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CME opportunity

There is a place for the right form of commercial educational support

Education pinned onto a notice boardThere are few areas in commercially supported engagement facing as much controversy as the field of continuing medical education (CME). However, beyond this, it should be recognised that there is a huge demand for improved postgraduate professional development; flat healthcare budgets driven by an ageing population and continuing innovation require more effective resource allocation then ever.

Medical education is increasingly becoming a key component in managing these challenges. Pharma and device companies must still educate those who purchase and use their products. Plus, the fact that education is set to become an element of product labels in Europe must be taken into account.

The collaboration of industry with healthcare professionals has benefited patients and the healthcare system, as Prof Thomas Stossel indicated in his keynote speech entitled 'Product Industry Money in Healthcare: Sin or Salvation', presented at the 15th annual meeting of the Global Alliance for Medical Education (GAME) in Canada earlier this year. He stated that the increase of 'medicated survivors' of 100-year-olds per million population was almost in sync with the increase in industry research spending. Significantly prolonged life expectancy is the result of the progress made.

This should speak for itself, but despite such achievements, the industry relationship with healthcare professionals is increasingly challenged in public, specifically regarding medical education.

Differentiation
A more transparent, collaborative approach and better differentiation of education versus promotion is needed, based on an engaged debate about the appropriateness and value of such collaboration, driven by evidence.

Hervé Maisonneuve stated in the white paper 'Continuing Medical Education in Europe: Evolution or Revolution?', published earlier this year, that there are primarily two sides in the social network of professionals engaged in medical education:
• Pro-industry; accepting and demanding industry support, maintaining standards to avoid inappropriate influence. Usually these people have no public voice, avoiding the challenge of public debate
• Con-industry; banning any direct interference of industry with healthcare professionals. Even industry grants are considered influential. They may publicly claim industry abuses healthcare funds through aggressive marketing practices while appealing for help in public.

No doubt there are some cases of bribery and inappropriate commercial influence, as well as misuse of healthcare resources for commercial benefit. However, positioning these violations as exceptions seems to be highly unpopular. Stakeholders with a primary interest in keeping healthcare expenses flat - eventually at the expense of innovation - tend to perpetuate this image and know how to leverage the media in order to achieve their goals.

The focus needs to be on the primary goals of medical education: improving knowledge, competence and skills of healthcare professionals and respective healthcare teams. This is less a debate about CME credits and hours of attendance or how much a commercial supporter is allowed to contribute to a programme. What are required are criteria based on international best practice, ensuring quality and effectiveness as well as robust processes to assess the needs of learners and measure the outcomes achieved.

If a system does not produce the expected results, the specifications need to change. Introducing restrictions and barriers will hardly produce improvement. Criteria to assure quality and effectiveness include:
• Educational needs assessment and performance gap analysis
• Appropriate definition of learning objectives
• Interactive formats based on instructional design
• More focus on e-learning
• Learning continuum and repetition instead of single events
• Content review processes dependent on the format of education
• Ongoing evaluation of achieved objectives.

These are some of the cornerstones for evolving medical education.

National and regional policies and codes of conduct, like those of the European Federation of Pharmaceutical Industries and Associations (EFPIA), barely recognise definitions related to medical education and the differentiation of education against promotion. Usually, the focus is on the funding and logistics related to educational events. In terms of content creation, often the policies for promotional materials are applied.

In the absence of a clear understanding of professional medical education, these policies are more barriers to evolving educational standards than giving guidance to supporters and providers. To reduce the risk of increased public scrutiny, these gaps must be closed. The work initiated by the Good CME Practice (gCMEp) Group is expected to give valuable direction. [Editor's note: see the article 'Raising the Bar' for more on the gCMEp Group.]

Controls and processes eliminating inappropriate commercial influence and disguised promotion are required, undoubtedly. Inappropriate influence can be determined by the programme's scope. For example, if objectives are too narrow around a specific product, with learning objectives based on sales and marketing needs instead of performance gaps or clinical needs of the primary audience, the programme is not compliant with the goals of education.

This is where involving third parties like education providers, who have a primary interest in the quality of programmes, is valuable to ensure appropriate balance. This does not exclude a potential business benefit to a sponsor as a secondary result of a programme, but there must be a synergy between the two. However, it is important that the business interest does not become the primary objective of a programme.

The delegation of some responsibilities to third parties does not mean pharma will be completely firewalled from education, or will have to support any type of programme without any decision making rights. The risk of top heavy bureaucracy needs to be balanced with the goal of effective allocation of resources and with controls to avoid misuse.

For commercial supporters, transparent documenting of budgets spent by the provider is needed, as compliance is a key component. The evaluation of outcomes achieved is part of this transparency, though there are some limits. The evaluation of commercial criteria like changes in prescriptions or market share as a direct result of education by a sponsor is inappropriate and its existence in association with a programme classifies the activity as promotion. If such evaluation is required, the data must be kept confidential at the provider level and used internally only.

Many tasks allow close collaboration of the education provider with the sponsor's education managers to ensure effective programme deployment: this includes high-level programme planning, format decisions, targeting and methods of measurement and evaluation. Details regarding needs assessment results, content creation and review, programme faculty management and programme evaluation should be the responsibility of the provider, with limited sponsor input.

There is some controversy over whether a provider should be able to identify scientific leaders or provide scientific information. The industry's expert knowledge is highly valuable and hard to find elsewhere, but it must be ensured that this input will be provided directly by scientists and medical managers without the influence of marketing departments.

If this collaboration is well maintained, kept transparent and there are controls to avoid abuse in place, all stakeholders benefit. Another way to help ensure the appropriate relationship is maintained is through using education managers with senior level experience and specific skills related to medicine and education.

Moving budget ownership for medical education out of marketing departments, as is often done in the US, does not guarantee programmes are of higher quality or less biased. It should be accepted and acknowledged by regulators that the budgets still remain within a commercial organisation. Usually the customer and business needs driving objectives are similar across departments.

Ensuring processes and procedures are following the same rules requires internal policy definition. Again, this is a task that needs the involvement of professional educators and this role is different from managing meeting logistics. Medical educators are not only better qualified to provide input to company policies or to judge on the appropriateness of programmes; they can offer programme formats based on instructional design, inform decisions regarding programme realisation, as well as give advice on deployment and evaluation, resulting in significant efficiencies. Value capture targets can be achieved by savings via reduced expenses, elimination of inappropriate programmes and the better performance of programmes supported.

The assumption that medical education is a national activity that cannot be adapted for different regions must be addressed. The spread of disease is global. Pathophysiology is global. Many educational needs are similar around the world. There are some differences in learning and communication preferences between cultures that need to be recognised, but these are minor. If variations in national accreditation requirements are assessed at the outset, they will not be barriers to deployment.

Consonances by far outperform the dissonances. For pharma and medical education providers there is substantial potential for achieving efficiencies through international coordination and collaboration. It is not about the 'should', but about the 'how'; defining and activating the right processes. As well as eliminating redundancies, the power of exchange of best practice between countries and regions is an enormous driver for success.

In the end it is the patient who will benefit the most from evolving standards for commercially supported medical education. Furthermore, benefits achieved in terms of improved patient outcomes will have a positive impact on business performance. At present, this is an under-utilised opportunity.

The Author
Thomas Kellner
is leader global medical education at MSD in Germany. He has no interest in selling a service that is related to medical education.

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

16th December 2010

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