Policy Analysis, 2002. Available at: http://www.cpb.nl/nl/pub/bijzonder/38 (accessed May 2005).
Abstract
Objective: To assess pharmaceutical advertisements in prescribing software, their adherence to code standards, and the opinions of general practitioners regarding the advertisements.
Design, setting and participants: Content analysis of advertisements displayed by Medical Director version 2.81 (Health Communication Network, Sydney, NSW) in early 2005; thematic analysis of a debate on this topic held on the General Practice Computer Group email forum (GPCG_talk) during December 2004.
Outcome measures: Placement, frequency and type of advertisements; their compliance with the Medicines Australia Code of Conduct, and the views of GPs.
Results: 24 clinical functions in Medical Director contained advertisements. These included 79 different advertisements for 41 prescription products marketed by 17 companies, including one generic manufacturer. 57 of 60 (95%) advertisements making a promotional claim appeared noncompliant with one or more requirements of the Code. 29 contributors, primarily GPs, posted 174 emails to GPCG_talk; there was little support for these advertisements, but some concern that the price of software would increase if they were removed.
Conclusions: We suggest that pharmaceutical promotion in prescribing software should be banned, and inclusion of independent therapeutic information be mandated.