Life Science Compliance Update

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36 posts from June 2010

June 30, 2010

AAMC-AACN Report: Lifelong Learning in Medicine and Nursing

 

In 2007, the Josiah Macy Foundation (JMF) sponsored a conference, which identified the need for improving continuing education (CE) in the health professions.  A report was then created incorporating the conferences findings, and covered issues such as:

 

-   Decreasing the focus on the didactic lecture as the primary format for CE;

-   Increasing awareness of practice-based learning;

-   Heightening attentiveness to the importance of CE as a tool to improve competency and performance in the academic health center;

-   Developing interprofessional education; and Instilling lifelong learning skills

 

The 2007 Report emphasized a more effective model of CE and increasing the linkage between CE, competency, and performance.  Unfortunately, they also made recommendations against everyone in CE who was not at the conference.  The first report also failed to address ways findings on effective CE could be implemented.

 

In finally addressing ways to implement changes to the CE system three years later, JMF’s recently released Lifelong Learning in Medicine and Nursing Final Conference Report, offers recommendations for health professionals’ CE or professional development and lifelong learning. Although the report comprehensively addresses a variety of education sources for health professionals and describes interesting ways to enhance CE, the study did not effectively address solutions to numerous obstacles, such as resource constraints, insufficient faculty numbers, inadequate financial support, and difficulty in bringing about change.

 

While some areas discuss ways to overcome these challenges, many only suggest that more research is needed before changes can be implemented, and thus do not address the feasibility of changes to CE (e.g. more time and money). 

 

Macy 2010 Report

 

In February 2009, JMF funded a jointly sponsored conference and consensus process, led by the Association of American Medical Colleges (AAMC) and the American Association of Colleges of Nursing (AACN).  The process and conference created a working group to find ways to implement changes regarding CE and began as a three-phase effort.

 

Phase 1 was a pre-conference planning phase in which a review of literature was done, white papers were created in several critical areas and an invitation was extended to key thought leaders and organizational representatives in Medicine and Nursing, subsequently known as the Expert Panel.

 

Phase 2 was an invitational conference involving these individuals, with a goal of facilitating the development of working structures and initiatives to ensure the implementation of the final report and recommendations. The specific objectives of the conference were to:

 

-   Develop recommendations arising from the White papers or other expertise;

-   Outline barriers and facilitators and next steps to the execution or implementation of these recommendations; and

-   Outline organizational and logistical frameworks to oversee their evolution, development, and assessment.

 

Phase 3 was a post-conference period devoted to expanding and consolidating the White papers and developing clear recommendations in five key areas. Individual recommendations were presented, discussed, and voted on by Expert Panel members via a final, summary webinar process. Following the teleconference and based on the consensus of the Expert Panel, a final draft report was completed.

 

In June 2009 a presentation on the initiative and recommendations was made by one of the project leads to the Federation of Associations of Schools of the Health Professions (FASHP), which includes the leadership of 14 health-professions organizations. In early August 2009, the final draft report was sent to members of an External Review Panel (not members of the Expert Panel), individuals and organizational representatives with expertise or a significant stake hold in five major areas:

 

-   Lifelong Learning;

-   Interprofessional Education (IPE);

-   Continuing Education (CE);

-   Work Place Learning; and

-   Point of Care Learning

 

With regards to these areas, the Expert Panel proposed over 30 major recommendations directed at a variety of organizational stakeholders, which placed greater emphasis on:

 

-   IPE and practice, preparation and assessment of graduates with skills that support lifelong learning;

-   Increased diversity in CE methods and self-learning opportunities;

-   Greater use of technologies to deliver evidence-based information and assess changes in practice; and

-   A focus on ways in which this vision could be applied in the workplace setting.

 

The recommendations were directed to stakeholders in three key areas:

 

-   Education: such as academic institutions, faculty members, CE providers

-   Practice: healthcare institutions/systems, insurers, granting agencies, etc; and

-   Regulatory: accrediting bodies

 

Part of these changes and recommendations occurred because of shifts in thinking about CE from recent research, such as a study that “illuminated the nature and size of the clinical care gap.” There was also a change in CE itself by augmenting didactic teaching methods with interactive and other adult-learning techniques. Additionally, JMF cited two recent systematic literature reviews of the effect of CE (at least for physicians), which confirmed that educational activities—when undertaken using interactive, multiple methods and sequencing techniques—can change provider behavior and health care outcomes while maintaining competence, knowledge, and skills.

 

Background

 

Although JMF notes a consensus about the need to re-examine how health professionals are prepared for lifelong learning, they recognize that “sizable work remains to be done by the health professions regarding the methods and formats of CE, IPE, and preparing future practitioners for meaningful lifelong learning.”  This work is needed “to address the shifts in the nation’s patient population, growing complexity in the healthcare system, and exponential growth of knowledge and advances in technology, biomedical, and related fields.”

 

This growth of knowledge has led to “the complexity of keeping up to date and the patient, family, and community dynamics that intersect with an increasingly complex healthcare system” has become difficult for doctors. “Rather than reducing these burdens and enhancing professional identity and preventing burnout, CE has frequently been viewed by practitioners as another task to accomplish within an inflexible system.” Disagreeing with these views:

 

“The Panel argued that health services research findings that suggest CE doesn’t work provides a limited perspective on the relevance and importance of CE. Further, the Panel argued that participation in CE had value in itself by ensuring that one’s practice was current, developing contacts with other health professionals, learning about the health system in which one practices, and enhancing self-efficacy. All have value beyond changes in performance or health care outcomes.”

 

As a result, they called for CE methods that embrace clinical systems, and complexity concepts using the best available evidence to demonstrate a high level of innovation, accessibility, effectiveness, timeliness, and relevance to healthcare practice and to the learner. This means emphasizing the role of CE in:

 

-   Validating individual practice and competence;

-   Engaging learners in new knowledge and skill acquisition for practice settings;

-   Reducing or closing practitioner-identified performance gaps;

-   Improving patient care outcomes;

-   Integrating knowledge, performance, competence and judgment; and

-   Generating professional satisfaction/identity to prevent or decrease burnout.

 

The JMF 2010 report also calls for a broader definition of CE regarding the type of educational/learning method or intervention, and one that does not “limit the use of the term, leading to confusion relative to credit systems, and impedes innovative thinking related to CE specificity is needed. According to the Expert Panel report, these changes are needed because several challenges and limitations to the form and structure of the current CE system.

 

First, the growing complexity in the contemporary work environment has led current, ‘traditional’ approaches to health professionals’ education to not fully develop the skills required to address the contingent nature of the work and the distributed expertise in the work place. Second, the unrelenting increase in biomedical (e.g., genomic and proteomic) information highlights the need for better information retrieval and knowledge-management skills – termed point-of-care learning. Third, limitations to the current approach to CE and the selection of learning activities with little or no objective feedback to participants contribute to variations in health care that may not reflect real gaps in care or knowledge, or practice performance.

 

Fourth, CE activities frequently do not provide information in a format that permits easy application to one’s practice, offer opportunities to practice using the new information, or receive feedback about one’s practice. Finally, despite the evidence and acknowledged potential for improving the processes and outcomes of care, there remains a generalized lack of focus on IPE learning experiences.

 

Types of Education: Changes and Challenges

 

According to the report, traditional CE generally has a positive role for physicians in acquiring knowledge, skills and attitudes, and, to a lesser extent, in affecting behavior and patient health outcomes. Such methods also “communicate new or reaffirm previous knowledge.” Despite the benefits of the current approach, the Expert Panel called for “educational activities employing a variety of educational methods, better needs assessments and design can alter clinician behavior and even health care outcomes.”

 

The panel noted several challenges however in using more interactive and learner-centered activities in planned conferences and other more interventionist approaches. For example, CE providers will have to broaden their competence in educational design, evaluation, and execution and be able to articulate the benefits of these interventions in improving healthcare outcomes. Faculty members responsible for the delivery of CE will need to develop new skills and strategies for using these learning methodologies. Finally, potential funders of such programs, such as insurers and state and other government agencies, will have to agree that activities decrease costs and increase quality, safety, and the delivery of evidence based practice.

 

Moving to IPE, the panel recommended significant interprofessional learning experiences in both the didactic and clinical components of the curriculum, and curricular experiences designed and presented collaboratively. They also emphasized using IPE to utilize newly developed and tested technologies that deliver up-to-date, evidence based information directly to health professionals in all practice settings and to document changes in practice and patient care outcomes. As a result, they called on educators, curriculum planner and others to consider and incorporate meaningful, formal and experiential, IPE in entry-level and advanced training of all health professionals.

 

The Panel also proposed that CE providers, faculty members, and certification and CE accreditation bodies should support and create strategies for meaningful, outcomes oriented IPE, and that investing in research to evaluate the efficacy of IPE and its impact on patient outcomes and the healthcare delivery system is inherent in this process. IPE recommendations would ultimately require the development of a national vehicle for fostering IPE, and an organization to implement structures and foster development of IPE initiatives

 

Challenges to the planning, implementation, and evaluation of IPE models in practice and education include several differences in the professions (e.g. history and culture, language and jargon, payment, etc.).  Within academic settings, there are more specific barriers including a lack of administrative support, financial and human resources for IPE, and time limitations.  There also remains “sizable regulatory and professional barriers to achieving full and meaningful implementation of effective IPE models.”

 

Next, the Expert Panel viewed Lifelong Learning as the "lifelong, life wide, voluntary, and self-motivated" pursuit of knowledge for either personal or professional reasons. As such, “lifelong learning enhances social inclusion, active citizenship and personal development, and it can bring personal satisfaction and even joy to learning and practice, can enhance professional identity and value, and may prevent burnout.”

 

Accordingly, the Panel recommended that all stakeholders “embrace a new construct of lifelong learning that includes the development, fostering, and testing of knowledge management and related skills.” This includes curricula that emphasize and reflect the value of lifelong learning and incorporate lifelong learning skills. They also proposed that higher education and healthcare institutions, professional organizations, and others fund and support the development and re-education of CE providers to achieve the goals of a newly envisioned, cost-effective CE system and to support effective lifelong learning across the health professions. To achieve changes in Lifelong Learning, the Panel proposed developing new business models that support learning, aligned with new CE opportunities, approaches, and methodologies.

 

Barriers to the full implementation of Lifelong Learning however, include widespread worker shortages and under-funding of CE programs within healthcare systems. Second, there exist differing mandates and priorities of healthcare authorities and professional bodies for lifelong learning, influenced by political, public, and organizational perspectives on the CE needs of healthcare professionals. A further challenge resides in the development of an integrated lifelong learning system that is closely tied to patients’ health outcomes, health system needs, and health professionals’ competencies.

 

Moreover, the panel noted insufficient financial and logistical support for lifelong learning and CE; lack of uniformity in health information technology; emphasis on hours of credit and other requirements imposed by regulators, including licensing, accrediting, and certifying bodies; the enormous size of the current CE enterprise; CE payment systems; individual practitioner inexperience with self assessment; and the lack of effective qualitative and quantitative tools to measure the impact of CE on practice.

 

The panel also made recommendations with regards to Workplace learning, which occurs in the clinical setting, and point of care learning, defined as information retrieved at the time and place of the health professional/patient visit or immediately thereafter.

 

Consequently, the panel addressed the need to modify classroom education to include interactive techniques to improve its effect in achieving performance change, even though they acknowledge “that didactic CE can increase knowledge, leading to awareness of new treatments and other findings, clearly an important objective of CE.” New techniques they recommend include:

 

-   Increasing and improving question and answer periods (e.g., by using electronic audience response methods);

-   Using case discussion methods, problem solving, and role playing;

-   Encouraging small groups to form within the context of large group sessions;

-   Brainstorming, quizzes, inviting patients to participate, among others.

-   The use of multiple media techniques (e.g., simulations, videotapes, role-playing), which may provide advantages over a single technique, since multiple exposures to a topic appear more effective than a single exposure.

 

The panel also recommended distributing at the time of the educational activity, patient education materials, flow-sheets and other checklists to serve as reminders, and links to websites and other learning resources. Other materials include email and other post-course methods to deliver to participants, materials or resources (such as printed educational materials or reminders.

 

Additional alternatives considered were using education technology such as informatics, web-based learning, and other modalities, and “the notion of ‘wrap-around’ learning, stressing that learning competency- and curriculum-based, rather than single, stand-alone activities that currently comprise much of CE.” From these ideas, the panel asserted that “alternative educational methods may be more effective in actively promoting the dissemination and possible implementation of best evidence, when compared to didactic educational strategies.”

 

Again, there were challenges to implementing such alternatives, such as the need for a reasonably extensive faculty development process. There would also be the need for modifications to the structure and planning for formal or newer methods of CE, possibly aided by changes in the credit and/or accreditation systems. Consequently, this widespread development of more complex workshops, small group and/or interactive sessions and other educational measures will require sizable structural, logistical, and financial re-thinking, aided by new business models for CE and possibly by new accreditation requirements.

 

Problems related to the business aspects of CE also exist as barriers to adopting alternative, outreach interventions because “funding sources appear to be limited when considering funding for alternative interventions.” Another problem is that “the use of alternative learning interventions is often not considered educational, thus not able to secure credit.” Alternative methods are also problematic “when not designed in a way that is sensitive to the needs and practices of the adult learner, they can suffer from a failure to engage the clinician, or to interact with him/her in a meaningful fashion, thus failing to accomplish their objectives.”

 

Conclusion

 

Before any of their proposals or recommendations can be implemented, “individual stakeholders will need to understand the literature behind the recommendations and their imperative.” While they are catching up on their reading, JMF needs to establish how they will come up with the “sizable allocation of resources, time, and energy directed towards the creation of curricula and other resources, as well as for faculty development.” Yet even before both of those needs are met, JMF wants IOM to develop a central, national entity that will provide the infrastructure for the recommendations and other initiatives.

 

Consequently, increasing awareness of the need for such support among granting agencies, hospitals and healthcare systems, and other funding bodies will not be adequate for the resources and money needed, and will not affect the time required for staff (or the additional need for staff).

 

While there is no dispute that “Lifelong learning and its partner, CE, offer not only enriching but also essential elements to healthcare reform,” implementing the broad and sweeping changes without the adequate resources, time, and energy makes the JMF 2010 report just another one for the shelves.

 

Accordingly, since “no health professional wants to deliver less than state-of-the science care, nor disappoint those entrusted to their care,” more realistic solutions are needed to address CE and lifelong learning, which contribute to improved health care quality and safety, cost effectiveness of care, and improved access. 

 

The best way to find solutions to enhance CE is by continuing the current support of CE by industry and expanding investment from the other participants in the health care system, including hospitals, government and insurance.  This can provide for reinvestment in individually focused, team and organizationally based lifelong learning and CE.  Since participation in CE “ensures that one’s practice is current, develops contacts with other health professionals, provides learning about the health system in which one practices, and enhances self-efficacy,” using industry support to maintain the current balance of CE is crucial.

 

We agree there needs to be more CME around “issues of screening, prevention, communication, teamwork related issues, and prevention medical errors.

 

There is tremendous benefit for patients who’s physicians are up to date and the health care team in engaged.

 

The reality is, with information and knowledge being continuously and constantly added, replaced, enhanced, and retro-fitted to a doctor’s expertise, as changes in technology and work processes gradually eliminate the need for skills they learned previously, CE necessitates the development of new ones.

 

Ultimately, since the future of CE seeks to close clinical care gaps by educational means, doctors and patients cannot afford losing the opportunity to gain such skills.  Keeping existing funding sources and adding to those sources will enable CE to make a meaningful difference in patients lives.

 

June 29, 2010

ACCME Adjusts Course and Provide Clarity on Industry Employees Presenting their Science

The Accreditation Council for Continuing Medical Education (ACCME) announced adjustments to their questions and answers around the standards for commercial support and how it relates to scientific presentations given by employees of pharmaceutical and device manufacturers at CME accredited educational activities.

They have issued new answers to questions posted on their website including:

What kinds of topics an industry employee can present

· Scientific discovery or the discovery process

· Reporting research results not connected to a product

· Presentations beyond the scope of the firms interest (disaster management…)

Under the following circumstances industry employees can present scientific data both orally and in writing:

· System of rigorous peer review is in place

· Mechanisms are in place to determine that the information is relevant and important to the learners  

 

Several additional factors can include:

 

· No patient care recommendations

· On the level of biology, physiology or physics and far from a product discussion

· Discussion on the discovery process

· Early research results

· The targeted audience are scientists

There has also been some confusion about the use of rooms and facilities for CME and non CME events i.e. demonstrations of medical devices, the ACCME states that the provider has the option to exclude some presentations or abstracts from their accredited program or present this content in a track that is outside of but in conjunction with accredited CME.  This option preserves the free flow of information.

According to a statement issued by Murray Kopelow, MD Chief Executive of the ACCME:

The ACCME policy in discussion is Standard 1 of the ACCME Standards for Commercial Support – and it is unchanged. Over the last 18 months, since the March 2009 addition to the ACCME’s Q&A, we have continued to provide guidance to providers on what constitutes INDEPENDENCE in CME – what meets the ACCME’s expectations for being compliant with SCS 1 of the ACCME SCS.  In our ongoing discussions with accredited providers, we have worked with them to ensure the free flow of scientific information and safeguarding independence in accredited CME activities.

We have definitely not reversed course, but continued our flow in that direction. Accredited providers want to include the reporting of science within accredited CME activities according to the controls set by our standards for commercial support and other requirements. This is a challenge. We will continue to support accredited providers in this process.

The employees of ACCME-defined commercial interests still cannot control the content of accredited CME. In the case of reporting the results of scientific research there is a way for accredited providers to maintain absolute control of the content while allowing the industry scientists to present the results.

The ACCME is focused on ensuring that accredited CME contributes to improvements in patient care and quality. The inclusion of new science in accredited CME is critically important to that process.

 

The accreditation system is based on CME that addresses professional practice gaps. Professional practice gaps go beyond patient care, they include research, executive and educational practice gaps. Providers are expanding the scope of accredited CME so that it can include helping participants improve their practice of research.

 

This process of working together with accredited providers to broaden the range of accredited CME activities has been an important affirmation of the accredited CME system. All accredited providers support our goal of independence. Independence is what distinguishes accredited CME from other information exchanges.

 

These are welcome clarifications from the ACCME.  The refined definitions are important in preserving the flow of scientific information. 

 

June 28, 2010

Massachusetts Code of Conduct: Impairs Local Biotech Industry

Earlier this month, Carey Kimmelstiel, MD, director of the adult cardiac cath lab and interventional cardiology at Tufts Medical Center, gave a presentation at the Society of Vascular Surgery (SVS) annual meeting in Boston. During his presentation, he asserted how “the proliferation of policies that have sought to distance the relationship between industry and healthcare providers could reduce medical innovations and ultimately, stunt improvements in patient care.”

In a follow up interview with Cardiovascular Business, he noted how these policies are contrary to what patients want and need because “most people operate under the assumption that an educated and informed physician provides patients with the best care, and patients benefit from innovative medications and devices.” Informing physicians and providing them with education means maintaining the relationships between industry and healthcare providers that have led to numerous achievements and better results for patients. Enacting regulations governing “what physicians do and how they do it,” with regards to the interactions of physicians with industry does not accomplish this.

Likewise, laws such as the Sunshine Act, federal and state policies, and the National Institutes of Health (NIH), which make corporate consulting almost nonexistent, do little in the way of making sure physicians remain educated for the benefit of innovative medicines and devices to treat their patients with.

For example, a law in Massachusetts enacted a gift ban, which applies to Massachusetts physicians not only when they are in the state, but also wherever they may travel to, and also placed “strict limits” on continuing medical education (CME) and academically professional presentations. Dr. Kimmelstiel noted that these regulations not only “made illegal practices that are not illegal elsewhere, but also elucidated a double standard because lawmakers are not adhering to these stipulations.” As a result, he acknowledged how “current regulations like those in Massachusetts and Minnesota, threaten the academic mission in terms of post-graduate medical practice.”

Another negative consequence from these kinds of laws in Massachusetts is that companies such as “
Pfizer pulled back grant funding for a visiting professorship program in Massachusetts.” This kind of company response is problematic because although “companies would not actually be breaking the law by continuing funding, they just don’t want to worry about compliancy issues.” That creates a huge problem for states like Massachusetts because companies “are just walking away from the state instead of having to worry about liabilities due to compliance.” As a result, jobs go elsewhere, taxes are lost, and surrounding businesses (e.g. restaurants) suffer.

This type of problem is also being seen by a “huge decline” in CME-funded meetings. Such a decrease is particularly problematic since there is very little data showing industry support can lead to bias in CME or non-CME presentations. Instead, Kimmelstiel noted a reported from the Accreditation Council in Continuing Medical Education released in June 2008, which found that there is “no empirical evidence to support or refute the hypothesis are biased, and there is limited evidence to suggest that CME activities funded by commercial interests can be effective in changing physicians’ prescribing practices.” This kind of evidence was also supported in three other studies (Cleveland Clinic, Medscape, and UCSF).

Dr. Kimmelstiel also noted the negative impact the Massachusetts law has had on “the clinical benefit that results from innovation.” For instance, he cited a Boston Business Journal article, which clearly showed that “in the year following the gift ban enactment in Massachusetts, jobs were being lost in the state, and fewer pharmaceutical companies and medical device makers are willing to host clinical trials in states with such laws.” This kind of loss is significant considering the cost and huge investment companies have to make to produce innovation.

Assessing closer the impact of the recent gift ban in the year since its enactment, a recent Massachusetts Institute of Technology thesis paper “found that 70 percent of industry respondents reported an “impaired ability to collaborate” with Massachusetts physicians and 83 percent reported a “decreased interest” with Massachusetts physicians. The results also showed that 83 percent of physicians reported an “impaired ability” to collaborate with industry to develop new devices and new technologies, and that 79 percent of physicians reported that their education had been impaired. In addition, over half of the respondents said they perceived a negative long-term impact on patient care through impaired physician education.

In the end, Dr. Kimmelstiel noted that “increasingly tight restrictions on free trade and interaction between manufacturers and prescribers will truly reduce innovation, efficiency and productivity.” At present, leaving understaffed and under resourced governmental agencies to wait years to approve drugs that sit in the “
valley of death” is unacceptable to patients and physicians.

What we need instead is for policymakers to determine “what method of innovation delivers cures to patients in a timely manner, and whether policies serve those characteristics.” Since it is clear that prohibiting interactions with industry will make delivery of new medicine and devices difficult, what we need now are policies that encourage such relationships and foster collaboration to its fullest because patients expect and deserve the most educated and informed physician for their treatment.

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