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Evolution of Education

Med ed agencies must meet the challenge of a changing European pharma landscape

blackboardThe pharma landscape within Europe has changed more in the past five years than ever before and agencies that support the pharma industry must evolve. According to Nick Bosanquet, Professor of Health Policy at Imperial College, London, The range of effective therapies has vastly increased over the last two decades. Now the challenge is how to get therapeutic results. For Europe the challenge is one of getting value from the vast amount of money already being spent. Pharma companies must disseminate information in a timely manner to the appropriate audiences.

Working with agencies
One way pharma companies can do this more efficiently is by working with external agencies. Choosing an agency involves assessing key elements such as: data publishing, pharmacovigilance knowledge, CME accreditation, emedia developments, KOL mapping and development techniques.

To win the confidence of clients, agencies must demonstrate an understanding of the changing regulatory, political and technological landscape within each area. The demands on medical education agencies have never been greater. The investment in medical education has escalated while advertising and PR spend has levelled off. This is because of the need to raise the scientific quotient on all product related communications in the marketplace and to examine the basis of the scientific positioning for a product in development.

Increased public and legal scrutiny of educational practices and processes have changed the landscape within which medical education agencies and pharmaceutical companies operate. The provision of an overt evidence base in all communications and information regarding products is now a requirement and a challenge to deliver when combined with the exacting time pressures to launch. The stakes are high and the consequences of failure great for agency and client alike. Success requires an effective client working relationship with an experienced agency.

Ethics of publishing data
The way pharma companies hire med ed agencies to ar range the publication of clinical trial data has been questioned in the media. The use of ghost writers in particular should concern all companies who wish to avoid negative publicity. Pharma companies and med ed agencies must adhere strictly to the various guidelines that have been developed both by journals and the various organisations that represent and advise medical writers. The Good Publication Practice (GPP) Guidelines published in 2003 outline how to avoid publication bias and ensure transparency of editorial input, sponsors and funding. Following these guidelines should ease publication and avoid bad publicity.

The guidelines show that medical writers can work with authors on the development of manuscripts, on the clear understanding that the author takes full responsibility for the paper, has had full access to all the raw data, and has shaped and directed the writing. Formal statements should be in place to record these agreements. Agencies should actively encourage all writers to keep up to date with developments in this area. Training, including seminars with leading editors, is key to being sufficiently informed to advise clients on best GPP approaches.

"Med Ed is by far the most important activity area for us in the oncology field. Clinician practice is dictated by fast moving evidence-based datasets and it is critical that timely dissemination of appropriate peer reviewed information is carried out to address this need. We adhere to strict best practice publications procedures and fully expect our agencies to do so too," said Howard Godman, Director of Marketing Excellence, Novartis Global Oncology.

The marketing of safety
Under increasing scrutiny from global regulators, pharmacovigilance "the detection, assessment, understanding and prevention of adverse events" has assumed new importance. Safety, rather than efficacy, is more likely to be the factor derailing a product during its lifecycle. Safety can also have a pivotal role in competitive positioning and marketing support companies must be able to engage with and understand pharmacovigilance output.

Risk management planning is an essential element of any new product application. The first step in modifying the behaviour of physicians and patients is to ensure they fully understand the requirements of risk minimisation. Well-informed agencies can help to ensure that marketing strategies encompass the necessary risk-benefit analysis and the risk management plan.

Agencies need to be able to advise and assist on communication of the key safety messages to healthcare professionals and patients. Equally important is monitoring of the ongoing safety profile of the product through tools such as the Period Safety Update Report (PSUR) to see if educational messages and the use of communication channels need to be reassessed. Only medical education agencies that fully understand all of these elements can help the marketer to develop a strategy to ensure the reduction in risk to the patient and the survival of the product.

E-media and Web 2.0
Clinicians have always been impatient for relevant information and over the past decade there has been a staggering increase in the communication options available via the internet. This has altered the way marketers need to think about addressing communication needs.

Over the past three years there has been a major shift in the way that the internet is being used. Termed Web 2.0, it is mainly represented by a move away from traditional static web pages towards collaborative activities, consolidation and aggregation of information, and opportunities for sharing and networking.Increasingly the internet can be seen as a medium that can 'push' information to you rather than merely a source of information that you can 'pull' from. The widespread availability of broadband means that video and audio can be delivered to users' desktops and downloaded to a portable multimedia player.

Further innovative areas include RSS news feeds, podcasts and collaborative software (e.g. Wikis, blogs and internet applications such as ('Google Docs and Spreadsheets'). These can allow worldwide, real-time and on-demand training, education, news updates and forums to be created. Most major medical journals have adopted podcasting to keeping readers informed about the content of current issues. These techniques, together with more traditional digital media or e-media approaches, should now form an integrated component of any communication portfolio. Agencies must devote time and investment to keeping up with the developments and separating the useful elements from the fads.

Whether agencies outsource or maintain an in-house e-media development team, strong processes are needed to deliver a coherent communication activity and ensure that the digital components are fully integrated into the programme.

KOL involvement
KOLs are critical to educating and preparing the marketplace for the launch and appropriate use of a product, but there has been recent concern about the extent of 'entanglement' of physicians with the pharmaceutical industry. KOLs may be involved in clinical trials, speaking engagements at congresses, satellite symposia and stand-alone meetings, and advising on product strategy and development through participation in advisory boards.

The accessibility of congress abstracts, and speaker activities via the web means that there is no excuse for KOL identification not to be based on a systematic examination of the publication record, visibility through presentations and congress activities, and status as reflected in positions such as on editorial boards and guidelines committees.Provided that data are captured within a user-friendly information system, this information can also be a valuable resource to identify and profile second-tier KOLs and 'rising stars'.

Data need to be regularly updated so currency, trends and developments can easily be tracked. Howard Godman, Director of Marketing Excellence, Novartis Global Oncology says: The national differences in industry codes and varying states and evolution of Government controls on how to engage with healthcare professionals, make such activities increasingly complex to carry out on a pan-European basis.

Face-to-face education and meetings are preferred by the medical profession yet, increasingly, companies are reviewing their physician interaction policies and there is a trend to adopt policies that restrict crossborder meetings to no more than 15 - 20 delegates. Such changes, together with increasing pressure to improve ROI, make internet-based communication activities increasingly attractive.

CME, education, promotion
Traditionally activities undertaken by med ed agencies range from publication planning and symposia to slide kits and newsletters. All have value in supporting market development and meeting medical education needs as well as encouraging close interaction with KOLs.

Some of these medical education activities qualify for formal CME accreditation. In Europe, unlike the US, there is no commonly adhered to vehicle for CME accreditation. This can be a frustration for pharma companies anxious to ensure academic independence and the validity of educational programmes. There continue to be significant differences between the US and Europe in the approach to CME and the kinds of activities that can be awarded accreditation.

There is growing use of a central agency, the European Accreditation Cou ncil for Continuing Medical Education (EACCME) but despite this, country differences make pan-European educational initiatives difficult. Inclusion of internet technologies will expand the scope of activities that can be accredited. Both the EACCME in Europe and the Royal College of Physicians in the UK are currently developing guidelines for accreditation of internet based programmes to be released during 2007.

There have been concerns expressed in the media that the boundaries between education and promotion are becoming blurred, and there are several vociferous groups mostly in the US keen to eliminate pharmaceutical sponsorship from medical education. Med ed agencies must follow the correct channels to avoid any negative publicity.

Conclusion
When choosing an agency remember that knowledge of GPP, pharmacovigilance and CME accreditation requirements are essential in creating a regulatory approved education programme. The agency also requires knowledge in KOL identification and development and the latest e-media communication vehicles to implement memorable and wide-reaching programmes tailored to both the clients' and audiences' needs.

All med ed agencies must ready themselves for change to ensure that they can navigate through the challenging landscape to work effectively with pharma companies.

The Author
Mark Forbes Irving is Managing Director for Wells Healthcare Communications

2nd May 2007

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