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Sue Pelletier MeetingsNet mad blogger, and editor of Medical Meetings magazine After spending my first 10 journalistic years mired in sewage sludge and garbage as a writer and editor of...more

Archive for October, 2006

CMMM moves forward with pilot program

The Certified Medical Meeting Manager movement took another step forward this fall in the form of a completed pilot program, according to James Montague, president and CEO of PMPN, Durham, N.C., which created the CMMM program. PMPN offers a network of independent meeting planners nationwide who serve as on-site logistics managers for medical meetings. Of the 18 PMPN planners who completed the pilot program coursework and took the test, 11 passed.


“We were really looking to get feedback on the body of knowledge we were presenting,” says Montague. Other goals included enhancing planners’ knowledge of the Pharmaceutical Research and Manufacturers of America code of ethics, the Office of Inspector General Guidance, and the other regulations, codes, and guidances that govern medical meetings of all kinds.


Of the three learning modules offered, two centered on the rules specific to medical meetings, while one dealt with meeting management and logistical issues. “If someone has a Certified Meeting Professional designation, they could opt out of [the latter] portion of it,” says Montague. The study guide includes not just information about the rules regarding medical meetings, but also why and how they are relevant to the meeting planner. “Why is it an issue if a pharmaceutical sales representative is in the room? Why is it so important that the feedback forms are sent in a timely manner? We wanted to take the guidelines and make them relevant to what are people are doing on-site.”


The fledgling CMMM program’s current goal is to be a certificate program, not an ongoing certification like the CMP, he adds. Recognizing that things can–and do–change frequently in the medical meetings industry, Montague says that the ultimate goal is to provide an ongoing certification program that has prerequisites for certification, and ongoing recertification, to ensure designees stay current.


“What we’re doing now is putting together a snapshot of where we are at this one point in time and making sure people are competent in what they need to know now,” he says. To roll it out to a broader audience–such as the 200 people who have sent PMPN requests for information about the CMMM in recent months–the company is looking for a nonprofit or accreditation organization to partner with on the project.


“We’re looking to work with bodies that are already used to accreditation and that are removed from the perception of commercial bias,” says Montague. PMPN has been criticized by some for starting the certificate program for its own commercial benefit. “We want it to be clear that this isn’t the PMPN certificate. We’re calling it what it is: A Certified Medical Meeting Manager certificate.” Working with a noncommercial partner to turn it into a full accreditation program, he believes, would make the distinction clear.

Kopelow’s Task Force presentation on the Web

The Accreditation Council for CME has put the presentation Murray Kopelow, MD, made at the National Task Force on CME Provider/Industry Collaboration available here on its Web site. While he delivered it with panache, he didn’t say much about the new criteria for ACCME accreditation that isn’t already contained in the FAQs released earlier. Still, it makes for some interesting reading.

Adult e-learning theme issues

From Anne Taylor-Vaisey:


    The journal Studies in Continuing Education has devoted two theme issues to researching in adult e-learning.

     

    July 2006

     

    November 2006


    The journal is available by subscription only.

Attendance is a bad way to measure CME effectiveness

File this one in the duh department, but I guess it does still need to be said. A new study from Cutting Edge Information finds that:


    Fewer than one quarter of pharmaceutical companies view attendance as a major concern for continuing medical education (CME) events. Only 23.5% of pharmaceutical and biotechnology companies agreed that attendance was a significant challenge for their CME department. However, attendance is the one metric that all companies track and use to make critical investment decisions for future events…


    Pharmaceutical companies must work with CME providers to develop outcomes measures that more accurately demonstrate an event’s

    effectiveness. For example, interviewed CME executives said that when considering which CME events to sponsor, they look for providers that have a solid plan in place for recruiting. Pharmaceutical companies also rely on providers to perform peer mapping and to target audition definitions up front. Simply inviting masses of people is no longer acceptable, and companies prefer their providers to be as targeted and specific as possible with their audiences.


From NEJM: Becoming a professional physician

From Anne Taylor-Vaisey:


    From the October 26 issue of the New England Journal of Medicine:

     

    Stern DT, Papadakis M. The developing physician - becoming a professional. N Engl J Med 2006; 355(17):1794-1799.

     

    Read more here

     

    Adult/Continuing Health Education Category here.

Tamar to be honored by Alliance for CME

I am so proud and happy to announce that Tamar Hosansky, editor, Medical Meetings magazine, has been selected to receive a 2007 President’s Award from the Alliance for CME, the international association of continuing medical education professionals. The award, which will be presented at the Alliance for CME’s annual conference in January 2007 in Phoenix, is in recognition of her leadership and educational contributions to the Alliance as editor of Medical Meetings.


This is so incredible—please join me in congratulating her!

Task Force Meeting: NAAMECC session

More from the NAAMECC session at the National Task Force on CME Provider/Industry Collaboration conference: There was lots of great discussion after the member and audience survey portion was done.


One audience member brought up this intriguing question: “The law and logic don’t necessarily equate sometimes. If we’re talking off-label at an oncology activity, the grantor would have to say that that is off-label and you can’t talk about it. So they’d be controlling the content. We’re supposed to do independent education. It’s clear in the ACCME Standards that it’s my concern to deal with mistakes in the content. [Letting supporters review content] puts ourselves and grantors in jeopardy.”


Lawrence Sherman, Chief Executive Officer with the Physicians Academy for Clinical and Management Excellence in New York and moderator of the discussion, asked, “Does any level of peer review coopt independence?”


Panelist Sondra Moylan, RN, President, American Academy of CME, said, “The ACCME recognizes that commercial supporters can be held accountable, so they may feel compelled to ask for review, and for the provider to let them review. However, it’s up to the provider to decide to make a change, to control the content.” It also makes a difference who is asking to do the review, and why (to check the science, or to approve the content), who the comments come back to, and who decides what to do with them. “I send it back to the faculty member and ask them to check their references. I like to involved the faculty chairperson too, and I like to go to an independent review. I don’t tell the faculty that the comment came from the commercial supporter. The idea was floated about adding another disclosure that the content was reviewed by pharma for scientific accuracy, but no one picked up and ran with it.


Someone else asked if the products of six companies were included in the content, does that mean you should let all six review, or just the commercial supporter?


Moylan said to have a policy in place and follow it: “Exceptions will get you in trouble.”


Panelist John Kamp, PhD, JD, Executive Director, Coalition Healthcare Communication, added, “I’m going to make sure every t is crossed, and I’m going to ask for a review. I wouldn’t want to deal with anyone who wouldn’t agree. I have to sign that report that goes to the OIG—I already know Jim Sheehan all too well, and I don’t want to get to know him any better.”


When asked if he would want to see all the data, or just that which is related to his company, the attorney said, “If you see an accident and stop to help, you may be liable. It’s best to drive by. But that’s a terrible way to be. I want to review everything.”


What about if the content is all off-label? “I’m not here to review on- or off-label just that it’s scientifically correct. If I ask for you to bias it in my direction, just as a test, and you do, I’ll never work with you again.” But wouldn’t that be taken as your company marketing off-label? “I’d say, ‘Jim, I did exactly what I said I’d do in our corporate integrity agreement and reviewed it for scientific accuracy.”


Lawrence wrapped up the session with a great sports analogy (and I really don’t like sports analogies, but this one was too perfect): “In baseball, the umpire makes the final call. In football, they now allow instant replay booth review. We’re moving from a baseball model to a football model. The question is: Who’s in the booth looking at the instant replay?”

Task Force Meeting: NAAMECC survey

The North American Association of Medical Education and Communication Companies held a meeting before Wednesday’s National Task Force on CME Provider/Industry Collaboration conference sessions, and it was pretty interesting.


They presented results of a member survey NAAMECC conducted recently that dealt with commercial supporter/provider relations. Forty-five percent of respondents said that they occasionally had been asked by a commercial supporter within the past year for a review of CME activity content; 9 percent said it happens often. It’s a rare occurence for 27 percent, and 18 percent said they were never asked for a review. Of those who said they were asked, 27 percent said the supporter wanted to review the content for scientific accuracy; 9 percent said they wanted a medical/legal or regulatory review. Thirty-six percent said more than one of these, while 9 percent said it varies by supporter. No one was asked for an overall content review.


It was almost an even split between those who allow a supporter to do a medical/legal or scientific review of CME materials (45 percent), and those who said it depends on the situation (55 percent). None said they allow it only if manufacturers of all related products can review materials, too, or refuse to allow it altogether.


When asked what type of supporter is generally most compliant with separating education from promotion, big pharma got more than half the vote (small pharma, biotech companies, and device companies got no votes), while 45 percent said they are all about the same. When asked who was least compliant, small pharma won with 36 percent of the vote, followed by device companies at 27 percent. Another 36 percent said they were all about the same.


When they asked the crowd in the room if they have a formal review process, more than half said no. Fifty-seven percent said that commercial supporters do request reviews, and 27 percent said the accredited provider requests a review. In joint-sponsored activities, 70 percent of the audience said that accredited providers were responsible for deciding if changes were appropriate, with 27 percent giving that responsibility to the faculty/chair, and just 3 percent to the non-accredited joint sponsor.


The next question made me wonder if reviews might not be a bad idea: When asked if a commercial supporter has found a significant error on data or other content, 32 percent said yes, while 66 percent said no and 2 percent said they didn’t allow review. As to why commercial supporters want to review data, 72 percent said it was to ensure that the content adequately reflects the best available data; 14 percent said it was to ensure the data has been adequately reviewed; and 11 percent said it was due to ignorance of independence requirements of FDA and ACCME. Only 3 percent said it was to ensure bias in favor of the grantor, which was good to hear.


What are grantors’ greatest fears? Almost a quarter of the audience thougght it was about providers not carefully following ACCME, FDA, and OIG rules; 12 percent said a lack of ability to evaluate the value of programs to the company; and 2 percent each picked bad publicity and a lack of data on advancing patient care. More than half picked the famous “all of the above.”


But, as one person said, “These questions are all irrelevant because I have no contact with the grantor. I have no idea what they’re thinking. We’re talking about collaboration here, and it would be nice to have some communication with scientific, medical, education, and legal, instead of working in a vacuum.”

Task Force Meeting: Communities of Practice synthesis

There were two sessions at the National Task Force on CME Provider/Industry Collaboration conference reserved for communities of practice (pharma, medical schools, MECCs, hospitals, societies) to get together and hash out their answers to two questions: What conflicts of interest do you face, and how did you clear them. Peter Vlasses, PharmD, Accreditation Council for Pharmacy Education, took on the unenviable slot after ACCME’s Murray Kopelow at the end of the meeting to put together what the various groups had come up with and synthesize the commonalities.


He listed the most commonly named conflicts, then had the audience vote via ARS on which are the most difficult to deal with. Company employees topped the list, followed by speakers bureaus, advisory boards/consultants/vendors, inventor/patent holders, clinical trial investigators, and stockholders.


The most common ways people deal with COI were: Peer review/approval of content/balance; require evidence-based content/references; inform about and document COI implications/risks; cancel activity/change speaker/change role; and tell speakers to refrain from making recommendations. When bias is reported, exclude that speaker from future activities.


Because the pharma group had different issues, that group was asked what emerging problems regarding collaboration between pharma and CME did they see. Their top four were: Lack of metrics, outcomes, and return on education in the proposals; weak proposals (especially in regard to needs assessment and objectives); lack of knowledge about educational design; and completeness of proposals (thoroughness, timeliness, ACCME compliance).


Some solutions the pharma group came up with to deal with these issues:


  • Develop standard definitions for metrics and outcomes. Include pharma’s expectations for outcomes on the letter of agreement.


  • Partner with the Alliance for CME to provide education about what to do to shore up weak and incomplete proposals.


  • Certify and pursue certification for expertise in adult education. CME departments should talk with graduate medical education departments to tap into expertise that’s already been developed.
  • Task Force Meeting: ACCME update

    ACCME’s Murray Kopelow, MD, took to the podium toward the end of the National Task Force on CME Provider/Industry Collaboration conference to provide an update on the implementation of the Standards for Commercial Support, and to talk a little about the new updated criteria for accreditation. Unfortunately, he only had an hour, so the talk stayed a bit on the general side.


    He started off by saying that CME is about helping doctors give the best care all the time, all over the world. “We are a strategic asset to physicians on their journey.” He walked through all the toolkits, phone support, and workshops the ACCME has provided to help CME providers come to grips with the new Standards. “It’s been two years since we introduced the new Standards for Commercial Support, and nothing bad has happened at reaccreditation. We’ve seen no surprising patterns, nothing we haven’t seen before.” He also stressed that the Standards are key to ensuring the validity of CME, and that providers now have the tools and mechanisms to resolve conflicts of interest. “As CME becomes safer for pharma, it will continue to place its money in CME,” he added. Perhaps as a hint on how to take the new criteria for accreditation, he said, “Remember the lessons of the past as we move forward.”


    He then launched into the new criteria, explaining as the background behind the decision how the maintenance of certification and the maintenance of licensure have gone toward the verification of good practice through a number of means. “CME has always been one of the mechanisms, but it can only stay so as long as it demonstrably improves patient care,” Kopelow said. “CME is going to be effective, and demonstrably effective. To that purpose, we released the new criteria…


    “We expect there will be a curve. We expect complete compliance to be a multiyear process,” he said. Some elements will be easier to do than others, he acknowledged, and some, such as the criteria related to commercial support, you’re already doing under the new Standards. “By 2012, we expect you will have the system in place to make the change.”


    To get the maximum effect for CME, he said, “we have to get out of our skins a little and get into the real-world processes. No date has been set for full compliance. We are willing to have you set the pace because how fast you move depends on the resources you have.” It’s all about closing the gap in quality, and the gap in the systems, he said. “Mind the gap.”


    One person from the pharma side, when asked by Kopelow for his response to the new criteria, said, “I’m personally optimistic that we’ll get there. I’m optimistic that we mean it and we’ll do it.”


    Another audience member asked how likely it is that any providers would be able to reach Level 3 accreditation when the first round under the new criteria begins in November 2008. Kopelow said, “We think some already meet these requirements. There are CME providers who already are linked into their larger environment. I think the only barrier to achieving Level 3 is the strategic decision to do it.”


    When asked what the gap is between where providers currently are and where they need to be, Kopelow said one main one to focus on was outcomes measurement, for which there already is a body of knowledge. The next gap, which he called “almost a political, organizational one,” is to get a seat at the quality improvement table. “If you’re not invited to a meeting, hold a meeting of your own.”


    “My concern is related to smaller providers,” said another audience member. “Are there ways to make it easier for them to get their foot in the door?” Kopelow answered that one of the reasons ACCME published the new criteria is to stay at the table with maintence of certification and licensure, and with Health Policy and Quality.

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