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Mutual benefit

Truly independent CME programmes can enhance pharma reputations and patient care

A series of figures with a question mark transposed on them, and one with 'CME' transposed on him.An increasing number of regulatory and societal bodies across Europe are placing voluntary or mandatory requirements on physicians to provide evidence of their ongoing training through various mechanisms, including attendance at continuing medical education (CME) courses. As a result, different organisations are offering to develop and implement these courses and are asking pharmaceutical organisations to support them financially.

Supporting CME programmes is often worthwhile, but the decision about whether to take part requires careful consideration.

Some of the advice provided here goes beyond what may be covered by regulatory agencies or codes of practice. However, it is built on experience in other parts of the world, notably the US, and is based upon the sound principle of maintaining a clear separation between the development of promotional materials and the support of independent education.

There is no middle ground; you cannot be a little bit independent. Any programme funded by the pharmaceutical industry that cannot be described as independent is promotional. This article implies no criticism of promotional programmes. Promotional activities clearly have their place and can be informative, useful and valuable. However, it is important to recognise that promotion and CME need to be clearly separated.

What is CME?
CME programmes cover education that is provided to the medical profession to enable physicians to maintain their knowledge of current best practice and treat their patients in the best way. A good working definition is: independently-developed education that addresses a defined medical need, is developed without bias and delivered in a transparent manner through the appropriate and independent selection of faculty and content and the declaration and resolution of potential or actual conflict of interest.

This definition highlights the key concepts of the choice of faculty and content not being influenced by supporters and any potential bias being dealt with openly. These concepts have important implications for the way programmes are developed and how potential financial supporters deal with organisations that present them with funding requests. The implications for the providers of CME programmes are also significant and affect organisational structure, sales strategy, IT structure and scientific content development strategy. It is clear that it is incumbent upon both the developer of a CME programme and the financial supporter(s) to ensure the programme is developed and implemented to the highest standards.

It is important to ascertain that the programme presented to you is independently developed and unbiased. To see why, consider the example of a CME programme that discusses a disease area for which your organisation has a drug approved. When you provide support for the programme you may know the faculty and agenda, but not the full details of what will be discussed. Within the programme, there may be legitimate and valuable discussion among members of the faculty and participants about the use of your drug at doses, or for indications, for which you do not have approval. Clearly you should not be involved in, or have influence over, the development of a programme that discusses these issues. If it is found that you have had influence over the content, then you may have broken regulatory rules, guidelines or even laws.

The following list provides some simple things to look for when considering the independence of a programme:
• Are you being presented with a well-defined programme? Are the faculty members already named and is the content already reasonably delineated? If the programme is vague, or if the organisation presenting it asks you to define it, then beware, because you are being asked to influence content. Look for a well-constructed programme that addresses a defined need
• Is the content created by people who can act independently? If the same people who develop your promotional content are involved with the content of an independent programme, you may be open to suggestions that your promotional spending influences their judgement. It is better to have people developing independent content who have not been involved in developing promotional content. Look for an organisation that is structured to protect the independent development of content and can explain its structure to you openly and clearly
• If an organisation suggests that a promotional programme can be "CME'd", alarm bells should sound. Even if it were able to gain approval from one of the accrediting bodies, the programme would potentially put you in jeopardy, as you clearly influenced the programme. Look for new programmes, not reworkings of previously developed promotional programmes
• The review processes at the accrediting bodies, such as the Royal Colleges in the UK, or the European Accreditation Council for CME (EACCME) in Europe, are thorough. Approval for one programme does not mean the next programme will be approved. Look for an organisation with an understanding of the approval process with various accrediting bodies and a track record of developing high quality programmes that are approved by a number of different accrediting bodies.

By now, you may be thinking that the support of CME programmes is challenging and potentially troublesome. It does not need to be and there are many good reasons to support good compliant CME programmes. Consider these:
• Your organisation will be seen to support education, going beyond your commercial goals. This is often in line with your organisation's goals and mission and enhances your organisation's image
• Your organisation will be associated with a high quality education programme. Not all education programmes are of a high quality. However, if you follow the guidance provided here, you are more likely to be able to discern the ones that are
• Your organisation will be supporting important education and potentially helping physicians improve patient care
• You will be recognised as an organisation that believes in helping to provide important services to the medical community, and ultimately to support improved patient care
• Depending on the type of programme, your organisation may be able to erect an exhibit stand and have company representatives attend the meeting. Important guidance is that physicians must visit the stand voluntarily, so stands cannot be placed in meeting rooms or at the entrance to meeting rooms. Often, company representatives are not allowed in the meeting room because of the nature of the content. Nevertheless, the opportunity for your organisation to have access to the audience and to be clearly seen as a supporter of education is available.

Discussion
It would be understandable if you now think you should not suggest anything or even ask too many questions of organisations that present CME programmes to you. However, there is much you can discuss and question. For example, if you are providing financial support for a programme, it is acceptable for you to insist that any internal rules or policies you might have, for example about the amount of honorarium paid to speakers or the type of venue used for a meeting, are followed. Some topics are suggested here:
• Honoraria levels. I believe that a supporter company can insist that a maximum level of honorarium is not exceeded. The developer of the programme may pay less than this, but not more. Thus, the supporter is not insisting on a level of honoraria, only setting a maximum level
• Choice of venues for meetings. The choice of venue should be secondary to the provision of education. Also, discuss the level of hospitality and whether alcohol will be provided. In my view, good education is incompatible with alcohol consumption
• How the faculty members were chosen, whether the provider organisation has asked them for declarations of conflict of interest and whether any conflicts of interest have been identified and suitable measures taken
• Which medical need, or needs, the CME programme is designed to address, and how these needs were identified
• Which accrediting body is being approached and why
• What outcomes or programme evaluation data will be provided after the educational programme is complete
• How the organisation ensures that there are no internal influences on the development of CME content. As mentioned, this is important. Expect the organisation to be able to present you with an organisational chart that describes how it manages and avoids the potential for influence on content development, as well as the rules and guidelines it provides to its staff, including a disciplinary procedure if rules are not followed, and any examples of recent programmes and how it has managed these issues.

There are several aspects of CME support that could not be covered in depth here. In particular, ways to resolve conflicts of interest, multiple supporter companies for a programme and evaluations and outcomes.

Conclusion
It is important to set high standards for the development and implementation of independent education programmes. Groups such as the Good CME Practice group are in the process of drawing up standards (see Raising the bar). It must be recognised that written standards inevitably lag behind the practice of high standards and that the standards are created to protect supporters, participants and developers. Supporters or programme developers who set standards too low are jeopardising more than their own reputations.

The support of CME programmes is worthwhile. Carefully consider the differences between CME programmes and promotional programmes. Look for well-defined, high quality, independently developed programmes from organisations that are structured for, and clearly understand the need for, independence and lack of bias.

If you achieve and maintain high standards, you will be recognised as supporting meaningful and useful education. This can only help your organisation's reputation and, of course, reputation is everything.

The Author
Chris Stevenson is VP international business at Physicians' Education Resource (PER)

To comment on this article, email pme@pmelive.com

25th May 2010

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