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Medical Education Nash-Wong. Last year’s predictions on regulatory changes had us believing medical education was a thing of the past. Not so, if one considers the fact that physicians continue to attend educational meetings, despite limited food budgets and a ban on spouses. So rather than forecasting what will change this year, I’ll predict an area of acceptance: patient-support programs, a “regulatory safe haven.” Encouraged by the FDA, HIPAA-friendly with the proper opt-in, and embraced by managed care and employer customers, true patient-focused (not product-focused) disease self-management programs can increase customer retention for a brand and, at the same time, improve patient satisfaction with a product. Such disease self-management programs will come into their own in 2005. Boily. One of the outcomes of these various guidelines has been an effect on the variety of promotional elements used by the industry. One of the more successful elements has been the use of medical education to provide valuable disease and drug information to physicians. The FDA guidelines and the recently adopted ACCME (Accreditation Council for Continuing Medical Education Standards for Commercial Support) guidelines have resulted in varied interpretations by all concerned parties. This has resulted in a significant retrenchment of medical education in 2004. Yet, physicians require scientific information that is objective and balanced. The question that remains is: to what extent will marketing and medical affairs use CME in 2005? Hamelin. One of the biggest changes right now relates to the entire field of publishing clinical-trial results. Historically, the industry has tried to do a good job of getting results published in leading journals that undergo a peer-review process, which is very healthy for the publications. Unfortunately, many of the best journals do not like to publish clinical-trial studies and results so companies end up publishing results in lesser read, not necessarily peer-reviewed journals. I find it very interesting that publications have been pushing for all clinical trials to be published in the best, peer-reviewed journals, but in my experience these same publications are rejecting many studies that are submitted. The whole arena of medical publications will be an interesting and controversial area in the coming years. This will have a huge impact, causing changes in marketing practices across the industry. What’s Your Opinion? 2005 — A look ahead What are the most significant business challenges you believe the industry will face in 2005? Medical education As an owner of an organization involved in education in the pharmaceutical industry, I believe that one the most significant business challenges in 2005 will be creating the level of educational programs required for medical professionals given the current regulatory climate. Misinterpretation of guidelines and an overriding fear of potential consequences are causing key physician educators to be removed from the learning process. Therefore, the necessary knowledge transfer is less effective. As an industry that depends on the creation and propagation of high-level clinical information, we need to come to grips with the regulations and apply them in a manner that fosters a meaningful educational environment. Pete Sandford Executive VP NXLevel Thomas Kempisty HealthEd Finding ways to integrate and leverage evidence-based education that helps patients overcome barriers to assessment, diagnosis, treatment, and adherence — and deliver this behavior-changing content through traditional marketing channels — represents the next true frontier. Choosing Educational Partners: Keys to Successful CME Collaboration Selection Criteria for CME Providers in Assessing Potential Supporters Operations Administration • Medical Education Department n Where it resides within the corporate organizational structure • Independent • Medical Affairs • Other • Organizational structure of unit (Director, Assistant, Manager) n Designated individual at a senior level position, or an executive committee accountable for overseeing Med Ed unit’s compliance with guidelines n Numbers of medical education personnel in unit and educational background n Responsibilities assigned by product/therapeutic category n Primary point of contact to enhance efficiencies Financial • Identification of where med ed funding originates and where grants are sourced • Person(s) responsible for budget allocation and grant review and disbursement Compliance Program • Med ed relationship to other departments/units in company • Corporate CME guidelines and processes communicated to other internal units • Role of regulatory or legal in overseeing CME activities and who is responsible for the ultimate approval, i.e., “sign-off” • Compliance officer who oversees CME compliance • Historical perspective re: regulatory breaches/warnings • Published procedures to address warnings • SOPs established for commercial support • Use of a referral list for CME providers versus a preferred vendor list Professionalism • Service to the CME community • Active participation in relevant organizations (ACME/PACME, PhRMA, others) • Employees holding leadership positions in service organizations educational framework Knowledge Base & Core Competencies • Preparation of strategic educational plans and participation in long-range plans for respective franchises • Documented understanding of adult learning principles and application to CME • Ongoing training programs for med ed personnel • Med ed personnel clearly make the distinction between education and promotion and demonstrate that understanding • Company-specific SOPs regarding interaction with providers; evidence of transparent collaboration • Types and numbers of programs supported • SOPs in place re: grantor review to accommodate timelines CME Process • CME provider: collaborator vs. vendor relationship Patient-care focused Learner focused Grant process • Grant process review done electronically, via phone, hard copy, etc. • If electronic, a grant process liaison is assigned to address inquiries • Procedures and guidelines for med-ed unit input into CME • Procedures that govern interface between marketing, med-ed unit and CME provider: published SOPs • Procedures result in complete internal and external transparency Assessment of learning and behavioral change • Appreciation that the support of an outcomes strategy creates regulatory transparency • Demonstrated ability to support programs that generate outcomes data • Interest in support of educational interventions that: Use proven methods to measure knowledge gained, application of knowledge to practice and behavioral change Differentiate change in physician behavior and patient outcomes (patient component beyond provider and/or physician control) Differentiate intent to change and resulting barriers to change • Support of practical and cost-effective means to assess outcomes Support an integrated educational strategy that includes measurement of outcomes Selection Criteria for Grantors in Assessing Potential Providers Operations Administration • Corporate, staffing, and organizational structure (parent organization; marketing/advertising separate from education) • Number, credentials, and specialty of personnel (i.e., editorial capabilities, project management skills, CME expertise, etc.) • Demonstrated expertise in therapeutic area(s) of interest • Demonstrated ability to collaborate with multiple stakeholders • Demonstrated ability to meet or beat established deadlines Financial • Operational capabilities including the level of documentation and support the company deems necessary to evaluate and substantiate expenses associated with an educational activity (therapeutic/clinical issues, etc.) Compliance Program • Appropriate written policies and procedures concerning specific risk areas including: Firewall structure and integrity Policies to ensure that industry directs personnel to CME provider for the provision of the following: fees, travel reimbursement policy, conflicts of interest, etc. Appropriate communication and responsiveness A means of handling incoming communications including appropriate channels of communication for employee and customer complaints A system to monitor and periodically assess the CME provider’s systems for compliance • Appropriate procedures to manage corrective action • Appropriate policies describing disciplinary actions that can arise from breach of the CME provider’s compliance requirements • Mechanism for resolving conflict of interest issues Professionalism • Service to the CME community • Active participation in relevant organizations (ACME/MECCA, NAAMECC, etc.) • Employees holding leadership positions in service organizations; ACCME site surveyors, etc. educational framework Adult Learning Principles • Application of adult learning principles throughout the educational design process based on education and/or training • Examples of application: small group discussion, audience response systems, learning over time methods, reinforced learning; question and answer Accreditation • Current accreditation status; number and type of accreditations held from various agencies • The results of recent assessments and a review of past and pending complaints received by the CME provider (provider could submit last letter of ACCME accreditation as evidence) • If not accredited, can provide a list of which providers are partners • Demonstrated ability to partner with other providers; track record of collaboration Educational Design • Input into planning should reflect a shared function of inter-divisional stakeholders who address the following questions from their individual perspectives: Procedures result in complete internal and external transparency Identification of unmet medical needs Existence of clinical data to satisfy those needs Identification of learning objectives required for understanding and to improve delivery of care Identification of target audiences: clinical, patient, etc. Methods to communicate the educational learning objectives by type of audience Definition of success Identification of remaining educational gaps post activity Assessment of learning and behavioral change • Appreciation that the inclusion of an outcomes strategy creates regulatory transparency • Demonstrated ability to generate outcomes data • Proven methods to measure knowledge gained, application of knowledge to practice and behavioral change Differentiation of change in physician behavior and patient outcomes (patient component beyond provider and/or physician control) Differentiation of intent to change and resulting barriers to change • Practical and cost-effective means to measure outcomes Integrated educational strategy that includes measurement of outcomes