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Meeting Information


February 26, 2013



Call in Number

USA +1-203-418-3123



Attending: Francis Kwakwa, Chair; Tony D’Ambrosio, Doris Auth, Pamela Ball, Jennifer Baumgartner, Mark Baczkowski, Jemma Contreras, Stephanie Cordato, Lisa Fennell, Brad Hill, Joanna Krause, Adam Martin, Tom McKeithen, Sue McGuinness, Andy Rabin, Nikki Reyes, Marissa Seligman, Valerie Smothers, Lorraine Spencer, and Brian Sullivan, John Sweeney, Julie White.

Agenda Items

  1. Review minutes of last meeting

The minutes were submitted as approved. Francis mentioned that Linda requested the change to minutes making it clear that the accreditors recommended working with MedBiquitous.  That change has been made.

    2.   Discuss poll results and analysis regarding total respondents

Francis reviewed question number one, Please indicate how you feel CE providers should collect practice type data from learners. 84.6% responded “ask learners to select the choice that best describes their practice (one response).”  15.4% selected “ ask learners to select all that apply (multiple responses).”  Two comments were received.

Julie asked whether practice type pertained only to physicians.  Valerie commented that she didn’t think we distinguished between different health professions, but it would not apply to some.  Julie stated it wouldn’t apply to pharmacist and she asked in terms of reporting data, is that important to agree on who we’re asking that question to.  Francis asked if Not Applicable was an option.  Valerie suggested revising the implementation guidelines to specify which professions practice type applies to. The group agreed that practice type applies to the following professions:

  • Physicians
  • Advanced practice nurses
  • Dentists
  • Physician Assistants

Doris commented that a dentist could be a TMJ specialist, and see themselves as pain management practitioners.  Julie asked if the question was required.  Valerie answered it is not required but is encouraged. The FDA is interested in knowing whether primary care, non pain specialist or pain specialists are participating.  Andy asked if the term primary care confuses things.  Valerie commented that the FDA wants to know if the education is reaching the audience it is intended to reach, and one audience identified is primary care physicians.  Doris stated that was accurate. She added that FDA is, interested in other professions such as oral surgeons and general dentistry.  Jennifer Baumgartner commented that the vocabulary wasn’t applicable to pharmacists.

Francis asked if this would be self reported.  Valerie answered yes.  Francis asked who would see this question.  Julie stated the preference would be to have the four groups that it would apply to see the question; the other three groups would not see the question.  Valerie noted in an electronic system you can make that happen, on paper you can skip to question five.  Andy commented it seemed more convenient just to add not applicable.  Francis and Pam agreed. Julie asked if we all need to do it exactly the same way.  Valerie noted that would be helpful.  If the learner has not applicable as an option; physicians might say none of it applies to me.  Then you miss the data you are trying to get to. 

Francis asked if this is a required item that they must respond to, if we leave NA out and nothing applies, will they leave it open and not respond?  Or will they need to pick one of them.  Julie commented they are forcing people to answer that question right now.  Francis asked if we leave out NA, what do people who are not applicable do.  Valerie answered they select the answer that best fits.  Julie shared presumably the non specialist. Francis commented if we add N/A we will get a true not applicable.  Valerie mentioned that could have unintended consequences of not getting the data you want.  Julie felt an individual would be one of those three categories.  Every physician would see themselves in one of those three categories: primary care, pain specialist or non-pain specialist. Lorraine agreed the majority of physicians would put NA it is a useless category in terms of who is taking the courses.  Tom commented it would not apply to a hospital- based pharmacist that specialize in pain care.  Linda asked about adding additional description to the survey; if you are dentist please identify yourself as this or that.  Valerie noted definitions could be used in the survey. She added that practice type doesn’t really target dentists and pharmacists.  That is the we are having a discussion on professions that aren’t even presented with this question. 

Jennifer commented that if the goal is getting prescriber information, there are very few pharmacists who are prescribers, maybe a handful.  Julie agreed.  There is a core group the FDA is interested in: doctors, dentists, NP’s and PA prescribers.  Andy asked if it’s all going to be electronic.  Julie commented we could report them as N/A, but only if we add N/A to the vocabulary. Lorraine thought that could be problematic and Valerie agreed.  There would be a way to address that in a paper form.  Francis asked about the pharmacist that is a true pain specialist. Where does that person fall?  Jennifer replied that she was not certain there are any pharmacists with DEA licenses for these drugs.  Valerie noted everyone could select the choice that best describes their practice with the following guidelines: one response per learner and only presenting to physician, advanced practice nurses and physician assistants.

Lorraine asked if prescribers successfully completing are providing practice type data.  Is it required or optional?  valerie replied it is strongly encouraged but optional.  Lorraine commented that if it doesn’t apply to all prescribers then it can’t be required.  Jennifer gave an example of having 20 hospital pharmacists more likely to self- identify themselves.  The majority are not prescribers.  Lorraine commented it wouldn’t be applicable to pharmacists, they wouldn’t see the questions. 

Valerie clarified that, based on the REMS, prescribers successfully completing by practice type is strongly encouraged but not required.  Julie’s preference was to require learners from relevant professions (physicians, advanced practice nurses, physician assistants, and dentists) to answer the question; others do not even see the question. 

DECISION:   Practice type applies only to Physicians, Advanced practice nurses, Dentists, and Physician Assistants. Primary care, Pain specialist, and Non-pain specialist are the choices under practice type.

2)     Please indicate whether or not MedBiquitous should add an attribute for the number of respondents responding to specific questions (including but not limited to practice type and profession). 

Valerie reviewed the responses, 38% answered yes, 30% said no and 30% had no opinion.  There were two comments, one questioning the need and the other pointing out that it doubles the number of data points. Francis commented that from a research point of view, each provider is reporting the number of attendees, the percentage of respondents could be determined. Francis commented that based on the survey results, we will leave it out for now. he asked the group to send Valerie any follow up responses in the next few days.

3)     Do you agree with the following change to the definition of ClassificationRelation (new text in red) ClassificationRelation describes whether the activity’s post-course assessment addressed the regulation component or whether the activity’s instruction addresses the regulation component. , 84% agreed with adding the words post course. Linda pointed out the REMS does use the term post course, best that is keeping with language used in REMS.

4)     What is your opinion on including a provider identifier for the CE activity in the REMS CE dataset? Such identifier could help prevent double counting of activities.  84% supported including an optional provider-supplied activity identifier. The comments related to whether the identifier should be optional or mandatory.  Valerie questioned whether accreditors can support collecting a provider supplied identifier.  Pam asked if such an identifier would lead to an activity being double counted.  Valerie clarified if you had a provider identifier for their activity, it would help to prevent double counting.  

Valerie agreed to make changes to the implementation guidelines and make other changes discussed on today’s call. 

 5)    Discuss updates to implementation guidelines

 6)    Open discussion


  • Practice type applies only to Physicians, Advanced practice nurses, Dentists, and Physician Assistants. Primary care, Pain specialist, and Non-pain specialist are the choices under practice type.
  • An attribute for the number of respondents is unnecessary
  • We will add the words post-course to the definition of ClassificationRelation.
  • We will add information in including an optional provider-supplied identifier.

Action Items

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